AU5400 In-Lab TRAINING MANUAL

AU5400 In-Lab Training Manual Page 1 of 193 Rev. A (Dec 2012) Beckman Coulter Professional Development

®

AU5400 In-Lab

TRAINING MANUAL

This manual is intended for use with the AU5400 Chemistry Analyzer



Document Disclaimers __________________________________________

Document Disclaimers

This document is not intended to replace the information in your Users Guides, Quick Response Guide or other product documentation. Information in the Users Guide, Quick Response Guide supersedes information in any other manual.

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 user 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 Manual (IFU), Users Guide and Quick Response Guide. Information in the Instructions for Use Manual supersedes information in any other manual.

Revision Status

Rev. A (Dec. 2012) First Presented Dec. 10, 2012, Beckman Coulter Training Center, Brea, Ca.

Trademarks AU5400® Chemistry Analyzer ____________________________________________



Table of Contents Introduction ..................................................................................................................... 7

Chapter 1 Instrument Overview ..................................................................................... 11

Chapter 2 Software Overview ....................................................................................... 21

Chapter 3 Reagents ...................................................................................................... 29

Chapter 4 Reagent Blank and Calibration ..................................................................... 37

Chapter 5 Quality Control .............................................................................................. 53

Chapter 6 Analyzer Daily Start Up ............................................................................... 66

Chapter 7 ISE Daily Start Up and Calibration ................................................................ 85

Chapter 8 Sample Processing ..................................................................................... 105

Chapter 9 Maintenance ............................................................................................... 113

Chapter 10 Troubleshooting ........................................................................................ 118

Chapter 11 Resources ................................................................................................ 127

Chapter 12 Appendix................................................................................................... 133

Chapter 13 Quiz .......................................................................................................... 161 Chapter 14 Practice …………………………………......................................................169



Introduction __________________________________________

Introduction

The In-Lab Training Manual is intended to be used by operators being trained by Field Applications Specialists on site or to be used by those operators that are being trained by another trained operator. A list of the Manual Chapters follows. The chapters should be followed in the order they are presented in this In-Lab Training Manual. ________________________________________

References

This AU5400 In-Lab Training Manual Version A, 080112, is based on material found in the following references: • AU5400 Users Guide Vol. 1 and Vol. 2 BM0562V1, Nov. 2009 • AU5400 Quick Response Guide, BM0562Q, Nov. 2009

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In-Lab Training Chapters Description

Instrument Overview

The Instrument Overview Chapter overviews: • Hardware components • Sample process • ISE test sequence

Software Overview

The Software Overview Chapter overviews: • Home Menu Screen • System Status Screen • Common Screen Elements

Reagents

The Reagents Chapter identifies: • Reagent information and status • Reagent check • Reagent load

Reagent Blank /Calibration

The Reagent Blank and Calibration Chapter identifies: • Calibrator set up • Calibration requisition • Calibration Data Review • Calibration Status

Quality Control

The Quality Control Chapter overviews: • QC definition • QC requisition • QC review

Analyzer Daily Start Up

The Analyzer Daily Start Up Chapter identifies: • Analyzer Daily Maintenance • Analyzer Daily Start up

ISE Daily Start Up and Calibration

The ISE Daily Start Up and Calibration Chapter identifies: • ISE Daily Maintenance • ISE Calibration • ISE Calibration review

Manual Contents


In-Lab Training Chapters Description

Sample Processing

The Sample Processing Chapter identifies: • Patient sample preparation • Patient racks and containers • Sample integrity • Barcoded sample process • Manual program process • Sample Data interpretation

Maintenance

The Maintenance Chapter overviews: • Maintenance requirements for Analyzer • Maintenance requirements for ISE

Troubleshooting

The Troubleshooting Chapter identifies: • Systematic approach to Troubleshooting • Error Messages and Corrective Actions • Sample Error Flags • Failed reagent blank, calibration, and QC report

information

Resources The Resources Chapter identifies: • Website information • Technical support contact • Table of resources • ISE Chapter diagram

Appendix The Appendix provides the following: • Daily Start Up Job Aid • Software Tree • End Process Job Aid • Job Aids

Practice

The Practice Chapter provides practice and apply knowledge of: • Instrument Daily Start Up • Software review • Hardware review • Reagent Blank and Calibration • Quality Control • Maintenance • Troubleshooting • Resources

Manual Contents



Chapter 1 Instrument Overview ___________________________________________

Introduction

The AU5400 is a fully automated chemistry analyzer designed for operational ease, speed, and flexibility. It uses liquid, barcoded reagents and Microsoft Windows ™ software. The system is available in two configurations, the AU5421, which has two units and the AU5431, which has three units. Additionally, the ISE unit and an Auto Repeat unit can be added. The ISE unit performs analysis for Na, K and Cl. The Auto Repeat unit is used to bring racks back to the analyzer units to perform repeat tests based on first results. The racks are returned to the units prior to returning the rack to the rack collection area of the rack feeder unit. Repeat criteria are defined by the operator. ___________________________________________

Reference

AU5400 Users Guide Volume 1 ___________________________________________


AU5400 Hardware Components

The AU5400 diagram on the following pages represents an AU5421 with ISE. Hardware components and their function are listed below each diagram in the component table. Each analyzer unit has the same components as listed in the table.

___________________________________________


AU5400 Hardware Aerial Line Diagram of a Two Unit System

Component Function

1 Rack Feeder Unit Holds racks waiting to process and feeds the racks through the AU5400 for sampling. Maximum racks are 30.

2 Sample Probes

Aspirate sample, in conjunction with the sample syringes, from the sample container and dispense the sample into a cuvette or the ISE sample pot. One sample probe delivers to cell 1 and cell 2 in the ISE unit. S1 of each unit delivers to the outer cuvette wheel of each unit. S2 of each unit delivers to the inner cuvette wheel of each unit.

3 Cuvette Wheels (Inner and Outer)

330 total (165 inner and 165 outer) glass cuvettes in each unit. This is where reactions occur and absorbance readings are taken

4 R1/R2 Refrigerated Compartments Two refrigerated compartments that house R1 or R2 reagents

5 R1 Reagent Probes Aspirate and dispense reagent, in conjunction with reagent syringes, into glass cuvettes located in the cuvette wheel. R1-1 delivers to outer wheel; R1-2 delivers to inner wheel

6 R2 Reagent Probes Aspirate and dispense reagent, in conjunction with reagent syringes, into glass cuvettes located in the cuvette wheel. R2-1 delivers to outer wheel; R2-2 delivers to inner wheel

7 Mix Bar Unit Contains multiple mix bars that mix the cuvette contents

8 Wash Nozzle Unit Contains multiple probes that clean, rinse and dry cuvettes before and after analysis

9 ISE Unit (Optional) Ion Specific Electrode (ISE) unit where sodium, potassium, and chloride are measured

10 Rack Collection Area Collects racks the system no longer needs so that an operator can remove them

Unit 1 Unit 2 ISE Rack Feeder Unit


AU5400 Hardware (Continued) Component Function

1 R2 Syringes Aspirate and dispense the specified volume of R2 reagent

2 R1 Syringes Aspirate and dispense the specified volume of R1 reagent

3 Sample Syringes Aspirate and dispense the specified sample volume

4 ISE Syringes

S = ISE Sample Syringe: Aspirates sample and delivers the sample to the ISE unit R = ISE Sample probe Wash syringe: Delivers DI H2O to the ISE sample probe Buffer Syringes/ Cell 1 and Cell 2; Not Pictured: Located in back of the ISE unit. Aspirates and dispenses ISE buffer

5 ISE Reagents The bulk reagents (ISE Buffer, ISE Reference and MID Standard) required for electrolyte analysis. Located in the back of the unit. One set of reagents per cell

6 Tank Storage This area houses the DI H2O tank, wash concentrate and dilute wash solution used throughout the system to wash probes, cuvettes and mix bars

7 System Buttons

• ON (green)-turns on the analyzer and the computer • EM STOP (orange)-emergency stop. Shuts-down the

analyzer, shut-down the computer using Ctrl+Alt+Delete• RESET (white)-used before the ON button following an

EM STOP or power failure


Process

The following steps occur once samples are loaded onto racks and loaded on the rack feeder unit:

• The operator selects Start on the software screen or on the keyboard to begin the testing process

• After the Start button is pressed, the sample rack is moved to the barcode reader where sample programming is determined

• The rack is moved to the sample aspiration point

• If ISE analysis is required for the sample, the ISE Sample probe working in conjunction with the ISE Sample syringe will aspirate sample for ISE analysis

• The sample then proceeds to the analyzer unit for analysis

• For analysis the R1 Reagent probe working in conjunction with the R1 syringe will aspirate R1 Reagent and deliver R1 reagent to a cuvette

• The R1 mix bar mixes the R1 reagent in a cuvette

• The photometer takes readings

• The sample probe working in conjunction with the sample syringe will aspirate sample and dispense in the cuvette in the cuvette wheel

• A sample bar mixes the sample plus R1 reagent and photometric readings are taken

• If there is an R2 reagent for the chemistry, the R2 probe working in conjunction with the R2 syringe dispenses R2 reagent to the cuvette containing R1 reagent and sample

• An R2 mix bar mixes the contents of the cuvette containing sample, R1 and R2

• Photometric readings are taken

• The cuvette is washed, rinsed and dried by the wash nozzle assembly using water/wash solution

• The sample rack moves to rack collection


Sample Process Overview

Step Action

1 A sample rack is placed in the rack feeder unit by the operator.

2 The operator presses Start.

3 The rack is moved to the barcode reader where sample programming is determined.

4 The rack is moved to the sample aspiration position.

5 An R1 reagent probe, working with the R1 reagent syringe, delivers R1 reagent into a cuvette.

6 An R1 mix bar mixes the reagent in the cuvette.


Step Action

7 The photometer starts taking readings.

8

A sample probe, working with a sample syringe, aspirates and dispenses sample into the cuvette in the cuvette wheel.

9 A sample mix bar mixes the sample and the reagent. The photometer continues to take readings.

10

If required, an R2 reagent probe, working with the R2 reagent syringe, delivers the R2 reagent into the cuvette.


Step Action

11 An R2 mix bar mixes the reaction mixture.

12 The photometer continues to take reaction readings.

13 The cuvette is washed, rinsed and dried by the wash nozzle probes using water/wash solution.

14 When the sample is no longer needed the rack is moved to the rack collection area.

Note: A priority sample may be processed using an emergency (red) rack at any time during routine sample processing. This allows the priority sample to be processed before samples in a routine (white) rack.


OD (Optical Density) Read Points Analysis 28 read points (P0-P27) for optical density are read by the

photometric system during a reaction. Each reaction takes the same amount of time to complete (approximately eight and a half minutes). The instrument uses the optical density readings to calculate the concentration of chemistry in a sample. Of the 28 read points, two read points are defined as the first and second read points used in the calculation. The read points are defined in the chemistry’s specific test parameters on the instrument. When reviewing Reagent Blank and Calibration data, the optical density read points will be displayed.

˜

˜ P0 P1 P2-P9 P10 P11 P12-P26 P27

R1 Dispense

R1 Mix Sample Dispense

Sample Mix

R2 Dispense

R2 Mix

• R1 Dispensing • R1 Mixing • P0 (first cuvette OD read point, R1

reagent only) • Sample Dispensing • Sample Mixing • P1 (OD read point sample + R1

reagent) • P2-P9 (OD read point intervals, 18

seconds) • P10 (last OD read of R1 + sample

before the addition of R2) • R2 Dispensing • R2 Mixing • P11 (first cuvette read point with R1 +

sample + R2) • P12-P26 • P27 (final read point)


ISE Test Sequence

Step Action

1 The mixture aspiration roller pump pulls reference solution from the bottle, past the reference electrode where measurements are taken, and then out to waste.

2 ISE buffer is delivered to the sample pot by the ISE buffer syringe.

3 Sample is aspirated by the sample probe and dispensed into the sample pot where the sample and buffer are mixed.

4

The mixture aspiration roller pump draws the sample/buffer mixture through the flow cell where measurements are taken. Excess fluid in the pot is pulled through the bypass tubing by the mixture aspiration roller pump and sent to waste.

5 After a urine sample is processed, the ISE syringe sends ISE buffer to the sample pot. The ISE buffer is pulled through the flow cell by the mixture aspiration rolling pump to rinse the flow cell after each sample.

6

After each sample is processed, the mid standard roller pumps pulls mid standard from the bottle and delivers it to the pot. The mixture aspiration roller pump draws the mid standard solution through the flow cell where measurements are taken. Excess fluid in the pot is pulled through the bypass tubing by the mixture aspiration roller pump and sent to waste.


Chapter 2 Software Overview _________________________________________

Introduction

AU5400 operating functions are performed from the AU5400 Operating software. An overview of the common menu components follows. Successful operation of the system requires software navigation. __________________________________________

References AU5400 Users Guide Volume 1 ∟ Chapter B

Quick Response Guide

__________________________________________


Navigation

The AU5400 system provides three software navigation methods that can be used to select an item on a screen or in a window:

• Touch a part of the screen using the tip of your finger or a touch device

• Use the mouse to point the cursor and click the left mouse button to select an item

• Press a key board equivalent key

Keyboard keys and their function :

• Start Key: Starts analysis • Stop/Standby Key: Stops analysis. The system moves

from stop to standby or standby to stop • Pause: Continues analyzing the current samples under

analysis, and then pauses. When pause is released by pressing start, analysis starts from the place it left off

• Feeder Stop: Stops the rack feed operation • Print Screen: Prints the screen content currently displayed • Alarm Clear: Clears the alarm sound when selected once,

clears the alarm when selected twice • Alarm Help: Displays the alarm help window • Menu Help: Displays the menu help window • End Process: Performs an end process, which turns off

power to the system excluding reagent refrigerator, incubator, or ISE

• Cursor Keys: - Arrow: Moves the cursor in the arrow directions - Delete: Deletes the character - Backspace: Deletes the character immediately before the

cursor • Num Lock: Allows use of numbers on the ten-key pad • ESC: Cancels input • System Status: Use to enter the [System Status] menu

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AU5400 Home Menu

Icon Description

Mode Display

Indicates the system’s operational status (Mode). Status includes Initial, Warm-up, Standby, Measure 1, Measure 2 and Stop.

• Measure 1: Normal mode the analyzer goes into from Standby. Racks are present on the rack feeder belt with samples being aspirated

• Measure 2: Normal mode the analyzer goes into from Measure1. No more racks are detected on the rack supply belt. System will go Standby from Measure 2 following completion of samples and cuvette cleaning.

Analysis

Start When selected starts analysis

Pause When selected pauses analysis

Feeder Stop When selected stops the rack feeder

Stop / Standby

When selected stops analysis. All tests in progress will be lost. When the system is stopped, select this button again to return the system to standby mode.

Icon Bar


AU5400 Home Menu (continued)

Icon Description System

Status Displays status information. See details on the next page

Alarm Help Accesses alarm help for the current message displayed

Operation Help Accesses online operational help when in Standby

System Date/Time Displays the current system date and time


System Status Screen

System Status

• Select to view status information and perform selected maintenance procedures

• Yellow flag ( ) indicates a non-fatal error is present • Red flag ( ) indicates a fatal error is present

Screen Element Function

(0) Reagent Status Perform reagent management tasks such as: determine reagent volumes, on-board stability, calibration stability, etc.

(1) ISE Status Request ISE calibration and view ISE calibration results. Perform ISE maintenance such as priming and cleaning procedures.

(2) Analyzer Status View status of components and bulk fluids

(3) Cuvette Status View/print results of photocal

(4) Data Display View results of completed samples

(5) Alarm List View history of alarms and display alarm help

(6) DPR Status View status of printer, resume printing following an error, view status of samples on the system


Common Screen Elements

Menu Bar: Provides access to the six main menus. When a menu is selected a pull-down menu displays a set of submenus.

Menu Function

(R) Routine Sub-menus set the start conditions and requisition tests. Also used to monitor reactions, calibrations, cuvette status, quality control, and manage data and reports

(P) Parameters Set analysis parameters. Includes common and specific test parameters, repeat parameters, calibration and QC parameters

(A) Auxiliary Perform statistics, correlations, gather reagent consumption data, manage parameters, perform calibration verification, and shift the analyzer to standby from warm-up

(M) Maintenance Perform maintenance, set the date and time, save data to floppy disc, manage consumables, and perform diagnostics

(U) Users Use to create a user --defined list of submenus (16 maximum) for frequently accessed areas of the software

(L) Logout Use to logout of the system when a password is in use

Menu Bar


Common Screen Elements (Continued)

Element Function

Pull- down menu List of submenus available for each Menu Bar option

Sub-menu Available if there are additional screens for the menu option(Additional screens indicated by presence of ►)

Alarm Message Displays the most recent alarm message or operation mode changes

Alarm Clear Button Silences an alarm when selected once, clears the alarm when selected a second time

Submenu

Pull Down Menu

Alarm Message Alarm Clear Button


Common Screen Elements (Continued) Tabs, Guidance Messages, and Function Buttons are available from the sub-menus. Below is an example of the location of these elements on a screen.

When sub-menus are selected, Tabs, Guidance Messages, and Function Buttons are displayed.

Element Function

Tabs Provides access to an additional screen layer

Guidance Message Identifies what can be entered at a prompt

Function Buttons Allows the operator to perform a screen specific function and corresponds to F1-F8 on the keyboard

Tabs

Guidance Message

Function Buttons


Chapter 3 Reagents

______________________________________ Introduction References

To perform analysis for each chemistry the instrument requires a reagent to be loaded on the system. Reagent overview:

• R1 reagent bottles are loaded in the R1 reagent refrigerator (48 positions )

• R2 reagent bottles are loaded in the R2 reagent refrigerator (48 positions)

• Each reagent box contains both the R1 and R2 reagent bottles for the chemistry and must be loaded as a set on the system (some reagents only have an R1 reagent)

• The reagent barcode contains the reagent name, type of reagent R1 or R2, lot number, serial number, and expiration date of the bottle

• Reagents without barcodes are fixed to a position with the operator providing the reagent information to the system

• Reagent preparation instructions for reagents requiring preparation is found at: www.beckmancoulter.com

∟Support ∟Technical Documents ∟ Reagent Instruction For Use sheet (Consumable IFU)

• Reagents are available in different bottle sizes • 15mL, 30mL, and 60 mL bottles use one position on the

reagent carousel • Larger bottles, 120mL, 180mL, and 300mL require

additional positions

1 Position 2 Positions 3 Positions 5 Positions 15mL 30mL 60mL

120mL 180mL 300mL

____________________________________________________ AU5400 Users Guide Volume 1 ∟ Chapter C Basic Operations

________________________________________________


Reagent Status

Reagent information is found in the Reagent Status screen.

First select the System Status Icon ,

Then select Reagent Status to view reagent information. The Reagent Status menu is used to: • Perform a reagent volume check • Assign or fix non-barcoded reagents to positions • Verify the remaining number of tests in the bottles

__________________________________________________ Reagent Check

A Reagent check identifies what reagents are required to be loaded on each unit. Reagents are loaded in Standby or Warm-up mode. When Check Start F5 is selected, the Reagent Check can be performed.


Reagent Check Options

Once the Check Start F5 is selected, the Reagent Check window displays. Reagent Check window

Options For Reagent Check

Unit

Reagent Status Check Options • Reset Only: Resets the status from Unchecked to Checked.

Volume check or reagent ID read is not performed. • Check specified position: Read the reagent ID and perform a

volume check on one or more specific R1 and /or R2 positions. R1 and R2 of a set must both be selected.

• Check specified position (with ID): Read the reagent ID and perform a volume check on specified positions.

• Check changed position (with ID): Read all positions for reagent ID. Perform a volume check on any new or moved reagents.

• Check all positions: Read the reagent ID and perform a volume check on all reagents

Selecting [Start] begins the reagent check for the option selected



Reagent Check Review

Reagent Check information is reviewed by Unit No. and Type. Unit No. is selected by using the arrows Type is selected by using the pull-down

Reagent refrigerator diagrams for R1 and R2: • Display the 48 reagent positions on each wheel • Inside Circle color:

- Blue: bottle present with no errors - Yellow: bottle present with errors - Gray :no bottle or positions included as part of a

120mL,180mL, or 300mL bottle position • Frame color:

- White: reagent ID, the barcode reader will read a Reagent ID in this position

- Blue: fixed , the barcode reader will not read a Reagent ID in this position

(continued on next page)

Examples of: Inside colors Frame

colors


Sample Probe Det-1, Det-2, Dilution Position Reagent Setting: • Selecting [Reagent Setting] F4 following a reagent check will list

reagents not set or loaded on the instrument.

Test Display: • Selecting [Test Display F7] following a reagent check displays

the following information per unit and type: - Volume (mL) of the remaining quantity of reagent - Reagent Shots (Number of tests) - On board stability of the reagent bottle remaining - Reagent Blank and Calibration stability remaining - Lot No. of the reagent bottle - Bottle No of the reagent bottle - Bottle size of the reagent bottle - Sequence number of the reagent bottle(1-5 bottles per

chemistry can be loaded) - Priority of use of sequenced bottles:

1. Lot number (lowest) 2. On-board stability 3. Volume (lowest) 4. Position (lowest) 5. Comment display of errors related to reagents


Reagent Load

Following a reagent check , review the test display and load : • Reagents that are unset • Load reagents with a low shot volume



Chapter 4 Reagent Blank and Calibration

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Introduction

Reagent Blanks and Calibrations must be performed on chemistries prior to processing.

All chemistries require a reagent blank to be performed prior to analyzing QC or patient samples. All chemistries except enzymes require a calibration to be performed prior to analyzing QC or patient samples. A Reagent Blank is part of a calibration. Each chemistry has a methodology sheet containing the specific test parameters and calibration information for each chemistry. Frequency of reagent blank, calibration, and on board stability varies per chemistry. This information is found in the User’s Guide Volume 2 and on the Beckman Coulter website. www.beckmancoulter.com. ___________________________________________________

References AU5400 Users Guide Volume 1

∟Chapter C Basic Operations Quick Response Guide ∟Preparing for Analysis ________________________________________


Calibrator Set Up

Prior to processing a calibration the calibrators must be defined or set up on the system Calibrators for each chemistry are set up or defined in the system parameter Menu. First a calibrator is set up on the system. The software pathway [Parameter], [Calibration] [Calibrator] provides access to the Calibration screen. Second, the specific parameter for each chemistry the calibrator is used to calibrate is set up on the system. The following software pathway provides access to the Calibration Specific screen, where calibrators for chemistries are set up. [Parameter], [Calibration],[Calibration Specific]


Calibration Requisition and Processing

Once calibrators are set up on the system, reagent blank and calibrations can be requested. Reagent blank and calibration requisitions are performed automatically when the calibration is expired, or for new bottles/lot numbers of reagent. By selecting from the main menu, [Routine], [Test Requisition], [Calibration] the requisitioned reagent blanks and calibrations can be viewed. When viewing the calibration requisition screen: • Blue background highlight of the chemistry identifies the

reagent blank has been requisitioned. • Yellow highlight of the chemistry identifies the calibration

has been requisitioned.

Manual requisitions of Reagent Blank and Calibrations can also be performed by using the Start Entry function button to request Reagent Blanks and Calibrations


View Calibrators Required

Following the requisition of reagent blank and calibration, the calibrators required for requisitioned calibrations can be viewed by selecting from the Main Menu, [Routine],[Rack Requisition],[Calibration],[Cal F6] Calibrators required for the requested chemistry calibrations are listed in black. Calibrators that are assigned to a rack but not needed for the requested calibrations are listed in red. • Details of the calibrators can be viewed from Detail Inf.


Reagent Blank and Calibration Racks

A reagent blank is performed using a blue reagent blank rack.

A calibration is performed using a yellow calibration rack for the calibrators

Reagent and Calibration Racks: • Instrument identifies the rack as a blue or yellow rack by the magnets on the

bottom of the rack. • RB, Cal, and QC racks can be configured to process simultaneously for each

unit. To perform calibrations load the following racks:

• Blue Reagent Blank rack • Yellow Calibration racks beginning with the lowest number of calibrator rack

followed with sequential rack numbers

• Use any validated container for calibrators

• Calibrators may be barcoded or assigned to a specific rack and position

• Calibrator racks are designated per sample type

• DI Water is the sample for the reagent blank

• DI Water is placed in a validated sample contain in :

- Position 1 for Serum - Position 4 for Other - Position 10 for Urine


Calibration and Reagent Blank Requisition

Step Action

1 From the main screen select (R) Routine, (T) Test Requisition, (C) Calibration

2 Use the Type pull-down menu to select the sample type

3 Verify the * is selected at “Unit No.” to show requirements for all units

4

Verify auto requisitions. Test names highlighted in blue have been auto requisitioned for reagent blank. Test names highlighted in yellow have been auto requisitioned for calibration

5

Select F4 Start Entry to request other tests for calibration or reagent blank Note: Reagent Blank and Calibration stability =1, should be requested. Expiration occurs in less than 24 hours.

6 Repeat steps 2-6 for each sample type (urine, other).

7 Prepare a Reagent Blank rack with DI water in positions 1 for serum, 4 for other and 10 for urine for reagent blanks.

8

Select F6 Cal to view a picture of the racks and calibrators required. Black text represents calibrators requisitioned. Red text represents calibrator not required. • Select “Detail Inf” to view the calibrator names and

assigned positions.

9 Prepare the tubes for the calibration in the racks identified in Step 10.

10 Select Close to exit the detailed list 11 Select Close again to exit the rack picture view 12 Select F2 Exit to return to the Home Menu

13

Place the prepared racks on the rack feeder in this order: • Reagent Blank (blue) • Calibrator rack(s) (yellow), with the lowest number, with

additional yellow racks in sequential order

14 Select Start 15 Review message box and select yes to process




Calibration Data Review Calibration Display Screen

Calibration data can be reviewed from the: 1. Data Display screen 2. Calibration curve screen 3. Calibration trace screen

Reagent Blank data can be reviewed from the:

1. Data Display screen 2. RB monitor screen

The Data Display screen can be viewed by selecting the

System Status Icon then Data Display


Calibration Status

The calibration status for chemistries can be viewed from the Calibration Trace screen. Selecting [Routine], [Calibration Monitor], [Calibration Trace] will open up the Calibration Trace window showing the status of each chemistry calibration. Pathway to the Calibration Trace Screen


Calibration Trace

The Calibration Trace screen identifies the following; Type of sample Unit Color identifies the calibration status: -Neutral=calibration passed -Yellow = calibration failed -Orange=calibration expired Calibration Trace Screen

.


Reagent Blank Monitor

The details of the reagent blank can be viewed from the Reagent Blank Monitor by selecting:[Routine], [Reagent Blank Monitor] then select the chemistry to view. The Reagent Blank Monitor screen identifies: Chemistry Type of sample Date of RB (Reagent Blank) Details of the RB (Reagent Blank) Optical Density read points for the current reagent blank and previous reagent blanks performed Reagent Blank Monitor Comparing the Reagent Blank Monitors from one reagent blank to previous can be helpful during troubleshooting.


Calibration Trace

The details of the calibration can be viewed from the calibration trace screen by selecting:[Routine],[Calibration Monitor],[Calibration Trace], then select the chemistry to view. The Calibration Trace Monitor screen identifies: Chemistry Type of sample Date of Calibration Details of Calibration Optical Density read points for the current calibration and previous calibrations performed Example of a Calibration Trace . Comparing the Calibration Trace from one calibration to previous calibrations can be helpful during troubleshooting.


Reagent Blank Report

The Reagent Blank report is viewed from the Data Display screen or on the Instrument printout. The terms listed below that have a color highlight have been identified with the same color in the Data report.

• The Reagent Blank is the test performed with water as the sample • The prefix R represents Reagent Blank • R001 indicates this is the first reagent blank run for the data index.

The next time the reagent blank is run in the data index would be designated as R002.

• Unit and cuvette wheel used • Rack No. are the first 4 digits and Position in the rack of the

DI water used for Reagent Blank is the last 2 digits. • The bottle (sequence) number can be from 1-5 (1-5 bottles on board

for each chemistry). • Sample Type is the sample type tested when the reagent is used • -1 is the 1st read point. The number of replicates performed for the

reagent blank is the same number of replicates defined for the calibrator. The system uses the average Optical Density(OD) of the replicates to determine acceptability. The read points are

chemistry specific. • -2 is the 2nd read point. The system uses the average OD of the

replicates to determine acceptability. The read points are chemistry specific

• The system prints all of the read 1 values then prints all of the read 2 values for that blank

• The system will print a Failed RB comment when a test fails reagent Blank

Data Log Report Example Reagent Blank

R001 Unit -1 (Inner) 0001-01 SEQ. 1 Serum AST-1 1.6298 TBIL-1 -0.0002 TBILB-1 -0.0007 AST-2 1.6272 TBIL-2 -0.0003 TBILIB-2 -0.0007

R001 Unit-1 (Outer) 0001-01 SEQ. 1 Serum CO2-1 1.6681 CRE-1 0.0106 MG-1 1.1223 CO2-2 1.6613 CRE-2 0.0109 MG-2 1.1162

R001 Unit -2 (Inner) 0001-10 SEQ Urine COC-1 1.6298 COC-2 1.6613 R001 Unit-2 (Outer) 0001-10 SEQ. 1 Urine CRE-1 0.0100 CRE-2 0.0107


Calibration Report

The Calibration report is viewed from the Data Display screen or on the instrument printout. The terms listed below that have a color highlight have been identified with the same color in the Data report seen below.

• The prefix A represents calibration • A001 indicates this is the first calibration run for the data

index. The next time the calibration is run in the data index would be A002.

• Unit and cuvette wheel used • Rack No. is the first 4 digits and Position in the rack of

the calibrator is the last 2 digits. • Cal No. is the position number and bottle (sequence)

number: sequence can be from 1-5 (1-5 bottles on board for each chemistry).

• Sample Type • Calibrator • The system uses from 1-4 replicates for calibrators. The

replicate number is determined by the Users. The system uses the average OD of the replicates to determine acceptability. These are chemistry specific.

• -1 is the 1st replicate. -2 is the 2nd replicate.. • System uses the average of the optical density (OD) read

points in the calibration calculation • Will print a failed Calibration comment when a test fails a

calibration • Prints flags xx

Data Log Report Example Calibration


A001 Unit -1 (Inner) 0001-01 CAL .NO. 1-1 S.ID Serum CAL.NAME CAL 1 TBIL-1 0.0653 TBIL-2 0.0652 xxx A001 Unit -1 (Outer) 0001-01 CAL. NO 1-1 S.ID Serum CAL. NAME CAL1 CRE-1 0.0083 CRE-2 0.0084 A001 Unit -1 (Outer) 0001-02 CAL. NO 2-1 S. ID Serum CAL. NAME CAL 2 MG-1 0.3200 MG-2 0.3198 A001 Unit -1 (Outer) 0001-02 CAL. NO 2-1 S. ID Serum CAL. NAME CAL 2CRE-1 0.0730 CRE-2 0.0728 A001 Unit -1 (Outer) 0001-3 CAL.NO. 3-1 S.ID Serum CAL.NAME CO2 20 CO2-1 0.1070 CO2-2 0.1062 A001 Unit -1 (Outer) 0001-3 CAL.NO. 4-1 S.ID Serum CAL.NAME CO2 40CO2-1 0.2112 CO2-2 0.2135 A001 Unit -2 (Outer) 0003-01 CAL.NO. 21-1 S.ID Urine CAL.NAME Urine Cal CRE-1 0.5095 CRE-2 0.5155 A001 Unit -2 (Inr) 0003-03 CAL.NO.23- S.ID Urine CAL.NAME DAU 3 COC-1 0.1197 COC-2 0.1175


Chapter 5 Quality Control _____________________________________________

Introduction

Quality control verifies the Reagent Blank and Calibration are valid. Quality Control should be processed on the AU5400:

• a minimum of two levels once a day • after calibration • with each new lot number of reagent • after maintenance • after troubleshooting • in accordance with regulatory requirements • in accordance with each laboratory ‘s standard procedure

_________________________________________________ Reference

AU5400 Users Guide Volume 1 ∟Preparing for Analysis ∟Obtaining Results Quick Response Guide ∟Preparing for Analysis ∟Obtaining Results

____________________________________________


Quality Control Definition

Quality Control for each chemistry is set up from the system Parameters Menu. The software path, [Parameter], [Quality Control], [QC Common] is used to define a QC. The following information is defined:

• Control No. • Control Name • Control ID • Expiration Date • Lot #

The software path, [Parameter], [Quality Control], [QC Specific] [Preset Tab] is used to define the QC for each chemistry. The following information is defined:

• Sample type • Mean • Standard Deviation • Range • Multi or Single rules for QC evaluation

Pathway for QC Set Up


Quality Control Requisition

Quality Control is requisitioned and processed on the system by either auto requisition or manual requisition. Auto requisition:

• Following a reagent check, QC is automatically requisitioned for all chemistries and sample types

Manual requisition: • Chemistries can be manually requisitioned to run QC by

selecting, [Routine],[Test Requisition],[QC], F4[Start Entry]

• Multiple bottles of chemistry can be selected to run QC by choosing Individual Requisition, when requisitioning QC. All bottles or individual bottles can be selected

• QC is requested per sample type( serum, urine, other ) • QC can be requested per unit and cuvette wheel


QC Requisition Screen

.

Details of the QC requisition screen

Sample type display pull-down Cuvette and Unit for QC request Individual requisition button Blue highlighted box indicates QC is requisitioned Grey box indicates QC not defined for sample type Start Entry F4 function button is used to manual requisition QC QC F6 function button when selected shows the QC material required for the requested chemistries

Individual Requisition


View QC Racks from QC F6 The QC screen shows the racks and QC material required for the requisitioned chemistries for either auto requisitioned or manual requisitioned QC Details of the QC screen: Data index Round Detail Inf (D) QC sample type and number Rack ID


QC Racks QC is performed using Green racks

• Use any validated container for QC material • QC material is barcoded or assigned to a rack and position • Racks may be configured to process simultaneously for each unit • Instrument identifies the rack as a QC rack by the magnets on the bottom of

the rack • QC racks are defined per sample type


Manual Requisition QC

The following step action table can be used to manually request Quality Control for specific chemistries.

Step Action

1 From the main screen select (R) Routine, (T) Test Requisition, (C) QC

2 Use the Type pull-down menu to select the sample type Serum

3 Verify the * is selected at “Unit No.” to show requirements for all units.

4

Verify auto requisitions. Test names highlighted in blue have been auto requisitioned. Optional: Perform manual request of QC:

• Select F4 Start Entry • Select tests or Deselect Tests F8 • Select Individual Requisition to request QC

for sequential bottles of chemistry. • Select F4 Entry

5 Repeat steps 2-5 for other sample types if needed. 6 Verify the tests to QC are highlighted in blue.

7

Select F6 Cal to view a picture of the racks and Quality Control required. Black text represents Quality Control required. Red text represents Quality Control defined but not required. • Select “Detail Inf” to view the Quality Control

names and assigned positions.

8

Prepare the tubes for Quality Control in the racks identified in Step 7. Always load the required QC racks in numerical order beginning with the lowest number first.

9 Select Close to exit the detailed list 10 Select Close again to exit the rack picture view 11 Select F2 Exit to return to the Main menu



Quality Control Review

Quality Control data can be reviewed at the: • Data display screen • QC monitor screen • QC report print outs.

Data Display Screen can be accessed by selecting [Home Menu], [Analyzer Status], [Data Display] The data processed on the system is displayed.


QC Monitor

The QC Monitor Screen is used to review QC data. Access the QC monitor screen by selecting, [Home Menu], [Routine], [QC Monitor], [Daily Control] [QC Monitor], then select the chemistries to review. Pathway to QC Monitor


The QC Monitor Screen components listed are used during QC evaluation Index Unit Sample Type Test Name Cuvette wheel used QC number

QC Monitor Screen


QC Data Report

QC data can be viewed at the data display or on the printed data report. The QC data report on the next page displays the following information:

• The prefix Q represents Quality Control • Q001 indicates this is the first quality control run for the data

index. The next time the quality control is run in the data index would be Q002

• Unit and cuvette wheel used • Rack No. are the first 4 digits and Position in the rack of the QC

are the last 2 digits • QC No. is the position number and the bottle (sequence) number:

1-5 bottles per chemistry can be sequenced on the system. • Sample Type • QC • There are separate result entries for electrolytes. The system

identifies which cell , 1 or 2 of the dual ISE 1flow cell the results are generated from and QC level

Chemistry Cell used QC number NA/ 1- 1 NA/ 2- 1

• Name of chemistry • Following the name of the chemistry -1, -2 represents the of QC

number ,-1 first level, -2 level of QC • Flag(s) data error flags appear next to the result when there is a

QC failure


Example of QC Data Report

Q001 Unit-1(Inner) 0001-01 QC NO 1- S.ID Serum QC NAME QC Level 1 NA/1-1 116.80 K/1-1 2.87 Cl/1-1 85.80 Q001 Unit-1(Outer) 0001-01 QC NO. 1- S.ID Na/2-1 116.80 K/2-1 2.87 Cl/2-1 85.80 Serum QC NAME QC Level 1 Q001 Unit-1(Inner) 0001-02 QC NO. 2- S.ID Na/1-2 132.20 K/1-2 4.15 Cl/1-2 100.00 Serum QC NAME QC Level 3 Q001 Unit-1(Outer) 0001-02 QC NO. 2- S.ID Serum QC NAME QC Level 3 Na/2-2 133.80 K/2-1 4.21 Cl/2-1 101.30

Q001 Unit-1(Inner) 0003-01 QC NO 21- S.ID Urine QC NAME QC Level 1 NA/1-1 82 K/1-1 31.0 Cl/1-1 85.80 Q001 Unit-1(Outer) 0003-01 QC NO. 21- S.ID Na/2-1 83 K/2-1 31.3 Cl/2-1 85.80 Urine QC NAME QC Level 1 Q001 Unit-1(Inner) 0003-02 QC NO.2 2- S.ID Na/1-2 175 K/1-2 81.8 Cl/1-2 180 Urine QC NAME QC Level 3 Q001 Unit-1(Outer) 0003-02 QC NO 2 2- S.ID Urine QC NAME QC Level 3 Na/2-2 173 K/2-1 81.3 Cl/2-1 176

Q001 Unit-2(Outer) 0001-01 QC NO 1-1 S.ID Serum QC NAME QC Level 1 CRE-1 0.58 Q001 Unit-1(Outer) 0001-01 QC NO. 1-1 S.ID Serum QC NAME QC Level 1 MG-1 0.58 CO2-1 14.83 1 Q001 Unit-1(Inner) 0001-01 QC NO. 1-1 S.ID Serum QC NAME QC Level 1 TBIL-1 0.89 Q001 Unit-2(Outer) 0001-02 QC NO. 2 -1 S.ID Serum QC NAME QC Level 3 CRE-2 3.0 Q001 Unit-1(Outer) 0001-02 QC NO. 2 -1 S.ID Serum QC NAME QC Level 3 MG-2 4.72 CO2-2 16.15 QC001 Unit-1(Inner) 0001-02 QC NO. 2-1 S.ID Serum QC NAME QC Level 3 TBIL-2 4.58


Chapter 6 Analyzer Daily Start Up __________________________________________________

Introduction

To prepare the AU5400 for daily operation and for optimum system performance, a daily start up is required. A daily start up consists of the following procedures: • Set a new data index • Perform analyzer daily maintenance • Perform ISE daily start up • Check reagents • Perform Reagent Blank, Calibration and QC

_________________________________________________ Reference

AU5400 Users Guide Volume 2 ∟Chapter F Maintenance Quick Response Guide ∟Preparing For Analysis

__________________________________________________


Set a new Data Index

A data index is a data file identified by the date and time. Create a new index daily, each shift or as needed. From the Main Menu, selecting, [Routine], [Start Conditions], the start conditions are displayed and the data index can be changed. The following information can be changed on the start condition screen:

• Data Index: Select to change to create a new index • Round: Select to change group of on-board test to perform • Operator name: Select to change the name of the operator • Start Sample No.: Changes Displays the next number to be

processed on the analyzer for each sample type and kind. When a new index is created, the Sample No. begins at the default sample number typically 0001.

Set a New Data Index Step Action Table

Step Action 1 Select Routine 2 Select Start Condition 3 Select F4 Set 4 At “Data Index” select option 1: Current Time from the pull-

down menu 5 At “Round No.” select option for your lab from the pull-down

menu 6 At “Operator Name”, type your designated name 7 Select F2 Exit 8 Select Yes at the Message window (if it appears) 9 Select F2 Exit


Set a New Data Index

At “Data Index” select Option 1: Current Time from the pull-down menu

At “Round No.” select the option for your lab from the pull-down menu

At “Operator Name” type your designated name

Select Routine

Select Start Condition

Select F4 Set

Select F2 Exit

Select Yes at the message window if it appears

Select F2 Exit


Perform Analyzer Daily Maintenance

Record maintenance on the Maintenance Log schedule located at the beginning of the maintenance chapter, in the User Guide Vol 2, Chapter F. All maintenance procedures are found in the: AU5400 Users Guide Volume 2 ∟Chapter F Maintenance

The Daily Maintenance procedures for the analyzer are: - Inspect the Sample and Reagent Syringes - Inspect the Concentrated Wash Solution Level - Inspect the Stability of the Upper Cover - Inspect & Clean the Sample Probes, Reagent Probes, & Mix Bars - Inspect the Printer and Paper - Prepare for a Sample Probe Wash - Change the DI Water in the Pre-dilutions Bottle


Inspect Sample and Reagent Syringes

Step Action

1 Open the left front cover.

2

Check for syringe leaks, using a dry cloth: • Bottom of the syringe case • Syringe case inside and out • Case head • Area around the fixing screw and tubing

3 Verify tubing attached to the syringes is not crimped.

4

Check the two fixing screws on the case head. If necessary tighten them by turning the bottom screw counterclockwise and the top screw clockwise.

5

Verify that the bottom screw is placed securely against the piston. Check that the piston is not tilted outward or inward as it is seated on the screw.

(continued on the next page)


6 Perform the following steps if condensation or leaks are found, otherwise proceed to step 8. - Loosen the top and bottom fixing screws and pull the

syringe and case forward. - Pull the piston down (not out of the syringe) to verify

a smooth resistant pull. -

Turn the syringe case by hand and check the following: If: Then: Case head and syringe case are loose

Tighten them with by turning the syringe case clockwise toward the case head.

Case head has cracks

Replace the case head

O-ring between the syringe and case head is missing or appears damaged

Place one new O-ring between the syringe and case head.

The Reagent syringe does not have the correct size syringe (reagent syringe)

Replace with a reagent syringe.

The Sample syringe does not have the correct size syringe (sample syringe )

Replace with a sample syringe.

7 Replace the syringe if the previous steps did not correct the leaking. Refer to the As Needed Maintenance procedure, Replace Sample, ISE and Reagent Syringes found in Volume 2 of the Users Guide, Chapter 7.5.

8 Close the covers.


Open the back cover and right front of the ISE unit

Inspect the Sample and Reagent Syringes

Check and tighten if needed the two fixing screws on the case head. Tighten the top screw

clockwise and the bottom counterclockwise(Check that the piston of the syringe is not tilted outward or inward as it is seated on the screw)

Close the covers

Touch the following areas to check for leaks, using a dry cloth:Bottom of syringeSyringe case inside and outCase headArea around the fixing screw and tubing

Leaks or Condensation

No Yes

Loosen the top and bottom fixing screws and pull the syringe and case

forwardVerify the syringe tubing is not crimped

Pull the piston down (not out of the syringe) to verify a smooth resistant

pull

Yes

Yes

Yes

Yes

Yes

Perform the following checks:

Case head and syringe are looseTighten by turning the syringe case clockwise toward the case head

Case head crackedReplace the case head

The O-Ring between the syringe and case head is damaged or not present

Place a new O-Ring between the syringe case

and head

Reagent syringe does not have the correct syringe(reagent)

Replace with a reagent syringe

Sample syringe does not have the correct syringe(sample)

Replace with a sample syringe

LeaksReplace the syringe

(As-Needed Maintenance , Replace the Sample , ISE, and Reagent Syringes

Users Guide Vol. 2 Chapter 7.5) Yes

No


Inspect the Concentrated Wash Solution Level

Inspect the Concentrated Wash Solution level of the detergent tank B. If there is room to add Wash Solution, refill the tank with Wash Solution. During normal operation if the Wash solution becomes low, an alarm would be generated and the system would shift to a Pause Mode. In Pause mode additional samples would not begin testing. Note: Do not allow your hands and clothing to come into contact with the Wash Solution. Refer to the MSDS sheet for cautions and warnings.

Step Action

1 Locate the wash detergent tank B by opening the right front covers

2 Visually inspect the volume of the wash solution in the tank

3 Remove the side cap of the tank. This cap does not have the level sensor attach

4 Pour wash solution into the detergent tank, using care to avoid spills. Wipe up any spills. Note: If your lab has a siphon pump, refer to the procedure in the Users Guide Volume 2, section 2.2.1 for use in refilling the wash solution using the siphon pump.

5 Replace the side cap of the tank securely

6 Push the tank back into position

7 Close the front covers




Inspect & Clean the Sample Probes, Reagent Probes, & Mix Bars

Inspect and clean the sample probes, reagent probes, and mix bars. Internally, when the instrument is requested to prime the washing line:• the mix bars are washed and rinsed • the wash nozzle unit performs a sequence • the sample and reagent probes dispense straight stream of DI

water Externally, the operators: • inspect each probe and mix bar for stains or crystallization • clean the probes and mix bars with alcohol if crystallization or

stains are present. • Replace any visibly scratched or bent probe • Replace any mix bar with chips in the Teflon coating or if bent

. Refer to the As Needed Maintenance procedure in the Users Guide Volume 2 to replace

Step Action 1 Verify instrument status is Warm-up or Standby

2 Open the upper cover of each unit

3 Select, [Maintenance], [ANL Maintenance], unit defaults

to All

4 Select, A/Prime Washing-line

5 Press the Diag. switch button on Unit 1

6 Visually verify the stream of DI water from the sample and reagent probes are straight

7 Repeat steps 5-6 for each unit

8 Visually inspect and clean any sample or reagent probe or mix bar, if stains or crystallization is present

9 Visually inspect and replace any sample or reagent probe, or mix bars if bent, or there is a chip in the mix bar

10 Close all covers


Open the upper cover of each unit

Verify the instrument status is Standby or Warm-up

Inspect and Clean the Sample Probes, Reagent Probes and

Mix Bars

Visualy Inspect and clean any sample probe,reagent probe, or mix bars if stains or crystallization is present

Select, [Maintenance],[ANL Maintenance](unit defaults to all)

Additional UnitsYes

No

Verify a straight stream of water is dispensed from the sample and reagent probes

Select A/Prime Washing Line

Press the Diag button on a Unit

Visualy Inspect and replace any sample probe,reagent probe, or mix bar if bent or a chip in the mix bar

Close all covers


Inspect the Printer and Paper

The printer receives results from the instrument. If the printer does not have paper and/or is not powered on and offline, an error can occur resulting in the data not being printed. Check for adequate paper in the printer and verify the printer is powered on, and online. View the status of the printer in Analyzer Status. The printer should appear in blue.

Step Action

1 Verify the printer is powered on and the online light is on.

2 Check that the paper is loaded correctly and there is a sufficient amount of paper in the printer tray.

3

Select [System Status], [Analyzer Status], to view the printer status. Printer should appear in blue. • If the printer is off line during Measure mode select,

[System Status], [DPR Status],F4Printer Control, then select the resume button



Prepare for a Sample Probe Wash

Located next to each sample probe are two 60mL bottles of 2% Wash Solution. The sample probes automatically go into the wash solution when the analyzer shifts from Standby to Measure 1 and from Measure 2 to Standby. In Reagent Status, the inner circle of Det. 1 or 2 will be yellow if the wash solution bottles are empty. 2% Wash Solution is prepared by diluting Concentrated Wash Solution with DI Water. (2mL Concentrated Wash Solution to 98mL of DI Water).

Step Action

1 Locate the two 60mL Wash solution bottles, in the Wash Positions (Det.1 and Det.2) next to each sample probe

2

Remove each bottle from the instrument and refill each bottle with 2% wash solution up to the top edge of the bottle. Avoid filling the cap opening with solution

3 Replace bottles in the Wash Positions


Remove each bottle

Locate the two 60mL Wash Solution bottlesin Wash Positions Det.1 and Det. 2

Prepare Sample Probe Wash

Refill each bottle to the edge of the bottle with*

2% Wash Solution

* 2% Wash Solution is prepared by diluting Concentrated Wash Solution 2mL Wash solution + 98 mL DI Water

Replace the Wash Solution bottles in Wash

Positions Det.1 and Det.2


Change the DI Water in the Pre-dilutions Bottle

The Pre-dilution bottle, located near the Reagent Probe 1, is used to make sample dilutions when the auto dilution feature is set up for repeats. It is also used for dilute urine samples requiring pre-dilution. Each day the operator fills the DI water bottle with fresh DI Water.

Step Action 1. Remove the Pre-dilution bottle from the instrument

2. Empty the contents of the bottle

3. Rinse the bottle with DI Water twice

4. Fill the bottle with fresh DI Water

5. Place the bottle back on the instrument, making sure the

bottle is seated properly



Perform ISE Daily Start up

Refer to the ISE Daily Start Up Chapter of this manual to perform the ISE daily maintenance and calibration procedures.

Perform Reagent Blank, Calibration and Quality Control

Refer to the Reagent Blank, Calibration and Quality Control Chapter of this manual to perform the Reagent Blank, Calibration and Quality Control.

Review

Review the Reagent Blank, Calibration, and Quality Control reports to verify all reagents are calibrated and in control prior to beginning sample processing.


Chapter 7 ISE Daily Start Up _____________________________________________________

Introduction

The AU5400 ISE requires a daily start up. The daily start up includes daily maintenance, calibration and QC.

____________________________________________________

Overview The dual ISE consists of 2 flow cells. The cells are labeled on the ISE unit. The system automatically alternates between cell 1 and cell 2 for calibration, cleaning, and processing samples. Data displays and prints as Na/1, Na/2, K/1, K/2, Cl/1, and Cl/2. (/1 is cell 1, /2 is cell 2). ISE start-up procedures are required to be performed every 24 hours. The Daily Start up includes: • Check ISE Reagent stability/volume. Replace and prime loaded

reagents • Inspect the ISE Syringes for leaks • ISE cleaning (short) • Check ISE sample probe dispense • Check ISE sample probe detergent • Clean the Mix Bar, Liquid Level Sensors, Sample Pot and

Sample Pot Tubing • Calibrate the ISE • Process QC

____________________________________________________ Reference

AU5400 Users Guide Volume 2 ∟Chapter F Maintenance ∟ ISE Maintenance ∟Daily and As-Needed ISE Maintenance

____________________________________________________


Reagent Check and Replacement

The following step/action table can be used to perform the Inspect/Replenish ISE reagent daily maintenance task.

Inspect/Replenish ISE Reagent

Step Action

1 Verify the system is in Standby or Warm-up 2 Open the back cover of the ISE unit

3

Inspect the ISE Reference, Mid Standard , and Buffer Reagents for cell 1 and cell 2: • Adequate volume (replace if volume is low) • Stability date (90 day stability)

4

Unscrew the cap of the ISE reagent bottle to be replaced and lift out of the bottle the aspiration tube. Do not remove the roller tubing from the mid-standard pump when replacing reagent.

5

Place the aspiration tube into the new bottle on the system. Discard the old reagent. Do not combine new and old reagent.

6 Tighten the cap on the new reagent bottle

7

Push the reagent bottle to the back of the reagent shelf making sure the reagent bottle is not tilted forward. Note: If the reagent bottle is positioned forward, the liquid-level sensor will not detect the reagent level. An alarm message may display indicating insufficient reagent.

8 Select [System Status],[ISE status]

9 Select function key [F6] to prime

10

If: Then select: Buffer reagent replaced Buffer Prime Mid and/or Reference replaced MID/REF

Prime

11 Press the Diag. Switch 12 Close the ISE front cover



ISE Daily Maintenance

Following reagent inspection and or replacement, the ISE Maintenance tasks are performed. The ISE Daily Maintenance Procedures are:

• Inspect the ISE Syringes for Leaks • ISE Cleaning (Short) • Check the ISE Sample Probe Dispense • Check the ISE Sample Probe Detergent • Clean the Mix Bar, Liquid Level Sensors, Sample Pot and

Sample Pot Tubing

For complete maintenance procedures refer to: AU5400 Users Guide Volume 2 ∟Chapter F Maintenance ∟ ISE Maintenance ∟ Daily ISE Maintenance The ISE Daily Maintenance procedures have been duplicated on the following pages for ease of use.


Inspect the ISE Syringes for Leaks

The ISE syringes dispense a very small amount of buffer to each sample pot. The buffer is used to make the ISE sample dilution. If buffer leaks from the syringes (1 buffer syringe per cell), incorrect amounts of buffer will be dispensed. The following step action table can be used when performing the maintenance task of checking the ISE syringes for leaks.

Inspect the ISE Syringe for Leaks

Step Action

1 Open the back cover and right front of the ISE unit

2

Touch the following areas, using a dry cloth to check for syringe leaks: • Bottom of the syringe case • Syringe case inside and out • Case head • Area around the fixing screw and tubing

3 Verify the tubing attached to the syringes is not crimped.

4

Check the two fixing screws on the case head are tight. If necessary tighten them by turning the bottom screw counterclockwise and the top screw clockwise


(Inspect the ISE syringe for leaks continued)

5

Verify that the bottom screw is placed securely against the piston. Check that the piston is not tilted outward or inward as it is seated on the screw

6

Perform the following steps if condensation or leaks are found, otherwise proceed to step 7. a Loosen the top and bottom fixing screws and pull the

syringe and case forward b Pull the piston down (not out of the syringe) to verify a

smooth resistant pull

c Turn the syringe case by hand to check the following: If: Then: Case head and syringe case are loose

Tighten by turning the syringe case clockwise toward the case head

Case head has cracks

Replace the case head

O-ring between the syringe and case head is not present or damaged

Place one new O-ring between the syringe and case head

The Buffer syringe does not have the correct size syringe (reagent syringe)


The Sample syringe does not have the correct size syringe (sample syringe )


7

Replace the syringe if the previous steps did not correct the leaking. Refer to the As Needed Maintenance procedure, Replace Sample, ISE and Reagent Syringes found in Volume 2 of the Users Guide, Chapter 7.5

8 Close the covers



Inspect the ISE Syringes for leaks


clockwise and the bottom counterclockwise (check that the piston of the syringe is not tilted outward or inward as it is seated on the screw)

Close the covers



No Yes




pull

Yes

Yes

Yes

Yes

Yes






and head

Buffer syringe does not have the correct syringe(reagent)







No


ISE Cleaning (Short)

The daily cleaning cleans the sample pot and electrode tubing. If the cleaning cycle is not performed, contamination or inaccurate results may occur. The following step action table can be used when performing the maintenance task of checking the ISE cleaning short procedure.

Step Action

1 Verify the system is in Standby or Warm-up

2 Fill an ISE calibration cup with approximately 1mL of ISE cleaning solution. (enough for 2 ISE cells)

3 Place the sample cup in the “CLEAN” position on the standard solution area

4 Select [System Status], [ISE Status],F5[ ISE Unit Start]

5 Select [E] Cleaning

6 Select Yes

7

When the cleaning is complete, discard the cup with the cleaning solution. The ISE status will go from Busy in red to ready in blue

8 Select, F2 Exit, F2 Exit



Check the ISE Sample Probe Dispense

This procedure verifies that a straight stream of water is dispensed from the sample probe. If no water is seen dispensed, this could indicate water is not getting to the sample probe. If the stream is not straight, this could indicate there is an obstruction or the probe may be bent. Correct Not Correct The following step action table can be used when performing the maintenance task of checking the ISE sample probe for dispense.

Step Action 1 Verify the system is in Standby or Warm-up.

2 Select [System Status], [ISE Status], F6 Prime

3 Select G/Replace Probe and Syringe

4

Press the DIAG button on the ISE unit • Watch while the DI water is dispensed from the

probe • Verify water is dispensed in a thin straight stream

and that the wash well is filling • Select Close



Check the ISE Sample Probe Detergent

There are two 60mLbottles next to the ISE sample probe. These are used to clean the ISE sample probe. To ensure there is an adequate supply of 2% wash solution in the bottles, operators fill the bottles during ISE daily start up. The following step action table can be used when performing the maintenance task of checking the ISE sample probe detergent.

Step Action 1 Verify the system is in Standby or Warm-up

2 Fill the two 60mL bottles by the ISE sample probe with

2% wash solution Note: The 2% wash solution is made from 100% Concentrated Wash Solution and DI Water.

3 Select, [System Status], [ISE Status], select the S-Detergent Tab

4 Select F5 Check Start

5 Select Yes

6 Select F2 Exit, F2 Exit



Clean the Mix, Bar, Liquid Level Sensors, Sample Pot and Sample Pot Tubing

Protein is removed from the mix bar, liquid level sensors, sample pot tubing, sample pot, bypass and pinch valve tubing during this procedure. The following step action table can be used when performing the maintenance task of cleaning the Mix Bar, Liquid Level Sensors, Sample Pot and Sample Pot Tubing.


2 Select [System Status], [ISE Status], F6 Prime

3 Select A/Replace Electrode

4

Press the DIAG button on the ISE unit to drain the flow cell Note: Only press the DIAG button once. If the DIAG button is pressed again, the flow cell will be primed.

5 Open the Analyzer cover and ISE unit cover

6

Perform the following: • Unplug the mix units from cell 1 and cell 2, loosen

the black knob and lift up to remove the mix unit. • Clean the mix bar and liquid level sensors with an

alcohol pad. Use a downward stroke when cleaning

• Remove the sample pots on each cell by loosening the retaining knob on the top of the sample pot and lifting the pot from the peg

• Remove the sample pot tubing from the inlet of the flow cell

• Remove the Cell 1 pinch valve tubing from the pinch valve (tubing #5)

• Remove the Cell 2 pinch valve tubing from the pinch valve (tubing #7)

• Disconnect the pinch valve tubing at the Y connector near the Mixture Aspiration pump

7

To clean the sample pot, fill each sample pot and tubing with 1% wash solution Note: A squeeze bottle with a pipette tip located on the tip of the bottle can be used to insert the 1% wash solution into the tubing Use caution to avoid contact with face/eyes.

(continued on the next page)


(continued)

8 Sonicate the sample pots for 10 minutes in a container of 1% wash solution placed in a DI Water bath of a sonicator

9 Following sonication, remove the sample pots and attached tubing from the sonicator

10 Rinse the sample pots and tubing with DI Water, forcing DI Water through the tubing and sample pot bottom

11 Verify the lines are flushed thoroughly with DI Water

12 Dry the sample pots

13

Re-install the sample pots, tubing and mix units: • Attach the small sample pot tubing onto the inlet of the

flow cell • Align the hole on the top of the Sample Pot with the

peg and place the screw in the slit on the opposite side

• Tighten the screw • Attach the pinch valve tubing to the Y connector at the

Mixture Aspiration Pump. - Cell 1 tubing goes to the Mixture Aspiration

Pump labeled 1 and 2. - Cell 2 tubing goes to the Mixture Aspiration

Pump labeled 3 and 4. • Insert the pinch valve tubing into the top slot of the

pinch valve • Place the correct Mix Unit on the two positioning pins. • Secure the Mix Unit by tightening the knob. • Connect the Mix Motor connectors and Liquid Level

Sensor connectors. Note; Do not force the connectors into the plugs. Each connector has pins the fit into the plug. If pins are damaged the Mix Bar will not turn and the level sensors will not function.

14

Perform E/MID/REF Prime, then D/Buffer Prime. Initiate prime each time by pressing the DIAG switch. Note: Verify the J Nozzles have straight streams of Buffer and Mid Standard and there are no bubbles in the flow cell.

15 Close the cover.





Calibrate the ISE

Calibrate the ISE following ISE maintenance, replacement of a reagent, and as part of the daily start up. The ISE Standards are placed in the designated locations as shown below in the standard solution area on the instrument. The standards open bottle stability is 90 Days and are stored at room temperature. S-H Serum Standard High S-L Serum Standard Low U-H Urine Standard High U-L Urine Standard Low


2 Place serum and/or urine high and low standards in ISE

2mL cups 3 Load serum and/or urine high and low standards on the

standard solution area (S-H, S-L, U-H, U-L) 4 Select [System Status], [ISE Status]. F5 ISE Unit Start

5 Select A/Calibration for Serum, B/Calibration for Urine

and /or C/Calibration for Serum + Urine

6 Select Yes

7 When the ISE calibration is complete, verify the Slope and MID Solution factor results are in range. If necessary select F8 Type Change to verify urine results are in range.

8 Select F7 Cell Change to verify results on both cells.



The ISE Calibration report can be viewed by selecting, [System Status], [ISE Status] view Results Cal tab. When viewing an ISE Calibration report:

Locate the Cell No and Sample Type box Review at the status screen : - Slope and Mid Solution factor are in range

o Yellow highlighting indicates ranges are out, calibration failed - Slope and Mid Solution factor are consistent with previous Change the cell to view using the F7[ Cell Change] Change the Type to view using the F8 [Type Change]

__________________________________________________________________

ISE Calibration Report


Chapter 8 Sample Processing

______________________________________________ Introduction

Samples are processed on the AU5400 by placing open (uncapped) primary tubes or other validated container into sample racks. The racks are loaded onto the rack feeder unit for the system to process. Samples must have requisitioned tests. Requisitioned tests are either downloaded from the Laboratory Information System (LIS), middle ware or manually requisitioned at the instrument. _____________________________________________

Reference

AU5400 Users Guide Volume 1 Quick Response Guide _____________________________________________

Oft


Patient Samples

Pre-Analytical handling of patient samples is critical to ensure accurate results. Utilize correct order of draw and Sample Handling recommendations. Verify your lab is following the required procedures for: • Order of Draw • Sample Handling

Draw correct volume Mix tubes containing additives Allow time to clot for serum Spin under correct conditions Aspirate don’t pour off from tubes

___________________________________________


Validated Sample Containers

Primary Tubes: • Outside diameter: 11.5-16 mm • Inside diameter:

9-15 mm • Height:

55-102 mm Sample Cups in Racks:

• 2.0 mL Hitachi Cups ( Part Number: MU853200 ) Sample Cups for ISE Calibration:

• 2.0 mL ISE Sample Cup ( Part Number MU9232 ) Nested Cups in tubes:

• Kendall EZEE-NEST® 16 mm cups ( Part Number 1270016000 )

• Kendall EZEE-NEST® 13 mm cups ( Part Number 1270013000 )

Additional information found in the Users Guide Volume 2, Hardware and Specs Tab, Chapter 1, Hardware or Specifications, Analysis Processing Specifications. Trademarks are property of owners


Rack Usage Follow these recommendations:

• Load racks on the rack supply belt with the #1 position facing into the analyzer

• Do not leave spaces between racks when loading Racks stop moving if a space is left between them on the rack supply belt

• Do not mix different sample types in the same rack • The probe descent and alignment must be set by a field service

engineer for optimal sampling. Do not change the type of containers used on a rack without consulting technical support

• Use of non validated containers may result in sampling errors • Racks are designated for barcoded sample or manual

programming (sequential or Rack ID samples). Barcoded samples are recommended

• 4 mm dead volume above non-usable sample (cells and/or gel) _______________________________________________

Rack Adapters Adapters are available to use with 11.5 to 13.5 mm tubes.

Racks are supplied without adapters in place. When using a tube between 11.5-13.5 mm insert an adapter in the rack to ensure the tube fits properly

Sample Integrity

The AU5400 performs the following integrity checks during sample processing: • Level sense

- Uses electronic circuitry to detect liquid.

• Obstruction detection

- Monitors pressure to determine if there is an

obstruction in the sample. The system will discard the

sample aspirated if a clot is detected and move to the

next specimen.

• Adequate sample aspiration

- System verifies the sample is still present in tube,

follow sample aspiration

• LIH (Lipemia, Icterus, Hemolysis; optional)

LIH reagent can be loaded and ordered as a test for a sample. The qualitative amount of the interfering substance is reported ________________________________________________


Processing Barcoded Samples

When processing samples: • Caps must be removed from the tubes • Samples are placed in white racks for routine testing • Samples are placed in red racks for emergency or STAT

testing • Barcode label must be aligned in the center of the opening in

the rack • Set the prepared racks on the rack feeder with the rack

barcode number facing the left side of the instrument • Place the racks in the rack feeder without leaving any open

spaces between racks. Do not place the racks in the area labeled (a) on the drawing below

Front of Instrument __________________________________________



From the main screen select, Routine, Test Requisition, Normal

Manually Program Samples

Use the TYPE pull-down menu to select the sample type to view each sample type

Select Ein the sample number

box

Emergency Rack

Yes

No

Select F2[Exit]

Select F4[Entry]

Enter the Sample ID (Barcode number) of the sample

Select the Demographics Tab and enter patient information

Select F4 [Start Entry]

Select the Test Requisition Tab and select individual tests or

Profile


Sample Data The operator can view completed results from: • Data Display Screen on the System Status computer screen

by selecting the [Home Menu], [Analyzer Status], [Data Display]

• Printed reports ___________________________________________

Data Interpretation

To differentiate sample type and kind of data, the instrument uses a prefix. The table below lists the prefix and meaning. List if Data Types Prefix Data Type Example R Reagent Blank R001 A Calibration A001 Q Quality Control Q001 None Serum Sample 0001 U Urine Sample U001 X Other Sample X001 E Emergency Sample E001 H Repeat H001

The table below is an example of a sample data report:

• S.NO. 0001 is the sample number assigned by the system the type of sample

• S.ID is the barcode sample ID for the sample • TYPE is the sample type, serum, urine, other • Test name of chemistry • Test result of chemistry • Flag for chemistry : error flags (maximum of 2) follow the

chemistry result

Sample Data Report

S. NO. 0001 S. ID 208493 TYPE SERUM

GLU 112 TP 5.5 CA 8.4

S .NO. U001 S.ID 208500 TYPE URINE

CRE 8.0 H _______________________________________________


Chapter 9 Maintenance ______________________________________________

Introduction

Reference

Maintenance Information: • Maintenance schedule and procedures are found in the Users Guide

Volume 2. ISE and analyzer maintenance are separate sections. • Maintenance recommendations may change. Always refer to the most

recent documentation for current maintenance requirements. • Document completed procedures using the maintenance log found in the

beginning of the maintenance section of the Users Guide. • Follow all documents maintenance procedures. • Function F6 (history) displays the 10 previous instances when

maintenance was performed and the next date and time it is due. • A list of consumable items used can be recorded on line in the

[Maintenance], [Consumable Management] screen. • Do not place any body parts in the pathway of moving equipment. Verify

the analyzer is in Stop or Standby and that diagnostic functions are not activated when performing maintenance procedures.

• Bleach (Sodium hypochlorite) used in the maintenance procedures is diluted to 10% (0.5% chlorine concentration) or 20% (1.0 % chlorine concentration). - Use Clorox, Javex-5 ™, Reagent Grade or other purified preparations

of sodium hypochlorite. - All dilutions should be made daily and in an area away from direct

sunlight. * 10%: 10ml bleach to 90ml DI Water * 20%: 20ml bleach to 80ml DI Water

- Under average fluorescent light environment, a bleach solution does not deteriorate within 24 hours if placed in a closed container.

• Wash Solution working concentrations are prepared by mixing wash solution and DI water. - 1%: 1ml wash solution to 99ml DI Water - 2%: 2ml wash solution to 98ml DI Water - 20%: 20ml wash solution to 80ml DI Water

• IMPORTANT: After performing analyzer maintenance you must

verify system performance by running QC. Following any ISE maintenance perform ISE Calibration and QC. __________________________________________________

AU5400 Users Guide Volume 1 Quick Response Guide

_____________________________________________________


The following tables list the maintenance required, frequency, and reference for each maintenance procedure.

Daily Maintenance

ISE Daily Maintenance

AU5400 User Guide Volume 2 ∟Maintenance Tab

∟ISE Maintenance Tab ∟Daily ISE Maintenance 8.1

Inspect Sample and Reagent Syringes

for Leaks ∟2.1 ♦

Analyzer (ANL) Maintenance

AU5400 Users Guide Volume 2 ∟Maintenance Tab

∟Daily Tab

Inspect the ISE Syringes for Leaks

∟8.1.1 ♦

ISE Cleaning (short) ∟8.1.2

Check ISE Sample Probe Detergent

∟8.1.4

Clean the Mix Bar, Liquid Level Sensors, Sample Pot and Sample Pot Tubing

∟8.1.5

Inspect the Printer and Paper ∟2.5

Check ISE Sample Probe Dispense

∟8.1.3 ♣

Inspect the Concentrated Wash Solution

Level ∟2.2

Inspect & Clean the Sample Probes, Reagent Probes, & Mix Bars

∟2.4

Prepare for a Sample Probe Wash

∟2.6 ♣

Change DI Water in the Pre-Dilution

Bottle ∟2.7 ♣

♦ The ISE procedure and the Analyzer procedure with these symbols may be performed together for efficiency. ♣ The ISE procedure and the Analyzer procedure with these symbols may be performed together for efficiency.

Inspect the Stability of the Upper Cover

∟2.3


Bi-Weekly, Weekly Maintenance

ISE Cleaning (Enhanced) ∟8.2.1 ♦

Perform a Selectivity Check for Na/K Electrodes ∟8.2.2

Perform a W1 Procedure ∟3.1

Perform a W2 and Perform a Photocal

∟4.1 ∟4.2 ♦

Wash the Sample Pre-dilution Bottles ∟4.4

Clean All Wash Wells ∟4.5

Clean Air Filters ∟4.6

Clean the Sample Probes and Mix Bars ∟4.7

∟4.7.1 ∟4.7.2

ISE Weekly Maintenance


∟ISE Maintenance Tab ∟Weekly ISE Maintenance 8.2



∟Daily Tab ∟Weekly Tab

Perform Photometer Check (after the photocal) ∟4.3

♦ Indicates both ISE and Analyzer procedures are performed together.

Clean Belts and Rack Transport Areas ∟4.8


Monthly Maintenance

Replace Pinch Valve Tubing ∟8.3.2

Replace the Mixture and Mid-Standard Pump Roller Tubing

∟8.3.1 Clean the Deionized- Water Tank

∟5.2

Clean the DI Water and the Sample Probe Filters ∟5.3

Clean the Cuvette Wash Nozzle ∟5.1

ISE Monthly Maintenance


∟ISE Maintenance Tab ∟Monthly ISE Maintenance

8.3


AU5400 Users Guide Volume 2 ∟Maintenance Tab ∟ Monthly Tab


As Needed Maintenance

Software Overview

Replace the Reference Electrode ∟8.4.1

Add Reference Electrode Solution ∟8.4.2

Replace the Wash Nozzle Joint Tubes ∟7.4

Replace Sample, Reagent and ISE Syringes ∟7.5

Replace or Clean Individual Cuvettes ∟7.1

Replace Mix Bars ∟7.3

Replace the Sample and Reagent Probes ∟7.2

Replace the Photometer Lamp ∟7.6

Perform a W1 Procedure ∟7.7

Clean or Replace the Static Discharge Brushes ∟7.8

Cleaning Cuvettes and Cuvette Wheel after a Cuvette Wheel Overflow

∟7.9

Replace Reagents ∟8.4.3

Replace the Na, K, or Cl Electrode ∟8.4.4

ISE Cleaning (Manual) Procedure ∟8.4.5

ISE Monthly Maintenance


∟ISE Maintenance Tab ∟As-Needed ISE Maintenance

8.4


AU5400 Users Guide Volume 2 ∟Maintenance Tab ∟ As-Needed Tab


Chapter 10 Troubleshooting ________________________________________

Introduction

This section provides tools for troubleshooting the analyzer and the ISE. Performing the scheduled maintenance on the system greatly reduces the chances of problems occurring with the analyzer. When troubleshooting, use the following tools: • Systematic approach to troubleshooting • Instrument indicators

- Measure Start Window - Alarm Help - Alarm List - Sample Error Flags - Reports

• RB, Calibration and QC monitors

_______________________________________ Reference

AU5400 Users Guide Volume 1 AU5400 Users Guide Volume 2 Quick Response Guide

_______________________________________


Systematic Approach to Troubleshooting

The systematic approach to troubleshooting is a logical, systematic approach to identifying an abnormal condition, assessing the condition, leading to resolution and returning to normal operations. Step 1: Identify Indicators

• Observations • Failures: RB, Cal, QC • Messages • Flags • Alarms

Step 2: Take an Inventory or history of the system • Have reagents been loaded? • Has maintenance been done or parts replaced? • Have new calibrators or QC been opened?

Step 3: Utilize Resources • Users Guides Vol 1 & 2, Quick Response Guide • Software: RB/Calibration Monitors, Reaction Monitors,

Alarm Help • Hotline • Co-workers

Step 4: Assess Severity • Did one or more chemistries fail? • Did one or more levels of calibrator or QC fail/ • What failed? Just RB, just Calibration, just QC, or a

combination of RB, Calibration and QC? • Is one patient or multiple patients affected?

Step 5: Use a systematic approach to resolve the failure • Based on your assessment, what is common to the

failure? What is unique to the failure? • Is it the sample that is common or unique? (calibrator,

QC,patient ) • Is it a reagent that is common or unique? • Is it instrument components that are common or

unique? - Cell-1/Cell-2 - ISE Sample Probe - Unit 1,2,or 3 - Inner/outer cuvettes - Sample probes (2 sample probes per unit) - 2 R1 probes and syringes per unit - 2 R2 probes and syringes per unit - S1 Mixers - R1 and R2 mixers

Step 6: Devise and Implement the plan


Measure Start Window

The Measure Start Window displays messages about the system status. The messages can be: • Yellow

- Caution: Impacted tests may not be measured correctly under current conditions

• Red - Warning: Fatal Error–Unable to run under current

conditions - Red status messages are linked to analyzer status.

Red messages are associated with Cal/QC/Patient results and hardware issues.

Alarm Help

When a message is displayed in the alarm message area: • Select one time to silence the audible

alarm • If “Alarm Clear” is selected a second time, message is cleared

from message line but can be found in the Alarm List (see below).

• Select Alarm Help icon-for current alarm message only. • Information displayed includes the “System Status”, “Users

Action” and “Cause”. • Print the alarm message by selecting [File], ]Print Topic] • Troubleshoot using the Help button information. • Call Technical Support if issue persists after troubleshooting.

Alarm List Alarm Messages are recorded in the Alarm List (a history of alarm

messages). To troubleshoot from the Alarm List:

• Select [System Status] , then [Alarm List] to view the list of alarms.

• Select the Alarm you are investigating, then select Display Help F6 to display the alarm description and corrective action

• Print the alarm message by selecting [File], [Print Topic]


Sample Error Flags

• Error Flags are generated by the system when a condition exists that could affect the result.

• Flags range from minor warnings to severe errors that require

immediate attention. • Review each flag and take appropriate action.

− Up to two flags print per result − Flag categories

• Reagent blanks * u or U: the OD is under the acceptable range; lower case

represents the measurement at the 1st read point; upper case represents the measurement at the 2nd read point

* y or Y: the OD is over the acceptable range: lower case represents the measurement at the 1st read point; upper case represents the measurement at the 2nd read point

• Calibration * b: calibration expired

• Quality Control * 1: failure using single check QC rule * 2-7: failure using multi check QC rules

• Patient data * Do not report results with an existing unresolved error flag.

• A summary of error flags, possible causes and recommended

actions can be found in the following references. Hardware troubleshooting (possible causes and corrective actions) can be found in the Troubleshooting tab of the Users Guide.

Users Guide, Volume 2 Error Flags Tab

Troubleshooting Tab Quick Response Guide Troubleshooting Tab

Non-Fatal Errors Fatal Errors


Reagent Blank and Calibration Tool

The Reagent Blank Monitor and Calibration Trace screens provide additional information useful in troubleshooting. Reagent Blank Monitor The details of the reagent blank can be viewed from the Reagent Blank Monitor by selecting: [Routine], [Calibration Monitor], [Reagent Blank Monitor]. Select the chemistry to view. Select the History Button.

• Each point represents the Optical Density (OD) of first and last read points of the test.

• Check to see if the OD is consistent with previous OD. • In this example reagent blank is consistent with previous

reagent blank points.


Calibrator Trace Monitor The details of the calibration can be viewed from the calibration trace screen by Selecting: [Routine], [Calibration Monitor], [Calibration Trace], then select the chemistry to view. (Note: points are in light blue inside red outlined box)

• Each point represents the Optical Density (OD) of each calibrator

• Check to see if the points are consistent with previous calibration points for the chemistry

• In this example the calibration point is consistent with previous calibration points


Troubleshoot Using Monitors

The red outlined area on the Reagent blank Monitor and Calibration Trace screen shown below displays an example of a passed reagent blank and a failed calibration for Creatinine. Observe the following: • All reagent blanks are consistent • The failed calibration has OD points for level 1 and 2 that are

much lower than previous calibrations.

Assessment:


Calibration Monitor

• Reagent Blank passed • Calibration failed • Calibrators are unique to what failed • Repeat calibration with fresh calibrators


Troubleshoot Using Monitors

The red outlined area is an example of three reagent blanks and calibrations that were performed for CO2. Observe the following: • The Reagent Blanks were lower than previous readings three

consecutive times • The calibrator points for both levels were lower than previous

readings three consecutive times

Assessment:

• Reagent Blank and Calibration failed • Reagent Blank indicates reagent integrity • Replace the CO2 reagent and repeat the reagent blank

and calibration. • If the reagent blank and calibration failed again, evaluate

common instrument components for reagent delivery


Calibration Monitor


Troubleshooting Worksheet

Systematic approach to Troubleshooting Worksheet 1. Review what you know about the system. What has changed, What has been performed since the errors occurred? ___________________________________________________

2. What chemistry(s) failed reagent blank? ___________________________________________________

3. Are there any reagent blank flags? ___________________________________________________

4. What chemistry(s) failed calibration? __ _________________________________________________

5. Are there any calibration flags? __________________________

6. What chemistry (s0 failed QC? ___________________________________________________

7. Are there any QC flags? ______________________________

8.Are the reagent blank readings consistent with previous readings? __________________________________________

9. Are the calibration readings consistent with previous readings? ___________________________________________________

10. What is common to failure(s)?

• Sample? __________________________________ • Reagent? _________________________________ • Instrument? ________________________________

4. Based on your evaluation, what is your plan of action? _______________________________________________


Chapter 11 Resources _____________________________________________________

Introduction

Knowing where to find information for the AU5400 system can be helpful for performing daily operations tasks through infrequently performed procedures. Included in this Chapter are: • Website Pathway to Information • List of Resources • Table of Resources for Tasks • ISE Chapter Diagram _______________________________________________________ The main resources for the AU5400 system are: • Users Guide Volume 1 and 2 • Quick Response Guide • Website information found at www.beckmancoulter.com └ Support └ Technical Documents └ Diagnostics └ Select Discipline, instrument └ Select Manual, IFU, etc. and └ Support └ Training and Education └ Diagnostics └ Select Discipline, instrument └ Tools and Aids • Reagent Guide ( refer to sales representative for details) • Technical Support : 800-854-3633 • Applications Specialist: _________________________________ • Service Engineer: _____________________________________

______________________________________________________


Table of Resources

Task Users Guide Quick Response Guide Other Daily Start Up Users Guide Vol 1

Chapter C Basic Operations ∟Preparing for Analysis & Users Guide Vol 2 Maintenance Tab ∟Daily Tab & ∟ISE Maintenance ∟Daily Tab

Preparing for Analysis Tab ∟Starting the AU5400 ∟Starting the ISE ∟Performing Calibrations and Reagent Blank ∟QC Analysis

Daily Start Up Job Aid www.beckmancoulter.com ∟Support ∟Training and Education ∟AU5400 ∟ Tools and Aids

Performing Reagent Blank and Calibration

Users Guide Vol.1 Preparing for Analysis Tab ∟2.3 Performing Calibrations and a Reagent Blank ∟2.3.1 Performing a Calibration and Reagent Blank on the Analyzer

Introduction Tab ∟General Operating Procedures ∟Creating Calibration Curves & Preparing for Analysis Tab ∟Performing Calibrations and a Reagent Blank

Performing QC Users Guide Vol.1 Preparing for Analysis Tab ∟2.4 Quality Control Analysis

Introduction Tab ∟General Operating Procedures ∟Creating Calibration Curves & Preparing for Analysis Tab ∟Quality Control Analysis

Performing a Reagent Check

Users Guide Vol.1 Software Tab Chap. D ∟Using System Status Tab ∟1.3 Reagent Status

Changing Reagents

Users Guide Vol.1 Basic Operations Tab ∟2.8 Daily Maintenance and Inspection ∟2.8.3 Changing Reagents

Preparing for Analysis Tab ∟Changing Reagents


(Table of Resources Continued) Task Users Guide Quick Response Guide Other Preparing Samples and Racks

Users Guide Vol.1 Basic Operations Tab ∟2.6 Preparing Samples and Racks

Preparing for Analysis Tab ∟Preparing Samples and Racks

Analyzer Maintenance

Users Guide Vol.2 Maintenance Tab ∟Daily Tab ∟Weekly Tab ∟Monthly Tab ∟As-Needed Tab

Perform ISE Maintenance

Users Guide Vol.2 Maintenance Tab ∟ISE Maintenance Tab ∟Daily ∟Weekly ∟Monthly ∟As-Needed

Flags Users Guide Vol.2 Error Flags Tab Chapter G ∟ Checking Results ∟ Data Error Flags

Troubleshooting Tab ∟Data Error Flags

Performing an Emergency Stop

Troubleshooting Tab ∟Performing a Stop or an Emergency Stop During Analysis ∟Performing a Stop ∟Resetting the System After a Stop ∟Performing an Emergency Stop

Recovering from an Emergency Stop or Power Loss

Troubleshooting Tab ∟Recovering from an Emergency Stop or Power Loss.

Troubleshooting the ISE

Users Guide Vol.2 Chapter H Troubleshooting ∟Troubleshooting the ISE Tab

Troubleshooting the Analyzer

Users Guide Vol.2 Chapter H Troubleshooting ∟Troubleshooting the Analyzer Tab


(Table of Resources Continued) Task Users Guide Quick Response Guide Other Performing an End Process at the end of the day

Finishing Analysis Tab ∟Ending ISE Analysis ∟Perform an End Process

Starting the ISE Users Guide Vol.2 Maintenance Tab ∟ISE Maintenance Tab ∟Daily & Users Guide Vol 1 Chapter C Basic Operations ∟Preparing for Analysis Tab ∟2.2 Starting the ISE

Preparing For Analysis Tab ∟Starting the ISE ∟Starting the ISE ∟Calibrate the ISE

Installation Specifications

Users Guide Vol 1 Chapter A Precautions and Installation ∟Installation Environments

Login/Logout Function

Users Guide Vol 1 Chapter B System Outline ∟Login/Logout Functions

Description of Measure Modes

Users Guide Vol 1 Chapter B System Outline ∟Description of Measure Modes

Help Function

Users Guide Vol 1 Chapter B System Outline ∟Outline of Screen Operations ∟Help Functions


(Table of Resources Continued) Task Users Guide Quick Response

Guide Other

Programming Individual Requisitions

Users Guide Vol 1 Chapter C Preparing For Analysis ∟2.5 Starting Normal Analysis ∟2.5.1 Entering Individual Requisitions (Routine and Emergency)

Programming Individual Requisitions by Batch

Users Guide Vol 1 Chapter C Basic Operations ∟Preparing for Analysis ∟2.5 Starting Normal Analysis ∟2.5.3 Entering a Group (Batch) Requisitions (Routine or Emergency)

Changing QC Ranges

Users Guide Vol 1 Chapter C Basic Operations ∟As Needed Tasks ∟6.7 Changing QC Ranges

Changing Calibrator Set Points

Users Guide Vol 1 Chapter C Basic Operations ∟As Needed Tasks ∟6.8 Calibration Set Points


ISE Chapter Component Identification

Software Overview


Chapter 12 Appendix

_____________________________________________________

Introduction

The material found in this appendix section contains additional resources that may be helpful to operators during basic operations. The following information is found in the Appendix:

• Daily Start Up job aid • Software Tree • Sample Handling Makes a Difference • End Process Job Aid

_____________________________________________________

Reference

AU5400 Users Guide Volume 1 AU5400 Users Guide Volume 2 Quick Response Guide

_____________________________________________________


Software Overview





Software Tree



Auto Power On and End Process

Configure Auto Power On

Use this step action table to configure a time to have the instrument automatically start up after you have performed an End Process. Once the Auto Power On is configured it does not have to be changed unless you choose to change the time.

Step Action

1 From the main screen, select (P) Parameter, (S) System, (P) Auto Power On

2 Select F4 Set

3 Select the desired day(s) and time(s) to start the Auto Power On function


Perform an End Process

Use this step action table to perform an End Process. By performing an End Process, the instrument power to the ISE and reagent refrigerators remains on. All other power is off, including the lamp.

Perform an End Process for specific maintenance procedures, during troubleshooting, or if your lab is not operational twenty four hours a day, seven days a week. An end process can be used to save lamp usage.

Step Action

1 From the main screen, select the End Process key on the keyboard

2 Select Yes


___________________________________




Inspect the Sample and Reagent Syringes


clockwise and the bottom counterclockwise(Check that the piston of the syringe is not tilted outward or inward as it is seated on the screw)

Close the covers



No Yes




pull

Yes

Yes

Yes

Yes

Yes






and head

Reagent syringe does not have the correct syringe(reagent)







No



Raise the Upper Cover of each unit

Inspect the Stability of the Upper Cover

Cover remains in upright position and does not descend when open

Yes

Contact Beckman Coulter authorized

personnel

Close covers

NO


Remove each bottle

Locate the two 60mL Wash Solution bottlesin Wash Positions Det.1 and Det. 2

Prepare Sample Probe Wash

Refill each bottle to the edge of the bottle with*

2% Wash Solution

* 2% Wash Solution is prepared by diluting Concentrated Wash Solution 2mL Wash solution + 98 mL DI Water

Replace the Wash Solution bottles in Wash

Positions Det.1 and Det.2


Empty the contents of the bottle

Remove the Pre-Dilution bottle from the instrument

Change the DI Water Pre-Dilution Bottle

Rinse the DI Water bottle twice

* Make sure the bottle does not protrude above the surface of the

analyzer top

Fill the bottle with fresh DI Water

* Place the bottle back on the instrument



Inspect the ISE Syringes for leaks


clockwise and the bottom counterclockwise (check that the piston of the syringe is not tilted outward or inward as it is seated on the screw)

Close the covers



No Yes




pull

Yes

Yes

Yes

Yes

Yes






and head

Buffer syringe does not have the correct syringe(reagent)







No


Place the cup in the “CLEAN” position on the standard area

Fill an ISE Calibration Cup with approximately 1mL of the ISE Cleaning Solution

Verify the system is in Standby or Warm-up

ISE Cleaning (Short)

Select [System Status], [ISE Status], F5 [ISE Unit Start]

Select [E] Cleaning

When the cleaning is complete(ISE box is blue and in ready), discard the cup with the

cleaning solution

Select Yes

Select F2 Exit

Select F2 Exit



Check the ISE Sample Probe Dispense

Select [System Status], [ISE Status], F6 Prime

Select G/Replace Probe and Syringe

Select Close

Press the Diag. button on the ISE unit:

Verify a straight stream of DI Water is dispensed from the sample probe



Check the ISE Sample Probe Detergent

Select [System Status], [ISE Status], select theS-Detergent Tab

Select F5 Check Start

Select F2 Exit, Exit

Fill the two 60mL bottles by the ISE Sample Probe with 2% Wash Solution

Select Yes





ISE Calibration

Select [System Status],[ISE Status], F5ISE Unit Start

Load the serum and/or urine high and low standards

Review ISE calibration screen following calibration; verify Slope and MID Solution factor results are in

range

Select one:A/Calibration for serumB/Calibration for urine

C/Calibration for Serum + Urine

Select Yes

Select F8 Type Changeto view urine type calibration

Select F7 Cell Change to view both cell results

Select F2 Exit, F2 Exit






From the main screen select, Routine, Test Requisition, Normal

Manually Program Samples

Use the TYPE pull-down menu to select the sample type to view each sample type

Select Ein the sample number

box

Emergency Rack

Yes

No

Select F2[Exit]

Select F4[Entry]

Enter the Sample ID (Barcode number) of the sample

Select the Demographics Tab and enter patient information

Select F4 [Start Entry]

Select the Test Requisition Tab and select individual tests or

Profile



Chapter 13 Quiz ________________________________________________________

Introduction

This quiz section of the In-lab Training Manual provides an opportunity to review the material covered in each chapter of the manual. The quiz consists of a series of questions for each chapter in the In-Lab Training Manual

_________________________________________________________ Instructions

Perform the following steps to complete this section 1. Refer to each chapter to complete the quiz questions 2. Compare your answers to the Reference Key (Chapter 15) 3. Check, initial and date each chapter box in the table below

Quiz Documentation Table

Chapter Quiz Completed Date Initials Ch.1 Instrument Overview □ Ch. 2 Software Overview □ Ch. 3 Reagents □ Ch. 4 Reagent Blank and Calibration □

Ch. 5 Quality Control □ Ch. 6 ISE Daily Start Up □ Ch. 7 Analyzer Daily Start Up □

Ch. 8 Sample Processing □ Ch. 9 Maintenance □ Ch.10 Troubleshooting □


Chapter 1 Instrument Overview

A. Name the numbered components on the diagram below: 1._________________ 2. _______________________

3. ________________ 4. _______________________ B. Name the component that contains multiple probes that clean, rinse and dry cuvettes before and after analysis ____________________ C. The S_ sample probe delivers to the outer cuvette wheel, and the S_ delivers to the inner cuvette wheel of each unit. _______________________________________________________

Chapter 2 Software Overview

A. List 6 Status Modes of the system: • _____________________ • _____________________ • _____________________ • _____________________ • _____________________ • _____________________

B. The _________ ____________ allows the operator to perform a screen

specific function and corresponds to F1-F8 on the keyboard. C. In System Status, a Red Flag (X) indicates a _______ ______ is

present. ________________________________________________________


Chapter 3 Reagents

A. __________ _________ F _ lists the reagents missing or unset on the unit.

B. A 300 mL bottle would take up __ positions on the reagent

refrigerator. C. A fixed reagent has a _______ frame color


________________________________________________________

A. In the Calibration Requisition screen a box highlighted blue means a __________ _____________ is requisitioned.

B. A box highlighted yellow means what is requisitioned a _______________________ is requisitioned.

C. What order do you place racks on the system?

(Circle the correct answer) a. Blue, Yellow (lowest rack number first and following in sequential

order) b. Yellow (lowest rack number first and following in sequential order),

Blue c. Blue, Yellow d. Blue or Yellow, it doesn’t matter which goes first ___________________________________________________


Chapter 5 Quality Control

A. Which chemistry in the data below has a QC flag? _________

B. How many times has QC processed in this Data Index? ______

C. What chemistry has QC results from two bottles? _________

S.No.Q002 QC Level 1 3.1: , , ,

0001 -01 Unit No.1 (outer) 1-1Phos-1 S.No.Q002 QC Level 1

3.0: , , , 0001 -01 Unit No.1 (outer) 1-2

Phos-1 S.No.Q002 QC Level 3

5.0: , , , 0001 -02 Unit No.1 (outer) 2-1


4.9: , , , 0001 -02 Unit No.1 (outer) 2-2


69: , , , 0001 -01 Unit No.1 (inner) 1-1

LDH-1 S.No.Q002 QC Level 3

176: , , , 0001 -02 Unit No.1 (inner) 2-1


6.1: , , , 0001 -01 Unit No.2 (outer) 1-2

CA-1 S.No.Q002 QC Level 3

8.1: , , ,Q 0001 -02 Unit No.2(outer) 2-2

CA-2

_________________________________________________________


Chapter 6 Analyzer Daily Start Up

A. The Pre-dilution bottles and Sample probe wash bottles daily maintenance is: a. Add to the Wash Solution bottles and DI water bottles b. Empty the Wash Solution bottles and DI water bottles c. Empty and refill the Wash Solution and add to the DI Water

bottles d. Add to the Wash Solution and empty and refill the DI Water

bottles.

B. What is the software path to check the status of the printer? System Status └ _________________ └ Printer Status

C. Check all tasks that are part of a daily start up for an analyzer with an ISE or without, (lab dependent), in the list below.

□ Inspect syringes for leaks

□ ISE Calibration

□ Change DI water bottle □ Perform a photocal □ ISE Cleaning (short) □ Perform reagent blank and

calibration □ Clean air filters □ Inspect Wash Solution □ New Data Index □ Inspect and clean probes and

mix bars □ Inspect printer and paper

□ Replenish ISE reagents

□ Prepare sample wash □ Replenish Analyzer reagents □ Perform QC □ Clean the DI Water tank □ Replace e the lamp □ Replace ISE drain tubing □ ISE sample probe dispense check

□ Clean mix bar, liquid level sensors, and sample pot


Chapter 7 ISE Daily Start Up

A. Draw a line to connect the action on the left column, with the action required on the right column.

The ISE Reference Solution was replaced on Cell 1

Press the DIAG button on the ISE Unit to view the straight a stream of water is being dispensed from the sample probe

The Daily ISE Clean (short) was performed

Select S-Detergent Tab

From the System Status, ISE Status, Prime, Replace the Probe and Syringe has been selected.

Perform an ISE Mid/Ref Solution Prime on Cell 1

The ISE sample probe detergent needs to be checked from the ISE Status Screen.

Perform a Total Prime then calibrate the ISE following daily maintenance

B. The stability of open bottles of ISE Calibrator and ISE Bulk Reagents are? _________________________________ C. What concentration of wash solution is used to clean the ISE mix

Bar, liquid level sensors, sample pot and sample pot tubing? __________________________________________________



A. A _____ rack has processing priority on the system.

B. Orange racks are used for _____________ samples

C. The ________ reagent is used to evaluate lipemia, icterus and hemolysis in a sample. _________________________________________________

Chapter 9 Maintenance

A. What mode does the system need to be in to perform the photometer check after a photocal? ___________________

B. The ISE procedure performed with the W2 and Photocal is the

ISE __________ Cleaning procedure.

C. Review the As-Needed maintenance procedures for the analyzer and ISE. • What state does the system need to be in to remove the

photometer lamp? _________________________________

• Following lamp replacement, what weekly maintenance procedure is required to be performed before running QC? ________________________________________________

• Using the As-Needed procedure “Replace or Clean Individual Cuvettes”, locate cuvette number 78 on the inner wheel and number 200 on the outer wheel of a unit. How were you able to locate these cuvettes? ________________________________________________

• What As-Needed procedure should be performed if the chips shown by arrows were present on your system? ________________________________________________


Chapter 10 Trouble-shooting

A. Three instrument components that are common to the Outer cuvette wheel are S1, R1-__, and R2-__.

B. What does the b flag mean? ____________ ____________.

C. Where can an operator locate a list of flags for reference? _________________________________________________

_________________________________________________


Chapter 14 Practice ________________________________________________________

Introduction

This practice section of the In-lab Training Manual allows you to practice utilizing the information from each chapter. The practice will give you some hands –on experience and build your skill level. The quiz consists of a series of questions for each chapter in the In-Lab Training Manual

_________________________________________________________ Instructions

Perform the following steps to complete this section 1. Complete each chapter’s practice after completion a chapter of manual. 2. Compare your answers to the Reference Key (Chapter 15) 3. Check, initial and date each chapter box in the table below

Quiz Documentation Table

Chapter Practice Completed Date InitialsCh.1 Instrument Overview □ Ch. 2 Software Overview □ Ch. 3 Reagents □ Ch. 4 Reagent Blank and Calibration □

Ch. 5 Quality Control □ Ch. 6 ISE Daily Start Up □ Ch. 7 Analyzer Daily Start Up □

Ch. 8 Sample Processing □ Ch. 9 Maintenance □ Ch.10 Troubleshooting □ Ch. 11 Resources □

________________________________________________________


Practice Chapter 1 Instrument Overview

You have had an opportunity to review the instrument through the instrument overview chapter of this In-Lab Training Manual. Now you can take some time to practice identifying the components on your instrument. __________________________________________________

What Will I Need?

You will need the materials listed below to complete this practice:

• Instrument • In-Lab Training Manual Chapter 1

_________________________________________________

Locate Components

Use the In–Lab Training Manual Chapter 1 to perform the following:

1. Locate the following components on your instrument □ Rack Feeder Unit □ Sample Probes □ Cuvette Wheels (Inner and Outer) □ R1/R2 Refrigerated □ Compartments □ R1 Reagent Probes □ R2 Reagent Probes □ Mix Bar Unit □ Wash Nozzle Unit □ ISE Unit □ R2 Syringes □ R1 Syringes □ Sample Syringes □ ISE Syringes □ ISE Reagents □ Tank Storage □ System Buttons 2. Locate the three lanes for racks, the bypass, primary and

return lane. _________________________________________________

The Finish Line

Congratulations! You have completed identifying components on your instrument. _________________________________________________


Practice Chapter 2 Software Overview

You have had an opportunity to review the software through the Software Overview Chapter 2 of this In-Lab Training Manual. Now you can take some time to practice navigating through the software on your instrument. ___________________________________________________

What Will I Need?


• Instrument • In-Lab Training Manual Chapter 2

___________________________________________________

Software Navigation

Use the In-Lab Training Manual Chapter 2 to perform the following: 1. Navigate to the System Status using the touch screen feature.

2. Navigate to each of the following screen elements :

□ Reagent Status □ ISE Status □ Analyzer Status □ Cuvette Status □ Data Display □ Alarm List □ DPR Status

3. Exit the System Status screen using the F2 key on the keyboard

4. Navigate through the Routine pull-down using your mouse to locate the Test Requisition Tab.

• What is the software path to Test Requisition? ______________, ________________, ______________

5. Navigate each main menu pull-down menu and submenu _________________________________________________

The Finish Line

Congratulations! You have practiced software navigation. _________________________________________________


Practice Chapter 3 Reagents

You have had an opportunity to review reagent information in Chapter 3 of this In-Lab Training Manual. Now you can take some time to practice performing a reagent check and loading a reagent. ________________________________________________

What Will I Need?


• Instrument • In-Lab Training Manual Chapter 3 and Chapter 11 • Reagent to load

_______________________________________________

Reagent Check and Load

Use the In-Lab Training Manual Chapter 3 ,Resources Chapter 11 and Daily Start Up Job Aid to perform the following: 1. Remove a reagent set (r1 and R2) from Unit 1

2. Perform a Check Start on Unit 1 using the option Check all

positions.

3. Select F4 Reagent Setting • What reagent is unset? _____________

4. Re-load on Unit 1 the reagent you unloaded in step 1.

5. Perform a Check Start on Unit 1, using check changed

position, check specified position, or check all positions.

6. Select F7 Test Display.

7. Locate the Shot, Onboard Stability, and Cal Stability for the reagent you re-loaded on Unit 1.

_________________________________________________ The Finish Line

Congratulations! You have practiced performing a reagent check and loading a reagent. _________________________________________________


Practice Chapter 4 Reagent Blank and Calibration

You have had an opportunity to review Reagent Blank and Calibration information in Chapter 4 of this In-Lab Training Manual. Now you can take some time to practice performing a Reagent Blank and Calibration on your instrument. ___________________________________________________

What Will I Need?


• Instrument • In-Lab Training Manual Chapter 4 and Chapter 11 • Daily Start Up Job Aid • DI Water • Calibrators • Reagent Blank and Calibrator Racks

__________________________________________________

Reagent Blank and Calibration

Use the In-Lab Training Manual Chapter 4 , Resources Chapter 11 and Daily Start Up Job Aid to perform the following: 1. Identify a reagent on Unit 1 that requires calibration.

2. Perform a Calibration Requisition for the reagent identified on

Unit1. • What is the software pathway you used to

requisition the calibration? _________, _____________,__________

• What Function button did you select to view calibrators required? _________________

3. Review the Reagent Blank and Calibration on the Data Display and Data Report

• Did you see any flags or messages? ________ 4. Review the status of your calibration in Calibrator Trace

• What is the status of your reagent calibration? _______

__________________________________________________

The Finish Line

Congratulations! You have practiced performing a reagent blank and calibration. __________________________________________________


Practice Chapter 5 Quality Control

You have had an opportunity to review Quality Control information in Chapter 5 of this In-Lab Training Manual. Now you can take some time to practice performing Quality Control on your instrument. _________________________________________________

What Will I Need?


• Instrument • In-Lab Training Manual Chapter 5 and Chapter 11 • Daily Start Up Job Aid • Quality Control Material • Quality Control Racks

________________________________________________

QC

Use the In-Lab Training Manual Chapter 5 , Resources Chapter 11 and Daily Start Up Job Aid to perform the following: 1. Navigate to the QC requisition screen to verify chemistries are

auto requisitioned

2. Select the pull-down TYPE to view auto requisition for each sample type

3. Identify what racks are required to perform QC

• What function button did you select to locate the QC material and racks required? _____

4. Process the QC racks on your instrument.

5. Review the QC data in the Data Display and Data report

• Are there any flags? ______________

__________________________________________________ The Finish Line

Congratulations! You have practice processing Quality Control. __________________________________________________


Practice Chapter 6 Analyzer Daily Start Up

You have had an opportunity to review Analyzer components, daily maintenance and start up procedures in Chapter 7 of this In-Lab Training Manual. Now you can take some time to practice performing an Analyzer Daily Start Up on your instrument. ___________________________________________________

What Will I Need?


• Instrument • In-Lab Training Manual Chapter 6 and Chapter 11 • Daily Start Up Job Aid • ISE Reagents • ISE Cleaning Solution • ISE Calibrators • Sonicator • 1% Wash Solution • 2% Wash Solution

__________________________________________________

Analyzer Daily Start Up

Use the In-Lab Training Manual Chapter 7 , Resources Chapter 11 and Daily Start Up Job Aid to perform the following: 1. Perform a Daily Start Up on the Analyzer 2. List the maintenance tasks your performed and documented in

the maintenance log; ________________, ______________, ______________ ________________, _______________

____________________________________________________

The Finish Line

Congratulations! You have practiced the Analyzer Daily Start Up. _____________________________________________________


Practice Chapter 7 ISE Daily Start Up

You have had an opportunity to review ISE components, daily maintenance and start up procedures in Chapter 6 of this In-Lab Training Manual. Now you can take some time to practice performing an ISE Daily Start Up on your instrument. __________________________________________________

What Will I Need?


• Instrument • In-Lab Training Manual Chapter 6 and Chapter 11 • Daily Start Up Job Aid • ISE Reagents • ISE Cleaning Solution • ISE Calibrators • Sonicator • 1% Wash Solution • 2% Wash Solution

________________________________________________

ISE Daily Start Up

Use the In-Lab Training Manual Chapter 6 , Resources Chapter 11 and Daily Start Up Job Aid to perform the following: 1. Perform a Daily Start Up on the ISE

• What prime did you select following the ISE Cleaning (Short) procedure/ ____________________

2. Review the calibration reports for Cell 1 and Cell 2 (Serum

and /or Urine) • Did all calibrations pass? _______________

How did you know? ___________________ ___________________________________ ________________________________________________

The Finish Line

Congratulations! You have practiced the ISE Daily Start Up ________________________________________________


Practice Chapter 8 Sample Processing

You have had an opportunity to review sample processing in Chapter 8 of this In-Lab Training Manual. Now you can take some time to practice performing sample processing on your instrument. ___________________________________________________

What Will I Need?


• Instrument • In-Lab Training Manual Chapter 8 and Chapter 11 • Samples • Sample racks

__________________________________________________

Sample Processing

Use the In-Lab Training Manual Chapter 8 and Resources Chapter 11 to perform the following: 1. Place samples for processing in red racks and white racks. 2. Load racks on the rack feeder and begin processing.

3. Identify which lane the red rack moved used ____________

4. Identify which lane all racks used to return to rack collection.

___________________________________________

__________________________________________________

The Finish Line

Congratulations! You have completed the Sample Processing practice. _________________________________________________


Practice Chapter 9 Maintenance

You have had an opportunity to review maintenance frequencies and maintenance procedures in Chapter 9 of this In-Lab Training Manual. Now you can take some time to practice performing ISE and analyzer maintenance on your instrument. __________________________________________________

What Will I Need?


• Instrument • In-Lab Training Manual Chapter 9 and Chapter 11 • User Guide Volume 2 • Maintenance supplies listed in the maintenance

procedure Volume 2 _________________________________________________

Maintenance

Use the In-Lab Training Manual Chapter 9 ,Resources Chapter 11 , User Guide Volume 2 Maintenance procedures to perform the following: 1. Perform ISE weekly maintenance and analyzer bi-weekly and

weekly maintenance 2. Perform Monthly ISE and analyzer maintenance 3. Compare the sample probe filter assembly on your instrument

to this picture. On your assembly : Is the filter positioning Ring inserted into the sample filter?

4. Perform QC for all analytes to verify maintenance

The Finish Line

_________________________________________________ Congratulations! You have practiced maintenance procedures. _________________________________________________


Practice Chapter 10 Troubleshooting

You have had an opportunity to review the systematic approach to troubleshooting in Chapter 10 of this In-Lab Training Manual. Now you can take some time to practice troubleshooting on your instrument. ___________________________________________________

What Will I Need?


• Instrument • In-Lab Training Manual Chapter 10 and Chapter 11

__________________________________________________

Troubleshooting

Use the In-Lab Training Manual Chapter 10 and Resources Chapter 11 , to perform the following: 1. Move the ISE Reference reagent to the edge of the shelf.

• What alarm was generated? _______________________________________

2. Select the Alarm Help icon to view the help for the current alarm.

• What is the corrective action? _______________________________________

3. Verify your plan of action was successful 4. Select a reagent on your instrument to review the reagent

blank monitor.

5. Select the calibration trace monitor for the same reagent • Verify that both reagent blank and calibration have a

status of passed • If the reagent blank had failed and calibration had

passed, which would you replace, the reagent blank or calibrators? _________________

________________________________________________ The Finish Line

Congratulations! You have practiced troubleshooting. ________________________________________________


Practice Chapter 11 Resources

You have had an opportunity to review the resources in Chapter 11 of this In-Lab Training Manual. Now you can take some time to practice using the resources for your instrument. ___________________________________________________

What Will I Need?


• Instrument • In-Lab Training Manual Chapter 11 • User Guides Volume 1 and User Guide Volume 2 • Internet

____________________________________________________

Use the In-Lab Training Manual Chapter 11 Resources and the User Guides Volume 1 and User Guide Volume 2 to perform the following: 1. Locate the consumable IFU (Instructions for Use ) document on

the Beckman Coulter website 2. Locate the following information in the Help Icon

• Part Number for the sample probe________

3. Locate the following information in the User Guide • Temperature and humidity conditions:

__________, _________________ • CS Table : On-Board Stability of Lipase _____

4. Locate the following information in the Quick Response Guide

• To recover from an Emergency Stop or Power Loss, how many seconds should an operator wait before selecting the green ON button following the reset button? ___

___________________________________________________

The Finish Line

Congratulations! You have completed the resources practice. ___________________________________________________


Chapter 15 Reference Key

________________________________________________________ Reference Key

The Reference Key provides the answers to the In-Lab Training Manual Quiz and Practice Chapters. By comparing your answers from the Quiz and Practice you will be able to verify your understanding of the material covered in the In-Lab Training Manual. __________________________________________________

Instructions

Compare your answers from the Quiz and Practice with the answers in the Reference Key Refer any questions you may have to your instructor or technical support representative


Chapter 1 Instrument Overview

A. Name the numbered components on the diagram below: 1. Rack Feeder Unit 2. ISE Module 3. Tank Storage 4. Syringes B. Name the component that contains multiple probes that clean, rinse and dry cuvettes before and after analysis Wash Nozzle C. The S 1sample delivers to the outer cuvette wheel, and the S2 delivers To the inner cuvette wheel of each unit. __________________________________________________________

Chapter 2 Software Overview

A. List 6 Status Modes of the system: • Initial • Warm Up • Standby • Measure 1 • Measure 2 • Stop

B. The Function Buttons allow the operator to perform a screen specific

function and corresponds to F1-F8 on the keyboard. C. In System Status, a Red Flag (X) indicates a fatal error is present.

D. Reagent Setting F 4 lists the reagents missing or unset on the unit.

__________________________________________________________


Chapter 3 Reagents

A. Reagent Setting F4 lists the reagents missing or unset on

the unit. B. A 300 mL bottle would take up 5 positions on the reagent refrigerator. C. A fixed reagent has a Blue frame color

____________________________________________________________


A. In the Calibration Requisition screen a box highlighted blue means

Reagent Blank is requisitioned.

B. A box highlighted yellow means what is requisitioned a Calibration is requisitioned.

C What order do you place racks on the system?

(Circle the correct answer) e. Blue, Yellow (lowest rack number first and following in

sequential order

__________________________________________________________

Chapter 5 Quality Control

A. Which chemistry in the data below has a QC flag? CA

B. How many times has QC been run in this Data Index? 2

C. What chemistry has QC been run on two bottles? Phos

S.No.Q002 QC Level 1 3.1: , , ,

0001 -01 Unit No.1 (outer) 1-1Phos-1 S.No.Q002 QC Level 1

3.0: , , , 0001 -01 Unit No.1 (outer) 1-2


5.0: , , , 0001 -02 Unit No.1 (outer) 2-1


4.9: , , , 0001 -02 Unit No.1 (outer) 2-2


69: , , , 0001 -01 Unit No.1 (inner) 1-1


176: , , , 0001 -02 Unit No.1 (inner) 2-1


6.1: , , , 0001 -01 Unit No.2 (outer) 1-2

CA-1 S.No.Q002 QC Level 3

8.1: , , ,Q 0001 -02 Unit No.2(outer) 2-2

CA-2

________________________________________________________


Chapter 6 Analyzer Daily Start Up

A. The Pre-dilution bottles and Sample probe wash bottles daily maintenance is: e. Add to the Wash Solution and empty and refill the DI

Water bottles.

B. What is the software path to check the status of the printer? System Status └ DPR Status └ Printer Status

C. Check all tasks that are part of a daily start up for an analyzer with an ISE or without, (lab dependent), in the list below.

√ Inspect syringes for leaks √ ISE Calibration √ Change DI water bottle □ Perform a photocal √ ISE Cleaning (short) √ Perform reagent blank & calibration □ Clean air filter √ Inspect Wash Solution √ New Data index √ Inspect and clean probes & mix bars√ Inspect printer and paper √ Replenish IS reagents √ Prepare sample wash □ Replenish Analyzer reagents √ Perform QC □ Clean the DI Water tank □ Replace the lamp □ Replace ISE drain tubing √ ISE sample probe dispense check

√ Clean mix bar, liquid level sensors, and sample pot.

________________________________________________________


Chapter 7 ISE Daily Start Up

A. Draw a line to connect the action on the left column, with the action required on the right column.

The ISE Reference Solution was replaced on Cell 1

Press the DIAG button on the ISE Unit to view the straight a stream of water is being dispensed from the sample prob

The daily Clean (short) was performed

Select S-Detergent Tab

From the System Status, ISE Status, Prime, Replace the Probe and Syringe has been selected.

Perform and ISE Reference Solution Prime on Cell 1

The ISE sample probe detergent needs to be checked from the ISE Status Screen.

Perform a Total Prime , then calibrate the ISE following daily maintenance

B. The stability of open bottles of ISE Calibrator and ISE Bulk Reagents are? 90 Days C. What concentration of wash solution is used to clean the ISE mix

bar, liquid level sensors, sample pot and sample pot tubing? 1% Wash Solution



A. A Red rack has processing priority on the system.

B. Orange racks are used for repeat samples

C. The LIH reagent is used to evaluate lipemia, icterus and hemolysis in a sample.

________________________________________________________


Chapter 9 Maintenance

A. What mode does the system need to be in to perform the photometer check after a photocal? Stop

B. The ISE procedure performed with the W2 and Photocal is the ISE

Enhanced Cleaning procedure.

C. Review the As-Needed maintenance procedures for the analyzer and ISE. • What state does the system need to be in to remove the

photometer lamp? End Process

• Following lamp replacement, what weekly maintenance procedure is required to be performed before running QC?

Photocal

• Using the As-Needed procedure “Replace or Clean Individual Cuvettes”, locate cuvette number 78 on the inner wheel and number 200 on the outer wheel of a unit. How were you able to locate these cuvettes? Rotate the cuvette wheel by selecting Replace Cuvette

• What As-Needed procedure should be performed if the chips shown by arrows were present on your system? Replace the mix bar

_________________________________________________________


Chapter 10 Trouble-shooting

A. Three instrument components that are common to the Outer cuvette wheel are S1, R1-1, and R2-1.

B. What does the b flag mean? Calibration expired

C. Where can an operator locate a list of flags for reference? Quick Response Guide , Troubleshooting Tab and the User Guide Volume, Error Flags Tab

_______________________________________________________


Practice Chapter 1 Instrument Overview

□ Rack Feeder Unit □ Sample Probes □ Cuvette Wheels (Inner and Outer) □ R1/R2 Refrigerated □ Compartments □ R1 Reagent Probes □ R2 Reagent Probes □ Mix Bar Unit □ Wash Nozzle Unit □ ISE Unit □ R2 Syringes □ R1 Syringes □ Sample Syringes □ ISE Syringes □ ISE Reagents □ Tank Storage

Locate the three lanes for racks, the bypass, primary and return lane. By Pass ( inside ) , Primary (middle), Return ( outside) ______________________________________________________

Practice Chapter 2 Software Overview

Navigate through the Routine pull-down using your mouse to locate the Test Requisition Tab.

• What is the software path to Test Requisition?

Routine, Test Requisition, Normal __________________________________________________

Practice Chapter 3 Reagents

Select F4 Reagent Setting • What reagent is unset? The reagent removed


Practice Chapter 4 Reagent Blank and Calibration

5. Perform a Calibration Requisition for the reagent identified on Unit1.

• What is the software pathway you used to requisition the calibration? Routine, Test Requisition, Calibration

• What Function button did you select to view calibrators required? F6 Cal

6. Review the Reagent Blank and Calibration on the Data Display and Data Report

• Did you see any flags or messages? If the calibration passed there should be no flags

7. Review the status of your calibration in Calibrator Trace • What is the status of your reagent calibration?

Passed or failed __________________________________________________

Practice Chapter 5 Quality Control

Identify what racks are required to perform QC • What function button did you select to locate the QC

material and racks required? F6 ___________________________________________________

Practice Chapter 6 Analyzer Daily Start Up

List the maintenance tasks your performed and documented in the maintenance log;

-Inspect Sample and Reagent Syringes for leaks -Inspect the Concentrated Wash Solution Level -Inspect and Clean the Sample Probes, Reagent Probes, and Mix Bars -Inspect the Printer and paper -Prepare for a Sample Probe Wash -Change DI Water in the Pre-Dilution Bottle

QC Passed ___________________________________________________

Practice Chapter 7 ISE Daily Start Up

Verify ISE Cell 1 and Cell 2 calibrated and QC passed. ___________________________________________________


Practice Chapter 8 Sample Processing

Identify which lane the red rack moved used By-Pass lane (inner lane)

Identify which lane all racks used to return to rack collection.

Return lane (outer lane) ___________________________________________________

Practice Chapter 9 Maintenance

Is the filter positioning ring inserted into the sample filter as Shown? The positioning ring must be inserted as shown, with the tip protruding QC Passed __________________________________________________

Practice Chapter 10 Troubleshooting

Move the ISE Reference reagent to the edge of the shelf. • What alarm was generated?

Reagent Short

Select the Alarm Help icon to view the help for the current alarm.

• What is the corrective action? Replace Reagent

• Verify that both reagent blank and calibration have a

status of passed Checked the Test Display to see the calibration stability or checked the Calibration Trace for a status of Passed

• If the reagent blank had failed and calibration had passed, which would you replace, the reagent blank or calibrators? Reagent, the RB is a check for reagent integrity

___________________________________________________


Practice Chapter 11 Resources

Locate the following information in the Help Icon • Part Number for the S1 sample probe MU8206

Locate the following information in the User Guide

• Temperature and humidity conditions: Temp. = 18-32 C (during measure a temp fluctuation of less than + or – 2 ) Humidity = 40-80%

• CS Table : On-Board Stability of Lipase 21 Locate the following information in the Quick Response Guide

• To recover from an Emergency Stop or Power Loss, how many seconds should an operator wait before selecting the green ON button following the reset button? 10 seconds

___________________________________________________

Congratulations

Congratulations on completing the In-Lab Training Manual: • Chapters • Quiz • Practice If applicable , have a Beckman Coulter or Laboratory representative sign the certificate


Has satisfactorily completed the AU5400 In-Lab Training Course

AU5400 System

______________________________________________________________

________________________________________ ________ Beckman Coulter or Laboratory Representative Date