IBS MediaClave User manual

User Manual 3.4
Bedienungsanleitung 3.4
Mode d’emploi 3.4

© 2009 INTEGRA Biosciences AG, Switzerland
All rights reserved. This manual may not be copied or reproduced in whole or in part in any way without the prior express written permission
of INTEGRA Biosciences. The company reserves the right to make alterations without prior notice.
Notwithstanding the above statements, INTEGRA Biosciences accepts no liability for possible mistakes or their consequences arising from
this manual.
This manual is identified by Art.No. 135900
Declaration of conformity
INTEGRA Biosciences AG - CH-7000 Chur, Switzerland
declares on its own responsibility that the product,
in accordance with the EC directives
is in compliance with the following standards or normative documents:
Standards for Canada and USA
Description Type, model
MEDIACLAVE 135020, 135025, 135030, 135035
73/23/EEC Low voltage equipment
89/336/EEC Electromagnetic compatibility
97/23/EC Pressure equipment
2002/95/EC Restriction of Hazardous Substances
2002/96/EC Waste Electrical and Electronic Equip-
ment
EN 61010-1:2001-02 Safety requirements for electrical equip-
ment for measurement, control and lab-
oratory use - General requirements.
EN 61010-2-041:1998 Particular requirements for autoclaves
using steam for the treatment of medi-
cal materials and for laboratory proc-
esses.
EN 61326-1 +A1:1998+A2:2000 Electrical equipment for measurement,
control and laboratory use - EMC
requirements.
CAN/CSA-C22.2 No.1010.1-92 Safety requirements for electrical equip-
ment for measurement, control and lab-
oratory use - General requirements.
UL Std. No. 3101-1 Safety requirements for electrical equip-
ment for measurement, control and lab-
oratory use - General requirements.
FCC, Part 15, Class A Emission
Chur, Date
June 10, 2009 Elmar Morscher, CEO Thomas Neher, Quality Manager
This equipment has been
tested and found to com-
ply with the limits for a
Class A digital device,
pursuant to both Part 15
of the FCC Rules and the
radio interference regula-
tions of the Canadian De-
partment of
Communications.
Theselimitsaredesigned
to provide reasonable
protection against harm-
ful interference when the
equipment is operated in
a commercial environ-
ment.
This equipment gener-
ates,usesandcanradiate
radio frequency energy
and, if not installed and
used in accordance with
the instructions manual,
may cause harmful inter-
ference to radio commu-
nications.

User Manual 3.4
INTEGRA Biosciences PAGE I
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Table of contents
1 MediaClave overview ................................................................................................ 1
1.1 About the MediaClave ......................................................................................................1
1.1.1 Introducing the MediaClave ...................................................................................... 1
1.1.2 Intended use ............................................................................................................. 1
1.1.3 Basic concepts ......................................................................................................... 2
1.2 Using the manual ............................................................................................................. 2
1.2.1 About the manual ..................................................................................................... 2
1.2.2 User manual symbols ............................................................................................... 3
1.3 General information ......................................................................................................... 4
1.3.1 Safety precautions .................................................................................................... 4
1.3.2 Safety regulations concerning service and maintenance ......................................... 5
1.3.3 Equipment disposal................................................................................................... 5
1.3.4 Warranty and liability ................................................................................................ 5
2 Installation ................................................................................................................. 7
2.1 Introduction ...................................................................................................................... 7
2.2 Operating environment .................................................................................................... 7
2.3 MediaClave drawings .......................................................................................................8
2.3.1 MediaClave vessel overview .................................................................................... 8
2.3.2 MediaClave rear panel ............................................................................................. 9
2.4 Electricity and water ....................................................................................................... 10
2.4.1 Provision of electricity ............................................................................................. 10
2.4.2 Water supply .......................................................................................................... 10
2.5 Filter and tubing installation ........................................................................................... 11
2.5.1 Sterile filter installation ........................................................................................... 11
2.6 Moving the MediaClave ................................................................................................. 11
2.6.1 Moving procedure ................................................................................................... 11
3 Operating controls .................................................................................................. 13
3.1 Introduction .................................................................................................................... 13
3.2 Preparation for different operational modes ................................................................... 13
3.2.1 Mode MEDIACLAVE .............................................................................................. 13
3.2.2 Mode AUTOCLAVE ................................................................................................ 15
3.2.3 Mode WATERBATH ............................................................................................... 17
3.3 Switching On and Off the MediaClave ........................................................................... 17
3.3.1 MediaClave start display ........................................................................................ 17
3.3.2 Soft key menu options explained ........................................................................... 18
3.3.3 LANGUAGE menu ................................................................................................. 19
3.3.4 PARAMETER menu ............................................................................................... 20

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4 Instruction for use .................................................................................................. 25
4.1 Introduction .................................................................................................................... 25
4.2 Safety precautions and specifications ............................................................................ 25
4.2.1 MEDIACLAVE and AUTOCLAVE sterilisation ....................................................... 25
4.2.2 WATERBATH ......................................................................................................... 25
4.3 Program operation .........................................................................................................26
4.4 MEDIACLAVE program operation ................................................................................. 26
4.4.1 AUTOCLAVE program operation ........................................................................... 30
4.4.2 WATERBATH program operation .......................................................................... 34
5 Cleaning instructions ............................................................................................. 37
5.1 Introduction .................................................................................................................... 37
5.2 Manually controlled cleaning routines ............................................................................ 37
5.2.1 General cleaning routine ........................................................................................ 37
5.2.2 Removing residual dirt ............................................................................................ 38
5.3 MediaClave Cleaning menu ........................................................................................... 39
5.3.1 Cleaning procedure ................................................................................................ 39
5.3.2 Overview ................................................................................................................39
5.3.3 EMPTY menu ......................................................................................................... 39
5.3.4 CLEAN menu ......................................................................................................... 40
6 Maintenance ............................................................................................................ 43
6.1 Introduction .................................................................................................................... 43
6.2 Paper handling ............................................................................................................... 43
6.2.1 Replacing the Printer paper roll .............................................................................. 43
6.3 Temperature calibration ................................................................................................. 45
6.3.1 Overview ................................................................................................................45
6.3.2 When to perform calibration ................................................................................... 45
6.3.3 Temperature calibration routine ............................................................................. 45
6.4 Troubleshooting + Error handling ................................................................................... 46
6.4.1 Possible solutions for problems .............................................................................. 46
6.4.2 Error handling ......................................................................................................... 47
6.5 Frequently Asked Questions .......................................................................................... 49
7 Accessories and Technical specifications ........................................................... 51
7.1 Introduction .................................................................................................................... 51
7.2 MediaClave accessories ................................................................................................ 51
7.2.1 MediaClave accessories list ................................................................................... 51
7.3 Country versions ............................................................................................................ 52
7.3.1 Electrical ratings ..................................................................................................... 52
7.4 Software default values .................................................................................................. 52
7.4.1 Overview ................................................................................................................52

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7.4.2 MEDIACLAVE programs 1–13 (1–9 L of medium) ................................................. 52
7.4.3 MEDIACLAVE program 14 (Without pressure test) ............................................... 53
7.4.4 MEDIACLAVE program 15 (Blood Agar) ................................................................ 53
7.4.5 General default values ........................................................................................... 54
7.5 Limitations and general notes ........................................................................................ 54
7.5.1 Overview ................................................................................................................54
7.5.2 Limit values within mode MEDIACLAVE ................................................................ 55
7.5.3 Limit values within mode AUTOCLAVE ................................................................. 55
7.5.4 Limit values within mode WATERBATH ................................................................. 55
7.6 Input / Output connectors ............................................................................................... 56
7.6.1 Overview ................................................................................................................56
7.6.2 First serial port RS232 ............................................................................................ 56
7.6.3 Second serial port RS232 ....................................................................................... 57
7.6.4 Interface for external safety cover lock switch and alarm ....................................... 58
7.7 Progress printouts .......................................................................................................... 59
7.7.1 Overview ................................................................................................................59
7.7.2 Test print ................................................................................................................ 59
7.7.3 Progress print ......................................................................................................... 60
7.8 MediaClave physical properties .................................................................................... 61
7.8.1 MediaClave data .................................................................................................... 61
7.8.2 Installation data ...................................................................................................... 61
8 Manufacturer and Customer Service .................................................................... 63
8.1 Manufacturer: ................................................................................................................. 63
8.2 Customer Service: .........................................................................................................63
9 Glossary ................................................................................................................... 65

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User Manual 3.4
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1 MediaClave overview
1.1 About the MediaClave
1.1.1 Introducing the MediaClave
Figure 1.1: The MediaClave
1.1.2 Intended use
The MediaClave is a highly versatile piece of equipment. It operates as a stand-alone device used to pro-
gram and control three integrated operation modes: MEDIACLAVE, AUTOCLAVE and WATERBATH.
The MEDIACLAVE program is used to prepare culture media. Insertion of a stainless steel base plate and
flexible PT100 temperature probe converts the MediaClave into the AUTOCLAVE. The AUTOCLAVE pro-
gram is used as a bench-top autoclave for sterilisation of culture media in single containers. The WATER
BATH program is used as a conventional water bath.
NOTE: Consult section 7.2.1 for a list of all standard and optional MediaClave accessories.
Safety Cover Lock
Safety Valve
Vessel Lid
Safety Cover
Outlet Cap
Inlet Cap
Form Feed Button
Printer Manometer Magnetic Front Panel
Graphic User
Interface (GUI)

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1.1.3 Basic concepts
The MediaClave offers many features to the user:
• Automatic initialisation and self-test execution
• Mode MEDIACLAVE – culture preparation of 1 to 9 L of agar containing medium or nutrient liquid
• Mode AUTOCLAVE – autoclave for sterilisation of culture media in single containers.
• Mode WATERBATH – fully running thermostatic water bath
• Preparation of highly sensitive culture media in a gentle and reproducible fashion
• Easy addition of growth additives, inhibitors and supplements
• Highly efficient intra-cooler – cool-down phase 60% faster than conventional jacket cooling; 60% less
water consumption
• Easy to follow, user-friendly menu operation via four soft keys
• Low energy costs
• Up to 15(x3) individual programs can be stored
• Alarmed error messages
• 4-level security system regarding temperature and pressure control. Over pressure valve and over-
heating sensor prevent danger to people and appliance.
• Full traceability of individual instrument functions and programmed processes – progress printouts
via the integrated printer
• Adjustment of the graphic user interface (GUI) to suit the laboratory environment
• Easy maintenance
• Space-saving compact design
• Host PC connection
• Interface for external serial printer (from software version 1.9.1 and with additional cable installed
1.2 Using the manual
1.2.1 About the manual
The MediaClave User manual has been designed to allow general users access to required information.
Any departure from the procedures outlined in theMediaClaveUsermanualmay leadto erroneous results
or instrument malfunctions and may adversely affect the safety of the MediaClave.
ATTENTION:The MediaClave is not suitable for sterilisation of medical devices.
NOTE:The MediaClave functionality, described in User manual version 3.4, is based on Media-
Clave software version 1.9.1 and higher. The interface for an external printer is only usable, if a
special cable is installed into MediaClave additinally to the software 1.9.1. (cable order number:
135245). MediaClave instruments with serial number 13505601 and later have this cable installed
by default.

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The MediaClave User Manual is divided into 9 parts
1.2.2 User manual symbols
The signal words WARNING, ATTENTION and NOTE are included in this manual to emphasise im-
portant instructions and alert the user to potential hazards. They have a special hazard alert symbol.
Chapter Name Description
1MediaClave overview General information
2Installation Installation, moving
3Operating controls MediaClave preparation
4Instructions for use MEDIACLAVE, AUTOCLAVE, WATERBATH operation
5Cleaning instructions Cleaning procedures
6Maintenance Error- and Troubleshooting, Calibration, Paper-handling
7Accessories and Technical
specifications Accessories, default values, ports, physical properties
8Manufacturer and Customer
service Addresses
9Glossary Term definitions
Table 1.1: User manual overview
Symbol Definition
WARNING indicates a potentially hazardous situation that, if not avoided, could
result in damage to the instrument or personal injury. This signal word is used
only in extreme situations and, therefore, requires special attention.
ATTENTION indicates special problems or important information. Read the
accompanying text carefully as it is important for understanding the specific topic
or command.
NOTE indicates information that is useful, but not essential, to a task. Read the
accompanying text carefully as it can help to clarify particular issues.
Table 1.2: Legend of symbols

MediaClave overview
INTEGRA Biosciences
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1.3 General information
1.3.1 Safety precautions
1.3.1.1 General safety precautions
• The MediaClave User manual must be read in detail before operating the MediaClave
• In the event of a situation arising where safe operation of the MediaClave cannot be guaranteed, the
instrument must be switched off and locked until qualified personnel can repair it. Such a situation
may include one of the following scenarios:
• The MediaClave is visibly damaged
• The MediaClave stops working properly
• The mains power switch automatically switches to position 0
• Steam escapes through the lid
• The safety cover or vessel lid does not close
• Repairs must only be carried out by authorised personnel, using genuine spare parts. In particular,
only qualified personnel can connect and replace the mains plug.
• Theappliance must onlybe operated by appropriately trained andinstructed persons who are familiar
with all aspects of safety relating to this appliance.
• Apart from the safety notes in these instructions, the specific requirements for the prevention of ac-
cidents as well as the generally applicable rules for work place safety must also be observed.
• These installation and operating instructions must at all times be readily available where the Media-
Clave is used.
• The MediaClave must not be used for any purpose apart from the outlined applications.
• Do not open the MediaClave. Do not carry out any conversions and alterations on the device.
1.3.1.2 Precautions during operation
• Do not leave the MediaClave unattended when running a program.
• Do not open the vessel lid when pressure is greater than 0.1 bar and temperature exceeds 80°C.
• Do not spill liquids on the MediaClave. If the MediaClave requires cleaning, consult chapter 5.
ATTENTION:The MediaClave is subject to high thermal and compressive stress during the sterilisation
cycle. It is therefore imperative to observe the safety notes of this User manual.
WARNING:For personal security, the MediaClave must be switched off and disconnected from power
supply before any installation, repair or maintenance work is carried out.
WARNING:To prevent unintended damage to the appliance it is absolutely essential that you read and
understand the operatinginstructions. Furthermore, the owner is responsible for ensuring that appropriate
instructions are provided to users of the appliance.
WARNING:First carefully read these instructions before operating the MediaClave.
WARNING: No water must flow over the front panel!

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1.3.2 Safety regulations concerning service and maintenance
• It is mandatory that a service is carried out at least once a year by authorised personnel because the
MediaClave is subject to high thermal and compressive stress during the sterilisation cycles. Ask your
distributor for support!
• The sterile filter at the rear of the instrument must be replaced every 6 month.
1.3.3 Equipment disposal
The MediaClave is labelled with the "crossed-out wheeled bin" symbol to indi-
cate that this equipment must not be disposed of with unsorted municipal
waste. Instead, it is your responsibility to correctly dispose of your waste equip-
ment by handing it over to an authorised facility for separate collection and
recycling.
For more information about where you can drop off your waste equipment for
recycling, please contact your local dealer from whom you originally purchased
the product or your local council.
By doing so, you will help conserve natural resources and you will ensure that
your waste equipment is recycled in a manner that protects human health and
the environment. Thank you!
1.3.4 Warranty and liability
NOTE: MediaClave shall not be modified. Defective parts shall be exchangedonly for originalspare parts
from INTEGRA Biosciences AG.
NOTE: MediaClave shall not be modified either as an equipment or with regard to the safety aspects.
Any modification will result in exclusion of responsibility for consequential injury or damage on the part of
INTEGRA Biosciences AG.
WARNING: MediaClave must not be opened! Repairs shall be carried out only by INTEGRA Biosci-
ences AG or an authorized customer service organization.

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INTEGRA Biosciences
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2 Installation
2.1 Introduction
The purpose of this chapter is to give a step-by-step guide to the installation procedures of the Media-
Clave. It is divided into the sections
• Operating environment
• MediaClave drawings
• Electricity and water
• Filter and tubing installation
• Moving the MediaClave
2.2 Operating environment
In choosing an appropriate operating environment for the instrument, several factors must be considered.
• The operation of the MediaClave is allowed inside buildings only!
• The MediaClave must not be operated at places which are located higher than 2000 metres above
sea level!
• The chosen area must not present a hostile environment to the instrument or its intended use and
show pollution degree l or ll.
• The ambient air temperature must be within 0 and 40°C. The maximum relative humidity for tempe-
ratures up to 31°C is 80% and then derates down to 50% at 40°C.
• The MediaClave must be placed on a clean, dry and horizontal surface which is capable of holding
at least 50kg. For user convenience and ease of access to the soft keys, the front edge of the instru-
ment must be positioned near the front of the bench. The instrument must be positioned in such a
way that the On/Off and power switches are always accessible.
• In case of voltage fluctuations, the INSTALLATION CATEGORIES (Overvoltage Categories) l, ll or lll
are authoritative! For the mains supply, the minimum and normal category is ll.
• The instrument must be located within easy reach of electrical outlets, and provisions must be made
to run the outlet tubes at the rear of the instrument into waste receptacles. These must be posi-
tioned lower than the Mediaclave over its whole length. (prevention of back pressure)
• Ensure all cables and tubes are positioned in a safe area to avoid people tripping over them.
• Do not place anything on the MediaClave safety cover. At the end of each cycle, or if a cycle is inter-
rupted and terminated, the safety cover opens automatically.
• Consult the local regulations before connecting the MediaClave to the drinking-water supply.
NOTE:Refer also to the Installation Qualification (IQ) which provides additional information. It should be
consulted, if the MediaClave is installed first time or moved from one to another location.
WARNING:Do not operate the instrument in an area that contains high concentrations of dust or humid-
ity, if there is a danger of explosion or if toxic chemicals are being used or stored nearby.
ATTENTION: If water splatters to the front panel cannot be prevented, the provided printer cover must
be installed.

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INTEGRA Biosciences
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2.3 MediaClave drawings
2.3.1 MediaClave vessel overview
Figure 2.1: Vessel lid
PT100 Temperature Probe
(Product Sensor)
Grip Vessel Lid
Safety Valve
Filling Port
Safety Cover Lock
Dispense Port
Grip Vessel Lid
.
.
Pressure Tube
(Steam Ventilation Tube)

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2.3.2 MediaClave rear panel
Figure 2.2: MediaClave rear panel
Figure 2.3: Waste tube of flow water outlet
For Service Use only
Product Sensor
Host RS232
Vessel Cover
and External Alarm RS232
Power Supply
Hot
Hot
Drain
Cold Water
Flow Water Outlet
Cooling Water Inlet
Cooling Water
Outlet
Sterile Filter
Filter Tube
.
External Printer

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INTEGRA Biosciences
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2.4 Electricity and water
2.4.1 Provision of electricity
• Before connecting the instrument to the power supply, ensure that the network voltage and fuse rat-
ing are compatible to that indicated on the instrument identification plate at the rear of the instrument.
(consult Table 7.3.1).
• To prevent electric shock, plug the MediaClave power cables into fully grounded power sources. Do
not use adapter plugs or remove grounding pins from a cable. If an extension cable must be used,
use a cable suitable for the appliance version (system voltage according to type plate) with properly
grounded plugs. Connect the MediaClave to the power socket from the building / laboratory.
2.4.2 Water supply
Three water connectors are situated on the MediaClave‘s rear panel. Two are for the cooling water inlet
and outlet, one is the flow water outlet.
To connect the MediaClave to the water supply, proceed the following steps:
• Connect the cooling water inlet tube to the cooling water inlet.
• Connect the cooling water outlet tube to the cooling water outlet.
• Connect the waste tube for condensation and water vapour to the flow water outlet.
WARNING:The MediaClave is an electrically heated pressure vessel and must only be operated by
trained personnel.
Version EU: (1 x 230V) 16A
Version EU: (3 x 400V) 6A pro Phase
Version USA: (1 x 240V) 16A
Version Japan: (1 x 200V) 20A
WARNING: If condensation is visible on the MediaClave, do not switch on or operate the instrument for
at least two hours.
WARNING: If the MediaClave is to be operated with 400 V, 3 phases, the voltage network must be iso-
lated with a circuit breaker power switch or by a suitable isolation device.
NOTE: A connection between the flow water outlet and cooling water outlet can only be made if a non-
return valve is fitted to the water supply.
ATTENTION: For an error-free venting of the instrument, backpressure in the waste tube must be avoid-
ed. Therefore, the waste tube must be led straight downwards from the flow water outlet of the instrument
- without any upward bending - into the lower lying water drain. Water must not accumulate within the tube
and its end must not submerge into the water, but must freely hang over the water drain. See figure
“Waste tube of flow water outlet” on page 9.

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2.5 Filter and tubing installation
2.5.1 Sterile filter installation
The sterile filter prevents contaminated air from entering into the vessel during operation
• Screw the sterile filter into position (see figure 2.2). Orientation of the text on the filter: Text must be
visible from the rear side.
• Using the milled screw, screw the support pressure tube into the sterile filter (see figure 2.2).
• Connect the end of the support pressure tube and secure it with a nut.
2.6 Moving the MediaClave
2.6.1 Moving procedure
• Remove any items from the top of the MediaClave
• Close vessel lid and safety cover
• Disconnect all cables and tubing
ATTENTION: Replace the sterile filter at least every six months.
INFO:Wetness or wearing out of the filter may provoke a pressure test failure!
ATTENTION: Before moving the MediaClave, it must be cooled down, emptied and disconnected from
the mains
NOTE: Two persons are required to lift the MediaClave.
ATTENTION: Never lift the instrument by the cover handle. Carry the instrument, holding it steady and
firmly at the base.
NOTE: After moving the MediaClave, the accomplishment of an Installation Qualification (IQ) procedure
is strongly recommended!

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INTEGRA Biosciences
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3 Operating controls
3.1 Introduction
This chapter gives needed information to prepare the MediaClave for every operation mode.
3.2 Preparation for different operational modes
3.2.1 Mode MEDIACLAVE
3.2.1.1 Installing the Rigid Temperature Sensor
1. Unplug the flexible temperature sensor from the rear panel if installed
2. Unscrew the sensor from the vessel lid (using the fork wrench provided)
3. Insert the rigid temperature sensor and tighten it
4. Plug in to rear panel
3.2.1.2 Installing the Decanting tube
1. Press the silicone decanting tube onto the dispense fitting nipple which is located on the underside
of the vessel lid’s dispense port (see figure 2.1)
2. Attach the tube to the vessel lid by rotating the stainless steel securing nut clockwise until it is finger-
tight.
3.2.1.3 Installing the cuvette
1. Place the cuvette in the MediaClave vessel
2. Using both grips, turn the cuvette clockwise until it locks into position
3. The stirrer magnet bar must be installed into the cuvette
3.2.1.4 Filling the cuvette
1. Place the stirring magnet bar inside the cuvette. Position it on the pivot of the cuvette base
2. Add the desired amount of liquid or agar to the cuvette
ATTENTION: Ensure that there is a O-ring attached to the temperature sensor.
ATTENTION: It is essential that the stirrer magnet is installed properly. A stirrer magnet bar which
is missing or not properly installed may lead to inhomogeneous temperatures during the sterilisa-
tion process!

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INTEGRA Biosciences
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3.2.1.5 Filling the vessel
In mode MEDIACLAVE, the heating water(coupling medium)filling level depends onthe amountsof prod-
uct. Fill the vessel with distilled or deionised water. Ensure that the water does not contain chalk or min-
erals. The water level (with the cuvette inserted) must be approximately 7 cm below the upper edge of the
vessel (approx. 2 litres).
3.2.1.6 Closing the vessel lid
1. Close the vessel lid by turning the grips clockwise around the attachment point. The grips of the ves-
sel lid (1) must be aligned above the white stickers (2), as shown in the picture below. Otherwise the
safety of the instrument is severely compromised.
Figure 3.1: Closing the vessel lid
2. Ensure the inlet and outlet caps are screwed finger-tight
3.2.1.7 Removing the cuvette
1. Once the MEDIACLAVE cycle is finished press END
2. Using both grips, turn the vessel lid anticlockwise until it unlocks and is released
3. Open the vessel lid
4. Remove the cuvette (Take care about the product temperature sensor)
NOTE: If insufficient water is added, an alarmed error message appears on the screen. Follow all on-
screen instructions.
ATTENTION: The vessel lid must be closed at all times during MEDIACLAVE program operation!
NOTE: If the white stickers are not present on the instrument they can be ordered from your distribution
partner as a retrofitting kit including instructions how to attach the stickers.
As long as the stickers are missing: The vessel lid is correctly closed if the 2 screws of the vessel lid holder
and the filling port are in line as shown as dashed line in Fig. 3.1.
NOTE: If there is a difficulty in opening the vessel lid, slightly unscrew the adding port caps to release
any residual pressure may help. This little residual pressure is mostly generated by the natural vaporisa-
tion of the hot media or water which is within the vessel. After releasing the residual pressure, the addition
port must be closed again before opening the vessel lid.
1
2
1
2