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iChemVelocity
Operator's Manual
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IRIS iChemVelocity Operator's Manual

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1. Introduction
Operator’s Manual
Table of Contents
Table of Contents
Chapter 1 - Introduction ......................... 12
Intended Use ................................................................................................................... 12
How to use the Operator’s Manual .................................................................................. 13
Precautions and Warnings .............................................................................................. 14
Tips ........................................................................................................................... 14
Notes ......................................................................................................................... 14
Cautions .................................................................................................................... 14
Warnings ................................................................................................................... 14
Biological Warnings ................................................................................................... 15
Iris Diagnostics Contact Information ............................................................................... 15
Manufacturer ............................................................................................................. 15
Authorized European Representative ....................................................................... 15
Symbols .......................................................................................................................... 16
Warnings, Precautions, Limitations ................................................................................. 17
Precautions and Safety ................................................................................................... 18
Requirements .................................................................................................................. 21
7BInstallation ....................................................................................................................... 21
Warranty.......................................................................................................................... 22
Limitation of Liability ........................................................................................................ 22
Chapter 2 – System Description .............. 23
Theory of Operation ........................................................................................................ 23
Measurements .......................................................................................................... 23
Analytes ............................................................................................................... 23
Specific Gravity ................................................................................................... 23
Color and Clarity .................................................................................................. 24
System Components ....................................................................................................... 24
Sampler .....................................................................................................................
Barcode Reader .................................................................................................. 24
Load and Unload Stations ................................................................................... 25
Optional Load and Unload Stations .......................................................................... 25
Strip Provider Module ................................................................................................ 25
Strip Conveyor System ............................................................................................. 25
Strip Reader Module ................................................................................................. 25
Specific Gravity, Color, and Clarity Module ............................................................... 26
Fluidics ...................................................................................................................... 27
Sample Probe ...................................................................................................... 27
Wash Station ....................................................................................................... 27
24
Table of Contents
Pumps ................................................................................................................. 27
Wash Container ................................................................................................... 27
Waste ........................................................................................................................ 27
Strip Disposal ...................................................................................................... 27
Liquid Waste Disposal ......................................................................................... 27
On Button .................................................................................................................. 27
System Status Lights ................................................................................................ 28
Green LED only is ON ......................................................................................... 28
166BBlue LED only is ON ............................................................................................ 28
167BRed LED only is ON ............................................................................................ 28
168BGreen and Red LED’s are ON ............................................................................. 28
169BBlue and Red LED’s are ON ............................................................................... 28
170BGreen – Blue – Red LED’s blink synchronously .................................................. 29
Racks ........................................................................................................................ 29
Sample rack ........................................................................................................ 29
Control rack ......................................................................................................... 29
CalChek rack ....................................................................................................... 29
Dilution rack ......................................................................................................... 29
Test Strips ................................................................................................................. 30
Test Specifications ............................................................................................ 30
Peripherals ................................................................................................................ 31
Keyboard ............................................................................................................. 31
Mouse .................................................................................................................. 31
Monitor ................................................................................................................ 31
Printer .................................................................................................................. 31
Software Functions ......................................................................................................... 32
iChemVELOCITY Status ...........................................................................................
View Selector ............................................................................................................ 33
Instrument Screen ..................................................................................................... 33
Shift Summary ........................................................................................................... 34
Alarms ................................................................................................................. 34
Screen Level Functions ....................................................................................... 35
Work List ................................................................................................................... 36
Chemistry Report ...................................................................................................... 37
Buttons ................................................................................................................ 38
On-board Help ........................................................................................................... 38
Opening the Help File .......................................................................................... 38
Accessing a Section Using the Bookmark Pane ................................................. 40
Following a Link inside the Manual ..................................................................... 40
Iris Logo .................................................................................................................... 41
Interface .................................................................................................................... 41
Result Storage .......................................................................................................... 41
Technical Specifications .................................................................................................. 42
Consumables or Part Replacement ................................................................................ 44
32
Table of Contents
Chapter 3 – Setup .................................... 45
Settings Screen ............................................................................................................... 46
Accessing a Setup Screen ........................................................................................ 47
Printing the Setup ...................................................................................................... 47
View Log ................................................................................................................... 48
Restore Button .................................................................................................... 49
Restore… Button ................................................................................................. 49
Save as… Button ................................................................................................ 49
Operator Accounts Settings ............................................................................................ 51
Adding a New Operator ............................................................................................. 52
Deleting an Operator ................................................................................................. 53
Modifying an Operator ............................................................................................... 53
Laboratory Information Settings ...................................................................................... 54
System Configuration Settings ........................................................................................ 55
Chemistry System Present ........................................................................................ 56
Enter Primary Chemistry Settings ....................................................................... 56
Enter Backup Chemistry Settings ........................................................................ 58
Validating the Changes ....................................................................................... 60
LIS Interface Settings ...................................................................................................... 61
Enable LIS ................................................................................................................. 61
Communication settings ............................................................................................ 62
Specimen information from LIS ................................................................................. 62
Skip Specimen if LIS Fails ................................................................................... 62
Obtain Patient Demographics Information from LIS ............................................ 62
Demographics ..................................................................................................... 62
Fluid Type – Formed Particles ........................................................................................ 63
Chemistry Settings .......................................................................................................... 64
Editing Chemistry Settings ........................................................................................
Editing Chemistry Values .................................................................................... 67
Validating the changes ........................................................................................ 69
QC Settings ..................................................................................................................... 70
REF Override Settings .................................................................................................... 70
Specimen Settings .......................................................................................................... 71
Flag barcode scan failures ........................................................................................ 71
Enable detailed audit trail .......................................................................................... 71
Report operator [auto] ............................................................................................... 72
Release Settings ............................................................................................................. 72
Urine Gating Settings ...................................................................................................... 73
Urine Auto-Release Settings ........................................................................................... 73
Urine Auto-Classify Settings ........................................................................................... 73
Sequence Number .......................................................................................................... 74
65
Table of Contents
Chapter 4 – Sample Processing ................ 75
Logon .............................................................................................................................. 75
Specimen Preparation ..................................................................................................... 76
Specimens at Room Temperature ............................................................................ 77
Gross Hematuria ....................................................................................................... 77
Specimen Volume ..................................................................................................... 77
Sample Tube Specifications ............................................................................................ 78
Preparing Sample Racks ................................................................................................ 79
Barcode Labels ......................................................................................................... 79
Manual Orders ................................................................................................................ 80
Accessing Manual Orders ......................................................................................... 80
Entering Manual Orders ............................................................................................ 81
Clearing Specimen Information ................................................................................. 82
From the Manual Orders screen ......................................................................... 82
From the Instrument screen ................................................................................ 82
Running Samples ............................................................................................................ 83
Consumables .................................................................................................................. 84
Loading Urine Chemistry Strips ................................................................................ 84
Replacing Wash Solution Container and Wash Solution Filter ................................. 87
Consumables Part Numbers ..................................................................................... 88
Chapter 5 – Quality Control .................... 89
Control Material ............................................................................................................... 89
Handling QC Material ................................................................................................ 89
Control Frequency ........................................................................................................... 89
QC Settings ..................................................................................................................... 89
Running QC .................................................................................................................... 90
QC Failure ....................................................................................................................... 91
Reviewing Quality Controls Results ................................................................................
Print List button ......................................................................................................... 93
Re-Report button ....................................................................................................... 93
Remove ..................................................................................................................... 93
Search button ............................................................................................................ 94
Lot field ................................................................................................................ 94
Type field ............................................................................................................. 94
Status field ........................................................................................................... 94
Date-time combo-box .......................................................................................... 94
Save Button ............................................................................................................... 95
QC Report ....................................................................................................................... 96
Print Button ............................................................................................................... 97
Save Button ............................................................................................................... 97
Saving all QC Results ......................................................................................... 97
92
Table of Contents
Saving a Specific QC Result ............................................................................... 97
QC Statistics ................................................................................................................... 99
QC Definitions ............................................................................................................... 101
Mean ....................................................................................................................... 101
Standard Deviation .................................................................................................. 101
Coefficient of Variation ............................................................................................ 101
Levey-Jennings Graph ............................................................................................ 101
Target Value ............................................................................................................ 101
Chapter 6 – Calibration Verifications ... 102
Calibration Check Material ............................................................................................ 102
Reflectance CalChek test strips .............................................................................. 102
CalChek Reagents .................................................................................................. 102
Specific Gravity CalChek solutions ................................................................... 102
Color CalChek solutions .................................................................................... 102
Clarity CalChek solutions .................................................................................. 102
Storage and Use ..................................................................................................... 102
CalCheks Frequency ..................................................................................................... 103
Running CalChek .......................................................................................................... 103
Reflectance CalChek .............................................................................................. 103
Specific Gravity, Color, and Clarity CalChek ........................................................... 110
CalChek Failure ............................................................................................................ 111
Reflectance CalChek Failure .................................................................................. 111
SG/Color/Clarity CalChek Failure ........................................................................... 111
Chapter 7 – Results ................................ 112
Results Interpretation .................................................................................................... 112
Reviewing Results ......................................................................................................... 113
Work List Screen ........................................................................................................... 113
Work List Screen .....................................................................................................
Found List Screen ................................................................................................... 114
Sort Work List .......................................................................................................... 114
Delete Specimen ..................................................................................................... 115
Un-Delete Specimen ............................................................................................... 116
Correct Specimen ID ............................................................................................... 117
Edit Demographics .................................................................................................. 117
Print List .................................................................................................................. 118
Re-Report ................................................................................................................ 118
Search ..................................................................................................................... 119
Search by specimen ID ..................................................................................... 119
Search by Sequence Number ........................................................................... 120
Search by Operator ID ...................................................................................... 120
113
Table of Contents
Search by date-time (range) .............................................................................. 120
Search by Demographics .................................................................................. 121
Show specimens awaiting transmission only .................................................... 123
Show released specimens only ......................................................................... 123
Show incomplete specimens only ..................................................................... 123
Clear Button ...................................................................................................... 123
Flagged Specimens ................................................................................................ 124
Review Flagged Specimen button ..................................................................... 125
Delete Flagged Specimen button ...................................................................... 125
Chemistry System Flag Messages .......................................................................... 125
CHEMTRANSLATE ........................................................................................... 125
CHEM CONFIRM .............................................................................................. 125
ID_Error ............................................................................................................. 126
Processing Failure ............................................................................................. 126
Processing not complete ................................................................................... 127
S1 ...................................................................................................................... 127
S2 ...................................................................................................................... 127
S3 ...................................................................................................................... 127
1.000 ................................................................................................................. 127
Specimen Screen .......................................................................................................... 128
Accessing the Specimen Screen ............................................................................ 128
Specimen Screen Buttons ....................................................................................... 129
Delete Flagged Specimen ................................................................................. 129
Review Flagged Specimen ................................................................................ 129
Accept ............................................................................................................... 129
Skip ................................................................................................................... 129
Edit .................................................................................................................... 129
Work List/Found List .......................................................................................... 129
Editing Results ........................................................................................................ 130
Editing a Chemistry Result Value ...................................................................... 130
Entering Manually a Microscopy Result Value .................................................. 132
Chapter 8 – Maintenance & Service ...... 135
Maintenance.................................................................................................................. 135
Precautions ............................................................................................................. 135
Daily Maintenance ................................................................................................... 135
Consumable Replenishment ................................................................................... 135
Periodic Maintenance .............................................................................................. 136
As Needed Maintenance ......................................................................................... 136
Daily Maintenance ......................................................................................................... 137
Empty and Clean the Waste Container ................................................................... 137
Discarding Liquid Waste ......................................................................................... 137
Cleaning the Sample Transport Module .................................................................. 138
Table of Contents
Cleaning the Optional Load/Unload Trays .............................................................. 138
Cleaning the Instrument Surfaces ........................................................................... 138
Consumable Replacement ............................................................................................ 139
Weekly Maintenance ..................................................................................................... 140
Cleaning the Strip Provider Module ........................................................................ 140
Monthly Maintenance .................................................................................................... 144
Cleaning the Wash Station Bath ............................................................................. 144
Cleaning the Strip Conveyor System ...................................................................... 145
Quarterly Maintenance .................................................................................................. 146
Perform Reflectance CalChek ................................................................................. 146
Perform SG/CC CalChek ........................................................................................ 146
Replacing Wash Solution Container and Wash Solution Filter ............................... 146
As Needed Maintenance ............................................................................................... 147
Cleaning the Sample Tube Detector ....................................................................... 147
Cleaning the Barcode Reader Window ................................................................... 147
Cleaning the Optical Sensors on the Sample Transport Module ............................ 148
Preparation for Long Term Shutdown ........................................................................... 149
Start-up after Long term Shutdown ............................................................................... 149
Prime the System Lines .......................................................................................... 150
Run CalChek ........................................................................................................... 150
Run Control Rack .................................................................................................... 150
Accessing the Maintenance Menu ................................................................................ 151
Auto Strip Counter Override .................................................................................... 152
Backup .................................................................................................................... 152
Restore Procedure .................................................................................................. 153
System Info ............................................................................................................. 154
Tallies ...................................................................................................................... 155
Errors ...................................................................................................................... 155
Shutdown ................................................................................................................ 156
Restart button .......................................................................................................... 157
Defragment button .................................................................................................. 158
Check Disk .............................................................................................................. 159
Alarm Messages ........................................................................................................... 160
Alarm 17 .................................................................................................................. 160
Alarm 18 .................................................................................................................. 160
Alarm 19 .................................................................................................................. 160
Alarm 21 .................................................................................................................. 161
Alarm 36 .................................................................................................................. 161
Alarm 37 .................................................................................................................. 162
Alarm 40 .................................................................................................................. 163
Alarm 41 .................................................................................................................. 163
Alarm 42 .................................................................................................................. 163
Alarm 43 .................................................................................................................. 163
Alarm 44 .................................................................................................................. 164
Table of Contents
Alarm 45 .................................................................................................................. 164
Alarm 46 to 69 ......................................................................................................... 164
Troubleshooting ............................................................................................................ 165
Test Strip Jam ......................................................................................................... 165
Strip Provider Module Jam ................................................................................ 165
Strip Conveyor Module Jam .............................................................................. 166
Rack Jam .......................................................................................................... 166
Switching from Primary to Backup Chemistry System ............................................ 167
Switching from Backup to Primary Chemistry System ............................................ 169
Accessing Internal Components ................................................................................... 171
Accessing the Strip Provider Module ...................................................................... 171
Accessing the Strip Conveyor Module .................................................................... 173
Maintenance Log........................................................................................................... 176
Chapter 9 - iWARE™ Expert System ...... 177
Data Management......................................................................................................... 177
Rule Generator .............................................................................................................. 178
Building Custom Rules Screen ............................................................................... 180
Rule Button ........................................................................................................ 180
Tagging Button .................................................................................................. 180
SQL Button ........................................................................................................ 180
Add Condition Button ........................................................................................ 181
Delete Conditions Button ................................................................................... 181
Make Usable Button .......................................................................................... 181
Import Button ..................................................................................................... 181
Create Button .................................................................................................... 181
Delete Button ..................................................................................................... 181
Save As Button .................................................................................................. 181
Save Button .......................................................................................................
Import Pre-Populated Rules .................................................................................... 182
Creating Customized Rules .................................................................................... 183
Creating a New Numbered Custom Rule .......................................................... 183
Creating a New Unnumbered Rule ................................................................... 183
Adding one Condition ........................................................................................ 184
Adding More Conditions to a Rule ..................................................................... 185
Deleting a Condition from a Rule ...................................................................... 185
Saving a Rule .................................................................................................... 186
Results/Rules Tagging .................................................................................................. 187
Tagging Options ...................................................................................................... 187
Validation Flag ................................................................................................... 187
Info Pane Tagging ............................................................................................. 188
LIS Tagging ....................................................................................................... 188
Report Tagging .................................................................................................. 188
181
Table of Contents
Tagging Using the Tagging Button .......................................................................... 188
Tagging from the Building Custom Rules Screen ................................................... 189
Report Generator .......................................................................................................... 190
Search with Additional Criteria ................................................................................ 190
Data Management Results ............................................................................................ 192
Patient Report with Tag ........................................................................................... 192
Chapter 10 - Consumables Traceability . 193
Consumables Traceability ............................................................................................. 193
Consumables Information ....................................................................................... 193
Entering Consumables Data ......................................................................................... 194
Chemistry QC Consumables ................................................................................... 195
Consumables Traceability Screen .......................................................................... 198
Print Button ........................................................................................................ 198
Save As Button .................................................................................................. 198
Add Button ......................................................................................................... 199
Update Button ................................................................................................... 199
OK Button .......................................................................................................... 199
Cancel Button .................................................................................................... 199
Adding a New Consumable ............................................................................... 199
Editing a Consumable ....................................................................................... 199
Deleting a Consumable ..................................................................................... 199
Consumables Report .................................................................................................... 200
Use of Expired Material ................................................................................................. 201
Quality Control / Calibration Material ...................................................................... 202
Chemistry Test Strips .............................................................................................. 203
Alarm Messages ........................................................................................................... 203
Alarm 50 .................................................................................................................. 203
Alarm 51 ..................................................................................................................
Alarm 52 .................................................................................................................. 204
Alarm 54 .................................................................................................................. 204
Alarm 59 .................................................................................................................. 204
Alarm 60 .................................................................................................................. 205
Alarm 61 .................................................................................................................. 205
Alarm 63 .................................................................................................................. 206
Alarm 66 .................................................................................................................. 206
Alarm 67 .................................................................................................................. 206
Alarm 68 .................................................................................................................. 207
Alarm 69 .................................................................................................................. 207
Expired Consumable Lockout Override .................................................................. 207
Accessing the Expired Consumable Lockout Override Option .......................... 207
Consumables Search .................................................................................................... 209
203
Table of Contents
Chapter 11 – Appendix ......................... 211
Performance Characteristics ......................................................................................... 211
Analytical Performance ........................................................................................... 211
Analytes Report Ranges (Includes pH and Specific Gravity) .................................. 211
Bilirubin .............................................................................................................. 211
Urobilinogen ...................................................................................................... 211
Ketones ............................................................................................................. 211
Glucose ............................................................................................................. 211
Protein ............................................................................................................... 212
Blood (Hemoglobin) ........................................................................................... 212
pH ...................................................................................................................... 212
Nitrite ................................................................................................................. 212
Leukocytes ........................................................................................................ 212
Ascorbic Acid ..................................................................................................... 213
Specific Gravity ................................................................................................. 213
Color and Clarity Report Ranges ............................................................................ 213
Colors ................................................................................................................ 213
Clarity ................................................................................................................ 213
Sensitivity and Measurement Range ............................................................................ 214
Analytical Sensitivity .......................................................................................... 214
iChemVELOCITY Urinalysis System ............................................................................ 215
Method Comparison ................................................................................................ 215
Expected Values and Ranges ................................................................................. 215
Precision ................................................................................................................. 216
Within Run Precision ......................................................................................... 216
Day-To-Day Precision ....................................................................................... 217
Instrument to instrument precision .................................................................... 218
Strip lot to strip lot precision ..............................................................................
20 Days Specific Gravity Day-to-Day Precision ................................................ 220
Day 1 – Day 20 Results for color and Clarity .................................................... 221
Clinical Concordance Tables .................................................................................. 222
Ascorbic Acid ..................................................................................................... 222
Bilirubin .............................................................................................................. 222
Blood ................................................................................................................. 222
Glucose ............................................................................................................. 223
Ketones ............................................................................................................. 223
Leukocytes ........................................................................................................ 223
Nitrite ................................................................................................................. 224
pH ...................................................................................................................... 224
Protein ............................................................................................................... 224
Urobilinogen ...................................................................................................... 225
Specific Gravity ................................................................................................. 225
Principles of the Tests and Limitations of the Procedure .............................................. 226
219
Table of Contents
Bilirubin ................................................................................................................... 226
Urobilinogen ............................................................................................................ 226
Ketones ................................................................................................................... 227
Ascorbic Acid .......................................................................................................... 227
Glucose ................................................................................................................... 227
Protein ..................................................................................................................... 228
Blood ....................................................................................................................... 229
pH ............................................................................................................................ 229
Nitrite ....................................................................................................................... 229
Leukocytes .............................................................................................................. 230
Specific Gravity ....................................................................................................... 230
Color and Clarity ..................................................................................................... 231
1 Introduction
Chapter 1 - Introduction
Intended Use
The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY ™ Urine Chemistry Strips. The iChem VELOCITY can be used as a stand-alone system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity.
iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular, they are not intended for visual reading. The iChem VELOCITY test strips are reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.
These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChem VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
This document is the Operator’s 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.
not intended for visual
1 Introduction
How to use the Operator’s 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.
This manual is designed for use with the software version 7.x. It is intended for anyone who will operate the system and must have a thorough knowledge of it. It also specifically references information concerning system components, operation, theory, utility, and performance
Before operating the iChemVELOCITY, read this manual carefully.
1 Introduction
Precautions and Warnings
The Operator’s 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
Notes
Cautions
Warnings
This icon indicates that the information is applicable only when an iQ Series System is linked to the chemistry system.
NOTE: Highlights important facts, gives helpful information and tips and
clarifies procedures.
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.
WARNING: Identifies potentially hazardous situations that could result in
serious injury to laboratory personnel.
1 Introduction
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.
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
Manufacturer
Iris Diagnostics 9172 Eton Avenue Chatsworth, CA 91311 USA
Authorized European Representative
Mdi Europa GmbH Langenhagener Str. 71 30855 Hannover-Langenhagen Germany +49-511-39089539
Control
Symbols
The following is a list of symbols used on the product labeling consumables, the instrument, and their meaning.
Symbol Meaning
1 Introduction
Caution Consult Accompanying Documents
Consult Operating Instructions
Control Negative
Control Positive
Date of Manufacture
Do not reuse
In Vitro Diagnostic Medical Device
Lot Number
Reference Number
Serial Number
Non Sterile
Lower Limit of Temperature
Temperature Limitation
Indicate that 20 years is the declared time where any
without posing any environmental threat.
1 Introduction
Symbol Meaning
Upper Limit of Temperature
Use By
Compliant with Waste Electrical and Electronic Equipment (WEEE) directive.
hazardous substances in the product will be stable
ETL Listed Mark.
Caution: Hot surface.
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.
1 Introduction
Precautions and Safety
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 analyzer 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 2 inches (5 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 68 condensing in a range of 20% to 80%.
o
F (18oC) and 82oF (28oC), and relative humidity non-
CAUTION: The equipment inside fixed covered areas of the instrument is not operator serviceable and may present electrical shock hazards.
1 Introduction
Do not install the system during lightning activity. For protection during lightning storms and power surges, contact your facility electrical department.
For added protection of the equipment during lightning and power surges, always unplug the power cord and the LIS connection. If the instrument is not used for a long period of time, unplug the power cord and the LIS connection.
To reduce the risk of electric shock, do not remove any panel unless under the direction of qualified personnel.
To reduce the risk of electric shock, do not use an extension cord, receptacle or other outlet unless the blades can be inserted completely with three-wire grounding type to prevent blade exposure.
Do not block any ventilation openings.
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.
CAUTION: Do NOT leave the test strips in the module for more than 5 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.
1 Introduction
WARNING: Observe Universal Precautions. Discard contaminated
materials according to applicable regulations.
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.
CAUTION: Use only DRY paper towel. Using a humid paper towel inside the Strip Provider Module will affect the results of the test strips.
CAUTION: Restoring data will overwrite current data and settings. Only a user with Manager Privilege can perform this procedure.
Requirements
The system has few special environmental requirements. It uses alternating current at 100V to 240V and 50 Hz to 60 Hz. (Input voltage and frequency selection does not require customer intervention.) Uninterruptible power supplies are recommended for the iChem VELOCITY to maintain system operation during short power outages and brownouts. This allows for an orderly shutdown of instruments without the loss of data.
1 Introduction
Select a room to set up the unit where the temperature can be controlled between 68 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 for safety
reasons.
WARNING: The instrument’s main supply inlet is being used as the
mains disconnect device.
7BInstallation
o
F (18oC) and 82oF (28oC), and relative humidity non-
The iChem VELOCITY will be installed by a factory-trained representative from Iris Diagnostics or an authorized Distributor.
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.
1 Introduction
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
Chapter 2 – System Description
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. The instrument aspirates the sample and sends it to the CCGM and then dispenses the sample on each pad. 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 several three color’s LEDs and one black and white CMOS (Complementary Metal Oxide Semiconductor) camera. See Strip Reader Module.
Endpoint reaction is used for measuring all tests.
Specific Gravity
Specific gravity of urine is obtained using an Atago 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.
2 System Description
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 uses RGB photodetectors to measure the color of the sample. The sample is illuminated at a 90 degree angle with a second LED white light to measure the amplitude of light scattered within the flowcell and 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.
2 System Description
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 additional 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 five (5) 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. 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.
2 System Description
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).
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
2 System Description
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 maximum capacity of 300 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, places the system in Standby.
2 System Description
System Status Lights
The system status lights display “Stand By” (Green), “Measure” (Blue) and “Error” (Red).
Green LED only is ON
The iChem VELOCITY is in Standby mode and ready for operation.
The main power switch has been turned on and the ON button (front door) has been pressed. The heater is on and the front door cannot be opened. All operations are interrupted immediately if the door is opened.
166BBlue LED only is ON
The iChem VELOCITY is in Measure mode.
A rack has been placed on the right side of the STM. The heater is on and the front door cannot be opened. All operations are interrupted immediately if the door is opened.
167BRed LED only is ON
The iChem VELOCITY has encountered an error.
A message has popped up on the instrument screen.
168BGreen and Red LED’s are ON
The iChem VELOCITY has run out of iChem Wash Solution.
A message is displayed. The heater is on.
169BBlue and Red LED’s are ON
The iChem VELOCITY has run out of iChem VELOCITY strips or there is a strip jam.
A message is displayed.
• If the SPM is empty, refill with strips.
• If a jam occurred, to clear the condition, turn the instrument main
power switch OFF then ON.
• If the system is a standalone, shutdown the system using the Shutdown button from the Maintenance screen.
NOTE: The heater is on.
Racks
2 System Description
170BGreen – Blue – Red LED’s blink synchronously
The main power switch has been turned on and the ON button (front door) has not yet been pressed.
The red LED will blink when the system is waiting to connect to the user interface software. In this state, the heater is not on. The door can be opened and closed.
Four types of racks are used with the iChemVELOCITY system:
• sample rack,
• control rack,
• CalChek rack,
• dilution 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.
Dilution rack
The Dilution rack numbered 23 must be used to run samples that will need dilution for microscopy on the iQ200 after being processed on the iChemVELOCITY .
Test Strips
The test strips have reagent-impregnated specialty paper pads to perform chemical analysis of:
iChem VELOCITY strips contain a color compensation pad to address color interference. The instrument does not apply automatic temperature correction on measured parameters.
2 System Description
• bilirubin
• urobilinogen
• ketones
• ascorbic acid
• glucose
• protein
• blood
• pH
• nitrite
• leukocytes
Test Specifications
iChem VELOCITY Urine Chemistry Strips are packaged in the Starter Kit with the iChem VELOCITY system. Additional strips may be purchased from Iris Diagnostics or your authorized distributor. Only iChem VELOCITY 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 5 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.
Monitor
The monitor can be used to make selections on the software screens.
2 System Description
Printer
An external USB port allows the connection of a Windows compatible printer.
Low priority
Medium priority
High priority
2 System Description
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 (Energy conservation)
Blue -> Measure (Sample measurement in progress)
Red -> Error (Error condition occurs)
• 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
iChemVELOCITY View Selector Area
Task Level Screen Level Functions Area
Information Pane
2 System Description
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:
Status Area
Information Area
Field
Display
Button
Operator
Currently logged on operator if any.
Logon Logoff
Last
Check
Date/time of the last successful
N/A
Last
Check
Date/time of the last successful
calibration check.
N/A
Last Chem QC
Date/time of the last successful chemistry quality control.
N/A
LIS
LIS status.
Check LIS
Manual Orders
Displays racks enabled in Manual Orders.
Clear All
Manual Orders
Give access to Manual Orders screen
Manual Orders
System Status
On Line Off Line (display in red)
Go Off Line Go On Line
Shift Summary
2 System Description
Reflectance
SG/Color/Clarity
reflectance calibration check.
specific gravity, color, and clarity
Alarms
Alarms appear in the Information Area of the screen and display the detailed list of unresolved alarms, sorted by priority, then date/time.
Button
Function
Manual Orders
Access the Manual Orders screen, see Manual
Orders
Consumables
Access the Consumables window; see
ConsumablesTraceability for more information.
Quality Review
Access the QC Review screen, see Reviewing
Quality Controls Results
QC Statistics
Access the QC Statistics screen; see Quality
Control for more information.
Settings
Access the Settings screen for user-defined
more information.)
Maintenance
Access the Maintenance screen for:
• Check Disk
Sequence #
Access the Sequence number screen, see
Sequence Number
2 System Description
Screen Level Functions
instrument setup (consult the Setup section for
• Reflectance Check
• Chemistry Service
• Auto Strip Counter Override
• Backup
• Restore
• System Info
• Tallies
• Errors
• Shutdown
• Restart
• Defragment
Work List
2 System Description
The Work List screen contains only unreleased results and 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 Chemistry report 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
• specimen number
• operator ID
2 System Description
• patient demographics
• date/time
• specimen awaiting transmission
• specimen already released.
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, you can re-report specimen results.
Chemistry Report
The Chemistry Report screen shows a summary of the results for the specimen chosen from the Work List/Found List.
Buttons
Functions
Delete Flagged
Non-recoverable flag. The specimen results will be
before the specimen can be run again.
Review Flagged Specimen
Recoverable flag. Allows the user to enter a specimen ID or clear a flag.
Accept
Un-delete list.
Skip
Edit
Work
2 System Description
Buttons
Specimen
List/Found List
On-board Help
deleted. The cause of the flag needs to be resolved
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
Skips the specimen results and display the next results available from the Work List.
This option can be used to edit chemistry results or enter microscopy results.
Closes the Specimen screen and returns to the Work List/Found list screen.
The Help button is located in the middle top of the screen and is visible virtually at all times.
Opening the Help File
1. Click on the Help button to display the Operator’s Manual available. An Open Help File window is displayed.
2 System Description
2. Select the file to open according to the desired language.
3. Click the Open button. The selected Operator’s Manual is displayed in a separate window.
2 System Description
Accessing a Section Using the Bookmark Pane
The Bookmark pane, located on the left side of the screen, can be used as a “linked” table of contents.
Click on a bookmark to go automatically to the starting page of the selected section.
1. To expand the selection, click on the + sign located next to the bookmark.
2. To collapse the selection, click on the - sign located next to the bookmark.
Following a Link inside the Manual
In order to avoid searching for a specific section, links have been created to jump to other locations and to give immediate access to the related information. Links are indicated in the following manner: the text is displayed in blue and bold italics. Example: see Iris Diagnostics
Contact Information.
1. Select the hand tool
2. Position the pointer over the linked area on the page until the pointer changes to the hand with a pointing finger .
3. Click the link, the destination screen is displayed.
4. To return to the previous section, click the Go to Previous View button.
.
Iris Logo
2 System Description
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. The results for the current lot of QC are stored indefinitively.
Measurement
Reflectance Photometry LEDs (472nm, 525nm,
method
Specimen
Barcode or keyboard entry of ID
10-tube rack system with continuous feed
Specimen Volume
Minimum volume 2 mL of un-spun urine Aspiration volume approx ~1mL
Test Strip Chamber
Maximum capacity of 300 strips On-board stability 5 days
Test Strip Waste Container
Capacity maximum 300 strips
Fluid Waste
Waste is pumped from the instrument to a sink,
the instrument.
Throughput
Barcode Labels
Code 128, Code 39, Codabar and Interleaved 2
mm)
Data Storage
Reporting Units
LIS Interface
Bi-directional with host query
Flagging
Results requiring confirmatory tests / Abnormal Quality results
2 System Description
Technical Specifications
Principle
Processing
Test Strips iChemVELOCITY Urine Chemistry Strips
630nm) with CMOS camera Specific gravity via optical refractive index
60 specimens walk away capability (210 specimens with optional Loading/Unloading stations)
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
210 Urine Test Strips per hour
of 5 at a minimum bar width of 0.005 in (0.127
Onboard storage of up to 10,000 patient results
Conventional, S.I., Qualitative or Combination
Workstation
Computer with monitor/keyboard/mouse and printer
Printer
Interfaces
Dimensions
Chemistry system
Printer
Weight
Chemistry module 100 lbs – 45.5 kgs
12 lbs - 5.2 kgs each
Electrical Power
Chemistry Module
(recommended by not provided)
Ambient
64° F to 82° F (18° C to 28° C)
1,200 British Thermal Units or BTUs
Instrument Warm-up
System at operating temperature on standby within 50 minutes of powering on.
Package
iChemVELOCITY system
Laser Jet Printer
2 System Description
External – Laser Jet
USB port, Ethernet
22 H x 21 W x 24 D (in.) 56 H x 53.5 W x 61 D (cm) Optional Loading/Unloading stations
Printer 23 lbs - 10 kgs Optional Loading/Unloading stations
Req.
Temperature Control
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
20% to 80% Relative Humidity Non condensing iChemVELOCITY heat output approximately
Monitor Mouse, standard keyboard
800-7212
iChemVELOCITY Urine Chemistry Strips
800-7704
iChem Wash Solution 7 liters container
800-7211
IRISpec CA/CB/CC Controls
800-7703
iChem CalChek Kit
2 System Description
Consumables or Part Replacement
REF Number Description
Chapter 3 – Setup
This section describes the steps necessary to setup and to customize the system.
iChemVELOCITY must be initially turned on in the following order to
The 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. When the Instrument Screen is displayed on the monitor, the status light will turn green.
4. If the optional Load/Unload Stations are attached, they should be empty during power up.
5. 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.
3 Setup
The following options are available for user-defined settings:
• Operator Accounts
• Lab Information
• System Configuration
• LIS Interface
• Chemistry
• QC
• Specimen
• Release
• Data Management
The following options are only available if an iQ 200 Series module is connected to the chemistry system:
• Formed Particles
• REF Override
• Urine Gating
• Urine Auto-Release
• Urine Auto-Classify
Accessing a Setup Screen
3 Setup
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.
View Log
3 Setup
Settings are saved in a log each time they are created, modified, or deleted. The log records the date/time and the operator that made the changes. This includes changes made to Chemistry QC such as expiration date such as expiration date made via the Instrument screen \ Consumables \ Chemistry QC screen.
To access the log, click the View Log button. The Settings Log screen is displayed.
NOTE: Only one change at the time can be selected for Restore,
Restore…, or Save as… options. After a setting has been restored, the user must restart the system for the change to take effect; see Chapter 8
– Restart button for more information.
3 Setup
Restore Button
This option can be used to restore setting change directly from the View Log.
1. From the list, select the change to restore, and then click the Restore button. The setting will be restored to its previous state.
2. The system signals that a restart is necessary.
Restore… Button
This option can be used to restore setting from a source other than the Settings Log, for example a USB drive; see Save as… Button.
1. Click the Restore… button, a Windows screen is displayed.
2. Select the source where the setting change was saved.
3. Select the file with a .slf extension, and then click the Open button. The setting will be restored to its previous state.
4. The system signals that a restart is necessary.
Save as… Button
This option can be used to save setting change to a source other than the Settings Log, for example a USB drive.
1. From the list, select the change to save, and then click the Save as… button, a Windows screen is displayed.
2. Select the destination where the setting change will be saved, the default is the Logs folder.
3. If necessary, change the name of the file, for example the setting parameter that was changed, and then click the Save button.
4. The setting change can be retrieved to restore the previous setting; see Restore… Button.
3 Setup
Viewing the Saved Settings
This function can be used to view the saved settings, and if necessary, transmit the settings to Iris Diagnostics or your distributor.
1. Perform a Save as… and select the Desktop for the destination, and then click the Save button.
2. Press the windows key
3. Right click the file with the .slf extension, and then select Rename.
4. Replace the .sfl extension with .xml and then press Enter.
5. Double-click on the .xml file. The Instrument Configuration is displayed in Windows Internet Explorer.
and the D key. The desktop is displayed.
Operator Accounts Settings
3 Setup
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.
Adding a New Operator
1. From the Operator Accounts screen, click the New button. The New Operator Account screen is displayed.
3 Setup
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.
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.
3 Setup
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.)
Laboratory Information Settings
The Laboratory Information screen displays seven lines allowing the user to enter specific laboratory information that will be displayed on reports.
3 Setup
1. Type the laboratory information in the order it will be displayed on reports.
2. To add a signature line to the last page of patient reports, enter the desired information into the Signature field. If no signature line is required, leave the field blank to suppress it.
3. Click OK to validate the entries and close the screen.
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.
The user has the possibility to mix conventional and qualitative chemistry settings for the Iris fully automated chemistry system. These values can be user-defined in the Chemistry Settings screen. The chemistry settings can be saved for a primary and a backup chemistry system.
The following options are only available if an iQ Series microscopy module is connected to the chemistry system:
• Microscopy System Present
• Skip microscopy if no chemistry available
• Consolidation window
• Gate on chemistry
3 Setup
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.
Chemistry System Present
3 Setup
Another chemistry system can be connected to the iChemVELOCITY using the iChem must be selected and configured at the time of installation. For example, an iChem VELOCITY can be used as primary chemistry system, and an iChem100 can be used as backup chemistry system.
1. Click the checkbox to enable the chemistry system.
2. In the ID field, enter the microscopy system Serial Number. The serial number plate is located on the back of the instrument.
®
BOOST™ Kit. If this kit is used, both chemistry systems
Enter Primary Chemistry Settings
1. From the Instrument screen, click the Go off line button. Click the Settings button. Click the System Configuration button.
2. From the System Configuration screen, select the analyzer to be used as primary system. Click the Install Settings button, the Select Chemistry Settings screen is displayed.
3 Setup
3. Use the pulldown button to select the primary chemistry system and settings to install.
4. Click the OK button to install the chemistry settings and return to the System Configuration screen.
5. Click the OK button.
6. The system will prompt to restart the software. From the Instrument screen, click the Maintenance button, and then click the Restart button.
7. When the system restarts, from the Instrument screen, click the Go off line button. Click the Settings button.
a. If the chemistry settings need to be personalized: click the
Chemistry button and edit the chemistry settings as necessary. When completed, click the OK button. The system will prompt to restart the software. From the Instrument screen, click the Maintenance button, and then click the Restart button.
b. If the chemistry settings do not need to be edited: click the
System Configuration button.
3 Setup
8. From the System Configuration screen, make sure the proper primary settings are displayed.
9. Click the Save as Primary button.
10. Click the OK button. The system will prompt to restart the software. From the Instrument screen, click the Maintenance button, and then click the Restart button.
Enter Backup Chemistry Settings
1. From the Instrument screen, click the Go off line button. Click the Settings button. Click the System Configuration button.
2. From the System Configuration screen, select the analyzer to be used as backup system – Other chemistry system. Click the Install Settings button, the Select Chemistry Settings screen is displayed.
3 Setup
3. Use the pulldown button to select the backup chemistry system and settings to install.
4. Click the OK button to install the chemistry settings and return to the System Configuration screen.
5. Click the OK button.
6. The system will prompt to restart the software. From the Instrument screen, click the Maintenance button, and then click the Restart button.
7. When the system restarts, from the Instrument screen, click the Go off line button. Click the Settings button.
a. If the chemistry settings need to be personalized: click the
Chemistry button and edit the chemistry settings as necessary. When completed, click the OK button. The system will prompt to restart the software. From the Instrument screen, click the Maintenance button, and then click the Restart button.
b. If the chemistry settings do not need to be edited: click the
System Configuration button.
3 Setup
8. From the System Configuration screen, make sure the proper settings are displayed.
9. Click the Save as Backup button.
10. Click the OK button. The system will prompt to restart the software. From the Instrument screen, click the Maintenance button, and then click the Restart button.
Validating the Changes
1. Click OK to validate the entries and close the screen.
2. If any change is made to the System Configuration settings, the system must be restarted for the changes to take effect. After rebooting, the Instrument screen will be displayed.
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.
The following options are only available if an iQ Series module is connected to the chemistry system:
• Obtain Chemistry Information from LIS
• Suppress Usage of Generated Chemistry Results when Obtaining
Specimen Information from LIS
• Specimen Information to LIS
• Send Chemistry Information before Querying LIS
3 Setup
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
Skip Specimen if LIS Fails
If this box is checked, the specimen will not be sampled for chemistry if the communications with the LIS failed.
Obtain Patient Demographics Information from LIS
3 Setup
If this box is checked, the Demographics button is enabled.
Demographics
1. Click the Demographics button to open the Demographics screen.
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.
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 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
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:
3 Setup
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 is displayed.
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 is displayed.
2. From the Chemistry Settings screen, click the Edit Map button. The Chemistry Map Settings screen is displayed 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.
Edit Box
3 Setup
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.
3 Setup
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.
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.
QC Settings
The QC screen allows the user to automatically send control results to the printer, the LIS or both for Chemistry QC.
3 Setup
1. Select the destination for QC results to be sent automatically for Chemistry QC.
2. Click OK to validate the selection and close the screen.
NOTE: Both the Printer and LIS checkboxes can be selected as
automatic release destinations for results.
REF Override Settings
This option is only available if an iQ Series microscopy module is connected to the chemistry system.
Specimen Settings
The Specimen screen allows the user to control whether barcode scan failures are flagged or not.
3 Setup
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.
Enable detailed audit trail
If checked, this option will indicate, inside the Audit Trail field of the report, any changes that were made to the results, including the name of the user that made these changes.
This option must be selected in order to edit chemistry results; see
Editing Results.
Report operator [auto]
If checked, this option will set the username to [Auto] for results that are auto-released.
If unchecked, the results will display the name of the user currently logged in when the results are auto-released.
Release Settings
The Release screen allows the user to select the destination for the release of results.
3 Setup
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.
Urine Gating Settings
This option is only available if an iQ Series microscopy module is connected to the chemistry system.
Urine Auto-Release Settings
This option is only available if an iQ Series microscopy module is connected to the chemistry system.
3 Setup
Urine Auto-Classify Settings
This option is only available if an iQ Series microscopy module is connected to the chemistry system.
Sequence Number
A sequence number is assigned to samples and functions as a counter of the number of samples that are run on the system. The sequence number is displayed on the Specimen Results screen, and is displayed and printed on the specimen report.
3 Setup
The Sequence button, located on the bottom right of the Instrument screen, gives access to a Sequence number screen into which the next sequence number to be used can be entered. The initial sequence number that can be entered must be comprised between 0 and
2147483647.
4 Sample Processing
Chapter 4 – Sample Processing
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.
1. Click Log On. The Log On screen is displayed.
4 Sample Processing
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-A3 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 2-8
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.
o
C. Bring the specimen to room temperature before testing.
4 Sample Processing
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.
Specimen Volume
Specimen volume for analysis by the iChemVELOCITY alone should be at least 2 mL.
Total Tube
Type of Tube
Maximum
without Spillage
15 mL
Fisherbrand Borosilicate Culture Tubes
12 mL
9.5 mL
Urine collection Conical Base
(Greiner Bio-one)
7.5 mL
15 mL
Hycor KOVA Tubes, Hycor Biomedical Inc.
12 mL
8 mL
BD Vacutainer® UAP Plus Tubes
6 mL
10 mL
BD Vacutainer® UAP Plus
round botton
8 mL
4 Sample Processing
Sample Tube Specifications
Dimensions: 16mm X 100mm glass or polystyrene plastic tubes.
Examples of tubes that may be used and their maximum volumes
Volume (mL)
Allowable Volume
Tubes with no stabilizer,
Tubes without preservative,
Backside oScreen Level
4 Sample Processing
Preparing Sample Racks
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 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.
4 Sample Processing
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 is displayed.
4 Sample Processing
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.
4 Sample Processing
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
4 Sample Processing
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 50 minutes if it was turned off for more than 6 hours.
1. Make sure that sufficient supplies and consumables are available to complete the anticipated workload; see Consumables Traceability.
2. Run the QC Rack on the iChemVELOCITY. See Running QC.
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 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.
1. Rotate the strip loader to the unlock
2. Remove and discard the old desiccants and
3. Fully extend the strip loader and tilt it at a 45 degree angle.
4. Load the urine chemistry strips inside the
5. Retract the strip loader, and then shake the
4 Sample Processing
Consumables
NOTE: Replenishment of consumables can be performed without
stopping the measurements.
Loading Urine Chemistry Strips
CAUTION: Do not leave the test strips in the module for more than 5 days. Strips exposed to the air for too long can cause erroneous results. Best practice is to allow the chamber to empty completely before adding new strips.
position, and then pull it out from the analyzer.
replace with the new ones provided with the chemistry strip vial.
Test Strip Loader as indicated on the Test Strip Loader (Iris logo facing the back of the loader.)
loader lightly so that the chemistry strips
are straight.
6. Insert the strip loader inside the
7. Look through the strip provider module
8. If some strips are not flat, rotate the strip
4 Sample Processing
analyzer. Rotate the strip loader to the lock position so that the chemistry strips drop inside the strip provider module. The strip provider module will tumble to place the strips in the flat position.
window to verify that the strips are flat and are oriented in the proper direction (black tab facing the back of the instrument).
loader 180 degrees, and then pull it out from the analyzer for 5 seconds.
9. Re-insert the strip loader inside the analyzer, and then rotate the strip loader to the lock position. The strip provider module will tumble to place the strips in the flat position.
10. If strips are still in the wrong orientation, they will need to be re-aligned or removed manually.
NOTE: If the front door is opened while samples are being processed, the
samples will be reported as Chem NA and will need to be rerun.
13. Open the Strip Provider Module; see
Accessing the Strip Provider Module.
Accessing the Strip Provider Module
16. Close the door. Turn the power back on
the left side of the chemistry system.
4 Sample Processing
11. If samples were being processed, wait two (2) minutes to allow the instrument to process the data.
12. Turn the power off by pressing the green button located on the left side of the chemistry system.
14. Wear gloves to avoid contamination of the strips while re-aligning the strips.
15. Close the Strip Provider Module; see
.
by pressing the green button located on
4 Sample Processing
Replacing Wash Solution Container and Wash Solution Filter
As needed or quarterly
CAUTION: Wear fresh gloves when changing the Wash Solution filter. Have a supply of paper towels to catch spills and drips.
The iChem Wash Solution is packaged with 4 filters. Replace the Wash Solution Filter with each bottle.
Items required: iChem Wash Solution (REF: 800-7704 and iChem Wash Solution Filter, paper towels and protective gloves.
When the “Chemistry Wash level is low” message appears:
1. Make sure the system is in Standby mode, as indicated on the top left of the instrument screen.
2. Remove the cap of the old wash solution bottle.
3. The filter located at the end of the tubing needs to be replaced with every container.
4. Remove the old filter by grasping the tube above the filter and pulling the filter straight off.
5. Remove the new filter from its package and push it straight onto the tube. The filter only goes on one way, with the narrow section going into the tube
6. Insert the tubes into the wash solution bottle and tighten the cap.
7. Do not mix the contents of the bottles.
8. Dispose of the old container and the old filter.
800-7212
iChemVELOCITY Urine Chemistry Strips
800-7704
iChem Wash Solution 7 liters container
800-7211
IRISpec CA/CB/CC Controls
800-7703
iChem CalChek Kit
4 Sample Processing
Consumables Part Numbers
REF Number
Description
5 Quality Control
Chapter 5 – Quality Control
The Quality Control program is used to collect QC data and display QC reports and statistics. These functions are used to obtain data, verify and monitor proper system operation.
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 800-7211).
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.
QC Settings
See Consumables Traceability chapter.
Position
Insert Color
Volume
Contents
Function
Barcode
8
3 mL
CA Control
Primary control
No
9
3 mL
CB Control
Primary control
No
10
3 mL
CC Control
Primary control
No
Running QC
Items required: Urine Control CA/CB/CC (REF 800-7211), 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. Color-coded reagents and color-coded control rack inserts eliminates mistakes in control set-up. Place the controls in the following positions onto the Control Rack:
5 Quality Control
4. Place the rack on the Sampler.
5. The system compares the expiration date of the QC material and chemistry strip to the current instrument date/time, to verify that the material or chemistry strip is valid for use.
6. If an expired material was used, the system will display a red alarm for the iChem VELOCITY only, and sample processing cannot be performed.
7. A manager user can enable the ‘Expired Consumable Lockout Override’ function in order to run samples on the instrument, see
Expired Consumable Lockout Override.
8. When control testing is completed, the results are sent to the LIS and/or printed as indicated in Settings.
9. The results will also automatically move to the QC Review and QC Statistics screens.
10. If the results are within the allowable range, the date and time of the QC will be displayed on the Last QC field of the Instrument screen. Proceed to patient testing.
11. When Control testing is completed, the results are printed and/or transmitted to the LIS depending on the user configuration (consult
QC Settings.)
QC Failure
QC Failure needs to be resolved in order to be able to process patient samples.
1. Repeat the run using the same lot number.
2. Repeat the run using a new lot number.
3. Run a Reflectance CalChek, see Reflectance CalChek.
4. If the CalChek is successful, repeat the QC run.
5. If the CalChek failed or if the QC fails again, contact Technical Services or your distributor.
5 Quality Control
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 (∆) 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 is displayed 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.
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 is displayed.
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 is displayed.
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.
5 Quality Control
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.
Save Button
This option allows the user to save QC results for long term storage in HTML format, which can be opened and saved on virtually any computer.
5 Quality Control
QC Report
1. The QC report for the chemistry system can be reviewed by highlighting the desired ID and by clicking Re-report.
2. A screen is displayed where the QC report destination can be selected; see Re-Report button.
3. The Chemistry QC report will display the Control name, operator identifier, analysis time stamp, rack position #, lot ID, 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.
4. If an expired material was used, mention of it is displayed in red for the iChem VELOCITY chemistry instrument; see Use of Expired
Material for more information.
5. A manager user can enable the ‘Expired Consumable Lockout Override’ function in order to run samples on the instrument; see Use
of Expired Material for more information.
5 Quality Control
Print Button
Click the Print button to send the report to the printer.
Save Button
This option allows to user 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 Quality Review screen is displayed.
3. Click the Save button, a standard save Windows popup is displayed.
4. Select the destination: a. E:/ USB drive b. F:/External hard drive
5. Select the folder, and then type the name for the file to be saved. Click the Save button.
5 Quality Control
Saving a Specific QC Result
1. Click Instrument.
2. Click Quality Review. The Quality Review screen is displayed.
3. Select the QC result to be saved, and then click the Re-Report button. The Report Results screen for the selected QC is displayed.
5 Quality Control
4. Click the Save button, a standard save Windows popup is displayed.
5. Select the destination: a. E:/ USB drive b. F:/External hard drive
6. Select the folder, and then type the name for the file to be saved. Click the Save button.
QC Statistics
1. Click Instrument.
2. Click QC Statistics. The QC Statistics screen is displayed.
3. To view a specific report, select the control lot number. The report is displayed.
5 Quality Control
a. Chemistry QCs are plotted by QC Lot number. b. Each type/lot specific report contains the control identifier, report
time stamp, lot number, and expiration date.
c. Chemistry QC chart indicates when chemistry strip lot changes
occurred. d. Chemistry QC chart does not display SD, Mean, and Target lines. e. The user can search QC statistics for the currently selected QC
material by selecting a specific time frame.
4. The next section is the Levey-Jennings chart (L-J chart), which lasts indefinitely for the "current" lot number. All previous QC and patient results are subject to a First In, First Out basis after 10,000 patient and QC records are reached..
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