Professional Documents
Culture Documents
MASTERCLAVE 10
®
MASTERCLAVE 20
Industry Use - EN
Table of Contents
Safety Information...................................................................................................2-1
System Compliance..................................................................................................... 2-1
FCC Compliance...............................................................................................2-1
IEC Compliance................................................................................................ 2-1
Industry Canada (IC) Compliance.....................................................................2-2
Instrument Labels........................................................................................................ 2-2
Safety Precautions.......................................................................................................2-3
Managing Messages..................................................................................................5-12
Reading a Message........................................................................................ 5-12
Deleting a Message........................................................................................ 5-12
Appendix - Troubleshooting..................................................................................A-1
Error Messages and Recovery Procedures.................................................................A-1
Appendix - Glossary...............................................................................................C-1
Adjustment.................................................................................................................. C-1
Calibration................................................................................................................... C-1
F0................................................................................................................................ C-1
LIMS............................................................................................................................ C-1
Revision History
Note: The screens and figures shown are intended as illustrations only and must not be interpreted
as actual representations of data, results or equipment.
Screens and equipment are not shown to scale.
IMPORTANT: Please read this document carefully before using the system.
Limited Warranty
bioMérieux warrants the performance of the product for its stated intended use provided that
all procedures for usage, storage and handling, shelf life (when applicable), and precautions
are strictly followed as detailed in the instructions for use (IFU).
Except as expressly set forth above, bioMérieux hereby disclaims all warranties, including any
implied warranties of merchantability and fitness for a particular purpose or use, and disclaims
all liability, whether direct, indirect or consequential, for any use of the reagent, software,
instrument and disposables (the "System") other than as set forth in the IFU.
Customer acknowledges and agrees that use of the System for testing of sample types or for
indications other than those described in the IFU is done solely at the Customer’s own risk.
Customer acknowledges and agrees that it is Customer’s sole and exclusive responsibility to
validate the System for any such intended use, and to determine whether the System is
suitable for that intended use. The performance of any validation studies and the subsequent
use of the System based on Customer’s validation studies shall be the Customer’s sole risk
and responsibility.
Product warranty details can be obtained from bioMérieux or your local distributor (contact
information available on www.biomerieux.com).
Intellectual Property
BIOMERIEUX, the BIOMERIEUX logo, MASTERCLAVE, PMI and DILUMAT are used,
pending, and/or registered trademarks belonging to bioMérieux, or one of its subsidiaries, or
one of its companies.
Any other name or trademark is the property of its respective owner.
© 2019 bioMérieux SA
bioMérieux SA 673 620 399 RCS Lyon
1 Introduction to the System
The MASTERCLAVE® is used for automated preparation of culture media, agars, or broths,
and is to be used for microbiological tests in the clinical, pharmaceutical, food processing, and
cosmetics industries.
This equipment is to be used by qualified, trained laboratory professionals in the
aforementioned industries.
MASTERCLAVE® optimizes the workflow through lab automation. It enhances the following:
• Productivity by removing the preparatory stages such as medium stirring and bottle
autoclaving
• Reproducibility by preventing human error and ensures batch-to-batch reproducibility.
• Flexibility as it is suitable for both agar and broth preparation.
• Easy to use by adding powder and distilled water to implement a cycle. No supervision
required during the cycle.
The MASTERCLAVE® must be used only for the purposes specified in the instructions for
use.
The user documentation uses several types of statements to alert you to important
information. Important information is labeled in text and identified using symbols.
Statement Types
The statement types are Warning, Caution, Important, and Note. The following examples
define each statement type. The general caution symbol is used in these examples, but other
symbols (see Standard Symbols) may be used instead.
The warning messages in this document mainly refer to:
WARNING
A Warning statement alerts the user to the possibility of injury, death, or
other serious adverse reactions associated with the use or misuse of the
device.
General Statements
This section provides important statements that apply to all products. Equipment meets the
requirements and standards stated in the certificate supplied with it.
WARNING
Equipment is intended for professional use only.
Laboratory personnel should be qualified and adhere to the principles of
good laboratory practice.
All the user documents supplied must be read prior to use of the equipment.
Under no circumstance should the user dismantle equipment due to the risk
of touching dangerous parts, including parts that may be infectious or
connected to a source of electric power.
Do not obstruct the equipment and hardware ventilation apertures, and leave
sufficient clearance around the equipment for the circulation of air.
All biological materials should be considered as potentially infectious.
Suitable individual protective equipment is required when handling chemical
or biological substances.
bioMérieux is in no case liable for the harmful consequences of incorrect use
or improper handling of these substances.
WARNING
Electromagnetic Compatibility (EMC):
The EMC class of the equipment is indicated on the certificate supplied with
it.
If equipment is a class A product, it may cause radio interference in a
domestic environment, in which case the user will be required to correct the
interference at his own expense.
Do not use this device near strong sources of electromagnetic radiation (for
example, intentionally unprotected radio-electric sources), which could
interfere with the operation of the equipment.
It is recommended to evaluate the electromagnetic environment before
starting the device.
WARNING
In order to avoid computer viruses or abnormal functioning of your
equipment, never download any software other than those ensuring the
protection of your network and those provided or recommended by
bioMérieux.
It is your responsibility to secure your network and ensure this protection is
appropriate and maintained. It is recommended to use all appropriate means
(including antivirus software, security patches, firewall) to protect your
network from virus intrusion, unauthorized use, alteration, manipulation and
disclosure.
In an effort to reduce the risk of spreading a virus to bioMérieux equipment,
it is recommended that only bioMérieux supplied USB devices are used with
bioMérieux equipment. The use of personal USB devices is not
recommended. To avoid computer viruses and the potential loss of
functionality and/or results, use caution when transferring USB devices
between computers. Do not use USB devices intended for bioMérieux
equipment in other computers that do not have current antivirus software
installed and active.
All computer media (CD, DVD, USB key) supplied with this equipment should
be stored and stocked in a suitable location.
Only modify the software configuration parameters you are authorized to
modify and which are described in the user documentation.
WARNING
Decontamination of equipment at the end of its life cycle:
The following instructions must be followed by all users in countries where
local legislation imposes the treatment and recycling of equipment at the end
of its life cycle.
As a general rule, and as a precautionary measure, any part of the equipment
(including sub-assemblies, components and materials) considered to be
potentially infectious, must be decontaminated, whenever possible, or
removed if decontamination is impossible or presents a risk.
Any part considered to be potentially infectious, which is not
decontaminated, must be removed from the instrument before following the
normal channels for elimination of infectious products, in accordance with
local regulations.
The decontamination instructions in the user documentation correspond to
the parts of the equipment that are potentially infectious according to their
intended use. These operations must be performed before the equipment is
transferred to a third party.
However, bioMérieux cannot exclude that other parts of the equipment have
not been contaminated in other circumstances, in particular as the result of
spillage of infectious substances. In this case, the user is solely responsible
for decontaminating these parts or removing them before they follow the
normal channels for elimination of infectious products.
WARNING
This statement only applies to European countries with regard to the waste
electrical and electronic equipment European directive:
You can play an important role in contributing to reuse, recycling, and other
forms of recovery of waste electrical and electronic equipment. Sorting this
type of waste significantly reduces potential negative effects on the
environment and human health as a result of the presence of hazardous
substances in electrical and electronic equipment.
At the end of the life cycle of this product, do not dispose of the product as
unsorted municipal waste, even if it is decontaminated. It is imperative that
you contact bioMérieux to assure its appropriate disposal.
IMPORTANT: Electrical or other connections should only be made using the accessories supplied
with the equipment.
IMPORTANT: The accuracy of results obtained with this equipment depends on the maintenance
operations described in the user documentation (user maintenance and/or periodic
preventive maintenance performed by bioMérieux).
IMPORTANT: The user should be aware that if the maintenance operations are not performed, are
only partially performed, or are not performed as described in the user
documentation, bioMérieux is in no case liable for any false test results obtained.
IMPORTANT: It is recommended to keep the original packaging materials in case the equipment
needs to be moved. Any damage directly or indirectly resulting from the transport of
the equipment without adequate containers will not be covered by the warranty.
Standard Symbols
The following table defines symbols that may appear in the instructions for use or on the
instrument, package inserts, or packaging. When surrounded by a triangle on a yellow
background, the symbol highlights an immediate warning and is positioned on the instrument
itself.
CE-Marking of Conformity
Eurasian Conformity
Irritant Recyclable
Equipotentiality ON (supply)
Ethernet port
It is essential that the warnings, cautions and safety requirements contained in this document
are read and understood by the user before operating the system.
Warning symbols have been placed on the system to draw your attention to areas of potential
hazards.
System Compliance
FCC Compliance
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference that may
cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with the instruction manual, may cause
harmful interference to radio communications. Operation of this equipment in a residential
area is likely to cause harmful interference in which case the user will be required to correct
the interference at his own expense.
Modifications: Any changes or modifications made to this equipment that are not approved by
BIOMERIEUX SA FRANCE may cause harmful interference and void the FCC authorization
to operate this equipment.
This equipment is compliant with the limits stipulated by the FCC regarding exposure to
radiation within an open access environment:
• This equipment must be installed and operated at a minimum distance of 20 cm from the
user and from any surrounding people.
• This emitter must not be placed next to or operated at the same time as another antenna
or emitter.
IEC Compliance
This instrument complies with the emissions and immunity requirements of IEC 61326.
This is a Class A product. The instrument was designed and tested against CISPR 11, class
A. In a domestic environment this product may cause radio interference, in which case the
user may be required to take adequate measures.
bioMérieux recommends the evaluation of the electromagnetic environment before operating
the instrument.
Instrument Labels
Note: The picture of the rating plate is provided for information purposes only. The marks of
conformity printed on it depend on the current regulations in each country in which the
instrument is marketed.
MASTERCLAVE® 10
MASTERCLAVE® 20
Safety Precautions
Pay particular attention to the following safety precautions. If these safety precautions are
ignored, injury to the operator or damage to the instrument may occur. Each individual
precaution is important.
WARNING
If the equipment is used in a manner not specified by the manufacturer, the
protection provided by the equipment may be impaired.
WARNING
All biological samples and quality control (QC) products incubated in this
system, as well as all waste in the waste containers, should be treated as
potentially biohazardous materials. All materials and mechanical
components associated with the waste systems should be handled
according to safe microbiological practices in compliance with the
installation site's biohazard procedures. Use the personal protective
equipment recommended by the facility when handling any of these
components, including gloves, safety glasses, and a lab coat.
The system must be decontaminated before its covers are removed by
service personnel. Ensure that appropriate decontamination is carried out if
hazardous materials are spilled on or into the equipment or surrounding
areas.
WARNING
Treat waste material, including consumable items, and any components
coming into contact with waste material as having the potential hazards of
the samples used.
All service personnel should be familiar with the Material Safety Data Sheet
(MSDS) for all materials used in the procedures relating to this instrument,
and the correct procedures for handling these materials.
WARNING
Even when power is removed from the instrument, the potential exists for
electricity to be generated if components, such as assemblies that are
mounted on belts, are moved too quickly. Components should be moved
slowly to prevent the buildup of electricity. Failure to comply may result in
injury to personnel or damage to the instrument.
WARNING
Do not replace detachable main supply cords by inadequately rated cords.
Only use main supply cords provided by the manufacturer.
Do not replace electric cables. If cables do not have the same technical
specificities, there is a risk of electrical shock.
WARNING
Electronic equipment can be the source of electrical shocks. Installation,
service, and repair should only be performed by authorized and qualified
bioMérieux personnel.
WARNING
All power switches should be off when connecting or disconnecting cables
to power outlets to reduce the risk of electrical shock.
WARNING
bioMérieux recommends connecting this instrument to a main power outlet
that is protected with a ground fault circuit interrupter to reduce the risk of
electrical shock.
WARNING
As with any mechanical system, certain precautions must be taken when
operating the instrument. The instrument has a protective cover intended to
prevent the operator from coming into contact with any moving parts and
aerosols. When servicing the instrument, take special care, as there are
moving parts that can cause injury.
WARNING
Cleaning and disinfecting solutions have corrosive properties. Always wear
protective (chemical resistant) gloves and safety glasses when handling
cleaning and disinfecting solutions.
WARNING
Hot surfaces can cause injury.
DANGER
Do not open the MASTERCLAVE® when the pressure gauge does not
indiquate 0. Wait for the vessel to cool down before opening. In case of
problem, contact bioMérieux or your local bioMérieux representative.
DANGER
Do not open the safety valve manually when the pressure gauge does not
indiquate 0. Wait for the vessel to cool down before opening. In case of
problem, contact bioMérieux or your local bioMérieux representative.
CAUTION: The computer and its operating system have been carefully
configured for optimal system performance. Altering the configuration may
severely hamper the usability of the instrument.
Note: Before performing electrical safety or other compliance testing on the instrument, contact
bioMérieux or your local distributor.
WARNING
The user must only perform the maintenance operations described in this
document and rigorously follow each of the steps.
The use of tools not specified by bioMérieux is forbidden.
Powder-less gloves, a lab coat and protective glasses or goggles must be
worn when performing maintenance operations.
Always use personal protective equipment, including gloves, a lab coat and
safety glasses or goggles when handling reagents.
CAUTION: Take extra care when moving the instrument to avoid injury.
Before moving the instrument, be careful to remove any mobile objects
(beakers, e-pump, etc.)
System Description
1 Safety cover
2 Cover assistance system
3 Light indicator
4 Control unit
5 On/off switch
6 Pressure gauge
7 Cover lock
8 Lid
1 Safety cover
2 Cover assistance system
3 Light indicator
4 Control unit
5 On/off switch
6 Pressure gauge
7 Cover lock
8 Lid
Control Unit
1 Touch screen
2 Menu keys
Context-Sensitive Help
The context-sensitive help system included in the panel gives direct access to information on
the instrument features.
1. Press , no matter which screen you are working on.
2. Press on the part of the screen with which you need help.
3. Read the information.
The Lid
7 Lid seal
8 Priming tube connector
9 Priming tube
1 Removable stirrer
2 Culture medium vessel handle
2 Removable stirrer
3 Culture medium vessel handle
DANGER
Never activate the safety valve when the vessel is pressurized.
4 Water inlet
5 Water outlet
6 Power supply cable
7 Peripherals connection panel
8 Lid assistance system
DANGER
Never activate the safety valve when the vessel is pressurized.
MASTERCLAVE® 20
1 Cover lock
2 Demineralized water supply connection
3 Water supply connection
MASTERCLAVE® 20
Light Indicators
Different light indicators keep the user informed on the state of the equipment.
1 I light indicator
Alarm Systems
Three types of alarms provide information on cycles in progress.
•
Visual alarms: The Light Indicator is located at the front of the instrument and displays
Reagents
To get ordering information, contact bioMérieux or your local distributor (contact information
available on www.biomerieux.com).
List of Accessories
To get ordering information, contact bioMérieux or your local distributor (contact information
available on www.biomerieux.com).
• M10 mobility kit (includes trolley and rapid coupler connectors)
• M20 mobility kit (includes trolley and rapid coupler connectors)
• Built-in ticket printer (includes thermal printer and 20 paper rolls)
• Masterclave dosing kit (includes e-pump + extension cord PMi Tubing set 3.2mm with
nozzles for M10-M20 and footswitch)
• Auto water filling for network (M20)
• Auto water filling for tank (M20)
• Adding port cap with septum
• Water gun
• 1D barcode reader (USB)
• 2D barcode reader (USB)
• WIFI adapter
• Power cord filling 230V EC or w/o plug (Only for countries with 220V-230V [one phase] -
Power supply: to be used in dispensing phase only)
• Rapid coupler connectors (2U)
• Footswitch
• E-pump
• IQ/OQ
List of Consumables
To get ordering information, contact bioMérieux or your local distributor (contact information
available on www.biomerieux.com).
• M10-M20 consumables package (includes priming port cap seals, adding port cap seals,
priming nozzle seals set, non-return valve seals, priming flexible tubing for M10 and M20,
decompression filters 0.22µm, stirrer axe black washers & black gaskets)
• PMi tubing set 3.2 mm for M10-M20
• PMi tubing set 4.8 mm for M10-M20
• PMi tubing set 6.4 mm for M10-M20
• Dilumat tubing set for M10-M20
• Dilumat tubing set dual mode M10-M20
• Masterclave priming nozzle
• Draining cap
• Air inlet non-return valve
• MASTERCLAVE® printer paper rolls
• Water inlet filter 12-20
• Stainless steel hose clamp
• Suction grid
• MASTERCLAVE® 10 Medium vessel
• MASTERCLAVE® 20 Medium vessel
• Stirrer
• Cleaning brush
• Septums (50U)
System Basics
The box is heavy. Exercise caution when moving lifting, and unpacking the instrument to
avoid injury. It is recommended to have at least three people to lift the instrument. Remember
to bend your knees to avoid back injury.
Note: Always keep the packaging (box, pallet, foam, and straps) for future transport.
4. Check that the device has not been damaged during transport.
5. Confirm that the accessories listed below are present.
2 draining caps
DANGER
This procedure must be performed by a trained technician.
IMPORTANT: Never use the lid or cover handles to transport, move or lift the instrument.
1. For optimal operation, follow the steps below to install the instrument:
• Set the instrument on a clean, stable, and horizontal surface.
• Set the instrument near a filtered water supply (for example, a water discharge
outlet, water inlet, or main supply) and near a single-or-three-phase power socket.
• For a MASTERCLAVE® 10, set at a height which allows the user to work in an
ergonomically comfortable position.
2. Make sure there is easy access to the rear and side connection ports and to the power
socket.
3. Make sure the installation complies with the altitude, temperature, and humidity limits
as specified in the Technical Data and Specifications section.
4. The instrument connection to the filtered water supply must comply with the following
criteria:
DANGER
This procedure must be performed by a trained technician.
1. If the cable is not equipped with the connector supplied by bioMérieux®, check that it
complies with local regulations and with the following specifications:
N Neutral
E Ground
1 Phase 1
2 Phase 1
3 Phase 1
2. Connect the power-supply cable to the instrument and tighten the connector locking
device.
3. Connect the instrument to the power supply.
IMPORTANT: Never touch exposed parts of the female connector when connecting the power
supply cable to the mains power supply.
N Not connected
E Ground
1 Phase 1
2 Phase 2
3 Phase 3
6. Connect the power-supply cable to the instrument.
7. Tighten the power-supply cable locking device.
8. Connect the instrument to the three-phase power socket.
IMPORTANT: Never touch the female connector when connecting the power supply cable to
the mains power supply.
DANGER
This procedure must be performed by a trained technician.
1. If the cable is not equipped with the connector supplied by bioMérieux®, check that it
complies with local regulations and with the following specifications:
N Neutral
E Ground
1 Phase 1
2 Phase 2
3 Phase 3
2. Connect the power-supply cable to the instrument.
3. Tighten the connector locking device.
4. Connect the instrument to the power-supply.
IMPORTANT: Never touch exposed parts of the female connector when connecting the
power-supply cable to the mains power supply.
N Not connected
E Ground
1 Phase 1
2 Phase 2
3 Phase 3
6. Connect the power-supply cable to the instrument.
7. Tighten the power-supply cable locking device.
8. Connect the instrument to the three-phase power socket.
IMPORTANT: Never touch the female connector when connecting the power-supply cable to
the mains power supply.
The MASTERCLAVE® 20 can be connected to a demineralized water supply source to fill the
water bath.
The MASTERCLAVE® 20 can be connected to:
• a demineralized water line already available in the building.
• a demineralized water tank, using an e-pump.
Installing the Auto Water Filling for Tank for the MASTERCLAVE® 20
The Auto Water Filling kit is used to connect the MASTERCLAVE® 20 to a tank of
demineralized water.
Note: The use of the Sartorius 150 5231307H4-OO-B water filter is recommended. Contact
Sartorius or approved Sartorius distributors for more information about the filter or for
an equivalent reference.
Installing the Auto Water Filling for Network for the MASTERCLAVE® 20
The Auto Water Filling kit is used to connect the MASTERCLAVE® 20 to a network of
demineralized water.
Note: The use of the Sartorius 150 5231307H4-OO-B water filter is recommended. Contact
Sartorius or approved Sartorius distributors for more information about the filter or for
an equivalent reference.
User Management
It is possible to create, modify, or remove user accounts. Only Administrators are allowed to
manage user account security settings.
When the Users option is activated, the user is automatically disconnected and needs
to open a new session to use the device.
Table 7: Programs
Note: Assign a barcode to the user account in the Access Badge field.
5. Press to confirm.
Note: Assign a barcode to the user account in the Access Badge field.
6. Press to confirm.
Note: If passwords are used, assign a password to each new user account creates. Users
can change the password in their user account. See Modifying My User Account.
5. Press to confirm.
6. Choose the configuration to import by selecting a folder, then a file in the right-hand
column.
7. Press to confirm.
The device will boot up again.
Enabling/Disabling Sounds
Enable or disable sounds emitted during certain events.
1. Press , then .
2. Press and enter the Administrator password.
3. Press then .
4. Enable or disable the sounds.
5. Press to confirm.
Activate or deactivate the automatic update installation and search feature and update the
firmware.
• If the user management feature is activated, log on as Administrator.
• A backup of the instrument configuration is exported (see Exporting the Configuration
Settings for the Instrument).
• The firmware is available on a USB flash drive or via the embedded FTP and is connected
to the instrument.
1. Press , then .
2. Press then to access the Update screen.
3. Press on the Update screen.
4. In the Content panel, select the host.
The host name appears in the File Manager panel.
5. Select the firmware file (.amf) and confirm.
®
• The update begins and the MASTERCLAVE restarts.
• A message Firmware Update completed is displayed.
6. Press OK.
7. When the update is finished, log on as usual.
8. Press , then .
9. Press , then .
10. Check the firmware version name to confirm the firmware has been uptated.
Before starting the system and creating workflows and instructions, confirm the following:
• The instrument is connected to a power socket.
• The instrument is connected to the water supply as recommended.
1. Set the MASTERCLAVE® on/off switch to ON.
The MASTERCLAVE® starts.
2. If the Users option is activated, select a user account.
3. Press to confirm.
4. If the Password Management is activated, enter the password.
5. Press to confirm.
IMPORTANT: Do not get the power socket wet or leave it in water when disconnecting the
instrument.
Managing Programs
• NORMAL mode: best mode to save resources and cycle duration. It is the
recommended mode for standard use.
• ECO mode: best mode to save resources but the cycle is longer.
• CUSTOM mode: only mode dedicated to specific application for complex media
(R&D application).
5. Under the Cycle tab, press each part of the graph to configure the settings.
F0: equivalent exposure time at 121.11°C than the actual exposure time at a variable
temperature calculated for an ideal microorganism with a temperature coefficient of
destruction of 10°C (Z).
6. Under the Options tab, choose checking mode F0, coefficient Z and the preparation
type.
• Preparation field:
◦ Select the medium for agar media preparation
◦ Select the diluent for broth preparation
7. Under the Formula tab, press to add the supplements.
8. Press each cell in the table to configure each supplement.
Deleting a Program
1. Press , then .
2. Press to access the Programs screen.
3. Select the program to delete.
4. Press .
Performing Cycles
Note: Automatic filling should only be used for broth preparation. It is not recommended to use it
for agar preparation.
1. Press .
2. Adjust the cycle settings:
Note: See Performing a Delayed Start Cycle for additional information to perform an
autostart cycle with the MASTERCLAVE® 20.
5. Press to confirm.
6. Follow the on-screen instructions and press to confirm each preparation stage.
7. Press to start the cycle.
DANGER
• Never unplug the instrument while a cycle is in progress. To power down
the instrument, wait until the current cycle has ended, switch off the
instrument, then disconnect from the power supply.
• Avoid touching the metal part of the top panel when the lid is open.
• Never open the vessel lid when a cycle is in progress.
Note: Automatic filling should only be used for broth preparation. It is not recommended for agar
preparation.
1. Press .
2. Press to access the Active programs screen.
3. Select a program in the list.
4. Press to confirm.
5. If required, change the number of stages and their settings.
6. Press .
7. Adjust the cycle settings:
• Select medium for agar media preparation.
• Select diluent for broth preparation.
• Select for manual media vessel filling.
• Select for automatic filling using the shower option.
• Select for automatic filling using filling kit option.
Note: See Performing a Delayed Start Cycle for additional information to perform an
autostart cycle with the MASTERCLAVE® 20.
8. Press to confirm.
9. Follow the on-screen instructions and press to confirm each preparation stage.
10. Press to start the cycle.
DANGER
• Never unplug the instrument while a cycle is in progress. To power down
the instrument, wait until the current cycle has ended, switch off the
instrument, then disconnect from the power supply.
• Avoid touching the metal part of the top panel when the lid is open.
• Never open the vessel lid when a cycle is in progress.
Note: Automatic filling should only be used for broth preparation. It is not recommended for agar
preparation.
4. Press to confirm.
5. Follow the instructions on the screen.
Note: It is recommended to stay by the MASTERCLAVE® during initialization until the Delayed
Start screen is displayed.
After a progress bar is displayed, the screen displays the delayed start details. A blue
indicator light will start blinking on the MASTERCLAVE®, and it will start the cycle as
programmed.
At this point, the cycle is Dispensing phase and the light indicator is blinking green.
At the end of the preparation cycle, pressurize the instrument to optimize the prepared
medium dispensing phase.
WARNING
In case of e-pump connection, turn off the instrument before connecting the
e-pump.
1.
< 78°C.
At this point:
• The cycle is in dispensing phase and the light indicator is blinking green.
• Only a single e-pump can be connected to the instrument.
1. Switch OFF the instrument.
2. Connect the e-pump at the rear of the instrument.
3. Switch ON the instrument.
4. Install the priming tube set.
5. Press .
6. Press NO PUMP and select Active.
The pump is detected and the e-pump light indicator turns on.
7. Press >.
8. Enter the dispensing settings.
9. Press > twice to configure the advanced dispensing option settings and press > twice
to return to the dispensing settings.
10. Press Calibrate and complete the fields.
11. Press to prime the pump.
12. Press Start to dispense a dose in a graduated container.
13. Enter the volume of the dispensed dose.
14. Check the volume:
• If it is equal to the volume to be dispensed, press Validate.
• If it is unsatisfactory, repeat the calibration as often as necessary and press
Validate.
15. Press Start to initiate the dispensing process.
All the cycle data are collected and saved in the Cycle History menu.
Note: The cycle history data can be saved for 90 days or infinite: to configure, Press , then .
Then press .
1. Press , then .
2. Select .
3. Select the year and press .
4. Select the month and press .
5. Select the week and press .
6. Select the cycle and press .
• On each selection screen, allows to export CSV files of the year/month/week.
• appears only when a printer has been installed (physical or virtual). It allows to
print 2D barcodes with prepared media traceability. It can be scanned on a Dilumat
or a PMi using the 2D barcode reader.
• appears only when a printer has been installed (physical or virtual). Allows to
print out cycle data with graph. Graph is only available with a built-in printer.
• allows to export cycle data and traceability in CSV format on peripheral devices.
• allows to export a PDF document based on the ISO 11133 recommendation
with Temperature graph, Cycle data, Traceability, Quality Control template step.
Access more features such as data management, updates, etc., by adding physical or virtual
peripherals sur as USB or WIFI stick, Ethernet, printer, virtual printer, number pad, barcode
reader, embedded FTP, remote FTP. Only Administrators may configure peripherals
connected to the instrument.
Note: It is possible to connect to the embedded FTP server from the computer by opening
an anonymous session using the Administrator password.
1. Press , then .
2.
Press , then .
IMPORTANT: Deactivate the USB stick before removing it to avoid loss of data.
3. Press .
4. Select remote FTP server, then press .
5. Complete the fields.
6. Press to confirm.
The remote FTP server is included in the list of peripherals.
3. Press .
4. Select Virtual Printer.
5. Press to confirm.
6. Complete the fields.
7. Press to confirm.
The virtual printer is displayed in the list of peripherals.
IMPORTANT: A barcode reader is configured according to the language of the country where
it is installed, like a keyboard. In France, for instance, keyboards are configured
in AZERTY format, while in English-speaking countries (UK, US, etc.) keyboards
are configured in QWERTY format. Please select the country code for the
localization settings needed for the barcode reader. Otherwise, the reader will
not be able to read the barcodes. Test the reader on a barcode with the content
displayed in the test zone to check if the reader configuration is correct.
5. Select the language for the localization settings you need for the barcode reader.
6. Press to confirm.
1. Press , then .
2. Press .
3. Select .
4. Configure the e-mails options.
Managing Messages
Reading a Message
A flashing envelope indicates that there is a new message, regardless of which screen is
open.
1. Press .
The Message screen is displayed.
2. Select the message to read, then press .
Deleting a Message
After reading the messages, delete them from the message list.
1. Press , regardless of which screen is open.
The Messages screen is displayed.
2. Select the message to delete, then press .
To change the name of the instrument and see the instrument technical data and program
versions use the following steps:
1. Press , then .
2. Press .
3. Press .
4. If needed, change the instrument name and see the available information.
For service information, contact bioMérieux or your local distributor (contact information
available on www.biomerieux.com).
Calibration and Adjustments
1. Press , then .
2.
Press then to access the Metrology screen.
Note: It is recommended to calibrate the demineralized water flow meter at least once a month.
1. Press , then .
2.
Press then to access the Metrology screen.
Printing a Certificate
It is possible to print calibration and adjustment certificates with a physical or virtual printer.
The labels are printed in .png format and may be stored on a USB stick, FTP server, etc.
Check that all the peripherals required for printing have been configure. See Managing the
Peripherals.
1. Press , then .
2. Press .
3.
Press .
Cleaning Procedures
CAUTION:
• Never clean the instrument when in operation.
• Never spray cleaning product directly onto the instrument.
• Do not use aggressive chloride or acid-based products.
• Do not use abrasive sponges.
• Clean with rubbing alcohol 70° and/or hot water
1. Fill the water bath with demineralized water to the maximum level.
2. Fill the culture medium vessel with 5L of demineralized water.
3. Start a cycle with the following settings:
• Sterilization at 121°C for 30 minutes
• Dispensing at 60°C
4. Drain the water bath.
Note: For replacement frequency of the filter, contact the filter manufacturer.
Note: For replacement frequency of the filter, if installed, contact the filter manufacturer.
Name Frequency
Priming port cap seal 16x2 (1) Every 250 cycles
Priming nozzle seal set (2) Large seal: every 90 cycles
Small seal: every 40 cycles
4. Press .
5. Follow the instructions on the screen.
It is possible to choose two different draining methods:
• Automatic draining when the instrument is locked and under pressure.
• Manual draining to clean the water bath and activate the water flow manually.
It is necessary to display and reset the maintenance logs for the instrument and send
anonymous reports to optimize their use.
1. Press , then .
2. Press and enter the administrator password.
3. Press , then .
4. If needed:
• See all maintenance logs.
• Reset User maintenance logs.
• Press to activate/deactivate the regular sending of anonymous reports to
bioMérieux®.
5. Press to confirm.
Authorize remote maintenance to allow customer service to take control of the instrument and
troubleshoot remotely.
It is necessary to contact customer service to authorize remote control.
1. Press , then .
2. Press , then .
3. Press .
4. Follow the instructions given by the customer service.
It is necessary to implement simple tests (light indicators, pumps, sound, etc.) and sequential
tests on the equipment to check for malfunction.
1. Press , then .
2. Press , then .
Failed sealing test. • Check that all caps are tightly screwed on
and that seals are in good condition.
• The filter is clogged. Replace it.
• The non-return valve may be clogged.
See Cleaning the Non-Return Valve.
• If the problem persists, contact Customer
Service.
The cooling phase seems to be too long or • Insufficient water inlet flow rate.
an error message indicates missing cooling
• Water inlet filter is clogged or upstream
water.
inlet tap may not be sufficiently open.
• The cycle mode selected is Normal or
Slow. They are used to save water. The
cooling phase might be longer than the
Fast mode.
Bubbles in the medium when dispensing. • Check the priming nozzle seal and the
state of the priming tube connector.
Third party software and any parts thereof identified in the left-hand column are subject to the
terms and conditions under which the specific licenses identified in the right-hand column are
granted.
Qt 4.8 http://doc.qt.io/archives/qt-4.8/licensing.html
Third-Party Licenses Used in Qt 4.8 http://doc.qt.io/archives/qt-4.8/3rdparty.html
libsmbclient https://www.samba.org/samba/docs/current/man-
html/libsmbclient.7.html
License GPL http://www.gnu.org/copyleft/gpl.html
Adjustment
The process of adjusting the equipment to reduce the deviation between the measurement
made and the reference or standard volume (benchmark).
Calibration
Calibration involves comparing a measurement made by the equipment with a reference or
standard volume (benchmark).
F0
Equivalent exposure time at 121.11°C than the actual exposure time at a variable temperature
calculated for an ideal microorganism with a temperature coefficient of destruction of
10°C (Z).
LIMS
LIMS (Laboratory Information Management System), is an integrated laboratory and
information management application.
www.biomerieux.com