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Instruction Manual

K SERIES Cryostorage System

IM: CryoCeK
Revision: 02
Approved by: CB
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4 DEVICE DESCRIPTION

4.1 DEVICE INTENDED USE

The Worthington Industries K SERIES Cryostorage System is a medical device intended to use



for cryogenic long-term storing of bags, vials and similar containers



with biological specimens of human origin, such as cord blood, stem cell or semen



that will eventually be investigated or introduced into the human body



at extremely low temperatures from -100 °C to -196 °C



supplied by liquid nitrogen as cyrogenic agent under normal atmospheric pressure.

Any other use is not declared by the manufacturer!

Worthington Industries and the distributors of the K SERIES Cryostorage System refuse
all liability when the device is not used in compliance with this instruction manual.

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.

The environment of professional health care does not include every arbitrary
location.

So this environment comprises not areas, where sensitive facilities or sources

of intense electromagnetic interference are located, such as radio frequency (RF)
shielded rooms for magnetic resonance imaging (MRI), areas in operation rooms with
active high frequency (HF) surgical equipment, electrophysical laboratories or areas
where short-wave therapy equipment is used.

For further details on the admissible ambient conditions for operating the K SERIES
Cryostorage System, see section 5.2.

The Worthington Industries K SERIES Cryostorage System is a medical device
intended to be used by trained professional users

, such as clinicians, medical and

laboratory technicians, medical and laboratory assistants and other health care
professionals, experienced with cyrogenic agents and cryogenic equipment.

Any other untrained person is not permitted to use the K SERIES
Cryostorage System in any way!

Worthington Industries and the distributors of the K SERIES Cryostorage System refuse
all liability when the user, operator or other person is not sufficiently instructed to use
this K SERIES Cryostorage System, with reference to this instruction manual including

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Summary of Contents for CryoCe10K

Page 1: ...TAND THE FOLLOWING WARNINGS AND SAFETY PRECAUTIONS BEFORE ATTEMPTING TO INSTALL OPERATE OR MAINTAIN THE CRYOSTORAGE SYSTEM DO NOT ATTEMPT TO INSTALL USE OR MAINTAIN THE CRYOSTORAGE SYSTEM UNTIL YOU READ AND UNDERSTAND THESE INSTRUCTIONS DO NOT PERMIT UNTRAINED PERSONS TO INSTALL USE OR MAINTAIN THIS CRYOSTORAGE SYSTEM IF YOU DO NOT FULLY UNDERSTAND THESE INSTRUCTIONS CONTACT WORTHINGTON INDUSTRIES...

Page 2: ...CTRICAL POWER SUPPLY CONNECTION 23 5 5 FIRMWARE 23 6 OPERATION OF DEVICE 24 6 1 SELECTING CRYOPROTECTANTS 24 6 2 INITIAL FILL 24 6 3 NORMAL FILL CYCLE 25 6 4 ADDING AN INVENTORY CONTROL SYSTEM 27 7 OPERATION OF LIQUID NITROGEN LEVEL CONTROL SYSTEM 28 7 1 CONTROLLER INITIAL START UP 28 7 2 CONTROLLER SET UP 29 7 3 CONTROLLER CONFIGURATION AND CALIBRATION 37 7 4 CONTROLLER OTHER SETTINGS ENGINEER ME...

Page 3: ...vision 02 Approved by CB 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 62 10 MANUFACTURER S DECLARATION 63 11 ADDITIONAL TECHNICAL DATA 64 LIST OF APPENDIXES 66 ...

Page 4: ...er 52 Table 11 Recommended inspection and maintenance schedule 55 Table 12 K SERIES Cryostorage System warranty terms 62 Table 13 Technical data of the K SERIES Cryostorage System 64 Table 14 Radiated Immunity 65 Table 15 Conducted Immunity 65 Figure 1 K SERIES CryoCe24K Standard Model 12 Figure 2 Level Controller Display type M505CE 13 Figure 3 Vial storage in boxes on racks 16 Figure 4 Rack arra...

Page 5: ...ar the operating location of your K SERIES Cryostorage System and should be accessible at all times to the persons involved in the use operation and maintenance The instruction manual should be included if the K SERIES Cryostorage System is transferred to another location In this instruction manual the following symbols are used Warnings and safety precautions This symbol indicates warnings and sa...

Page 6: ...efore 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 Extremely cold refrigerant may cause freezing injuries Your K SERIES Cryostorage System operates with liquid nitrogen a cryogenic liquid...

Page 7: ...erator When installing piping or fill hose assemblies make sure a suitable safety relief valve is installed in each section of plumbing between shut off valves Trapped liquefied gas will expand greatly as it warms and may burst hoses or piping causing damage or personal injury A relief valve is installed in the refrigerator plumbing to protect the line between the customer supplied shut off valve ...

Page 8: ... absolute minimum Do not make any modifications Repairs and maintenance services to your K SERIES Cryostorage System must be carried out by service personnel instructed and authorized only by Worthington Industries Use only approved accessories and replacement parts Your K SERIES Cryostorage System is supplied with Worthington Industries approved accessories and replacement parts Except Printers a...

Page 9: ...ified Body number Declares compliance with EU Directive 93 42 EEC Medical Device Directive 20XX Manufacturer as defined in EU Directive 93 42 EEC Combined with year of manufacture of medical device Manufacturer s model reference of medical device Manufacturer s serial number of medical device Follow this instruction manual for important warnings and safety precautions Danger Use protective gloves ...

Page 10: ...ndle medical device with care Keep medical device away from sunlight and heat Keep medical device dry Temperature limits to which the medical device can be safely exposed Humidity limits to which the medical device can be safely exposed Atmospheric pressure limits to which the medical device can be safely exposed Do not dispose of medical device or parts with unsorted non recyclable waste The pack...

Page 11: ...medical laboratories The environment of professional health care does not include every arbitrary location So this environment comprises not areas where sensitive facilities or sources of intense electromagnetic interference are located such as radio frequency RF shielded rooms for magnetic resonance imaging MRI areas in operation rooms with active high frequency HF surgical equipment electrophysi...

Page 12: ... pressure uses liquid nitrogen as cryogenic agent that is non toxic and non flammable stainless steel vacuum vessel with superior vacuum performance wide neck opening allows easy loading and retrieval of samples robust design of smooth surfaces for easy cleaning and disinfection thermally insulated and lockable lid microprocessor based controller with intuitive touch controls for o liquid level an...

Page 13: ...signed for fitting to CryoCe10K and CryoCe24K M505CE B boxed version designed for fitting to CryoCe38K Figure 2 Level Controller Display type M505CE NOTE Level controller displays are identical for type M505CE and M505CE B Use only Worthington Industries approved electronic liquid level controllers If other liquid level controllers are required please contact Worthington Industries before putting ...

Page 14: ... plumbing assembly liquid nitrogen racks boxes vials and samples 332 669 1037 Static Holding Time days 33 52 74 NOTE Evaporation Rate and Static Holding Time are nominal Actual rate may be affected by the nature of the contents atmospheric conditions container history and manufacturing tolerances The K SERIES Cryostorage System has a maximum weight capacity which exceeds the maximum amount of liqu...

Page 15: ...em specifications MODEL CryoCe10K CryoCe24K CryoCe38K Racks per 25 cell boxes 4 6 6 Racks per 100 81 cell boxes 7 17 28 Cell box size 5 in x 5 in 127 mm x 127 mm square 3 in x 3 in 76 mm x 76 mm square Shelves per rack 13 13 13 Vials per 2 ml 12 5 mm O D internal thread 10 400 24 050 38 350 Straws per 0 5 cc 10 per goblet 2 13 mm goblets per can 44 000 59 400 114 000 Bags per 50 ml 7 level rack 34...

Page 16: ...ual K SERIES Cryostorage System IM CryoCeK Revision 02 Approved by CB 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 ...

Page 17: ...Instruction Manual K SERIES Cryostorage System IM CryoCeK Revision 02 Approved by CB Page 17 of 87 Figure 4 Rack arrangements for 50 ml cassettes 7 level configuration ...

Page 18: ...Instruction Manual K SERIES Cryostorage System IM CryoCeK Revision 02 Approved by CB Page 18 of 87 Figure 5 Rack arrangements for 250 ml cassettes 5 level configuration ...

Page 19: ...Instruction Manual K SERIES Cryostorage System IM CryoCeK Revision 02 Approved by CB Page 19 of 87 Figure 6 Rack arrangements for 500 ml cassettes 5 level configuration ...

Page 20: ...ivered in new condition For your own protection take time to visually inspect each shipment for external damage Open the shipping containers Use the packing list to check off each item as the system is unpacked Inspect for damage Be sure to inventory all components supplied before discarding any shipping materials All claims for damage apparent or concealed or partial loss of shipment must be made...

Page 21: ...d not in direct sunlight or near radiators or other sources of heat Allow enough clearance so that the lid can fully be opened Provide sufficient ventilation so as to avoid persistent condensation Deviation from the admissible ambient conditions may lead to malfunction of the K SERIES Cryostorage System This K SERIES Cryostorage System has no Radio Transmitter Intentional Radiator functions and do...

Page 22: ...frigerator solenoid valve Inlet pressure should not exceed 1 5 bar 152 kPa Higher liquid nitrogen supply pressure at the inlet to the refrigerator opens the relief valve on the refrigerator Once this pressure relief device has opened and cooled to liquid nitrogen temperature it will not reseat until it has warmed to near ambient temperature THIS COULD PERMIT THE ENTIRE CONTENTS OF THE LIQUID NITRO...

Page 23: ...The mains plug is the only device used to connect and disconnect the power supply from the refrigerator Incorrect electrical power supply connection can cause servere personal injury or damage to the device Worthington Industries and the distributors of the K SERIES Cryostorage System refuse all liability when the device is used in locations where the electrical installations do not meet the natio...

Page 24: ...lose consideration to the type and concentration of the cryoprotectant being used A careful analysis of literature regarding standard operating procedures for your cell type and small scale experimentation can save the frustration and cost of having to repeat lengthy experimentation as a result of poor cryopreservation conditions Worthington Industries and the distributors do not assume any respon...

Page 25: ... atmosphere to cause dizziness unconsciousness or death If the fill fails to stop for any reason quickly close the liquid supply valve to prevent overfilling until the cause of the problem can be determined Liquid phase or vapor phase storage Prior to the initial fill of your K SERIES Cryostorage System you should determine whether the liquid phase or the vapor phase cryostorage will be utilized 6...

Page 26: ...r 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 When samples are immersed in liquid nitrogen they will assume the temperature of the liquid 196 ºC In a typical liquid phase storage sy...

Page 27: ...tronic areas of the refrigerator from liquid nitrogen that may spill from the rack inserts These parts of the refrigerator are subject to damage from the extreme low temperature of the refrigerant The purpose of the inventory control system is to bring order to the storage of many small samples and to allow direct retrieval of the particular sample you need at any time Use only suitable inventory ...

Page 28: ...re and level example If the vessel is empty or the LN2 level is low the refrigerator will begin to fill Alarms may occur 2 Press the Alarm Mute switch 2 to silence the audible alarm Ignore any alarm messages for the time being 3 Press the mute switch again to return to the temperature and level display When the refrigerator has finished filling the controller should be set up and calibrated as per...

Page 29: ...roller Menu TIMERS CLOCK Alarm Temperature Maximum Temperature for temperature control Fill Timer Sim Fill Delay Remote timer Remote Alarm for LN2 Supply failure On Off Lid timer Auto Defog timer Quick Chill timer Extra High Alarm Delay Gas Bypass Timer Settings for use with M507CE I Refrigerator Number Battery voltage monitor Clock setting Day off week setting For timed fill Timed Fill Setting Ti...

Page 30: ...rsor is on the last digit If a code is requested and it is not known the password will have to be reset as per section 7 3 If the code is accepted or not requested the following menu will appear NOTE On initial installation setup first configurate the required features in the CONFIG CALIBRATE menu and then go back to the TIMERS CLOCK menu 4 Press switch 1 to set up timers and or clock If the TIMER...

Page 31: ...ivated and the solenoid valve will be switched off Switching off the solenoid valve reduces the risk of overheating if the LN2 supply fails It is also a safeguard against possible masking of the sensors by a build up of ice This situation could cause overfilling of the refrigerator A time out during filling is additionally indicated by the Led blue slow flashing To cancel the alarm the LN2 Fill So...

Page 32: ...mer setting displays the time that will elapse between the occurrence of the first alarm and activation of the remote alarm relay In the case of an extra high level alarm the remote alarm timer defaults to 5 minutes maximum 9 Use the and keys to set the remote timer the REMOTE TIMER setting is adjustable between 0 min and 90 min in 5 minute steps Press key when finished The following message examp...

Page 33: ...EFOG timer setting is adjustable between 0 sec and 90 sec in 5 second steps Press key when finished The following message example will appear When the lid is closed liquid nitrogen is allowed into the refrigerator for the displayed time This has the effect of rapidly cooling the vessel NOTE A lid switch must be fitted to utilise this feature 13 Use the and keys to set the quick chill timer the QUI...

Page 34: ...refrigerator to start filling 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 15 Use the and keys to set the gas bypass timer the GAS BYPASS TIMER setting is adjustable betwe...

Page 35: ...r The real time clock and RAM require a minimum of 2 2 V to function correctly and retain their settings when mains power is removed If the battery voltage is too low a warning will be displayed and the clock settings should be checked A warning will also be given if the battery voltage is too high This indicates a battery fault possible open circuit 18 Press key to finish The following message ex...

Page 36: ...hen no staff are likely to be present Security filling takes place at a time when it can easily be monitored Simultaneous filling several refrigerators may be filled at the same time without the need for interconnection Sequential filling by staggering the start times several refrigerators may be filled in sequence without the need for interconnection 21 Use the and keys to set the correct hour Us...

Page 37: ...up on off Valve On Off No LN2 Analogue Output On Off Settings Calibration check Timed Fill On Off Timed Fill Off 24hr 48hr 72hr or select days of week Password protection setup Before proceeding to set up the data log should be cleared as per section 7 7 Table 8 Procedure for configuration calibration the controller No Steps of procedure Display and notes 1 Press key to enter the menu The Firmware...

Page 38: ... to CONFIGURATE CALIBRATE If the CONFIG CALIBRATE menu is selected the following message example will appear 5 Use the and keys to select the LANGUAGE English German French Press the key when finished If the calibration of the first thermocouple is disabled skip to step 10 If the calibration is enabled see Engineering menu as per section 7 4 the following message will appear NOTE Thermocouples are...

Page 39: ...on is successful after a few seconds the following message will appear followed by NOTE Transfer the thermocouple to the liquid nitrogen and allow at least 10 ten seconds for the temperature of the thermocouple to stabilise before continuing LN2 calibration 8 Press the key to continue calibration The following message example will be displayed for a few seconds The number in the bottom right of th...

Page 40: ...mmended that the calibration is confirmed by checking the temperature display with the thermocouple in ice and liquid nitrogen 10 If the temperature of the thermocouple is not stable during the ice or LN2 calibration the following message may appear If the temperature of the thermocouple is out of an acceptable range e g if it is not correctly inserted into the ice or LN2 during calibration one of...

Page 41: ...appear 15 Use the and keys to select the PRINTER CONNECTION options M506 M507 If the M506 option is selected printer output is routed to the 7 pin plug on the controller If the M507 option is selected printer output is routed to the M507CE PSU Connector box via the 25 pin I O connector on the M506CE NOTE To use the M507 option an M512CE RS232 RS485 Interface PCB must be installed in the M507CE Con...

Page 42: ...sitions are known the level may be calculated from the time elapsed since the last fill On the initial fill evaporate cycle a Nominal Evaporation Rate for the refrigerator type is assumed On subsequent cycles the actual rate is computed NOTE The positions of the high and the normal sensors should be set as per Appendix D 17 Use the and keys to select the LEVEL DISPLAY mode High Low Normal Press th...

Page 43: ...PERATURE CONTROL on off If the temperature control option is set to off go to step 23 If the temperature control option is set to on the following message example will be displayed The valve on time is the period for which the solenoid valve is opened during the temperature control cycle The optimum setting will depend upon the length and layout of the pipe work and is best found by trial and erro...

Page 44: ...mocouple and send a signal to start venting when filling is called for 25 Use the and keys to select the correct gas bypass type M360 Off M507I Press key when finished The following message example will be displayed The LN2 supply alarm fill timer may be disabled if required e g to avoid false alarms on systems with long filling times If the Alarm Off option is selected the refrigerator will fill ...

Page 45: ...ill be displayed NOTE If an Analogue Output PCB M511CE is fitted the output range may be set to any of the above options If Off is selected the output is set 0 V 4 mA 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 Indus...

Page 46: ...t for MONday off or on Press key to step to TUESday and Repeat the steps for each day of the week up to SUNday then Press key to finish The following message example will be displayed PASSWORD PROTECTION uses a four digit access code to prevent unauthorised alterations to the controller settings and to monitor access to the refrigerator There are two priority levels at supervisor level the Supervi...

Page 47: ...and keys to move the cursor Press key to finish when the cursor is on the last digit The following message will appear 35 Set the code for Operators 02 to 08 in the same way as for OPERATOR 01 NOTE Unused operator codes should be set to the same value as the Supervisor code Press key when all Operator codes have been set The following message will appear All settings are saved in non volatile memo...

Page 48: ... 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 Filling may also be triggered by an external fill signal Simultaneous Fill On...

Page 49: ...ments of the operating company A list of the default alarm settings is given in Appendix I To prevent unauthorised changes to the controller alarm settings the PASSWORD PROTECTION option must be enabled and the supervisor s code should be changed from its default setting see section 7 3 Caution should be exercised in setting the various alarm limits to appropriate values to reduce risk to stored s...

Page 50: ... state If further Alarms occur the LED reverts to flashing Pressing the Mute key also displays the current alarm state s on the character display If more than one alarm is present these are displayed in sequence Longer alarm messages are scrolled across the display Pressing the Mute key also toggles the character display between its normal status display temperature and level and the alarm display...

Page 51: ...for 4 weeks minimum by an internal battery When the log is full the oldest records are overwritten General Alarm If a certain number of alarms currently set to 25 occur in a 24 hour period time a General Alarm is raised The controller needs to be reset to clear the alarm or alternatively it will also be cleared at the end of a 24 hour period Midnight The general alarm indicates when multiple inter...

Page 52: ...following message will appear 2 Press and hold the key until the controller will bleep three times The following message will appear 3 Press the key to proceed or Press the key to return to the Temperature Level display If PASSWORD PROTECTION is enabled the following message will appear 4 Enter the four digit supervisor s code using the numbered keys and the and keys to move the cursor Press key t...

Page 53: ...ds the Temperatur Level display should reappear NOTE If the controller is restarted with a PC cable plugged in it will start the Program Loader If this happens remove the PC cable and switch off the power to the controller for a few seconds Alternatively wait for a few minutes and the main program will restart Do not press any keys while the Program Loader screen is present ...

Page 54: ...he case of special events e g crash racks topple down refrigerator collision with other equipment exposure to high temperatures significant modifications which have not been foreseen by the manufacturer major repairs which have adverse effects on the safety of the Cryostorage System an extraordinary test for proper condition after repair shall be done If a defect is identified during a recurring i...

Page 55: ...oved The purge gas may also simply be delivered to the refrigerator through a bent metal tube under the lid A flow rate of 8 to 17 m3 h regulated at 0 3 to 0 5 bar is sufficient to prevent water from collecting inside the refrigerator 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 Wort...

Page 56: ...placement 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 The refrigerator will not fill properly if the strainer is clogged with ice or d...

Page 57: ... This blockage can result in the liquid level dropping to very low levels and may cause the low alarm sensor and the low LN2 supply alarm to be activated Ice blockage would typically form in the fill tube at the point at which water will form ice This location may be just inside the storage area near the top Warm with a hair dryer or other safe low heat source with the solenoid valve in the open p...

Page 58: ...ide 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 Vent the fill line of all pressure Turn the controller off Disconnect the power source and the liquid nitrogen source Remove all stored samples and inventory control system components Allow the residual liquid nitrog...

Page 59: ... 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 When a warm tube is inserted into liquid nitrogen liquid will spout from the top of the tube and may cause personal injury To perform an NER test fol...

Page 60: ...ent a Cryo Product Return Information Form see Appendix C must be filled in before returning the device to Worthington Industries Any K SERIES Cryostorage System received without this Cryo Product Return Information will be returned to the sender It is your responsibility to assure that the goods are adequately packaged for return If necessary consult Worthington Industries for shipping and packin...

Page 61: ...paper and the molecular sieve must be disposed of as industrial waste or incinerated Electronic components controller control unit must be supplied to the hazardous waste 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 electroni...

Page 62: ...ce with date of purchase for the device in question Describe the defect or malfunction discovered The warranty shall be rendered null and void if it is discovered that The inspection and maintenance instructions have not been followed as per section 8 2 The device was damaged by force or an user error or that it was used in any way contrary to that set out in this instruction manual Accessories sp...

Page 63: ...is a class IIa medical device and complies with the EU Directive 93 42 EEC Medical Device Directive This conformity is indicated by the CE mark followed by the registration number 0044 of the notified body TÜV Nord Cert GmbH Langemarckstraße 20 45141 Essen Germany This Worthington Industries K SERIES Cryostorage System complies with the following EU Directives WEEE Directive 2012 19 EU Waste of El...

Page 64: ... 1 0 A max Proctection code EN 60529 IP20 Fuses EN 60127 1x T 1AH 250 V M507CE next to power inlet 1x T 1AH 250 V M507CE transformer cover 1x T 1AH 250 V M507CE PSU PCB 1x T 3 15AH 250 V M507CE PSU PCB Operating mode Continuous operation Supply connection Appliance coupler Mains cord built in safety isolating transformer No patient applied parts Only operator contact Firmware Microcontroller Softw...

Page 65: ... NOTE The temperature fluctuated by 1 C and the current fluctuated by 0 1 mA All fluctuations were within the tolerances Table 15 Conducted Immunity NOTE The temperature fluctuated by 1 C and the current fluctuated by 0 07 mA All fluctuations were within the tolerances Immunity to Burst No malfunctions or influences were detected The device fulfills the required criterion ...

Page 66: ...x A2 INITIAL INSTRUCTION LOG Appendix B SERVICE HISTORY LOG Appendix C CRYO PRODUCT RETURN INFORMATION FORM Appendix D SENSOR AND THERMOCOUPLE POSITIONING Appendix E REMOTE ALARM CONNECTIONS Appendix F SIMULTANEOUS AND SEQUENTIAL FILLING Appendix G CONNECTIONS FOR GAS VENTING Appendix H ALARMS AND EVENTS Appendix I ALARMS OVERVIEW Appendix J OPTIONAL ACCESSORIES ...

Page 67: ...ling Yes No Filling Yes No Temperature Temperature LN2 Supply ltr bar kPa Supply Alarm On Off Ice Build up a little a lot Remote Alarm On Off Gasket Condition seals leaks Audible Alarm On Off Display Lights On Off Temperature Control Setpoint at C Initial Installation Checks Controller Alarms Test Yes No Remarks LN2 Shut off Valve Yes No Remarks LN2 Relief Valve Yes No Remarks LN2 Pressure Regulat...

Page 68: ...Personal No Signature Print Name Personal No Signature Print Name Personal No Signature Print Name Personal No Signature Print Name Personal No Signature With your signature you confirm that you has been committed to the proper handling of the respective medical device with reference to this instruction manual including all relevant aspects for the proper operation and necessary safety precautions...

Page 69: ... Company Name Cryostorage System Information Cryostorage Model Serial No Controller Model Serial No Version No Following services inspection tests repairs have been logged Date LOG NO Parts serviced and or replaced Technician Company Signature NOTE Keep this Service History Log up to date for your own protection For medical device vigilance reasons please send a copy of this updated form to Worthi...

Page 70: ...al or chemical matter C The equipment was exposed to radiological biological or chemical matter was decontaminated and is rendered safe for handling use or disposal Authorization By accepting authorization to return this product the customer assumes all responsibility and liability for biological radiological and chemical decontamination and cleaning Worthington Cylinders GmbH reserves the right t...

Page 71: ... tube to the bottom of the refrigerator then subtracting the desired liquid level The result is used to position a split rubber bung on the sensor leads When correctly installed the bung will position the sensors at the correct level when the sensor assembly is inserted into its tube The bung caps the tube and functions as a sensor retainer The lead with the single pod is the low level sensor asse...

Page 72: ...Instruction Manual K SERIES Cryostorage System IM CryoCeK Revision 02 Approved by CB Page 72 of 87 Figure 8 Sensor positioning ...

Page 73: ...emperature data and this should be given priority when selecting the desired monitoring point Typically the product will be stored in vapour phase with about 15 to 20 cm of liquid in the vessel The worst case temperature for vapour phase storage is just below the lid of the refrigerator and it is suggested that the optimum position for the thermocouple is within the sensor tube and level with eith...

Page 74: ...unction and ambient temperature NOTE The tip of the thermocouple is insulated with a plastic sleeve If this sleeve becomes detached it is possible for the thermocouple to short to the sensor tube If the temperature readout is incorrect or erratic check that the insulating sleeve is still in place Additional Thermocouples M505CE 2T The second thermocouple TC2 may be used as an additional temperatur...

Page 75: ...Instruction Manual K SERIES Cryostorage System IM CryoCeK Revision 02 Approved by CB Page 75 of 87 Figure 10 Suggested Form of Thermocouple for Vapour Phase Storage ...

Page 76: ...ecognize the potential impact and hazards and to assess the necessary measures A changeover relay contact is provided Terminals 12 13 and 14 of the M507CE to facilitate reporting of an alarm condition at a point remote from the refrigerator In the good condition the relay is energised i e the Normally Open NO contact is closed and the Normally Closed NC contact is open If the remote alarm is activ...

Page 77: ...ed to and to as shown in Figure 11 Whenever a refrigerator in the connected group starts to fill a signal is sent to all the others This causes them to start a fill cycle if they are not already full Up to 20 refrigerators may be connected together in this way Make sure however that the supply pressure is adequate to complete filling in a reasonable time If not a supply alarm may be generated by o...

Page 78: ... a loop When a refrigerator requires filling it opens its solenoid valve and fills to the High level sensor When the liquid reaches the High sensor filling is terminated and the auxiliary relay is energised for approx 10 seconds This starts the fill cycle for the next refrigerator The fill signal is passed on from one refrigerator to the next until it reaches the originating refrigerator To preven...

Page 79: ...Instruction Manual K SERIES Cryostorage System IM CryoCeK Revision 02 Approved by CB Page 79 of 87 Figure 11 Connection for Simultaneous Filling ...

Page 80: ...Instruction Manual K SERIES Cryostorage System IM CryoCeK Revision 02 Approved by CB Page 80 of 87 Figure 12 Connection for Sequential Filling ...

Page 81: ...Instruction Manual K SERIES Cryostorage System IM CryoCeK Revision 02 Approved by CB Page 81 of 87 Appendix G CONNECTIONS FOR GAS VENTING Figure 13 Connection for Gas Venting ...

Page 82: ...02 LEVEL EXTRA LOW 03 LEVEL EXTRA HIGH 04 SENSOR SHORT EXTRA LOW 05 SENSOR SHORT NORMAL 06 SENSOR SHORT HIGH 07 SENSOR SHORT EXTRA HIGH 08 SENSOR OPEN EXTRA LOW 09 SENSOR OPEN NORMAL 0A SENSOR OPEN HIGH 0B SENSOR OPEN EXTRA HIGH 0C NO LN2 SUPPLY FILL TIMER 0D WARNING CHECK PRINTER 0E NOTE 1 THERMOCOUPLE OPEN 0F EXTERNAL FILL INPUT S CCT 10 UNAUTHORISED ACCESS 11 GAS BYPASS THERMOCOUPLE FAULT 12 NO...

Page 83: ...ART Temp Control 36 FILL START PC 37 FILL START Timed Auto Fill 38 FILL STOP Manual 39 FILL STOP Auto 3A FILL STOP Defog Chill 3B FILL STOP Temp Control 3C FILL STOP PC 3D FILL STOP Time out no LN2 3E TIMER SETTING CHANGED NOTE 2 Battery Backup 24 Settings Restored from Flash 25 Data recovery 26 NOTE 1 This alarm is displayed but not recorded in the data log NOTE 2 If PASSWORD PROTECTION is enable...

Page 84: ...hes fill on False Ex Low Alarm Prompt High N A N A Depending on level condition a false level may be reported Sensors are low resistance at ambient but not a known failure mode Sensor Short Normal Switches fill on Prompt High N A N A Sensor Short High Fill stays on once triggered Prompt High N A N A Sensor Short Extra High Ex high not reported Prompt High N A N A Sensor Open Extra Low Sensor is op...

Page 85: ...07CE I only No LN2 Gas Bypass Timer Liquid not detected at vent valve within pre set time limit No Fill until liquid detected Continue venting Prompt High 0 60min 30 mins M507CE I only Gas Bypass fault Valve Open Liquid still detected at vent valve after pre set time Vent valve stuck open Immediate High 0 15min 5 mins M507CE I only General Alarm 20 Intermittent alarms in 24hr period No Change Prom...

Page 86: ...ocket on the Level Controller panel M529CE Ethernet Internet Interface PCB M531CE Battery pack for maintaining temperature logging during power failures M549CE USB PC Cable USB version of M519CE M507CE I Enhanced M507CE with Individual Gas Bypass feature plus RS485 Interface NOTE For valid combinations of some accessories see below Standard Controller Type M505CE or M505CE B M510CE M511CE M512CE M...

Page 87: ...proved by CB 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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