Sartorius Stedim Biotech Biostat RM 200 Rocker User manual

85037-547-60
Operating Manual
Biostat®RM 200 Rocker
124.000 | 124.001
Fermenter | Bioreactor
*** TeDIS Valid on Date Printed Printed on: 20-09-2023 11:08:57 ***
185013007863

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– Windows, MacOS X
– Browser with JavaScript enabled
– PDF-Reader
Use start.html to run the application
The enclosed CD contains the operating instructions
as a PDF file in various international languages.
If the CD is missing, you can obtain a copy form us
by specifying the order number:
Order number: 85037-548-92
Sartorius Stedim Biotech GmbH
Technical Editorial Department
August-Spindler-Strasse 11
37079 Goettingen, Germany
[email protected]
www.sartorius-stedim.com
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Operating Instructions Biostat®RM 200 Rocker 3
Contents
Contents
1. About This Document ............................................................6
1.1 Validity .......................................................................7
1.2 Accompanying Documents...................................................7
1.3 Symbols Used.................................................................8
1.4 Abbreviations.................................................................8
2. Safety Precautions ...............................................................9
2.1 General Safety Precautions ..................................................9
2.2 Informal Safety Measures ....................................................9
2.3 Symbols Used on the Device ............................................... 10
2.4 Intended Use and Foreseeable Misuse...................................... 11
2.5 Residual Risks from Use of the Unit........................................ 12
2.6 Danger Due to Electrical Power ............................................ 12
2.7 Danger Due to Components Under Pressure ............................... 13
2.8 Danger Due to Gases ....................................................... 14
2.9 Danger Due to Escaping Materials ......................................... 15
2.10 Danger Due to Hot Surfaces ............................................... 15
2.11 Danger Due to Moveable Components..................................... 15
2.12 Danger Due to Use of Incorrect Consumables ............................. 16
2.13 Hazards Due to Improper Safeguarding or Movement of the Device ..... 16
2.14 Hazards Due to System Failures ............................................ 16
2.15 Hazards Due to Non-compliance with the
Maintenance and Calibration Intervals .................................... 16
2.16 Safety and Protective Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.16.1 Main Switch........................................................ 17
2.16.2 On/Off Switch for the Power Supply.............................. 17
2.16.3 Overheating Protection ............................................ 17
2.17 Personal Protective Equipment............................................. 18
2.18 Emergency Instructions .................................................... 19
2.19 Operator Responsibilities................................................... 19
2.20 Personnel Requirements.................................................... 20
2.20.1 Personnel Qualification Requirements............................. 20
2.20.2 Personnel Responsibilities.......................................... 21
2.20.3 Responsibilities..................................................... 21
2.20.4 Unauthorized Personnel ........................................... 21
2.20.5 Instruction ......................................................... 22
3. Device Description.............................................................. 23
3.1 Operation................................................................... 23
3.1.1 Variants of the Control Unit ....................................... 24
3.1.2 Temperature Control............................................... 24
3.2 Setup ....................................................................... 25
3.2.1 Front View ......................................................... 25
3.2.2 Rocker Platform - Top View........................................ 26
3.2.3 Rear View .......................................................... 26
3.2.4 Connections (Left and Right Sides of the Device) ................. 27
3.3 Device Components ........................................................ 28
3.3.1 Rocker Platform / Guide Rails ..................................... 28
3.3.2 The Hood of the Device ............................................ 28
3.3.3 Aeration............................................................ 28
3.3.4 Temperature Regulator ............................................ 29
3.3.5 Filter Heater........................................................ 30
3.3.6 Load Cell (Optional) ................................................ 30
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4 Operating Instructions Biostat®RM 200 Rocker
Contents
3.4 Sensors ..................................................................... 31
3.4.1 Surface Temperature Sensor ....................................... 31
3.4.2 DO and pH Sensors................................................. 31
3.5 Equipment Supplied........................................................ 31
3.6 Culture Bags Flexsafe®RM ................................................. 32
4. Transport........................................................................ 33
4.1 Ambient Conditions During Transport ..................................... 33
4.2 Shipping Instructions....................................................... 33
4.3 Inspection Upon Acceptance by the Recipient............................. 34
4.3.1 Reporting and Documenting Transport Damage .................. 34
4.3.2 Checking Completeness of the Delivery ........................... 34
4.3.3 Packaging .......................................................... 34
5. Setup ............................................................................ 35
5.1 Delivery Check.............................................................. 35
5.2 Acclimatizing the Device ................................................... 36
5.3 Ambient Conditions ........................................................ 36
5.4 Work Area Preparation..................................................... 36
5.4.1 Work Surfaces and Loads .......................................... 36
5.4.2 Laboratory Energy Sources ........................................ 37
5.5 Setting Up the Device ...................................................... 41
5.5.1 Remove the Transport Lock (Devices with Load Cells) ............. 41
5.6 Setting up the Control Unit ................................................ 41
6. Getting Started ................................................................. 42
6.1 Installation Kit.............................................................. 42
6.2 Connecting the Hood of the Device........................................ 42
6.3 Connecting the Load Cells.................................................. 42
6.4 Connecting the Temperature Control ...................................... 43
6.4.1 Connecting the Heating Plates .................................... 43
6.4.2 Connecting the Heating / Cooling Plates ......................... 43
6.4.3 Connecting the Surface Temperature Sensors..................... 45
6.4.4 Connecting the Compressed Air and CO2Feeds ................... 46
6.5 Connecting the Device to the Power Supply............................... 46
6.6 Connecting the Device to the Control Unit ................................ 47
6.7 Turning the Device On and Off............................................. 47
7. Preparing and Running the Process........................................... 48
7.1 Overview.................................................................... 48
7.2 General Notes on Running the Process .................................... 48
7.3 Installing Culture Bags ..................................................... 49
7.3.1 Placing the Culture Bag in the Rocker Platform................... 49
7.3.2 Assembling the Filter Heaters with the Culture Bag............... 50
7.3.3 Connecting the Aeration System to the Culture Bag ............. 51
7.3.4 Inflating the Culture Bag .......................................... 51
7.3.5 Connecting the pH and DO Sensors ............................... 52
7.3.6 Filling the Culture Bag with Culture Medium ..................... 53
7.4 Setting the Cultivation Parameters and Starting Cultivation.............. 54
7.4.1 Cultivation Parameters (Overview) ................................ 54
7.4.2 Turning the Device On ............................................. 54
7.4.3 Selecting the Unit (Twin Variant of Control Unit) ................. 55
7.4.4 Setting the Cultivation Parameters................................ 56
7.5 Process Monitoring......................................................... 57
7.6 Sampling and Inoculation.................................................. 58
7.6.1 Preparing for Sampling or Inoculation ............................ 58
7.6.2 Inoculation......................................................... 59
7.6.3 Sampling ........................................................... 59
7.7 Completing the Process, Cell Harvesting and Shutting Down the Device . 60
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Operating Instructions Biostat®RM 200 Rocker 5
Contents
8. Malfunctions.................................................................... 61
8.1 Safety Instructions ......................................................... 61
8.2 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
8.3 Breakdown of Communication Between Device and Control Unit ........ 62
8.4 Hardware-related Faults.................................................... 63
8.4.1 Troubleshooting Table “Contamination”........................... 63
8.4.2 Troubleshooting Table “Tempering”................................ 64
8.4.3 Troubleshooting Table “Tempering Module”....................... 65
8.5 Alarm Messages ............................................................ 66
9. Cleaning and Maintenance .................................................... 67
9.1 Preliminary Steps........................................................... 68
9.2 Cleaning .................................................................... 68
9.3 Maintenance ............................................................... 69
9.3.1 Device Servicing by Operating Personnel.......................... 69
9.3.2 Device Servicing by the Operator.................................. 70
9.3.3 Device Servicing by Authorized Personnel......................... 71
10. Storage.......................................................................... 72
11. Disposal.......................................................................... 73
11.1 General Notes .............................................................. 73
11.2 Hazardous Materials........................................................ 73
11.3 Decommissioning the Unit ................................................. 74
11.4 Disposing of the Device .................................................... 75
12. Technical Specifications........................................................ 76
12.1 Dimensions and Weights ................................................... 76
12.2 Electrical Characteristics ................................................... 76
12.2.1 Biostat®RM 200 Rocker / 124.000................................. 76
12.2.2 Biostat®RM 200 Rocker / 124.001................................. 76
12.2.3 Aeration............................................................ 77
12.3 Measurement and Control Ranges ......................................... 77
12.3.1 Rocker Function.................................................... 77
12.3.2 Aeration............................................................ 77
12.3.3 Temperature Control............................................... 77
12.3.4 Measurement of pH- and DO Values .............................. 78
12.4 Device Components ........................................................ 78
12.4.1 Filter Heater........................................................ 78
12.4.2 Heating Plate ...................................................... 78
12.4.3 Heating / Cooling Plate ............................................ 78
12.4.4 Load Cell ........................................................... 78
12.4.5 Surface Temperature Sensor....................................... 79
12.5 Acoustic Emission .......................................................... 79
12.6 Ambient Conditions ........................................................ 79
12.7 Minimum Distances ........................................................ 79
12.8 Consumables ............................................................... 79
12.9 Accessories ................................................................. 79
13. Conformity & Licenses ......................................................... 80
14. Appendix ........................................................................ 82
14.1 Service...................................................................... 82
14.2 Decontamination Declaration.............................................. 82
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6 Operating Instructions Biostat®RM 200 Rocker
About This Document
1. About This Document
All information and instructions in this operating manual have been compiled in
consideration of applicable standards and guidelines, the state of technology and
our many years of experience and knowledge.
These operating instructions provide you with all the information necessary to install
and operate the Biostat
®RM 200 Rocker (referred to as “device” or simply “rocker” in
the following).
The operating instructions inform you about how to:
− operate the unit safely,
− service the unit according to guidelines,
− clean the unit according to guidelines,
− take appropriate measures should a fault occur.
The operating instructions must be read, understood and used by all personnel
entrusted with the operation, maintenance, cleaning and troubleshooting of the
device. This applies particularly to the safety instructions listed.
t Please read these operating instructions carefully and completely before using
this device.
t These instructions are part of the product. Keep them in a safe and easily
accessible place near the device’s site of installation.
t If the instructions should be lost or misplaced, please contact Sartorius for a
replacement or download the latest version from our website: www.sartorius.com
The device may only be used with the equipment and under the operating
conditions described in [Chapter “3. Device Description”, page 23and in
Chapter “12. Technical Specifications”, page 76].
The user must be qualified to handle the device, media and cultures and be aware
of the hazards potentially associated with the process.
The process may make it necessary to equip the device or the work area with
additional safety equipment or to take other measures for the protection of
personnel and the work environment.
The documentation does not include more detail about such conditions or legal or
otherwise obligatory guidelines.
Safety and danger instructions in the documentation only apply to this unit and
supplement the guidelines of the operator in the work area for the process in
question.
In addition to the operating manual, all generally valid, legal and otherwise binding
regulations for accident protection and environmental protection of the country of
use must be observed.
− Any guarantees and warranties shall apply to manufacturing-related defects and
malfunctions.
− The unit is designed for usual laboratory conditions and techniques.
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Operating Instructions Biostat®RM 200 Rocker 7
About This Document
1.1 Validity
The operating instructions apply to the Biostat® RM 200 Rocker:
− Version
− 124.000 (230 V)
− 124.001 (120 V)
− in combination with the control unit Biostat®B
− in combination with the culture bags
− Flexsafe®RM 100L basic / optical / perfusion ATF
− ®RM 100L basic / optical / perfusion ATF
1.2 Accompanying Documents
This operating manual contains the instructions for operating the device with the
standard equipment intended for this purpose.
In addition to this operating manual, you can find all necessary technical
documentation on the device, e.g. P&I diagrams, a spare parts list, installation plans,
technical drawings etc., in the folder “Technical Documentation”.
If customer-specific modifications were implemented, the appropriate documents
can either be integrated into the “Technical Documentation” folder or they can be
delivered together with the device as separate documents.
If the documents supplied do not match the equipment delivered to you or if any
documents are missing, please contact the person responsible for your area at
Sartorius Stedim Biotech GmbH.
In addition to the operating manual, please refer to the following:
− the notes in the documentation of the culture bags.
− the notes in the operating instructions of the control unit “Biostat®B”.
− the notes in the documentation of other components.
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8 Operating Instructions Biostat®RM 200 Rocker
About This Document
1.3 Symbols Used
As a means of instruction and direct warning against hazards, all text statements to
be particularly noted in these operating instructions will be marked as follows:
This symbol denotes a possible danger with medium risk that death or severe injury
may result if it is not avoided.
This symbol denotes a possible danger with risk that moderate or minor injury may
result if it is not avoided.
This symbol denotes a danger with low risk that can result in property damage if the
risk is not avoided.
This symbol
− is an indication of a function or setting on the device.
− is an indication that caution should be exercised while working.
− identifies useful information.
The following presentations will also be used:
– Texts that follow this mark are lists.
tTexts that follow this mark describe activities that must be carried out in the
specified order.
yTexts that follow this mark describe the result of an action.
” “ Texts in quotes are references to other chapters or sections.
1.4 Abbreviations
PLC Programmable logic control
vvm Volume of the flow of gas per volume of liquid per minute
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Operating Instructions Biostat®RM 200 Rocker 9
Safety Precautions
2. Safety Precautions
Failure to observe the following safety precautions can have severe consequences:
− danger to personnel due to electrical, mechanical, or chemical influences
− failure of important functions of the device
Read the safety precautions and dangers listed in this section thoroughly before
starting the device.
In addition to the instructions in this operating manual, also observe all generally
valid safety and accident protection guidelines.
In addition to the instructions in this operating manual, the operator / user must
observe all existing national, workplace, operating and safety guidelines.
Existing internal plant guidelines must also be observed.
2.1 General Safety Precautions
− The device may only be set up, started, or serviced after gaining familiarity with
this operating manual.
− Use the device only for its intended purpose (see Chapter “2.4 Intended Use and
Foreseeable Misuse”, page 11).
− The device is not ATEX (ATmosphère EXplosive)-certified. The device may not be
operated in potentially explosive atmospheres.
− During operation of the unit, do not permit any work method that hinders the
safety of the unit.
− Always keep the working area of the unit clean and orderly, in order to avoid
danger from dirt or scattered parts.
− Always squat to work on low-lying components; do not bend over. Carry out
work on high components in an upright, straight body position.
− Do not exceed the technical performance data (see data sheet for the unit).
− Keep all safety precautions and hazard notices on the device in a legible
condition, and replace them as needed.
− Operation as well as work on the device may only be carried out by authorized
specialists.
− Do not start the unit if other people are in the danger zone.
− In case of malfunction, immediately stop the device. Have the fault corrected by
appropriately trained personnel or by your Sartorius Service Center.
2.2 Informal Safety Measures
− Always keep the operating manual in the location where the device is in use.
− In addition to the operating manual, follow all general and local regulations for
accident prevention and environmental protection.
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10 Operating Instructions Biostat®RM 200 Rocker
Safety Precautions
2.3 Symbols Used on the Device
The following symbols are affixed to the device:
Electrical hazard from voltage or current!
Work on the electrical equipment of the device may only be carried out by Sartorius
Service or authorized technicians.
Electrical hazard from voltage or current!
Before opening the casing disconnect the unit from power supply.
− The device may be opened only by authorized personnel of Sartorius Stedim
Biotech.
− Disconnect the device from the power supply before carrying out any work on
the device.
Danger of burns!
The equipment may become hot when in operation.
− Avoid accidental, unintentional contact.
− Use protective gloves when operating the equipment.
− Let the heating elements and equipment cool down before carrying out assembly
work.
− Please ensure that the surface temperature sensor is correctly installed.
Danger of crushing!
There is a danger of crushing with the rocker device.
− Proceed carefully when closing the hood of the device. Use the handle on the
hood of the device.
− Keep the hood of the device closed during operation.
Transport locking device
The device is provided with a transport locking device. The transport locking device
must be removed before using the device.
Some of the markings and labels on the equipment were attached by the equipment
manufacturers. These may not always match the safety signs conventionally used by
Sartorius Stedim Biotech.
t Keep all safety precautions and hazard notices on the device in a legible
condition, and replace them as needed.
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Operating Instructions Biostat®RM 200 Rocker 11
Safety Precautions
2.4 Intended Use and Foreseeable Misuse
The operational safety of the device is only ensured when it is used for its intended
purpose and operated by authorized and trained personnel.
The device is used for cultivation of cells and microorganisms in single-use systems.
The device may only be used indoors. The device may only be used in combination
with suitable single-use culture bags (Flexsafe®RM) and the control unit Biostat®B.
The intended use also includes:
− Observation of all instructions from the operating manual,
− Training of the operating personnel
− Compliance with maintenance schedules
− The use of oils and greases which are suitable for use with oxygen,
− The use of operating and auxiliary materials according to applicable safety
guidelines
− Observation of operating and repair conditions.
All other applications are not considered the intended use. They may include risks
that cannot be estimated and they are the sole responsibility of the operator.
Claims of any kind resulting from damages due to use other than the intended use
are excluded. Sartorius Stedim Biotech bears no liability for damages caused by use
other than the intended use.
Training of the operating personnel
Operating personnel must be trained by the plant operator in the operation of the
device. The device should be operated only by personnel who have been trained.
Training in the operation of the device includes:
− the safe operation of the device
− awareness of possible hazards that could arise in the operation of the device
− awareness of how these hazards can be avoided
Please follow the safety instructions in this operating manual. The safety instructions
contain information on the type of hazards and how these can be avoided
Danger due to use other than the intended use!
Any use beyond and / or other than the intended use of the device can lead to
dangerous situations. For example, the following uses are considered not to be the
intended use and are strictly forbidden:
− Processes using biological materials in Safety Classes 3 and 4
− Cultivation in non-aqueous solutions
− Installation of forbidden objects in the rocker platform.
− Operation of the device outside the performance limits
− Operation outdoors
− Carrying out of unauthorized changes or other technical modifications to the
device
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12 Operating Instructions Biostat®RM 200 Rocker
Safety Precautions
2.5 Residual Risks from Use of the Unit
This device is a state-of-the-art machine and is developed and built in accordance
with recognized safety standards. Nevertheless, the use of the device may pose
bodily or physical harm to users or third-parties as well as potentially cause
impairments to the testing system itself or other material damage.
Anyone assigned to the installation, commissioning, operation, maintenance or repair
of the device must have read and understood the operating manual.
The device may only be used:
− for its intended purpose,
− with its safety systems in perfect working order,
− by qualified and authorized personnel.
Furthermore, the following rules must be followed:
− All screw connections must be checked at regular intervals and tightened if
necessary.
− All accessories and consumables must be in perfect working order.
− No objects may be attached to or placed on the rocker platform and the hood.
2.6 Danger Due to Electrical Power
Danger to life caused by electrical voltage!
Electrical switching elements are installed in the device. Contact with parts under
voltage represents a direct danger of death. Damage to the insulation or individual
components can be fatally dangerous.
− In case of defects, turn the power supply off immediately and have the defects
corrected by Sartorius Service or authorized technicians.
− Make sure that the power connection is equipped with a ground lead.
− Work on the electrical equipment of the device may only be carried out by
Sartorius Service or authorized technicians.
− Never open the device. The device may only be opened by Sartorius Service or
authorized specialists.
− In case of any repairs to the electrical equipment, the device must be switched
off and checked for disconnection from the power supply.
− Check the electrical equipment of the unit regularly for defects such as loose
connections or damage to the insulation.
− Check the protective earth conductor system upon delivery and after each
maintenance interval.
− During maintenance and cleaning, turn the power supply off and secure it
against reactivation.
− Keep moisture away from parts which conduct electricity, as it can lead to short
circuits.
− Have the following tested by a qualified electrician according to the national
regulations: electrical components, connection cables with plugs and extension
and device connector cables with their sockets, if used.
− Please observe the protection class of the device (see Chapter “12. Technical
Specifications”, page 76).
Life-threatening hazard due to unsuitable power supply cable!
You could sustain life-threatening injuries as a result of using unsuitable power
supply cables.
− Please use only the original power cable supplied to connect the device to the
power supply socket.
− Please contact the Sartorius Service Center if the power cable needs to be
replaced.
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Operating Instructions Biostat®RM 200 Rocker 13
Safety Precautions
2.7 Danger Due to Components Under Pressure
Danger of injury from leaked substances!
If individual components are damaged, gaseous and liquid materials may escape
under high pressure and e.g. cause injury to eyes. Therefore:
− Turn the unit off and secure it against reactivation when working on pressurized
components.
− Release the pressure from system sections and pressure lines to be opened before
starting any repair work.
− Regularly check all lines, hoses and connections under pressure for leaks and
externally detectable damage.
Risk of death from energy that is unexpectedly released, e. g. electric shocks!
Energy supply lines may be incorrectly dimensioned and not protected against
impermissible fluctuations and faults. Energy connections must be fitted with fully
functional safety equipment:
− Ground fault circuit interrupters (residual current protection) for mains
connections
− Fittings for shutting off water, compressed air and gas supplies.
Observe the energy specifications on the type plates [Section Chapter “5.4.2.1
Manufacturer’s ID Label”, page 38].
Danger due to bursting of the culture bags!
In case of application of non-permissible levels of pressure to the culture bags, there
is danger of the culture bags bursting. This could be caused, for example, when using
aeration devices from third-party manufacturers or in case of penetration of
pressurized media.
− Always use only the integrated aeration module of the control unit, which has a
pressure over-load protection device.
− Always use a filter heater in the cultivation process.
− Comply with the necessary maintenance and calibration intervals.
− Depending upon the nature of the process and its duration, use the second
exhaust air path additionally (only if a filter heater is installed)
Danger due to bursting of the aeration unit!
In case of non-permissible pressurization of the internal aeration module, there is
the danger of the pressure hoses bursting within the control unit.
− Observe the instructions for the layout of the workplace (see Chapter “5.4 Work
Area Preparation”, page 36).
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14 Operating Instructions Biostat®RM 200 Rocker
Safety Precautions
2.8 Danger Due to Gases
Danger Due to Oxygen
Danger of explosion and fire!
− Keep pure oxygen away from flammable materials.
− Avoid sparks in the vicinity of pure oxygen.
− Keep pure oxygen away from ignition sources.
− Keep the whole aeration segment free from oil and grease.
− Make sure that the cooling water flows back without pressure.
Reactions with other substances!
− Ensure that pure oxygen does not come into contact with oil or grease.
− Use only materials and substances suitable for use with pure oxygen.
Danger Due to Nitrogen
Danger of suffocation due to escaping nitrogen!
Escaping gas at high concentrations may force the air out of closed rooms and can
cause loss of consciousness, leading to suffocation.
− Check the gas lines and culture bags for leaks.
− Ensure good ventilation of the installation site.
− Keep a breathing device independent of ambient air ready for emergencies.
− If personnel appear affected by symptoms of suffocation, immediately provide
them with a breathing device independent of ambient air, bring them into fresh
air, make them comfortable, and keep them warm. Call a doctor.
− If a person stops breathing, initiate first aid measures with artificial respiration.
− Monitor the limit values at the system and in the building (sensors recom-
mended).
− Check process gas lines and filters regularly for leaks.
Danger Due to Carbon Dioxide
Danger of suffocation by escaping carbon dioxide.
− Check the gas lines and connectors of the culture bags for leakage upon delivery
and in the course of every service interval.
− Ensure good ventilation of the installation site.
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Operating Instructions Biostat®RM 200 Rocker 15
Safety Precautions
2.9 Danger Due to Escaping Materials
Danger of scalding due to defective components!
− Inspect the unit before starting the process.
− Check the connections of the culture bags and the connections to the supply
unit.
− Regularly check all hoses for leaky places and replace any leaking hoses.
Danger of injury from escaping feed and culture media!
− Use the specified hoses only.
− Use hose fastenings on connecting pieces.
− Empty the feed hoses before loosening the hose connection.
− Wear personnel protective equipment.
− Wear safety glasses.
Danger of contamination from escaping feed and culture media!
Uncontrolled escape of culture media indicates a leakage.
This can lead to contamination of the culture medium.
− Empty the feed hoses before loosening the hose connection.
− Wear personnel protective equipment.
− Wear safety glasses.
2.10 Danger Due to Hot Surfaces
Danger of burns upon contact with hot surfaces!
− Avoid contact with hot surfaces such as the tempered heating plates / heating-
cooling plates and the motor housing.
− Use protective gloves when operating the equipment.
− Block the danger zone off.
− Wear suitable protective gloves when working with hot culture media.
2.11 Danger Due to Moveable Components
Danger of crushing and being hit by the rocker!
− Do not remove the safety mechanisms.
− Allow only qualified and authorized personnel to work on the device.
− Disconnect the device from power when performing maintenance and cleaning
tasks.
− Do not tamper with the device when it is in operation. There is a risk of crushing
between the rocker platform and the lower frame.
− Keep the hood of the device closed during operation.
− Operate the connections only when the rocking motion has stopped.
− Keep a safe distance from the device after it has been switched on. The rocker
platform automatically performs an initial cycle 10 s after it has been switched
on.
− Wear protective work clothing.
Danger of injury due to body parts or clothing getting caught in the device
while the rocker motion is being used.
− Allow only qualified and authorized personnel to work on the device.
− Switch off the rocker motion with the main switch in case of imminent injury.
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16 Operating Instructions Biostat®RM 200 Rocker
Safety Precautions
2.12 Danger Due to Use of Incorrect Consumables
Danger of injury due to incorrect consumables!
− Incorrect or erroneous consumables can lead to damage, malfunction or the total
failure of the unit, as well as affecting safety.
− Use only original consumables.
− Purchase consumables through Sartorius Stedim Biotech. You can find
all necessary specifications for consumable materials in the folder “Technical
Documentation”.
2.13 Hazards Due to Improper Safeguarding or Movement of the
Device
Danger of injury due to uncontrolled rolling away of the device!
− The machine should be placed on level surfaces. If necessary, use a spirit level to
check that it is level.
− Lock all four castors of the device by activating the brakes provided for this
purpose.
Danger of crushing when activating the brakes and when moving the device!
− Operate the brakes of the castors only with the foot.
− Wear safety shoes.
2.14 Hazards Due to System Failures
Danger of injury due to the device starting up unintentionally or unexpectedly!
Please note that, depending upon the settings of the control unit; the device begins
operating again automatically after a power outage, using the set parameters.
− Follow the instructions to set the system behavior
(see operating instructions for the control unit, Chapter “Software”).
2.15 Hazards Due to Non-compliance with the Maintenance and
Calibration Intervals
Danger of damage to the system due to failure of individual device
components!
Always comply with the necessary maintenance and calibration intervals in order
to prevent failures of the device components. These are, for example:
− Drive system / Motor
− Fan cooling of the control unit
− Aeration
Maintenance of the machine must be performed by authorized personnel.
Danger of measurement errors during the process!
Maintain the required calibration intervals in order to prevent measurement errors.
Calibration of the device must be carried out by Sartorius Service.
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Operating Instructions Biostat®RM 200 Rocker 17
Safety Precautions
2.16 Safety and Protective Systems
2.16.1 Main Switch
The main switch is located on the left side of the device. The activation of the main
switch switches the machine off.
2.16.2 On/Off Switch for the Power Supply
The power connection (2) is located on the rear side of the device designed to act as
the physical on/off switch for the power supply.
t Unplug the power plug from the socket to disconnect the device from the power
supply.
2.16.3 Overheating Protection
Danger of burns from overheated components!
If individual components are damaged, gaseous and liquid materials may escape
under high pressure and e.g. cause injury to eyes.
− Do not start the unit without overheating protection.
− Observe the information in the folder “Technical Documentation”.
The overheating protection within the unit limits the maximum permissible
temperature for the temperature control system. The following temperature control
systems can be used:
− Electrical heating plate
− Heating / Cooling plates (water cooling)
The functionality of the overheating protection must be regularly checked in order to
ensure safe operation of the device. Observe the notes in Chapter “9.3 Maintenance”,
page 69.
1
2
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18 Operating Instructions Biostat®RM 200 Rocker
Safety Precautions
2.17 Personal Protective Equipment
When operating the device, personal protective equipment must be worn in order to
minimize dangers to health.
− During work, always wear the protective equipment needed for that work.
− Follow any instructions posted in the work area pertaining to personal protective
equipment.
Wear the following personal protective gear during all work:
Protective work clothing
Protective work clothing is tight-fitting work clothing with low tear resistance, tight
sleeves and without any projecting parts. It is primarily intended to protect you from
being caught by moving machine parts.
Do not wear rings, chains or other jewelry.
Head covering
To protect your hair from being caught and pulled into moving parts of the unit,
wear a head covering.
Safety gloves
Wear safety gloves to protect your hands from process materials.
Safety glasses
Wear safety glasses to protect yourself from media escaping under high pressure.
Safety boots
Wear non-slipping safety boots to protect against slipping on smooth floors and to
protect the feet from being crushed.
*** TeDIS Valid on Date Printed Printed on: 20-09-2023 11:08:57 ***

Operating Instructions Biostat®RM 200 Rocker 19
Safety Precautions
2.18 Emergency Instructions
Preventive Measures
− Always be prepared for accidents or fire.
− Keep first aid equipment (bandages, blankets, etc.) and fire extinguishers handy.
− Familiarize personnel with accident reporting, first aid, fire extinguishing and
rescue facilities.
− Keep entry and rescue routes free for rescue vehicles and rescue personnel.
Measures to be Taken After Accidents
− Turn the device off at the main switch.
− Keep personnel out of the danger zone.
− In case of stopped heart or breathing, initiate first aid measures immediately.
− Report personal injuries to the first aid officer and an emergency doctor and / or
the rescue service.
− Keep entry and rescue routes free for rescue vehicles and rescue personnel.
− Extinguish fires in the electrical equipment with a CO2extinguisher.
2.19 Operator Responsibilities
The device is used in the commercial sphere. The operator of the device is therefore
subject to the legal obligations for workplace safety.
In addition to the safety instructions in this operating manual, the safety, accident
prevention and environmental protection regulations valid for the location of use of
the device must also be observed.
This applies particularly:
− The operators must inform themselves of the applicable workplace safety
regulations and carry out a hazard evaluation to determine additional dangers
that may result due to the special working conditions at the location of use of
the unit. These must be expressed in the form of operational instructions for the
operation of the unit (hazard prevention plan).
− During the entire period of use of the unit, the operator must check whether the
operating instructions correspond to the current state of regulations and adapt
them as needed.
− The operator must clearly regulate and determine responsibilities for operation,
maintenance and cleaning.
− The operator may only allow trained and authorized individuals to work with
the device. Trainees such as apprentices or auxiliary staff members are only
allowed to work with the unit under supervision of qualified technicians (see
Chapter “2.20 Personnel Requirements”, page 20).
− The operator must ensure that all employees involved with the unit are suitable
in terms of physical capacity, person and character to operate the unit
responsibly.
− The operator must also ensure that all employees are familiar with the basic
regulations concerning workplace safety and accident prevention, trained in
handling the unit, and have read and understood the operating manual.
− Furthermore, the operator must evaluate the safety-consciousness of how the
personnel work at regular intervals and provide further safety training and notify
personnel of hazards whenever appropriate.
− The operator must avoid stress situations during operation of the unit by making
both technological and organizational preparations for the work.
− The operator must provide adequate workplace lighting in the place of operation
of the unit in accordance with locally applicable workplace guidelines.
− The operator must provide personnel with personal protective equipment.
− The operator must ensure that no one works on the device whose reaction time is
impaired, for example by drugs, alcohol, medications or the like.
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20 Operating Instructions Biostat®RM 200 Rocker
Safety Precautions
Furthermore, the operator is responsible for ensuring that the unit is always in
technically perfect condition.
The following therefore applies:
− The operator must ensure that the maintenance intervals described in this
operating manual are observed.
− The operator must regularly have the safety systems tested for functionality.
2.20 Personnel Requirements
Danger of injury if personnel qualifications are insufficient!
Improper use can lead to significant personal injury and/or property damage.
Have all activities performed only by qualified personnel.
Only those individuals who can be expected to carry out their work reliably are
permitted as personnel. No-one may work on the unit whose reaction time is
impaired, for example by drugs, alcohol, medications, or the like.
2.20.1 Personnel Qualification Requirements
In the operating manual, the following qualifications are cited for different areas of
activity:
Trainee
A trainee such as an apprentice or an auxiliary staff member does not know all the
dangers that can occur during operation of the device. They may only perform work
on the device under the supervision of technicians.
Trained Person
A trained person has been informed in a training session by the operator about the
tasks assigned to them and the possible dangers of improper behavior.
Technician
Due to his or her technical education, knowledge and experience, as well as
knowledge of applicable regulations, a technician is capable of carrying out tasks
assigned to him or her and independently detecting and avoiding possible dangers.
*** TeDIS Valid on Date Printed Printed on: 20-09-2023 11:08:57 ***