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Access 2 In-Lab Training Manual of 119 Version 1.0 (November 2017) Beckman Coulter Technical Product Training

Access 2 Immunoassay System In-Lab Training Manual

___________________________________


Access 2 Immunoassay System

WARNINGS AND PRECAUTIONS Read all product manuals and consult with Beckman Coulter-trained personnel before attempting to operate the instrument. Beckman Coulter, Inc. urges its customers and employees to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, suitable laboratory attire when operating or maintaining this or any other automated laboratory equipment.

INTENTION FOR USE This document is not intended to replace the information in your instruments Instructions for Use, Quick Reference Guide or Help System Documentation. Information in any of the above documentation supersedes information in any other manual.

REVISION STATUS Version 1.0 (October 2017) Based on:

Access 2 Immunoassay System Software version 3.5.0 Access 2 Immunoassay System Instructions for Use C02062AA Access 2 Immunoassay System Operators Guide C02060AB Access 2 Immunoassay System Reference Manual C02061AA

TRADEMARKS Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.


Access 2 Immunoassay System In-Lab Training Manual

Table of Contents

Chapter 1 Analyzer Overview ....................................................................................... 9

System Hardware ...................................................................................................... 10

Access 2 Systems with Enhanced Features .............................................................. 12

Communicating with the Access 2 ............................................................................. 13

Sample Processing Sequence ................................................................................... 14

Assay Technology ...................................................................................................... 15

Chapter 2 Software Overview ..................................................................................... 19 Common Screen Elements ........................................................................................ 20

Main Menu Function Buttons ..................................................................................... 24

Software Navigation ................................................................................................... 25

Keyboard Function Keys ............................................................................................ 26

Filters ......................................................................................................................... 27

Printing ....................................................................................................................... 27

Using the Help System .............................................................................................. 27

Chapter 3 Daily Start Up ............................................................................................. 29 Check System Status ................................................................................................. 30

Check Zone Temperatures ........................................................................................ 30

Check System Supplies: Wash Buffer ...................................................................... 30

Check System Supplies: Empty the Liquid Waste .................................................... 31

Substrate Handling Conditions ................................................................................... 33

Check System Supplies: Prime Substrate................................................................. 33

Check System Supplies: Load Reaction Vessels ....................................................... 35

Check System Supplies: Change the RV Waste Bag ............................................... 37

Reagent Pack Handling Conditions ........................................................................... 38

Reagent Inventory ...................................................................................................... 38

Check System Supplies: Load Reagent Packs ......................................................... 39

Check System Supplies: Unload Reagent Packs ...................................................... 42

Confirm System Backup............................................................................................. 42

Setup an Automatic Backup ....................................................................................... 43

Inspect the Fluidics Module ........................................................................................ 44


Clean the Wash Carousel Probe Exteriors................................................................. 45

Daily Clean System Routine ...................................................................................... 46

Special Clean Routine ............................................................................................... 47

Calibration Test Requests .......................................................................................... 48

Quality Control Test Requests ................................................................................... 49

Chapter 4 Sample Management ................................................................................. 51 Sample Racks and Containers ................................................................................... 52

Calculating Sufficient Sample Volume ....................................................................... 52

Processing LIS Test Requests ................................................................................... 55

Processing Manual Test Requests ............................................................................ 56

Additional Sample Programming Features................................................................. 57

Rerunning a Test ....................................................................................................... 58

Manually Add on Test(s) ............................................................................................ 58

Chapter 5 Data Management ...................................................................................... 59 Calibrator Setup ......................................................................................................... 60

Reviewing Calibration Data ........................................................................................ 61

Setting up Quality Controls ........................................................................................ 63

Reviewing Quality Control Data ................................................................................. 65

Reviewing Patient Data .............................................................................................. 67

Test Result Reports ................................................................................................... 69

Applying a Test Results Filter .................................................................................... 71

Chapter 6 Weekly Maintenance .................................................................................. 73 Clean the Instrument Exterior .................................................................................... 74

Inspect the Liquid Waste Bottle for Wear ................................................................... 74

Check for Fluid in the Waste Filter Bottle ................................................................... 75

Insect and Clean the Primary Probe .......................................................................... 76

Replace Aspirate Probes ........................................................................................... 77

Clean the Aspirate Probes ......................................................................................... 79

System Verification following Weekly Maintenance ................................................... 82

Run the System Check Routine ................................................................................. 83

Reviewing and Printing System Check Data .............................................................. 84

Chapter 8 Troubleshooting ........................................................................................ 85 Enabling the Utility Assay........................................................................................... 86

Run the Utility Assay .................................................................................................. 86

Resolving Sample Errors ........................................................................................... 87


Troubleshooting Events ............................................................................................. 88

Troubleshooting System Check Failures ................................................................... 89

Troubleshooting Calibration Failures ......................................................................... 91

Troubleshooting Quality Control Failures ................................................................... 92

Test Result Flags ....................................................................................................... 93

Chapter 9 Resources .................................................................................................. 95 Beckman Coulter Support Personnel ......................................................................... 95

References ................................................................................................................. 96

Chapter 10 In-Lab Training Competency Exercise ................................................... 99 In-Lab Training Competency Exercise Reference Key ............................................ 111


Chapter 1

Analyzer Overview

Introduction The Access 2 is an automated immunoassay system that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. The system is for in vitro diagnostic use only. The Access 2 performs automated analysis of serum, plasma, urine, and amniotic fluid. This chapter will cover the following:

System hardware components. Sample processing overview. Assay technology and process overview.

Understanding the function of hardware components in the processing of samples on the system can assist in efficient operation, as well as with performing maintenance and troubleshooting.

Practice Use the information presented in the following pages to identify the hardware

components on the system. Review the sample processing sequence overview.

Identify the assay technology and the processing steps.

NOTE: Additional learning materials can be found on the Beckman Coulter website www.beckmancoulter.com


System Hardware

Location

Description

Carousel Module

Main Pipettor

Analytical Module

Fluidics Module


System Hardware (continued)

Module and Functions

Hardware Components Included

1

Carousel

Process Sample Racks and

Reagent Pack Storage

Internal Bar Code Reader Cup / Tube Detector Reagent Carousel Internal Reagent Bar Code Reader (on some systems) Sample Carousel

2

Main Pipettor

Sample / Reagent Pickup and Delivery to

Reaction Vessels Obstruction Detection

Precision Pump and Valve Pipettor Gantry Main Pipettor (Ultra sonic Transducer and Primary

Probe) Pressure Monitor

3

Analytical Reaction Vessel

Loading, Incubation,

Washing, Reading and Disposal

Luminometer Incubator Track and Belt Wash / Read Carousel Wash Arm RV Loader (Rake and Shuttle) RV Load Door RV Waste Bag

4

Fluidics Probe Washing, Wash Buffer and

Liquid Waste Processing

Wash Pump and Valve Probe Wash Tower Substrate Pump, Valve and Heater Vacuum Pump and Reservoir Peristaltic Waste Pump Fluids Tray (Wash Buffer Reservoir, Waste Filter

Bottle, Liquid Waste Bottle and Substrate Bottles)


Access 2 Systems with Enhanced Features If your Access 2 system has a serial number ≥ 57000, some of the external components are configured differently and a status light bar has been added. All of the system processes are the same and diagrams are included in this manual to illustrate the differences in the configurations. An internal reagent bar code reader has been added to facilitate loading of multiple reagent packs. The software on these systems reflects this capability. The system is also PROService ready, please contact Technical Support if you are interested in utilizing this feature.

System Modes and their associated Status Light Bar colors

System ModeStatus

Light Bar

Re-Configured External Fluids

Tray

Internal Reagent Bar Code Reader


Communicating with the Access 2 Following the communication sequence in the table below will insure that the instrument will update supply levels, track expirations and process samples accurately.

Tell = Function button selection by operator.

Wait = Instrument may be busy performing previously requested action. System readiness will be indicated when a pop-up box appears with instructions.

Do = Operator performs action as directed by pop-up box instruction.

Done = Operator selects Done (Yes) or Cancel (No).

*In many instances Run will need to be selected to initiate system action.


Sample Processing Sequence NOTE: The order of sample and reagent addition is assay specific.

1 The operator places samples into an appropriate rack. Using the Access 2 software (TELL…WAIT…DO…DONE), the operator loads the sample rack onto the Sample Carousel.

2 The operator presses the Run button. The Sample Carousel rotates the rack past the Internal Bar Code Reader and the Cup/Tube Detector while the rack ID is scanned.

3 The Cup/Tube Detector determines if a sample is present. The Internal Bar Code Reader scans the sample IDs. Test orders are matched with each rack position.

4 The sample to be tested (in the Sample Carousel) and the appropriate reagent pack (in the Reagent Carousel) are moved in line with the Main Pipettor Module and the row of reaction vessels (RVs) in the RV Shuttle.

5 The Primary Probe is cleaned using the Ultrasonic Transducer and flushed with wash buffer in the Probe Wash Tower.

6 The Primary Probe moves along the Pipettor Gantry towards the sample and the Ultrasonic Transducer is used for level sensing.

7 The Primary Probe aspirates the assay-specific sample volume then dispenses the sample aliquot into the first RV in the RV Shuttle. The Primary Probe is cleaned at the Probe Wash Tower.

8

The Primary Probe moves to the Reagent Carousel and the Ultrasonic Transducer is used to re-suspend the paramagnetic particles in the reagent pack. The Primary Probe aspirates reagent and dispenses the reagent into the RV containing the sample aliquot. The Primary Probe is cleaned at the Probe Wash Tower.

9 The Primary Probe moves to the Reagent Carousel to aspirate the second reagent (conjugate) and then dispenses the conjugate into the RV containing the sample and paramagnetic particles. The RV contents are mixed by the Ultrasonic Transducer.

10 The Primary Probe is cleaned at the Probe Wash Tower. 11 The RV Shuttle transfers the RV into the Incubator Belt.

12 The RV remains in the Incubator Belt (while the belt moves back and forth) for an assay-specific incubation time during which the antibody-antigen reactions occur.

13 After the incubation time is complete, the RV is transferred to the Wash/Read Carousel.

14

Three washing steps (Wash Arm moves up and down as wash buffer dispense is followed by aspiration in a magnetic field) are performed. These washes remove the unbound material from the RV while retaining material that is bound to the paramagnetic particles. After the last wash, Substrate is added.

15

The contents of the RV are incubated while the RV is moved toward the Luminometer. During this incubation, substrate reacts with alkaline phosphatase bound to the paramagnetic particles to produce light. The Luminometer measures the light in Relative Light Units (RLUs).

16 The RV is transferred from the Wash/Read Carousel back into the Incubator Belt.

17 When the RV aligns with the RV Shuttle, the RV is transferred by the RV Shuttle from the Incubator Belt into the RV Waste Bag (by way of the waste chute).


Assay Technology

Immunoassay is an analytical method that uses antigen-antibody reactions to detect or measure a specific analyte in a sample of body fluid.

The Access 2 uses enzyme-mediated chemiluminescence. Chemiluminescence is a chemical reaction in which one of the end products is

the emission of light. The light emitted is measured in Relative Light Units (RLU).

Step Process

1 Sample and reagent components are aspirated and dispensed by the main pipettor into a reaction vessel (RV). The main pipettor mixes the contents in the RV.

2 The RV is incubated for the required time for the assay.

3 Following incubation, the RV is transferred to the wash/read carousel where it is washed three times in a magnetic field to remove unbound material.

4 Substrate is dispensed into the RV.

5 The RV is incubated to allow the bound analyte complexes to react with the substrate.

6 The light generated by the reaction is read by the Luminometer. The RLU reading is converted to analyte concentration using the calibration curve.

Access 2 Enzyme-Mediated Chemiluminescence Process


Assay Technology (continued)

Sandwich Assay

Coated paramagnetic particles bind to an analyte to be measured in a sample. A second reagent (called conjugate) also binds to the analyte. The analyte is bound between the particle on one side and the conjugate on the

other (like a sandwich). The conjugate has alkaline phosphatase bound to it. This enzymatically triggers

the substrate to produce a glowing light. The Relative Light Units (RLUs) produced are directly proportional to the

amount of analyte in the sample (the more RLUs, the higher the analyte concentration).

The system uses a calibration curve to convert the measured light emission to an analyte concentration.


Assay Technology (continued)

Competitive Binding Assays

Coated paramagnetic particles bind to an analyte to be measured in a sample. A second reagent (called conjugate) also binds to the coated paramagnetic

particles (the enzyme labeled conjugate is the same analyte as the analyte being measured).

The analyte from the sample and the conjugate compete for binding sites on the coated paramagnetic particles.

The conjugate has alkaline phosphatase bound to it, this enzymatically triggers the substrate to produce a glowing light.

The Relative Light Units (RLUs) produced are inversely proportional to the amount of analyte in the sample (the more RLUs, the lower the analyte concentration).

The system uses a calibration curve to convert the measured light emission to an analyte concentration.


Chapter 2

Software Overview

Introduction The software is used by the operator to interact with the analyzer and perform system operations. Being familiar with the software can assist in understanding and efficiently operating the system. This chapter will cover the following:

Common Screen Elements. Main Menu Function Buttons. Navigation. Filters. Printing. Using the Help System.

Practice Use the information on the following pages to identify the Common Screen

Elements. Select Main Menu Function Buttons to navigate and review the screen specific

information displayed there. Access the Help button to identify the information available on the system. Select a Show Me Help Link Button to display an illustration contained within a help

procedure. Use a filter button to increase or reduce the amount of information displayed in the

Test Results screen. Return to the Main Menu from any other screen by selecting F9 on the keyboard.


Common Screen Elements The Access 2 displays certain elements on every screen so you can continuously monitor the system’s status.


Common Screen Elements (continued) System Modes There are four system modes the current mode is displayed in the upper left corner of every screen.

The system is ready to begin processing samples.

The system is performing a function, such as processing samples or running a maintenance routine.

No new tests are scheduled, but currently scheduled tests continue processing.

The system is not ready to process samples and will require initialization.

NOTE: On Access 2 systems equipped with a status light bar, the light bar color will change to match the system operating mode background color.

System Command Buttons

System command buttons are used to run, pause and stop the instrument.

Select to process samples or Run a maintenance routine.

Select to Pause the instrument. The instrument stops pipetting after it finishes pipetting the current sample and processing continues on samples already in progress.

Select to Stop the instrument. If a popup is confirmed, the system immediately stops processing and cancels any tests in progress.


Common Screen Elements (continued) System Status Button Background Colors

Most of the system status buttons are color coded to alert the operator to a system condition that requires attention.

NEUTRAL Normal operational conditions. No Action is required.

YELLOW CAUTION condition or event has occurred that requires investigation.

RED WARNING condition or event has occurred that requires immediate attention.

Status Button examples:

Condition Required Action

Neutral Substrate status button. No action is required, there is sufficient volume and time to expiration for the on board bottle of substrate reagent.

Caution RV status button. This condition change indicates a low number of RVs remaining on board the system. RVs should be loaded soon to accommodate test requests and prevent the status from progressing to a Red Warning condition.

Warning Event Log status button. The Event Log status button should be selected to determine if an event has occurred that requires the operator’s attention before continuing with operations.

Status Line This area displays the instrument serial number, software version and the current date and time. It may also display other information such as what activity the system is currently performing or a message prompt for the operator.


Common Screen Elements (continued) System Status Buttons The ten system status buttons can be viewed at the top of every screen. The buttons change color to inform the operator of a Caution (Yellow) or Warning (Red) condition or event. Select each button to view its related supply status.

Wash Buffer Changes color (Red) to indicate a critical low level.

Quality Control Changes color (Red) to indicate that QC result(s) have exceeded ranges. Select to view QC results or to configure QC.

Liquid Waste Changes color (Red) to indicate a critical high level.

Event Log Changes color (Yellow or Red) to indicate that a caution or warning event has occurred. Select to view informational, caution and warning events generated by the system.

Substrate Changes color (Yellow or Red) to indicate a low volume of tests remaining. Select to view the Supplies screen.

Work Pending Changes color (Yellow) to indicate a sample is required. Select to view details.

Reaction Vessels (RVs) Changes color (Yellow or Red) to indicate a low number of remaining RVs. Select to view the Supplies screen.

Supplies Required Changes color (Yellow) to indicate that supplies and/or calibrations are needed to process the requested tests. Select to view details.

RV Waste Bag Changes color (Yellow or Red) to indicate a low number of available space in the RV waste bag. Select to view the Supplies screen.

Help Select to display screen-specific topics or to access the entire Help system. Button remains Neutral (does not change color).


Main Menu Function Buttons

The Access 2 system displays a row of eight function buttons across the bottom of each screen.

Selecting a function button performs an action or displays a menu of additional function buttons.

Function buttons vary from screen to screen, according to the operations you can perform on each screen.

View sample status or request new tests for calibration, QC, patient, or maintenance samples.

View or print test results.

View and manage system supplies, waste containers and reagent packs.

Configure quality controls and review quality control results.

Add/delete calibrator lots and view/print calibration reports.

Review system temperatures, enable/disable Utility Assay, review / print results for non-routine maintenance procedures.

Access a menu for system initialization, fluidics priming and additional diagnostic procedures.

Access a menu for system configuration, assay configuration, and PC Administration functions (e.g., data backup, system shutdown).


Software Navigation

The Access 2 Immunoassay System has three navigation methods that you can use in any combination: touch screen, mouse and keyboard.

A tab becomes available when you move past the main menu to allow for easy movement between screens.

The main menu function buttons can be accessed by the tab when it appears on the right side of a screen.

Scroll bars appear when there is more information than can be contained in the

viewing pane.

Touch Screen

Use your finger tip to touch the console screen to select the desired item.

Mouse

Move the cursor to the desired item and select with a left click.

Keyboard

Press a keyboard equivalent function key to select an item.


Keyboard Function Keys

The keyboard function keys are located at the top of the keyboard and a template has been applied to simplify identification (P/N 973041).

The following table lists the keyboard equivalents you can use to perform common actions.

Keyboard Equivalent

Action

F1 – F8 Perform the indicated function or go to the indicated screen.

F9 Go to the Main Menu.

F10 Check system supplies.

F11 Start sample processing.

F12 Display the Help system.

Esc Go back to the previous screen.

Down Arrow

Display a list in the field.

Pause Pause the system.

Shift-Pause Stop the system.

Print Screen

Print what is currently displayed on the screen.

Scroll Lock View the Event Log.


Filters

function buttons are available on many screens throughout the software

allowing the user to expand or reduce the amount of information displayed.

Many filters have a sort order feature for selecting the display order of the filtered

data.

Custom filters can be created to easily find frequently sought information.

Printing

Print function buttons are available on many screens; select the

function button on the screen to print a screen specific report.

The Print Screen key on the keyboard will print a copy of the screen being

displayed.

The Help Window Button Bar is available for printing when in the Help system.

Using the Help System

Access the Help System by selecting the Help Button on the screen or by

selecting F12 Help on the keyboard.

When you select Help from a screen the information displayed is specific to the

screen you are on.

Green Text Links can be selected to link to the topic named in the text.

Select from the Help Window Button Bar to display the entire

contents of the Help System.

The Help System is intended as a reference only. You must return to the User

Interface (UI) to perform any function.

Exit the Help System by selecting the button in the upper right corner of

the help window or selecting any visible portion of the UI beyond the help

window.


Using the Help System (continued) The nine Help Link Buttons depicted in the table below indicate links to related information.

Help Link Button Help Information Description

See Also Select to display a window listing related topics that can offer more information about the subject.

Flowchart

Select to display an overview or procedure flowchart. You can find this button at the top of a procedure window.

Example

Select to display a relevant example.

Select to display another topic containing more information about the selected topic.

Forward

Select to display a related topic

More Info

Select to display another topic containing more information about the selected topic.

Show Me

Select to display an illustration of the procedure or step. You can find the button anywhere in the Help system text, where a graphic would be helpful.

Navigation

Select to display the associated screen or window navigation topic. Navigation topics include directions on how to access the screen or window, lists of required and optional fields, and keyboard equivalents.

Screen View

Select to display a graphic of the associated screen or window. After the screen or window is displayed, you can move the cursor over the graphic to find out what areas of the graphic are selectable.

Glossary

Select to display the definition of the glossary term (used only in the Glossary).


Chapter 3

Daily Start Up

______________________________________________________________________ Introduction A daily maintenance should be performed on the Access 2 Immunoassay System after the longest period of inactivity and prior to processing patient samples. The following system checks and maintenance tasks are required for daily start up:

Check System Status. Inspect Fluidic Module. Clean the Wash Carousel Probe Exteriors. Prime Substrate. Run the Daily Clean System or Special Clean Routine. Document task performance on the Maintenance Log.

Step/Action Table Information Step/action tables are provided for each daily start up task in this chapter. These step/action tables are available as a quick reference for the daily start up procedures. Review your instruments’ Instructions for Use for any Notes, Cautions, and Warnings as well as step-by-step instructions. For complete instructions to the daily start up procedures, refer to:

From ANY screen:

Help Help Topics Contents

Operator’s Procedures Routine Maintenance Daily Maintenance

_____________________________________________________________________ Practice Use the information and step/action tables on the following pages to practice the

daily start up procedures and determine an efficient order based on your laboratory workflow.

Based on your laboratory workflow, which shift will be in charge of daily maintenance?


Check System Status Checking the system status is comprised of three tasks: Check Zone Temperatures, Check System Supplies and System Backup. Check Zone Temperatures

Step Action

1 From the Main Menu screen, select Maintenance Review F6.

2 Verify that the temperatures in the Zone Temperature fields are within their expected ranges.

NOTES

Out of range temperatures are displayed in red. Contact Technical Support if any of the zone temperatures are out of

range.

3 Document the completion of this task on the Maintenance Log.

Check System Supplies: Wash Buffer The wash buffer bottle drains into the wash buffer reservoir. The wash buffer bottle needs to be replaced when the bottle is empty. You can change the wash buffer at any time. Follow the step/action table below to change the wash buffer bottle.

Step Action

1 Mix the contents of the new Wash Buffer Bottle by gently inverting the sealed bottle three or four times.

2 Remove the cap and the inner seal from the new bottle.

3 Lift the empty bottle from the fluids tray reservoir.

4 Unscrew the wash buffer dispense cap assembly from the empty bottle and screw the dispense cap assembly on the new bottle.

NOTES

To avoid contamination do not touch any part of the dispense cap assembly that enters the reservoir.

To avoid potential overflowing, make sure that the dispense cap assembly is not cross-threaded and is tightly screwed on.

5 Turn the new bottle upside down and place the dispense cap assembly into the reservoir receptacle.


Check System Supplies: Empty the Liquid Waste

NOTE: If your system is plumbed to a drain, this maintenance task will not be necessary. No software interaction is required to empty the liquid waste bottle. Depending on the system mode, follow the appropriate step/action table below. Your laboratory procedures will determine how to dispose the contents of the Liquid Waste Bottle.

Procedure A – Access 2 Ready OR Not Ready

Step Action

1 Detach one tubing on the bottle cap by pressing the button on the quick disconnect (see image on following page) while pulling on the tubing.

2 Immediately connect this tubing by snapping it into the quick disconnect on the cap of a clean liquid waste bottle.

3 Repeat the above steps for the second tubing.

4 Make sure that the clean, connected liquid waste bottle is correctly placed into the fluids tray.

5 Dispose of the liquid waste bottle contents. Thoroughly rinse the bottle and cap with tap water and invert to dry.


Procedure B – Access 2 Running OR Paused

Step Action

1 Remove the liquid waste bottle cap with the two tubes still attached to the cap (see image on following page).

2 Immediately screw this cap onto a clean liquid waste bottle.

CAUTION Take care to orient the underside of the cap away from you. Liquid waste is continuously expelled while the system is processing samples.

3 Make sure that the clean, connected liquid waste bottle is correctly placed into the fluids tray.

4 Dispose of the liquid waste bottle contents. Thoroughly rinse the bottle with tap water and invert to dry.



Empty the Liquid Waste (continued) NOTE: The fluids tray containing the liquid waste bottle has two configurations (A or B). The connections to the liquid waste bottle are similar.


Substrate Handling Conditions

Condition Storage Stability

Unopened 2-8°C Until expiration date stated

on the label

Equilibration prior to use (unopened)

15-30°C (room temperature)

Minimum 18 hours Maximum 14 days

In use (opened) External fluids tray substrate position

Maximum 14 days

Check System Supplies: Prime Substrate

Substrate should be primed once every 24 hours; by either loading a new bottle or priming the onboard bottle.

Substrate priming takes approximately eight minutes. During this time the instrument software cannot be used, however the Help System can be accessed.

To load a new bottle of substrate follow the step/action table below.

Step Action

1 Confirm that the system is in the Ready mode.

2 From the Main Menu select Supplies F3.

3 Then select Change Substrate F5.

4 WAIT until the screen displays the Change Substrate window.

5 Enter the bar code of the new unopened equilibrated substrate bottle by scanning the bottle with the handheld bar code reader.

6 Remove the cap from the new equilibrated substrate bottle.

NOTE Avoid substrate contamination by not popping bubbles, contacting bottle neck area, touching inside the supply cap or wiping the straw.

7 Unscrew the substrate supply cap from the bottle in use and immediately screw it onto the new bottle. Place the new bottle into the fluids tray. A new bottle of substrate contains 600 tests.

8 Select Done F1. Select YES F1 to request priming. The system mode screen will change from Ready to Running while the prime is being performed.

9 Document the completion of the task on the Maintenance Log.


Prime Substrate (continued) If sufficient volume is available in the onboard bottle, prime the substrate following the step/action table below.

Step Action

1 Confirm that the system mode is Ready.

2 From the Main Menu screen, select Diagnostics F7.

3 Select Prime Fluidics F2.

4 Select the Substrate box. Leave the default setting of 4 priming cycles.

5 Select Start Priming F2. 32 tests are used when priming through the fluidics.

6 When the priming cycles have been completed, select OK F1 and then Done F8 to return to the Main Menu.


NOTE: There are two configurations (A or B) of the substrate location in the fluids tray.


Check System Supplies: Load Reaction Vessels

Access 2 RV cartridges contain 98 reaction vessels attached to a support spine.

Maximum capacity is 3 cartridges for a total of 294 reaction vessels. .

Step Action

1 Confirm that the system mode is Ready OR Paused OR Running.

2 Select Load RVs F4.

3 WAIT until the screen displays the Load RVs window.

4 Confirm that all RVs are firmly seated on the cartridge spine by pressing down on the spine before you load the cartridge.

5 Open the Supplies Door and then open the RV Load Door (see diagram on the next page).

6 Remove the RV Cartridge cover and lift the RVs and attached spine from the cartridge case. Load into the RV Supply Area.

7 Release the cartridge spine from the RVs by pressing down firmly on the RV Load Door. Open the RV Load Door and remove the empty spine to prevent possible damage to the RV rake.

NOTE Only load full cartridges. Fill in any missing RVs noted when spine is removed.

8 Close the RV Load Door, close the Supplies Door and select Done F1.


Load Reaction Vessels (continued)


Check System Supplies: Change the RV Waste Bag Waste RVs are collected on the system in a waste bag. Follow the step/action table below to change the RV waste bag through the software.

Step Action

1 Confirm that the system mode is Ready OR Paused OR Running.

2 Select Change RV Waste Bag F6.

3 WAIT until the screen displays the Change RV Waste window.

4 Open the Supplies Door on the front of the instrument.

5 Unfold a new waste bag, grasp its sides, and pull open gently to expand it.

6 Remove the on-board RV Waste bag by pulling straight up on the plastic collar until it is free of the waste chute.

NOTE RV waste vessels will continue to be ejected (every 36 seconds) when the instrument mode is Running or Paused.

7 Remove the RV in the exit position of the waste chute to ensure that it does not get pushed back into the system.

8 Place the new bag into position by sliding the plastic collar on the bag into the slot on the waste chute. Press down firmly to be sure that the collar is completely seated.

9 Seal the used waste bag with the tape provided. Discard the used biohazardous waste bag according to lab policy.

10 Close the Supplies Door. Select Done F1. Supplies screen RV Waste count will update to 300 spaces available.

NOTE From the Ready mode, the system will not start sample processing without a waste bag in place.


Reagent Pack Handling Conditions

IF THEN

The reagent pack is new (un-punctured)

50 tests

Gently invert the pack to remove any paramagnetic particles from the underside of the pack seal before loading.

The reagent pack has been previously used (punctured)

< 50 tests

Do not invert the pack before loading to prevent potential reagent leakage.

WARNING

No partial pack sharing is allowed between Access 2 systems.

Loading a punctured pack onto a different system may result in the pack being disabled.

NOTE: TSH (3rd IS) is a 100 test reagent pack. Reagent Inventory The Access 2 system keeps an inventory of all on-board and off-board reagent packs using bar coded information from the reagent pack bar code and also tracks non-bar coded information generated by the system regarding the pack status. Bar Coded: Pack Name, Lot Number, Serial Number and Lot Expiration Date. Non Bar Coded: Number of Tests, Number of Days Open, Pack Expiration, Calibration Expiration, Slot Position and Instrument.

Available Actions

From the Supplies screen, select Reagent Inventory F7 to view information for individual reagent packs.

Load Reagent Pack F1 Select to load a reagent pack.

Unload Reagent Pack F2 Select to unload a reagent pack.

Delete Pack F5 Select to delete a pack from inventory.

Print F7 Select to print reagent inventory.


Filter F8 Select to see All, On-board or Off-board packs.

Check System Supplies: Load Reagent Packs

Follow the step/action table below to load reagent packs and manually enter bar code information.

Step Action


2 Select Load Reagent Pack F1. If the system is running, it will pause to allow for reagent pack loading.

3 WAIT until the screen displays the Load Reagent Pack window.

4 Slide the carousel door to the left to open it. Open the reagent carousel door.

NOTES Gently invert unpunctured reagent packs several times prior to

loading. Do not invert punctured reagent packs, as contents may leak.

5 Scan the reagent pack bar code (see diagram on next page).

NOTE If the bar code will not scan, enter the characters above the pack bar code into the Bar Code field.

6 Close the reagent carousel door. Slide the carousel door to the right to close it.

7 Select Done F1.


Load Reagent Packs (continued)


Load Reagent Packs (continued) Use this step/action table to load multiple reagent packs on systems equipped with an internal reagent bar code reader (available on systems with serial numbers ≥ 570000) and the internal bar code reader is enabled. NOTE: Access 2 systems with an internal reagent bar code reader are able to perform a reagent inventory remap by selecting Remap F3 on the Supplies screen. The system will scan all reagent slots in the event that a pack was incorrectly loaded.

Step Action


2 Select Load Reagent Pack F1. If the system is running, it will pause to allow for reagent pack loading.

3 WAIT until the screen displays the Load Reagent Pack window.


5

Insert the reagent pack into the empty slot directly under the reagent carousel door. Angle the narrow end of the reagent pack down into the slot and, while pressing forward towards the carousel center, lower the reagent pack into place.

6 To load additional reagent packs, select Next F2.

7

The carousel will move an empty slot into position under the reagent carousel door. Allow the carousel to come to a complete stop, and then insert the reagent pack into the slot. If you wish to load another reagent pack select Next F2 to continue loading.

8 When you have added the last reagent pack, select Done F1, the system will perform a scan and add the reagent packs to the reagent inventory.

NOTES Reagent packs with unreadable bar codes will scan as ????. These packs will need to be unloaded and reloaded using the external

bar code reader or by manually keying in the bar code information.

9 If your system is paused select Run to resume processing.


Check System Supplies: Unload Reagent Packs Follow the step/action table below to unload reagent packs.

Step Action

1 On the Supplies screen select the button of the reagent you want to unload.

2 Select Unload Reagent Pack F2.

3 WAIT until the screen displays a pop-up window.


5 Remove the pack from the slot directly under the reagent carousel door by first pressing forwards towards the carousel center and then angling the wider end of the pack up and out.

6 Close the reagent carousel door. Slide the carousel door to the right to close it.

7 Select Done F1.

Confirm System Backup

A backup will enable a faster restore of the system in the event of a PC failure.

Step Action

1 From the Main Menu screen, select Configure F8, then PC Admin F7.

2 Document the completion of a successful system backup on the Maintenance Log.


Setup an Automatic Backup

The system can be set to run an automatic backup and an on screen pop-up box will indicate a successful or failed backup. Follow the step/action table below to setup an automatic backup.

Step Action

1 From the Main Menu screen, select Configure F8, then PC Admin F7.

2 Select Scheduled Backup. Enter your system password. Select OK F1.

3 The Scheduled Backup window will be displayed. Select Enable Automatic Backup.

4 Select Daily Backup to schedule the system to backup every day at the time specified in the Start Time drop-down list.

5 Select Weekly Backup to schedule the system to backup to run weekly on the day selected in the Day drop-down list.

6 Select OK F1 to save selections and exit.

NOTES

The backup needs to launch in the Ready mode and will then run in the background, allowing other operations to be performed.

If the most recent backup has failed, select PC Admin [F7] and run an Immediate Backup [F2].

The default password (case sensitive) is Access2Admin.


Inspect the Fluidics Module Open the front panel and inspect all the accessible tubing connections, valves and pump fittings (see diagram below for check points) for crystalline buildup or corrosion. Confirm the system is in the Ready or Not Ready mode. If any crystalline buildup or corrosion is found contact Technical Support for assistance. Deposits indicate that a connection may be leaking. If no deposits are found document completion of the task on the Maintenance Log.

Location Check Point Description

1 Vacuum Pump

2 Precision and Wash Pumps

3 Vacuum Reservoir Bottle

4 Wash Valve

5 Substrate Valve, Pump & Heater

6 Probe Wash Tower

7 Probe Wash Valve

8 Peristaltic Waste Pump

9 Fluids Tray


Clean the Wash Carousel Probe Exteriors Use the step/action table and diagram bellow to clean the exterior of each dispense, aspirate and substrate probe.

Step Action

1 Confirm that the system is in the Ready OR Not Ready mode.

2 Open the front panel of the instrument.

3 Locate the Substrate, Dispense and Aspirate probes (see diagram below).

NOTES

Do not bend probes or damage the fragile probe tips. To avoid contamination, use a new swab for each type of probe. Do not wipe the tip of the probe. Fibers on or inside of the probes can clog the

probes or valves in the fluidics module.

4 Gently wipe the exteriors of the three dispense probes located at positions 1, 3 and 5 on the wash arm, with a new fiber-free polyester swab moistened with wash buffer or deionized water.

5 Gently wipe the exteriors of the three aspirate probes located at positions 2, 4 and 6 on the wash arm, with a new fiber-free polyester swab moistened with wash buffer or deionized water.

6 Gently wipe the exterior of the substrate probe located at position 7 on the wash arm, with a new fiber-free polyester swab moistened with wash buffer or deionized water.

7 Close the front panel of the instrument.

8 Document completion of this task on the Maintenance Log.


Daily Clean System Routine The Daily Clean System Routine cleans the interior of the primary, dispense and aspirate probes and primes the wash buffer lines. A Daily Clean System Routine should be run every 24 hours. This routine should also be run if the system will not be processing samples for an extended period of time. The routine takes about 15 minutes to run. Use the step/action table to program and process a Daily Clean System Routine.

Step Action

1 From the Sample Manager screen, enter the sample rack ID number into the Rack ID field and press Enter. The rack will be displayed on the Off Board list.

NOTE A 400 series rack and 2.0 mL cups must be used for the Daily Clean System Routine.

2 Select Maintenance Request F4.

3 Select the Daily Clean System option. Select OK F1.

4 Place 2.0 mL sample cups in rack positions 1, 2 and 3.

5 Pipette 2.0 mL of Contrad 70 cleaning solution into the sample cup in position 1.

6 Pipette 2.0 mL of a 1/5 dilution of Citranox cleaning solution (1 part Citranox and 4 parts deionized water) into the sample cup in position 2.

7 Pipette 2.0 mL of Wash Buffer (or deionized water) into the sample cup in position 3.

NOTE To avoid QNS (Quantity Not Sufficient) errors, fill cups 1, 2 and 3 to the specified volumes.

8 Select Load Rack F1.

9 WAIT until the screen displays the Load Rack window.

10 Load the rack and select Done F1. Select Run.

NOTE While the Daily Clean rack is processing other racks may be programmed, butnot loaded until the Utility Assay in Progress message is flashing in System Mode.



Special Clean Routine If you run the Vitamin B12 assay on your system, perform the Special Clean Routine at the end of each day the assay was in use or whenever the system will not process samples for 8 hours or more. Technical Support may also direct you to run a Special Clean Routine for troubleshooting. The Special Clean Routine takes 35 minutes to run. Use the step/action table below to program and process a Special Clean Routine.

Step Action

1 From the Sample Manager screen, enter the sample rack ID number into the Rack ID field and press Enter. The rack will be displayed on the Off Board list.

NOTE A 400 series rack and 2.0 mL sample cups must be used for the Special Clean Routine.

2 Select Maintenance Request F4.

3 Select the Special Clean option. Select OK F1.

4 Place 2.0 mL sample cups in rack positions 1 through 6.

5 Pipette 2.0 mL of Contrad 70 cleaning solution into the sample cup in position 1.

6 Pipette 2.0 mL of a 1/5 dilution of Citranox cleaning solution (1 part Citranox and 4 parts deionized water) into the sample cup in position 2.

7 Pipette 2.0 mL of Wash Buffer (or deionized water) into the sample cup in position 3.

8 Pipette 2.0 mL of 70% Alcohol (Ethanol or Methanol diluted 7/10 in wash buffer) into each of the sample cups in positions 4, 5 and 6.

NOTE To avoid QNS (Quantity Not Sufficient) errors, fill cups 1 through 6 to the specified volumes.

9 Select Load Rack F1.


11 Load the rack and select Done F1. Select Run.

NOTE While the rack is processing other racks may be programmed but not loaded until the Utility Assay in Progress message is flashing in System Mode.



Calibration Test Requests You periodically calibrate assays on an Access 2 instrument to establish values that the system uses to correctly report test results for patient and quality control samples. The APF (Assay Protocol File) will evaluate the results and either Pass or Fail the calibration. Use the step/action table below to process a calibration.

Step Action

1 From the Main Menu select Sample Manager F1 screen.

2 Enter the sample rack ID into the Rack ID field and press Enter. The rack will be displayed on the Off Board list.

NOTE Use a 2500 series rack and 0.5 mL cups to minimize waste of the calibrator material.

3 Select Test Request F3. Select Request Calibration F6.

4 Select the appropriate calibrator set (assay and calibrator lot number) from the displayed list of configured calibrators. Select OK F1.

5 Place the filled sample cups in rack positions corresponding to the positions on the load list displayed on the screen.

NOTES

The required volume can be determined using the Calculating Sufficient Sample Volume in Chapter 4 of this manual.

Assay pickup volumes can be found in the Assay Summary Tables or the Consumable IFU/CIS/Setting Sheets on the Beckman Coulter website.

Change Reagent Lot will allow you to select a specific reagent lot to calibrate when multiple lots are onboard.

7 Select Load a Rack F1.


9 Load the rack and select Done F1. Select the Run button.


Quality Control Test Requests Quality controls (QC) are samples of known reactivity and should be run along with patient samples to monitor for analytical performance and validity of patient sample results. The frequency for running QC samples will be determined by your laboratory. The recommended minimum is two levels for every 24 hours the assay is in use. Use the step/action table below to program and process QC samples.

Step Action

1 From the Main Menu, select Sample Manager F1, enter the sample rack ID into the Rack ID field and press Enter. The rack will be displayed on the Off Board list.

2 Select Test Request F3. Select Request QC F5.

3 Select the check boxes for configured QC levels desired, select OK F1.

4 Select the rack position for the first QC sample, then select Show Test Menu F3 to display all enabled tests. Select all assays to be run on this QC sample. Repeat for next QC sample position.

NOTES Ordering QC does not automatically order specific assays. Change Reagent Lot will allow you to select a specific reagent lot to QC

when multiple lots are onboard.

5 Place the filled QC sample containers into the rack positions that correspond to the positions on the load list displayed on the screen.

NOTES

The containers used will be dependent on the rack series selected to process the QC.

The required volume can be determined using the Calculating SufficientSample Volume in Chapter 4 of this manual.

6 Select Load a Rack F1.


8 Load the rack and select Done F1. Select the Run button.

9 From the Main Menu select Quality Control F4 to review, setup and print QC results.

NOTE Where you review and document QC results will be determined by your laboratory procedures.


Chapter 4

Sample Management

______________________________________________________________________ Introduction In this chapter you will identify the racks and validated sample containers that are available on the Immunoassay system. The racks and containers that you use in your lab are setup by your Applications Specialist during installation. To reduce the risk of system errors and provide accurate test results it is important to use the appropriate racks and validated containers when processing samples on the system. Proper sample collection and handling provides the instrument with a quality specimen for analysis. Refer to the manufacturer’s sample collection container Instructions for Use when preparing specimens for analysis. This chapter will also include information on:

Processing samples with bar codes and LIS programming. Processing and programming samples without LIS programming. Ordering an add-on or rerun test at the analyzer. Additional sample programming features available on the system.

From ANY screen:

Help Help Topics Contents

Operator’s Procedures Sample Management

______________________________________________________________________

Practice

Proper rack selection based on the containers used in your lab. Processing samples with bar codes and LIS programming. Processing and programming samples without LIS programming. Calculate the minimum volume needed for a short sample and determine the most

efficient rack and container to process it.

NOTE: How reruns, add-ons and reprints are handled will depend on how your laboratory’s LIS and/or middleware are configured. Options shown here are at the analyzer level.


Sample Racks and Containers

To accommodate different sizes of validated sample containers, there are three different rack sizes: 13 mm, 16 mm and 16 mm elevated.

The instrument identifies the sample container in use based on the Rack ID bar code.

Each rack accommodates only one type of sample container. The operator identifies the rack based on the Rack ID bar code and the colored

Rack Icon. All sample containers must be uncapped prior to processing. All sample containers must be seated all the way down into the rack. Assay pickup volumes can be found in the Assay Summary Tables or the

Consumable IFU/CIS/Setting Sheets located on the Beckman Coulter website. The following tables list all of the containers that are currently validated for use

on the Access 2 instrument along with the corresponding rack ID range and the dead volume for each container.

Dead Volume is the amount of sample that must be present to allow the primary probe to accurately pick up the sample aliquot.

Calculating Sufficient Sample Volume

Required sample pickup

volume (per replicate)

x Number of replicates +

Dead volumeof sample container

=Minimum Sample Volume

Example: Minimum sample volume required for a CK-MB assay calibration using a 0.5 mL sample cup.

55 uL x 2 + 80 uL = 190 uL

Example: Minimum sample volume required to process one level of QC or a patient sample for CK-MB, HCG5 and Ferritin assays using a 2.0 mL sample cup.

55 uL +

25 uL +

10 uL =

90 uL

x 1 + 150 uL = 240 uL


Racks for primary sample tubes

Verify there is adequate sample volume for testing by following the instructions on: Sample Height Guidelines for 12 mm, 13 mm, and 16 mm Sample Tubes template that was supplied with your system.

Rack Icon

Sample ContainerRack Type

Rack Bar Code

Series Dead Volume

13 (or 12) x75 mm tube

13 mm 1300 to 1399 500 µL

13 x 100 mm tube 13 mm 1400 to 1499 3.0 mL

16 x 75 mm tube 16 mm

elevated1000 to 1099 700 µL

16 x 100 mm tube 16 mm 1500 to 1599 4.5 mL


Racks for aliquot sample containers Sufficient sample volume is verified using the minimum sample volume calculation.

Rack Icon

Sample Container Rack Type

Rack Bar Code

Series

Dead Volume

0.5 mL Sample Cup

(P/N 651412) 13 mm 2500 to 2599 80 µL

Pediatric Insert Cup (P/N 81916)

in Pediatric Tube Adapter (P/N 472987)

13 mm 1800 to 1899 100 µL

2 mL Sample Cup (P/N 81902 or

652730) 13 mm 400 to 499 150 µL

3 mL Sample Cup

(P/N 81914)

Caps (P/N 81922A)

13 or 16 mm

500 to 599 150 µL

1 mL Insert Cup

(P/N 81915)

in 13 x 75 tube

13 mm 700 to 799 300 µL

1 mL Insert Cup

(P/N 81915)

in 13 x 100 tube

13 mm 600 to 699 400 µL

2 mL Insert Cup

(P/N 81917)

in 16 x 100 tube

16 mm 200 to 299 400 µL

Autoaliquot tube

(P/N 2910034) 13 mm 1600 to 1699 400 µL


Processing LIS Test Requests If you are using bar coded sample containers and are downloading test requests from an LIS (Laboratory Information System), use this procedure to load racks and run the tests. You can load up to six racks at one time.

Step Action

1 Remove the caps from the sample containers and place them in the appropriate rack designated for the container size.

2 Verify the container bar code is visible through the slot in the rack and the container is completely seated into the bottom of the rack.

3 From the Main Menu select Sample Manager F1.

4 Select Load a rack F1. Wait for the Load Rack window. If the system is processing samples, it enters the Paused mode. The system will present a rack loading location.

5 Open the sample carousel door, pick up the rack by the top handle and place it onto the sample carousel (refer to image below) and select Done F1. Continue loading racks until all racks loaded.

NOTE Verify there are no red tube icons. Red tube icons indicate a sample tube read error (see Chapter 8: Resolving Sample Errors in this manual).

6 When all racks are loaded select the Run button to initiate sample processing. Verify the system mode changes from Ready to Running.


Processing Manual Test Requests If you do not use bar codes or have disabled sample bar code scanning, use this step/action table to manually enter test requests and sample information. You can program ten samples per rack and load up to six racks at one time.

Step Action

1 Remove the caps from the sample containers and place them in the appropriate rack designated for the container size.

2 Verify the container is completely seated into the bottom of the rack.

2 From the Main Menu select Sample Manager F1. Select a rack button from the off board list, key in or scan in the rack ID number into the Rack ID field and press Enter.

3 Select Test Request F3 to display the Test Requests screen.

4 In the Sample ID field, enter the sample ID and press Enter. If needed enter the Patient ID, Dilution Factor, Sample Type, STAT or Comment.

5 To order tests, select Show Test Menu F3. From the menu (see image below), select desired test(s) to be run on the sample.

NOTES

Tests can be run in replicates by selecting the desired test button multiple times.

Incorrectly selected tests or undesired replicates can be deleted by highlighting the test and selecting the Remove button.

6 Select Load Rack F1. Wait for the Load Rack window. If the system is processing samples, it enters the Paused mode. The system will present a rack loading location. Load the rack and select Done F1.

NOTE Verify there are no red tube icons. Red tube icons indicate a sample tube read error (see Resolving Sample Errors section in this manual).

7 When all racks are loaded select the Run button to initiate sample processing. Verify the system mode changes from Ready to Running.

Test Menu Example

NOTE: Your Test Menu will display the assays you have enabled to run on your system.


Additional Sample Programming Features

Manual Programming Options

From the Test Requests screen, type in the first sample ID and press Enter. Select More Options F8. Select the desired option(s) and Turn On. Options can be used singly or simultaneously for programming racks. Options will stay enabled until turned off or the rack is loaded.

Auto Sample ID

Auto Sample ID simplifies test request entry when not using bar coded sample ID’s and sample numbers are consecutive. Example: If the first sample ID is Sample A1, the next will be Sample A2 and so on.

Batch Request

Batch Request simplifies test request entry when the same test(s) are being ordered on subsequent samples. Example: If the first sample has Test X ordered, after the next sample ID is entered Test X will be ordered automatically.


Rerunning a Test Follow the step/action table below to repeat a test previously processed on the system.

Step Action

1 From the Main Menu, select Test Results F2.

2 On the Test Results screen, select the specific test to be rerun (option use Find F2 to locate specific test).

3 Select Rerun Test F3. The system displays a message.

4 Select OK F1 to complete the request and exit the window.

5 Place sample into a rack. Select Load a Rack F1. Select Done F1 and then Run.

Manually Add on Test(s) Follow the step/action table below to add on new test(s) to a sample previously processed on the system.

Step Action

1 From the Main Menu select Sample Manager F1. Select a rack button from the off board list, key in or scan in the rack ID number into the Rack ID field and press Enter.

2 Select Test Request F3 to display the Test Requests screen.

3 In the Sample ID field, enter the sample ID and press Enter. The previously entered information will populate the field.

4 To add on tests, select Show Test Menu F3. From the menu select desired test(s) to be run on the sample.

5 Place sample into a rack. Select Load a Rack F1. Select Done F1 and then Run.


Chapter 5

Data Management

______________________________________________________________________ Introduction The Access 2 creates and stores data for every test sample the system runs. Test samples include: patient samples, quality control samples and calibration sample sets as well as some maintenance samples. In this chapter you will learn how to search, review and print test sample data. It is important to review the results for calibration and QC before processing samples. Patient samples should be reviewed for any flags before releasing results. This chapter will cover the following:

Calibrator setup. Reviewing calibration status. Setting up quality controls. Reviewing QC charts and data. Reviewing patient results. Printing test result reports. Applying filters to define the displayed patient data.

The system can be setup to automatically print calibration and patient results. You can also print or reprint reports as needed. NOTE: Where you review and manage QC and patient test results will be determined by your laboratory policies and procedures. ______________________________________________________________________ Practice Configure a calibrator. Use the information presented in the following pages to navigate to the Calibration

Data screen to review and print a calibration report. Setup a quality control. Review Quality Control data and print a Quality Control report. Review patient results and print a report. Apply a filter to the Test Results screen.


Calibrator Setup Calibrator lot sets must be configured into the system to be available for selection when ordering an assay calibration. A calibration card is supplied with each calibrator sample set. Use the step/action table below to configure a calibrator lot into the system. A Total T4 calibration card is shown as an example below.

Step Action

1 From the Main menu, select Calibration F5 to display the Calibration screen.

2 Select Calibrator Setup F5, and then select Add Calibrator F1.

3 Use the handheld bar code reader to scan the bar code ID’s listed on the calibrator card.

NOTES

For quantitative multi-level calibrators, you must enter the bar code for each level in the Bar Code field. The system then displays the level information in the table.

For qualitative multi-level calibrators, the system populates the calibrator levels, stated concentrations and units automatically in the table.

Some calibrators are used to calibrate more than one assay. A separate calibration card is used for each assay.

If you scan an expired calibrator, the system displays a warning message. If you cannot scan the bar code ID on the calibration card, you can type

the characters printed underneath the bar code in the Bar Code field.

4 Verify the information you entered is correct and select OK F1.


Reviewing Calibration Data The system creates and stores calibration data for each calibration you run. Depending on the type of assay, the system generates an associated calibration curve or a cutoff. Use the following step/action table to review and print calibration reports.

Step Action

1 From the Main Menu, select Calibration F5.

2 On the Calibration screen (see image below) select a button for the assay reagent lot you want to review.

3 Select Review Data F2. The Calibration Data screen (see image on next page) will display the current active calibration curve for the assay you selected.

NOTE You have the option of viewing or printing the previous active calibration or the last run calibration by selecting Select Curve F1 and then Previous Active F2 or Last Run F3.

4 Select Print F7 to print the calibration report.

NOTE

It is recommended to have the calibration reports set to automatically print when complete. From the Main Menu select Configure F8. Select System Setup F1, select Reports Setup F7, and in the Auto

Print section select Calibration Report. Select OK F1 to save and exit.


Reviewing Calibration Data (continued)

NOTE: Not all fields are covered in the table below. See section 6.2 in the Access 2 Operator’s Guide for a complete listing of all Calibration Data screen fields and descriptions.

Field Display Descriptions Test Test name of the calibrated assay.

Reagent Lot

Assay reagent lot used to generate the calibration.

Calibrated or

Established Date and time the calibration was run or established.

Expiration Date and time the calibration expires. Units

or Cutoff

Units of measure that are configured for the calibrator sample type or the cutoff value defined for the calibrator sample type; in the APF.

Curve Which of the stored calibration curves is shown. Status Pass or Fail status of the calibration.

Reason Failure code for a failed calibration. Cal Lot Calibrator lot number used to generate the calibration data. Curve

or Acceptance

Limits

Curve generated from the calculated RLU means for the calibration or information about the upper and lower cutoff configured for this assay.

Data Table A list of the calibration samples run and the results specific to each test replicate.


Setting up Quality Controls The QC Setup Screen can be used to view all of the controls that have been setup on the system. This screen is also used to add, edit or delete a quality control. Follow the step/action table below to setup a quality control for use on the system. NOTE: See the Add a Control window on the next page for reference.

Step Action

1 From the Main Menu, select Quality Control F4 to display the Quality Control screen, then select QC Setup F4.

2 Select Add a Control F1. The Add Control window (shown on the next page) is displayed.

3 In the Control field enter a unique quality control name.

4 In the Lot Number field enter a unique quality control lot number.

5 In the Expiration field enter the expiration date of the quality control.

6 In the Sample Type field select a sample type from the drop down list.

7 In the Test Name field select a test name from the drop down list of tests enabled on the system.

8 In the Mean field enter the expected mean value you have calculated for the test.

9 In the SD field enter the expected SD you have calculated for the test.

10 In the Unit field the selected test reporting unit s are displayed.

11 In the Westgard QC Rules boxes select the rule(s) you want to apply to each of the test results.

12 Selecting OK F1 will save and exit the Add a Control window.

13 Clear Row F3 will clear entries made on the currently highlighted selection.

14 Cancel F8 will exit the Add a Control window without saving any changes or entries made.

15 Selecting Help F12 will open the Add a Quality Control procedure.


Setting up Quality Controls (continued) Add a Control window (example)


Reviewing Quality Control Data Quality controls (QC) are samples of known reactivity. You run quality controls along with patients to monitor your system performance. The system performs quality control calculations by comparing the results to the acceptable range of expected values you have entered into the system in the QC setup screen for each analyte you want to monitor. Westgard rules (see the table below) can be applied to the collected QC data to decrease subjectivity of data analysis and flag results when rules are broken. QC data is displayed graphically as Levey-Jennings charts and numerically in a data grid. Graphs and grid data can be viewed and printed separately or together. You may omit points from the calculations and add comments to points to explain why they were omitted or other information about a point you wish to document. To get to the Quality Control screen from the Main Menu, select Quality Control F4 or select the QC status button from any screen. The calculated QC values tracked by the system are:

The mean (average) test result value. The standard deviation (SD) from the mean. The percent coefficient of variation (%CV).

Westgard Rules

Rule Interpretation

1 - 2s The system marks a data point if it is more than 2 SD from the mean.

2 - 2s The system marks a data point if two consecutive points of a given quality control are more than 2 SD from the mean. The system only marks the second point.

1 - 3s The system marks a data point if it is more than 3 SD from the mean.

4 - 1s The system marks a data point if four consecutive points of a given quality control are more than 1 SD from the mean in the same direction. The system only marks the fourth point.

10x The system marks a point if ten consecutive points of a given control are on the same side of the mean. The system only marks the tenth point.


Reviewing Quality Control Data (continued)

NOTE: Not all fields are covered in the table below. See section 7.2 in the Access 2 Operator’s Guide for a complete description of all QC Chart and Data Screen fields.

Field Display Description Test Displays the test name.

Control Displays the quality control name. Control

Lot Displays the quality control lot number.

Expiration Displays the quality control lot expiration date. Reagent

Lot Displays the reagent pack lot number used for the QC run. The default value is All.

Mean Displays the calculated mean of the points within the date range selected.

SD Displays the calculated standard deviation of the points within the date range selected.

% CV Displays the calculated coefficient of variation of the points within the date range selected.

Levey-Jennings

Chart

Displays a graph of the plotted points from each control. Points for up to 31 days can be viewed at once.

Data Grid Displays a list of the QC results and information specific to a data point within the date range selected.

Filter F1 Select a filter to apply a limit to displayed data information. Delete

Point F5 Select to delete a data point from the system. This is a password protected feature.


Reviewing Patient Data The Access 2 system creates and stores data for every patient test the system runs. As the system completes patient sample processing, the test results become available for you to review, manage and print in the Test Results screen. Test result flags will be indicated on screen and on printed reports. The operator should evaluate all test result flags prior to releasing test results. For assistance in evaluating test result flags (see Chapter 8: Troubleshooting in this manual). Data filters can be used within the Test Results screen to limit the data displayed. Custom filters can be created to easily display specific data. Test Result screen (example)


Reviewing Patient Data (continued)

Function Key Description

Filter F1

Displays a list of available filters, sort order and ascending options. Filters can be selected, created, deleted and edited here.

Find F2

Use to search filtered results for a specific test result. Search by Sample ID, Rack ID, Patient ID or Test Name.

Rerun Test F3

Use to rerun the currently selected test(s).

Sample Details

F4

Select to view information about a specific sample. Information includes:

Patient ID and demographics. Sample ID. Sample Type. Dilution. Test Name. Reference Range. Result, Comments. Flags.

Send to LIS F5

Use to manually send selected results to LIS.

Copy to Disk F6

Use to copy selected test results to a disk or USB flash drive.

Print F7

Use to print selected test results as Completed Samples, Sample, Test and Patient reports.

More Options

F8

Use to change or reorganize the columns displayed on the Test Results Screen.


Test Result Reports You can manually print test result data in several report formats. Auto-printing of Stat and Continuous Sample reports can be setup to be done automatically. Follow the software steps in the table below to print the type of report you need.

Format Description

Continuous Sample Report

Prints test results on a landscape page, when there are enough results to fill a page or when the run is complete. Calibration and maintenance routine results are not included in this report. To setup the automatic print option: From the Main Menu select Configure F8. Select System Setup F1, then Reports Setup F7. Fill in the header information fields and select the Auto Print option. Select OK F1 to save and exit.

Sample Report

Prints test result information associated with a particular sample. To print a Sample Report: From the Main Menu select Test Results F2. Select the desired test sample(s) you want to print. Select Print F7, then Report F1. From the Report dropdown list select Sample Report, from the

Print What list. Select a radio button for Current Result, Current Selection or All

(filtered results). Select OK F1 and the report(s) will print.

STAT Report

Prints STAT Sample Reports automatically when processing is complete. To set up automatic STAT Sample Report printing: From the Main Menu select Configure F8. Select System Setup F1, then Reports Setup F7. Select the Sample Report for STAT Samples option. Select OK F1 to save and exit.


Test Result Reports (continued)

Format Description

Patient Report

Prints test result information associated with a particular patient, identified by the patient ID. To print a Patient Report: From the Main Menu select Test Results F2. Select the desired patient ID(s) you want to print a report(s) for. Select Print F7, then Report F1. From the Report dropdown list select Patient Report, from the Print

What list. Select a radio button for Current Result, Current Selection or All

(filtered results), and the report(s) will print. Select OK F1 and the report(s) will print.

Selected Test

Results Report

Prints all selected test results as displayed on the Test Result screen. To print a Selected Test Results Report: From the Main Menu select Test Results F2. Select the test results you want to print, then Print F7. Select Report F1 and from the dropdown list select Test Results

Report. Select OK F1, then select Current Selection radio button from the

Print What list. Select OK F1 and the report will print.


Applying a Test Results Filter Use this step action table to apply an available filter to the Test Results screen data.

Step Action

1 From the Main Menu select Test Results F2.

2 In the Test Results screen select Filter F1 and the Filter window (see diagram below) will open.

3 Select a Filter from the list showing the system-defined filters and any custom filters that have been created.

4

Select the radio buttons for the desired 1st and 2nd Sort Order. You may organize the sorts as Ascending by selecting the appropriate box, below the sort order or leaving the boxes unselected will organize the data in a descending order.

5 Select OK F1 and the filter will be applied to the test result data.

NOTE If you select a filter that has a date and time parameter you will be prompted to select a date and time range in the Specify a Date Range box, then select OK F1 to apply the filter.


Chapter 6

Weekly Maintenance

______________________________________________________________________ For optimal performance, the Access 2 system requires routine maintenance. Routine maintenance includes: Daily Maintenance (covered in Chapter 3: Daily Start Up), Weekly Maintenance, system verification and the Utility Assay. This chapter will cover the weekly maintenance procedures:

From Sample Manager screen: Help

Requesting Routine Maintenance Weekly Maintenance

Clean the Instrument Exterior Inspect Liquid Waste Bottle for Wear Check for Fluid in the Waste Filter Bottle Inspect and Clean the Primary Probe Exterior Replace the Aspirate Probes Clean the Aspirate Probes Run System Check

Review the system IFU or quick Reference Guide for Warnings, Cautions, Important, Notes, and Tip alerts as well as step-by-step instructions. ______________________________________________________________________ Practice Weekly Maintenance tasks. Verify your system performance by running System Check. Document your actions on the Maintenance Log.


Clean the Instrument Exterior It is important to minimize dust from getting into the interior of the Access 2 system. Dust and other particulate matter may contain elements that can interfere with testing over time. Use the following step/action table to clean the exterior of the instrument.

Step Action

1 Moisten a clean lint-free cloth with deionized water.

NOTE Deionized water is the recommended cleanser for the exterior surfaces of the instrument.

2 Wipe the exterior of the instrument with the moistened cloth.


Inspect the Liquid Waste Bottle for Wear Over time, the waste bottle can degrade, become brittle, and potentially crack. Any defect that is not removed by routine cleaning is a sign of deterioration. If you detect any issues with the liquid waste bottle, discard it and replace with a clean spare bottle. Discard the old bottle according to your laboratory’s biohazardous waste disposal procedure.

Signs of deterioration include (but are not limited to) discoloration, cracking, crazing (spider web like cracking) and bulging.

Inspect the color of the liquid waste bottle. Observe if the color has changed from opaque white (new bottles) to yellow, orange or pink (deteriorated bottles). If you observe a change in color, replace the bottle.

Inspect the area of the bottle that is nearest the handle and along all seams of the bottle for cracking or crazing (spider web cracking), which are signs of deterioration. If you observe cracking or crazing, replace the bottle.

Inspect the waste bottle for bulges. NOTE: If you detect any bulges, contact Technical Support to discuss the inspection findings and any further action.

Document completion of this task on the Maintenance Log.


Check for Fluid in the Waste Filter Bottle The waste filter should remain dry for efficient filtering of the waste air. Condensation on the inside surface may occur in humid environments. If condensation is noted on inspection, follow the step/action table below to change the bottle with a clean spare bottle. If bottle is dry, initial Maintenance Log and proceed to the next task. NOTES:

The entire waste filter assembly must be replaced if liquid is present. Once a year the entire waste filter bottle assembly should be replaced.

Step Action

1 Unscrew the waste filter bottle from the top of the waste bottle filter assembly.

WARNING The filter is a biohazard. It has sharp edges and is made of fiberglass. Do not touch any portion of the filter. Do not place hand into the bottle.

2 Immediately place the filter into a clean, dry spare bottle and screw on the top of the waste bottle filter assembly.

3 Decontaminate and dispose of the bottle contents according to your laboratory procedures.

4 Rinse the dirty bottle twice with tap water and allow the bottle to air dry for future use. Dirty bottles may also be autoclaved.



Insect and Clean the Primary Probe A bent, damaged or dirty primary probe can lead to level sensing errors. Visually inspect the primary probe weekly for any damage before cleaning the probe exterior. Use the following step action table to inspect and clean the primary probe.

Step Action


2 Open the front panel of the instrument.

3 Visually inspect the primary probe for damage.

NOTE If the primary probe is bent or damaged, call Technical Support for assistance.

4 Inspect the upper portion (see diagram below) of the primary probe for crystalline buildup. If any buildup is present carefully wipe the upper portion with an alcohol pad or lint free cloth dampened with alcohol.

CAUTION Do not wipe the tip of the probe. Fibers on or in the probe tip can clog the probe or pump valve.

5 Close the front panel of the instrument.



Replace Aspirate Probes Once a week the aspirate probes are removed from the wash arm and replaced with clean ones from the CARE Kit. Use the following step/action table to remove the dirty probes and place clean probes into the instrument.

Step Action


2 Turn the instrument off by pressing the lower portion of the black power switch on the lower right side of the instrument to the off position.

3 Open the front panel. The aspirate probes are at positions 2, 4 and 6 on the wash arm (see top figure on the next page).

NOTE The top cover may also be opened to allow for more light into the interior of the instrument.

4 Gently grasp a black aspirate probe retainer above the wash arm. Gently pushdown on the retainer, then rotate it 1/4 turn counterclockwise.

5 While holding the probe by the black probe retainer, lift up to remove the probe from the wash arm. Be careful not to bend the probe.

NOTE Handle probes with care. The probes are fragile and will not function correctly if bent.

6 At the barbed fitting, grasp and pull the aspirate probe tubing until it separates from the fitting (see bottom figure on the next page). Set the probe aside for cleaning.

7 Install a clean aspirate probe. Push the aspirate probe tubing onto the barbed fitting of a clean aspirate probe, being careful not to damage the barbed fitting or probe assembly.

NOTES

Confirm that the tubing is pushed all the way on to the barbed fitting collar.

Route the tubing under both the clear, rigid pipettor tubing and the wiring located to the left of the pipettor gantry.

8 From the top of the wash arm, carefully route the clean probe down through the opening in the wash arm. Rotate the black probe retainer until the two tabs engage the slots in the wash arm.

9

While holding the probe by the black probe retainer, gently push down on the retainer and then turn it 1/4 turn clockwise. Lift gently on the probe tubing to be sure the probe moves up and down and is securely locked into place on the wash arm.

10 Repeat steps 4 through 9 to install the other two clean aspirate probes.

11 Close the front panel and top cover of the instrument.

12 Turn the instrument on by pressing the upper part of the power switch to on.



Replace the Aspirate Probes (continued)


Clean the Aspirate Probes The aspirate probes are cleaned in three steps: Pre-clean, Clean and Rinse. Once the probes have been cleaned they can be stored in the CARE kit for the next weekly maintenance. Follow the step/action tables below for the three steps required to clean the aspirate probes for the next weekly maintenance probe replacement. Pre-cleaning the Aspirate Probes

Step Action

1 Fill a small beaker with approximately 20 mL of Contrad 70 cleaning solution.

2

Dip the aspirate probe brush in the undiluted Contrad 70 cleaning solution. Carefully insert the aspirate probe brush into the bottom end of the aspirate probe and push it in until the brush tip protrudes slightly from the other end of the probe.

NOTE Do not scrub the brush in and out, the interior of the probe may become scored by this action.

3 Remove the brush. Repeat steps 2 through 3 several times on the same probe, or until no orange residue is visible on the brush after removing it from the probe.

4 Repeat steps 2 and 3 for the other two aspirate probes using the same aspirate probe brush.

NOTES

Contrad 70 is caustic. Proper eye and hand protection is required.

Do not save a used brush for future use.

Dispose of the used brush in a biohazard sharps container.

If the probes cannot be cleaned within one hour of removal from the

system, place them in a container of distilled water.


Clean the Aspirate Probes (continued) Cleaning the Aspirate Probes with Contrad 70 Cleaning Solution

Step Action

1 Using the beaker of Contrad 70 from the pre-cleaning step, fill the syringe with Contrad 70

2 Attach the syringe fitting assembly on to the syringe (see diagram below). Push the plastic barbed fitting of the aspirate probe into the open end of the tubing on the syringe fitting assembly.

3 Empty the syringe, forcing the solution through the probe and back into the beaker.

4 Flush the probe again by drawing the Contrad 70 cleaning solution into the syringe through the aspirate probe and then emptying the syringe through the probe into the beaker.

5 Remove the probe from the syringe fitting assembly tubing and set aside.

6 Repeat steps 1 through 5 on the remaining two aspirate probes.


Clean the Aspirate Probes (continued) Rinsing the Aspirate Probes with Distilled Water

Step Action

1 Fill a beaker with approximately 50 mL of distilled water.

2 Draw distilled water from the beaker into the syringe.

3 Attach the probe tubing at the barb to the syringe fitting assembly.

4 Empty the syringe, forcing the distilled water into a sink or waste container.

5 Rinse the probe three more times by repeating steps 2 through 4.

6 Remove the aspirate probe tubing from the syringe fitting.

7 Carefully wipe the exterior of the probe with an alcohol pad.

8 Position the probe upright on absorbent lint free paper for about 10 minutes to allow for any residual fluid to drain.

9 Repeat steps 2 through 7 for the remaining two aspirate probes.

10 Store the cleaned aspirate probes in your CARE kit for the next weekly maintenance.


System Verification following Weekly Maintenance Following weekly maintenance it is required to verify your systems performance by running the System Check routine. For efficiency you may combine System Check with Daily or Special Clean and daily maintenance. The System Check routine challenges three major functional components (pipetting, RV washing, substrate-luminometer) of the Access 2 system. System Check routine may also be used for troubleshooting system hardware components by running all or selected tests. See the table below to learn more.

Function or Component Tested System Check Test

Reaction Vessel Wash System Wash Check Clean Check Wash Efficiency

Substrate and Substrate Dispense System

All

Main Pipettor module Unwashed Check

Luminometer All

Mixing System Washed Check

Aspirate Probes

Wash Check Clean Check Wash Efficiency Substrate Ratio

NOTE: For more detailed information about System Check see sections 3.5 and 5.11 of the Access 2 Reference Manual.


Run the System Check Routine Use the step/action table below to prepare and run the System Check routine. Once loaded the routine takes approximately 40 minutes to process.

Step Action

1 Select a 400 series rack for 2.0 mL cups.

2 From the Main Menu select Sample Manager F1 and enter the rack ID number.

3 In the Off Board rack select Maintenance Request F4.

4 Select the System Check box and select All from the list. Select OK F1.

5 Place empty 2.0 mL cups in positions 7, 8, 9 and 10.

6 In cup 7 pipette 2.0 mL of undiluted System Check Solution.

NOTE Sample cup 7 should be full, but not higher than the top of the cup.

7 In cup 8 pipette at least 1.0 mL of wash buffer.

8 Leave cup 9 empty.

9 In cup 10 pipette 1.0 mL of 1:501 diluted System Check Solution.

10 Select Load Rack F1. Wait for the Load Rack window.

11 Load the rack and select Done F1.

12 Select Run.

NOTE When performing weekly maintenance, you can select the Daily Clean System or Special Clean option to combine the routines. Fill the indicated cups with the appropriate cleaning solutions.


Reviewing and Printing System Check Data Use the step/action table below to review or print the completed System Check report for pass or fail of the individual tests. System Check test failures will be discussed in Chapter 8 Troubleshooting of this manual.

Step Action

1 From the Main Menu, select Maintenance Review F6.

2 Select System Checks F2. The most recent System Check will be indicated by the blue cursor on the System Checks screen.

3 Select System Check Data F2 to display the System Check Data screen.

4 Select the System Check result you want to view or print. The default selection displayed will be the most recent System Check run.

5 Select Print F7 to print the System Check report.

6 Review the report for Pass or Fail of System Check tests.

7 If all tests Pass, record the results of the System Check routine in the appropriate section of the Maintenance Log.

8

If any tests Fail, repeat the entire routine with all fresh solutions. Troubleshoot any repeat failures before using the system to process samples (see Troubleshooting System Check Failures in Chapter 8 of this manual).


Chapter 8

Troubleshooting

Introduction Troubleshooting is a three step process:

Identify the problem. Find the appropriate troubleshooting information. Follow the corrective actions to fix the problem.

It is recommended to keep a troubleshooting log for your instrument. The log may consist of printed Event Log pages, screen printouts, test result reports or notes from consultation with Field Service and Technical Support. A Troubleshooting Log form is provided in the appendix of the Access 2 Reference Manual (A-9). The following troubleshooting scenarios are covered in this chapter.

Resolving sample errors. Troubleshooting events. Troubleshooting System Check failures. Troubleshooting Calibration failures. Troubleshooting Quality Control failures. Test result flags.

Practice Use the information in the following pages to:

Review system events in the event log. Identify the difference of a Fatal versus a Non-Fatal flag. Review tools available for troubleshooting system check, calibration, and QC

failures. Check to confirm that the Utility assay is enabled on your Access 2 system.


Enabling the Utility Assay There is a Utility Assay that runs at the end of every batch of samples processed by the system. This Utility Assay is automatic and cannot be disabled. There is a second Utility Assay that will run every 4 hours when the system is idle, this Utility Assay can be enabled and disabled as needed. Follow the step/action below to confirm that your idle time Utility Assay is enabled.

Step Action


2 The Utility Assay is enabled if function key F6 reads Disable Utility Assay.

NOTES

It is recommended that this idle time Utility Assay be enabled for optimal performance of your system.

The Utility Assay uses three RVs, three RV Waste Bag spaces and three tests of substrate for every four hours the system is idle.

Run the Utility Assay You can run a Utility Assay manually when additional cleaning is required following an unexpected processing stop, when directed to by a Help procedure or as requested by Technical Support. Follow the step/action table below to run the Utility Assay manually.

Step Action

1 From the Main Menu select Maintenance Review F6.

2 Select Run Utility Assay F5, then select Yes F1.

3 The Utility Assay will launch and the system mode will change from Ready to Running.


Resolving Sample Errors View the On Board column of the Sample Manager screen to verify there are no red tube icons. Red tube icons indicate a sample tube read error. Sample tube read errors can include QNS (Quantity Not Sufficient), an unreadable bar code or a sample programming conflict.

Step Action

1 Resolve sample tube read errors by selecting the rack containing a red tube icon.

2 Select Test Request F3.

3 In the Test Requests screen look for errors in the Status field for the sample that is indicated by the red tube icon. The specific error will be shown in red font.

4 Select Get/Edit Rack F1. The rack will return to the loading position, allowing errors to be corrected while the rack is on board.

5 Make the necessary corrections. Once corrections have been made, select Done F1.

6 The rack will be rescanned by the system. Verify the red tube icon turns blue indicating the sample tube read error has been resolved.

7 Select Run to begin processing.


Troubleshooting Events The Event Log is a list of events the system generates as it monitors the status of system parameters and details of these events may be used to assist with troubleshooting.

Step Action

1 Select the YELLOW or RED Event Log status button.

NOTES

Events are presented chronologically, with the most recent event displayed at the top of the screen, this may not be the causative event.

Scroll back to the where the first Yellow or Red event appears in the Event Log.

A filter may be applied to limit the types of events shown.

2 Select the caution or warning event you want to get information for.

3 Select Troubleshoot F2, a troubleshooting Help topic is displayed.

NOTES

If multiple causes for the event are listed, the most common cause will be at the top of the list.

Start your troubleshooting with the most likely cause. If the most common cause does not resolve the problem, move to the

next most common cause.

4 Select the green Help link text to get to the detailed troubleshooting instructions.

5 If a printout is desired for your Troubleshooting Log, select Details F4 the Details window will be displayed.

6 Select Print F7 then select OK F1 to exit the window.

NOTE Help is not available for all events and may require you to contact Technical Support for assistance.


Troubleshooting System Check Failures System check may be used to troubleshoot hardware components. The tests may be run together as is done following weekly maintenance, run individually to troubleshoot specific components or to verify proper operation following some troubleshooting procedures. Each test has an expected range of values for the RLU mean and %CV that must be met to pass the test. This step/action table will guide you to the System Check Troubleshooting Tables for the specific type of test failure and the corrective action.

Step Action


2 Select System Checks F2.

3 Select System Check Data F2 to display the System Checks Data screen.

4 Select Help to display the System Check Data screen topics.

5 Select the green System Check Routine Expected Results link to open the System Check Routine Expected Results window.

6 Find the green link System Check Troubleshooting topic and select it. Help for specific types of System Check test failures will be shown.

7

There are four System Check Troubleshooting tables: Substrate Check Problems.

Unwashed Check Problems.

Washed Check Problems.

Wash Efficiency Problems.

Select the green link for the test that failed.


Troubleshooting System Check Failures (continued)

Step Action

8 Select the green Show me link next to the icon to open the table.

9 A table will open with two columns: Symptoms and Possible Causes with links to corrective actions.

10 Find the Symptom that most closely relates to the failure.

11 Possible Causes are listed from the most common at the top and move downwards to less common causes.

12 Follow the Corrective Action instructions to resolve the problem.

13 Run the System Check routine to confirm resolution of the problem.

14 If the problem is not resolved, follow the instructions for the next most common Possible Cause and rerun the System Check routine to check for resolution of the problem.

15 Continue following the above steps until the system passes all System Check tests and is verified for use.

NOTE Some Corrective Action items will direct you to Contact Technical Support.


Troubleshooting Calibration Failures When a calibration fails the Event Log status button turns yellow and a caution event message is generated. An active calibration curve is needed to calculate assay results. Troubleshooting help is available to resolve a failed calibration. Follow the step action tables below to get assistance troubleshooting a failed assay calibration in the Help system.

Step Action

1 Select the YELLOW Event Log status button.

2 Highlight the caution message for the failed assay calibration and select the Troubleshoot F2 function key.

3 The Calibration failed for assay XXX Help window will open.

4 Select the assay calibration troubleshooting instructions link, this will open the Assay Calibration Problems window.

5 Select Show me the Assay Calibration Troubleshooting Table.

NOTES

Two pieces of information are needed to troubleshoot a failed calibration: First is the Reason Code for the failure, located below the status field on

the calibration report. The second is the general perception of the calibration assay’s precision

as represented by the %CV’s. Use your lab protocol for determining if the precision is generally good or

generally poor. The Assay Protocol File (APF) contains all of the parameters used to

determine pass or fail of an assay calibration, this information is not available for review.

6 Match the failed assay calibration Reason Code and Precision to the descriptions in the Symptoms column of the table.

7 Read across to the Possible Causes to find the Corrective Action needed to resolve the failed assay calibration. The most common causes of failure will be listed first.

8 Select the green link for the failure and follow the Help instructions to correct the problem and run a new calibration.


Troubleshooting Quality Control Failures When a Quality control result violates a QC rule that has been setup in the system, the QC status button will turn red until the QC Data screen is reviewed. To get to the Quality Control screen from the Main Menu, select Quality Control F4 or select the QC status button from any screen. Quality Control results may fail for the following reasons:

Confirm that there were no Yellow or Red system events that occurred during the time the QC was processing, by reviewing the Event Log.

o If any system events are found, correct these prior to troubleshooting the failed QC result(s).

Confirm that Daily or Weekly Maintenance has been performed.

o If maintenance was not done or done incorrectly, correctly perform the

maintenance prior to troubleshooting the failed QC result(s).

If there are no Yellow or Red events in the Event Log and maintenance was performed correctly then troubleshoot the failed QC material.

o Confirm the correct QC material was poured. o Confirm the integrity of the QC material (expiration date, open bottle

stability, time at room temperature, reconstituted correctly, contamination). o Confirm correct QC material is placed in the correct rack position. o Confirm the correct QC lot number is in use and range is entered

correctly. o Confirm that the QC material has not been on the instrument too long and

has evaporated.

If no issues are found and or the repeated QC result(s) fails.

o Review assay calibration status (expiration date, correct calibrator storage, correct calibrator lot).

o Review reagent details (open expiration date, lot number, new shipment). o Confirm that substrate was properly equilibrated prior to loading on the

system. NOTE: More Quality Control troubleshooting help can be found in section 7.5 Establishing QC Ranges in the Access 2 Operator’s Guide and Table A-18 in the Access 2 Reference Manual.


Test Result Flags

If something occurs while a sample is running, the system associates a flag to the test result.

Use the Sample Details window to read the flag description associated with a result. Select Troubleshoot F2 to find troubleshooting information about the flag. There are two types of test result flags.

Fatal Flags - no calculated result is given.

Select the green flag and the flag description and corrective action will be displayed.

o Example: CLT an obstruction was detected.

Follow the corrective action instructions.

o Example: Review the Event Log and troubleshoot according to the error events with a similar date and time to this event.

Repeat the test.

If the problem persists call Technical Support.

CCR

Could not Calculate

Result

CLT

Obstruction Detected

IND

Indeterminate Result

NCR

No Calibrated Reagent

QNS

Quantity Not Sufficient

RLU

Relative Light Units out of

Range

SYS

Device Error Occurred

during Processing

TRI

Incubator Temperature

Out of Range

TRS

Substrate Temperature

Out of Range

TRW

Wash/Read Temperature

Out of Range

NOTE: The system may print the same flag twice on a sample report. Ignore the duplicate flag.


Test Result Flags (continued) Non-Fatal Flags – a result was calculated, but a condition exists for the result.

Some flags may require corrective action before a result can be reported.

o Example: EXS (substrate is expired) would require changing the substrate and repeating the test.

Other flags may be informational and require no corrective action.

o Example: RFX (reflex test result) is a valid result and no corrective action is

necessary.

If you have questions about the result, or if the problem persists, contact Technical Support.

CEX

Calibration Expired

CRH

Critical Range High

CRL

Critical Range Low

EXS

Expired Substrate

GRY

Gray Zone Result

LEX

Reagent Lot Expired

LRH

LIS Range High

LRL

LIS Range Low

LOW

Below Reportable Range

ORH

Above Reference Range High

ORL

Below Reference Range Low

OVR

Above Highest Calibrator Value

PEX

Reagent Pack Expired

QCF

Quality Control Failure

QEX

Quality Control Lot Expired

RFX

Reflex Test Result

NOTE: Additional information and corrective actions can be found in the Access 2 IFU in the Troubleshooting section and in Tables A - 20 and A - 21 of the Access 2 Reference Manual.


Chapter 9

Resources

Introduction This chapter identifies and describes resources available to assist you with the operation and maintenance of your Access 2 Immunoassay System. Beckman Coulter Support Personnel

Technical Support (Hotline): Your Access 2 System ID ____________________________ Provides 24 hour phone support. Contact at 1-800-854-3633 www.beckman.com/help Support Request Applications Specialist: Provides installation support. Your applications specialist is ___________________________

(Name) Field Service Engineer: Installs the system. Repairs and assists in maintaining your system. Your Field Service Engineer is __________________________

(Name)


References

Beckman Coulter Website: www.beckmancoulter.com: Sign up for “My Technical Documents” to receive updates on documents pertaining

to your analyzer and the assays you use. Access the “My Technical Documents” User Guide and Virtual Tutorial link s from the website: SUPPORT Technical Documents for instructions on how to sign up

Access 2 System IFU (Quick Reference Guide), Operators Guide and

Reference Manual can be found using the following pathway from the website:

SUPPORT Technical Documents make the following selections from the Search By Product drop-down lists:

Market Segment: Diagnostics Product Line: Immunoassay Product Series: Access Systems Product: Access 2 Document Category: Instrument IFU/Manual

Access 2 Assay Reagent and Calibrator Instructions for Use can be found using

the following pathway from the website:

SUPPORT Technical Documents make the following selections from the Search By Product drop-down lists:

Market Segment: Diagnostics Product Line: Immunoassay Product Series: Access Systems Product: Access 2 Document Category: Consumable IFU/CIS/Setting Sheet (to search for

documents for a specific test, use the Search By Reagents/Calibrators/Controls or Search By Item/REF/Document Number options)

Access 2 Safety Data Sheets (SDS/MSDS) can be found using the following

pathway from the website:

SUPPORT Technical Documents Safety Data Sheets (SDS/MSDS) tab enter Search By and Search For criteria


Access 2 Tools, Job Aids, and E-learning can be found using the following pathway from the website:

SUPPORT Training & Education Diagnostics Immunoassay Access 2: Tools & Aids

Job Aids (Sample Processing, Supplies) Access 2 Competency Checklist Tips for Working With Your Field Service Representative Access 2 In Lab Training Manual

On Demand

Access 2 Overview

Instructor Led Access 2 Basic Operations Class: Course description


Chapter 10

In-Lab Training Competency Exercise

The competency exercise should be completed by the end of the in-lab training session. All materials supplied with the Access 2 Immunoassay System or used during training may be used to complete this exercise. The exercise is a combination of performing learned skills and knowledge review.


Analyzer Overview 1. Match each hardware component listed below with its component function:

Hardware Component

Letter of matching Function

Component Function

Carousel Module

A Probe Washing, Wash

Buffer and Liquid Waste Processing

Main Pipettor

B Reaction Vessel Loading,

Incubation, Washing, Reading and Disposal

Analytical Module

C Process Sample Racks

and Reagent Pack Storage

Fluidics Module

D Sample / Reagent Pickup

and Delivery to Reaction Vessels

2. Use the following words: Wait / Run / Done / Tell / Do, to fill in the blanks on how

to communicate with the Access 2: ________ the Access 2 what you want to do by selecting a function button or key. __________ until the Access 2 says it is ready, a pop-up window will indicate that

the system is ready. ________ the task as directed.

Press _______ to let the Access 2 know you are finished. If appropriate, press

________ to initiate system action.


3. Circle T for true statements and F for false statements in the table below:

T or F Statement

T F The end product of the chemiluminescence reaction is heat.

T F Reagent Carousel is refrigerated for onboard reagent storage.

T F The primary probe uses ultrasonics for level sensing.

T F Sandwich assays have an indirectly proportional relationship between Relative Light Units and Concentration.

T F Substrate is the light generating reagent used on the Access 2.

T F Paramagnetic particles are coated with antibodies.

T F The luminometer is part of the fluidics module.

T F Access 2 assays use the enzyme-mediated chemiluminescence methodology.

T F You can only use the mouse to navigate the system software.


Software Overview 4. Use the Help onboard your Access 2 system to identify the name of each System

Status Button and the potential colors it may turn to alert the user of a condition requiring attention: N = neutral, Y = yellow, R = red.

Button Name Circle the Button Colors

N Y R

N Y R

N Y R

N Y R

N Y R

N Y R

N Y R

N Y R

N Y R

N Y R


5. Selecting the ________ system command button will cancel all work in progress and

put the system into the Not Ready mode.

a. Run

b. Stop

c. Pause

6. Which button do you select to display specific information about the screen you are

on or to navigate to lists of related topics? ________.

a. Help

b. Event Log

7. Selecting the ________ ________ system status button will display information

about samples for which the system cannot schedule tests.

a. Work Pending

b. Supplies Required

8. The screen specific function buttons correspond to the keyboard ________ keys.

a. Number

b. Function

c. Letter

9. Many screens have a ________ button to expand or reduce the amount of

information displayed.

a. Print

b. Filter

10. The ________ Help Link button can be selected to display a graphic illustration.

a. Camera

b. Magnifying Glass


Daily Start Up 11. Place a D in each box for all of the daily maintenance tasks in the table below:

Daily Maintenance Tasks

Clean Instrument Exterior

Check Zone Temperatures

Check System Supplies

Empty Liquid Waste Container

Replace/Clean Aspirate Probes

Check System Backup

Inspect Fluidic Module

Run System Check

Clean Probe Exteriors

Prime Substrate

Check Waste Filter Bottle

Run Daily Clean(Special Clean)

Inspect/Clean Primary Probe

12. Where should you go to view the system temperatures? Circle the correct answer.

Supplies F3

Diagnostics F7

Maintenance Review F6

Sample Manager F1


13. TRUE or FALSE? RVs, RV Waste Bag, Substrate and Reagent are supplies that must be loaded through the software to update and track the onboard levels correctly.

14. TRUE or FALSE? Daily or Special Clean routines must be run in a 400 series rack

in 2.0 mL cups. 15. A newly loaded bottle of substrate has ________ tests available and expires after

________ days onboard the system.

a. 500 / 20

b. 600 / 14

16. TRUE or FALSE? One Texwipe swab can be used to clean all of the probes on the

wash arm. 17. If you run the ________ assay you should process a Special Clean routine at the

end of the day or if the system will not process samples for 8 hours or more.

a. Vitamin D

b. Vitamin B12 18. TRUE or FALSE? The Reagent Inventory gives detailed pack information

regarding pack status such as pack expiration and calibration expiration. 19. How many tests are available in a new (un-punctured) pack? _________.

a. 50

b. 25

c. 75

20. TRUE or FALSE? If crystalline deposits are found when inspecting the fluidics

module you should contact Technical Support for assistance. 21. Perform a Daily Start Up on your Access 2 analyzer.


Sample Processing and Programming 22. Match the sample container size with the correct rack series that should be used to

process samples:

Sample Container Size Matching Letter Rack Series Bar Code

Numbers

0.5 mL cup

A

1500 to 1599

16 x 100 mm tube

B 400 to 499

1 mL insert in a

13 x 75 mm tube

C

1300 to 1399

13 x 100 mm tube

D 2500 to 2599

2.0 mL cup

E 700 to 799

13 x 75 mm tube

F 1400 to 1499

23. TRUE or FALSE? If you have samples that have bar codes and host programming in your laboratory information system, the tests will automatically be ordered when the sample bar code is read.

24. Use the sample pick up volumes given for each assay to calculate the minimum

sample volume required to process one level of quality control for CK-MB (55 uL), HCG5 (25 uL) and Ferritin (10 uL) using a 0.5 mL cup ________.

25. When you select Done F1 after loading a rack you must also select _________ to

start sample processing.

a. Stop

b. Pause

c. Run


Weekly Maintenance

26. Place a W in each box for all of the weekly maintenance tasks in the table below:

Weekly Maintenance Tasks




Inspect Liquid Waste Container


Check System Backup


Run System Check


Prime Substrate


Run Daily Clean(Special Clean)



27. TRUE or FALSE? The entire waste filter assembly must be replaced if liquid is present.

28. The system power must be ________ when replacing the aspirate probes.

a. On

b. Off

29. List the three steps involved in cleaning the aspirate probes:

__________________________

__________________________

__________________________

30. Following weekly maintenance you should run the ________ ________ routine to verify system performance.

a. System Check

b. Carry Over

31. TRUE or FALSE? The utility assay should be enabled on your system for optimal system performance.

32. Practice and review any additional tasks from the In-Lab Training Manual required of your role and responsibilities in your lab.

33. You have completed the competency check. Have your trainer compare the answers of your completed competency check with the Reference Key and review any questions you might have.

CONGRATULATIONS!


Congratulations

_________________________________________________

has successfully completed the In-Lab Training Course on the operation of the

Access 2 Immunoassay System

________________________________________

__________________

Beckman Coulter Representative Date


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In-Lab Training Competency Exercise Reference Key Analyzer Overview 1. Match each hardware component listed below with its component function:

Hardware Component

Letter of matching Function

Component Function

Carousel Module C

A Probe Washing, Wash

Buffer and Liquid Waste Processing

Main Pipettor D

B Reaction Vessel Loading,

Incubation, Washing, Reading and Disposal

Analytical Module B

C Process Sample Racks

and Reagent Pack Storage

Fluidics Module A

D Sample / Reagent Pickup

and Delivery to Reaction Vessels


2. Use the following words: Wait / Run / Done / Tell / Do, to fill in the blanks on how

to communicate with the Access 2: Tell the Access 2 what you want to do by selecting a function button or key. Wait until the Access 2 says it is ready, a pop-up window will indicate that the

system is ready.

Do the task as directed.

Press Done to let the Access 2 know you are finished. If appropriate, press Run to

initiate system action.

3. Circle T for true statements and F for false statements in the table below:

T or F Statement

T F The end product of the chemiluminescence reaction is heat.

T F Reagent Carousel is refrigerated for onboard reagent storage.

T F The primary probe uses ultrasonics for level sensing.

T F Sandwich assays have an indirectly proportional relationship between Relative Light Units and Concentration.

T F Substrate is the light generating reagent used on the Access 2.

T F Paramagnetic particles are coated with antibodies.

T F The luminometer is part of the fluidics module.

T F Access 2 assays use the enzyme-mediated chemiluminescence methodology.

T F You can only use the mouse to navigate the system software.


Software Overview 4. Identify the name of each System Status Button and the potential colors it may turn

to alert the user of a condition requiring attention: N = neutral, Y = yellow, R = red.

Button Name Circle the Button Colors

WASH BUFFER R

LIQUID WASTE R

SUBSTRATE Y R

REACTION VESSELS

Y R

RV WASTE BAG Y R

QUALITY CONTROL

R

EVENT LOG Y R

WORK PENDING Y

SUPPLIES REQUIRED

Y

HELP N


5. Selecting the ________ system command button will cancel all work in progress and

put the system into the Not Ready mode.

d. Run

e. Stop

f. Pause

6. Which button do you select to display specific information about the screen you are

on or to navigate to lists of related topics? ________.

c. Help

d. Event Log

7. Selecting the ________ ________ system status button will display information

about samples for which the system cannot schedule tests.

c. Work Pending

d. Supplies Required

8. The screen specific function buttons correspond to the keyboard ________ keys.

d. Number

e. Function

f. Letter

9. Many screens have a ________ button to expand or reduce the amount of

information displayed.

c. Print

d. Filter

10. The ________ Help Link button can be selected to display a graphic illustration.

c. Camera

d. Magnifying Glass


Daily Start Up 11. Place a D in each box for all of the daily maintenance tasks in the table below:

Daily Maintenance Tasks


D Check Zone Temperatures

D Check System Supplies

D Empty Liquid Waste Container


D Check System Backup

D Inspect Fluidic Module

Run System Check

D Clean Probe Exteriors

D Prime Substrate


D Run Daily Clean(Special Clean)


12. Where should you go to view the system temperatures? Circle the correct answer.

Supplies

Diagnostics

Maintenance Review

Sample Manager


13. TRUE or FALSE? RVs, RV Waste Bag, Substrate and Reagent are supplies that must be loaded through the software to update and track the onboard levels correctly.

14. TRUE or FALSE? Daily or Special Clean routines must be run in a 400 series rack in 2.0 mL cups. 15. A newly loaded bottle of substrate has 600 tests available and expires after 14 days onboard the system.

a. 500 / 20

b. 600 / 14 16. TRUE or FALSE? One Texwipe swab can be used to clean all of the probes on the wash arm. 17. If you run the VITAMIN B 12 assay you should process a Special Clean routine at the end of the day or if the system will not process samples for 8 hours or more.

a. Vitamin D

b. Vitamin B12 18. TRUE or FALSE? The Reagent Inventory gives detailed pack information

regarding pack status such as pack expiration and calibration expiration. 19. How many tests are available in a new (un-punctured) pack? 50

a. 50

b. 25 c. 75

20. TRUE or FALSE? If crystalline deposits are found when inspecting the fluidic

module you should contact Technical Support for assistance. 21. Perform a Daily Start Up on your Access 2 analyzer.


Sample Processing and Programming 22. Match the sample container size with the correct rack series that should be used to

process samples:

Sample Container Size Matching Letter Rack Series Bar Code Numbers

0.5 mL cup

D

A 1500 to 1599

16 x 100 mm tube

A

B 400 to 499

1 mL insert in a

13 x 75 mm tube

E C

1300 to 1399

13 x 100 mm tube

F

D 2500 to 2599

2.0 mL cup

B

E 700 to 799

13 x 75 mm tube

C

F 1400 to 1499

23. TRUE or FALSE? If you have samples that have bar codes and host programming in your laboratory information system, the tests will automatically be ordered when the sample bar code is read.

24. Use the sample pick up volumes given for each assay to calculate the minimum

sample volume required to process one level of quality control for CK-MB, HCG5 and Ferritin assays using a 0.5 mL cup 170 uL.

25. When you select Done F1 after loading a rack you must also select Run to start

sample processing.

a. Stop

b. Pause

c. Run


Weekly Maintenance 26. Place a W in each box for all of the weekly maintenance tasks in the table below:

Weekly Maintenance Tasks

W Clean Instrument Exterior



W Inspect Liquid Waste Container

W Replace/Clean Aspirate Probes

Check System Backup


W Run System Check


Prime Substrate

W Check Waste Filter Bottle

W Run Daily Clean(Special Clean)

W Inspect/Clean Primary Probe


27. TRUE or FALSE? The entire waste filter assembly must be replaced if liquid is present.

28. The system power must be OFF when replacing the aspirate probes.

a. On

b. Off

29. List the three steps involved in cleaning the aspirate probes:

PRE-CLEANING

CLEANING

RINSING

30. Following weekly maintenance you should run the SYSTEM CHECK routine to verify system performance.

a. System Check

b. Carry Over

31. TRUE or FALSE? The utility assay should be enabled on your system for optimal system performance.

32. Practice and review any additional tasks from the In-Lab Training Manual required of your role and responsibilities in your lab.

33. You have completed the competency check. Have your trainer compare the answers of your completed competency check with the Reference Key and review any questions you might have.