Access 2 in lab training manual

Tài liệu hướng dẫn vận hành access 2 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.

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)

 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

Carousel Module Main Pipettor Analytical Module Fluidics Module

System Hardware (continued)

 Internal Bar Code Reader

 Cup / Tube Detector

 Incubator Track and Belt

 Wash / Read Carousel

 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 Mode Status

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

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)

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

 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)

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:

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

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

screen-Main Menu Function Buttons

 The Access 2 system displays a row of eight function buttons across the bottom

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

allow for easy movement between screens

appears on the right side of a screen

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

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

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

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 Linkscan be selected to link to the topic named in the text

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

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

 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:

 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

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

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

1 Mix the contents of the new Wash Buffer Bottle by gently inverting the

sealed bottle three or four times

3 Lift the empty bottle from the fluids tray reservoir

and screw the dispense cap assembly on the new bottle

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

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

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

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

Equilibration prior to use

(unopened) (room temperature) 15-30°C 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

1 Confirm that the system is in the Ready mode

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

Prime Substrate (continued)

If sufficient volume is available in the onboard bottle, prime the substrate following the

step/action table below

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

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

4 Confirm that all RVs are firmly seated on the cartridge spine by pressing

down on the spine before you load the cartridge

on the next page)

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

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

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

it

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

biohazardous waste bag according to lab policy

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

The reagent pack

has been previously

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

2 Select Load Reagent Pack F1 If the system is running, it will pause to

allow for reagent pack loading

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

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

Load Reagent Packs (continued)