INSTRUMENTATION LABORATORY ACL ELITE / ELITE · PDF fileSetup / Review System Configuration Save Rotor Map ... N – No Test; Identified sample ... Pre-run Checklist

INSTRUMENTATION LABORATORY ACL ELITE / ELITE PRO* System

QUICK REFERENCE GUIDE

PN 774413AA (November 2010) Miami Education Center Miami, FL 33196

i

REVISION STATUS

Revision A Initial Issue (May, 2006)

Software release 3.05

Revision AA Software release 3.01.04

Library V 02.00.00

New Operators Manual * Instrumentation Laboratories, the IL Logo , ACL, ACL Elite, HemosIL and Accutrak are trademarks or registered trademarks of Instrumentation Laboratory Company in the United States and in several international jurisdictions.

PN 774413 Rev AA (November 2010) Miami Education Center ii

PN 774413 Rev AA (November 2010) Miami Education Center iii

WARNINGS AND PRECAUTIONS READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT. DO NOT ATTEMPT TO PERFORM ANY PROCEDURE BEFORE CAREFULLY READING ALL INSTRUCTIONS. ALWAYS FOLLOW PRODUCT LABELING AND MANUFACTURER’S RECOMMENDATIONS. IF IN DOUBT AS TO HOW TO PROCEED IN ANY SITUATION, CONTACT YOUR BECKMAN COULTER REPRESENTATIVE. HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS WARNINGS, CAUTIONS and IMPORTANTS alert you as follows:

WARNING – Can cause injury. CAUTION – Can cause damage to the instrument. IMPORTANT – Can cause misleading results.

BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. WARNING Risk of operator injury if: • All doors, covers and panels are not closed and secured in place prior to and during instrument operation. • The integrity of safety interlocks and sensors is compromised. • Instrument alarms and error messages are not acknowledged and acted upon. • You contact moving parts. • You mishandle broke parts. • Doors, covers and panels are not opened, closed, removed and/or replaced with care. • Improper tools are used for troubleshooting. To avoid injury: • Keep doors, covers, and panels closed and secured in place while the instrument is in use.

• Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors. • Acknowledge and act upon instrument alarms and error messages. • Keep away from moving parts.

• Report any broken parts to your Beckman Coulter Representative. • Open/remove and close/replace doors, covers and panels with care. • Use the proper tools for troubleshooting.

CAUTION System integrity might be compromised and operational failures might occur if: • This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product

Manuals. • You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your

system’s computer with software authorized by Beckman Coulter. • You install software that is not an original copyrighted version. Only use software that is an original copyrighted

version to prevent virus contamination. IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter distributor, and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most current information bulletins concerning the product. If you purchased this product from a third party and would like further information concerning this topic, call your Beckman Coulter Representative.

HEMOSTASIS: ENDOTHELIUM AND PROTEINS PN 774413 Rev AA (November 2010) Miami Education Center iv

PN 774413 Rev AA (November 2010) Miami Education Center

ACL ELITE / ELITE PRO Quick Reference Guide

Table of Contents

Components / Icons / Colors Software Tree Hardware Components Overview Windows / Toolbar / Message Icons Reagent / Sample Loading Material Status Colors Materials Map Sample Status Pre-run Checklist Processing Samples Maintenance Frequency Log Sheet Order information for Expendables Quality Controls Calibration Troubleshooting Coagulations Errors Troubleshooting Error Codes Troubleshooting Calibration Errors AccuTrak Enrollment New Test Setup (flowchart) New Lot

SOFTWARE TREE

ANALYSIS QC CALIBRATION DIAGNOSTIC SETUP UTILITY

PN 774413 Rev AA (November 2010) Miami Education Center Page 1 of 29

MULTI TEST SESSION Single Test Session

Loadlist Session History

Calibrate Upgrade IL Library Tests ► Review Calibration Backup / Restore Multi-Test ► Analytical Reference Archive Liquids

QC Software ► Interfaces ► Setup / Review Save Rotor Map System Configuration

Save Trace Security Test / Material ► Audible Alarms

Priming Debug (dimmed) Date / Time Cleaning Testing (dimmed)UnitsMaintenance Temperature Control Needles Position

View / Define SW Identification Session Error History Sort Test SW Upgrade ► File Error History Interference Table Logbook Default Tests Service (dimmed) Reflex Tests

Software Upgrade SW Master ► SW Slave► SW REM►

Profiles Test Groups

Backup Test Group Profiles Sort Multi-Tests Upload Default Multi-Test

Upload Upgrade

Host Printer Internal Barcode External Barcode Keyboard Network (dimmed) Modem (dimmed)

Hardware Component Overview


Window Icons

Window Icons Command / Action

Confirm

Cancel (dimmed if Edit action not allowed)

Print


i t i (Host) Transmit

Delete

d l t i Add to the list

Remove an item from the list

Transfer an item from one list to

another

Details

Information in different languages

New Sample

t i

Extract Sample Data

Note

Patient Name

Patient Details

Save information to floppy disk

Toolbar Icons

Toolbar Icons

Commands / Actions

Instrument Status

(Icon active)

Short Turn Around Time (STAT) - Urgent sample Pressing this button opens a window that guides the operator. Confirmation is required

Operating Hold

Instrument Status Informs the operator about the status of

the operation in progress

O Operating Hold

Close/Open cover This operation is disabled if there is a

possible interference with the instrument operation

Ready Hold

STOP Confirmation is required

Ready Operating

Hold

Resume Starts the operations paused due to a

STAT request

Hold

Data Base View The system goes back to the database

view or “Main” screen

Ready Operating Hold

Host Status

h t d i

Icon appears only during communication with the Host to inform the operator about the status of this action.

Ready Operating Hold Failure

Warning This icon appears when there is at least one warning. Press to open “Warning List”.

Ready Operating Hold Failure

Log Out Ready Allows the operator to Failure exit the screen. Confirmation is required


Message Icons

Icon Meaning

QUALITY CONTROL Indicates there are data (results) in the database

QUALITY CONTROL Indicates a failure in a quality control test result

REAGENT VIAL ICON Indicates the status of the reagent map. (Warning No reagent)

REAGENT VIAL ICON Indicates the status of the reagent map. (Warning reagent low)

REAGENT VIAL ICON Indicates the status of the reagent map. (Sufficient reagent)

ERROR. To call attention to high priority failures and fault messages

WARNING To deliver different kinds of messages, i.e. to warn the user of a “not allowed/wrong” operation, or of problems/errors detected by the instrument during or after an operation

QUESTION To request confirmation by the user before starting an operation or before canceling an action

INFORMATION To offer general information. In some boxes, but not always, the message is followed by a request for confirmation


Material Status Colors

Color Status Letter / Symbol Status


Empty or Available

STAT

Not Programmed Pending

Programmed Complete

Not Programmed Processing

Sample Processing Complete

Quality Control Pending

Warning or Errors

Low Volume

Sample not Identified

Empty Cup in Position Empty

Materials Map


Reagent Loading – The Materials map displays a graphical representation of liquid positions on the instrument. The map displayed above represents an ACL Elite PRO only. An ACL Elite does not have positions (R9-R12), as shown above. The external barcode reader can be used to load liquid reagents in displayed materials map. Or select the icons: reset volume and start timer when loading a new liquid, this is an optional operation defined by the user. The materials map screen can display the status of liquids by color onboard along with additional information when clicked on each colored circle positions: Green – Volume of liquid position is greater than the warning limit and stability is OK. Orange – Volume of liquid position is less than the warning limit or either the onboard or lot number stability has expired. Red – Instrument detects the shortage of liquid in the position. NOTE: When you select start / resume a run, the materials map is not checked by the instrument sample arm liquid sensor for volume status. The analysis will proceed regardless of color of the reagent position. The colors displayed are only visual alerts. Make it a habit to: check the status of the reagents before starting a run, physically and color making appropriate adjustments, as needed.

Sample Status

Sample Positions are displayed by quadrants, ten per quadrant, (1-10, 11-20, 21-30 and 31-40). Refer to Material Status Colors for additional information.

Selecting the sample position circle will display the information about that sample.


#: Sample Position on the tray +: Sample Priority - STAT indicated by a checkmark S: Status of Tests (P, C, or N) P – Pending; one or more tests missing a result C – Complete; all tests programmed are analyzed N – No Test; Identified sample has no tests programmed F: Flags associated with sample


Pre-run Checklist

Instrument Status in Ready, prepare the start of a run by performing these tasks or verify performance:

Daily Maintenance (See Maintenance section, Training Manual or Operators manual for specifics)

Reagent Status – Check for adequate reagent volumes and acceptable on-board stability (See Materials Map page, Training Manual or Operators Manual for specifics)

Check QC Status – if necessary program and process controls (See QC section, Training Manual or Operators Manual for specifics)

Process Patient Samples – Program if necessary (See Sample Status Sample Programming, Training Manual or Operators manual for specifics)

Processing Samples

Connected to Host with Default Tests Enabled

1. Place primary tubes with barcode labels facing outward on Sample Tray

2. Select Materials Map icon and confirm: reagents are onboard, in correct position, lot number and volumes are updated, Rotors and Wash R Emulsion supplies are onboard

3. Select Start icon

Note: May be prompted to load new rotor or identify the next available cuvette position; can occur when user has requested rotor cover to open or sensor detects questionable position availability due to reagents dried out in a cuvette position.

Default Tests enabled and sample having no tests ordered after host query, the default tests will be completed on the sample.


No Host Connection and No Default Tests Enabled

1. Place primary tubes with or without barcode labels, and/or sample cups onto Sample Tray (Ensure barcode specimens are orientated outward)

2. Select Analysis

3. Multi-test Session (or Single Test Session)

4. Select the Test Profile with the tests ordered for the specimens placed on the Sample Tray

5. Select Read Bar Codes icon

Note: The Sample Tray engages, the barcode reader reads any bar coded specimens and the sensor places any non-bar coded sample positions on the map and generates the following message:

Warning: Error in Sample Identification

6. Acknowledge the message by selecting OK

7. Locate the unidentified sample position icon within the Quadrant

8. Select Program Sample icon

9. Enter the patient information/demographics based on your laboratory protocol

10. Select Tests order tests from list of enabled tests

11. Select Confirm OR select the to move to the next unidentified specimen. Repeat entering patient information/demographics until all samples identified.

12. Select Prev. Prog. icon if tests requested are same as previous sample, if different select Tests

13. Select Materials Map icon and confirm: reagents are onboard, in correct position, lot number and volumes are updated, Rotors and Wash R Emulsion supplies are onboard

14. Select Start icon



Pause Session / Adding STAT

1. Instrument Status is Operating

2. Select STAT / Pause Session icon

3. Message appears asking; “The running session will be held. Is that OK?” Answer Yes

4. Message appears; “STAT has been requested please wait”

5. The instrument will prompt; “STAT sample can be inserted now” Select OK

6. Add primary tube or cups

7. Select Read Bar Codes icon (With Host Connection, tests will be ordered based on the host query. If not….)

8. Identify any samples, order tests, select STAT icon for STAT priority

9. Select Resume / Start icon (Resume / Start icon now located in lower left corner of toolbar, took position of STAT icon)

10. Message; “STAT was successfully resumed” Select OK

Note: Database View screen displays STAT samples by automatically placing a in the column


SAMPLE ANALYSIS

Review Results

Load Samples

Select Analysis

Host

Material Map

Barcoded Non Barcoded

Warning: ID Specimen Enter demographics Order tests

Verify Reagents

No Host

Start

Start


Maintenance

Be sure to wear personal protective equipment (PPE) when completing maintenance: Lab coat, gloves, and either full face shield or protective eyewear. Refer to Maintenance Module in Training Guide and/or Chapter 5 in Operators Manual for complete instructions. Daily:

Check Wash R Emulsion volume Check Liquid Waste, if necessary Empty Rotor Waste Container Perform Clean Cycle Clean Waste Line, if necessary, dependent upon daily workload Perform Prime Procedure

Weekly:

Clean all key instrument areas Clean Rinse Waste Reservoir

Bi-Weekly:

Reboot Instrument Clean Rotor Holder and Optic Path

Monthly: Clean Air Filter

As Needed: Replace Needle Block Align Needles Waste Line Bleaching Decontamination Clean LCD Touch Screen Hard Drive Maintenance Disk – Defrags and Optimizes Hard Drive


Maintenance

Log Sheet

Make Copies as needed

ev A

A (N

ovem

ber 2

010)

Pa

ge 1

6 of

30

AC

L E

LIT

E /

EL

ITE

PR

O S

yste

m M

aint

enan

ce L

og1

2 3

4 5

6 7

8 9

1011

1213

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

Mon

th__

____

____

Ye

ar _

____

____

__

DA

ILY

CH

EC

K W

AS

H R

-EM

ULS

ION

LE

VE

L

EM

PTY

LIQ

UID

WA

STE

IF

NE

CE

SS

AR

Y

EM

PTY

RO

TOR

WA

STE

C

ON

TAIN

ER

PE

RFO

RM

NE

ED

LE C

LEA

NIN

G

PR

OC

ED

UR

E

CLE

AN

WA

STE

LIN

E,

DE

PE

ND

EN

T O

N D

AIL

Y

WO

RK

LOA

D

PR

IMIN

G -

STA

RT

OF

SH

IFT/

DA

Y

PR

IMIN

G- E

ND

OF

SH

IFT/

DA

Y

W

EEK

LY

CLE

AN

INS

TRU

ME

NT

C

LEA

N R

INS

E R

ES

ER

VO

IR

B

IWEE

KLY

R

EB

OO

T TH

E A

NA

LYZE

R

CLE

AN

RO

TOR

HO

LDE

R A

ND

O

PTI

C P

ATH

M

ON

THLY

CH

EC

K A

ND

CLE

AN

AIR

FIL

TER

A

S N

EED

ED

MA

INTE

NA

NC

E

RE

PLA

CE

NE

ED

LE

NE

ED

LES

PO

SIT

ION

P

ER

FOR

M W

AS

TE L

INE

B

LEA

CH

ING

DE

CO

NTA

MIN

ATI

ON

P

RO

CE

DU

RE

CLE

AN

LC

D S

CR

EE

N

HA

RD

DR

IVE

MA

INTE

NA

NC

E

DIS

K

TE

CH

INIT

IALS

PN

774

413

RM

iam

i Edu

catio

n C

ente

r


Ordering Information for Expendables

Catalog Number

Item Description # Pieces in Package

Unit 181108-98* Sample Tray for 13x75 & 13x100 mm, (5 mL)

tubes 1

181812-85 Sample Tray for Sarstedt 11.5x66 mm (3 mL) & 11.5x92 mm (5 mL) tubes

1

190764-00 Sample Tray adapter for plastic cup 4 190763-00 Sample Tray adapter for 4 mL vials 6 181812-65 Adapter for 10 mL reagent vials with magnetic

stirring (gray) 4

190762-00 Adapter for 10 mL reagent vials without magnetic stirring (pink)

6

190761-00 Adapter for 4 mL reagent vials without magnetic stirring (green)

4

97466-06 Magnetic Stirrer 6 189241-00 Glass Vials, 10 mL 10 67992-00 Sample Cups, 0.5 mL 1000 55751-00 Sample Cups, 2 mL 1000 67994-00 Cups, 4 mL, plus Labels 100 68000-00 Rotors- 20 cuvettes 100 181812-77 Rotor Refill Tool 1 181108-97 Rotor Waste Container 1 181108-43 Block Probe Assembly 1 181039-41 Needles Adjustment Tool 1 73289-01 Sample and Reagent Tubing, 1.5 m 1 181080-65 Sample and Reagent Tubing Extractor Tool 1 181812-72 Waste Reservoir, for needles wash 1 181057-69 Liquid Waste Bottle 1 99095-03 Waste Tube, 1.5 m 1 181812-71 Air Filter, molded 1 68931-02 Fuses 6.3 AT 2 148821-00 Power Cord, 100-115 V 1 197255-00 Power Cord, 220-240 V 1 84864-50 External Printer Cable 1 184202-38 Host Computer Cable (9 pin – 9 pin) 1 200024-00 Wash/Reference Emulsion, 1 liter 1 190068-00 Operator’s Manual, English version 1

*Sample Tray included in Start-up Kit


Quality Control

Set up QC

1. Select QC

2. Setup / Review

3. Select Control Material from list to define and setup QC

4. Select Tests from Enabled Test list

5. Move Selected Tests to Configured Test List

6. Enter Lot Number and Expiration Date of QC Material

7. Select each Configured Test and input:

o Units for each Test

o Target Mean

o Target SD

o SD Range

8. Select QC Range Check-Flags if out of Range based on input

9. Select Flag Patient Results-Flags patients results after an out of range control is detected

Setup QC LoadList

1. Analysis

2. Multi-Test Session

3. Select the Multi-test that contains the tests for QC material

4. Select Add QC, a list will display all setup QC Liquid List

5. Select QC Material, continue until all QC is setup

6. Store Loadlist, 1-20

7. Select Confirm

Running Quality Controls

1. Select Analysis

2. Select Multi-test Session

3. Check Loadlist No. icon

4. Enter Loadlist number for QC Materials

5. Select Enter, programmed Loadlist will display on Multi-test Analysis Screen

6. Label cups with QC Material and place on tray based on display

7. Select Materials Map, confirm all reagent levels

8. Select Confirm

9. Select Start

Review Quality Control Results

1. Select icon from Toolbar region on screen

2. QC out of range will show the QC icon with a red ! alert

3. Results:

o Within range display in black

o Outside 2SD range display in violet or blue

o Outside 3SD range display in red

Results can be omitted by selecting Cumulative file from the QC List OR QC / Setup /Review, then Select QC level and Specific test to be reviewed / omitted ( displays in omit column)

4. Select Note icon add a note for QC out of range (note can contain up to30 alphanumeric characters)

5. To clear icon, clear single QC level out of range from the QC List (results remain in QC database until a new lot is entered)

6. The Levey Jennings Chart from the Plot / Statistics screen displays:

o Black asterisk result within range

o Blue diamond ◊ result outside 2SD

o Red triangle Δ result outside 3SD (point is in direction out)


Printing Controls

Print All QC

Print Today QC

Levey Jennings

Cumulative

Clear All

Clear Single

1. Select the Print Today QC icon to print only today’s QC

2. Select the Print All QC icon prints all QC in List (stores 100 tests)

3. Review a specific result and QC file, Select the Cumulative Results icon

4. View a Levey Jennings chart for a control level, Select Plot and Statistics icon

5. Review and Confirm to close



Calibrations

Calibration procedures are common to all calibrated tests. Variables are test-specific reagents and material used during calibration. The instrument requires certain tests to be calibrated either prior to or during sample analysis.

Dedicated: Calibration is a separate session, is initiated from the Calibration menu and is stored as the last executed calibration curve. The curve is viewable under calibration review from drop down menu.

In Session: Calibration is executed with the sample run and then can be used in later sample runs. (Calibration Plasma onboard sample tray, calibration will be performed automatically; if not the onboard stored calibration curve will be utilized for additional sample runs.)

Each Rotor: Every time a new rotor is loaded for that test a calibration must be done for that assay.

Calibration Summary

1. Select Calibration from drop down menu

2. Select Calibrate

3. Select Test from Tests to Calibrate

4. Select Materials Map and ensure: all reagents are onboard have ample volume and stability, this includes rotor supply, and Wash R Emulsion

5. Select Start

6. Upon completion review data and ensure r2 value is in acceptable range for assay and no errors are displayed (Repeat if necessary)

7. Successful completion, select Confirm to store calibration

CALIBRATION

Calibration

Materials Map

Verify/Change Lot Specific Information: • Lot Number • Expiration Date • ISI • Calibration Target

Analysis

Calibrate Select the Test to Calibrate

Review Calibration

Review data: • Acceptable r2 value • No calibration errors • Accept Calibration

Select Multi-Test or Single Test • Check Materials Map • Load Samples • Select Start

• Drop down menu displays all enabled tests for calibration



Troubleshooting

Types of messages generated with system problems

Warnings: displays as a yellow icon in the lower right toolbar region. Selecting the warning icon allow viewing of description of error. Instrument may continue to run, with some limitations depending on problem.

Alarm: warns user of problem requiring immediate attention. Some sub-functions and operations will still be available. Log off instrument, power off and on again; if error persists contact Call Center.

Failure: message indicates a problem serious enough to prevent further use of instrument. Attempt to log off instrument (if serious enough may not be able to navigate in software), power off and on again; if error persists contact Call Center.

Troubleshooting steps:

1. Gather information (what, how, when….)

2. Identify the symptoms (only when we do ____ )

3. Broadly Categorize (QC, sample tray, rotor area, temperature…)

4. Isolate the issue and develop a plan (what can I do before calling Call Center?)

5. Correct the issue

6. Verify the corrective action (run QC, re-calibrate, run samples….)

7. Document (use for regulatory or future training for peers)

Coagulation Errors

Error Description Abbreviated Flag Priority

Data Reduction Errors R 1 (highest)

Temperature Errors T 2

Instrument Errors E 3

Calibration Errors C 4

Analytical Reference Errors A 5

QC Errors Q 6

Parallelism Errors P 7

Errors on Algorithms, Ratio, Ranges W 8

Materials Errors M 9 (lowest)


Error codes/meanings/remedies

Error Code

Meaning Flags Results Action

1 No flush/optical error

R Cycle abort

No results Replace Reference Emulsion bottle, clean optics and retest sample.

5 Optical failure

R Error 5 No result

ADC saturation (signal above 9.5 V at the end of clotting curve). Possible high Fibrinogen concentration. Dilute the sample 1:1 with factor Diluent and repeat the test.

6 No Coag R Error 6 No result

First threshold not passed. Sample does not clot within the acquisition time. Repeat the test in extended acquisition time.

7 Coag error R Error 7 No result

Second threshold not passed. Sample clot is noisy and does not give a normal clot signal within the acquisition time. Repeat the test in extended acquisition time.


Delta time between the two thresholds is higher than the selected value. Possible non-phasic clotting curve. Review the clot curve. Possible sample interference with clotting reaction.


Initial slope of the reaction curve is higher than the selected value. Possible bi-phasic clotting curve. Review the clot curve. Possible sample interference with the clotting reaction.


Final slope of the reaction curve is higher than the selected value. Unstable endpoint of the clotting curve. Review the clot curve. Possible sample interference with the clotting reaction. Repeat the test in the extended acquisition time.

11 Final delta error

R Error 11 No result

Final delta of the reaction curve is higher than the selected value. If this is a nephelometric reaction, it may be an indication of an unstable endpoint in the clotting curve. Review the clot curve. Possible sample interference with the clotting reaction. Repeat the test in extended acquisition time. If this is an absorbance test, it may be an indication of an absorbance value outside the specified limit.


Maximum peak of the first derivative is below the selected limit value. First derivative peak is not significant enough to indicate a real clotting reaction point. Review the clot curve. Repeat the test in extended acquisition time.


Maximum peak of the second derivative is below the selected limit value. Second derivative peak is not significant enough to indicate a real clotting reaction point. Review the clot curve. Repeat the test in extended acquisition time.

14 Offset error R Error 14 No result

Offset of the initial part of the curve is above the selected limit value. Initial reaction turbidity is relatively high. Review the clot reaction curve.

30 Offset error (delta algorithm )


Initial reaction turbidity is relatively low. Review the clot reaction curve. Check integrity of reagents, and make sure no bubbles are present.


Error Code

Meaning Flags Results Action

31 Minimum Curve Delta not met

R. Error 31 instead of the result.

Review the curve and rerun the sample. Sample may have an extended clotting time.

32 Reaction curve baseline readings are erratic

Q-Noisy Baseline/ Reaction curve

Numeric Result displayed

Review Curve and repeat sample.

33 Reaction curve baseline readings are erratic

Q-Noisy Baseline/ Reaction curve

Numeric Result displayed

Review Curve and repeat sample.

40 QC not valid (No check QC selected)

Error 40. No QC result

No flag on samples

QC gives a non-valid result. Review the reaction curves. Repeat the test with freshly prepared materials.

41 QC not valid No flag on samples



42 QC out of range

No flag on samples

QC result is not flagged

QC gives a result out of range. Review the reaction curves. Repeat the test with freshly prepared materials.

43 QC invalid s Q – Flag on patient samples



44 QC out of range

Q – Flag on patient samples

QC is flagged


70 Curve Sequence error


Check sample and rerun. Clot curve not available. Sample may have an extended clotting time.

71 Too many spikes error


Review curve, check sample and rerun. Invalid result. Sample may have an extended clotting time.

72 Baseline SD error

R Error 72 No results


73 SyX value greater than Max. SD

R Error 73 No results


Note: Full list of all errors codes are in Operators Manual, Chapter 6. This list represents a numerical sequence of more common error codes. (Operators Manual separates error codes by type of error, for example: QC, Calibration, Session Errors, Ratio and INR…, not necessarily sequenced numerically)

AccuTrak

AccuTrak is Instrumentation Laboratory’s inter-laboratory quality control program. This program will assist your QC program by:

• Statistically comparing your results with other labs using like reagents and instrumentation.

• Providing users with ongoing peer comparisons for managing laboratory quality. • Monitoring laboratory accuracy and precision. • Providing users with a selection of reports excellent for reviewing instrument

performance and satisfying inspectors’ requirements.

Enrolling in AccuTrak There are two choices for enrollment.

1. Call the AccuTrak center at 1-800-678-0710, option 7 and request a new users account.

• AccuTrak Laboratory Code Number. • AccuTrak Quality Control Program Procedures Manual. • 2 sets of data input forms. • Pre-addressed mailing envelopes. • Calendar with mailing dates indicating when your data should be put in

the mail. • AccuTrak On-Line Account Access registration information for on-line

QC services. After that, additional supplies can be ordered online at the website below or by calling at the number above.

2. Enroll on-line at www.ilus.com by selecting:

Service and Support ► AccuTrak ►complete enrollment information then Send Request.

Or type entire URL:

Once enrolled, you will receive an e-mail confirming registration and activation of your account.


http://www.ilus.com/

WWW.ILUS.COM



CHANGE THE DATE AND TIME

Select Setup / Date/Time

Drop Down arrow Cancel

Confirm Date/Time

Select Date Format- Use The Drop Down Box ▼ • dd.mm.yyyy (European style)

• yyyy.mm.dd (Japanese style)

• mm.dd.yyyy (USA style)

Set Date and Time, two numeric fields are available.

Note: Changing date to a previous date may impact results (Patient, QC and Calibration) and database FIFO (First In, First Out) operation. Follow the same procedure when changing the time to Daylight Savings Time (if applicable).

Review and select Confirm


NEW TEST SETUP

Select the Test to Calibrate • Load Reagents. Per Materials Map: • Calibrate the Assay • When calibration is complete

review data and ensures that there is not error.

Setup Liquids

Enter Lot Specific Information: • Lot Number • Expiration Date • ISI* • Calibration Target

Select Multi-Test or Single Test • Check Materials Per Materials Map • Load Samples • Press Start

Analysis

Setup Test

• Enable Test • Modify Ranges • Calculation Setup

Mean of the Normal Range (MNR)

QC QC Setup/Review: • Mean & SD • QC Range Check • Patient Flag

View/Define:

Calibrate (dedicated)

New Test Setup


Documents

INSTRUMENTATION LABORATORY ACL ELITE / ELITE · PDF fileSetup / Review System Configuration Save Rotor Map ... N – No Test; Identified sample ... Pre-run Checklist