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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.

iRICELL Customer Training


REV B (April 2015) Beckman Coulter Professional Development
IRICELL CUSTOMER TRAINING

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

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IRICELL CUSTOMER TRAINING

REVISION STATUS

iRICELL Customer Training


Revision A Initial Release (January 2015)
Software release 7.0 (and higher)
Presented January 2015, Miami, Florida.

Revision B Release (April 2015)


Software release 7.0 (and higher)
Presented April 2015, Miami, Florida

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IRICELL CUSTOMER TRAINING

iv of iv iRICELL Customer Training


Beckman Coulter Professional Development Rev B (April 2015)
iRICELL Complete Urinalysis System

COURSE MAP- IRICELL CUSTOMER TRAINING

Routine
Operations

Maintenance &
Troubleshooting

Setup

Additional
Topics

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Routine Operations Modules Date Initial Facilitator

System Overview

Daily Maintenance

Quality Control

Sample Analysis
Auto Release and Result
Verification
Maintenance/ TB Modules Date Initial Facilitator
Sample Flow/ Component
Identification
Weekly Maintenance

Monthly Maintenance

Quarterly Maintenance

As Needed Maintenance

Troubleshooting

System Shutdown & Restart

Setup Modules Date Initial Facilitator

Security Access

QC Configuration

Additional Topics Date Initial Facilitator

Processing Dilutions 2

Importing and Exporting Results

Body Fluids

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COURSE MAP – ROUTINE OPERATIONS

Software Overview

Daily Maintenance

Quality Control

Sample Analysis

Auto-Release and
Result Verification

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iRICELL Complete Urinalysis System

SYSTEM OVERVIEW

OBJECTIVES
Given an operating iRICELL Complete Urinalysis System:
 Log On and Log Off the APUI
 Be able to identify the iRICELL System Software

Why Is It Important?
This module introduces the basics of the iRICELL Complete Urinalysis
System. A basic hardware overview allows identification of the general
parts of the system. A basic software overview will help identify common
screen elements useful for efficient navigation. The introduction to
System HELP shows you how to access the information contained in the
Operator’s Manuals.
These topics form the building blocks for the rest of your learning journey.

Resources
iChemVELOCITY Operator’s Manual
iQ Operator’s Manual

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INFORMATION/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

Until someone is logged on, the Specimen button ,


NOTE
Worklist button , and Instrument button
are inactive

2 The operator field will display

To logon, select the Logon button , choose the


3 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

Type in the Password: bci (case sensitive)

4 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.

5 Select

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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)
 Specimen screen

Instrument Screen
Status Area

Information
Area

Task Level
Information
Area

Screen Levels Functions Area

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Common Screen Elements


Instrument Screen
Menu Description
Status light Indicator:
 Grey: Off
 Green: Standby (Energy conservation)
 Blue: Measure (Sample measurement in progress)
 Red: Error (Error condition occurred)

Status Area
iQ Status IChemVELOCITY Status Alarm

Rack/Position number, 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 virtually all the time. Select the Help button
to display the folders containing the Operator’s Manuals, and the How
To documents available for additional procedures not contained in the
manuals
Operator Identification of currently logged operator
Last Micro Date and time of the last successful microscopic calibration includes
Calibration 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
Date and time of the last successful microscopic automatic focus
Auto Focus
Last Reflectance Date and time of the last successful reflectance calibration
Check verification check
Last
Date and time of the last successful specific gravity, color, and clarity
SG/Color/Clarity
calibration check
Check
Last Chem QC Date and time of the last successful chemistry quality control
LIS Identifies if the LIS is OK, down, or disabled
Displays racks manually programmed and gives access to the Manual
Manual Orders
Orders screen. It allows the operator to clear racks
System Status On Line or Off Line (displays in red when off line)
Appear in the Information Area and display the detailed list of
Alarms
unresolved alarms (sorted by priority) then date and time

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Screen Level Functions


Button Function
Use when LIS programming is not available or when barcodes are
not available or being used. Allows the operator to enter the
specimen identification and the rack and position number to be used

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 print


and save QC information

Use to view, print, or save (external media) the Levey-Jennings


charts which are plotted by QC lot number

User-defined instrument setup is configured using the available


selections such as: Operator Accounts, Lab Information, System
Configuration, LIS Interface, Chemistry, QC, Specimen, Release,
Auto Release Data Management, and Auto Classify, set confirmation
thresholds

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

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Work List Screen

Work List Functions


The Work List contains only unreleased results. It displays
Work List the Specimen ID, date and time the sample was processed,
Screen rack and tube position numbers, sequence number, and the
status of each specimen results
An operator can:
 Sort the Work List  Correct/Modify the Specimen ID
While On  Delete a specimen  Edit patient demographics
Line
 Un-delete a specimen  Review and release sample results
 Print the Work List

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

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Search Screen

Select the Search button from the Work List to make


selections to view samples in the Found List by:
 Specimen ID  Patient demographics
Search screen  Sequence number  Patient location
 Operator ID  Specimen awaiting transmission
 Date/time range  Specimen already released
 Incomplete samples

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Found List Screen

Found List Functions


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

Search The Search button is a toggle between the Work List


button and Found List

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Specimen Screen
The Specimen screen displays a graphical representation of the results for each
particle with user-defined thresholds. Values that fall within normal range are
green, results that fall within abnormal range are red, and results that indicate a
review is required are yellow

Information
Area

Particle Concentration
button button

Main Area Displays the following information


Particle Shows the short name of the particle category
Concentration Shows the particle concentration
Current status for the specimen
 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)
Information  URINE CULTURE INDICATOR CHECKLIST-provides information
Area that a urine culture is recommended. Indicators include Nitrite
and Leukocyte Esterase results (when connected to the
IChemVELOCITYor 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

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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

Toggle button between Turbo and Full Edit. Turbo Edit not
used with software version 7.0 or higher. All particles are
available for review in Full Edit mode
If Auto-Release is enabled, the first category needing to be
reviewed is displayed in yellow. The Edit button can be
used to edit chemistry results or enter microscopy 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
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.

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Operator’s Manual (HELP)


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

From the Look in window, select Desktop from the drop down
menu

Choose the desired Ops Manual (VELOCITY or iQ), then click


Open. For this exercise, select IChemVELOCITY Operator’s
Manual 301-7146

The selected Operator’s Manual displays in a separate window

Help is a PDF version of the Operator’s Manual and How to


NOTE
documents

Access sections in the PDF by using the Bookmark Pane


3
located on the left side of the screen.

Click on the Bookmark to go automatically to the starting page


4 of the selected section. For this exercise, select the + next to
Chapter 2-System Description.

To expand the selection, click on the + sign located next to the


NOTE bookmark or to collapse the selection, click on the –sign
located next to the bookmark

6 Select System Status Lights

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7 Select File from the pdf toolbar

8 Select Print

NOTE You can also select the printer icon from the manual toolbar

Select the Pages radio button and enter the page number
9
from_____ and to_________ then select OK

10 Select the X in the upper right corner to close Help

Using steps above, access the iQ Operator’s Manual 300-


11
4320

12 Go to Chapter 2- System Description

13 Open Microscopic Particle Identification

14 Print Auto Classification Categories section

15 Close Help

Congratulations, you have finished the System Overview! Continue to the


Skill Check.

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SYSTEM OVERVIEW SKILL CHECK


1. Label the sections of the Instrument screen:

4
2

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2. Using Help as a reference, complete the table below:

System Status Light On Meaning


The iChemVELOCITY is in

The iChemVELOCITY has

The iChemVELOCITY has

The iChemVELOCITY is in

The iChemVELOCITY has

The main power switch

All lights blinking


simultaneously

3. Using the Auto Classification Categories printed earlier, fill in the table
below:

Category Abbreviation
Non-squamous
epithelial cells
UNCX

WBCC

Yeast

SQEP

Unclassified Casts

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DAILY MAINTENANCE

OBJECTIVES
Given an operational iRICELL Complete Urinalysis System and using the
Quick Reference guides, 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

Why Is It Important?
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 Operator’s Manual
iChemVELOCITY Maintenance Quick Reference Guide
iQ Operator’s Manual
iQ Maintenance Quick Reference Guide

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INFORMATION/PRACTICE
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

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

3 Clean the waste container with Alcohol and then rinse with tap water

4 Thoroughly dry the waste container

5 Reinstall the waste container

6 Close the waste container door

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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

Clean the drain bottle with a mild detergent and water and then
3
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 Cleaner diluted 1:10

2 Wipe the STM to remove any deposits

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

4 Wipe again using distilled water

5 Wipe dry

Cleaning the optional load/ unload stations (if applicable)


Step Action

1 Moisten paper towels with Iris System Cleaner diluted 1:10

2 Wipe the STM to remove any deposits

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

4 Wipe again using distilled water

5 Wipe dry

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Cleaning the instrument surfaces


Step Action

1 Moisten paper towels with Iris System Cleaner diluted 1:10

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

3 Wipe again using distilled water

4 Wipe dry

Loading Urine Chemistry Strips


Step Action

Rotate the strip loader to unlock position and


1
pull out from the analyzer

Remove and discard the old desiccants and


replace with the new ones provided with the
2 chemistry strip vial

NOTE: Do not cut desiccants; fold over

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


degree angle.

Place only the necessary amount of strips


3 needed for today’s run (approximately 10
strips) inside the strip loader in the correct
orientation (Iris logo facing the back of the
instrument)

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
4
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

NOTE: Use a quick consistent rotation

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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 the message “Chemistry Wash level is low”

Step Action

Visually inspect the volume of the Wash Solution. If low, proceed


1
with remainder of steps

NOTE Wear fresh gloves when changing the Wash Solution filter

Make sure the system is in Standby mode as indicated on the top


2
left of the Instrument screen

3 Remove the cap of the old Wash Solution bottle

The filter located at the end of the tubing needs to be replaced with
NOTE
every container

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

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

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

NOTE Do not mix the contents of the bottle

Discard old container and old filter according to your local


7
regulations

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DAILY MAINTENANCE ON iQ 200

Cleaning the instrument surfaces


Step Action

1 Moisten paper towels with Iris System Cleaner diluted 1:10

Wipe the exterior surfaces of the analyzer to remove any


2
deposits.

3 Wipe again using distilled water

4 Wipe dry

Cleaning the Sample Transport Module (STM)


Step Action

1 Moisten paper towels with Iris System Cleaner diluted 1:10

2 Wipe the STM to remove any deposits

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

4 Wipe again using distilled water

5 Wipe dry

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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

Step Action

Visually inspect the volume of the Lamina solution. If low, proceed


1
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

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
NOTE
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

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Delete all previous manual programming


Step Action

1 Ensure the Instrument screen is displayed

Select the Clear All button on the Manual Orders


line
2
NOTE: The Clear All button is only available if there are manual
orders in the system

3 Select Yes to the confirmation message

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 Cleaner must be used
to clean the sample lines and the flowcell.

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

Congratulations, you have finished Daily Maintenance! Continue to the Skill


on the next page.

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DAILY MAINTENANCE SKILL CHECK

1. 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

2. 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

3. True or False: The Auto Strip Counter Override button should be used
every time that you empty the strip waste container.

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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 Operator’s Manuals 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

Why Is It Important?
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 Operator’s Manual
iQ Operator’s Manual

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INFORMATION/PRACTICE

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.

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Analyzing Commercial Controls on the iChemVELOCITY

Step Action

Using the iChemVELOCITY control


rack, pour (DO NOT PIPETTE; DO
1
NOT SHAKE) 3mL of CA/CB/CC in
positions 8, 9, and 10 respectively

Position Insert Volume Contents


color
CA
8 3 mL
Control
CB
9 3 mL
Control
CC
10 3 mL
Control
2 Store rack out of light and allow material to warm to room temperature.

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)
3
NOTE: Position 10, which has the CC control, should be all the way to the
right

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Analyzing Commercial Controls for the iQ200

Step Action

1 Bring Control and Focus material to room temperature

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
2 dispersed. Repeat this step with the iQ Positive control.

NOTE: Do not mix the iQ Negative Control

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

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

NOTE DO NOT put anything in position 4

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

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

Fill a labeled (Negative Control Barcode) tube with 3 mL of Negative control


7
material (DO NOT MIX) and place in position 7 of the same iQ control rack

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

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Position of iQ Control Material


NOTE: DO NOT place a tube in position 10. It will shut down the System

Insert Bar
Pos Vol Contents Function
color code
System
1 Gray 3 mL Cleans lines No
Cleanser
2 Gray 3 mL Diluent Rinses cleanser No
3 Gray 3 mL Diluent Rinses cleanser No
4 Empty position
5 Blue 6 mL iQ Focus Focuses camera Yes
6 Orange 3 mL iQ + control Primary lot positive ctrl Yes
7 Blue 3 mL iQ - control Primary lot negative ctrl Yes
8 *Secondary lot positive control
9 *Secondary lot negative control
10 **Empty position
NOTE: Position 8 and 9 are optional and intended to allow the laboratory to
run controls in parallel for new lots. Do not place a tube in positions 10. This
will shut down the system

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Viewing/Reviewing Control Results

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

Step Action

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

From the Instrument screen, locate the Last QC field. If all of the
2 results are within acceptable range, the date and time will display. If
any QC material failed, the Last QC field will display (--)

To see the individual QC runs from the Instrument screen, select the
3
Quality Review button . The Quality Review is displayed

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

The iQ Series QC report consists of Control name, operator identifier,


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

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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.
5
TRY THIS NOW

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


with Manager status

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

6 Restore button

Restore the QC you removed in the previous step.

Manually Printing Control Data


Step Action
To manually print an individual QC run, from the Instrument screen,
1 select the Quality Review button . The Quality Review is
displayed

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

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

5 Change the destination from Screen to Printer and select OK

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

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Auto Print Set Up for Controls


Step Action

1 From the Instrument screen, select Go off line

3 Select the Settings button

4 Select the QC button

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

Please continue to the Skill Check on the next page.

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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. Show Facilitator a printed control file.

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

_____________ , _____________ , and _____________

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

______________________________________

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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 cassettes
 Identify approved tube types
 Process bar coded samples
 Manually add a test order
 Process a diluted sample
 Interpret Data Review and Release Results

Why Is It Important?
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
Bar code labels
Sample Racks

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INFORMATION/PRACTICE
Types of Racks
Types of
Racks

Sample

IChemVELOCITY
Controls

CalChek

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Types of
Racks
continued

Dilution Rack

iQ Controls
with
Daily Cleaning &
Focus
Notes:
 Primary lot of positive and negative controls
must be processed at the same time
 Secondary controls must be run behind
primary controls
 Placing a sample in position 10 of the rack
will shut the system down

iQ Calibration

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Sample Tube
The following table identifies the validated sample tubes that can be used on the
system:
Type/Manufacture Size Volume Material
Plastic
Greiner bio-one 16X100 mm 12 mL Polystyrene round bottom tube
(PN 160101)
Globe Scientific 16X100 mm 12 mL Polystyrene round bottom tube
(PN 111012)
Alpha Laboratories 16X100 mm 12 mL Polystyrene round bottom tube
(PN X73002)
Iris Plastics 16X100 mm 12 mL Polystyrene tubes (PN 660-
3021) included in the iQ starter
kit
Any Glass 16X100 12 mL Round bottom
Body Fluids
Iris Plastic Body Fluid 10 mL Conical bottom tubes
Tubes ONLY (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. Refer to
current Operator’s Manual>Sample Processing for additional approved sample tubes

Specimen Information
Notes

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

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

 Mix specimen well before testing


 Do NOT add disinfectant or detergent to the specimen
3
 Keep specimens out of direct sunlight
 Do NOT centrifuge urine specimens

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Sample Volume:

iChemVELOCITY alone requires 2 ml

iQ200 Series alone requires 3 mL


4
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

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.
5
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

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Running Specimens with Barcodes


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

Step Action

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

Remove the caps from the patient samples. Keep the caps to place on the tubes at
2
the end of this exercise

3 Verify the system is in Standby

Place the rack on the iChemVELOCITY sampler area with the barcodes facing the
4
instrument, and the rack positioned to the back of the sampler area

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

6 Verify the systems change from Standby to Measure

Once samples are finished processing, remove the rack from the unload area of the
7
iQ

8 Replace the caps on the samples and save for later

9 From the Instrument screen, select the Work List button

Select the first sample on the Work List by double clicking on the specimen row to
10
open the Specimen screen

11 Accept the results for the samples just processed

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Running Samples without Barcodes


Step Action

1 Obtain two non-barcoded specimens

2 From the Instrument screen, select the Manual Orders button .


The Manual Order screen is displayed

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, this rack is NOT
available for programming

Enter the specimen information corresponding to the specimen position:

 Specimen Identifier: Type in Specimen ID found on tube

2  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

3 Select the OK & Print button to get a list of the manual orders

4 Place the sample in the assigned rack and position

Verify that the samples are processing by making sure the status changes
5
on the iChemVELOCITY and iQ from Standby to Measure

Do not take action at this time for any samples with error (alarms). We will
6
review results later
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Dilution
Diluting a microscopic sample may be required before processing the sample on
the iQ and/or iChemVELOCITY, and it needs to be consolidated with the part of
the sample that did not have an error.
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 Operator’s
Manual.

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)

First, the chemistry portion of any sample that WILL be diluted should be run
UNDILUTED using an ORANGE rack on the Chemistry (Velocity) portion of the
system. This rack is specially labeled so that it will not be processed by the
Microscopy (iQ) portion of the system. This rack will skip the iQ sampling station
and be transferred automatically to the unloading station for retrieval

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Step Action

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

Place the labeled undiluted patient tube in the dilution rack

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

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

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

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

4
This label reads “URN 4”.
According to the software
screen above, the label
used indicates a 1 to 10
dilution was made for this
sample.

Prepare the desired dilution using sample taken from your undiluted
5
specimen and Iris Diluent

6 Load the dilution tube into a regular patient rack (NOT THE
DILUTION RACK)
Load the rack on the iQ module directly and press the Start button
7
on the front of the instrument to run the sample
Once the diluted sample is complete, the results from the undiluted
8 chemistry specimen will automatically combine with the results from
the dilution tube and a collated report will be produced
There will be a dilution indicator in the heading of the report
NOTE 1:X= where X would be the dilution based on the label you placed on
the sample tube
If there are no flags present, the results will automatically be released
9
and printed out
If there are flags present, you must review and accept the results from
10
the Worklist before it prints out

Please continue to the Skill Check on the next page.

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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?
_________________________________________________________

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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

Why Is It Important?
Knowledge of instrument functions will enable you to operate the system
more efficiently and determine when you should reclassify results and/or
view the sample under the microscope.

Resources
iChemVELOCITY Operator’s Manual
iQ Operator’s Manual
iQ Image Encyclopedia

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INFORMATION/PRACTICE

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

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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

Auto-Particle Recognition (APR) is a type of computerized neural


network that has been “trained” to classify urine particles

4  There are 12 auto-classifications with 26 subclassifications


Particle (subclassifications are used by the operator to further classify
Classification particles)
(Outputs)
 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 - BACT=Bacteria


- WBC=White Blood Cells - SPERM=Sperm
- WBCC=White Blood Cell Clump - MUCOUS=Mucous
- SQEP=Squamous Epithelial - UNCX=Unclassified
- NSE=Non-Squamous Epithelial Crystal (CRYS is
- HYAL=Hyaline Cast previous terminology)
- UNCC=Unclassified Cast - BYST=Yeast (YST is
previous terminology)

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4 How does APR work?


Particle
Classification  If the unknown particle meets > 90% confidence level of an expected
(Outputs) matrix, its image will be classified into a category
continued
 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)

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Results Review

Specimen screen

Chapter 3 iQ page 68

Chemistry
Results

Microscopic Microscopic
Results Review
Indicator

Results  Chemistry and microscopic results are consolidated on the same


screen

 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)

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Resulting with Edit Free Release

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


Release
algorithm  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  Employs an intuitive method for verification of particle classification


Verification
Range (PVR)  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 Review Auto


Release Results Release

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


Exceeded
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

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Verification of Results in Yellow

Specimen screen

Specific particle screen

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Verifying  The Work List displays all samples not auto-released. Select the
Results in sample to view the sample in the Specimen screen
Yellow
 Selecting the Edit button from the specimen screen will
automatically open the first category that is yellow for that sample

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

 Use the Back and Next buttons to continue


reviewing particles classified in yellow for the sample being
reviewed

 Reclassify when it will be clinically significant

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

Particle  50% Rule:


Review/
Reclassify o If you open a particle category and more than 50% of the particles
Process have been classified correctly, then agree with the results and
(yellow continue with the next yellow category
categories)
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


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Microscope The presence of four elements require a manual microscopic review for
Required 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

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Edit Chemistry results can be edited if required. This feature is only


Chemistry available when the Detailed Audit Trail feature is enabled
Results

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Bacterial  Automatic Bacteria Grading and Auto-classification


Grading
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

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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 Operator’s Manual

 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

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Pop-up  Used as a way for the system to get the operator’s attention for
Messages 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

Dilutions  Do not dilute a specimen for chemistry testing

 Must use the orange dilution rack #23 for samples that will be used to
dilute for microscopy

 Recommended to dilute or process using a manual method for the


following samples:

o Grossly bloody
o Heavy mucoid
o Very dense
o Short samples

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Result Verification
Step Action

Load barcoded samples into a patient rack with the barcode


1
showing through the opening of the rack

Remove the caps from the patient samples. Keep the caps to place
2
on the tubes at the end of this exercise

3 Verify the system is in Standby

Place the rack on the iChemVELOCITY sampler area with the


4 barcodes facing the instrument, and position the rack to the back of
the sampler area

The system will automatically move the rack forward to the sample
5
aspiration area

6 Verify the system changes from Standby to Measure

Once samples are finished processing, remove the rack from the
7
unload area of the iQ

8 Replace the caps on the samples and save for later

9 From the Instrument screen, select the Work List button

Select the first sample on the list by double clicking on the


10
specimen row to open the Specimen screen

11 Accept the results

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Edit Results
Step Action

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

2 From 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


3
categorized correctly, skip to step 7

If 50%or more (refer to memory jogger) of the particles DO NOT


4 belong in the category and need to be reclassified, continue with
next step

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

Once the reclassification is complete, select the original category


name button in the top left corner. (i.e. RBC in the above
example)

6 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

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(i.e. WBC) when the Next button is selected

Select the Next button

 If the number of particles exceeds the space on the screen,


7 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)

8 Select the Accept button from the Specimen screen


when the verification is complete on a sample

9 Repeat steps 1 - 8 for each specimen to verify

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RESULT VERIFICATION SKILL CHECK

1. Print one specimen that was processed and show facilitator the patient printout

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?

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COURSE MAP – MAINTENANCE/TROUBLESHOOTNG

Sample Flow
Component
Identification

Weekly &
Monthly
Maintenance

Quarterly
&
As Needed
Maintenance
Maintenance

Troubleshooting

System
Shutdown and
Restart

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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

Why Is It Important?
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 Operator’s Manual
iQ Operator’s Manual

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INFORMATION/PRACTICE
The iRICELL system 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 iQ PC. If a microscopy is
required, the chemistry results will be held in the Work List. 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
Moves the racks from the load station (right side of the
SampleTransport
1 instrument), to the pipetting station (barcode reader), and
Module (STM)
then to the unload station (left side of the instrument)
Located inside the instrument facing the pipetting station.
The barcode scanner reads the sample barcodes and will
2 Barcode Readers query the LIS or the instrument PC for sample
programming to either skip/run based on sample
requirements
Connection between the iChemVELOCITY and the iQ
systems. Sample racks are transferred automatically from
the chemistry system to the microscopic system. When
3 Sample Bridge 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

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Front view of iChemVELOCITY

Component Function

1 Lights display: Standby (Green), Measure


System Status Lights
(Blue), and Error (Red)

Component used to load strips into the Strip


2 Strip Loader
Provider Module (SPM)

Moves the racks from the load station (right side


Sample Transport Module of the instrument), to the pipetting station
3 (STM) (barcode reader), and then to the unload station
(left side of the instrument)

Pressing this button after applying power to the


4 On/Off Button
instrument places the system in standby

5 Start Button This button is not used on the iChemVELOCITY

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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
Strip Loader (top)-Holds 300 strips maximum with an on-
Strip Provider board stability of five days. The strips will be delivered
1 Module from the strip loader to the SPM (bottom). When the
(SPM) sampler detects the presence of a test tube, a test strip is
delivered facing up to the Strip Conveyor System
Strip Conveyor Moves the test strips through 8 light reading positions
System (SCS) every 15 seconds:
2
(below strip reader  Any face down strip will be turned face up
module)  The strips go through a loading and dosing position
Measures the color of each pad of the chemistry test
Strip Reader
strips at different incubation times and uses the
3 Module
information to obtain the analytes semi-quantitative
(SRM)
concentrations
Specific gravity is obtained using a refractometer. Color
Specific Gravity, and Clarity are obtained using a flowcell using white light,
4 Color, and Clarity color sensor to detect the color of the sample, and the
Module (CGM) amplitude of light scattered within the flowcell to
determine clarity of the sample

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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
Fluidics solution. There is 1 pump that aspirates and dispenses
5
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

Strip disposal into waste container (300 strip maximum) and


6 Waste (not pictured)
liquid waste disposal either in a drain or waste container

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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 Results sent to
Host Computer

Sample dispensed on strip

Color Reaction
detected and measured by
Strip Reader Module (SRM)

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

Composed of iQ Lamina container and 3 peristaltic pumps that


3 Fluidics aspirate and circulate the sample surrounded by the iQ lamina
through the instrument, into the flowcell, and then to waste

Waste (not The waste pump discards the fluids into a drain or waste
4
pictured) container
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iQ 200 Analysis Process

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.

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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

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WEEKLY & MONTHLY MAINTENANCE

OBJECTIVES
Given an operational iRICELL System and Quick Reference Guides, be
able to:
 Clean the Strip Provider Module (SPM)
 Clean the Wash Station Bath
 Clean the Strip Conveyor System
 Using TSB2012-024, clean the Specific Gravity, Color, and Clarity
Module
 Run CalCheck
 Perform Backup

Why Is It Important?
Performing routine maintenance including cleaning and calibrations will
keep your instrument in optimal operating condition.

Resources
iChemVELOCITY Operator’s Manual
iChemVELOCITY Quick Reference Guide
iQ Operator’s Manual
iQ Quick Reference Guide
Customer/ Technical Service Bulletin: TSB2012-024
Blank CD

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INFORMATION/PRACTICE

WEEKLY MAINTENANCE FOR ICHEMVELOCITY

Clean the Strip Provider Module

Step Action

Procedure is to be performed on a weekly basis based on


throughput:

NOTE  200 samples or less a day – Clean once per week

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


week

Locate the Weekly Maintenance section in the iChemVELOCITY


1
Maintenance Quick Reference Guide

2 Follow the procedure to Clean the Strip Provider Module

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

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CLEAN THE SPECIFIC GRAVITY COLOR CLARITY MODULE


NOTE: This procedure is not found in the Maintenance Quick Reference Guide or Operator’s Guide.
Please refer to CUSTOMER / TECHNICAL SERVICE BULLETIN: TSB2012-024

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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

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


2
Specimen button

3 Select OK to the message

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

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
NOTE
take an action on. All results should now be selected
(highlighted in blue)

MONTHLY MAINTENANCE FOR ICHEMVELOCITY


Clean the Wash Station Bath

Step Action

Using the iChemVELOCITY Maintenance Quick Reference


1
Guide, locate the monthly maintenance

2 Perform the steps provided to clean the Wash Station Bath

DO NOT insert the cotton swab inside the wash tube.


NOTE
Cotton particles may clog the tubing connectors

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Clean Strip Conveyor System

Step Action

Procedure is to be performed on a monthly basis based on


throughput:

NOTE  200 samples or less a day – Clean once per month

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


month

Using the iChemVELOCITY Maintenance Quick Reference


1
Guide, locate the monthly maintenance

2 Perform the steps provided to Clean the Strip Conveyor System

We will be leaving the Strip Conveyor System out of the system


NOTE
overnight to dry in the training lab
The Operator’s Manual and Maintenance Quick Reference Guide
states there is need for a 50 minute warm up. This is no longer
NOTE
true. There is essentially no warm-up time needed now. This is
documented in TSB2012-019

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IQ200 MONTHLY MAINTENANCE


iQ Calibration

Step Action

Using a iQ control rack, load the following material:


Insert
Pos Vol Contents Barcode
color
Gray 3 mL Iris System No
1 1
Cleanser
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

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Running iQ Calibration
Step Action

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

Place the barcoded calibrator tube in position 1 of the iQ


calibration rack

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

Verify the iQ calibrator has warmed to room temperature. Hold


3 the bottle upside down and give five hard sharp shakes followed
by five gentle inversions

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

Fill ten 16X100mm tubes with 4 mL of iQ calibrator including the


5
barcoded calibrator tube in position 1 of the calibration rack

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


6
calibration rack

7 Load the rack onto the right side of the iQ sampler

8 Press the Start button on the iQ

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Perform a backup

The backup screen identifies which files were backed up such as Data, QC,
Settings, and Configurations

Step Action

From the Instrument screen, select the Go off line button


1

2 Select the Maintenance button

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

When the Backup Dialog pop-up message appears, select or


4
verify the “take no action” options is highlighted. Select OK

From the Maintenance screen, select the Backup button


and select OK
5
NOTE: This step can take several minutes. The Backup Dialog
Box displays progress

6 When the Backup process is complete, select OK

The CD drive will open automatically when the process is


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

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

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WEEKLY & MONTHLY MAINTENANCE SKILL CHECK


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

Maintenance Procedures for iChemVELOCITY Initials

Weekly Maintenance

Clean Strip Provider Module

Clean CGM

Monthly Maintenance

Clean Wash Station Bath

Clean Strip Conveyor System

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

Maintenance Procedures for iQ200 Initials

Monthly Maintenance

Calibration

3. Why is the orange dilution rack used for the weekly maintenance of

the CGM? ________________________________________________

_________________________________________________________

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QUARTERLY AND AS NEEDED MAINTENANCE

OBJECTIVES
Given an operating iRICELL System, be able to:
 Perform Reflectance CalChek
 Perform Specific Gravity, Color, Clarity CalCheck
 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
 Replace Lamina Solution

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

Resources
iChemVELOCITY Operator’s Manual
iChemVELOCITY Quick Reference Guide
iQ Operator’s Manual
iQ Quick Reference Guide
Customer/Technical Service Bulletin: TSB2013-003

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INFORMATION/PRACTICE

iChemVELOCITY Quarterly Maintenance


Reflectance CalChek

Step Action

From the Instrument screen, check to verify that the system


1
status is Online

Open iChemVELOCITY Operator’s Manual>>Chapter 6 –


2 Calibration Verifications >>Running CalCheck >>Reflectance
CalCheck >> Specific Gravity, Color, and Clarity CalCheck

Use the strips found in the supplied iChemVELOCITY CalChek


3
kit

4 Select the Maintenance button

5 Select the Reflectance Check button

6 The system will display a series of six screens

Follow the instructions on each of the screens


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

From the Instrument screen, verify the Reflectance Check


8
passed or check the print out

9 Notify facilitator if the Reflectance Check fails

Specific Gravity, Color, and Clarity CalChek

Step Action

1 Remove the tubes from the iChemVELOCITY CalChek kit

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

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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
Bar-
Pos Contents Value code
1 Specific Gravity CalChek solution 1.002+/- 0.003 Yes

2 Specific Gravity CalChek solution 1.030+/- 0.005 No

3 Specific Gravity CalChek solution 1.060+/- 0.005 No


3
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

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.
5 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

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As Needed Maintenance
Step Action

Using the iChemVELOCITY Maintenance and iQ Quick Reference Guides, locate the
1
as needed maintenance procedures

2 Perform the following As Needed Maintenance Procedures:

 Clean the Sample Tube Detectors

 Clean the Barcode Reader Windows

 Clean the Optical Sensors on the Sample Transport Module


3
 Clean the Rinse/Waste Bath (iQ)

 Replace Wash Solution (iChemVELOCITY)

 Replace Lamina Solution (iQ)

Using instructions in the Customer/Technical Service Bulletin TSB2013-003 located


4
below, perform the Cleaning the Sample Filter procedure

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Please continue to the Skill Check on the next page.

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MAINTENANCE SKILL CHECK

1. Record the maintenance performed for the iChemVELOCITY in the table


below:

Maintenance Procedures for iChemVELOCITY Initials

Quarterly Maintenance

Perform Specific Gravity, Color, Clarity, Calcheck

Perform Reflectance Check

As Needed Maintenance

Clean Sample Tube Detector

Clean the Barcode Reader Window

Clean the Optical Sensors on the Sample Transport Module

Replace Wash Solution and Filter

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

Maintenance Procedures for iQ200 Initials

As Needed Maintenance

Clean Sample Tube Detector

Clean Barcode Reader Window

Clean the Optical Sensors on the Sample Transport Module

Replace Lamina Solution and Filter

Clean the Rinse/Waste Bath

Clean the Sample Filter

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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

Why Is It Important?
This information will help you in the event you need to troubleshoot a
sample, reagent, or instrument issue.

Resources
iChemVELOCITY Operator’s Manual
iQ Operator’s Manual

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INFORMATION/PRACTICE
A Systematic Approach to Troubleshooting
Step Action

Identify the indicators:

 Focus, QC, and Calibration Failures

1  Questionable patient results

 Flags and Alarms

 Observations: Sights/Sounds

Inventory: What Just Happened?

 Processed Focus, Calibrator, or QC


o Lot number
o Expiration date
o Preparation/mixing not done correctly
o Labeling QC tubes correctly

 Processed Patient Samples:


o Very dense
o Bloody
o Heavy Mucous
o Short Sample
o Wrong rack used
o Dilution needed and sample was labeled incorrectly
o Not Manually ordered correctly

2  Changed/loaded reagents or supplies:


o Loaded correctly
o Expiration date
o Correct filter installed
o Wash Solution or Lamina containers in correct position
o Chemistry strips loaded incorrectly, expired lot number, on
board >5 days

 Instrument Issues:
o Maintenance performed or due
o Component replacement performed
o Peripheral issues: printer, keyboard, mouse, touch screen
o Rack damages

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

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Use Resources:

 iChemVELOCITY and iQ Operator’s Manuals

 Quick Reference Guides

 Alarm displays showing Cause/Remedy instructions

 Memory Joggers (Job Aids)


3  Lab troubleshooting log

 Maintenance log

 Another instrument

 How To Documents: The procedures are specific to troubleshooting


and instrument repair. Utilize the procedures with guidance from
the call center or a field service engineer. The procedures may
require you to work with the micro or chemistry service software

Assess Severity:
 Calibration/Calibration Verification Failures
o CalChek and/or iQ Calibration
 QC Failures
o CA, CB, and/or CC
o Positive and/or Negative iQ controls
o Focus
o All tubes or just one
 Questionable patient results
o All patients or one patient
o From a specific department or site

 Flags
o Instrument Screen Flags
4  Does the flag require a restart, rerun Pos/Neg iQ QC,
rerun iQ Focus, rerun iQ calibrator?
 Are there multiple events?
 Do you have to contact field service?

 Hardware Errors or Alarms?

 Chemistry Analyzers Errors or Alarms


o Multiple patients or one patient
o Hardware flags/failures

 Observations
o Is the system stuck in Measure or Error Status?
o Is it the entire system or only one area of the instrument?

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Devise a Plan:
 Sample
o Calibrator
 Pour new calibrator and recalibrate
o QC Material
 Pour new QC and run
 Patient Samples
o Dilute the sample
o Request a new specimen and repeat
o Validate with microscopic check
5
 Supplies
o Load new chemistry strips
o Load a new bottle of Lamina and/or replace the filter
o Load a new bottle of Wash Solution and/or replace the filter
 Instrument
o Perform suggested remedy for alarms and flags
o Perform maintenance
 Verify system performance as required
o Replace component
 Verify system performance as required

Implement and Evaluate Plan:

 Successful?
6 o Good work

 Unsuccessful?
o Devise new plan and implement

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Instrument Screen Flags

The Instrument screen displays the flags generated by the iRICELL. Any flag displayed
will also display a Cause/Remedy screen for the flag and force the system Offline. The
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

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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.

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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

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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.

Introduction

In this section, we will be creating a series of flags by purposely doing things the
WRONG way. These are operator type errors that you may run into when training new
people or dealing with new operators.

Seeing how these errors are created and then correcting each one later on in this
exercise will give you a better understanding of troubleshooting these types of errors.

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Rack and Sample Errors

Step Action

For each of the scenarios given below, document any of the


following information given:

 Instrument screen for delta errors

 Quality Review screen


1
 Work List screen

 Specimen screen for any Work List sample that may be


flagged

NOTE: Not all of the areas above will have information for
specific errors

2 Document any observations for each given scenario

Print out any Cause/Remedy reports and number the print out
3
corresponding to the scenario

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Scenario 1

Place an unlabeled tube of Focus in Position 5 of the iQ control rack. Load


the rack on the iQ and press the Start button on the iQ

Documentation

Instrument
Screen

Quality Review

Work List/
Specimen
Screen

Observation

(see printout) If no printout, document here

Cause/Remedy

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Scenario 2

Place an unlabeled tube of Positive control in Position 6 of the iQ control


rack. Load the rack on the iQ and press the Start button on the iQ

Documentation

Instrument
Screen

Quality Review

Work List/
Specimen
Screen

Observation

(see printout) If no printout, document here

Cause/Remedy

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Scenario 3

Place a correctly labeled tube of Negative control in Position 7 of the iQ


control rack. Load the rack on the iQ and press the Start button on the iQ

Documentation

Instrument
Screen

Quality Review

Work List/
Specimen
Screen

Observation

(see printout) If no printout, document here

Cause/Remedy

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Scenario 4

Place a correctly labeled tube of Negative control in Position 6 of the iQ


control rack. Load the rack on the iQ and press the Start button on the iQ

Documentation

Instrument
Screen

Quality Review

Work List/
Specimen
Screen

Observation

(see printout) If no printout, document here

Cause/Remedy

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Scenario 5

Place correctly labeled tubes of Positive and Negative controls in positions


8 (positive) and 9 (negative) of the iQ control rack. Load the rack on the
iQ and press the Start button on the iQ

Documentation

Instrument
Screen

Quality Review

Work List/
Specimen
Screen

Observation

(see printout) If no printout, document here

Cause/Remedy

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Scenario 6

Place five barcoded patient samples in positions 1-5 of the iQ calibration


rack. Load the rack on the iQ and press the Start button on the iQ.
Observe the rack as it runs

Documentation

Instrument
Screen

Quality Review

Work List/
Specimen
Screen

Observation

(see printout) If no printout, document here

Cause/Remedy

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iRICELL Complete Urinalysis System

Scenario 7

Place five barcoded patient samples in position 1-5 of an iQ control rack.


Load the rack on the iQ and press the Start button on the iQ. Observe the
rack as it runs

Documentation

Instrument
Screen

Quality Review

Work List/
Specimen
Screen

Observation

(see printout) If no printout, document here

Cause/Remedy

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Scenario 8

Place an unlabeled tube with Diluent in position 1 of the iQ calibration


rack. Load the rack on the iQ and press the Start button on the iQ

Documentation

Instrument
Screen

Quality Review

Work List/
Specimen
Screen

Observation

(see printout) If no printout, document here

Cause/Remedy

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TROUBLESHOOTING SKILL CHECK


1. Load and process an iQ control rack with the material listed in the table below:

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. What flag(s) disappeared from the Instrument screen when the Focus was
processed correctly?
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
3. Allow the system to go to Standby. Load and process iQ Calibration correctly.
(Refer to Quick Reference Guide, if needed). What flag(s) was/were cleared
from the Instrument screen?
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________

4. Allow the system to go to Standby. Load and process an iQ control rack with the
material listed in the table below:

Pos Insert color Vol Contents Barcode


6 Orange 3 mL Primary Positive Ctrl Yes
7 Blue 3 mL Primary Negative Ctrl Yes
8 Orange 3 mL Secondary Positive Ctrl Yes
9 Blue 3 mL Secondary Negative Ctrl Yes

5. What flag(s) was/were cleared from the Instrument screen?


______________________________________________________________________
______________________________________________________________________

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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

Why Is It Important?
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 Operator’s Manual
iChemVELOCITY Quick Reference Guide
iQ Operator’s Manual
iQ Quick Reference Guide
Customer/ Technical Service Bulletin: TSB2012-24
Blank CD

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iRICELL Complete Urinalysis System

INFORMATION/PRACTICE

Shutting down the System

Step Action

From the Instrument screen, select Go off line

The following message will appear:

1 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 Select the Maintenance button

Select the Shutdown button . The following


message will appear:
3
Do you want to shut down the instrument?

Select Yes

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


4 button on the left front of the iQ

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


iChemVELOCITY

For this exercise, you do not need to turn off the main power
NOTE switch of the instruments that are located on the back of the
instrument; however, Technical Support may direct you to do so.

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Restarting the System

Step Action

Restart the computer by pressing the On/Off button on the front


1
of the PC

When the Instrument screen is displayed,

Power on the chemistry module by pressing the green On/Off on


2 the front of the iChemVELOCITY

Power on the microscopy module by pressing the green On/Off


button on the left front on the iQ

Log on to the system


3 NOTE: The system will automatically initialize, and the system
will be On Line

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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

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COURSE MAP – SETUP

Security
Access

QC Configuration

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SECURITY ACCESS

OBJECTIVES
At the completion of this module, be able to:
 Create a new user
 Delete users

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

Resources
iChemVELOCITY Operator’s Manual
iQ Operator’s Manual

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Beckman Coulter Professional Development PN: REV B (April 2015)
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INFORMATION/PRACTICE
Creating a new user
Step Action

From the Instrument screen, select the Logon button


1

2 Select [IRIS] from the identifier drop-down menu

In the password window, type in iris2k1 and select OK


3
NOTE: Identifier and passwords are case sensitive

Select Go Off line

The following message will appear:

4 Any specimens currently being analyzed will be completed. The


rack (if any) will be ejected.

Continue going Off Line?

Select Yes to confirm message

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

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).
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Select the New button to display the New Operator


Account screen

Note Operator identifiers and passwords are both case sensitive

Type the new operator identification in the Operator Identifier


field
8
NOTE: The follow characters cannot be used [ ] ‘ or spaces

Select the corresponding button to assign access level


9
(Technologist or Manager)

Type the new operator password in the Password field and in


10
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

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

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

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

Step Action

From the Operators Accounts screen, select the operator to be


1
deleted, and click the Delete button

The following message will appear:

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.

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SECURITY ACCESS SKILL CHECK

1. Show facilitator the operators set up


2. Show facilitator how to delete an operator

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QUALITY CONTROL 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
 Back up the configuration
 Perform parallel testing of primary and secondary lots of positive and
negative controls

Why Is It Important?
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 Operator’s Manual
iQ Operator’s Manual
Blank CD

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INFORMATION/PRACTICE
Step Action

Only iChemVELOCITY Quality Control information requires input


NOTE into the software. The iQ Quality Control information is
embedded in the barcode of the corresponding material.

Select Go Off line from the Instrument screen

The following message will appear:

1 Any specimens currently being analyzed will be completed. The


rack (if any) will be ejected.

Continue going Off Line?

Select Yes to confirm message

From the Screen Level Function Area, select the Consumables

button to access the Consumables window

From the Consumables window, select the Chemistry QC


3
button

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

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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

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

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


ranges
8
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

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

It is recommended to restart the system when any changes are


NOTE
made to configurations

11
Go to the Maintenance button and select the Restart
button . Once system restarts, log on using your
Identifier and Password

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

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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

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COURSE MAP – ADDITIONAL TOPICS

Processing
Dilutions 2

Importing and
Exporting
Results

Body Fluids

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PROCESSING DILUTIONS 2

OBJECTIVES
Given an operating iRICELL System, be able to:
 Split chemistry and microscopy results and rerun
 Split chemistry and microscopy results and rerun using manual
programming
 Merge and consolidate IDs

Why Is It Important?
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 Operator’s Manual
iQ Operator’s Manual

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INFORMATION/PRACTICE

Splitting Results and Rerunning


Step Action

Process a barcoded urine specimen and release. From the Work List
screen, select the Search button to find the Specimen ID
used in this exercise
1
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

Double click on the desired Specimen ID to navigate to the Specimen


2
screen for that sample
From the Specimen screen, select the Other… button
3
(on lower right of screen)
Select the option Separate microscopy and chemistry results from
4
window
5 Select OK
6 Select the Accept button (on lower right of the screen)
7 The results should be back on the Found List screen
The chemistry and microscopy results should be separated with two
8
entries for the sample
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
NOTE b Select the Search button again
Verify the correct Specimen ID is in the ID box. If not, type
c in the Specimen ID, and select the Today button

d Select OK
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
Rerun the diluted portion of the sample on the iQ by placing the patient
12
rack on the right side of the iQ and pressing the Start button
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When complete, verify the results matched up with the existing


13
chemistry results
14 Review and release

Splitting Results and Rerunning using Manual Entry


Step Action

From the Work List screen, select the Search button to


find the Specimen ID used in the previous exercise
1
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

Split the Chemistry and Microscopy results (use previous exercise as


2
reference if needed)

Delete the Microscopy results (use previous exercise as reference if


3
needed)

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
4 dilution label used)
Work Order: RUN

(Refer to page SO-47 in the training guide as a reference, if needed,


for manual programming)

Place the diluted specimen into the corresponding position of the


5 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

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Merging/Consolidating
Step Action

Clear all manual orders by selecting the Clear All button


NOTE on the Instrument screen before performing the
following exercise

1 Place a barcoded sample on the iChemVELOCITY

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
2
NOTE: This should result in the iQ not being able to identify the
microscopy part of the sample

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

3 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

Select the Accept button to merge the two halves of the


10 report

NOTE: If any red messages appear, please contact facilitator

11 Review and release

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PROCESSING DILUTIONS 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. _________________________________________________

_________________________________________________________

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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

Why Is It Important?
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 Operator’s Manual
iQ Operator’s Manual
Blank CD
Esoteric CD

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INFORMATION/PRACTICE

Importing Results
Step Action

1 From the Instrument screen, select Go off line

Place the Esoteric CD in the CD drive. A CD drive pop up window will


2 appear displaying an “Archive” folder on the CD in the drive. This may
take a few minutes to appear

3 Select the red X in the upper right corner to close the window

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

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

Select OK . A list of all the results on the Esoteric CD will


7 appear on the Select Specimens to Import screen

NOTE: This may take a few minutes

Highlight all of the samples

8 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

Select OK

NOTE: The import may take a few minutes. The Import Status
window will display:
9
 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

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11 From the Work List screen, select the Search button

12 Select the Clear button to clear any previous search


selections

13 Check the Show released specimens only checkbox

14 Select the Today button in the Date-Time area

15 Select OK . All the results from the Esoteric CD will display


on the Found List

Remove the Esoteric CD from the CD drive


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

Exporting Results

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

Step Action

1 Place a blank CD-R into the CD drive

In the CD drive pop up window, verify “Take no action” option is


2
highlighted and select OK

3 Select the Export All button to display the Select


Export Destination pop up window

In the Select Export Destination field, ensure the D:/ drive is selected
4
NOTE: The window will also display the space required for storing the
data

Select OK

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

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 Number of results to be exported


 Number of results successfully exported
 Number of results that failed export

Select OK when export is complete


6
NOTE: When export is complete, the OK button will turn blue and the
CD drive will open

7 Remove and label the copy of the CD as Esoteric CD

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IMPORTING AND EXPORTING SKILL CHECK


1. Show facilitator imported samples

2. Show facilitator exported CD

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BODY FLUIDS

OBJECTIVES
Given an operating iRICELL System, be able to:
 Run Body Fluid Controls
 Run Body Fluid Background
 Run Body Fluid Samples

Why Is It Important?
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 Operator’s Manual
iQ Body Fluids Quick Reference Guide

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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

2 From the Instrument screen, select Go off line

3 Select the Maintenance button

4 Select the Shutdown button to allow the software to


shutdown

5 When shutdown is complete, turn on PC and allow software to load

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


6
Password

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Body Fluid Controls


Step Action

1 Warm body fluid controls to room temperature

Place 3 unlabeled conical bottom tubes in position 2, 3, and 4 of


2
the Body Fluid QC (BFQC) rack.
Place barcodes on the tubes in positions 3 and 4 with the level of
3
control to be tested

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

Pipette 1.0 mL of iQ Body Fluid Lysing Reagent into the tube in


5
position 3

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

To mix iQ Controls:
 Hold vial horizontally between the palm back and forth for
7
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

Place the BFQC rack on the iQ system and press Start button
10 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
Select the control to be reviewed, and select the Specimens
12
button to navigate to the Specimen screen
Review and edit the results in the same manner as a body fluid
13 patient specimen by moving all artifacts into the designed ART
classification

Click the Accept button


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

Place 3 unlabeled conical bottom tubes in positions 2, 3, and 4 of


2
the Body Fluid QC (BFQC) rack.
Place Background barcodes on the tubes in positions 3 and 4 with
the level of control to be tested
3
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

Pipette 1.25 mL of iQ Body Fluid Lysing Reagent into the tube in


5
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

To review reagent background count, select the Work List button


8
to locate the background in the Work list
Select the control to be reviewed, and click the Specimens button
9
to navigate to the Specimen screen
Review and edit the results in the same manner as a body fluid
10
patient specimen

Click the Accept button


11
NOTE: Edited background passes if there are ≤ 3 particles/µL

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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

Choose the appropriate dilution using dilution chart below:

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
4
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

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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
NOTE 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

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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

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

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


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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.

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