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Service Manual CBS 2101

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1. Profile Program Path C Rate Freezer Data System Files Profiles prf 1 Atthe main menu click on the program button A 2 Clicking the program button A will open a new window called PROGRAM PROFILE The program profile screen is where you will enter the steps of the program The step number G will automatically be cre ated when entered 3 Click the pointer on the cooling rate area B and enter a desired cooling rate 4 Click the pointer on the target temperature area C and enter desired target temperature 5 Click the pointer on the hold time area D and enter the desired time HH MM SS 6 Click on add a step area E to add a program step 7 Click on delete a step F to remove entire last step 8 Verify all information is correct 9 Continue steps 3 6 until program is complete NOTE The recommended method for starting a freezing cycle is to program a wait function Enter a 0 zero as the cooling rate by clicking the cooling rate area B see program profile above Enter a target temperature in area C see program profile above This function will pre cool the chamber and hold the chamber temperature at the programmed target temp C see program profile above A O zero degree rate will hold indefinitely at the programmed target temp C see program profile above NOTE If you do not desire a wait pre cool function go to step 1 of the create a program section
2. er Date modified Date modified Type 1 20 2003 6 44 et n _ CBS TEST tst 7 12 20071 0 PM TST File Optional 2 sample with 7 to 12 percent 1 20 2003 6 44 et os _ Multi Probe tst 5 4 2010 9 14 AM TST File Skin Packet 4 x6 inch with 10 percent Cryop 1 20 2003 6 44 AM et Blood Bag Bone Marrow 1 20 2003 6 44 AM Desktop Standard Embryo Freeze using 25 or 50 ml 1 20 2003 6 44 T l standard Microtest Tray Freeze 1 20 2003 6 44 AM et Libraries File name M Save Path C Program Files Cryogemic Freezng Software Release Custom Biogenic Manual Operation Files of type All Files 7 Cancel Saveastype Custom Patem 40 Cool wand 4 Select a program profile from the window and click OK D 3 Click ASSIGN FREEZE NAME E 6 Assign the freeze a name and click OK H 7 To start a freeze click RUN G 8 To cancel a freeze click CANCEL F 9 To begin the freeze run click RUN I 10 Atthe end of a freeze run click RUN WARM J this will automatically warm the chamber up to 259C for shut down 11 Click EXIT K after freeze run is complete www custombiogenics com 9 CEB lt gt lt es Operating Instructions Preview a Profile f Custom Biogenic Systems Controlled Rate Freezin
3. OLL AJLA O2SV YZL LL eee sed eee DELE Ol aqold 6 e Iain Kole a CC DE MT smt SGNNNRNNSEINSESNINMEANSEQLOEI qnc gabd 0e b gerens ensqepeed 50 SU SPA c L 777777777777777777777777 NOQ 31220g nennt mm 931 UXUPT OON SEE suum im mmm eu neminem dO LIS EA SEDI OE TO d uondu seq QI La vd DNISWfYId 9343395 31V amp 8 LOIC C E3 lt gt 35 logenics com www customb CLEANING amp MAINTENANCE Cleaning Use a mild non abrasive household type cleaner for cleaning all surfaces of the unit except for the notebook PC A mixture of 40 bleach 60 water may be used inside the chamber of the unit for decontamination or heavy cleaning purposes Check with Custom BioGenic Systems before using any cleaners not mentioned above A lint free cloth or compressed air of no more than 20 p s i may be used to clean the laptop The use of any chemicals cleaners or methods not mentioned above will void the warranty Maintenance The following should be performed at least once annually 1 Test all alarm functions for proper operation 2 Check accuracy of the chamber probe sample probe and chart recorder If calibration is required see section 3 8 3 Check for leaks at all connection points of the liquid nitrogen lines 4 Besure that all electrical wires are free of damage and plugs are firmly in place SOLENOID
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5. s Main Menu View Old Audit Functions Patent Comments A F Data User Accounts g Calibration Config Fields At the main screen click the VIEW OLD DATA button A LEA al Optional 2 ml sample with 7 to 12 percent 1 20 2003 6 44 Skin Packet 4 6 inch with 10 percent Cryop 1 20 2003 6 44 AM Standard Blood Bag Bone Marrow 1 20 2003 6 44 AM standard Embryo Freeze using 25 or 50 1 20 2003 6 44 AM 2 At the Data Query screen click the VIEW OLD FILE button B this will 2 display all the files that you have saved Test instructions L1 L1 L1 L1 L1 3 Select the file you wish to open and click OK C NOTE The stored information the test graph and the profile that created will each be displayed Search Old Data Custom Biogenic Systems Controlled Rate Freezing System Custom Biogenic Systems Check the boxes for the Fields to Search by Cg L1 Date of Test 20128001 2 A little more stuff Time of Test Joro rm Controlled Rate Freezing System Teraperature of chamber 9 000 of Embryos Main Menu Test instructions A View Old Audit Functions raaa Data User Accounts 9 Calibration Config Fields e 7 avein les et Ey 1 At the main screen click the VIEW OLD DATA button A I ame Date modified 1 20 2003 6 44 Optional 2 sample with 7
6. www custombiogenics com 15 CB Operating Instructions Calibration 1 Unplug the chamber from the power source The controller computer will continue ot operate on battery power Ei cu stom Bio iogenic nic Systems Controll olled Rate F Free zing System Custom THER non Controlled Rate Freezing System mu Main Menu View Old Audit Functions Poaout Data User Accounts 9 Calibration Config Fields 2 Atthe main screen click the CALIBRATION button A Calibration 3 the calibration screen verify the toggle switch is in the Auto Equation position B If not click on switch to change to the Auto Equation position 4 Theunit is now ready to be calibrated www custombiogenics com 16 55 Operating Instructions Chamber Probe Calibration 4 Phillips Head Screws 1 Remove back cover of freezing chamber by removing 4 phillips head screws A Chamber Probe 2 Locate and remove chamber probe by loosing the brass fitting using 3 8 wrench B www custombiogenics com 17 CB Operating Instructions 3 Place chamber probe into ice bath and allow 10 15 seconds for chamber probe temperature to Stabilize Custom Biogenic Systems Controlled Rate Freezing System Version 1 3 os Biogenic Systems Calibration Screer Thermocouple Calibration Acquired Temp 159098 0 293 Actual Temp 3 196000 5 0000 Calibration i Config Fields 4 C
7. www custombiogenics com 26 CB 5 Theory Of Operation This Cryogenic Rate Freezer freezes at pre defined user programmable rates This means that the user has total freedom when it comes to programming their freezing profiles A few good practices when programming and running profiles is 1 THE CHAMBER TEMPERATURE SHOULD BE USED FOR CONTROLLING THE FREEZING OF THE SAMPLE This means that due to the principles of Thermodynamics any mass such as a sample that is within the chamber HAS to follow that chamber s temperature profile 2 THE SAMPLE TEMPERATURE SHOULD ONLY BE USED TO AUTOMATICALLY CONTROL THE ADVANCEMENT OF STEPS WITH IN A PROFILE NOT TO CONTROL THE ENTIRE FREEZING PROCESS 3 PLACING THE SAMPLE PROBE WITHIN THE SAMPLE WILL ALWAYS YIELD THE MOST ACCURATE AND REPEATABLE GRAPH LINE If it is not possible to place a probe inside a sample due to the sensitivity of the material an equivalent dummy sample can be used This just involves using the same type of sample receptacle i e vial bag straw that has an equivalent mixture of whatever is being frozen minus the actual sample material See page 22 amp 23 for probe place ment In this way the user can be confident they re getting the most accurate and repeatable results pos sible without compromising an actual sample The Notebook Computer The notebook computer that ships with the Cryogenic Rate Freezer is DEDICATED to controlling the machine It is not intended to be used fo
8. VALVE MAINTENANCE The solenoid valves may be opened and cleaned if they are not working smoothly If this is done use the diagram below to reassembly the valves properly If the valve is found to be defective it must be replaced as replacement parts are not available individually 1 Valve Body 5 2 Plunger 4 3 Flange 4 Valve Coil Locknut 5 Coil 6 Spec Plate 2 7 Valve Cap www custombiogenics com 38 55 NOTES ars ms Freeze d e Freezing Syste contre nd Boxes Freez transfer Lines 5 solenoid Valve Alar d Le el amp Te p Contro Liqui Level amp Te per Monitors Liquid ature ecorde essories Y 2101CRFTM101612 Rev ORG O 2001 2006 Custom BioGenic Systems All designs and materials contained herein are protected under Federal copyright law Unauthorized distribution or use will be subject to prosecution to the fullest extent of the law
9. storage of the rate freezer for more than six months If longer stor age time is required contact the factory for additional storage information www custombiogenics com 3 CES Operating Instructions Custom Biogenic Systems E Custom Biogeni ic Systems Controlled Rate Freezing System Controlled Rate Freezing System TA lain Start Freeze Run B View Old Audit Data User Accounts 9 F C 1 5 J G www custombiogenics com 4 C E Ss Operating Instructions A PROGRAM This menu button allows the user to program edit and save freezing profiles This function is typically done after the profile is perfected in the preview menu B VIEW OLD DATA This menu button allows users to view and print previously saved freeze runs The default print out consists of information header and the graph See page 22 Advanced Setup for other printing options C CALIBRATION This menu button allows the user to access the thermocouple calibration screen Calibration should only be attempted by CONFIDENT users This means that although calibration is relatively simple it should not be attempted until the user has read the manual and is comfortable with the machine For a more detailed explanation on how to calibrate your 2101 Rate freezer please refer to pages 16 23 D START FREEZE RUN This menu button brings up the profile and freeze name selection screen E AUDIT FUNCTI
10. to 12 percent 1 20 2003 6 44 AM Packet 4 x6 inch with 10 percent Cryop 1 20 2003 6 44 AM Standard Blood Bag Bone Marrow 1 20 2003 6 44 AM 2 Atthe Data Query screen click the VIEW OLD FILE button B this o will display all the files that you have saved 3 Select the file you wish to open and click OK C 3 Save as type Custom Pattem X 4 Select the field s you wish to query D 5 Click the QUERY button E to search the data 6 To cancel your search click the CANCEL button F www custombiogenics com 11 55 Operating Instructions Add a User Custom Biogenic Systems Controlled Rate Freezing System Custom Biogenic Systems User Name Level Days Unitl Password Expires Controlled Rate Freezing System me Main Menu View Old Audit Functions WEN Data User Accounts 9 Calibration Config Fields 1 Edit User Accou Password Retype Password User Level Administrator Cancel 1 At the main screen click the USER ACCOUNTS button A 2 Click the disable security checkbox to enable security B 3 Atthe administrator utility menu click the NEW USER button C 4 Fill in the fields USERNAME D PASSWORD E RETYPE PASSWORD F and USER LEVEL G User Level Allows Administrator Access to all areas Operator 1 Program run preview view old data log out calibration and exit O
11. when ordered Either 120 VAC or 220 VAC The notebook PC has a universal power supply rated for 100 240 VAC Outputs Outputs data to a printer Printer is set up independently and supplied by the user No of Channels 2 Thbermocouples Type T 50 C to 200 C Chamber Temperature Tolerance 2 C This means that any point in the chamber is within 2 C of the chamber probe temperature Range of Returnable Rates Slowest rate possible is 01 degrees per minute Fastest rate possible with a 22 psi liquid supply is 99 degrees per minute Bench Top Installation The rate freezer should be set on a bench top in a vertical position to ensure proper operation En sure that you have the proper clearances for the liquid nitrogen connection Optional Storage Cart Installation Same as above except the rate freezer is set on the optionally purchased storage cart Connection Make all of the following connections BEFORE turning on the notebook PC www custombiogenics com 2 C E Ss Initial Installation Power Connections The rate freezer is designed to operate on either 120VAC or 220VAC must be specified when unit is ordered depending on the users needs Check to make sure that the rate freezer voltage is the correct voltage for the local power system The rate freezer is supplied with either a North American style plug or a European style plug depending on the destination country User supplied adapters may still need to b
12. CUSTOM BIOGENIC SYSTEMS 2101 CONTROLLED RATE FREEZER SET UP amp TECHNICAL MANUAL Custom UA B B WWW custombiogenics com B ioGen 150 Shafer Drive Romeo 48065 USA Syste ms 1 800 523 0072 Tel 1 586 331 2600 Fax 1 586 331 2588 Leading the World with Innovative Cryopreservation Technology Solutions IMPORTANT INFORMATION We at Custom Biogenic Systems are proud of our work and appreciate your purchase of this product With proper care this equipment will be trouble free for many years to come Before setting up and using your new cryogenic storage unit first check to see that all parts are accounted for and that no damage has occurred during shipping Also read this manual completely before proceeding to set up If at any time you are unsure of the procedures for set up and use of this product please contact CBS or your CBS sales representative NOTE If equipment is used in a manner not specified by Custom Biogenic Systems the protection provided by the equipment will be impaired PRODUCT WARRANTY Custom Biogenic Systems warrants all manufactured cryogenic equipment to be free from defects in workmanship or materials for a period of one year Custom Biogenic Systems liabilities under the warranty shall be limited to correcting or replacing defective workmanship or materials A claimant under the warranty must notify Custom Biogenic Systems within 10 days after the discovery of the defect
13. Custom Biogenic Systems reserves the right at their discretion to correct the defect s in the field without return shipment to the factory This warranty does not cover defects on cryogenic equipment resulting from abusive handling and subsequent structural failure Serial Number Model number For Technical Assistance Call 1 800 523 0072 U S Only Phone 586 331 2600 Fax 586 331 2588 www custombiogenics com _ www custombiogenics com CEB Ss lt LIQUID NITROGEN SAFETY WARNING LIQUID NITROGEN IS AN EXTREMELY COLD LIQUID LIQUID NITROGEN EXISTS AT 196 C BECAUSE OF THESE COLD TEMPERATURES LIQUID NITROGEN WILL CREATE A FROST BITE IF THEY COME INTO CONTACT WITH SKIN NEVER ALLOW DIRECT SKIN CONTACT WITH LIQUID NITROGEN OR SERIOUS FROST BITE WILL RESULT ALTHOUGH LIQUID NITROGEN ITSELF IS NON TOXIC WHEN RELEASED INTO A CONFINED SPACE IT CAN DISPLACE OXYGEN CAUSING ASPHYXIATION ENTERING AN OXYGEN DEFICIENT ROOM CAN CAUSE UNCONSCIOUSNESS WITHOUT WARNING ALWAYS CHECK AIR QUALITY UPON ENTERING A ROOM WHERE CRYOGENIC LIQUIDS ARE BEING USED AND IF POSSIBLE HAVE AIR RESPIRATORS AVAILABLE INTRODUCING EQUIPMENT WHICH IS AT ROOM TEMPERATURE INTO LIQUID NITROGEN IS ALWAYS SOMEWHAT HAZARDOUS BEWARE OF SPLASHING AND BOILING WHICH MAY OCCUR ALL PERSONNEL PERFORMING THESE OPERATIONS SHOULD BE FULLY INFORMED OF PROPER HANDLING PROCEDURES AND SHOULD ALWAYS WEAR A FACE SHIELD AND PROTECTIVE CLOTHING LIQUID NITR
14. Instructions 4 Phillips Head Screws 10 Replace the back cover of freezing chamber by tightining the 4 phillips head screws G Sample Probe Calibration Custom Biogenic Systems amp Controlled Rate Freezing System 1 Open the chamber door A www custombiogenics com 20 CB 5 Operating Instructions Sample Probe C Mem EWILERTZ Hagen mauu MI du p ee M MS BER y d 3 Place chamber probe into ice bath and allow 10 15 seconds for sample probe temperature to stabilize 1 Custom Biogenic Systems Controlled Rate Freezing System Version 1 3 Custom Biogenic Systems Custom s Calibration Screen Thermocouple Calibration Thermocouple Acquired Temp 189 098 0293 Actual Temp gt 196 000 5 0 000 Calibration Config Fields 4 Click on the drop down box that is under the header of Thermocouple and select chamber C www custombiogenics com T CBS a Operating Instructions 1 Custom Biogenic Systems Controlled Rate Freezing System Version 1 3 Custom Biogenic Systems Custo m Calibration Screen Thermocouple Calibration Thermocouple al 4 c M D prn Acquire Acquire Temp Temp Acquired Temp 189098 0293 Actual Temp 196 000 5 0 000 Calibration Config Fields 5 Click on the white box that is labeled Acquire Temp D 6 Remove the sample thermocouple fr
15. Log In s f Custom Biogenic Systems Controlled Rate Freezing System Custom Biogenic Systems Uie Audit Utility Controlled Rate Freezing System Custom is Main Menu View Invalid Log In s Delete Invalid Log In s View Old Audit Functions Data User Accounts 9 Return i Audit Functions vi Invalid Log In Summary Date 5 31 2012 Time 10 22 AM 1 Atthe main menu screen click the AUDIT FUNCTIONS button A Se tered Reason for Invalid Log In The Username or Password is incorrect Please try again 2 At the Audit Utility menu click VIEW INVALID LOG IN S button B 3 To print the invalid log ins click the PRINT button C 4 To return to the Audit utility menu click the RETURN button D Return www custombiogenics com 24 ELT Operating Instructions Delete Invalid Log In s Custom Biogenic Systems Controlled Rate Freezing System Custom Biogenic Systems Audit Utility View the Audit Trail View Invalid Log In s Controlled Rate Freezing System Main Menu Delete Invalid Log In s View Old Audit Functions maaari Data User Accounts 9 Calibration Config Fields 1 Atthe main menu screen click the AUDIT FUNCTIONS button A 2 Atthe Audit Utility menu click DELETE INVALID LOG IN S button 3 In the next window if you would like to delete the invalid log in s click YES C 4 Inthe next window if you would like to save the inva
16. OGEN SHOULD NEVER BE USED IN COMBINATION WITH OTHER SUBSTANCES WITHOUT KNOWING WHAT THE RESULT WILL BE WHEN IN DOUBT CONTACT A COMPETENT AUTHORITY HANDLING LIQUID NITROGEN Personnel handling liquid nitrogen should be thoroughly instructed as to the nature of these materials Proper training is essential to safety and will ensure the accident free use of this equipment Because of its low temperature liquid nitrogen will cause frost bite to the skin much in the same way as hot liquids can burn For this reason always wear the proper protective clothing when handling these materials It is advised that during use handlers of liquid nitrogen should protect themselves by wearing goggles or face shields cryogenic gloves large enough to allow quick removal and a cryogenic apron It is preferable that shoes worn at these times have high tops as to not permit accidently spilled liquid from entering as well as pant legs which come down over the tops of shoes for further protection Also because of the extremely low temperatures liquid nitrogen should only be handled and transported in approved containers Many materials become brittle and may shatter when put into contact with liquid nitrogen www custombiogenics com C E L5 TABLE OF CONTENTS Introduction 1 Unpacking 1 Initial Inspection 1 Detected Damage 2 Equipment Return 2 Installation 2 Connection 2 Power Connections 3 Thermocouple Connections 3 Liquid Nitrogen Supply Conn
17. ONS This menu button brings up the audit trail details after enabling User Accounts Security F USER ACCOUNTS This menu button allows the user to configure multiple users and passwords and also to enable or disable security There are also different levels of access that can be assigned to each user G EXIT Closes software H Preview This menu button allows the user to preview a previously programmed profile or to see a graph of the rates in their programming as they make changes This function is intended to simplify the creation of freezing profiles LOGOUT This menu button is only usable when security is enabled in the user accounts menu It allows users to logout of the system J CONFIG FIELDS This menu button allows the user to define the labels only for the database fields that can be saved for each freeze run This information is entirely optional and is used for database searching of freeze run information www custombiogenics com C B Ss Operating Instructions Turn On Computer 1 Push and release the POWER button not shown 2 After the computer boots up click on the shortcut to the cryogenic freezing software A to launch the application Create a Program Custom Biogenic Systems Controlled Rate Freezing System Custom Biogenic Systems Controlled Rate Freezing System m Main Menu View Old Audit Functions CORO Data User Accounts 9 Calibration Config Fields
18. be jack located in the upper left corner of the fan guard If the alarm goes away you know the problem is in the probe If it doesn t go away continue your way back towards the computer checking the connections This alarm is NOT self correcting and only goes away once the cause has been fixed and the software re started Isolate the open or broken connection s The most common cause is within the thermocouple connection jacks anywhere between the tip of the probe and the computer Start by shorting the Male Chamber probe jack located in the rear 2100 housing If the alarm goes away you know the problem is in the probe If it doesn t go away continue your way back towards the computer checking the connections C E TROUBLESHOOTING GUIDE ALARMS CONDITIONS SOLUTIONS Tracking Alarm The chamber temperature conecto has been deviated from the which means that the alarm target temperature for the will reset once the values programmed amount of time come back into range Verify and temperature deviation proper LN2 supply operation i e correct pressure 18 22 psi 22 psi max and use of the shortest possible transfer hoses Also alarm time and deviation are saved along with the steps in a freezing profile The default values are 5 degrees of deviation for 1 min These may need to be adjusted depending on the installation of the user s LN2 supply www custombiogenics com C_
19. e utilized to properly connect to main power The notebook PC has its own universal power supply that operates between 100 240VAC and can be plugged into an available power outlet in the rear electrical panel See 2 3 5 Optional Power Connections Thermocouple Connections The rate freezer uses two different Type T thermocouples labeled as CHAMBER and SAMPLE probes The CHAMBER probe is factory installed and should not need to be adjusted The SAMPLE probe connection is located on the inside of the chamber in the upper left hand corner of the fan guard Insert the male end of the SAMPLE probe into the female jack in the fan guard The thermocouple plugs are designed to only fit one way so make sure that the male and female sides of the plug are lined up correctly USB Connections USB connection are connected at the factory make sure they are connected properly with a good connection Liquid Nitrogen Supply Connection The liquid nitrogen supply connection is located on the right rear corner This connector accepts a standard LN2 transfer hose Side view of the Controlled Top view of the Liquid Rate Freezer showing the Nitrogen Supply tank show liquid nitrogen hose connec ing the liquid nitrogen hose tion point connection point Liquid Nitrogen Hose Storage For prolonged storage before installation re pack the rate freezer in the shipping container and store in a cool dry area We do not recommend
20. ection 3 Storage Operating Instructions 4 Turn On Computer 6 Create a Program 6 Save a Program 7 Edit a Program 8 Run a Program 9 Preview a Profile 10 View Old Data 11 Search Old Data 11 Add a User 12 Change a Password 13 Change a Users Security 14 Disable Security 15 Calibration 16 Chamber Probe Calibration 17 Sample Probe Calibration 20 View the Audit Trail 24 View Invalid Log In s 24 Delete Invalid Log In s 25 Configuring Fields 25 Logout of the System 26 Exiting the System 26 Basic Operation 27 Theory of Operation 27 The Notebook Computer 27 The Hold Function 27 Alarm Deviation 27 Advanced Setup 28 Printing Options 28 Audit Trail Functions 28 Sample Probe Placement 29 Proper Run 31 Trouble Shooting 32 2101 Rate Freezer Part I D 34 2101 Rate Freezer Plumbing Part I D 35 Cleaning amp Maintenance 36 Solenoid Valve Maintenance 36 www custombiogenics com CBS Initial Installation Introduction Welcome to the Custom BioGenic Systems model 2101 Controlled Rate Freezing System This system con sists of a freezing chamber computer controlled rate freezing software optional rolling cart a sample rack a sample probe and a liquid nitrogen transfer hose The software that is provided and comes preloaded on your 2101 controlled rate freezer computer operates using the same navigation and conventions as windows based operating systems menus basic commands etc This manual will provide you with the info
21. eze Done By 11 28 2001 12 36 53 AM Hi A 00 00 00 00 10 00 00 20 00 00 30 00 00 40 00 00 50 00 01 00 00 01 16 43 SBSSERVER Users RDodge My Documents Controlled Rate Freezer Info 2100 INFO Load Data 42100 Programs test tst E 1 Data Viewer Screen Test Graph View Profile Freeze Done 11 28 2001 12 36 53 AM Alarm Time hh mm ss 09 1 00 Alarm Deviation C 5 00 Profile used 2 SBSSERVER Users RDodge My Documents Controlled Rate Freezer Info 2100 INFO Load Data Print Rep ort 42100 Programs test tst www custombiogenics com 31 CEB lt gt TROUBLESHOOTING GUIDE ALARMS CONDITIONS Sample Probe Alarm Chamber Probe Alarm www custombiogenics com CAUSES One or both of the thermocouple s conductors are broken or disconnected This can occur anywhere between the tip of the probe and the computer One or both of the thermocouple s conductors are broken or disconnected This can occur anywhere between the tip of the probe and the computer 32 SOLUTIONS This alarm is NOT self correcting and only goes away once the cause has been fixed and the software re started Isolate the open or broken connection s The most common cause is within the thermocouple connection jacks anywhere between the tip of the probe and the computer Start by shorting the Female sample pro
22. g System Custom Biogenic Systems Controlled Rate Freezing System m Main Menu View Old Audit Functions FORO E Data User Accounts g m Alarm Deviation C 54 Alarm Time Mins ism Profile Path Date modified 1 20 2003644 AM Fi Optional 2 ml sample with 7 to 12 percent 1 20 2003 6 44 ile Skin Packet 4 x6 inch with 10 percent Cryop 1 20 2003 6 44 ile Standard Blood Bag Bone Marrow 1 20 2003 6 44 AM ile Standard Embryo Freeze using 25 or 50 ml 1 20 2003 6 44 ile Standard Microtest Tray Freeze 1 20 2003 6 44 AM ileType 4 i File name S Files of type Custom Pattem prf X 1 Atthe main screen press the PREVIEW button A 2 At the preview profile screen select a profile to load and click B 3 Watch the screen C display the freezing protocol 4 When you have finished previewing the protocol hit the OKAY button D to return to the main menu 5 To preview a different program click PREVIEW NEW PROGRAM E www custombiogenics com 10 CB 5 Operating Instructions View Old Data Custom Biogenic Systems Controlled Rate Freezing System peen Check the boxes for the Fields to Custom Biogenic Systems EE Data Query mn 2 a A little more stuff Time of Test 9 07 00 00 PM Random Number 9 0 00 Test Controlled Rate Freezing System Temperature of chamber 9 0 00 HofEmbryos
23. lick on the drop down box that is under the header of Thermocouple and select chamber C 1 Custom Biogenic Systems Controlled Rate Freezing System Version 1 3 omni Biogenic Systems Screen Thermocouple Calibration E 1 03 K5 0 30 D M Chamber T D Acquired Temp 189 098 0 293 Actual Temp 196 000 5 0000 Calibration Config Fields 5 Click on the white box that is labeled Acquire Temp D www custombiogenics com 18 CB Ss Operating Instructions dp A 4 4 Jp s 4 y 6 Remove the chamber thermocouple from the ice bath allow probe to dry before placing in a container of liquid nitrogen Allow 10 15 seconds for chamber probe temperature to stabilize Custom Biogenic Systems Controlled Rate Freezing System Version 1 3 Custom Biogenic Systems s Calibration Screen Thermocouple Calibration Thermocouple 103 n did 3 0 30 Chamber f Reus Acquired Temp 189098 0 29 Actual Temp 196 000 5 0000 Calibration Config Fields 7 Click on the white box that is labeled Acquire Temp E 8 Remove the probe from liquid nitrogen and allow the probe to return to room temperature 4 Chamber Probe Y 1 57 9 Locate and replace the chamber probe by tighting the brass fitting using 3 8 wrench F _ www custombiogenics com CEB S 19 Operating
24. lid log in s click NO D Configuring Fields B Custom Biogenic Systems Controlled Rate Freezing System Custom Biogenic Systems Controlled Rate Freezing System mu Main Menu View Old Audit Functions Data User Accounts 9 Calibration Config Fields 1 At the main menu click the CONFIG FIELDS button A 2 The Header Config Fields screen will appear 3 Change the required field names B by moving the pointer to it and click 4 Use the delete and backspace on the computer keyboard to remove the existing field name 5 By using the computer keyboard you can now enter a new field name for each field When you have completed all of your changes click on the OK button D If you do not want to save your changes click the cancel button C www custombiogenics com 25 QC ELT Operating Instructions Logout of the System f Custom Biogenic Systems Controlled Rate Freezing System Custom Biogenic Systems Controlled Rate Freezing System 5e Main Menu View Old Audit Functions Wes Data User Accounts 9 Calibration Config Fields 1 At the main menu screen click the LOGOUT button A Exiting of the System Custom Biogenic Systems Controlled Rate Freezing System Custom Biogenic Systems Controlled Rate Freezing System m Main Menu View Old Audit Functions Data User Accounts Calibration Config Fields 1 At the main menu screen click the EXIT button A
25. of this manual NOTE If you desire a negative number for the target temperature you must enter a minus sign for temperatures below zero Example 50 degrees C NOTE This software does not require an end of program command www custombiogenics com 6 CEB lt gt pS et Operating Instructions Save a Program Program Profile Screen TS ee 88 seen Name Date modified D 1 20 2003 6 44 Optional 2 ml sample with 7 to 12 percent 1 20 2003 6 44 skin Packet 4 x6 inch with 10 percent Cryop 1 20 2003 6 44 AM Desktop Standard Blood Bag Bone Marrow 1 20 2003 6 44 AM 2 4 Standard Embryo Freeze using 25 50 ml 1 20 2003 6 44 Standard Microtest Tray Freeze 1 20 2003 6 44 AM DECOTE AERE S FPHREHHH4 T NN aves aa Pe Tea TE N RI See Libraries le Computer Network Alarm Deviation C 2500 Alarm Time Mins 2 000100 Profile Program Path SSS After you have created a program you may save edit or delete it To save a program 1 Create a program see page 6 steps 1 8 2 Click on the SAVE PROGRAM button A 3 Type the name you wish to give to this program in the save profile window B 4 Click on the OK button C The program is now saved in the computer www custombiogenics com 7 C_B S Opera
26. om the ice bath allow probe to dry before placing in a container of liquid nitrogen Allow 10 15 seconds for sample probe temperature to stabilize www custombiogenics com 22 CB 5 Operating Instructions 1 Custom Biogenic Systems Controlled Rate Freezing System Version 1 3 Custom Biogenic Systems wa Calibration Screen Thermocouple Calibration Thermocouple 109 BE Chamber v Equation Acquired Temp 189098 029 Actual Temp gt 196 000 5 0000 Calibration Config Fields 7 Click on the white box that is labeled Acquire Temp E 8 Remove the probe from liquid nitrogen and allow the probe to return to room temperature 9 Plug chamber into power source and resume normal operation www custombiogenics com 23 CEB Ss Operating Instructions View the Audit Trail Custom Biogenic Systems Controlled Rate Freezing System Audit Functions vi Custom Biogenic Systems Uie Audit Utility Controlled Rate Freezing System Ml View the Aucit Trail Custom 5 BloGenic T Main Menu wu Start Freeze Run Delete Invalid Log In s View Old Audit Functions Data User Accounts g Return Calibration Config Fields 1 At the main menu screen click the AUDIT FUNCTIONS button A 2 Atthe Audit Utility menu click VIEW THE AUDIT TRAIL button B 3 To print the audit trail click the PRINT button C 4 Toreturn to the Audit utility menu click the RETURN button D View Invalid
27. perator 2 Run preview view old data log out calibration and exit Operator 3 Preview log out calibration and exit 5 Click the OK button H when finished www custombiogenics com 12 Se Operating Instructions Change a Password f Custom Biogenic Systems Controlled Rate Freezing System Custom Biogenic Systems Administration Utility User Name Level Days Unitl Password Expires Controlled Rate Freezing System EERE m Main Menu View Old Audit Functions Data User Accounts 9 Y UU Disable security Calibration Config Fields l Edit User Information Password Retype Password User Level Administrator 1 Atthe main screen click the USER ACCOUNTS button A 2 Atthe administrator utility menu select and highlight the user that you wish to change the password for located in the far left box B 3 Select the EDIT USER button C 4 Type in the new password in both the PASSWORD D RETYPE PASSWORD E fields Make sure both fields contain the exact same password passwords are case sensitive 5 Click the OK button F when finished www custombiogenics com 13 CB S Operating Instructions Change a User s Security Access Level Custom Biogenic Systems Controlled Rate Freezing System Custom Biogenic Systems Administration Utility Level Days Unitl Password Expires Controlled Rate Freezing System z s Main Men
28. r NORMAL computer functions i e internet browsing networking word processing etc with the exception of the uses defined in this manual such as printing Because it is strictly a controller for the chamber the notebook computer does not have any anti virus software and has its network options DISABLED Any uses other than the ones explained in this manual will be considered to void the warranty The Hold Function Another important aspect of the Cryogenic Rate Freezer is the fact that ANY STEP WITHIN A PROFILE THAT IS PROGRAMMED WITH A ZERO DEGREE RATE AUTOMATICALLY GETS INTERPRETED BY THE SOFTWARE AS A HOLD FUNCTION This means that if the step is programmed to cool at 0 per minute the machine will attempt to cool to the set point as fast as possible and then hold there until the Continue button is pressed regardless if any hold time is programmed in This is typically done during the first step in a profile based on how the user prepares the samples for insertion into the chamber EXAMPLE A user is freezing 2ml vials of fluid They keep the samples in an ice bath until they are ready to insert them into the chamber An ice bath is typically no warmer than 4 C so the user programs the first step in the profile to cool at 0 per minute down to 4 C The ZERO DEGREE RATE causes the chamber to cool to and hold at 4 C The user then loads the samples into the chamber presses the Continue button and the freezing profile ad
29. re to check that those items were also received If something that you ordered was not received please contact CBS immediately www custombiogenics com CEB lt gt Ed Initial Installation Detected Damage Once all items are removed from their packaging check them for damage Also check that the unit is as ordered If damage is detected after unpacking the rate freezer immediately report it to the shipping agent and re pack the rate freezer for return to the factory as described in the following section Equipment Return Before returning damaged or malfunctioning equipment to the factory for repair contact the sales organization from which you purchased the equipment A Return Merchandise Authorization RMA number MUST be obtained from the factory before returning equipment for any reason Installation Specifications The rate freezer is intended to operate in the following environment Indoor use only Installation Category II per IEC664 Pollution Degree Level Il per IEC60601 1 Temperature 10 C to 50 C operating per IEC60601 1 Humidity Maximum relative humidity 80 for temperatures up to 31 C decreasing linearly to 50 relative humidity at 40 C Rate Freezer Power Requirement 120VAC or 220VAC depending on destination country Check indication on unit Liquid Nitrogen Supply Pressure Must be between 18 22 psi 22 psi max Input Power The chamber voltage depends on destination country and should be specified
30. rmation you will need to operate maintain troubleshoot and safely operate this equipment It is of the utmost importance that you completely read and understand the material in this manual before attempting to install operate or service this equipment Custom Biogenic Systems Controlled Rate Freezing System Main Menu oo CT E M Systems um 6 Unpacking Your 2101 Rate Freezer will arrive on a pallet in a box that is 30 x 30 x 30 L x W x H open a pallet that is 48 x 40 Before unpacking check for any visual damage if there is visual damage be sure to sign the Proof of Delivery as damaged and notify Custom BioGenic Systems Start by cutting the banding that is hold ing the box to the pallet Open the box from the top and remove the foam that is surrounding the unit Next carefully cut the box around the unit and pull the box off of the pallet When the unit is the only thing seen on the top of the pallet carefully lift it off and set it in the desired location NOTE It is recommended that two people lift the unit due to the weight and size of the unit Initial Inspection Check to make sure that you have received your unit in its entirety At a minimum you should receive the freezing Chamber the controller a freezer rack a sample probe and a liquid nitrogen transfer hose If you order optional equipment or any other items that were suppose to ship with this order make su
31. rofile changes It also keeps track of invalid log ins and locks the system out after repeated failed attempts It only operates if security is Enabled in the user accounts menu The audit trail is saved as an un modifiable file and builds up indefinitely until the hard drive runs out of space It is possible to disable the audit trail while still retaining user account functionality Consult factory for details www custombiogenics com 28 CB Sample Probe Placement Sample probe placement is very important The position of this probe determines the accuracy and repeatability of the sample trace line on the viewer screen see page 24 Vial Probe Placement Probe tip must be equal distance from each side of the vial and from the bottom of the vial Probe Tip Bag Press Probe Placement Jg J t Plastic probe end must be positioned in the center of the fluid that is inside the bag making sure there is no contact with air bubbles that may be present in the bag www custombiogenics com 29 QC ET Sample Probe Placement Canister Probe Placement Plastic probe end must be positioned in the center of the fluid that is inside the bag making sure there is no contact with air bubbles that may be present in the bag www custombiogenics com 30 OCES Proper Run Custo ER Data Viewer Screen rece Test Graph View Profile Header Information Fre
32. s does exist but only builds up when the ALL DATA view is selected for an entire freeze run The vast majority of users will not be concerned with this effect When viewing data after a freeze run click on the ES button on the main menu to select a file to view Use the DATA VIEWING FUNCTIONS A indicated by the small magnifying glass cross hair and hand icons located to the right of the graph to view the data Clicking on these icons reveals zoom selection and manipulation modes The DATA VIEWING FUNCTIONS are also available during a freeze run H zelgni da Advanced Setup The following options require the modification of an INI file located in the hard drive of the notebook PC C Program Files Cryogenic Rate Freezer release custom biogenic systems data crfs DO NOT ATTEMPT TO MODIFY THIS FILE UNTIL THIS ENTIRE MANUAL IS READ AND UNDERSTOOD After the INI file is modified correctly press ctrl S to save the INI file in its modified form Only then will the changes take effect Printing Options There are several printing options that can be enabled through the modification of the INI file These are as follows SHORT info header and graph default setting LONG info header graph and every data point taken from the thermocouples during the run GRAPH graph only printouts Audit Trial Functions The audit trail is an advanced feature that allows the tracking of freeze runs new users added users deleted users edited and p
33. ting Instructions Edit a Program Custom Biogenic Systems Controlled Rate Freezing System Program Profile Screen Custom Biogenic Systems Controlled Rate Freezing System Main Menu Temperature View Old Audit Functions roa Data User Accounts 9 Calibration Config Fields Alarm Deviation C 5 00 Alarm Time Mins 00 01 00 Profile Program Path q C Rate Freezer Data System Files Profiles mil prf B Een Ies F zT 1 20 2003 6 44 AM Skin Packet 4 x 6 inch with 10 percent Cryop 1 20 2003 6 44 AM Standard Blood Bag Bone Marrow 1 20 2003 6 44 AM LE Standard Embryo Freeze using 25 or 50 ml 1 20 2003 6 44 Standard Microtest Tray Freeze 1 20 2003 6 44 AM Custom BioGenic Systems has provided you with six preset programs that you can use as templates for many common freezing processes Both User created and preset programs can be edited 1 At the main menu screen press the PROGRAM button A At the program profile screen click the EDIT PROGRAM button B Locate the program to be edited C and click OK D to open it Move the pointer to the step you wish to change and click on that area E Use the backspace or delete keyboard keys to delete the value you wish to change Enter a new value Repeat steps 4 7 until yo
34. u View Old Audit Functions Data User Accounts 9 Calibration Config Fields 1 Edit User Account Edit User Information Password Retype Password User Level Administrator Cancel 1 Atthe main screen click the USER ACCOUNTS button A 2 Atthe administrator utility menu select and highlight the user that you wish to change security level located in the middle box B 3 Select the EDIT USER button C 4 From the USER LEVEL pull down D select the level of security you wish to assign the user Access Allows Administrator Access to all areas Operator 1 Program run preview view old data log out calibration and exit Operator 2 Run preview view old data log out calibration and exit Operator 3 Preview log out calibration and exit 5 Click the OK button E www custombiogenics com CEB lt gt 14 _ es Operating Instructions Disable Security f Custom Biogenic Systems Controlled Rate Freezing System Custom Biogenic Systems Administration Utility User Name Level Days Unitl Password Expires 4 Administrator Never Controlled Rate Freezing System mu Main Menu View Old Audit Functions Data User Accounts 9 Calibration Config Fields 1 Atthe main screen click the USER ACCOUNTS button A Delete User 2 Atthe Administration Utility menu click the DISABLE SECURITY check box B 3 Click the EXIT button C
35. u have made all the changes you desire If you wish to save your changes click the save program button F see page 7 for saving instructions If you do not wish to save your changes click the return to main menu button G www custombiogenics com 8 2 355114 Operating Instructions Run a Program f Custom Biogenic Systems Controlled Rate Freezing System Custom Biogenic Systems amp Bx Freezing Information S More Stuff Random Number 9 0 00 Controlled Rate Freezing System an a c WofEmbryos 2 0 Main Menu Test instructions View Old Audit Functions de Data User Accounts orments Patient Comments Calibration Config Fields Selec EE Every time you run a program you create a unique set of data In many cases you will wish to save this data using a unique file name if you don t your old program data will be overwritten by the latest data 1 Atthe MAIN MENU screen click the START FREEZE RUN button A 2 Atthe FREEZING INFORMATION screen fill in the optional fields B with the information you desire NOTE The freezing information B is a form that is customized to each customer s need The information entered will differ according to use and customer 3 Click the SELECT FREEZE PROGRAM button C fe Run Screen Recent Data All Data View Program Cool Demand Hold Time Step Rate C Min Temp C 0 0 00 4 00 Lookin Profiles e aa Savein Data
36. vances to the next step It will then continue to advance through the programmed steps as long as another ZERO DEGREE RATE is not encountered Alarm Deviation The alarm deviation consists of two things 1 The temperature difference between the CHAMBER and TARGET values that has to exist for a TRACKING ALARM to occur and 2 The amount of time that these two values are not equal before a TRACKING ALARM occurs The default settings are 5 C for 1 minute This means that if the CHAMBER temperature is deviated 5 C or more from the TARGET temperature for 1 minute a TRACKING ALARM occurs These values can be changed in the PROGRAM menu www custombiogenics com 27 QC ET Reviewing Data Data can be viewed as it is being acquired and after the freeze run has completed When viewing data during a freeze run there are two tabs at the top of the graph labeled RECENT DATA and ALL DATA The RECENT DATA view is selected by default and shows only the most recent portion of the freeze run The ALL DATA view is used to see the entire run up to the current time Due to the fact that the software is continually updating and displaying a growing number of data points the same loop of code takes longer and longer to execute as time goes on This manifests itself as a time loss as compared to real time It has been observed to be 10 15 seconds of loss per hour While it does not adversely affect the operation of the Cryogenic Rate Freezer this time los

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