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NOVA BIOMEDICAL BIOPROFILE FLEX2 Instructions For Use Manual
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NOVA BIOMEDICAL BIOPROFILE FLEX2 Instructions For Use Manual

NOVA BIOMEDICAL BIOPROFILE FLEX2 Instructions For Use Manual

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Summary of Contents for NOVA BIOMEDICAL BIOPROFILE FLEX2

  • Page 3 FAX: 1-800-316-1178 (in the U.S.A.) or Waltham, MA 02454-9141 U.S.A. +1-781-891-9718 (outside the U.S.A.) Website: www.novabiomedical.com Technical Assistance For technical assistance inside the United States and Canada, call Nova Biomedical Technical Services at: U.S.A.: 1-800-545-NOVA 1-781-894-0800 or FAX: 1-800-316-1178 Canada: 1-800-263-5999 For technical assistance outside the United States and Canada, call your local Nova subsidiary or authorized distributor.

  • Page 5: Table Of Contents

    Table of Contents Introduction 1.1 About This Manual ..................1-1 1.2 Safety ......................1-1 1.3 System Requirements ..................1-3 1.4 Intended Use and Tests Performed ..............1-4 1.5 Operation Overview ..................1-4 System Details 2.1 ESM15 vs. ESM250 ..................2-1 2.2 ESM System Details ..................2-1 2.3 ESM Sample Cup..................2-2 2.4 FLEX2 + ESM/ambr®...
  • Page 6 BioProfile FLEX2 ESM Instructions for Use Manual Troubleshooting 6.1 Troubleshooting Procedures ................6-1 6.2 Error Codes ....................6-1 Appendix A.1 Spare Parts and Supplies List ..............A-1 A.2 Warranty ..................... A-1 TOC-2...

  • Page 7: Introduction

    Sartorius Stedim Biotech. This section introduces the ESM and covers the intended use and operational overview, including system requirements for both the FLEX2 and  ESM. NOTE: Nova Biomedical is only responsible for the service and support of those devices exclusively manufactured by Nova Biomedical. All service and support of any external device or system connected to or integrated with the BioProfile FLEX2 ESM is the responsibility of the End User and/or the external system manufacturer.
  • Page 8 BioProfile FLEX2 ESM Instructions for Use Manual 8. Place the system away from heat sources. 9. Connect the system to a power supply only of the type described in the operating instructions or marked on the device. 10. Do not defeat the safety purpose of the polarized or grounding type plug.

  • Page 9: System Requirements

    1 Introduction 1.3 System Requirements Electrical Requirements Two  grounded,  3-wire  receptacles  within  5  feet  of  the  system  are  required  for  • operation. It is recommended that the BioProfile FLEX2 Analyzer and the ESM are connected  • to a 1100 – 1200 VA Universal Power Supply (UPS) to maintain the power load  in the event of a power outage. FLEX2 Fuse Requirements • Operating Voltage: 90 - 264 VAC Operating Frequency: 50 - 60 Hz •...

  • Page 10: Intended Use And Tests Performed

    • Saturation (Bicarbonate) Concentration • NOTE: The BioProfile FLEX2 ESM Module is an accessory sample delivery system for the BioProfile FLEX2 Analyzer, not an analytical device. 1.5 Operation Overview Sampling is performed by the ambr® liquid handler robot arm, which draws a sample  from a selected ambr® vessel and deposits it into the ESM sample cup. The ESM automatically transfers the sample from the cup to the BioProfile FLEX2 Analyzer for ...

  • Page 11: System Details

    2 System Details 2 System Details 2.1 ESM15 vs. ESM250 The ESM15 serves to integrate the FLEX2 with the ambr® 15, and the ESM250 serves  to integrate the FLEX2 with the ambr® 250 automated bioreactor system. In either configuration,  the  components,  set  up,  operation,  and  maintenance  required  for  the  External  Sampling  Module  are  largely  the  same,  with  a  few  key  differences.  When  pertinent, sections in this manual will use "ESM15" or "ESM250" notation to distinguish ...

  • Page 12: Esm Sample Cup

    BioProfile FLEX2 ESM Instructions for Use Manual The ESM is installed using an accessory pack which is configured for either ambr® 15 or  ambr® 250 integration. In either case, the accessory pack contains the following components  necessary for FLEX2 + ambr® integration: ○ An ESM Reagent Cartridge that contains: • System Fluid Solution • Internal Waste Collection Pouch • Deproteinizing Solution • Performance Check Solution ○ A power cable for separate power supply to the ESM ○ A serial cable for communication between the ESM and FLEX2 ○...

  • Page 13: Flex2 + Esm/Ambr® Integration Overview

    2 System Details 2.4 FLEX2 + ESM/ambr® Integration Overview The BioProfile FLEX2 ESM is part of an integrated system as shown in Figure 2.4. An  online analysis is scheduled from the ambr®  computer, and the ambr® robot arm draws  a sample from the selected microculture vessel, positions itself above the ESM sample  cup and deposits the sample. The ESM syringe pump automatically drains the sample from the cup, drawing it to the ESM air detector inside the FLEX2 analytical unit to ensure  there is sufficient sample volume. Then, the ESM pinch valve closes, and the FLEX2  sample probe aspirates the sample from the ESM sample port. Sample analysis by the FLEX2 proceeds as usual, depending on the modules configured for the selected FLEX2 ...
  • Page 14 BioProfile FLEX2 ESM Instructions for Use Manual...

  • Page 15: Implementation

    The system should not be installed on the same bench top or within proximity to any high-speed centrifuge system. Since these systems often create a significant amount of vibration, placement of the BioProfile FLEX2 and/or BioProfile ESM near or on the same bench top may impact sample results.

  • Page 16: Spatial Considerations

    BioProfile FLEX2 ESM Instructions for Use Manual 3.2 Spatial Considerations This section serves to inform the End User of the FLEX2 and ESM component dimensions and tubing specifications so that the required space next to the ambr® system can be  prepared prior to install. 3.2.1 FLEX2 + ESM Component Dimensions Table 3.1 FLEX2 + ESM Component Dimensions...

  • Page 17: Esm Fluid Line Details

    3 Implementation Figure 3.3 Right Side View- FLEX2 + Osm + ESM 3.2.2 ESM Fluid Line Details The  table  below  details  the  different  lines  of  tubing  that  comprise  the  ESM  External  Tubing Set (PN 59209). It should be noted that there is a single part number for the ESM  Tubing Set, whether it is to be installed on an ESM15 or ESM250. The FLEX2 + ESM  must sit directly to the left of the ambr®; and their positioning in relation to the ambr® is  restricted by the lines in red. The FLEX2 and ESM must be close enough together such that the Waste (EF) line is not under strain, and the FLEX2 must be close enough to the ...

  • Page 18: Esm15/Ambr® 15 Spatial Requirements

    BioProfile FLEX2 ESM Instructions for Use Manual 3.2.3 ESM15/ambr® 15 Spatial Requirements The FLEX2 and ESM15 must be placed on a surface to the left of the ambr® 15 system. The maximum distance the FLEX2 can reside from the ambr® is constrained by the  sample (CF) tubing line which runs from the base of the sample cup to the right-side  cover of the FLEX2. The FLEX2 + ESM must be close enough together such that the waste (EF) tubing line, which runs from the FLEX2 right side cover to the ESM syringe ...
  • Page 19 3 Implementation ● Option 2 – ESM placed below FLEX2. This arrangement is required for ambr®15 with Analysis Module.* ○ When obtaining a shelf or cart to support the ESM, ensure that the top of the  ESM resides no further than 4.0 in (10.1 cm) from the base of the FLEX2. ○ Ensure that the right side of the FLEX2 resides no further than 5.0 in. (12.7cm) from the left outer wall of the BSC. ○ The right side of the FLEX2 and the right side of the ESM should be approximately  in-line vertically. ○ The FLEX2 should be positioned forward (proud) enough so that the main door is not impeded when opening or closing. *Analysis Module not pictured Figure 3.5 Option 2: ESM Below FLEX2 Table 3.4 Estimated Bench Space Required (Left of ambr®...
  • Page 20 BioProfile FLEX2 ESM Instructions for Use Manual 3.2.3.1 Biosafety Cabinet Preparation (ambr® 15) An existing sterile hood or biosafety cabinet may need preparation prior to installation  of ambr® 15 and subsequent integration with FLEX2 + ESM, unlike ambr® 250 which is  installed as a standalone biosafety cabinet. If an access opening on the left-side wall of the hood does not already exist, one must be drilled in order to route the ESM External  Tubing Set (CF, CW, and PC lines) from the sample cup mounted on the ambr® 15 deck  out to the FLEX2 + ESM. Care should be taken to position the access hole so that it creates the shortest distance for the Sample (CF) line. As a general guideline, both the height and the depth of the ...

  • Page 21: Esm250/Ambr® 250 Spatial Requirements

    3 Implementation 3.2.4 ESM250/ambr® 250 Spatial Requirements The FLEX2 ESM250 sits on a shelf mounted directly to the left wall of the ambr® 250 BSC. As with ambr® 15 integration, the FLEX2 must be placed on a table/bench to the left of the  ambr® 250 BSC, and FLEX2 positioning is constrained by the length of external tubing lines  listed in Table 3.2. The FLEX2 must be close enough to the BSC and ESM such that the Sample (CF) and Waste (EF) fluid lines are not stretched or crimped.

  • Page 22: Connectivity Requirements

    BioProfile FLEX2 ESM Instructions for Use Manual 3.3 Connectivity Requirements The FLEX2 and ambr® control computer communicate over TCP/IP to allow for the FLEX2 + ESM to receive sampling instructions from and be managed remotely by the ambr® computer. This also enables the ambr® software to receive measured and calculated sample results from the FLEX2 following an analysis.

  • Page 23: Date And Time Settings

    3 Implementation In the third arrangement, the FLEX2 and ambr® computer are connected to the network  directly. In addition to the Ethernet cable connecting the FLEX2 and ambr® computer to each other, one Ethernet cable is required to connect the ambr® control computer to  a laboratory/corporate network port, and another cable is needed to connect the FLEX2  to another available laboratory/corporate network port. Network ambr® Control Computer Figure 3.11 Option 3: FLEX2 and ambr® directly connected to network NOTE: The Ethernet-to-USB adapter included in the ESM accessory pack should only be used to connect the FLEX2 to a local area network port.
  • Page 24 BioProfile FLEX2 ESM Instructions for Use Manual 3-10...

  • Page 25: Esm System Operation

    4 ESM System Operation 4 ESM System Operation 4.1 ESM Setup & Initialization This section details the steps and system checks that should be taken to bring the ESM to a “Ready” state in preparation to receive samples from an external sample handling  device. 1. Ensure that the FLEX2 and ESM are each plugged into an appropriate power supply.

  • Page 26: Esm Reagent Cartridge Replacement

    BioProfile FLEX2 ESM Instructions for Use Manual 4.1.1 ESM Reagent Cartridge Replacement Step 1: Septum and Pinch Valve Tubing Installation A sample port septum and pinch valve tubing must be installed in the BioProfile FLEX2 for  the ESM sample to be properly aspirated by the FLEX2 sample probe. A new septum and pinch valve tubing segment are included with each new ESM Reagent Cartridge. Nova  Biomedical recommends that these components be installed with each ESM Reagent Cartridge replacement or after extended periods of ESM inactivity.
  • Page 27 4 ESM System Operation Step 2: Reagent Cartridge Installation Inside the ESM reagent cartridge bay is an RFID reader that recognizes if a reagent cartridge is present. An ESM Reagent Cartridge must be installed and recognized by the FLEX2 for the system to be made ready for sampling. If a reagent cartridge is in place when the FLEX2 + ESM is powered on, the FLEX2 Smart Maintenance system ...

  • Page 28: Esm System Status

    BioProfile FLEX2 ESM Instructions for Use Manual 4.2 ESM System Status The ESM Status icon (i.e. ESM 80%) appears in the Status Bar which is always present  at the top of the FLEX2 User Interface (Fig. 4.5). If the ESM is not enabled in the software,  there will be no indication of its existence on the User Interface. Selecting the Module  Status icon from the top right corner of the screen opens the ESM Status window (Fig.  4.6), where more detailed information is tracked including the ESM reagent cartridge lot  number,  install  date,  expiration  date,  samples  remaining,  Depro  fluid  remaining;  and  ESM version (i.e. 15 or 250). The ESM Status icon displays the status of the ESM at-a- glance using a system of color codes. Figure 4.5 ESM in Status Bar it is in Ready status, meaning ...

  • Page 29: Esm Configuration

    4 ESM System Operation 4.3 ESM Configuration 4.3.1 Configuring Sample Types Once the ESM is in Ready status, a FLEX2 Sample Type must be selected before external  sampling can occur. The End User can use an existing Sample Type or can program a  Sample Type tailored for online sampling with customized parameter panels, module  selections and configurations, a defined ESM sampling volume (ambr® 15, only), and  specific key parameters. At least one selected analytical module must be available for  sampling to proceed. To Create a Sample Type: 1. From within any of the FLEX2 Sample Analysis Figure 4.7 Create Button screens,  select  Create next to the Sample Type ...
  • Page 30 BioProfile FLEX2 ESM Instructions for Use Manual 7. To configure a specified process range for each parameter, set the Lower Limit and  Upper Limit to the desired values. The process ranges established in any given Sample Type function independently of the analytical range limits of the system. If a parameter’s value is outside of the analytical range, an error will be  • logged in the error log indicating [Parameter] Analytical Range High/Low.
  • Page 31 4 ESM System Operation 4.3.1.1 Key Parameters The  Key  Parameters  function  provides a means of suppressing analysis of online samples when specific "key" parameters are not  available due to calibration failure or  Quality  Control  failure  (if  QC  Lockout  is  enabled).  The  Key  Parameters function only applies to samples supplied to the FLEX2 by the External Sampling Module ...

  • Page 32: Online Sampling

    BioProfile FLEX2 ESM Instructions for Use Manual 4.4 Online Sampling 4.4.1 Analysis Preparation Prior to sampling, the ambr® queries the FLEX2 for ESM status along with the status  of the analytical modules included in the selected Sample Type. The ESM must be connected, initialized, and primed.  Further, all consumables  must  be  installed  and  valid  (non-expired),  the  selected  FLEX2 modules must be available and primed, and key  parameters  must  be  calibrated  and  passing  QC  (if  QC ...

  • Page 33: Maintenance

    5 Maintenance 5 Maintenance The following sections provide detailed information and directions to operate and maintain the BioProfile FLEX2 ESM. It is important to perform and/or schedule routine  maintenance as recommended. WARNING: Cell culture samples are potential sources of infectious agents. Handle all sample and flow path components with care. Gloves and protective clothing are recommended.
  • Page 34 BioProfile FLEX2 ESM Instructions for Use Manual 5.1.1 ESM Depro The ESM Depro function allows an operator with appropriate privileges to perform a Depro of the ESM sample flow path. During an ESM Depro, the ESM syringe pump draws  Deproteinizing solution from the ESM Reagent Cartridge and deposits it into the ESM sample cup via the cup wash (CW) tubing line. The syringe pump then drains the Depro  solution through the sample (CF) line and out the waste (EF) line to the self-contained  waste receptacle in the ESM Reagent Cartridge.
  • Page 35 Sample (CF) and Waste (EF) lines as biohazardous. Gloves and protective clothing are recommended. NOTE: Nova Biomedical recommends that the pump tubing typically be changed every 12 months. This frequency may vary depending on system usage, and should be replaced as needed.

  • Page 36: Change Esm Syringe

    BioProfile FLEX2 ESM Instructions for Use Manual 4. Replace the Cup Wash (CW) Line: Carefully CW/PC disconnect the CW line from the ESM syringe pump (Fig. 5.4) by turning the fitting counterclockwise until  it releases. Carefully pull the other end of the CW line off the metal port on the sample cup to which it is ...

  • Page 37: Initialize Esm

    5 Maintenance 4. Install the new syringe assembly making sure to secure the threaded connections. 5.  When the new syringe is installed, select Continue to prime the syringe pump. Figure 5.8 Syringe Plunger and Barrel Removal 5.1.4 Initialize ESM The Initialize ESM function allows an operator with appropriate privileges to initialize the ESM when required. During an initialization procedure, the ESM primes the flowpath with ...

  • Page 38: Esm Long-Term Shutdown

    BioProfile FLEX2 ESM Instructions for Use Manual 5.1.5 ESM Long-Term Shutdown The ESM Long-Term Shutdown function is an important maintenance procedure that an operator should be familiar with performing. If the ESM will be powered off for a period greater than 72 hours, the system should be purged of all residual fluid in the internal ...

  • Page 39: Cleaning Flex2 + Esm Surfaces

    WARNING: Vapor from other cleaning reagents used within the lab may be corrosive to the BioProfile FLEX2 + ESM and could result in damage to the system. Use caution and protect the system, as needed, when using reagents that produce...
  • Page 40 BioProfile FLEX2 ESM Instructions for Use Manual...

  • Page 41: Troubleshooting

    6 Troubleshooting 6 Troubleshooting This section describes the error codes and associated troubleshooting procedures for the BioProfile FLEX2 ESM. WARNING: Cell culture samples are potential sources of infectious agents. Handle all sample and flow path components with care. Gloves and protective clothing are recommended. 6.1 Troubleshooting Procedures The recommended troubleshooting procedures use the most logical and direct steps to resolve the error code.
  • Page 42 BioProfile FLEX2 ESM Instructions for Use Manual ESM Line Not Primed The ESM is not primed properly. Recommended Solutions 1. Run a Prime sequence through the ESM status menu. 2. Verify the percent remaining in the ESM Reagent Cartridge. If the pack has less than 10% fluid remaining or is within 1 day of expiry, replace the cartridge, septum, ...

  • Page 43: A Appendix

    Appendix A Appendix A.1 Spare Parts and Supplies List You can order the following parts and supplies from Nova Biomedical and its Distributors. Description Part Number (PN) Syringe, 2.5 mL, w/ Teflon Seal ..............60018 ESM Reagent Cartridge ................56227 ESM External Tubing Set ................59209 Pre-Pierced Septum (for ESM, Gas QC, and EOLS) 3/pack ......59228 ESM Swivel Adapter Kit ................. 61326 ESM Sample Cup (ambr® 15/250) ..............59975 ESM Sample Cup (ambr® 15+Analysis Module) ..........60094 Split Gland-Nut Assembly (ambr® 15 BSC) ........... 60251 ESM Shutdown Cartridge ................
  • Page 44 BioProfile FLEX2 ESM Instructions for Use Manual 1.  Consumable items, including the reagent cartridges and tubing are warranted  to be free of defects at time of installation. The item must be placed into service prior to the expiration date printed on the packaging. All defects must be promptly  reported to Nova Biomedical in writing. This warranty is invalid under the conditions  specified after item 2. 2. Freight is paid by the customer. The above warranties are invalid if: 1.  The date printed on the package label has been exceeded. 2.  Non-Nova Biomedical reagents or controls are used, as follows: Nova Biomedical ...