IDS IDS-iSYS

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List of symbols used on the analyser

Manufacturer.

In vitro diagnostic medical device.

Consult the instructions for use.

Caution recommended: see Safety Precautions.

Risk of biological contamination.

Risk of crushing injury.

Electrical and electronic waste.

Dispose of in accordance with current country-

speciﬁc laws.

High temperature.

Risk of hand injury.

Preface

IDS-iSYS User Manual - Revision M1" P 5

Software version V 14

Main Page

Table of Contents8
Section 1 Operating Principle13
1-1- Field of Use14
- Operating Principle15
1-2- General Overview16
1-3- Characteristics20
1-4- Installation23
- 1-4-1- Environment23
- 1-4-2- Electricity Supply24
- 1-4-3- Connections24
1-5- Operating Principles25
- 1-5-1- Luminescence Measurements25
- 1-5-2- Absorbancy Measurements25
- 1-5-3- Immunoassays26
- 1-5-4- Biochemistry Assays27
1-6- Precautions for Use28
- 1-6-1- General Precautions28
- 1-6-2- Special Precautions29
- 1-6-3- Safety Precautions29
- Section 2 User Interface Software30
2-1- Structure of the Software32
- User Interface Software32
2-2- Main Screen33
2-3- Menus39
- 2-3-1- FILE Menu39
- 2-3-2- SESSIONS Menu40
- 2-3-3- DATA Menu41
- 2-3-4- MAINTENANCE Menu42
- 2-3-4- MAINTENANCE Menu (Continued)43
- 2-3-5- SETUP Menu44
- 2-3-6- MANAGEMENT of LOTS Menu45
- 2-3-7- HELP Menu46
2-4- Functions Keys47
- Section 3 Use48
Information on the Lid Opening50
- Use50
3-1- Start up52
- 3-1-1- Initial Start up52
- 3-1-2- Start up from Standby Mode52
3-2- Installation of Reagents53
- 3-2-1- Colour Codes Associated with Reagent Positions in the Reagent Compartment58
- 3-2-2- Information Displayed with Reagents58
- 3-2-3- Management of on Board Reagents59
3-3- Installation of Ancillary Reagents61
- 3-3-1- Installation of Internal Ancillary Reagents62
- 3-3-2- Installation of External Ancillary Reagents63
- 3-3-3- Installation of IDS-Isys Cuvettes65
3-4- System Performance Checks (Immunoassay Only)67
- 3-4-1- Programming the Qualiﬁcation Proﬁle67
- 3-4-2- Management of Results68
3-5- Programming Calibrations and Controls70
- 3-5-1- Programming Calibrations70
- 3-5-2- Programming Quality Controls73
3-6- Loading of Calibrators, Controls or Samples in the Sample Compartment75
- 3-6-1- Removable Trays76
- 3-6-2- Fixed Tray79
- 3-6-3- Conﬁgure a Position Without Barcode80
- 3-6-4- End of Loading81
- 3-6-5- Colour Codes Associated with Sample Positions82
- 3-6-6- Colour Codes Associated with Removable Trays82
- 3-6-7- Colour Codes Associated with Position Contour83
3-7- Programming Samples84
3-8- Assays85
- 3-8-1- Performing Assays85
- 3-8-2- Adding Samples During an Assay86
- 3-8-3- Adding or Replacing a Reagent During an Assay87
- 3-8-4- Releasing an Alarm During an Assay88
- 3-8-5- Unloading Samples During an Assay90
- 3-8-6- Performing Reﬂex Tests91
- 3-8-7- Performing Dilutions92
3-9- Adding an Emergency (STAT) Sample94
3-10- Results95
- 3-10-1- Result of a Calibration96
- 3-10-2- Result of Controls100
- 3-10-3- Sample Results101
- 3-10-4- Work List Results102
3-11- Messages Associated with Results104
3-12- Results Storage108
3-13- Quality Control Management110
- 3-13-1- Cumulative Analysis110
- 3-13-2- Westgard Rules113
3-14- Switching the Analyser Oﬀ115
- 3-14-1- Emptying the Solid Waste116
- 3-14-2- Emptying the Liquid Waste117
3-15- Switching the Analyser Oﬀ Completely118
Section 4 Messages119
4-1- Messages Associated with Calibrations121
- Messages121
4-2- Messages Associated with Calibration Controls123
4-3- Messages Associated with Results124
4-4- Warning Messages128
4-5- Error Messages129
- Section 5 Maintenance130
5-1- Daily Maintenance132
- Maintenance132
5-2- Weekly Maintenance135
- 5-2-1- General Maintenance136
- 5-2-1-1- Cleaning the Reagent Compartment and Plexiglas136
- 5-2-1-2- Cleaning the Sample Tray and Plexiglas136
- 5-2-1-3- Cleaning the Rinsing Well137
- 5-2-1-4- Checking Dilutors and IDS-Isys System Liquid Pumps137
- 5-2-2- Immunoassay Maintenance138
- 5-2-2-1- Rinsing of the IDS-Isys Triggers Tubing138
5-3- Monthly Maintenance139
- 5-3-1- General Maintenance139
- 5-3-1-1- Cleaning the IDS-Isys System Liquid Pump Shafts139
- 5-3-1-2- Cleaning the Liquid Waste Pump Shaft139
- 5-3-1-3- Cleaning the IDS-Isys D-Sorb Pump and Level Sensor Shafts140
- 5-3-1-4- Cleaning the Liquid Waste Level Sensor140
- 5-3-1-5- Checking Lamp References141
- 5-3-1-6- Switch off the Instrument141
- 5-3-2- Immunoassay Maintenance141
- 5-3-2-1- Cleaning the IDS-Isys Wash Solution Pump and Level Sensor Shafts141
- 5-3-2-2- Rinsing of the AP Substrate Tubing142
5-4- Analyser Interventions143
- 5-4-1- Replacement of Lamp143
- 5-4-2- Replacement of Probe144
- 5-4-3- Replacement of Primary Fuses145
- 5-4-4- Replacement of Secondary Fuses146
- 5-4-5- Replacement of IDS-Isys Wash Solution Pump (Immunoassay)147
- 5-4-6- Replacement of IDS-Isys System Liquid Pump147
- 5-4-7- Replacement of Liquid Waste Pump147
- 5-4-8- Replacement of IDS-Isys D-Sorb Pump148
- 5-4-9- Removal of the On-Board IDS-Isys Cuvettes Cube148
- 5-4-10- Adjustment of Probe Reference Position149
- 5-4-10-1- Adjustment Procedure for Analyser Without Lid Locking System150
- 5-4-10-2- Adjustment Procedure for Analyser with Lid Locking System153
- 5-4-11- Unclogging the Sampling Probe158
- 5-4-12- Intervention in System Conﬁguration Menu160
- Section 5 Maintenance160
5-5- Analyser Cleaning163
- 5-5-1- Decontaminating the Containers of Solid and Liquid Waste164
- Section 6 Problems & Corrective Action165
Resolving Errors in Cartridge Check System (CCS)167
- Section 7 System Configuration169
7-1- Programming the Automatic Qualiﬁcation Proﬁle171
- System Configuration171
7-2- Creating the Reﬂex Tests172
- 7-2-1- Creating a New Rule173
- 7-2-2- Launch Option of Reﬂex Tests175
- 7-2-3- Modifying an Existing Rule176
- 7-2-4- Importing/Exporting Rules176
- 7-2-5- Removing a Rule176
7-3- Conﬁguring the Print Settings177
7-4- Options of Validating and Transferring the Results178
7-5- User Management179
7-6- Updating the Analytical Conﬁguration181
- Appendices a183
Waste Disposal a184
Decontaminating the Analyser a185
Cleaning/Decontaminating Declaration a186
Disposal of the Analyser a187
IDS-Isys User Manual - Revision M1187
- 1- Versions of ASTM Protocol199
- 2- ASTM Compatible Version200
- 2-1- General Information200
- 2-2- the Header Block202
- 2-3- the Patient Block203
- 2-5- the Result Block208
- 2-6- the Request Information Block210
- 2-7- the Message Terminator Block212
- 2-8-1-Equipment Conﬁguration213
- 2-8-2-Change to Connection Setup213
- 3- ASTM Compatible V2 Version215
- 3-1- General Information215
- 3-2- the Header Block217
- 3-3- the Patient Block218
- 3-5- the Result Block223
- 3-6- the Comment Block225
- 3-7- the Manufacturer Information Block226
- 3-8- the Request Information Block228
- 3-9- the Message Terminator Block230
- 3-10-1-Equipment Conﬁguration231
- 3-10-2-Change to Connection Setup231
- 3-10-3-Transferring Quality Control Results233
- 4- ASTM Compatible V3 Version234
- 4-1- General Information234
- 4-2- the Header Block236
- 4-3- the Patient Block237
- 4-5- the Result Block242
- 4-6- the Comment Block244
- 4-7- the Manufacturer Information Block245
- 4-8- the Request Information Block247
- 4-9- the Message Terminator Block249
- 4-10-1-Equipment Conﬁguration250
- 4-10-2-Change to Connection Setup250
- 4-10-3-Transferring Quality Control Results252
- 6- Examples of Data Transfer254
- 6-1- Data Transferred by the LIS255
- 6-2- Data Transferred to the LIS with ASTM Compatible Version257
- 6-3- Data Transferred to the LIS with ASTM Compatible V2 Version258
- 6-3- Data Transferred to the LIS with ASTM Compatible V3 Version259

Table of Contents