TABLE OF CONTENTS

1. INTRODUCTION

Installation of v5 Software ……………………………………….………1-1

2. SCREEN CHANGES

Instrument Screen …………………………………………………….… 2-1

Work/ Found List Screen …...…………………………………….……. 2-2

Settings Screen ……………………………………………………..……2-3

Manual Orders ………………………………………………….……….. 2-4

Specimens Screen ………………………………………………..…….. 2-6

Flagged Specimen Screen ……………………………………..……….2-7

Search Screen …………...……………………………………….……...2-8

Tallies …………………………………………………………….………. 2-9

3. SETTINGS

System Configuration ……………………………………………………3-1

LIS Interfaces ……………………………………………………………. 3-4

Patient Demographics ………………………………………………….. 3-6

Chemistry Settings ……………………………………………………… 3-10

Formed Particle Settings ……………………………………………….. 3-12

Specimen Settings …………………………………………………….…3-13

Urine Auto-Release Settings .………………………………………….. 3-14

Additional Language Translations …………………………………….. 3-15

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 TABLE OF CONTENTS

4. RESULTS

Consolidation of Microscopy and Chemistry Results ……………….. 4-1

Separation of Consolidated Results ……………………………………4-3

Saving Isolated Images ………………………………………………… 4-5

Audit Trail ………………………………………………………………… 4-6

Report Changes ………………………………………………………….4-7

5. MAINTENANCE

Saving Quality Control Data …………………………………………….5-1

iQ Series Calibration ……………………………………………………. 5-3

Body Fluids Quality Control ……………………………………………. 5-4

6. TRAINING CHECKLIST

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 1. INTRODUCTION

This tutorial is to be used to train current iQ®Series Automated Urine Microscopy

(iQ Series) users on version 5 (v5) software features. Included are v5 feature
explanations, screenshots, and references to the v5 iQ®Series Operators
Manual. The below table is a basic listing of changes unique to this software.

Screen Changes Setup Results Maintenance

Instrument Screen System Configuration Consolidation of Saving Quality Control
Microscopy and Data
Audit Trail LIS Interfaces Chemistry Results
Calibration
Work/Found List Patient Demographics Separation of
Screens Consolidated Results Body Fluids (BF)
Chemistry Settings Quality Control
Settings Screen Report Changes
Formed Particle
Manual Orders Settings Saving Isolated
Images
Specimen Review Specimen Settings
Screen
Auto-Release Settings
Flagged Specimen
Additional Language
Search Feature Translations

Tallies

Note: Any iQ Series functions and/or features not mentioned

within this tutorial have not been changed (e.g. editing
results).

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 1. INTRODUCTION

Installation of v5 Software

Version 4 (v4) software must be loaded onto the iQ Series before upgrading to
v5. To verify that v4 has been loaded, click on Maintenance and System Info. If
this screen shows a software version other than v4 (e.g. v3 or v2), please contact
Iris Diagnostics to obtain the appropriate instruction.

The instrument configuration will not change by performing the v5 upgrade. Iris
recommends that customers consult their LIS coordinator before installing the v5
upgrade CD. Many features unique to v5 will not impact the LIS. Below is a list
of five new v5 features that will require mapping within the LIS only if the user
activates them.

1. If the System Configuration Chemistry Analyzer Input Settings is

changed, the additional chemistry reporting values must be added.

2. If Reporting Dysmorphic RBCs is enabled, DRBC will have to be mapped

in the LIS Formed Particles mapping as a percentage.

3. If Report Possible Amorphous Flag is enabled, this flag must be added.

4. If Patient Demographics is enabled, this bidirectional feature must be

mapped.

5. Tracking Body Fluids QC within the LIS will require LIS mapping.

If the user chooses to not activate the above features, the LIS must still be
consulted on the addition of the Audit Trail. To learn more about the Audit Trail
refer to page 2-2.

For additional LIS mapping information, please contact Iris Diagnostics at

US Customers International Distributors

Phone: 1.800.776.4747 option 3 +818.709.1244 option 3
Email: clinsupport@proiris.com clinsupport@proiris.com

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 2. SCREEN CHANGES

Instrument Screen

The onboard Operators Manual link has been removed from the software.
Instead a v5 Operators Manual CD will be included in the v5 Upgrade Kit. This
CD can be opened on any computer with Adobe Acrobat Reader installed;
including the iQ Series PC.

The Sequence # and Auto-Release Counter have been removed.

Racks that have been enabled in Manual Orders will be displayed on the
Instrument screen within the Manual Orders section. These racks can be
cleared from within Manual Orders or from the Instrument screen using the
Clear All button.

The Login name shown in the shift summary has been added to the area just
below the Instrument Status section. This login can be viewed while in the
Instrument, Work List, Found List, Specimens, and Specimen Edit screens.
Its function is to alert users to the login that any specimen edits or QC results will
be assigned to.

Login ID

Enabled Rack
Numbers

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 2. SCREEN CHANGES

Work/Found List Screens

Since the sequence number has been removed from the Instrument screen, it
will no longer be shown in the Work/Found Lists or be a searchable criteria.

The Hold button has been replaced by an Edit Demographics button. Refer to
page 3-7 for more information on this feature.

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 2. SCREEN CHANGES

Settings Screen

The Settings screen has been reorganized to reflect the new features and the
workflow of inputting settings. The previous Interface Settings menu has been
divided into System Configuration and LIS Interface in v5 software. A picture
of the new iQ Series System Settings screen is shown below.

For more information about System Configuration and LIS Interface, refer to
the following pages within SETUP.

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 2. SCREEN CHANGES

Manual Orders

Manual Orders is used to identify microscopic specimens that do not have a

barcode identification label. As of v5 software, Manual Orders will be able to
accommodate the input of information for multiple racks. All possible rack
numbers are listed at the top of the Manual Orders screen. If the iQ® Series
Body Fluids Module is enabled, racks 25, 26, and 27 will also be shown.

To enable Manual Orders, first click on the aerial button next to the rack number
that will be used to run the specimens. Then input the specimen identifier, fluid
type (if diluting), dilution (if applicable), and work order (if change required). New
to v5, when a specimen identifier is input, the Work Order field auto-fills Run.
Once the specimen information has been input, place the specimen into the
corresponding position within the enabled rack and click OK (or OK & Print).
The enabled rack number will be shown on the Instrument screen in the Manual
Orders section. Within Manual Orders, all enabled racks will be highlighted in
turquoise and will display an asterisk.

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 2. SCREEN CHANGES

Enabled racks

As analysis is completed for these specimens, their status will change within
Manual Orders to state Processed. When a rack is completed, it must be
cleared by the user to avoid identifying specimens with ID_ERRORs incorrectly.
There are three ways to clear the specimen information input for a rack,

1. Wait until all racks that have been enabled in Manual Orders to
complete analysis and click Clear All on the Instrument screen.
2. Again, wait for all racks that have been enabled in Manual Orders to
complete analysis and click Clear All within the Manual Orders
screen.
3. Once the last specimen for a given rack has completed analysis, select
this rack within Manual Orders, and click Clear Rack. This will clear
only the rack number shown on the Manual Orders screen when the
Clear Rack button is clicked.

If the iQ Series Analyzer is connected to a Chemistry Analyzer (AX-4280, etc),

Manual Orders will only identify the microscopy results without barcode
identification labels. The chemistry results will still be shown as ID_ERRORs on
the Work List. As of v5 software, the user will be able to manually consolidate
these results. For more information relating to consolidating results refer to page
4-1.

Note: If an enabled rack is run, with barcoded specimens, before the

specimen information is removed, the barcode identifications will
override any information input for this rack in Manual Orders.

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 2. SCREEN CHANGES

Specimens Screen

Specimen results editing is not changed with v5 unless the user enables the
dysmorphic RBC (DRBC) feature found in Specimen settings. If this is enabled,
the user is required to move all dysmorphic RBCs into the DRBC sub-
classification for them to be correctly calculated. The DRBC results are shown
as a percentage within the specimen information and specimen image sections.

The Hold button can now be used if an operator must leave the Specimens
screen before accepting their edits. This button will enable once an image has
been sub-classified or reclassified. If the user must leave the Specimens screen
before accepting their edits, click Hold and the edits will be saved. When the
user re-enters this Specimens screen, their previous edits will be present. To
review the specimen as it was before edits were made, click Redo.

The All Art button has changed to state Other. The Other button includes All Art
and Separate Microscopy and Chemistry. For more information, please see
Separation of Consolidated Results on page 4-3.

Patient demographics will also be seen within the Specimens screen, if they are
enabled.

If the user sets an All Small Particle count Auto-Release threshold, the All Small
Particle count will be displayed in red once the threshold has been exceeded.

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 2. SCREEN CHANGES

Flagged Specimen Screen

Flagged Specimen Review screens will no longer display the Edit Specimen ID
button. Now when clearing all flags, click Review Flagged Specimen and the
appropriate screens will automatically appear to clearly direct the user to the next
step of clearing the flag. The change to the Edit Specimen Identifier pop up will
be explained in the Results section of this document.

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 2. SCREEN CHANGES

Search Screen

The search screen and options have been updated to reflect the new features.
These searchable options include operator ID, patient demographics, and
specimens awaiting transmission only.

These new features should address and improve workflow of the associated
tasks. For example, Show specimens awaiting transmission only can be used
when the user wishes to retransmit results of specimens that were run while the
LIS was down.

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 2. SCREEN CHANGES

Tallies

The tallies screen has been changed to accommodate customer needs. Unlike
before, only one date/time range will be displayed and the urine microscopy,
urine chemistry, and body fluids run data are divided into their specific groupings.

Urine
Microscopy

Urine
Chemistry

Body
Fluids

Note: Body Fluids are shown as a complete grouping as

well as divided into their specific Body Fluids type.

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 3. SETTINGS

There are changes to the iQ Series software that will impact how the settings are
input and are designed to ease the installation of the analyzer. As before, only
users with the privilege level of Manager or logged in as [IRIS] will be able to
change settings.

System Configuration

The System Configuration screen allows the user to determine which

instrument configuration is being used. The possible instrument configurations
include Microscopy Only, Chemistry Only, or Chemistry and Microscopy System.
Based on the system configuration, certain settings and options will be hidden or
deactivated. Those settings that are deactivated will be grayed and locked.

- iQ® Series Standalone Settings Body Fluids Enabled

- Chemistry Standalone Settings

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 3. SETTINGS

Previously, the user would initiate communication between the AUTION MAX™
AX-4280 Automated Urine Chemistry Analyzer (AX-4280) and the iQ Series
Analyzer by clicking on the Enable Direct Connection check box found in
Interface Settings. Enable Direct Connection has been replaced with Chemistry
Analyzer Present, which is found in System Configuration. When upgrading an
iQ Series System from v4, both Microscopy Analyzer Present and Chemistry
Analyzer Present will be checked. If at any time the software must be scratched,
the factory default settings will only have the Microscopy Analyzer Present
checked because the connectivity software, which is needed to initiate
communication between the analyzers, requires loading. Load the AUTION
MAX™ AX-4280 Connectivity Software (PN 700-3085) using the current
instructions. This will unlock the Chemistry Analyzer Present button and the
associated options within the System Configuration screen.

These chemistry specific options will allow the user to identify their chemistry
reporting, gate, set a chemistry/microscopy consolidation time window, and not
perform a microscopy if a chemistry result is not present.

The Install Settings button is used to specify the chemistry edit map. There are
three choices to choose from when connected to the AX-4280. These options
include quantitative/semi-quantitative, quantitative (mg/dL), and semi-quantitative
(1+, 2+, etc). Quantitative/semi-quantitative and quantitative reporting will

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 3. SETTINGS

include all possible chemistry reporting stated on the package insert for the
Aution Sticks. When upgrading from v4, the semi-quantitative option is
automatically used. This will retain the current chemistry reporting without user
intervention required.

To change the chemistry reporting click on the Install Settings button and
choose the desired chemistry reporting. Upon clicking OK, the user will be
prompted that the Chemistry Edit Map will change from the current
configuration to the default of the chosen chemistry selection and require that the
system be restarted.

Upon clicking OK on the System Configuration screen, the system will

generate a Restart Necessary flag and return the user to the main Settings
screen.

2. Setup

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 3. SETTINGS

LIS Interfaces

The LIS Interface settings were developed to make connecting the iQ Series
Analyzer to a LIS user friendly. Those frequently asked reporting/transmitting
issues have now been incorporated into this screen with the use of predefined
checkboxes. In addition, settings for patient demographics have been included.
When upgrading from v4, any changes made to the iQ Series registry will
continue to function as normal and will not require the selection of these new
features.

In this section, unless an option is new or has wording changes, it functions

exactly as it did in v4. Below is a screenshot of the new LIS Interfaces screen.
Explanations of the new features follow.

When Suppress “[none]” results is checked, any formed particle with the result
value of [none] will not transmit to the LIS. Henceforth, the manipulation of
“[none]” as a test result value at the LIS level may not be necessary.

If Suppress chemistry result that precedes consolidation with iQ Series

Microscopy module is checked, chemistry results will not transmit to the iQ
Series printer when the AX-4280 prints the results on the thermal tape. Instead,
the chemistry result will only transmit to the printer if it is finalized. Finalized is
defined as the chemistry either does not require a microscopy to be performed or
it has been consolidated with a microscopy result. If the user does not

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 3. SETTINGS

wish the instrument to function this way; the user will have to uncheck this box. If
this box is not checked, chemistry results will transmit to the iQ Series printer as
soon as the results print on the AX-4280 thermal tape and again with the
finalized microscopic results.

When Suppress usage of iQ Series generated Chemistry Results when obtaining

specimen information from LIS is checked, the chemistry results will not transmit
to the LIS unless finalized (see previous paragraph for definition of a finalized
chemistry). If this option is unchecked, chemistry results will automatically
release to the LIS when the results print on the AX-4280 thermal tape and again
with the microscopy results.

When Obtain specimen information from LIS is checked, the user cannot check
Gate on Chemistry, which is found in System Configuration. Instead, the LIS
and Urine Gating will be used together to gate specimens.
By clicking Obtain patient demographics information from LIS, the
Demographics button enables and Obtain specimen information from LIS and
Enable LIS are automatically checked. Below is a screen shot showing this.

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 3. SETTINGS

Patient Demographics

There are seven demographic options that may be used in desired combinations.
The iQ Series obtains the patient demographics from the LIS at the time the
barcode accession number is read. Below is a screenshot of the selectable
demographics.

Note: Consult the LIS Coordinator to obtain which

demographics will be available to the iQ Series before
enabling the fields. Any enabled fields that are not
filled before transmission to the LIS will transmit
[none].

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 3. SETTINGS

If a selected demographic is missing, the specimen will still be run and the
sample result will have a status of "flagged" within the Specimens screen.

Demographics can be changed and/or added in the Work/Found List screens

by all users. The Edit Demographics button is circled within the Work List
screenshot below.

2. Setup

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 3. SETTINGS

After clicking the Edit Demographics button, a popup (shown below) will
appear. The header of the popup will include the specimen accession number,
run date and time, and rack/position number. Regardless if patient
demographics are enabled within LIS Interfaces or not, the user will be able to
add data to all demographic fields shown below.

If the user does input demographics when the feature is not enabled in LIS
Interfaces, the demographics will be shown in the Specimens screen, printed
report and transmitted to the LIS. Be sure that if the iQ Series is connected to an
LIS, this manual option will not cause issues if used. These manually input
demographics will transmit to both the iQ Series printer and LIS.

For those customers that do not have LIS systems, this feature will allow the user
to manually input this data and have a formal printout that includes complete
patient identification. This report could then be given directly to the physician or
nurse depending on the procedures of the facility.

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 3. SETTINGS

The demographics, whether supplied by the LIS or manually input, will be shown
on the Specimens screen, printed on the report and transmitted to the LIS.
Below are screenshots of how this will appear.

Note: The Specimens screen has been designed to only

display the patients first name, last name, date of
birth, and gender fields. Other enabled fields will
appear on the report (e.g. Medical Record Number
and Location).

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 3. SETTINGS

Chemistry Settings

Previously, the iQ Series software limited the reporting results of the AX-4280.
For example, the iQ Series and the AX-4280 previously communicated using
only semi-quantitative chemistry results (1+, 2+, etc…). As of v5, these
reportable limitations no longer exist. Both the semi-quantitative gradings and
quantitative mg/dL values will be transmitted from the AX-4280 to the iQ Series
PC if configured to do so. There are three options that may be used to configure
the chemistry outputs. These options are explained in the System Configuration
section.

The current chemistry configuration will not be changed when upgrading to v5. If
one of the new chemistry reporting features is desired, make that chemistry
reporting change in System Configuration Install Settings and reconfigure the
LIS to accommodate the change. As always, this reporting output can be
changed by anyone with manager privilege or logged in as [IRIS]. These outputs
must match the mapping within the LIS. Any analyte except specific gravity, pH,
color and clarity will be affected if the user enables one of the new chemistry
reporting features.

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 3. SETTINGS

To accommodate the AX-4280 specific gravity transmitted result of OVER

(results > 1.050), OVER has been added to the input and output of the chemistry
edit map. This was done so that the result will no longer be flagged Chem
Confirm/Chem Translate when this result is obtained. The SG result of OVER
should have been pre-mapped within the LIS, since the system has been
reporting this way regardless of the iQ Series Chemistry Edit Map.

A change to the System Configuration Install Settings will also affect the setup
of Urine Gating and Chemistry QC Settings. Please review these settings to
assure the proper configuration.

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 3. SETTINGS

Formed Particle Settings

If enabled in Specimen settings, DRBC will be added to the Formed Particle

list. The only DRBC settings that are user definable are the long and short
names. DRBCs are a sub-classification reported as a percentage. Like Renals,
Transitionals and Casts, all DRBC images must be moved into the DRBC sub-
classification for them to be correctly calculated. The DRBC final result will be a
representative percentage of the total RBCs. This result can be viewed on both
the right side of the screen (above the bacteriuria checklist) and left side of the
screen (overview section). If Report Dysmorphic RBCs is not selected in
Specimen settings, DRBC will be hidden within Formed Particle Settings and
will not be available to report.

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 3. SETTINGS

Specimen Settings

Additional options have been added to the Specimen settings screen. These
include Report Dysmorphic RBCs, Automatically clear “HIGH
CONCENTRATION” flag, Automatically clear “Possible Amorphous” flag, and
Report “Possible Amorphous” flag.

The Report Dysmorphic RBCs checkbox will enable the DRBC settings to appear
within Formed Particles, the DRBC editing button to appear within the
Specimen Edit screen, and a Specimens Red Blood Cells section. The Red
Blood Cells section includes the RBC and DRBC count. It will also cause results
for DRBCs to transmit to the iQ Series printer and LIS depending on presence
and transmission configuration. If this feature is not selected, all fields/buttons
associated with DRBCs will be hidden.

The Automatically clear “HIGH CONCENTRATION” flag and Automatically clear

“Possible Amorphous” flag checkboxes are designed to automatically
acknowledge the flags if selected. These flagged specimens will no longer be
held on the Work List because of these flags and, depending on the auto-
release criteria, can be auto-released to the printer and LIS.

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 3. SETTINGS

With software versions preceding v5, the Possible Amorphous flag does not
transmit to the printer and LIS. By checking Report “Possible Amorphous” flag;
the flag will transmit to the iQ Series printer and LIS within the appropriate flags
section of the report. This feature will need to be mapped within the LIS since it
will be added to the report when enabled.

Urine Auto-Release Settings

The auto-release threshold for All Small Particles (ASP) has been added. If the
ASP count exceeds the input auto-release threshold, the specimen will be held
on the Work List for review and the ASP count will be highlighted in red on the
Specimens screen.

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 3. SETTINGS

Additional Language Translations

Three additional languages have been incorporated into v5. These include
Greek, Simplified Chinese, and Turkish. In total Iris Diagnostics will support nine
languages with the release of this software. The previous six languages are
French, Spanish, Brazilian Portuguese, Italian, German and English.

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 4. RESULTS

Consolidation of Microscopy and Chemistry Results

Consolidation of microscopy and chemistry results is now possible with

ID_ERRORs present for one or the other analyzer. To clear the ID_ERROR the
user must be in the Specimens screen. The user will then click Review
Flagged Specimen, which will generate an Edit Specimen Identifier pop up. In
this pop up, the user will input the specimen identification and check the
Consolidate microscopy and chemistry checkbox. This will cause the software to
search for the other half of the result with a matching identification run within the
consolidation window.

Once the software finds the other half of the result, the screen will refresh with
the combined microscopic/chemistry result shown on the screen. At this time, it
will look the same as any specimen run with both analyzers reading the
specimen identification from a barcode. This feature can also be used to
consolidate chemistry results with microscopy results that were identified using
Manual Orders. This manual consolidation feature only exists for specimens
with ID_ERRORs.

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 4. RESULTS

After the results have consolidated, two screens will be present on the Work List
for this specimen. One screen will show the microscopic result consolidated with
the chemistry result. The second screen will not contain any specimen
information or results, but will display a message stating that the software cannot
load the specimen. This screen is used to notify the user that the consolidation
was successful.

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 4. RESULTS

Separation of Consolidated Results

Specimen results (microscopic and chemistry) can be separated if needed. To

perform this task, the user must be on the Specimens screen. If the specimen is
flagged, the flag must be cleared in order to separate the results. The previous
All Art button, found in the lower right corner of the screen, has changed to state
"Other" in v5.

Click on Other to open a pop up box. This pop up box has two options, All Art
and Separate Microscopy and Chemistry.

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 4. RESULTS

Upon choosing Separate chemistry and microscopy results and clicking OK, the
Specimens screen will display Click Accept to separate chemistry and
microscopy results.

After clicking Accept, the screen will refresh and the results will be shown
separated. Each half of the result will be shown on the Work List. The chemistry
half will display a status of released and will require the user to click Accept.
The microscopy, however, will be left on the Work List with a status of review. If
the specimen ID must be changed at this point, this task must be done from the
Work List. Once the specimen results have been separated, they will only
consolidate with the complimentary other half if that half is rerun and has an
ID_ERROR. Review the Consolidation section for more information.

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 4. RESULTS

Saving Isolated Images

Users can save select images to an external source and transmit images to the
printer as part of the report. To do this, right click on the selected image. This
will cause a pop-up to appear. In this pop-up the user will have four options, two
of which will be enabled. These two enabled options are, Add image to report
and Save image…. If Save image… is selected, the image will be saved as a
bmp (bit map) to the chosen drive. The available drives include the hard drive
(C:\), CD drive (D:\), and USB drive (E:\ or F:\).

Add image to report will cause the top right corner of the frame to turn red. This
will alert the user as to which image(s) has been selected and will be shown on
the printed report. The image width is fixed on the report and any extra space
not used by the image will be black.

Edit image annotation allows

the user to input notes that will
be shown next to the saved
image on the report.

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 4. RESULTS

Audit Trail

As with v4, the login ID of the last user to accept specimen results will be shown
at the top of the report along with the rest of the specimen run information for that
sample. New to v5, a complete list of names that have accepted edits for the
specimen will be shown within the audit trail located at the end of the report. The
last user login and date/time will be recorded at the top of this list.

Last user to click “Accept” shown in

specimen run information

Last user to click “Accept” shown in Audit Trail

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 4. RESULTS

Report Changes

The report has changed to be more intuitive. Most changes have been discussed
thus far, except for the presence of only one time stamp. This single time stamp
is called Analysis Time Stamp and is the time that the instrument released the
original results. The Report, Chemistry, and Microscopy Time Stamps have
been removed.

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 5. MAINTENANCE

Saving Quality Control Data

Quality control (QC) can now be saved to an external drive (C:/, D:/, E:/, F:/) for
long term storage needs by using the Save button. To save QC, the user must
be in the QC Review or QC Statistics screens. All privilege level logins can
save QC.

If the user clicks Save while in the QC Review screen, all QC listed on the
screen will be saved just as it is shown. To save a specific time period, perform
a search and click Save once the search is shown on the screen. To save a
single QC result, review the result on the screen by performing a Re-Report,
then click Save when the results are shown.

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 5. MAINTENENACE

If a user clicks Save while in the QC Statistics screen, only the lot data displayed
on the screen will be saved. To save all data stored within QC Statistics, click
on each lot number and then click Save.

In all cases, clicking save within these three screens will cause the standard
Windows Save pop-up to appear. This will allow the user to save to the hard
drive (C:/), CD drive (D:/), or USB drive (E:/ or F:/) as is done on a personal
computer. The save feature changes the QC format to html, which can be
opened and saved on virtually any computer.

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 5. MAINTENANCE

iQ Series Calibration

Calibration will continue to be run using ten tubes and the current iQ Calibration
rack. What has changed is the labeling! With v5, the user will only label the first
of the ten tubes (position 1). This will decrease prep time.

If the tube in position 1 of the calibration rack does not have the appropriate
calibration label, the specimen will not be aspirated and the rack will be ejected.
If the label was a patient barcode, a result using the patient identification will be
displayed on the Work List. The flag within the Specimens screen will say
QC/Cal ID Error.

If the user tries to run the calibration rack without labeling any tubes, the rack will
also be ejected. This will cause a patient to be created on the Work List with an
ID_ERROR. This specimen will be flagged with QC/Cal ID Error. In both
scenarios, a yellow flag will generate on the Instrument screen and state
Calibration Label Mismatch. This flag will still allow patient samples to be run.

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 5. MAINTENANCE

Body Fluids Quality Control

The incorporation of the body fluids controls into QC Review and QC Statistics
is an important addition to v5. Like the urine module, barcode labels will be
provided for both levels of controls and background check. These barcode labels
include the lot identification, number, expiration date, and cell counts for the
controls. The pass/fail criteria are hard-coded within the software for all three.
Results will be stored within QC Review and Levey-Jennings charts will be
created within QC Statistics for all three.

The incorporation of the body fluids controls does not eliminate the need for
editing. The instructions for how to run the body fluids controls are as follows,

1. Label the tubes in positions 3 and 4 with the provided barcode label
that is appropriate for the control being run
2. Dispense 1 mL of reagent into the appropriate tube(s).
3. Dispense 250µL of control into each of the reagents in positions 3 and 4
4. Gently mix the controls and place the tubes into the Body Fluids
Control rack
5. Put the control rack onto the iQ Series Analyzer and press the Start
button
6. Repeat for other level of controls or background check.
* When running the background check pour a minimum of 1.25mL of
each reagent into the appropriate tubes and skip numbers 2 – 4
discussed above.

When the analysis is complete, the results will appear on the Work List. The
control will be identified by lot number and type.

ID Type

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 5. MAINTENANCE

At this time the user will edit the QC by moving all artifact into the designated
ART classification. To expedite the QC editing process, the ART classifications
do not automatically generate for the controls since there should be little, if any,
artifact in the product.

The Bacteria and Crystal buttons have been removed from the BF QC Total
Cells editing screen, as they should not be present in the control material.
The final results are calculated the same as they are for patient specimens.
Once the user clicks Accept, the results will transmit to QC Review, QC
Statistics, printer (optional) and LIS (optional). To print and/or transmit this data
to the LIS, configure the transmission options in the QC settings. This data will be
captured the same as the QC data for the urine module.

If the BF control fails, a yellow flag will be generated on the Instrument screen.
This flag will distinguish which body fluid control failed. If this failure is displayed,
the user will not be allowed to run body fluid patient specimens until the flag is
remedied. Urine patient specimens will be unaffected by this BF QC failure flag.
If the urine controls, focus, or calibrator fail, neither BFs or urines will be allowed
to run until the flag(s) is cleared. The user has the option to rerun the failed
control or the manager can re-edit the original. To re-edit a failed BF QC,
perform a search from the Work List screen the same as is done for a specimen.
A technologist can manipulate and view the images, but the Accept button is
disabled. The manager privilege is the only user for which the Accept button is
enabled. Upon clicking Accept, the results will transmit to QC Review, QC
Statistics, printer (optional) and LIS (optional).

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 6. TRAINING CHECKLIST

Training Checklist

This training checklist is to be used once the iQ Series has been upgraded to
software v5. It will provide the necessary documentation for the training of the
key operator and laboratory staff. The LIS can be disabled while training.

Iris requests that a copy of page 6-10 of the key operators training be signed and
faxed to Iris Clinical Support at 888.269.4747 (one per customer account). This
information will be used to track the number of customers that have performed
the software upgrade and the overall customer training and satisfaction with the
iQ Series software upgrade version 5. A comment field has been added at the
end for additional feedback. Any major concerns should be directed to Clinical
Support:

US Customers International Distributors

Phone: 1.800.776.4747 option 3 +818.709.1244 option 3
Email: clinsupport@proiris.com clinsupport@proiris.com

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 6. TRAINING CHECKLIST

Date: __________________ Tech: ________________________________

Instructor: _______________________ Facility: ________________________

1. _____Trained on Instrument screen changes.

A. Verify that the following buttons have been removed from the
instrument screen
1. Operators Manual
2. Sequence#
3. Auto-Release Counter

B. Verify that the user login appears the same in the Login
area and just below the Instrument Status area.
1. Click on the Work List and Specimens buttons. Verify
that the login can be seen in each screen.

C. Verify that the Manual Orders section functions properly

1. Without enabling a rack in Manual Orders, the Instrument
screen displays N/A.
2. Enable a rack within Manual Orders. Is the rack number
displayed on the Instrument Screen?

2. _____ Trained on Work/Found List changes.

A. Verify that the third column states Rack/Pos

B. Verify that the Hold button has been replaced by Edit

Demographics.

3. _____ Trained on Settings screen changes.

A. Verify that the Settings screen matches the illustration
shown on page 2-3.

B. Verify that the Interfaces button has been divided into

System Configuration (page 3-2) and LIS Interface (page 3-
4).

4. _____Trained on System Configuration settings.

A. Verify that the System Configuration screen matches the
illustration shown on page 3-2.

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 6. TRAINING CHECKLIST

B. Verify that the Microscopy and Chemistry Analyzer Present

buttons are checked.

5. _____Trained on LIS Interfaces.

A. Verify that the LIS Interfaces screen matches the illustration
shown on page 3-4.

6. _____Trained on Chemistry settings.

A. Verify that the input of OVER and output of >1.050 has been
added to the specific gravity edit map.

7. _____Trained on Specimen settings.

A. Verify that the Specimen settings screen matches the
illustration shown on page 3-13.

8. _____Trained on Urine Auto-Release settings.

A. Verify that All Small Particles has been added as an option
within Urine Auto-Release settings.

9. _____Trained on Manual Orders changes.

A. Verify that the Manual Orders screen appears as it does on
page 2-4.

B. Pour 6 test specimens into unlabeled tubes and divide the

specimens into two racks. Enable these racks within Manual
Orders and input the specimen information for the
appropriate positions. Click OK & Print when completed.
Run these two racks on both the chemistry analyzer and the
microscopy analyzer once the following steps have been
verified.
1) Upon entering the specimen ID, did the Work Order
auto-fill "run"?

2) Are the enabled rack numbers shown on the Instrument

screen?

3) Are the enabled rack numbers highlighted turquoise and

marked with an asterisk when Manual Orders is re-
opened?

4) Upon completion of analysis, verify that the specimen

identifiers used in Manual Orders are used in identifying

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 6. TRAINING CHECKLIST

the microscopy results for the identified racks. The

chemistry results will be flagged with ID_ERRORs.

5) Pour 3 unlabeled test specimens and place these tubes

into a rack which is not enabled in Manual Orders. Run
this rack in the same fashion as before.
a) Were the microscopies given an identification or
ID_ERRORs?

6) Clear the racks by clicking Clear All on the Instrument

screen.
a) Is the rack information erased from the Instrument
and Manual Orders screens?

7) Input information into Manual Orders for two new racks.

Click OK when finished.
a) Are these rack numbers shown on the Instrument
screen?

b) Are these rack numbers highlighted and marked

with an asterisk within Manual Orders?

8) Clear the racks by clicking Clear All within Manual

Orders.
a) Is the rack information removed from the Instrument
and Manual Orders screens?

9) Input information into Manual Orders for two new racks.

Click OK when finished.
a) Are these rack numbers shown on the Instrument
screen?

b) Are these rack numbers highlighted and marked

with an asterisk within Manual Orders?

c) Re-enter Manual Orders and click on the aerial

button for one of the enabled racks.

d) Clear this rack by clicking Clear Rack.

i) Is the information for this rack removed from the
Instrument and Manual Orders screens?

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 6. TRAINING CHECKLIST

ii) Is the other rack's information still shown on the

Instrument and Manual Orders screens?

iii) Click Clear All on the Instrument screen to

clear the information for this remaining rack.

9. _____Trained on consolidation of results.

A. Sort the Work List by date and time. Enter the first chemistry
result. Verify that this screen no longer displays the Edit ID
button below the Review Flagged Specimen button.

B. Click Review Flagged Specimen.

1) Did the Edit Specimen Identifier pop-up appear?

C. Enter a random specimen ID and check the 'Consolidate

microscopy and chemistry box'. Click OK when finished.
1) Did a pop-up appear stating the other half could not be
found? Click OK when this pop-up is verified.

2) Was this result identified with the ID input in the Edit

Specimen Identifier pop-up? Click Accept when
finished.

D. Note the second microscopy identification run. Enter the

Specimen review screen for the corresponding chemistry
result. Click Review Flagged Specimen, enter the
microscopy identification (case sensitive), and check the
'Consolidate microscopy and chemistry box'.
1) When the screen refreshes, do the microscopy and
chemistry results appear consolidated on the screen?

E. Consolidate the next specimen results as in the previous

step.
1) Verify that the ALL ART button has been replaced with
Other …

2) Click Other…, Separate chemistry and microscopy

results and OK.
i) Do the microscopy and chemistry results unmerge?

ii) Do both results appear, with the same ID, on the

Work List?

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 6. TRAINING CHECKLIST

iii) Does the chemistry result have a status of

Released?

10. _____Trained on manual input of Patient Demographics.

A. Highlight a microscopy result on the Work List and click the
Patient Demographics button.
1) Is the patient identification, run date/time, and
rack/position shown in the header of the Patient
Demographics pop-up?

2) Input the patient last name, first name, and gender.

Click OK when finished.

3) Enter the Specimens screen for this result.

a) Are the patient demographics that were entered
shown on the screen? Click Accept when
finished.

B. Highlight another microscopy result on the Work List and

click the Patient Demographics button.
1) Input patient information into all provided fields. Click
OK when finished.

2) Enter the Specimens screen for this result.

a) Verify that only the patient last name, first name,
date of birth, and sex should be shown on the
screen. Note the Specimen ID and click Accept
when finished.

11. _____Trained on new search features.

A. From the Work List, click on Search.
1) Verify that the Search screen matches the illustration
shown on page 2-8.

2) Input the patient last name used for 10A. Click Show
released specimens only and OK when finished.
a) Is the specimen from 10A the result of this
search?

b) Open the Specimens screen for this result and

click Accept.

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 6. TRAINING CHECKLIST

3) Perform a search using the current login ID and

today's date and time.
a) Are the results that have been accepted by this
user, during this date/time, the results of this
search?

4) Perform a search using the 'show specimens awaiting

transmission only' check box.
a) Are the results that have not been transmitted to
the LIS the results of this search?

12. _____Trained on the Audit Trail.

A. Perform a search on the specimen ID recorded for 10B.

B. Perform a re-report to the printer/screen on this specimen.

C. Verify that the Patient Demographics are shown at the top

of the report.

D. Verify that the last user login to click Accept shows in the
specimen run information at the top of the report and is the
first login ID shown in the Audit Trail found at the bottom of
the report.

13. _____Trained on saving isolated images to a report.

A. Perform a date/time search. Choose a specimen with a
microscopy result. Enter the specimen review screen for
this specimen and select one of the classifications. Select
a particle image by right clicking on the image. Click Add
image to report.
1) Verify that the upper right corner of the particle image
is highlighted in red.

2) Click Hold for this specimen. From the Found List,

re-report this specimen to the printer/screen. Verify
that the particle image is shown on this report.

3) Re-enter this patient's Specimens screen and find the

particle image that was saved to the report. Right
click on this image and click Edit image annotation.
Enter a comment into the image annotation pop-up.
Click Hold when finished.

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 6. TRAINING CHECKLIST

a) Just as before, re-report this specimen to the

printer/screen. Verify that the annotation has
been added next to the particle image.

4) Re-enter this patient's Specimens screen and find the

particle image that was saved to the report. Right
click on this image and click Remove image from
report.
a) Verify that the red highlight has been removed
from the screen.

b) Verify that the image has been removed from the

report by doing a re-report as described above.

14. _____Trained on saving quality control data to a CD.

A. Input a blank, unformatted CD into the CD drive. Format
the CD, using Roxio Easy CD Creator as described in the
Operators Manual page 7-24. From QC Review, click
Save.
1) Verify that the standard Windows Save pop-up
appears.

2) Save this data to the D:\ drive. Eject this CD and

open it on another Windows based computer. Can
this data be opened?

3) Verify that this data is in the same format as is shown

in QC Review.

B. Input a blank, unformatted CD into the CD drive. Format

the CD, using Roxio Easy CD Creator as described in the
Operators Manual page 7-24. From QC Review, perform a
re-report to the screen for a selected QC result. Click
Save from within this report screen.
1) Verify that the standard Windows Save pop-up
appears.

2) Save this data to the D:\ drive. Eject this CD and

open it on another Windows based computer. Can
this data be opened?

3) Verify that this data is saved in the same format as is

shown in the QC Review re-report screen.

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 6. TRAINING CHECKLIST

C. Input a blank, unformatted CD into the CD drive. Format

the CD, using Roxio Easy CD Creator as described in the
Operators Manual page 7-24. From QC Statistics, click
Save.
1) Verify that the standard Windows Save pop-up
appears.

2) Save this data to the D:\ drive. Eject this CD and

open it on another Windows based computer. Can
this data be opened?

3) Verify that this data is saved in two parts. One part is

the graph by itself and the other is a screen shot
matching the QC Statistics report screen.

15. _____Trained on running iQ Series Calibration.

A. Run ten tubes of iQ Calibration making sure to label only
the tube in position 1 of the iQ Calibration rack.
1) Verify that the calibration rack runs without giving a
Calibration Label Mismatch flag.

16. _____(Body Fluid Customers only) Trained on running Body Fluids

Quality Control using barcode labels.
A. Using the Body Fluids QC rack, input 3 tubes into positions
2, 3 and 4.

B. Using the Body Fluids QC labels provided, label the tubes

in positions 3 and 4 with the same level control (e.g. Level
II)

C. Pipette 1 mL of lyse into the tube in position 3 and 1 mL of

diluent into the tube in position 4. Pour at least 1.25 mL of
diluent into the tube in position 2.

D. Pipette 250 µL of control into the tubes in positions 3 and

4.

E. Run this rack on the iQ Series Analyzer only.

1) Verify that the controls are identified similarly to the
illustration shown on page 5-4.

2) Verify that the Work List Type column states the level
of control (e.g. BL1, BL2).

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 6. TRAINING CHECKLIST

3) Verify that the Specimens screen for the Body Fluids

QC does not auto-classify the ART classifications for
Total and NUCL.

4) Edit the Body Fluids Control by moving all artifacts to

the artifact categories. Upon clicking accept, review
QC Review to verify that the Body Fluids QC, that
was just edited, is saved with Pass/Fail.

I, the undersigned, acknowledge that I have successfully upgraded to iQ Series

version 5 software and completed the version 5 training checklist.

______________________________ __________
(Key Operator Signature) (Date)

______________________________
(Facility Name)

Comments:

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