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Updated EC Rep address

Updated Safety Notice

Updated Connections:

• Power Express Aliquot Module Key Features
• Aliquotter

Update existing procedures:

• Set Load Timeout for the Level Detector
• Replace the Roll of Labels in the Labeler
• Empty the Defective Secondary Tube Container
• Add Aliquot Tips
• Empty Aliquot Tip Biohazard Container
• Error Recovery General Information

— Aliquot Module Function Codes
— Function Code Procedure
— General Error Recovery

• Stop Button Recovery
• Aliquot Drip Tray Error Recovery

Updated Error and Function codes

Updated/Added diagrams

B31449AC, 06/2015

Cennexus software version 2.0

Line Control computer software version 2.00

Updated Aliquot priority setting.

Updated Stop Button Procedure.

Updated Error Code.

B31449AB, 11/2014

Cennexus software version 1.1

Line Control computer software version 1.00

Initial Issue, B31449AA, 12/2013

Cennexus software version 1.1

Line Control computer software version 1.00-R04

Revision History

B31449AE

Содержание Power Express Aliquot

Страница 1: ...Instructions for Use Power Express Aliquot Module For In Vitro Diagnostic Use B31449AE May 2018 Beckman Coulter Inc 250 S Kraemer Blvd Brea CA 92821 U S A...

Страница 2: ...marks mentioned herein are trademarks or registered trademarks of Beckman Coulter Inc in the United States and other countries All other trademarks are the property of their respective owners Find us...

Страница 3: ...roughout the IFU Updated the Power Express Aliquot Module Key Features section Chapter 2 Aliquot Module Procedures Updated the Set Load Timeout for the Level Detector section Updated the Replace the R...

Страница 4: ...e Function Codes Function Code Procedure General Error Recovery Stop Button Recovery Aliquot Drip Tray Error Recovery Updated Error and Function codes Updated Added diagrams B31449AC 06 2015 Cennexus...

Страница 5: ...ulter replaces any part under this warranty or as a result of any Services performed Beckman Coulter will own the replaced part Your exclusive warranty for Services not performed in a workmanlike mann...

Страница 6: ...Warranty and Service vi B31449AE...

Страница 7: ...ntially hazardous situation which if not avoided could cause death or serious injury Warning can indicate the possibility of erroneous data that could cause an incorrect diagnosis Caution Caution indi...

Страница 8: ...te the system only with all covers in place Caution Do not load or view the Instructions for Use PDF files onto any computer connected to the automation system Failure to follow this caution can reduc...

Страница 9: ...y or biohazard Please Hold This Portion Label This label located on the drawer in the Dynamic Inlet and Outlet modules and the top cover of the centrifuge indicates the most stable position to hold th...

Страница 10: ...s and materials declaration table the Table of Hazardous Substance s Name and Concentration meet People s Republic of China Electronic Industry Standard SJ T11364 2006 Marking for Control of Pollution...

Страница 11: ...n assessed before being placed on the market and has been found to meet the applicable directives relating to the European Union safety health and environmental protection requirements RoHS Caution Sy...

Страница 12: ...Symbol Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot for a variety of reasons be presented on t...

Страница 13: ...ds and lab coats Handle and dispose of biohazardous materials according to your laboratory procedures Title of Symbol Warning Crushing of hands Meaning of Symbol To warn of a closing motion of mechani...

Страница 14: ...l device labels labelling and information to be supplied Part 1 General Requirements 5 1 2 Title of Symbol Manufacturer Meaning of Symbol Indicates the medical device manufacturer as defined in EU Dir...

Страница 15: ...nd off button for the device Title of Symbol OFF power Meaning of Symbol To indicate disconnection from the mains at least for mains switches or their positions and all those cases where safety is inv...

Страница 16: ...labelling and information to be supplied Part 1 General Requirements 5 1 7 Title of Symbol Stop Meaning of Symbol To identify the control or the indicator to stop the active function Standard Number T...

Страница 17: ...ental electronic information products This logo indicates that this electronic information product does not contain any toxic or hazardous substances or elements and is green and is environmental The...

Страница 18: ...r crush This label is found in several locations Caution parts move automatically While the system is in operation do not touch or go close to any moving parts Close protective guards and covers durin...

Страница 19: ...econdary Tube Container 2 6 Add Aliquot Tips 2 8 Empty Aliquot Tip Biohazard Container 2 9 CHAPTER 3 Error Recovery Procedures 3 1 Introduction 3 1 Error Recovery General Information 3 2 Aliquot Modul...

Страница 20: ...otter Error Codes 4 21 Aliquot Merge Lane 4 38 T Lane Error Codes 4 39 Sensor Diagrams 4 46 Level Detector Unit 4 48 Labeler Unit 4 49 Aliquot Unit 4 52 APPENDIX A Related Documents A 1 Related Docume...

Страница 21: ...wer Express Aliquot module This manual contains information and instructions to perform Power Express Aliquot module operations and troubleshooting functions Note Follow all safety cautions and warnin...

Страница 22: ...Introduction Scope of this Manual xxii B31449AE...

Страница 23: ...an LIS assigned sample ID Automatically prints and applies aliquot tube bar code labels decreasing the possibility of incorrect labels Labels can be printed according to content as described in CLSI A...

Страница 24: ...quot module includes three main hardware components Level Detector Labeler Aliquotter The three components of the Aliquot module work in sequence to process the sample tubes 1 The Level Detector measu...

Страница 25: ...tor gel for gel tubes Or the separation between the red cells and the serum or plasma for non gel tubes 4 The Level Detector measures the height from the bottom of the tube to the top of the red cells...

Страница 26: ...further information please contact your Beckman Coulter representative Important The secondary sample tubes and tube caps supplied with the automation system are not Department of Transportation DOT o...

Страница 27: ...Labeler checks the bar code on each label 6 If the Labeler cannot read the bar code a It discards the secondary tube into a chute for disposal in the defective secondary tube container b It repeats St...

Страница 28: ...econdary tubes the Aliquotter uses one of the following user defined priority settings to 1 create as many secondary tubes as possible regardless of aliquot priority 2 create as many secondary tubes a...

Страница 29: ...iquot tip aspirates the total serum volume required to fill all the secondary sample tubes 3 The Aliquotter reads the bar code of each secondary tube and verifies it to be associated with the primary...

Страница 30: ...Power Express Aliquot Module Description Components 1 8 B31449AE...

Страница 31: ...the Level Detector The Level Detector loads and measures up to five primary sample tubes at a time The Load Timeout parameter is the period of time in seconds that the Level Detector waits before it...

Страница 32: ...low Figure 2 1 Aliquot Module Labeler 1 Aliquot Sample Tube Supply Bin 2 Label Assembly Drawer 2 Confirm that the label roll has a sufficient supply of labels for the run To replace a roll of labels r...

Страница 33: ...e back 3 Remove the empty spool or feed through any paper that is left on the label roll 4 Check the inside of the printer for dust If necessary clean the inside of the printer and the print head a Re...

Страница 34: ...ines at the bottom For ease of installation remove seven labels from the start of the roll 7 Insert the start of the new roll of labels through the label paper intake slot at the front of the printer...

Страница 35: ...of the U clamp Push the U clamp into the slots on the uptake spindle 9 Take up any paper slack by manually winding the label paper clockwise on the uptake spindle 10 Close the printer door and press t...

Страница 36: ...the bottom of the line inside the bin Do not fill to capacity 3 Close the door 4 Select the warning message on the control panel to clear the warning and then resume operation Empty the Defective Seco...

Страница 37: ...amaged aliquot tubes c Place undamaged unlabeled aliquot tubes back into the aliquot tube supply bin Refer to Figure 2 5 Aliquot Module Labeler Figure 2 5 Aliquot Module Labeler 1 Label Assembly Drawe...

Страница 38: ...message 1 Select the warning message on the control panel to silence the alarm 2 Open the aliquot tip supply bin door and check the supply level Refer to Figure 2 6 Aliquotter Consumables Figure 2 6...

Страница 39: ...zard procedures 1 Select the warning message on the control panel to silence the alarm 2 Open the aliquot tip disposal door at the lower front of the Aliquotter Refer to Figure 2 7 Aliquot Tip Biohaza...

Страница 40: ...he door Note If you do not push the drawer all the way back in the system displays a No Pail Error on the control panel Check for loose tips or other obstructions behind the drawer 7 Select Restart to...

Страница 41: ...laboratory policies and procedures related to the handling of biohazardous materials Refer to the applicable sources such as Material Safety Data Sheets for specific hazard information Caution Before...

Страница 42: ...tion on a connected instrument The following table lists the Power Express module function codes by associated module with descriptions of the action triggered by each function code You must place a m...

Страница 43: ...ance to disable drip trays Function Code Procedure 1 Select Manual and OK to place the module in Manual mode 2 Select Maintenance on the control panel 3 Select the number field to display the onscreen...

Страница 44: ...ecovery Procedures This section provides information to identify and resolve errors related to system operational problems that are not specific to any Power Express module System Error Recovery proce...

Страница 45: ...r Contact your Beckman Coulter representative for assistance Jammed Sample Tube Carrier Error Recovery To recover from a jammed sample tube carrier error follow this procedure 1 Select Mute on the con...

Страница 46: ...ain ON The air system also remains on Note If you press the Centrifuge Stop button refer to the Centrifuge Stop Button Recovery Procedure in the Centrifuge Module IFU PN B31456 Important Press the Sto...

Страница 47: ...d RF02 positions e Determine which rack or Bulk Inlet the samples removed in steps c and d were loaded from Reload the sample tubes to racks in the Inlet module or the Bulk Inlet bin 5 At the Error La...

Страница 48: ...ld Repeat and manually move both arms to an accessible location Remove sample tubes from Loading and Retrieval Arm grippers Use a flexible claw like grabber tool to reach inside the module to retrieve...

Страница 49: ...the diagrams below Note Any samples removed from a Storage module with any floor configured for Sarstedt tubes the sample tube cannot be reloaded You must remove the sample tube from the track and sto...

Страница 50: ...N033 FS002 ON FS004 ON FS006 ON FS032 ON FS034 ON or FS036 ON error Remove the tubes from the sample tube carrier at SN003 or SN033 When the module is placed back into Auto mode the empty sample tube...

Страница 51: ...es in the Unload rack so that the tubes start at position 1 and have no empty spaces e Block any tubes behind RF01 position Select Auto and OK to place the module back into operation Allow the system...

Страница 52: ...this rack s in the output tray on the right side of the instrument s d Remove sample tubes from the instrument load shuttle Place these tubes into another rack and place this rack in the output tray o...

Страница 53: ...reroutes them to another analyzer for testing If the analyzer is a non dynamic analyzer the system considers aspiration to be complete and you must manually request retesting or retrieve samples using...

Страница 54: ...layed dispose of the aliquot tip down the disposal chute 4 Unlock the rear doors of the Aliquotter and open the rear doors 5 Collect the sample by placing a 2ml sample cup below aliquot tip 1 and then...

Страница 55: ...PS043 is generated for the sample tube that was at BR01 Confirm the sample ID noted in step a manually remove the cap e Select Clear from the control panel to clear the PS041 PS042 or PS043 and relea...

Страница 56: ...push it forward to release the carrier c Press the Stop button again This resets the Stop button d Turn the Centrifuge power switch OFF and wait at least a minute The system displays Unlock when you...

Страница 57: ...procedure on the Centrifuge D Lane control panel Select Maintenance on the control panel r Select the number field to display the onscreen keyboard s Enter function code 84 and select Enter twice t A...

Страница 58: ...e Aliquot component b Select the number field to display the onscreen keyboard c Enter code 32 and select Enter twice on the control panel d If TIP ERR 12 TIP ERR 13 or TIP ERR 23 occurs select Clear...

Страница 59: ...to hold tubes at bar code reader BR02 and to release tubes after BR02 f Remove all tubes in the Aliquotter and the Labeler Do not remove any sample tubes at BR02 or before the tube is in the Labeler...

Страница 60: ...ld to display the onscreen keyboard c Enter code 32 and select Enter twice on the control panel d If TIP ERR 12 TIP ERR 13 or TIP ERR 23 occurs select Clear and OK on the control panel If the Clear op...

Страница 61: ...the cause of the error The Solution column provides resolution instructions Nomenclature The following table contains definitions of the alphabetic portion of error codes found in the Error Code colu...

Страница 62: ...X Printer Syntax PRNT CUT Printer Cut PRNT HEAT Printer Heat PRNT PAUSE Printer Pause PS Photo Sensor REG RST Register Reset RF RFID RF INI RF Initialization RST Reset SL Cylinder SN Sensor TIP ERR Ti...

Страница 63: ...the carrier CCIE ERR Established communication between PLC and LC has been disrupted 1 Confirm the cable connection between LC and PLC located at the upper stream side of the Error unit 2 Confirm all...

Страница 64: ...ng arm 3 Place the module in Auto mode to resume operation Note If the error still occurs reboot the module then place it in Auto mode to resume operation PM001 LIM The current register setting forced...

Страница 65: ...Select Restart on the control panel to resume operation SL011A ON SL011B ON SL011 OFF Error at the Y axis cylinder on the carrier transfer arm ON error The cylinder does not respond correctly to an ON...

Страница 66: ...ch is working correctly 2 Confirm that the compressed air supply is within the normal pressure range SL093 ON SL093 OFF Locking cylinder error The cylinder that locks the front door lock is not workin...

Страница 67: ...to resume operation SN002 PAS SN003 PAS SN004 PAS SN005 PAS SN102 PAS SN202 PAS SN204 PAS SN206 PAS Passage sensor error A passage sensor does not detect a carrier within a predetermined timeout peri...

Страница 68: ...of an aliquot tube either here or somewhere else The sample tube will need to be removed and select Clear to recover from the error 03 indicates the sample tube bar code label was read however the ID...

Страница 69: ...moving to the home position 1 Place the module in Manual mode 2 Confirm that nothing interferes with the movement of the rotating table 3 Place the module in Auto mode to resume operation PM001 JOG H...

Страница 70: ...he Y axis inner arm or retrieve arm motor moves towards the home position and the home sensor works correctly 2 Confirm that nothing interferes with the movement of the loading arm 3 Place the module...

Страница 71: ...ss Label Feed button on the Label Printer Refer to figure 2 3 and rotate spindle to take up any loose label paper Close drawer and press Restart PRNT STATE Failed to send data to the printer 1 Confirm...

Страница 72: ...sor at the carrier does not detect the tube 1 Confirm that PS024 works correctly 2 If a secondary container was dropped pick up the tube and place it in the carrier at PS024 PS031 ON Jammed or stuck s...

Страница 73: ...S051 works correctly 2 If there is a secondary container at PS051 remove the tube from the carrier PS051 OFF Secondary container detection error at BR03 1 Confirm that PS051 works correctly 2 Tube was...

Страница 74: ...secondary container is level and is not jammed or stuck 2 Confirm that the air compressor is on and the auto switch is working correctly 3 Confirm that the compressed air supply is within the normal...

Страница 75: ...or is on and the auto switch is working correctly 3 Confirm that the compressed air supply is within the normal pressure range SL006 ON SL006 OFF Secondary container guiding clamps are not working cor...

Страница 76: ...al pressure range SL021 ON SL021 OFF Error at the gripper on the secondary container transfer arm ON error The cylinder does not respond correctly to an ON signal from a PLC OFF error The cylinder doe...

Страница 77: ...o switch is working correctly 3 Confirm that the compressed air supply is within the normal pressure range SL034 ON SL034 OFF Push up cylinder error inside the secondary container supply box ON error...

Страница 78: ...ctions 2 Confirm that the air compressor is on and the auto switch is working correctly 3 Confirm that the compressed air supply is within the normal pressure range SL041 ON SL041 OFF SL042 ON SL042 O...

Страница 79: ...air compressor is on and the auto switch is working correctly SL086A ON SL086B ON SL086 OFF Error at the Z axis cylinder on the carrier transfer arm ON error The cylinder does not respond correctly t...

Страница 80: ...Confirm that SN011 turns on when the drawer is secured in position 3 If error repeats press the Label Feed button on the Label Printer Refer to figure 2 3 and rotate spindle to take up any loose label...

Страница 81: ...If necessary reprint the bar code label and re apply it to the sample tube 3 If the error persists select Clear on the control panel to release the carrier The aliquot process and all sample tubes in...

Страница 82: ...It processed Tube with aliquoting error HI VOL2 Unexpected serum level was detected Logged as an aliquoting error in System Error Log HI VOL2_S A sensor detected an impact when a nozzle attempted to...

Страница 83: ...on Note If the error still occurs reboot the module then place it in Auto mode to resume operation PM001 POS Loading arm positioning error 1 Place the module in Manual mode 2 Confirm that nothing inte...

Страница 84: ...hing interferes with the movement of the loading arm 3 Place the module in Auto mode to resume operation PM002 HOM Error generated while the arm was moving to the home position 1 Place the module in M...

Страница 85: ...ated while the arm was moving to the home position 1 Place the module in Manual mode 2 Confirm that nothing interferes with the movement of the loading arm 3 Place the module in Auto mode to resume op...

Страница 86: ...module in Manual mode 2 Confirm that nothing interferes with the movement of the loading arm 3 Select Restart on the control panel to resume operation PM101 ERR Motor error 1 Place the module in Manu...

Страница 87: ...hat nothing interferes with the movement of the loading arm 3 Select Restart on the control panel to resume operation PM102 LIM Motor error 1 Place the module in Manual mode 2 Confirm that nothing int...

Страница 88: ...Select Restart on the control panel to resume operation PS004 OFF Tip detection error at Nozzle A The sensor did not detect a tip on the nozzle when arm A attempted to discard it down the duct 1 Confi...

Страница 89: ...k of the tip supply box Inspect for and remove jammed or stuck tips PS086 ON Jammed or stuck tip at the front of the tip supply box Inspect for and remove jammed or stuck tips PS104 OFF Tip detection...

Страница 90: ...within the normal pressure range 4 Select Restart on the control panel to resume operation SL016A ON SL016B ON Error at the splash guard cover at the aspiration point 1 Inspect for and remove any obst...

Страница 91: ...e range SL051 ON SL051 OFF Error at lateral tube stopper 1 ON error The cylinder does not respond correctly to an ON signal from a PLC OFF error The cylinder does not respond correctly to an OFF signa...

Страница 92: ...or The cylinder does not respond correctly to an ON signal from a PLC OFF error The cylinder does not respond correctly to an OFF signal from a PLC 1 Confirm that a carrier is not jammed or stuck and...

Страница 93: ...rror The cylinder does not respond correctly to an ON signal from a PLC OFF error The cylinder does not respond correctly to an OFF signal from a PLC 1 Confirm that a carrier is not jammed or stuck 2...

Страница 94: ...essor is on and the auto switch is working correctly 3 Confirm that the compressed air supply is within the normal pressure range 4 Select Restart on the control panel to resume operation SL091 ON SL0...

Страница 95: ...l from a PLC OFF error The cylinder does not respond correctly to an OFF signal from a PLC 1 Confirm that a carrier is not jammed or stuck 2 Confirm that the air compressor is on and the auto switch i...

Страница 96: ...uard cover at the aspiration point 1 Inspect for and remove any obstructions 2 Confirm that the air compressor is on and the auto switch is working correctly 3 Confirm that the compressed air supply i...

Страница 97: ...TIPFALL NG B Discarded tip not detected in tip disposal bin sensor PS058 1 Select the warning message on the control panel to silence the alarm 2 Inspect and remove any obstructions from the tip disp...

Страница 98: ...auto switch is working correctly 3 Confirm that the compressed air supply is within the normal pressure range 4 Select Restart on the control panel to resume operation SL106A ON SL106B ON SL106 OFF St...

Страница 99: ...XX is unable to determine how to handle the sample tube and why it is unable to handle the sample tube 0y 01 indicates the sample tube bar code label is unreadable Repeat the read operation or reprin...

Страница 100: ...estart on the control panel to resume operation QJ71GF ERR The PLC module QJ71GF used for the communication between the PLC and LC malfunctioned 1 Reset the PLC 2 If the reset does not recover from th...

Страница 101: ...m that the compressed air supply is within the normal pressure range 4 Select Restart on the control panel to resume operation SL013 ON SL013 OFF Diverter error The diverter is not working correctly O...

Страница 102: ...in the normal pressure range 4 Select Restart on the control panel to resume operation SL025A ON SL025B ON SL025 OFF Diverter error The diverter is not working correctly ON error The cylinder does not...

Страница 103: ...d air supply is within the normal pressure range 4 Select Restart on the control panel to resume operation SL045A ON SL045B ON SL045 OFF Diverter error The diverter is not working correctly ON error T...

Страница 104: ...does not respond correctly to an ON signal from a PLC OFF error The cylinder does not respond correctly to an OFF signal from a PLC 1 Confirm that a carrier is not jammed or stuck 2 Confirm that the a...

Страница 105: ...ror The cylinder does not respond correctly to an ON signal from a PLC OFF error The cylinder does not respond correctly to an OFF signal from a PLC 1 Confirm that a carrier is not jammed or stuck 2 C...

Страница 106: ...at a carrier is not jammed or stuck and that the belt moves 2 Select Restart on the control panel to resume operation 3 If no sample tube carrier is there or stopped the passage of the carrier did not...

Страница 107: ...has occurred and then look up the error code in the Error Code tables in this document The most common errors tend to be jammed sample tube carriers which can happen anywhere along the track Sample tu...

Страница 108: ...4 1 Level Detector Sensor Diagram SN031 AS021 SL021 SN011 SN013 PM001 SL014 AS022 SN032 SN033 SN034 SN035 2 3 5 4 1 AS019 AS017 AS015 AS016 AS018 AS012 SL011B AS011 SL013 AS014 SL012 AS013 SL011A 4 4...

Страница 109: ...04 SN062 BR03 BR04 SN066 SN063 SL043 AS043 c SL042 AS042 AS041 SL041 b a SL044 DM041 DM041 SN064 SN054 SL053 AS053 f SL052 AS052 AS051 SL051 e d DM051 DM051 FS041 SN043 PS061 RF03 SN053 i g h SN061 SN...

Страница 110: ...Figure 4 3 Tube Supply Sensor Diagram 4 50 B31449AE Troubleshooting...

Страница 111: ...Figure 4 4 Label Supply Sensor Diagram B31449AE 4 51 Troubleshooting...

Страница 112: ...Aliquot Unit Figure 4 5 Overview Sensor Diagram 4 52 B31449AE Troubleshooting...

Страница 113: ...AS021 SL021 B SL121 AS121 d A SL022 AS022 AS122 SL122 B SL025 A SL125 B AS123 SL123 SL124 DM021 A DM121 B AS023 SL023 f B AS126 SL126A A AS026 SL026A SL024 B A A B SL126B SL026B h B AS131 SL131 A SL03...

Страница 114: ...Figure 4 7 Tip Supply Sensor Diagram 4 54 B31449AE Troubleshooting...

Страница 115: ...001 AS002 SL003B SL003A SL103B SL103A SN001 SN002 Z2 PM103 PM003 PM002 PM102 SN101 SN102 Z1 A B A B PRS11 AS104 AS105 SL104A SL104B PS104 PS004 PRS01 SN103 SN003 AS004 AS005 SL004A SL004B SN104 SN004...

Страница 116: ...43 SL043 l k AS004 SL004 AS003 SL003 x w AS042 SL042 AS041 SL041 5 4 3 2 1 SN062 y z SN061 A A Y SN066 SN067 SL066a SL066b AS064A SL064a AS064B SL064b SL067a SL067b AS067 AS068 PS063 PS061 PS065 PS062...

Страница 117: ...Figure 4 10 Optional Track Sensor Diagram B31449AE 4 57 Troubleshooting...

Страница 118: ...Figure 4 11 Merge Lane Sensor Diagram 4 58 B31449AE Troubleshooting...

Страница 119: ...APPENDIX A Related Documents Related Documents General System Operation IFU PN B31448 B31449AE A 1...

Страница 120: ...Related Documents Related Documents A 2 B31449AE...

Страница 121: ......

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