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14-02-037-B WashPRO Alpha User Instructions

1. Ed sten Data 0 NS E Adnunmstrabon Gen Adriaen a mn ra ee User Profile y Syre System o o a SynGen Carmel coke GER Ur HI Tecknscan 1 Uber Bok Lab Techrecan Des posabio Cater GryoPRO Workstation Last Hunn Sm Actes F GOPRO Bag Set First Marne Jerry E t r te eme nee Humber Pee al E ga 0 gt E EN j 2 Select the applicable User Role using the dropdown menu 3 Verify the ACTIVE checkbox is checked 4 Click the ADD USER button to enter the user or the CANCEL button to clear the information 5 A successful entry will display User saved successfully Page 32 www syngeninc com support syngeninc com 14 02 037 B 7 8 9 a SynGen N ew users will be required to log in the first time using the default password The password may be changed in the PREFERENCES section of the software after initial login Default password for Administrator is Admin 1 Default password for Lab Supervisor is Supervisor 1 Default password Lab Technician is Technician 1 10 To edit a User Profile click the appropriate name under the User ID column 11 The corresponding information will appear in the entry fields and can be edited except for the User ID 12 Unchecking the ACTIVE checkbox will inactivate the user Inactive users will be unable to log in to the DataTrak software 13 To save changes click t
2. WashPRO Alpha System USER MANUAL Sacramento CA USA support syngeninc com Customer Service 1 844 363 0709 or 1 916 256 2423 Fax 1 916 706 0832 WashPRO Alpha User M anual SynGen 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 proprietary trademarks are property of SynGen Inc and are protected under U S trademark laws and international treaties SynGen SynGenX WASH SynGen DataTrak and WashPRO are proprietary trademarks and service marks and may not be used except as provided by law without prior written consent of SynGen Inc Sorvall and Legend are trademarks of Thermo Scientific Inc in the United States and or other countries Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and or other countries Intel is a trademark of the Intel Corporation in the United States and or other countries SynGen Inc Sacramento CA USA Phone 916 706 0923 It is strongly recommended that all users read this manual in its entirety before using the WashPRO System
3. Plugin the USB cable into the USB port of the Docking Station and the USB port of the host computer or USB hub if applicable 3 Plug power cord into Docking Station and then into the appropriate electrical outlet 4 Verify the POWER STATUS INDICATOR is lit red and place a Control Module on the Docking Station The POWER STATUS INDICATOR will turn green upon successful connection between the Docking Station and the Control Module WashPRO Control Module TheWashPRO Control Module battery should be charged in the SynGen Docking Station overnight or for at least 6 hours prior to initial use 1 Placethe Control Module onto a Docking Station that is plugged into an electrical outlet 2 Verify that the Docking Station POWER STATUS INDICATOR is green 3 Leavethe Control Module charging in the Docking Station until the Control Module BATTERY LED INDICATOR remains green without blinking SynGen DataTrak Software Ensure that the computer is virus free and has the latest update of the antivirus software prior to the SynGen DataTrak Software installation U pdate the operating system service pack and antivirus software on a regular basis Do not leave the internet active while installing or using the DataT rak Software 1 Verify that the computer meets the DataTrak Softw are requirements 2 Verify that all updates have been completed 3 Ensurethat administrator access is available The software will be installed
4. SCCUOM oacasnesucectnasecacsuiaseteanssecdeinssosccansbecu nssaintatessbodanisniawoeasucdensasidedescesieosssnnestaaninsassctinwass 24 Operations 6 SPP ee Te NR 24 Section 4 Operating Instructions System Set U Pu cecccsssssecssssseeesssseeeessseeeeessseseeesssesesessseeesssaeess 30 SynGen Docking Station sicssvincesssssnessaestonsanssesnsansionenayssinnenavteaenavisstuesdscinnsduasinersdisineesdxsseeredisnersevasonsness 30 WashPRO Control M odule s ssssssssossrnnsnsrnnosrnnssrnnronrnnnornnnenrnnnonrnnennnnnonrnnnonrnnennnnnennnnnnnnnnennnnnennnnee 30 STIG Dalal rak OTER 30 ME 31 Section 5 Operating Instructions SynGen DataTrak Administration Mode rrrrrrrvrrrrrrrvverrn 32 Page 4 www syngeninc com support syngeninc com 14 02 037 B SynGen SOW re LOGI NN EN EN 32 PAGING AG 0 1 0 a USG sandra sind ssa a sida EN 32 Resetting a Password arapusasasifngaa tada doada ro ing ea iaG ao EE alan adiada nanda jaeos 33 Registering and Editing aWashPRO Control Module eee 33 Adding and Inactivating a CeNtrifUGe cccccccccssssccsssseecsssseeeeseseeeeesseeeeeesseeeessseeeeessseeesssssesssseess 34 Adding and Editing a SynGenX WASH Disposable Set ereta 35 Editing add lt lt 6 PRIDE 36 Exiting Administration Mode ereennnnnvvennnnvvennnnnvvennnnvvennnnnvnennnnvvensnnnnensnnnneesnnnnnesnnnnneennnnnnesnnnnnensnnnnnee 37 Section 6 Operating Instructions SynGen DataTrak Operations M O
5. The WashPRO System will be used for manufacturing cellular products in a cGMP laboratory or manufacturing facility including the concentration and washing of ex vivo expanded cultured cells The WashPRO System consists of the following components Component Part Number WashPRO Workstation TBD Alpha WashPRO Control Module with its associated firmware SG1 0046 SynGenX Docking Station with its associated firmware 561 0120 SynGen DataTrak Software 2 0 SynGenX WASH Disposable Set TBD Alpha WashPRO Software TBD Alpha An accessory kit is provided with the WashPRO System including a 1 kg calibration weight cables and a bucket for draining waste The WashPRO System requires the following instrumentation for operation These are not provided by SynGen Inc e Tubing Sealer for PVC and EVA tubing e Sterile Connection Device e Thermo Scientific Sorvall Legend XT or XTR Centrifuge with 750 mL buckets or equivalent e Computer e g desktop or laptop PC or tablet with Windows 7 or 8 1 Operating System and at least one available USB port additional U SB port required for optional barcode scanner o For Windows 7 Operating Systems only USB 2 0 Ports are compatible with the DataTrak software M aterials and equipment that are required but not supplied e Call culture sample concentrated to a total volume of less than 480 mL loaded into a transfer bag e Cell wash medium loaded into a transfe
6. USER NOTES Enter appropriate information and then click the SAVE USER NOTES button 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 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 To close the file click the red X in the upper right window q PF W NP Page 69 14 02 037 B WashPRO Alpha User M anual SynGen Section 8 Maintenance Cleaning and Disinfection Always follow established procedures for handling and discarding biohazardous materials Prior to cleaning power down the WashPRO Control Module and unplug the SynGenX Docking Station For cleaning use a dry cloth or paper towel to wipe away any cell solution or other fluid that has not yet dried For disinfection wet a paper towel with a 10 bleach solution or a 0 isopropyl alcohol solution and wipe down all outside surfaces taking care not to allow any cleaning solution to enter into the Control Module Allow the wet surface to sit for 5 minutes before drying The Control Module should be returned to SynGen Inc annually for preventive maintenance Any electromechanical device disposal must follow local regulations If an error code is experienced first consult the Troubleshooting section of this manual If the problem persists please call SynGen at 844 3
7. button Page 40 www syngeninc com support syngeninc com 14 02 037 B Ul gt Export L 2 3 SynGen To print the processing report click the PRINT button Verify printer and click the PRINT button To export the processing report as a CSV file click the EXPORT button Select the file location and edit the file name as needed Click the SAVE button Reviewing the Report Only a Lab Supervisor may add a Graph Reviewed By signature to a processing report L 2 3 dl 5 6 Click the dropdown menu GRAPH REVIEWED BY and select the username To save the processing report as a PDF file the SAVE AS PDF button Select the file location and edit the file name as needed Click the SAVE button To print the processing report click the PRINT button Verify the printer and click the PRINT button Setting Preferences L Click the PREFERENCES section on the lower left navigation pane 2 The PREFERENCES window will appear Preferences Password RESET ds SA Old puridrerord Faner patie Tarecut 105 minutes Confirm nes password Fart Log keel item dotar tre dance T Control nascida Oreo Workstabon Deosenlosd preferences Expirabon and maintenance T rn DP Show report aber downdoad l 2 Boks in advance am A pW Click the AUTOMATIC LOGOUT CHECKBOX and select the appropriate time in minutes from the dropdown menu Select the STARTING TOP LEVEL ITEM from t
8. by a SynGen Inc technical representative 4 Theusers components of the WashPRO System centrifuges and must be entered into the software before processing data can be downloaded Follow the directions described in the Operating Instruction DataTrak Administration section to prepare the software e If not already completed attach the associated WashPRO System components to the host computer via the USB ports or USB hub e g the Docking Station and or barcode scanner Page 30 www syngeninc com support syngeninc com 14 02 037 B amp SynGen Initial Login The DataTrak software is programmed with a default name and password for the Administrator profile and default passwords for Lab Supervisors and Lab Technicians profiles to allow initial access to the software Thelogin will require the default name and password for Administrators and the default password for Lab Supervisors and Lab Technicians PW NE ul USER PROFILE USER ID PASSWORD Administrator admin Admin 1 Lab Supervisor Assigned by Administrator Supervisor 1 Lab Technician Assigned by Administrator Technician 1 ue o NOTE User names and passwords are case sensitive Launch DataTrak software by double clicking the icon located on the desktop In the User ID and password fields enter the User ID admin and default password Admin 1 Click the SUBMIT button If the User ID and or password is entered incorrectly an Unknown username or incorr
9. ig ri between wash cycles Centrifugation Download Control Run Module Data if desired Drain Waste and Mix Harvested Samples Harvest Sample Page 44 WWW syngeninc com support syngeninc com 14 02 037 B a SynGen Setting up the WashPRO System for O peration Calibrating the Load Cell The Load Cells should be calibrated weekly to ensure accurate volume transfer during washing steps Power the WashPRO system on Power the computer on and launch the WashPRO Software using the WASHPRO icon on the desktop 3 Remove any cell suspension bags wash media bags and SynGenX WASH Disposable Sets from the WashPRO Workstation Click SETTINGS at thetop left corner of the screen and choose CALIBRATE VOLUMES Follow the instructions on the top of the Volume Calibration Window NP aS To begin the volume calibration process remove any bags on the suspension and wash bag hangers and press Next Current Calibration Values New Calibration Values Suspension offset Suspension gain Suspension offset Suspension gain 0 042 0 915 0 000 0 000 Wash offset Wash gain Wash offset Wash gain 0 038 0 929 0 000 0 000 Restart a Verify that nothing is on any of the load cell hooks i Click NEXT b Adda 1 kg standard weight to the cell suspension bag hanger i When the weight is no longer moving click NEXT c Adda 1kg standard weight to the diluent wash bag hanger i When the weight is no longer moving clic
10. loss of cell functionality requiring the buffy coat to be discarded Only use the SynGen DataTrak software for downloading and storage of processing information Page 10 www syngeninc com support syngeninc com 14 02 037 B SynGen e Ensure that the computer is virus free and has the latest update of antivirus software prior to installing the DataTrak Software e Updatethe operating system service pack and antivirus software on a regular basis e Donotleavethe internet active while installing or using the DataTrak Software Safety and EMC Compliance Information The WashPRO Workstation is an Alpha system and has not been submitted for safety and compliance testing for this phase of the development Disclaimer The WashPRO System including all hardware software and consumables are considered Research Only Devices or Investigation Only Devices The products are in the process of development and have not completed all of the design verification testing including safety testing Device performance and usability feedback from end users will be considered but may or may not be used in the final product design All device performance and usability feedback remains the property of SynGen Inc There may be small differences in appearance in products in actual use versus those images found in this User Manual Page 11 14 02 037 B WashPRO Alpha User M anual SynGen Section 3 WashPRO System Description
11. of June 2015 Indications for Use The WashPRO System is intended for laboratory useto allow for fast automated and reproducible washing of cultured cells in a closed and sterile environment The Alpha system is intended for testing and validation for the purpose of product development and improvement prior to design finalization Principles of O peration The SynGenX WASH Disposable Set is composed of two Disposable Cartridges interconnected by an input tubing set which allow for precise distribution of cell harvest and diluents into the Cartridges Tube connections from each Cartridge s harvest compartment to the main compartment of the opposite Cartridge allow for quick easy and sterile preparation of the cells for subsequent wash cycles The WashPRO System is composed of the following e SynGenX WASH Disposable Set e Elevated strain gauge capable of holding bags for cultured cell solution or diluent e Two rotating platforms for the Disposable Set to facilitate transfer e Pump to apply positive or negative pressure to the Disposable Set facilitating and controlling the flow rate of fluid between Cartridges and bags e Pinch valves to control movement of fluid and or cell suspension between Cartridges and bags e User interface for the operator which supports downloading processing data to a PC Symbol Key The following symbols are used on the WashPRO System labeling packaging or within the User Manual oomo me Sp
12. 00 25000 18 GB 90 GB 50000 35 GB 175 GB User Profiles The DataTrak software has three user profiles that are designed to restrict software operations based on level of responsibility Lab Technician U ser The Lab Technician User can download the data from the WashPRO System components view the data history customize their software views and change their password Lab Supervisor User The Lab Supervisor User level has all of the abilities of the Lab Technician User profile as well as the additional ability to approve reports Administrator U ser The Administrator User profile is a management function level only The Administrator User can add edit or inactivate users serial numbers of the system equipment and lot numbers of the disposable components The Administrator User does not have the ability to download data from the WashPRO System components or view data history This ability is restricted to the Lab Supervisor and Lab Technician User profile D ataT rak Software Description The DataTrak software is divided into two modes of functionality Administration and Operations Administration M ode The Administration mode includes two sections of operating functions Administration and Preferences The active section will be highlighted in yellow The Administration section provides the data record of users equipment and materials Once data is entered it cannot be deleted only edited or made inactive Click the LOGOUT but
13. 63 0709 in the USA or at 916 256 2423 international Page 70 www syngeninc com support syngeninc com 14 02 037 B p SynGen Section 9 Customer Service All WashPRO Systems purchased will be 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 will always be available for specific questions or clarifications For assistance with technical or application issues please contact your local representative or SynGen Inc Customer Service SynGen Inc Sacramento CA USA Website www syngeninc com Email support syngeninc com Customer Service 844 363 0709 in the USA or 916 256 2423 international Fax 1 916 706 0832 Page 71 14 02 037 B WashPRO Alpha User M anual SynGen Section 10 Troubleshooting The Troubleshooting section will describe 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 844 363 0709 in the USA or at 916 256 2423 international SynG enX WASH Disposable Set Visual Inspection The Disposable Set has been designed to be optically clear and provide excellent viewing of the post processed separated liquid fractions in each of the compartments as described below v Central Funnel Compartment center compartment that will contain the waste fract
14. D of the appropriate Control Module in the table The Control Module edit fields will appear Only the ACTIVE STATUS and the LAST MAINTENANCE fields may be edited Click the ACTIVE checkbox to uncheck Inactive Control Modules will not be recognized for data download Click the SUBMIT EDIT button to inactivate or click the CANCEL button to cancel the edit To return a Control Module into use after maintenance click the ID of the appropriate Control Module in the table Click the ACTIVE checkbox and then select the LAST MAINTENANCE date from the dropdown menu Click the SUBMIT EDIT button to activate the Control M odule or click the CANCEL button to cancel the edit Adding and Inactivating a Centrifuge 1 Click CENTRIFUGE on the left navigation pane rd Syrtken Pista rod e Administration ghairin User Profite P Ci Centrifuge Syren e Control Wia Det p riabio Cand CryoPRO Workstation Serial amber Calibration Due Date GryoPRO 2 Bag Set Terne ry Adie FF Sariai humbas A Pobre edel f d Lab C r ribuge Page 34 WWW syngeninc com support syngeninc com 14 02 037 B SynGen 2 Enter the SERIAL NUMBER and DESCRIPTION optional Select the CALIBRATION DUE DATE from the dropdown menu The software will not accept calibration due dates in the past The ACTIVE button default is checked to inactivate clic
15. H Disposable Set on the WashPRO Workstation 48 Preparing the Cell Culture and Wash Media mmm rrrrrravvvrrrrrvrrrrrnrvvrrnrnnrrsrnnnvvesnnnnrrsnnnnrrensnnnnnennnn 50 Verify the Centrifuge Programming unnnnvvennnnnvvennnnvvennnnnvvennnnvvennnnnvnennnnnvennnnnnnennnnnnennnnnneennnnnneesnn 51 Prepare the WashPRO Control Modules for Operation mmmasrrrrrarvvrnrnnrvvrnrnnnvvrnrnnnvrnrnnnnnenrnnn 51 Loading Cell Culture and Wash Media into the SYStOM ccccssccccsssesssssseeesssseeessseeeesssseeeeesaes 52 PFIN 59 Draining the Waste from the Cartridges cccccccssscccsssseecssseeeecsseeesesseeeeessseeesssseeeeessseeeeessseeeesseaes 62 Preparing for the Wash Cyde rrnnsnnvvrnnannvennnnnvvennnnnvvennnnvesnnnnnvesnnnnnvesnnnnnesnnnnnnensnnnnvesnnnnnensnnnnvennnnnnee 63 Page 5 14 02 037 B WashPRO Alpha User M anual SynGen TVEN red 66 Harvesting Ne Sample gone sind adegas sig E 67 Download Control Module Data ccccssccssssccsssseeeessseeessseeecesseeeeessesesessseeeeesseneeesssaseesssseeeeseess 68 TENNE 69 Section 8 Maintenance Cleaning and Disinfection sssserssssrressrrnesrrrnssrrrnsrrrnnsnrrnnrnnnnsrnnnnsrnnnnnn 70 TENNENE 71 Section 10 TrOUDICSNOOTING cccccccsssseccsssseeeessseecesseeeecssceeecssseeeessceeeessceseesssseeeeseseeeessseasessssasessessaeess 72 SynGenX WASH Disposable Set Visual INSpection s esssnsssrressrrnessrrnnsrrnssrnrnnsrrrnnsrrrnsrrnnsn
16. IT button to accept the entry or the CANCEL button to cancel the entry Preferences Password RESET ds SA El paris r Mw patio Timerut i mates Confirme nes pissed Lar tr top lewel item T Control nascida Oreo Workstabon cH AM Download preferences Expirabon and maintenance WETA D Show report afber downdoad l a Memis in advance Automatic Logout Includes a LOG OUT AFTER INACTIVITY checkbox and an up down selection menu to configure a timeout from 10 to 500 minutes in 10 minute increments Starting top level item Includes selection buttons to select the opening display screen HISTORY or PROCESS Download Preferences Includes checkbox to show report after download Select to the checkbox to activate the option Password Includes the following entry fields for changing a login password OLD PASSWORD NEW PASSWORD and CONFIRM NEW PASSWORD Starting device Includes selection buttons for the device to be opened upon login Control M odule or CryoPRO Workstation Expiration and maintenance warning Includes up and down keys and dropdown menu selection to designate the amount of advance notification of expiration and calibration due dates in days weeks or months Page 29 14 02 037 B WashPRO Alpha User M anual SynGen Section 4 O perating Instructions System Set Up SynGen Docking Station Handlethe SynGen Docking Station with care 2
17. Page 2 WWW syngeninc com support syngeninc com 14 02 037 B SynGen ADVISORY NOTE This user manual is part of an Alpha product release and is considered a work in progress The intention of this user manual is to provide a basic set of generalized user instructions Specific instructions for specific cell types are not included This Alpha system is Production Equivalent as of June 2015 Any comments suggestions for change feature requests etc may be sent by email to Sales syngeninc com VARIATIONS IN APPEARANCE OR FUNCTION BETWEEN PRODUCT ON SITE AND THE MANUAL MAY OCCUR SEND FEEDBACK AND COMMENTS TO SUPPORT SYNGENINC COM Page 3 14 02 037 B WashPRO Alpha User M anual SynGen Table of Contents SECO ANE OU CLIO aspas ana orando sa A 7 ale 1 es ao gg fo WSC EE NE NE 7 dale 0 Or O 0 aU O NE ee 7 POY MOO EN pg DO ai 7 ADOLOVI ON SEE re ee 8 SOON ZE C0 EM ME NE 10 RA 9 110 EE E E E geuanasoeapumagenase 10 CUON SEE EE EE E E 10 Safety and EMC Compliance Information rrrnrrrrnnnnrvvrnnnnvvvrnnnrvrrnnnnnvrrnnnnnnnrsnnnnnesnnnnnnssnnnnnnsssnnnnsnnnnn 11 BE e EEE 11 Section 3 WaShPRO System Description ccccccccssscccssseeecssseeecsssseeesseseecessseeesssseueessssesesessseeeessneess 12 SynGenX WASH Disposable Set erereeeerereaeerereanener ea anenera nene cana nene cana renas anen a 13 Disposable Set Components c ccccscssccsssseccsssseeccsseeessseeeeeesseeessseeeesssueesessee
18. bes on the Disposable Set during processing F A pump to apply positive or negative pressure to the Disposable Set to facilitate and control the flow rate of fluid between the various bags and Disposable Set compartments during processing G Two vacuum pressure tubes to interface between the pump and Disposable Cartridge Page 19 14 02 037 B WashPRO Alpha User M anual SynGen H Sterile Docking Device mounted on a swing arm for easy use I Load Cell Hooks provide volume measurement during operation A user interface is provided for the operator and a computer interface is provided for downloading data to a PC WashPRO Control Software The WashPRO Control software provides the basic controls for the Workstation There is no data tracking capability in the Alpha product release The Control Module will track centrifugation data for download into the SynGen DataTrak software SynGen DataTrak Software Introduction The SynGen DataTrak software provides the interface between the operator and the WashPRO Control Module Disposable Cartridge and Docking Station through a host computer It downloads processing and system information and stores it in a database on the host computer The data collected includes information gathered during each processing run and serves as a means to support CGMP compliance The SynGen DataTrak System software includes the Microsoft MS SQL Server 2008 R2 Express Edition as the database se
19. cess The name of the user that was logged into the software when the data was downloaded Page 27 14 02 037 B WashPRO Alpha User M anual SynGen DATA TRANSFER TIME The date and time when the download occurred CONTROL MODULE TheID of the Control Module used for the harvest process CENTRIFUGE The serial number of the centrifuge used for the harvest process DC LOT The lot number of the Disposable Cartridge used for the harvest process DC EXPIRATION DATE The Disposable Cartridge lot expiration date USER NOTES An area to add comments to the processing record A SAVE USER NOTE button appears after initial entry Click SAVE USER NOTE to retain the comment DEPLETION VALVE OPEN The time in seconds that depletion valve was open DURATION during the process HARVEST VALVE OPEN Not applicable during WashPRO processes DURATION HARVEST TARGET VOLUME The target harvest volume TEM PERATURE C The minimum average and maximum temperatures that occurred within the centrifuge during processing GRAPH REVIEWED STATUS Dropdown menu where the Lab Supervisor can provide an electronic review signature of the processing report Page 28 www syngeninc com support syngeninc com 14 02 037 B O SynGen Preferences Section The PREFERENCES section allows the Lab Supervisor and Lab Technician User to configure the software as indicated below The software is configurable to each user s designated choices Click the SUBMIT ED
20. cking Station If the battery status indicator is o Steady green or slow blinking green if the battery has a sufficient charge to perform a harvest process o Steady red if the battery is insufficiently charged The operator should immediately charge the battery 3 Verify that the status display is 0 If dP is displayed download the data on the Control Module before proceeding If any other character is displayed contact SynGen Customer Support Turn the Control Module off by pressing and holding the POWER button approximately 3 seconds until the display shows no lighted indicators up Page 51 14 02 037 B WashPRO Alpha User M anual SynGen Loading Cell Culture and Wash M edia into the System 1 Open the WashPRO Software fie Sethege Help Status System idle 33 790 59 400 zs a sn arter EEE se Ea E 400 E E E Te 5 300 amp 10 ml E ne 4 1500 0 9 i 6 2 20 DC A Harvest Chamber 7 5 DC B Harvest Chamber 256 Cell Suspension mi 362 Wash Medium mi 629 DC Main Chamber 26 1 DC B Main Chamber 261 2 Select LOAD to launch the culture and media loading steps Cell suspension volume per cartridge ml 180 Wash volume per cartridge ml 10 Cancel a Enter the CELL SUSPENSION VOLUME PER CARTRIDGE IN ML Note The volume of the cell suspension per Cartridge must be between 40 mL and 240 mL b Enter the WASH VOLUME of media to dispense into the ha
21. clear the entries Re enter the correct U ser ID and password then click the SUBMIT button pa Page 38 www syngeninc com support syngeninc com 14 02 037 B SynGen Downloading WashPRO Control Module Data L Verify that the SynGenX Docking Station is connected to the computer via the USB cable Click the SYNGENX SYSTEM icon on the left navigation pane Place the Control Module in the Docking Station per instructions for use Scan barcode or enter the Control Module serial number and BLOOD UNIT ID Select the appropriate WashPRO DISPOSABLE CARTRIDGE LOT and CENTRIFUGE Serial number from the dropdown menu A green checkmark 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 3 te mar supervisor Lab Supervisor 9 AWN Connected Docking Stations and Control Modules Docking Staten ID Contra Mock ae ID Data Present Control Module 102 100196 Blood Unit ID IFS Disposable Cartndoe Lot 706 354 CryoPRO Workstation hi s Centntuge yY DOWNCOAD CLEAR 7 Click the DOWNLOAD button to download the data located on the Control Module or the CLEAR button to clear the fields Processing Reports The mechanisms to view processing reports which are the output of the data downloaded from the Control Module e Access the report through the HISTORY section e Configur
22. d e sssssssrssesrrrreserrressrrens 38 LOGIO NE 38 Downloading WashPRO Control Module Data ereta 39 Processing RODO EE DD TEE 39 Accessing the History Section ccccsccccsssseeecssseeecsseeeecsseeeeeesseeeessceseeeesseueesssceueessseueeesssueeesssseaeessaes 40 Launch Report on Down10ad cccccsscccesssseesesseeeessseeeceseeeeessseueessseeeeessseeecssseueeessseuesessseeeessssaeesseaas 40 Setting Preferences cccccecsccsssssecssseeecssseeeecseeeeeseseeeeessseeeeseseeeeeseseeeeseseeeeeseseeseeeseeeeesessessessenseesessaeeeseas 41 EO PEN 42 Section 7 Operating Instructions WaSNPRO System mmmmsvrrnrnvvrrrrnnvvrrranrvrrssnnrrrrrsnrvrrsrnnrrrssrnnnnenn 43 Acceptable Processing Volume runrnnvvrnnnnvvrnnnnnvvennnnnvennnnnveennnnnvesnnnnvesnnnnnnesnnnnnvessnnnneennsnnnensnnnneennnnnnee 43 Equipment Materials and ReagentS srrrnrrarvvrnnnanvvrnnnnnvrrnnanvvrnnnnnnnesnnnnvnrsnnnnnnsssannnssnnnnnrsnnnnnnnssnnnnenn 43 ETE 43 MANN PROD OR DR RIR OR UR 43 0 q ARREDORES NRO CD E ERRO RR RR 43 PROC OE 44 Setting up the WashPRO System for Operation ccccsscccsssseessssseeesssseeessseeeesesseeeeeesseeeeesssneeeegs 45 Calibrating the Load Call PR RR E 45 Understanding Clamp Operation erereereereereaeerere arenas aaere ee anen res nnares anne 46 Preparing the SynGenX WASH Disposable Set cccccsscccsssseessssseessssseeessseeeessssesessssseeeeess 46 Mounting the SynGenX WAS
23. d Central Funnel Tubes Il TheMedia Bag and Cell Culture Bag Tubing provide connections through sterile docking or sterile connection to the Disposable Set J ThePinch Clamps are controlled by the Control Modules to pinch and release the tubing to control the movement of cells and media between compartments WashPRO Control Module The WashPRO Control Module is a lithium ion battery operated microprocessor controlled electromechanical device Two motor gear cam assemblies in the Control Module rotate in order to operate an integrated tube pinch release mechanism that enables transfer of cultured cells to the harvest compartment The Control Module is also equipped with an accelerometer to measure acceleration and four optical sensors that detect interfaces betw een cell populations and cell culture media The Control Module firmware is the computer code that provides the operating instructions to the electromechanical components of the Control Module It gathers and stores information during each harvesting run including accelerometer readings infrared optical sensor readings Page 14 www syngeninc com support syngeninc com 14 02 037 B o SynGen and timing and duration of the pinch and release of the cell fraction transfer tubes The collected data serves to support CGMP compliance by documenting each harvesting run Control Module Components Optical Sensors Receivers Latch Point for Disposable Cart
24. draining the status on the computer will say Drain Process Complete Remove the waste line tubing from the Disposables Discard waste line and waste container per established procedures for handling biohazardous materials 10 Replace the caps on the waste line connector ports Preparing for the Wash Cyde L q RUN Page Press the WASH button from the main screen of the WashPRO Software Main chamber wash medium volume 180 per cartridge mi Harvest chamber wash medium volume per cartridge ml 10 a Input the desired MAIN COMPARTMENT WASH MEDIUM VOLUME PER CARTRIDGE The main compartment wash medium volume should be between O mL and 240 mL This volume is transferred to the central funnel compartment b Input the desired HARVEST COMPARTMENT WASH MEDIUM VOLUME PER CARTRIDGE The harvest compartment wash volume is the fresh media the harvested cells will be resuspended in Typical volumes range between 0 mL and 25 mL Press OK The wash process will begin and the wash window will close Upon completion of the wash process put harvest compartment access tubes into the slots on the side of the Disposable housings Close clamps on the central funnel tubing at the top of each Disposable 14 02 037 B 5 WashPRO Alpha User M anual SynGen 6 Using the tube sealer seal the tubing between the two Y Connectors 8 Disconnect the vacuum pressure tubes from the two Disposables E wo AN h 9 Press t
25. e Disposable Cartridge information or the CLEAR button to clear the entry 5 Verify the Disposable Cartridge information is displayed in the table 6 Only the quantity and active status may be edited once the Disposable Cartridge information has been entered Click the appropriate lot number to display the edit fields 7 Unchecking the ACTIVE checkbox will inactivate the lot number Inactive lot numbers will not appear in the DOWNLOAD dropdown menu option 8 Enter the quantity in the QUANTITY field as applicable 9 Tosavechanges click the SAVE CARTRIDGE button or the CLEAR button to clear all changes made Editing Preferences 1 Click the PREFERENCES Section on the lower left navigation pane 2 ThePREFERENCES window will appear Pa E 1 3 Admin Administrator i ao Preferences e o SynGen Aboma but Password 4 Log Sut aber ruastriby Old potire ra Faner patio 2 i Timeout 1643 minutes Confinn new password ol or Ek acer rem Dara Lee ad mabe war Geer prodie pi Months in advance Central edu E pe it T Disposable Cortrdgs r OrSPEO Werke tae T CreceRo Z Bag Sat 3 Clickthe AUTOMATIC LOGOUT checkbox and select the appropriate time in minutes from the dropdown menu Page 36 www syngeninc com support syngeninc com 14 02 037 B Ct SynGen 4 Selectthe STARTING ADMIN item from the options d
26. e the report to launch upon download Page 39 14 02 037 B WashPRO Alpha User M anual SynGen A ccessing the History Section 1 Click the appropriate icon e g SYNGENX SYSTEM on the left navigation pane to highlight 2 Click HISTORY on the lower left navigation pane A supamisort Lab Superta a History SynGenx Data P a E Gag com header here t Grau by Ha usa iiad urt 1 Litdr Flame ahihi Datu Treasa Tria F414 eS rye Marksiaben Hii 3 Click the BLOOD UNIT ID of the report to be viewed The report is displayed in anew window Launch Report on Download 1 Click the PREFERENCE section on the lower left navigation pane 2 Check the checkbox next to SHOW REPORT AFTER DOWNLOAD under DOWNLOAD PREFERENCES area 3 Click theSUBMIT EDIT button to save the change 4 Thereport will now be displayed automatically after each download Adding User Notes 1 Toadd comments to the report place the cursor in the USER NOTES field 2 Enter comments a SAVE USER NOTE button appears after initial entry 3 Click theSAVE USER NOTE button to retain the comment The comment is documented with the date time and logged in user for each entry saved Saving or Printing the File 1 Tosavethe processing report as a PDF file click the SAVE AS PDF button 2 Select the file location and edit the file name as needed 3 Click the SAVE
27. ecial disposal for electronic waste required REF Product or Part Number Manufactured By Page 7 14 02 037 B WashPRO Alpha User M anual SynGen e o me A free Storage Temperature Range Storage H umidity Range Storage Pressure Range Consult Instructions For Use Negative Tip Polarity Abbreviations Below are abbreviations that are used in the User M anual and their associated definitions ABBREVIATION D EFINITION Buffy Coat Concentration of platelets and white blood cells in a BC solution that contains some RBCs and plasma CSV Comma Separated Values es woese me Menufocurerstqupmet oo Page 8 WWW syngeninc com support syngeninc com 14 02 037 B SynGen ee rera cone por PortabiedocumentFomst SSS mr SSS Rm Recinto SSS wec xg Gravitational AealeaionFore SSS Page 9 14 02 037 B 2 SynGen WashPRO Alpha User Manual Section 2 Safety Warnings serious adverse reactions associated with the use or misuse of the device 1 A Warning is a statement that alerts the user to the possibility of injury death or other READ THIS USER MANUAL COMPLETELY PRIOR TO USING THE WASHPRO WORKSTATION Always follow established procedures for handling and discarding biohazardous materials The SynGenX WASH Disposable Set is a single use device with a sterile non pyrogenic fluid path Do not use if packaging or product is damaged Do not re sterilize No modifica
28. ect password error will occur Click the CLEAR button to clear the entries Re enter the correct U ser ID and password then click the SUBMIT button The password should be changed once initial login is accomplished Refer to the Setting Preferences section to change the password A new user must be set up as a Supervisor or Lab Technician in order to be able to access the OPERATION mode of the software Page 31 14 02 037 B WashPRO Alpha User M anual SynGen Section 5 Operating Instructions SynGen DataTrak Administration Mode Only users with Administrator roles can access the ADMINISTRATION mode of the software Verify all data entries prior to submitting as they cannot be edited once accepted by the software Exit the software completely once any entry field has been submitted or edited Software Login 1 Doubleclick the SYNGEN DATATRAK icon located on the desktop to launch the software 2 Enter ADMINISTRATOR USER ID the associated password and click the SUBMIT button 3 If the User ID was entered incorrectly an Invalid User ID error will occur If the password is entered incorrectly a Password is incorrect error will occur Select CLEAR to clear both entries ensure the user ID and password are correct then click the SUBMIT button Adding and Editing a User 1 Verify USER PROFILE section on the left paneis highlighted Enter the appropriate information into the USER PROFILE fields
29. ectly a Password is incorrect error will occur Select Clear to clear both entries ensure user ID and password are correct then click the SUBMIT button 5 Click the SYNGENX SYSTEM section of the left navigation pane if not already highlighted 6 Scan barcode or enter the Control Module serial number and UNIT IDENTIFICATION manually 7 Enter the appropriate DISPOSABLE CARTRIDGE BARCODE LOT NUMBER and CENTRIFUGE barcode serial number or select the appropriate Disposable lot number and Centrifuge serial number from the dropdown menu N Page 68 www syngeninc com support syngeninc com 14 02 037 B SynGen 8 A green checkmark 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 Connected Docking Stations and Control Modules Docking Suton ID Corral Hod de ID Dare Present Aa Control Module 102 100196 EV 4 gt Blood Unit ID IFS hsposable Carindge Lot ros 550 CryoPRO Workstation spo hore Certrifuge Y DOWNLOAD CLEAR 9 Click the DOWNLOAD button to download the data located on the Control Module or the CLEAR button to clear the fields 10 After data transfer the Control Module is ready for subsequent processing Processing Report Review report and obtain supervisor approval as appropriate To add anote to the report move cursor to the field beside
30. ed in a table below the data entry fields CryoPRO Workstation this section not applicable CryoPRO 2 Bag Set this section not applicable Page 23 14 02 037 B WashPRO Alpha User M anual SynGen Preferences Section The PREFERENCES section allows the A dministrator User to configure the software as indicated below Click the SUBMIT EDIT button to accept the entry or the CANCEL button to cancel the entry e T Freterences Automatic logout Password J Log Sut ds SA Old parison Mar pacer x E 103 tiro Conn nes Pissed rar krig Jorun N r op a et md mare wW At ary Lg prodie p months in advance Control essa E pe it D Desposabhs Cartridge Grom Waikela T CreceRD Z Bag Sat Automatic logout Includes a LOG OUT AFTER INACTIVITY checkbox and an up down selection menu to configure a timeout from 10 to 500 minutes in 10 minute increments Starting admin item Includes selection buttons for the field displayed upon Admin login Password Includes the following entry fields for changing a login password OLD PASSWORD NEW PASSWORD and CONFIRM NEW PASSWORD Expiration and calibration warning Includes up and down keys and dropdown menu selection to designate the amount of advance notification of expiration and calibration due dates in days weeks or months O perations M ode 1 TheoPERATIONS mode include
31. esssseueeesesseeessseeeeags 13 WashPRO Control M OCUIEC cccccccssssecesssseeessseeesessseessseeeecessceeesesseeeessseueessscuseessssneessssnseeesssseess 14 Control Module Components vascieiestsctescavesetssacaetavensatuniensvaxsauseedsvexsedsvensheussectuexeanedebenentebedenseeds dane 15 User Interface Label nsreennonnvoennnnvvrnnnnnvvennnnnvennnnnnesnnnnnnensnnnnensnnnnnenssnnnnesnnnnnensnnnnnensnnanennnnnnenennnnnenene 16 SYNGEN Docking Station wssscsccsscasscescaesaeeseansiatexeaseneiioassanncdunsetsdunsateswassdensiexbdenseansadenediadexeatyautseiiaencduee 17 WashPRO WOSKSUALION cccccccccessseccsssseecesssseecssseeeeessseseesseesesssseuseeesceeeessssuseesscseeessssaeeessssaeessssaeess 19 WashPRO Control SOMW ARO asas ccascaincdissnnencusstsnxuvatsi docas rsrs pise Se ja pa ei 20 SynGen DataTrak Software rrnnrrrnnnnnvrennnnnvrnnnnnvvennnnnvvrnnnnvvennnnnvvennnnnnnennnnneennnnnnnennnnnnennnnnneennnnnenesnn 20 ATOU COI OW ee 20 Intended US RD RP DOR RR RR OR RP nnen 21 Computer System Requirements rmranvvvnnvnnvvrnnnnnvennnnnvvrnnnnnvvennnnnvennnnnvvennnnnvnsnnnnnevennnnenennnnnenennnnnene 21 EO SP RO OO ee RD RD RD eiaeiiai 22 DataTrak Software DescriptiOn m vrurrssvvrrnnnvvrnnnnnvvrnnnnnvennnnnvvsnsnnnvvensnnveennnnnvnensnnnnensnnnvesnnnnnnensnn 22 Administration MOde rrrnnvvrnsnnverrnnnnnernnnnvennnnnnensnnnnnensnnnnensnnnnneennnnnesnnsnnnensnnnnesnnnnnnennnnnneennnnnneensnn 22 Preferences
32. evice according to the agreement in place Device failure or malfunction 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 79 14 02 037 B
33. he RESET button on the WashPRO Software to open the valves 10 Carefully remove the tubing below the tube seal from the WashPRO Workstation valves Page 64 WWW syngeninc com support syngeninc com 14 02 037 B SynGen 1L Remove the Disposables from the rotating holders by pressing on the side release buttons on either side of the Disposable housings 12 Attach each Disposable to a Control Module 13 Power on the Control Module and place the Disposable Control M odule sets in the centrifuge Page 65 14 02 037 B WashPRO Alpha User M anual SynGen The Next Steps 1 The Disposable Control Module sets are placed in the centrifuge and processed per The First Centrifuge Run section of this manual 2 Following the centrifugation step the spent media is drained according to the Draining the Waste from the D isposables section of this manual 3 Additional wash steps may be performed per the Preparing for the Wash Cycle section of this manual NOTE Changing media types is possible at the start of any wash step Page 66 WWW syngeninc com support syngeninc com 14 02 037 B SynGen Harvesting the Sample 1 Placethe Disposables back on the rotating holders 2 Leavethe clamps on the central funnel tube closed 3 Tubeseal the harvest compartment access tubes and detach aa mr x BS eS a A 4 Sterile dock the harvest bag tubes coming from the Y to each of the harvest compa
34. he SUBMIT EDIT button or click the CANCEL button to cance all changes made Resetting a Password L 2 3 Only default passwords are stored to reset a password click the appropriate name under the USER ID column Click the RESET PASSWORD checkbox Click the SUBMIT EDIT button to reset the password to the default setting or click the CANCEL button to cancel the edit Registering and Editing a WashPRO Control Module L Place an unregistered Control Module into aSynGenX Docking Station that is connected to the computer 2 Click the CONTROL MODULE on the left navigation pane Ps yen D taTesk Admirestraton User Profile SyrGenk System Canini Adran Administratoe Control Nlodale Dis posabis Carindge CrvoPRO Viorkslabon CryorROZ Bag bel 56 E ds REGISTER CONTROL MODULE Bb g mm Langt 3 Click the REGISTER CONTROL MODULE button Page 33 14 02 037 B WashPRO Alpha User M anual SynGen 4 10 11 12 13 The REGISTER CONTROL MODULE window will appear Scan or type the serial number of the Control Module and select the received date from the dropdown menu The default will bethe current date Click the REGISTER button to register the Control Module Click the CANCEL button to exit without registering Verify the Control Module information displayed in the table To inactivate a Control Module click the I
35. he harvested contents of the Disposable can be transferred to anew Disposable Set if additional wash steps are required to achieve the desired reduction of contaminants Contact SynGen Customer Service and return Control Module for service 14 02 037 B WashPRO Alpha User M anual SynGen ERROR DESCRIPTION ACTION BY USER MESSAGE Harvest valve The harvest pinch valve Place the same loaded Disposable on a open failed failed to open when directed new Control Module and repeat the run and the harvest did not take Contact SynGen Customer Service and place return Control Module for service Harvest The harvest pinch valve The pinch valve will automatically close Timeout failed to close when directed when the Disposable is removed from the Control Module Contact SynGen Customer Service and return Control Module for service Out of FRAM Control Module ran out of Verify centrifuge cycle times are set memory to record processing properly ota Contact SynGen Customer Service for further troubleshooting Valvebattery Battery did not have Place the same loaded Disposable on a threshold sufficient charge to rotate new Control Module and repeat the run error cam Charge the Control Module SynGenX DataTrak Software Launch Error DataTrak is launched within a framework called Microsoft SQL Server Occasionally this server may stop This can be caused by a range of reasons within the Windows operating s
36. he options displayed The selection will automatically appear upon after logging into the software Click the SHOW REPORT AFTER DOWNLOAD checkbox to either enable or disable To edit a password enter the current password the new password and confirm the new password by reentry Page 41 14 02 037 B WashPRO Alpha User M anual SynGen Ky Password must be between 8 and 20 characters and must include one F number and one punctuation character 7 Select the STARTING DEVICE from the options displayed The selection will automatically appear upon after logging into the software 8 Set the EXPIRATION and CALIBRATION warning using the dropdown menu for days weeks or months 9 Click the SUBMIT EDIT button to save the changes or the CANCEL button to cancel all changes made Logging Out amp Exiting 1 Tolog out from the DataTrak program select LOGOUT in the upper right corner to Preferences Aboma kpout Password J Leg Sut after ruastriby Chel padidrord Min pisiwa Turret 1805 manutes Confirme na passwd Party lop lewel item E Control leche T CrroPRO Workstation Download preferences Expeaton and maintenance warrang F Show report after download 13 Montia in advance 2 Toexit out of the DataTrak program close the window by selecting the red X icon on the upper right side of the window Page 42 www syngeninc com support syngeninc com 14 02 037 B SynGen Section 7 Operat
37. iate actions to remedy SynGen Docking Station The SynGen Docking Station is a multifunctional system component that concurrently charges the battery of the Control Module and enables transmission of data to and from the Control Module and a host PC Each Docking Station holds one Control Module at a time Four Docking Stations can be connected In series and powered by asingle cable to allow charging of up to four Control Modules simultaneously A single Docking Station can be used independently for both data transfer and Control Module charging The components of the Docking Station are described below Page 17 14 02 037 B 5 WashPRO Alpha User M anual SynGen Docking Station Connecter Port Pogo Pins Link Bracket Data Port Device Information Label Power Cord Port Pogo Pins Retractable pins which align and contact with electrical connectors on the bottom of the docked Control Module for data communication and battery charging These pins are inactive when no Control Module is docked User Interface Label Identifies the device and allows the user to see an LED with three states e Green if a Control Module is present and charging e Red if no Control Module is present or is present but not seated properly or Control Module is not functional The operator should assess which of these situations has occurred and take appropriate actions to remedy e Not illuminated if the Docking Station is not
38. ing Instructions WashPRO System A 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 WashPRO System prior to initial use Acceptable Processing Volume The WashPRO System is intended to process cell cultures with volumes between 40 mL and 480 mL in a single wash cycle Equipment Materials and Reagents Equipment Two WashPRO Control Modules SynGen Docking Station Sterile Connection Device for closed system processing Biological Safety Cabinet if applicable Thermo Scientific Sorvall Legend XT or XTR centrifuge or equivalent Customized Centifuge H ub for Tubing Management Cord Blood Unit ID Label Generator Digital Scale Tube Sealer Computer with SynGen DataTrak Software and WashPRO Software Waste Container 1 kg Calibrated Weight M aterials e SynGenxX WASH Disposable Set e Labels e Harvest bag R eagents e Washing buffers as many types as desired Page 43 14 02 037 B WashPRO Alpha User M anual SynGen Process Flow Load Cell Calibration using Calibrated Weight Setting up the WashPRO for Operation Loading Cell Culture and Wash Media into the System Download Control Module Data if desired required if a second wash and centrifugation run is desired Repeat Wash Steps as Desired changing media if desired a
39. ion v Harvest Compartment side compartment opposite the lot number label that will contain the Buffy Coat fraction Cells will be transferred to this compartment suspended in media After processing determine if there are displayed errors on the Control Module or error messages on the Processing Report from the SynGen DataTrak Software Follow instructions under Action by User for the indicated error or message In the event that liquids enter the WashPRO Control Module return the Control Moduleto SynGen Inc for service WashPRO Control M odule Alerts and Error Codes Thetable below identifies displayed alerts and error codes for the WashPRO Control Module and appropriate user actions DISPLAYED ERROR DESCRIPTION ACTION BY USER CHARACTER Battery Low Thereis Charge the Control Module bL insufficient power for a centrifugation process Blank Process error Review the DataTrak Processing Report for the error message and appropriate user no actions display Cam failure The Control Do not use the Control M odule for M odule s self test has processing determined that the cam has failed to reset to starting position Contact SynGen Customer Service and return Control M odule for service Page 72 WWW syngeninc com support syngeninc com 14 02 037 B ERROR DESCRIPTION DISPLAYED CHARACTER Calibration required The Control Module needs to be Cr calibrated to manufacturer s specification
40. isplayed The selected item will automatically appear upon after logging into the software 5 Set the EXPIRATION and MAINTENANCE WARNING up down keys to set the number and the dropdown menu for the days weeks or months 6 To edita password enter the current password the new password and confirm the new password by reentry of the new password The password must be betw een 8 and 20 characters and must include one number and one punctuation character 7 Click the SUBMIT EDIT button to save the changes or the CANCEL button to cancel all changes made Exiting Administration Mode 1 Toexit the DataTrak System ADMINISTRATION mode click the LOGOUT icon in the upper right corner to return you to the initial login screen 2 To exit the software completely click the red x in the upper right section of the window Page 37 14 02 037 B WashPRO Alpha User M anual SynGen Section 6 Operating Instructions SynGen DataTrak Operations Mode Logging In 1 Doubleclick the DATATRAK ICON located on the desktop to launch the software 7 n Ed Senter DeraTrak DataTrak Version 2 0 3 23 4 SynGen USER ID DD E PASSWORD F al o fi g 1 Ei 4 n 2 Enter the appropriate USER ID and PASSWORD Click the SUBMIT button 4 If the User ID and or Password are entered incorrectly an Unknown username or Incorrect password error will occur Click the CLEAR button to
41. k NEXT d Press NEXT to apply and save the calibration coefficients 6 Remove the 1 kg weights from the load cell hooks Page 45 14 02 037 B WashPRO Alpha User M anual SynGen Understanding Clamp O peration It is critically important that there is familiarity in how the pinch clamps on the tubing sets work Facing all clips in the same direction across the WashPRO Workstation and Disposable Sets will make it easier to operate the system Preparing the SynGenX WASH Disposable Set Always follow established procedures for handling and disposing of biohazardous materials 1 Removethe X WASH Disposable Set from its packaging 2 Visually inspect Disposable Set Do not use any Disposable Set that has missing or damaged components Page 46 www syngeninc com support syngeninc com 14 02 037 B amp SynGen 4 Remove caps from both air filters and discard Page 47 14 02 037 B WashPRO Alpha User M anual SynGen M ounting the SynGenX WASH Disposable Set on the WashPRO Workstation 1 Locate the rotating holders on the front of the WashPRO Workstation aad l nn TT A JR E dio al Es o a o Ee A es 2 Placethe Cartridges on the left and the right rotating holders 3 Starting at the Cartridges position the tubing in the pinch valves The backdrop of the WashPRO Workstation shows where the tubing connects Lower Y Connector Central fun
42. k the ACTIVE checkbox Click the SAVE CENTRIFUGE button to save the centrifuge information or the CLEAR button to clear the entry Verify Centrifuge information is displayed in the table To make the Centrifuge inactive click the appropriate SERIAL NUMBER of the centrifuge in the table Click the ACTIVE checkbox to uncheck Inactive Centrifuges will not appear in the download dropdown menu option To save the change click the SAVE CENTRIFUGE button or click the CLEAR button to clear the change NO PA W 90 O Adding and Editing a SynGenX WASH Disposable Set L Click DISPOSABLE CARTRIDGE on the left navigation pane Disposable Cartridge MA m CrvoPRO Viorkslabon LAP Bag Set Page 35 14 02 037 B amp WashPRO Alpha User Manual SynGen NOTE Alpha version SynGenX WASH Disposable Sets may or may not have lot ir numbers If nolot number is published on a sticker on the Cartridge Set this will not be trackable in theSynGen D ataT rak Software 2 Enter the LOT QUANTITY ACTIVE Status EXPIRATION DATE in the format yyyy mm and the DATE RECEIVED from the dropdown menu 3 The software will not accept an expiration date in the past or a date received in the future An expired lot will not be available for download and will not appear in the DOWNLOAD dropdown menu 4 Click the SAVE CARTRIDGE button to save th
43. kg without the tube sealer re Operating Temperature 10C lt Operating Temperature lt 35C Operating Pressure 70kPA lt Operating Pressure lt 106kPA 526 3 MMHG lt Operating Pressure lt 797 mmHG Relative Humidity 10 lt Operating Storage Humidity lt 95 Storage Temperature 20C lt Storage and Transport Temperatures 70C Storage Pressure 50 kPA lt Storage and Transport Pressures 106kPA 376 mmHG lt Operating Pressures 797 mmHG Storage H umidity 10 lt Operating Storage and Transport Humidity lt 95 Page 78 www syngeninc com support syngeninc com 14 02 037 B SynGen Section 12 Warranty SynGen Inc warrants to original purchaser that the WashPRO Control Module and SynGen Docking Station 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 Control Module and Docking Station 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 d
44. l and configure the software application for customer use The minimum required computer specifications are e Windows 7 or 8 1 Operating System e Microsoft N et Framework 4 0 e Minimum Intel amp Corei5 1 7 GHz processor or equivalent e Minimum 46GB RAM of memory e Minimum Hard disk size of 120 GB e Minimum Hard disk free space of 100 GB dedicated to the SynGen DataTrak database e Atleast 2 available USB Ports o For Windows 7 Operating Systems only USB 2 0 Ports are compatible with the DataTrak software The recommended required computer specifications are e Windows 7 or 8 1 Operating System e Microsoft N et Framework 4 0 e Minimum Intel Core 15 1 7 GHz processor or equivalent e Minimum 8GB RAM of memory e Minimum Hard disk size of 500 GB e Minimum Hard disk free space of 200 GB dedicated to the SynGen DataTrak database e Atleast 2 available USB Ports o For Windows 7 Operating Systems only USB 2 0 Ports are compatible with the DataTrak software All data captured by DataTrak is stored within a database The storage size requirements for this database are dependent on the number of samples run in a year Page 21 14 02 037 B WashPRO Alpha User M anual SynGen Here are some rough guidelines on annual requirements of data storage NUMBER OF PROCESSES ESTIMATED STORAGE CAPACITY ESTIMATED STORAGE CAPACITY SAMPLES RUN IN AN YEAR REQUIRED FOR LYEAR OF DATA REQUIRED FOR 5YEARS OF DATA 2500 10 GB 100
45. led tubing 13 Press the RESET button on the WashPRO Software and select YES to open the valves 14 Carefully remove the tubing below the tube seal from the WashPRO Workstation pinch valves Page 57 14 02 037 B WashPRO Alpha User M anual SynGen 15 Remove the Disposables from the rotating holders by pressing on the release buttons on either side of the Disposable housings 16 Attach the Disposable Set to two Control Modules 17 Power on the Control Modules Page 58 www syngeninc com support syngeninc com 14 02 037 B Ko SynGen The First Centrifuge Run L Placethe Disposables Control Modules into the centrifuge buckets directly across the rotor from each other 2 Rotate the Disposables in the centrifuge pointing the arrows on the top of each Disposable toward the cup that is counterclockwise to the Disposable Page 59 14 02 037 B S WashPRO Alpha User M anual SynGen 3 Place tubing in the custom rotor hub cup by matching the colors on the tubes to the colors in the cup RS RE a 4 Placeall additional tubing into the central cup and securely place the cover over the cup Page 60 www syngeninc com support syngeninc com 14 02 037 B D SynGen Close the centrifuge lid and press START Upon completion of the centrifugation run remove the cap from the cup Remove the tubes from the cup and remove the Disposables Control Modules from the centrif
46. ling below the following thresholds e Battery Voltage lt 3 95V 1 blink pattern e Battery Voltage 3 95V and lt 4 1V 2 blink pattern e Battery Voltage gt 4 1V and lt 4 15V 3 blink pattern e Battery Voltage gt 4 15V Steady fully charged POWER BUTTON Press this button for approximately one 1 second to power on the Control Module Press it for approximately three 3 seconds to power off the Control Module POWER STATUS INDICATOR Green if Control Moduleis powered on Not illuminated if Control Module is powered off Page 16 WWW syngeninc com support syngeninc com 14 02 037 B 0 SynGen STATUS DISPLAY Displays the status or error code of the Control Module Standard Status Codes are described below Refer to the Troubleshooting section for error codes and additional information CHARACTER DEFINITION PROCESS DESCRIPTION O Ready to Operate The Control Module is ready for processing PP Pas The process is has The process is has completed successfully Successfully E Present Ni sa E data needs to be downloaded in preparation for a new process ATTENTION INDICATOR Green if the Control Module is ready for processing or has successfully completed a centrifugation process Red if the Control Module has failed a centrifugation process has gone into an error state or the Control Module was powered down prior to downloading the data The operator should assess which of these situations has occurred and take appropr
47. nel holder tubing is placed fo wars in upper valve Central funnel tubing is placed In upper valve Harvest Chamber access tubi ng IS placed in lower valves 4 Theharvest chamber access tubes are placed into the lower valves 5 Thecentral funnel tubing is placed in the valves just above the Cartridge 6 TheY connector should be placed into lower Y connector holder Page 48 support syngeninc com www syngeninc com 14 02 037 B SynGen 7 Placethe Y connector located below the media bag and cell culture bag tubing into the upper Y connector holder Route the extra tubing to the right through the tubing holder Upper Y Connector holder 4 Excess tubing is routed through the tubing holder Page 49 14 02 037 B WashPRO Alpha User M anual SynGen 9 Placethe waste line tubing coming from the waste bucket in the tube holders near the blue vacuum pressure tubes These are not used at this time Preparing the Cell Culture and Wash M edia 1 Preparethe bags of cell culture and wash media following lab best practices 2 Locatethe Y Connector below the cell culture and wash media bags 3 Theclips on thetubing below the cell culture and wash media bags must be closed until the WashPRO Workstation valves are closed as seen when the valve indicators are green Sterile dock Spike the cell culture bag to the LEFT tube from the Y Connector Sterile dock Spike the wash media bag to the RIGHT
48. nn 72 WashPRO Control Module Alerts and Error CodeS srrrnrannvvrnrnnnvvrnnnnrvvrssnrrvrnsnnrvrsnsnnrvrsssnnrveenn 72 SynGenX DataTrak Software Download Error Message s sessssresssrnesrrnrsrrrnnsrrrnnsrrrnsrrrnesnna 73 SynGenX DataTrak Software Launch Error ccccccssssecesssseeeessseeesessseeessseeeeesseeeeessseeeeessseeeess 14 WashPRO Software Error Message cccccsscccessssecesssseeeeesseeesssseeeesssaeesessceeeseeseueeeesssueeesssnseeesssneess 14 Section 11 SpecificatiOnS rrrssevrnrsveverrrsrvrrsrrevennnnnevennaneresnnnnevesnnnnenennnnenennnnnenennnnnesnnnnnenennnnenennnnnenne 15 SynGenX WASH Disposable Set Specifications eee aerea nennda 15 WashPRO Control Module SPecifiCatlONS ccccccccsseccssssecesssseeeeesseeeesssseeeesssseeesssseeeeesssaeessssneess 76 SynGen Docking Station Specifications cccccccsssscssssseeesssseeeeesseeeeesseeeessseeeessseeeessseesessseeeeegs 77 WashPRO Workstation Specifications cccccccsssscccsssseecsssseeecssseeeecsseeesesseneeesssseeessseseeeessseessssaeess 78 TN NE 19 Page 6 WWW syngeninc com support syngeninc com 14 02 037 B D SynGen Section 1 Introduction The WashPRO Alpha System is used for the washing and concentration of cells from cell cultures frozen cells or other concentrated cell populations This is an Alpha system and not a commercially released product This Alpha is Production Equivalent as
49. r bag e Cell medium for final suspension e Biological Safety Cabinet or clean room area e Digital Scale e Label Printer s for component labeling e Syringes for sample if applicable e Labels for components and sample tubes e Final harvest collection bag or container Page 12 WWW syngeninc com support syngeninc com 14 02 037 B SynGen SynGenX WASH Disposable Set The SynGenX WASH Disposable Set is composed of two Disposable Cartridges interconnected with additional input tubing which allows for even distribution of cell harvest and diluents into both Cartridges Tube connections from each Cartridge s harvest compartment to the main compartment of the opposite Cartridge allow for quick easy and sterile preparation of the cells for subsequent centrifugation for washing Each Cartridge in the Set can accommodate up to 240 mL of cell culture and or wash medium in the central funnel compartment The harvest compartment can accommodate up to 30 mL of harvested cells and suspension media The cell culture filled Disposable Set is then placed into the WashPRO Control Modules for subsequent centrifugation following a preprogrammed profile Integrated within the Disposable Cartridge are mechanisms that pinch or release the tubing allowing for transfer of the cellular components during centrifugation This operation IS managed by the WashPRO Control Modules Disposable Set Components A TheDispo
50. receiving power Docking Station Connector Port Allows for side by side linking with up to four Docking Stations The connectors are located on each side of the Docking Station Data Port Port for connection to the host computer via the USB cable Power Cord Port Port for connection to the external power source via the power cable To remove mains power unplug the cable from the wall Device Information Label Provides information specific to the Docking Station as well as SynGen Inc contact information Link bracket Provided on every Docking Station to lock together the side by side linked Docking Stations Page 18 www syngeninc com support syngeninc com 14 02 037 B SynGen WashPRO Workstation The WashPRO Workstation is the basic automated processing system that enables fluid transfer betw een cell cultures and culture media bags into the Disposable Set The WashPRO Workstation components include e e e e O EE meee e ee O O mm mm eee A Elevated strain gauge load cell for holding a cultured cell solution bag left and a diluent wash bag right B A computer to control the WashPRO Workstation C Upper and Lower Y connector holders for the SynGenX WASH Disposable Set D Two rotating holders for the Disposable Set to facilitate transfer of waste to the waste bag and mixing of cells collected in the harvest compartments E Six pinch valves for closing tu
51. ridge Latch Point Serial Number Label User Interface Label Electrical Connectors for Pogo Pins Device Information Label 260048 ee KLE Bynder inc Er 102 100001 ACE Page 15 14 02 037 B WashPRO Alpha User M anual SynGen The Control Module components and display elements are described below Optical Sensors and Receivers Four optical sensors and receivers that detect the cell interfaces during centrifugation Latch Point for Disposable Cartridges The three connections for latching the Disposable Cartridge to the Control Module Device Information Label Provides information specific to the Control Module as well as SynGen Inc contact information Electrical Connectors for Pogo Pins The connectors that make contact with the Docking Station Pogo Pins and facilitate data transmission and charging Serial Number Label Control Module barcode and human readable text label User Interface Label POWER BUTTON STATUS DISPLAY BATTERY STATUS INDICATOR ATTENTION INDICATOR POWER STATUS INDICATOR BATTERY STATUS INDICATOR Steady green if the battery has a sufficient charge to perform a harvest process Steady red if the battery is insufficiently charged The operator should immediately charge the battery When the Control Module is placed on the Docking Station for charging the battery status indicator will blink at the following rates in response to battery charge fal
52. rtment access tubes 5 Properly place the two welded tubes in the two bottom pinch valves of the WashPRO Workstation Attach the vacuum pressure tubes to the air filter on the tops of the Disposables Attach the waste lines to the waste line connector ports On the main screen of the WashPRO Software press the DRAIN button After draining the status on the computer will read Drain Process Complete 0 Remove the waste line drain tubing Discard the waste line drain tubing per established procedures for handling biohazardous materials 11 Replace the caps on the waste line connector ports HONA Page 67 14 02 037 B WashPRO Alpha User M anual SynGen 12 Open the weld on the harvest compartment access tubes and remove the cap on the filter of the harvest bag 13 On the main screen of the WashPRO Software press the HARVEST button 14 After the Harvest process is complete tube seal the harvest compartment access tubes and detach the harvest bag Discard Disposables per established procedures for handling biohazardous materials Download Control M odule Data 1 Verify that the Docking Station is connected to the computer via the USB cable Double click the SYNGEN DATATRAK icon 3 Enter Lab Supervisor or Lab Technician User ID the associated password and click the SUBMIT button 4 If the User ID was entered incorrectly an Invalid User ID error will occur If the password was entered incorr
53. rver for a host computer SS E E Sen Dessa E DataTrak Version 2 0 3 5 SynGen q PASSWORD F 7 Page 20 www syngeninc com support syngeninc com 14 02 037 B SynGen NOTE TheSynGen DataT rak Software is broadly used for several products within d the SynGen family TheDataTrak Software compatibility for the WashPRO System is limited to data transfer from the Control M odules and tracking lot numbers of the D isposable Sets NOTE TheCryoPRO Workstation and CryoPRO 2 bag set are not used with the WashPRO however they will still be represented in D ataT rak screen shots Actual data created using the WashPRO Control M odules may differ from the data shown in this M anual Intended Use The DataTrak Software is intended for use with WashPRO Control Module X WASH Disposable Set and SynGenX Docking Station As of the release of the Alpha WashPRO Systems no information on the specific processing of the WashPRO Workstation is captured within DataTrak Softw are users should be familiar with the applicable WashPRO System components prior to using the DataTrak Software The DataTrak Software is not intended for use with computer system specifications other than those listed in the Computer System Requirements Computer System Requirements A computer printer USB hub and barcode scanner are not provided with the software A SynGen representative will instal
54. rvest compartment of the Cartridge Page 52 WWW syngeninc com support syngeninc com 14 02 037 B SynGen NOTE This is the volume of fresh media the harvested cells will be resuspended in Typical volumes range between 5 mL and 40 mL 3 Pressok when the volumes have been entered 4 Immediately open the clips below both the cell culture bag and the new wash media bag NOTE If you do not open the valves quickly enough the volumes of liquid will not comeout at an even rate 5 TheWashPRO will automatically dispense the selected cell suspension volume to the central funnel compartment of each Disposable along with the selected wash volume in the harvest compartment of each Disposable Page 53 14 02 037 B WashPRO Alpha User M anual SynGen 6 Atthe completion of the load process all the valve indicators will illuminate green indicating they are closed Page 54 WWW syngeninc com support syngeninc com 14 02 037 B SynGen 7 Manually close the tube clamps below the wash media and cell suspension bags 8 Closethe clamps on the central funnel tubes at the top of each Disposable Page 55 14 02 037 B WashPRO Alpha User M anual SynGen 9 Placethe harvest compartment access tubes in the slots on the side of the Disposable Page 56 WWW syngeninc com support syngeninc com 14 02 037 B SynGen IL Using scissors carefully cut the sea
55. s before it can be used for the centrifugation process F Data Present The data was not downloaded from the Control Module before powering down Fail The stratification depletion or harvest cycles have failed to complete SynGen ACTION BY USER Do not use the Control Module for processing Contact SynGen Customer Service and return Control Module for service Download the data from the Control Module Review the DataTrak Processing Report for the error message and appropriate user actions SynGenX DataTrak Software Download Error Message Thetable below identifies the errors displayed on the Processing Report and appropriate user actions ERROR DESCRIPTION MESSAGE A ccelerometer The accelerometer failed to Timeout Centrifuge Abort Harvest valve close failed Page 73 update the processor at the start of the centrifugation process so no cells were depleted or harvested The Control Module did not detect all the programmed centrifuge cycles The harvest pinch valve failed to close when directed Spent media will be collected along with the desired cells ACTION BY USER Place the same loaded Disposable on a new Control Module and repeat the run Contact SynGen Customer Service and return Control Module for service Verify the centrifuge program used is correct for using the WashPRO System Re process the Disposable Set using the correct centrifuge program T
56. s the three sections of operating functions PROCESS HISTORY and PREFERENCES ThePROCESS section allows the user to download the data from the WashPRO System components The data cannot be edited by a user Click the LOGOUT button to exit the OPERATIONS AREA and return to the login Screen The PROCESS section includes the following process options for data entry Page 24 support syngeninc com www syngeninc com 14 02 037 B SynGen Process Section DES syngeri Ostatak Process DG spaninort Lab Supenizey I Process SynGenX Syste Pi k SynGen E Connecled Decking Stations and Control Modules Docking Station ID Cannel Module ID DutePresent a ya n a Control Module Blood Unit ID Disposable Cartridge Lol m CrP Warkstaben Centrifuge o amp SynGenX System Select the SynGenX System picture to display the CONTROL MODULE DOWNLOAD field Includes the following required entries for download CONTROL MODULE SERIAL NUMBER BLOOD UNIT ID DISPOSABLE CARTRIDGE dropdown menu and CENTRIFUGE dropdown menu A green checkmark will indicate a valid entry and a red X will indicate and invalid entry for the Control Module Serial Number the Centrifuge Serial Number and the Disposable Cartridge Lot Number CryoPRO Workstation this section not applicable Page 25 14 02 037 B WashPRO Alpha U
57. sable Cartridge H ousing contains the individual compartments H arvest Compartment and Central Funnel Compartment and integrated pinch mechanisms B TheHarvest Compartment is where the harvested final product is collected in a small volume of suspension media Page 13 14 02 037 B WashPRO Alpha User M anual SynGen C TheAir Filter is 0 2 micron hydrophobic filter that facilitates air management during filling l the Disposable Cartridges or pushing fluid out of the Cartridges The V acuum Pressure Lo Tube is connected to this port with the task of providing a vacuun air pressure system to l facilitate fluid transfer out of the Disposable Cartridge and between the Cartridges D The Central Funnel Compartment is where cell cultures and media are loaded into the Disposable Cartridge E TheHarvest Compartment Access Tube s e EEE are for the filling of the harvest compartment with suspension medium transfer of the H l harvested cells to the central funnel of the opposite Cartridge and the draining of the final harvest into a collection bag F The Waste Line Connector Port is where spent media is sent to a waste container G The Central Funnel Tube s enable the flow of cell culture and media into the central funnel compartment H The Bridge Tubing is the length of tubing joining the upper M edia and Culture bag tubing to the lower Disposable Cartridge Harvest Compartment A ccess Tubes an
58. ser M anual SynGen History Section The HISTORY section will display the data records for selected component e g if the SYNGENX SYSTEM section is selected the download data from the Control Modules will be listed To review a PROCESSING REPORT click the appropriate Blood Unit ID frag lue heder hire bo gro bry B l cole iad unit BE pe Litt arte Page 26 WWW syngeninc com support syngeninc com 14 02 037 B SynGen The CONTROL MODULE PROCESSING REPORT contains the following information Processing Report for Blood Unit ID 123456789 Control Module 102 100116 CryoPRO Workstation 104 100011 SynGenX Processing Report Unit ID 123456789 Stratification Depletion Restratification Harvest O Process Complete Process Complete 900 1200 1500 1500 Time Seconds User ID labtech1 Depletion Valve Open Duration sec 114 8 Data Transfer Time 12 23 2014 9 54 57 AM Harvest Valve Open Duration sec 43 9 Control Module 102 100116 Harvest Target Volume mL 20 0 Centrifuge 41559969 Temperature C Min 20 0 Avg DC Lot 72979 0000 Graph Reviewed By Jane Supervisor DC Expiration 2015 06 Date Time The Blood Unit ID for the process report Allows the data to be exported as a CSV file Allows the report to be saved as a PDF file PRINT button Allows the report to be printed Graphic display of the harvest pro
59. tion of this equipment is allowed Only SynGen Inc authorized replacement parts may be used Cautions device associated with its use or misuse Such problems include device malfunction 1 A Caution is a statement that alerts the user to the possibility of a problem with the device failure damage to the device or damage to other property The caution statement includes the caution that should be taken to avoid the hazard Follow aseptic procedures Operators should be trained on the WashPRO prior to initial use Avoid liquid contact with the WashPRO Control Module internal components In the event that liquids enter the Control Module stop using and turn off the Control Module Return the Control Module to SynGen Inc for service Do not to insert any objects including fingers into the Control Module while powering on Handlethe SynGen Docking Station with care When connected to another device the overall system must be evaluated to the IEC 60601 1 3 edition by the end user Avoid dropping any of the components of the WashPRO system as this may cause damage Keep the SynGenX WASH Disposable Set upright during and after filling Do not invert once filled The WashPRO Control Module battery should be charged in the SynGen Docking Station overnight or for at least 6 hours prior to initial use Do not exceed 2000 x g centrifugation at any time as an inappropriate transfer of blood between compartments may occur causing a
60. ton to exit the administrative area and return to the login screen Page 22 www syngeninc com support syngeninc com 14 02 037 B to SynGen Administration Section The Administration section includes the following selections on the left side of the display screen for administrative functions Selected sections will be highlighted in yellow PS dee tk sp SynGen AM GALA User Profile Includes the following fields for data entry USER ID LAST NAME FIRST NAME PHONE NUMBER USER ROLE and ACTIVE checkbox Entered User information is displayed ina table below the data entry fields Control Module Primary screen displays a REGISTER CONTROL MODULE button and a table with the registered CONTROL MODULE ID RECEIPT DATE and ACTIVE State Clicking the REGISTER CONTROL MODULE button displays the REGISTER CONTROL MODULE field which includes a field for the S N barcode of the Control Module DATE RECEIVED dropdown menu and a REGISTER button Centrifuge Includes the following fields for data entry CENTRIFUGE SERIAL NUMBER DESCRIPTION CALIBRATION DUE DATE dropdown menu and ACTIVE checkbox Entered centrifuge information is displayed in a table below the data entry fields Disposable Cartridge Includes the following fields for data entry DISPOSABLE CARTRIDGE LOT NUMBER QUANTITY EXPIRATION DATE dropdown menu LOT RECEIVED DATE dropdown menu and ACTIVE checkbox Entered Disposable Cartridge information is display
61. ts are not for human use Page 75 14 02 037 B WashPRO Alpha User M anual SynGen WashPRO Control M odule Specifications wah Operating Pressure 70kPA lt Operating Pressures 106 kPA 526 3 mmHG lt Operating Pressures 797 mmHG Relative H umidity 10 lt Operating Storage Humidity lt 95 Centrifugation Speed Nominal 50 2 000 RCF Storage Temperature 20C lt Storage and Transport Temperatures 70C Storage Pressure 50 kPA lt Storage and Transport Pressures 106 kPA 376 mmHG lt Operating Pressures 797 mmHG Storage H umidity 10 lt Operating Storage and Transport Humidity lt 95 Page 76 www syngeninc com support syngeninc com 14 02 037 B SynGen SynGen Docking Station Specifications AC Input Voltage 100 240 VAC Frequency 50 60 Hz Power Consumption 1 0 0 6A Operating Temperature 10C lt Operating Temperature lt 35C Operating Pressure 70kPA lt Operating Pressure lt 106kPA 526 3 mmHG lt Operating Pressures 797 mmMHG Relative Humidity 10 lt Operating Storage Humidity lt 95 Storage Temperature 20C lt Storage and Transport Temperatures 70C Storage Pressure 50 kPA lt Storage and Transport Pressures 106 kPA 376 MMHG lt Operating Pressures 797 mmHG Storage H umidity 10 lt Operating Storage and Transport Humidity lt 95 Page 77 14 02 037 B WashPRO Alpha User M anual SynGen WashPRO Workstation Specifications SPECIFICATION 57 Ibs 25 85
62. tube from the Y Connector NOTE Sterile docking of the two bags to the D isposable Set can be completed prior to hanging the bags on the WashPRO Workstation However the clips on the input tubing must be clamped prior to docking Close the clips below the cell suspension bag and wash media bag until the valves on the system are closed automatically a IS a l i Page 50 WWW syngeninc com support syngeninc com 14 02 037 B OD SynGen 6 Hang the cell culture bag from the left load cell hook 7 Hang the wash media bag on the right load cell hook Verify the Centrifuge Programming 1 Select the centrifuge program that was established for the WashPRO protocol and verify that the program includes the following steps 1000 g for 10 minutes 100 g for 1 5 minutes 1000 g for 1 minute 100 g for 1 5 minutes Stop following processing Pang NOTE The above steps are the default program for the WashPRO System These steps may differ or be customized depending on the end application cell types and preferences Prepare the WashPRO Control M odules for O perati on 1 Obtain a Control Module and press the POWER button Do not to insert any objects including fingers into the WashPRO Control Module while powering on 2 Verify the battery status indicator is green If not charge the Control Module e If thereis any concern about the battery charge level place the Control Module on the Do
63. uge NO Yl 8 Remove the Disposables from the Control Modules Page 61 14 02 037 B WashPRO Alpha User M anual SynGen ir 9 The data from the Control Modules can be downloaded following the directions in the Downloading WashPRO Control M odule Data section of this manual D raining the Waste from the Disposables 1 Placethe Disposables back on the rotating holders 2 Sterile dock the top media bags to the Disposable Set 3 Replace all tubing connections of the Disposables as described in the M ounting the SynG enX WASH Disposable Set on the WashPRO Workstation section of this document a Attach the vacuum pressure tubes to the filter ports on the tops of the Cartridges 4 Attach the waste lines coming from the waste buckets to the waste line connector port Waste Lines N Page 62 support syngeninc com www syngeninc com 14 02 037 B O OO N SynGen Ensure that the waste lines are connected to the waste line connector ports and the waste containers After the drain process starts unpinch the sterile weld between the two Y connectors Remove the harvest compartment access tubes from slots on the side of the Disposable housings Unclamp all four clamps NOTE All tubing must be unclamped or removed from the slots on the side of the D isposable housings prior to starting the drain process On the main screen of the WashPRO Software press the DRAIN button After
64. ystem When the SQL Server stops a range of error messages may display when the DataTrak software is launched Additionally other errors within the Windows environment may lead to a failure message when DataTrak is launched To fix the problem close all open programs and reboot the computer DataTrak will launch normally after reboot WashPRO Software Error M essage In the event an error message is displayed please contact SynGen Customer Support at 844 363 0709 in the USA or 916 256 2423 international for assistance Page 74 www syngeninc com support syngeninc com 14 02 037 B D SynGen Section 11 Speafications SynGenX WASH Disposable Set Speafications rain gere Sterilization method by Gamma Irradiation manufacturer OPERATING ENVIRONMENT Operating Temperature 10C lt Operating Temperature lt 35 C Operating Pressure 70kPA lt Operating Pressures 106 kPA 526 3 mmHG lt Operating Pressure lt 797 mmHG Relative H umidity 10 lt Operating Storage Humidity lt 95 Storage Temperature 7C lt Storage and Transport Temperatures 50C Storage Pressure 50 kPA lt Storage and Transport Pressures 106 kPA 376 mmHG lt Operating Pressures 797 mmHG Storage H umidity 10 lt Operating Storage and Transport Humidity lt 95 TheSynGenX WASH Disposable Set has been subjected to gamma irradiation but validation to confirm sterility has not been completed at this time These Disposable Se

14-02-037-B WashPRO Alpha User Instructions

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