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DO NOT PERMIT UNTRAINED PERSONS TO INSTALL, USE OR MAINTAIN THIS CRYOSTORAGE SYSTEM. IF YOU DO NOT FULLY UNDERSTAND THESE INSTRUCTIONS, CONTACT WORTHINGTON INDUSTRIES OR YOUR DISTRIBUTOR FOR FURTHER INFORMATION. NOTE: Devices may differ slightly from the image English European Edition —...
IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 2 of 87 CONTENTS 1 USER DIRECTIONS ............................5 2 SAFETY PRECAUTIONS ..........................6 3 SYMBOLS ................................9 4 DEVICE DESCRIPTION ..........................11 4.1 DEVICE INTENDED USE ........................11 4.2 DEVICE INTENDED LOCATION AND USER ..................
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 3 of 87 8.6 NORMAL EVAPORATION RATE (NER) TEST .................. 59 8.7 TRANSPORT OF DEVICE ........................60 8.8 RETURN OF DEVICE ..........................60 8.9 DISPOSAL OF DEVICE .......................... 60 9 WARRANTY TERMS ............................
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TABLES AND FIGURES Table 1 K SERIES Cryostorage System specifications ..............14 Table 2 K SERIES Cryostorage System Inventory Control System specifications ......15 Table 3 K SERIES Cryostorage System admissible ambient conditions ........... 21 Table 4 Procedure for initial start up of the controller ................ 28 Table 5 Timers/Clock Menu's options of the controller ..............
K SERIES Cryostorage System, or poor performance of this medical device! THIS INSTRUCTION MANUAL IS FOR PROFESSIONAL STAFF ONLY! Do not permit any other untrained person to install, use or maintain this K SERIES Cryostorage System. THIS INSTRUCTION MANUAL IS AN ESSENTIAL ACCESSORY TO YOUR K SERIES CRYOSTORAGE SYSTEM.
Check your K SERIES Cryostorage System for faults and signs of damage before use. If the K SERIES Cryostorage System is suspected of malfunction, take it out of operation immediately and affix appropriate warning labels to ensure that the K SERIES Cryostorage System is no longer in use until the necessary repairs have been carried out.
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K SERIES Cryostorage System Page 7 of 87 IMPORTANT The following safety precautions apply to the Worthington Industries K SERIES Cryostorage System (continued): Inlet pressure should not exceed 1.5 bar / 152 kPa: Higher pressures could result in damage to equipment and/or sufficient depletion of oxygen in the atmosphere to cause dizziness, unconsciousness, or even death.
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Approved by: CB K SERIES Cryostorage System Page 8 of 87 IMPORTANT The following safety precautions apply to the Worthington Industries K SERIES Cryostorage System (continued): Electrical shock can kill: Always disconnect the electrical power cord before you attempt any repair or maintenance on your K SERIES Cryostorage System.
Approved by: CB K SERIES Cryostorage System Page 9 of 87 3 SYMBOLS IMPORTANT The following symbols apply to the Worthington Industries K SERIES Cryostorage System: CE mark with Notified Body number Declares compliance with EU Directive 93/42/EEC (Medical Device Directive)
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Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 10 of 87 IMPORTANT The following symbols apply to the Worthington Industries K SERIES Cryostorage System (continued): AC voltage DC voltage Protective earth conductor Ingress protection rating Transport and move medical device in upright position...
4.2 DEVICE INTENDED LOCATION AND USER The Worthington Industries K SERIES Cryostorage System is a medical device intended to be used in locations in the area of professional health care facilities, such as hospitals, clinics, medical practices, medical laboratories.
4.3 DEVICE OVERVIEW AND KEY FEATURES The Worthington Industries K SERIES Cryostorage System is a state-of-the-art cryogenic storage system with the following key features: ...
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Approved by: CB K SERIES Cryostorage System Page 13 of 87 The Worthington Industries K SERIES Cryostorage System is available with the following types of level controller display: M505CE (standard version), designed for fitting to CryoCe10K and CryoCe24K M505CE-B (boxed version), designed for fitting to CryoCe38K...
Revision: 02 Approved by: CB K SERIES Cryostorage System Page 14 of 87 4.4 CRYOSTORAGE SPECIFICATIONS The Worthington Industries K SERIES Cryostorage System is designed for the following models: Table 1 K SERIES Cryostorage System specifications MODEL CryoCe10K CryoCe24K CryoCe38K...
4.5 INVENTORY CONTROL SYSTEM SPECIFICATIONS The Worthington Industries K SERIES Cryostorage System standard models will accommodate inventory control systems or provide unobstructed storage area for larger samples: Table 2 K SERIES Cryostorage System Inventory Control System specifications MODEL CryoCe10K CryoCe24K CryoCe38K...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 16 of 87 The following images show the different rack arrangements for the K SERIES Cryostorage System: Figure 3 Vial storage in boxes on racks...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 17 of 87 Figure 4 Rack arrangements for 50 ml cassettes (7-level configuration)
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 18 of 87 Figure 5 Rack arrangements for 250 ml cassettes (5-level configuration)
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 19 of 87 Figure 6 Rack arrangements for 500 ml cassettes (5-level configuration)
5.1 UNPACKING AND INSPECTION The Worthington Industries K SERIES Cryostorage System is delivered in new condition. For your own protection, take time to visually inspect each shipment for external damage.
K SERIES Cryostorage System Page 21 of 87 5.2 CONDITIONS OF OPERATION AND STORAGE The Worthington Industries K SERIES Cryostorage System is designed to operate under the following conditions: Table 3 K SERIES Cryostorage System admissible ambient conditions Temperature for operation: 0 °C to +40 °C...
Page 22 of 87 5.3 LIQUID NITROGEN SUPPLY CONNECTION IMPORTANT The following safety precautions apply to the Worthington Industries K SERIES Cryostorage System: The liquid nitrogen source must have a shut-off valve, and may be any portable liquid cylinder or a bulk supply.
K SERIES Cryostorage System. 5.5 FIRMWARE The Worthington Industries K SERIES Cryostorage System is equipped with the liquid nitrogen level controller system (M505CE or M505CE-B) preloaded with a firmware ready to run.
6 OPERATION OF DEVICE 6.1 SELECTING CRYOPROTECTANTS The Worthington Industries K SERIES Cryostorage System is designed to operate with liquid nitrogen at extremely low temperatures from -100 °C to -196 °C under normal atmospheric pressure. The cryoprotectant selected for long-term storage of cells can have...
The cooling effect required for the cryogenic storage of the samples is maintained by continuous evaporation of the liquid nitrogen. The necessary evaporation heat is removed from the environment by heat transfer. Over a certain evaporation period time the liquid nitrogen level in your K SERIES Cryostorage System drops permanently:...
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Do not make any physical intervention to the sensors: Sensor and thermocouple positioning to your K SERIES Cryostorage System shall be carried out only by trained professionals or persons or service centers instructed and authorized by Worthington Industries. The liquid phase storage is normally utilized when liquid nitrogen temperatures are required to maintain stored sample viability and the storage medium is adequate for storage in liquid nitrogen.
Operating the refrigerator with high liquid levels characteristic of liquid phase storage may result in turbulence during fill cycles. 6.4 ADDING AN INVENTORY CONTROL SYSTEM IMPORTANT The following safety precautions apply to the Worthington Industries K SERIES Cryostorage System: Protect your eyes and cover your skin when handling stored samples:...
IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 28 of 87 7 OPERATION OF LIQUID NITROGEN LEVEL CONTROL SYSTEM 7.1 CONTROLLER INITIAL START UP Check that the Sensor Assembly and Thermocouple is in the required position as per section 6.3.
IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 29 of 87 7.2 CONTROLLER SET UP There are no internal switches to set on the controller. All set-up options are accessed via the two main menus TIMERS/CLOCK and CONFIG/CALIBRATE.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 30 of 87 Table 6 Procedure for setting up the controller Steps of procedure Display and notes Press key to enter the menu The Firmware Version number and serial...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 31 of 87 Steps of procedure Display and notes steps Press key when finished If the temperature of the thermocouple rises above the set value the solenoid valve is opened for a short period of time.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 32 of 87 Steps of procedure Display and notes connected refrigerators simultaneously, resulting in LN2 supply alarms. This may be overcome by staggering the fill start times by setting a sim fill delay, which delays the start of filling following the receipt of a sim fill input signal.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 33 of 87 Steps of procedure Display and notes The lid timer setting is the maximum length of time that the lid can be left open before an alarm is activated.
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If liquid is not detected within a preset time an alarm is sounded and the vent solenoid valve is closed. This preset time is controlled by the gas bypass timer. NOTE For further details consult the separate manual (IM1017) or contact Worthington Industries or your distributor.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 35 of 87 Steps of procedure Display and notes This refrigerator number will be printed in the page headings of the data log when it is printed out.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 36 of 87 Steps of procedure Display and notes NOTE The day of week setting is required for some of the timed fill options. Use the + and – keys to set the correct...
IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 37 of 87 7.3 CONTROLLER CONFIGURATION AND CALIBRATION Table 7 Configuration/Calibration Menu's options of the controller Menu CONFIG/CALIBRATE Language Thermocouple calibration Printer/PC connection and mode of operation.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 38 of 87 Steps of procedure Display and notes Enter the four digit supervisor's code using If the code is accepted (or not requested) the the numbered keys and the and keys...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 39 of 87 Steps of procedure Display and notes Press the key to continue calibration The following message (example) will be displayed for a few seconds:...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 40 of 87 Steps of procedure Display and notes followed by: The calibration is complete Press switch 1 to repeat the calibration; or Press the key to proceed to next step; or Press the ...
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RS232/RS485 level signals should be applied to the printer/PC connection ports as per the instructions in the separate manual IM1005. For further details contact Worthington Industries or your distributor. NOTE If a PC mode is selected, input/output routing defaults to the 25 pin I/O connector...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 42 of 87 Steps of procedure Display and notes on the M506CE. If a PC is plugged into the 7 pin plug on the controller panel it is automatically detected and the input/output data is re-routed Press the ...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 43 of 87 Steps of procedure Display and notes Press the key when finished Use the + and – keys to input the position The following message will be displayed:...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 44 of 87 Steps of procedure Display and notes the VALVE INTERVAL time setting is adjustable between 0 sec and 90 sec in 5- second steps Press ...
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This feature allows the Analogue Output PCB (M511CE) to be tested and enables connected equipment to be calibrated for Zero and Full Scale Outputs. NOTE For further details consult the separate manual (IM1019) or contact Worthington Industries or your distributor.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 46 of 87 Steps of procedure Display and notes Use the + and - keys to select the required The following message (example) will be Voltage/Current option (in % of full scale...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 47 of 87 Steps of procedure Display and notes Use the + and - keys to select the required If the SETTINGS AND ACCESS or the...
Set Baud rate for serial communications 7.5 CONTROLLER IN NORMAL OPERATION During normal operation of the K SERIES Cryostorage System the controller display shows the actual temperature of the thermocouple and the liquid level relative to the sensors. Filling takes place automatically to compensate for evaporative losses.
In particular the settings for Temperature Alarms and the maximum Fill time should be carefully considered. If the K SERIES Crostorage System is installed in an unattended location it is important that use is made of the remote alarm feature: This will give a global Alarm signal to a remote location to indicate that prompt attention is required.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 50 of 87 Alarm signal Generation Delay (Local Alarm signals) Local alarm signals are generated within 5 (five) seconds of the alarm condition occurring. The exception is the Extra High alarm. This has a delay which may be programmed from 0 to 120 seconds.
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All alarms are logged with time and date and a unique alarm code. A list of all alarm codes is given in Appendix H. NOTE For further details consult the separate manual (IM1026) or contact Worthington Industries or your distributor.
IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 52 of 87 7.7 CONTROLLER RESET The RESTARTING function can be used to force the controller to go through its start-up sequence. This can be used for resetting the controller and clearing the data log.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 53 of 87 Steps of procedure Display and notes Release the key After a few seconds the Temperatur/Level display should reappear NOTE If the controller is restarted with a PC cable plugged in it will start the Program Loader.
8 CARE AND MAINTENANCE OF DEVICE 8.1 GENERAL CONSIDERATIONS The Worthington Industries K SERIES Cryostorage System should be subject to a maintenance schedule to ensure its functionality and safety of the professional user, operator or any other person. It is the sole responsibility of the operating company to ensure that the...
This flow of purge gas will also speed the warming of the refrigerator to ambient temperature. NOTE For further detailed instructions see the subsequent sections. Worthington Industries strongly recommends to inspect and maintain your K SERIES Cryostorage System as follows: Table 11 Recommended inspection and maintenance schedule...
Replace the solenoid valve and other replacement parts as necessary Every three years In particular, local specific regulations may also apply to your K SERIES Cryostorage System to which extended inspections and tests require shorter periods of time. 8.3 CLEANING THE STRAINER The Worthington Industries K SERIES Cryostorage System is supplied with a strainer.
Excessive ice and frost buildup on the lid may also occur if the lid is misaligned or the insulative gasket material is damaged. Should this occur, please contact Worthington Industries or your distributor for assistance.
NOTE A suitable disinfactant for use herein is a non-glutaraldehyde cold sterilant manufactured by Alcide Corporation and known commercially as EXSPOR™ To clean and disinfect the K SERIES Cryostorage System follow the procedure: Close the liquid nitrogen supply valve to the refrigerator, ...
opening the lid to retrieve and/or adding samples. However, if the nitrogen consumption of the K SERIES Cryostorage System seems excessive, it may be appropriate to perform an estimated Normal Evaporation Rate (NER) test. Never use hollow rods or tubes as dip-sticks to perform the NER test.
Page 60 of 87 8.7 TRANSPORT OF DEVICE When moving your K SERIES Cryostorage System to or from its current location to a transport vehicle or new location for any reason, make sure to use a suitable forklift or pallet truck.
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Dispose of this device and discarded samples in line with local regulations. Your local authority will give all disposal information on the available local waste collection system or recycle facilities for electrical and electronic products or contact your local distributor for returning the Cryostorage System to Worthington Industries.
Measures for repair or servicing are undertaken by service personnel not authorized by Worthington Industries. If Worthington Industries is required to meet a warranty claim in accordance with these terms, the operating company shall bear the cost and risk of transporting the Cryostorage System from and to the location of use.
WEEE - Directive 2012/19/EU (Waste of Electrical and Electronic Equipment) RoHS 2 - Directive 2011/65/EU (Restriction of Hazardous Substances in Electrical and Electronic Equipment) NOTE A copy of the Declaration of Conformity is supplied with the K SERIES Cryostorage System and is also available upon request.
Microcontroller-Software Version V4.0 (from SN xxx onwards) NOTE for UK equipment only: Fused Mains Plugs are fitted with a 3 Amp fuse (1” x ¼) Disconnect the K SERIES Cryostorage System completely from the mains supply before replacing internal fuses.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 65 of 87 Electromagnetic Compatibility (EMC) Test Results Table 14 Radiated Immunity NOTE The temperature fluctuated by +/-1 °C and the current fluctuated by 0.1 mA.
IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 66 of 87 LIST OF APPENDIXES Appendix A1 INITIAL INSTALLATION LOG Appendix A2 INITIAL INSTRUCTION LOG Appendix B SERVICE HISTORY LOG Appendix C CRYO-PRODUCT RETURN INFORMATION FORM...
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K SERIES Cryostorage System Page 67 of 87 Appendix A1 - INITIAL INSTALLATION LOG IMPORTANT: Fill in this form after the initial installation of your Worthington Industries Cryostorage System has been done. Customer Information Operating Company Name: Service Company Name:...
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K SERIES Cryostorage System Page 68 of 87 Appendix A2 – INITIAL INSTRUCTION LOG IMPORTANT: Fill in this form after the initial instruction of your Worthington Industries Cryostorage System has been done. Customer Information Operating Company Name: Service Company Name:...
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K SERIES Cryostorage System Page 69 of 87 Appendix B - SERVICE HISTORY LOG IMPORTANT: Fill in this form each time a service of your Worthington Industries Cryostorage System has been done. Customer Information Operating Company Name: Service Company Name:...
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K SERIES Cryostorage System Page 70 of 87 Appendix C - CRYO-PRODUCT RETURN INFORMATION FORM IMPORTANT: Fill in this form before returning any part of your Worthington Industries Cryostorage System for repair, maintenance or replacement to Worthington Cylinders GmbH. Product Information...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 71 of 87 Appendix D - SENSOR AND THERMOCOUPLE POSITIONING Installation as well as all associated inspections should only be performed by qualified persons: These persons are qualified due to their special education and their practical experiences, in particular with regard to the relevant legislation and standards, to recognize the potential impact and hazards and to assess the necessary measures.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 72 of 87 Figure 8 Sensor positioning...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 73 of 87 Thermocouple Position The thermocouple(s) may be positioned anywhere in the refrigerator within the limits of their length. For models with two thermocouples, thermocouple TC1 is used for collection of temperature data and this should be given priority when selecting the desired monitoring point.
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Positioning of the second thermocouple is dependent on individual customer requirements. Contact Worthington Industries or your distributor for queries and advice. Other Thermocouple Types NOTE The M505CE Controller is optimised for use with type T thermocouples and other types should not be substituted.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 75 of 87 Figure 10 Suggested Form of Thermocouple for Vapour Phase Storage...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 76 of 87 Appendix E - REMOTE ALARM CONNECTIONS Installation as well as all associated inspections should only be performed by qualified persons: These persons are qualified due to their special education and their practical experiences, in particular with regard to the relevant legislation and standards, to recognize the potential impact and hazards and to assess the necessary measures.
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Simultaneous Filling Where two or more K SERIES Cryostorage Systems are connected to the same liquid nitrogen supply, economies in the use of nitrogen may be realised by synchronising the filling of the refrigerators.
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Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 78 of 87 The normally open contact of the auxiliary relay on each refrigerator is connected to the External Fill terminals of the next refrigerator in the system. The auxiliary relay contact of the last refrigerator in the system is connected to the External Fill terminals of the first to form a loop.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 79 of 87 Figure 11 Connection for Simultaneous Filling...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 80 of 87 Figure 12 Connection for Sequential Filling...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 81 of 87 Appendix G - CONNECTIONS FOR GAS VENTING Figure 13 Connection for Gas Venting...
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Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 82 of 87 Appendix H - ALARMS AND EVENTS This is a summary of the possible alarms and events that can be reported by the liquid nitrogen level control system.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 83 of 87 * LID OPENED - OPERATOR No. 2 * * LID OPENED - OPERATOR No. 3 * * LID OPENED - OPERATOR No. 4 * * LID OPENED - OPERATOR No.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 84 of 87 Appendix I - ALARMS OVERVIEW Alarm Name Alarm Description Behaviour in Attention Priority Range Default Notes Alarm Condition required High Thermocouple TC1 No change...
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 85 of 87 Alarm Name Alarm Description Behaviour in Attention Priority Range Default Notes Alarm Condition required Open (TC1) open circuit or reading (4 disconnected dashes on...
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Analogue Temperature O/P + Relay Outputs RS485 + RS232 Relay Outputs Ethernet Interface Analogue Temperature O/P RS485 standard NOTE For a complete list of available accessories and replacement parts for the K SERIES Cryostorage System contact Worthington Industries or your distributor.
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IM: CryoCeK Instruction Manual Revision: 02 Approved by: CB K SERIES Cryostorage System Page 87 of 87 Contact Details for the Responsible Organisation Technical Services / Customer Care: tel +43 7485 606 286 techservices@worthingtonindustries.com customerservice@worthingtonindustries.com lifesciences@wthg.at www.WorthingtonIndustries.com/LifeSciences...
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