Mocom Millenium B2
Mocom Millenium B2
STEAM
®
STERILIZER
OPERATING MANUAL
Ed. 1
Rev. 5
Date: January 2008
TABLE OF CONTENTS
REVISIONS
1 1 02-03 A few modifications; added new chapter “Replacing the printer paper”
TABLE OF CONTENTS
1 - INTRODUCTION ............................................................................................................................ 1
APPLICABLE EUROPEAN DIRECTIVES ........................................................................................................ 1
INTENDED USE................................................................................................................................................. 1
PURPOSE OF THE MANUAL ........................................................................................................................... 2
GENERAL WARNINGS...................................................................................................................................... 2
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
I
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
II
TABLE OF CONTENTS
SAFETY DEVICES........................................................................................................................................... 54
WATER SUPPLY CHARACTERISTICS........................................................................................................... 55
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 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
III
1. INTRODUCTION
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.
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
APPLICABLE The product described in this manual is manufactured in accordance with the highest safety
EUROPEAN 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:
DIRECTIVES
73/23/CEE, for the approximation to the legislation of the Members States related to low
voltage equipment (and following modifications).
2004/108/CEE, for the approximation to the legislation of the Members States related to the
electromagnetic compatibility (and following modifications);
93/42/CEE, concerning the medical devices (and following modifications).
INTENDED USE The product described in this manual is exclusively intended for the sterilization of solid and
hollow re-usable instruments and porous materials.
WARNING
THE DEVICE MUST ONLY BE USED BY QUALIFIED PERSONNEL. IT MAY
NOT BE USED OR HANDLED BY INEXPERT AND/OR UNAUTHORIZED
PERSONNEL FOR ANY REASON.
THIS DEVICE MUST NOT BE USED FOR THE STERILIZATION OF FLUIDS,
LIQUIDS OR PHARMACEUTICAL PRODUCTS.
NOTE
THE MANUAL INFORMATION ARE SUBJECT TO CHANGES WITHOUT ANY NOTICE.
MO.COM. LTD. CO. WON'T BE RESPONSIBLE FOR DIRECT, INDIRECT, ACCIDENTAL,
CONSEQUENT DAMAGES OR OTHER DAMAGES RELATED TO THE SUPPLY OR THE USE OF
SUCH INFORMATION.
THIS DOCUMENT MAY NOT BE REPRODUCED, ADAPTED OR TRANSLATED, IN WHOLE OR IN
PART, WITHOUT THE PRIOR, WRITTEN AUTHORIZATION OF M.O.COM. SRL
AND ARE REGISTERED TRADEMARKS OF M.O.COM. SRL
1
1. INTRODUCTION
GENERAL When using this product, always follow the instructions in the manual and never use for
WARNINGS anything other than its intended purpose.
WARNING
THE USER IS RESPONSIBLE FOR ALL LEGAL REQUIREMENTS RELATED
TO THE INSTALLATION AND USE OF THIS PRODUCT. THE
MANUFACTURER WILL NOT BE RESPONSIBLE FOR ANY BREAKAGE,
MALFUNCTIONS, PROPERTY DAMAGE OR INJURY IN THE EVENT THAT
THE PRODUCT IS NOT INSTALLED OR USED CORRECTLY.
Please observe the following precautions in order to avoid injury or property damage:
– Use ONLY distilled water of high quality.
WARNING
THE USE OF WATER OF INADEQUATE QUALITY CAN SEVERELY
DAMAGE THE DEVICE.
SEE APPENDIX A, TECHNICAL CHARACTERISTICS IN THIS REGARD .
WARNING
WHENEVER IT IS NOT POSSIBLE TO DISCONNECT THE ELECTRICITY TO
THE DEVICE, OR IF THE EXTERNAL POWER GRID SWITCH IS FAR AWAY
OR, AT ANY RATE, NOT VISIBLE TO THE MAINTAINER, PLACE A WORK
IN PROGRESS SIGN ON THE EXTERNAL POWER GRID SWITCH AFTER
TURNING IT OFF .
– Make sure the electrical system is grounded conforming to current laws and/or standards;
– Do not remove any label or nameplate from the device; request new ones, if necessary.
– Use only original replacement parts.
WARNING
THE FAILURE TO OBSERVE THE ABOVE, RELEASES THE
MANUFACTURER FROM ALL LIABILITY.
2
2. CONTENTS OF THE PACKAGE
NOTE
IN THE CASE OF A WRONG PRODUCT, MISSING PARTS OR ANY TYPE OF DAMAGE,
IMMEDIATELY PROVIDE A DETAILED DESCRIPTION TO THE RESELLER AND THE
TRANSPORTER THAT MADE THE DELIVERY.
DESCRIPTION OF
THE CONTENTS
NOTE
THE CUSTOMER MUST KEEP THE WARRANTY CERTIFICATE TOGETHER WITH THE
RECEIPT.
3
2. CONTENTS OF THE PACKAGE
HANDLING THE Where possible, the packaged product must be handled using suitable mechanical means
PRODUCT (forklift truck, transpallet, etc.) and following the instructions shown on the package.
In the case of manual handling, the product must be lifted by two persons using the handles
cut in the side of the box.
Once removed from the box, the sterilizer must be lifted by two persons and transported on a
cart or other similar device.
WARNING
WE RECOMMEND THAT THE DEVICE BE TRANSPORTED AND STORED
AT A TEMPERATURE NO LOWER THAN 5 °C. PROLONGED EXPOSURE
TO LOW TEMPERATURE AN DAMAGE THE PRODUCT.
NOTE
KEEP THE ORIGINAL PACKAGING AND USE IT WHENEVER THE DEVICE IS TO BE
TRANSPORTED. THE USE OF DIFFERENT PACKAGING COULD DAMAGE THE PRODUCT
DURING SHIPMENT.
DANGER
BEFORE TRANSPORT, LEAVE THE DEVICE TURNED-OFF FOR ABOUT 30
MINUTES AFTER THE LAST PROGRAM FINISHES AND DRAIN THE
DISTILLED WATER AND USED WATER TANKS SO THAT THE ALL THE
HOT INTERNAL PARTS WILL HAVE TIME TO COOL.
4
3. PRODUCT INTRODUCTION
PRODUCT 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.
INTRODUCTION
It is a sophisticated but, at the same time, easy to use device that, thanks to its wide range of
INTRODUCTION 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.
Its exclusive steam generation system, effective plumbing circuit and electronic management
(supplemented by high-precision sensors) guarantees high process execution speeds and
excellent thermodynamic parameter stability.
Moreover, its Process Evaluation System constantly monitors all the machine's “vital”
parameters in real-time, guaranteeing absolute safety and a perfect result.
It offers users 11 sterilization programs (of which one completely programmable), all equipped
with customizable, optimized drying for the fast, effective sterilization of the various types of
loads (instruments and materials) used in a medical environment.
Four of these can be selected directly from the control panel, which has a new simplified,
design.
And then, there are interesting options for configuring the preheating mode (based on the
sterilizer's frequency of use), printing the end of cycle report, methods for filling the water
supply, draining the used water and more.
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.
5
3. PRODUCT INTRODUCTION
FRONT
LCD display and
control panel
Door
On/Off switch
Service compartment
access panel
Printer paper
output slot
Sterilization
chamber
Door microswitch
Motorized
closing system
Bacteriological filter
Millflash interface
Built-in printer
Service
compartment open
Used water drain quick connector
6
3. PRODUCT INTRODUCTION
Safety valve
Heat exchanger
Power cord
Mains fuses
7
3. PRODUCT INTRODUCTION
CONTROL
PANEL
Command keys
The function of the command keys differ according to operating mode of the equipment.
4 lines of 20 characters
LCD DISPLAY
Illuminated icon
ALARM
Setup status
Process status
Door status
Water level
8
3. PRODUCT INTRODUCTION
OPERATING The Millennium B² sterilization program can be described as a succession of phases, each
CYCLE EXAMPLE 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):
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)
PROCESSO
2.10
2.00
1.00
Tempo (min)
0.00
-0.80
NOTE
PLEASE REFER TO APPENDIX B (PROGRAMS) FOR MORE DETAIL.
9
4. INSTALLATION
INSTALLATION The first and fundamental step in achieving good sterilizer operation, long life and complete
use of its features is a correct, careful installation. Moreover, this precaution will avoid the
danger of physical injury or property damage, not to mention malfunctions and damage to the
INTRODUCTION 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.
THE STERILIZER HAS PASSED ALL REQUIRED INSPECTIONS BEFORE BEING PLACED ON
THE MARKET. IT DOES NOT REQUIRE ANY ADDITIONAL CALIBRATION BEFORE BEING
PLACED IN SERVICE.
660
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.
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.
DO NOT REMOVE THE UPPER COVER OR ANY OTHER EXTERNAL PART. WHEN INSTALLED
IN THE COMPARTMENT, THE DEVICE MUST BE COMPLETE WITH ALL ITS PARTS.
PLEASE REFER TO APPENDIX A (TECHNICAL CHARACTERISTICS) FOR COMPLETE
TECHNICAL DATA.
10
4. INSTALLATION
GENERAL Obey the following warnings for the correct operation of the device and/or to avoid risky
INSTALLATION situations:
PRECAUTIONS Install the sterilizer on a flat surface; if necessary, adjust the leveling feet to compensate for
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 (at least 10 cm on each side) all around the
sterilizer, especially in back.
If the device is built-in to a cabinet, be sure to respect the warnings in the preceding
paragraph, avoiding an obstructions to the air intake;
– Do not install the sterilizer near tubs, sinks or similar places, to avoid contact with water or
liquids. This could cause short circuits and/or potentially dangerous situations for the
operator;
– Do not install the sterilizer in a place that is excessively humid or poorly ventilated;
– Do not install the machine were there is gas or inflammable and/or explosive vapors;
– Install the device so that the power cord is not bent or crushed. It must run freely all the
way to the socket.
– Install the device that any external fill/drain tubing is not bent or crushed. They must run
freely to the drain tank.
ELECTRICAL The sterilizer's must be connected to a socket of the electrical system of adequate capacity for
CONNECTIONS the device's absorption and ground provided, in conformity with current laws and/or standards.
The socket must be suitably protected by a breaker having the following characteristics:
– Nominal current In 16 A
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, ADAPTERS OR OTHER ACCESSORIES.
CONNECTING THE The sterilizer can be connected to MILLFLASH allowing the recording of the cycle data on .txt
DATA RECORDING format file and its management by PC.
MILLFLASH The connectors of the service box are used for interfacing; refer to MILLFLASH Operating
Manual for the installation instructions.
11
4. INSTALLATION
CONNECTING AN To avoid having to periodically fill the water tank (see Chapter 5, “First Start-Up”), it is
EXTERNAL 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
WATER FILLING with accumulation tank.
TANK
(OPTIONAL, automatic In that case, when the internal water tank reaches the MIN level, the autoclave activates a
filling function) 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
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 ”.
CONNECTING The sterilizer can be connected to MILLDROP (water treatment system by reverse osmosis)
DEMINERALIZER warranting the automatic reservoir filling with high quality demineralized water.
MILLDROP 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).
12
4. INSTALLATION
CONNECTING AN An external drain tank (supplied as an option) can be used to avoid having to periodically
EXTERNAL DRAIN empty the internal used water tank, which is then manually emptied or connected to central
drain system.
TANK
OPTIONAL, external
drain function) 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:
NOTE
MAKE SURE THE TUBE IS NOT BENT,
CRUSHED OR OBSTRUCTED IN ANY WAY.
NOTE
MAKE SURE THE PLUG IS CORRECTLY
INSERTED. A POOR CONNECTIN IS
INTERPRETED AS A MAX LEVEL SIGNAL,
WITH A CONSEQUENT ALARM WHENEVER
YOU INSIST ON STARTING THE CYCLE.
– 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”..
Connecting the tank to To avoid having to periodically empty the draining tank, it
is possible to connect it directly to a central drain. Replace the
a central draining point pipe-fitting
– Insert the screw plug in place of the free vent hose by the plug
union on the side connector of the draining tank; Plug
13
4. INSTALLATION
– 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.
Connection point
Sterilizer of the centralized draining plant
Support plane
DRAIN
This point must be lower CENTRALIZED
than the support plane
X
Connection point
of the draining tank
Draining tank
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+30 MM. HIGHER CONNECTIONS COULD COMPROMISE THE CORRECT
EMPTYING OF THE TANK.
DIRECT Follow the instructions shown below for a correct direct connection to a centralized draining
CONNECTION TO A point:
CENTRALIZED – Insert the silicone tube (provided) or other suitable plastic tube on hose union A; push the
DRAINING POINT 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.
Centraliz ed
draining point
Support plane Was her
A Clip
Pipe 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.
14
5. FIRST START-UP
FIRST START-UP 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.
TURNING ON THE
EQUIPMENT NOTE
DO THIS WITH THE STERILIZER'S DOOR OPEN.
INITIAL When turned on, the control panel lights up and beeps so you can visually check its correct
AUTOMATIC operation. The panel then displays this message:
TEST
M I L L E N N I U M B 2
R . E x x x x / B G y y y y y y
D E V I C E C H E C K - U P
NOTE
IF THE DOOR IS CLOSED, THE TEST IS INTERRUPTED. THE PANEL THEN BEEPS AND
DISPLAYS THE FOLLOWING MESSAGE.
O P E N D O O R
T O C O N T I N U E
Open the door to allow the test to continue. At the end of the test you will see:
M I L L E N N I U M B 2
R . E x x x x / B G y y y y y y
C H E C K - U P C O M P L E T E
ACQUISITION AND The sterilizer measures the ambient pressure for the correct operation of several auxiliary
UPDATING OF THE 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
AMBIENT set value, the system automatically updates the stored value after a brief delay. Otherwise,
PRESSURE the data remains unchanged without updating.
VALUES 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):
A M B I E N T P R E S S U R E
V A L U E U P D A T E D
- 0 . 0 1 b a r
↵ t o c o n t i n u e
When ↵ is pressed, the device goes to STAND-BY mode (see the following paragraph).
NOTE
ALSO SEE THE PARAGRAPH, “ACQUIRING THE AMBIENT PRESSURE VALUE” IN THIS
REGARD.
15
5. FIRST START-UP
STAND-BY MODE After the initial test, the sterilizer goes to STAND-BY mode and the display shows:
C o u n t e r x x x x x / y y y y y
S t a n d - b y H I G H
2 3 . 6 ° C 3 0 / 0 8 / 0 2
- 0 . 0 1 b a r 1 8 : 1 3 : 0 5
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
PHASE), EXCLUDING THE PREHEATING PHASE. A CYCLE ENDS AT THE END OF THE
PROGRAM (SEE THE CHAPTER, “PROGRAM EXECUTION”).
TO SET THE DATE AND TIME AS WELL AS SELECT THE PREHEATING MODE, PRINT THE
DATA AND FILL THE TANK, PLEASE REFER TO THE CHAPTER, “CONFIGURING THE
DEVICE”.
At regular intervals, the first two lines on the display alternate with the modes set for printing
(ON/OFF) and filling (Manual/Automatic):
P r i n t O N
F i l l i n g M A N U A L
2 3 . 6 ° C 3 0 / 0 8 / 0 2
- 0 . 0 1 b a r 1 8 : 1 3 : 0 5
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.
16
5. FIRST START-UP
FILLING DISTILLED The first time the sterilizer is used, and later when the MIN water level indicator comes on, you
WATER will have to fill, or top-off, the internal distilled water tank.
Manual filling With reference to the figure (and with the door open), proceed as follows:
click;
3. Place the container in a vertical position, at the same
time, loosening the plug and taking care not to spill
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 the connection point, keeping it horizontal;
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. When the MAX level icon comes on (accompanied by a beep), stop filling and detach the
quick connector as described in points 7 and 8.
NOTE
THE ICON MAX DOES NOT HAVE TO BE ON TO START A STERILIZATION PROGRAM. THE
ICON MIN INDICATOR OFF IS SUFFICIENT.
Automatic filling 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.
NOTE
USE ONLY HIGH QUALITY DISTILLED WATER. FOR THE SPECIFICATIONS OF THE WATER
SUPPLY, SEE APPENDIX A (TECHNICAL CHARACTERISTICS).
To set the automatic filling option, please refer to the Chapter, “Configuring the Device”.
WARNING
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.
17
5. FIRST START-UP
MAX LEVEL IN THE When the water level in the internal or external drain tank reaches the MAX level, the LCD
INTERNAL/ display alternatively lights the MAX and MIN icons.
EXTERNAL DRAIN
TANK
NOTE
IN THIS CONDITION THE UNIT WILL GENERATE AN ALARM INDICATION (SEE APPENDIX E -
ALARM) AS YOU ATTEMPT TO LAUNCH A STERILIZATION CYCLE.
Remove the top cap from the external tank and empty into a sink the water exceeding the
Emptying the external
signed level.
tank (option)
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.
18
6. CONFIGURATION
CONFIGURATION 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.
INTRODUCTION
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. CUSTOMER SUPPORT (SEE APPENDIX Z) IS AVAILABLE TO HELP USERS BY
PROVIDING SUGGESTIONS OR ADVICE ON THE BEST WAY TO USES THE OPTIONS IN THE
SETUP PROGRAM
STARTING AND To start the SETUP program, hold down the Ç key on the control panel for several seconds,
ENTERING THE until the display shows:
SETUP MODE
M I L L E N N I U M B 2
S E T U P
↵ t o c o n t i n u e
Ç t o e x i t
NOTE
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).
NOTE
THE SETUP PROGRAM CAN ONLY BE STARTED IN STAND-BY MODE. IT IS NOT
ACCESSIBLE DURING STERILIZATION OR TEST CYCLES.
MEANING OF THE In SETUP mode the control panel keys have different functions than in normal mode.
KEYS IN SETUP
MODE
Key SETUP mode
19
6. CONFIGURATION
MILLENNIUM B2
SETUP
2nd MENU 3rd MENU 4th MENU 5th MENU MILLENNIUM B2
↵ to continue
LEVEL LEVEL LEVEL LEVEL Setup Layout
⇑ to exit NOTES
Selecting the EXIT item, the previous menu is displayed
(ESC key has the same effect of EXIT command)
LANGUAGE ITALIANO INSERT PASSWORD CONFIRM PASSWORD
*************** *************** Selecting the last option of the current menu (or the item
DATE SETTING ENGLISH ↵ to enter ↵ to enter TO ENTER), the previous menu is displayed
1st MENU ⇑ to exit ⇑ to exit
LEVEL TIME SETTING FRANCAIS
PASSWORD DEUTSCH 134c HOLLOW STANDARD DRYING SHORT DRYING
EXIT ESPANOL 121c HOLLOW FAST DRYING LONG DRYING
EXIT
134c SOLID EXIT EXIT
BASIC 121c SOLID
dd/mm/yyyy
+/- to set 134c EMERGENCY
↵ to enter
⇑ to exit 134c WRAPPED STANDARD DRYING
YES
SPECIAL AMBIENT PRESSURE ACQUISITION OF THE Is the door
AMBIENT PRESSURE NO time
open? PRESSURE VALUE
↵ to enter limited
LCD CONTRAST SET INTO MEMORY
⇑ to exit (+ beep)
EXIT
ADJUSTMENT OF THE WARNING!
ONLY AVAILABLE FOR LCD CONTRAST
SERVICE MOCOM SERVICE +/- to set OPEN THE DOOR
⇑ to exit TO CONTINUE
20
6. CONFIGURATION
DESCRIPTION OF Now, we describe the meaning of the various main menu and second-level menu items.
THE MENU ITEMS
MAIN MENU
The main menu has 6 entries that open additional (second-level) menus:
NOTE
THE METHODS FOR CHANGING THE VARIOUS ITEM SETTINGS ARE FOUND IN THE
PARAGRAPH, ACTIVATING CONFIGURATION OPTIONS.
BASIC Menu
The Basic menu (basic options) consists of the items:
ADVANCED Menu
The Advanced menu (advanced options) consists of the items:
SPECIAL Menu
The Special menu (special options) consists of the following items:
SERVICE Menu
The Service menu can ONLY be accessed by the Service department.
21
6. CONFIGURATION
M I L L E N N I U M B 2 D A T E
R . E x x x x / B G y y y y y y d d / m m / y y y y
L A N G U A G E T I M E
E N G L I S H h h : m m : s s
Firmware version
1 s t P R E S E T 2 n d P R E S E T
1 3 4 ° C P O R O U S 1 3 4 ° C H O L L O W
S T A N D A R D D R Y I N G F A S T D R Y I N G
3 r d P R E S E T 4 t h P R E S E T
1 3 4 ° C W R A P P E D 1 3 4 ° C E M E R G E N C Y
E X T R A D R Y I N G + 0 5 F A S T D R Y I N G
S t a n d - b y o p t i o n P r i n t o p t i o n
H I G H I N T E R N A L
1 2 0 m i n 1 C O P Y ( i e s )
F i l l i n g o p t i o n
A U T O M A T I C
D r a i n o p t i o n
I N T E R N A L
E X I T
D A T A R E V I E W
↵ t o c o n t i n u e
Press ↵ to confirm
NOTE
FOR THE MEANING OF THE TERMS SHOWN, SEE THE PARAGRAPH, ACTIVATING
CONFIGURATION OPTIONS.
22
6. CONFIGURATION
DEFAULTS The sterilizer leaves the factory with the following settings:
SETTINGS
DATE: current date
TIME: current time
NOTE
THE PROGRAMS INDICATED SHOULD BE CONSIDERED AS PREFERENTIAL SETTINGS.
HOWEVER, OTHER COMBINATIONS ARE POSSIBLE BASED ON THE DESTINATION MARKET.
ACTIVATING Now, we provide a detailed explanation of how to select the various available options,
CONFIGURATION proceeding in the shown in the previous paragraph.
OPTIONS
Select LANGUAGE using the ↵ key. The following screen will appear:
Setting the language
(LANGUAGE on the
BASIC Menu) → I T A L I A N O +
E N G L I S H ↑
F R A N Ç A I S ↓
D E U T S C H -
E S P A Ñ O L
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.
Setting the date When DATE SETTING is selected with the ↵ key, you will see:
(DATE SETTING on the
BASIC Menu) d d / m m / y y y y
+ / - t o s e t
↵ t o e n t e r
Ç t o e x i t
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.
23
6. CONFIGURATION
Setting the time When TIME SETTING is selected with the ↵ key, you will see:
(TIME SETTING on the
BASIC menu) h h : m m : s s
+ / - t o s e t
↵ t o e n t e r
Ç t o e x i t
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.
Setting the password When PASSWORD is selected with the ↵ key, you will see this menu:
(PASSWORD on the
BASIC menu) → D I S A B L E D +
A N Y P O W E R O N ↑
A N Y C Y C L E S T A R T ↓
E X I T -
Select DISABLED to use the device freely, without any limitation on operator access.
Select ANY POWER-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, WE RECOMMEND ONLY ACTIVATING THIS OPTION WHEN
IT IS REALLY NEEDED.
When the ANY POWER-ON or ANY CYCLE START options are selected, the following
screen is displayed:
I N S E R T P A S S W O R D
↵ t o e n t e r
Ç t o e x i t
Enter the password with the + and – keys (fixed length, 8 characters).
Confirm with the ↵ key. Then, the following message will appear:
C O N F I R M P A S S W O R D
↵ t o e n t e r
Ç t o e x i t
24
6. CONFIGURATION
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 The program setting and their storing in four pre-set positions is achieved in various steps
programs using several menus in sequence.
(PROGRAMS on the Each pre-set position can be associated to a standard or user configurable cycle (CUSTOM).
ADVANCED menu) Let's look at the two cases separately.
To associate a standard program and define several of its parameters, proceed as follows:
→ 1 s t P R E S E T +
2 n d P R E S E T ↑
3 r d P R E S E T ↓
4 t h P R E S E T -
E X I T
Define the position (1, 2, 3 or 4) to which the sterilization program will be associated using
the + and - keys. Confirm with the ↵ key.
→ 1 3 4 ° C H O L L O W +
1 2 1 ° C H O L L O W ↑
1 3 4 ° C S O L I D ↓
1 2 1 ° C S O L I D -
1 3 4 ° C E M E R G E N C Y
1 3 4 ° C W R A P P E D
1 2 1 ° C W R A P P E D
1 3 4 ° C P O R O U S
1 2 1 ° C P O R O U S
1 3 4 ° C P R I O N
X X X ° C C U S T O M
E X I T
Using the + and - keys, scroll the list until you identify the sterilization program desired.
When the PRION program is selected, you will go to a screen for selecting the sterilization time.
T I M E : X X m i n
+ / - t o s e t
↵ t o e n t e r
Ç t o e x i t
25
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.
→ S T A N D A R D D R Y I N G +
F A S T D R Y I N G ↑
E X I T ↓
-
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.
→ S T A N D A R D D R Y I N G +
I N T E L L . D R Y I N G ↑
E X T R A D R Y I N G ↓
E X I T -
NOTE
WITH LARGE LOADS OR SPECIAL MATERIALS, THE STANDARD OPTION MAY NOT
PROVIDE A PERFECT RESULT. IN THIS CASE, EXTEND THE DRYING PHASE BY USING THE
EXTRA MODE.
WITH PARTICULARLY COMPLEX TYPES OF LOADS (SUCH AS WRAPPED INSTRUMENTS IN
A "CONTAINER" FOR STERILIZATION) "INTELLIGENT" DRYING MAY NOT WORK
CORRECTLY, WITH WORSE THAN EXPECTED RESULTS. IN THESE CASES, USE THE
STANDARD OR EXTRA OPTIONS, DEPENDING ON THE NEED.
E X T R A : X X m i n
+ / - t o s e t
↵ t o e n t e r
Ç t o e x i t
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.
WHENEVER 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:
T H I S P R O G R A M
I S A L R E A D Y P R E S E T
26
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:
→ 1 3 4 ° C P R O C E S S +
1 2 1 ° C P R O C E S S ↑
E X I T ↓
-
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:
T I M E : X X m i n
+ / - t o s e t
↵ t o e n t e r
Ç t o e x i t
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:
→ F R A C T I O N . V A C U U M +
S I N G L E V A C U U M ↑
E X I T ↓
-
4. At this point, you come to another menu where you set the drying mode:
→ S H O R T D R Y I N G +
L O N G D R Y I N G ↑
E X I T ↓
-
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.
27
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:
→ S T A N D A R D D R Y I N G +
F A S T D R Y I N G ↑
E X I T ↓
-
→ S T A N D A R D D R Y I N G +
I N T E L L . D R Y I N G ↑
E X T R A D R Y I N G ↓
E X I T -
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:
T H I S P R O G R A M I S
A L R E A D Y P R E S E T
NOTE
THE SELECTION CAN BE CHANGED AT ANY TIME BY FOLLOWING THE PROCEDURE
DESCRIBED ABOVE.
28
6. CONFIGURATION
Setting the STAND-BY Based on the equipment's frequency of use, or other considerations, it is possible to select the
mode heating level during the STAND-BY (preheating) phase and the time beyond which STAND-BY
(STAND-BY OPTIONS on is deactivated.
the ADVANCED menu) When you select STAND-BY OPTIONS with the ↵ key, you access the following menu:
→ S T - B Y M O D E +
S T - B Y T I M E - O U T ↑
E X I T ↓
-
When you select STAND-BY MODE, an additional menu appears where you can set the
heating level:
→ O F F +
L O W ↑
H I G H ↓
E X I T -
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:
T I M E O U T : X X X m i n
+ / - t o s e t
↵ t o e n t e r
Ç t o e x i t
It is possible to set a value between 0 and 300 minutes (in 30-minute increments), after which
the heating elements are turned off (a condition analogous to STAND-BY OFF), avoiding the
useless consumption of electricity.
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 .
29
6. CONFIGURATION
Setting the printing The sterilizer is equipped with a printer for recording sterilization program data; it is necessary
mode to set the parameters required for its proper operation.
(PRINT OPTIONS on the
ADVANCED menu) 1. Select PRINT OPTIONS using the ↵ key and the following menu appears:
→ P R I N T E R +
R E P O R T ↑
E X I T ↓
-
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
→ O F F +
I N T E R N A L ↑
E X T E R N A L ↓
E X I T -
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:
Printer model 1 → T Y P E 1 +
T Y P E 2 ↑
E X I T ↓
-
If, on the other hand, you choose EXTERNAL, the data will be printed on an external
peripheral. Following this selection, another menu opens:
→ C R T Y P E +
C R + L F T Y P E ↑
C R ( + F F ) T Y P E ↓
C R + L F ( + F F ) T Y P E -
E X I T
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, TRY PRINTING WITH THE VARIOUS OPTIONS TO
IDENTIFY THE CORRECT SETTING.
30
6. CONFIGURATION
b) Item REPORT
→ P R I N T O U T M O D E +
N R . C O P I E S ↑
P R I N T L A S T ↓
E X I T -
Select item PRINTOUT MODE to chose the mode the data are printed: The following
options appear:
→ A T C Y C L E E N D +
S T E P B Y S T E P ↑
E X I T ↓
-
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.
THE VACUUM AND HELIX TEST REPORT PRINT IS CARRIED OUT ONLY IN MODE “AT
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:
C O P I E S : X X
+ / - t o s e t
↵ t o e n t e r
Ç t o e x i t
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:
→ N O R M A L P R I N T +
E X T E N D E D P R I N T ↑
E X I T ↓
-
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).
31
6. CONFIGURATION
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
MODE. IF THE LAST CYCLE WAS INTERRUPTED BY AN ALARM (MANUAL STOP
EXCLUDED) IT ONLY THE EXTENDED MODE WILL BE AVAILABLE.
N O W P R I N T I N G
T H E R E P O R T
P L E A S E W A I T . . .
Setting the tank filling The internal tank can be filled either manually or automatically, in the latter case, drawing
mode water from an external device (tank or demineralizer Milldrop connected to the device- see
(FILLING OPTIONS on Chapter, “Installation”).
the ADVANCED menu)
After FILL OPTIONS is selected, the following menu appears:
→ A U T O M A T . F I L L I N G +
M A N U A L F I L L I N G ↑
E X I T ↓
-
NOTE
ONLY ACTIVATE THE AUTOMATIC FILLING MODE AFTER THE EXTERNAL TANK HAS BEEN
FILLED WITH HIGH QUALITY DISTILLED WATER OR THE MILLDROP HAS BEEN TURNED ON.
ALSO REMEMBER TO OPEN THE TAP ON THE EXTERNAL 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.
Setting the The water used for the sterilization cycle can be drained into either the internal tank (standard
water draining mode configuration) or an external tank of greater capacity (offered as an option – see chapter
(DRAIN OPTIONS from “Installation”) so as to reduce the frequency of emptying the used water.
the ADVANCED menu)
After DRAIN OPTIONS is selected, the following menu appears:
→ I N T E R N A L D R A I N +
E X T E R N A L D R A I N ↑
E X I T ↓
-
32
6. CONFIGURATION
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 MAX 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.
IN THE CASE OF AN INSTALLATION WITH THE DRAIN CONNECTED TO THE CENTRAL
SYSTEM, SELECT INTERNAL DRAIN.
Scroll through the items with the + and - keys; confirm with the ↵ key.
Acquisition of the The first time the sterilizer is used and after any reinstallation, the sterilizer must acquire the
ambient pressure ambient pressure.
(AMBIENT PRESSURE This operation is necessary or the correct operation of several of the device's auxiliary
on the SPECIAL menu) systems.
When AMBIENT PRESSURE is activated, the following screen appears:
A C Q U I S I T I O N O F T H E
A M B I E N T P R E S S U R E
↵ t o e n t e r
Ç t o e x i t
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:
O P E N T H E D O O R
T O C O N T I N U E
Confirm the acquisition of the data by pressing the ↵ key. This message appears:
P R E S S U R E V A L U E
S E T I N T O M E M O R Y
33
6. CONFIGURATION
Adjusting the The LCD contrast adjustment allow to obtain the screen reading as clear as possible,
contrast of the liquid compensating different sterilizer positioning or ambient brightness.
crystal display
(LCD CONTRAST on the When LCD CONTRAST is activated, this screen appears:
SPECIAL menu)
A D J U S T M E N T O F T H E
L C D C O N T R A S T
+ / - t o s e t
Ç t o e x i t
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.
EXIT THE Completed the sterilizer configuration, proceed as follows to return in normal mode:
CONFIGURATION
– Go to the first-level menu
MODE (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.
ALTERNATIVELY, YOU CAN PRESS Ç (ESC) KEY ONE OR MORE TIMES.
M I L L E N N I U M B 2
S E T U P C O M P L E T E
↵ t o e x i t
Ç t o r e s u m e
After several seconds, the device returns to normal operation in STAND-BY mode.
34
7. PREPARING THE MATERIAL
PREPARING THE 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
MATERIAL orderly manner.
INTRODUCTION 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 suggestions regarding these aspects, leaving
the user to study the subject further in the most suitable way.
TREATING THE First of all, it should be recalled that, when handling and managing contaminated material, it
MATERIAL is a good idea to take the following precautions:
BEFORE – Wear rubber gloves of adequate thickness;
STERILIZATION – Clean your gloved hands with a germicide detergent;
– Always carry the instruments on a tray.
– Never carry them in your hands;
– Protect your hands from contact with any sharp points or edges; this will avoid the risk of
contracting a dangerous infection;
– Immediately remove any article that does not need to be sterilized or that is not capable of
withstanding the process;
– Carefully wash your still gloved hands when done handling non-sterile material.
All materials and/or instruments to be sterilized must be perfectly clean, without any type of
residue (deposits of organic/inorganic material, fragments of paper, cotton/gauze pads, lime,
etc.).
NOTE
IN ADDITION TO CAUSING PROBLEMS DURING STERILIZATION, THE FAILURE TO CLEAN
AND REMOVE RESIDUE CAN DAMAGE THE INSTRUMENTS AND/OR THE STERILIZER,
ITSELF.
NOTE
SOLUTIONS CONTAINING PHENOLS OR QUATERNARY AMMONIA COMPOUNDS CAN CAUSE
CORROSION ON INSTRUMENTS AND THE METAL PARTS OF ULTRASOUND DEVICES.
5. After washing, carefully rinse the instruments and make sure that residues have been
completely eliminated; if necessary, repeat the washing cycle or clean manually.
NOTE
TO AVOID THE FORMATION OF LIME SPOTS, RINSE WITH DEIONIZED OR DISTILLED WATER,
IF POSSIBLE. WHENEVER VERY HARD TAP WATER IS USED, WE RECOMMEND ALWAYS
DRYING THE INSTRUMENTS.
35
7. PREPARING THE MATERIAL
For handles (turbines, contra-angles, etc.), supplement the above with treatment in suitable
dedicated devices that provide effective internal cleaning (occasionally including lubrication).
NOTE
THE END OF THE STERILIZATION PROGRAM, REMEMBER TO LUBRICATE THE INTERNAL
HANDLE MECHANISMS USING THE SPECIAL STERILE OIL. BY TAKING THESE
PRECAUTIONS, THE INSTRUMENTS USEFUL LIFE WILL NOT BE REDUCED IN ANY WAY
WARNING
CONSULT THE INSTRUCTIONS PROVIDED BY THE MANUFACTURER OF
THE INSTRUMENT/MATERIAL TO BE STERILIZED BEFORE SUBJECTING
IT TO AUTOCLAVE TREATMENT, CHECKING FOR ANY
INCOMPATIBILITIES. SCRUPULOUSLY FOLLOW THE METHODS OF
USING DETERGENTS OR DISINFECTANTS AND THE USAGE
INSTRUCTIONS OF THE AUTOMATIC DEVICES FOR WASHING AND/OR
LUBRICATING THEM.
On the other, as regards textile material (or porous, in general), such as smocks, napkins,
caps and other, carefully wash and then dry them before treating them in the autoclave.
NOTE
DO NOT USE DETERGENTS WITH A HIGH CONTENT OF CHLORINE AND/OR PHOSPHATES.
DO NOT BLEACH WITH CHLORINE-BASED PRODUCTS. THESE SUBSTANCES CAN DAMAGE
THE TRAY SUPPORTS, TRAYS AND ANY METAL INSTRUMENTS THAT MAY BE PRESENT IN
THE STERILIZATION CHAMBER.
ARRANGING THE Follow the instructions below for the most efficient sterilization process, preserve the material
LOAD and increase its useful life.
– Arrange instruments made of different metals (stainless steel, tempered steel, aluminum,
etc.) on different trays or well separated from each other.
– In the case of instruments not made of stainless steel, place a paper sterilization napkin or
a muslin cloth between the tray and the tool, avoiding direct contact between the two
different materials;
OK
– In any case, arrange the objects sufficiently distant from each other that they will remain so
for the entire sterilization cycle;
– Make sure that all instruments are sterilized in an open position;
– Position cutting instruments, (scissors, scalpels, etc.) so they can not come into contact
with each other during sterilization; if necessary, use a cotton or gauze cloth to isolate and
protect them;
– Arrange recipients (glasses, cups, test tubes, etc.) resting on their side, or upended, so
avoid pooling water;
– Do not load trays beyond their indicated limit (see Appendix A).
– Since this value is understood to be the maximum allowed limit, it can be excessive in
OK some cases, so always use common sense.
– Do not stack trays or put them in direct contact with the walls of the sterilization chamber.
– Always use the tray support provided.
– To insert and extract trays from the sterilization chamber, always use the extractor
provided.
NOTE
PLACE A CHEMICAL STERILIZATION INDICATOR ON EVERY TRAY TO INDICATE THAT THE
PROCESS HAS OCCURRED: THIS AVOIDS USELESSLY REPROCESSING THE SAME LOAD
OR, WORSE, USING NON-STERILIZED MATERIAL. IF PROCESSING WRAPPED MATERIAL,
PLACE THE INDICATOR INSIDE ONE OF THE WRAPPINGS.
36
7. PREPARING THE MATERIAL
– Always rinse before use with pyrogen-free water; do not dry them;
OK – Arrange the tubing on the tray so that their ends are not obstructed or crushed.
– Do not bend or wind them, but allow them to lie as straight as possible.
– Arrange packages side-by-side, suitably spaced and absolutely not piled, to avoid their
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.
OK
– Wrap instruments individually or, when more than one instrument are placed in the same
wrapping, make sure that they are made of the same metal;
– Seal the wrapping with adhesive tape for autoclaves or heat-sealing machines.
– Do not use staples, pins or other fasteners since they can compromise the maintenance of
sterility;
– Arrange the envelopes so as to avoid forming air pockets that obstruct the correct
penetration and removal of the steam.
– Orient the envelopes so as to leave the plastic side up and the paper side down (tray
side).
– In any case, check that they are correctly positioned, turning them over, if necessary.
– If possible, place the envelopes edgewise to the tray, with a suitable support.
– Never superimpose envelopes on top of each other.
WARNING
WHENEVER YOU ANTICIPATE PROLONGED STORAGE, ALWAYS WRAP
THE INSTRUMENTS. SEE THE CHAPTER, “PRESERVING STERILIZED
MATERIAL”.
37
8. PROGRAM SELECTION
NOTE
A GUIDE TO SELECTING THE MOST SUITABLE PROGRAM FOR THE LOAD IS PROVIDED IN
APPENDIX B (PROGRAMS).
NOTE
IFA PASSWORD HAS BEEN ENABLED (SEE THE CHAPTER CONFIGURATION - SETTING
THE PASSWORD), YOU WILL BE ASKED TO ENTER THE ACCESS CODE:
I N S E R T P A S S W O R D
↵ t o e n t e r
Ç t o e x i t
Enter the password using the + and – keys. Confirm with the ↵ key.
NOTE
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 of the selected
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 1 3 4 ° C P O R O U S
N O R M A L D R Y I N G
1 3 4 . 0 ° C ( B )
2 . 1 0 b a r 0 4 : 0 0
After a brief interval, the display changes and shows the temperature and pressure values of
the chamber, with the current date and time.
1 1 3 4 ° C P O R O U S
N O R M A L D R Y I N G
1 0 1 . 0 ° C 3 0 / 0 8 / 0 2
0 . 0 1 b a r 1 8 : 1 3 : 0 5
38
8. PROGRAM SELECTION
NOTE
IF NO STERILIZATION PROGRAM IS SELECTED, THE EQUIPMENT CANNOT START A
STERILIZATION CYCLE, AND THE FOLLOWING MESSAGE APPEARS ON THE DISPLAY, WITH
A BEEP:
S E L E C T A P R O G R A M
P L E A S E . . .
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.
39
9. RUNNING THE PROGRAM
RUNNING 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
THE CYCLE and drying method.
INTRODUCTION 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.
STARTING THE After placing the load in the sterilization chamber (with the precautions explained in the
CYCLE Chapter, “Preparing the Material”) and selecting the desired program, close the door until
you hear the click.
NOTE
IF A PASSWORD HAS BEEN ENABLED WITH THE OPTION ANY CYCLE START (SEE THE
CHAPTER CONFIGURATION - SETTING THE PASSWORD), YOU WILL BE ASKED TO ENTER
THE ACCESS CODE:
Password check
I N S E R T P A S S W O R D
↵ t o e n t e r
Ç t o e x i t
Enter the password using the + and – keys. Confirm with the ↵ key.
Printer paper-out check The equipment checks the presence of the paper into the on-board printer; if out or ended the
following message will be displayed:
W A R N I N G
P A P E R O U T
↵ t o c o n t i n u e
Ç t o e x i t
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.
If Millflash is connected 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:
W A R N I N G
C F C A R D M I S S I N G
↵ t o c o n t i n u e
Ç t o e x i t
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.
40
9. RUNNING THE PROGRAM
In case of the memory full or insufficient to store the new cycle data, the following message
will be displayed:
W A R N I N G
C F C A R D F U L L
↵ t o c o n t i n u e
Ç t o e x i t
or
W A R N I N G
M E M O R Y F U L L
↵ t o c o n t i n u e
Ç t o e x i t
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.
When START is pushed, and for the entire sterilization cycle, the lower lines of the display will
show the following parameters:
1 1 3 4 ° C P O R O U S
W A R M U P
1 0 1 . 9 ° C
0 . 0 1 b a r 0 0 : 0 0
The time is counted from the start of the sterilization cycle (first vacuum phase), excluding the
preheating phase.
PROGRAM Now, we will analyze the execution of a sterilization cycle, phase by phase.
EXECUTION For our example, let's take the most complete and important cycle, i.e., the program 134 °C
POROUS, which is characterized by a fractionated pre-vacuum.
When the START button is pressed, the first phase is PREHEATING, which brings the
Preheating chamber to temperature required for starting the cycle. The display shows the following:
1 1 3 4 ° C P O R O U S
W A R M U P
2 3 . 9 ° C
0 . 0 1 b a r 0 0 : 0 0
The icon that shows the status of the sterilization process is off.
41
9. RUNNING THE PROGRAM
First 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 1 3 4 ° C P O R O U S
1 . V A C U U M P U L S E
8 4 . 1 ° C
- 0 . 6 9 b a r 0 1 : 2 5
First rise in When the pre-set vacuum value is reached, steam is injected and the pressure begins to rise
pressure (1st PRESSURE PULSE), until the established value is reached.
1 1 3 4 ° C P O R O U S
1 . P R E S S U R E P U L S E
1 0 8 . 0 ° C
0 . 4 7 b a r 0 3 : 5 8
Second vacuum phase 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 1 3 4 ° C P O R O U S
2 . V A C U U M P U L S E
9 3 . 3 ° C
- 0 . 7 9 b a r 0 6 : 0 6
Second rise in After the second vacuum phase, steam is again injected into the sterilization chamber, with a
pressure relative rise in pressure (2nd PRESSURE PULSE).
1 1 3 4 ° C P O R O U S
2 . P R E S S U R E P U L S E
1 1 . 4 ° C
0 . 7 2 b a r 0 7 : 4 4
The icon that shows the status of the sterilization process is always off.
Third vacuum phase At the end of the second pressure rise, there is another discharge and the last vacuum phase
begins (3rd VACUUM PULSE).
1 1 3 4 ° C P O R O U S
3 . V A C U U M P U L S E
8 9 . 9 ° C
- 0 . 8 0 b a r 0 9 : 5 2
42
9. RUNNING THE PROGRAM
Third rise in After the last vacuum phase, the pressure in the sterilization chamber must rise to the value
pressure set for the sterilization process (3rd PRESSURE PULSE), always through the injection of
steam.
1 1 3 4 ° C P O R O U S
3 . P R E S S U R E P U L S E
1 2 8 . 6 ° C
1 . 7 0 b a r 1 2 : 3 3
When the pressure and temperature values for the selected program have been reached, it is
Thermodynamic a good idea to wait a moment to allow the temperature in the chamber and the load to stabilize
equilibrium (EQUILIBRATION). The liquid crystal display shows:
1 1 3 4 ° C P O R O U S
E Q U I L I B R A T I O N
1 3 5 . 4 ° C
2 . 1 5 b a r 1 3 : 4 0
Sterilization When the thermodynamic parameters are balanced, the actual sterilization phase of the
time 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 1 3 4 ° C P O R O U S
H O L D I N G T I M E
countdown
1 3 5 . 6 ° C 0 4 : 0 0
2 . 1 6 b a r 1 3 : 5 5
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.
Steam discharge At the end of the sterilization phase, the steam is released from the sterilization chamber
(STEAM DISCHARGE). The liquid crystal display shows:
1 1 3 4 ° C P O R O U S
D E P R E S S U R I Z A T I O N
1 2 3 . 9 ° C
1 . 2 4 b a r 1 8 : 2 0
43
9. RUNNING THE PROGRAM
Drying 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 1 3 4 ° C P O R O U S
D R Y I N G ( N O R ) Standard drying
1 0 1 . 1 ° C
0 . 0 0 b a r 1 8 : 5 1
1 1 3 4 ° C P O R O U S
Intelligent drying
D R Y I N G ( I N T )
1 0 1 . 1 ° C
0 . 0 0 b a r 1 8 : 5 1
1 1 3 4 ° C P O R O U S
EXTRA DRYING
D R Y I N G ( + X X ) (+XX) is the time
1 0 1 . 1 ° C set
0 . 0 0 b a r 1 8 : 5 1
When the drying phase is finished, it is followed by a VENTILATION phase in which fresh
Ventilation
sterile air is injected, while maintaining a vacuum in the chamber, to eliminate condensate and
cool the load.
1 1 3 4 ° C P O R O U S
V E N T I L A T I O N
8 4 . 4 ° C
- 0 . 7 7 b a r 2 6 : 5 1
Leveling to the
At the end of the ventilation phase, the chamber is brought back to atmospheric pressure
atmospheric pressure (LEVELLING) by injecting sterile outside air to allow the opening of the door and the retrieval
of the load.
1 1 3 4 ° C P O R O U S
L E V E L L I N G
8 6 . 9 ° C
- 0 . 4 3 b a r 2 9 : 2 1
When the pressure in the sterilization chambers returns within the pre-set safety limits, the
Completion door lock system is released.
of the cycle
As a consequence, the door status indicator flashes. At the same time, it also beeps.
1 1 3 4 ° C P O R O U S
C Y C L E C O M P L E T E
8 6 . 2 ° C
- 0 . 0 2 b a r 2 9 : 4 0
44
9. RUNNING THE PROGRAM
NOTE
AT THE END OF THE CYCLE, AND UP TO THE OPENING OF THE DOOR, THE HEATING
ELEMENTS ARE OFF. AS A CONSEQUENCE, THE DEVICE IS SLOWLY COOLING
REGARDLESS OF WHAT THE STAND-BY MODE IS.
NOTE
WHENEVER THE STERILIZER'S' DOOR IS NOT OPENED AT THE END OF THE CYCLE, THE
VACUUM PUMP IS PERIODICALLY ACTIVATED TO REMOVE ANY TRACES OF CONDENSATE
FROM THE STERILIZATION CHAMBER. THE DISPLAY SHOWS:
F O R C E D V E N T I L A T I O N
Ç t o s t o p
3 5 . 2 ° C
- 0 . 0 2 b a r 2 9 : 4 0
Open the door Open the door and retrieve the sterilized material, using the extractor provided.
The icon symbol goes off.
When the door is opened, the device goes to STAND-BY mode as previously set.
Report print 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.
RESULT OF THE After the cycle is finished, it is important to check the sterilization results.
CYCLE
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.
45
9. RUNNING THE PROGRAM
CHECK OF THE However, it is a good practice to check that the print report issued at the end of the sterilization
CYCLE DATA program, also specifies a positive outcome.
REPORT 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.
NOTE
THE OPERATOR CAN ALSO REQUEST AN EXTENDED PRINTOUT OF THE STERILIZATION
PROCESS DATA, INCLUDING THE RECORDED VALUES OF ALL THE SENSORS INSTALLED
ON THE MACHINE. TO START THIS PRINT FUNCTION, HOLD DOWN THE Ç (ESC) KEY ON
THE CONTROL PANEL WHILE OPENING THE DOOR.
FOR COMPLETE DETAILS ABOUT PRINTING THE SUMMARY, PLEASE REFER TO THE
REPORT EXAMPLES SHOWN IN APPENDIX B, PROGRAMS.
MANUAL CYCLE The operator can manually interrupt the cycle at any time by pressing the START/STOP key
INTERRUPTION for three seconds.
The command generates the error E999, given that the cycle did not finish correctly. As a
consequence, until safe conditions are reached, the display shows, along a beep:
M A N U A L S T O P
L E V E L L I N G . . .
1 0 1 . 2 ° C E 9 9 9 Error code
- 0 . 4 7 b a r 2 6 : 0 1
> 3s
When safe conditions are reached, the machine activates a special procedure, first asking the
user to manually unlock the door by displaying the following instruction:
P R E S S Ç T O
U N L O C K T H E D O O R
8 6 . 2 ° C E 9 9 9
- 0 . 0 2 b a r 2 6 : 0 1
M A N U A L S T O P
O P E N T H E D O O R
8 5 . 8 ° C E 9 9 9
- 0 . 0 1 b a r 2 6 : 0 1
46
9. RUNNING THE PROGRAM
Finally, when the door is opened, you will be asked to reset the device by the following
message:
M A N U A L S T O P
R E S E T S Y S T E M
8 5 . 5 ° C E 9 9 9
- 0 . 0 1 b a r 2 6 : 0 1
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.
> 3s
NOTE
WHENEVER AN ALARM IS GENERATED IN CERTAIN PHASES OF THE CYCLE, AN
AUTOMATIC PROCEDURE IS ACTIVATED TO CLEAN THE PLUMBING CIRCUIT. FOR A
COMPLETE DESCRIPTION OF THE ALARMS, SEE APPENDIX E “ALARMS”.
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.
47
10. STORING STERILIZED MATERIALS
STORING The sterilized material must be adequately treated and stored to maintain its sterility over time,
until its use.
STERILIZED
MATERIALS Inadequate storage can cause rapid recontamination.
INTRODUCTION 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.
HANDLING Assuming that the sterilizer is located in a clean place, free of dust and not too damp, the
following precautions should be taken when handling and/or carrying sterile material:
1. Remove the load from the sterilization chamber wearing gloves and a clean, or even
better, sterilized smock. As an additional precaution, wear a protective mask on your face;
2. Rest the tray on a dry, suitably clean and disinfected surface. Take care to distance or, at
any rate, separate the sterile material from the area where contaminated material is kept
waiting to be sterilized;
3. Touch the material and/or instruments as little as possible, taking extreme care not to cut
or damage the wrappings;
4. Let the instruments cool before any transport (and subsequent storage). If necessary for
transport, transfer the material using dry, clean and disinfected containers. The containers
must be closed or, if open, covered with clean cloths.
STORAGE Sterile material waiting for used must be stored using the appropriate techniques. These will
significantly slow recontamination:
1. Store the material and/or instruments in the protective wrappings that were used during
sterilization. Do not wrap the instruments after sterilization since, in addition to being
useless and completely senseless, is also potentially damaging;
2. Store the material in a dry, suitably clean and disinfected place, far from the area where
infected material passes. If possible, use closed compartments equipped with ultraviolet
light;
3. Identify the sterile material by attaching the sterilization data (attaching a copy of the
printed report or an adhesive label);
4. First use the material that has been stored the longest (FIFO, "First In First Out"). This
results in material that is homogeneously stored, avoiding storing for too long, with the
consequent risks.
5. Never store material for too long. In fact, do not overlook the fact that materials will tend to
degrade and be recontaminated in a finite time, even when the above instructions are
followed.
NOTE
CONSULT THE SPECIFICATIONS PROVIDED BY THE MANUFACTURER OF THE PACKAGING
MATERIAL RELATIVE TO THE MAXIMUM ALLOWED STORAGE TIME
48
11. TEST PROGRAMS
TEST PROGRAMS To protect the safety of users and patients, a fundamental process like sterilizing medical
devices should be periodically checked.
INTRODUCTION 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.
HELIX/BD TEST To select the HELIX/BD Test program, press the Test Selection key one or two times until
the display reads:
H E L I X / B D T E S T
1 3 4 . 0 ° C
2 . 1 5 b a r 0 3 : 3 0
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 SUPPLIED WITH THE DEVICE. TO REQUEST INFORMATION IN THIS REGARD,
CONTACT M.O.COM.'S CUSTOMER SUPPORT DEPARTMENT (SEE APPENDIX Z).
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.
THE POSSIBLE WARNING MESSAGES, AND THE CONSEQUENT ACTIONS TO CARRY OUT,
ARE THE SAME AS DESCRIBED FOR A STANDARD STERILIZATION CYCLE.
49
11. TEST PROGRAMS
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, YELLOW, ETC.) TO A
DARK COLOR (BLUE, VIOLET OR BLACK). IN ANY CASE, SCRUPULOUSLY FOLLOW THE
INSTRUCTIONS PROVIDED BY THE INDICATOR'S MANUFACTURER FOR ITS METHODS OF
USE AND INDICATION AND ANY OTHER TECHNICAL DETAILS.
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.
VACUUM TEST To select the VACUUM TEST program, press the Test Selection key one or two times until
the display reads:
V A C U U M T E S T
- 0 . 8 0 b a r
The Vacuum Test program is run with the sterilization chamber empty, and only the trays
and their supports.
NOTE
RUN THE VACUUM TEST AS THE FIRST CYCLE AFTER POWERING-ON THE EQUIPMENT.
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:
W A R N I N G !
P T 1 O V E R H E A T I N G
- 0 . 8 0 b a r
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 THE
VACUUM TEST, LEAVE THE STERILIZER'S DOOR OPEN UNTIL THE CORRECT
TEMPERATURE IS REACHED.
50
11. TEST PROGRAMS
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.
THE POSSIBLE WARNING MESSAGES, AND THE CONSEQUENT ACTIONS TO CARRY OUT,
ARE THE SAME AS DESCRIBED FOR A STANDARD STERILIZATION CYCLE.
V A C U U M T E S T
V A C U U M P U L S E
- 0 . 6 9 b a r 0 1 : 0 2
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):
V A C U U M T E S T
W A I T I N G P E R I O D
0 5 : 0 0
- 0 . 8 0 b a r 0 1 : 4 8
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:
V A C U U M T E S T
L E A K A G E P E R I O D
1 0 : 0 0
- 0 . 7 9 b a r 0 6 : 4 8
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.
V A C U U M T E S T
L E V E L L I N G
- 0 . 2 9 b a r 1 7 : 1 9
51
11. TEST PROGRAMS
V A C U U M T E S T
T E S T P A S S E D
- 0 . 0 1 b a r 1 7 : 4 4
NOTE
IF THE PRESSURE CHANGE EXCEEDS THE PRE-SET LIMIT, THE PROGRAM IS INTERRUPTED
AND ALARM MESSAGE IS GENERATED.
SEE A COMPLETE DESCRIPTION OF THE ALARMS IN APPENDIX E .
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.
52
APPENDIX A – TECHNICAL CHARACTERISTICS
53
APPENDIX A – TECHNICAL CHARACTERISTICS
SAFETY DEVICES
The sterilizer is equipped with the following safety devices for which we provide a brief description of their function:
– Safety valve
Protection against overpressure in the sterilization chamber.
Action: release of the steam and restoration of the safety pressure.
54
APPENDIX A – TECHNICAL CHARACTERISTICS
NOTE
WHEN PURCHASING DISTILLED WATER, ALWAYS CHECK THAT THE QUALITY AND CHARACTERISTICS
DECLARED BY THE PRODUCER ARE COMPATIBLE WITH THOSE SHOWN IN THE TABLE.
WARNING
THE USE OF WATER FOR GENERATING STEAM CONTAINING CONTAMINANTS IN
LEVELS EXCEEDING THOSE SHOWN IN THE TABLE WILL SIGNIFICANTLY SHORTEN
THE STERILIZER'S LIFE.
IN ADDITION, THIS MAY INCREASE THE OXIDATION OF MORE SENSITIVE MATERIALS
AND INCREASE LIME RESIDUES ON THE GENERATOR, BOILER, INTERNAL SUPPORTS
AND INSTRUMENTS.
55
APPENDIX B – PROGRAMS
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).
NOTE
DEPENDING ON THE CONFORMATION OF THE MATERIAL (SOLID, HOLLOW OR POROUS), ANY PACKAGING
(PAPER/PLASTIC ENVELOPE, STERILIZATION PAPER, CONTAINER, MUSLIN NAPKIN, ETC.) AND ITS HEAT-
RESISTANCE, IT IS INDISPENSABLE THAT YOU CHOOSE THE APPROPRIATE PROGRAM BY REFERRING TO THE TABLE
SHOWN ON THE NEXT PAGE.
WARNING
THE DEVICE MUST NOT BE USED FOR STERILIZING FLUIDS, LIQUIDS OR PHARMACEUTICAL
PRODUCTS.
56
APPENDIX B – PROGRAMS
Pre-vacuum
(kWh/cycle)
MAX MASS
MAX MASS
(EN 13060)
PROGRAM
Cycle type
(ml/cycle)
Pressure
(min)
DESCRIPTION NOTES
(bar)
(kg)
(°C)
TYPE
Porous, unpackaged
1,25 0,40 0.30
material
Porous material in
1,00 0,30 0.25
single package
Porous material in
0,75 0,25 0.20
double package
134 °C POROUS 134 2,10 4 B F L 40÷44 675 0.8
Solid and hollow
material in single 4,00 1,25 0.25
package
Solid and hollow
instruments in double 2,00 0,60 0.25
package
Porous, unpackaged
1,25 0,40 0.30
material For material and
Porous material in instruments in
1,00 0,30 0.25
single package (single and
Porous material in double)
0,75 0,25 0.20
134 °C PRION 134 2,10 >18 B F L 52÷56 700 0.9 double package packaging, we
Hollow instruments in recommend
4,00 1,25 0.25 using the 3-tray
single package
Solid and hollow configuration
instruments in double 2,00 0,60 0.25
package
Porous, unpackaged
1,25 0,40 0.30
material
Porous material in
1,00 0,30 0.25
single package
Porous material in
0,75 0,25 0.20
121 °C POROUS 121 1,10 20 B F L 54÷58 700 0.8 double package
Hollow instruments in
4,00 1,25 0.25
single package
Solid and hollow
instruments in double 2,00 0,60 0.25
package
Unpackaged hollow
134 °C HOLLOW 134 2,10 4 S F S 36÷42 625 0.7 7,50 1,50 0.50
instruments
Unpackaged hollow
121 °C HOLLOW 121 1,10 20 S F S 50÷56 700 0.7 7,50 1,50 0.50
instruments
Solid instruments in
134 °C WRAPPED 134 2,10 4 S S L 30÷32 375 0.6 4,00 1,25 0.25
single package We recommend
using the 3-tray
Solid instruments in configuration
121 °C WRAPPED 121 1,10 20 S S L 44÷46 400 0.6 4,00 1,25 0.25
single package
Unpackaged solid
134 °C SOLID 134 2,10 4 N S S 24÷26 375 0.5 7,50 1,50 0.50
instruments
Unpackaged solid
121 °C SOLID 121 1,10 20 N S S 38÷40 400 0.5 7,50 1,50 0.50
instruments
Unpackaged solid
134 °C EMERGENCY 134 2,10 3 N S Fast 14 375 0.45 0,50 0,50 0.50
instruments
Variable
134 2.10 >4 parameters
XXX°C CUSTOM Unpackaged solid
or or or n.d. F/S L/S n.d. n.d. n.d. n.d. n.d. n.d. depending on
(see note) instruments
121 1.10 > 20 the settings
made
Test device only
HELIX/BD TEST 134 2.10 3.5 - F S 22 - - - - -
(no other load)
VACUUM TEST - -0.80 - - - - 18 - - Empty chamber - - -
57
APPENDIX B – PROGRAMS
NOTES
1) FRACTIONATED = PRE-VACUUM WITH THREE VACUUM PULSES (SEE FIGURES IN THE FOLLOWING PAGES)
SINGLE = PRE-VACUUM WITH SINGLE VACUUM PULSE (SEE FIGURES IN THE FOLLOWING PAGES)
2) LONG = 10 MINUTES VACUUM DRYING (TYPICAL OF POROUS AND WRAPPED CYCLES)
SHORT = 4 MINUTES VACUUM DRYING (TYPICAL OF HOLLOW AND SOLID CYCLES)
3) ACCESS 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
58
APPENDIX B – PROGRAMS
Pressure (bar)
PROGRAM
134c POROUS
PROCESS
134°C - 4' 00''
2.10
2.00 PROGRAM
134c PRION
134°C - 18' 00''
1.00
Time (min)
0.00
-0.80
Pressure (bar)
PROGRAM
121c POROUS
121°c - 20'00''
PROCESS
1.10
1.00
Time (min)
0.00
-0.80
LONG DRYING
FRACTIONATED PRE-VACUUM
59
APPENDIX B – PROGRAMS
1.00
Time (min)
0.00
-0.80
-1.00
FRACTIONATED PRE-VACUUM SHORT DRYING
Pressure (bar)
PROGRAM
121c HOLLOW
121°c - 20'00''
PROCESS
1.10
1.00
Time (min)
0.00
60
APPENDIX B – PROGRAMS
Pressure (bar)
PROGRAM
PROCESS
134c WRAPPED
134°C - 4'00''
2.10
2.00
1.00
Time (min)
0.00
-1.00
ONE SHOT PRE-VACUUM LONG DRYING
Pressure (bar)
PROGRAM
121c WRAPPED
121°C - 20'00''
PROCESS
1.10
1.00
Time (min)
0.00
-1.00
ONE SHOT PRE-VACUUM LONG DRYING
61
APPENDIX B – PROGRAMS
1.00
Time (min)
0.00
-1.00
ONE SHOT PRE-VACUUM SHORT DRYING
PROCESS
1.10
1.00
Time (min)
0.00
-1.00
ONE SHOT PRE-VACUUM SHORT DRYING
62
APPENDIX B – PROGRAMS
1.00
Time (min)
0.00
-1.00
ONE SHOT PRE-VACUUM DRYING
SETUP
Temperature:134°C
121°C
SETUP
Time: 4’÷30’ (134°C)
ONE SHOT PRE-VACUUM 20’÷30’ (121°C)
or
FRACTIONATED PRE-VACUUM
1.10
1.00
Time (min)
0.00
SETUP
LONG DRYING
or
SHORT DRYING
-1.00
63
APPENDIX B – PROGRAMS
Pressure (bar)
PROGRAM
BOWIE & DICK TEST
PROCESS 134°C - 3'00''
2.10
2.00
1.00
Time (min)
0.00
-1.00
FRACTIONATED PRE-VACUUM SHORT DRYING
1.00
P0
5 minutes 10 minutes
VACUUM
PHASE
WAITING LEAKAGE
-0.80 P2 P3
P1
64
APPENDIX B – PROGRAMS
OPERATOR ---------------------------------------------------------
..................................
65
APPENDIX B – PROGRAMS
STERILISATION NEGATIVE
CAUTION !
PLEASE REFER TO USER MANUAL
----------------------------------------------------------
66
APPENDIX C – MAINTENANCE
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 For better quality maintenance, supplement ordinary checks with regular periodic
examinations by the service department (see Appendix Z).
The ordinary maintenance described below consists in easy manual operations and preventive
interventions involving simple instruments.
WARNING
IN THE EVENT OF THE REPLACEMENT OF THE DEVICE'S COMPONENTS
OR PARTS, REQUEST AND/OR USE ORIGINAL REPLACEMENT PARTS
ONLY.
ORDINARY The table summarizes the maintenance required to keep the sterilizer operating at peak
MAINTENANCE efficiency. In the case of very intense use, we recommend shortening maintenance
intervals:
PROGRAM
Clean the gasket on the porthole
DAILY
Clean external surfaces
WEEKLY Clean the sterilization chamber and relative accessories
Disinfect external surfaces
MONTHLY Clean the internal (and external - if installed) distilled water tank
Safety valve maintenance
Clean (or replace) the drain filter
EVERY 3-6 MONTHS
(depending on Replace bacteriological filter
frequency of use)
ANNUALLY Validate sterilizer (see dedicated paragraph)
NOTE
THE FORMATION OF WHITE SPOTS ON THE BASE OF THE INTERNAL WALLS OF THE
STERILIZATION CHAMBER MEANS THAT YOU ARE USING LOW-QUALITY DEMINERALIZED
WATER.
67
APPENDIX C – MAINTENANCE
DANGER
BEFORE PERFORMING ORDINARY MAINTENANCE, MAKE SURE THAT
THE POWER SUPPLY CORD IS REMOVED FROM THE MAINS SOCKET.
MAINTENANCE With reference to the preceding table, let's take a summary look at the various maintenance to
DESCRIPTION be performed.
Clean gasket and To remove traces of lime, clean the gasket of the container under pressure and the porthole
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 external surfaces Clean all the external parts using a clean cotton cloth dampened with water and, possibly, the
addition of a neutral detergent.
Dry the surfaces and remove any residue before using the device.
Clean sterilization Clean the sterilization chamber, support and trays (and internal surfaces in general) with a
chamber and clean cotton cloth soaked in water and, possibly, the addition of a small amount of neutral
accessories detergent. Carefully rinse with distilled water, taking care not to leave any type of residue in
the chamber or on accessories.
NOTE
DO NOT USE SHARP OR POINTED INSTRUMENTS TO REMOVE LIME ENCRUSTATION FROM
THE STERILIZATION CHAMBER. WHENEVER THERE ARE VISIBLE DEPOSITS, IMMEDIATELY
CHECK THE QUALITY OF THE DISTILLED WATER USED (SEE APPENDIX A,).
Disinfect external For the occasional disinfection of the external surfaces, you can use either denatured alcohol
surfaces or detergents with a minimum percentage of sodium hypochlorite (or equivalent).
68
APPENDIX C – MAINTENANCE
Clean internal distilled 1. Arrange an empty container on the floor near the sterilizer and put the free end of a tube
water tank 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
6. Drain again the internal tank and discard the solution. Close the draining point with the
plug.
Clean external distilled 1. Disconnect the external tank from the sterilizer; eventually recover the distilled water
water tank 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. Reconnect the tank to the sterilizer.
Safety valve 1. Access the safety valve located on the rear of the machine.
maintenance 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.
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
IS COMPLETELY SCREWED ON AND TIGHTENED.
For cleaning (or replace) the filter, open the door of the sterilizer and remove the nut (1) with a
hexagonal wrench n. 14.
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.
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.
69
APPENDIX C – MAINTENANCE
Replace bacteriological When it is due to be changed, or when you notice visible clogging of the filter (indicated by a
filter 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, PLEASE REFER TO APPENDIX Z, TECHNICAL SUPPORT.
1. open the door (1) of the service compartment to access the printer,
Printer type 2 2. push the button (2) on the left to open the printer door (3) and access the paper
compartment,
2 3. remove the empty roll and place a new roll of thermal paper so that the paper unrolls off
the top;
the roll must have the following dimensions:
- width 57 mm / diameter max 45 mm
3 4. unroll about 15 cm of paper and close the compartment door (the paper will automatically
1 advance outside the window for several centimeters),
5. thread the paper in the slot of door of the service compartment and reclose.
70
APPENDIX C – MAINTENANCE
PERIODIC As happens with all equipment, it is possible, and sometimes inevitable, to have a decrease in
STERILIZER performance and the effectiveness of components along its lifespan, in a period of time
dependent on its frequency of use.
VALIDATION
To guarantee the safety of the process over time, it is periodically (possibly annually)
necessary to verify the thermodynamic process parameters (pressure and temperature), to
check if they continue to remain within allowed limits or not.
The requalification of the sterilizer's performance is the responsibility of the user of the
product.
The reference European standards EN 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 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.
RECYCLING / The sterilizer is mainly built from fiber-reinforced polymers, metals and electronic components.
DISPOSAL
In case of disposal:
INSTRUCTIONS
- Separate the various components according to the materials they are made of.
71
APPENDIX D – GENERAL PROBLEMS
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.
An alarm was triggered, with the Check the alarm code and take the appropriate action.
The alarm icon is lit. generation of the relative code and (See the following paragraphs, Alarms, Alarm Codes
message (see LCD). and Troubleshooting).
Check that the knurled locking ring is correctly
tightened on the upper part of the safety valve.
Locking ring loosened.
The safety valve has DANGER
intervened. Presence of anomalous
overpressure in the chamber. LET THE DEVICE COOL, OR WEAR
GLOVES TO AVOID BEING BURNED
WHEN TOUCHING THE VALVE.
72
APPENDIX D – GENERAL PROBLEMS
73
APPENDIX D – GENERAL PROBLEMS
NOTE
SHOULD THE PROBLEM PERSIST, CONTACT THE CUSTOMER SERVICE (SEE APPENDIX Z) PROVIDING THE MODEL
OF THE STERILIZER AND THE SERIAL NUMBER. THIS INFORMATION IS FOUND ON THE SERIAL NUMBER PLATE ON
THE REAR OF THE DEVICE AND ON THE WARRANTY CERTIFICATE.
74
APPENDIX E – ALARMS
APPENDIX E – ALARMS
INTRODUCTION Every time an anomalous condition occurs during the operation of the sterilizer, an alarm is
generated, identified by a specific code (consisting of a letter followed by a 3-digit number).
• 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)
ALARM
INTERVENTION 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 depending on whether it occurs during the execution of
the program or outside, and is structured to guide the user to the necessary RESET of the
sterilizer.
Alarm during a cycle If the alarm intervenes during a program, the display will show the message:
Alarm Message
( A l a r m M e s s a g e )
L E V E L L I N G Alarm Code
1 1 4 . 6 ° C X X X X
0 . 7 0 b a r 1 1 : 3 0
( A l a r m M e s s a g e )
C I R C U I T C L E A N I N G Alarm Code
1 0 0 . 6 ° C X X X X
0 . 7 0 b a r 1 1 : 4 0
75
APPENDIX E – ALARMS
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:
P R E S S Ç T O
U N L O C K T H E D O O R
1 0 1 . 0 ° C X X X X
0 . 0 1 b a r 1 1 : 4 0
Press the Ç key to unlock the door lock mechanism; the following message appears:
( A l a r m M e s s a g e )
O P E N T H E D O O R
1 0 0 . 8 ° C X X X X
0 . 0 1 b a r 1 1 : 4 2
Once the door is open, the user is finally asked to reset the system:
( A l a r m M e s s a g e )
R E S E T S Y S T E M
9 5 . 5 ° C X X X X
0 . 0 0 b a r 1 1 : 4 3
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) WILL BE PRINTED FOR THE INTERRUPTED STERILIZATION PROGRAM
AND THE ALARM THAT INTERVENED. 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”.
Alarm outside
the cycle If the alarm intervenes outside the sterilization or test program the display will show:
Alarm Message
( A l a r m M e s s a g e )
A L A R M ! Alarm Code
8 0 . 5 ° C X X X X
0 . 0 0 b a r
76
APPENDIX E – ALARMS
( A l a r m M e s s a g e )
R E S E T S Y S T E M
8 0 . 5 ° C X X X X
0 . 0 0 b a r
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.
RESETTING THE The system is RESET in two alternative ways, depending on the alarm that occurred (see the
SYSTEM Alarm Code List further below in this appendix):
WARNING
NEVER TURN THE DEVICE OFF BEFORE EXECUTING A RESET.
>3s
2. Turn-off the device and then power-on using the main switch.
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.
77
APPENDIX E – ALARMS
ALARM CODES
The list of alarm codes and, consequently, the messages displayed on the LCD and relative RESET mode, is as follows:
ERRORS (category E)
ALARMS (category A)
78
APPENDIX E – ALARMS
A 250 1st vacuum pulse not reached within timeout PV1 TIMEOUT
1st rise to atmospheric pressure not reached
A 251 ATM1 TIMEOUT
within timeout
A 252 1st pressure pulse not reached within timeout PP1 TIMEOUT
A 253 2nd vacuum pulse not reached within timeout PV2 TIMEOUT
2nd rise to atmospheric pressure not reached
A 254 ATM2 TIMEOUT Press key
within timeout
A 255 2nd pressure pulse not reached within timeout PP2 TIMEOUT
A 256 3rd vacuum pulse not reached within timeout PV3 TIMEOUT (> 3 seconds)
3rd rise to atmospheric pressure not reached
A 257 ATM3 TIMEOUT
within timeout
A 258 3rd pressure pulse not reached within timeout PPP TIMEOUT
A 259 Phase of PROCESS not started within timeout PROCESS TIMEOUT
Chamber depressurization not completed within
A 260 PPD TIME-OUT
timeout
HAZARDS (category H)
79
APPENDIX E – ALARMS
Based on the type of alarm, below we provide instructions for identifying the possible causes and restoring correct
operation:
ERRORS (category E)
80
APPENDIX E – ALARMS
ALARMS (category A)
81
APPENDIX E – ALARMS
Intervention of the steam generator Manually rearm the thermostat(s) located on the back of the device (see
safety thermostat. the Chapter, “Product Introduction”).
Intervention of the heating element Unscrew the black plastic protection cap, press the red button until you
A 200 safety thermostat. hear a click and replace the cap.
Turn-off (RESET) and then turn-on the device.
Heating or steam generator heating
element malfunction. 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
Presence of water or condensate in
again.
the sterilization chamber.
Do not put material impregnated with water, or liquids in general, in the
chamber.
Drain filter of the sterilization Clean or replace the drain filter
A 250 chamber obstructed. (See Appendix C “Maintenance”).
Perform RESET following the instructions.
Carefully clean the gasket with a clean cotton cloth dampened with
Air leaking through the gasket.
water.
Start the program again.
Vacuum pump broken.
Contact the Technical Support Department (see Appendix Z).
Problem in the plumbing circuit.
Water injection pump malfunction.
Contact the Technical Support Department (see Appendix Z).
Problem in the plumbing circuit.
Intervention of the steam generator
safety thermostat.
A 251 See A200
Heating element safety thermostat
intervened. If the problem persists contact the Technical Support Department
(see Appendix Z).
Heating or steam generator heating
element malfunction.
82
APPENDIX E – ALARMS
83
APPENDIX E – ALARMS
HAZARDS (category H)
84
APPENDIX E – ALARMS
85
86
APPENDIX F – DIAGRAMS
DOOR
SWITCH
SEC. TANK
MAX LEVEL
PROBE
MAINS FILTER
FAN 24V
APPENDIX F – DIAGRAMS
APPENDIX F – DIAGRAMS
LCD
RESERVOIRS
MAX MAX
USED WATER
DISTILLED WATER
RS232
MIN
FUSE PTR
T 4A
Flowmeter
Datalogger
SC+
MPX
SC-
JACK FOR MAX LEVEL
PROBE CONNECTION ON
SS+
Flash/serial
SSE
PT2
PT3
DOOR
Door
SWITCH
ELECTRONIC
Door lock
PT4
BOARD
TYPE “T”
Motor lock
6.3A T
F1
AC-LPT
START/STOP
MILLDROP
F2 24V
Pump injection
Fan
Line Generator Bandage Vacuum pump
FAN 24V
MAINS FILTER
BOARD
F 16A
220-240V
F 16A 50-60HZ
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APPENDIX F – DIAGRAMS
PLUMBING DIAGRAM
Air
Air
CHAMBER
Recovery Main
tank tank
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APPENDIX G – DECLARATION OF CONFORMITY
DECLARATION OF CONFORMITY
Application of Directives 93/42/CEE - 2004/108/CEE - 73/23/CEE
Model:
conforms
31/012008
Date Signature
Alfio VILLA
Name and Surname
Legal Representative
Function
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APPENDIX H – NOTES PER THE OPERATOR
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APPENDIX Z – TECHNICAL SUPPORT
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.
M.O.COM. Srl
Customer Support
Via delle Azalee, 1
20090 Buccinasco (MI)
ITALY
Tel. (+39) 02-45701505
Fax (+39) 02-45701258
e-mail [email protected]
website www.mocom.it
To help us in the indispensable work of improving the quality of our products and service, please send your comments
and/or suggestions to the following e-mail address:
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