14-02-016-D CryoPRO Workstation User Manual
Contents
1. Page 10 14 02 016 Revision D CryoPRO Workstation User Manual Table C Guidance and manufacturer s declaration Electromagnetic Immunity for EQUIPMENT and SYSTEM that are not LIFE SUPPORTING The CryoPRO Workstation is intended for use in the electromagnetic environment specified below The customer or the user of the CryoPRO Workstation should ensure that it is used in such an environment IMMUNITY IEC 60601 COMPLIANCE TEST TEST LEVEL LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the CryoPRO Workstation including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conad 3 Vrms Recommended separation distance RF o d 1 2 VP IEC 61000 4 6 80 MHz Radiated RF 3V m d 1 2VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 9 GHz d 2 3 VP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol o 4 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE2. Process 8 labtech1 Lab Technician Connected CryoPRO Workstations CryoPRO Workstation ID Data Present SynGenX System Sida CryoPRO Workstation ID 104 100011 Blood Unit ID 123456789 Bag Set Lot DOWNLOAD CLEAR Figure 20 Acceptable entry with green check marks 66 A green check mark will indicate an acceptable entry a red X will indicate an unacceptable entry Verify information associated with a red X and re enter as appropriate 67 Click the DOWNLOAD button to download the data located on the Control Module 68 Review report and obtain supervisor approval as indicated 69 To add a note to the report move cursor to the field beside USER NOTES Enter appropriate information and then click the SAVE USER NOTES button 70 To print the report click the PRINT button The print preview window is displayed Click FILE then PRINT Select the appropriate printer and click the PRINT button 71 To save the report as a PDF file click the SAVE AS PDF button Select the file location and edit the file name if applicable and click the SAVE button 72 To close the file click the red X in the upper right window 73 To export the file click the EXPORT button Select the file location and edit the file name if applicable The file will be saved in CSV format 74 After data transfer the CryoPRO Workstation is ready for subsequent processing as indicated by the presence of the symbol on
3. CryoPRO Workstation User Manual CryoPRO Workstation Processing Report Error On rare occasion data strings are not completely deleted within the CryoPRO Workstation after data has been transferred into DataTrak Should this happen this remaining data may be misinterpreted during the next download If this occurs a note will appear in the USER NOTES section indicating that the process was completed normally but that a data communication storage error existed for that run No further action is required on the part of the user Processing Report for Blood Unit ID 1234567890 CryoPRO Workstation 104 100011 CryoPRO Workstation Processing Report Unit ID 1234567890 EE EXPORT ET PRINT Cooling m Priming Dispensing ee Dispense Complete eee Plate Temperature Error Process Complete MM rere completed successfully 600 500 1000 1200 1400 1600 Time Seconds labtech1 Cryoprotectant Addition Data Transfer Time 12 23 2014 9 58 48 AM Duration sec 900 CryoPRO Workstation 104 100011 Volume ml 4 99 Bag Set Lot 3774 0000 Graph Review Status Unreviewed Bag Set Lot Expiration 2015 06 Process Completed Successfully Date Time User Text 12 23 2014 9 58 48 AM DataTrak Process completed normally However data communication storage Figure 20 Processing Report showing a data storage error Page 36 14 02 016 Revision D CryoPRO Workstation User Manual Section 9 CryoPRO Workstation Speci
4. GSynGen amp CryoPRO Workstation USER MANUAL Sacramento CA USA support syngeninc com Customer Service 1 844 363 0709 or 1 916 256 2423 Fax 1 916 706 0832 CryoPRO Workstation User Manual Copyright 2015 by SynGen Inc All rights reserved Permission is granted to the owner to make one copy for record retention and internal personal use This does not create a license to the owner under any copyright trademark patent or to other intellectual property right of SynGen Inc For additional copies of this manual contact SynGen Inc or your local representative Trademark SynGen Inc propriety trademarks are property of SynGen Inc and are protected under U S trademark laws and international treaties SynGen Inc SynGenX 1000 and propriety trademarks and service marks may not be used except as provided by law without prior written consent of SynGen Inc BD and Luer lok are trademarks of Becton and Dickinson Company Excel is a registered trademark or trademark of Microsoft Corporation in the United States and or other countries synGen Inc Sacramento CA USA 916 706 0923 EC REP MDSS GmbH Schiffgraben 41 D 30175 Hannover C It is strongly recommended that all users read this manual in its entirety before using the CryoPRO Workstation Page 1 14 02 016 Revision D CryoPRO Workstation User Manual Table of Contents POCO Fe TIVO UCU senn E E 4 OU PN AE A ede pee an
5. While the CryoPRO 2 Cryopreservation Storage Bag Set and the Disposable Cartridge may be operated without the use of the CryoPRO Workstation the CryoPRO Workstation provides the functions of mixing cooling and addition of the cryoprotectant in one unitary workstation This minimizes the need for multiple power cords crisscrossing tubing lines and widely separated operating controls for each individual unit The CryoPRO Workstation comes programmed from the manufacturer with a 2 minute mixing motion for the Disposable Cartridge a cryoprotectant dispensing syringe pump that flows at a rate of 5 mL in 15 minutes and an Orbital Mixing Thermoelectric Cooling Module that maintains the buffy coat between 4 and 6 C The CryoPRO Workstation is capable of a 10 second to 20 minute mixing motion range for the Disposable Cartridge the cryoprotectant dispensing syringe pump can flow at a maximum rate of 5 mL in 1 minute and the orbital cooling mixer can maintain the buffy coat between 1 and 19 If desired for other applications these operating values either singly or in combination can be supplied directly from SynGen Inc They may also be re programmed in the field by the operator using a standard digital interface and off the shelf software Contact SynGen for re programming interface and instructions The CryoPRO Workstation is intended for use under routine laboratory conditions Overview In addition to simplifying the use of the Cry
6. access tubing to the input tubing on the CryoPRO 2 Cryopreservation Storage Bag Set per manufacturer s instructions for use The tubing length between the Disposable Cartridge and the Air Filter should be approximately 14 1 inches to facilitate lean process flow and allow the Mixing Chamber to be seated in the ROTATING MIXING CHAMBER HOLDER 14 Label the Freezing Bag and Sampling Bulb of the CryoPRO 2 Cryopreservation Storage Bag Set Ensure that labels are in place before removing from the sterile connection device Buffy Coat Transfer 15 Remove the Disposable Cartridge from the Control Module by squeezing both locking tabs and lifting straight up Figure 5 Disposable Cartridge removed from Control Module Page 20 14 02 016 Revision D CryoPRO Workstation User Manual 16 Place the Disposable Cartridge in the OSCILLATING DISPOSABLE CARTRIDGE HOLDER so that the label is facing to the right locking tabs will be parallel to the back of the Workstation Squeeze the locking tabs and then set onto the stand Release the tabs and ensure that the Disposable Cartridge is latched into place Figure 6 Disposable Cartridge latched onto the OSCILLATING DISPOSABLE CARTRIDGE HOLDER 17 Place the Mixing Chamber into the Rotating Mixing Chamber Holder so that the DMSO Filter is away from you 12 o clock 18 Remove and retain the cap from the DMSO filter and open the clamp below the Air Filter W eE ar Figure 7 Mixing Cham
7. for reasons other than those caused by defects in materials or manufacturing defect such as improper handling of the machine misuse accident or non compliance with the User Manual is not covered under the SynGen warranty program and such device will be replaced or repaired at the charge of the end user Any alterations or modification made to the device other than those made by SynGen will render the warranty null and void SynGen will not be responsible for any consequential or incidental damages resulting from device malfunction or loss of use of device SynGen shall under no circumstances be liable for consequential or economic damage that may be an indirect or direct consequence of a defective part Page 38 14 02 016 Revision D
8. will always be available for specific questions or clarifications For assistance with technical or application issues please contact your account representative or SynGen Inc Customer Service at 1 844 363 0709 or 1 916 256 2423 outside of the USA or by email at support syngeninc com Contact hours for SynGen Customer Service are 9 00 to 17 00 Pacific Time Email submissions will be responded within 1 business day of receipt synGen Inc Sacramento CA 95825 Email support syngeninc com Customer Service at 1 844 363 0709 or 1 916 256 2423 outside of the USA Fax 1 916 706 0832 Page 32 14 02 016 Revision D CryoPRO Workstation User Manual Section 8 Troubleshooting The Troubleshooting section describes the appropriate steps to take in the event that a processing run did not perform as intended For additional troubleshooting or technical assistance contact SynGen Inc Customer Service at 1 844 363 0709 or 1 916 256 2423 outside of the USA or by email at support syngeninc com CryoPRO Workstation Alerts and Error Codes The table below identities the displayed alerts and error codes for the CryoPRO Workstation and appropriate user actions All alerts and errors include an audible beep in addition to the LED display DISPLAYED DESCRIPTION ACTION BY USER CHARACTER MIXING THERMOELECTRIC COOLING Do not use the CryoPRO Workstation MODULE communication failure for further processing Contact SynGen Customer Service and
9. yarn eae pers N E dp ita E 4 e E A EEA ace RAA T AEE E E N EA E A E ATE 5 AOE O r saucers canna T E aos E EEE se Deus S E EET 6 ONE Uy e I T E ea Useareasieast 7 VT EE P NE A E E 7 E EE E A A A eee 7 Safety and EMC Compliance Information sssesssessseseseressrsssrssrresressresressresrreseresreseressresseesreeseres 8 Sa O EE o e E E T E A ET E E A A A EA 8 Section 3 CryoPRO Workstation Description eeesseesseesseesssoesseosssooesoeessossssesssosessosssessssesssee 12 CHOFRO Workstation TPO PA ersiiaienieriisrnriireo ririn iarten Eni EEE ie ish NTETE Ei EEEE Enans 12 CryoPRO Workstation Lower Back Panel cosas atts eerste niahotshtaiasenoatarenstanegieensnstaencasdtaadvatbectee 13 CryoPRO Workstation Control Panel sssesssesssesssereseressrsssessrrssresereseressrssrrestrssrrsrreseressresrreserens 14 Section 4 Operating Instructions System Installation e seeosooossoosseosssesssseessossssesssesssee 16 Section 5 Operating Instructions CryoPRO Workstation eeeseeeseeesseosssossseoessossssesssesesee 17 Equipment Materials and REAQEn iS srsieriireenbirerrsiieersisrieieni eiie en rraian inie e DINEE reien 17 OTIBE NG AE NON E IE E E A O A E A T A E E 17 Cryogenic Freezer MatfialScssnesnrroorein or a o ir eT eaa n 17 TRS ann T E E 17 TEV SST VOC TEONE A EA A A A satus aenacineeest 18 O a CUO T A E A E aaaeonant ieee 19 PY SS TO e E N E E E E A E E E E E E ieeas teases 19 Sterile Connection and Labelng sorairciicirerr
10. 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the CryoPRO Workstation is used exceeds the applicable RF compliance level above the CryoPRO Workstation should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the CryoPRO Workstation b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Page 11 14 02 016 Revision D CryoPRO Workstation User Manual Section 3 CryoPRO Workstation Description The following section provides a description of the CryoPRO Workstation components CryoPRO Workstation Front Panel MIXING MIXING BUTTON CHAMBER Bs DRAINING FIXTURE OSCILLATING DISPOSABLE CARTRIDGE THERMAL HOLDER INSERT FREEZING BAG FREEZING BAG HOLDER COMPRESSION CRYOPROTECTANT MODULE DISPENSING DULE CONTROL PANEL OPERATE e BUTTON _ ROTATING MIXING MIXING CHAMBER HOLD
11. CONTROL PANEL Obtain and remove the CryoPRO 2 Cryopreservation Storage Bag Set and extension tube from its packaging Visually inspect the CryoPRO 2 Bag Set and confirm that the gamma irradiation symbol is red Do not use any CryoPRO 2 Bag Set that has missing or damaged components or if the gamma irradiation symbol is not red Close all clamps on the CryoPRO 2 Cryopreservation Storage Bag Set Aseptically fill the 10mL BD Luer lok syringe with at least 6 2 mL of DMSO Dextran solution Eliminate any extra air that may be present in the syringe as it may impact the total volume delivered Remove the cap from the extension tubing and aseptically attach the tubing to the solution filled syringe 10 Refrigerate the syringe and extension tubing until needed for cryoprotectant addition Sterile Connection and Labeling 11 Ensure that the SynGenX 1000 Control Module processing data has been downloaded Page 19 to the DataTrak Software before proceeding with the buffy coat transfer to the CryoPRO 2 Cryopreservation Storage Bag Set 14 02 016 Revision D CryoPRO Workstation User Manual 12 Identify the buffy coat sample access tubing opposite of the SynGenX 1000 Disposable Cartridge label and pull the tubing from the clamps Squeeze the tubing where it was clamped to ensure that it is fully open Figure 4 Buffy Coat Sample Access Tube identified and squeezed 13 Sterile connect the Disposable Cartridge buffy coat sample
12. CryoPRO Workstation is not in use Ensure the door to the MIXING THERMOELECTRIC COOLING MODULE is closed Rotate the ROTATING MIXING CHAMBER HOLDER to the horizontal position Attach the power cord to the back of the device Attach the USB cable to the USB CABLE PORT and to a USB hub port connected to the computer or directly to the computer as applicable Connect the power cord to power source 7 Press the POWER SWITCH to the ON position 8 The CryoPRO Workstation MIXING button will illuminate and the MIXING THERMOELECTRIC COOLING MODULE will rotate and home 9 The CryoPRO Workstation is ready for processing once the COLD PLATE READY light and the OPERATE button are illuminated 10 Register the CryoPRO Workstation into the SynGen DataTrak software per instructions for use found in the SynGenX 1000 System User Manual aie gt D Page 16 14 02 016 Revision D CryoPRO Workstation User Manual Section 5 Operating Instructions CryoPRO Workstation It is strongly recommended that users review the entire manual and operating instructions prior to initial system use Follow aseptic procedures Operators should be trained on the SynGenX 1000 System prior to operating the CryoPRO Workstation Equipment Materials and Reagents Equipment e CryoPRO Workstation with power and USB cables e Sterile Connection Device for closed system processing e Tube Sealer s for PVC and EVA tubing e Barcode Label Generator
13. ER THERMOELECTRIC COOLING MODULE Figure 1 CryoPRO Workstation Front MIXING BUTTON Activates the mixing and transfer of the buffy coat from the Disposable Cartridge to the CryoPRO 2 Cryopreservation Storage Bag Set Mixing Chamber The MIXING button is illuminated when waiting to start the mixing cycle and unlit during the mixing cycle OSCILLATING DISPOSABLE CARTRIDGE HOLDER Holds and oscillates the Disposable Cartridge during buffy coat transfer from the Disposable Cartridge to the CryoPRO 2 Cryopreservation Storage Bag Set Mixing Chamber FREEZING BAG COMPRESSION MODULE Holds the Freezing Bag upright and in place A rotating lever compresses the bag and eliminates the air CONTROL PANEL Provides status light and temperature indicators during CryoPRO Workstation operation OPERATE BUTTON Initiates the cryoprotectant addition process The button is illuminated when waiting to start at the end of the process and unlit during the process If an error occurs the Page 12 14 02 016 Revision D CryoPRO Workstation User Manual button will illuminate and be accompanied by an audible beeping sound Pressing the OPERATE button will stop the audible beeping sound ROTATING MIXING CHAMBER HOLDER Holds the Mixing Chamber during buffy coat transfer and rotates the Mixing Chamber for optimal sample collection MIXING THERMOELECTRIC COOLING MODULE Monitors and controls the temperature of the buffy coat during cryoprotectant addition a
14. T gt 95 dip in UT for5s COMPLIANCE LEVEL 6 kV contact 8kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for5s ELECTROMAGNETIC ENVIRONMENT GUIDANCE Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the CryoPRO Workstation requires continued operation during power mains interruptions it is recommended that the CryoPRO Workstation be powered from an uninterruptible power supply or a battery 14 02 016 Revision D CryoPRO Workstation User Manual IMMUNITY IEC 60601 TEST COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT TEST LEVEL GUIDANCE Power Power frequency magnetic fields should frequency be at levels characteristic of a typical 50 60 Hz location in a typical commercial or magnetic field hospital environment IEC 61000 4 8 W NOTE UT is the A C mains voltage prior to application of the test level
15. above the retaining pins of the holder and close the door ensuring it latches RETAINING PINS Figure 13 Flanges of syringe above retaining pins 37 Place the Freezing Bag into the Freezing Bag Compression Module 38 Remove the cap from the Air Filter and open the clamp below the Air Filter 39 Promptly press the OPERATE button to start the MIXING THERMOELECTRIC COOLING MODULE 40 Once the appropriate temperature is achieved the PROCESSING light will illuminate and the CRYOPROTECTANT DISPENSING MODULE will begin the cryoprotectant addition automatically Page 25 14 02 016 Revision D CryoPRO Workstation User Manual Compress Freezing Bag 41 Open both clamps on the Freezing Bag segment tubing then rotate the handle counter clockwise until it can go no further and the Freezing Bag is fully compressed C n T i d Figure 14 Compressed Freezing Bag 42 Close both clamps on the segment tubes leading to the Freezing Bag 43 Rotate the handle clockwise until it can go no further and the FREEZING BAG COMPRESSION MODULE is fully open Transfer to Freezing Bag 9 The following steps should be performed without excessive delay 44 The cryoprotectant addition process is complete when the PROCESS COMPLETE light illuminates and an alert sounds Page 26 14 02 016 Revision D CryoPRO Workstation User Manual Figure 15 PROCESS COMPLETE light illuminated 45 Press the OPERATE button
16. ber in Rotating Mixing Chamber Holder with DMSO Filter at 12 o clock Page 21 14 02 016 Revision D CryoPRO Workstation User Manual 19 Allow the buffy coat to drain until it is approximately half empty The fluid level should be at or slightly below the seam iD Fluid level at or below the seam Figure 8 Fluid level drained half way and level with the seam 20 Close the clamp below the Air Filter and then press the MIXING button 21 Once mixing has stopped open the clamp below the Air Filter and allow all of the buffy coat to transfer to the Mixing Chamber 22 Close the clamp below the Air Filter 23 Replace the cap on the DMSO filter Sample Collection 24 Rotate the ROTATING MIXING CHAMBER HOLDER to the vertical position Figure 9 Mixing Chamber rotated to the vertical position Page 22 14 02 016 Revision D CryoPRO Workstation User Manual 25 Squeeze the Sampling Bulb approximately 10 times to thoroughly mix the buffy coat 26 Return the ROTATING MIXING CHAMBER HOLDER to the horizontal position Squeeze the Sampling Bulb to obtain the appropriate sample volume and then remove any blood from the line with air from the Sampling Bulb Figure 10 Sample collection Y Each line on the sample bulb represents approximately 0 5 mL 27 Seal the tubing leading to the Sampling Bulb and the tubing directly above the Air Filter 28 Detach the Sampling Bulb and Disposable Cartridge 29 Access sample f
17. connector Seal tubing segments directly below the Y connector then detach the Freezing Bag and remove both clamps Figure 17 Freezing Bag with clamps removed and tubing sealed 58 Page 28 Make segments by sealing the tubing perpendicular to the Freezing Bag 14 02 016 Revision D CryoPRO Workstation User Manual Figure 18 Freezing Bag with segments prepared 59 Fold segments over top of Freezing Bag to prepare for overwrapping if applicable and freezing 60 Freeze per manufacturer s instructions for use and established procedures 61 Discard Mixing Chamber per established procedures Download Processing Data 62 Double click the SYNGEN DATATRAK icon located on the PC desktop to launch the software 63 Enter appropriate user ID and corresponding password and click the SUBMIT button 64 Click the CRYOPRO WORKSTATION picture on the left navigation pane Ej SynGen DataTrak CryoPRO Worksta Connected CryoPRO Workstations CryoPRO Workstation ID Data Present 104 100011 CryoPRO Workstation ID Blood Unit ID Bag Set Lot DOWNLOADs sb EA R Figure 19 CryoPRO Workstation download window Page 29 14 02 016 Revision D CryoPRO Workstation User Manual 65 Scan the barcodes or enter the information in the order indicated below on the download window O CRYOPRO WORKSTATION ID O BLOOD UNIT ID O BAG SET LOT Ej SynGen DataTrak Eo Eo s _ el
18. fications Frequency 50 60 Hz Power Consumption 150 Watts Max OPERATING ENVIRONMENT Operating Temperature 10 C lt Operating Temperature lt 35 C Operating Pressure 70 kPA lt Operating Pressure lt 106 kPA 526 3 mmHG lt Operating Pressure lt 797 mmHG Relative Humidity 30 lt Operating Humidity lt 75 Operating Altitude Up to 6600 feet 2000 meters Storage Temperature 7 C lt Storage and Transport Temperature lt 50 C Relative Humidity 30 lt Storage and Transport Humidity lt 75 Page 37 14 02 016 Revision D CryoPRO Workstation User Manual Section 10 Warranty SynGen Inc warrants to original purchaser that the CryoPRO Workstation will be free from defects in material or workmanship for one 1 year from date of shipment SynGen also warrants that replacement parts will be free from defects in material workmanship for a period of ninety days 90 or maximum time required by applicable local law from date of shipment of replacement part SynGen products are designed and manufactured to provide trouble free and reliable performance when properly maintained and used in accordance with the instructions provided in this manual Each CryoPRO Workstation referred to as Device is carefully inspected and tested before shipping In case of device failure or malfunction SynGen will replace or repair the concerned device according to the agreement in place Device failure or malfunction
19. nd provides orbital mixing throughout the process CRYOPROTECTANT DISPENSING MODULE Provides a controlled rate of cryoprotectant infusion Includes a spring activated door latch syringe holder with placement pins and dispensing base FREEZING BAG HOLDER Mechanically sets the volume for the two Freezing Bag chambers THERMAL INSERT An insert that is placed within the MIXING THERMOELECTRIC COOLING MODULE when the module is not in use MIXING CHAMBER DRAINAGE FIXTURE Orients the Mixing Chamber for optimal drainage of the cryoprotected cells into the Freezing Bag CryoPRO Workstation Lower Back Panel ON OFF POWER SWITCH SGI 0265 SynGen Ill MINIM SN 104 100001 plas cap casd ted som ByaGadbacbaes CONNECTION Pe ALT C o 90 264 VAC 50 60Hz 1 7A MAX CRYOPRO CRYOPRO WORKSTATION VENTS WORKSTATION USB CABLE PORT DEVICE LABEL Figure 2 CryoPRO Workstation Lower Back Panel CRYOPRO WORKSTATION VENTS Exhaust vents for the CryoPRO Workstation electrical and mechanical components CRYOPRO WORKSTATION DEVICE LABEL Provides information specific to the CryoPRO Workstation Page 13 14 02 016 Revision D CryoPRO Workstation User Manual USB CABLE PORT Port for data connection to the host PC via a data cable POWER CORD CONNECTION Port for connection to the external power source via the power cord To remove mains power unplug the cable from the wall ON OFF POWER SWITCH Power switch for the CryoPRO Work
20. oPRO Cryopreservation Storage Bag Set and the Disposable Cartridge the CryoPRO Workstation is designed to provide process consistency and electronic documentation of buffy coat cryoprotection It simplifies e Buffy coat transfer from the SynGenX 1000 Disposable Cartridge to the CryoPRO 2 Cryopreservation Storage Bag Set Mixing Chamber e Temperature control of the buffy coat during cryoprotectant transfer e Precise flow rate control of the cryoprotectant solution e Storage bag compression to aid in air removal from the storage bag e Transfer of the cryoprotected buffy coat to the storage bag e Mechanical verification of storage bag fill volume for fitting into freezing cassettes Page 4 14 02 016 Revision D CryoPRO Workstation User Manual Symbol Key The following symbols are used on the CryoPRO Workstation device labeling packaging or within the User Manual Page 5 Ono eea X Special disposal for electronic waste required Product meets European Standard for Safety EC REP Authorized Representative for European Union Manufactured By A Warning to be observed by the user ON Caution to be observed by the user A note to be observed by the user ey Consult Instructions For Use EF Product or Part Number 14 02 016 Revision D CryoPRO Workstation User Manual Abbreviations Below are abbreviations that are used in the User Manual and their associated definitions ABBREVIATION DEFINITION C I L P Comma Sepa
21. process The button is illuminated when waiting to start at the end of the process and unlit during the process If an error occurs the button will illuminate and be accompanied by an audible beeping sound Pressing the OPERATE button will stop the audible beeping sound Page 15 14 02 016 Revision D CryoPRO Workstation User Manual Section 4 Operating Instructions System Installation Operators should be trained on the SynGenX 1000 System before setting up and operating the CryoPRO Workstation The CryoPRO Workstation transfers processing data to the SynGen DataTrak Software The data from each processing run must be downloaded to the software before a next processing run can be conducted Prior to setting up the CryoPRO Workstation ensure the host computer has the DataTrak Software installed and the CryoPRO Workstation has been registered in the software Refer to the SynGenX 1000 System User Manual Operating Instructions DataTrak Software for registering the CryoPRO Workstation The CryoPRO Workstation comes fully assembled and includes the power cord and USB cable Carefully unpack the Workstation and verify all components are present and undamaged Contact SynGen Customer Service at 1 844 363 0709 or 1 916 256 2423 outside of the USA or by email at support syngeninc com if any component is missing or any parts are damaged 1 Ensure that the THERMAL INSERT is in place The THERMAL INSERT must be in place when the
22. rated Value International Electro Technical Commission Manufacturer s Equipment WD Light Emitting Diode SV EC ED ME N RF JN e fes OOOO Page 6 14 02 016 Revision D CryoPRO Workstation User Manual Section 2 Safety Warnings A warning is a statement that alerts the user to the possibility of injury death or other serious adverse reactions associated with the use or misuse of the device READ THIS USER MANUAL COMPLETELY PRIOR TO USING THE CRYOPRO WORKSTATION Read the CryoPRO Workstation User Manual prior to using the device Always follow established laboratory procedures for handling and disposing biohazardous materials No modification of this equipment is allowed Only SynGen authorized replacement parts may be used Cautions A A caution is a statement that alerts the user to the possibility of a problem with the device associated with its use or misuse Such problems include device malfunction device failure damage to the device or damage to other property The caution statement includes the precaution that should be taken to avoid the hazard Page 7 The CryoPRO Workstation contains modules with moving parts Avoid placing any foreign object near or into the moving components as damage may occur Do not allow fluid to enter into the CryoPRO Workstation In the event of a spill turn the power switch off and clean the spill as quickly as feasible following established laboratory p
23. ren inrsin isine ri a irei EEEa ENEE ENNEK ES EE 19 PA Oe e A N E TEE T E A E re 20 e AE E E OA EE E E EEA 22 CPO loc tani ACA ONE petrosani aei EE EAEE SEE ET E TE EEE EEEE 24 OI CSS FCO E EEA EA A E E NEE 26 B E ah CAA A E N E E E E A A wre 26 P EA E D A E N EE E E E eaasetes 29 Section 6 Disinfection Cleaning and Maintenance eesssesseoesseeesoeessoesssesssesessossssesssesesee 31 Section 7 Customer Servie sisisrsssrsssessdstisrekecstner enedes niero dun in eiriau nesaka n eeke naire neskan Esu R aE E 32 one Troup les OC INS oiean E E A tana 33 Page 2 14 02 016 Revision D CryoPRO Workstation User Manual CryoPRO Workstation Alerts and Error CONS tris otesstartaucinssseantvatainendeeeroedsuninargnnevaenanliiosieds 33 CryoPRO Workstation Processing Report Error sessesssessesssssissressressresrssrresrresersrresressresrreserens 36 Section 9 CryoPRO Workstation Specifications seessseessoesseosssecessoessoesssosssoeessossseesssesssee 37 Sechan 10 Warranty irsin setuentsenesededacssesdieacssassiestoseuseaseasseoets 38 Page 3 14 02 016 Revision D CryoPRO Workstation User Manual Section 1 Introduction The CryoPRO Workstation is a piece of manufacturing equipment intended to simplify the operation of the CryoPRO 2 Cryopreservation Storage Bag Set or its equivalent It also provides convenient mixing for the transfer of the buffy coat from the SynGenX 1000 System Disposable Cartridge or its equivalent
24. rence in nearby electronic equipment RF emissions Harmonic The CryoPRO Workstation is suitable for use in all emissions IEC Class A establishments including domestic establishments and 61000 3 2 those directly connected to the public low voltage Voltage power supply network that supplies buildings used for fluctuations flicker domestic purposes Complies emissions IEC 61000 3 3 Page 8 14 02 016 Revision D CryoPRO Workstation User Manual Table B Guidance and manufacturer s declaration Electromagnetic Emission for all Equipment and Systems GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY FOR ALL ME EQUIPMENT AND ME SYSTEMS The CryoPRO Workstation is intended for use in the electromagnetic environment specified below The customer or the user of the CryoPRO Workstation should ensure that it is used in such an environment IMMUNITY TEST Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Page 9 IEC 60601 TEST LEVEL 6 kV contact 8kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 U
25. return for service CRYOPROTECTANT DISPENSING Close the CRYOPROTECTANT MODULE door is open during DISPENSING MODULE door Process processing will automatically resume If the door is left open too long the process will be aborted Follow internal procedures for cryoprotectant addition time limits Problem interacting with flash Do not use the CryoPRO Workstation memory for further processing Contact SynGen Customer Service and return for service MIXING THERMOELECTRIC COOLING Turn off the CryoPRO Workstation MODULE fans out of range Verify the fans are not obstructed and remove if present Turn on the CryoPRO Workstation If error repeats contact SynGen Customer Service and return for service Page 33 14 02 016 Revision D CryoPRO Workstation User Manual DISPLAYED DESCRIPTION ACTION BY USER CHARACTER MIXING THERMOELECTRIC COOLING Verify that the MIXING MODULE home failure THERMOELECTRIC COOLING MODULE is not obstructed Turn the CryoPRO Workstation off and then on If error repeats contact SynGen Customer Service and return for service MIXING THERMOELECTRIC COOLING Do not use the CryoPRO Workstation MODULE motion failure for further processing Contact SynGen Customer Service and return for service MIXING THERMOELECTRIC COOLING Do not use the CryoPRO Workstation MODULE plate temperature delta too for further processing large Contact SynGen Customer Service and return for ser
26. rocedures Contact SynGen customer support at 1 844 363 0709 or 1 916 256 2423 outside of the USA or by email at support syngeninc com for further action Immediately replace the Thermal Insert once the Mixing Chamber has been removed after processing to prevent moisture buildup within the Mixing Thermoelectric Cooling Module When connected to another device the overall system must be evaluated to IEC 60601 1 3rd edition by the end user 14 02 016 Revision D CryoPRO Workstation User Manual Safety and EMC Compliance Information Safety Standards Regulations and recommendations contained in this document are in compliance with appropriate international safety standards This includes electrical instruments used in laboratory protection of laboratory staff and electrical safety Table A Guidance and manufacturer s declaration Electromagnetic Emission for all Equipment and Systems GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS FOR ALL ME EQUIPMENT AND ME SYSTEMS The CryoPRO Workstation is intended for use in the electromagnetic environment specified below The customer or the user of the CryoPRO Workstation should ensure that it is used in such an environment EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE The CryoPRO Workstation uses RF energy only for its RF emissions enue internal function Therefore its RF emissions are very CISPR 11 low and are not likely to cause any interfe
27. rom Sampling Bulb via the needleless access port and transfer to tubes per established procedures 30 If desired for other purposes the RBCs within Disposable Cartridge may be accessed by syringe via the sample access tube near the Disposable Cartridge label and plasma may be accessed by syringe via the Central Funnel Compartment access port at the top of the Disposable Cartridge Page 23 14 02 016 Revision D CryoPRO Workstation User Manual Cryoprotectant Addition 31 Verify that the COLD PLATE READY light on the CONTROL PANEL is illuminated Figure 11 COLD PLATE READY light illuminated 32 Obtain the cryoprotectant solution filled syringe Remove the cap from the DMSO Filter and extension tubing and connect the tubing to the DMSO Filter 33 Slide the MIXING THERMOELECTRIC COOLING MODULE door open and remove the THERMAL INSERT 34 Keep the Mixing Chamber upright then place it into the MIXING THERMOELECTRIC COOLING MODULE so that the DMSO filter is away from you 1 o clock The Freezing Bag will be positioned left toward the FREEZING BAG COMPRESSION MODULE Slide the door closed Figure 12 Mixing Chamber placed in the Mixing Thermoelectric Cooling Module with DMSO Filter at 1 o clock Page 24 14 02 016 Revision D CryoPRO Workstation User Manual 35 Open the CRYOPROTECTANT DISPENSING MODULE door by pushing on the door which releases the door latch 36 Load the syringe so that the flange of the syringe is
28. s for Freezing Bag cassette and sample tubes e Computer with SynGen DataTrak Software installed Cryogenic Freezer Materials e SynGenX 1000 Disposable Cartridge with processed cord blood e CryoPRO 2 Cryopreservation Storage Bag Set e 10mL BD Luer lok Syringe e Freezing bag labels e Sample bulb and sample tube labels Reagents e DMSO Dextran Solution 55 dimethyl sulfoxide with 5 Dextran 40 solution Page 17 14 02 016 Revision D CryoPRO Workstation User Manual Process Flow System Set Up Sterile Connection and Labeling Buffy Coat Transfer Sample Collection Cryoprotectant Addition Transfer to Freezing Bag Seal and Freeze Download Data Page 18 14 02 016 Revision D CryoPRO Workstation User Manual Operating Instructions A Always follow established procedures for handling and disposing of biohazardous materials System Setup i p ee 9 Press the ON OFF POWER SWITCH to the ON position on the rear left of the CryoPRO Workstation The Workstation should remain on until all processing for the day is complete Verify that the THERMAL INSERT is in place within the MIXING THERMOELECTRIC COOLING MODULE The THERMAL INSERT must be left in place when the Workstation is not in use Verify that the door to the MIXING THERMOELECTRIC COOLING MODULE is closed Verify that the ROTATING MIXING CHAMBER HOLDER is set to a horizontal position Verify the symbol is displayed on the
29. station Press to turn on I or off O CryoPRO Workstation Control Panel SynGen CryoPRO Workstation O TEMPERATURE AND MESSAGE DISPLAY COLD PLATE READY LIGHT PROCESSING LIGHT PROCESS COMPLETE LIGHT ALERT LIGHT OPERATE BUTTON Figure 3 CryoPRO Workstation Control Panel TEMPERATURE AND MESSAGE DISPLAY Displays the temperature in degrees Celsius as well as non numeric status and error codes The status messages are indicated below Refer to the Troubleshooting section for error codes and additional information Page 14 14 02 016 Revision D CryoPRO Workstation User Manual STATUS DISPLAY STATUS DESCRIPTION Waiting to process dP Data present and available for download COLD PLATE READY LIGHT Illuminates when the temperature of the MIXING THERMOELECTRIC COOLING MODULE is within the specified temperature range PROCESSING LIGHT I lluminates during the cryoprotectant addition process PROCESS COMPLETE LIGHT lluminates at the completion of the cryoprotectant addition process ALERT LIGHT I lluminates either a red or yellow LED A yellow LED corresponds to an error that occurred during the cryoprotectant addition process The associated error code is displayed on the Sample Temperature Display A red LED indicates that there is a hardware fault in the CryoPRO Workstation The operator should return the CryoPRO Workstation to SynGen for service OPERATE BUTTON Initiates the cryoprotectant addition
30. the Control Panel display Page 30 14 02 016 Revision D CryoPRO Workstation User Manual Section 6 Disinfection Cleaning and Maintenance Always follow established procedures for handling and discarding biohazardous materials Power down and unplug the CryoPRO Workstation For cleaning use a dry cloth or paper towel to wipe away any liquid that maybe present For disinfection wet a paper towel witha 10 bleach solution or a 70 isopropyl alcohol solution or use an appropriate laboratory cleaning wipe and wipe down all outside surfaces taking care not to allow any solution to enter directly into the modules or vents Allow the solution to stay on the surface for 5 minutes then dry with a paper towel The CryoPRO Workstation should undergo annual maintenance by SynGen Inc Any electromechanical device disposal must follow local regulations Besides disinfection there is no other routine maintenance required If an error code is experienced first consult the Troubleshooting section of this manual If the problem persists please contact SynGen Inc Customer Service at 1 844 363 0709 or 1 916 256 2423 outside of the USA or by email at support syngeninc com Page 31 14 02 016 Revision D CryoPRO Workstation User Manual Section 7 Customer Service The CryoPRO Workstation is supplied with a copy of the User Manual In addition professional and competent technical staff will provide end user training prior to its use and
31. to stop the MIXING THERMOELECTRIC COOLING MODULE 46 Slide the MIXING THERMOELECTRIC COOLING MODULE door open and remove the Mixing Chamber 47 Place the Mixing Chamber in the MIXING CHAMBER DRAINING FIXTURE so that the DMSO Filter is uppermost and toward you Figure 16 Mixing Chamber placed within MIXING CHAMBER DRAINING FIXTURE with DMSO Filter uppermost and toward you 48 Place the Air Filter onto the filter retainer on the fixture Page 27 14 02 016 Revision D CryoPRO Workstation User Manual 49 50 51 52 53 54 55 56 97 Replace the THERMAL INSERT into the MIXING THERMOELECTRIC COOLING MODULE and slide the door closed Open the clamp leading to the small chamber of the Freezing Bag Buffy coat will fill most of the chamber automatically Completely express the air from the small chamber to allow it to fill then close the clamp leading to small chamber Open the clamp from tubing leading to large chamber of the Freezing Bag Buffy coat will fill most of the chamber automatically Completely express air from the large chamber and allow to it fill until the Mixing Chamber has emptied then close the clamp leading to the large chamber Place Freezing Bag into FREEZING BAG HOLDER Open the clamps and the buffy coat will equilibrate between the two chambers and tubing segments Ensure that the segment tubing is completely filled then close both clamps when the fluid is at or slightly below the Y
32. vice and then turn back on and restart the process If error repeats Contact SynGen Customer Service and return for service CRYOPROTECTANT DISPENSING Press the OPERATE button to silence MODULE failed to engage the syringe the alarm Open the CRYOPROTECTANT DISPENSING MODULE door and verify that the DMSO Dextran solution syringe has the proper fill volume and is correctly placed within the compartment Press the OPERATE button to resume processing If the error repeats Contact SynGen Customer Service and return for service PH CRYOPROTECTANT DISPENSING Open CRYOPROTECTANT DISPENSING MODULE home failure MODULE door and verify that there are no obstructions Turn off the CryoPRO Workstation Page 34 14 02 016 Revision D CryoPRO Workstation User Manual DISPLAYED DESCRIPTION ACTION BY USER CHARACTER SF Out of memory Turn the off the CryoPRO Workstation and then turn on Download the processing data If error repeats contact SynGen Customer Service and return for service MIXING THERMOELECTRIC COOLING Do not use the CryoPRO Workstation MODULE sample temperature is too for further processing high gt 10 C Contact SynGen Customer Service and return for service MIXING THERMOELECTRIC COOLING Do not use the CryoPRO Workstation MODULE sample temperature too low for further processing lt 1 C Contact SynGen Customer Service and return for service Page 35 14 02 016 Revision D
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