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MODULE 7

QUALITY CONTROL

7-2

AEROSET

Customer Training Guide

94858-103 — July 2003

CONTENTS

Page

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Ordering Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Reviewing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12

Deleting QC Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27

Printing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28

QC Summary Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-35

Westgard QC Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-40

Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-42

Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-44

Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-45

Summary of Contents for Aeroset

Page 1: ...Abbott Laboratories Abbott Park IL 60064 94858 103 July 2003 AEROSET Customer Training Guide...

Page 2: ...ii AEROSET Customer Training Guide 94858 103 July 2003 NOTES...

Page 3: ...tten authorization of Abbott Laboratories except to identify the product or services of Abbott Laboratories All other trademarks brands product names and trade names are the property of their respecti...

Page 4: ...ens etc are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations Data shown in sample printouts and screens do not reflect actual patient names...

Page 5: ...raining Guide is designed to be your introduction to using the AEROSET System The Modules in this guide are intended for initial training of Operators and should be used in conjunction with the AEROSE...

Page 6: ...OF TRAINING vi SYSTEM TOUR 1 1 BASIC RUN 2 1 DAILY START UP AND CHECKS 3 1 RUN OPTIONS 4 1 RESULT HANDLING 5 1 CALIBRATION 6 1 QUALITY CONTROL 7 1 CONFIGURATION 8 1 ICT UNIT 9 1 MAINTENANCE 10 1 COMPO...

Page 7: ...ependent carousel and FastTrack Samplers Overview The AEROSET System Training Program is an integrated ongoing approach designed to provide optimum use of the AEROSET System The Abbott Customer Servic...

Page 8: ...questions and answers Example screens and printouts throughout the training guide are used to acquaint the Operator with the format and content of the various types of AEROSET System screens and print...

Page 9: ...bility of electrical shock if procedural or engineering controls are not observed WARNING The general WARNING icon identifies an activity or area that may present a physical mechanical or chemical haz...

Page 10: ...System Operations Manual using the book icon When you see the icon you will be instructed to review detailed information in the Operations Manual on a particular procedure or topic AEROSET Application...

Page 11: ...in accordance with local state and federal regulations governing the treatment of regulated medical waste Solid Waste Generally accepted procedures for the treatment of consumable potentially infectio...

Page 12: ...n a sample Module 3 Daily START UP and Checks includes information which explains how to per form the Daily Checks and START UP Procedures and when performance of these procedures must be done Module...

Page 13: ...boratory Module 9 ICT Unit provides an overview of the design and operation of the Inte grated Chip Technology used for ISE measurement Module 10 Maintenance provides important information on how to p...

Page 14: ...xiv AEROSET Customer Training Guide 94858 103 July 2003...

Page 15: ...AEROSET Customer Training Guide 1 1 94858 103 July 2003 MODULE 1 SYSTEM TOUR MODULE 1 SYSTEM TOUR m...

Page 16: ...1 2 AEROSET Customer Training Guide 94858 103 July 2003 CONTENTS Page Objectives 1 3 Introduction 1 4 Instrument Tour 1 5 Consumables and Accessories 1 17 Software Tour 1 29 Review Questions 1 39 Answ...

Page 17: ...E 1 SYSTEM TOUR OBJECTIVES Upon completion of this Module you will be able to 1 Locate and identify the AEROSET System components 2 Identify and state the use of each consumable and accessory 3 Identi...

Page 18: ...on takes you on a tour of the instrument and introduces the principal hardware components Your attention is focused on the identification and location of hardware components accessories and consumable...

Page 19: ...lowing 1 System Control Center including Color Touchscreen Monitor Keyboard Computer CPU Printer Component Stand optional GPIB Communication Cable 2 Analyzer including Sampling Processing Area Front D...

Page 20: ...our System Control Center The System Control Center SCC controls the operation of the System Using the SCC the Operator orders tests reviews data defines configuration initiates a run or maintenance p...

Page 21: ...ter CPU IBM PC AT compatible The computer plugs into the Analyzer 4 Floppy Disk Drive Used to install assay files upgrade System software and copy files from the CPU 5 Printer Dot matrix printer The p...

Page 22: ...YSTEM TOUR 1 8 AEROSET Customer Training Guide 94858 103 July 2003 Figure 1 4 AEROSET Analyzer Back View Rear Folding Panel Right Side Panel ICT Pump Access Door Rear Left Panel Rear Right Panel 12562...

Page 23: ...ixer Unit 6 Reagent Supply Center 2 11 Cuvette Washer 9 Reagent Arm 2 12 ICT Unit 9 Reagent Arm 1 5 Reagent Supply Center 1 8 Sample Arm 1 FastTrack Sampler 3 Reaction Carousel Reserved STAT Position...

Page 24: ...ng on the FastTrack Sampler 2 Carousel Sampler Lift Carousel out to show Calibrator Control C C Carousel Calibrators and controls are loaded in sample cups in fixed positions The temperature is 10 C b...

Page 25: ...e Sample Carriers on the FastTrack Sampler 8 Sample Arm Dual probes on a single arm Dual fluidics system identified as A Line and B Line serves to increase throughput 9 Reagent Arms Dual arms with a s...

Page 26: ...The red arrow illuminates when the Sample Carrier is in the sampling position 16 Front Display Panel Indicates the Power status and FastTrack Sampler status Refrig Main Circuit Breaker Switch is ON A...

Page 27: ...e Wash Pumps Used to wash the inside of the Sample and Reagent Probes Behind the Front Middle Door Item Component Description 3 Sample Syringe Drives Performs sample aspiration and dispense 4 Reagent...

Page 28: ...tion Pump Dilutes and supplies Alkaline and Acid Wash Solutions to the Cuvette Washer Bulk Solutions The onboard supply of ICT Reference Solution Alkaline Wash Solution and Acid Wash Solution are plac...

Page 29: ...ves ICT Reference Solution from the Bulk Solution bottle through the preheater tubing in the incubator to the cup beneath the ICT Unit Left Side of Analyzer Component Description Rotary Power Control...

Page 30: ...tion Waste tubing which can be attached to a separate Waste Container The serial number is located above this area 3 Refrigerator Condensation Pan Captures condensation from the reagent refrigeration...

Page 31: ...ample Diluent ICT Calibrators ICT Cleaning Fluid ICT Reference Solution Wash Solutions Water Bath Additive Calibrators The AEROSET System Accessories include Sample Carriers End of Run Sample Carrier...

Page 32: ...on the sample Largest Assay Pair Volume Largest defined assay volume ordered on the A Line Largest defined assay volume ordered on the B Line All Abbott assay applications have a defined sample volume...

Page 33: ...AEROSET Customer Training Guide 1 19 94858 103 July 2003 NOTE The Cup Tube Adapter is required when loading sample cups in all positions except on the Calibrator Control Carousel Figure 1 10 AEROSET...

Page 34: ...Diluent diluted Wash Solutions and Water Bath Additive There are four types of Reagent Cartridges Large White or Natural approximately 90 mL Small White or Natural approximately 55 mL 20 mL White or...

Page 35: ...CT Sample Diluent ICT Calibrators The ICT Calibrators 7 bovine serum albumin base and ICT Urine Calibrators aqueous base are used to calibrate the ICT Module Each set contains two levels Low and High...

Page 36: ...ution container is loaded onto a weight platform behind the front right door It is aspirated and analyzed by the ICT Unit before and after each sample to provide a reference concentration used to calc...

Page 37: ...placed in an outer segment of Reagent Supply Center 1 It is dispensed into the water bath during the Change Water In Bath Procedure performed during START UP or SHUTDOWN Water Bath Additive is ready...

Page 38: ...er labels are available Each carrier has five positions designed to hold the following types of sample containers 16 x 100 mm 10 mL tubes 16 x 75 mm 7 mL tubes 13 x 100 mm 7 mL tubes with Cup Tube Ada...

Page 39: ...ied the FastTrack Sampler stops sampling If Auto Return is defined the Analyzer then returns the carriers to the starting position and begins sampling reruns Samples must not be loaded in this carrier...

Page 40: ...le Carriers Figure 1 18 Sample Carrier Tray with Sample Carriers Sample Carrier Tray Covers The Sample Carrier Tray Covers can be placed on the Sample Carrier Trays to cover open sample containers The...

Page 41: ...e 1 20 Reagent Cartridge Adapters Manuals Two manuals are provided with the AEROSET System AEROSET System Operations Manual A complete reference to the operation of the AEROSET System During the class...

Page 42: ...ckwise every 4 5 seconds During each cycle a pair of samples is dispensed As the Reaction Carousel continues to rotate reagents are added to the samples the samples and reagents are mixed 33 photometr...

Page 43: ...CT ASSAYS FOR STAT START UP OPTIONS SHUTDOWN OPTIONS ERROR LOG Host Communication Printer Config Log On System Config Start Beep Off Sampling Seq Sampling Online Config Reset Err System SCC Rgt Area 2...

Page 44: ...UMMARY QC SUMMARY CAL CONTROL Stored Details Dates Config Calib Export Datalist Details QC Status Form 1 2 Export Import FreeText Options Recalc Edit Rerun RxnGraph Accept Calibration Base Outline Add...

Page 45: ...103 July 2003 Screen Display After Log On the screen for operating the AEROSET System is displayed The Main Display is divided into the following areas Figure 1 21 Main Display Information Access Are...

Page 46: ...ed accesses the QC SUMMARY screen in which the Operator can view a summary of the QC statistics for all assays and levels The Operator can also access the Levey Jennings Graphs and QC Details from thi...

Page 47: ...or Cuvette Washers so the Assay Read Times are not affected CAUTION The System completes the dispensing and mixing of any sample and reagent already aspirated Confirm the PAUSE status in the System St...

Page 48: ...ftware Backup and Restore features Define options for Printer A When selected allows clearing of the printer buffer and defines the automatic report printing options NOTE The format of the Patient Rep...

Page 49: ...isplay Area NOTE Unless the Operator exits the displayed screen typically by selecting OK before selecting a new option the new screen overlays the earlier screen Status Area This area displays the Sy...

Page 50: ...reagent is dispensed where appropriate When the bar reaches the right end the sample is complete and the results are displayed in the DATABASE screens NOTE The Run Progress Area bar represents approxi...

Page 51: ...causes the field to revert to the previous entry Buttons Pictures or text are displayed on the buttons or icons When a button or icon is selected the frame of the button changes to blue or the button...

Page 52: ...x and allows the Operator to select from the list but it also allows the Operator to create new items on the list through keyboard entry Checkbox On screens where checkboxes appear multiple items can...

Page 53: ...are placed on weight platforms behind the front right door 3 Other than reagents what solutions are placed in the Reagent Supply Centers 4 What must the Operator use to run a sample cup in a Sample C...

Page 54: ...Alkaline Wash Solution Acid Wash Solution 3 1 Alkaline Wash Solution Saline Diluent 0 5 Acid Wash Solution Water Bath Additive R1 only ICT Sample Diluent R1 only 4 Cup Tube Adapter 5 Alkaline Wash So...

Page 55: ...103 July 2003 SUMMARY In this Module you have Located and identified each of the AEROSET System components Identified and described the use of each consumable and accessory Identified and described th...

Page 56: ...1 42 AEROSET Customer Training Guide 94858 103 July 2003 NOTES MODULE 1 SYSTEM TOUR...

Page 57: ...AEROSET Customer Training Guide 2 1 94858 103 July 2003 MODULE 2 BASIC RUN MODULE 3 BASIC RUN m...

Page 58: ...Guide 94858 103 July 2003 CONTENTS Page Objectives 2 3 Introduction 2 4 Checking Reagent Inventory 2 5 Reagent Loading Activity 2 17 Basic Steps to Order and Run a Sample 2 19 Basic Run Activity 2 29...

Page 59: ...ompletion of this Module you will be able to 1 Manually order patient samples to run on the FastTrack Sampler 2 Load samples 3 Initiate a patient run 4 Recognize the various System messages that are d...

Page 60: ...ng Guide 94858 103 July 2003 INTRODUCTION You will use this Module to practice the correct procedure for performing a basic run on the AEROSET System This Module focuses on the steps that are necessar...

Page 61: ...in the Action Area The volume remaining in the Reagent Cartridges onboard can be viewed by selecting Reagents in the Information Access Area Reagent View The View page of the REAGENTS screen is displ...

Page 62: ...ests field indicates the status of the reagent Green The volume is sufficient Pink The expiration date has been exceeded Brown The volume is below the configured Reagent Low Rgt Lo Alert level Red The...

Page 63: ...ow to close the list 2 Select Print The REAGENTS dialog window displays 3 Select OK to print the report Reagent Report Screen Column Description Pos Reagent segment and position Active reagent Name Re...

Page 64: ...TE The remaining volume field displays NLLS no liquid level sense for a new reagent cartridge The volume updates when the reagent probe senses fluid in the cartridge at first use and with each aspirat...

Page 65: ...manually configured Refer to Load Reagents in this section for details 2 Select Reagents in the Information Access Area of the Main Display The REAGENTS screen displays Figure 2 3 REAGENTS Screen View...

Page 66: ...ab The selected Reagent Segment page displays Figure 2 4 REAGENTS Screen R1 A Page 6 When all reagent cartridges have been reviewed select OK in the upper right corner of the screen 7 If desired selec...

Page 67: ...ble throughput A Line Tests reagents always reside in segments A B or C B Line Tests reagents always reside in segment D New cartridges should always be loaded in a higher numbered position than cartr...

Page 68: ...NOTE Pausing the System only allows access to Reagent Supply Center 1 The System status must be READY to gain access to both Reagent Supply Centers A reagent scan must be performed to update reagent i...

Page 69: ...manual configuration will be overwritten by a bar coded reagent each time a reagent scan is performed When a reagent scan is performed manually defined reagents have priority over bar code labeled re...

Page 70: ...y Center at the same time new cartridges must be loaded in a higher numbered position than the cartridges already onboard The System first aspirates from the cartridge in the lowest number position An...

Page 71: ...A maximum of two sets of reagent cartridges per assay are allowed The lowest R1 position is linked to the lowest R2 position and the highest R1 position is linked to highest R2 position Each time a re...

Page 72: ...tion Area of the Main Display to update the reagent status NOTE If a new reagent lot or cartridge is scanned an Error Log Message displays The Operator can order a calibration and load the calibrators...

Page 73: ...of the reagent loading activity you will be familiar with Determining the line a reagent gets loaded on Loading reagents using the appropriate adaptors Checking reagent inventory Reagent scan Assay s...

Page 74: ...the R2 reagent carousel 5 Repeat steps one through four for the following reagents Total Protein ALT Glucose Albumin P 6 After completion of loading above reagents select RGT SCAN in the action area o...

Page 75: ...highlighted the Order Samples dialog window is displayed Figure 2 7 Order Samples Dialog Window Step Action 1 Order patient samples 2 Review and print the Loadlist 3 Load samples 4 Select Run options...

Page 76: ...screen displays when Order is selected Figure 2 8 Order Samples Screen 4 Enter the patient sample information Within 30 seconds after entering the information press either Enter or Tab on the keyboard...

Page 77: ...right hand column of the Order Samples screen to save the order and continue to the next patient sample order 7 Repeat steps 4 6 for all patient samples to be ordered 8 When ordering is complete selec...

Page 78: ...E screen The Print Options dialog window displays Figure 2 9 Print Options Dialog Window 3 Select Loadlist The print confirmation dialog box displays Figure 2 10 Loadlist Dialog Window 4 Select OK NOT...

Page 79: ...uns For primary tubes ensure that there is sufficient sample volume for the assays to be measured plus inch 13 mm of sample above the clot gel separator or plasma red cell interface If the specimen vo...

Page 80: ...r individual assay sample volume requirements refer to the parameters in the assay specific Package Inserts Verify that samples are free of foam bubbles fibrin or particulate matter Use Cup Tube Adapt...

Page 81: ...onfiguration for information on configuring the System to read sample bar code labels 2 Place the Sample Carrier s into a Sample Carrier Tray 3 Place the blue End of Run Carrier to the right of the la...

Page 82: ...re 2 11 RUN OPTIONS Screen 2 Place a checkmark in the box to the left of the Patient option by touching the box 3 Select Start in the right hand corner of the RUN OPTIONS screen to initiate sample pro...

Page 83: ...System Status The following System status types are displayed during a run Status System Action READY The System is not performing any operation and is ready to begin the run RUN The System is samplin...

Page 84: ...rmed there are several possible options for Clear Database If the Cal QC option is selected SID and C P are deleted for complete incomplete and validated samples These samples are now preserved sample...

Page 85: ...k Sampler Printing a Loadlist Loading samples Selecting Run options Starting a run System status types that are displayed during a run Necessary Materials Reagents ICT Sample Diluent Albumin ALT AST C...

Page 86: ...ion dialog window 12 Load the samples in the specified positions and place on the FastTrack Sampler 13 Select RUN from the Action Area 14 Select the Patient option and deselect all Calibration and QC...

Page 87: ...tween the Loadlist and the Order List in the Print Options screen 6 What is the purpose of the End of Run Carrier 7 Why is it important to remove bubbles from the samples 8 What color are the samples...

Page 88: ...ample information and position The Order List prints the sample information position and assays ordered 6 It indicates to the System to stop sampling from the Sample Carriers and if Auto Rerun is conf...

Page 89: ...In this Module you have Manually ordered patient samples to run on the FastTrack Sampler Loaded samples Initiated a patient run Observed the various System status types displayed during processing Ide...

Page 90: ...2 34 AEROSET Customer Training Guide 94858 103 July 2003 NOTES MODULE 2 BASIC RUN...

Page 91: ...AEROSET Customer Training Guide 3 1 94858 103 July 2003 MODULE 3 DAILY START UP AND CHECKS MODULE 2 DAILY START UP AND CHECKS m...

Page 92: ...8 103 July 2003 CONTENTS Page Objectives 3 3 Introduction 3 4 System Log On and Log Off 3 5 START UP and SHUTDOWN 3 7 Solutions Used for START UP SHUTDOWN and Daily Operation 3 15 Solution Volume Disp...

Page 93: ...3 MODULE 3 DAILY START UP AND CHECKS OBJECTIVES Upon completion of this Module you will be able to 1 Log On to the AEROSET System 2 Describe and perform START UP Procedures 3 Describe and perform SHUT...

Page 94: ...3 4 AEROSET Customer Training Guide 94858 103 July 2003 INTRODUCTION To ensure smooth daily work flow it is important to perform the Daily Checks and START UP This Module familiarizes you with these...

Page 95: ...perform the following procedure 1 Type the User Code NOTE Do not press Enter after typing the User Code 2 Press Tab on the keyboard 3 Type the Password NOTE Both fields are case sensitive 4 Press Ent...

Page 96: ...F Procedure 1 Close or exit any open screens 2 Select the Exit icon from the Action Area of the Main Display 3 The EXIT dialog window is displayed Figure 3 2 EXIT Dialog Window 4 Select OK The Log On...

Page 97: ...cedures The following table lists the options available on the START UP OPTIONS and SHUTDOWN OPTIONS screens Option Description Screen 1 Change Water in Bath START UP or SHUTDOWN 2 Wash Cuvettes START...

Page 98: ...iod and require 30 minutes to complete Change Water in Bath Wash Cuvettes Wash Probes and Mixers with 1 Alkaline Wash Solution Wash ICT with ICT Cleaning Fluid and ICT Reference Solution Drain Fill IR...

Page 99: ...m is configured to Save by Carrier ID no sample bar codes Sample Carrier Positions cannot be reused and must be cleared using this procedure The Delete function on the Database screen will not clear t...

Page 100: ...sh ICT module with ICT Reference Solution Drain Fill IRef Cup Flush Water Lines SHUTDOWN 30 min These options should be performed at the end of the daily operation and require 30 minutes to complete C...

Page 101: ...ear Database then C P SID and PID are deleted for complete incomplete and validated results these samples become preserved samples A search cannot be performed for a preserved sample Text color on the...

Page 102: ...n and Solution Volume Display within this Module for details 4 Select Start to begin the START UP Procedure NOTE If the power to the System is turned OFF when power is reinitiated the text on the STAR...

Page 103: ...UTDOWN Procedure NOTE A pink line below the text of any START UP or SHUTDOWN option indicates the option was not completed successfully or power to the System was turned off Review any Error Log Messa...

Page 104: ...cute at the specified time To configure the Automatic Power ON START UP and SHUTDOWN options select the Maintenance Utilities icon in the Action Area to access the MAINTENANCE UTILITIES screen For inf...

Page 105: ...Cleaning Fluidd Calibrator Control Carousel Position 43 200 L ICT Sample Diluent Reagent Supply Center 1 outer segment ICT Reference Solution On the weight platform behind the front right door Drain...

Page 106: ...rs is 14 days When placed in the Calibrator Control Carousel the stability is one day The Reagent Supply Center positions for the 1 Alkaline Wash Solution and 0 5 Acid Wash Solution are pre configured...

Page 107: ...TDOWN and Daily Operation as configured on the Assay Disk Reagent Supply Center 1 Reagent Supply Center 2 Calibrator Control Carousel Front Right Door Outer Inner Outer Inner 1 Alkaline Wash Solution...

Page 108: ...xceeded Brown The volume is below the specified Rgt Lo Alert level Position Definition 1 1 Alkaline Wash Solution in Reagent Supply Center 1 outer segment 2 0 5 Acid Wash Solution in Reagent Supply Ce...

Page 109: ...color of the position The status is indicated by the following colors Green The volume is sufficient Red The volume is insufficient The approximate volume remaining in each bottle is I Ref 140 mL Alk...

Page 110: ...d continue to process Once the Run Progress bar in the lower left hand screen indicates that all the samples have been processed select STOP to change the status to READY 1 Ensure the System status is...

Page 111: ...ow these samples to complete Select STOP to change the System status to READY Select UNPAUSE to continue sample aspiration of photometric assays only ICT results completed after the Error Log Message...

Page 112: ...erroneous results 7 Place the bottle securely on the tray Verify the following conditions exist Area is clean and free of debris Bottles are seated properly Upward movement of the wash solution tray i...

Page 113: ...nges Check Wash Solution Trays Check Sample and Reagent Syringes and Solenoid Valves Check High Concentration Waste Container Check Refrigerator Condensation Pan Check DI Water System Check Reagent In...

Page 114: ...the syringe if leaking is observed For replacement of a 1 mL syringe refer to Component Replacement in Section 9 Service and Maintenance of the AEROSET System Opera tions Manual 3 Open the ICT Pump ac...

Page 115: ...2 NOTE Replace if leaking is observed NOTE Refer to Component Replacement in Section 9 Service and Maintenance of the AEROSET System Operations Manual for details NOTE It is normal for bubbles to appe...

Page 116: ...2 Verify that no liquid has accumulated in the tray under the Wash Solution bottles 3 Check that the bottles have not overfilled indicating that a solenoid valve is defective Contact your Abbott Repre...

Page 117: ...er 2 Inspect the Sample and Reagent Syringes for leaks from the syringe body 3 Inspect the three 3 connections of the Sample and Reagent Syringes for leaks as shown in the following illustration 1 Sam...

Page 118: ...lower syringe body is acceptable as long as there are no leaks at the bottom of the syringe NOTE If leaking is observed refer to Observed Problems Sample Reagent Syringe Leaks in Section 10 Diagnostic...

Page 119: ...connections shown in the following illustration to check for leakage NOTE If a leak is observed refer to Observed Problems Sample Reagent Syringe solenoid valve leaks in Section 10 Diagnostics and Tro...

Page 120: ...Waste Container cap by unscrewing the locking ring and disconnecting the cable 3 Place an absorbent towel next to the container to catch any drips from the container cap 4 Unscrew the High Concentrati...

Page 121: ...ing it level to prevent spills 3 Empty the water collected in the condensation pan NOTE This water is condensation from the reagent refrigeration units and is not considered potentially biohazardous 4...

Page 122: ...supplying water to the AEROSET System NOTE For water specifications refer to Section 4 Performance Characteristics and Specifications of the AEROSET System Operations Manual CAUTION If the DI Water su...

Page 123: ...Procedures to perform what should you consider 3 What solution is used during the Change Water in Bath Procedure 4 Where is the ICT Cleaning Fluid placed onboard the instrument 5 How does the System i...

Page 124: ...On screen 2 If the instrument is operational for a 24 hour period or if the instrument is idle for less than eight hours day 3 Water Bath Additive 4 Position 43 on the Calibrator Control Carousel 5 T...

Page 125: ...Summary AEROSET Customer Training Guide 3 35 94858 103 July 2003 SUMMARY In this Module you have Performed the Log On Procedure Described and performed the START UP SHUTDOWN and Daily Check Procedures...

Page 126: ...3 36 AEROSET Customer Training Guide 94858 103 July 2003 NOTES MODULE 3 DAILY START UP AND CHECKS...

Page 127: ...AEROSET Customer Training Guide 4 1 94858 103 July 2003 MODULE 4 RUN OPTIONS MODULE 4 RUN OPTIONS m...

Page 128: ...July 2003 CONTENTS Page Objectives 4 3 Introduction 4 4 Order Entry 4 5 Sample Order Options 4 8 Ordering and Running a STAT Sample 4 16 Editing Patient Sample Orders 4 19 Adding Samples During a Run...

Page 129: ...ost interface download or Host Query 2 Enter patient orders manually to run in the Sample Carousel 3 Order sample replicates 4 Order samples for onboard dilution or to be corrected for manual dilution...

Page 130: ...3 INTRODUCTION In Module 2 you learned about a basic run In this Module you will learn the various Run options that are available for performing tests on the AEROSET System Prior to beginning the Modu...

Page 131: ...ule 2 Basic Run you performed manual order entry To review the steps 1 Select Database from the Information Access Area 2 Select Order 3 Enter the desired sample information Sample ID required Name C...

Page 132: ...f the screen The On line Data Transfer dialog window is displayed Figure 4 1 On line Data Transfer Dialog Window 3 Select the desired option 4 The selected patient samples are downloaded and displayed...

Page 133: ...bar code If the AEROSET System is configured for Host Order Query the Operator loads the bar code labeled samples and initiates a run The AEROSET System scans the bar code and determines it lacks an...

Page 134: ...ne which available Sample Carousel carrier and position will be used for the sample to be run NOTE If no carrier positions are available highlight the sample s occupying the position s to be used and...

Page 135: ...nel s be run on the sample NOTE Assays with green button text meet all required conditions If button text is pink or yellow further investigation is necessary before performing the assay Refer to Conf...

Page 136: ...d 2 Load the samples in the specified carrier and position If the sample tube is bar code labeled face the label toward the center of the Sample Carousel NOTE When the System is configured to read sam...

Page 137: ...ing the READY status the Sample Carousel begins with Position A1 When loading samples during the PAUSE status the Sample Carousel begins with the position located at the aspirate position For priority...

Page 138: ...e If 3 replicates are entered the System will dispense and analyze each selected assay 3 times Manual Dilution Enter a multiplier in the Manual Dil field if an off line dilution was done The multiplie...

Page 139: ...s selected the underline remains green CAUTION The Operator must verify the correct dilution is selected for each assay on each patient ordered manually Failure to verify dilution could affect patient...

Page 140: ...and A dilution is requested for one or more of the assays used in the ratio calculation and The constituent assay displays with a blue or yellow underline to indicate the dilution protocol requested D...

Page 141: ...nown Male or Female using a Drop down list box Age yyy mm Up to 3 digits are allowed for the year up to 2 digits are allowed for the month Birthdate 4 digits are required for the year up to 2 digits a...

Page 142: ...P automatically increments The Sample ID automatically increments only if it is defined as numeric format in the SYSTEM CONFIGURATION screen NOTE When using the Batch ordering option on the Sample Car...

Page 143: ...TAT Position in the Sample Carousel prior to placing the order Confirm that the STAT Sampling Indicator Light is not illuminated and place the sample in the STAT position Figure 4 8 Top View of the Sa...

Page 144: ...in the Reserved STAT Position A sample Bar Code Reader is not available for that location NOTE If the Operator does not enter the STAT sample ID on the SELECT ASSAYS FOR STAT screen the System automat...

Page 145: ...her investigation is necessary before performing the assay For more information refer to Confirmation of Assay Parameter Settings in Section 2 Installation Procedures and Special Requirements of the A...

Page 146: ...ht hand column on the DATABASE screen The Order Samples dialog window is displayed 4 Select Edit The Order Samples screen is displayed 5 Make the desired edits Sample information can be added or edite...

Page 147: ...k Sampler moves soon after the Tray Status LED begins blinking orange 3 Confirm that the Tray Status LED is not blinking orange and place the Sample Carrier on a free section of the Sample Carrier Tra...

Page 148: ...IONS screen to pause sampling 5 Wait for the System status to change to PAUSE 6 Place the sample in the specified carrier and position 7 Place the Sample Carrier on a free section of the Sample Carrie...

Page 149: ...anged to PAUSE Wait 20 seconds before accessing the Sample Carousel area WARNING The AEROSET System does not stop the movement of the Reagent 2 Probes ICT Unit Mixers or Cuvette Washers so the Assay R...

Page 150: ...Carousel has completed sampling the Sample Carousel Movement Indicator Light is not illuminated or blinking If the FastTrack Sampler is still sampling the System status is RUN but if both the Sample C...

Page 151: ...t the carrier number specified when the test was initially ordered is entered in the Car r section of the RUN OPTIONS Screen 9 Select Unpause in the right hand column of the RUN OPTIONS screen to resu...

Page 152: ...MODULE 4 RUN OPTIONS 4 26 AEROSET Customer Training Guide 94858 103 July 2003...

Page 153: ...and FastTrack Sampler Creating batch orders Editing patient sample orders Entering patient demographic information Ordering sample replicates Ordering samples for onboard dilution Ordering a patient...

Page 154: ...mation 2 Select Copy 3 Enter 4 for the number of copies 4 Select OK on the Copy Order dialog window 5 Select OK on the Order Samples screen Edit Patient Sample Orders 1 In the DATABASE screen highligh...

Page 155: ...the Car r number defined for Sample Carousel Section A is 1000 10 Select Start Wait for sampling to begin before proceeding to the next step C P SID Name PID Patient Info Edits 3 1 A12345 Beans Frank...

Page 156: ...creen 4 Order the following patient samples in the Sample Carousel 5 Select PAUSE in the Action Area 6 Select Pause in the right hand column of the RUN OPTIONS screen 7 Wait for the System status to c...

Page 157: ...three ways to enter orders 2 When ordering patient samples in the Sample Carousel on which screen is the carrier number defined 3 What is the maximum number of replicates that can be ordered for a sam...

Page 158: ...MODULE 4 RUN OPTIONS 4 32 AEROSET Customer Training Guide 94858 103 July 2003...

Page 159: ...4 33 94858 103 July 2003 ANSWERS 1 a Manually b Downloaded from a Host computer c Host Order Query 2 RUN OPTIONS screen 3 Five 4 Batch ordering is used when the same assays will be ordered for more t...

Page 160: ...download or Host Order Query Manually entered patient orders to run in the Sample Carousel Ordered sample replicates and samples for onboard dilution or to be corrected for manual dilution Entered pa...

Page 161: ...AEROSET Customer Training Guide 5 1 94858 103 July 2003 MODULE 5 RESULT HANDLING MODULE 5 RESULT HANDLING m...

Page 162: ...idating Samples 5 15 Printing Results 5 16 The Limited Run Feature 5 18 Rerunning Results 5 21 Reviewing and Selecting Rerun and Replicate Results 5 26 Adding Assays to a Completed Sample 5 30 Editing...

Page 163: ...u will be able to 1 Review accept validate and delete results in the DATABASE and RESULT screens 2 Find results save results print results and retransmit results to the Host computer 3 Describe the Li...

Page 164: ...Training this Module Show the layout of the DATABASE and Result Screens Reviewing Results Section then show the following functions on the RESULT Screen only Print Accept Rerun Edit Select Delete Add...

Page 165: ...SE screen select the arrow buttons at the bottom of the right hand column or press or on the keyboard to scroll right and left The DATABASE screen is configured like a spreadsheet with rows and column...

Page 166: ...or has occurred for the result To review the Result Error Code access the RESULT screen Processing Code Status Description I Incomplete An error occurred for one or more of the sample results This may...

Page 167: ...rm the following steps to configure the customized view 1 Select Database in the Information Access Area if the screen is not currently displayed 2 Select Custom at the bottom of the DATABASE screen T...

Page 168: ...Figure 5 3 Modify Customized View Dialog Window 4 Place a checkmark in the box to the left of each desired Sample Status and Sample Type option to be included in the customized view 5 Select OK to sa...

Page 169: ...g procedure 1 Select Database in the Information Access Area if the screen is not currently displayed 2 Select Custom at the bottom of the Display Area The Customized View dialog window displays 3 Sel...

Page 170: ...alog Window 4 The following criteria can be entered for the search Criteria Description Sample ID An individual Sample ID can be entered Last Name Enter up to 20 alphanumeric characters Patient ID Ent...

Page 171: ...meeting the search criteria are displayed NOTE After a search has been performed a magnifying glass icon appears on Search on the Search dialog window When the magnifying glass is displayed the DATAB...

Page 172: ...displayed 2 Select the sample to be reviewed 3 Select Result in the right hand column The RESULT screen is displayed Figure 5 6 RESULT Screen For each completed result the following information is di...

Page 173: ...he defined reference range L Out of range low H Out of range high Result Error Code If one or more errors occurred for the result the highest priority Result Error Code is displayed Example SS Short S...

Page 174: ...in the DATABASE screen The results for this sample will need to be evaluated by the Operator for acceptance or further action rerunning diluting editing etc To review and accept the results perform th...

Page 175: ...d System configuration refer to Module 8 Configuration To validate a sample after all results are acceptable perform the following procedure 1 Select Database in the Information Access Area if the scr...

Page 176: ...ct Form 1 or Form 2 A confirmation dialog window is displayed 5 Select OK Printing Multiple Result Reports from the DATABASE Screen 1 Select Database in the Information Access Area if the screen is no...

Page 177: ...rently displayed 2 Select the sample to be printed 3 Select Result in the right hand column of the DATABASE screen 4 Select Print in the right hand column of the RESULT screen A confirmation dialog wi...

Page 178: ...ted This feature may be used when The reagent for an assay is not onboard The sample requires pretreatment before the assay can be performed TIBC etc Limiting Assays in a Run WARNING Potential Biohaza...

Page 179: ...in color meet all required conditions If the button text is pink or yellow further investigation is necessary before performing the assay For more information refer to Confirmation of Assay Parameter...

Page 180: ...ckmark from the Limited option by touching the box 3 Select Start in the upper right corner of the RUN OPTIONS screen to begin sampling All pending assays are aspirated CAUTION If the limited assay re...

Page 181: ...T occur if the Auto Return for Sample Crsl and or Track Sampler Auto Rerun and Sample Bar Codes options are all configured ON and the following conditions also exist If Then A completed sample had a r...

Page 182: ...d column The Rerun dialog window is displayed Figure 5 12 Rerun Dialog Window 4 Select Select Assay The Select Assays screen is displayed 5 Select the assay s to be rerun The sample measurement type S...

Page 183: ...originally selected 1 Select Database in the Information Access Area if the screen is not currently displayed 2 Select the sample s to be rerun To highlight multiple consecutive samples in a list sel...

Page 184: ...ation Access Area if the screen is not currently displayed 2 Select the sample to be reviewed 3 Select Result in the right hand column The RESULT screen is displayed 4 Select the result that needs to...

Page 185: ...Position CAUTION It is important to confirm the identification of the sample in the Reserved STAT Position because bar code labels are not read in this position Failure to confirm the identification o...

Page 186: ...s a processing code of r Reviewing Rerun Results To review the results of the original and rerun or replicate samples perform the following procedure 1 Select Database in the Information Access Area i...

Page 187: ...2 This indicates that this sample was run twice and that the original result is displayed 5 The Drop down list box to the right of the Result indicates that the original result is displayed 6 To view...

Page 188: ...AEROSET Customer Training Guide 94858 103 July 2003 7 Select the return arrow The RESULT screen displays with the original result and the selected rerun or replicate result Figure 5 17 RESULT Screen...

Page 189: ...OTE To select all rerun results for a sample press O or o not case sensitive on the keyboard 3 Select Select in the right hand column of the RESULT screen or press S on the keyboard CAUTION Once a rer...

Page 190: ...displayed Figure 5 18 Add Assays Screen 5 Select the assay s panel s to be added to the completed sample 6 Select OK The added assays display on the RESULT screen 7 Select OK to exit to the DATABASE...

Page 191: ...d assay result 5 Select Edit in the right hand column of the RESULT screen or press E on the keyboard 6 A blue box appears around the result to be edited and a cursor appears in the Result field Figur...

Page 192: ...the keyboard To highlight multiple random samples hold down Ctrl while selecting the samples on the screen NOTE A sample cannot be deleted while it is running the text is brown NOTE Deletion of an ori...

Page 193: ...remains pending If the result was completed and calculated by the AEROSET System the assay name and result remains but a D is displayed on the left by the assay name NOTE The printed report for a sam...

Page 194: ...ng procedure 1 Select Database in the Information Access Area if the screen is not currently displayed 2 Select the sample s to be transmitted To highlight multiple consecutive samples in a list selec...

Page 195: ...the format must be Windows 95 or DOS 5 0 or higher 1 Insert a disk into the floppy disk drive of the SCC computer 2 Select Database in the Information Access Area if the screen is not currently displ...

Page 196: ...58 103 July 2003 6 Select OK The Export confirmation dialog window is displayed Figure 5 23 Export Confirmation Dialog Window 7 Select OK Result data are transferred to the floppy disk 8 Remove the di...

Page 197: ...Handling Activity you will be familiar with Reviewing results Rerunning results Adding assays to a completed sample Editing results Printing results Selecting rerun results Accepting and validating r...

Page 198: ...arriers with an empty tube and an adapter in Sample Carrier 9 Position 3 Place the carriers on the FastTrack Sampler 7 Select RUN from the Action Area 8 Select the Patient option 9 Select Start 10 Whi...

Page 199: ...ul Review and print the results from the RESULT screen 5 Doctor Dolittle wants the Na on Ted E Baer rerun 6 Elmer Sklue was supposed to have a low Glucose result of 35 Edit the result and reprint a re...

Page 200: ...____________________________ 4 What would a yellow line under the assay name in the RESULT screen indicate 5 What color would the result text be if the result was outside the defined reference range 6...

Page 201: ...Review Questions AEROSET Customer Training Guide 5 41 94858 103 July 2003 NOTES...

Page 202: ...ed to the original results 3 a Select Database b Deselect all limited view buttons at the bottom of the DATABASE screen except Pending 4 The result was analyzed using the Dil 2 option 5 Brown 6 The Li...

Page 203: ...idated and deleted results in the DATABASE and RESULT screens Demonstrated how to find save and print results Discussed how to retransmit results to the Host computer Described the Limited Run feature...

Page 204: ...MODULE 5 RESULT HANDLING 5 44 AEROSET Customer Training Guide 94858 103 July 2003...

Page 205: ...AEROSET Customer Training Guide 6 1 94858 103 July 2003 MODULE 6 CALIBRATION MODULE 6 CALIBRATION m...

Page 206: ...e 94858 103 July 2003 CONTENTS Page Objectives 6 3 Introduction 6 4 Calibration Theory 6 5 Calibration Frequency 6 10 Calibration Options 6 11 Calibrating an Assay 6 13 Calibration Review 6 19 Activit...

Page 207: ...knowledge of kinetic rate and end point assays and the different calibration methods 2 Describe the calibration types available 3 State the reasons for calibrating the AEROSET System 4 Order calibrat...

Page 208: ...you will learn how assays are calibrated This Module introduces you to the different types of calibration for photometric assays the frequency of calibration and how to order calibrations In addition...

Page 209: ...e absorbance readings The absorbance readings used for calibration and the absorbance readings used to calculate results are measured during this equilibrium time Rate There is a constant change in ab...

Page 210: ...range in complexity from a simple subtraction to a non linear least squares best fit The available methods are Abs Factor 1 Point Linear Blank and one calibrator Multi Point Linear Blank and 2 8 calib...

Page 211: ...that varies little between different instruments and reagent lots therefore a single factor is used to calculate all results Only a reagent blank is performed for calibration To calculate results the...

Page 212: ...0 0023 Conc 0 0 Level 1 0 1105 Conc 2 0 Level 2 0 3010 Conc 5 1 2 For each of the two calibrators the reagent blank absorbance is subtracted from the measured absorbance Level 1 0 1105 0 0023 0 1082...

Page 213: ...t blank water and five levels of calibrators Use Fac Blk Factor and Blank If an assay is defined as Use Fac Blk it does not generate a calibration curve but uses the factors and reagent blank from a c...

Page 214: ...ield Service Representative replaces the System Control Center SCC and assay files have not been backed up It is recommended that a backup be performed routinely It is required per assay application A...

Page 215: ...w are the four calibration types Full Calibration Blank Calibration 1 Point Adjustment 2 Point Adjustment Full Calibration All data points reagent blank and calibrators specified on the Calibration pa...

Page 216: ...Automatic Calibration option to be used the calibrators must be defined on the Calibrator Control Carousel NOTE When configured an automatic calibration is performed only when a reagent lot change or...

Page 217: ...uch the Drop down list box next to Calibration and select the Calibrator Control Carousel and Sample Carousel configurations desired Option Calibrator Locations The System only uses calibrators on the...

Page 218: ...r selects the Patient option the Cal ibration option is no longer selected If the blank _______ Calibration option is selected then only patient samples can be loaded in the Sample Carou sel and calib...

Page 219: ...Installation Procedures and Special Requirements of the AEROSET System Operations Manual for information on calibration configuration NOTE To run quality control after calibration place a checkmark i...

Page 220: ...been selected the required QC samples are highlighted with a yellow line under the QC name on each button 2 Pipette the appropriate calibrator materials into sample cups NOTE When water is defined fo...

Page 221: ...I Index index solution is not currently used but Calibrator Control position 42 I Index must have a concentration of zero defined for all ICT assays If the concentrations are not defined the ICT butto...

Page 222: ...is required and a screen is displayed indicating which calibrations are required 2 Select OK The SELECT ASSAYS FOR CALIBRATION screen is displayed Four options are available 3 Select the desired optio...

Page 223: ...System errors occur and the calibration results are within the assay parameter specifications the calibration passes The assay button text in the ASSAYS screen is green If a System error occurs or if...

Page 224: ...ailed and any associated Calibration Error Codes perform the following steps 1 Select Assays in the Information Access Area The ASSAYS screen is displayed Figure 6 5 ASSAYS Screen 2 Select the desired...

Page 225: ...tercept used since it always draws a line through 0 2 Absorbance Values C1 C8 are corrected for reagent blank 3 Factor calculated for each portion of the curve 4 Calibrator Concentration 8 Scrolls bet...

Page 226: ...corrected by the blank value 3 Factor This column displays the calculated factor for each section of the curve Factor 1 Slope 4 Conc This column displays the calibrator concentration configured in the...

Page 227: ...rformed is displayed in the lower right hand corner of the Calibration Information area The previous calibration curve and the date and time performed text are gray The current calibration is blue NOT...

Page 228: ...on the lower right hand corner of the Calibration Information area of the ASSAY STATUS screen 2 The absorbance data and curve from the previous calibration curve are displayed 3 Select 4 The absorbanc...

Page 229: ...ils Screen 2 The absorbance values measured for all the replicates are displayed on the top half of the Calibration Details screen The values displayed have not been corrected for the reagent blank NO...

Page 230: ...the Factor Slope field the number of decimal places configured must be reduced to allow the System to display the actual factor slope The maximum number of digits that can be displayed in this field i...

Page 231: ...the assay name and select Detail To view the date and time that each calibration was performed select Dates in the right hand column The calibration dates are displayed Figure 6 10 CALIBRATION SUMMAR...

Page 232: ...data to save to the stored average by selecting the assay name To highlight multiple consecutive assays in the list select the first assay name in the list then highlight the remaining assays by holdi...

Page 233: ...for each calibrator level Conc concentration Mean SD standard deviation CV coefficient of variation Range N number NOTE Assay specific stored calibration averages can be viewed on the Calibration Det...

Page 234: ...Calibration Error Code is generated If the new calibration curve is acceptable after reviewing calibration and QC data the previous curve must be deleted Use the following instructions to delete the...

Page 235: ...in the Information Access Area The CALIBRATION SUMMARY screen is displayed 2 Select Stored in the right hand column of the CALIBRATION SUMMARY screen The stored averages are displayed 3 Select the ass...

Page 236: ...een A confirmation dialog window is displayed Figure 6 15 Printer Confirmation Dialog Window 3 Select OK to print the report Printing the Stored Calibration Summary To print a report of the stored cal...

Page 237: ...on curves Necessary Materials Reagents Albumin ALT AST Calcium Creatinine Glucose Phosphorus Total Protein Urea and Iron Other Abbott Multiconstituent Calibrators Abbott Iron Magnesium Calibrators Qua...

Page 238: ...mn 12 Select OK on the confirmation dialog window 13 Select Cancel on the RUN OPTIONS screen to exit the screen without starting the run Loading the Calibrators 1 Select Cal Control in the Information...

Page 239: ...tion Review When the calibrations are complete perform the following 1 Print a copy of the current calibration summary 2 Delete the previous calibration curve data for Phosphorus 3 Select the current...

Page 240: ...___ f ______________________________________________ 2 What is the most common Calibration option used on the Aeroset 3 Does the AEROSET System require you to calibrate an assay if the controls are ou...

Page 241: ...uly 2003 8 How does the AEROSET System indicate that a calibration has failed 9 How does the AEROSET know to use calibrators loaded in the Sample Carousel 10 Can the AEROSET run a calibration using ca...

Page 242: ...e ASSAY STATUS screen 6 If the factors from the new and the previous curve vary by more than the defined FAC limit 7 a CALIBRATION SUMMARY stored b Calibration Details 8 The assay button text in the A...

Page 243: ...and end point assays and the different calibration methods Listed the available calibration options Stated the reasons for calibrating the AEROSET System Ordered calibrations and loaded the calibrato...

Page 244: ...6 40 AEROSET Customer Training Guide 94858 103 July 2003 NOTES MODULE 6 CALIBRATION...

Page 245: ...AEROSET Customer Training Guide 7 1 94858 103 July 2003 MODULE 7 QUALITY CONTROL MODULE 7 QUALITY CONTROL m...

Page 246: ...de 94858 103 July 2003 CONTENTS Page Objectives 7 3 Introduction 7 4 Ordering Controls 7 5 Reviewing QC Results 7 12 Deleting QC Data 7 27 Printing QC Results 7 28 QC Summary Report 7 35 Westgard QC R...

Page 247: ...Upon completion of this Module you will be able to 1 Identify the different methods of running QC and how to order them 2 Load QC samples and initiate the run 3 Identify the screens and reports used...

Page 248: ...94858 103 July 2003 INTRODUCTION This Module presents the different methods of running Quality Controls on the AEROSET System Information is included to explain how to review QC data and how the AERO...

Page 249: ...rols perform the following procedure 1 Select RUN in the Action Area The RUN OPTIONS screen is displayed Figure 7 1 RUN OPTIONS Screen 2 Place a checkmark in the box to the left of the QC option desir...

Page 250: ...1 QC8 3 Interval QC At specified count sample or time intervals defined on the QC tab of the Assay Configuration screen NOTE The count sample interval refers to the total number of samples aspirated n...

Page 251: ...rformed only when a reagent lot change or cartridge change occurs during a run Automatic QC is not performed when a reagent lot or cartridge change is detected at the start of a run that is initiated...

Page 252: ...and foaming Do not run samples when these conditions exist Use the following instructions to load controls 1 Select Save in the right hand column of the RUN OPTIONS screen to save the QC order A conf...

Page 253: ...hlighted controls into sample cups and load into the positions indicated on the CALIBRATOR CONTROL screen 8 Replace the Calibrator Control Carousel cover Align the hole in the cover with the track tha...

Page 254: ...reagent already aspirated Confirm the PAUSE status in the System Status Area and confirm that the R1 Indicator on the LUI Local User Interface is illuminated before proceeding 3 Wait for the System st...

Page 255: ...UN OPTIONS screen to pause sampling 5 Wait for the System status to change to PAUSE 6 Select UNPAUSE in the Action Area The RUN OPTIONS screen is displayed NOTE Do not select RUN to reinitiate samplin...

Page 256: ...ARY screens The data can be printed on the Levey Jennings Graph or QC Data List forms The QC data can also be exported to a floppy disk Expected concentration and SD can be defined for the QC and West...

Page 257: ...ys in the Information Access Area The ASSAYS screen is displayed 2 Select an assay name The ASSAY STATUS screen is displayed Figure 7 4 ASSAY STATUS Screen The Quality Control Information portion of t...

Page 258: ...the Assay Configuration screen QC page and the QC name as defined in the CALIBRATOR CONTROL screen Conc The expected concentration defined in the CALIBRATOR CONTROL screen Mean The actual mean of the...

Page 259: ...he left hand section for each level up to 450 values The following table describes the information displayed in the left hand section NOTE The mean SD CV range and N are calculated using all data poin...

Page 260: ...the top or bottom of the graph Excluded values greater than 3 SD display as pink bars at the top or bottom of the graph The vertical dotted lines indicate separate days Values can be excluded from th...

Page 261: ...ph is also highlighted in blue Figure 7 7 Levey Jennings Graph Screen 2 The following information for the highlighted point is displayed at the bottom of the Levey Jennings Graph screen Result value a...

Page 262: ...dialog window for a point perform the following steps 1 Select the point for which details are desired 2 Select Details on the right hand side of the Levey Jennings Graph screen The Details dialog wi...

Page 263: ...sult if the value is outside the defined 2 SD range A Result Error Code is displayed if an error occurred for the result Min The lowest result value in the QC data Max The highest result value in the...

Page 264: ...lect OK The selected comment is added to the Details dialog window 7 To configure a new comment select Comment on the Details dialog window The Comments dialog window displays Figure 7 10 Comments Dia...

Page 265: ...t 15 Select OK to return to the Details dialog window 16 If Cancel is selected on the Comment Edited dialog window the Comments dialog window displays NOTE It is not possible to edit a previous QC com...

Page 266: ...evels display To view additional QC values for the displayed levels or to view additional levels select the arrow buttons in the right hand column of the screen The following information displays for...

Page 267: ...s Figure 7 13 QC SUMMARY Screen The QC statistics for the first level defined for each assay display To view the statistics for other levels defined select to scroll right NOTE When the QC SUMMARY scr...

Page 268: ...he expected concentration defined in CALIBRATOR CONTROL screen Mean The actual mean of the QC data SD The actual standard deviation of the QC data CV The actual coefficient of variation of the QC data...

Page 269: ...Range dialog window displays 2 Enter the date range then select ON to confirm the selection The Date Range dialog window displays 3 Select OK Statistics for the selected date range of the highlighted...

Page 270: ...Range The Date Range dialog window displays 2 Select OFF The Date Range dialog window displays 3 Select OK 4 When date range is deactivated for an assay the text is black and from__ __ __ to __ __ __...

Page 271: ...After the QC data are deleted they are no longer accessible on the QC SUMMARY Levey Jennings Graph and QC Data List screens The QC data continues to display on the DATABASE screen until the database...

Page 272: ...An L or H Flag is displayed next to the result if the value is outside the defined 2 SD range A Result Error Code is displayed if an error occurred for the result QC Data List Lists all QC values wit...

Page 273: ...S screen displays 2 Select the assay name The ASSAY STATUS screen displays 3 Select QC in the right column of the screen The Levey Jennings Graph screen displays Figure 7 15 Levey Jennings Graph Scree...

Page 274: ...addition to Only Selected Date Range Option Description Only Selected Assay Only QC statistics for the assay selected on the ASSAYS or QC SUMMARY screen are printed NOTE If multiple assays are highli...

Page 275: ...nt QC Data List confirmation dialog window displays Figure 7 17 Print QC Data List Confirmation Dialog Window 10 Select OK Option Description Assay All QC report s print for one assay before printing...

Page 276: ...the assay name The ASSAY STATUS screen displays 3 Select QC in the right column of the screen The Levey Jennings Graph screen displays NOTE The QC SUMMARY screen can also be used to access the Levey J...

Page 277: ...stics for the assay selected on the ASSAYS or QC SUMMARY screen are printed NOTE If multiple assays are highlighted on the QC SUMMARY screen and the Print Options dialog window is accessed from the Le...

Page 278: ...n be selected 9 Select the QC level to be included in the report 10 Select OK The Print QC Data List confirmation dialog window displays Figure 7 20 Print QC Data List Confirmation Dialog Window 11 Se...

Page 279: ...print a date range select either Only Selected Assay or All Assays in addition to Only Selected Date Range 4 Select one of the following sort options Option Description Only Selected Assay Only QC sta...

Page 280: ...n be selected 6 Select the QC level to be included in the report 7 Select OK The Print QC Data List confirmation dialog window displays Figure 7 22 Print QC Data List Confirmation Dialog Window 8 Sele...

Page 281: ...NOTE Use a formatted floppy disk The disk can be formatted on the System Control Center If an alternate format is used the format must be Windows 95 or DOS 5 0 or higher QC SUMMARY Screen Use the foll...

Page 282: ...cted on the QC SUMMARY screen are exported All Assays QC statistics for all configured assays are exported Only Selected Date Range Only QC statistics for the configured date range are exported Option...

Page 283: ...disk drive of the SCC computer NOTE Ensure FLOPPY DISK displays in the Drive field 10 Select OK The Export QC Data confirmation dialog window displays Figure 7 25 Export QC Data Confirmation Dialog W...

Page 284: ...e checked when a value is within 2 SD the first QC rule 1 2 SD must be modified by adding a zero in the Num field box of this rule This would allow QC results to be evaluated against the other rules I...

Page 285: ...ontrol and are not evaluated against the other QC rules No Westgard rule Error Log Message appears on the ASSAY STATUS screen when the data are considered in control An example of a Westgard Rule viol...

Page 286: ...__________________________________________________ 2 How does the System indicate that a QC sample is required for a run 3 Starting from the Main Display list the software steps to view the Levey Jen...

Page 287: ...Review Questions AEROSET Customer Training Guide 7 43 94858 103 July 2003...

Page 288: ...is displayed on the button in the CALIBRATOR CONTROL screen 3 a Select Assays b Select Calc c Select QC OR a Select QC Summary b Highlight Calcium c Select LJ Graph 4 An Error Log Message is generated...

Page 289: ...In this Module you have Identified the different methods of running QC and how to order them Loaded QC samples and initiated a run Identified the screens and reports used to review QC results Stated t...

Page 290: ...7 46 AEROSET Customer Training Guide 94858 103 July 2003 NOTES MODULE 7 QUALITY CONTROL...

Page 291: ...AEROSET Customer Training Guide 8 1 94858 103 July 2003 MODULE 8 CONFIGURATION MODULE 8 CONFIGURATION...

Page 292: ...2003 CONTENTS Page Objectives 8 3 Introduction 8 4 Log On Password 8 5 System Configuration 8 9 Print Options 8 19 Host Configuration 8 21 Panel Configuration 8 23 System Configuration Activity 8 24...

Page 293: ...with different access levels for logging onto the System 2 Define System Configuration options 3 Define Print options 4 Describe the Host Interface options 5 Create assay panels 6 Describe the configu...

Page 294: ...03 INTRODUCTION Configuration enables you to customize the AEROSET System to meet your laboratory requirements In this Module you are introduced to the configuration screens and options The AEROSET Sy...

Page 295: ...Deleting QC YES NO YES YES Patient demographics in the RESULT screen NO NO YES System configuration dependent Calibrator Control Carousel configuration NO NO YES YES Reagent configuration NO NO YES YE...

Page 296: ...igure 8 1 Log On Screen 2 To configure a new user code and password use one of the following codes to determine an access level 3 Type the user code Press Tab on the keyboard NOTE Do not press Enter a...

Page 297: ...er codes can be displayed registered or deleted for only the same access level b Type any character up to 6 in the Password field then press Enter on the keyboard Add displays NOTE An asterisk display...

Page 298: ...he Log On screen Figure 8 3 Log On Screen 2 To delete an existing user code and password use one of the following codes to open the appropriate access level 3 Type the user code and password to be del...

Page 299: ...Training Guide 8 9 94858 103 July 2003 SYSTEM CONFIGURATION The System Configuration options are configured on two screens RUN OPTIONS screen Figure 8 4 RUN OPTIONS Screen SYSTEM CONFIGURATION screen...

Page 300: ...lly ordered reruns Auto Reruns The default is OFF unselected Car r Allows the Operator to define the carrier numbers that are used when ordering samples to run in the Sample Carousel Refer to Ordering...

Page 301: ...s initiated The default setting is 10 minutes Enable Cal Edits Allows the Operator to edit read values i e absorbances for calibrators in the ASSAY STATUS screen The default setting is ON NOTE If conf...

Page 302: ...l Cycle Time 0 1 Allows the Operator to enter the length of time in tenths of seconds for each quarter turn of the Reaction Carousel The default is 45 x 0 1 sec 4 5 seconds CAUTION The Abbott applicat...

Page 303: ...ID To edit the Bar Code Length Skip ID field the ID must be edited first This allows the Skip and Bar Code Length fields to be edited NOTE The smallest number which can be configured in the Bar Code...

Page 304: ...option is selected the Sample Bar Code option must be OFF deselected NOTE This option can only be edited by an Abbott Representative Fixed Digit When selected the System requires the same number of c...

Page 305: ...t Representative ScreenSaver min Allows the Operator to define the number of minutes the System permits for no screen interaction prior to initiating the screensaver The default setting is 10 minutes...

Page 306: ...stem Configuration in Section 2 Installation Procedures and Special Requirements of the AEROSET System Operations Manual SmplSeq Sampling Sequence Continued In the desired order repeat the preceding s...

Page 307: ...he System goes into the SUSPEND status The System goes into the READY status To configure audible alarms on the SYSTEM CONFIGURATION screen Select RUN in the Action Area to display the RUN OPTIONS scr...

Page 308: ...tions 1 R 3 13S One control value exceeded 3 standard deviations 2 R 2 22S Two consecutive control values for one level exceed 2 standard deviations on the same side of the mean 2 R 4 R4S The differen...

Page 309: ...idated All Reports print automatically when the results are completed The Default for Printer A is All and Printer B is Request Wait Time for Multi PrintFeature sec This option is not used for the def...

Page 310: ...se forms Select Database in the Information Access Area Select Print in the right hand column Select Page Setup For information about editing the page set up of Form 1 and 2 refer to DATABASE Screen i...

Page 311: ...results with Result Error Codes Transmit QC Results When selected the QC results are transmitted to the Host Use Transmission Check Digit When selected a check digit is accepted with message transmiss...

Page 312: ...nsmission Interval sec The delay time between data messages is defined The default setting is 0 seconds The acceptable interval is 0 99 seconds RS 232C Config Allows selection of the Data Bits L Stop...

Page 313: ...panels Select Database in the Information Access Area Select Order Select PanelCfg For information about configuration of assay panels refer to Panel Configuration in Section 2 Installation Procedure...

Page 314: ...ion Editing the on line communication configuration Entering an address and editing the assay display order in a sample result report Necessary Materials Reagents ICT Diluent Albumin ALT AST Calcium C...

Page 315: ...ine communication options to Protocol Type Type 1 Result Transmission Mode All Deselect the Transmit QC Results option Deselect the Use Transmission Check Digit option RS 232 Config 8L 1S NP and 9600...

Page 316: ...ratories Select RGT SCAN from the Action Area of the Main Display after the reagent cartridges have been loaded For reagent cartridges without bar code labels configuration is performed by selecting R...

Page 317: ...2 Reagent 2 Diluent sample diluent AlkW onboard diluted alkaline wash AcidW onboard diluted acid wash Dtg optional detergent as a wash solution Additive water bath additive Cartridge Size The size of...

Page 318: ...le if the reagent expiration date was edited to reflect onboard stability this manual configuration will be overwritten by a bar coded reagent each time a reagent scan is performed When a reagent scan...

Page 319: ...Center at the same time new cartridges must be loaded in a higher numbered position than the cartridges already onboard The System first aspirates from the cartridge in the lowest number position An...

Page 320: ...red ON the Reagent Link option is not functional i e R1 and R2 cartridges are not linked R1 and R2 cartridges are not linked R1 and R2 are utilized independently The linked reagent pair R1 R2 to be us...

Page 321: ...dures and Special Requirements of the AEROSET Systems Operation Manual Assay Parameter Configuration The Assay Configuration screen is accessed by selecting Assays in the Information Access Area From...

Page 322: ...8 32 AEROSET Customer Training Guide 94858 103 July 2003 Outline Page Figure 8 6 Assay Configuration Screen Outline Page Photometric End point Assay Figure 8 7 Assay Configuration Screen Outline Page...

Page 323: ...no Rerun rule associated with this value Use the L Linear Range H fields to define limits that are automatically adjusted for the sample dilution and for which there are available Rerun rules LL and...

Page 324: ...TION 8 34 AEROSET Customer Training Guide 94858 103 July 2003 Base Page Figure 8 8 Assay Configuration Screen Base Page Photometric End point Assay Figure 8 9 Assay Configuration Screen Base Page Phot...

Page 325: ...that will be used for measuring the Self Blank Sample and Reagent Enter the read time 1 33 Abs Window A range of read points is defined for measuring the sample color for color correction of the Abs...

Page 326: ...o Type Number in Section 2 Installation Procedures and Special Requirements of the AEROSET System Operations Manual for details Reaction Check Used for immunologic reactions to evaluate a reaction for...

Page 327: ...alibration Page Figure 8 10 Assay Configuration Screen Calibration Page Photometric End point Assay Figure 8 11 Assay Configuration Screen Calibration Page Photometric Rate Assay NOTE The fields descr...

Page 328: ...beyond the linearity of the assay NOTE This only displays for Linear Spline Logit 4 Logit 5 Exponent Use Factor and Use FAC BLK Calibration Modes Span If the Span Data check will be performed the Oper...

Page 329: ...tion Modes NOTE The FAC Limit was defined as 10 in all versions of software preceding version 1 02ER000 Factor Used to calculate results of a factor assay the factor is a fixed value and only the reag...

Page 330: ...Interval QC option will be used the amount of time minutes between QC runs may be defined Use QC Rules Select this option to use the defined Westgard Rules QC1 QC8 The control name position and expect...

Page 331: ...the inside of reagent probes and mixers NOTE The wash cycle is performed only one time Vol Enter the volume of the defined wash solution to be used Range is 10 345 L Cuvette Reagent interference invo...

Page 332: ...y For each Result Error Code that can be generated for a result the Operator can define a rerun option The options are Same Dil 1 and Dil 2 The Auto Rerun feature must be selected in the SYSTEM CONFIG...

Page 333: ...e System maximizes ______________________ and minimizes ____________________________________ 5 What button is selected from the Main Display to configure the System to automatically print the Sample R...

Page 334: ...to make Add appear 3 The Save by Car r ID option 4 Throughput empty cuvettes 5 The Printer B icon button in the Action Area 6 The PAGE SETUP screen accessed by selecting Database then Print 7 Valid 8...

Page 335: ...dule you have Created User Codes and Passwords Defined System Configuration options Described the Host Interface options Created assay panels Described the configuration necessary to define and run an...

Page 336: ...8 46 AEROSET Customer Training Guide 94858 103 July 2003 NOTES MODULE 8 CONFIGURATION...

Page 337: ...AEROSET Customer Training Guide 9 1 94858 103 July 2003 MODULE 9 ICT UNIT MODULE 9 ICT UNIT...

Page 338: ...58 103 July 2003 CONTENTS Page Objectives 9 3 Introduction 9 4 ICT Fluid Delivery 9 5 Components of the ICT Unit 9 6 Reviewing ICT Calibration Information 9 8 ICT Unit Component Replacement 9 10 Activ...

Page 339: ...TIVES Upon completion of this Module you will be able to 1 Describe the ICT or Integrated Chip Technology fluid delivery 2 Identify the components of the ICT Unit 3 View the calibration information di...

Page 340: ...2003 INTRODUCTION An Integrated Chip Technology ICT is used to measure electrolytes on the AEROSET System This Module familiarizes you with the components used to measure ICT assays and the ICT fluid...

Page 341: ...T FLUID DELIVERY The following flow diagram describes the flow of the ICT sample and solutions which is important to understand for troubleshooting and maintenance Figure 9 1 Flow Diagram of ICT Fluid...

Page 342: ...baseline for checking for electrode drift The second read measurement is used to calculate the sample result This Bulk Solution is placed on a weight platform behind the front right door ICT Referenc...

Page 343: ...s ICT Reference Solution from the cup into the ICT Module for processing ICT Sample Diluent A supply of ICT Sample Diluent must be placed onboard in an outer segment of Reagent Supply Center 1 A B or...

Page 344: ...the CALIBRATION SUMMARY screens ASSAY STATUS Screen The Calibration Information area of the ASSAY STATUS screen of the Na S assay is shown below Figure 9 2 Calibration Information for Na S Assay Most...

Page 345: ...with a blue line The brown line indicates the 45 slope limit 2 mV This column displays the measured mV millivolt values of the Low and High Calibrators 3 Slope This field displays the slope of the cu...

Page 346: ...ction 9 Service and Maintenance of the AEROSET System Operations Manual ICT Unit Whole assembly ICT Module Electrode Chip only ICT Probe is not changed each time module is changed Take students to an...

Page 347: ...calibration Objectives Upon completion of the ICT Module Activity you will be familiar with Removing and replacing the ICT Module Removing and replacing the ICT Probe Aligning the ICT Probe Ordering a...

Page 348: ...ace the ICT Probe and ICT Module CAUTION Ensure that the probe and tubing connector are screwed in finger tight only If they are screwed in too tightly the seal may twist and block flow through the IC...

Page 349: ...d to 37 C before filling the ICT Reference Solution cup 3 What volume is aspirated from a sample cup or tube for ICT measurement 4 Describe the two lines displayed on the calibration graph in the ASSA...

Page 350: ...ICT Reference Solution preheater a narrow metal tubing around the water bath 3 15 L 4 Blue Line The current calibration slope Brown Line The 45 slope limit 5 To ensure that the tubing and probe are c...

Page 351: ...5 94858 103 July 2003 SUMMARY In this Module you have Described the ICT fluid delivery Identified the components of the ICT Unit Viewed the calibration information displayed for the ICT assays Removed...

Page 352: ...9 16 AEROSET Customer Training Guide 94858 103 July 2003 NOTES MODULE 9 ICT UNIT...

Page 353: ...AEROSET Customer Training Guide 10 1 94858 103 July 2003 MODULE 10 MAINTENANCE MODULE 10 MAINTENANCE...

Page 354: ...enance Activity 10 7 Monthly Maintenance 10 8 Monthly Maintenance Activity 10 9 Quarterly Maintenance 10 11 Quarterly Maintenance Activity 10 12 Semi Annual Maintenance 10 13 Semi Annual Maintenance A...

Page 355: ...MAINTENANCE OBJECTIVES Upon completion of this Module you will be able to 1 List and perform weekly monthly quarterly semi annual and annual Maintenance Procedures 2 Describe the sections of the AEROS...

Page 356: ...will use the AEROSET System Operations Manual to perform the recommended maintenance procedures This Module also discusses the System Backup and Restore Procedures This feature is introduced to help...

Page 357: ...Waste Pump Output T Fitting Clean Touchscreen Display Check ICT Probe and Tubing MONTHLY Check Clean Reagent Supply Centers Clean Carousel Sampler Area and Carousels Check Sample and Reagent Dispense...

Page 358: ...ng Weekly Maintenance Procedures must be performed Clean the Outside of the Sample and Reagent Probes Clean Mixers Clean Touchscreen Display Check ICT Probe and Tubing Check Sample and Reagent Probes...

Page 359: ...ROSET System Operations Manual NOTE The materials required for each procedure are defined in the AEROSET System Operations Manual Procedure The information for the following steps is found in the AERO...

Page 360: ...ollowing Monthly Maintenance Procedures must be performed Clean Check Reagent Supply Centers Clean Carousel Sampler Area and Carousels Check Sample and Reagent Dispense Components Clean Cuvette Washer...

Page 361: ...you will be familiar with Cleaning and checking the Reagent Supply Centers Cleaning the Carousel Sampler Area and Carousels Checking the Sample and Reagent Dispense Components Cleaning the Cuvette Was...

Page 362: ...r area and carousels 3 Check the sample and reagent dispense components 4 Clean the Cuvette Washer Nozzles 5 Check the Cuvette Washer High Concentration Waste Nozzle Tubing 6 Clean DI Water Filter if...

Page 363: ...ing Quarterly Maintenance Procedures must be performed Syringe Seal Tip and O Ring replacement on sample reagent and wash solution syringes 1 mL Wash Solution Syringe replacement 1 mL ICT Reference So...

Page 364: ...rials AEROSET System Operations Manual NOTE The materials for each procedure are defined in the AEROSET System Operations Manual Procedure The information for the following steps is found in the AEROS...

Page 365: ...10 13 94858 103 July 2003 SEMI ANNUAL MAINTENANCE The following Semi Annual Maintenance Procedures must be performed Wash Solution Filters Replacement ICT Reference Solution Filter Replacement Instru...

Page 366: ...ilters Replacing the ICT Reference Solution Filter Necessary Materials AEROSET System Operations Manual NOTE The materials for each procedure are defined in the AEROSET System Operations Manual Proced...

Page 367: ...NTENANCE The following Annual Maintenance Procedures must be performed Check Valve Replacement Wash Solution and Reference Solution Pump 1 mL Syringes Instructor will need the following for demo Beake...

Page 368: ...ill be familiar with Replacing Check Valves Necessary Materials AEROSET System Operations Manual NOTE The materials for each procedure are defined in the AEROSET System Operations Manual Procedure The...

Page 369: ...ANCE The following maintenance procedures should be performed when needed to ensure proper operation of the AEROSET System Format a Floppy Disk Backup System Configuration Files Restore System Configu...

Page 370: ...an interval for System backup to capture QC or calibration data The AEROSET System Backup Procedure provides a means to transfer System and assay files onto floppy disks The files are divided among f...

Page 371: ...15 minutes Robotics less than 10 seconds Library dependent upon the amount of data stored in the library For further information and details about using the System Backup and Restore options refer to...

Page 372: ...r more information on cleaning the reagent Bar Code Reader window Clean Cuvettes A cuvette may become dirty due to build up over time with usage or if the water is allowed to dry in the cuvettes repea...

Page 373: ...As Needed Maintenance AEROSET Customer Training Guide 10 21 94858 103 July 2003 NOTES...

Page 374: ...le and Calibrator Control Carousels cleaned monthly with a 10 bleach solution 6 To remove the cover from the ___________ Arm you must access the MAINTENANCE UTILITIES screen to move it over the cuvett...

Page 375: ...two steps a ______________________________________________ b ______________________________________________ 10 How often should sample reagent and wash solution syringe seal tips and O rings be repla...

Page 376: ...nt calibrators are entered c QC means are adjusted or edited for a new lot of controls d Changes are made to System configuration files e Robotic adjustments are made by the Customer or Field Service...

Page 377: ...25 94858 103 July 2003 SUMMARY In this Module you have Performed the Weekly Monthly Quarterly Semi Annual and Annual Maintenance Procedures Described the sections of the AEROSET System Maintenance Log...

Page 378: ...10 26 AEROSET Customer Training Guide 94858 103 July 2003 NOTES MODULE 10 MAINTENANCE...

Page 379: ...AEROSET Customer Training Guide 11 1 94858 103 July 2003 MODULE 11 COMPONENT REPLACEMENT AND TROUBLESHOOTING MODULE 11 COMPONENT REPLACEMENT AND TROUBLESHOOTING...

Page 380: ...Guide 94858 103 July 2003 CONTENTS Page Objectives 11 3 Introduction 11 4 Error Codes and Messages 11 5 Power OFF Procedure 11 11 MAINTENANCE UTILITIES Screen 11 13 Component Replacement 11 20 Compon...

Page 381: ...t Power OFF Procedure 3 Identify and use the various pages of the MAINTENANCE UTILITIES screen to Set the System date and time Check temperatures Track component usage Control robotic movements Check...

Page 382: ...of the code or message The second section presents the correct Power OFF Procedure that should be used prior to performing some troubleshooting and component replacement procedures The third section...

Page 383: ...Error Code of the same priority is generated for a result the first error to occur is displayed in the RESULT screen and printed on the Patient Report To view all Result Error Codes generated for a re...

Page 384: ...d corrective action in Section 10 Diagnostics and Troubleshooting of the AEROSET System Operations Manual An example of the RESULT screen with both Result Flags and Result Error Codes is displayed bel...

Page 385: ...ion in Section 10 Diagnostics and Troubleshooting of the AEROSET System Operations Manual An example of the ASSAY STATUS screen with a Calibration Error Code is displayed below Figure 11 3 ASSAY STATU...

Page 386: ...is displayed to give an explanation of the color change The Calibration Error Codes are listed with appropriate probable causes and corrective action in Section 10 Diagnostics and Troubleshooting of t...

Page 387: ...until the error is reset in the ERROR LOG screen by an Operator with super Log On access If a Level 1 error occurs during a START UP or SHUTDOWN Procedure the System immediately stops 2 Pink backgroun...

Page 388: ...w Error Log Message s 4 A checkmark is placed next to each Error Log Message and the Error Log icon no longer has a colored background The Error Log Messages are listed with appropriate probable cause...

Page 389: ...to shutdown the software prior to turning the power OFF 1 Close or exit any open screens 2 Select the Exit icon from the Action Area of the Main Display 3 Select OK The Log On screen is displayed Fig...

Page 390: ...aker Switch to the OFF position Rotary Power Control Switch Setting Action AUTO Once the Power OFF sequence is complete the power is automatically disconnected from the Analyzer and System Control Cen...

Page 391: ...erform the System Backup and Restore Procedures When selected the MAINTENANCE UTILITIES screen overlays the entire display Therefore the ErrorLog icon is present on the right hand column to allow the...

Page 392: ...DOWN SHUTDOWN 2 and SHUTDOWN 3 5 Assay Counts View the individual as well as the total assay counts NOTE When Na is ordered and run by itself or with any other ICT assay the Na assay count is incremen...

Page 393: ...chscreen This is not an alignment procedure 2 System Backup Restore Perform the System Backup or Restore Procedure This portion of the screen also allows the Operator to format a floppy disk 3 Library...

Page 394: ...ontrol and Sample Carousels The Operator may also turn the Bar Code Reader ON and rotate the Sample Carousel to read the bar code labels on the samples loaded in the carousel 5 Track Sampler Move the...

Page 395: ...nt Arm vertically and horizontally The horizontal control allows the Reagent Arm to be moved to the following positions Home CUV cuvette Add Water Bath Additive dispense position for R1 A only WCup Wa...

Page 396: ...cle 4 Photometer Collect electronic A D data for the photometer and the ICT turn the shutter ON or OFF and access the cuvette blank Cuvette Integrity data 5 ICT Move the ICT Unit vertically and horizo...

Page 397: ...water bath The Fill button may need to be selected several times to completely fill the water bath 9 IRef Pump Cycle the pump 10 Asp aspiration Pump Cycle the pump 11 This area displays a blue triang...

Page 398: ...n Sample and Reagent Probe Tubing The connection between the probes and the tubing is loose or leaking Bubbles in the tubing are observed during monthly maintenance Result imprecision Cuvette Dryer Ti...

Page 399: ...ispense components refer to Component Replacement in Section 9 Service and Maintenance of the AEROSET System Operations Manual Perform the Sample and Reagent Dispense Component Replacement Activity at...

Page 400: ...Cuvette Pairs Removing and replacing the Sample Carousel Tube Bottom Holders Removing and replacing the Source Lamp Removing and replacing Poppet Valves Necessary Materials AEROSET System Operations M...

Page 401: ...ltiple assays What could be causing this error 5 Name six activities that can be performed in the MAINTENANCE UTILITIES screen ______________________________________________ __________________________...

Page 402: ...TENANCE UTILITIES 4 The lamp housing cover was not correctly seated 5 Any six of the following a Setting the date and time b Defining the Automatic Power ON START UP and SHUTDOWN c Component tracking...

Page 403: ...Module you have Identified the different Error Messages and Codes that are displayed by the System Demonstrated the correct Power OFF Procedure Successfully removed and replaced the AEROSET System com...

Page 404: ...11 26 AEROSET Customer Training Guide 94858 103 July 2003 NOTES MODULE 11 COMPONENT REPLACEMENT AND TROUBLESHOOTING...

Page 405: ...AEROSET Customer Training Guide 12 1 94858 103 July 2003 MODULE 12 ACTIVITIES MODULE 12 ACTIVITIES...

Page 406: ...MODULE 12 ACTIVITIES 12 2 AEROSET Customer Training Guide 94858 103 July 2003 CONTENTS Page Multiple Skills Activity 12 3 Lab Day Activity 12 7...

Page 407: ...tiple Skills Activity you will be familiar with Performing a basic run Ordering a calibration Ordering controls Limiting a run Rerunning results Editing results Selecting rerun results Validating resu...

Page 408: ...s select any C P in the Sample Carousel desired 6 Highlight the ordered patient samples on the DATABASE screen and print a Loadlist SID Name PID Other Assays 7896 Mander Sally 12349876 ICT crea Dil 1...

Page 409: ...es to begin sampling before proceeding to the next step Adding a Sample in the Reserved STAT Position 1 Confirm that the STAT Sampling Indicator Light is not illuminated then place the sample in the R...

Page 410: ...nd available for sampling 4 Initiate the run using the appropriate procedure for the System status of your instrument 5 While in the RUN OPTIONS screen deselect the Limited Run option Reviewing Result...

Page 411: ...y have to rerun samples Fortunately the skills and knowledge you learned in earlier Modules will allow you to overcome these challenges successfully Objective Upon completion of the Lab Day Activity y...

Page 412: ...guration screen Result Printing Mode Request Select the Auto Print Control Reports option Select the Auto Print Patient Reports option 4 ONLINE CONFIGURATION screen Protocol Type Type 1 Result Transmi...

Page 413: ...d the remaining routine samples on the FastTrack Sampler and initiate the run using the appropriate procedure for the System status of your instrument Controls Out of Range 1 Review the Start QC resul...

Page 414: ...rmation Access Area d Enter the bar code number into the Sample ID field on the ORDER ASSAYS FOR STAT screen Do not order any assays e Select Start in the right hand column Reviewing Results When the...

Page 415: ...AEROSET Customer Training Guide Glossary 1 94858 103 July 2003 GLOSSARY GLOSSARY GLOSSARY...

Page 416: ...cceptable for measurement purposes Values outside this range are not used for calculation Absorbance Limit Check A calibration data check that evaluates the absorbance or change in absorbance obtained...

Page 417: ...the outer segments A B or C of the Reagent Supply Center Alkaline Wash Solution Used to clean Reagent and Sample Probes and Reaction Cuvettes Application Describes the assay parameter definition proce...

Page 418: ...gent location as the inner segment D of the Reagent Supply Center Button A screen operation that is selected for a specific action Calculated Absorbance The rate of change of absorbance calculated usi...

Page 419: ...ght calibrators of different concentrations are measured and a calibration curve is generated using these data points Calibration Logit 4 A calibration mode for assays in which the absorbance or absor...

Page 420: ...est Reagent blank measurement is required even if the calibration curve of another assay is used Calibrator Control Carousel A carousel located in the Carousel Sampler that has the capacity of 45 posi...

Page 421: ...cted to the AEROSET System Consumable An item that is exhausted in the process of running tests Cuvette Washer A series of nozzles including a drying nozzle that wash and dry the cuvettes Display Area...

Page 422: ...y An assay in which the concentration is calculated using the absorbance data obtained in the Main Read Time specified on the Base page of the ASSAY CONFIGURATION screen Extrapolated Calculation For t...

Page 423: ...ion A calibration type performed for all data points specified for the reagent blank and calibrators Hazards Situations that could cause physical harm to a user or damage to the Analyzer or laboratory...

Page 424: ...sensor detects the remaining volume by monitoring weight changes and issues a warning when the volume is less than the specified level ICT Reference Solution Preheater Preheats the ICT Reference Solut...

Page 425: ...ICT Probe and the ICT Module Information Access Area Area at the bottom of the Main Display that contains buttons to select information configuration and databases Integrated Chip Technology ICT Soli...

Page 426: ...A function that improves throughput with efficient utilization of cuvette pairs minimizing the single test measurement cycles Linearity A check of a rate assay to ensure that the reaction remains lin...

Page 427: ...ocedures performed on the AEROSET System to ensure continued proper functioning MaxAbsVar The stability of the reaction of an end point assay during the Main Read Time Mixer Unit A unit that houses th...

Page 428: ...tests can be ordered quickly by touching only one button instead of all the individual assay buttons Panic Value High PVH Result code that notifies Operator that the result generated is higher than t...

Page 429: ...be when an obstacle is detected Prozone Reaction Check In immune reactions if the antigen concentration in the sample greatly exceeds the antibody concentration in the reagent the result is falsely lo...

Page 430: ...orbance change within the read time RATE RATIO A ratio of absorbance changes A B used as a reaction check for Prozone RATE SUB Differences between absorbance changes A B used as a reaction check for P...

Page 431: ...umes of reagent Reagent Segments Sections 4 of each Reagent Supply Center in which the reagent is placed Reagent Supply Center Dual carousel which holds the Reagent Cartridges There are two Reagent Su...

Page 432: ...le Probes from the FastTrack Sampler or Sample Carousel to the Reaction Carousel Sample Blank Test Measurement used for correcting the absorbance data obtained during the Main Read Time There are two...

Page 433: ...hold up to 10 Sample Carriers Used in the FastTrack Sampler Sample Cup A type of sample container that can be used in the FastTrack and Carousel Samplers Sample Probe Dispenses samples into Reaction C...

Page 434: ...and Reagent Syringe Drives Specifications Describes the measurement principles power requirements of the AEROSET System etc Status Area Area of the Main Display that displays the System status date an...

Page 435: ...operations automatically at a programmed time of day for each day of the week Touchscreen Screen that allows the user to make a selection by touching the screen Warranty Continues for a period of one...

Page 436: ...to inhibit bacterial growth and prevent bubble formation Westgard Multi Rule A series of statistical control rules for interpreting control data that keep the probability for false rejections low and...

Page 437: ...AEROSET Customer Training Guide Appendix 1 94858 103 July 2003 APPENDIX HAZARDS APPENDIXHAZARDS m...

Page 438: ...ET Customer Training Guide 94858 103 July 2003 CONTENTS Page Hazard Types Appendix 3 Biosafety Hazards Appendix 4 Chemical Hazards Appendix 8 Electrical Hazards Appendix 10 Mechanical Hazards Appendix...

Page 439: ...rd Types AEROSET Customer Training Guide Appendix 3 94858 103 July 2003 HAZARD TYPES Classifications of hazards covered include the following types Biosafety Chemical Electrical Mechanical Physical La...

Page 440: ...ve the actual or potential presence of a biological hazard Handling samples reagents calibrators and controls Cleaning spills Handling and disposing of waste Moving the System Performing maintenance p...

Page 441: ...CFR Part 1910 1030 or other equivalent biosafety procedures Handling Probes The probes are sharp and potentially contaminated with infectious materials Avoid contact with the tip of the probes Cleani...

Page 442: ...s contain thimersol or mercury and may be considered hazardous under various environmental regulatory agencies Check with your local sanitary district to determine limits for mercury in waste water Ty...

Page 443: ...e wash solution Refer to Section 9 Service and Maintenance for instructions If probes will be reused place in a disinfectant solution a minimum of 30 minutes before reinstallation AEROSET System Surfa...

Page 444: ...ous gloves and protective eye wear and clothing Always maintain good housekeeping Do not eat drink or store food and beverages in areas where chemicals are used If irritation or signs of toxicity occu...

Page 445: ...ted of azide accumulation the U S National Institute of Occupational Safety and Health recommends the following procedure 1 Siphon liquid from the trap using a rubber or plastic hose 2 Fill the trap w...

Page 446: ...ument OFF before disconnecting the power cord and before servicing any electrical or internal components In the event of a blown fuse or thrown circuit breaker determine the cause and correct the prob...

Page 447: ...on the Analyzer by the Operator It is very important that sample cups and reagent cartridges are correctly positioned before executing any program Although the Sample and Reagent Arms are equipped wi...

Page 448: ...enter a range of mechanical movement during System operation Do not wear articles of clothing or accessories that could catch on the System Keep pockets free of items that could fall into the System B...

Page 449: ...in place to prevent laser light exposure from the optics bench The inner protective covers should only be removed by qualified Abbott Service Representatives Exposure to Heavy Objects CAUTION Lifting...

Page 450: ...Appendix 14 AEROSET Customer Training Guide 94858 103 July 2003 NOTES HAZARDS...

Page 451: ...AEROSET Customer Training Guide Index 1 94858 103 July 2003 INDEX...

Page 452: ...alibration 6 11 Other Calibrations 6 11 Calibration Review 6 19 CALIBRATION SUMMARY Screen 6 26 9 9 Calibration Theory 6 5 Calibrators 1 23 Chemical Hazards Appendix 8 Required Precautions Appendix 8...

Page 453: ...Log On Screen 8 6 8 8 M Maintenance Annual 10 15 As Needed 10 17 10 18 Clean Cuvettes 10 20 Clean the Reagent Bar Code Reader Window 10 20 Monthly 10 8 Quarterly 10 11 Schedule 10 5 Semi Annual 10 13...

Page 454: ...entially Contaminated Materials Appendix 5 Rerunning Results 5 21 DATABASE Screen 5 22 Reserved STAT Position 5 25 RESULT Screen 5 24 Result Error Codes 11 5 Result Flags 11 5 Result Handling 5 1 Resu...

Page 455: ...3 17 START UP and SHUTDOWN 3 15 Volume Display 3 18 Spline 6 9 Start Up and Shutdown 3 7 Start Up Procedure 3 12 Starting the Run 2 26 Status Area 1 35 Syringes 1 mL Syringes 3 23 Reagent Syringes 3 2...

Page 456: ...Index 6 AEROSET Customer Training Guide 94858 103 July 2003 NOTES Index...

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