Mocom millennium B User manual

Rev. 1

Rev.1
Page 1- 1
1. · UTILIZATION· ··
GENERAL................................................................ 3
APPLICABLE EUROPEAN DIRECTIVES 3
SYMBOLS USED THROUGH THE MANUAL 3
GENERAL NOTES 3
INTENDED USE 4
GENERAL WARNINGS 4
M.O.COM. CUSTOMER SERVICE 5
PRODUCT OVERVIEW 6
FRONT VIEW 7
REAR VIEW 5
CONTROL PANEL 6
LCD DISPLAY 6
TECHNICAL CHARACTERISTICS 7
SAFETY DEVICES 8
WATER SUPPLY CHARACTERISTICS 9
INSTALLATION..................................................... 10
GENERAL 10
PACKING CONTENT 11
HANDLING THE PRODUCT 12
GENERAL INSTALLATION PRECAUTIONS 13
COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATIONS 13
ELECTRICAL CONNECTIONS 14
CONNECTING THE DATA RECORDING MILLFLASH 14
CONNECTING AN EXTERNAL WATER FILLING TANK 15
CONNECTING DEMINERALIZER MILLDROP 16
CONNECTING AN EXTERNAL DRAIN TANK 17
DIRECT CONNECTION TO A CENTRALIZED DRAINING POINT 19
ACQUISITION AND UPDATING THE AMBIENT PRESSURE VALUES 20
CONFIGURATION 21
General.............................................................................................................21
Starting and entering the Setup Mode .............................................................21
Meaning of the keys in Setup mode.................................................................22
Setup flow diagram...........................................................................................23
Menu items.......................................................................................................24
ACTIVATING CONFIGURATION OPTIONS – BASIC MENU 25
Setting the language ........................................................................................25
Setting the Date................................................................................................25
Setting the Time...............................................................................................26
Setting the Password .......................................................................................26
ACTIVATING CONFIGURATION OPTIONS – ADVANCED MENU 28
Setting the sterilization programs.....................................................................28
Setting the STAND-BY modes.........................................................................34
Setting the Printer mode...................................................................................36
Setting the tank Filling mode............................................................................39
Setting the Water Draining mode.....................................................................40
ACTIVATING CONFIGURATION OPTIONS – SPECIAL MENU 41
Acquisition of the ambient pressure.................................................................41
Adjusting the contrast of the liquid crystal display ...........................................42

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ACTIVATING CONFIGURATION OPTIONS – SERVICE MENU 42
Device Test.......................................................................................................44
Test cycles........................................................................................................45
MOCOM............................................................................................................46
H2O circuit........................................................................................................46
Counter reset....................................................................................................46
Factory Data.....................................................................................................47
Technical report................................................................................................47
PT1 correction ..................................................................................................47
DATA REVIEW 48
EXIT THE SETUP MODE 49
DEFAULT SETTING 49
PREPARING THE MATERIAL TO BE STERILIZED 50
General.............................................................................................................50
Treating the material before sterilization ..........................................................50
Arranging the load ............................................................................................52
STORING STERILIZED MATERIAL 54
General.............................................................................................................54
Handling............................................................................................................54
Storage .............................................................................................................54
FIRST START-UP 55
Turning on.........................................................................................................55
Initial automatic test..........................................................................................55
Stand-by mode .................................................................................................56
Filling distilled water..........................................................................................57
Manual filling................................................................................................57
Automatic filling............................................................................................57
MAX level in the internal/ external drain tank...................................................58
Emptying the internal tank................................................................................58
Emptying the external tank...............................................................................58
MAINTENANCE.....................................................59
GENERAL 59
ORDINARY MAINTENANCE PROGRAM 59
Maintenance schedule .....................................................................................59
General notes...................................................................................................60
Maintenance description ..................................................................................60
Clean the gasket and porthole....................................................................60
Clean external surfaces ..............................................................................60
Clean sterilization chamber and accessories..............................................61
Disinfect external surfaces..........................................................................61
Clean internal distilled water tank ...............................................................61
Clean external distilled water tank ..............................................................61
Safety valve maintenance...........................................................................62
Clean (or replace) the water drain filter.......................................................62
Replace bacteriological filter.......................................................................63
Replace the printer paper............................................................................63
Periodic sterilizer validation..............................................................................64

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GENERAL
APPLICABLE EUROPEAN DIRECTIVES
The product described in this manual is manufactured in accordance with the highest safety standards and doesn't represent any danger for the
operator if used according to the following instructions.
The product is in accordance with the following European Directive as applicable:
73/23/CEE, for the approximation to the legislation of the Members States related to low voltage equipment (and following modifications).
2004/108/CEE, for the approximation to the legislation of the Members States related to the electromagnetic compatibility (and following
modifications);
93/42/CEE, concerning the medical devices (and following modifications);
SYMBOLS USED THROUGH THE MANUAL
ePay special attention to the paragraphs indicated by the pointing finger.
WARNING! This symbol indicates a potential danger of injury. Follow the procedures described in the manual to avoid injuring the user
and/or others.
DANGER! This symbol indicates a potential danger of property damage. Follows the instructions in the manual to prevent potential
damage to materials, equipment or other property.
CAUTION! This symbol indicates a potential danger due to the high temperature.
The material the sterilizer is composed of must be disposed according to the directive 2002/96/CEE
GENERAL NOTES eThe information included in this manual 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.
Any reproduction, modifications or translation of this document or parts of it is forbidden without previous written authorization by
M.O.COM. Ltd. Co.
and are registered trademarks of M.O.COM. Srl.

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INTENDED USE
The product described in this manual is exclusively intended for the sterilization of solid and hollow re-usable instruments and porous materials.
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.
GENERAL WARNINGS
When using this product, always follow the instructions in the manual and never use for anything other than its intended purpose.
THE USER IS RESPONSIBLE FOR ALL LEGAL REQUIREMENTS RELATED TO THE INSTALLATION AND USE OF THIS PRODUCT.THE MANUFACTURER
WILL NOT BE RESPONSIBLE FOR ANY BREAKAGE,MALFUNCTIONS,PROPERTY DAMAGE OR INJURY IN THE EVENT THAT THE PRODUCT IS NOT
INSTALLED OR USED CORRECTLY.
Please observe the following precautions in order to avoid injury or property damage:
– Use ONLY distilled water of high quality.
The use of water of inadequate quality can severely damage the equipment. See Characteristics of the filling water.
– Do not pour water or other liquids on the equipment;
– Do not pour inflammable substances on the equipment;
– Do not use the equipment in the presence of gas or explosive or inflammable vapors;
– Before performing any maintenance or cleaning, ALWAYS DISCONNECT the electricity.
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;

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– Do not remove any label or nameplate from the device; request new ones, if necessary.
– Use only original replacement parts.
The failure to observe the above, releases the manufacturer from all liability.
M.O.COM. CUSTOMER SERVICE
M.O.COM. Ltd. Co. is completely available to customers to provide any technical information about the product as well as to offer suggestions
and advice on steam sterilization procedures.
In this regard, please refer to the following address:
M.O.COM. Srl
Customer Support
Via delle Azalee, 1
20090 Buccinasco (MI)
ITALY
Tel. [phone]
Fax [phone]
e-mail [email protected]

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PRODUCT OVERVIEW
Millennium B is MO.COM.'s revolutionary type B (EN 13060) small steam sterilizer and a new de facto standard for safety, performance,
flexibility and ease of use.
It is a sophisticated but, at the same time, easy to use device that, thanks to its wide range of configuration options and patented operating
devices, satisfies every need for sterilizing medical devices, guaranteeing the maximum performance under all conditions.
It also features a better way of relating to users who, rather than having to adapt to the machine and its characteristics, are able to "converse"
with it and configure it to meet their own needs.
Thanks to its remarkable ease of use, small size and pleasant appearance, it is the ideal partner for all professional who demand the maximum
sterilization safety
Millennium B is a completely microprocessor-controlled steam sterilizer with a sterilization chamber (17-liter) made of stamped stainless steel.
It is characterized by an advanced fractionated vacuum system for the complete removal of air, even from hollow, porous materials, and an
effective final vacuum drying phase capable of eliminating all traces of humidity from any load.
Its exclusive steam generation system, effective plumbing circuit and electronic management (supplemented by high-precision sensors)
guarantees high process execution speeds and excellent thermodynamic parameter stability.
Moreover, its Process Evaluation System constantly monitors all the machine's “vital” parameters in real-time, guaranteeing absolute safety and a
perfect result.
It offers users 11 sterilization programs (of which one completely programmable), all equipped with customizable, optimized drying for the fast,
effective sterilization of the various types of loads (instruments and materials) used in a medical environment.
Four of these can be selected directly from the control panel, which has a new simplified, design.
And then, there are interesting options for configuring the preheating mode (based on the sterilizer's frequency of use), printing the end of cycle
report, methods for filling the water supply, draining the used water and more.
Please refer to the chapter, “Setting”for more detail.
Finally, Millennium B 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.
ePlease refer to chapter Technical characteristics for a description of the safety devices.

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FRONT VIEW
LCD display and
control panel
Service
compartment access
pa
n
e
l
Door
Printer paper
output slot (option)
on/off switch
Door micro-switch
Motorized door-
closin
g
s
y
stem
Bacteriological filter
Sterilization chamber
Distilled water fill quick connector
Used water drain quick connector
Water drain filter
Service
compartment
o
pen
Built-in printer
(option)
RS232 serial port
Door
Millflash interface

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REAR VIEW
Distilled water tank vent hole
Safety valve
Heat exchanger
Mains fuses
Power cord
Band heating element safety thermostat and manual rearm
Connection for directl
y
drainin
g
the used water tank
Connection for automatically filling the distilled water tank
Steam generator safety thermostat and manual rearm
Jack socket for the external tank level
sensor (option)
Distilled water tank draining point
(maintenance)
Jack for Milldrop Start/Stop cable

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CONTROL PANEL LCD DISPLAY
Liquid Crystal
Display (LCD)
Enter Setup mode key
(ESC, quit the current
menu)
Cycle Start/Stop key
(Enter, confirmation of
the value/option
se
l
ected
)
Sterilization cycle
selection key (Value
increment / Forward
scroll of the menu
options)
Test cycle selection key
(Value decrement /
Backward scroll of the
menu options)
4 lines of 20
characters
Illuminated icons
Door status
Water level
Process status
Setup status
Alarm

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TECHNICAL CHARACTERISTICS
Equipment Steam sterilizer
Classification (as per
93/42/CEE) IIa
Manufacturer M.O.COM. S.r.l.
Via delle Azalee, 1
20090 BUCCINASCO (MI) - ITALY
Power supply 220/240 V
Frequency 50/60 Hz
Mains fuses
(6,3 x 32 mm) F 16A 250V
PCB fuses (board type
“G”)
(5 x 20 mm)
F1: T 5A 250V (trafo secondary winding
– 24V)
F2: T 2A 250V (digital signal 5V / analog
12V )
F3: T 2A 250V (trafo primary winding
– 230V)
F4: F 200mA 250V (door-locking protection)
F5: F 1.25A 250V (door-locking gear motor
overload)
F1 PTR: T 5 A (printer protection-
optional)
PCB fuses (board type
“T”)
(5 x 20 mm)
F1: T 6,3A 250V (trafo secondary winding)
F2: T 3.15A 250V (trafo primary winding)
F1 PTR: T 3,15A 250V (printer protection -
optional)
External dimensions
(LxDxH) 480 x 560 x 420mm (excluding rear connections)
Nominal power 2300 W (10A)
Insulation class Class I
Installation category Cat. II
Environment of use Internal use
Noise level <60 db(A) max
Environmental operating
conditions
Temperature: +15°C ÷ +40°C
Relative Humidity: max 80%,
non condensing
Altitude: max 3000 m (a.s.l.)
Net weight
approx. 50 kg (empty)
approx. 55 kg (empty, with trays and
support)
approx. 59 kg (empty, with trays and
supports and water at
Max level)
Sterilization chamber
dimensions (Øx D) 250 x 350 mm
Sterilization chamber total
volume about 17 l (0.017 m3)
Sterilization chamber useful
volume (with tray supports
inserted) about 10 l (0.010 m3)
Distilled water tank capacity
(supply) about 4.6 l (water at MAX level)
about 0.8 l (water at MIN level)
Sterilization programs Available: 11
Pre-sets: 4(direct selection by
user)
Test programs HELIX/BD Test
Vacuum Test
Preheating time
(from cold) about 10 minutes
RS232 serial interface DB-9 pin (female) connector
Bacteriological filter
(PTFE filtering element) Porosity: 0.2 µm
Connection: male 1/8" NPT connector

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SAFETY DEVICES
The sterilizer is equipped with the following safety devices for which we provide a
brief description of their function:
– Mains fuses (see summary table data)
Protection inside the device against a fault in the heating elements.
Action: cuts the electricity.
– Fuses protecting the electronic circuits (see summary table data)
Protection against a fault in the primary transformer circuit and low voltage uses.
Action: cuts power to one or more low-voltage circuits.
– Thermal circuit breakers on the mains voltage windings
Protection against overheating of the vacuum pump motor and the primary transformer
windings.
Action: temporary cut-off (until cooling) of the winding.
– Safety valve
Protection against overpressure in the sterilization chamber.
Action: release of the steam and restoration of the safety pressure.
– Steam generator manual rearm safety thermostat
Protection against steam generator overheating.
Action: cut-off of the electricity to the steam generator.
– Heating element manual rearm safety thermostat
Protection against overheating of the heating elements of the container under pressure.
Action: cut-off of the electricity to the chamber heating element.
– Door position safety microswitch
Confirmation of the correct closing position of the door of the container under pressure.
Action: signals wrong door position.
– Mechanized door lock mechanism with electromechanical protection (pressure
switch)
Protection against accidental opening of the door (even in a blackout).
Action: prevents accidental opening of the door during a program.
– Door lock mechanism safety microswitch
Confirmation of the correct closing of the door lock.
Action: signaling the failure or incorrect operation of the door lock mechanism.
– Self-leveling plumbing system
Plumbing system structure for the spontaneous leveling of the pressure in the case of a
manual interruption of the cycle, alarm or blackout.
Action: automatic restoration of atmospheric pressure in the sterilization chamber.
– Integrated system for evaluating the sterilization process
Continuous verification of the sterilization process parameters entirely managed by
microprocessor.
Action: immediate interruption of the program (in case of anomaly) and generation of
alarms.
– Monitoring of the sterilizer's operation
Real-time oversight of all significant parameters when the machine is powered.
Action: generation of alarm messages (in the case of anomaly) with possible interruption
of the cycle.

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CHARACTERISTICS OF THE FILLING WATER
DESCRIPTION WATER SUPPLY
VALUES VALUES IN
CONDENSATE
DRY RESIDUE < 10 mg/l < 1 mg/l
SILICON OXIDE SiO2< 1 mg/l < 0,1 mg/l
IRON < 0,2 mg/l < 0,1 mg/l
CADMIUM < 0,005 mg/l < 0,005 mg/l
LEAD < 0,05 mg/l < 0,05 mg/l
HEAVY METAL RESIDUES
(except iron, cadmium and lead) < 0,1 mg/l < 0,1 mg/l
CHORIDES < 2 mg/l < 0,1 mg/l
PHOSPHATES < 0,5 mg/l < 0,1 mg/l
CONDUCTIVITY AT 20°C < 15 µs/cm < 3
µ s/cm
pH VALUE 5 - 7 5 - 7
APPEARANCE colorless, transparent,
without sediments colorless, transparent,
without sediments
HARDNESS < 0,02 mmol/l < 0,02 mmol/l
eWhen purchasing distilled water, always check that the quality and characteristics declared by the producer are compatible with those
shown in the table.
The use of water for generating steam containing contaminants in levels exceeding those shown in the table will significantly
shorten the sterilizer's life.
In addition, this may increase the oxidation of more sensitive materials and increase lime residues on the generator, boiler,
internal supports and instruments.

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

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PACKING CONTENT
Dimensions and weight
Height 610 mm
Width 690 mm
Depth 560 mm
Total weight ab. 67 kg
eCheck the integrity of the package upon receipt.
Once the package is opened, check that:
- the supply matches the specifications of the order (see the accompanying
document);
- that there is no obvious product damage.
eIn 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.
Content
The package contains the following items:
-steam sterilizer;
-Stainless steel wire instrument tray (5 pcs.) (Ref. 1);
-Stainless steel wire tray support (Ref. 2);
-Instruction manual (Ref. 3);
-Warranty certificate (Ref. 4) (see note).
-Tray extractor (Ref. 5);
-Container with quick connector for adding distilled water (about 2 l ) (Ref. 6);
-Extra bacteriological filter (Ref. 7).
-Silicone tube (2 m) for draining water, with quick connector (Ref. 8).
-Water drain filter (Ref. 9)
eThe customer must keep the warranty certificate together with the receipt.
690
610
560

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420
HANDLING THE PRODUCT
Where possible, the packaged product must be handled using suitable mechanical means (forklift truck, transpallet, etc.) and following the
instructions shown on the package.
In the case of manual handling, the product must be lifted by two persons using the handles cut in the side of the box.
Once removed from the box, the sterilizer must be lifted by two persons and transported on a cart or other similar device.
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.
eKeep the original packaging and use it whenever the device is to be transported. The use of different packaging could damage the
product during shipment.
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.
Dimensions and weight of the unit
– Height (total) 420 mm
– Width (total) 480 mm
– Depth 560 mm
(excluding rear connections)
– Weight (total) 55 kg

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500
570
550
GENERAL INSTALLATION PRECAUTIONS
Obey the following warnings for the correct operation of the device and/or to avoid risky situations:
– 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 equipment weight (about 60 kg);
– Leave adequate space for ventilation (at least 10 cm on each side) all around the sterilizer, especially in back.
If the device is built-in to a cabinet, be sure to respect the warnings in the preceding paragraph, avoiding an obstructions to the air intake;
– Do not install the sterilizer near tubs, sinks or similar places, to avoid contact with water or liquids. This could cause short circuits and/or potentially
dangerous situations for the operator;
– Do not install the sterilizer in a place that is excessively humid or poorly ventilated;
– Do not install the machine were there is gas or inflammable and/or explosive vapors;
– Install the device so that the power cord is not bent or crushed. It must run freely all the way to the socket.
– Install the device that any external fill/drain tubing is not bent or crushed. They must run freely to the drain tank.
COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATIONS
When installing the sterilizer inside a cabinet, you must provide adequate space all around the device (>10cm, specially in the rear part) to
provide effective ventilation as well as a large enough opening in the back that, in addition to allowing the passage of the power cord will also
provide an adequate air flow and the consequent optimum cooling of the heat exchanger.
It is indispensable that the built-in compartment have the following minimum dimensions shown in the figure:
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.
eIf 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.
ePlease refer to Technical Characteristics for complete technical data.

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ELECTRICAL CONNECTIONS
The sterilizer's must be connected to a socket of the electrical system of adequate capacity for the device's absorption and ground provided, in
conformity with current laws and/or standards.
The socket must be suitably protected by breakers having the following characteristics:
– Nominal current In16 A
– Differential current I∆n0,03 A
eThe 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.
eAlways connect the power cord directly to the socket. Do not use extension cords, adapters or other accessories.
CONNECTING THE DATA RECORDING MILLFLASH
The sterilizer can be connected to MILLFLASH allowing the recording of the cycle data in .txt format file and its management by PC.
The connectors of the service box are used for interfacing; refer to MILLFLASH Operating Manual for the installation instructions.
Differential switch
Mains switch
Mains socket
with earth pin

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CONNECTING AN EXTERNAL WATER FILLING TANK
(OPTIONAL, automatic filling function)
To avoid having to periodically fill the water tank (see First start-up), it is possible to connect the sterilizer to an external filling tank (supplied as
an option), that the user will periodically fill, or to a commercially-available, reverse-osmosis water purification system with accumulation tank.
In that case, when the internal water tank reaches the MIN level, the autoclave activates a pump that automatically fills the internal tank.
Follow the instructions below for the correct connection of the external tank:
– Install the tap provided on the filling tank; use Teflon tape or connector sealant for a perfect seal .
– Use the filling tanks silicone tube (or other suitable tube, max length 2 m) 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.
eFor this option setting, refer to chapter “Configuring the equipment –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 Service
Clip
Silicon pipe
Tap
Filling
tank Clip
Teflon

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CONNECTING DEMINERALIZER MILLDROP
(OPTIONAL, automatic filling option)
The sterilizer can be connected to MILLDROP (water treatment reverse osmosis system) warranting the automatic reservoir filling with high
quality demineralized water.
Refer to MILLDROP operating manual for the installation instructions:
– Connect the supplied water filling tube to the rear fitting point; lock with clip.
– Connect the supplied START/STOP cable to the rear jack connector.
– Switch on the MILLDROP.
– Switch on the sterilizer and set the filling option (see chapter “Setting tank filling mode”.
For additional information and advice about the correct connection of the sterilizer to the various water purification systems, contact
M.O.COM. Customer Service .
Clip
Water filling tube
(from demineralizer)
Start/stop cable
Jack
connector