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iRICELL Complete Urinalysis Training Guide of 187 Beckman Coulter Ver 2.1 (July 2017) Technical Training

iRICELL Customer Training Modules

Name_________________________

This document is not intended to replace the information in your Instrument Instructions for Use Manual (IFU). Information in the Instructions for Use Manual supersedes information in any

other manual.


WARNINGS AND PRECAUTIONS

READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT. 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 EQUIPMENT.

TRADEMARKS

The iChem®VELOCITY and iQ®200 Series system are trademarks of Iris Diagnostics Division of IRIS International, Inc. All other trademarks are the property of their respective owners Beckman Coulter and the stylized logo are trademarks of Beckman Coulter, Inc. and are registered with the USPTO. IRIS is a trademark of Iris International, Inc. and is registered with the USPTO All other trademarks, service marks, products or services are trademarks or registered trademarks of their respective holders.

Made in USA


REVISION STATUS

iRICELL Customer Training

Revision1.3 Release (Nov 2015) Software release 7.0 (and higher) Presented December 2015, Miami, Florida

Revision2.0 Release (June 2017) Software release 7.0 (and higher) Presented November 2016, Miami, Florida


TABLE OF CONTENTS –

Section 1- Routine Operations

Module Page

Package Inserts 7

Software Overview 13

Daily Maintenance 27

VELOCITY Consumables (QC Configuration) 37

Processing Quality Control 43

QC Statistics 53

Sample Analysis 61

Auto-Release and Result Verification 73

Importing and Exporting Results 93

Section 2- Maintenance

Sample Flow component Identification 103

Weekly and Monthly Maintenance 115

Quarterly and As Needed Maintenance 123

Troubleshooting 131

Shutdown and Restart 141

Section 3-Additional Topics

Body Fluids 149

Sample Analysis 2 161

Security Access 169

Traceability 177

View Log 183


ICHEM VELOCITY STRIPS PACKAGE INSERTS

OBJECTIVES

Given an iChemVELOCITY Strip package insert be able to:

Locate what specific tests are based on

Locate sensitivity of specific tests

Locate and describe the limitations of specific tests

Why Is It Important?

The iChemVELOCITY Strips are manufactured for use only with the iChemVELOCITY Urine Chemistry system and are intended for use exclusively by healthcare professionals. These qualitative or semi-quantitative measurements can be used along with other diagnostic tools in the evaluation of renal, urinary, and metabolic disorders.

Resources

iChemVELOCITY Package insert


INFORMATION/PRACTICE

The iChemVELOCITY strip package inserts are laid out in the following order:

Intended Use: The iChemVELOCITY Strips are manufactured for use only with the iChemVELOCITY Urine

Chemistry system and are intended for use exclusively by healthcare professionals. These

qualitative or semi-quantitative measurements can be used along with other diagnostic tools in

the evaluation of renal, urinary, and metabolic disorders.

Principle of the tests and chemical composition of each pad:

Precautions

Storage and Stability of the strips

Specimen collection and preparation

Procedure

Follow the directions in the system’s IFU. The system will automatically read each analyte

and the results are displayed or printed as soon as they are available.


Quality Control

Clinical performance of the iChemVELOCITY Strips should be confirmed regularly using

IRISpec Urine Chemistry Controls CA/CB/CC. Each individual laboratory should establish its

own guidelines for acceptable clinical performance. Follow Local, State and Federal

guidelines concerning quality controls.

Limitations of the procedure which include:

Expected Values

Sensitivity

Performance Characteristics

Limitations

Technical Support

References

Method Comparison

The performance of the iChemVELOCITY was compared with commercially available

urinalysis systems. Urine samples were from a hospital or a commercial laboratory. Samples

with concentrations covering the entire assay reporting range were tested. The urinalysis

systems used provided semi-quantitative and/or qualitative results with the exception of

glucose and SG, where quantitative results were provided.

Precision

Within-run precision – Three levels of target analyte concentrations for each assay

(negative, first positive level and highest positive level) were tested 3 times each for 20 runs.

The exact % agreement with expected results is shown

Day to day precision – Three levels of target analyte concentrations for each assay

(negative, first positive level and highest positive level) were tested over 20 non-consecutive

days. The exact % agreement with expected results is shown.

Congratulations, you have finished this module! Continue to the Skill on the next page


SYSTEM OVERVIEW SKILL CHECK

Using an iChemVELOCITY Strip package insert answer the following questions:

1. Ascorbic Acid is based on what method test?_______________________________

2. Which type of bacteria is not detected in the Nitrite test?______________________________

3. What color does the blood pad change to based on the peroxidase effect of hemoglobin and

myoglobin?________________________________________________________________

4. What is the sensitivity of Protein? ________________________________

5. What is the sensitivity of Ascorbic Acid?____________________________

6. What is the sensitivity of Bilirubin?________________________________

7. What is the sensitivity of Leukocytes Esterase?_____________________________

8. Ascorbic Acid can interfere with the following at what concentration?

a. Blood_____________________________

b. Bilirubin____________________________

c. Nitrite______________________________

d. Glucose_____________________________

e. Ketone______________________________


SOFTWARE OVERVIEW

OBJECTIVES

Given an operating iRICELL Complete Urinalysis System:

Log On and Log Off the APUI

Be able to identify the iRICELL System Software


This module introduces the basics of the iRICELL Complete Urinalysis System. A basic software overview allows identification of the general parts of the operating system known as the APUI (Analysis Processor User Interface and help identify common screen elements useful for efficient navigation. The introduction to System HELP shows how to access the information contained in the IFUs.

Resources

iRICELL System

iChemVELOCITY IFU

iQ IFU


I

NFORMATION/PRACTICE

Logoff/Logon to the APUI (Analysis Processing User Interface)

In order to process patient samples, you must log on. Both an Operator ID and a Password are required. The system administrator will assign these to you in the lab. For classroom purposes, use BCI as the Operator ID and bci (lower case) as the Password. Both the Operator ID and Password are case-sensitive.

Step Action

1 Select the Logoff button at the top right of the Instrument screen.

NOTE

Until someone is logged on, the Specimens, Work List, and Instrument

buttons are inactive.

The operator field will display

2

Select the Logon button then choose the user name: BCI (case sensitive) in the Identifier field using the drop down browser on the right side of the field to display and select the user name.

3

Type in the Password: bci (case sensitive)

NOTE: Neither the Operator ID “BCI” nor the password “bci” are present in the system. Upon installation, Operator IDs and Passwords must be set up.

4 Select .


iRICELL Software

The iRICELL User Interface Software is composed of three main screens:

Instrument screen

Work List /Found List screens (used to search; toggle between both lists)

Specimens screen

Instrument Screen

Number Description Number Description

1 Status Area 4 Screen Level Function Area

2 View Selector Area 5 Task Level Information Area

3 Information Pane

5

4

3

1

2


Common Screen Elements

Instrument Screen

Menu Description

Status Area

Status light Indicator:

Grey: Off

Green: Standby (Energy conservation)

Blue: Measure (Sample measurement in progress)

Red: Error (Error condition occurred)

iQ Status

IChemVELOCITY Status

Alarm

Rack/Position (sequence number), and identification of the currently aspirated tube (if any).

Icon of the highest priority alarm (if any) and short description of the error condition.

Low priority Medium priority High priority

The Help button is visible all the time. Select the Help button to display the folders containing the IFUs.

Operator Identification of currently logged operator.

Last Micro Calibration

Date and time of the last successful microscopic calibration includes the REF (Run Equivalency Factor): result range 1.4-2.7.

Last Micro QC Date and time of the last successful microscopic quality control.

Last Micro Auto Focus

Date and time of the last successful microscopic automatic focus.

Last Reflectance Check

Date and time of the last successful reflectance calibration verification check.

Last SG/Color/Clarity

Check

Date and time of the last successful specific gravity, color, and clarity calibration check.

Last Chem QC Date and time of the last successful chemistry quality control.

LIS Identifies if the LIS is OK, down, or disabled.

Manual Orders Displays racks manually programmed. It allows the operator to clear racks.

System Status On Line or Off Line (displays in red when off line).

Alarms Appear in the Information Area and display the detailed list of unresolved alarms (sorted by priority) then date and time.


Screen Level Functions

Button Function

Access to Manual Orders screen: Used when LIS is not available or when manual program is needed.

Access to view the consumables window to monitor and track consumable usage (traceability) or to identify the lot numbers for chemistry strips and chemistry QC.

View and manage QC results and calibration history.

Use to view, print, or save (external media) QC files including the Levey-Jennings charts which are plotted by QC lot number.

Access to user-defined instrument settings such as: Operator Accounts, Lab Information, System Configuration etc. IMPROTANT: Prior to making any changes in Settings please contact a Beckman Coulter Representative.

Access to various maintenance procedures such as: Reflectance Check, Chemistry Service, Auto Strip Counter Override, Backup, Restore, System Info, Tallies, Errors, Shutdown, Restart, Defragment, and Check Disk.

Each sample run on the system is assigned a sequence number. Use the screen to enter the next sequence number to be used or reset the sequence number back to number 1.


Work List Screen

Work List Functions

Work List Screen

The Work List contains only unreleased results. It displays the Specimen ID, date and time the sample was processed, rack and tube position numbers, sequence number, and the status of each specimen results.

While On Line

An operator can:

Sort the Work List

Delete a specimen

Un-delete a specimen

Print the Work List

Correct/Modify the Specimen ID

Edit patient demographics

Review and release sample results

Search button

Select the Search button from the Work List to view samples in the Found List. See the next page for search options.


Search Screen

Search screen

Select the Search button from the Work List to make selections to view samples in the Found List by:

Specimen ID

Sequence number

Operator ID

Date/time range

Patient demographics

Patient location

Specimen awaiting transmission

Specimen already released

Incomplete samples


Found List Screen

Found List Functions

Found List Screen

From the Found List, you can edit specimen results, re-report specimen results, print, or transmit. Select the sample to open the Specimen Screen to view the chemistry and microscopic results.

Search button

The Search button is a toggle between the Work List and Found List.


Instruction for Use (IFU)

All graphics including screens and printouts are for illustration purposes only and must not be

used for any other purpose.

Step Action

1 Select the System HELP icon . An Open Help File window will display.

2

From the Look in window, select Desktop from the drop down menu. Locate and open the folder label Ops Manual.

Choose the desired IFU (VELOCITY or iQ), then click Open. For this exercise, select IChemVELOCITY IFU.

The selected IFU displays in a separate window.

NOTE Help is a PDF version of the IFU (Instructions for Use)

3 Select the Search icon.

4 Type System Status Lights in the search area and select search.


5

Use the help topic located in the previous step to fill in the chart below:

System Status Light On Meaning

The iChemVELOCITY is in

The iChemVELOCITY has


The iChemVELOCITY is in


All lights blinking simultaneously

The main power switch

5 Select the X in the upper right corner to close Help.

6 Using steps 1 and 2 above if needed, access the iQ IFU.

7 From the iQ IFU navigation pane open Chapter 2, Operations Principles using the + sign.

8 Select the topic “Microscopic Particle Identification.”

9

Using the Auto-Classification Categories fill in the chart below:

Category Abbreviation

Non-squamous epithelial cells

UNCX

WBCC

Yeast

SQEP

Unclassified Casts

10 Close Help.



SOFTWARE OVERVIEW SKILL CHECK

1. Label the sections of the Instrument screen:

1

2

3

4

5

1

2

4

3

5


2. Identify the following

3. What screen are samples that require review placed? _____________

4. How does the operator switch from the Found List to the Work List?


DAILY MAINTENANCE

OBJECTIVES

Given an operational iRICELL Complete Urinalysis System and using the IFU be able to:

Empty and Clean the iChemVELOCITY strip waste container

Discard liquid waste (if applicable)

Clean the Sample Transport Module on both the iChemVELOCITY and iQ200

Clean the optional Load and Unload trays (if applicable)

Clean iChemVELOCITY and iQ200 instrument surfaces

Add chemistry strips and desiccant to the iChemVELOCITY

Check Lamina and Wash Solution, change if needed


Maintenance should be performed to ensure optimal system performance. Performing the daily maintenance procedures will ensure your system has an adequate amount of supplies and reagents for processing patient samples. It is recommended to process QC to verify system performance before processing patient samples.

Resources

iChemVELOCITY IFU

iQ IFU

Alcohol wipes

1:10 dilution of Iris System Cleanser

DI water

Paper towles/guaze



DAILY MAINTENANCE ON iChemVELOCITY

Empty and clean strip waste container

The strip waste container should be emptied and cleaned at least daily. High volume labs should empty and clean their strip waste container after every 300 strips.

Step Action

1 Open the waste container door.

2 Remove the waste container and discard used test strips according to local regulations.

3 Clean the waste container with alcohol or mild detergent and then rinse with tap water.

4 Thoroughly dry the waste container.

5 Reinstall the waste container.

6 Close the waste container door.

Discard liquid waste (NOT NEEDED IN CLASS)

Step Action

1 Remove the drain bottle cap and tubing from the drain bottle.

2 Discard the liquid waste according to local regulations.

3 Clean the drain bottle with a mild detergent and water and then rinse with tap water.

4 Insert the drain tube into the drain bottle and tighten the cap.


Cleaning the Sample Transport Module (STM)

Step Action

1 Moisten paper towels with Iris System Cleanser diluted 1:10.

2 Wipe the STM to remove any deposits.

3 Clean under the belts and the pulleys. Do not excessively stretch belts or pulleys.

4 Wipe again using distilled water.

5 Wipe dry.

Cleaning the instrument surfaces

Step Action


2 Wipe the exterior surfaces of the analyzer to remove any deposits.


4 Wipe dry.


Loading Urine Chemistry Strips

Step Action

1 Rotate the strip loader to unlock position and pull out from the analyzer.

2 Remove and discard the old desiccant and replace with the new desiccant.

3

Fully extend the strip loader and tilt it at a 45-degree angle.

Load the urine chemistry strips inside the Test Strip Loader as indicated on the Test Strip Loader (Iris logo facing the back of the instrument).

4

Retract the strip loader, and then shake the loader lightly so that the chemistry strips are straight.

Insert the strip loader inside the analyzer, and rotate the strip loader counter clockwise to the lock position. The chemistry strips drop inside the strip provider module, and the strip provider module will tumble to place the strips in the flat position using a quick consistent rotation.

NOTES: Load 5 days of strips (up to 300 strips maximum) by loading up to 100 strips at a time.

The strip provider module chamber can hold a maximum of 300 strips

Remove and replace one desiccant pouch with each strip load (or strip loading event) or when the

SPM is opened (i.e. strip jam or SPM maintenance). Any existing strips must be replaced with new

strips whenever the SPM is opened.

A strip loading event is defined as loading up to 300 strips in the SPM chamber by filling the strip

loader with up to 100 strips at a time and turning the strips to drop into the SPM chamber.

Allow the chamber to empty completely before adding new strips.

Desiccant and strips must be removed and replaced with each strip load completion.

CAUTION: Do not leave the test strips in the module for more than 5days. Strips exposed to the air

for too long can cause erroneous results.


Check Wash Solution / Replace if needed

The iChemVELOCITY Wash Solution comes packaged with the filters (one per bottle). Replace the Wash Solution Filter with each bottle. The instrument will display a message when empty. The Wash Solution has a 90 day open stability.

Step Action

1 Visually inspect the volume of the Wash Solution. If low, proceed with remainder of steps.

NOTE Wear fresh gloves when changing the Wash Solution filter.

2 Make sure the system is in Standby mode as indicated on the top left of the Instrument screen.

3 Remove the cap of the old Wash Solution bottle.

4 Remove the old filter by grasping the tube above the filter and pulling the filter straight off and discard according to local regulations.

5 Remove the new filter from its package and push straight onto the tubing of the Wash Solution cap. The filter only fits with the narrow section attaching into the tube.

6 Insert the tubing with the new filter into the new Wash Solution container and tighten the cap.

NOTE Do not mix the contents of the bottle.

7 Discard old container and old filter according to your local regulations.

DAILY MAINTENANCE ON iQ 200

Cleaning the instrument surfaces

Step Action


2 Wipe the exterior surfaces of the analyzer to remove any deposits.


4 Wipe dry.


Cleaning the Sample Transport Module (STM)

Step Action


2 Wipe the STM to remove any deposits.

3 Clean under the belts and the pulleys. Do not excessively stretch belts or pulleys.


5 Wipe dry.

Check Lamina Solution / Replace if needed

iQ Lamina is a buffered, isotonic solution containing proprietary laminar flow stabilizers, bacteriostatic agents, fungicidal agents, and preservatives. It is used to hydrodynamically position the flow of specimen within the focal depth of the lens of the microscope and to ensure streamlined flow by rinsing and wetting all fluidic components. This product may be stored at room temperature. The iQ Lamina open stability is good until date on bottle.

Step Action

1 Visually inspect the volume of the Lamina solution. If low, proceed with remainder of steps.

NOTE Wear fresh gloves when changing the Lamina Solution filter.

2 Remove the cap from the new container.

3 Remove the cap of the old container.

4 Attach the cap connected to the instrument to the new container.

NOTE The green filter located at the end of the tubing needs to be replaced every 4th bottle. A new filter comes with each box of Lamina containers. Best practice is to change the filter when loading the first bottle of a new case.

NOTE Do not mix the contents of the bottle.

5 Discard old container and old filter according to local regulations.


Wash Cycle

A wash cycle should be performed at the beginning of each workday to prevent accumulation of residue in the fluidic system. Iris System Cleanser must be used to clean the sample lines and the flowcell.

Congratulations, you have finished this module! Continue to the Skill on the next page.

NOTE: If Cleanser is run as part of the Control rack, this procedure does

not need to be performed separately.

In class, we will perform this procedure when we run controls


DAILY MAINTENANCE SKILL CHECK

1. How often is the requirement for changing the filter for the following:

iChem Wash ___________________

iQ Lamina______________________

2. Record the maintenance performed for the iChemVELOCITY in the table below:

Maintenance Procedures for iChemVELOCITY Initials

Daily Maintenance

Empty and Clean Waste Container

Clean STM (Sample Transport Module)

Clean Optional Load and Unload Trays

Clean Instrument Surfaces

Check Wash Solution and Replace if Needed

3. Record the maintenance performed for the iQ200 in the table below:

Maintenance Procedures for iQ200 Initials

Daily Maintenance

Clean STM (Sample Transport Module)

Clean Optional Load and Unload Trays

Clean Instrument Surfaces

Check Lamina Solution and Replace if Needed


CONSUMABLES (QC CONFIGURATION)

OBJECTIVES

By completion of this exercise, be able to:

Set up a new lot of Chemistry QC

Set up a new lot of Chemistry Strips

Restart the instrument to save the changes to system configuration


To avoid unnecessary troubleshooting and ensure the most reliable results, the system should contain the most current information for supplies used on the system.

Resources

iChemVELOCITY IFU

CA/CB/CC package insert

CA/CB/CC Control lot number and expiration date


I

NFORMATION/PRACTICE

Step Action

NOTE

iChemVELOCITY Quality Control information requires input into the software.

Note: The iQ Quality Control information is embedded in the barcode of the corresponding material.

1

Select Go Off line from the Instrument screen.

The following message will appear:

Any specimens currently being analyzed will be completed. The rack (if any) will be ejected.

Continue going Off Line?

Select Yes to confirm message.

2

From the Screen Level Function Area, select the Consumables button

to access the Consumables window:

3 From the Consumables window, select the Chemistry QC button

.

4

Enter the Test Strip Lot ID of the Chemistry strips located on the bottle of strips. Then, use the drop down box to access a calendar to enter the Expiration date.


NOTE: Expiration dates are YYYY/MM/DD. When inputting the expiration date in the software, choose the last day for the month in which it expires.

5 Select the Next button in the bottom left corner to access the first chemistry control level.

6 In the field for Control Name (Position 8), type in CA.

7 Enter the Lot Number located on the bottle of CA, and input the expiration date.

8

NOTE: In class, do not make any changes to the control ranges.

To fill in the lower and upper limits for each particle, use the drop down buttons only. Control limits are found in the package insert located in the IRISpec CA/CB/CC control box.

9 Select the Next button and repeat for CB (Position 9) and CC (Position 10) controls.

10 Once CA, CB, and CC lot numbers and expiration numbers have been entered in the system, select OK to confirm the entries and OK again to close the Consumables window.

NOTE It is recommended to restart the system when any changes are made to configurations.

11 Go to the Maintenance button and select the Restart button

. Once system restarts, log on using your Identifier and Password.


CONSUMABLE (QC CONFIGURATION) SKILL CHECK

1. What is the first step to put in new lot number for iChemVELOCITY strips and QC?

a. Select Chemistry QC

b. Go off line

c. Enter lot number and expiration date

d. Select the Work List button

2. Do you have to input QC information for the iQ controls? Why or Why not?

___________________________________________________________________________

___________________________________________________________________________

_____________________________________________

3. When changes are made to the configuration, what must be done?

a. Shutdown the system

b. Log Off and On

c. Nothing

d. Restart the system


QUALITY CONTROL

OBJECTIVES

Given an operating iRICELL Complete Urinalysis System, access to the System Help, and package inserts from control products, be able to:

Describe proper storage and handling for IRISpec™ CA/CB/CC

Describe proper storage and handling for iQ Control/Focus

Use the IFUs for procedures to run the various controls

Process the various controls

Access the control data (results), select various controls

Review control results: data and graphs

Recognize flagged results


Understanding how to store, handle, and use the control products available ensures reporting out the most accurate results possible to the clinician.

Resources

iRICELL Complete Urinalysis System

Control package inserts for Control products for processing

iChemVELOCITY IFU

iQ IFU

IriSpec Controls

iQ Auto Focus and Controls

Control Racks



Control Storage and Handling

Obtain the product insert sheets for each control and answer these questions on proper storage and handling:

IRISpec CA/CB/CC controls

Store refrigerated at _______ºC.

Yes or No: The CA/CB/CC controls should be mixed. YES NO

Remove CA/CB/CC from the refrigerator and pour an aliquot from each bottle into a separate tube. (3mL). Return tightly capped control bottles to the refrigerator _____________________.

Allow aliquots to warm to room temperature and protect from ______________.

Controls must be run within _______.

The open stability of CA/CB/CC controls is ______days.

True or False: CA/CB/CC controls should be pipetted into the tubes.

IRIS iQ Control/Focus

Store iQ Focus and iQ Positive control at _______ºC.

Store iQ Negative controls at ____________ ºC.

True or False: iQ Positive control and Focus material should be shaken before use.

True or False: iQ Negative should be shaken before use.

Focus and Daily controls should be processed every ______hours.


Analyzing Commercial Controls on the iChemVELOCITY

Step Action

1

Using the iChemVELOCITY control rack, pour (DO NOT PIPETTE; DO NOT SHAKE) 3mL of CA/CB/CC in positions 8, 9, and 10 respectively.

Position Insert color

Volume Contents

8

3 mL CA

Control

9

3 mL CB

Control

10

3 mL CC

Control

2 Store rack out of light and allow material to warm to room temperature.

3

Load the control rack on the right hand side of the sampler with the open end of the rack facing the instrument (as seen in the picture above).

NOTE: Position 10, which has the CC control, should be all the way to the right.

Analyzing Commercial Controls for the iQ200

Step Action

1 Bring Control and Focus material to room temperature.

2 Hold the bottle of iQ Focus Material upside down and give five hard sharp shakes followed by five gentle inversions. Let sit one minute until air bubbles are dispersed. Repeat this step with the iQ Positive control. NOTE: Do not mix the iQ Negative Control.

3 Fill a tube with 3mL of Iris System Cleanser and place into position 1 of the iQ control rack.

4 Fill two tubes with 3mL of Iris Diluent and place in positions 2 and 3 of the same iQ Control rack.

NOTE DO NOT put anything in position 4.

5 Fill a tube labeled with a Focus barcode label with 6mL of properly mixed Focus material and place in position 5 of the same iQ Control rack.


6 Fill a labeled (Positive Control Barcode) tube with 3mL of properly mixed Positive control material and place in position 6 of the same iQ control rack.

7 Fill a labeled (Negative Control Barcode) tube with 3 mL of Negative control material (DO NOT MIX) and place in position 7 of the same iQ control rack.

8 Load the control rack onto the right side of the iQ sampler, and press the Start button on the iQ.

NOTE If the iQ control results are out of range, repeat using fresh aliquots of both iQ Positive and iQ Negative Controls.

Viewing/Reviewing Control Results

Step Action

1 When control testing is complete, the results will automatically print (if it is set up in settings for QC to release to printer).

2 From the Instrument screen, locate the Last QC field. If all of the results are within acceptable range, the date and time will display. If any QC material failed, the Last QC field will display (--) accompanied with a specific alarm related to control failure.

3

To see the individual QC runs from the Instrument screen, select the Quality Review

button . The Quality Review is displayed.

4

To see the QC report for a specific material, highlight the desired ID and click the Re-

report button . You can also double click on the desired ID to open the Re-Report destination screen.

Ensure the Current Row is selected, and Screen is selected as the destination. Select

OK .

NOTE The iQ Series QC report consists of Control name, operator identifier, analysis time stamp, lot ID, expiration date, and status (pass/fail). The report will also indicate the results for the count, lower and upper limit of acceptance, and status (Pass/Fail).


5

To remove a QC result from statistical data, highlight the result and select the Remove

button . A comment window will display with the users id allowing a comment to be added to the removed result.

TRY THIS NOW.

NOTE: In order to remove a QC result, the user must be logged in with Manager status.

6

To restore a removed QC result, highlight the result, and select the Restore button

Restore the QC you removed in the previous step.

NOTE If controls fail but do not display on the Quality Review screen, check the Work List screen. ANY specimen with a Flag will be placed on the Work List

Manually Printing Control Data

Step Action

1

To manually print an individual QC run, from the Instrument screen, select the Quality

Review button . The Quality Review is displayed.

3 Double click on the desired QC run or highlight and select the Re-Report button

.

4 From the Re-Report destination screen, select Current Row.

5 Change the destination from Screen to Printer and select OK.

NOTE You may also print from the QC report page by selecting the Print List button.

Auto Print Set Up for Controls (Optional)

Step Action

1 From the Instrument screen, select Go off line .

3 Select the Settings button .

4 Select the QC button .

5

Choose Printer for both of the following options:

On microscopic control completion, automatically send to

On Chemistry control completion, automatically send to


6 Select OK .



QUALITY CONTROL SKILL CHECK

1. On what screen(s) can an operator see the status of both the iChemVELOCITY and iQ

controls?__________________________

2. From the Instrument screen, how do you know if the controls did not

pass?_________________________

3. Yes or No: Can patient samples be processed if controls did not pass?

4. Show facilitator how to remove and restore a QC result.

5. True or False: If iQ negative control fails, it is OK to just run the negative control again.

6. What Quality Control material is used on the iChemVELOCITY?

_____________ , _____________ , and _____________.

7. What Quality Control material is used on the iQ?

______________________________________


QC STATISTICS

OBJECTIVES

Given an operating iRICELL Complete Urinalysis System access to System Help, be able to:

Locate QC statistics Screen

Locate QC files for specific QC Lot Number

Print QC statistics

Save QC statistics


Understanding how to store, handle and use the control products available ensures reporting the most accurate results possible to the clinician. Knowing how to review and output control results is an important follow-up to control processing. It allows recognition of shifts or trends in QC that might indicate control or instrument problems.

Resources

iRICELL System

iChemVELOCITY and iQ200 Operator Manual


NFORMATION/PRACTICE

QC Statistics Screen

Lot number are located in the upper left hand box.

IQ Controls are listed first with the most current lot number at the top.

iChemVELOCITY are listed second with the most current lot number at the top.

Search by specific date and time, in the upper right hand corner input the From and To date and time and select the Do Search button.


iChemVELOCITY Statistics

Each type/lot specific report contains the control identifier, report time stamp, lot number, and

expiration date.

Chemistry QC chart indicates when chemistry strip lot changes occurred.

Chemistry QC chart does not display SD, Mean, and Target lines.

The next section is the Levey-Jennings chart (L-J chart), which lasts indefinitely for the

current lot number. All previous QC and patient results are subject to a first-in, first-out basis

after 10,000 patient and QC records are reached.

Below the L-J chart is a list of each point on the chart with its status. Printing this list on the

same date every month will provide the laboratory with complete documentation of QC

activity.

IQ Statistics

• Each type/lot specific report contains the control identifier, report time stamp, lot number,

mean value, standard deviation, Coefficient of Variation, minimum and maximum counted

values, target value, and the upper and lower acceptable limits.

• The next section is the Levey-Jennings chart (L-J chart), which lasts indefinitely for the

current lot number. All previous QC and patient results are subject to a first-in, first-out basis

after 10,000 patient and QC records are reached.

• Below the L-J chart is a list of each point on the chart with its status. Printing this list on the

same date every month will provide the laboratory with complete documentation of QC

activity

QC results can be saved for long term storage in HTML format, which can be opened and saved on

virtually any computer.


PRINTING QC STATISTICS

Step Action


2 Select the button.

3 Select the most recent iChemVELOCITY or iQ Control lot number

4 For classroom purposes leave the date range at the default

5 Select Print

SAVING QC STATISTICS

Step Action


2 Select the button.

3 Select the most recent iQ or iChemVELOCITY control lot number

4 For classroom purposes leave the date range as the default

5 Insert removable media CD or Flashdrive

6 Select the Save…Button



7

Select my computer

8

Choose the destination corresponding to removable media flash drive or CD

Note: If saving to a flash drive select the (E) drive. If saving to a CD select the (D) drive

9 Remove removable media


QC STATISTICS SKILL CHECK

1. Show facilitator the saved QC statistic file.

2. In what Format is QC statistics saved?

a. Excel b. HTML c. PDF D. CSV

3. The Levey-Jennings chart (L-J chart), lasts _____________ for the current lot number. All

previous QC and patient results are subject to a first-in, first-out basis after _________ patient and

QC records are reached.

4. How often should QC statistics be saved or printed for complete QC documentation?

a) Daily

b) Weekly

c) Monthly

d) At end of lot number


SAMPLE ANALYSIS

OBJECTIVES

Given an operating iRICELL Complete Urinalysis System, access to System Help, and urine specimens, be able to:

State the aspiration volume for sampling

Identify the different types of racks

Identify approved tube types

Process bar coded samples

Manually add a test order

Process a diluted sample


The iRICELL System is a quantitative or qualitative, multi-parameter, automated urinalysis analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. Running samples is a daily task that occupies much of your time in the lab. Learning how to process samples efficiently on the iRICELL System saves you time.

Resources

iRICELL System

Urine specimens

Barcode labels

Sample Racks



Sample Tube

The following table identifies the validated sample tubes that can be used on the system:

Body Fluids

Iris Plastic Body Fluid Tubes ONLY

10 mL Conical bottom tubes

(PN 800-3215)

NOTE: Do not attempt to run body fluids using other tubes. Improper tubes could cause the system to create a “Short Sample” flag. In addition, it is possible that your specimen could adhere to the walls of the tubes that have not been approved by Iris Diagnostics..


Specimen Information

Notes

1 Use only fresh urine specimens, as defined in CLSI (Clinical and Laboratory Standards Institute) GP16-A3 Urinalysis and Collection, Transportation, and Preservation of Urine Specimen, Good Laboratory Practices and the Laboratory’s Procedure Manuals.

2 Collect urine in clean and/or sterile containers. If a specimen is not processed within an hour after collection, cap the container tightly and store 2-8 °C. Bring the specimen to room temperature before testing.

3

Mix specimen well before testing

Do NOT add disinfectant or detergent to the specimen

Keep specimens out of direct sunlight

Do NOT centrifuge urine specimens

4

Sample Volume:

iChemVELOCITY alone requires 2 ml.

iQ200 Series alone requires 3 mL.

Specimen volume for analysis by both the automated chemistry system and the iQ200 series should be at least 4 mL.

NOTE: 1 mL is dead volume.

5

Hematuria:

iChemVELOCITY: use a manual method for chemistry results.

iQ200: Iris Diagnostics recommends that dilutions be performed on grossly bloody, heavy mucoid or very dense specimens, and short samples, in order to avoid clogging the specimen filter.

Very Dense or Viscous Specimens:

Very viscous or very dense specimens may cause flow errors or clogs and require dilutions before being run on the iQ200 Series.

DO NOT run diluted specimens on the iChemVELOCITY.


Running Specimens with Barcodes

Obtain specimens and barcode labels from your facilitator. This section assumes bidirectional LIS download.

Step Action

1

Load barcoded samples into a patient rack with the barcode showing through the opening of the rack as shown below:

2 Verify the system is in Standby.

3 Place the rack on the iChemVELOCITY sampler area with the barcodes facing the instrument, and the rack positioned to the back of the sampler area.

4 The system will automatically move the rack forward to the sample aspiration area. Once the samples are aspirated on the iChemVELOCITY, they will transfer to the iQ and be processed.

5 Verify the systems change from Standby to Measure.

6 Once samples are finished processing, remove the rack from the unload area of the iQ.


Running Samples without Barcodes

Step Action

1 Obtain non-barcoded specimen(s).

2 From the Instrument screen, select the Manual Orders button . The Manual Order screen is displayed.

3

From the Manual Order screen, select the rack number to be used by clicking the button next to the corresponding number.

NOTE: The screen defaults to the 0 rack; however, there is NO rack 0. If samples are programmed using the default, the specimens will have an ID_ERROR.

4

Enter the specimen information corresponding to the specimen position:

Specimen Identifier: Type in Specimen ID found on tube

Fluid Type: Select URN from the drop down menu

Dilution Code – Select 0 from the drop down menu

Work Order: Select RUN from the drop down menu

5 Select the OK button to save the programming.

6 Place the sample in the assigned rack and position.

7 Verify that the samples are processing by making sure the status changes on the iChemVELOCITY and iQ from Standby to Measure.

8 Do not take action at this time for any samples with error (alarms). We will review results later.


Dilution

Diluting a microscopic sample may be required before processing the sample on the iQ, It is recommended that dilutions be performed on grossly bloody, heavily mucoid, or very dense specimens (in order to avoid clogging the specimen filter), and short samples.

In order to use the dilution factors entered in the setup, a secondary barcode label printed in code 128 must be used. An example of the dilution factors screen is shown below. To find this information on your system, go to the Instrument screen and select the Settings

button then the Formed Particles button . Select the Dilution

Codes button to display the dilutions set up for your system. This information is detailed in Chapter 3 of the iQ IFU.

The dilution barcode is composed of 4 digits, the letters “URN” followed by the line number of the desired dilution ratio with a leading symbol that identifies it as a dilution barcode to the instrument. (See example on next page).


The chemistry portion of a dilution should be run UNDILUTED using an ORANGE rack (23) on the iChemVELOCITY. This rack is specially labeled so that it will not be processed by the iQ200 and will skip the iQ sampling station and be transferred automatically to the unloading station for retrieval.

Step Action

Note Utilize the two identically labeled tubes. One will have the UNDILUTED sample (for the iChemVELOCITY) and one empty tube for making the dilution.

1

Place the labeled undiluted patient tube in the dilution rack.

2 Load the dilution rack containing the undiluted sample onto the sampler of the iChemVELOCITY.

3 Using the dilution code screen, select the appropriate dilution label. FOR CLASSROOM PURPOSES ONLY, use any of the dilution labels.

4

Fix the desired dilution barcode label on the second empty tube as indicated below.

NOTE: The Dilution rack (numbered 23) must be used to run samples that will need dilution for microscopy on the iQ200 after being processed on the iChemVELOCITY


5 Prepare the desired dilution using sample taken from your undiluted specimen and Iris Diluent. (For classroom purposes you do not need to physically make a dilution).

6 Load the dilution tube into a regular patient rack (NOT THE DILUTION RACK).

7

Load the rack on the iQ module directly and press the Start button on the front of the instrument to run the sample.

NOTE: Ensure that the iChemVEOCITY has run the Chemistry before running the dilution.

8 Once the diluted sample is complete, the results from the undiluted chemistry specimen will automatically consolodate with the results from the dilution tube and a collated report will be produced.

NOTE

There will be a dilution indicator in the heading of the report

1:X= where X would be the dilution based on the label you placed on the sample tube.

NOTE If there are no flags present, the results will automatically be released and printed out.

NOTE If there are flags present, you must review and accept the results from the Work List before it prints out. DO NOT review any samples at this time.

.


SAMPLE ANALYSIS SKILL CHECK

1. What is the minimum volume required to run a sample on:

iChemVELOCITY only__________________

iQ200 only___________________

Both________________________

2. What rack number is the default for Manual Orders? ____________

3. What does the number after the URN on a dilution label indicate?

_________________________________________________________

4. What racks are used and what is placed in each rack when performing a dilution?

_______________________________________________

_______________________________________________


AUTO RELEASE AND RESULT VERIFICATION

OBJECTIVES

At the completion of this module, be able to:

Understand Microscopic Analysis Process

Understand Auto-Particle Recognition (APR)

Understand Particle Verification Range (PVR)

Understand Edit Free Release

Understand Auto Release exceptions

Know when a microscope confirmation is needed

Understand Bacterial Grading


For specimens with severely abnormal/pathologic particles, a trained operator may visually

confirm the identification of the particles based on their morphological detail as displayed on

the screen. The images presented for operator review are sufficient so that a trained

operator can easily recognize the particle images. In cases requiring visual review, all the

particle images are sorted and displayed in the auto-classified categories, which enhances

the verification process. While the classification of particles is computer-aided, human

judgment should still be exercised.

NOTE Images should only be reclassified if the edit will change the clinical

significance of the result.

Resources

iChemVELOCITY IFU

iQ IFU

iQ Image Encyclopedia

Specimen Results



iQ 200 Microscopic Analysis Process:

1. Digital Image Capture 2. Particle Detection 3. Feature Extraction 4. Particle Classification 5. Quantitative Result Report

1 Digital Image Capture

The strobe light flashes 24 times/second

The sample passes through the flowcell surrounded by iQ Lamina

The Digital (Charge Coupling Device, CCD) camera captures 500 frames per sample

2 Particle Detection

Each frame is analyzed for the presence of particles

Each individual particle is isolated, the edge of each object is traced and its size is identified


3 Feature Extraction (Inputs)

Each isolated particle is analyzed for specific features (size, contrast, shape, and texture)

Features of each particle are converted to numerical values by a series of algorithms

4 Particle Classification (Outputs)

Auto-Particle Recognition (APR) is a type of computerized neural network that has been “trained” to classify urine particles

There are 12 auto-classifications with 26 subclassifications (subclassifications are used by the operator to further classify particles)

Classifies particles by matching the particle numerical values with the auto-classifications hard coded values

Neural network trained using over 26,000 particle images

Classifications as follows:

- RBC=Red Blood Cells - WBC=White Blood Cells - WBCC=White Blood Cell Clump - SQEP=Squamous Epithelial - NSE=Non-Squamous Epithelial - HYAL=Hyaline Cast - UNCC=Unclassified Cast

- BACT=Bacteria - SPERM=Sperm - MUCOUS=Mucous - UNCX=Unclassified

Crystal (CRYS is previous terminology)

- BYST=Yeast (YST is previous terminology)


4 Particle Classification (Outputs) continued

How does APR work?

If the unknown particle meets > 90% confidence level of an expected matrix, its image will be classified into a category

If the particle’s matrix is < 90% confidence level of all the auto-classified categories, its image will be placed in Unclassified (UNCL) and is incorporated into the particle type concentration

Once all particles have been placed into their appropriate classifications, the software quantitates the results using the number of cells auto-classified, additional cells in UNCL, and the total volume analyzed

- UNCL represents the entire specimen sorted by size

- Used by the technologist to account for all NSEs and Casts

5 Quantitative Result Reporting

Particle concentration is calculated using the number of images and the

volume analyzed (REF: Run Equivalency Factor)


Results Review

Specimen screen

Chapter 3 iQ page 68

NOTE: Chemistry and Microscopy results are consolidated onto one screen

Chemistry

Results

Microscopic

Results

Microscopic

Review

Indicator


Resulting with Edit Free Release

Auto Release algorithm

Reporting can be configured to match the lab’s current method

Allows each lab to establish their own range to release results obtained by the APR

RBC, WBC, and SQEPS are released based on user defined Particle Verification Range (PVR). The table below is an example:

Particle Min Abn Threshold Max

RBC 2 3 20

WBC 5 6 9

SQEPS 5 6 20

All other particles are released using a series of decision trees

Particle Verification Range (PVR)

Employs an intuitive method for verification of particle classification

Minimizes on screen verification

Color indicator Meaning

Results are below the minimum verification value and are accepted as normal

Results are within the particle verification range and need to be reviewed by the operator

Results are above the maximum verification value and are accepted as abnormal

Edit Free Release Process

Results

Auto

Release

Auto

Release

Review

Results


Linearity Exceeded

If the “Review when Linearity is Exceeded” is enabled:

o The range indicator for the particle exceeding linearity is displayed in yellow and requires an operator verification

If the “Review when Linearity is Exceeded” is NOT enabled:

o The range indicator for the particle exceeding linearity will be displayed in red

All particles are calculated in μL, but result reporting can be configured to match the current method being used

Linear range = 0-1000/μL for all particles

μL results are converted automatically when High Power Field (HPF) and/or Low Power Field (LPF) are selected in settings

o HPF = μL/5.5 (range = 0-182/HPF) o LPF = μL x 2.9 (range = 0-2900/LPF)


Results Review

Specimen screen

Chapter 3 iQ page 68

Main Area Displays the following information

Particle Shows the short name of the particle category

Concentration Shows the particle concentration

Information

Area

Specimen ID and patient demographics (if enabled)

Date/Time of specimen aspiration by the iQ

Rack/Position and sequence number

Dilution ratio (1:1 is the default which represents no dilution)

Red blood cells section and dysmorphic RBCs (if enabled)

URINE CULTURE INDICATOR CHECKLIST-provides information that a urine culture is recommended. Indicators include Nitrite and Leukocyte Esterase results (when connected to the IChemVELOCITY or iChem100), Bacteria, WBC results and All Small Particles (ASP) count for the microscopy

Chemistry results

Comment, if entered by the operator

Active/cleared flag, if any


Button Function

Select to classify all particles in the specimen as amorphous.

Opens a window for 3 options:

ALL ART-classifies all the particles in the specimen as artifact

Separate chemistry and microscopy results

Edit chemistry results (this option is hidden unless Detailed Audit trail is enabled)

Use to enter a single line comment that will be transmitted to the

LIS.

Turbo Edit on the iQ Series is a statistical sampling procedure that reduces the number of images shown. Turbo Edit is not recommended with software version 7.0 or higher. When the text inside the orange Turbo Edit button is white, turbo edit is enabled; to go back to full edit mode (recommended) use the Turbo Edit button. (Black Text) and ALL particles are available for review in Full Edit mode.

Select Edit to review images from the first particle category displayed in the Results screen. If the Auto-Release function was enabled, the first category needing to be reviewed by the operator is displayed in yellow The Edit button can be also used to edit chemistry results. If the

Detailed Audit Trail is enabled, the operator initials that made the

changes will be in the audit trail section of the chemistry report.

Restores the particle classifications to the original instrument

classifications and current instrument settings

Skips the displayed specimen results to display the next available

specimen on the Work List/Found List

Is available when the operator has made edits. Use when edits

need to be saved without having to accept the results and the

operator wants to exit the specimen screen without losing edits

made


Verifying Results in Yellow

The Work List displays all samples not auto-released. Select the sample to view the sample in the Specimen screen

Selecting the Edit button from the specimen screen will automatically open the first category that is yellow for that sample

Saves the results after sample verification

If the Review Flag button was used, the Accept button clears the

specimen’s flags and transmits the specimen results to the LIS

and/or the printer if all specimen auto-release criteria are met

If there was an ID Error flag, the Accept button allows for the ID

to be corrected

If the Delete Flag button was used, the Accept button deletes the

specimen results as displayed with no review

When seen in the lower left portion of this screen, the Next button

will display additional particles if there are more than can fit on

one screen. The Back button would move you back to the

previous display, if needed.


Specific particle screen

Verifying Results in Yellow

NOTE: Once a category has been opened for review, the particle range indicator will no longer be yellow from the specimen screen

Reclassify when it will be clinically significant

Use the Back and Next buttons to continue reviewing particles classified in yellow for the sample being reviewed

Once all particles and grading are verified, select the Accept button to release and print the sample results.

Category

Concentration


Particle Review/ Reclassify Process (yellow categories)

50% Rule:

o If you open a particle category and more than 50% of the particles have been classified correctly, then agree with the results and continue with the next yellow category

o If you open a particle category and 50% or more of the particles have

been classified incorrectly, then disagree with the results and reclassify the particles as another category or place it into the artifact category (“art it out”)

Always Reclassify: o UNCX (unclassified crystal)

o NSE (non-squamous epithelial) and UNCC (unclassified cast) will

cause UNCL (unclassified) to turn yellow for review

o UNCL-check for the following (NO 50% rule):

Renal epithelial Transitional epithelial Casts

NOTE: Refer to the Memory Joggers for additional information

Microscope Required

The presence of four elements require a manual microscopic review for ID and confirmation: 1. Oval Fat Bodies- confirm using polarized light microscopy

2. Fat- confirm using polarized light microscopy 3. Trichomonas- confirm presence of flagella by motility (wet mount required

for proper identification) 4. Any cellular cast to ID the cell type if the cell type is questionable


Bacterial Grading

Automatic Bacteria Grading and Auto-classification

o APR will identify bacteria >3 microns in size as isolated images

o Bacteria <3 microns in size are too small to be automatically identified by APR and require an operator to identify and grade

o When automatic bacteria grading is enabled, the particle button and range indicators for bacteria are grey

o When automatic bacteria grading is enabled and, if any urine culture indicator (LEU, NIT, WBC, BACT, ASP) is abnormal, a message “Urine Culture Recommended” is sent to the LIS

Manual classification of Bacteria category

o If automatic bacteria grading is NOT enabled, the range indicators are displayed in green or red

o There are two ways to verify results, and it is directly related to the presence/absence of bacteria. Using the Urine Culture Indicator Checklist, one or more abnormal particles/chemistries indicate the possible presence of bacteria. Abnormal results are distinguished in red and have an H

Absence Presence

Verification of presence of bacteria for manual bacteria grading: o Verify that the auto-classified particle images (bacteria

category) match the categories they are displayed within o Manually grade bacteria based on what is observed within the

backgrounds of the WBC, WBCC, SQEP, and MUCS classifications. The visual quantitation is the same as what is done under the manual microscope and can be reported as Present/Absent or Few/Moderate/Many

NOTE: Refer to the Bacterial Grading Memory Jogger for more information.


Flags Flags will STOP the specimen from being Auto Released. Shown below are some examples of flags seen on the system. Additional information on flags can be found in the Appendix of the iQ IFU

Specimen flags include:

High concentration flag

Possible Amorphous flag

Sperm Present flag

Sperm Previous Sample

Chemistry flags include:

CHEMSTRANSLATE

Chem CONFIRM

CHEM N/A (Processing Failure)

CHEM N/A (Processing not complete)

No wash

Strip deviate Instrument Errors:

Motor errors for SPM, SCS and STM (iQ and iChemVELOCITY)

Instrument Flags:

ID errors (iQ and iChemVELOCITY)

Short Sample (iQ and iChemVELOCITY)

Flow (iQ)

Image Acquisition (iQ)

Light fluctuation (iQ)

Sequential flag when Short Sample, Flow, Image Acquisition, and/or Light fluctuation flag appear in 3 consecutive specimens

Note: A Sequential Flag can be remedied by processing an iQ QC rack using Cleanser, Diluent, and Focus

Pop-up Messages

Used as a way for the system to get the operator’s attention for certain conditions when the user has selected the Accept button on the results screen. The operator must acknowledge the pop-up in order to proceed

Potential Carryover

Chem/Micro Correlation

Bacteria Present

Minimum to Auto-Classify Overridden


Edit Chemistry Results

Chemistry results can be edited if required. This feature is only available when the Detailed Audit Trail feature is enabled


Result Verification

Edit Results

Step Action

1

Run one barcoded sample

Run one non-barcoded sample

Run one dilution

2 From the Work List screen, select the first sample by double clicking on the specimen row to open the Specimen screen

Select the Edit button to display the first yellow category (needs review).

If greater than 50% (refer to memory jogger) of the particles are categorized correctly, skip to step 7.

If 50%or more (refer to memory jogger) of the particles DO NOT belong in the category and need to be reclassified, continue with next step.

6

From the right hand pane, select the desired re-categorized particle type (i.e WBC), then select the individual particles that need to be moved to that category.

In the example below, the category being displayed are RBCs. The reclassification category is WBC and the first image (blue box) has been moved to the WBCs.


7

Once the reclassification is complete, select the original category name button in the top left corner. (i.e. RBC in the above example).

NOTE: To reclassify all particles on the screen, select the desired particle (i.e.

WBC), and press the Next button .

NOTE: If the original category name is not selected, the system will automatically classify the particles based on what is selected (i.e. WBC) when the Next button is used.

8

Select the Next button .

If the number of particles exceeds the space on the screen, selecting the Next button navigates to an additional particle screen(s) until all particles are viewed

Once particles are viewed, choose the Next button to go to the next yellow category (needs review)

9 Select the Accept button from the Specimen screen when the verification is complete on a sample.

10 Repeat steps 1 - 8 for each specimen to verify.

IMPORTANT Do not use the Back button to exit the Results screen or after reclassification of an entire category has been made. This can lead to unexpected results including loss of data or loss of a category.


RESULT VERIFICATION SKILL CHECK

1. When reviewing specimens, after opening the sample to display the specimen screen what is the next step?

a. Hit the accept button

b. Hit Redo

c. Hit Turbo Edit

d. Hit Edit

2. True or False: A specimen that has a Chem N/A will not be auto released.

3. Yes or No: You open up the WBC category, and it has 40 images in it. Of the 40 images,

10 images are not WBCs. Should these images be reclassified?

4. What does the Turbo Edit Button do and why should it not be used?

_____________________________________________________

_____________________________________________________

5. In what case would you use the Turbo Edit Button?

______________________________________________________

______________________________________________________


IMPORTING AND EXPORTING RESULTS

OBJECTIVES

Given an operating iRICELL System, be able to:

Import results from a CD into the iRICELL

Export results from the iRICELL onto a CD


The system can import specimen results that have been previously generated on the same or different instrument of the same model from a CD. Specimen results can be exported for storage or for training purposes.

Resources

iChemVELOCITY IFU

iQ IFU

Blank CD

Esoteric CD



Importing Results

Step Action


2 Place the Esoteric CD in the CD drive. A CD drive pop up window may appear displaying an “Archive” folder on the CD in the drive. This may take a few minutes to appear.

3 If the archive folder displays,select the red X in the upper right corner to close the window, if not move to next step.

4 Select the Work List button on the top right of the screen to navigate to the Work List.

5 Select the Import button located on the lower right of the screen.

6 Verify the D:/ drive is displayed on the Import Source field of the Select Import Source pop up window.

7 Select OK . A list of all the results on the Esoteric CD will appear on the Select Specimens to Import screen.

NOTE: This may take a few minutes.

8

Highlight all of the samples.

NOTE: Select the first sample, scroll down to the last sample, hold the Shift key on the keyboard, and left click the mouse. All results should now be highlighted.

9

Select OK .

NOTE: The import may take a few minutes. The Import Status window will display:

Number of results to be imported

Number of results successfully imported

Number of results that failed import

10 Click OK when the importing is complete.


Locating imported samples

1 From the Work List screen, select the Search button .

2 Select the Clear button to clear any previous search selections.

3 Check the Show released specimens only checkbox.

4 Select the Today button in the Date-Time area.

TIP: To only view the imported samples, a time frame may also be needed, based around the time the import was performed.

5 Select OK . All the results from the Esoteric CD will display on the Found List.

6

Remove the Esoteric CD from the CD drive.

NOTE: You may see a pop up after removing the CD. Select the red X to close the pop up window.


Exporting Results

Step Action

1 Place a external media (CD or Flash Drive) into the computer.

2 If a CD drive pop up window displays, verify “Take no action” option is

highlighted and select OK .

3 Select the Export All button to display the Select Export Destination pop up window.

4

In the Select Export Destination field, select the desired external media.

D:/ for CDs

E:/ for flash drive

NOTE: The window will also display the space required for storing the data.

5

Select OK .

NOTE: The import may take a few minutes. The Export Status window will display:

Number of results to be exported

Number of results successfully exported

Number of results that failed export

6 Select OK when export is complete.

NOTE: When export is complete, the OK button will turn blue and the CD drive will open.

7 Remove and label the external media as Esoteric.

NOTE: If two students are working on the instrument, complete exercise

individually, so that each student has a copy of the Esoteric CD for their lab.


Reviewing imported samples for training

Step Action

1 From the Found List screen, select the first sample by double clicking on the specimen row to open the Specimen screen

2

Hit the turbo edit button and the redo button, to re-review the sample.

There should now be categories in Yellow; if not, the turbo edit and redo buttons were not selected.

3 Select the Edit button to display the first yellow category (needs review).

4 Review and accept

Repeat steps 1-4 for each sample on the list


IMPORTING AND EXPORTING SKILL CHECK

1. Show facilitator imported samples.

2. Show facilitator exported CD.

3. Prior to importing or exporting ensure the instrument is ______________________

4. Can exported samples be viewed on any computer? ________________________


SECTION 2- MAINTENANCE AND TROUBLESHOOTING


SAMPLE FLOW/ COMPONENT IDENTIFICATION

OBJECTIVES

Given an operating iRICELL Complete Urinalysis System, be able to:

Identify components of the iChemVELOCITY

Identify component of the iQ200


Knowledge of instrument functions will enable you to operate the system more efficiently and may help you when troubleshooting situations arise. Using the correct racks and sample containers will help you avoid related errors, alarms, or flags.

Resources

iChemVELOCITY IFU

iQ IFU



The iRICELL system INFORMATION/PRACTICE consists of two instruments. The system is designed to always have the specimen analyzed by the Chemistry analyzer first. The chemistry results transmit directly to the APUI. The microscopy and chemistry results are consolidated at the time the patient identification barcode is read by the iQ. This allows the two results to be viewed on the Specimen screen at one time for ease of results verification.

iQ for Microscopic Analysis & iChemVELOCITY for Chemistry Analysis

Component Function

1 SampleTransport Module (STM)

Moves the racks from the load station (right side of the instrument), to the pipetting station (barcode reader), and then to the unload station (left side of the instrument).

2 Barcode Readers

Located inside the instrument facing the pipetting station. The barcode scanner reads the sample barcodes and will query the LIS or the instrument PC for sample programming to either skip/run based on sample requirements.

3 Sample Bridge

Connection between the iChemVELOCITY and the iQ systems. Sample racks are transferred automatically from the chemistry system to the microscopic system. When the chemistry and iQ systems are connected, the samples must complete their analysis on the chemistry system before being placed on the iQ. If only microscopy is being performed, then place the sample directly on the iQ side.


Front view of iChemVELOCITY

Component Function

1

System Status Lights Lights display: Standby (Green), Measure (Blue), and Error (Red).

2 Strip Loader

Component used to load strips into the Strip Provider Module (SPM).

3 Sample Transport Module (STM)

Moves the racks from the load station (right side of the instrument), to the pipetting station (barcode reader), and then to the unload station (left side of the instrument).

4 On/Off Button Pressing this button after applying power to the instrument places the system in standby.

5 Start Button This button is not used on the iChemVELOCITY


iChemVELOCITY Chemistry Theory

The system produces quantitative results for specific gravity, semi-quantitative or qualitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones, ascorbic acid, nitrites, color, and clarity.

Component Function

1 Strip Provider Module (SPM)

Strip Loader (top)-Holds 300 strips maximum with an on-board stability of five days. The strips will be delivered from the strip loader to the SPM (bottom). When the sampler detects the presence of a test tube, a test strip is delivered facing up to the Strip Conveyor System.

2

Strip Conveyor System (SCS) (below strip reader module)

Moves the test strips through 8 light reading positions every 15 seconds: The strips go through a loading, dosing and eight reading positions.

3 Strip Reader Module (SRM)

Measures the color of each pad of the chemistry test strips at different incubation times and uses the information to obtain the analytes semi-quantitative concentrations.

4 Specific Gravity, Color, and Clarity Module (CGM)

Specific gravity is obtained using a refractometer. Color and Clarity are obtained from a flowcell using white light, color sensor to detect the color of the sample, and the amplitude of light scattered within the flowcell to determine clarity of the sample.


5 Fluidics

Consists of a Sample Probe that mixes the specimen inside the sample tube. The Wash Station is used to rinse the inside and outside of the sample probe and to discard wash solution. There is 1 pump that aspirates and dispenses sample, and 2 pumps are used to wash and clean the fluidics system. A 7 liter wash container supplies the iChemVELOCITY wash solution. A 125 mL reservoir also supplies the system.

6 Waste (not pictured) Strip disposal into waste container and liquid waste disposal

either in a drain or waste container.

Chemistry: Sample Processing Overview

Strip Provider Module (SPM)

places the strip on the

Strip Conveyer System (SCS)

Sample aspirated

Specific Gravity, Color, Clarity

Module (CGM) Analysis

Color Reaction

detected and measured by

Strip Reader Module (SRM)

Sample dispensed on strip

Results sent to

Host Computer


iQ 200 Microscopic Theory

The system produces quantitative or qualitative counts of all formed sediment elements present in urine including cells, casts, crystals and organisms. The system pipettes specimen from sample tubes, collects images from the samples using digital image capture of particles presented in a flow microscope, and performs image processing to isolate individual particles.

Component Function

1 Pipetting Station

Located in the front of the system. The pipettor mixes the sample by delivering an air bolus and then aspirates approximately 1 mL of sample. NOTE: Urine run on the iRICELL system should not be used for any other testing.

2 Optic System

Consists of: Strobe lamp, Microscope, CCD camera, and Flowcell. The strobe lamp is attached to the microscope. The strobe lamp flashes are synchronized with the CCD camera. Each picture captured represents the view of a small quantity of sample. Each of the pictures represents a precisely measured volume of un-centrifuged specimen present in the flowcell under magnification.

3 Fluidics Composed of iQ Lamina container and 3 peristaltic pumps that aspirate and circulate the sample surrounded by the iQ lamina through the instrument, into the flowcell, and then to waste.

4 Waste (not pictured)

The waste pump discards the fluids into a drain or waste container.


iQ 200 Analysis Process Recoginition (APR)

1 Digital Image

Capture

2 Particle

Detection

3 Feature

Extraction

4

Particle Classification

5 Quantitative

Result Reporting

Congratulations, you have finished! Continue to the Skill Check.


SAMPLE FLOW SKILL CHECK

Use the Analyzer Component CheckList below.

Get numbered tabs from the facilitator.

Place the numbered tabs on the correct components. Please work with your partner.

When you are finished, call a facilitator to check your work.

1. STM 10. SRM

2. Barcode Reader 11. CGM

3. Sample Bridge 12. SCS

4. Strip Loader 13. Pipetting Station

5. Status Lights 14. Optic System

6. On/Off Switch 15. Fluidic System (Pumps)

7. Start Button (iQ) 16. Sample Filter

8. Strip Waste Container Door 17. Wash Station

9. SPM


WEEKLY & MONTHLY MAINTENANCE

OBJECTIVES

Given an operational iRICELL System and IFUs, be able to:

Clean the Strip Provider Module (SPM)

Clean the CGM

Clean the Wash Station Bath

Clean the Strip Conveyor System

Perform Calibration on the iQ

Perform Backup


Performing routine maintenance including cleaning and calibrations will keep your instrument in optimal operating condition.

Resources

iChemVELOCITY IFU

iQ IFU

Blank CD



WEEKLY MAINTENANCE FOR ICHEMVELOCITY

Step Action

1 Locate the Weekly Maintenance section in the iChemVELOCITY IFU.

2 Follow the procedure to Clean the Strip Provider Module.

NOTES

SPM cleaning procedure is to be performed on a weekly basis based on throughput:

200 samples or less a day – Clean once per week

Greater than 200 samples a day – Clean two times per week

Greater than 500 samples per day – Clean daily

Remove old desiccant and replace with new desiccant when the SPM is opened.

Remove any remaining strips inside the SPM and replace with new strips after cleaning the SPM.

DO NOT use any liquids inside the SPM. Using Iris Cleaner or wet towel/tissue inside the Strip Provider Module will affect the results of the test strips

3

Locate and Follow the procedure for Cleaning the Color Clarity Module (CGM).

NOTE: This process required the use of 20 strips.

NOTE: For Classroom purposes do not run controls.

When performing this procedure in the laboratory running controls at the end of the procedure is required.


Delete ID Errors

Delete ID Errors from the Work List caused by the rack used to clean the Specific Gravity, Color, Clarity Module.

Step Action

1 Select the Work List button .

2 Select a sample with an ID error, and then select the Delete Specimen

button .

3 Select OK to the message.

4 Repeat steps 2-4 for each of the 20 samples that were used in the previous exercise.

NOTE To select multiple lines, you can hold the Shift key on the keyboard and left click the mouse on the last file you want to take an action on. All results should now be selected (highlighted in blue).

MONTHLY MAINTENANCE FOR ICHEMVELOCITY

Step Action

1 Locate the Monthly Maintenance section in the iChemVELOCITY IFU.

2 Follow the procedure for Cleaning the Wash Station Bath.

NOTE DO NOT insert the cotton swab inside the wash tube. Cotton particles may clog the tubing connectors.

3 Follow the procedure for Cleaning the Strip Conveyor System.

NOTE

Procedure is to be performed on a monthly basis based on throughput:

200 samples or less a day – Clean once per month

Greater than 200 samples a day – Clean two times per month

NOTE For classroom purposes only leave Strip Conveyor System out of the system overnight to dry.


IQ200 MONTHLY MAINTENANCE

iQ Calibration

Step Action

1

Using a iQ control rack, load the following material:

Pos Insert color Vol Contents Barcode

1 Gray 3 mL Iris System Cleanser No

2 Gray 3 mL Iris Diluent No

3 Gray 3 mL Iris Diluent No

4 Leave this position empty

5 Blue 6 mL iQ Focus Yes

2 Load on the iQ200 sampler, and press the Start button on the iQ.

3 Ensure the Focus passed.

4 Ensure the system is in Standby before continuing.

5 Load one 16X100 mm tube with the iQ calibrator barcode label.

6

Place the barcoded calibrator tube in position 1 of the iQ calibration rack.

NOTE: Picture above shows the front and back of the rack.

7 Verify the iQ calibrator has warmed to room temperature. Hold the bottle upside down and give five hard sharp shakes followed by five gentle inversions.

8 Let the bottle sit one minute to allow air bubbles to disperse

9 Fill ten 16X100mm tubes with 4 mL of iQ calibrator including the barcoded calibrator tube in position 1 of the calibration rack

10 Place the non-barcoded tubes in position 2-10 of the iQ calibration rack.

11 Load the rack onto the right side of the iQ sampler.

12 Press the Start button on the iQ.


Perform a backup

Backup includes Instrument configuration, results, and QC data

Step Action

1 From the Instrument screen, select the Go off line button

.

2 Select the Maintenance button .

3 Open the CD drive, load a blank CD-R into the drive, and close the CD drive.

4 When the Backup Dialog pop-up message appears, select or verify the “take no action” options is highlighted. Select OK.

5

From the Maintenance screen, select the Backup button and

select OK .

NOTE: This step can take several minutes. The Backup Dialog Box displays progress.

6 When the Backup process is complete, select OK .

7

The CD drive will open automatically when the process is complete.

Remove the CD, close the CD drive, and select OK to exit the Maintenance screen.

8

Label the backup CD with the date and the software version. NOTE: The software version can be located by selecting the System Info button

from the Maintenance screen.

Congratulations, you have finished! Continue to the Skill Check


WEEKLY & MONTHLY MAINTENANCE SKILL CHECK

Record the maintenance performed for the iChemVELOCITY in the table below:


Weekly Maintenance

Clean Strip Provider Module

Clean CGM

Monthly Maintenance

Clean Wash Station Bath

Clean Strip Conveyor System

Record the maintenance performed for the iQ200 in the table below:


Monthly Maintenance

Calibration

1. Why is the orange dilution rack used for the weekly maintenance of the CGM?

_________________________________________________________

_________________________________________________________


QUARTERLY AND AS NEEDED MAINTENANCE

OBJECTIVES


Perform Reflectance CalChek

Perform Specific Gravity, Color, Clarity CalCheck

Flush the Waste Line

Clean the Sample Tube Detectors

Clean the Barcode Reader Windows

Clean the Optical Sensors on the Sample Transport Module

Clean the Rinse/Waste Bath

Clean the Sample Filter

Replace Wash Solution (if needed)

Replace Lamina Solution (If needed)


Performing “As Needed Maintenance” procedures will help keep your instrument up and running to avoid unscheduled service calls.

Resources

iChemVELOCITY IFU

iQ IFU



iChemVELOCITY Quarterly Maintenance

Reflectance CalChek

Step Action


2 Select the Reflectance Check button .

Note The system will display a series of six screens.

3

Follow the instructions on each of the screens.

NOTE: Make sure to put the SPM back together again after removing strips.

IMPORTANT: Do forget to load the reflectance strips found in the supplied iChemVELOCITY CalChek kit

4 From the Instrument screen, verify the Reflectance Check passed or check the print out.

5 Notify facilitator if the Reflectance Check fails.

Specific Gravity, Color, and Clarity CalChek

Step Action

1 Remove the tubes from the iChemVELOCITY CalChek kit.

2 Gently invert the tubes one or two times to mix the solution.

3

Remove the caps from each tube and place the tubes in the blue CalChek Calibration rack in the positions listed below:

Verify the barcodes on tubes 1, 4, and 8 are visible in the open slit.


CalChek rack

Pos Contents Value Bar-code

1 Specific Gravity CalChek solution 1.002+/- 0.003

Yes


No


No

4 Color CalChek solution Colorless Yes

5 Color CalChek solution Straw No

6 Color CalChek solution Normal yellow

No

7 Color CalChek solution Normal amber

No

8 Clarity CalChek solution Slightly cloudy

Yes

9 Clarity CalChek solution Cloudy No

10 Clarity CalChek solution Turbid No

4 Load the Calibration rack on the iChemVELOCITY sampler.

5

When the calibration rack completes, verify it is successful. The date/time of the new SG/Color/Clarity CalChek will be displayed on the Instrument screen and on the print out.

NOTE: The measured values are compared to acceptable ranges stored in the system. If the results are within range, the CalChek is verified and found acceptable. You can also check the results using the Quality

Review button .

6 Notify the facilitator immediately if the CalChek failed.


As Needed Maintenance

Step Action

1 Using the iChemVELOCITY and iQ IFU, locate the as needed maintenance procedures.

2 Perform the following As Needed Maintenance Procedures:

3

Clean the Sample Tube Detectors (Both)

Clean the Barcode Reader Windows (Both)

Clean the Optical Sensors on the Sample Transport Module (Both)

Flush the Waste Line (VELOCITY)

Clean Sample Filter (Use Procedure 2) (iQ)

Clean the Rinse/Waste Bath (iQ)

Congratulations, you have finished! Continue to the Skill Check


MAINTENANCE SKILL CHECK

Record the maintenance performed for the iChemVELOCITY in the table below:


Quarterly Maintenance

Perform Specific Gravity, Color, Clarity, CalChek

Perform Reflectance Check


Clean Sample Tube Detector

Clean the Barcode Reader Window


Replace Wash Solution and Filter

Flush the Waste Line

Record the maintenance performed for the iQ200 in the table below:



Clean Sample Tube Detector

Clean Barcode Reader Window


Replace Lamina Solution and Filter

Clean the Rinse/Waste Bath

Clean the Sample Filter


TROUBLESHOOTING

OBJECTIVES

At the completion of this module, the learner will understand:

Principles of Troubleshooting

Instrument screen and Chemistry and Hardware flags

Resources for troubleshooting failed Focus, QC, and Calibration


This information will help you in the event you need to troubleshoot a sample, reagent, or instrument issue.

Resources

iChemVELOCITY IFU

iQ IFU


I

NFORMAITON/PRACTICE

Instrument Screen Flags

The Instrument screen displays the flags generated by the iRICELL. Any high priority flag displayed will also display a Cause/Remedy screen. Medium priority and Low priority flags will not auto display the cause remedy screen. Flags can only be removed when the issue is resolved. The Cause/Remedy screen can be printed and/or retrieved by double clicking on the flag of interest on the Instrument screen.


iQ Hardware Errors

Hardware alarms generated by the iQ Series will be displayed on the Instrument screen as specific alarm numbers and as a Microscopy System Error as well as a red status light on the front of the iQ. Specific error locations and descriptions can be viewed by clicking the Maintenance button

, then selecting the Errors button . Check the information in the Detail for specific part failure information.


iQ Focus/QC/Calibration Verification Failures

iQ Focus/QC/Calibration Failures will only be shown as a flag on the Instrument screen. To document the failures, print the Cause/Remedy screen for the failure. This will print the failure description with the date and time it occurred.

Selecting the Quality Review button will display all Quality Control runs including failed QC analysis. Check the Work List Screen for specific event information such as QC/Cal ID Error or Out of Order.


Chemistry Analyzer Flags

There are some flags specific to chemistry testing that appear on the reports. These flags will cause the sample to be flagged and show the exact chemistry flags that cause the issue. These flags include “Chem N/A” and “No Sample”. If any of these flags are obtained, the chemistry should be rerun.


A Systematic Approach to Troubleshooting

Step Action

1

Gather Information:

Observations-both normal and abnormal

Instrument messages/sounds/logs

Who, what, when, where

What was the last thing that was done before the symptom occurred

o Focus, QC, and Calibration Failures Lot number Expiration date Preparation/mixing not done correctly Labeling QC tubes correctly

o Questionable patient results Very dense Bloody Heavy Mucous Short Sample Wrong rack used Dilution needed and sample was labeled incorrectly Not Manually ordered correctly All patients or one patient? From a specific department or site?

o Changed/loaded reagents or supplies: Loaded correctly Expiration date Correct filter installed Wash Solution or Lamina containers in correct

position Chemistry strips loaded incorrectly, expired lot

number, on board >5 days o Instrument Issues:

Maintenance performed or due Component replacement performed Peripheral issues: printer, keyboard, mouse, touch

screen Rack damages Removed a splash guard

o Environmental Changes: Temperature/humidity Power/electrical/static Waste issues (drain problem)


2

Identify the symptom:

Develop a clear statement about the issue

What is common?

What is unique?

Intermittent or Reproducible?

What is the easiest and least expensive to check?

3

Investigate/Isolate the issue?

Further segregate the issue through testing

Use a systems approach

Narrow down by ruling out.

4

Devise a Plan and test:

Perform identified corrective action

o Repeat controls, calibrators, CalChecks

o Perform Maintenance if needed

o Remove Strip Jams

o Remove obstacle

5

Verify the repair:

Verify system performance

Resolved – resume operations

Unresolved- Revise plan


TROUBLESHOOTING SKILL CHECK

Using the troubleshooting section and in the iChemVELOCITY and iQ200 operator manual answer the following questions:

1. What can cause an alarm 41 on the iChemVELOCITY, and what are some remedies? ____________________________________________________________________

____________________________________________________________________

__________________________________________________

2. What can cause an alarm 40 on the iChemVELOCITY, and what are some remedies? ____________________________________________________________________

____________________________________________________________________

__________________________________________________

3. What can cause an Alarm 5 on the iQ200, and what are the remedies? ____________________________________________________________________

____________________________________________________________________

__________________________________________________

4. What can cause an Alarm 7 on the iQ200, and what are the remedies? ____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

5. What can cause an Alarm 25 on the iQ200, and what are the remedies ____________________________________________________________________

____________________________________________________________________

__________________________________________________


SYSTEM SHUTDOWN AND RESTART

OBJECTIVES

Given an operational iRICELL System, be able to:

Shut down the iRICELL System

Restart the iRICELL System in proper sequence


The system may need to be shut down and restarted during troubleshooting or as directed by Technical Support.

Following the proper procedures will help avoid damage to the instrument or corruption of the system’s database.

Resources

iChemVELOCITY IFU

iQ IFU


NFORMATION/PRACTICE

Shutting down the System

Step Action

1

From the Instrument screen, select Go off line .






3

Select the Shutdown button . The following message will appear:

Do you want to shut down the instrument?

Select Yes.

4

When the computer shutdown is complete, the computer will automatically turn off. (You do not have to press the power button).

Turn off the microscopy module by pressing the green On/Off button on the left front of the iQ.

Then, press the On/Off button on the left front of the iChemVELOCITY.

NOTE For Classroom purpose, you do not need to turn off the main power switch of the instruments that are located on the back of the instrument; however, You may need to do so at the direction of a Beckman Coulter representative.


Restarting the System

Step Action

1 Restart the computer by pressing the On/Off button on the front of the PC.

2

When the Instrument screen is displayed,

Power on the chemistry module by pressing the green On/Off on the front of the iChemVELOCITY.

Power on the microscopy module by pressing the green On/Off button on the left front on the iQ.

3

Log on to the system.

NOTE: The system will automatically initialize, and the system will be

On Line.


SHUTDOWN AND RESTART SKILL CHECK

1. In what order should the iRICELL System be put into shutdown?

a. iQ>>iChemVELOCITY >>Computer

b. iChemVELOCITY>>iQ>>Computer

c. Computer>>iQ>>iChemVELOCITY

2. In what order should the iRICELL System be turned back on?

a. iQ>>iChemVELOCITY >>Computer

b. iChemVELOCITY>>iQ>>Computer

c. Computer>>iQ>>iChemVELOCITY

d. Computer>>iChemVELOCITY>>iQ


ADDITIONAL TOPICS


BODY FLUIDS

OBJECTIVES


Run Body Fluid Controls

Run Body Fluid Background

Run Body Fluid Samples


The iRICELL System has an optional iQ Body Fluids Module that creates a workflow solution for processing body fluid samples. Performing manual body fluid counts is a daily task that can occupy much of your time in the lab. Learning how to process body fluids efficiently on the iRICELL System saves you time.

Resources

iQ IFU


INFORMATION/PRACTICE Theory of Operation

The iQ Series System auto-identifies, processes, and identifies images from specimens that are loaded into specific body fluid racks. Body Fluids specimens are prepared by splitting the specimens into two aliquots. One aliquot is mixed with iQ ® Body Fluids Lysing Reagent and the other is mixed with Iris Diluent. The two aliquots are prepared differently because successful analysis relies on subjecting one aliquot to selective cell lysis. Selective lysis is a chemical process that destroys red blood cells’ membrane causing the membrane to burst and releasing its contents into the solution. The iQ Body Fluids Module reports the total number of cells in each of the two aliquots. The cells from the diluted aliquot are called "Total Cells”, and the cells from the lysed aliquot are called “Nucleated Cells” because the RBCs have been destroyed. The difference between the "Total Cells" and the "Nucleated Cells" represents the number of RBCs in the specimen. The lower linearity is Zero, and the upper linearity of 10,000 cells/ul , but is extended with the Extended Linearity Procedure.

CSF samples are to have a minimum of 1:5 dilution

Serous Fluids (e.g. Peritoneal, Pericardial, etc..) need to have a minimum of 1:20 dilution

Body Fluid Start Up Procedure

In order to run Body Fluids, the Body Fluid CD must be in the system.

Step Action

1 Place the Body Fluid Module CD in the CD drive.



4 Select the Restart button.

5 When the Main Screen appears, log on using User ID and Password.

6 Select Manual Order and verify that racks 25,26,and 27 are listed

NOTE

There are three area that change when Body Fluids are enabled.

Manual order screen – Additional racks listed

Settings – Formed Particle Button changes to Fluid Type

Work List/Found List – Additional Column Type


Body Fluid Controls

Step Action

1 Warm body fluid controls to room temperature.

2 Place 3 unlabeled conical bottom tubes in position 2, 3, and 4 of the Body Fluid QC (BFQC) rack.

3 Place barcodes on the tubes in positions 3 and 4 with the level of control to be tested.

4 Pour 1.25 mL of Iris Diluent into the tube in Position 2.

5 Pipette 1.0 mL of iQ Body Fluid Lysing Reagent into the tube in position 3.

6 Pipette 1.0 mL of Iris Diluent into the tube in Position 4.

7

To mix iQ Controls:

Hold vial horizontally between the palm back and forth for 20-30 seconds

Mix by rapid inversion

8 Pipette 250 µL of control into both tubes in positions 3 and 4.

9 Tap gently to mix tubes 3 and 4.

10

Place the BFQC rack on the iQ system and press Start button.

NOTE: It is recommended to run well-mixed body fluid control material IMMEDIATELY after performing the dilutions.

11 To review BF Controls, select the Work List button to locate the controls in the Work List.

12 Select the control to be reviewed, and select the Specimens button to navigate to the Specimen screen.

13 Review and edit the results in the same manner as a body fluid patient specimen by moving all artifacts into the designed ART classification.

14 Click the Accept button .

NOTE: If the BF QC fails, a yellow flag will be displayed on the Instrument screen, and body fluid specimens will not be allowed to run.

15 Repeat steps 2-14 for the next level of control until both levels of control have been processed.


Body Fluid Background

A reagent background check must be performed weekly using the reagents straight with the same type of barcoding as the QC. It is run to ensure that the system reagents have not been contaminated.

Step Action

1 Warm lysing reagent to room temperature.

2 Place 3 unlabeled conical bottom tubes in positions 2, 3, and 4 of the Body Fluid QC (BFQC) rack.

3

Place Background barcodes on the tubes in positions 3 and 4 with the level of control to be tested.

NOTE: The Background barcodes used can be found in the Body Fluid Controls set.

4 Pour 1.25 mL of Iris Diluent into the tube in Position 2.

5 Pipette 1.25 mL of iQ Body Fluid Lysing Reagent into the tube in Position 3.

6 Pipette 1.25 mL of Iris Diluent into the tube in Position 4.

7 Place the BFQC rack on the iQ system and press the Start button.

8 To review reagent background count, select the Work List button to locate the background in the Work list.

9 Select the control to be reviewed, and click the Specimens button to navigate to the Specimen screen.

10 Review and edit the results in the same manner as a body fluid patient specimen.

11 Click the Accept button .

NOTE: Edited background passes if there are ≤ 3 particles/µL.

NOTE: Each specimen is run on its own Body Fluids rack while operating in

the iQ Body Fluids Module mode. Use racks 25, 26, and 27 for running

samples.


Processing Patient Samples

Step Action

1 Choose Body Fluid Racks 25, 26, or 27.

2 Place patient barcode labels along with appropriate dilution labels.

3

Choose the appropriate dilution using dilution chart below:

4

Use BF Conical tubes in the following sequence:

Position Material

1 1.25 mL of Iris Diluent (optional).

2 1.25 mL of Iris Diluent.

3 Pipette appropriate amount of Lyse based on desired dilution.

4 Pipette appropriate amount of Diluent based on desired dilution.

5 1.25 mL of Iris Diluent (optional or following turbid, bloody, or extremely viscous body fluid samples).


5 Place the appropriate amount of BF sample in positions 3 and 4.

NOTE

Always add the correct amount of lysing reagent or diluent to the tube first. It is very important to add the specimen to the lysing reagent or diluent not vice versa. Specimens that are added directly to empty tubes can adhere to the wall of the tube which can impede them from mixing properly into solution. For the same reason, it is important not to apply the specimen to the wall of the tube above the solution.

6 Tap gently to mix tubes 3 and 4.

7 Place the BF sample rack on the iQ and press the Start button.


Body Fluid Results Verifying

The iQ Body Fluids Module initially classifies particles based on their size which streamlines the editing process. After editing is complete, a report quantifying the number of RBCs and the number of Nucleated Cells in the fluid specimen is created.

Even though the iQ Body Fluids Module initially counts the number of Nucleated Cells and Total Cells, the module calculates and reports the number of RBCs by subtracting the number of cells in the lysed aliquot (in which the RBCs are destroyed) from the number of cells in the diluted aliquot.


Reviewing and Re-Classifying Images

When the Body Fluid software is enabled, the Work List automatically displays an extra column labeled Type, which identifies the type of fluid sample. The Rack ID/barcode label for tubes analyzed with the Body Fluids Module will always be racks 25, 26, or 27, and the tube position will always read 3 (the position of the lysed sample).

Step Action

1

Select the specimen results on the Work List, then click the Specimens button

.

NOTE: The Specimen screen in the body fluids module displays the aggregate results from the two sample tubes (lysed and diluted) within the same BF rack.

2

Select the Total Cells button to display the initial cell count.

Re-Classify cells to other categories (Bacteria, Crystals or ART) as needed.

3 Click the Next button to review Total Nucleated Cells.

4 When review is complete, click the Accept button .


BODY FLUIDS SKILL CHECK

1. Show facilitator processed Body Fluid Quality Control results.

2. In the table below, identify each position’s contents in a Body Fluid rack:

Position 1

Position 2

Position 3

Position 4

Position 5

3. True or False: A special sample tube is required to process body fluid samples.


SAMPLE ANALYSIS 2

OBJECTIVES


Split chemistry and microscopy results and rerun

Split chemistry and microscopy results and rerun using manual programming

Merge and consolidate IDs


When a dilution barcode is missing or not properly attached to the specimen, it may cause the chemistry and microscopy results to be separated.

This process is also helpful when you do not have enough specimen to run through both the chemistry and microscopy side of the system. In this situation, the chemistry portion is run on the undiluted sample while the microscopy portion can be processed using a dilution to bring the volume up to the minimum.

Resources

iChemVELOCITY IFU

iQ IFU



Splitting Results and Rerunning from the Work List

Step Action

1 Process a diluted sample. Refer to Sample Analysis if needed.

2 From the Worklist double click on the desired Specimen ID to navigate to the Specimen screen for that sample.

3 From the Specimen screen, select the Other… button (on lower right of screen).

4 Select the option Separate microscopy and chemistry results from window.

5 Select OK .

6

In the information area the following message will appear: “Select accept to separate the chemistry and microscopy”. Select the

Accept button .

7 The results should be back on the Work List screen.

8 The chemistry and microscopy results should be separated with two entries for the sample.

9 Highlight the microscopy portion of the sample.

10 Select the Delete Specimen button from the task pane.

11 Select Yes to pop-up message.

12 Rerun the diluted portion of the sample on the iQ by placing the patient rack on the right side of the iQ and pressing the Start button.

13 When complete, verify the results matched up with the existing chemistry results.

14 Review and release.


Splitting Results and Rerunning from the Found List

Step Action

1

From the Work List screen, select the Search button to find the Specimen ID used in the previous exercise.

NOTE: The Work List changes to the Found List when a search is performed. It converts back to the Work List when the Search button is selected again.

2 Split the Chemistry and Microscopy results (use previous exercise as reference if needed).

NOTE

If the specimen does not have two entries, refresh to Found List screen by following steps below:

a Select the Search button to return to Work List screen

b Select the Search button again

c Type in the Specimen ID, and select the Today button

d Select OK

3 Delete the Microscopy results (use previous exercise as reference if needed).

4

Manually program the sample using the following information: Sample Identifier: Patient ID Fluid Type: URN Dilution: Select the appropriate dilution for the sample (based on the dilution label used) Work Order: RUN

5 Place the diluted specimen into the corresponding position of the selected rack WITH THE BARCODE FACING AWAY FROM THE SYSTEM.

6 Place the rack on the iQ and press the Start button.

7 When completed, verify the results matched up correctly.


Merging ID Errors

Step Action

NOTE Clear all manual orders by selecting the Clear All button on the Instrument screen before performing the following exercise.

1 Place a barcoded sample on the iChemVELOCITY.

2

After the sample gets aspirated and the rack begins to move towards the bridge, turn the sample around so the barcode is facing the wrong way.

NOTE: This should result in the iQ not being able to identify the microscopy part of the sample.

3

Go to the Work List, the microscopy portion of the run should have an ID ERROR.

NOTE: If the chemistry portion of the sample was flagged, it will also appear in the Work List with the Specimen ID. If there are no errors on the chemistry portion of the sample, it will automatically be released and not appear on the Work List.

4 Double click on the MICRO result with the ID error/flag.

5 Select the Review Flagged Specimen button located on the lower right of the screen.

6 Type in the barcode from the sample tube in the pop up box.

7 Select Consolidate Microscopy and Chemistry.

8 Select OK .

10 Select the Accept button to merge the two halves of the report.

NOTE: If any red messages appear, please contact facilitater.

11 Review and release.


SAMPLE ANALYSIS 2 SKILL CHECK

1. Show facilitator the merged samples you ran.

2. List the steps necessary to separate Chemistry and Microscopy results.

a. _____________________________________

b. _____________________________________

c. _____________________________________

d. _____________________________________

e. _____________________________________

3. Explain how you would run a dilution if you do not have any dilution labels available.

_________________________________________________

_________________________________________________


SECURITY ACCESS

OBJECTIVES


Create a new user

Delete users


By creating privileges, you will help decide the levels of security access for those working with you based on their laboratory responsibilities.

Resources

iChemVELOCITY IFU

iQ IFU



Creating a new user

Step Action

1 From the Instrument screen, select the Logon button .

2 Select BCI from the identifier drop-down menu.

3 In the password window, type in bci and select OK .

NOTE: Identifier and passwords are case sensitive.

4

Select Go Off line .





5 From the Screen Level Function Area, select the Settings button

.

6

Select the Operator Accounts button to display the Operators Accounts window.

NOTE: The Operator Accounts screen displays the list of authorized users and their privilege level (Technologist or Manager).


7

Select the New button to display the New Operator Account screen:

Note Operator identifiers and passwords are both case sensitive.

8 Type the new operator identification in the Operator Identifier field

NOTE: The follow characters cannot be used [ ] ‘ or spaces.

9 Select the corresponding button to assign access level (Technologist or Manager).

10 Type the new operator password in the Password field and in the Confirm password field.

11 Select OK to add the new operator to the Operator Accounts screen.

12 Select OK to validate the new operator entry and close the screen.

13 Log on to the system using the operator level just created and explore the software.

14 Using the steps above, create another operator with a Tech level.


Deleting a User

The currently logged operator cannot delete his/her own user account

Step Action

1 From the Operators Accounts screen, select the operator to be deleted, and

click the Delete button .

2


“Really delete the selected operator account?”.

Select Yes to delete the selected operator from the user list.

3 Select OK to validate the deletion and close the screen.

Congratulations, you have finished! Continue to the Skill Check.


SECURITY ACCESS SKILL CHECK

1. Show facilitator the operators set up.

2. Show facilitator how to delete an operator.


TRACEABILTY

OBJECTIVES


Add a consumable to traceability

Update a consumable


This feature allows you to keep track of the system consumables and to verify when a specific lot was in use by the system.

Resources

iChemVELOCITY IFU

iQ IFU



Consumables tracking data are stored in the system for patient specimens currently stored or up to

18 months, whichever is greater. In order for the system to purge consumables tracking data, the

related patient data must be purged from the database. The system maintains 10,000 patient results

in the database.

This function provides usage tracking for the following consumables automatically:

iChemVELOCTY

Controls CA CB’ CC

Calibration CalChek Strips CalChek Liquid Reagents

iQ200

Controls and Focus Auto-Focus Primary Positive Primacy Negative Secondary Positive Secondary Negative Level 1 (Body Fluids) Level 2 (Body Fluids)

Calibration iQ Calibrator

The following consumables DO NOT automatically go into traceability. In order to electronically track

them they will need to manually entered into traceability:

iChem Test Strips

iChem Wash solution

iQ Lamina

Body Fluid lysing agent

Iris Diluent

Iris System Cleanser


Adding a New Consumable

Step Action

1 From the instrument screen, go off-line.

2 Select Traceability.

3 Select Add.

4

Fill in the following information:

Name:

Lot Number:

Expiration:

Note: The start date and time are automatically filled.

5 Select OK to return to the Consumables window.

Updating a New Consumable

Step Action

1 From the instrument screen, go off-line

2 Select Traceability

3 Select Consumable to update

4 Edit the fields, as needed

5 Select Update.

6 Select OK to return to the Consumables window.


TRACEABILTY SKILL CHECK

1. Is it necessary to put all consumables into traceability manually?

YES NO

2. What consumables do not automatically go into traceability?

a. CA/CB/CC controls

b. iQ Controls

c. iQ Calibrator

d. iChemVELOCITY Strips

‘


VIEW LOG

OBJECTIVES


Save settings

Understand when to restore settings


Settings are saved in a log each time they are created, modified, or deleted. The log records the date/time and the operator who made the changes. This includes changes made to Chemistry QC such as expirations date made via the Instrument > Consumables > Chemistry QC

Resources

iChemVELOCITY IFU

iQ IFU



View Log saves any changes made to settings only

Step Action

1 From the Instrument screen, select Go off line

2 Go into the Setting Screen.

3

From the Settings Screen, click the View Log button. The Settings Log screen is

displayed

4 Click on a the View Log file you wish to export

5 Click on the Save as button a Windows screen is displayed

6 Select the destination where the setting change will be saved, the default is the Logs

folder.

7

For this exercise, access the Desktop, create a folder and name it “View Log”, and

change the name of the file to ‘iRICELL view log MMDDYYYY”, then click the Save

Button.

8 Restore the View Log backup you just created

9 Click the button a Windows screen is displayed.

10 Select the source where the setting change was saved, in this case, the folder on the

instrument Desktop

11 Select the file you saved earlier, and then click the Open button. The View Log file

will be restored to its previous state.

12 For classroom purposes delete the file you created earlier


VIEW LOG SKILL CHECK

1. Show facilitator the saved View Log

2. The View Log in the iRICELL software contains backups in a first in first out format (FIFO) of 100 files. TRUE FALSE

3. What is the difference between a Backup and view log file?

a. Backup saves everything and view log only saves the settings

b. Nothing both are same, allows operator to save information from two different screens

c. View log saves everything and backup saves on the settings

d. View log saves settings, QC lot numbers and REF value only.

4. When you save a view log in goes into what extension?

a. CSV

b. SLF

c. HTML

d. XML

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