cytiva Sefia ReadySelect Operator's Manual
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cytiva Sefia ReadySelect Operator's Manual

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Sefia™ ReadySelect application
Operator Manual
Original instructions
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Summary of Contents for cytiva Sefia ReadySelect

  • Page 1 Sefia™ ReadySelect application Operator Manual Original instructions cytiva.com...

  • Page 2: Table Of Contents

    Table of Contents Table of Contents Introduction ......................4 Important user information ........................5 About this manual ............................6 Associated documentation ........................7 Safety instructions ..................... 8 Application and kit description ................. 10 Application overview ............................ 11 CT‑350.1 kit ..............................13 Application workflow ............................
  • Page 3 Table of Contents Contact information ............................. 90 ReadySelect application Operator Manual 29479384 AE...

  • Page 4: Introduction

    1 Introduction Introduction About this chapter This chapter contains important user information that you must read before operating the ReadySelect application, and information about the user documentation. In this chapter Section See page Important user information About this manual Associated documentation ReadySelect application Operator Manual 29479384 AE...

  • Page 5: Important User Information

    1 Introduction 1.1 Important user information Important user information Read this before operating the product All users must read the entire Operating Instructions for the Sefia™ S-2000 instrument and the Sefia Select™ module, and the Operator Manual for the application before installing, operating or maintaining the product. Always keep the Sefia S-2000 cell processing instrument Operating Instructions (29315810), Sefia Select module Operating Instructions (29417241), and this manual at hand when operating the product.

  • Page 6: About This Manual

    1 Introduction 1.2 About this manual About this manual Purpose of this manual The ReadySelect Operator Manual provides you with the information needed to set up and operate the ReadySelect application in a safe way. Scope of this manual This manual covers the ReadySelect application for the Sefia S-2000 cell processing instrument and the Sefia Select module used with the CT‑350.1 kit.

  • Page 7: Associated Documentation

    Associated documentation Introduction This section describes the user documentation that is delivered with the product, and how to find related literature that can be downloaded or ordered from Cytiva. User documentation for the ReadySelect application The user documentation is listed in the table below.

  • Page 8: Safety Instructions

    2 Safety instructions Safety instructions About this chapter This chapter describes safety precautions for the ReadySelect application. Important WARNING All users must read and understand the entire contents of this general safety chapter, and the specific safety precau- tions information in each subsequent chapter of this manual to become aware of the hazards involved.
  • Page 9 Only properly trained personnel are allowed to operate and main- tain the product. WARNING Accessories. Use only accessories supplied or recommended by Cytiva. WARNING The single-use kits are sterilized with Ethylene Oxide (EtO) and anaphylactic reactions can occur in hypersensitive people.

  • Page 10: Application And Kit Description

    3 Application and kit description Application and kit description About this chapter This chapter gives an overview of the ReadySelect application and CT‑350.1 kit. In this chapter Section See page Application overview CT‑350.1 kit Application workflow Parameters Application scenarios ReadySelect application Operator Manual 29479384 AE...

  • Page 11: Application Overview

    3 Application and kit description 3.1 Application overview Application overview Introduction to the ReadySelect application The ReadySelect application works in combination with the Sefia Select system running on BPAS 2.0 or higher. The ReadySelect application uses the single-use kit CT‑350.1. Note: The application can only be executed if the Sefia Select module is connected to the Sefia instrument, enabled, and turned on.
  • Page 12 3 Application and kit description 3.1 Application overview Parameter Range Initial cellular product volume for cryo- 5 to 300 mL preparation Final volume for ready-to-use formula- 10 to 250 mL tion Final volume for cryopreparation 10 to 300 mL ReadySelect application Operator Manual 29479384 AE...

  • Page 13: Ct-350.1 Kit

    3 Application and kit description 3.2 CT‑350.1 kit CT‑350.1 kit Overview of the kit 4 3 2 11 10 9 Note: The dimensions of lines and bags in the drawing are not proportional to the real dimensions of the kit. Note: The colors correspond to the colors of the lines and clamps of the kit.
  • Page 14 3 Application and kit description 3.2 CT‑350.1 kit Line descriptions All lines are made out of PVC with a 4.1 mm outer diameter. Line Name Description Processing bag line Line with a bag compatible with the thermal mixer of the Sefia instru- ment.

  • Page 15: Application Workflow

    3 Application and kit description 3.3 Application workflow Application workflow Introduction This section describes the main procedural steps when using the ReadySelect applica- tion. Application graph The application graph below represents the liquid volume inside the processing bag and the thermal mixer mixing. Increasing processing bag volume indicates that liquid is flowing from the bags of the kit to the processing bag.
  • Page 16 3 Application and kit description 3.3 Application workflow Line identification The image below shows a schematic diagram of the bags and lines of the CT‑350.1 kit. The colors correspond to the colors of the fluid pathways shown in the application graph.
  • Page 17 3 Application and kit description 3.3 Application workflow Workflow description The following table describes the phases the application goes through during a proce- dure. The phases can differ based on the user parameter configuration. For more infor- mation, see Section 3.4 Parameters, on page Phase Description Preliminary steps...
  • Page 18 3 Application and kit description 3.3 Application workflow Phase Description Cryopreparation (optional) This phase consists of: 1. Manual mixing of the initial cellular product bag (if appli- cable) 2. Transfer of a fraction of initial cellular product from the initial cellular product volume to the processing bag Note: Excess initial cellular product (if any) will remain in the initial bag.

  • Page 19: Parameters

    3 Application and kit description 3.4 Parameters Parameters Introduction This section describes the parameters when using the ReadySelect application. In this section Section See page 3.4.1 Parameter values 3.4.2 Parameter validation ReadySelect application Operator Manual 29479384 AE...

  • Page 20: Parameter Values

    3 Application and kit description 3.4 Parameters 3.4.1 Parameter values 3.4.1 Parameter values NOTICE Application parameters must be validated by the user. The following sections list the available parameters and default settings for the ReadySelect application. Ready-to-use formulation parameters The following parameters are applicable during the ready-to-use formulation phase. Parameter Range Description...
  • Page 21 3 Application and kit description 3.4 Parameters 3.4.1 Parameter values Parameter Range Description Formulation bag Enabled or Disa- If enabled, the procedure is paused at the end of standby bled ready-to-use formulation phase for a duration of 3 hours. If disabled, the procedure does not pause at the end of ready-to-use formulation phase.
  • Page 22 3 Application and kit description 3.4 Parameters 3.4.1 Parameter values Parameter Range Description Cryobag solution 3 0 to 295 mL Defines the volume of solution 3 added to the vol. processing bag for cryopreparation phase. Note: If cryoprotectant is used, it must be used as solution 3. Default: 0 mL Solution 3 hang bag Enabled or Disa-...
  • Page 23 3 Application and kit description 3.4 Parameters 3.4.1 Parameter values Parameter Range Description Cryo – conditioning 00:00 to 59:59 Defines the mixing duration of the thermal mixer prior time mm:ss to the addition of solution 3 to the processing bag during cryopreparation phase.
  • Page 24 3 Application and kit description 3.4 Parameters 3.4.1 Parameter values Parameter Range Description Cryobag 2 final 10 to 300 mL Defines the final product volume collected inside volume cryobag 2 for the cryobag splitting phase. Set 0 mL if no cryobag 2 is used Default: 0 mL Cryobag 3 final 10 to 300 mL...

  • Page 25: Parameter Validation

    3 Application and kit description 3.4 Parameters 3.4.2 Parameter validation 3.4.2 Parameter validation The parameter values must follow the guidelines given in the following sections. The instrument displays an on-screen prompt after the Parameters screen if one or more parameters are incompatible. General •...

  • Page 26: Application Scenarios

    3 Application and kit description 3.5 Application scenarios Application scenarios Introduction This section describes the different scenarios when using the ReadySelect application. In this section Section See page 3.5.1 Application scenarios overview 3.5.2 Scenario 1: ready-to-use formulation only 3.5.3 Scenario 2: cryopreparation only ReadySelect application Operator Manual 29479384 AE...

  • Page 27: Application Scenarios Overview

    3 Application and kit description 3.5 Application scenarios 3.5.1 Application scenarios overview 3.5.1 Application scenarios overview The application can be configured with following scenarios to collect the final cellular product. Combination of final bags Parameters One ready-to-use formulation bag All parameters are relevant. and up to four cryobags Section 3.4 Parameters, on page 19 more information.

  • Page 28: Scenario 1: Ready-To-Use Formulation Only

    3 Application and kit description 3.5 Application scenarios 3.5.2 Scenario 1: ready-to-use formulation only 3.5.2 Scenario 1: ready-to-use formulation only Description In this scenario, only the ready-to-use formulation is performed. Parameter settings The table below summarizes the key parameters for this scenario. All the parameters related to cryopreparation and cryobag splitting are not applicable.

  • Page 29: Scenario 2: Cryopreparation Only

    3 Application and kit description 3.5 Application scenarios 3.5.3 Scenario 2: cryopreparation only 3.5.3 Scenario 2: cryopreparation only Description In this scenario, only the cryopreparation and cryobag splitting are performed. Parameter settings The table below summarizes the key parameters for this scenario. All other parameters that are not listed below can be set within their full range.

  • Page 30: Operation

    4 Operation Operation About this chapter This chapter gives instructions on how to run the application using the Sefia instru- ment, the Sefia Select module, and the CT‑350.1 kit. In this chapter Section See page Prerequisites and required materials Prepare the solutions for the procedure Prepare the Sefia Select system and the ReadySelect application Start and monitor the procedure...

  • Page 31: Prerequisites And Required Materials

    Required materials supplied by Cytiva ReadySelect requires two CT‑350.1 kits— one for the procedure and one as backup, available from Cytiva. Required materials supplied by the customer NOTICE The user is responsible for validating all materials.

  • Page 32: Prepare The Solutions For The Procedure

    4 Operation 4.2 Prepare the solutions for the procedure Prepare the solutions for the procedure Introduction NOTICE The user must validate the types of solutions used. NOTICE When using a cryoprotectant solution, it must be used with the solution 3 line. This allows the user to control the hang bag valida- tion prompt, temperature, and transfer rate separately from the other solutions.
  • Page 33 4 Operation 4.2 Prepare the solutions for the procedure Where, • V is the required volume for the solution 2 in mL, and TOTAL,SOL2 • V is the value of the parameter Cryobag solution 2 vol. SOL2,CRYO Use the following formula to prepare the solution 3 connected to line 4: + 10 mL TOTAL,SOL3 SOL3,CRYO...
  • Page 34 4 Operation 4.2 Prepare the solutions for the procedure Use the following formula to prepare the solution 3 connected to line 4: + 10 mL TOTAL,SOL3 SOL3,CRYO • V is the required volume for the solution 3 in mL, and TOTAL,SOL3 •...

  • Page 35: Prepare The Sefia Select System And The Readyselect Application

    4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application Prepare the Sefia Select system and the ReadySelect application In this section Section See page 4.3.1 Start the system and the ReadySelect application 4.3.2 Verify and prepare the kit 4.3.3 Connect the cryobags to the kit 4.3.4...

  • Page 36: Start The System And The Readyselect Application

    4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.1 Start the system and the ReadySelect application 4.3.1 Start the system and the ReadySelect application To prepare the Sefia instrument, Sefia Select module, and the ReadySelect application, follow the steps below.
  • Page 37 4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.1 Start the system and the ReadySelect application Step Action Tap the arrow next to the parameter group name to proceed with the selected parameters. Result: Additional screens display relevant information or warnings if the parameter configuration is invalid.

  • Page 38: Verify And Prepare The Kit

    • Verify the sterility indicator on the Tyvek® cover is green and the text is visible. This indicates the kit was sterilized by exposure to EtO. If the sterility indicator is not green, contact Cytiva. Open the kit blister pack...
  • Page 39 4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.2 Verify and prepare the kit Step Action Note: Make sure the optical sensor cover and the separation chamber covers are closed. Push down the levers on the Sefia Select module into the unlocked position. Place the baseplate on the Sefia instrument.
  • Page 40 4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.2 Verify and prepare the kit The following illustration shows the correct locations of the bags and lines in relation to the hooks on the Sefia Select system. See the following section for more details on how to hang the bags and lines of the CT‑350.1 kit.
  • Page 41 4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.2 Verify and prepare the kit Hang the bags and lines Prior to installation, the bags and lines must be separated and set in the correct loca- tions. Follow the steps below to unpack the lines and bags from the blister pack. Step Action Remove the processing bag from the baseplate and place it inside the...
  • Page 42 CAUTION Check for twisted, crushed, or kinked tubing. Do not use if defective. Do not use if a clamp is closed, as the sterility can be compromised. Contact Cytiva for more informa- tion. Verify stopcock position Before continuing with the kit installation, follow the steps below to verify the positions of the stopcocks.
  • Page 43 Examples of acceptable positions are shown below. If any of the lines are partially or fully closed, do not use the kit and contact Cytiva. Examples of partially or fully closed lines are shown below. ReadySelect application Operator Manual 29479384 AE...

  • Page 44: Connect The Cryobags To The Kit

    4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.3 Connect the cryobags to the kit 4.3.3 Connect the cryobags to the kit Follow the procedure below to connect the cryobag(s) to the kit. NOTICE To preserve sterility and integrity of the single-use kit, only use an SCD to connect the bags to the lines of the kit.
  • Page 45 4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.3 Connect the cryobags to the kit Step Action If more than one cryobag is used, measure the lengths of the cryobag lines to ensure that all cryobag connections are performed at the same length. Start the measurement from the middle of the stopcock valve and mark the end with a pen to indicate the inlet port of the cryobags.

  • Page 46: Install The Ct-350.1 Kit

    4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.4 Install the CT‑350.1 kit 4.3.4 Install the CT‑350.1 kit Follow the steps below to install the kit. Step Action Remove the stopcock cassette from the baseplate. Remove the baseplate from the Sefia instrument and follow local regula- tions for disposal.
  • Page 47 4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.4 Install the CT‑350.1 kit Step Action Pull up the levers until they reach the locked position. Tip: It is easier to first pull up the two lower fixation levers and then the upper lever.
  • Page 48 4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.4 Install the CT‑350.1 kit Step Action Open the peristaltic pump cover and insert the silicone (non-colored) portion of the processing bag line (line 1) into the peristaltic pump on the right side of the Sefia instrument.
  • Page 49 4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.4 Install the CT‑350.1 kit Step Action Secure processing bag line 1 into the line holder on the left side of the Sefia instrument. Close all clamps. Tip: For ease of use, close the clamps close to the stopcock cassette.

  • Page 50: Connect The Solution And Initial Bags To The Kit

    4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.5 Connect the solution and initial bags to the kit 4.3.5 Connect the solution and initial bags to the kit Follow the procedure below to connect the bags to the kit. NOTICE To preserve sterility and integrity of the single-use kit, only use an SCD to connect the bags to the lines of the kit.

  • Page 51: Complete Application Preparation

    4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.6 Complete application preparation 4.3.6 Complete application preparation Edit Traceability screen After installing the kit and proceeding through the Kit installation screens, follow the steps below to edit traceability IDs. Step Action Tap Next to continue to the Traceability screen.
  • Page 52 4 Operation 4.3 Prepare the Sefia Select system and the ReadySelect application 4.3.6 Complete application preparation Step Action Tap Start. Result: The stopcocks automatically turn to the closed position When prompted, check the stopcocks are in the closed position, as shown. Tap Next if the stopcocks are in the correct positions, or tap Back if the stopcocks need to be realigned.

  • Page 53: Start And Monitor The Procedure

    4 Operation 4.4 Start and monitor the procedure Start and monitor the procedure Safety precautions CAUTION Make sure the area around the thermal mixer is clear before starting the procedure. Remove anything blocking or interfering with the motion of the thermal mixer. NOTICE Make sure that the processing bag is inside the thermal mixer on the left side of the Sefia instrument to allow proper temperature...
  • Page 54 4 Operation 4.4 Start and monitor the procedure Kit test After installing the kit and checking the stopcocks, start the automated procedure following the steps below. Step Action Tap Next to begin the automated procedure. Follow the on-screen instructions, open the requested clamp or clamps, and tap Next.
  • Page 55 4 Operation 4.4 Start and monitor the procedure Prompt Action Open the relevant clamps. Manually mix the initial bag Formulation bag is ready. Final volume is X ml. Tap Continue to continue the procedure or Stop to interrupt the procedure. Procedure will continue automatically in X minutes. Manually mix the initial bag Connect the solution 3 bag to line 4.

  • Page 56: End The Procedure

    4 Operation 4.5 End the procedure End the procedure Remove and dispose the kit At the end of the automated workflow, the on-screen instructions instruct the user to end the procedure according to the following steps. Step Action Close all clamps. Remove all bags and kit components from the Sefia instrument and the Sefia Select module.

  • Page 57: Emergency Stop During A Procedure

    4 Operation 4.6 Emergency stop during a procedure Emergency stop during a procedure Follow the steps below when you need to abort the automated procedure immediately. Step Action On the instrument control panel: Press the STOP button to irreversibly abort the procedure.

  • Page 58: Troubleshooting

    This chapter provides information to assist users to identify and correct problems that may occur when operating the system. If the suggested actions in this guide do not solve the problem, or if the problem is not covered by this guide, contact your Cytiva representative for advice.

  • Page 59: Overview

    5 Troubleshooting 5.1 Overview Overview Introduction NOTICE The user is responsible for validating the troubleshooting proce- dure and verifying the integrity of the recovered cellular product. This section provides general instructions for handling interruptions during a proce- dure. Interruptions include any warning or error alarm, emergency stop of the proce- dure, emergency shutdown of the instrument, and power failure.
  • Page 60 5 Troubleshooting 5.1 Overview Step Action Write down the error message, if applicable. Close all clamps. Remove the lines from the air bubble sensor grooves. Remove the pressure filters from the pressure sensors. Make sure the area around the thermal mixer is clear. Remove anything blocking or interfering with the motion of the thermal mixer.
  • Page 61 3. Tap Cancel. Retrieving and submitting files for support The reports and log files record data that allow Cytiva representatives to diagnose malfunctions or low performance procedures. To retrieve and submit the relevant files, refer to the instrument Operating Instruc- tions.

  • Page 62: Smartresume

    5 Troubleshooting 5.2 SmartResume SmartResume Introduction NOTICE The single-use kit used for the resumed procedure must be the same as the one used during the interrupted procedure. The SmartResume feature allows to resume an interrupted procedure from the last known state. If SmartResume cannot be used, go to Section 5.3 Recovery scenarios, on page When loading the application, SmartResume automatically detects the status of the...
  • Page 63 5 Troubleshooting 5.2 SmartResume Step Action When prompted, visually confirm that the stopcocks are in the closed posi- tion. NOTICE If the stopcocks are not in the position shown on the on- screen guidance, detach the cassette, manually rotate the stopcocks to the correct position, and reattach the cassette.

  • Page 64: Recovery Scenarios

    5 Troubleshooting 5.3 Recovery scenarios Recovery scenarios Introduction If it is not possible to resume the procedure using SmartResume, the cellular product can be recovered using one of the recovery scenarios described in this section. When restarting the procedure, a new kit is required. The following sections list the recovery actions for each sub-phase of the application workflow.

  • Page 65: Interruption During Preliminary Steps Phase

    5 Troubleshooting 5.3 Recovery scenarios 5.3.1 Interruption during preliminary steps phase 5.3.1 Interruption during preliminary steps phase Sub-phase Recovery actions 0.1: Kit test An issue occurred during the preliminary steps such as cryobag priming, processing bag priming, solution line priming or pump initialization. The initial 0.2: Cryobags cellular product is still in the initial bag.

  • Page 66: Interruption During Ready-To-Use Formulation Phase

    5 Troubleshooting 5.3 Recovery scenarios 5.3.2 Interruption during ready-to-use formulation phase 5.3.2 Interruption during ready-to-use formulation phase Sub-phase Recovery actions 1.1: Initial product An issue occurred during the prompt asking the user to manually mix the initial split/manual cellular product bag. The initial cellular product is still in the initial bag. mixing prompt Restart the procedure with the same parameter values as the interrupted procedure.
  • Page 67 5 Troubleshooting 5.3 Recovery scenarios 5.3.2 Interruption during ready-to-use formulation phase Sub-phase Recovery actions 2.2: Formulation An issue occurred during the transfer of solution 1 to the formulation bag. The preparation/ fraction of initial cellular product required for the ready-to-use formulation is in transfer solution 1 the formulation bag and partially diluted with solution 1.

  • Page 68: Interruption During Cryopreparation Phase

    5 Troubleshooting 5.3 Recovery scenarios 5.3.3 Interruption during cryopreparation phase 5.3.3 Interruption during cryopreparation phase Sub-phase Recovery actions 3.1: Cryobag prepara- An issue occurred during the prompt asking the user to manually mix the tion / manual mixing initial cellular product bag of the cryopreparation phase. The initial cellular prompt product is still in the initial bag.
  • Page 69 5 Troubleshooting 5.3 Recovery scenarios 5.3.3 Interruption during cryopreparation phase Sub-phase Recovery actions 3.3: Cryobag prepara- An issue occurred during the transfer of solution 1 to processing bag of tion/transfer solution 1 the cryopreparation phase. The initial cellular product is in the processing to processing bag bag and might be partially diluted with solution 1.
  • Page 70 5 Troubleshooting 5.3 Recovery scenarios 5.3.3 Interruption during cryopreparation phase Sub-phase Recovery actions 3.4: Cryobag prepara- An issue occurred during the transfer of solution 2 to processing bag of tion/transfer solution 2 the cryopreparation phase. The initial cellular product is in the processing to processing bag bag and might be partially diluted with solution 2.
  • Page 71 5 Troubleshooting 5.3 Recovery scenarios 5.3.3 Interruption during cryopreparation phase Sub-phase Recovery actions 3.7: Cryobag prepara- The measured volume = CP + S1 + S2 tion/solution 3 priming Where, • CP is the value of the parameter Cryobag cellular product vol., •...

  • Page 72: Interruption During Cryobag Splitting Phase

    5 Troubleshooting 5.3 Recovery scenarios 5.3.4 Interruption during cryobag splitting phase 5.3.4 Interruption during cryobag splitting phase Sub-phase Recovery actions 4.1: Cryobag dosing/ An issue occurs during the mixing step after the addition of solution 3 (cryo- product mixing protectant) to the processing bag or during the splitting to cryobag(s). The initial cellular product diluted with solution 3 (cryoprotectant) is in the 4.2: Cryobag dosing/ processing bag .

  • Page 73: Restart The Interrupted Procedure

    5 Troubleshooting 5.3 Recovery scenarios 5.3.5 Restart the interrupted procedure 5.3.5 Restart the interrupted procedure NOTICE The processing kit cannot be reused. When restarting the proce- dure, a new processing kit must be prepared and installed. Follow the steps below to restart the procedure with a new kit. Step Action On the Applications screen, tap the name of the application.

  • Page 74: Manual Transfer Of Bag Content

    5 Troubleshooting 5.4 Manual transfer of bag content Manual transfer of bag content NOTICE Make sure that the destination bag is large enough to collect the transferred volume before performing any manual transfer proce- dure. The content of a source bag can be manually transferred to a destination bag using gravity.

  • Page 75: Line Identification

    5 Troubleshooting 5.5 Line identification Line identification Line diagram The image below shows the line numbering of the CT‑350.1 kit. The colors correspond to the colors of the fluid pathways shown in the application graph. For more informa- tion, see Application graph, on page Line Definition...
  • Page 76 5 Troubleshooting 5.5 Line identification Stopcock configurations The stopcocks are controlled by the system to connect lines to the flow path depending on what phase the procedure is in. The following illustrations show stopcock configurations for opening or closing lines to the flow path.
  • Page 77 5 Troubleshooting 5.5 Line identification Line 5 open Line 6 open Line 7 open Line 8 open Line 9 open Line 10 open ReadySelect application Operator Manual 29479384 AE...
  • Page 78 5 Troubleshooting 5.5 Line identification Line 11 open Line 12 open ReadySelect application Operator Manual 29479384 AE...

  • Page 79: Warning Messages

    • Tap Next and Abort to abort the procedure. 3. If the issue cannot be corrected by re-connecting the pressure filters, re-instal- ling the silicone tubing, or opening the yellow clamps, contact Cytiva. ReadySelect application Operator Manual 29479384 AE...
  • Page 80 • Tap Next to continue the kit test. • Tap Abort to abort the procedure. 3. If the issue cannot be corrected by re-doing the kit test, contact Cytiva. ReadySelect application Operator Manual 29479384 AE...
  • Page 81 • Tap Next to continue the kit test. • Tap Abort to abort the procedure. 3. If the issue cannot be corrected by re-doing the kit test, contact Cytiva. General warning messages Warning message Description Corrective action Check that the While initial product is trans- 1.
  • Page 82 5 Troubleshooting 5.6 Warning messages Warning message Description Corrective action Check that the While solution 1 is primed, the 1. Verify that the solution 1 bag is solution(s) bag is air bubble sensor on the Sefia hung on the yellow hook. correctly hung on Select module detects liquid 2.
  • Page 83 5 Troubleshooting 5.6 Warning messages Warning message Description Corrective action Check that the line No liquid is detected by the air 1. Verify the following points: #1 is correctly bubble sensor on the Sefia • The processing bag line is inserted in the air Select module but there is well inserted in the air...
  • Page 84 5 Troubleshooting 5.6 Warning messages Warning message Description Corrective action Check that solution High vacuum is detected 1. Verify the following points: bag clamps are open. inside the kit by the pressure • All the relevant clamps are sensor of the Sefia Select open.
  • Page 85 5 Troubleshooting 5.6 Warning messages Warning message Description Corrective action Sefia Select module High vacuum is detected 1. Verify the following points: pressure warning. inside the kit by the pressure • All the relevant clamps are sensor of the Sefia Select open.
  • Page 86 5 Troubleshooting 5.6 Warning messages Warning message Description Corrective action Check cryobag X. The priming of the current 1. Verify the following points: cryobag cannot reach an end • The cryobags are because the removal of air connected. has taken too long. The cause can be an incorrect connec- •...
  • Page 87 5 Troubleshooting 5.6 Warning messages Warning message Description Corrective action Check cryobag High pressure is detected 1. Verify the following points: clamps. inside the kit by the pressure All relevant clamps are sensor during the priming of open. cryobags. No lines are obstructed. All welds are open.

  • Page 88: Reference Information

    6 Reference information Reference information In this chapter Section See page Get Help Contact information ReadySelect application Operator Manual 29479384 AE...

  • Page 89: Get Help

    6.1 Get Help Get Help Introduction You can submit your case online by creating an account on the Cytiva Web Portal at cytiva.com. To directly report the event, click on My Account and select Support Cases. The following sections list the information that should be always reported in case of any event.
  • Page 90 6 Reference information 6.2 Contact information Contact information Contact information for support To find local contact information for support and sending troubleshooting reports, visit cytiva.com/contact. Manufacturing information The table below summarizes the required manufacturing information. Requirement Information Name and address of the legal manu- Biosafe S.A.
  • Page 91 Page intentionally left blank...
  • Page 92 QR code. cytiva.com Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corp or an affiliate doing business as Cytiva. Sefia and Sefia Select are trademarks of Global Life Sciences Solutions USA LLC or an affiliate doing business as Cytiva.

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