Mocom millenium B2 Operating Manual

Download

Quality System certified by

STEAM

STERILIZER

OPERATING MANUAL

Ed. 1 Rev. 5 Date: January 2008

TABLE OF CONTENTS

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

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

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

III

1. INTRODUCTION

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.

APPLICABLE EUROPEAN DIRECTIVES

INTENDED USE

THE MATERIAL THE STERILIZER IS COMPOSED OF MUST BE DISPOSED ACCORDING TO THE DIRECTIVE 2002/96/CEE

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

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

AND

ARE REGISTERED TRADEMARKS OF M.O.COM. SRL

SUCH INFORMATION

HIS DOCUMENT MAY NOT BE REPRODUCED, ADAPTED OR T RANSLATED, IN WHOLE OR IN

PART, WITHOUT THE PRIOR, WRITTEN AUTHORIZATION OF M.O.COM. SRL

1. INTRODUCTION

PURPOSE OF THE MANUAL

GENERAL WARNINGS

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 materia ls before and after sterilization.

Its appendices also provide: – the product's general technical specifications;

– sterilization program specifications; – maintenance; – troubleshooting; – a variety of other documentation.

When using this product, always anything other than its intended purpose.

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

– Do not – Do not – Do not

distilled water of high quality.

THE USE OF WATER OF INADEQUATE QUALITY CAN SEVERELY DAMAGE THE DEVICE. SEE APPENDIX A, TECHNICAL CHARACTERISTICS IN THIS REGARD .

pour water or other liquids on the device; pour inflammable substances on the device; use the device in the presence of gas or explosive or inflammable vapors;

follow the instructions in the manual and never use for

WARNING

– 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 – Do not – Use only

remove any label or nameplate from the device; request new ones, if necessary.

original replacement parts.

THE FAILURE TO OBSERVE THE ABOVE, RELEASES THE MANUFACTURER FROM ALL LIABILITY.

conforming to current laws and/or standards;

WARNING

2. CONTENTS OF THE PACKAGE

CONTENTS OF THE PACKAGE

DIMENSIONS AND WEIGHT

DESCRIPTION OF THE CONTENTS

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

610

690

560

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

2. CONTENTS OF THE PACKAGE

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 DURING SHIPMENT.

. THE USE OF DIFFERENT PACKAGING COULD DAMAGE THE PRODUCT

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

PRODUCT INTRODUCTION

INTRODUCTION

GENERAL CHARACTERISTICS

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.

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) use d in a medica l enviro n ment. 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.

3. PRODUCT INTRODUCTION

Millflash

interface

FRONT

LCD display and control panel

Door

On/Off switch

Service compartment access panel

Printer paper output slot

Sterilization

Door microswitch

Motorized closing system

Bacteriological filter

RS232 serial port

Built-in printer

Used water drain qu ick connector Distilled water fill quick connector

Water drain plug and filter Door

Service

3. PRODUCT INTRODUCTION

used water tank

distilled water tank

REAR

Connection for automatically filling the

Mains fuses

Power cord

Band heating element safety thermostat and manual rearm

Steam generator safety thermostat and manual rearm

Connection for directly draining the

Jack for Milldrop Start/Stop cable

Distilled water tank vent hole

Safety valve

Heat exchanger

Distilled water tank draining point (maintenance)

Jack socket for the external tank level sensor (option)

3. PRODUCT INTRODUCTION

CONTROL PANEL

LCD DISPLAY

Liquid Crystal Display (LCD)

Command keys

The function of the command keys differ according to operating mode of the equipment.

Key NORMAL mode SETUP mode

Cycle Start/Stop

Sterilization cycle selectio n

Test cycle selection

Enter Setup mode ESC, quit the current menu

Enter, confirmation of the value/option selected

Value increment / Forward scroll of the menu options

Value decrement / Backward scroll of the menu options

4 lines of 20 characters

Illuminated icon

Water level

Door status

Process status

Setup status

ALARM

3. PRODUCT INTRODUCTION

OPERATING CYCLE EXAMPLE

The Millennium B² sterilization program can be described as a succession of phases, each with a specific purpose.

For example, after loading the material in the chamber, closing the door, selecting the program and starting the cycle (and the consequent locking of the door opening mechanism), the standard program (for porous materials, 134 °C - 4’) offers the following sequence (see chart, below):

1. preheating the generator and sterilization chamber;

2. removing the air and penetration of the material by steam through a series of vacuum (extraction of the fluid from the sterilization chamber) and pressure(injection of steam into the chamber) phases;

3. raising the pressure, with the consequent increase in the temperature of the steam, until reaching the conditions required for sterilization (in the example, 134 °C);

4. stabilizing the pressure and temperature;

5. sterilizing for the required time (in the example, 4 minutes);

6. depressurizing the sterilization chamber ;

7. vacuum-drying phase;

8. ventilating the load with sterile air;

9. bringing the pressure of the sterilization chamber back to the atmospheric level.

After reaching atmospheric pressure, the door is automatically unlocked and it can be opened to remove the load from the sterilization chamber.

It should be emphasized that phases 1, 3, 4, 6 and 9 are identical in all cycles, with slight variations 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.

Pressione (bar)

2.10

2.00

1.00

0.00

-0.80

VUOTO FRAZIONATO

PROCESSO

ASCIUGATURA SOTTO VUOTO

Tempo (min)

NOTE

PLEASE REFER TO APPENDIX B (PROGRAMS) FOR MORE DETAIL.

4. INSTALLATION

660

480

420

5006705

INSTALLATION

INTRODUCTION

COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATIONS

The first and fundamental step in achieving good sterilizer operation, long life and complete use of its features is a correct, careful installation. Moreover, this precaution will avoid the danger of physical injury or property damage, not to mention malfunctions and damage to the machine. So, please follow the instructions in this chapter scrupulously

NOTE

M.O.COM. CUSTOMER SUPPORT (SEE APPENDIX Z) WILL ANSWER YOUR QUESTIONS

AND PROVIDE ADDITIONAL INFORMATION

HE 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

– Height (total) 420 mm – Width (total) 480 mm – Depth

(excluding rear connections) 660 mm

– Total weight 63 kg

Electricity

The electrical system to which the sterilizer will be connected must be suitably dimensioned based on the electrical characteristics of the device. This information is shown on the back of the machine.

When installing the sterilizer inside a cabinet, you must provide adequate space all around the device (>10cm, specially in the rear part) to provide effective ventilation as well as a large enough opening in the back that, in addition to allow the passage of the power cord will also provide an

adequate air flow and the consequent optimum cooling of the heat exchanger.

It is indispensable that the built-in compartment have the following minimum dimensions

shown in

the figure.

WARNING

COMPARTMENT DIMENSIONS LESS THAN THOSE SHOWN MAY COMPROMISE 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 MAIN SWITCH IS INACCESSIBLE WHEN INSTALLED IN THE COMPARTMENT, USE AN

ELECTRIC PLUG THAT INCORPORATES AN ON/OFF SWITCH.

O NOT REMOVE THE UPPER COVER OR ANY OTHER EXTERNAL PART. WHEN INSTALLED

IN THE COMPARTMENT

LEASE REFER TO APPENDIX A (TECHNICAL CHARACTERISTICS) FOR COMPLETE

TECHNICAL DATA

, THE DEVICE MUST BE COMPLETE WITH ALL ITS PARTS.

4. INSTALLATION

GENERAL INSTALLATION PRECAUTIONS

ELECTRICAL CONNECTIONS

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

Install the sterilizer on a flat surface an irregular surface and to slightly tilt lower the front part of the sterilizer. Make sure that the support surface is strong enough to support the device's weight (about 65 kg);

– Leave adequate space for ventilation

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

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 – Install the device so that the power cord is not

way to the socket.

– Install the device that any external fill/drain tubing is not

freely to the drain tank.

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

– Nominal current In 16 A

; if necessary, adjust the leveling feet to compensate for

(at least 10 cm on each side) all around the

contact with water or

or inflammable and/or explosive vapors;

bent or crushed. It must run freely all the

bent or crushed. They must run

CONNECTING THE DATA RECORDING MILLFLASH

– Differential current I∆n 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.

If it is necessary to replace the plug on the power cord, use one with equal characteristics or, at any rate, adequate to the device's electrical characteristics. The user is entirely responsible for the selection and replacement of the plug.

NOTE

ALWAYS CONNECT THE POWER CORD DIRECTLY TO THE SOCKET. DO NOT USE

EXTENSION CORDS

The sterilizer can be connected to MILLFLASH allowing the recording of the cycle data on .txt format file and its management by PC.

The connectors of the service box are used for interfacing; refer to MILLFLASH Operating Manual for the installation instructions.

, ADAPTERS OR OTHER ACCESSORIES.

4. INSTALLATION

CONNECTING AN EXTERNAL WATER FILLING TANK

(OPTIONAL, automatic filling function)

To avoid having to periodically fill the water tank (see Chapter 5, “First Start-Up”), it is possible to connect the sterilizer to an external filling tank (supplied as an option), that the user will periodically fill, or to a commercially-available, reverse-osmosis water purification system with accumulation tank.

In that case, when the internal water tank reaches the MIN level, the autoclave activates a pump that automatically fills the internal tank.

Follow the instructions below for the correct connection of the external tank: – Install the tap provided on the filling tank; use Teflon tape or connector sealant for a perfect

seal.

Filling tank

Clip

CONNECTING DEMINERALIZER MILLDROP

Teflon

Tap

Clip

Silicon pipe

– Use the filling tanks silicone tube (or other suitable tube, max length 2m) and insert it on

the filling connector taking care to push it completely on. – Lock the tube to connector with the plastic tie provided. – Insert the other end of the tube on the tap of the filling tank. – Make sure that the tube runs freely from the device to the filling tank, without being bent,

crushed or obstructed in any way. – Loosen the upper plug to facilitate the flow of water (also remove any gasket or under-

plug); – Open the tap on the filling tank.

NOTE

REFER TO THE CHAPTER, “CONFIGURING THE DEVICE – AUTOMATIC FILLING OPTION ”.

The sterilizer can be connected to MILLDROP (water treatment system by reverse osmosis) warranting the automatic reservoir filling with high quality demineralized water.

Refer to MILLDROP operating manual for the installation instructions.

NOTE

FOR THIS OPTION SETTING, REFER TO CHAPTER “CONFIGURING THE DEVICE – AUTOMATIC FILLING OPTION”.

For additional information and advice about the correct connection of the sterilizer to the various water purification systems, contact M.O.COM. customer support (see Appendix Z).

4. INSTALLATION

CONNECTING AN EXTERNAL DRAIN TANK

OPTIONAL, external drain function)

Connecting the tank to a central draining point

An external drain tank (supplied as an option) can be used to avoid having to periodically

empty the internal used water tank, which is then manually emptied or connected to central

drain system.

NOTE

CHECK THAT THE DRAIN SILENCER IS CORRECTLY INSTALLED INSIDE THE TANK,

CORRESPONDING TO CONNECTION

“A”.

Follow the instructions below for the correct connection of the tank:

– Insert the silicone tube (provided with the option) on

connector A on the machine; push the tube all the way on and lock it with the plastic tie;

– Cut the silicone tube to measure, push the free end

on connector A on the drain tank and lock it with the plastic tie;

NOTE

MAKE SURE THE TUBE IS NOT BENT,

CRUSHED OR OBSTRUCTED IN ANY WAY

– Connect the plug of the level sensor to the jack

(optional) on the back of the device (see figure);

NOTE

MAKE SURE THE PLUG IS CORRECTLY

INSERTED INTERPRETED AS A MAX LEVEL SIGNAL, WITH A CONSEQUENT ALARM WHENEVER YOU INSIST ON STARTING THE CYCLE

. A POOR CONNECTIN IS

– Fill the tank with normal tap water up to the level marked on the container.

DANGER

HOT WATER AND STEAM UNDER PRESSURE COME OUT OF THE DRAIN CONNECTORS. CONNECT ALL THE ELEMENTS OF THE DRAIN CIRCUIT CAREFULLY TO AVOID PROPERTY DAMAGE AND/OR INJURY.

NOTE

FOR THIS OPTION SETTING, REFER TO CHAPTER “CONFIGURING THE DEVICE – SETTING

THE WATER DRAINING MODE

”..

To avoid having to periodically empty the draining tank, it

is possible to connect it directly to a central drain.

– Insert the screw plug in place of the free vent hose

union on the side connector of the draining tank;

Plug

eplace th pipe-fitting by the plug

– Screw the 1/8" hose union, supplied, on the side

connector; use a wrench to hold the connector to be tightened;

– Use Teflon tape or connector sealant for a perfect

seal.

– On this tube union, insert a tube of suitable material

and dimensions (NOT

SUPPLIED); push the tube all

the way on and lock with the plastic tie provided.

To the draining plant

Clip

Pipe-fitting

raining tank

Teflon

4. INSTALLATION

DIRECT CONNECTION TO A CENTRALIZED DRAINING POINT

– Connect the other end of the tube to the centralized draining point, checking the seal.

NOTE

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

The following diagram provides an indicative arrangement of the components:

Connection point

Sterilizer

Support plane

This point must be lower than the support pla ne

Draining ta n k

of the centralized draining plant

CENTRALIZED

Connection point of the draining tank

DRAIN

NOTE

DIMENSION X IS THE HEIGHT OF THE SIDE CONNECTOR OF THE TANK ABOVE THE FLOOR. THE CONNECTION BETWEEN THE TANK AND THE CENTRALIZED DRAINING POINT MUST

NO HIGHER THAN X

EMPTYING OF THE TANK

+30 MM. HIGHER CONNECTIONS COULD COMPROMISE THE CORRECT

Follow the instructions shown below for a correct direct connection to a centralized draining point:

– Insert the silicone tube (provided) or other suitable plastic tube on hose union A; push the

tube all the way on and lock with the plastic tie or other means;

– Cut the tube to measure, push the free end on the connection provided on the centralized

draining point and lock with the plastic tie or other means;

NOTE

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

The following diagram provides an indicative arrangement of the components:

Centralized

Clip

Pipe

To the centralized draining point

Su pport plane

This point must be at level lower than the steri l izer’s support plane

Washer

draining point

Clip

NOTE

THE CONNECTION POINT TO THE CENTRAL DRAIN MUST BE LOWER THAN THE

STERILIZER

'S SUPPORT SURFACE. OTHERWISE, THE TANK MAY NOT EMPTY CORRECTLY.

5. FIRST START-UP

FIRST START-UP

TURNING ON THE EQUIPMENT

INITIAL AUTOMATIC TEST

Once the sterilizer has been correctly installed, it may be turned on and prepared for use. Turn on the equipment by the main (luminous) switch located on the right side of the machine.

NOTE

DO THIS WITH THE STERILIZER'S DOOR OPEN.

When turned on, the control panel lights up and beeps so you can visually check its correct operation. The panel then displays this message:

MILLENNIUM B2

R. Exxxx/BGyyyyyy

DEVICE CHECK-UP

NOTE

IF THE DOOR IS CLOSED, THE TEST IS INTERRUPTED. THE PANEL THEN BEEPS AND

DISPLAYS THE FOLLOWING MESSAGE

OPEN DOOR

TO CONTINUE

ACQUISITION AND UPDATING OF THE AMBIENT PRESSURE VALUES

Open the door to allow the test to continue. At the end of the test you will see:

MILLENNIUM B2

R. Exxxx/BGyyyyyy

CHECK-UP COMPLETE

The sterilizer measures the ambient pressure for the correct operation of several auxiliary devices. Whenever the difference between the value read and that previously stored (see the Chapter, “Configuring the Device - Acquisition the ambient pressure) is higher than a set value, the system automatically the data remains unchanged After updating, the device performs the initial automatic test procedure (see the preceding paragraph). At the end, the display shows the following notice (accompanied by a beep):

When ↵ is pressed, the device goes to STAND-BY mode (see the following paragraph).

ALSO SEE THE PARAGRAPH, “ACQUIRING THE AMBIENT PRESSURE VALUE” IN THIS

REGARD

without updating.

AMBIENT PRESSURE

-0.01 bar ↵ to continue

updates the stored value after a brief delay. Otherwise,

VALUE UPDATED

NOTE

5. FIRST START-UP

STAND-BY MODE

After the initial test, the sterilizer goes to STAND-BY mode and the display shows:

Counter xxxxx/yyyyy Stand-by HIGH

23.6 °C 30/08/02

-0.01 bar 18:13:05

The upper line is the cycle counter for sterilizations performed, with the number of correctly completed cycles on the left

and the total number started on the right. The line below shows the Stand-by status and the preheating mode (High-Low-Off). The two lower lines show the temperature and pressure of the sterilization chamber on the left and current date and time on the right.

NOTE

A CYCLE BEGINS WITH THE START OF THE STERILIZATION CYCLE (FIRST VACUUM

), EXCLUDING THE PREHEATING PHASE. A CYCLE ENDS AT THE END OF THE

PHASE PROGRAM

(SEE THE CHAPTER, “PROGRAM EXECUTION”).

O SET THE DATE AND TIME AS WELL AS SELECT THE PREHEATING MODE, PRINT THE

DATA AND FILL THE TANK

”.

DEVICE

, PLEASE REFER TO THE CHAPTER, “CONFIGURING THE

At regular intervals, the first two lines on the display alternate with the modes set for printing (ON/OFF) and filling (Manual/Automatic):

Print ON Filling MANUAL

23.6 °C 30/08/02

-0.01 bar 18:13:05

The icons in the lower part of the LCD screen remain off with the exception of the door status and/or water level indicators, which light-up if the door is closed and/or the level in the filling tank reaches its MIN or MAX values (or the MAX value in the drain tank).

During the first start-up, the MIN water level icon in the filing tank is normally on. The device waits for the selection of the desired sterilization program (see the Chapter,

“Program Selection”).

DANGER

WHEN THE DOOR IS OPEN IN STAND-BY MODE, A LONG BEEP OF ABOUT 30 SEC. INDICATES THAT THE SURFACES INSIDE THE DEVICE ARE HOT. TO AVOID BURNS, TAKE CARE NOT TO TOUCH THE STERILIZATION CHAMBER, THE SUPPORTS PROVIDED OR THE INSIDE OF THE DOOR WITH YOUR BARE HANDS.

5. FIRST START-UP

FILLING DISTILLED WATER

Manual filling

Automatic filling

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

With reference to the figure (and with the door open), proceed as follows:

1. Fill the manual container (2 l) with distilled water, keeping it horizontal;

2. Connect the tube’s quick connector to the corresponding female connector under the chamber

entrance (marked click;

3. Place the container in a vertical position, at the same time, loosening the plug and taking care not water on the machine.

4. The water will begin to flow into the tank;

5. Continue filling until the MIN level indicator turns off.

6. Continue until the water is drained from the container;

7. At this point, lower the connector below

8. While pinching the tube with your fingers, press the metal lever located on the side of the connector and detach the quick connector;

9. Refill the container (2 l) and repeat the operations described in points 2, 3 and 4 a second time;

10. W hen the MAX level quick connector as described in points 7 and 8.

THE ICON MAX DOES NOT HAVE TO BE ON TO START A STERILIZATION PROGRAM. THE

MIN INDICATOR OFF IS SUFFICIENT.

ICON

In the event of sterilizer installation for automatic filling from an external tank or demineralizer Milldrop (see the Chapter, “Installation”), the filling will occur automatically after the automatic filling option has been selected. Obviously, for the correct operation, the user must fill the external tank or switch on the Milldrop in advance.

USE ONLY HIGH QUALITY DISTILLED WATER. FOR THE SPECIFICATIONS OF THE WATER

SUPPLY

To set the automatic filling option, please refer to the Chapter, “Configuring the Device”.

THE AUTOMATICALLY FILLING SYSTEM MUST NEVER RUN DRY; THIS CAUSES PREMATURE WEAR TO THE AUXILIARY WATER-INJECTION PUMP. PERIODICALLY CHECK THE WATER LEVEL IN THE EXTERNAL TANK.

), pushing until you hear a

to spill

the connection point, keeping it horizontal;

icon comes on (accompanied by a beep), stop filling and detach the

NOTE

, SEE APPENDIX A (TECHNICAL CHARACTERISTICS).

WARNING

5. FIRST START-UP

MAX LEVEL IN THE INTERNAL/ EXTERNAL DRAIN TANK

Emptying the internal tank

Emptying the external tank (option)

When the water level in the internal or external drain tank reaches the MAX level, the LCD display alternatively lights the MAX and MIN icons.

NOTE

IN THIS CONDITION THE UNIT WILL GENERATE AN ALARM INDICATION (SEE APPENDIX E - ALARM) AS YOU ATTEMPT TO LAUNCH A STERILIZATION CYCLE.

In this case, empty the internal or external draining tank.

Referring to the figure, open the door and operate in the following way:

1. Arrange an empty tank on the floor near the sterilizer and put the free end of the supplied tube into the tank;

2. Connect the quick connector to the corresponding female connector under the chamber entrance

(marked

3. Wait for the complete empty of the internal tank; then while pinching the tube with your fingers, press the metal lever located on the side of the connector and detach the quick connector.

Remove the top cap from the external tank and empty into a sink the water exceeding the signed level.

Refer to chapter “CONNECTING AN EXTERNAL DRAINING TANK” for more details.

), pushing until you hear a click;

WARNING

DO NOT EMPTY THE TANK COMPLETELY, BUT KEEP A QUANTITY OF WATER UP TO THE MARKED LEVEL. OTHERWISE THE WATER DRAINING SOUND AND THE STEAM ESCAPE FROM THE VENT-HOLE WILL INCREASE CONSIDERABLY.

6. CONFIGURATION

CONFIGURATION

INTRODUCTION

STARTING AND ENTERING THE SETUP MODE

MEANING OF THE KEYS IN SETUP MODE

Millennium B² offers personalization options never previously seen on any steam sterilizer. Users may configure the device to meet their own needs. For example, the device's performance may be adapted on the basis of the type of activity, the type of material to be sterilized or its frequency of use.

The SETUP program allows selecting from numerous options that users activate through an intuitive, easy-to-use menu.

NOTE

USE THE SETUP PROGRAM WHENEVER NECESSARY. A CORRECTLY PERSONALIZED

DEVICE PROVIDES THE BEST PERFORMANCE AND THE MOST SATISFACTORY USE

M.O.COM.

PROVIDING SUGGESTIONS OR ADVICE ON THE BEST WAY TO USES THE OPTIONS IN THE

SETUP PROGRAM

To start the SETUP program, hold down the Ç key on the control panel for several seconds, until the display shows:

ICON SETUP ON THE DISPLAY LIGHTS-UP AND STAYS ON OR THE ENTIRE

CONFIGURATION PHASE.

When you press the ↵ key, you enter the SETUP mode. The screen shows the first-level menu items (see the paragraph, SETUP flowchart).

Pressing the ESC key Ç quits the SETUP program and takes you back to normal operation (stand-by mode).

THE SETUP PROGRAM CAN ONLY BE STARTED IN STAND-BY MODE. IT IS NOT

ACCESSIBLE DURING STERILIZATION OR TEST CYCLES

In SETUP mode the control panel keys have different functions than in normal mode.

Key SETUP mode

CUSTOMER SUPPORT (SEE APPENDIX Z) IS AVAILABLE TO HELP USERS BY

MILLENNIUM B2

SETUP

↵ to continue

Ç to exit

NOTE

function ENTER, confirm the selected option or value Increase the value /scroll down

Decrease the value /scroll up the menu items ESC, exit the selected menu option

6. CONFIGURATION

YES

EXIT

EXTRA

: XX mi n

to enter

MANUAL

EXIT

REPORT

EXIT

NORMAL

EXTENDED

EXIT

COPIES

to set to enter

. COPIES

EXIT

INTERNAL

EXTERNAL

EXIT

134c

PROCESS

121c

PROCESS

EXIT

MILLENNIUM B2

NOTES

REPORT

NOW PRINTING

PLEASE WAIT...

SHORT

DRYI N G

LONG

DRYING

EXIT

FRACTION

. VACUUM

SINGLE

VACUUM

EXIT

EXTRA

DRYING

REVIEW

PRESSURE VALUE

SET INTO MEMORY

WARNING!

OPEN THE DOOR

Is the door

time

limited

(+ beep)

AMBIENT PRESSURE

EXIT

LCD CONTRAST

TYPE CR

+LF TYPE

EXIT TYPE 1

TYPE 2

EXIT

ACQUISITION OF THE

starting

Firmware

release

Date

dd/mm/yyyy

STANDARD

Stand

by option

option

EXTERNAL

Filling

option

AUTOMATIC

EXIT

REVIEW

to confirm

WRAPPED

EMERGENCY

INTERNAL

AT CYCLE END

EXTERNAL

STEP BY STEP

EXIT

TIME

: XX min

to enter

starting

TYPE (+FF)

+LF TYPE (+FF)

CONFIRM

PASSWORD

Setup Layout

Selecting the last option of the current menu (or the item

1st MENU LEVEL

MILLENNIUM B2

SETUP

to continue

↵ ⇑

to exit

1st MENU

LEVEL

BASIC

ADVANCED

2nd MENU

LEVEL

LANGUAGE DATE SETTING TIME SETTING

PASSWORD EXIT

PROGRAMS STANDBY OPTIONS

PRINT OPTIONS FILLING OPTIONS DRAIN OPTIONS EXIT

3rd MENU

ITALIANO ENGLISH FRANCAIS DEUTSCH ESPANOL

EXIT

+/-

to set

to enter

↵

to exit

⇑

+/-

to set

to enter

↵ ⇑

to exit

DISABLED ANY POWER ON ANY CYCLE START EXIT

1st PRESET 2nd PRESET 3rd PRESET 4th PRESET EXIT

ST-BY MODE ST-BY TIMEOUT EXIT

PRINTER

LEVEL

dd/mm/yyyy

hh:mm:ss

4th MENU

LEVEL

INSERT PASSWORD * * * * * * * * * * * * * * *

↵

to enter

⇑

to exit

134c HOLLOW 121c HOLLOW 134c SOLID 121c SOLID 134c EMERGENCY 134c WRAPPED 121c WRAPPED 134c POROUS 121c POROUS 134c PRION XXXc CUSTOM EXIT

OFF LOW HIGH

TIMEOUT: XXX min +/- to set

↵

to enter

⇑

to exit

OFF

5th MENU

LEVEL

* * * * * * * * * * * * * * *

↵

to enter

⇑

to exit

STANDARD DRYING

FAST EXIT

STANDARD DRYING

INTELL. DRYING

EXIT

+/+/-- to set

↵ ⇑

to exit

Selecting the item, the previous menu is displayed

ESC

( key has the same effect of EXIT command)

EXIT

TO ENTER), the previous menu is displayed

+/- to set

↵

to exit

⇑

from 18’

to set

↵ ⇑

to exit

from 01’

SPECIAL

SERVICE

EXIT SETUP

ONLY AVAILABLE FOR

MOCOM SERVICE

Exxxx / BP yyyyyy

Language

ENGLISH

Time

hh:mm:ss

MILLENNIUM B2

EXIT SETUP?

to confirm

↵

to resume

⇑

+/ to scroll

confirm

resume

AUTOMATIC

AMBIENT PRESSURE

to enter

↵

to exit

⇑

ADJUSTMENT OF THE

LCD CONTR A S T

+/- to set

to exit

⇑

1st PRESET

134c POROUS

DRYING

2nd PRESET

134c HOLLOW FAST DRYING

EXIT SETUP AND

GO TO STAND-BY MODE

BACK TO

+/to scroll

PRINTOUT MODE

PRINT LAST

open?

3rd PRESET

134c

EXTRA DRYING (+05)

4th PRESET

134c

FAST DRYING

: XX

+/-

↵ ⇑

to exit

TO CONTINUE

+/to scroll

HIGH

120 min

1 copy

CR+LF

THE REPORT

+/to scroll

Drain option

INTERNAL

6. CONFIGURATION

DESCRIPTION OF THE MENU ITEMS

Now, we describe the meaning of the various main menu and second-level menu items.

MAIN MENU

The main menu has 6 entries that open additional (second-level) menus:

BASIC (basic options) ADVANCED (advanced options) SPECIAL (special options

SERVICE (menu not accessible to users)

DATA REVIEW (summary EXIT SETUP (exit the SETUP program and return to normal operation. In

this regard, see the paragraph, Exiting the SETUP program)

THE METHODS FOR CHANGING THE VARIOUS ITEM SETTINGS ARE FOUND IN THE

PARAGRAPH

BASIC Menu

The Basic menu (basic options) consists of the items:

LANGUAGE (language setting DATE SETTING (setting the current date TIME SETTING (setting the current time PASSWORD (setting the password) EXIT (exit

ADVANCED Menu

The Advanced menu (advanced options) consists of the items:

PROGRAMMES (setting preselected sterilization programs STAND-BY OPTIONS (stand-by

PRINT OPTIONS (setting printer and printing options) FILLING OPTIONS (setting modes for filling DRAIN OPTIONS (setting the modes for emptying EXIT (exit

SPECIAL Menu

The Special menu (special options) consists of the following items:

AMBIENT PRESSURE (acquisition of the ambient pressure LCD CONTRAST (adjusting the contrast EXIT (exit

SERVICE Menu The Service menu can ONLY

DATA REVIEW Menu

The Data Review displays a summary of the device's current settings verify their correctness.

It has the following screens (shown by way of example):

, ACTIVATING CONFIGURATION OPTIONS.

the BASIC menu and return to the main menu)

LCD display)

the ADVANCED menu and return to the main menu)

the SPECIAL menu and return to the main menu)

be accessed by the Service department.

)

of options selected)

NOTE

)

); )

, shown on the

mode settings)

the distilled water tank)

the used water tank)

)

of the Liquid Crystal Display)

, allowing users to

6. CONFIGURATION

MILLENNIUM B2 R. Exxxx/BGyyyyyy LANGUAGE ENGLISH

Firmware version

Use the keys

1st PRESET

134°C POROUS STANDARD DRYING

Use the keys

3rd PRESET

134°C WRAPPED EXTRA DRYING +05

Use the keys

Stand-by option

HIGH 120 min

Use the keys

Filling option AUTOMATIC Drain option INTERNAL

Use the keys

EXIT DATA REVIEW

↵ to continue

DATE dd/mm/yyyy TIME hh:mm:ss

+ / - to scroll through the menu

2nd PRESET

134°C HOLLOW FAST DRYING

+ / - to scroll through the menu

4th PRESET

134°C EMERGENCY FAST DRYING

+ / - to scroll through the menu

Print option

INTERNAL 1 COPY(ies)

+ / - to scroll through the menu

Press ↵ to confirm

NOTE

FOR THE MEANING OF THE TERMS SHOWN, SEE THE PARAGRAPH, ACTIVATING CONFIGURATION OPTIONS.

6. CONFIGURATION

DEFAULTS SETTINGS

ACTIVATING CONFIGURATION OPTIONS

Setting the language

(LANGUAGE on the BASIC Menu)

Setting the date

(DATE SETTING on the BASIC Menu)

The sterilizer leaves the factory with the following settings:

DATE: current date TIME: current time

PROGRAMS: Preset 1: 134°C POROUS (standard drying)

Preset 2: 134°C HOLLOW (standard drying) Preset 3: 134°C SOLID (standard drying) Preset 4: 134°C EMERGENCY

NOTE

THE PROGRAMS INDICATED SHOULD BE CONSIDERED AS PREFERENTIAL SETTINGS. HOWEVER, OTHER COMBINATIONS ARE POSSIBLE BASED ON THE DESTINATION MARKET.

ST-BY MODE: HIGH (preheating) PRINT OPTIONS: INTERNAL

1 copy

FILLING OPTIONS: MANUAL DRAIN OPTIONS: INTERNAL

Now, we provide a detailed explanation of how to select the various available options, proceeding in the shown in the previous paragraph.

Select LANGUAGE using the ↵ key. The following screen will appear:

ITALIANO +

→

ENGLISH ↑ FRANÇAIS ↓ DEUTSCH ESPAÑOL

Select the desired language. Move using the + or – keys and confirm using the ↵ key to store the selection. After the data is confirmed, you return to the second-level menu.

NOTE

AS SOON AS THE SELECTION IS CONFIRMED, ALL THE MENUS OF THE SETUP PROGRAM

WILL BE DISPLAYED IN THE LANGUAGE SET

When DATE SETTING is selected with the ↵ key, you will see:

dd/mm/yyyy +/- to set ↵ to enter

Ç to exit

Proceed as follows: – The day flashes: set the current date with the + and - keys. Confirm with ↵.

– The month flashes: set the current month with the + and - keys. Confirm with ↵. – The year flashes: set the current year with the + and - keys. Confirm with ↵.

The date is stored. Once the last confirmation is given, you return to the second-level menu.

6. CONFIGURATION

Setting the time

(TIME SETTING on the BASIC menu)

Setting the password

(PASSWORD on the BASIC menu)

When TIME SETTING is selected with the ↵ key, you will see:

hh:mm:ss +/- to set ↵ to enter Ç to exit

Proceed as follows: – The hours flash: set the current hour with the + and - keys. Confirm with ↵.

– The minutes flash: set the current value with the + and - keys. Confirm with ↵.

The time is stored. Once the last confirmation is given, you return to the second-level menu.

When PASSWORD is selected with the ↵ key, you will see this menu:

DISABLED +

→

ANY POWER ON ↑ ANY CYCLE START ↓ EXIT -

Select DISABLED to use the device freely, without any limitation on operator access. Select ANY P OWER-ON to protect the machine with a password at the time it is turned-on

(power-on from the main switch). This makes sure that the machine can only be powered-on by authorized personnel, but afterwards it can be used by others without limitation.

Select ANY CYCLE START to protect the autoclave with a password to be entered both at power-on and at the start of every sterilization program. Only authorized personnel will be able to use it.

NOTE

ENTERING A PASSWORD PROVIDES MORE CONTROLLED USE OF THE PRODUCT BUT, AT

THE SAME TIME, INEVITABLY MAKES IT MORE CUMBERSOME. SO AS NOT TO OVERLY COMPLICATE USING THE DEVICE IT IS REALLY NEEDED

, WE RECOMMEND ONLY ACTIVATING THIS OPTION WHEN

When the ANY POWER-ON or ANY CYCLE START options are selected, the following screen is displayed:

INSERT PASSWORD

↵ to enter

Ç to exit

Enter the password with the + and – keys (fixed length, 8 characters). Confirm with the ↵ key. Then, the following message will appear:

CONFIRM PASSWORD

↵ to enter

Ç to exit

Enter the password again using the + and – keys.

6. CONFIGURATION

Confirm with the ↵ key.

NOTE

TO CHANGE THE PASSWORD, FIRST SELECT THE DISABLE OPTION, WHICH CANCELS

THE PREVIOUS PASSWORD

, AND THEN SELECT THE ANY POWER-ON OR ANY

CYCLE START OPTION, ENTERING THE NEW PASSWORD AS DESCRIBED ABOVE.

Setting the sterilization programs

(PROGRAMS on the ADVANCED menu)

The program setting and their storing in four pre-set positions is achieved in various steps using several menus in sequence. Each pre-set position can be associated to a standard or user configurable cycle (CUSTOM). Let's look at the two cases separately.

To associate a standard program and define several of its parameters, proceed as follows:

1. Select PROGRAMS using the ↵ key; the following menu appears:

1st PRESET +

→

2nd PRESET ↑ 3rd PRESET ↓ 4th PRESET EXIT

Define the position (1, 2, 3 or 4) to which the sterilization program will be associated using the + and - keys. Confirm with the ↵ key.

2. From here, you enter the list of available cycles:

134 °C HOLLOW +

→

121 °C HOLLOW ↑ 134 °C SOLID ↓ 121 °C SOLID -

134 °C EMERGENCY 134 °C WRAPPED 121 °C WRAPPED 134 °C POROUS 121 °C POROUS 134 °C PRION XXX °C CUSTOM EXIT

Using the + and - keys, scroll the list until you identify the sterilization program desired.

3. Confirm the selection with the ↵ key.

When the PRION program is selected, you will go to a screen for selecting the sterilization time.

TIME: XX min +/- to set ↵ to enter Ç to exit

A value can be set, starting from 18 minutes.

6. CONFIGURATION

As a function of the choices made, you will go to one of two alternative menus that allow selecting

the type of drying to associate to the selected program.

a) Programs with short drying (HOLLOW, SOLID, EMERGENCY):

→ STANDARD DRYING +

FAST DRYING ↑ EXIT ↓

It is possible to select STANDARD mode (the default setting) or FAST (reduced drying, recommended for light loads). Move using the + and - keys and confirm with the ↵ key.

NOTE

THE EMERGENCY PROGRAM PROVIDES ONLY FAST DRYING.

b) Programs with long drying (POROUS, WRAPPED, EXTRA):

→ STANDARD DRYING +

INTELL. DRYING ↑ EXTRA DRYING ↓ EXIT -

It is possible to select STANDARD (default setting), INTELLIGENT (automatic drying that adjusts its duration longer or shorter than standard drying on the basis of the volume and/or quantity and type of load) or EXTRA (drying extended by a selectable value, recommended for critical loads). Move using the + and - keys and confirm with the ↵ key.

NOTE

WITH LARGE LOADS OR SPECIAL MATERI ALS, THE STANDARD OPTION MAY NOT

PROVIDE A PERFECT RESULT. IN THIS CASE, EXTEND THE DRYING PHASE BY USING THE

EXTRA MODE.

ITH PARTICULARLY COMPLEX TYPES OF LOADS (SUCH AS WRAPPED INSTRUMENTS IN

"CONTAINER" FOR STERILIZATION) "INTELLIGENT" DRYING MAY NOT WORK

A CORRECTLY, WITH WORSE THAN EXPECTED RESULTS. IN THESE CASES, USE THE

STANDARD OR EXTRA OPTIONS, DEPENDING ON THE NEED.

When the EXTRA option is activated, the following screen appears:

EXTRA: XX min +/- to set ↵ to enter Ç to exit

which permits setting the duration of extra drying from between 1 and 15 minutes (time to be added to the STANDARD DRYING time). Set the value using the + and - keys and confirm the selection with the ↵ key.

NOTE

THE SELECTION CAN BE CHANGED AT ANY TIME BY FOLLOWING THE PROCEDURE

DESCRIBED ABOVE

HENEVER AN IDENTICAL STERILIZATION PROGRAM IS ALREADY PRESENT IN ANOTHER

POSITION, THE SELECTION IS NOT ACCEPTED. THE FOLLOWING WARNING APPEARS ON THE DISPLAY

, ALONG WITH A BEEP:

THIS PROGRAM

IS ALREADY PRESET

6. CONFIGURATION

To define the CUSTOM program to associate to one of the pre-set position (1, 2, 3 or 4) proceed as follows:

1. Select PROGRAMS, select the program number to which the program is to be associated

(see the previous description) and then select CUSTOM in the next screen; the following menu appears:

→

134°C PROCESS +

121°C PROCESS ↑ EXIT ↓

Select 121 °C to perform a custom program with a sterilization process at 121 °C or 134 °C for one at 134 °C. Move using the + and - keys and confirm with the ↵ key.

2. You will then go the screen:

TIME: XX min +/- to set ↵ to enter Ç to exit

Use the + and - keys to set the duration of the sterilization process and confirm with the ↵ key.

NOTE

THE DURATION OF THE STERILIZATION PROCESS IS VARIABLE FROM 4 TO 30 MINUTES

FOR THE PROGRAM AT 134 °C, AND FROM 20 TO 30 MINUTES FOR THE PROGRAM AT

121 °C.

3. After selecting the time, you go to the menu where you specify the type of initial vacuum:

→ FRACTION. VACUUM +

SINGLE VACUUM ↑ EXIT ↓

Select FRACTION. to perform a fractionated vacuum (indispensable for sterilizing hollow bodies and porous materials), or SINGLE for a single preliminary vacuum phase (solid instruments). Move using the + and - keys and confirm with the ↵ key.

4. At this point, you come to another menu

SHORT DRYING +

→

where you set the drying mode:

LONG DRYING ↑ EXIT ↓

Select LONG drying suitable for porous and/or wrapped loads, or SHORT if you need to sterilize solid, loose materials (and even hollow so long as not wrapped). Move with the + and - , confirm with the ↵ key.

6. CONFIGURATION

5. Depending on the selection (SHORT or LONG) one of two different menus will open (these menus are the same for the standard cycles), i.e.:

In SHORT mode the following is displayed:

→ STANDARD DRYING +

FAST DRYING ↑ EXIT ↓

In LONG mode the following is displayed:

STANDARD DRYING +

→

INTELL. DRYING ↑ EXTRA DRYING ↓ EXIT -

For the choice criteria, refer to the instruction of page 26.

Whenever the CUSTOM program is already present in another position, the selection is not accepted. The following warning appears on the display, along with a beep:

THIS PROGRAM IS ALREADY PRESET

NOTE

THE SELECTION CAN BE CHANGED AT ANY TIME BY FOLLOWING THE PROCEDURE

DESCRIBED ABOVE

HE LIST OF AVAILABLE PROGRAMS, THEIR SCREENS AND THE CHARACTERISTICS OF

STERILIZABLE MATERIALS

(IN RELATION TO THE PROGRAMS) ARE CONTAINED IN

APPENDIX B (PROGRAMS).

CCESS TO A CUSTOM CYCLE DOES NOT REQUIRE A PASSWORD. NONE OF THE

COMBINATIONS POSSIBLE IN THE CUSTOMIZATION PHASE CREATE ANY RISKS OR DANGERS OF INJURY TO THE OPERATOR OR DAMAGE TOT HE DEVICE

6. CONFIGURATION

Setting the STAND-BY mode

(STAND-B Y OPTIO NS on the ADVANCED menu)

Based on the equipment's frequency of use, or other considerations, it is possible to select the heating level during the STAND-BY (preheating) phase and the time beyond which STAND-BY is deactivated. When you s elect STAND-BY OPTIONS with the ↵ key, you access the following menu:

ST-BY MODE +

→

ST-BY TIME-OUT ↑ EXIT ↓

When you select STAND-BY MODE, an additional menu appears where you can set the heating level:

→

OFF +

LOW ↑ HIGH ↓ EXIT -

Select HIGH (high preheating level) for intense use or, at any rate, to reduce the wait time between one cycle and the next to a minimum.

Select LOW (low

preheating) for normal use, since the wait time will be relatively shorter, in

any case. Select OFF (deactivate

preheating) for occasional use. In this case, the wait time will be longer (up to about 10-12 minutes for a "cold start"). Move using the + and - keys ; confirm with the ↵ key.

On the other hand, when the ST-BY TIME-OUT option is selected, it is possible to set the time for deactivating STAND-BY, i. e., how many minutes after the last cycle the heating elements are turned off. The following screen appears:

TIMEOUT: XXX

min

+/- to set ↵ to enter Ç to exit

It is possible to set a value between 0 and 300 minutes (in 30-minute increm ents), after which the heating elements are turned off (a condition analogous to STAND-BY OFF), avoiding the useless consumption of electricity.

Set using the + and - keys; confirm with the ↵ key.

NOTE

THIS OPTION IS ALSO ACTIVE WITH STAND-BY OFF. HOWEVER, IN THIS CONDITION

THE TIMER VALUE OBVIOUSLY HAS NO EFFECT SINCE THE HEATING ELEMENTS ARE TURNED OFF ANYWAY AT THE END OF THE STERILIZATION PROGRAM

HEN ANY CYCLE SELECTION KEY (STERILIZATION OR TEST) IS PRESSED, OR THE

MACHINE IS TURNED OFF AND ON WITH THE MAIN SWITCH MODE (HIGH OR LOW) IS IMMEDIATELY REACTIVATED.

, THE ORIGINAL STAND-BY

6. CONFIGURATION

Setting the printing mode

(PRINT OPTIONS on the ADVANCED menu)

Printer model 1

The sterilizer is equipped wi th a printer for recording sterilization program data; it is necessary to set the parameters required for its proper operation.

1. Select PRINT OPTIONS using the ↵ key and the following menu appears:

PRINTER +

→

REPORT ↑ EXIT ↓

Select PRINTER to select the settings for the printer used, or REPORT to set the number of copies to print and to reprint data from the last program executed.

a) Item PRINTER

The following screen appears:

→

OFF +

INTERNAL ↑ EXTERNAL ↓ EXIT -

Select OFF to deactivate the printing of data at the end of a sterilization (or test) cycle. Select INTERNAL to enable the thermal printer set inside the front of the sterilizer. In

this case, another menu opens:

→

TYPE 1 +

TYPE 2 ↑ EXIT ↓

Printer model 2

Select Type 1 for the model 1 of the printer installed. Select Type 2 for the model 2 of the printer installed.

If, on the other hand, you choose EXTERNAL, the data will be printed on an external peripheral. Following this selection, another menu opens:

CR TYPE +

→

CR+LF TYPE ↑ CR (+FF) TYPE ↓ CR+LF (+FF) TYPE EXIT

Activate CR to use printers that advance the paper only on the CR (Carriage Return) command, or CR+LF for that require the CR+LF (Carriage Return + Line Feed) commands, or with +FF (Form-Feed) for printers that require the addition of this command.

NOTE

CONSULT THE PRINTER MANUAL TO DETERMINE THE TYPE OF COMMAND USED. IF THIS

INFORMATION IS NOT AVAILABLE IDENTIFY THE CORRECT SETTING.

, TRY PRINTING WITH THE VARIOUS OPTIONS TO

6. CONFIGURATION

b) Item REPORT

The following screen appears:

→ PRINTOUT MODE +

NR. COPIES ↑ PRINT LAST ↓ EXIT -

Select item PRINTOUT MODE to chose the mode the data are printed: The following options appear:

AT CYCLE END +

→

STEP BY STEP ↑ EXIT ↓

Select AT CYCLE END to print the report al the end of the cycle. Select STEP BY STEP to print the data at each phase of the cycle, as result in the normal printout (see Examples of printed report in Appendix B).

NOTE

IN STEP BY STEP MODE IS NOT POSSIBLE MORE REPORT COPIES.

HE VACUUM AN D HELIX TEST REPORT PRINT IS CARRIED OUT ONLY IN MODE “AT

T CYCLE END”.

Activate NR. COPIES to set the number of copies of the cycle report to print at the end of the program. The following text appears:

COPIES: XX +/- to set ↵ to enter Ç to exit

Set the number of copies desired (up to a maximum

of 5). Confirm with the ↵ key.

On the other hand, the selection PRINT LAST reprints the report for the last cycle executed (whether it terminated correctly or was interrupted by an alarm). The following screen appears:

→ NORMAL PRINT +

EXTENDED PRINT ↑ EXIT ↓

The NORMAL PRINT command activates normal printing (that with salient cycle data produced at the end of a correctly executed cycle), while EXTENDED PRINT activates complete printing (including all the data typical of a cycle interrupted by an alarm).

6. CONFIGURATION

Setting the tank filling mode

(FILLING OPTIONS on the ADVANCED menu)

NOTE

IF THE LAST CYCLE COMPLETED CORRECTLY (OR WAS INTERRUPTED BY MANUAL STOP) IT WILL BE POSSIBLE TO REPRINT IT IN EITHER NORMAL OR EXTENDED

. IF THE LAST CYCLE WAS INTERRUPTED BY AN ALARM (MANUAL STOP

MODE EXCLUDED

) IT ONLY THE EXTENDED MODE WILL BE AVAILABLE.

Following the reprint command, this message will be displayed:

NOW PRINTING

THE REPORT

PLEASE WAIT...

which will remain on the screen until printing is finished.

The internal tank can be filled either manually or automatically, in the latter case, drawing water from an external device (tank or demineralizer Milldrop connected to the device- see Chapter, “Installation”).

After FILL OPTIONS is selected, the following menu appears:

AUTOMAT. FILLING +

→

MANUAL FILLING ↑ EXIT ↓

Setting the water draining mode

(DRAIN OPTIONS from the ADVANCED menu)

When AUTOMATIC FILL is selected, automatic filling is activated. In this case, as reached the minimum water level (icon MIN on) in the internal tank, the equipment enable the auxiliary water feeding pump for a pre-set time or a time needed to reach the maximum level (icon MAX on). When the maximum leve l (MAX signal) is reached, the automatic system is deactivated.

NOTE

ONLY ACTIVATE THE AU TOM ATI C FIL LIN G MO DE AFTER THE EXTERNAL TANK HAS BEEN

FILLED WITH HIGH QUALITY DISTILLED W ATER OR THE MIL LDROP H AS BEEN TURNED ON.

ALSO REMEMBER TO OPEN THE TAP ON THE EXTERN AL TANK OR THE MILLDROP.

When MANUAL FILL is selected, the internal tank must be filled manually (see the Chapter, “First Start-Up”).

Scroll through the items with the + and - keys; confirm with the ↵ key.

The water used for the sterilization cycle can be drained into either the internal configuration) or an external

tank of greater capacity (offered as an option – see chapter

tank (standard “Installation”) so as to reduce the frequency of emptying the used wa ter. After DRAIN OPTIONS is selected, the following menu appears:

→

INTERNAL DRAIN +

EXTERNAL DRAIN ↑ EXIT ↓

6. CONFIGURATION

Acquisition of the ambient pressure

(AMBIENT PRESSURE on the SPECIAL menu)

When INTERNAL DRAIN is enabled, the reading of the MAX level sensor in the internal tank is enabled.

The EXTERNAL DRAIN command also activates the MA X level sensor located in the external tank.

NOTE

THE LEVEL SENSOR IN THE INTERNAL TANK REMAINS ACTIVE IN ANY CASE, TO PREVENT

A POSSIBLE MALFUNCTION OF THE EXTERNAL TANK OR A MISSING OR FAULTY CONNECTION OF THE OPTIONAL EXTERNAL DRAIN TANK

N THE CASE OF AN INSTALLATION WITH THE DRAIN CONNECTED TO THE CENTRAL

, SELECT INTERNAL DRAIN.

SYSTEM

Scroll through the items with the + and - keys; confirm with the ↵ key.

The first time the sterilizer is used and after any reinstallation, the sterilizer must acquire the ambient pressure. This operation is necessary

or the correct operation of several of the device's auxiliary

systems. When AMBIENT PRESSURE is activated, the following screen appears:

ACQUISITION OF THE

AMBIENT PRESSURE ↵ to enter Ç to exit

NOTE

CHECK THAT THE STERILIZER DOOR IS COMPLETELY OPEN. IF YOU TRY TO ACQUIRE

THE PRESSURE WITH THE DOOR CLOSED

THE FOLLOWING MESSAGE WILL BE DISPLAYED:

OPEN THE DOOR

TO CONTINUE

which remains until the door is opened. Confirm the acquisition of the data by pressing the ↵ key. This message appears:

PRESSURE VALUE

SET INTO MEMORY

accompanied by a beep. The ambient data pressure has been acquired. On the other hand, press the

Ç key to cancel the operation.

6. CONFIGURATION

Adjusting the contrast of the liquid crystal display

(LCD CONTRAST on the SPECIAL menu)

EXIT THE CONFIGURATION MODE

The LCD contrast adjustment allow to obtain the screen reading as clear as possible, compensating different sterilizer positioning or ambient brightness.

When LCD CONTRAST is activated, this screen appears:

ADJUSTMENT OF THE

LCD CONTRAST +/- to set Ç to exit

Press the + key increases the contrast while the - key decreases it. Place yourself in your usual working position and adjust the contrast until the display is as

clear and readable as possible.

Completed the sterilizer configuration, proceed as follows to return in normal mode: – Go to the first-level menu

(see the SETUP layout).

NOTE

TO RETURN TO THE FIRST LEVEL FROM ANY CURRENT MENU LEVEL, JUST SELECT ITEM EXIT OF THE CURRENT MENU AND CONFIRM BY ↵ KEY. A

LTERNATIVELY, YOU CAN PRESS Ç (ESC) KEY ONE OR MORE TIMES.

– Select EXIT and confirm with the ↵ key.

This text appears on the display:

MILLENNIUM B2

SETUP COMPLETE

↵ to exit

Ç to resume

After several seconds, the device returns to normal operation

in STAND-BY mode.

7. PREPARING THE MATERIAL

PREPARING THE MATERIAL

INTRODUCTION

TREATING THE MATERIAL BEFORE STERILIZATION

The sterilization process can be considered effective, reliable and repeatable so long as the material is suitably treated first and then correctly arranged in the sterilization chamber in an orderly manner.

In fact, it should be emphasized that organic residues or deposits of substances used in medical practice are the inevitable receptacles of microorganisms and may obstruct contact between the steam and the walls of the instrument, deactivating, at least locally, the lethal process that sterilization normally provides.

On the other hand, an incorrect arrangement of the load can make the circulation and/or penetration of the steam into the material difficult and sometimes impossible with the imaginable consequences. Even the drying process can be strongly influenced by this factor. For this reason, below we provide some basic the user to study the subject further in the most suitable way.

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

– Wear rubber gloves of adequate thickness; – Clean your gloved hands with a germicide detergent; – Always carry the instruments on a tray. – Never carry them in your hands; – Protect your hands from contact with any sharp points or edges; this will avoid the risk of

contracting a dangerous infection;

– Immediately remove any article that does not need to be sterilized or that is not capable of

withstanding the proces s;

– 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 residue (deposits of organic/inorganic material, fragments of paper, cotton/gauze pads, lime, etc.).

IN ADDITION TO CAUSING PROBLEMS DURING STERILIZATION, THE FAILURE TO CLEAN

AND REMOVE RESIDUE CAN DAMAGE

ITSELF

An effective cleaning

1. Rinse the instruments under running water immediately

2. Separate metal instruments by type of material (carbon steel, stainless steel, brass, aluminum, chromium, etc.), to avoid electroly tic oxidation-reduction;

3. Wash in an ultrasound cleaner using a mixture of water and germicidal solution, carefully following the manufacturer's recommendations.

4. For best results, use a detergent specifically designed for ultrasound washing, with a neutral pH.

5. After washing, carefully rinse the instruments and make sure that residues have been completely eliminated

consists of the following:

SOLUTIONS CONTAINING PHENOLS OR QU ATERNARY AMMONIA COM POUNDS CAN C AUSE

CORROSION ON INSTRUMENTS AND THE METAL PARTS OF ULTRASOUND DEVICES.

; if necessary, repeat the washing cycle or clean manually.

TO AVOID THE FORMATION OF LIME SPOTS, RINSE WITH DEIONIZED OR DISTILLED WATER,

IF POSSIBLE DRYING THE INSTRUMENTS

. WHENEVER VER Y HARD TAP WATER IS USED, WE RECOMMEND ALWAYS

suggestions regarding these aspects, leaving

NOTE

THE INSTRUMENTS AND/OR THE STERILIZER,

after use;

NOTE

7. PREPARING THE MATERIAL

OK OK

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

On the other, as regards textile material caps and other, carefully wash

ARRANGING THE LOAD

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

General notes for positioning on trays.

– Arrange instruments made of different

– In the case of instruments not

– In any case, arrange the objects sufficiently distant from each other that they will remain so

– Make sure that all instruments are sterilized in an open – Position cutting instruments

– Arrange recipients (glasses, cups, test tubes, etc.) resting on their side, or upended, so

– Do not – Since this value is understood to be the maximum allowed limit

– 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

NOTE

THE END OF THE STERILIZATION PROGRAM, REMEM BER TO LUBRI CATE THE IN TE RNAL

HANDLE MECHANISMS USING THE SPECIAL STERILE OIL PRECAUTIONS

, THE INSTRUMENTS USEFUL LIFE WILL NOT BE REDUCED IN ANY WAY

. BY TAKING THESE

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 DISINFECTANTS AND THE USAGE INSTRUCTIONS OF THE AUTOMATIC DEVICES FOR WASHING AND/OR LUBRICATING THEM.

(or porous, in general), such as smocks, napkins,

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 THE STERILIZATION CHAMBER

, TRAYS AND ANY METAL INSTRUMENTS THAT MAY BE PRESENT IN

metals (stainless steel, tempered steel, aluminum,

etc.) on different trays

or well separated from each other.

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;

for the entire sterilization cycle;

position;

, (scissors, scalpels, etc.) so they can not come into contact with each other during sterilization; if necessary, use a cotton or gauze cloth to isolate and protect them;

avoid pooling water;

load trays beyond their indicated limit (see Appendix A).

, it can be excessive in

some cases, so always use common sense

provided.

NOTE

PLACE A CHEMICAL STERILIZATION INDICATOR ON EVER Y TRAY TO INDICATE THAT THE

PROCESS HAS OCCURRED

, WORSE, USING NON-STERILIZED MATERIAL. IF PROCESSING WRAPPED MATERIAL,

OR PLACE THE INDICATOR INSIDE

: THIS AVOIDS USELESSLY REPROCESSING THE SAME LOAD

ONE OF THE WRAPPINGS.

7. PREPARING THE MATERIAL

OK OK

Notes for rubber and plastic tubing

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

Notes for packets and packages

– Arrange packages side-by-side, suitably spaced and absolutely not

piled, to avoid their

coming in contact with the walls of the chamber.

– Whenever it is necessary to wrap particular objects, always

use suitably porous material (sterilization paper, muslin napkins, etc.), closing the wrapping with autoclave adhesive tape.

Notes for wrapped material

– Wrap instruments individually

wrapping, make sure that they are made of the same metal

– Seal the wrapping with adhesive tape

or, when more than one instrument are placed in the same

;

for autoclaves or heat-sealing machines.

– Do not use staples, pins or other fasteners since they can compromise the maintenance of

sterility;

– Arrange the envelopes so as to avoid forming air pockets that obstruct the correct

penetration and removal of the steam.

– Orient the envelopes so as to leave the plastic side up and the paper side down (tray

side).

– In any case, check that they are correctly positioned, turning them over – If possible, place the envelopes edgewise – Never

superimpose envelopes on top of each other.

to the tray, with a suitable support.

, if necessary.

WARNING

WHENEVER YOU ANTICIPATE PROLONGED STORAGE, ALWAYS WRAP THE INSTRUMENTS. SEE THE CHAPTER, “PRESERVING STERILIZED MATERIAL”.

8. PROGRAM SELECTION

PROGRAM SELECTION

INTRODUCTION

PROCEDURE

Program selection is fundamental Since each instrument, or material in general, has different shape, consistency and properties,

it is important to identify the most suitable program for it characteristics (avoiding or, at any rate, limiting alterations) as well to guarantee the most effective sterilization.

A GUIDE TO SELECTING THE MOST SUITAB LE PROGRAM FOR THE LOAD IS PROVIDED IN

APPENDIX B (PROGRAMS).

Power-on the device as described in the Chapter, “First Start-Up”.

IF A PASSWORD HAS BEEN ENABLED (SEE THE CHAPTER CONFIGURATION - SETTING

THE PASSWORD

↵ to enter

Ç to exit

Enter the password using the + and – keys. Confirm with the ↵ key. The display does not offer any active preselection.

The device is waiting for the user to select Press the PROGRAM SELECTION key one or more times until you reach the desired

program (1, 2, 3 or 4, also shown on the upper left of the display).

WHEN THE SELECTION KEY IS PRESSED, THE FIRST STERILIZATION PROGRAM PROPOSED

IS THE ONE USED FOR THE LAST CYCLE EXECUTED

In the two lines above the description, the display shows the description program and the type of drying set and, below, the set-point values for the temperature (°C), pressure (bar) and time (mm:ss) of the cycle selected. By way of example, the display shows:

1 134°C POROUS

134.0 °C (B)

2.10 bar 04:00

After a brief interval, the display changes and shows the temperature and pressure values of the chamber, with the current date and time.

1 134°C POROUS

101.0 °C 30/08/02

0.01 bar 18:13:05

for a successful sterilization process.

, both for preserving its physical

NOTE

), YOU WILL BE ASKED TO ENTER THE ACCESS CODE:

INSERT PASSWORD

a program.

NOTE

NORMAL DRYING

of the selected

To cancel the selection, press ESC Ç on the control panel.

8. PROGRAM SELECTION

NOTE

IF NO STERILIZATION PROGRAM IS SELECTED, THE EQUIPMENT CANNOT START A

STERILIZATION CYCLE

A BEEP

, AND THE FOLLOWING MESSAGE APPE ARS ON THE DISPLAY, WITH

SELECT A PROGRAM

PLEASE...

WARNING

IF YOU USE A PROGRAM THAT IS INAPPROPRIATE FOR THE TYPE OF MATERIAL TO BE STERILIZED (SEE APPENDIX B) THE EFFECTIVENESS OF THE STERILIZATION PROCESS IS NOT GUARANTEED.

9. RUNNING THE PROGRAM

RUNNING THE CYCLE

INTRODUCTION

STARTING THE CYCLE

Password check

Printer paper-out check

If Millflash is connected

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

The electronic control system monitors the various phases, at the same time checking that the various parameters are respected; if any type of anomaly is encountered during the cycle, the program is immediately interrupted, generating an alarm identified by a code, with a relative message 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 placing the load in the sterilization chamber (with the precautions explained in the

Chapter, “Preparing the Material”) and selecting the desired program, close the door until you hear the click.

The door status icon Press the START button.

IF A PASSWORD HAS BEEN ENABLED WITH THE OPTION ANY CYCLE START (SEE THE

Enter the password using the + and – keys. Confirm with the ↵ key.

The equipment checks the presence of the paper into the on-board printer; if out or ended the following message will be displayed:

Push key ↵ to continue however (replace the paper during or at the end of the sterilisation cycle). Push key Ç to return in Stand-by mode.

Depending on the type of the device connected, the equipment checks the presence of the Compact Flash card. If not plugged in, the display shows:

CHAPTER CONFIGURATION - SETTING THE PASSWORD), YOU WILL BE ASKED TO ENTER

THE ACCESS CODE

flashes (door closed).

NOTE

INSERT PASSWORD

↵ to enter Ç to exit

WARNING

PAPER OUT ↵ to continue Ç to exit

WARNING CF CARD MISSING ↵ to continue Ç to exit

Plug in the CF card in the recording device and press the key ↵ on the command panel. Push the key Ç to interrupt the start command and return in Stand-by mode.

9. RUNNING THE PROGRAM

Door locking

In case of the memory full or insufficient to store the new cycle data, the following message will be displayed:

WARNING

CF CARD FULL ↵ to continue Ç to exit

WARNING

MEMORY FULL ↵ to continue Ç to exit

Push key ↵ to continue without recording the cycle data. Push key Ç to interrupt the start command; download the files on PC and delete the memory

content according to the instructions of the Millflash Operating Manual. Repeat the Start command.

The equipment locks the door. The door status icon

When START is pushed, and for the entire sterilization cycle show the following parameters:

Pressure of the sterilization chamber (bar) Temperature of the sterilization chamber (°C) Progressive time of the sterilization cycle (mm:ss)

remains steady on

1 134°C POROUS

WARMUP

101.9 °C

0.01 bar 00:00

(door locked).

, the lower lines of the display will

PROGRAM EXECUTION

Preheating

The time is counted from the start of the sterilization cycle (first vacuum phase), excluding the preheating phase.

Now, we will analyze the execution of a sterilization cycle, phase by phase. For our example, let's take the most complete POROUS, which is characterized by a fractionated pre-vacuum.

When the START button is pressed, the first phase is PREHEATING, which brings the chamber to temperature required for starting the cycle. The display shows the following:

1 134°C POROUS

WARMUP

23.9 °C

0.01 bar 00:00

The icon that shows the status of the sterilization process

and important cycle, i.e., the program 134 °C

is off.

9. RUNNING THE PROGRAM

First vacuum phase

First rise in pressure

Second vacuum phase

Second rise in pressure

Third vacuum phase

When the optimum temperature is reached, the first vacuum phase (1st VACUUM PULSE) is started and brings the chamber pressure down to the established value. The display shows:

1 134°C POROUS

1. VACUUM PULSE

84.1 °C

-0.69 bar 01:25

When the pre-set vacuum value is reached, steam is injected and the pressure begins to rise (1st PRESSURE PULSE), until the established value is reached.

1 134°C POROUS

1. PRESSURE PULSE

108.0 °C

0.47 bar 03:58

At the end of the pressure rise, the steam, mixed with residual air, is discharged and the second emptying of the sterilization chamber begins (2nd VACUUM PULSE).

1 134°C POROUS

2. VACUUM PULSE

93.3 °C

-0.79 bar 06:06

After the second vacuum phase, steam is again injected into the sterilization chamber, with a relative rise in pressure (2nd PRESSURE PULSE).

1 134°C POROUS

2. PRESSURE PULSE

11.4 °C

0.72 bar 07:44

The icon that shows the status of the sterilization process

is always off.

At the end of the second pressure rise, there is another discharge and the last vacuum phase begins (3rd VACUUM PULSE).

1 134°C POROUS

3. VACUUM PULSE

89.9 °C

-0.80 bar 09:52

9. RUNNING THE PROGRAM

Third rise in pressure

Thermodynamic equilibrium

Sterilization time

Steam discharge

After the last vacuum phase, the pressure in the sterilization chamber must rise to the value set for the sterilization process (3rd PRESSURE PULSE), always through the injection of steam.

1 134°C POROUS

3. PRESSURE PULSE

128.6 °C

1.70 bar 12:33

When the pressure and temperature values for the selected program have been reached, it is a good idea to wait a moment to allow the temperature in the chamber and the load to stabilize (EQUILIBRATION). The liquid crystal display shows:

1 134°C POROUS

EQUILIBRATION

135.4 °C

2.15 bar 13:40

When the thermodynamic parameters are balanced, the actual sterilization phase of the materials begins (HOLDING TIME). Thanks to continuous monitoring of the thermodynamic parameters and sophisticated management of the plumbing circuit, the pressure and temperature are maintained constant within the limits required by the program. A countdown begins of the sterilization time. The display shows the following:

1 134°C POROUS

HOLDING TIME

135.6 °C 04:00

countdown

2.16 bar 13:55

The icon for the sterilization process status flashes to indicate that the treatment of the load is in progress.

At the end of the sterilization phase, the icon

remains steady on

to indicate the complete

sterilization of the material in the sterilization chamber.

WARNING

IF, FOR SOME REASON, THE STERILIZATION CYCLE HAS BEEN INTERRUPTED BEFORE COMPLETION, THE ICON CONTINUES

FLASHING. IN THIS CASE, THE MATERIAL CANNOT BE CONSIDERED STERILE AND MUST ABSOLUTELY NOT BE USED.

At the end of the sterilization phase, the steam is released from the sterilization chamber (STEAM DISCHARGE). The liquid crystal display shows:

1 134°C POROUS

DEPRESSURIZATION

123.9 °C

1.24 bar 18:20

The icon for the sterilization process status

is steady on.

9. RUNNING THE PROGRAM

EXTRA DRYING

set

Drying

Ventilation

Leveling to the atmospheric pressure

Completion of the cycle

After the steam under pressure is released, its forced removal begins with the vacuum pump (DRYING): for this purpose, low pressure is created in the sterilization chamber to facilitate the evaporation of the steam and its consequent elimination. As a function of the type of drying set, one of the following screens will appear:

1 134°C POROUS

DRYING (NOR)

Standard drying

101.1 °C

0.00 bar 18:51

1 134°C POROUS

DRYING (INT)

Intelligent drying

101.1 °C

0.00 bar 18:51

1 134°C POROUS

DRYING (+XX)

101.1 °C

(+XX) is the time

0.00 bar 18:51

When the drying phase is finished, it is followed by a VENTILATION phase in which fresh sterile air is injected, while maintaining a vacuum in the chamber, to eliminate condensate and cool the load.

1 134°C POROUS

VENTILATION

84.4 °C

-0.77 bar 26:51

At the end of the ventilation phase, the chamber is brought back to atmospheric pressure (LEVELLING) by injecting sterile outside air to allow the opening of the door and the retrieval of the load.

1 134°C POROUS

LEVELLING

86.9 °C

-0.43 bar 29:21

When the pressure in the sterilization chambers returns within the pre-set safety limits, the door lock system is released.

As a consequence, the door status indicator flashes. At the same time, it also beeps.

1 134°C POROUS

CYCLE COMPLETE

86.2 °C

-0.02 bar 29:40

The icon for the sterilization process status

is steady on.

9. RUNNING THE PROGRAM

Open the door

Report print

Equipment ready

RESULT OF THE CYCLE

NOTE

AT THE END OF THE CYCLE, AND UP TO THE OPENING OF THE DOOR, THE HEATING

ELEMENTS ARE OFF REGARDLESS OF WHAT THE

. AS A CONSEQUENCE, THE DEVICE IS SLOWLY COOLING

STAND-BY MODE IS.

NOTE

WHENEVER THE STERILIZER'S' DOOR IS NOT OPENED AT THE END OF THE CYCLE, THE

VACUUM PUMP IS PERIODICALLY FROM THE STERILIZATION CHAMBER

ACTIVATED TO REMOVE ANY TRACES OF CONDENSATE

. THE DISPLAY SHOWS:

FORCED VENTILATION

Ç to stop

35.2 °C

-0.02 bar 29:40

Press Ç to interrupt ventilation and open the door.

the door and retrieve the sterilized material, using the extractor provided.

Open The icon

symbol goes off.

When the door is opened, the device goes to STAND-BY mode as previously set.

When the door is opened, the report for the sterilization cycle executed is automatically produced. Check the document, initial it in the space provided and file it in a suitable place. Refer to the print report examples shown in Appendix B, Programs.

NOTE

IF SELECTED THE PRINTOUT STEP BY STEP OPTION, THE REPORT WILL BE PRINTED

DURING THE PHASES OF THE CYCLE

The device is ready

to execute a new cycle. Repeat the procedures explained in the Chapter, “Program Selection” for executing a new sterilization cycle.

After the cycle is finished, it is important to check the sterilization results.

Whenever a cycle finishes (message CYCLE COMPLETE and icon

on ), without, therefore, being interrupted by any type of alarm, you are guaranteed to have completely aseptic material.

The report of the sterilization parameters is an additional check tool.

9. RUNNING THE PROGRAM

> 3s

CHECK OF THE CYCLE DATA REPORT

MANUAL CYCLE INTERRUPTION

However, it is a good practice to check that the print report issued at the end of the sterilization program, also specifies a positive outcome.

At the end of the cycle, the salient data for the thermodynamic parameters of the sterilization, temperature and pressure (°C and bar), and time (minutes) of the sterilization cycle, with particular attention to the sterilization phase true and proper, is printed by simply opening the door.

So, check the values on the print report and any additional indications for a further confirmation of the good outcome of the sterilization process.

The operator should sign in the space provided and file the document for possible future use. If necessary, copies of the document can be used to identify the load (or parts of it) with the

date/time of sterilization and details of the type of cycle performed.

To select the number of copies to print, consult Chapter 6

NOTE

THE OPERATOR CAN ALSO REQUEST AN EXTENDED PRINTOUT OF THE STERILIZATION

PROCESS DATA ON THE MACHINE. TO START THIS PRINT FUNCTION, HOLD DOWN THE Ç (ESC) KEY ON THE CONTROL PANEL WHILE OPENING THE DOOR

OR COMPLETE DETAILS ABOUT PRINTING THE SUMMARY, PLEASE REFER TO THE

REPORT EXAMPLES SHOWN IN

The operator can manually interrupt the cycle at any time by pressing the START/STOP key for three seconds. The command generates the error E999 consequence, until safe conditions are reached, the display shows, along a beep:

101.2 °C E999

-0.47 bar 26:01

, INCLUDING THE RECORDED VALUES OF ALL THE SENSORS INSTALLED

APPENDIX B, PROGRAMS.

, given that the cycle did not finish correctly. As a

MANUAL STOP

LEVELLING...

, Configuring.

Error code

When safe condi tion s are re ache d, the machi ne acti vates a spec ial pro cedure user to manually unlock the door by displaying the following instruction:

PRESS Ç TO

UNLOCK THE DOOR

86.2°C E999

-0.02 bar 26:01

Press the Ç key to unlock the door. The following message is then displayed:

MANUAL STOP

OPEN THE DOOR

85.8°C E999

-0.01 bar 26:01

, first ask ing t he

9. RUNNING THE PROGRAM

> 3s

Finally, when the door is opened, you will be asked to reset the device by the following message:

MANUAL STOP

RESET SYSTEM

85.5°C E999

-0.01 bar 26:01

To RESET the system, hold down, for at least three seconds,

the PROGRAM SELECTION

key until you hear the confirming beep. When the door is opened, the report for the sterilization cycle executed is produced, including

the error code (E999). Check the report, initial it in the space provided and file it in a suitable place. Refer to the print report examples shown in Appendix B

, Programs.

After the RESET, the device goes to STAND-BY mode, ready to execute a new program

NOTE

WHENEVER AN ALARM IS GENERATED IN CERTAIN PHASES OF THE CYCLE, AN

AUTOMATIC PROCEDURE IS ACTIVATED TO CLEAN THE PLUMBING CIRCUIT COMPLETE DESCRIPTION OF THE ALARMS

, SEE APPENDIX E “ALARMS”.

. FOR A

WARNING AFTER A PROGRAM IS MANUALLY INTERRUPTED (MANUAL STOP) ALWAYS CHECK THE STATUS OF THE ICON

BEFORE USING THE

MATERIAL IN THE STERILIZATION CHAMBER. IF THE ICON

IS STEADY ON, THE MATERIAL IN THE STERILIZATION CAN BE CONSIDERED STERILE AND, THUS, BE USED. WE RECOMMEND USING IT IMMEDIATELY.

HOWEVER, IF IT IS OFF, THE MATERIAL IN THE STERILIZATION CHAMBER CANNOT BE CONSIDERED STERILE AND ABSOLUTELY MUST NOT BE USED.

10. STORING STERILIZED MATERIALS

STORING STERILIZED MATERIALS

INTRODUCTION

HANDLING

STORAGE

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

Inadequate storage can 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 operator 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

1. Remove the load from the sterilization chamber wearing gloves better, sterilized smock

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 or damage

4. Let the instruments cool transport, transfer the material using dry, clean and disinfected containers. The containers must be closed

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 useless and completely senseless, is also potentially damaging;

2. Store the material in a dry 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 consequent risks.

5. Never degrade and be recontaminated in a finite time, even when the above instructions are followed.

the wrappings;

store material for too long. In fact, do not overlook the fact that materials will tend to

CONSULT THE SPECIFICATIONS PROVIDED BY THE MANUFACTURER OF THE PACKAGING

MATERIAL RELATIVE TO THE MAXIMUM ALLOWED STORAGE TIME

cause rapid recontamination.

and/or carrying sterile material:

and a clean, or even

. As an additional precaution, wear a protective mask on your face;

to cut

before any transport (and subsequent storage). If necessary for

or, if open, covered wi th clean cloths.

wrap the instruments after sterilization since, in addition to being

, suitably clean and disinfected place, far from the area where

, avoiding storing for too long, with the

NOTE

11. TEST PROGRAMS

LASH CARD AND ITS

TEST PROGRAMS

INTRODUCTION

HELIX/BD TEST

To protect the safety of users and patients, a fundamental

process like sterilizing medical

devices should be periodically checked. In this regard, Millennium B² offers the possibility of, simply and automatically, executing two

distinct test programs:

• HELIX/BDTest

• Vacuum Test

The HELIX/BD Test program executes a cycle at 134 °C characterized, however, by a sterilization phase of a particular duration (3.5 min); the cycle has a fractionated vacuum phase similar to that used in the POROUS and HOLLOW programs. Using a suitable device, it is possible to evaluate the correct penetration of the steam inside hollow loads (see the following paragraph). This cycle is also suitable for measuring the penetration of the steam inside porous loads (Bowie & Dick test pack).

On the other hand, the Vacuum Test program allows checking the perfect seal of the sterilizer's entire plumbing system. By measuring the variation in the degree of vacuum in a certain span of time and comparing it with pre-set limit values, it is possible to determine the effectiveness of the seal of the sterilization chamber, the various tubes and the cut-off devices.

To select the HELIX/BD Test program, press the Test Selection key one or two times until the display reads:

HELIX/BD TEST

134.0°C

2.15 bar 03:30

The test device is a 1.5-m tube made of PTFE with an internal diameter of 2 mm, with a small sealed screw capsule attached to one end, capable of holding a suitable amount of chemical. The other end of the tube is left free to allow the penetration of the steam and evaluate its effectiveness.

To execute the test insert the chemical indicator, which consists of a strip of paper with a special reagent ink, inside the capsule of the device (which is always to be used perfectly dry). Tighten the capsule so that seepage through the gasket seal will not

be possible.

NOTE

THE DEVICE AND CHEMICAL INDICATORS FOR RUNNING THE HELIX/BD TEST PROGRAM

ARE NOT CONTACT M.O.COM.'S CUSTOMER SUPPORT DEPARTMENT (SEE APPENDIX Z).

SUPPLIED WITH THE DEVICE. TO REQUEST INFORMATION IN THIS REGARD,

Place the device on the device's central tray, approximately in the middle. Do not put any other material inside the chamber.

Close the door and start the program with the START key.

NOTE

IF A PASSWORD HAS BEEN SET WITH THE ANY CYCLE START OPTION (SEE THE CHAPTER, CONFIGURATION, SETTING THE PASSWORD), YOU WILL BE ASKED TO ENTER

THE ACCESS CODE

N ADDITION, THE EQUIPMENT CHECKS THE PRINTER PAPER PRESENCE AND, IF

I MILLFLASH IS CONNECTED, THE PRESENCE OF THE COMPACT F

MEMORY CAPACITY.

HE POSSIBLE WARNING MESSAGES, AND THE CONSEQUENT ACTIONS TO CARRY OUT,

ARE THE SAME AS DESCRIBED FOR A STANDARD STERILIZATION CYCLE

11. TEST PROGRAMS

VACUUM TEST

The cycle phases are analogous to what is described in the Chapter, “Running a Sterilization Program”.

At the end of the program, remove the test device, open the capsule and remove the indicator from its housing.

If the steam has correctly penetrated, the ink will have completely changed color from what it was before, along the entire length of the strip; if not (insufficient penetration) there will be only a partial variation or none at all.

NOTE

NORMALLY THE COLOR CHANGE IS FROM A LIGHT COLOR (BEIGE, YELL OW, ETC.) TO A

DARK COLOR INSTRUCTIONS PROVIDED BY THE INDICATOR USE AND INDICATION AND ANY OTHER TECHNICAL DETAILS

(BLUE, VIOLET OR BLACK). IN ANY CASE, SCRUPULOUSLY FOLLOW THE

'S MANUFACTURER FOR ITS METHODS OF

The duration of the test is about 22 minutes. As the door is opened at the end of the cycle, a report will be printed of the salient data for the

test cycle performed. Attach the chemical indicator in the space provided, initial the document and file it in a suitable place.

For complete details about printing summaries, please refer to the report examples shown in

Appendix B

, Programs.

To select the VACUUM TEST program, press the Test Selection key one or two times until the display reads:

VACUUM TEST

-0.80 bar

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

NOTE

RUN THE VACUUM TEST AS THE FIRST CYCLE AFTER POWERIN G-ON THE EQUIPMENT.

, and only the trays

To avoid the heating of the sterilization chamber influencing the variation of the vacuum value measured during the Vacuum Test, the system is programmed to prevent its execution when the temperature sensors of the sterilization chamber shows a value higher than 50° C.

If you try to start the program with a higher temperature than indicated above, the liquid crystal display will read:

WARNING!

PT1 OVERHEATING

-0.80 bar

After a short time, the device will automatically return to STAND-BY mode, ready for use.

NOTE

TO RAPIDLY LOWER THE TEMPERATURE OF THE CHAMBER AND, THUS, PERFORM TH E VACUUM TEST, LEAVE THE STERILIZER'S DOOR OPEN UNTIL THE CORRECT

TEMPERATURE IS REACHED

11. TEST PROGRAMS

LASH CARD AND ITS

Close the door and start the program with the START key.

NOTE

IF A PASSWORD HAS BEEN SET WITH THE ANY CYCLE START OPTION (SEE THE CHAPTER, CONFIGURATION, SETTING THE PASSWORD), YOU WILL BE ASKED TO ENTER

THE ACCESS CODE

N ADDITION, THE EQUIPMENT CHECKS THE PRINTER PAPER PRESENCE AND, IF

I MILLFLASH IS CONNECTED, THE PRESENCE OF THE COMPACT F

MEMORY CAPACITY.

HE POSSIBLE WARNING MESSAGES, AND THE CONSEQUENT ACTIONS TO CARRY OUT,

ARE THE SAME AS DESCRIBED FOR A STANDARD STERILIZATION CYCLE

The vacuum phase begins immediately and the display reads:

VACUUM TEST

VACUUM PULSE

-0.69 bar 01:02

The display shows the pressure (bar), and the total time from the start of the program. When the pre-set pressure is reached (-0.80 bar) the pump stops and the pressure

stabilization phase begins (

WAITING PERIOD

), which lasts 5 minutes

(shown on the display

as a scalar value):

VACUUM TEST

WAITING PERIOD

05:00

-0.80 bar 01:48

During this phase, a variation of the maximum low pressure is allowed of not more than 10%, without this causing the test to fail.

When the wait phase ends, the pressure verification

phase, true and proper, begins

(LEAKAGE PERIOD), with a duration of 10 minutes:

VACUUM TEST

LEAKAGE PERIOD

10:00

-0.79 bar 06:48

In this phase, a variation of up to ±0.02 bar is allowed, compared to the initial phase value. Higher variations cause the test to fail. The time is counted down until the phase is completed.

When this phase is also completed, the pressure is brought back to atmospheric pressure.

VACUUM TEST

LEVELLING

-0.29 bar 17:19

11. TEST PROGRAMS

When the program finishes , the display will read:

VACUUM TEST TEST PASSED

-0.01 bar 17:44

The end of the program is signaled with a beep.

NOTE

IF THE PRESSURE CHANGE EXCEEDS THE PRE-SET LIMIT, THE PROGRAM IS INTERRUPTED

AND ALARM MESSAGE IS GENERATED

EE A COMPLETE DESCRIPTION OF THE ALARMS IN APPENDIX E .

The duration of the test is about 18 minutes. When the door is opened at the end of the program, a report of the test cycle is printed with all

the salient data. For complete details about printed reports, please refer to the examples shown in Appendix

B, Programs.

APPENDIX A – TECHNICAL CHARACTERISTICS

SUMMARY TABLE

Device Steam Sterilizer Classification (as per 93/42 CEE) Model

Manufacturer

Power supply voltage Frequency 50/60 Hz Mains fuses

(6.3 x 32 mm)

On-board fuses (board type “G”)

(5 x 20 mm)

On-board fuses (board type “T”) (5 x 20 mm)

External dimensions (LxDxH) 480 x 660x 420 mm (excluding rear connections) Nominal power 2300 W (10A)

Insulation class Installation category Environment of use

Noise level <60 db(A)

Environmental operating conditions

Net weight

Sterilization chamber dimensions

(Ø x D)

Sterilization chamber total volume about 21 l (0.021 m3) Sterilization chamber us eful volume

(with tray supports inserted)

Distilled water tank capacity

(supply)

Sterilization programs

Test programs Preheating time (from cold) about 10 minutes

Serial connection DB-9 pin (female) connector Bacteriological filter

(PTFE filtering element)

M.O.COM. S.r.l.

Via delle Azalee, 1

20090 BUCCINASCO (MI) - ITALY

220V – 240 V~

F 16A 250V

F1: T 5A 250V (trafo second ary wi ndi ng– 24V ) F2: T 2A 250V (digit al sig nal 5V/an alo g 12V) F3: T 2A 250V (trafo primary winding – 230V) F4: F 200mA 250V (door-locking protection) F5: F 1.25A 250V (door-locking gear motor overload) F1 PTR: T 5A 250V (printer protection)

F1: T 6,3A 250V (trafo secondary winding) F2: T 3.15A 250V (trafo primary winding) F1 PTR: T 3,15A 250V (printer protection)

Class I Cat. II Internal use

Temperature: +15 °C ÷ +40 °C Relative humidity: max 80%, non-condensing Altitude: max 3000 m (a.s.l.)

about 58 kg (empty) about 63 kg (empty with trays and support)

about 67 kg (empty, with trays and supports and water at MAX level)

250 x 450 mm

about 13 l (0.013 m

about 4.6 l (water at MAX level) about 0.8 l (water at MIN level)

Available: 11 (see Appendix B) Pre-sets: 4 (direct selection by user)

HELIX/BD Test Vacuum Test

Porosity: 0.2 µm Connection: male 1/8" NPT connector

)

APPENDIX A – TECHNICAL CHARACTERISTICS

SAFETY DEVICES

The sterilizer is equipped with the following safety devices

– Mains fuses (see summary table data)

Protection inside the device against a fault in the heating elements. Action

: cuts the electricity.

– Fuses protecting the electronic circuits (see summary table data)

Protection against a fault in the primary transformer circuit and low voltage uses. Action: cuts power to one or more low-voltage circuits.

– Thermal circuit break er s on the mains voltage windings

Protection against overheating of the vacuum pump motor and the primary transformer windings. Action: temporary cut-off (until cooling) of the winding.

– Safety valve

Protection against overpressure in the steriliz ati on cha mber.

: release of the steam and restoration of the safety pressure.

Action

– Steam genera tor manual rearm safety thermostat

Protection against steam generator overheating. Action: cut-off of the electricity to the steam generator.

– Heating element manual rearm safety thermostat

Protection against overheating of the heating elements of the container under pressure. Action

: cut-off of the electricity to the chamber heating element.

– Door position safet y microswitch

Confirmation of the correct closing position of the door of the container under pressure. Action: signals wrong door position.

– Mechanized door lock mechanism with electromechanical protection (pressure switch)

Protection against accidental opening of the door (even in a blackout). Action: prevents accidental opening of the door during a program.

– Door lock mechanism safety microswitch

Confirmation of the correct closing of the door lock.

: signaling the failure or incorrect operation of the door lock mechanism.

Action

– Self-leveling plumb ing system

Plumbing system structure for the spontaneous lev el ing of the pressure in the case of a manual interruption of the cycle, alarm or blackout.

: automatic restoration of atmospheric pressure in the sterilization chamber.

Action

– Integrated system for evaluating the sterilization process

Continuous verification of the sterilization process parameters entirely managed by microprocessor.

: immediate interruption of the program (in case of anomaly) and generation of alarms.

Action

– Monitoring of the sterilizer's operation

Real-time oversight of all significant parameters when the machine is powered. Action: generation of alarm messages (in the case of anomaly) with possible interruption of the cycle.

for which we provide a brief description of their function:

APPENDIX A – TECHNICAL CHARACTERISTICS

WATER SUPPLY CHARACTERISTICS

DESCRIPTION WATER SUPPLY VALUES

DRY RESIDUE SILICON OXIDE SiO2 IRON CADMIUM LEAD HEAVY METAL RESIDUES

(except iron, cadmium and lead)

< 10 mg/l

< 1 mg/l

< 0.2 mg/l

< 0.005 mg/l

< 0.05 mg/l

< 0.1 mg/l

VALUES IN

CONDENSATE

< 1 mg/l < 0.1 mg/l < 0.1 mg/l

< 0.005 mg/l

< 0.05 mg/l

< 0.1 mg/l

CHLORINES PHOSPHATES CONDUCTIVITY AT 20 °C

pH VALUE APPEARANCE

HARDNESS

WHEN PURCHASING DISTILLED WATER, ALWAYS CHECK THAT THE QUALITY AND CHARACTERISTICS

DECLARED BY THE PRODUCER ARE COMPATIBLE WITH THOSE SHOWN IN THE TABLE

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.

< 2 mg/l

< 0.5 mg/l

< 15 µs/cm < 3

colorless, transparent,

without sediments

< 0.02 mmol/l

NOTE

WARNING

5 - 7

< 0.1 mg/l < 0.1 mg/l

s/cm

5 - 7

colorless, transparent,

without sediments

< 0.02 mmol/l

APPENDIX B – PROGRAMS

INTRODUCTION

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

The following material can normally

– Stainless steel surgical/generic instruments; – Carbon steel surgical/generic instruments; – Rotating and/or vibrating instruments driven by compressed air (turbines) or mechanical transmission (counter-angles,

tooth scalers); – Glass articles: – Mineral-based articles; – Articles made of heat-res ist ant plastic; – Articles made of heat-res ist ant rubber; – Heat-resistant textiles; – Medication mat eria ls ( gauz e, p ads, etc. ); – Other generic material suitable for autoclave treatment.

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 TAB LE SHOWN ON THE NEXT PAGE

THE DEVICE MUST NOT BE USED FOR STERILIZING FLUIDS, LIQUIDS OR PHARMACEUTICAL PRODUCTS.

be sterilized with steam:

NOTE

WARNING

APPENDIX B – PROGRAMS

134

2.10

> 4

PROGRAM SUMMARY TABLE

NOMINAL VALUES

BASIC PROGRAM

PARAMETERS

STERILIZABLE MA TERIAL

PROGRAM

DESCRIPTION

134 °C POROUS

134 °C PRION

121 °C POROUS

134 °C HOLLOW

121 °C HOLLOW

134 °C WRAPPED

121 °C WRAPPED

134 °C SOLID

121 °C SOLID

134 °C EMERGENCY

XXX°C CUSTOM

(see note)

HELIX/BD TEST

VACUUM TEST

(°C)

Pressure

Temperature

134 2,10

121 1,10

134 2,10

121 1,10

134 2,10

121 1,10

134 2,10 121 1,10

134 2,10

121

1.10

134 2.10

- -0.80

(bar)

(min)

Cycle type

(EN 13060)

Holding time

4 B F L 40÷44 675 0.8

>18 B F L 52÷56 700 0.9

20 B F L 54÷58 700 0.8

4 S F S 36÷42 625 0.7

20 S F S 50÷56 700 0.7

4 S S L 30÷32 375 0.6

20 S S L 44÷46 400 0.6

4 N S S 24÷26 375 0.5

20 N S S 38÷40 400 0.5

3 N S

> 20

3.5 - F S 22 - -

- - - -

Pre-vacuum

(F=fractionated; S=single)

n.d. F/S L/S n.d. n.d. n.d.

Standard drying

Fast

(L=long; S=short)

Total cycle time

14 375 0.45

18 -

(ml/cycle)

(average load ÷ max load)

Average consum pti o n H

TYPE

(kWh/cycle)

Average energy co ns um p ti on

Porous, unpackaged material Porous material in single package Porous material in double package Solid and hollow material in single package Solid and hollow instruments in double package Porous, unpackaged material Porous material in single package Porous material in double package Hollow instruments in single package Solid and hollow instruments in double package Porous, unpackaged material Porous material in single package Porous material in double package Hollow instruments in single package Solid and hollow instruments in double package

Unpackaged hollow instruments

Solid instruments in single package

Unpackaged solid instruments Unpackaged solid instruments

Unpackaged solid instruments

Unpackaged solid instrument s

Test device only

(no other load)

- Empty chamber

(kg)

MAX MASS

PER TRAY (kg)

MAX TOTAL MASS

1,25

0,40 0.30

1,00

0,30 0.25

0,75

0,25 0.20

4,00

1,25 0.25

2,00

0,60 0.25

1,25

0,40 0.30

1,00

0,30 0.25

0,75

0,25 0.20

4,00

1,25 0.25

2,00

0,60 0.25

1,25

0,40 0.30

1,00

0,30 0.25

0,75

0,25 0.20

4,00

1,25 0.25

2,00

0,60 0.25

7,50

1,50 0.50

7,50

1,50 0.50

4,00

1,25 0.25

4,00

1,25 0.25

7,50

1,50 0.50

7,50

1,50 0.50

0,50

0,50 0.50

n.d. n.d. n.d.

- - -

- -

PER ARTICLE (kg)

For material and

instruments in

(single and

packaging, we

recommend

using the 3-tray

configuration

We recommend using the 3-tray

configuration

parameters

depending on

the settings

NOTES

double)

Variable

made

APPENDIX B – PROGRAMS

1) FRACTIONATED = PRE-VACUUM WITH THREE VACUUM PULSES (SEE FIGURES IN THE FOLLOWING PAGES)

INGLE = PRE-VACUUM WITH SINGLE VACUUM PULSE (SEE FIGURES IN THE FOLLOWING PAGES)

2) L

ONG = 10 MINUTES VACUUM DRYING (TYPICAL OF POROUS AND WRAPPED CYCLES)

HORT = 4 MINUTES VACUUM DRYING (TYPICAL OF HOLLOW AND SOLID CYCLES )

3) A

CCESS TO A CUSTOM CYCLE DOES NOT REQUIRE A PASSWORD. NONE OF THE COMBINATIONS POSSIBLE IN

THE CUSTOMIZATION PHASE CREATE ANY RISKS OR DANGERS OF INJURY TO THE OPERATOR OR DAMAGE TOT HE DEVICE

NOTES

APPENDIX B – PROGRAMS

STERILIZATION PROGRAM DIAGRAM

Pressure (bar)

PROCESS

2.10

2.00

1.00

PROGRAM

134c POROUS

134°C - 4' 00''

PROGRAM

134c PRION

134°C - 18' 00''

0.00

-0.80

Pressure (bar)

1.10

1.00

PRE-VACUUM

PROCESS

LONG DRYING

Time (min)

PROGRAM 121c POROUS 121°c - 20'00''

0.00

-0.80

Time (min)

FRACTIO N AT ED PRE-VACUUM

LONG DRYING

APPENDIX B – PROGRAMS

Pressure (bar)

2.10

2.00

1.00

PROCESS

PROGRAM 134c HOLLOW

134°C - 4'00''

0.00

-0.80

-1.00

Pressure (bar)

1.10

1.00

FRACTIONATED PRE-VACUUM

PROCESS

SHORT DRYING

Time (min)

PROGRAM 121c HOLLOW 121°c - 20'00''

0.00

-1.00 PRE-VACUUM

Time (min)

SHORT DRYING

APPENDIX B – PROGRAMS

Pressure (bar)

PROGRAM

PROCESS

2.10

2.00

1.00

134c WRAPPED

134°C - 4'00''

0.00

-1.00 ONE SHOT PRE-VACUUM

Pressure (bar)

1.10

1.00

PROCESS

LONG DRYING

Time (min)

PROGRAM

121c WRAPPED

121°C - 20'00''

0.00

-1.00 ONE SHOT PRE-VACUUM

LONG DRYING

Time (min)

APPENDIX B – PROGRAMS

Pressure (bar)

2.10

2.00

1.00

PROCESS

PROGRAM

134c SOLI D

134°C - 4'00''

0.00

-1.00 ONE SHOT PRE-VACUUM

Pressure (bar)

1.10

1.00

Time (min)

SHORT DRYING

PROGRAM 121c SOL ID 121°C - 20'00''

PROCESS

0.00

-1.00 ONE SHOT PR E- VACUUM

Time (min)

SHORT DRYING

APPENDIX B – PROGRAMS

PROGRAM

Time (min)

SETUP

SHORT DRYING

Pressure (bar)

PROGRAM

134c EMERGENCY

PROCESS

2.10

2.00

1.00

134°C - 3'00''

0.00

-1.00 ONE SHOT PRE-VACUUM

Pressure (bar)

2.10

2.00

1.10

1.00

SETUP

ONE SHOT PRE-V ACUUM

FRACTIONATED PRE-VACUUM

DRYING

Temperature:

4’÷30’ (134°C)

Time:

20’÷30’ (121°C)

134°C 121°C

Time (min)

XXXc CUSTOM

134°C - from 4'00'' to 30'00''

121°C - from 20'00'' to 30'00’’

0.00

LONG DRYING

-1.00

APPENDIX B – PROGRAMS

Time (m in)

t2 = t1+300 s

t3 = t2+600 s

End co nd i ti on for

positive test result

DIAGRAMS OF THE TEST PROGRAMMES

Pressure (bar)

2.10

2.00

1.00

0.00

PROCESS

PROGRAM

BOWIE & DICK TEST

134°C - 3'00' '

Pressure (bar)

0.00

-1.00

1.00

VACUUM PHASE

FRACTIONATED PRE-VACUUM

Intermediate condition for the continuation of the test

(P2-P1) < (P0-P1)/10

5 minutes 10 minutes

SHORT DRYING

PROGRAM

VACUUM TEST (VT)

-0.8 0 bar

(P3-P2) < 0.02 ba r

WAITING LEAKAGE

-0.80 P

APPENDIX B – PROGRAMS

EXAMPLES OF PRINTED REPORTS

Cycle Report (normal)

Model MILLENNIUM B2 S/N 03 BG 0001 Ver. SW Exxxx/BGyyyyyy Counter 0007/0015 Selection 134c SOLID Temperature 134 °C Pressure 2.10 bar Process time 4 min Stand-by LOW Pre-vacuum SINGLE Drying FAST

CYCLE START 19/11/02 12:14

Time C bar

---------------------------------------------------------00:01 CS 079.4 +0.00 02:02 1PV 093.7 -0.80 05:48 ET 135.6 +2.15 06:02 SS 135.9 +2.17 07:02 135.6 +2.14 08:02 135.5 +2.14 09:02 135.4 +2.14 10:02 SE 135.5 +2.15 10:37 DS 104.1 +0.00 11:41 SPD 047.5 -0.90 16:08 DE 047.6 -0.84 17:12 CE 084.6 -0.04

06:32 MAX 136.0 09:59 MIN 135.4

Drying PuIses 01 CYCLE END 19/11/02 12:27

STERILIZATION: POSITIVE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

---------------------------------------------------------Model MILLENNIUM B2

S/N 03 BM 0001 Ver. SW Exxxx/BGyyyyyy Counter 0007/0015 Selection 134c POROUS Temperature 134 °C Pressure 2.10 bar Process time 4 min Stand-by HIGH Pre-vacuum FRACTIO NATED Drying STANDARD

CYCLE START 19/11/02 09:52

Time C bar

---------------------------------------------------------00:01 CS 075.1 -0.00 01:57 1PV 047.S -0.80 04:53 1PP 120.5 +1.00 07:00 2PV 061.1 -0.80 09:15 2PP 120.4 +0.98 11:22 3PV 061.1 -0.80 15:04 ET 135.5 +2.15 15:19 SS 135.9 +2.17 16:19 135.4 +2.14 17:18 135.5 +2.15 18:19 135.4 +2.14 19:19 SE 135.5 +2.15 19:53 DS 104.4 +0.00 20:57 SPD 048.4 -0.90 26:55 EPD 094.9 -0.86 29:15 DE 112.6 -0.47 29:43 CE 115.8 -0.04

16:20 MAX 135.9 18:11 MIN 135.4

Drying Pulses 05 CYCLE END 19/11/02 10:17

STERILIZATION: POSITIVE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

OPERATOR

Cycle Report (extended)

at the operator's request

Model MILLENNIUM B2 S/N 03 BG 0001 Ver. SW Exxxx/BGyyyyyy Counter 0007/0015 Selection 134c POROUS Temperature 134 °C Pressure 2.10 Bar Process t ime 4 min Stand-by HIGH Pre-vacuum FRACTIO NATED Drying STANDARD

CYCLE START 19/11/02 09:52

Time T1 P T2 T3 T4

------------------------------------------------------------------00:01 CS 075.1 -0.00 130.9 115.2 093.4 00:11 074.9 -0.28 133.3 114.2 094.0 00:21 074.4 -0.46 146.3 113.2 094.5 00:31 074.3 -0.57 152.6 112.2 095.0 00:35 .. 074.3 -0.59 154.2 111.9 095.2 00:51 .. 078.9 -0.62 152.2 110.4 095.6 01:01 .. 074.9 -0.73 146.6 109.6 095.7 01:27 .. 047.8 -0.78 149.3 107.7 095.7 01:57 .. 047.8 -0.80 155.3 105.8 095.4

02:07 .. 076.5 -0.57 149.9 105.2 095.1 02:17 .. 081.1 -0.49 142.1 104.6 094.6 …………… …………… 08:15 … 068.4 -0.76 151.8 104.7 102.3 08:22 … 061.1 -0.80 153.6 104.5 101.7

08:32 ... 097.4 +0.01 154.7 104.0 100.8 08:42 … 104.6 +0.24 148.9 103.7 101.0 …………… …………… 15:04 … 135.5 +2.15 143.3 111.7 131.7

15:19 … 135.9 +2.17 148.5 113.5 132.6 15:28 … 135.3 +2.16 153.6 115.9 133.0 …………… …………… 19:19 … 135.5 +2.15 157.4 126.5 132.5

19:34 … 134.4 +1.07 157.0 126.8 131.2 19:49 … 108.3 +0.25 156.4 126.8 119.9 19:53 .. 104.4 +0.00 156.1 126.6 116.2

20:04 … 094.2 - 0.50 155.1 125.9 112.4 20:19 … 069.2 -0.73 153.7 124.5 112.9 20:34 … 059.2 -0.81 152.3 123.4 113.5 20:49 … 053.8 -0.87 151.2 122.9 113.6 20:57 … 048.4 -0.90 150.9 122.7 113.5

21:04 … 047.1 -0.80 151.0 122.5 113.5 23:31 … 042.3 -0.89 153.3 122.0 112.2 …………… …………… 26:55 … 094.9 -0.90 153.3 121.7 112.3

27:10 … 101.4 -0.67 154.0 121.7 112.3 27:25 … 105.4 -0.57 153.7 121.5 112.3 …………… …………… 29:15 … 112.6 -0.47 149.6 119.1 111.2

29:28 … 115.2 -0.10 143.0 118.4 110.7 29:43 CE 115.8 -0.04 147.4 110.1 110.7

16:20 MAX 135.9 18:11 MIN 135.4

Drying pulses 05 CYCLE END 19/11/02 10:17

STERILIZATION: POSITIVE OPERATOR

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

EXTENDED REPORT REQUESTED BY THE OPERATOR

---------------------------------------------------------

Model MILLENNIUM B2 S/N 03 BG 0001 Ver. SW Exxxx/BGyyyyyy Counter 0007/0015 Selection 134c POROUS Temperature 134 °C Pressure 2.10 bar Process time 4 min Stand-by HIGH Pre-vacuum FRACTIO NATED Drying STANDARD

CYCLE START 19/11/02 11:13

Time C bar

---------------------------------------------------------00:01 CS 077.6 +0.01 01:40 1PV 088.7 -0.80 04:40 1PP 120.6 +1.00 05:40 2PV 062.9 -0.80 07:10 2PP 135.6 +1.00 08:20 3PV 135.5 -0.80 11:20 ET 135.4 +2.15 11:39 SS 135.5 +2.17 12:39 135.5 +2.14 13:39 104.1 +2.15 14:39 047.5 +2.15

STERILIZATION: NEGATIVE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ALARM CODE: E999 DESCRIPTION MANUAL STOP

----------------------------------------------------------

Model MILLENNIUM B2 S/N 03 BG 0001 Ver. SW Exxxx/BGyyyyyy Counter 0006/0012 Selection 134c CUSTOM Temperature 134 °C Pressure 2.10 bar Process time 07 min Stand-by HIGH Pre-vacuum FRACTIO NATED Drying FAST

CYCLE START 19/11/02 15:31

BLACK OUT 19/11/02 15:45

STERILIZATION NEGATIVE OPERATOR

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ALARM CODE: E000 DESCRIPTION BLACK-OUT

----------------------------------------------------------

Report following a

Manual Stop

OPERATOR

Report following a

Blackout

APPENDIX B – PROGRAMS

Report following an alarm

Model MILLENNIUM B2 S/N 03 BG 0001 Ver. SW Exxxx/BGyyyyyy Counter 0007~0015 Selection 134c POROUS Temperature 134 °C Pressure 2.10 Bar Process time 4 min Stand-by HIGH Pre-vacuum FRACTIO NATED Drying STANDARD

CYCLE START 19/11/02 11:30

Time T1 P T2 T3 T4

02:07 .. 076.5 -0.57 149.9 105.2 095.1 02:17 .. 081.1 -0.49 142.1 104.6 094.6 …………… …………… 08:15 … 068.4 -0.76 151.8 104.7 102.3 08:22 … 061.1 -0.80 153.6 104.5 101.7

08:32 ... 097.4 +0.01 154.7 104.0 100.8 08:42 … 104.6 +0.24 148.9 103.7 101.0 …………… …………… 15:04 … 135.5 +2.15 143.3 111.7 131.7

15:19 … 135.9 +2.17 148.5 113.5 132.6 15:28 … 135.3 +2.16 153.6 115.9 133.0 …………… …………… 19:19 … 135.5 +2.15 157.4 126.5 132.5

19:34 … 134.4 +1.07 157.0 126.8 131.2 19:49 … 108.3 +0.25 156.4 126.8 119.9 19:53 DS 104.4 +0.00 156.1 126.6 116.2

STERILISATION NEGATIVE

ALARM CODE: A112 DESCRIPTION PTC SHORTCIRCUIT

PLEASE REFER TO USER MANUAL

----------------------------------------------------------

CAUTION !

Cycle Report

Model MILLENNIUM B2 S/N 03 BG 0001 Ver. SW Exxxx/BGyyyyyy Counter 0011/0019 Selection HELIX/BD TEST Temperature 134 °C Pressure 2.10 bar Process time 3.5 min

CYCLE START 19/11/02 16:38

Time C bar

---------------------------------------------------------00:01 CS 076.4 +0.00 02:06 1PV 089.3 -0.89 04:35 1PP 120.4 +0.99 05:45 2PV 062.5 -0.78 07:02 2PP 120.2 +0.97 08:15 3PV 061.1 -0.79 11:00 .. 135.6 +2.15 11:14 .. 136.0 +2.17 12:14 135.6 +2.14 13:14 135.6 +2.15 14:14 135.5 +2.14 14:45 .. 135.4 +2.14 15:20 .. 111.5 +0.00 16:34 … 047.8 -0.89 18:21 … 059.5 -0.86 19:21 .. 075.4 -0.50 20:06 CE 078.7 -0.04

12:33 MAX 136.0 14:44 MIN 135.4

Drying pulses 01 CYCLE END 19/11/02 16:38

HELIX/BD TEST COMPLETE Please attach the indicator hereunder

OPERATOR

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

----------------------------------------------------------

HELIX/BD TEST

Cycle Report

VACUUM TEST

Model MILLENNIUM B2 S/N 03 BG 0001 Ver. SW Exxxx/BGyyyyyy Counter 0011/0019 Selection VACUUM TEST

CYCLE START 19/11/02 11:37

Time C bar

---------------------------------------------------------00:00 CS 035.0 +0.00

01:39 E1F 037.4 -0.80 6:39 E2F 038.4 -0.79 16:39 E3F 042.0 -0.79 17:54 CE 045.5 -0.01 CYCLE END 19/11/02

11:41 VACUUM TEST: POSITIVE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

----------------------------------------------------------

OPERATOR

APPENDIX C – 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.

INTRODUCTION

ORDINARY MAINTENANCE PROGRAM

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

It is also fundamental to perform a periodic sterilizer validation thermodynamic parameters of the process, comparing them with the reference values provided with suitably calibrated instruments. In this regard, see the paragraph, “Periodic Sterilizer's Validation”, further below in this Appendix.

The ordinary maintenance desc ribed 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.

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

DAILY WEEKLY

MONTHLY

EVERY 3-6 MONTHS (depending on frequency of use)

ANNUALLY

Keep the following general warnings – 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

– Do not allow lime residue or other substances to accumulate in the sterilization chamber or

use chemical products or disinfectants to clean the sterilization chamber. In fact,

these products can damage the sterilizat ion cha mb er, even ir reparab ly ;

on the door and its gasket, but periodically remove them. In fact, they can damage parts over time in addition to compromising along the plumbing circuit.

THE FORMATION OF WHITE SPOTS ON THE BASE OF THE INTERNA L WALLS OF THE

STERILIZATION CHAMBER MEANS THAT YOU ARE USING LOW

WATER

Clean the gasket on the porthole Clean external surfaces

Clean the sterilization chamber and relative accessories Disinfect external surfaces

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

Replace bacteriological filter

Validate sterilizer (see dedicated paragraph)

in mind:

, we recommend shortening maintenance

the operation of the components installed

NOTE

, i.e., a check of the

these

-QUALITY DEMINERALIZED

APPENDIX C – MAINTENANCE

MAINTENANCE DESCRIPTION

Clean gasket and porthole

Clean external surfaces

Clean sterilization chamber and accessories

Disinfect external surfaces

With reference to the preceding table, let's take a summary look at the various maintenance to be performed.

To remove traces of lime, clean the gasket of the container under pressure and the porthole with a clean, cotton cloth soaked in a weak solution of water and vinegar (or similar product, after first checking its contents on the label). Dry the surfaces and remove any residue before using the device.

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

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

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

DANGER

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

WHENEVER IT IS NOT POSSIBLE, PUT IN OFF THE EXTERNAL BREAKER OF THE EQUIPMENT POWER SUPPLY LINE.

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

NOTE

DO NOT USE SHARP OR POINTED INSTRUMENTS TO REMOVE LIME ENCRUSTATION FROM

THE STERILIZATION CHAMBER CHECK THE QUALITY OF THE DISTILLED WATER USED

. WHENEVER THERE ARE VISIBLE DEPOSITS, IMMEDIATELY

(SEE APPENDIX A,).

APPENDIX C – MAINTENANCE

Clean internal distilled water tank

Clean external distilled water tank

Safety valve maintenance

1. Arrange an empty container on the floor near the sterilizer and put the free end of a tube into it.

2. Unscrew the plug (1) from the rear draining point and plug-in the other end of the tube.

3. Wait until the internal tank is completely drained; close the draining point with the plug.

4. Prepare 4 liter of distilled water mixed with 10% of pure alcohol and fill the supplied standard container

5. Now fill completely the internal tank with this solution (see chapter “Filling distilled water” for the procedure) and allow the solution to sit for 30 minutes.

WARNING

DO NOT RUN ANY CYCLE DURING THIS PERIOD.

6. Drain again the internal tank and discard the solution. Close the draining point with the plug.

1. Disconnect the external tank from the sterilizer; eventually recover the distilled water contained in it.

2. Fill the tank with a solution of distilled water and alcohol (10%)

3. Allow the solution to sit for 30 minutes.

4. Drain the tank and discard the solution.

5. Reconn ect the tank to the sterilizer.

1. Access the safety valve located on the rear of the machine.

2. Loosen the knurled locking ring with your fingers (or a suitable tool inserted in the two holes in the ring itself), turning counter-clockwise until it reaches the end and turns loosely.

3. Retighten the locking ring and repeat the operation a couple of times.

4. Definitively

tighten the locking ring all the way down.

Clean/replace the drain filter

WARNING

THIS OPERATION IS NECESSARY TO GUARANTEE THE CORRECT FUNCTIONING OF THE VALVE OVER TIME. AT THE END OF MAINTENANCE, MAKE SURE THAT THE LOCKING RING

With use, various residues will probably tend to accumulate inside the filter, obstructing the lower drain tube over time.

For cleaning (or replace) the filter, open the door of the sterilizer and remove the nut (1) with a hexagonal wrench n. 14.

Then remove the fitting (2) and the filter (3). Remove the filter from the support and carefully clean it under a throw of running water, using

if necessary a pointed tool to remove possible material of greater dimensions. If the filter cannot be reused, replace it with a new one. Plug the filter in the support, block it with a drop of sealing (if available), having care to not

obstruct the holes.

Reassemble all parts following reversely the above procedure, paying attention on screwing down the fitting (2) so as to let the draining holes (4) at level of the chamber wall.

IS COMPLETELY SCREWED ON AND TIGHTENED.

APPENDIX C – MAINTENANCE

Replace bacteriological filter

Replacing the paper in the printer

Printer type 1

Printer type 2

When it is due to be changed, or when you notice visible clogging of the filter (indicated by a color markedly tending towards gray) unscrew the bacteriological filter from its support and replace it with a new one by screwing it all the way down on the connector on the front of the machine.

NOTE

A REPLACEMENT BACTERIOLOGICAL FILTER IS SUPPLIED WITH THE DEVICE. TO

REQUEST OTHERS

To replace a used-up roll of paper in the printer:

1. open the door (1) of the service compartment to access the printer,

2. push the tongues (2) to open the printer door and access the paper compartment,

3. remove the empty roll and place a new roll of thermal paper the top;

the roll must have the following dimensions:

- width 57 mm / diameter max 45 mm

4. unroll about 15 cm of paper and close the compartment door,

5. thread the paper in the slot of door of the service compartment and reclose.

1. open the door (1) of the service compartment to access the printer,

2. push the button (2) on the left to open the printer door (3) and access the paper compartment,

3. remove the empty roll and place a new roll of thermal paper the top;

the roll must have the following dimensions:

- width 57 mm / diameter max 45 mm

4. unroll about 15 cm of paper and close the compartment door (the paper will automatically advance outside the window for several centimeters),

5. thread the paper in the slot of door of the service compartment and reclose.

, PLEASE REFER TO APPENDIX Z, TECHNICAL SUPPORT.

so that the paper unrolls off

APPENDIX C – MAINTENANCE

PERIODIC STERILIZER VALIDATION

RECYCLING / DISPOSAL INSTRUCTIONS

As happens with all equipment, it is possible, and sometimes inevitable, to have a decrease in performance and the effectiveness of components along its lifespan, in a period of time dependent on its frequency of use.

To guarantee the safety of the process over time, it is periodically (possibly annually) necessary to verify 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 554 (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

The sterilizer is mainly built from fiber-reinforced polymers, metals and electronic components. In case of disposal:

the thermodynamic process parameters (pressure and temperature), to

in these activities.

NOTE

THE M.O.COM. SRL CUSTOMER SUPPORT DEPARTMENT (SEE APPENDIX Z) IS

AVAILABLE TO PROVIDE ANY INFORMATION RELATIVE TO THE PERIODIC VALIDATION OF STEAM STERILIZERS

- Separate the various components according to the materials they are made of.

- Drop the sterilizer with a company specialized on recycling these products.

- Do not abandon the sterilizer in unsecured places.

- Always refer to current/applicable laws in the country of use.

APPENDIX D – GENERAL PROBLEMS

INTRODUCTION

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

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

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

ANALYSIS AND RESOLUTION OF PROBLEMS

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

PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION

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

be immediately concerned.

The sterilizer does not power-on.

After pressing START, the sterilization cycle does not

The MIN water level icon is lit.

The alarm icon is lit.

The safety valve has intervened.

At the end of the program (CYCLE COMPLETE), I'm not able to open the door.

start.

There is no voltage at the socket.

The main switch and/or differential switch are OFF.

The mains fuses are blown.

The device is preheating.

The distilled water level inside the tank is below the minimum level.

An alarm was triggered, with the generation of the relative code and message (see LCD).

Locking ring loosened. Presence of anomalous

overpressure in the chamber.

There is residual pressure remaining in the sterilization chamber at the end of the cycle.

: the display shows:

NOTE

NOW LEVELLING PLEASE WAIT…

At the end of the cycle, the safety door lock remains on.

Check the cause of the lack of voltage at and socket and fix it.

Turn the switch ON.

Replace with good fuses of equal nominal value. (See the Summary Table in Appendix A, Technical

Characteristics). Wait for the sterilizer to reach the proper operating

conditions for starting the program.

: Under normal conditions, the average

NOTE

preheating time is about 10-15 minutes.

Fill the distilled water tank until the MAX level indicator comes on (or, at any rate, until the MIN level signal turns off).

Check the alarm code and take the appropriate action. (See the following paragraphs, Alarms, Alarm Codes

and Troubleshooting). Check that the knurled locking ring is correctly

tightened on the upper part of the safety valve.

DANGER

Wait several minutes, until the pressure returns to 0.00 bar, and try

Check if the bacteriological filter is clogged and, if necessary, replace it with a new one.

The procedure for storing the ambient temperature (SET 0 bar function) was not executed correctly.

Contact the Technical Support Department (see Appendix Z)

Contact the Technical Support Department (see Appendix Z).

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

to open the door again.

APPENDIX D – GENERAL PROBLEMS

PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION

Check the tightness of the fittings; if necessary,

Drain connectors or tubing (optional external tank) not correctl y connected to the device.

reassemble, paying more attention to sealing. Check that the tubes to the drain tank are completely

pushed onto the connectors; make sure that the plastic ties have been applied.

There is water on the support surface of the sterilizer.

There is water around the drain tank.

The sterilizer has problems creating a vacuum in the chamber (drying problems, presence of water in the sterilization chamber at the end of the cycle, etc.).

The water supply tube from the external tank (optional) is not well connected.

Steam leaks from the gasket.

Drain tubes (optional drain tank) not correctly connected to the tank.

Drain filter of the sterilization chamber obstructed.

Drain circuit obstructed or drain tubes choked (optional drain tank).

The air intake on the frame and/or the cover are obstructed or the heat exchanger is not sufficiently ventilated.

Excessive quantity of material inside the sterilization chambe r.

Check the tightness of the connector; if necessary, reassemble, paying greater attention to sealing (see the Chapter,

Check that the tube coming from the external tank is completely pushed onto the connector; make sure that the plastic tie has been applied.

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

Check that the tubes connected to the drain tank are correctly and completely pushed-on to the connectors.

Clean (See Appendix C Check that the drain tubes (and the connectors they

are pushed onto) are not obstructed and run freely from the device to the tank.

Remove all possible obstructions from the air intake and heat exchanger.

Check that the device is not in direct contact with walls or surfaces (see the Chapter,

Check the quantity of material sterilized and make sure that it does not exceed the maximum allowed quantity, depending on the type of load.

(See the Summary Table in Appendix A Characteristics”).

“Installation”).

or replace the drain filter

“Maintenance”).

“Installation”).

, Technical

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

Traces of oxidation or spots on instruments

Material not correctly positioned.

Wrong sterilization program selection

Drain filter of the sterilization chamber obstructed.

Quality of the instruments is not adequate.

Quality of the distilled water not adequate.

Organic or inorganic residues on the instruments

Position the material, and especially wrapped material, according to the instructions.

(See the Chapter, Select the appropriate sterilization program for the type

of material to be treated. (See the Summary Table in Appendix B

“Programs”).

or replace the drain filter

Clean (See Appendix C “Maintenance”).

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

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

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

Carefully clean the materi al before subjecting it to the sterilization cycle.

(See the Chapter,

“Preparing the Material”).

APPENDIX D – GENERAL PROBLEMS

PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION

(continue)

Blackening of the instruments or damage to the material.

The printer is not printing the summary report

SHOULD THE PROBLEM PERSIST, CONTACT THE CUSTOMER SERVICE (SEE APPENDIX Z) PROVIDING THE MODEL

OF THE STERILIZER AND THE SERI AL NUMBER. THIS INFORM ATION IS FOUND ON THE SERIAL NUMBER PLATE ON THE REAR OF THE DEVICE AND ON THE WARRANTY CERTIFICATE

Contact between instruments made of different metals.

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

Wrong sterilization program selection.

Wrong printer configuration.

Paper used-up.

Paper jammed.

NOTE

Separate instruments made of different metals. (See the Chapter, “Preparing the Material”). Clean the device and its parts, as required.

(See Appendix C

“Maintenance”).

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

(See the Summary Table in Appendix B

“Programs”). Configure the sterilizer for the type of printer used

(Configuration program). (see the Chapter,

“Configuring the Device”). Insert a new roll of paper. (See Appendix C

, “Replacing the Paper”).

Clear the jam. Check the dimensions of the roll of paper.

(See Appendix C

, “Replacing the Paper”).

APPENDIX E – ALARMS

INTRODUCTION

ALARM INTERVENTION

Alarm during a cycle

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 Wrong maneuver and/or use, or a cause external to the device. A problem that can generally be fixed by the user. Code format: Exxx (xxx = identifying number from 000 ÷ 999)

• A = ALARM First-level fault, not linked to safety. A problem that normally is fixed by a specialized technician on-site. Code format: Axxx (xxx = identifying number from 000 ÷ 999)

• H = HAZARD Second-level

fault, linked to safety. A problem generally fixed by the Technical Support Center. Code format: Hxxx (xxx = identifying number from 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”).

The intervention of the alarm causes the interruption of the cycle (or the normal equipment operation) with the relative appearance of an alarm code and a message on the display, accompanied by a beep and the lit alarm icon (intermittent).

NOTE

DURING THE ALARM PROCEDURE, THE DISPLAY ALWAYS SHOWS THE CURRENT

TEMPERATURE AND PRESSURE IN THE STERILIZATION CHAMBER

This procedure is designed so as not to allow the user to mistake an anomalous cycle for a correctly completed cycle and, as a consequence, involuntarily using non-sterile material.

The alarm procedure is differentiated the program or outside

, and is structured to guide the user to the necessary RESET of t he

depending on whether it occurs during the execution of

sterilizer.

If the alarm intervenes duri ng a program

(Alarm Message)

114.6°C XXXX

, the display will show the message:

LEVELLING

Alarm Message

Alarm Code

0.70 bar 11:30

Whenever an alarm is generated in certain phases of the cycle, an automatic procedure is activated to clean the internal water circuit. The display will contain the notice:

(Alarm Message)

CIRCUIT CLEANING

Alarm Code

100.6°C XXXX

0.70 bar 11:40

APPENDIX E – ALARMS

Alarm outside the cycle

At the end of what has been described and having reached safe conditions, the machine activates a special procedure

, that asks the user to manually unlock the door:

PRESS Ç TO

UNLOCK THE DOOR

101.0°C XXXX

0.01 bar 11:40

Press the Ç key to unlock the door lock mechanism; the following message appears:

(Alarm Message)

OPEN THE DOOR

100.8°C XXXX

0.01 bar 11:42

Once the door is open, the user is finally asked to reset the system:

(Alarm Message)

RESET SYSTEM

95.5°C XXXX

0.00 bar 11:43

Perform a RESET (described below) and then turn-off the equipment and check the error or make the repair.

NOTE

WHEN THE DOOR IS OPENED, THE REPORT (NORMAL OR EXTENDED DEPENDING ON THE

TYPE OF ALARM AND THE ALARM THAT INTERVENED PROVIDED AND FILE IT IN A SUITABLE PLACE. REFER TO THE PRINT REPORT EXAMPLES SHOWN IN

) WILL BE PRINTED FOR THE INTERRUPTED STERILIZATION PROGRAM

. CHECK THE DOCUMENT, INITIAL IT IN THE SPACE

APPENDIX B, PROGRAMS”.

If the alarm intervenes outside the sterilization or test program

(Alarm Message)

ALARM!

the display will show:

Alarm Message

Alarm Code

80.5 °C XXXX

0.00 bar

Turn-off the equipment and check the alarm. Or, depending on the type of alarm:

(Alarm Message)

WARNING!

Alarm Message

Alarm Code

80.5 °C XXXX

0.00 bar

APPENDIX E – ALARMS

RESETTING THE SYSTEM

which is automatically transformed to the message:

(Alarm Message)

RESET SYSTEM

80.5 °C XXXX

0.00 bar

Perform a RESET (described below) and then turn-off the device and check the alarm.

NOTE

ALARMS THAT INTERVENE OUTSIDE OF A PROGRAM DO NOT PRODUCE A PRINTED

REPORT

The system is RESET in two alternative ways, depending on the alarm that occurred (see the Alarm Code List further below in this appendix):

1. Press the A beep confirms the RESET;

PROGRAM SELECTION key for about 3 seconds.

WARNING

NEVER TURN THE DEVICE OFF BEFORE EXECUTING A RESET.

>3s

2. Turn-off the device

Upon power-up, the sterilizer will perform its normal initial test.

After RESET, and any technical intervention necessary to eliminate the fault, the device will go to STAND-BY mode, ready to execute a new program.

and then power-on using the main switch.

APPENDIX E – ALARMS

ALARM CODES

The list

of alarm codes and, consequently, the mess ages displayed on the LCD and relative RESET m ode, is as follows:

CODE ALARM DESCRIPTION LCD INDICATION RESET MODE

ERRORS (category E)

E 000 E 010

E 020

E 021 E 030

E 031 E 041

E 900

E 901

E 902 E 999

A 022 A 023

A 024 A 032

A 040

A 101

A 102

A 103

A 104

A 111

A 112

A 113

Blackout BLACK-OUT Door open DOOR OPEN Exceeded timeout for activating door lock

system (closing) Exceeded timeout for activating door lock

system (opening) Water in the fill tank at minimum (MIN) level WATER MIN Water in the drain tank at maximum (MAX) level EXHAUST MAX Filling the tank too frequently

(automatic filling) Vacuum Test failed

(during the LEAKAGE PHASE) Vacuum Test failed

(during the WAITING PHASE) Vacuum Test failed

(vacuum pulse timeout exceeded) Manual cycle interruption MANUAL STOP

ALARMS (categor y A)

System door lock microswitches failed (OFF- OFF)

System door lock microswitches failed (ON-ON) System door lock microswitches failed (ON-OFF) Sensor-level problem LEVEL PROBLEM Failure to fill the tank

(automatic filling) PT1 broken

(sterilization chamber) PT2 broken

(steam generator) PT3 broken

(heating element) PT4 broken

(sterilization chamber wall) PT1 short-circuited

(sterilization chamber) PT2 short-circuited

(steam generator) PT3 short-circuited

(heating element)

DOOR UNLOCKED

DOOR LOCKED

FILLING PROBLEM

TEST FAILED

LOCKING PROBLEM LOCKING PROBLEM

LOCKING PROBLEM

FILLING PROBLEM

PTC BROKEN

PTC SHORTCIRCUIT

Press key

(> 3 seconds)

Turning-off

device

A 114

A200

PT4 short-circuited (sterilization chamber wall)

Pre-heating not performed within the timeout (heating resistor problem).

PTC SHORTCIRCUIT

HEATING PROBLEM

APPENDIX E – ALARMS

CODE

ALARM DESCRIPTION LCD INDICATION

RESET MODE

A 250

A 251 A 252

A 253 A 254 A 255

A 256 A 257 A 258

A 259 A 260

H 150 H 160

H 400

H 401

H 402

H 403

H 404

H 405

H 406

H 410

H 990

H 991

H 992

H 993

1st vacuum pulse not reached within timeout PV1 TIMEOUT 1st rise to atmospheric pressure not reached

within timeout

ATM1 TIMEO U T

1st pressure pulse not reached within timeout PP1 TIMEOUT 2nd vacuum pulse not reached within timeout PV2 TIMEOUT 2nd rise to atmospheric pressure not reached

within timeout

ATM2 TIMEO U T

2nd pressure pulse not reached within timeout PP2 TIMEOUT 3rd vacuum pulse not reached within timeout PV3 TIMEOUT 3rd rise to atmospheric pressure not reached

within timeout

ATM3 TIMEO U T

3rd pressure pulse not reached within timeout PPP TIMEOUT Phase of PROCESS not started within timeout PROCESS TIMEOUT Chamber depressurization not completed within

timeout

PPD TIME-OUT

HAZARDS (category H)

MPX pressure sensor broken MPX BROKEN MPX pressure sensor short-circuited/not

connected Ratio P

/T not balanced (P

conv

>T)

(Phase PROCESS) Ratio T/P

not balanced (T>P

conv

)

(Phase PROCESS) Temperature above MAX limit

(Phase PROCESS) Temperature below MIN limit

(Phase PROCESS) Temperature fluctuating over the limit

(Phase PROCESS) Pressure above MAX limit

(Phase PROCESS) Pressure below MIN limit

(Phase PROCESS) Wrong maintenance time

(Phase PROCESS)

Excessive pressure (sterilization chamber, MPX ) Overheating

(sterilization chamber, PT1) Overheating

(steam generator, PT2) Overheating

(band heating element, PT3)

MPX SHORTCIRCUIT

P/T PROBLEM

T/P PROBLEM

T OVER LIMIT

T UNDER LIMIT

PT1 FLUCTUATING

P OVER LIMIT

P UNDER LIMIT

TIMING PROBLEM

OVERPRESSURE

OVERHEATING PT1

OVERHEATING PT2

OVERHEATING PT3

Press key

(> 3 seconds)

Turning-off

device

Press key

(> 3 seconds)

APPENDIX E – ALARMS

ANALYSIS AND RESOLUTION OF PROBLEMS

Based on the type of alarm operation:

CODE POSSIBLE CAUSE PROPOSED SOLUTION

, below we provide instructions for identifying the possible causes and restoring correct

ERRORS (category E)

E 000

E 010

E 020

E 021

E 030

E 031

E 041

E 900

Sudden power failure (blackout). Accidentally turning-off the main

switch and/or pulling the plug out of the socket.

Mains fuses blown.

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

Door position microswitch broken.

Limit microswitch (CLOSED position) of the door lock mechanism broken.

Door lock system gear motor broken.

Limit microswitch (OPEN position) of the door lock mechanism broken.

Door lock system gear motor broken.

Water level in the fill tank below minimum (MIN) level.

MIN water level indicator broken. Water level in the drain tank (or

possible optional external drain tank) over the MAX level.

Wire of the external tank (optional) level indicator not connected to the device.

MAX water level indicator broken.

Connection tube between the sterilizer and a possible external filling device not

Water filling pump broken. Problem in the plumbing circuit.

Air leaking through the gasket

Problem in the plumbing circuit.

correctly installed.

Wait for electricity to return and perform RESET following the instructions.

Reconnect the plug and/or power-on the device and perform RESET following the instructions.

Replace with good fuses of equal nominal value. (See the Summary Table in Appendix A Turn-on the device and perform RESET following the instructions.

Perform RESET following the instructions. Close the door properly

Contact the Technical Support Department (see Appendix Z

Perform RESET following the instructions. Try to start the program a second time. If the problem persists contact the Technical Support Department

(see Appendix Z).

Perform RESET following the instructions.

Contact the Technical Support Department (see Appendix Z).

Perform RESET following the instructions. Top-off the water until the MAX level indicator comes on (or at least until

MIN indicator goes off).

Contact the Technical Support Department (see Appendix Z).

Perform RESET following the instructions and empty the tank. If installed, empty the external tank (optional), leaving water up to the

level indicated. Perform RESET following the instructions. Connect the plug of the level indicator wire (coming from the optional

external tank) to the female socket located on the back of the device.

Contact the Technical Support Department (see Appendix Z).

Perform RESET following the instructions. Check that the water supply tube is correctly and solidly connected to the

relative connectors. Eliminate all possible obstructions along the path of the tube.

Contact the Technical Support Department (see Appendix Z

Perform RESET following the instructions. Carefully clean the gasket with a clean cotton cloth dampened with

water. Start the program again.

Contact the Technical Support Department (see Appendix Z

and restart the program.

, Technical Characteristics”).

APPENDIX E – ALARMS

CODE POSSIBLE CAUSE PROPOSED SOLUTION

E 901

E 902

E 999

Excessive humidity in the sterilization chamber.

Air leaking through the gasket

Problem in the plumbing circuit.

Excessive humidity in the sterilization chamber.

Air leaking through the gasket

Vacuum pump broken. Problem in the plumbing circuit.

Manual interruption of sterilization or test program.

(Also see the Chapter, the Program”)

“Running

Perform RESET following the instructions. Carefully dry the inside of the sterilization chamber and start the program

again. Perform RESET following the instructions. Carefully clean the gasket with a clean cotton cloth dampened with

water. Start the program again.

Contact the Technical Support Department (see Appendix Z).

Perform RESET following the instructions. Carefully dry the inside of the sterilization chamber and start the program

again. Perform RESET following the instructions. Carefully clean the gasket with a clean cotton cloth dampened with

water. Start the program again.

Contact the Technical Support Department (see Appendix Z

Perform RESET following the instructions. Check that the load has been correctly sterilized (see LCD indicators)

before using the material.

A 022

A 023

A 024

A 032

A 040

A 101

A 102

A 103

A 104

Limit microswitch(es) on the door lock mechanism broken.

Connector of the water level indicators not connected.

Level indicator(s) broken. Lack of water in the external tank or

Milldrop turned off (automatic filling).

Connection tube between the sterilizer and a possible external filling device not

Water filling pump broken. Chamber temperature sensor (PT1)

broken. Steam generator temperature

sensor (PT2) broken. Heating element temperature

sensor (PT3) broken. Chamber wall temperature sensor

(PT4) broken.

correctly installed.

ALARMS (categor y A)

Contact the Technical Support Department (see Appendix Z).

Perform RESET following the instructions. Fill the tank with a sufficient quantity of water, remembering to

periodically

Perform RESET following the instructions. Check that the water supply tube is correctly and solidly connected to the

relative connectors. Eliminate all possible obstructions along the path of the tube.

Contact the Technical Support Department (see Appendix Z).

Contact the Technical Support Department (see Appendix Z

check the level, or turn on the Milldrop.

APPENDIX E – ALARMS

CODE POSSIBLE CAUSE PROPOSED SOLUTION

Incorrect connection of the

temperature sensor (sterili zation

A 111

A 112

A 113

A 114

chamber) to the connector. Temperature sensor short circuit

(sterilization chamber). Incorrect connection of the

temperature sensor (steam generator) to the connector.

Temperature sensor short circuit (steam generator). Incorrect connection of the

temperature sensor (heating element) to the connector.

Temperature sensor short circuit (heating element).

Incorrect connection of the temperature sensor (chamber wall) to the connector.

Temperature sensor short circuit (chamber wall).

Contact the Technical Support Department (see Appendix Z

A 200

A 250

A 251

Intervention of the steam generator safety thermostat.

Intervention of the heating element safety thermostat.

Heating or steam generator heating element malfunction.

Presence of water or condensate in the sterilization chamber.

Drain filter of the sterilization chamber obstructed.

Air leaking through the gasket.

Vacuum pump broken. Problem in the plumbing circuit. Water injection pump malfunction. Problem in the plumbing circuit. Intervention of the steam generator

safety thermostat. Heating element safety thermostat

intervened. Heating or steam generator heating

element malfunction.

Manually rearm the thermostat(s) located on the back of the device (see the Chapter, “Product Introduction”).

Unscrew the black plastic protecti on cap, pres s the red button hear a click and replace the cap.

Turn-off (RESET) and then turn-on the device. If the problem persists contact the Technical Support Department

(see Appendix Z

Perform RESET following the instructions. Carefully dry the inside of the sterilization chamber and start the program

again.

put material impregnated with water, or liquids in general, in the

Do not

chamber. Clean or replace the drain filter

(See Appendix C Perform RESET following the instructions. Carefully clean the gasket with a clean cotton cloth dampened with

water. Start the program again.

Contact the Technical Support Department (see Appendix Z).

See A200 If the problem persists contact the Technical Support Department

(see Appendix Z

“Maintenance”).

until you

APPENDIX E – ALARMS

CODE POSSIBLE CAUSE PROPOSED SOLUTION

Perform RESET following the instructions. Carefully clean the gasket with a clean cotton cloth dampened with

water. Start the program again. Perform RESET following the instructions. Check the quantity of material in the sterilization chamber and make sure

it does not exceed the maximum quantity allowed. (See the Summary Table in Appendix A

Contact the Technical Support Department (see Appendix Z

See A200 If the problem persists contact the Technical Support Department

(see Appendix Z).

Perform RESET following the instructions. Carefully dry the inside of the sterilization chamber and start the program

again.

Do not

chamber. Perform RESET following the instructions. Carefully clean the gasket with a clean cotton cloth dampened with

water. Start the program again.

Contact the Technical Support Department (see Appendix Z

See A200 If the problem persists contact the Technical Support Department

(see Appendix Z).

Perform RESET following the instructions. Carefully clean the gasket with a clean cotton cloth dampened with

water. Start the program again. Perform RESET following the instructions. Check the quantity of material in the sterilization chamber and make sure

it does not exceed the maximum quantity allowed. (See the Summary Table in Appendix A, Technical Characteristics).

Contact the Technical Support Department (see Appendix Z

See A200 If the problem persists contact the Technical Support Department

(see Appendix Z).

put material impregnated with water, or liquids in general, in the

, Technical Characteristics).

A 252

A 253

A 254

A 255

Steam leaking through the gasket.

Excessive load.

Problem in the plumbing circuit. Intervention of the steam generator

safety thermostat. Heating element safety thermostat

intervened. Heating or steam generator heating

element malfunction.

Presence of water or condensate in the sterilization chamber.

Air leaking through the gasket.

Vacuum pump broken. Problem in the plumbing circuit. Water injection pump malfunction. Problem in the plumbing circuit. Intervention of the steam generator

safety thermostat. Heating element safety thermostat

intervened. Heating or steam generator heating

element malfunction.

Steam leaking through the gasket.

Excessive load.

Problem in the plumbing circuit. Intervention of the steam generator

safety thermostat. Heating element safety thermostat

intervened. Heating or steam generator heating

element malfunction.

APPENDIX E – ALARMS

CODE POSSIBLE CAUSE PROPOSED SOLUTION

Perform RESET following the instructions. Carefully dry the inside of the sterilization chamber and start the program

again.

put material impregnated with water, or liquids in general, in the

Do not

chamber. Perform RESET following the instructions. Carefully clean the gasket with a clean cotton cloth dampened with

water. Start the program again.

Contact the Technical Support Department (see Appendix Z

See A200 If the problem persists contact the Technical Support Department

(see Appendix Z

Perform RESET following the instructions. Carefully clean the gask et with a clean cotton cloth dampened with water

and start the program again. Perform RESET following the instructions. Check the quantity of the material in the sterilization chamber and make

sure that it does not exceed the maximum allowed quantity, depending on the type of load.

(See the Summary Table in Appendix A

Contact the Technical Support Department

See A200 If the problem persists contact the Technical Support Department

(see Appendix Z

Perform RESET following the instructions. Check the quantity of the material in the sterilization chamber and make

sure that it does not exceed the maximum allowed quantity, depending on the type of load.

(See the Summary Table in Appendix A Perform RESET following the instructions. Carefully clean the gask et with a clean cotton cloth dampened with water

and start the program again.

Contact the Technical Support Department (see Appendix Z

A 256

A 257

A 258

A 259

A 260

Presence of water or condensate in the sterilization chamber.

Air leaking through the gasket.

Vacuum pump broken. Problem in the plumbing circuit. Water injection pump malfunction. Problem in the plumbing circuit. Intervention of the steam generator

safety thermostat. Heating element safety thermostat

intervened. Heating or steam generator heating

element malfunction.

Steam leaking through the gasket.

Excessive load.

Problem in the plumbing circuit. Intervention of the steam generator

safety thermostat. Heating element safety thermostat

intervened. Heating or steam generator heating

element malfunction.

Excessive load.

Steam leaking through the gasket.

Problem in the plumbing circuit. Problem in the plumbing circuit.

, Technical Characteristics).

(see Appendix Z).

, Technical Characteristics).

HAZARDS (category H)

H 150

H 160

Pressure sensor (MPX) broken. Incorrect connection of the

pressure sensor (MPX) to the connector.

Pressure sensor (MPX) short circuit.

Contact the Technical Support Department (see Appendix Z

APPENDIX E – ALARMS

CODE POSSIBLE CAUSE PROPOSED SOLUTION

H 400 H 401

H 402

H 403

H 404

H 405

H 406

H 410 H 990 H 991 H 992 H 993

Problem in the plumbing circuit. Problem in the plumbing circuit. Steam generator malfunction. Problem in the plumbing circuit. Steam generator malfunction. Problem in the plumbing circuit. Problem in the plumbing circuit. Steam generator malfunction. Problem in the plumbing circuit. Steam generator malfunction. Problem in the plumbing circuit. Steam generator malfunction. Timer problem General operating problem. General operating problem. General operating problem. General operating problem.

Contact the Technical Support Department (see Appendix Z

APPENDIX F – DIAGRAMS

MAINS FILTE

APPENDIX F – DIAGRAMS

ELECTRICAL DIAGRAM (BOARD TYPE “G”)

SEC. TANK

MAX LEVEL

PROB E

JACK FOR MAX LEVEL

PROBE CONNECTI ON ON

EXTERNAL TANK

(OPTION)

DOOR

SWITCH

FAN 24V

APPENDIX F – DIAGRAMS

DOOR

SWITCH

FAN 24V

JACK FOR MAX LEVEL

PROBE CONNECTION ON

EXTERNAL TANK (OPTION)

KEYBOARD

STEAM GEN.

ELECTRONIC

Pump injection

DISTILLED WATER

RESERVOIRS

START/STOP

ELECTRICAL DIAGRAM (BOARD TYPE “T”)

LCD

FUSE PTR

T 4A

PARALL EL

Datalogger

MPX

PT1

PT2

PT3PT4

6.3A T F1

RS232

SERIAL

Flash/serial

BOARD

TYPE “T”

MAX

LCD

Flowmeter

SC+SC-SS+SSE

DoorDoor lock

Motor l ock

USED WATER

EV1 EV2 EV3

EV4 EV5

MAX

MIN

EV6

MAINS FILTER

BOARD

S-trafo AC-LPT

3.15A T F2

P-tra fo

Vac uu m pum p

F 16A

Generator

Bandage

220-240V

50-60HZ

Line

Aux pump

EC output

MILLDROP

PUMP

24V

Fan

APPENDIX F – DIAGRAMS

PLUMBING DIAGRAM

Air

CHAMBER

Recovery

tank

Main

tank

APPENDIX G – DECLARATION OF CONFORMITY

DECLARATION OF CONFORMITY

Application of Directives 93/42/CEE - 2004/108/CEE - 73/23/CEE

Manufacturer's Name: M.O.COM. S.r.l. - Manufacture of Dental Accessories Manufacturer's Address: Via delle Azalee, 1 - 20090 Buccinasco (MI) - ITALY Product description: Steam sterilizer

Model: Constructed in: ITALY

Reference standards: EN 61010-1 EN 61010-1-A2 EN 61010-2-040 CEI EN 50081-1 CEI EN 50082-1 EN 55014 EN 55022 EN 60555-2 EN 60555-3 EN 61000-4-2 EN 61000-4-3 EN 61000-4-4 EN 61000-4-5 EN 61000-4-6 EN 61000-4-8 EN 61000-4-11 ENV 50204 EN 13060

31/012008 Date Signature

The undersigned declares that the above material

conforms

to the EEC Directives 93/42 - 2004/108 - 73/23 (and following updates).

Alfio VILLA

Name and Surname

Legal Representative

Function

APPENDIX H – NOTES PER THE OPERATOR

APPENDIX H – NOTES PER THE OPERAT OR

APPENDIX Z – TECHNICAL SUPPORT

FOR ANY REQUEST FOR

TECHNICAL SERVICE FOR THE PRODUCT,

WHETHER IN OR OUT OF WARRANTY,

DIRECTLY CONTACT THE

TECHNICAL SUPPORT DEPARTMENT

OF THE DEALER OR RESELLER

THAT SUPPLIED THE PRODUCT.

M.O.COM. Srl is completely available to customers to provide any technical information about the product as well as to offer suggestions and advice on steam sterilization procedures.

In this regard, please refer to the following address:

M.O.COM. Srl Customer Support Via delle Azalee, 1 20090 Buccinasco (MI) ITALY Tel. (+39) 02-45701505 Fax (+39) 02-45701258 e-mail at@mocom.it

website www.mocom.it

To help us in the indispensable work of improving and/or suggestions to the following e-mail address :

uc@mocom.it (Commercial /Sales Department)

Or, you can send a letter Thank you in advance for your valuable assistance.

the quality of our products and service, please send your comments

or fax to the above address.

Mocom millenium B2 Operating Manual

Specifications and Main Features

Frequently Asked Questions

User Manual