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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 .
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