It may include separation of mammalian cells (~ 10 microns in size) from culture medium; or it may include separation of some molecules from other molecules or from a suspending solvent. The focus in this manual will be on the use of the XCell ATF System and process for separation of these constituents by filtration, based primarily on size.
ATF System Pump Cycle The Diaphragm Pump is the heart of the ATF process. It produces an alternating flow through the HFM (lumen side) or SM. The XCell ATF System provides a pulsating, reversible, flow of liquid, back and forth, between the process vessel and the Diaphragm Pump.
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XCell ATF System with C410:V3 Controller User Guide Figure 2. XCell ATF System Pump Cycles Note on the Exhaust Cycle: WARNING Glass bioreactors or single-use bioreactors (SUBs), unless otherwise specified by the manufacturer of the vessel, should not be pressurized. Such vessels can explode if pressurized.
User Guide 1.2 XCell ATF System Control Scope and Objectives: The C40:V3 controller provides the process control functionality of the XCell ATF4, ATF6, and ATF10 Systems. The C410:V3 controller is designed to: 1. Control ATF flow rates in both pressure and exhaust phases 2.
XCell ATF System with C410:V3 Controller User Guide 1.4 XCell System Interconnectivity Drawing Figure 3. C410:V3 controller with XCell ATF10 stainless steel pump housing and pressure relief valve...
XCell ATF System with C410:V3 Controller User Guide Size and Weight The size of a Filtration Assembly may vary slightly based on XCell ATF system configuration and accessories. The C410:V3 controller dimensions are fixed. COMPONENT DIMENSIONS COMMENTS C410:V3 inches Controller PNEUMATIC BOX Includes all plugs and connectors.
User Guide XCell™ ATF Pump Housing Assemblies The Filtration Assembly of XCell™ ATF pump housing is shown in Figure 3. Certain parts may vary, depending on requirements and specifications. Optional components for the XCell™ ATF housing include bioreactor connection kits, pressure transducers, vacuum pump, and options for sanitary diaphragm valves.
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XCell ATF System with C410:V3 Controller User Guide Table 4a. XCell™ ATF 10 Pump Housing Parts List ITEM DESCRIPTION Material QTY. ASME Clamp, Assembly, XCell™ 316 SS Pump Hemisphere Air Side, SA479 316L SS Lifting Handle, Assembly, XCell™ 316 SS...
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XCell ATF System with C410:V3 Controller User Guide Figure 4b. Exploded View of XCell™ ATF 10 Single-use Device with 0.2u PES Hollow Fiber Filter...
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XCell ATF System with C410:V3 Controller User Guide Table 4b. XCell™ ATF 10 Single-use Device Components...
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XCell ATF System with C410:V3 Controller User Guide Figure 4c. Exploded View of XCell™ ATF 6 System Filtration Assembly (P/N ATF6:PH-GMP)
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XCell ATF System with C410:V3 Controller User Guide Table 4c. XCell™ ATF 6 Pump Housing Parts List...
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XCell ATF System with C410:V3 Controller User Guide Figure 4d. Exploded View of XCell™ ATF 6 Single-use Device with 0.2u PES Hollow Fiber Filter...
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XCell ATF System with C410:V3 Controller User Guide Figure 4e. Exploded View of XCell™ ATF 4 System Filtration Assembly (P/N XCell™ ATF4:PH- GMP)
XCell ATF System with C410:V3 Controller User Guide Table 4e. XCell™ ATF 4 Pump Housing Parts List See Appendix 7 for list of spares and accessories C410:V3 Controller Layout 5.1 General Layout The controller consists of two parts: the E-Box, Figure 5, and the P-Box, Figure 4. The two are interconnected with a cable that relays signal and power.
XCell ATF System with C410:V3 Controller User Guide facilitate positioning and handling of the boxes within the facility. One can envision the P-Box in proximity to the Filtration Assembly, while the E-Box positioned distant to the Filtration Assembly, possibly mounted on a wall or a skid.
Do not exceed 90 psi / 6.1 bar on the Air inlet Exhaust/ vacuum line (f) - Located on the P-Box. This line is connected to a vacuum source. A vacuum source should always be connected to the exhaust line to ensure reliable operation of the XCell ATF.
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XCell ATF System with C410:V3 Controller User Guide In addition to vessel pressure, the hydrostatic pressure generated by the height difference between vessel liquid level and pump level may assist or hamper the exhaust flow Pump line (d) - Located on the P-Box. The line connects the P-Box to the Diaphragm Pump.
See Appendix 4 for instructions on how to set IP Addresses and connections. XCell ATF Operations- Remote Monitoring and Data Acquisition The following diagram shows the network architecture for controlling the XCell Equipment from an OPC Server and OPC Client Software over Profinet®:...
The OPC Client Software is any OPC capable program that will connect through the OPC Server to the XCell ATF Equipment. The OPC Client Software will Control the XCell Equipment remotely and/or read the status of the XCell ATF Equipment. Examples of OPC Client Software include Microsoft Excel, WinCC HMI by Siemens, and FTView HMI by Rockwell Automation.
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XCell ATF System with C410:V3 Controller User Guide For numerical entries as the value is being typed, a Min and Max range dialog box appears, showing the user the acceptable value range. Any value outside the min/max range, or any text strings or letters is not accepted.
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XCell ATF System with C410:V3 Controller User Guide Description of Screens and Buttons LOGON Logon screen appears when the C410:V3 controller is powered up. Click on LOGON to bring up User/Password Dialog Box and Keyboard. For first time use, enter ADMIN for USER and...
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/cycle, valve transition between pressure and exhaust cycles and flow direction. From the Main screen, an operator can: 1. Monitor and control XCell ATF System processes. In the Main screen and all subsequent screens, all data fields with a white background are for display only. The operator, based upon security levels, can change data fields with a beige background.
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XCell ATF System with C410:V3 Controller User Guide The main screen displays the parameters in the following tables: Field Description Date/Time Displays current Date and Time User ID Displays current User ID Entries in Main Field entries by Administrator (or, if authorized, by Engineer) through the...
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XCell ATF System with C410:V3 Controller User Guide Indicator Description Indicates Controller PLC is ON and in RUN mode Pump ON Indicates Diaphragm Pump is in RUN mode Standby Indicates Controller OFF/ON Status SOL 1 Indicates Flow Direction Solenoid is OFF/ON...
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XCell ATF System with C410:V3 Controller User Guide SET UP From the Set Up Screen, an Engineer/Administrator can make entries in the following: • Basic Set Up Screen • Advance Set Up Screen • Calibration Screen • Help Guide • Exit to Primary Screens •...
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XCell ATF System with C410:V3 Controller User Guide The Basic Set-Up screen will display the parameters in the following tables: Field Description Process Set Up Groups the following fields: Pump Model No Press to select Pump Model No ATF4, 6, 8, 10, 10-R...
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XCell ATF System with C410:V3 Controller User Guide P-PV Step Size (%) Sets the (%) incremental change in PV1 when PRV1 exceeds its set limits E-PV Step Size (%) Sets the (%) incremental change in PV2 when PRV2 exceeds its set limits Slope Function Enable: Don’t enable this function unless you thoroughly...
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XCell ATF System with C410:V3 Controller User Guide From the Advanced Set Up Engineer/Administrator can set the following Diaphragm Pump Parameters: The Advanced Set-Up screen will display parameters in the following tables: Field Description Max P-FLOW (LPM) Maximum limit for PFLOW set point (LPM) Max P-FLOW (sec.)
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XCell ATF System with C410:V3 Controller User Guide START-UP GUIDE The Start Up Guide page shows a Quick reference guide for the operator. This information should be reviewed by all Users before operating the C410:V3 controller. The Start Up Guide screen will display parameters in the following tables:...
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XCell ATF System with C410:V3 Controller User Guide CALIBRATION Analog Input Configuration / Calibration: Only accessible to the Administrator and Engineer Login. The Analog Input Configuration / Calibration screen allows for the setup of analog inputs. For each analog input the Administrator and Engineer will be able to configure the Engineering Units, the Minimum Engineering Value, the Maximum Engineering Value, and perform a two point calibration.
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XCell ATF System with C410:V3 Controller User Guide Button Description Accept Settings This button will enable the new settings. Exiting the screen without Accepting the settings will discard them. Analog Input Select This button will select which of the Analog Inputs is selected...
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XCell ATF System with C410:V3 Controller User Guide TRENDING The Trending screen displays an Overview screen from where the following trends are selected. PROCESS TREND monitors, in real time, the Flow and Exhaust Set Points and Process Values in This screen...
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XCell ATF System with C410:V3 Controller User Guide The Process Trend screen monitors, in real time, the Flow and Exhaust Set Points and Process Values in LPM. The screen has the following screen control options: Field Description Enter maximum value for the chart Y Axis...
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XCell ATF System with C410:V3 Controller User Guide These screens monitor, in real time, the specific analog signal. Trend buttons select trend to display. All screens have the following screen control options: Field Description Enter maximum value for the chart Y Axis...
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User Guide WEIGHT TREND Available in the TRENDING screen During the XCell ATF System cycle, the weight of the Filtration Assembly changes in response to the liquid flow to and from Diaphragm Pump. The weight profile is directly proportional to the position of the diaphragm within the Diaphragm Pump, (or to how much liquid is in the Diaphragm Pump).
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XCell ATF System with C410:V3 Controller User Guide The Alarm screen will display parameters in the following tables: Field Description Time Indicates time of Alarm Date Indicates Date of Alarm Text Describes Alarm Button Description Horn Acknowledge Press to turn off Horn...
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The following is a list of C410:V3 controller Alarms that can occur during normal operation: • XCell ATF System Warning has not been acknowledged. XCell ATF System function halted. • Main Power Loss (120/220) while Diaphragm Pump was running.
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XCell ATF System with C410:V3 Controller User Guide ADMIN. Only accessible to the Administrator who can navigate to the following screens: USERS The screen allows creation/amending of User ID’s and passwords. There are three (3) levels of security: 1. Operator 2.
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The controller must be in the standby mode. WARNING: Do not turn the Sol. Force to the ON position when the XCell ATF is connected to the P-box (with air pressure utility). Doing so may over expand the diaphragm causing potential blowout.
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XCell ATF System with C410:V3 Controller User Guide BATCH INFO. Display batch information as in the following screens OVERVIEW Overview of Batch information is shown The Batch Info Overview screen will display parameters in the following tables: Field Description Batch Data...
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XCell ATF System with C410:V3 Controller User Guide ALGORITHM XCell ATF System cycle change can occur by either of three algorithms. The screen tracks cycle change Algorithm performance. The three Algorithms are: 1. Set Point - normal process based on set up parameters.
6.0-6.7L See also Appendix 1. Cycle time vs. Flow rate Therefore, selection of a Flow Rate (L/min) by a user, using an XCell™ ATF System with a known Pump Displacement Volume (L), it is possible for the C410:V3 controller to calculate the Pump’s Cycle Time, Calculated CT.
REGULATOR PRV2 XCell™ ATF System Flow control is achieved by regulating the pneumatic air flow to and from the Diaphragm Pump; the pneumatic flow control is achieved with a two stage control, by regulating its pressure and with a flow restrictor. Two Proportional Pressure Regulators Valves, PRV1 and PRV2, are designed to make fine adjustments in pressure to the air stream flowing from the manual pressure regulator to a flow restrictor.
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XCell ATF System with C410:V3 Controller User Guide • Vacuum source connected 6.3.1 Following LOGON and entry of BATCH Information, go to the SET UP screen. 6.3.2 Go to the BASIC SET UP screen, and enter the following field values.
When working with an XCell ATF System connected to an unpressurized vessel, refer to Figure 1 for an overview of positioning the Filtration Assembly, P-Box and E-Box...
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P-BOX. Do not connect the Pump Line from the C410:V3 controller to the Diaphragm Pump at this point. 6. Power ON the E-Box. Wait for system to boot up and display the XCell System LOGON screen. 7. LOGON, the main screen will be displayed. Proceed to the SET UP screen.
Following the change, re-START the controller. It will start with the diaphragm in the fully exhausted position. Filtrate or Harvest: Start the Filtrate (or Harvest) pump only after XCell ATF System flow has stabilized. Stop the Filtrate / Harvest pump when stopping the XCell ATF System flow;...
Hollow Fiber Module Preparation Instructions that are included with every hollow fiber. There are different preparation methods depending on the module type purchased. Two types of HFMs are available for the XCell ATF System; accordingly, two types of Filter Housings are available: S-line Housing for use with HFM with “O”...
If the SM is being used, contact Repligen for replacement instructions. 7.5 Diaphragm replacement: Replacement or placement of a diaphragm within the Diaphragm Pump is part of the Diaphragm Pump assembly process which differs slightly among the XCell ATF4 System, ATF6 System, and ATF10 System.
Secure the Diaphragm Pump to the stand. Diaphragm replacement Procedure for the XCell ATF10 System The diaphragm within the Diaphragm Pump of the XCell ATF10 System contains a short right angle bend on the diaphragm periphery which mates with a counterpart groove in the PA pump hemisphere flange; therefore, for the XCell ATF10 System, these two parts are assembled first.
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XCell ATF System with C410:V3 Controller User Guide Repligen recommends sterilization of the Filtration Assembly by autoclaving. An appropriately sized autoclave is required. Contact Repligen for dimensional analysis of the autoclave. Sterilization of the Filtration Assembly by autoclaving is one of the simplest methods to sterilize the system.
Use caution during the procedure so not to damage attached parts or tubing. Avoid kinking or stressing attached tubing. 8.2 Autoclave Cycle 8.2.1 The XCell ATF systems have been designed to be sterilized using an autoclave. The XCell ATF System Filter Preparation and Autoclave Guide provides detailed guidance on the entire procedure including the recommended filter integrity test procedures and specifications.
While autoclave conditions may vary based on requirements, the following are typical autoclave conditions for the Filtration Assembly. Please refer to the XCell™ ATF System Filter Preparation and Autoclave Guide for more details. The entire cycle may take 4-5 hours.
135°C, for 30minutes, 3 times. 10.3 “O” Rings, gaskets and Quick Connects The o-rings on the ventilation ports and quick connects (XCell ATF4 System and ATF6 System) should be replaced every two or three runs. Replacement kits are available from Repligen.
Inspection of air and vacuum connection to the P-box Inspection of pneumatic fittings Inspection of the pneumatic tube from the P-box to the XCell™ ATF pump housing Inspection of enclosure for damage, locks and hinge performance, external electrical connection, cables and pneumatic tubing...
XCell ATF System with C410:V3 Controller User Guide Appendix 1: XCell Cycle Time vs. Flow Rate Cycle time vs. Flow rate XCell System ATF4 ATF6 ATF8 ATF10 lgcy ATF10 PUMP VOLUME (L) Cycle time (sec) FLOW RATE (L/MIN) 18.8 37.5 76.5...
XCell ATF System with C410:V3 Controller User Guide Appendix 2: User Access Access levels to the C410:V3 Controller User Level Option Controller Function Parameter Permissions General Access General Access Upon Login Start/stop General Allowed LPM SP Not Allowed LMP PV...
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XCell ATF System with C410:V3 Controller User Guide User Level Option Controller Function Parameter Permissions View and allowed to WI Trend General adjust Min and Max Name View Only Elapsed Time View Only Batch Data Cycle Count View Only Batch Info-...
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XCell ATF System with C410:V3 Controller User Guide User Level Option Controller Function Parameter Permissions View and allowed to Overview General adjust Min and Max View and allowed to Process Trend General adjust Min and Max View and allowed to...
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XCell ATF System with C410:V3 Controller User Guide User Level Option Controller Function Parameter Permissions Slope Function Allowed to adjust Enabled Bioreactor Allowed to adjust Pressure Height Allowed to adjust Differential Allowed to adjust Pressure Offset pressure and exhaust cycle fields...
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XCell ATF System with C410:V3 Controller User Guide User Level Option Controller Function Parameter Permissions Allowed to adjust PV2(%) min and max Allowed to adjust PRV1(psi) min and max Allowed to adjust PRV2(psi) min and max Accept Changes Allowed Allowed...
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XCell ATF System with C410:V3 Controller User Guide User Level Option Controller Function Parameter Permissions Actual Value Not Allowed Allowed (No changes Accept occur) Select Allowed Eng Units Not Allowed Point Not Allowed Eng Units Not Allowed Analog Input P3...
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XCell ATF System with C410:V3 Controller User Guide User Level Option Controller Function Parameter Permissions General Access General Access Upon Login Start/stop General Allowed LPM SP Allowed LMP PV View Only PFlow Status Sec Calculated View Only Sec Actual View Only...
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XCell ATF System with C410:V3 Controller User Guide User Level Option Controller Function Parameter Permissions Elapsed Time View Only Cycle Count View Only Batch Info- User ID View Only Overview Name Allowed Batch Setup Allowed Reset General Access General Allowed...
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XCell ATF System with C410:V3 Controller User Guide User Level Option Controller Function Parameter Permissions Allowed to Adjust Pressure Cycle LPM and Seconds Flow Max field Allowed to Adjust Pressure Cycle LPM and Seconds Flow Min field Allowed to Adjust...
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XCell ATF System with C410:V3 Controller User Guide User Level Option Controller Function Parameter Permissions Remote TSAP Allowed General Access General Allowed Select Allowed Eng Units Allowed Point Allowed Analog Input P2 Eng Units Allowed Point Allowed Actual Value View Only...
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XCell ATF System with C410:V3 Controller User Guide User Level Option Controller Function Parameter Permissions Eng Units Allowed Point Allowed Actual Value View Only Accept Allowed Select Allowed Eng Units Allowed Point Allowed Analog Input P5 Eng Units Allowed Point...
Directive 97/23/EC and indicate the pumps are compliant with the SEP (Sound Engineering Practice). For XCell ATF pumps shipped after July, 18, 2016, the XCell ATF4, ATF6, and ATF10 pump falls under the article 4.3 of the Pressure Equipment Directive 2014/68/EU and indicate the pumps are compliant with SEP.
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User Guide A copy of the Declaration of Conformity is included with the equipment. Sample Nameplate The XCell ATF System with C410 Controller, software v3 has been marked legibly and indelibly with the following information: • Name and address of the •...
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Inspect enclosure for damage, locks and hinges for performance, o Inspect the XCell ATF system housing components, especially the internal and sealing surfaces for damage, rust, cracks, scoring o Perform a pressure hold test of the XCell ATF System Handling Instructions Transportation: The XCell ATF controller E-Box weighs 23 kg (50 lbs) and the P-Box weighs 13 kg (29 lbs).
70 PSI) and marked in accordance with the ASME Boiler and Pressure Vessel Code. XCell ATF Single-use devices are designed and validated to withstand a pressure of 60 PSIG at 40 C. All device units are subjected to a pressure hold of 30 PSIG as part of standard release testing.
XCell ATF System with C410:V3 Controller User Guide Appendix 5: Profinet Communication Set/Change IP Address of HMI HMI IP Address setting: a. Select settings from the start menu, select network and dial up connections, then select PN_X1. b. From this interface, the IP Address, Subnet Mask and all other Ethernet Properties can be adjusted.
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XCell ATF System with C410:V3 Controller User Guide Information for Remote data logging Monitor Points List Name Data Offset Address Description type CYCLENO DInt %DB1.DBD0 Batch Cycle Count TOTAL_CYCLENO DInt %DB1.DBD4 Total Cycle Count PRV1 Real %DB1.DBD10 Flow Regulator Value Real %DB1.DBD14...
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XCell ATF System with C410:V3 Controller User Guide PRV2MAX Real %DB1.DBD226 Exhaust Regulator Value Max value PRV2MIN Real %DB1.DBD230 Exhaust Regulator Value Min Value PRV2 Real %DB1.DBD498 Exhaust Regulator Value FDRVFORCESP Real %DB1.DBD502 Flow Driving Pressure SP EDRVFORCESP Real %DB1.DBD506...
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XCell ATF System with C410:V3 Controller User Guide Input/ Output List Tagname Description PLC Tag Engineering Valve Real Address Fail Time Range Decimal Units Position Trend Places System Stop %I0.0 System Stop %I0.1 Spare Spare Spare Spare Spare Spare Spare...
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.ALARM_REG(0) condition has not been .DBX110.0 and Alarm Delay Stop, Activate reset within the alarm Timer Setpoint System Fault delay time, XCell™ ATF is Greater than Warning Horn function halted. Zero. "DB1" Main Power Loss %DB1 First Scan of PLC...
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