Operator Manual

1.
Introduction
Operators Manual
300-4410 Rev A 03/2006Operators Manual 1

Table of Contents
Addendum
Specimen Settings .........................................................................................................A-2
Running QC ...................................................................................................................A-3
QC Statistics ..................................................................................................................A-3
Maintenance Screen ......................................................................................................A-4
Running STAT samples .................................................................................................A-5
Preparing STAT Rack ....................................................................................................A-5
QC Failure ......................................................................................................................A-5
CalChek Failure .............................................................................................................A-6
Reflectance CalChek Failure .........................................................................................A-6
SG/Color/Clarity CalCheck Failure.................................................................................A-6
Test Strip Jam ................................................................................................................A-7
Strip Provider Module Jam .............................................................................................A-7
Strip Conveyor Module Jam ...........................................................................................A-8
Rack Jam .......................................................................................................................A-8
Accessing the Strip Provider Module .............................................................................A-9
Accessing the Strip Conveyor Module .........................................................................A-11
Chapter 1 - Introduction
Intended Use ................................................................................................................... 10
How to use the Operators Manual .................................................................................. 10
Precautions and Warnings .............................................................................................. 11
Tips .............................................................................................................................. 11
Notes ........................................................................................................................... 11
Cautions ...................................................................................................................... 11
Warnings ..................................................................................................................... 11
Biological Warnings ..................................................................................................... 11
Warnings, Precautions, Limitations ................................................................................. 12
Iris Diagnostics Contact Information ............................................................................... 12
Warranty.......................................................................................................................... 13
Limitation of Liability ........................................................................................................ 13
Chapter 2 – System Description

Theory of Operation ........................................................................................................ 16
Measurements ............................................................................................................. 16
Analytes ................................................................................................................... 16
Specific Gravity ........................................................................................................ 16
Color and Clarity ...................................................................................................... 16
System Components ....................................................................................................... 17
Sampler ....................................................................................................................... 17
Barcode Reader ....................................................................................................... 17
300-4448 English Rev B 05/2008 Operators Manual 1

Table of Contents
Load and Unload Stations........................................................................................ 17
Optional Load and Unload Stations ............................................................................. 17
Strip Provider Module .................................................................................................. 18
Strip Conveyor System ................................................................................................ 18
Strip Reader Module.................................................................................................... 18
Specific Gravity, Color, and Clarity Module ................................................................. 19
Fluidics ........................................................................................................................ 19
Sample Probe .......................................................................................................... 19
Wash Station............................................................................................................ 19
Pumps ...................................................................................................................... 20
Wash Container ....................................................................................................... 20
Waste .......................................................................................................................... 20
Strip Disposal ........................................................................................................... 20
Liquid Waste Disposal ............................................................................................. 20
On Button .................................................................................................................... 20
Start Button.................................................................................................................. 20
System Status Lights ................................................................................................... 20
Racks........................................................................................................................... 20
Sample rack ............................................................................................................. 20
Control rack.............................................................................................................. 20
CalChek rack ........................................................................................................... 21
Test Strips ................................................................................................................... 21
Test Specifications ................................................................................................. 21
Peripherals .................................................................................................................. 22
Keyboard.................................................................................................................. 22
Mouse ...................................................................................................................... 22
Touchscreen Monitor ............................................................................................... 22
Printer ...................................................................................................................... 22
Software Functions ......................................................................................................... 23
iChemVELOCITY Status ............................................................................................. 23
View Selector............................................................................................................... 24
Instrument Screen ....................................................................................................... 24
Shift Summary ............................................................................................................. 25
Alarms ...................................................................................................................... 25
Screen Level Functions ........................................................................................... 26
Work List...................................................................................................................... 27
Specimen Results........................................................................................................ 28
Buttons ..................................................................................................................... 28
Iris Logo ....................................................................................................................... 29
Interface....................................................................................................................... 29
Result Storage ............................................................................................................. 29
Technical Specifications.................................................................................................. 30
Precautions ..................................................................................................................... 32
Consumables or Part Replacement ................................................................................ 33

Table of Contents
Chapter 3 - Setup
Setup ............................................................................................................................... 35
Settings Screen ............................................................................................................... 36
Accessing a setup screen ........................................................................................ 37
Printing the setup ..................................................................................................... 37
Operator Accounts Settings ............................................................................................ 38
Adding a New Operator ............................................................................................... 39
Deleting an Operator ................................................................................................... 40
Modifying an Operator ................................................................................................. 40
Laboratory Information Settings ...................................................................................... 41
System Configuration Settings ........................................................................................ 42
LIS Interface Settings ...................................................................................................... 44
Enable LIS ................................................................................................................... 44
Communication settings .............................................................................................. 44
Specimen information from LIS ................................................................................... 44
Obtain Patient Demographics Information from LIS ................................................ 44
Demographics .......................................................................................................... 44
Fluid Type – Formed Particles ........................................................................................ 45
Chemistry Settings .......................................................................................................... 46
Editing Chemistry Settings .......................................................................................... 47
Editing chemistry values .......................................................................................... 49
Validating the changes............................................................................................. 51
QC Settings ..................................................................................................................... 52
REF Override Settings .................................................................................................... 53
Specimen Settings .......................................................................................................... 54
Flag Barcode scan failures .......................................................................................... 54
Skip Specimen if ID scan fails ..................................................................................... 54
Release Settings ............................................................................................................. 55
Urine Gating Settings ...................................................................................................... 56
Urine Auto-Release Settings ........................................................................................... 56
Urine Auto-Classify Settings ........................................................................................... 56
Chapter 4 – Specimen Processing

Logon .............................................................................................................................. 58
Specimen Preparation..................................................................................................... 60
Specimens at Room Temperature............................................................................... 60
Gross Hematuria ......................................................................................................... 60
Very Dense or Viscous Specimens ............................................................................. 60
Specimen Volume ....................................................................................................... 60
Sample Tube Specifications............................................................................................ 61
Preparing Sample Racks ................................................................................................ 62
Barcode Labels............................................................................................................ 62

Table of Contents
Loading Urine Chemistry Strips ................................................................................... 63
Strip Provider Module not Empty ............................................................................. 63
Strip Provider Module Empty ................................................................................... 63
Manual Orders ................................................................................................................ 64
Accessing Manual Orders ........................................................................................... 64
Entering Manual Orders .............................................................................................. 65
Clearing Specimen Information ................................................................................... 66
From the Manual Orders screen .............................................................................. 66
From the Instrument screen ..................................................................................... 66
Running Samples ............................................................................................................ 67
Chapter 5 – Quality Control

Quality Control ................................................................................................................ 69
Control Material ............................................................................................................... 69
Handling QC Material .................................................................................................. 69
Control Frequency........................................................................................................... 69
Running QC .................................................................................................................... 70
Reviewing Quality Controls Results ................................................................................ 71
Print List button............................................................................................................ 72
Re-Report button ......................................................................................................... 72
Remove ....................................................................................................................... 72
Search button .............................................................................................................. 73
Lot field .................................................................................................................... 73
Type field ................................................................................................................. 73
Status field ............................................................................................................... 73
Date-time combo-box............................................................................................... 73
Save Button ................................................................................................................. 74
Saving all QC Results .............................................................................................. 74
QC Statistics ................................................................................................................... 74
Chapter 6 - Calibration Verifications

Auto-Calibration .............................................................................................................. 76
Calibration Check Material .............................................................................................. 76
Reflectance CalChek test strips .................................................................................. 76
CalChek Reagents ...................................................................................................... 76
Specific Gravity CalChek solutions .......................................................................... 76
Color CalChek solutions .......................................................................................... 76
Clarity CalChek solutions ......................................................................................... 76
Storage and Use.......................................................................................................... 76
CalCheks Frequency....................................................................................................... 76
Running CalChek ............................................................................................................ 77

Table of Contents
Reflectance CalChek ................................................................................................... 77
Specific Gravity, Color, and Clarity CalChek ............................................................... 83
Chapter 7 - Results
Reviewing Results........................................................................................................... 85
Work List Screen ............................................................................................................. 85
Sort Work List .......................................................................................................... 86
Delete Specimen...................................................................................................... 87
Un-Delete Specimen ................................................................................................ 87
Correct Specimen ID................................................................................................ 88
Edit Demographics................................................................................................... 88
Print List ................................................................................................................... 89
Re-Report ................................................................................................................ 89
Search...................................................................................................................... 91
Flagged Specimens ..................................................................................................... 94
Review Flagged Specimen button ........................................................................... 95
Delete Flagged Specimen button............................................................................. 95
Chemistry System Flag Messages .............................................................................. 95
CHEMTRANSLATE ................................................................................................. 95
CHEM CONFIRM..................................................................................................... 95
ID_Error ................................................................................................................... 96
Insufficient Sample................................................................................................... 96
Short Sample ........................................................................................................... 96
Processing Failure ................................................................................................... 97
Processing not complete.......................................................................................... 97
Specimen Screen ........................................................................................................ 98
Accessing the Specimen Screen ............................................................................. 98
Specimen Screen Buttons ....................................................................................... 99
Interferences ................................................................................................................... 99
Chapter 8 – Maintenance and Service

Maintenance.................................................................................................................. 101
Precautions................................................................................................................ 101
Daily Maintenance ..................................................................................................... 101
Consumable Replenishment ..................................................................................... 101
Periodic Maintenance ................................................................................................ 101
As Needed Maintenance ........................................................................................... 102
Discarding Liquid Waste ........................................................................................ 103
Cleaning the Sample Transport Module ................................................................ 104
Cleaning the Optional Load/Unload Trays ............................................................. 104
Cleaning the Instrument Surfaces.......................................................................... 104

Table of Contents
Consumable Replacement ........................................................................................ 105
Replacing Wash Solution ....................................................................................... 105
Weekly Maintenance ................................................................................................. 106
Cleaning the Strip Provider Module ....................................................................... 106
Monthly Maintenance ................................................................................................ 108
Perform Reflectance CalChek ............................................................................... 108
Perform SG/CC CalChek ....................................................................................... 108
Cleaning the Wash Station Bath ............................................................................ 108
Cleaning the Strip Conveyor Module ..................................................................... 109
Replacing Wash Solution Filter .............................................................................. 111
Cleaning the Sample Tube Detector ...................................................................... 112
Cleaning the Barcode Reader Window .................................................................. 112
Cleaning the Optical Sensors on the Sample Transport Module ........................... 113
Preparation for Long-Term Shutdown ........................................................................... 114
Start-up after Long-term Shutdown ........................................................................... 114
Prime the System Lines ......................................................................................... 115
Run CalChek.......................................................................................................... 115
Run Control Rack................................................................................................... 115
Accessing the Maintenance Menu ................................................................................ 116
Tallies ........................................................................................................................ 117
Shutting Down the Instrument ................................................................................... 118
Maintenance Log........................................................................................................... 119
Chapter 9 – Appendix
Performance Characteristics ......................................................................................... 121
Analytical Performance.............................................................................................. 121
Analytes Report Ranges (Includes pH and Specific Gravity) .................................... 121
Bilirubin .................................................................................................................. 121
Urobilinogen ........................................................................................................... 121
Ketones .................................................................................................................. 122
Glucose .................................................................................................................. 122
Protein.................................................................................................................... 122
Blood (Hemoglobin) ............................................................................................... 123
pH .......................................................................................................................... 123
Nitrite...................................................................................................................... 123
Leukocytes ............................................................................................................. 123
Ascorbic Acid ......................................................................................................... 124
Specific Gravity ...................................................................................................... 124
Color and Clarity Report Ranges............................................................................... 124
Colors..................................................................................................................... 124
Clarity ..................................................................................................................... 124
Sensitivity and Measurement Range ............................................................................ 125

Table of Contents
Limitations ..................................................................................................................... 126
Specimens ................................................................................................................. 126
Gross Hematuria ....................................................................................................... 126
iChemVELOCITY Urinalysis System ............................................................................ 127
Expected Values and Ranges ................................................................................... 127
Precision .................................................................................................................... 127
Within Run Precision.............................................................................................. 127
Day-To-Day Precision ............................................................................................ 127
20-Day Day-To-Day Negative Analyte Concentrations .......................................... 127
Day-To-Day Positive Analyte Concentrations ........................................................ 128
20 Days Specific Gravity Day-to-Day Precision ..................................................... 128
Day 1 – Day 20 CC/CB/CA Control results for color .............................................. 129
Day 1 – Day 20 CC/CB/CA Control results for clarity ............................................ 130
Principles of the Tests and Limitations of the Procedure .............................................. 131
Bilirubin ...................................................................................................................... 131
Urobilinogen .............................................................................................................. 131
Ketones ..................................................................................................................... 132
Ascorbic Acid ................................................................................................................ 132
Glucose ..................................................................................................................... 132
Protein ....................................................................................................................... 133
Blood ......................................................................................................................... 133
pH .............................................................................................................................. 134
Nitrite ......................................................................................................................... 134
Leukocytes ................................................................................................................ 135
Specific Gravity.......................................................................................................... 135
Color and Clarity ........................................................................................................ 135

Addendum
Addendum ......................................................................................................................A-2
Specimen Settings .........................................................................................................A-2
Running QC ...................................................................................................................A-3
QC Statistics ..................................................................................................................A-3
Maintenance Screen ......................................................................................................A-4
Running STAT samples .................................................................................................A-5
Preparing STAT Rack.................................................................................................A-5
QC Failure ......................................................................................................................A-5
CalChek Failure .............................................................................................................A-6
Reflectance CalChek Failure ......................................................................................A-6
SG/Color/Clarity CalCheck Failure .............................................................................A-6
Test Strip Jam ................................................................................................................A-7
Strip Provider Module Jam .........................................................................................A-7
Strip Conveyor Module Jam .......................................................................................A-8
Rack Jam .......................................................................................................................A-8
Accessing the Strip Provider Module .............................................................................A-9
Accessing the Strip Conveyor Module .........................................................................A-11
300-4484 English Rev A 05/2008 Operators Manual A-1

Addendum
Addendum
Since the development of the Operators Manual, changes have been
made to the instrument or the software impacting some sections. This
Addendum lists the changes and corrects the sections from the Operators
Manual. In order to find rapidly the appropriate sections, links have been
inserted for each modification and are displayed in blue, bold and italics.
Specimen Settings
Only one option is displayed on this screen. The Specimen screen allows
the user to control whether barcode scan failures are flagged or not.
See Chapter 3 – Settings, Specimen Settings.

Addendum
Running QC
Use only positions 8, 9, and 10 to run quality control material.
See Chapter 5 – Running QC.
Items required: Urine Control CA/CB/CC (REF 800-7702), Control Rack,

sample tubes, protective gloves.
1. Make sure there are enough Test Strips in the Test Strip Provider.
2. Prepare Control Tubes according to the directions on the package
insert.
3. Place the controls in the following positions onto the Control Rack:
Position Insert Volume Contents Function Barcode

Color
8 Blue 3 mL CA Control Primary control No
9 Green 3 mL CB Control Primary control No
10 Red 3 mL CC Control Primary control No
4. Place the rack on the Sampler.

5. Press the START button. The system detects the Control Rack and
displays the position number.
6. When Control testing is completed, the results are printed and/or
transmitted to the LIS depending on the user configuration.
QC Statistics
QC statistics are not available for the chemistry quality control results.
See Chapter 2 – Screen Level Functions.

Addendum
Maintenance Screen
Change of terminology for the second button displayed on this screen.
See Chapter 8 - Accessing the Maintenance Menu.

Addendum
Running STAT samples

If it is necessary to run STAT samples, positions 1 through 7 on the
Control rack can be used.
NOTE: Make sure that positions 1 through 7 only are used to load STAT
samples. If a sample tube is placed in positions 8, 9, or 10, they will be
processed as a control.
Preparing STAT Rack

1. Apply barcode labels to sample tubes, placing the start of the barcode
(not the barcode label), approximately ½ inch below the top of a
16x100mm tube or just below the flare of a Kova or Kova-like tube.
2. Transfer at least 2.0 mL of well mixed, native urine into the barcoded
tubes. You may add more if needed, but do not exceed the maximum
volume indicated based on the tube type.
3. Place the barcode labeled tubes in the Control rack – positions 1 to 7
ONLY.
4. Place the Control rack in front of the sample racks waiting for
processing on the right side of the sampler.
5. Samples will be processed.
6. The samples will be marked as STAT when they appear on the Work
List.
QC Failure
QC Failure needs to be resolved in order to be able to process patient
samples, see Chapter 5 - Quality Control.
1. Repeat the run using the same lot number.

2. Repeat the run using a new lot number.
3. Run a Reflectance CalChek, see Chapter 6.
4. If the CalChek is successful, repeat the QC run.
5. If the CalCheck failed or if the QC fails again, contact Technical
Services or your distributor.

Addendum
CalChek Failure
Reflectance CalChek Failure
1. Repeat the run using the same lot number.
3. If the CalCheck failed again, contact Technical Services or your
distributor.
SG/Color/Clarity CalCheck Failure

1. Repeat the CalChek run using the same tube solutions.
3. If the CalCheck failed again, contact Technical Services or your
distributor.

Addendum
Test Strip Jam

Strip Provider Module Jam
If a jam occurs before a test strip is transferred from the Strip Provider
Module to the Strip Conveyor Module, any strip that received patient
sample BEFORE the jam occurred will be processed and the results will
be displayed and/or released depending on the user-defined
configuration. The system will display Chemistry Strip empty or there
may be a jam. The last reported result will be displayed indicating the
rack number and the tube position.
Causes Solutions
A test strip was not transferred 1. Click OK to close the error message
to the Strip Conveyor Module. screen.
The strip remains inside the 2. From the Instrument screen, click on
singulator (see below) or is the Go off line button. The system
partially extracted from the strip status will change to Off Line.
provider module. 3. Press the ON button on the front of
the instrument to turn the power off.
4. Access the Strip Provider Module; see
Accessing the Strip Provider
Module.
5. Locate the strip jam.
6. Using tweezers, gently remove the
jammed strip.
7. Re-install the Strip Provider Module in
place; see Accessing the Strip
Provider Module.
8. Reload the rack and press the Start
button to repeat the run.
9. If the problem persists, call Technical
Services.

Addendum
Strip Conveyor Module Jam

If a jam occurs on the Strip Conveyor Module, the system will stop and
display a Chemistry Error message. The last reported result will be
displayed indicating the rack number and the tube position.
Causes Solutions
Test strips are misaligned 1. Click OK to close the error message
on the Strip Conveyor screen.
Module, or the wrong type 2. From the Instrument screen, click on the
of strips was used. Go off line button. The system status will
change to Off Line.
3. Press the ON button on the front of the
instrument to turn the power off.
4. Access the Strip Conveyor Module; see
Accessing the Strip Conveyor Module.
5. Locate the strip jam.
6. Using tweezers, gently remove the
jammed strip(s).
7. Re-install the Strip Conveyor Module in
place; see Accessing the Strip
Conveyor Module.
8. Reload the rack and press the Start
button to repeat the run.
9. If the problem persists, call Technical
Services.
Rack Jam
Causes Solutions
If a rack cannot enter the sampling 1. Remove any element causing
position, check the bottom and the the obstruction.
front of the rack to make sure that 2. Clean the rack using warm
nothing is attached causing the water with mild detergent or
obstruction, i.e. barcode label, or alcohol swab.
parafilm. 3. Reload the rack and repeat the
run.
4. If the problem persists, repeat
using another rack.

Addendum
Accessing the Strip Provider Module

1. From the Instrument screen, click on the Go off line button. The
system status will change to Off Line.
2. Press the ON button on the front of the instrument to turn the power
off.
3. Open the front door, the right side door and the waste container door.
4. Loosen the thumbscrew holding

the barcode reader shield and
then tilt the shield to the
horizontal position to the right.
5. Remove the two thumbscrews

holding the splashguard to the
main frame. Remove the
splashguard and set aside with
the screws.
6. Pull the blue knob to release

the strip provider module and
then tilt the strip provider
module to the right.
7. If necessary, using a
screwdriver, loosen the two
screws holding the strip loader
to access the inside of the strip
provider module

Addendum
8. After cleaning inside the strip
provider or removing any strip
jam, close the strip loader and
snugly reattach the screws. Do
not over tighten.
9. Pull the blue knob to release

the strip provider module and tilt
it back to the left. When the
front door is closed, the strip
provider module will be
maintained into position.
10. Close the side doors.

11. Raise the barcode reader shield
and attach using the
thumbscrew.
12. Re-install the splashguard by

sliding it so that the two tabs
slide inside the two slots at the
bottom of the splashguard.
Reattach the thumbscrews,
finger tight only.
CAUTION: Make sure that the two tabs slide inside the two holes located
at the bottom of the splashguard. If the tabs are not inside the holes, rack
jam can occur.
13. Close the front door.
14. Turn the power on by pressing the green button located on the left
side of the chemistry system.
15. Click on the Go On line button. The system status will change to On
Line.

Addendum
Accessing the Strip Conveyor Module

1. From the Instrument screen, click on the Go off line button. The
system status will change to Off Line.
2. Press the ON button on the front of the instrument to turn the power
off.
3. Loosen the thumbscrew holding

the barcode reader shield and
then tilt the shield to the
horizontal position to the right.
4. Remove the two thumbscrews

holding the splashguard to the
main frame. Remove the
splashguard and set aside with
the screws.
5. Tilt the wash station to the left

until it is in horizontal position.
This will raise the Strip Provider
Module.
6. Pull out and then push down

the blue latch holding the strip
conveyor handle and then slide
it under the bottom plate.

Addendum
7. Using the handle, gently pull the
strip conveyor away from its
location.
8. When the maintenance or the

jam clearance is complete,
replace the strip conveyor
module back inside the
instrument, pushing it all the
way.
9. Pull the blue latch and move it

up in place to maintain the
handle in place.
10. Raise the wash station back to

the vertical position.
11. Close the side doors.

12. Raise the barcode reader shield
and attach using the
thumbscrew.

Addendum
13. Re-install the splashguard by
sliding it so that the two tabs
slide inside the two slots at the
bottom of the splashguard.
Reattach the thumbscrews,
finger tight only.
CAUTION: Make sure that the two tabs slide inside the two holes located
at the bottom of the splashguard. If the tabs are not inside the holes, rack
jam can occur.
Line.

1 Introduction
Intended Use ................................................................................................................... 10
How to use the Operators Manual .................................................................................. 10
Precautions and Warnings .............................................................................................. 11
Tips .............................................................................................................................. 11
Notes ........................................................................................................................... 11
Cautions ...................................................................................................................... 11
Warnings ..................................................................................................................... 11
Biological Warnings ..................................................................................................... 11
Warnings, Precautions, Limitations ................................................................................. 12
Iris Diagnostics Contact Information ............................................................................... 12
Warranty.......................................................................................................................... 13
Limitation of Liability ........................................................................................................ 13

1 Introduction
Intended Use
The iChem®VELOCITY™ Urine Chemistry System is an automated urine
chemistry system for the in vitro measurement of the following analytes in
urine: bilirubin, urobilinogen, ketones, ascorbic acid, glucose, protein,
blood, pH, nitrite, leukocyte esterase, specific gravity, color, and clarity.
The iChem®VELOCITY™ Urine Chemistry System is intended for use only
with iChem®VELOCITY™ Urine Chemistry Strips.
This document is the Operators Manual for the iChemVELOCITY Urine

Chemistry System. It is intended to explain system operation in detail
and to be used as the basis for training new operators. Retain this
manual for future use. It is an information guide and a troubleshooting
reference. It explains program settings and gives maintenance
instructions.
How to use the Operators Manual

This manual contains important information on the functions of the
iChemVELOCITY manufactured by Iris Diagnostics. This manual
contains instructions for the operation, maintenance and troubleshooting
of the iChemVELOCITY.
Before operating the iChemVELOCITY, read this manual carefully.

1 Introduction
Precautions and Warnings

The Operators Manual includes information and warnings that must be
observed by the operator in order to ensure safe operation of the system.
Important messages are highlighted with borders and special icons
identifying the type of message enclosed.
There are five types of messages: Tips, Notes, Cautions, Warnings and
Biological Warnings.
Tips
This icon indicates that the information is applicable only when an iQ
Series System is linked to the chemistry system.
Notes
NOTE: Highlights important facts, gives helpful information and tips and
clarifies procedures.
Cautions
CAUTION: Electrical caution! Unplug before handling.
CAUTION: Important information on the proper operation of the

iChemVELOCITY Urine Chemistry System. This information is crucial in
preventing instrument damage and maintaining the system.
Warnings
WARNING: Identifies potentially hazardous situations that could result in
serious injury to laboratory personnel.
Biological Warnings
WARNING: Use care when handling specimens or used test strips.
Always wear gloves to prevent exposure to pathogens; i.e., bloody
specimens. Incorrect or imprecise procedures may result in exposure to
pathogens. This unit must only be used by operators trained in proper
procedures for clinical testing and handling of biohazardous waste.

1 Introduction
Warnings, Precautions, Limitations

• Do not place the iChemVELOCITY in water.
• Do not drop or throw the instrument.
• Operate the instrument on a dry, level surface.
• Do not move the instrument while a test is in process.
• Plug the instrument into a grounded power source.
• Avoid sources of bright light/heat.
Iris Diagnostics Contact Information

Customer opinion and input is extremely important to us. Iris Diagnostics
wants to design products that meet your needs. Comments on this
manual should be directed to:
Iris Diagnostics
Attention: Clinical Support
9172 Eton Avenue
Chatsworth, CA 91311
USA
Telephone
From U.S. and Canada locations +1-800-PRO-IRIS (776-4747)
From outside the U.S. +1-818-709-1244
Fax +1-818-700-9661
E-mail clinsupport@proiris.com

1 Introduction
Warranty
Iris Diagnostics, a Division of IRIS International, Inc. (Iris) warrants that
the products manufactured by it or its affiliates and sold hereunder shall
be free from defects in material and/or workmanship, under normal use
and service, for the period expiring twelve (12) months from the
completion of installation, or upon Purchaser’s signature on Iris
Diagnostics Warranty/ Acceptance form, or fifteen (15) months from
shipment, whichever occurs first. No warranty extended by Iris
Diagnostics shall apply to any products which have been modified,
(including any third party software), altered, or repaired by persons other
than those authorized or approved by Iris Diagnostics or to products sold
as “used.”
Iris Diagnostics’ obligation under this warranty is limited SOLELY to the

repair or replacement, at Iris Diagnostics’ option, of defective parts,
F.O.B. warehouse or local Iris Diagnostics office, or as otherwise
specified by Iris Diagnostics. Repairs or replacement deliveries shall not
interrupt or prolong the term of this warranty. Iris Diagnostics’ warranty
does not apply to consumable materials, except as specially stated in
writing, nor to products or parts thereof manufactured by the Purchaser.
This limited warranty is made on condition that immediate written notice

of any defect be given to Iris Diagnostics and that Iris Diagnostics
inspection reveals that the Purchaser’s claim is valid under the terms of
this warranty.
Iris Diagnostics makes no warranty other than the one set forth herein or
that which may be provided in a separate warranty covering the
applicable product category. such limited warranty is in lieu of all other
warranties, expressed or implied, including but not limited to any
expressed or implied warranty of merchantability or fitness for particular
purposes and such constitutes the only warranty made with respect to the
products.
Limitation of Liability
Iris Diagnostics shall not be liable for any loss of use, revenue or
anticipated profits, or for any consequential or incidental damages
resulting from the sale or use of the products.

2 System Description
Theory of Operation ........................................................................................................ 16
Measurements ............................................................................................................. 16
Analytes ................................................................................................................... 16
Specific Gravity ........................................................................................................ 16
Color and Clarity ...................................................................................................... 16
System Components ....................................................................................................... 17
Sampler ....................................................................................................................... 17
Barcode Reader ....................................................................................................... 17
Load and Unload Stations........................................................................................ 17
Optional Load and Unload Stations ............................................................................. 17
Strip Provider Module .................................................................................................. 18
Strip Conveyor System ................................................................................................ 18
Strip Reader Module.................................................................................................... 18
Specific Gravity, Color, and Clarity Module ................................................................. 19
Fluidics ........................................................................................................................ 19
Sample Probe .......................................................................................................... 19
Wash Station............................................................................................................ 19
Pumps ...................................................................................................................... 20
Wash Container ....................................................................................................... 20
Waste .......................................................................................................................... 20
Strip Disposal ........................................................................................................... 20
Liquid Waste Disposal ............................................................................................. 20
On Button .................................................................................................................... 20
Start Button.................................................................................................................. 20
System Status Lights ................................................................................................... 20
Racks........................................................................................................................... 20
Sample rack ............................................................................................................. 20
Control rack.............................................................................................................. 20
CalChek rack ........................................................................................................... 21
Test Strips ................................................................................................................... 21
Test Specifications ................................................................................................. 21
Peripherals .................................................................................................................. 22
Keyboard.................................................................................................................. 22
Mouse ...................................................................................................................... 22
Touchscreen Monitor ............................................................................................... 22
Printer ...................................................................................................................... 22
Software Functions ......................................................................................................... 23
iChemVELOCITY Status ............................................................................................. 23
View Selector............................................................................................................... 24
Instrument Screen ....................................................................................................... 24
Shift Summary ............................................................................................................. 25
Alarms ...................................................................................................................... 25
Screen Level Functions ........................................................................................... 26
Work List...................................................................................................................... 27

Specimen Results........................................................................................................ 28
Buttons ..................................................................................................................... 28
Iris Logo ....................................................................................................................... 29
Interface....................................................................................................................... 29
Result Storage ............................................................................................................. 29
Technical Specifications.................................................................................................. 30
Precautions ..................................................................................................................... 32

Theory of Operation
The iChemVELOCITY is an automated urine chemistry system
performing measurements of urine physical and chemical constituents
utilizing test strips read by Wavelength Reflectance, and specific gravity
using the Refractive Index. Since the iChemVELOCITY also determines
color and clarity, a complete urinalysis is determined automatically. Visual
measurements are no longer necessary.
The iChemVELOCITY has its own power supply. A barcode reader is

used to identify specimens, control and calibration material. Motors drive
mechanical portions of the system and a fluidic system pipettes samples
from specimen tubes. The system can be linked to a Laboratory
Information System (LIS).
Test strips are dispensed from the strip provider module, and placed face
up on the strip conveyer system. The sample probe mixes the specimen,
then aspirates an aliquot of urine from the tube and dispenses the sample
onto each reagent pad. The test strip reagent pads and urine
components react causing the color of the test strip to change, and the
color change is measured by the instrument. The test strip is then
transported to the waste container.
Measurements
Analytes
The Optical Unit is composed of three color LEDs and one black and
white CMOS (Complementary Metal Oxide Semiconductor) camera.
Specific Gravity
Specific gravity of urine is obtained using an Abbe refractomer and a
linear photodiode array in place of a human eye to locate the shadow.
The refractive index changes according to the specific gravity of the
sample.
Specific gravity is not measured by using a strip pad. A small flowcell is

attached to a SG meter and the raw video from the linear photodiode
array inside the device extends the measurement range to 1.060.
Color and Clarity

A Color and Clarity Module measures the color and clarity of a sample
aspirated by the instrument.

A narrow tubular flowcell equipped with a color sensor is located inside
the Color and Clarity Module. When passing through the flowcell, the
sample is illuminated with a white light and the color sensor is used to
measure the color of the sample. The sample is illuminated at a 90
degree angle with a white light and the color sensor measure the
amplitude of light scattered within the flowcell to determine the clarity of
the sample.
A photodiode array sensor is used to obtain the tone and hue of the urine
sample. The colors are reported as codes representing user-defined
color names.
System Components
Sampler
The sampler moves the test tube racks from the load station (right side of
the instrument) to the pipetting station, and then to the unload station (left
side of the instrument). The test tube racks are presented to the pipetting
station where the presence of a tube is detected whether or not a barcode
label is attached to the tube. The sample is aspirated from the tube for
analysis. The sampler signals when the unload station is full.
Barcode Reader
The barcode reader reads the racks’ identifiers so that patient samples
can be related to positions within a known identity rack. When a barcode
label is attached to a sample tube, the barcode reader reads the label and
provides the patient identification data to the system.
Load and Unload Stations
Six (6) test tube racks (maximum of 60 test tubes) can be placed onto the
load station for measurement. After sampling is completed, the test tube
racks are transferred to the unload station for removal.
Optional Load and Unload Stations

When load and unload stations are connected via serial connections to
the system, fifteen (15) additional test tube racks can be loaded onto the
loading tray bringing the batch capacity of the system to 210 test tubes for
routine analysis. After sampling is completed, the first fifteen test tube
racks are transferred to the unload tray and when the unload tray is full,
the next six racks remain on the sampler.

Strip Provider Module

The strip provider module can hold at least 300 strips with an on-board
stability of fourteen (14) days * (without opening the module during that
period). The strip provider module has a window allowing the user to
visually check the strip supply. When the sampler detects the presence
of a test tube, a test strip is delivered facing up to the strip conveyor
system.
Strip Conveyor System

The strip conveyor system moves the test strips through a number of
positions, moving to the next position every 15 seconds. The positions
are as follows:
• a loading position where the presence of a test strip is detected,
• a dosing position where the sample is distributed onto the test strip,
• eight (8) reading positions in sequence.
The test strips are held in place at each reading position so that the strip
reader can capture a complete image of each strip pad. The strip
conveyor system maintains the bottom surface of the strips at a nominal
temperature of 37 degrees Celsius. After the last reading, the test strip is
discarded into the waste container.
Strip Reader Module

The strip reader module measures the color of each pad of the chemistry
strips at different incubation times and uses these colors to obtain the
analytes semi-quantitative concentrations. All eight reading positions are
visible in the captured images allowing measurement of the pad color in
15-second increments.
At the reading positions, a CMOS camera captures images of all twelve
(12) pads of each chemistry strip successively illuminated with a red,
green and blue light. The test strips are illuminated at each reading
position with a sequence of three different LED wavelengths for less than
one (1) second. The nominal LED wavelengths are 472 nm, 525 nm, and
630 nm +/- 2 nm.
Illumination fluctuations are adjusted automatically by using an internal

reflectance standard imaged simultaneously with the strip pads. The
internal reflectance standards are positioned between and parallel to
each chemistry strip. The figure below shows the field of view with eight
(8) test strips in reading positions 1-8 and the internal standards (grey
between each strip).
* Pending final verification

The system software analyzes the captured images and quantifies the
reflectance from each pad relative to the reflectance from a neighboring
area of the Munsell standard mask plate, with a known reflectance value.
Specific Gravity, Color, and Clarity Module

See Specific Gravity.
See Color and Clarity.
Fluidics
Sample Probe
The sample probe mixes the specimen inside the sample tube.
Approximately 1mL of sample is aspirated and fills the specific gravity and
color-clarity flowcells. Approximately 10µL of sample is dispensed onto
each pad of the test strip. When dispensing of the specimen is
completed, the sample probe is cleaned with the wash solution. At the
same time, specific gravity, color and clarity measurements are
completed; and the flowcells and tubing are rinsed with the wash solution.
Wash Station
The wash station is used to rinse the outside of the sample probe and to
discard the wash solution.

Pumps
One pump is used for aspirating and dispensing the sample.
Two pumps are used to wash and clean the fluidics system.
Wash Container
A 7 liter wash container supplies the iChem Wash Solution.
Waste
Strip Disposal
The system automatically disposes used test strips into a waste container
with a capacity of a least 500 test strips.
Liquid Waste Disposal
Waste fluids are discarded into a drain or a waste container.
On Button
The On button is located on the left of the iChemVELOCITY. Pressing
this button after applying power to the instrument, place the system in
Standby.
Start Button
The START button is located on the left of the iChemVELOCITY.
Pressing this button starts the sample processing after the sample racks
have been loaded onto the iChemVELOCITY sampler.
System Status Lights

The system status lights display “Stand By” (Green), “Measure” (Blue)
and “Error” (Red).
Racks
Three types of racks are used with the iChemVELOCITY system:
A sample rack,
A control rack,
A CalChek rack
Sample rack
Patient samples are presented to the instrument in test tubes loaded into
sample racks. Ten sample tubes can be loaded onto a sample rack.
Control rack
Chemistry controls: IRISpec CA/CB/CC controls.

CalChek rack
SG, Color, and Clarity Calibration Checks:
Three Specific Gravity controls with specific gravities of 1.002, 1.030, and
1.060.
Four color controls including colorless, straw, yellow, and amber

Three clarity controls are straw in color, with clarity values of 1, 2, and 3.
Test Strips
The test strips have reagent-impregnated specialty paper pads to perform
chemical analysis of:
• bilirubin
• urobilinogen
• ketones
• ascorbic acid
• glucose
• protein
• blood
• pH
• nitrite
• leukocytes
Test Specifications
iChemVELOCITY Urine Chemistry Strips are packaged in the Starter Kit
with the iChemVELOCITY system. Additional strips may be purchased
from Iris Diagnostics or your authorized distributor. Only
iChemVELOCITY Urine Chemistry Strips may be used. Other
manufacturer strips cannot be read by the instrument.
A maximum of 300 test strips can be stored in the strip provider module.
CAUTION: Do NOT leave the test strips in the module for more than 14
days. If test strips are exposed to the air too long, they may absorb
moisture or collect dust, causing incorrect results. Best practice is to
allow the chamber to empty completely before adding new strips.
CAUTION: Do NOT touch the reagent pad of a test strip; this may cause
incorrect results. Do NOT use expired test strips or any test strip if the
reagent pads show any signs of discoloration, deformation or
deterioration. Read the package insert of the test strips carefully.

Peripherals
Keyboard
The keyboard is used to enter alphanumeric specimen identifiers and
data input.
Mouse
The mouse is used to navigate the software screens.
Touchscreen Monitor
The touchscreen can be used to make selections on the software
screens.
Printer
An external USB port allows the connection of a Windows compatible
printer.

Software Functions
The software provides the following functions:
• Controls the mechanical functions of the iChemVELOCITY for
specimen transport and fluid handling.
• Automatically computes chemistry analyte concentrations, specific
gravity, color and clarity results for each specimen and the results
are auto-reported, unless a system flag is present.
• Controls the User Interface
o Generates, prints, and electronically transmits reports.
o Maintains a list of flagged specimens identifying those
requiring further intervention due to missing IDs or other
analytical or processing situations.
The User Interface software is composed of three main screens:

• Instrument screen
• Specimen screen
• Work List screen
iChemVELOCITY Status
Located on the top left side of the screen, displays:
• Status light indicator: Grey -> OFF
Green -> Standby
Blue -> Measure
Red -> Error
• Identification of the currently logged operator
• Identification of the currently aspirated tube (if any)
• (Rack# - Position#)
• Icon of the highest priority alarm (if any) and short description of
the error condition
Low priority
Medium priority
High priority

View Selector
Located on the top right side of the screen, allows the user to access the
following screens by clicking on the corresponding buttons:
• Specimen screen
• Work List screen
• Instrument screen
Instrument Screen
The Instrument screen is accessed by clicking on the Instrument button
and is composed of the following elements:
View Selector Area
iChemVELOCITY
Status Area
Task Level
Information Area
Screen Level Functions Area Information Area

Shift Summary
Field Display Button
Operator Currently logged on operator if Logon
any. Logoff
Last Date/time of the last successful N/A
Reflectance reflectance calibration check.
Check
Last Date/time of the last successful N/A
SG/Color/Clarity specific gravity, color, and clarity
Check calibration check.
Last Chem QC Date/time of the last successful N/A
chemistry quality control.
LIS LIS status. Check LIS
Manual Orders Displays racks enabled in Manual Clear All
Orders.
Manual Orders Give access to Manual Orders Manual Orders
screen
System Status On Line Go Off Line
Off Line (display in red) Go On Line
Alarms
Alarms appear in the Information Area of the screen and display the
detailed list of unresolved alarms, sorted by priority, then date/time.

Screen Level Functions
Button Function
QC Review Access the QC Review screen
QC Statistics Access the QC Statistics screen
Settings Access the Settings screen for user-defined
instrument setup (consult the Setup section for
more information.)
Maintenance Access the Maintenance screen for:
Reflectance Check
Chemistry Service
System Info
Tallies
Errors
Shutdown

Work List
The Work List contains only unreleased results. The Work List screen is
accessed by clicking on the Work List button. The Work List displays the
specimen ID, date and time at which the specimen was processed, rack,
and tube position numbers, and status of each specimen results. Clicking
on a specimen ID and clicking on the Specimens tab, or double-clicking
on the specimen ID opens the Result screen for that specimen.
From the Work List, while On Line you can:

• sort the Work List
• delete a specimen
• un-delete a specimen
• correct/modify the specimen ID
• edit patient demographics
• print the Work List
The Search button allows searching in history by ID number, operator ID,
demographics, date/time or specimen awaiting transmission. The results
are displayed in the "Found List." The Search button toggles between the
Work List and the Found List. When the Found List is displayed, clicking
on the Search button toggles back to the Work List.
From the Found List, while Off Line, you can re-report specimen results.

Specimen Results
The Specimen screen shows a summary of the results for the specimen
chosen from the Work List/Found List.
Buttons
Buttons Functions
Delete Flagged Non-recoverable flag. The specimen results will be
Specimen deleted. The cause of the flag needs to be resolved
before the specimen can be run again.
Review Recoverable flag. Allows the user to enter a specimen
Flagged ID or clear a flag.
Specimen
Accept If the Review Flag button was used:
Assigns the new specimen ID, if it had an ID flag.
Clears the specimen’s flags and transmits the
specimen results to the LIS and/or the printer.
If the Delete Flag button was used:
Deletes the specimen results and sends them to the
Un-delete list.

Buttons Functions
Skip Skips the specimen results and display the next results
available from the Work List.
Instrument Closes the Specimen screen and returns to the
Instrument screen.
Iris Logo
The Iris logo is displayed only when the Work List is empty.
Interface
Contact Iris Diagnostics Technical Service Department or your authorized
distributor for information.
Result Storage
A maximum of 10,000 patient results can be stored in memory. Stored
results can be reprinted and/or retransmitted.

Technical Specifications
Measurement Reflectance Photometry LEDs (472nm, 525nm,
Principle 630nm) with CMOS camera
Specific gravity via optical refractive index
method
Specimen Barcode or keyboard entry of ID
Processing 60 specimens walk away capability (210
specimens with optional Loading/Unloading
stations)
10-tube rack system with continuous feed
Specimen Volume Minimum volume 2 mL of un-spun urine
Aspiration volume approx ~1mL
Test Strips iChemVELOCITY Urine Chemistry Strips
Test Strip Chamber Maximum capacity of 300 strips
On-board stability 14 days*

Test Strip Waste
Capacity at least 500 strips
Container
Fluid Waste Waste is pumped from the instrument to a sink,
floor drain or suitable container. Drain must be
below or at same height as bench and should
be less than 10 feet (3 meters) from the back of
the instrument.
Throughput 240 Urine Test Strips per hour
Barcode Labels Code 128, Code 39, Codabar and Interleaved 2
of 5 at a minimum bar width of 0.005 in (0.127
mm)
Data Storage Onboard storage of up to 10,000 patient results
Reporting Units Conventional, S.I., Qualitative or Combination
LIS Interface Bi-directional with host query
Flagging Results requiring confirmatory tests /

Abnormal Quality results

Workstation Computer with monitor/keyboard/mouse and

printer
Printer External
Interfaces USB port, Ethernet
Dimensions Chemistry system
22 H x 21 W x 24 D (in.)
56 H x 53.5 W x 61 D (cm)
Optional Loading/Unloading stations
Printer
Weight Chemistry module 100 lbs – 45.5 kgs
Printer 23 lbs - 10 kgs
Optional Loading/Unloading stations
12 lbs - 5.2 kgs each
Electrical Power Chemistry Module
Req. 100-240 VAC 50-60 Hz 150 watts max
Monitor
100-240 VAC 50-60 Hz 40 watts max
Printer
100-240 VAC 50-60 Hz 100 Watts max
Uninterrupted Power Supply (UPS) 800VA
(recommended by not provided)
Ambient 64° F to 82° F (18° C to 28° C)
Temperature 20% to 80% Relative Humidity Non condensing
Control iChemVELOCITY heat output approximately
1,200 British Thermal Units or BTUs
Instrument Warm- System at operating temperature on standby
up within 20 minutes of powering on.
Package iChemVELOCITY system
Touchscreen LCD
Mouse, standard keyboard

Precautions
The entire unit weighs approximately 100 lbs – 45.5 kgs. Choose a place
to set up the unit before completing its assembly.
If the unit must be moved, separate the Sampler from the system before
moving. If these two units come apart while being carried, it may result in
injury or severe damage.
Always keep a distance of at least 5 inches (13 cm) between the rear of
the unit and the wall. If this distance is not maintained, the connecting
tubes and cables may overheat.
Do NOT use power frequencies or voltage other than those specified in

this document. Connection to an inappropriate power source may cause
injury or fire.
Make certain that the power supply for the iChemVELOCITY is from a
dedicated line that provides power to no other instruments or appliances.
If power is not clean and steady, a UPS and/or power conditioner is
recommended.
Do NOT disassemble or modify the unit. Doing so may cause injury

and/or instrument malfunction and void the warranty.
Place the unit on a stable and level surface free of vibration. Failure to do
so may cause injury or malfunction of the unit.
Do NOT place the unit where it may be affected by chemicals, corrosive

gases or electronic noise. Doing so may cause injury or malfunction of the
unit.
Do NOT place the unit where it may be affected by water, direct sunlight
or draft. This may yield incorrect results, and the unit may be damaged.
Select a room to set up the unit where the temperature can be controlled
between 68oF (18oC) and 82oF (28oC), and relative humidity non-
condensing in a range of 20% to 80%.
CAUTION: The equipment inside fixed covered areas of the instrument is

not operator serviceable and may present electrical shock hazards.

WARNING: For continued protection against risk of fire and hazard,

replace only with the same type and rating fuse.
WARNING: Equipment requires connection to protective earth ground for

safety reasons.
WARNING: The instrument’s main supply inlet is being used as the

mains disconnect device.
Consumables or Part Replacement

REF Number Description
800-7204 iChemVELOCITY Urine Chemistry Strips

800-7704 iChem Wash Solution 7 liters container
800-7702 IRISpec CA/CB/CC Controls
800-7703 iChem CalChek Kit

3 Setup
Setup ............................................................................................................................... 35
Settings Screen ............................................................................................................... 36
Accessing a setup screen ........................................................................................ 37
Printing the setup ..................................................................................................... 37
Operator Accounts Settings ............................................................................................ 38
Adding a New Operator ............................................................................................... 39
Deleting an Operator ................................................................................................... 40
Modifying an Operator ................................................................................................. 40
Laboratory Information Settings ...................................................................................... 41
System Configuration Settings ........................................................................................ 42
LIS Interface Settings ...................................................................................................... 44
Enable LIS ................................................................................................................... 44
Communication settings .............................................................................................. 44
Specimen information from LIS ................................................................................... 44
Obtain Patient Demographics Information from LIS ................................................ 44
Demographics .......................................................................................................... 44
Fluid Type – Formed Particles ........................................................................................ 45
Chemistry Settings .......................................................................................................... 46
Editing Chemistry Settings .......................................................................................... 47
Editing chemistry values .......................................................................................... 49
Validating the changes............................................................................................. 51
QC Settings ..................................................................................................................... 52
REF Override Settings .................................................................................................... 53
Specimen Settings .......................................................................................................... 54
Release Settings ............................................................................................................. 55
Urine Gating Settings ...................................................................................................... 56
Urine Auto-Release Settings ........................................................................................... 56
Urine Auto-Classify Settings ........................................................................................... 56

3 Setup
Setup
This section describes the steps necessary to setup and to customize the
system.
The iChemVELOCITY must be initially turned on in the following order to

achieve correct communication between the instrument and the
computer:
1. At initial start-up or if the instrument has been turned off completely,

start the iChemVELOCITY by pressing the power switch on the back
of the instrument. During routine use, this button will remain on.
2. Press the ON button located on the front of the instrument to apply
power to the system.
3. Press the START button located on the front of the instrument.
4. When the Instrument Screen appears on the monitor, the status light
will turn green.
5. If the optional Load/Unload Stations are attached, they should be
empty during power up.
6. If the optional Load/Unload Stations are attached, turn on the power
by pressing the power switch at the rear of the Load/Unload Station.

3 Setup
Settings Screen
NOTE: Only a Manager can modify the user-defined settings. Any user
can view the settings.
1. To access the Settings menu, click on the Instrument button on the

top right side of the main screen.
2. Click on the Go off line button.
3. A “Confirm” window pops up (with warnings). Click Yes
4. Click on the Settings button located at the bottom of the Instrument
screen.
Settings button
The following options are available for user-defined settings:

• Operator Accounts
• Lab Information
• System Configuration
• LIS Interface
• Chemistry
• QC
• Specimen
• Release

3 Setup
The following options are only available if an iQ Series module is
connected to the chemistry system:
• Formed Particles
• REF Override
• Urine Gating
• Urine Auto-Release
• Urine Auto-Classify
Accessing a setup screen
To access a specific setup screen, click on the appropriate button.
Only Managers can make changes to the Settings, but both Managers
and Technologists can view the data.
Printing the setup
To print the instrument settings, click the Print button.

3 Setup
Operator Accounts Settings
The Operator Accounts screen displays the list of authorized users and
their privilege level (Technologist or Manager). From this screen, users
can be added or deleted.

3 Setup
Adding a New Operator

1. From the Operator Accounts screen, click the New button. The
New Operator Account screen is displayed.
NOTE: The Operator Identifier, Password, and Confirm password fields

are case-sensitive.
2. Type the new operator identification in the Operator Identifier field (the
following characters cannot be used: [ ] ‘ and no space insertion)
3. Select the user level by clicking on the corresponding button
(Technologist or Manager).
4. Type the new operator password in the Password field.
5. Retype exactly the new operator password in the Confirm password
field.
6. Click OK to add the new operator to the Operator Accounts screen.
7. Click OK to validate the new operator entry and close the screen.

3 Setup
Deleting an Operator
NOTE: The currently logged in operator cannot delete his/her own user
account.
1. From the Operator Accounts screen, select the operator to be deleted,

and then click the Delete button.
2. The system prompts for confirmation: “Really delete the selected
operator account?”
3. Click Yes to delete the selected operator from the user list.
4. Click OK to validate the deletion and close the screen.
Modifying an Operator
To modify any information concerning an existing user, first delete the
user from the list, and then add the user with the new information (i.e.,
changing password.)

3 Setup
Laboratory Information Settings

The Laboratory Information screen displays seven lines allowing the
user to enter specific laboratory information that will be displayed on
reports.
1. Type the laboratory information in the order it will be displayed on

reports.
2. Click OK to validate the entries and close the screen.

3 Setup
System Configuration Settings

The System Configuration Settings screen is used to select the
presence of microscopy and/or chemistry system, and to choose the
reporting units for the chemistry system.
1. Click the appropriate checkbox depending on the laboratory

configuration.
2. The Options field is enabled only if the Microscopy System Present
checkbox is selected.
3. Click the Iris fully-automated chemistry system checkbox to select the
iChemVELOCITY. The last chemistry settings are displayed next to
the Install settings button. To change the settings, click the Install
settings button, the Select Chemistry Settings screen is displayed.

3 Setup
4. Use the pulldown button to select the reporting units.

5. Click the OK button to install the chemistry settings.
NOTE: If user-defined chemistry settings have already been entered, (see

Chemistry Settings), selecting a chemistry setting and clicking the OK
button on the Select Chemistry Settings screen will overwrite the user-
defined settings and the system will apply the new settings.
The following options are only available if an iQ Series microscopy

module is connected to the chemistry system:
• Skip microscopy if no chemistry available
• Consolidation window
• Gate on chemistry

3 Setup
LIS Interface Settings

The LIS Interface screen is used to enable LIS communication and
configure the LIS communication settings. It is used also to enter the
patient demographics settings.
Enable LIS
Check this box to enable communication with the LIS.
Communication settings
Use the dropdown boxes to select the specific communication settings for
the LIS.
Specimen information from LIS

Obtain Patient Demographics Information from LIS
If this box is checked, the Demographics button is enabled.
Demographics
1. Click the Demographics button to open the Demographics screen.

3 Setup
2. Select the demographics options required from the LIS after the
barcode label on the patient specimen is read.
3. Click OK to validate the entries and return to the LIS Interface
screen.
The following options are only available if an iQ Series module is

connected to the chemistry system:
• Obtain Specimen information from LIS
• Skip Specimen if LIS fails
• Obtain Chemistry Information from LIS
• Suppress Usage of Generated Chemistry Results when Obtaining
Specimen Information from LIS
• Specimen Information to LIS
4. When all the settings have been entered, click OK to validate the
entries and return to the Settings screen.
Fluid Type – Formed Particles

This option is only available if an iQ Series microscopy module is
connected to the chemistry system.

3 Setup
Chemistry Settings
The Chemistry Settings screen allows the user to enter chemistry
specific information, such as short name, long name, reporting units,
confirmation threshold, and abnormal threshold.
The chemistry system present and its reporting units are defined in the
System Configuration Input Settings screen (see System Configuration
Settings). The following lists the short and long names used for each
chemistry analyte:
Chemistry short name Chemistry long name

BIL Bilirubin
URO Urobilinogen
KET Ketones
ASC Ascorbic Acid
GLU Glucose
PRO Protein
BLD Blood
pH pH
NIT Nitrite
LEU Leukocytes
SG Specific Gravity
COLOR Color
CLA Clarity
Do not change any Chemistry Input Settings without consultation

with Iris Clinical Support. Output may be changed as needed to reflect
the usual reporting terminology of the laboratory.

3 Setup
Editing Chemistry Settings

1. Select the row corresponding to the chemistry to be edited and click
the Edit button or double-click on the row. The Chemistry Settings
screen appears.

3 Setup
2. In the Short Name field, enter the chemistry abbreviation that will be
displayed on the Specimen results screen (alphanumeric.)
3. In the Long Name field, enter the chemistry name that will appear on
the final reports (alphanumeric.)
4. In the Units field, enter the reporting units.
5. Choose a Confirmation Threshold, if applicable. A Confirmation
Threshold can be used to prevent Auto-release of specific chemistry
results. If “No Threshold” is selected, chemistry results for that
analyte will not be flagged for review.
• If a threshold value is selected, chemistry results with values
equal to or higher than the confirmation threshold chosen will be
flagged for review. This flag must be cleared before the results
can be released. Abnormal chemistry results can thus be
reviewed before clearing the flag.
• The intent of the Confirmation Threshold is to remind the user to
perform a confirmatory test. In most laboratories, Bilirubin is the
most commonly confirmed test. Most analytes will use “No
Threshold”.
6. The Abnormal Threshold defines the level at which a result is
considered abnormal:
• If No Threshold is selected, no abnormal flags will appear with
results.

3 Setup
• If a threshold value is selected, chemistry results with values
equal to or higher than the abnormal threshold will be flagged H
(high). The high result and the “H” flag will be displayed in red on
the screen.
7. Edit the Chemistry Setting, if desired, by following the directions in the
next section.
8. When all modifications for the chosen analyte are completed, click
Next to move to the next analyte. When finished all changes, click
OK to close the Settings screen.
9. Click OK to confirm the changes and close the Chemistry screen.
Editing chemistry values
1. Select the row corresponding to the chemistry to be edited and click
the Edit button or double-click on the row. The Chemistry Settings
screen for the chosen analyte appears.
2. From the Chemistry Settings screen, click the Edit Map button. The
Chemistry Map Settings screen appears for the chosen analyte.
3. The Input Value is the value that comes from the chemistry analyzer
to the Analysis Processor. The Output Value is the result that
appears on the Monitor, the printed result, and the result transmitted
to the LIS.
NOTE: The outputs for the chemistry system are originally selected
within the System Configuration settings. If any further changes are
desired, use the Edit Map Settings from the Chemistry Settings screen.

3 Setup
Edit Box
Moving a value
Select the desired row, and then click the Move Up or Move Down
button. Results must be in the same reporting order as the package
insert for the strips or flags and QC failures will result.
Changing a value
Select the desired row. The value is displayed in the edit box.
Enter the new value in the edit box, and then click the Change button.
Deleting a value
Select the desired row, and then click the Delete button. Do this only with
the assistance of Iris Clinical Support.
Adding a value
Enter the new values in the edit boxes, and then click the Add button. The
new values are added to the list. Do this only with the assistance of Iris
Clinical Support.
NOTE: Input values must match the values received from the chemistry
module. Do not change the input values without the assistance of Iris
Clinical Support.

3 Setup
Validating the changes
1. When all the changes are completed for a specific chemistry, click
Next to move to the next analyte, or click OK to close the screen. The
Chemistry Settings screen is displayed reflecting the changes.
2. When all desired changes have been made, click OK to confirm the
changes and close the screen.

3 Setup
QC Settings
The QC screen allows the user to automatically send control results to the
printer, the LIS or both for Chemistry QC. The screen also allows the
user to set up strip lot information and chemistry QC such as name, lot
ID, expiration date and lower and upper limit for each analyte.
1. Select the destination for QC results to be sent automatically for

Chemistry QC.
NOTE: Both the Printer and LIS checkboxes can be selected as

automatic release destinations for results.
2. Click on Chemistry QC Settings button.

3. Fill in the lot ID and expiration date for the chemistry test strips.
4. Click on Next.
5. Fill in the name of control material, lot ID, expiration date. Select the
lower and upper limits for each analyte listed.
NOTE: The lower and upper limits should be selected by using the pull
down buttons only. Do not type any values in the lower and upper limits
fields.

3 Setup
6. Color and Clarity are not applicable.
7. After completion, click OK.
8. The chemistry settings screen will appear.
9. Repeat the process for your second control, using the next button.
10. Enter the acceptable range for each analyte for that control.
11. After setting up all the controls, exit the screen by clicking OK.
REF Override Settings


3 Setup
Specimen Settings
The Specimen screen allows the user to flag barcode scan failures, and
to skip the specimen if the barcode reader fails to read the barcode label
located on the sample tube.
Flag Barcode scan failures

1. If checked, barcode scan failures will be flagged as ID_ERROR.
2. If unchecked, the condition will not be flagged and the specimen will
be assigned an identifier consisting of underlines. If unchecked, “Skip
specimen if ID scan fails” will be also unchecked. This option is not
compatible with Manual Orders.
Skip Specimen if ID scan fails

If checked, the specimen will not be sampled for chemistry if the barcode
reader cannot read the barcode label.

3 Setup
Release Settings
The Release screen allows the user to select the destination for the
release of results.
1. Check the destination for the release of results.

2. Click OK to validate the selection and close the screen.
NOTE: Both the Printer and LIS checkboxes can be selected as the
release destinations for results.

3 Setup
Urine Gating Settings

Urine Auto-Release Settings

Urine Auto-Classify Settings


4 Specimen Processing
Logon .............................................................................................................................. 58
Specimen Preparation..................................................................................................... 60
Specimens at Room Temperature............................................................................... 60
Gross Hematuria ......................................................................................................... 60
Very Dense or Viscous Specimens ............................................................................. 60
Specimen Volume ....................................................................................................... 60
Sample Tube Specifications............................................................................................ 61
Preparing Sample Racks ................................................................................................ 62
Barcode Labels............................................................................................................ 62
Manual Orders ................................................................................................................ 63
Accessing Manual Orders ........................................................................................... 64
Entering Manual Orders .............................................................................................. 65
Clearing Specimen Information ................................................................................... 66
From the Manual Orders screen .............................................................................. 66
From the Instrument screen ..................................................................................... 66
Running Samples ............................................................................................................ 67

Logon
The Logon button is located on the top right side of the Instrument
screen. Until someone is logged on, the Specimen, Worklist and
Instrument buttons are inactive.
Logon button
1. Click Log On. The Log On screen appears.

2. Type the user name in the Identifier field or use the drop down
browser on the right side of the field to display and select the user
name.
3. Type the user password in the Password field.
4. Click OK to logon.

Specimen Preparation
Use only fresh urine specimens, as defined in CLSI (Clinical and
Laboratory Standards Institute) GP16-A2 Urinalysis and Collection,
Transportation, and 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 an hour after collection, cap the container tightly and
store at 2-8o C. Bring the specimen to room temperature before testing.
Mix specimen well before testing.
Do NOT add disinfectant or detergent to the specimen.
Keep specimens out of direct sunlight.
Do NOT centrifuge urine specimens.
Specimens at Room Temperature

The specimen should always be tested at room temperature. If the
specimen temperature is outside this range, the specific gravity as
indicated may be inaccurate. Allow all refrigerated specimens to return to
room temperature before testing.
Gross Hematuria
Use manual methods.
Very Dense or Viscous Specimens

Use manual methods.
Specimen Volume
Specimen volume for analysis by the iChemVELOCITY alone should be
at least 2 mL.

Sample Tube Specifications

Dimensions: 16mm X 100mm glass or polystyrene plastic tubes.
Examples of tubes that may be used and their maximum volumes
Total Tube Type of Tube Maximum

Volume (mL) Allowable Volume
without Spillage
15 mL Fisherbrand Borosilicate 12 mL
Culture Tubes
9.5 mL Urine collection Conical Base 7.5 mL
Tubes with no stabilizer,
(Greiner Bio-one)
15 mL Hycor KOVA Tubes, Hycor 12 mL
Biomedical Inc.
8 mL BD Vacutainer® UAP Plus 6 mL
Tubes
10 mL BD Vacutainer® UAP Plus 8 mL
Tubes without preservative,
round botton

Preparing Sample Racks

Barcode Labels
7. Apply barcode labels to sample tubes,
placing the start of the barcode (not
the barcode label), approximately ½
inch below the top of a 16x100mm
tube or just below the flare of a Kova
or Kova-like tube.
8. Transfer at least 2.0 mL of well mixed, Backside of sample rack
native urine into the barcoded tubes.
You may add more if needed, but do not exceed the maximum
volume indicated based on the tube type.
9. Place the barcode labeled tubes in the sample racks.
Barcode Labels
Barcodes accepted are Code 128, Code 39, Codabar and Interleaved 2
of 5 (I 2 of 5).
NOTE: Make sure the barcode labels are properly oriented in the rack.
The sample tubes must be placed straight and resting in the middle of the
grommets located in the base of the rack.

Loading Urine Chemistry Strips

NOTE: In order to preserve the on-board stability of the chemistry strips, Iris
Diagnostics recommends discarding strips still present into the Strip Provider
Module before refilling or wait until the Strip Provider Module is empty.
Strip Provider Module not Empty

CAUTION: Access to the Strip Provider Module has changed; see the
Addendum, Accessing the Strip Provider Module.
If test strips are present inside the Strip Provider Module, they need to be
removed. If the Strip Provider Module is
empty, proceed to the next step.
1. Open the system front and right side
Locking pin
doors to access the Strip Provider
Module.
2. Pull the knob to disengage the
module, and then pull the locking pin
to open the top access door. Knob
3. Remove and discard all chemistry
test strips present inside the module.
4. Close the top door and then pull the
knob to re-engage the Strip Provider Module in place.
5. Close the front and left side doors.
6. When the Strip Provider Module is empty, proceed as indicated
below.
Test Strip Loader
Strip Provider Module Empty
1. Pull out the Test Strip Loader.
2. Remove and discard the old desiccants and
replace with the new ones provided with the
chemistry strip vial.
3. Load the urine chemistry strips inside the Test
Strip Loader as indicated on the Test Strip
Loader (Iris logo facing the back of the
loader.)
4. Push the Test Strip Loader back inside
the system.
5. Rotate the Test Strip Loader 180
degrees so that the chemistry strips drop
inside the Strip Provider Module. Rotate the Test Strip Loader back
180 degrees so that the desiccants are facing the Strip Provider
Module (down).

Manual Orders
When an LIS is not available for any reason, this function allows the user
to manually enter a Work List for chemistry.
Accessing Manual Orders

1. To access the Manual Orders Menu, click on Instrument on the top
right side of the main screen.
2. Click on the Manual Orders button located on the lower left side of the
Instrument screen. The Manual Orders screen will be displayed.

Entering Manual Orders

1. Select the first rack number to be used.
2. Enter the specimen information:
a. Specimen Identifier
Patient ID can be entered in this field. If a barcode label is
present on the tube, the results will be displayed with the
information from the barcode. The Work Order option will
change to "Run".
b. Fluid Type - select URN.
c. Dilution - not available for the iChemVELOCITY.
d. Work Order - default No Order
• No Order
The sample will be processed according to the user
defined criteria.
3. When the specimen information is entered, place the sample tube into
the corresponding position of the selected sample rack.
4. Repeat for each specimen to be run for the selected sample rack.
5. If more than one rack is to be run, select a new rack number and then
enter the specimen information.

6. Click OK to save the manual entries only or click OK & Print to save
the entries and print a report.
7. The rack numbers for which a manual order has been requested will
be flagged with an asterisk and highlighted by color on the Manual
Orders screen and will be displayed on the Instrument screen.
Clearing Specimen Information

From the Manual Orders screen
Clear Rack button
When analysis of the last specimen for a specific rack is completed
(status is processed), select the rack on the Manual Orders screen and
then click Clear Rack to clear all specimen information entered for the
selected rack.
Clear All button

When analysis for all sample racks are completed, click Clear All to clear
all specimen information for these racks.
From the Instrument screen

When analysis for all Manual Orders sample racks are completed, click
the Clear All button on the Manual Orders line to clear all specimen
information for these racks

Running Samples
NOTE: If a QC run fails, the system will not allow the operator to run
specimens. The QC run should be repeated and be successful before
running patient specimens.
CAUTION: The instrument should be allowed to warm up for 10 minutes if

it was turned off for more than 6 hours.
1. Ensure that sufficient supplies and consumables are available to

complete the anticipated workload.
2. Run the QC Rack on the iChemVELOCITY. See Running QC
section.
3. While the controls are running, transfer patient specimens into
barcode labeled tubes and place the tubes into the sample rack(s).
4. When QC results are satisfactory for both instruments, place the
sample racks containing specimens on the right side of the
iChemVELOCITY Sampler.
5. If the iChemVELOCITY is in Standby (green light lit), press the
START button.
6. If the iChemVELOCITY is in Measure (blue light lit), block the sensor
at the front of the Sampler (nearest to the operator), and the rack will
move to the sampling position automatically.
Consumables or Part Replacement

REF Number Description
800-7204 iChemVELOCITY Urine Chemistry Strips

800-7704 iChem Wash Solution 7 liters container
800-7702 IRISpec CA/CB/CC Controls
800-7703 iChem CalChek Kit

5 Quality Control
Quality Control ................................................................................................................ 69

Control Material ............................................................................................................... 69
Handling QC Material .................................................................................................. 69
Control Frequency........................................................................................................... 69
Running QC .................................................................................................................... 70
Reviewing Quality Controls Results ................................................................................ 71
Print List button............................................................................................................ 72
Re-Report button ......................................................................................................... 72
Remove ....................................................................................................................... 72
Search button .............................................................................................................. 73
Lot field .................................................................................................................... 73
Type field ................................................................................................................. 73
Status field ............................................................................................................... 73
Date-time combo-box............................................................................................... 73
Save Button ................................................................................................................. 74
Saving all QC Results .............................................................................................. 74
QC Statistics ................................................................................................................... 74

5 Quality Control
Quality Control
NOTE: If a QC run fails, the system will not allow the operator to run
specimens. The QC run should be repeated and be successful before
running patient specimens.
Control Material
The condition and accuracy of the system can be checked by performing
Control Measurements using Urine Control CA/CB/CC (REF 800-7702).
The iChemVELOCITY supports the use of three (3) control solutions (CA,
CB and CC) to validate the positive responses for each urine chemistry.
Handling QC Material
These products should be refrigerated for long-term storage. After
opening, these products should be stored between 2° to 8°C
(refrigeration). Consult the package insert for more information.
Control Frequency
All controls should be run at least once every 24 hours or as specified in
the Laboratory’s QC Procedure manual.

5 Quality Control
Running QC
Items required: Urine Control CA/CB/CC (REF 800-7702), Control Rack,
sample tubes, protective gloves.
CAUTION: Tubes positions have changed; see the Addendum, Running

QC.
7. Make sure there are enough Test Strips in the Test Strip Provider.
8. Prepare Control Tubes according to the directions on the package
insert.
9. Place the controls in the following positions onto the Control Rack:
Position Insert Volume Contents Function Barcode

Color
5 Blue 3 mL CA Control Primary control No
6 Green 3 mL CB Control Primary control No
7 Red 3 mL CC Control Primary control No
8 Blue 3 mL CA Control Secondary control in parallel No
9 Green 3 mL CB Control Secondary control in parallel No
10 Red 3 mL CC Control Secondary control in parallel No
10. Place the rack on the Sampler.

11. Press the START button. The system detects the Control Rack and
displays the position number.
12. When Control testing is completed, the results are printed and/or
transmitted to the LIS depending on the user configuration (consult
QC Settings.)

5 Quality Control
Reviewing Quality Controls Results

1. Click Instrument.
2. Click Quality Review. The Quality Review screen is displayed.
3. Data can be sorted by clicking on a column header. A repeat click will

toggle between ascending (Δ) and descending (∇) order. The default
is Date/Time – ascending order.
4. The Quality Control report can be reviewed by highlighting the desired
ID and by clicking on Re-report. A screen will appear where the QC
report destination can be selected (i.e. printer, LIS, or both). The
report will consist of Control name, system identifier, analysis time
stamp, report time stamp, rack position, lot ID, Control expiration date,
test strip lot ID, test strip expiration date and status (pass/fail). The
report will also indicate the results for all the analytes, lower and
upper limit of acceptance and status (pass/fail). The overall status will
be indicated as fail if any of the analytes has failed.

5 Quality Control
Print List button

Clicking Print List will print all the QC results on the list.
Re-Report button
Select a row and click Re-Report. The Re-Report screen appears.
Remove
The Remove button allows a manager to remove a known human error.
The user with manager status logged in at the time is documented and
the reason for removal should be documented.
1. Select the result to be removed and then click the Remove button.
The Comment screen will appear.
2. A comment must be entered before validation of the removal by
clicking the OK button.
3. After selecting OK, the status will be changed to reflect the fact that
the result has been removed and is no longer included in the
statistics. During the process of removing QC data, the Remove
button changes to Restore to allow restoring the removed QC data.

5 Quality Control
Search button
The Search button allows access to the Quality Search screen. The
user can search the QC database using specific criteria.
Chemistry button searches for chemistry controls.

Lot field
Displays the control lot information.
Type field
Displays the control type (CA/CB/CC, Specific Gravity/Color-Clarity and
Reflectance.)
Status field
Displays the status (passed-failed).
Date-time combo-box
Check Use Date-time to display the From and To dropdown boxes
available for selection.
Select the specific criteria for the Search, and then click OK to display the
results.

5 Quality Control
Save Button
This option allows the operator to save QC results for long term storage in
HTML format, which can be opened and saved on virtually any computer.
Saving all QC Results
1. Click Instrument.
2. Click Quality Review. The QC Review screen is displayed.
3. Click the Save button, a standard save Windows popup is displayed.

4. Select the destination:
• C:/ hard drive
• E:/ USB drive
5. Select the folder, and then type the name for the file to be saved.
Click the Save button.
QC Statistics
QC statistics are not available for the chemistry quality control results.

6 Calibration Verifications
Auto-Calibration .............................................................................................................. 76
Calibration Check Material .............................................................................................. 76
Reflectance CalChek test strips .................................................................................. 76
Specific Gravity CalChek solutions.............................................................................. 76
Color CalChek solutions .............................................................................................. 76
Clarity CalChek solutions ............................................................................................ 76
Storage and Use ............................................................................................................. 76
CalCheks Frequency....................................................................................................... 76
Running CalChek ............................................................................................................ 77
Reflectance CalChek ................................................................................................... 77
Specific Gravity, Color, and Clarity CalChek ............................................................... 83

Auto-Calibration
A fixed internal standard, located within the Strip Reader Module, is used
to perform an auto-calibration each time the system is powered. If the
auto-calibration is successful, the system goes into Ready mode.
Calibration Check Material

Reflectance CalChek test strips
Five (5) CalChek Strips have fixed calibration values with no lot specific
data.
CAUTION: CalChek strips and CalChek solutions are SINGLE USE

ONLY. Using the CalChek strips again will cause the reflectance CalChek
to fail.
CalChek Reagents
Specific Gravity CalChek solutions
Three (3) SG CalChek solutions are straw in color and have specific
gravities of 1.002, 1.030, and 1.060.
Color CalChek solutions
Four (4) color controls are colorless, straw, normal yellow, and normal
amber. All color controls are non-turbid.
Clarity CalChek solutions
Three (3) clarity controls are all straw in color, with the following clarities:
hazy, slightly cloudy, and cloudy.
Storage and Use

Consult the package insert for more information concerning the storage
and use of the products.
CalCheks Frequency
CalCheks should be performed monthly on the iChemVELOCITY system.
If the instrument was moved, a CalChek should be performed to make
sure that the instrument is properly calibrated.

Running CalChek
Reflectance CalChek
The Reflectance is the measure of LED illumination light reflected from
the chemistry pads.
In this mode, the instrument directs the operator to remove all chemistry
test strips from the Strip Provider Chamber and to place all five CalChek
Strips into the Strip Provider chamber. The CalChek strips are
automatically loaded into position in the Strip Reader Module and the
dosing step is bypassed. The measured reflectance values are
compared to an acceptance range and if the values fall within that range,
the CalChek is verified and found acceptable.
NOTE: Since the test strips remaining inside the test strip chamber must
be discarded, it is recommended to perform a reflectance CalChek when
the chamber is empty.
1. Click on the Instrument button on the top right side of the main
screen.
2. Click on the Maintenance button located at the bottom of the
Instrument screen. The Maintenance screen is displayed.

3. Click on the Reflectance Check button. The system will display a
series of six screens. Follow the instructions on the screens.
NOTE: The CalChek procedure can be stopped by pressing the Cancel

button when available on a calibration check screen.

4. If needed, access the test strip provider. Remove and discard all
chemistry test strips present inside the chamber.
5. Pull the test strip loader out of
the system. Load the CalChek
strips inside the test strip
loader, and then push the test
strip loader back inside the
system. Rotate the
test strip loader Test Strip
180 degrees to Loader
transfer the strips Test Strip
to the test strip Provider
provider.

6. Verify that the Lot ID number and the expiration date from the
CalChek strip container match the data from the screen. Modify if
necessary.


7. Pull the test strip loader out of
the system. Load the test strips
and the desiccant inside the test
strip loader, and then push the
test strip loader back inside the
system. Rotate the Test Strip
test strip loader 180 Loader
degrees to transfer
the strips to the test Test Strip
strip provider. Provider
8. Press Finish to return
to the Chemistry strip lot
information screen. Check the
information related to the
loaded test strips, modify if necessary.
9. The reflectance CalChek results can be reviewed in the Quality
Review screen.

Specific Gravity, Color, and Clarity CalChek

Pos
Contents Value Barcode
#
1 Specific Gravity CalChek solution 1.002 +/- 0.003 Y
2 Specific Gravity CalChek solution 1.030 +/- 0.005 N
3 Specific Gravity CalChek solution 1.060 +/- 0.005 N
4 Color CalChek solution Colorless Y
5 Color CalChek solution Straw N
6 Color CalChek solution Normal yellow N
7 Color CalChek solution Normal amber N
8 Clarity CalChek solution Hazy Y
9 Clarity CalChek solution Slightly cloudy N
10 Clarity CalChek solution Cloudy N
1. Obtain CalChek solution tubes as needed according to the table

above.
2. Gently invert the tubes one or two times to mix the solution.
3. Remove the cap from each tube, and then place the tubes on the
Calibration rack according to the table above making sure that the
barcode labels are placed at the correct positions.
4. Load the Calibration rack onto right side of the iChemVELOCITY
sampler.
5. Press START. The rack will be processed and all calculations
performed automatically.
6. When the CalChek is successful, the date/time of the new SG/CC
CalChek will be displayed on the shift summary screen.
7. The SG/CC CalChek status (Pass/Fail) can be reviewed in the QC
Review screen.
8. The measured values are compared to acceptance ranges stored in
the system. If all the values fall within the appropriate ranges, the
CalChek is verified and found acceptable.

7 Results
Reviewing Results........................................................................................................... 85
Work List Screen ............................................................................................................. 85
Sort Work List .......................................................................................................... 86
Delete Specimen...................................................................................................... 87
Un-Delete Specimen ................................................................................................ 87
Correct Specimen ID................................................................................................ 88
Edit Demographics................................................................................................... 88
Print List ................................................................................................................... 89
Re-Report ................................................................................................................ 89
Search...................................................................................................................... 91
Flagged Specimens ..................................................................................................... 94
Review Flagged Specimen button ........................................................................... 95
Delete Flagged Specimen button............................................................................. 95
Chemistry System Flag Messages .............................................................................. 95
CHEMTRANSLATE ................................................................................................. 95
CHEM CONFIRM..................................................................................................... 95
ID_Error ................................................................................................................... 96
Insufficient Sample................................................................................................... 96
Short Sample ........................................................................................................... 96
Processing Failure ................................................................................................... 97
Processing not complete.......................................................................................... 97
Specimen Screen ........................................................................................................ 98
Accessing the Specimen Screen ............................................................................. 98
Specimen Screen Buttons ....................................................................................... 99

7 Results
Reviewing Results
Unreleased results can be reviewed using the Work List Screen.
Released results can be reviewed using the Found List Screen.
Work List Screen

To display the Work List, click on the Work List button located on the top
right part of the screen. A number in parentheses indicates the number of
specimen results available in the Work List. The Work List contains only
unreleased results. The Work List screen allows the user to quickly
identify specimens with flags or needing operator review. A vertical
scrollbar can be used if all specimen results cannot be displayed on the
screen.
1. To find a released result, click on Search and enter the search

criteria. The results will be displayed on the Found List. Clicking on
Search while the Found List is displayed will return to the Work List.

7 Results
The following descriptions apply to the Work List and the Found List.
• Specimen ID
• Date/Time of analysis
• Rack number and Tube position
• Specimen status
• Status
2. To review a specimen, double click the specimen row or select the

row and click the Specimens button.
Sort Work List

The work list can be sorted by Specimen ID, Date/Time of analysis, Rack
number and tube position, or Specimen status in ascending or
descending order. Sorting can be done by using the Sort Work List
button or by clicking on the header.
NOTE: The header of the column selected as “sort criteria” displays

ascending U or descending V order. Double click on the header of the
desired criteria to change the sort criteria or reverse the order.
1. Click the Sort Work List button. The Sort Work List screen appears.
2. Select the primary sort criteria.

3. Press OK. The screen closes. The Work List displays the sorted
results.

7 Results
The ascending sort order for the Status column is:
• “Flag”
• “Released” (when in the Found List only)
• Date/time
Delete Specimen
This function allows the user to delete specimen results from the Work
List or Found List depending on the status.
1. Select the specimen results to be deleted, and then click on the

Delete Specimen button.
2. A pop-up box appears prompting you to confirm the deletion.
Click Yes.
3. The specimen results are removed from the Work List. They are
transferred to the Delete list where they are stored until the
system deletes them on a first in first out basis.
Un-Delete Specimen
This function allows the user to restore deleted specimen results to the
Work List.
1. Click on the Un-Delete Specimen button. The Un-Delete Specimen

screen appears. Specimen results are displayed on this screen in a
strict time order, oldest at the top.

7 Results
2. Select the specimen results to be restored. If multiple results need to

be restored, hold the Shift key on the keyboard and left-click on the
results.
3. When all the required results are selected, click OK.
Correct Specimen ID
This function allows a manager to correct a specimen ID that did not have
an ID error. Any logged-in user can correct the ID of a specimen with an
ID error.
Edit Demographics
If a specific demographic is missing (see Obtain Patient Demographics
Information from LIS), the specimen will be processed and the result will
be flagged on the Specimen screen. Even if the Demographics option
was not required from the LIS, a user will be able to add or edit data to all
demographics fields.
1. Select the specimen results to be edited, and then click on the Edit
Demographics button. The Edit Demographics screen will be
displayed, and the header will include the specimen ID, run date/time,
and rack number/ position.

7 Results
2. Enter the desired patient demographics, and then click OK. The
patient demographics will be displayed on the Specimen screen,
printed on the printout reports, and transmitted to the LIS.
Print List
Clicking the Print List button prints the entire Work List.
Re-Report
The Re-Report function, enabled on the Found List only, allows the user
to select a destination to re-report specimen results already released.
NOTE: Only released specimen results can be re-reported.
1. Select the row for the specimen results to be re-reported.

2. Click the Re-Report button. The Re-Report screen appears.

7 Results
3. Make the row selection (current row or all rows).

4. Select the re-report destination (more than one destination can be
selected.)
5. Click OK to re-report the results and close the screen.

7 Results
Search
The Search function allows the user to search the archived specimen
results for specific data.
1. Click the Search button. The Search screen will be displayed.
Search by specimen ID
1. To search specimens within a range:
a. Enter the first specimen ID # in the From edit box.
b. Enter the last specimen ID # in the To edit box.
c. Click OK.
2. To search for a specific specimen #:

a. Enter the specimen ID # in the From edit box.
b. Click OK.

7 Results
Search by Operator ID
1. To search specimens released by a specific operator:
• Use the pull down button to select the operator ID.
• Click OK.
2. To search specimens released for all operators:
• Leave the field blank to obtain a complete search.
1. Click OK.
Search by date-time (range)
1. Check the “Use date-time” check box.

2. To search specimens within a range:
a. Enter the date or click on the down arrow and select a date from
the calendar.
b. Click on the hour and use the arrows to change. Minutes and
seconds can be done the same way.
3. Click OK.

7 Results
Search by Demographics
1. To search specimens with a specific last name:

a. Enter the last name in the first edit box.
b. Click OK.
2. To search specimens with a specific first and last name:
a. Enter the last name in the first edit box.
b. Enter the first name in the first edit box.
c. Click OK.
3. To search specimens within a specific last name range:
a. Enter the initial last name in the first edit box.
b. Enter the final last name in the To edit box.
c. Click OK.
4. To search specimens within a specific first name range:
a. Enter the initial first name in the first edit box.
b. Enter the final first name in the To edit box.
c. Click OK.
5. To search specimens within a combination of first and last names:
a. Enter the initial last name in the first edit box.
b. Enter the final last name in the To edit box.
c. Enter the initial first name in the first edit box.
d. Enter the final first name in the To edit box.
e. Click OK.
Show specimens awaiting transmission only
This option can be combined with the other search options.
1. Click the checkbox to restrict the search to results pending
transmission.
2. Click OK.
Show released specimens only
This option can be combined with the other search options
1. Click the checkbox to restrict the search to released specimen.
2. Click OK.

7 Results
Flagged Specimens
On the Work List screen, flags will be indicated in the Status column.
To view the flag condition, double-click on the flagged specimen’s row.
The Specimens screen is displayed and the flags are indicated.
Flag
Flags appear in the right side of the Specimen screen. There are two
types of flags: recoverable and non-recoverable.
If a flag is recoverable, the Review Flagged Specimen and the Delete

Flagged Specimen buttons will be displayed. After clicking on the Review
Flagged Specimen and Accept buttons, the Specimen Results screen will
refresh. If the results match the auto-release criteria, they will be
automatically transmitted to the printer and/or LIS after the flag is cleared.
If a flag is non-recoverable, only the Delete Flagged Specimen button will

be displayed. The cause of the flag will need to be resolved before the
specimen can be run again.

7 Results
Review Flagged Specimen button
1. Press Review Flagged Specimen to prepare the specimen to have its
flag cleared.
2. Press Accept to clear the specimen flag.
Delete Flagged Specimen button
1. Press Delete Flagged Specimen to prepare the specimen to be
deleted.
2. The Task information indicates that clicking Accept will delete the
specimen.
3. Press Accept to delete the specimen results.
Chemistry System Flag Messages
CHEMTRANSLATE
One or more chemistry names or result received from the
iChemVELOCITY do not match the expected name or result (data
entered in the input settings). DO NOT change chemistry input values
without assistance from Iris Clinical Support or your authorized distributor.
The results presenting this flag are displayed in italics.
Remedies
1. Make sure the displayed results are valid values.
2. Check the setup map for the specific chemistry. Add that value if
valid.
3. If the result is valid, but the map settings were wrong, clear the flag
and accept.
CHEM CONFIRM
One or more of the chemistry results exceeded the user-defined
confirmation threshold. The results that met or exceeded the confirmation
threshold will be displayed in italics on the Results screen.
Remedies
1. Clear the flag.
2. Confirm the results according to Laboratory Protocol.
3. The confirmation results may be added in the Edit Comment box, if
desired.

7 Results
ID_Error
The barcode reader was not able to read the barcode label.
Remedies
1. From the Work List screen, double-click on the specimen to open the
Specimen Review screen.
2. Click on the Review Flag Specimen button, the Edit Specimen
Identifier screen appears.
3. Enter the specimen ID in the Specimen identifier edit box.

4. Click OK. The screen closes and the Specimen screen displays the
new specimen ID.
5. Click Accept to clear the ID flag and refresh the screen.
Insufficient Sample
There was not enough control material in the one of the control tube
present on the control rack.
Remedies
1. Reject the flag to remove the results from the Work List.
2. Refill the control rack with tubes containing at least 2.0 mL of control
material.
3. Re-run the control rack.
Short Sample
There was not enough specimen in the sample tube.

7 Results
Remedies
2. Refill the sample tube with at least 2.0 mL of specimen.
3. Re-run the specimen.
Processing Failure
The system has detected an internal error. If the error is recoverable, the
instrument continues processing strips that are already dosed.
Remedies
2. Refill the sample tube(s) with at least 2.0 mL of specimen.
3. Re-run the specimen(s).
Processing not complete

The system has detected an internal irrecoverable error.
The instrument stops processing new specimens and raises an audible

and/or visual alarm to signal a problem, and displays a message
indicating that an unrecoverable error has occurred.
The system flags the remaining specimens in process with “Processing

not complete” flags and for each one indicates the specimen ID, rack ID,
tube position, Operator, and Flag on the Work list.
Remedies
2. Refill the sample tube(s) with at least 2.0 mL of specimen.
3. Re-run the specimen(s).

7 Results
Specimen Screen
Accessing the Specimen Screen
From the Work List screen, double-click on the specimen’s row or select
the specimen and then click the Specimen button.
The following data are included in the Chemistry report:
• Specimen ID and Patient Demographics (if enabled).

• Operator ID: the logged in user that last released the specimen
results will be displayed.
• Analysis Time Stamp: time at which the instrument read the
barcode label.
• Rack number and position number
• Chemistry results.
• Comment, if one was entered by the operator.
• Active/cleared flag, if any.
• Audit Trail: This field lists the operator's login ID that has saved
the edits for the specimen, and the date and time at which this
happened. The most recent user is located at the top of the list.

7 Results
Specimen Screen Buttons
Delete Flagged Specimen
See Delete Flagged Specimen.
Review Flagged Specimen
See Review Flagged Specimen.
Accept
Click Accept to validate an option for flagged specimens.
Skip
Skip the displayed specimen results, and displayed the next results
available on the Work List.
Instrument
Click the Instrument button, to return to the Work List screen.
Interferences
Certain drugs may cause incorrect clarity results.
High levels of ascorbic acid (Vitamin C) may falsely lower results for
Glucose and Blood.

8 Maintenance and Service
Maintenance.................................................................................................................. 101
Precautions................................................................................................................ 101
Consumable Replenishment ..................................................................................... 101
Periodic Maintenance ................................................................................................ 101
Discarding Liquid Waste ........................................................................................ 103
Cleaning the Sample Transport Module ................................................................ 104
Cleaning the Optional Load/Unload Trays ............................................................. 104
Cleaning the Instrument Surfaces.......................................................................... 104
Consumable Replacement ........................................................................................ 105
Replacing Wash Solution ....................................................................................... 105
Weekly Maintenance ................................................................................................. 106
Cleaning the Strip Provider Module ....................................................................... 106
Monthly Maintenance ................................................................................................ 108
Perform Reflectance CalChek ............................................................................... 108
Perform SG/CC CalChek ....................................................................................... 108
Cleaning the Wash Station Bath ............................................................................ 108
Cleaning the Strip Conveyor Module ..................................................................... 109
Replacing Wash Solution Filter .............................................................................. 111
Cleaning the Sample Tube Detector ...................................................................... 112
Cleaning the Barcode Reader Window .................................................................. 112
Cleaning the Optical Sensors on the Sample Transport Module ........................... 113
Preparation for Long-Term Shutdown ........................................................................... 114
Start-up after Long-term Shutdown ........................................................................... 114
Prime the System Lines ......................................................................................... 115
Run CalChek.......................................................................................................... 115
Run Control Rack................................................................................................... 115
Accessing the Maintenance Menu ................................................................................ 116
Tallies ........................................................................................................................ 117
Shutting Down the Instrument ................................................................................... 118
Maintenance Log........................................................................................................... 119

Maintenance
Precautions
WARNING: Observe Universal Precautions. Discard contaminated

materials according to applicable regulations.
Daily Maintenance
Items Suggested Intervals
Emptying and cleaning the Waste Daily
Container
Discarding Liquid Waste Daily
Cleaning the Sample Transport Daily
Module
Cleaning the Load/Unload Trays Daily
Cleaning the Instrument Surfaces Daily
Consumable Replenishment
Replacing Wash Solution After 600 Tests or weekly
Periodic Maintenance
Cleaning the Strip Provider Module Weekly or every 1,200
specimens
Perform Reflectance CalChek Monthly see Reflectance
CalChek
Perform SG/CC CalChek Monthly see Specific Gravity,
Color, and Clarity CalChek
Cleaning the Wash Station Bath Monthly
Cleaning the Strip Conveyor Module Monthly

As Needed Maintenance
Replacing the Wash Solution Filter As Needed
Cleaning the Sample Tube Detector As Needed
Cleaning the Barcode Reader Window As Needed
Cleaning the Optical Sensors on the As Needed

Sample Transport Module

Daily Maintenance
WARNING: Wear protective gloves to prevent exposure to pathogens.

Discard contaminated materials according to applicable regulations.
Items required: Alcohol, paper towels, protective gloves.
1. Open the waste container door.

2. Remove the waste container and
discard used test strips according to
local regulations.
3. Clean the waste container with
alcohol, and then rinse with tap water.
4. Thoroughly dry the waste container.
5. Reinstall the waste container.
6. Close the waste container door.
Discarding Liquid Waste

WARNING: Dispose of waste product, unused product and contaminated

packaging in compliance with applicable legal regulations. If unsure of
the applicable legal requirements, contact the local authorities for
information.
This procedure is not required if the instrument is connected to a

drain.
Items required: Mild detergent, protective gloves.
1. Remove the drain bottle cap and tubing from the drain bottle.
2. Discard the liquid waste.
3. Clean the drain bottle with a mild detergent and water, and then rinse
with tap water.
4. Insert the drain tube into the drain bottle and tighten the cap.

Cleaning the Sample Transport Module

Items required: Alcohol, lint-free tissue and protective gloves.
1. Moisten a tissue with the alcohol and wipe the Sample Transport
Module to remove any deposits. Check under the belts and the
pulleys.
2. Wipe again using distilled water.
3. Wipe dry.
Cleaning the Optional Load/Unload Trays

1. Moisten a tissue with the alcohol and wipe the Load/Unload

Stations to remove any deposits. Check under the belts and the
pulleys.
3. Wipe dry.
Cleaning the Instrument Surfaces

1. Moisten a tissue with the alcohol and wipe the instrument to

remove any deposits.
3. Wipe dry.

Consumable Replacement
Replacing Wash Solution
After 600 Tests or weekly
Items required: iChem Wash Solution (REF: 800-7704)
1. The system signals when the Wash

Solution level is low.
2. Make sure the system is in Standby
mode, as indicated on the top left of
the instrument screen.
3. Remove the cap of the wash solution
bottle.
4. Insert the tubes into the wash solution
bottle and tighten the cap.

Weekly Maintenance
Cleaning the Strip Provider Module
NOTE: This procedure should be performed weekly or every 1,200

specimens.
CAUTION: Access to the Strip Provider Module has changed; see the
Addendum, Accessing the Strip Provider Module

Items required: Paper towels, protective gloves, and eye protection.
1. Make sure the System is in Standby

screen.
3. Click on the Go off line button. The system status will change to Off
Line.
4. Turn the power off by pressing the green button located on the left
5. Open the system front and right side

doors to access the Strip Provider
Locking pin
Module.
6. Pull the knob to disengage the

module, and then pull the locking pin
to open the top access door. Knob
7. Remove and discard all chemistry

test strips present inside the module.
8. Using a dry paper towel, wipe the inside of the Strip Provider Module
collecting the dust in the paper towel.

CAUTION: Use only DRY paper towel. Using a humid paper towel inside
the Strip Provider Module will affect the results of the test strips.
9. Close the top door and then pull the knob to re-engage the Strip
Provider Module in place.
10. Close the front and left side doors.
Line.
13. Let the system warm up for 10 minutes before resuming operation.

Monthly Maintenance
Perform Reflectance CalChek
See Reflectance CalChek.
Perform SG/CC CalChek

See Specific Gravity, Color, and Clarity CalChek.
Cleaning the Wash Station Bath

Items required: Deionized water, cotton swabs and protective gloves

2. Click on the Instrument button on the top right side of the main screen.
3. Click on the Go off line button. The system status will change to Off Line.
5. Open the front door to access the wash station bath.
6. Using a cotton swab moistened with deionized water,

remove salt deposits present on the wash bath.
CAUTION: Do not insert the cotton swab inside the wash tube; cotton
particles may clog the tubing connectors.

Line.

Cleaning the Strip Conveyor Module
CAUTION: Access to the Strip Conveyor Module has changed; see the
Addendum, Accessing the Strip Conveyor Module.


screen.
Line.
5. Open the front and right side door.
6. Loosen the thumbscrew located on the front, bottom left of the safety
shield, then tilt the safety shield to the right.
7. Tilt the wash station to the left until it is in horizontal position. This will
raise the Strip Provider Module.
8. Pull out and then push down the blue latch securing the Strip
Conveyor.
9. Pull the handle to remove the Strip

Conveyor Module from its location.
10. Dip the Strip Conveyor Module into

warm soapy water.
11. Rinse under tap running water while

turning the knob to rotate the links.

12. Shake off any excess water and wipe
using lint-free tissue.
13. Replace the Strip Conveyor Module

by pushing it inside the system.
14. Replace the blue latch to secure the

strip conveyor handle.
15. Lift the wash station back to its vertical position.
16. Close the front and side door.
Line.
19. Let the system warm up for twenty minutes before use.

As Needed Maintenance
Replacing Wash Solution Filter
Items required: Paper towels and protective gloves.
CAUTION: Wear fresh gloves when changing the Wash Solution filter.
Have a supply of paper towels to catch spills and drips.
When the “Wash Solution Container is low” message appears:
1. Remove the cap from the new container.
2. Remove the cap from the old container.
3. Attach the cap connected to the instrument to the new container.
4. 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 Wash
Solution containers. Best
practice is to change the
filter when loading the first bottle of a new case.
5. Remove the old filter by grasping the tube above the filter and
pulling the filter straight off.
6. Remove the new filter from its package and push straight onto the
tube. The filter only goes on one way, with the narrow section
going into the tube.
7. Do not mix the contents of the bottles.
8. Dispose of the old container.

Cleaning the Sample Tube Detector

Items required: Deionized Water, cotton swabs and protective gloves.
This should be performed only if the detector is missing tubes. Contact

Technical Services or your authorized distributor before cleaning the
window.
1. Make sure the instrument is in

Standby mode, as indicated on the top
left of the instrument screen.
2. The tube detector window is located

on the front side of the tube
detector.
3. Using a cotton swab moistened with

deionized water, wipe the sample
tube detector. Dry using a clean
cotton swab.
Cleaning the Barcode Reader Window

Item required: Deionized water, lint-free tissue, and protective gloves
Contact Technical Services before cleaning the window.


screen.
Line.
5. Open the front door to access the barcode reader.
6. Using tissue moistened with deionized

water, wipe the barcode reader
window. Dry using a clean tissue.
8. Turn the power on by pressing the

green button located on the left side of
the chemistry system.

Line.
Cleaning the Optical Sensors on the Sample Transport

Module

Items required: Deionized water, cotton swabs and protective gloves.
1. Make sure the instrument is in

Standby mode, as indicated on the
top left of the instrument screen.
2. Using a cotton swab moistened with deionized water, wipe the

optical sensors located on the front right and back left corners of
the sampler.
3. Dry using a clean swab

Preparation for Long-Term Shutdown

If the system is not used for more than a week, crystal formation may
occur that can cause damage.

1. Clean the Wash Station Bath, see Cleaning the Wash Station Bath.
2. Perform Daily Maintenance, see Daily Maintenance.
4. Turn off the power by pressing the main power switch located on the
back of the chemistry system.
Start-up after Long-term Shutdown

After long term shutdown (over one week), follow the instructions below
before using the system:
1. Turn on power using the Main power switch on the back of the
system.
2. Wait until the Instrument screen is displayed. Make sure the status on
the top left corner of the screen is “OFF”.
3. Press the green ON/OFF button on the front of the system. The status
should change to Standby.
4. Logon to the system.

NOTE: Verify the system is in Standby mode as indicated by a status light

(green) on the instrument and displayed on the top left side of the screen.
5. After startup, the wash solution bottle located inside the system will
refill automatically.
Prime the System Lines

1. Place three tubes in the first three positions of the Control rack. Fill
each tube with Iris Diluent.
2. Run the Control rack twice to prime the internal lines.
Run CalChek
See Running CalChek.
Run Control Rack

See Running QC.

Accessing the Maintenance Menu

From the Instrument screen, choose Maintenance.
Maintenance options:
• Reflectance Check: Allows an operator to run a Reflectance

Calibration Check (see Reflectance Cal-Check.)
• iChem® 200 Service: This option is reserved for Service
Technicians only.
• Backup: This option is not available when the instrument is setup
as standalone.
• Restore: This option is not available when the instrument is setup
as standalone.
• System Info: Describes the version of software currently loaded on
the instrument.
• Tallies: Allows the user to select a data range for the tally. The
default is the last full month. Provides a record of tests performed.
• Errors: User accessible Error Log of Chemistry Errors.
• Shutdown: after going off line, allows the operator to shutdown the
system.

Tallies
This option allows the user to obtain detailed information concerning the
number of tests and controls run on the iQ Series system for a specific
period of time.
From the Instrument screen, choose Maintenance.

From the Maintenance screen, choose Tallies.
Enter the specific time range and then click OK.
The screen will display a report similar to the one below.

Shutting Down the Instrument

When it is necessary to restart the instrument, shut down the instrument
in the following order:
screen.
2. Click on the Maintenance button located at the bottom of the
Instrument screen.
3. Click on the Shutdown button. The system will prompt: “Do you want
to shut down the instrument?”
4. Click on the Yes button. Windows will close.
5. Turn off the iChemVELOCITY by pressing the green button at the
front middle top of the system.

Maintenance Log

9 Appendix
Performance Characteristics ......................................................................................... 121
Analytical Performance.............................................................................................. 121
Analytes Report Ranges (Includes pH and Specific Gravity) .................................... 121
Bilirubin .................................................................................................................. 121
Urobilinogen ........................................................................................................... 121
Ketones .................................................................................................................. 122
Glucose .................................................................................................................. 122
Protein.................................................................................................................... 122
Blood (Hemoglobin) ............................................................................................... 123
pH .......................................................................................................................... 123
Nitrite...................................................................................................................... 123
Leukocytes ............................................................................................................. 123
Ascorbic Acid ......................................................................................................... 124
Specific Gravity ...................................................................................................... 124
Color and Clarity Report Ranges............................................................................... 124
Colors..................................................................................................................... 124
Clarity ..................................................................................................................... 124
Sensitivity and Measurement Range ............................................................................ 125
Limitations ..................................................................................................................... 126
Specimens ................................................................................................................. 126
Gross Hematuria ....................................................................................................... 126
iChemVELOCITY Urinalysis System ............................................................................ 127
Expected Values and Ranges ................................................................................... 127
Precision .................................................................................................................... 127
Within Run Precision.............................................................................................. 127
Day-To-Day Precision ............................................................................................ 127
20-Day Day-To-Day Negative Analyte Concentrations .......................................... 127
Day-To-Day Positive Analyte Concentrations ........................................................ 128
20 Days Specific Gravity Day-to-Day Precision ..................................................... 128
Day 1 – Day 20 CC/CB/CA Control results for color .............................................. 129
Day 1 – Day 20 CC/CB/CA Control results for clarity ............................................ 130
Principles of the Tests and Limitations of the Procedure .............................................. 131
Bilirubin ...................................................................................................................... 131
Urobilinogen .............................................................................................................. 131
Ketones ..................................................................................................................... 132
Ascorbic Acid ................................................................................................................ 132
Glucose ..................................................................................................................... 132
Protein ....................................................................................................................... 133
Blood ......................................................................................................................... 133
pH .............................................................................................................................. 134
Nitrite ......................................................................................................................... 134
Leukocytes ................................................................................................................ 135
Specific Gravity.......................................................................................................... 135
Color an Clarity .......................................................................................................... 135

9 Appendix
Performance Characteristics
Analytical Performance
The system demonstrates an agreement > 95% within +/- 1 color block
with respect to results for the same specimens run on a competitive
instrument.
Analytes Report Ranges (Includes pH and Specific

Gravity)
Conventional S. I. Units Qualitative Units

Parameter
Units
Bilirubin Neg Neg Neg

0.5 mg/dL 8.5 µmol/L +
1 mg/dL 17 µmol/L
2 mg/dL 34 mmol/L ++
3.0 mg/dL 50 mmol/L
4 mg/dL 70 mmol/L
6.0 mg/dL 100 mmol/L +++
8 mg/dL 140 mmol/L
10 mg/dL 170 mmol/L
>10 mg/dL >170 mmol/L ++++
Urobilinogen Normal Normal Normal

2.0 mg/dL 34 µmol/L +
3.0 mg/dL 50 µmol/L
4.0 mg/dL 70 µmol/L ++
8.0 mg/dL 140 µmol/L +++
>12.0 mg/dL 200 µmol/L ++++

9 Appendix
Conventional S. I. Units Qualitative

Parameter
Units Units
Ketones Negative Negative Negative

- - Trace
- -
10 mg/dL 1 mmol/L +
20 mg/dL 2 mmol/L
40 mg/dL 4 mmol/L ++
60 mg/dL 6 mmol/L
80 mg/dL 8 mmol/L +++
100 mg/dL 10 mmol/L
150 mg/dL 15 mmol/L ++++
> 150 mg/dL > 15 mmol/L
Glucose Negative Negative Negative

30 mg/dL 1.7 mmol/L Trace
50 mg/dL 2.8 mmol/L
70 mg/dL 3.9 mmol/L +
100 mg/dL 5.6 mmol/L
150 mg/dL 8.3 mmol/L ++
200 mg/dL 11 mmol/L
300 mg/dL 17 mmol/L +++
500 mg/dL 28 mmol/L
1000 mg/dL 56 mmol/L ++++
> 1000 mg/dL > 56 mmol/L
Protein Negative Negative Negative

10 mg/dL g/L Trace
20 mg/dL g/L
30 mg/dL 03 g/L +
50 mg/dL 0.5 g/L
70 mg/dL 0.7 g/L

9 Appendix

Parameter
Units Units
100 mg/dL 1 g/L ++
200 mg/dL 2 g/L
300 mg/dL 3 g/L +++
600 mg/dL 6 g/L
> 600 mg/dL > 6 g/L ++++
Blood Negative Negative Negative

(Hemoglobin) 0.03 mg/dL 0.3 mg/L Trace
0.06 mg/dL 0.6 mg/L +
0.10 mg/dL 1 mg/dL
0.20 mg/dL 2 mg/L ++
0.50 mg/dL 5 mg/L
mg/dL 10 mg/L +++
>1.0 mg/dL >10 mg/dL
pH 5.0 5.0 5.0

5.5 5.5 5.5
6.0 6.0 6.0
6.5 6.5 6.5
7.0 7.0 7.0
7.5 7.5 7.5
8.0 8.0 8.0
8.5 8.5 8.5
9.0 9.0 9.0
Nitrite Negative Negative Negative
Positive Positive Positive

(0.1 mg/dL) (0.1 mg/dL) (0.1 mg/dL)
(0.2 mg/dL) (0.2 mg/dL) (0.2 mg/dL)
Leukocytes Negative - Negative

25 WBCs/µL - Trace
75 WBCs/µL - +

9 Appendix

Parameter
Units Units
250 WBCs/µL - ++
500 WBCs/µL - +++
Ascorbic Acid Negative - Negative

20 mg/dL - +
40 mg/dL - ++
Specific From 1.000 - From 1.000

to 1.060 to 1.060
Gravity
Color and Clarity Report Ranges
Colors Levels
Yellow Light Yellow, Yellow, Dark Yellow

Amber Light Amber, Amber, Dark Amber
Red Light Red, Red, Dark Red
Brown Light Brown, Brown, Dark Brown
Straw Straw
Green Green
Blue Blue
Orange Orange
Colorless Colorless
Other Other
Clarity Clear, Hazy, Slightly Cloudy, Cloudy

9 Appendix
Sensitivity and Measurement Range
Analyte Pad Analytical Sensitivity Measuring Range
Glucose 30 mg/dL 30 - 1000 mg/dL

Protein 10 mg/dL 10 - 600 mg/dL
Bilirubin 0.5mg/dL* 0.5 - >10.0 mg/dL
Urobilinogen 2 mg/dL* 2.0 – 12.0 mg/dL
pH N/A pH 5.0 - 9.0
Blood 0.02 mg/dL Hemoglobin 0.03 - 1 mg/dL
Ketones 5 mg/dL 10 - 150 mg/dL
Negative- 0.1 mg/dL-0.2
Nitrite 0.05 mg/dL
mg/dL
Leukocytes 15 WBC/ µL 25 - 500 Leukocytes/µL
Ascorbic Acid 15 mg/dL 20-40 mg/dL
Specific Gravity 1.005-1.090

9 Appendix
Limitations
Specimens
Use only fresh urine specimens, as defined in NCCLS (National
Committee on Clinical Laboratory Standards) GP16-A2 Urinalysis and
Collection, Transportation, and Preservation of Urine Specimen, good
laboratory practices and the laboratory’s procedure manuals.
Collect urine in clean containers and cap the container tightly. If a

specimen is not processed within one hour after collection, store at
2-8oC. Bring the specimen to room temperature before testing.
Mix specimen well before testing.
Do NOT add any preservative, disinfectant, or detergent to the specimen.
Keep specimens out of direct sunlight.
Do NOT centrifuge urine specimens.
Gross Hematuria
Gross hematuria may cause incorrect results in subsequent samples. Do
not test specimens exhibiting gross hematuria.

9 Appendix
iChemVELOCITY Urinalysis System

Expected Values and Ranges
See package insert for more information.
Precision
Within Run Precision
Pending final verification.
Day-To-Day Precision
Since biological solutions are traditionally unstable over time a stable
control material, IRISpec CA/CB/CC, was utilized to carry out the Day-To-
Day Precision studies. For each of three instruments IRISpec CA/CB/CC
control materials were analyzed each day using three lot numbers of
iChem VELOCITY Urine Chemistry Strips. The data represents the
aggregate of all three instruments and all three urine chemistry strip lot
numbers.
See Day-To-Day Precision Table below. NOTE: Only one of the three
controls (CA, CB or CC) produces a positive result for a particular
analyte; the remaining two controls will produce a negative result.
20-Day Day-To-Day Negative Analyte Concentrations
ANALYTE Report Agreement ±1 Report

N
Concentration Concentration
Bilirubin 692 0 mg/dL 100%
Urobilinogen 688 0 mg/dL 100%
Ketones 688 0 mg/dL 100%
Ascorbic Acid 690 0 mg/dL 100%
Glucose 692 0 mg/dL 100%
Protein 692 0 mg/dL 100%
Blood 692 0 mg/dL 100%
pH 692 <6.0 100%
Nitrite 688 0 mg/dL 100%
Leukocytes 687 0 WBC/μL 100%

9 Appendix
Day-To-Day Positive Analyte Concentrations
Report Agreement ±1
ANALYTE N Report
Concentration Concentration
Bilirubin 343 8.0 mg/dL 100%
Urobilinogen 347 16 mg/dL 100%
Ketones 347 60-80 mg/dL 100%
Ascorbic Acid 345 40 mg/dL 100%
Glucose 343 1100 mg/dL 100%
Protein 343 450 mg/dL 100%
Blood 343 1.43 mg/dL 99.7%
pH 343 >8.0 100%
Nitrite 347 0.5 mg/dL 100%
Leukocytes 347 500 WBC/μL 100%
20 Days Specific Gravity Day-to-Day Precision
Percent Coefficient
Mean Standard Deviation
of Variation
IRISpec CA = 1.009 0.00052 0.05%
IRISpec CB = 1.013 0.00063 0.06%
IRISpec CC = 1.008 0.00037 0.04%

9 Appendix
Day 1 – Day 20 CC/CB/CA Control results for color

The color measurement day-to-day precision of the iChem VELOCITY
over a wide dynamic range is demonstrated using CA, CB, and CC
controls, which are dark amber, light yellow, and straw (or colorless to
some observers), respectively.
CA CB CC
DARK % LIGHT % %
Samples Total AMBER Agreement Total STRAW YELLOW YELLOW Agreement Total STRAW COLORLESS Agreement
Day 1 18 18 100% 18 0 18 0 100% 18 6 12 33%
Day 2 14 14 100% 13 0 13 0 100% 14 3 11 21%
Day 3 18 18 100% 18 0 18 0 100% 18 6 12 33%
Day 4 18 18 100% 18 0 18 0 100% 18 6 12 33%
Day 5 18 18 100% 17 5 12 0 71% 18 6 12 33%
Day 6 18 18 100% 18 0 16 2 89% 18 6 12 33%
Day 7 16 16 100% 17 5 12 0 71% 17 5 12 29%
Day 8 17 17 100% 17 3 14 0 82% 18 6 12 33%
Day 9 16 16 100% 17 0 17 0 100% 16 5 11 31%
Day 10 16 16 100% 17 2 15 0 88% 15 5 10 33%
Day 11 18 18 100% 17 0 17 0 100% 18 7 11 39%
Day 12 14 14 100% 16 2 14 0 88% 16 5 11 31%
Day 13 18 18 100% 18 0 18 0 100% 18 7 11 39%
Day 14 18 18 100% 18 0 18 0 100% 18 6 12 33%
Day 15 18 18 100% 18 0 18 0 100% 18 6 12 33%
Day 16 14 14 100% 14 3 11 0 79% 13 7 6 54%
Day 17 17 17 100% 17 0 17 0 100% 17 6 11 35%
Day 18 17 17 100% 18 0 18 0 100% 17 6 11 35%
Day 19 18 18 100% 18 0 18 0 100% 17 9 8 53%
Day 20 17 17 100% 18 0 17 1 94% 18 9 9 50%
Total 338 338 342 20 319 3 340 122 218
1020 100% 100% 100% 6% 93% 1% 100% 36% 64%

9 Appendix
Day 1 – Day 20 CC/CB/CA Control results for clarity

The day-to-day precision of clarity measurements on the iChem
VELOCITY using CA, CB, and CC controls, which are clear (slightly
cloudy to some observers), slightly cloudy, and clear, respectively,
indicate good repeatability
CA CB CC
SLIGHTLY SLIGHTLY SLIGHTLY
Samples Total CLEAR CLOUDY CLOUDY Total CLEAR CLOUDY CLOUDY Total CLEAR CLOUDY CLOUDY
Day 1 18 18 0 0 18 0 14 4 18 18 0 0
Day 2 14 14 0 0 13 0 13 0 14 14 0 0
Day 3 18 17 0 1 18 0 18 0 18 18 0 0
Day 4 18 17 1 0 18 0 18 0 18 18 0 0
Day 5 18 18 0 0 17 3 9 5 18 18 0 0
Day 6 18 16 2 0 18 0 16 2 18 18 0 0
Day 7 16 16 0 0 17 2 15 0 17 17 0 0
Day 8 17 17 0 0 17 6 11 0 18 18 0 0
Day 9 16 16 0 0 17 0 17 0 16 16 0 0
Day 10 16 16 0 0 17 0 17 0 15 15 0 0
Day 11 18 15 3 0 17 0 17 0 18 18 0 0
Day 12 14 14 0 0 16 0 15 1 16 16 0 0
Day 13 18 18 0 0 18 0 17 1 18 18 0 0
Day 14 18 18 0 0 18 0 18 0 18 18 0 0
Day 15 18 18 0 0 18 0 18 0 18 18 0 0
Day 16 14 12 2 0 14 0 13 1 13 13 0 0
Day 17 17 15 2 0 17 0 14 3 17 17 0 0
Day 18 17 16 1 0 18 0 15 3 17 17 0 0
Day 19 18 15 3 0 18 2 13 3 17 17 0 0
Day 20 17 16 1 0 18 2 15 1 18 18 0 0
Total 338 322 15 1 342 15 303 24 340 340 0 0

9 Appendix
Principles of the Tests and Limitations of the

Procedure
Bilirubin
This test is based on the coupling of bilirubin with diazonium salt in an
acidic medium. A pinkish tan color proportional to bilirubin concentration
is generated.
• Expected Values: In normal urine, no detectable level of bilirubin
should be obtained. Positive results require further investigation.
• Sensitivity: 0.5 mg/dL bilirubin*
• Performance Characteristics: This test is specifically developed for
bilirubin. Biliverdin does not react with this test pad.
• Limitations: Some urine specimens may contain impurities such as
food dyes and therapeutic pigments that produce a yellowish or
reddish discoloration of the test pad that may lead to the interference.
Elevated concentrations of ascorbic acid and nitrite may inhibit the
reactions. Bilirubin is light sensitive and prolonged exposure of the
urine specimens to light may result in diminished or false negative
values. Elevated urobilinogen concentrations may slightly enhance
the response of this test pad.
Urobilinogen
This test is based on the coupling reaction of urobilinogen with a stable
diazonium salt in buffer. A pink to red color proportional to the
urobilinogen concentration is generated.
• Expected Values: In normal urine, urobilinogen is usually present at
concentration up to 1 mg/dL. A result of 2 mg/dL represents the
transition from normal to abnormal state and the specimen should be
investigated further for liver disease and hemolytic disorders.
• Sensitivity: 2 mg/dL urobilinogen*
• Performance Characteristics: The diazonium-based test is more
specific for urobilinogen than Ehrlich’s reagent based- test. Test strips
cannot determine the absence of urobilinogen, which may be
significant in biliary obstruction.
• Limitations: This test is inhibited by elevated concentrations of
formaldehyde. Food dyes and medications that have an intrinsic red
color in acidic medium such as red beets, azo dyes, phenazopyridine

9 Appendix
and p-aminobenzoic acid may produce false positive results.
Prolonged exposure to light may lead to diminished or false negative
values.
Ketones
This test is based on Legal’s method in which the test pad contains
sodium nitroprusside and glycine in an alkaline medium. A violet color
proportional to methylketone is generated.
• Expected Values: Detectable amounts of ketone do not appear in
the urine of normal specimens. Positive ketone values may result for
the following conditions: starvation, dietary imbalance, diabetes
mellitus, eclampsia, insulin dosage monitoring, vomiting and other
metabolic disorders.
• Sensitivity: 5 mg/dL ketone
• Performance Characteristics: The test does not measure β-
hydroxybutyric acid and is only slightly sensitive to acetone.
• Limitations: Elevated concentrations of phenylpyruvic acid may
interfere with the test pad and produce a variety of colors. Phthalein
and anthraquinone derivates exhibit a red color in alkaline medium
that this may mask the response. Large amounts of levodopa and
medications containing sulfhydrl groups may produce atypical color
reactions.
Ascorbic Acid
This test is based on Tillman’s reaction in which the presence of ascorbic
acid leads to the decolorization of the test pad from gray-blue to orange.
• Expected values: Ascorbic acid is found in various food supplies
and dietary supplements. Concentrations of ascorbic acid greater that
20 mg/dL can be expected to cause strong interference with glucose,
blood and nitrite.
• Sensitivity: 15 mg/dL ascorbic acid
• Performance Characteristics: The oxidized form, dehydroascorbic
acid, does not react with this test pad.
• Limitations: No interferences are reported.
Glucose
This two-step enzymatic reaction uses glucose oxidase, peroxidase and a
chromogen. Glucose oxidase catalyzes the formation of gluconic acid and
hydrogen peroxide via the oxidation of glucose. Peroxidase then
catalyzes the reaction of hydrogen peroxide with a chromogen via the

9 Appendix
oxidation of chromogen to colors ranging between green to gray-blue.
Other sugar compounds are not detected.
• Expected Values: A small amount of glucose (up to 20 mg/dL) may
be present in normal urine. The detectable sensitivity of this test has
been adjusted to exclude minute amounts of glucose. Therefore, any
positive response should be further evaluated.
• Sensitivity: 30 mg/dL glucose
• Performance Characteristics: The test pad does not react with
other reducing sugars such as fructose and galactose.
• Limitations: Ascorbic acid is the main interfering substance for
glucose. If the ascorbic acid test pad is positive, the glucose test
should be repeated 10 hours after discontinuing the administration of
vitamin C or a photometric test that is not affected by ascorbic acid
should be used. High specific gravity, acidic pH values and gentisic
acid may inhibit color formation. Cleaning agents such as hypochlorite
and peroxide may lead to false positive results.
Protein
This test is based on the “protein error” of pH indicators on the green
color developed from the presence of protein. This dye-binding test is
particularly strong with albumin.
• Expected Values: Normal urine contains very little protein: usually
less than 10 mg/dL is excreted. Positive protein results are considered
pathological and should be investigated.
• Sensitivity: 10 mg/dL protein
• Performance Characteristics: the test pad detect primarily albumin.
A negative result does not exclude the presence of other protein
molecules such as Bence Jones proteins, globulin and mucoproteins.
• Limitations: Food dyes; such as red beets, and therapeutic
pigments such as; methylene blue and pyridium, may mask the
coloration of the test pad. False positive results may occur in highly
alkaline urines (pH > 9) with high specific gravity. The interference
may come from disinfectants, wetting agents and blood substitutes
(quartenary ammonium compounds, polyvinylpyrolidone,
chlorohexidine). Highly alkaline urine specimen should be acidified
with diluted acetic acid before testing.
Blood
This pseudo-enzymatic test contains organic peroxide and a chromogen.
The peroxidase effect of hemoglobin and myoglobin causes a color
change to green.

9 Appendix
• Expected Values: Normal urine contains no detectable hemoglobin
or intact red blood cells. Any positive results should be further
evaluated.
• Sensitivity: 0.02 mg/dL blood
• Limitations: Reducing agents such as ascorbic acid, uric acid,
glutathione and gentisic acid may cause false negative results.
Preservatives (formalin) and cleaning agents such as hypochlorite
may result in false positives. High concentrations of nitrite and specific
gravity can delay the reaction.
pH
This test contains a mixed indicator which assures a marked change in
color between pH 5 and pH 9. Colors range from orange through yellow
and green to cyan.
• Expected Values: The normal pH of urine can vary between pH 5.0
and pH 9.0
• Performance Characteristics: pH values are determined to within
0.5 unit over the range from 5.0 to 9.0.
• Limitations: No interferences are reported.
Nitrite
This test is based on modified Griess reaction in which nitrite in the urine
reacts with amide to form a diazonium compound. The subsequent
coupling reaction yields a pink color in the presence of nitrite. Some Gram
positive and non-nitrite-forming bacteria are not detected in this test.
• Expected Values: Normal urine contains no detectable nitrite.
However, a negative result does not rule out a urinary tract infection.
• Sensitivity: 0.05mg/dL nitrite
• Performance Characteristics: This test is specific for nitrite. Results
may depend on the ability of bacteria to reduce nitrate to nitrite, the
number of bacteria and the retention time of the urine in the bladder.
• Limitations: Food dyes and therapeutic pigments such as red beets
and pyridium may cause false positive responses. A negative
response in the presence of bacteriuria may be caused by the
following: non-nitrite producing microorganisms, low-nitrate diet,
antibiotic therapy, strong diuresis, high levels of ascorbic acid, high
specific gravity or insufficient urinary retention time in the bladder.

9 Appendix
Leukocytes
This enzymatic test pad contains an indoxyl ester and a diazonium salt.
Granulocyte esterases react with indoxyl ester and diazonium salt to
generate a violet color.
• Expected Values: Normal urine specimen should not produce a
positive result.
• Sensitivity: 15 WBCs/μL
• Performance Characteristics: Leukocyte test detects the presence
of esterase in the granulocytic white blood cells. The test result is
most frequently accompanied by the presence of bacteria that may or
may not produce a nitrite positive reaction.
• Limitations: False positive results may occur in the presence of
preservatives such as formaldehyde and formalin. High
concentrations of protein, glucose, cephalexin, gentamicin and
specific gravity may diminish the color response. Test results may be
positive in the absence of observable cells if the granulocytes have
lysed. The test can be negative in the presence of visible leukocytes if
they have not lysed and/or are not ganulocytes.
Specific Gravity
Specific gravity is physically determined by refractometry in the Urine
Chemistry System and is not analyzed by strip chemistry.
Color and Clarity

Color and Clarity are measured directly from transmitted and scattered
light in the sample using proprietary algorithms embedded in the Urine
Chemistry System.

Index
20 Days Specific Gravity Day-to-Day Calibration Check Material ................. 76

Precision ....................................... 128 Cautions ............................................. 11
20-Day Day-To-Day Negative Analyte CHEM CONFIRM ............................... 95
Concentrations ............................. 127 Chemistry Settings ............................. 46
Chemistry System Flag Messages ..... 95
A CHEMTRANSLATE ............................ 95
Clarity CalChek solutions ................... 76
Clarity ............................................... 124
Accessing a setup screen .................. 37 Cleaning the Barcode Reader Window
Accessing Manual Orders .................. 64 ...................................................... 112
Accessing the Maintenance Menu ... 116 Cleaning the Instrument Surfaces .... 104
Accessing the Specimen Screen ....... 98 Cleaning the Optical Sensors on the
Accessing the Strip Conveyor Module A- Sample Transport Module ............. 113
11 Cleaning the Optional Load/Unload
Accessing the Strip Provider Module A-9 Trays ............................................. 104
Adding a New Operator...................... 39 Cleaning the Sample Transport Module
Alarms ................................................ 25 ...................................................... 104
Analytes Report Ranges (Includes pH Cleaning the Sample Tube Detector 112
and Specific Gravity) .................... 121 Cleaning the Strip Conveyor Module 109
Analytes ............................................. 16 Cleaning the Strip Provider Module .. 106
Analytical Performance .................... 121 Cleaning the Wash Station Bath ....... 108
As Needed Maintenance ........... 102,111 Clearing Specimen Information .......... 66
Ascorbic Acid ............................ 124,132 Color and Clarity Report Ranges ...... 124
Auto-Calibration ................................. 76 Color and Clarity .......................... 16,135
Color CalChek solutions ..................... 76
B Colors ............................................... 124
Communication settings ..................... 44
Consumable Replacement ............... 105
Barcode Labels .................................. 62 Consumable Replenishment ............ 101
Barcode Reader ................................. 17 Consumables or Part Replacement .... 33
Bilirubin ..................................... 121,131 Consumables or Part Replacement .... 67
Biological Warnings............................ 11 Control Frequency .............................. 69
Blood (Hemoglobin) .................. 123,133 Control Material .................................. 69
Buttons ............................................... 28 Control rack ........................................ 20
Correct Specimen ID .......................... 88
C
D
CalChek Failure ................................ A-6
CalChek rack...................................... 21 Daily Maintenance ..................... 101,103
CalChek Reagents ............................. 76 Date-time combo-box ......................... 73
CalCheks Frequency.......................... 76

Index
Day 1 – Day 20 CC/CB/CA Control How to use the Operators Manual ...... 10
results for clarity ........................... 130
Day 1 – Day 20 CC/CB/CA Control
results for color ............................. 129 I
Day-To-Day Positive Analyte
Concentrations ............................. 128 iChemVELOCITY Status .................... 23
Day-To-Day Precision ...................... 127 iChemVELOCITY Urinalysis System 127
Delete Flagged Specimen button ....... 95 ID_Error .............................................. 96
Delete Specimen ................................ 87 Instrument Screen .............................. 24
Deleting an Operator .......................... 40 Insufficient Sample ............................. 96
Demographics .................................... 44 Intended Use ...................................... 10
Discarding Liquid Waste .................. 103 Interface .............................................. 29
Interferences ....................................... 99
E Iris Diagnostics Contact Information ... 12
Iris Logo .............................................. 29
Edit Demographics ............................. 88

Editing Chemistry Settings ................. 47
Editing chemistry values .................... 49 J
Enable LIS.......................................... 44
Entering Manual Orders ..................... 65 Jam Rack .......................................... A-8
Expected Values and Ranges .......... 127 Jam Strip Conveyor Module ............. A-8
Jam Strip Provider Module ............... A-7
F Jam Test Strip .................................. A-7
Flag Barcode scan failures................. 54 K

Flagged Specimens ........................... 94
Fluid Type – Formed Particles ........... 45 Ketones ..................................... 122,132
Fluidics ............................................... 19 Keyboard ............................................ 22
From the Instrument screen ............... 66
From the Manual Orders screen ........ 66
L
G Laboratory Information Settings ......... 41
Leukocytes ....................................... 123
Leukocytes ....................................... 135
Glucose ..................................... 122,132 Limitation of Liability ........................... 13
Gross Hematuria ......................... 60,126 Limitations ........................................ 126
Liquid Waste Disposal ........................ 20
H LIS Interface Settings ......................... 44
Load and Unload Stations .................. 17
Loading Urine Chemistry Strips .......... 63
Handling QC Material ......................... 69 Logon .................................................. 58
Lot field ............................................... 73

Index
M Principles of the Tests and Limitations of

the Procedure................................ 131
Print List button ................................... 72
Maintenance Log.............................. 119 Print List .............................................. 89
Maintenance Screen ......................... A-4 Printer ................................................. 22
Maintenance..................................... 101 Printing the setup ................................ 37
Manual Orders ................................... 64 Processing Failure .............................. 97
Measurements ................................... 16 Processing not complete .................... 97
Modifying an Operator........................ 40 Protein ....................................... 122,133
Monthly Maintenance ....................... 108 Pumps ................................................ 20
Mouse ................................................ 22
N Q
Nitrite ......................................... 123,134 QC Failure ........................................ A-5
Notes .................................................. 11 QC Settings ........................................ 52
QC Statistics ................................ 74,A-3
O Quality Control .................................... 69
Obtain Patient Demographics R

Information from LIS ....................... 44
On Button ........................................... 20 Rack Jam .......................................... A-8
Operator Accounts Settings ............... 38 Racks .................................................. 20
Optional Load and Unload Stations ... 17 REF Override Settings ........................ 53
Reflectance CalChek Failure ............ A-6
P Reflectance CalChek test strips ......... 76
Reflectance CalChek .......................... 77
Release Settings ................................ 55
Perform Reflectance CalChek.......... 108 Remove .............................................. 72
Perform SG/CC CalChek ................. 108 Replacing Wash Solution Filter ........ 111
Performance Characteristics ............ 121 Replacing Wash Solution ................. 105
Periodic Maintenance....................... 101 Re-Report button ................................ 72
Peripherals ......................................... 22 Re-Report ........................................... 89
pH.............................................. 123,134 Result Storage .................................... 29
Precautions and Warnings ................. 11 Review Flagged Specimen button ...... 95
Precautions ................................. 32,101 Reviewing Quality Controls Results ... 71
Precision .......................................... 127 Reviewing Results .............................. 85
Preparation for Long-Term Shutdown Run CalChek .................................... 115
...................................................... 114 Run Control Rack ............................. 115
Preparing Sample Racks ................... 62 Running CalChek ............................... 77
Preparing STAT Rack ....................... A-5 Running QC ................................ 70 ,A-3
Prime the System Lines ................... 115 Running Samples ............................... 67

Index
Running STAT samples .................... A-5 Strip Conveyor System ....................... 18
Strip Disposal ..................................... 20
S Strip Provider Module Empty .............. 63
Strip Provider Module Jam ............... A-7
Strip Provider Module not Empty ........ 63
Sample Probe .................................... 19 Strip Provider Module ......................... 18
Sample rack ....................................... 20 Strip Reader Module ........................... 18
Sample Tube Specifications............... 61 System Components .......................... 17
Sampler .............................................. 17 System Configuration Settings ........... 42
Save Button........................................ 74 System Status Lights .......................... 20
Saving all QC Results ........................ 74
Screen Level Functions...................... 26
Search button ..................................... 73
Search ................................................ 91 T
Sensitivity and Measurement Range 125
Settings Screen .................................. 36 Tallies ............................................... 117
Setup .................................................. 35 Technical Specifications ..................... 30
SG/Color/Clarity CalCheck Failure.... A-6 Test Specifications ........................... 21
Shift Summary.................................... 25 Test Strip Jam .................................. A-7
Short Sample ..................................... 96 Test Strips .......................................... 21
Shutting Down the Instrument .......... 118 Theory of Operation ............................ 16
Skip Specimen if ID scan fails ............ 54 Tips ..................................................... 11
Software Functions ............................ 23 Touchscreen Monitor .......................... 22
Sort Work List..................................... 86 Type field ............................................ 73
Specific Gravity CalChek solutions .... 76
Specific Gravity .................... 16,124,135
Specific Gravity, Color, and Clarity U
CalChek .......................................... 83
Specific Gravity, Color, and Clarity Un-Delete Specimen .......................... 87
Module ............................................ 19 Urine Auto-Classify Settings ............... 56
Specimen information from LIS .......... 44 Urine Auto-Release Settings .............. 56
Specimen Preparation........................ 60 Urine Gating Settings ......................... 56
Specimen Results .............................. 28 Urobilinogen .............................. 121,131
Specimen Screen Buttons.................. 99
Specimen Screen ............................... 98
Specimen Settings ...................... 54 ,A-2
Specimen Volume .............................. 60 V
Specimens at Room Temperature ..... 60
Specimens ....................................... 126 Validating the changes ....................... 51
Start Button ........................................ 20 Very Dense or Viscous Specimens .... 60
Start-up after Long-term Shutdown .. 114 View Selector ...................................... 24
Status field ......................................... 73
Storage and Use ................................ 76
Strip Conveyor Module Jam .............. A-8

Index
W
Warnings ............................................ 11
Warnings, Precautions, Limitations .... 12
Warranty............................................. 13
Wash Container ................................. 20
Wash Station ...................................... 19
Waste ................................................. 20
Weekly Maintenance ........................ 106
Within Run Precision ........................ 127
Work List Screen ................................ 85
Work List ............................................ 27

Operator Manual

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Operator Manual

Uploaded by

Copyright:

Available Formats

1.

300-4410 Rev A 03/2006Operators Manual 1

Chapter 2 – System Description

300-4448 English Rev B 05/2008 Operators Manual 1

300-4448 English Rev B 05/2008 Operators Manual 2

Chapter 4 – Specimen Processing

300-4448 English Rev B 05/2008 Operators Manual 3

Chapter 5 – Quality Control

Chapter 6 - Calibration Verifications

300-4448 English Rev B 05/2008 Operators Manual 4

Chapter 8 – Maintenance and Service

300-4448 English Rev B 05/2008 Operators Manual 5

300-4448 English Rev B 05/2008 Operators Manual 6

300-4448 English Rev B 05/2008 Operators Manual 7

300-4484 English Rev A 05/2008 Operators Manual A-1

See Chapter 3 – Settings, Specimen Settings.

300-4484 English Rev A 05/2008 Operators Manual A-2

See Chapter 5 – Running QC.

Items required: Urine Control CA/CB/CC (REF 800-7702), Control Rack,

Position Insert Volume Contents Function Barcode

4. Place the rack on the Sampler.

See Chapter 2 – Screen Level Functions.

300-4484 English Rev A 05/2008 Operators Manual A-3

See Chapter 8 - Accessing the Maintenance Menu.

300-4484 English Rev A 05/2008 Operators Manual A-4

Running STAT samples

Preparing STAT Rack

1. Repeat the run using the same lot number.

300-4484 English Rev A 05/2008 Operators Manual A-5

SG/Color/Clarity CalCheck Failure

300-4484 English Rev A 05/2008 Operators Manual A-6

Test Strip Jam

300-4484 English Rev A 05/2008 Operators Manual A-7

Strip Conveyor Module Jam

300-4484 English Rev A 05/2008 Operators Manual A-8

Accessing the Strip Provider Module

4. Loosen the thumbscrew holding

5. Remove the two thumbscrews

6. Pull the blue knob to release

300-4484 English Rev A 05/2008 Operators Manual A-9

9. Pull the blue knob to release

10. Close the side doors.

12. Re-install the splashguard by

13. Close the front door.

300-4484 English Rev A 05/2008 Operators Manual A-10

Accessing the Strip Conveyor Module

3. Loosen the thumbscrew holding

4. Remove the two thumbscrews

5. Tilt the wash station to the left

6. Pull out and then push down

300-4484 English Rev A 05/2008 Operators Manual A-11

8. When the maintenance or the

9. Pull the blue latch and move it

10. Raise the wash station back to

11. Close the side doors.

300-4484 English Rev A 05/2008 Operators Manual A-12

14. Close the front door.

300-4484 English Rev A 05/2008 Operators Manual A-13

300-4448 English Rev B 05/2008 Operators Manual 9

This document is the Operators Manual for the iChemVELOCITY Urine

How to use the Operators Manual

Before operating the iChemVELOCITY, read this manual carefully.

300-4448 English Rev B 05/2008 Operators Manual 10