Atellica COAG 360 System Instruction Manual, 2022-02 DXDCM 09017fe9806d21ab-1652782216861 PDF

Atellica COAG 360 System

Instruction Manual
2022-02
siemens-healthineers.com
Table of contents
1 Introduction 13
1.1 About this manual 13
1.2 User manuals 13
1.2.1 Viewing a PDF document 13
1.2.2 Getting online help on a dialog 14
1.2.3 Getting online help on a status alert 14
1.3 Orientation tips 14
1.4 Identification 15
1.5 Service 15
1.6 Warranty 15
1.7 Ordering information 16
1.8 Third-party software copyrights 16
1.9 Trademarks 17
1.10 Manual version history 17
2 Safe handling 18
2.1 Intended use 18
2.1.1 System functions 18
2.2 Intended user 19
2.3 Reporting of serious incidents 19
2.4 General safety information 19
2.4.1 Operator qualification 19
2.4.2 Electrical safety 20
2.4.3 Mechanical safety 20
2.4.4 Operational safety 21
2.4.5 Safe handling of samples, reagents, controls, calibrators, and consumables 22
2.4.6 Safe handling of personal data 23
2.5 IT security measures 24
2.5.1 Hardware requirements 24
2.5.2 IT network characteristics 24
2.5.3 Security measures 24
2.5.4 Protection against unauthorized access 25
2.5.5 Software-related measures to protect personal data 25
2.5.6 Security whitepaper 25
2.6 Safety messages 25
2.7 Symbols 26
2.8 Statutory provisions 30
3 Life cycle 31
3.1 Delivery 31
3.2 Installation 31
3.3 Non-operation 31
3.3.1 Up to 2 weeks 31
3.3.2 More than 2 weeks 31
3.4 De-installation 32
3.5 Movement 32
3.6 Disposal 32
4 Description of the hardware 34

4.1 Analyzer 34
4.1.1 Operating elements 35
4.1.2 Components inside the analyzer 44
Instruction Manual Atellica COAG 360 System | 2022-02

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4.2 External devices 53

4.2.1 LIS 54
4.2.2 LAS (optional) 54
4.2.3 UPS (optional) 55
4.3 Consumables and accessories 55
4.3.1 Racks 55
4.3.2 Adapters 57
4.3.3 Rack tray 57
4.3.4 Evaporation caps 57
4.3.5 Cartridge tool 58
4.3.6 Carriers 59
4.3.7 Cuvette 59
4.3.8 Stirrer bar 59
4.3.9 Cuvette waste bag 59
4.3.10 Water containers 60
4.3.11 Purging solution container 60
4.3.12 Probe cleaner container 61
4.3.13 Opening tool 61
4.3.14 Liquid waste container 62
4.3.15 Tap 62
4.3.16 SVS solution 62
4.3.17 Third-party accessories for centrifugation of samples in racks 63
4.4 Reagents, calibrators, and controls 63
5 Description of the software 64

5.1 Overview of the screen 64
5.2 General elements 65
5.2.1 Status information 65
5.2.2 Automatic transmission 67
5.2.3 Common display functions in dialogs 68
5.2.4 Common action buttons 72
5.2.5 Flags 73
5.3 Dialogs 78
5.3.1 Loading 78
5.3.2 Problem racks 78
5.3.3 Pre-identification 80
5.3.4 Jobs 82
5.3.5 Special order 88
5.3.6 Sample info 89
5.3.7 Sample result info 91
5.3.8 Raw value info 95
5.3.9 Measurement curve 95
5.3.10 Alternative curves 98
5.3.11 Multi-dilution assay curve 98
5.3.12 Analyzer 100
5.3.13 Re-fill stirrer bars 101
5.3.14 Register cuvettes 101
5.3.15 Replace probe cleaner 102
5.3.16 Empty cuvette waste 102
5.3.17 Reagents 102
5.3.18 Overview 102
5.3.19 Loading 105
5.3.20 Assays availability 107
5.3.21 Calibration 108

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5.3.22 Curve filter 111

5.3.23 New calibration 112
5.3.24 Calibration curve 113
5.3.25 Calibration calculator 115
5.3.26 Calibration curve info 116
5.3.27 Controls 117
5.3.28 Control result info 117
5.3.29 Info 118
5.3.30 Alerts 118
5.3.31 Audit log 120
5.3.32 About 125
5.3.33 Setup 125
5.3.34 Archive viewer 125
5.3.35 ASCII converter 129
5.3.36 Assay statistics 130
5.3.37 New statistics 131
5.3.38 Header setup 131
5.3.39 Barcode maker 131
5.3.40 Settings (for barcode maker) 133
5.3.41 Data manager 133
5.3.42 Backup 134
5.3.43 Restore 135
5.3.44 Export 136
5.3.45 Document viewer 137
5.3.46 LAS connection 140
5.3.47 LIS connection 140
5.3.48 Quality control (optional) 140
5.3.49 Reflex testing 141
5.3.50 New rule 142
5.3.51 Edit rule 143
5.3.52 Creating rules for reflex testing 143
5.3.53 Remote services 147
5.3.54 Result export 147
5.3.55 Secure download 148
5.3.56 Service software 149
5.3.57 Definitions loader 150
5.3.58 Installation info 152
5.3.59 User administration 152
5.3.60 New user 154
5.3.61 Edit user 155
5.3.62 Language 155
5.3.63 Assay activation 155
5.3.64 Assay customization 156
5.3.65 Sample result processing 158
5.3.66 Control assignment 159
5.3.67 Control 161
5.3.68 Assay 161
5.3.69 Alerts 162
5.3.70 Barcodes 162
5.3.71 Auto start 164
5.3.72 Printout 164
5.3.73 System (for general settings) 165
5.3.74 Expiration warnings 166
5.3.75 Maintenance 167

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5.3.76 Maintenance task 168

5.3.77 HIL warning 169
5.3.78 Updates 170
5.3.79 Shared folders 170
5.3.80 Maintenance 171
5.3.81 Periodic tasks 171
5.3.82 Maintenance log 172
5.3.83 Manual entry 174
5.3.84 Task execution 174
5.3.85 Data 175
5.3.86 Raw data 175
5.3.87 Lot data 176
5.3.88 Assigned values 178
5.3.89 New assigned value 180
5.3.90 Add lot number 180
5.3.91 Result history 181
5.3.92 Display cleanup 181
5.3.93 User 182
5.3.94 Initialization 182
5.3.95 System (for operating the system) 183
5.3.96 Reagent storage 184
5.3.97 Temperature problem 184
5.3.98 Cuvette waste counter 185
5.3.99 Remote control 185
5.3.100 Help 185
5.3.101 Print 186
5.3.102 Working with the dialogs Data definition and Rack definition 187
5.3.103 Rack definition 190
5.3.104 Sample tubes 190
5.3.105 Calibrator and control racks 192
5.3.106 Sample racks 192
5.3.107 Sample rack templates 193
5.3.108 Data definition 194
5.3.109 Product definition 194
5.3.110 Assay definition and Assay groups 196
5.3.111 Assay procedures 197
5.3.112 Process steps 200
5.3.113 Transfer 200
5.3.114 Incubation 203
5.3.115 Measurement 204
5.3.116 Evaluation methods for raw value 206
5.3.117 Assays 207
5.3.118 Assay measurement 209
5.3.119 Assay measurement assignment 211
5.3.120 Assay calibration 211
5.3.121 Meta-assay 213
5.4 Evaluation methods 215
5.4.1 Delta A 215
5.4.2 Delta A per minute 216
5.4.3 Drifting baseline 216
5.4.4 Absorbance 217
5.4.5 Fixed absorbance 217
5.4.6 Fixed Delta A 217
5.4.7 Percent Delta A 217

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5.4.8 Point of inflexion 218

5.4.9 VLin Integral 218
5.4.10 ETP_cmax, ETP_tmax, ETP_tlag, ETP_auc 219
5.4.11 VMaxDyn 220
5.4.12 VMax_sabs, VMax_sfirst, VMax_ssec, VMax_tabs, VMax_tfirst, VMax_tsec 221
5.4.13 PlateAgg 222
5.5 Check methods 223
5.5.1 Angle 224
5.5.2 Angle DB 224
5.5.3 Drop 225
5.5.4 Drop 2 225
5.5.5 AMaxMin 226
5.5.6 Min Delta A 226
5.5.7 New wave 226
5.5.8 New wave 2 227
5.5.9 Plateau 227
5.5.10 Antigen excess check 228
5.6 Calibration methods 228
5.6.1 Akima 228
5.6.2 Akima II 229
5.6.3 Point-to-point 230
5.6.4 Linear regression 230
5.6.5 Orthogonal regression 231
5.6.6 LogitLog5B 231
6 Configuring the system 235

6.1 Setting the language 235
6.2 Managing user accounts 235
6.2.1 Adding a user account 235
6.2.2 Editing a user account 236
6.2.3 Deleting a user account 236
6.3 Configuring printouts 236
6.4 Setting acoustic signals on status alerts 237
6.5 Selecting the active assays 237
6.5.1 Activating assays 237
6.5.2 Deactivating assays 238
6.5.3 Changing the order of the active assays 238
6.6 Assigning the default template to a sample rack 238
6.7 Making settings in the dialogs Rack definition and Data definition 239
6.7.1 Defining a sample rack 239
6.7.2 Defining a calibrator and control rack 242
6.7.3 Defining a reagent 243
6.7.4 Defining a calibrator 243
6.7.5 Defining a control 244
6.7.6 Defining an assay group 245
6.7.7 Defining an assay procedure 246
6.7.8 Defining an assay 250
6.8 Defining a default assay 252
6.9 Assigning controls 252
6.9.1 Select assay group 252
6.9.2 Edit assay parameters 253
6.10 Configuring automatic control measurements 253
6.10.1 Configure sample result framing 254
6.11 Configuring the sample result release 254

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6.12 Configuring automatic calibrations 255

6.13 Deactivating and activating the HIL check 256
6.13.1 Deactivating the HIL check 256
6.13.2 Activating the HIL check 257
6.14 Configuring automatic display cleanup 257
6.15 Making sample ID settings for barcodes and for the LIS 257
6.15.1 Using additional characters 258
6.15.2 Setting sliders 259
6.16 Configuring shared folders 260
6.17 Configuring the LIS connection 260
7 Preparing for the analysis 261

7.1 Starting the system from cold 261
7.2 Starting the system from eco mode 262
7.3 Logging on 263
7.4 Loading cuvettes 263
7.5 Loading stirrer bars 265
7.6 Re-filling purified water 266
7.6.1 Re-filling the container 266
7.7 Re-filling or replacing purging solution 267
7.7.1 Opening the purging solution container 268
7.7.2 Replacing the purging solution 268
7.7.3 Re-filling the purging solution 269
7.8 Replacing the probe cleaner container 269
7.8.1 Removing the probe cleaner container 270
7.8.2 Inserting the probe cleaner container 270
7.9 Emptying the cuvette waste container 271
7.9.1 Removing the cuvette waste bag 272
7.10 Emptying the liquid waste container 273
7.10.1 Emptying a container 273
7.11 Loading data 274
7.11.1 Loading data using a USB storage device 274
7.11.2 Loading data using the shared folder 275
8 Performing the analysis 277

8.1 Preparing a bottle for loading into the reagent manager 277
8.2 Loading a bottle or a cartridge into the reagent manager 278
8.3 Identifying a bottle loaded into the reagent manager 280
8.3.1 Re-positioning a bottle 280
8.3.2 Identifying the bottle 281
8.4 Loading calibrator and control bottles into the sample manager 282
8.4.1 Unloading the calibrator and control rack 284
8.5 Adding lot data to the software 284
8.5.1 Selecting an expiration date 284
8.5.2 Entering ISI and MNPT 285
8.5.3 Entering a mean normal value 285
8.5.4 Entering assigned values 285
8.6 Measuring a control 287
8.6.1 Measuring Siemens Healthineers controls 287
8.6.2 Measuring control samples 288
8.6.3 Measuring third-party controls 289
8.6.4 Evaluating control results 290
8.7 Ejecting a bottle or cartridge 291

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8.8 Unloading a bottle or cartridge 291

8.8.1 Re-using a bottle 292
8.8.2 Discarding a bottle 292
8.8.3 Discarding a cartridge 293
8.9 Loading barcoded primary sample tubes 293
8.10 Loading STAT samples in barcoded primary sample tubes 298
8.11 Loading barcoded sample tubes on sample racks with the sample rack setting For manual
orders 302
8.12 Pre-identifying and loading samples and STAT samples in non-barcoded secondary
sample tubes 304
8.12.1 Identifying positions on the sample tube rack 307
8.13 Loading and unloading sample tubes using a rack tray 309
8.13.1 Unloading sample tubes using a rack tray 313
8.14 Troubleshooting unidentified samples or samples causing other problems 314
8.14.1 Selecting a sample position 314
8.14.2 Unreadable barcode 315
8.14.3 Identical barcodes 316
8.14.4 Other problems 316
8.15 Unloading samples 317
8.16 Displaying data in the job list 318
8.16.1 Display functions 318
8.17 Searching for a sample ID or a patient name 319
8.18 Displaying results and navigating through assays and samples 320
8.18.1 Displaying all results of a job 320
8.18.2 Navigating through assays and samples 320
8.19 Displaying a measurement curve 320
8.19.1 Displaying curves 321
8.19.2 Customizing the display of measurement curves 322
8.20 Displaying the results of the PSI check for a sample and its results 323
8.20.1 Proper fill 323
8.20.2 HIL check 324
8.21 Releasing results 325
8.22 Printing results 326
8.22.1 Evaluating and printing results for percent platelet aggregation 326
8.22.2 Printing results for selected or all samples 327
8.23 Displaying and validating the control results for an assay in a control period 327
8.24 Displaying all results affected by an invalid control 327
8.25 Calibrating an assay 328
8.25.1 Evaluating a calibration curve 329
8.26 Printing barcode labels 331
9 Finishing the analysis 333

9.1 Washing the probes 333
9.2 Cleaning up jobs and controls 333
9.2.1 Deleting off-board sample IDs manually from the job list 334
9.2.2 Starting automatic display cleanup 334
9.3 Accepting or rejecting remote control 335
9.4 Logging off 335
9.5 Switching to eco mode or shutting down the system 336

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10 Performing maintenance and cleaning 338

10.1 List of maintenance tasks 338
10.2 Types of maintenance tasks 339
10.2.1 Automatic and semi-automatic maintenance tasks 339
10.2.2 Manual maintenance tasks 339
10.3 Performing maintenance tasks 340
10.3.1 Performing periodic maintenance tasks 340
10.3.2 Performing as needed maintenance tasks 341
10.4 Weekly maintenance 342
10.4.1 Cleaning the purging solution container 342
10.4.2 Purging the tubings 344
10.4.3 Cleaning the water containers 345
10.5 Monthly maintenance 348
10.5.1 Cleaning the aliquot probe 348
10.5.2 Backing up data 351
10.5.3 Cleaning the racks, the adapters, and the carriers 352
10.5.4 Cleaning the cuvette waste container 353
10.5.5 Cleaning the liquid waste containers 356
10.5.6 Checking the functioning and the precision of the pipettors 358
10.6 As needed maintenance 360
10.6.1 Cleaning the surface of the analyzer, the handheld barcode reader, the sample
manager, and the reagent manager 360
10.6.2 Cleaning the touchscreen monitor 361
10.6.3 Cleaning the keyboard and the mouse 362
10.6.4 Cleaning the accessories drawer 362
10.6.5 Cleaning the HIL cuvette 363
10.6.6 Priming the tubings 364
10.6.7 Replacing the aliquot pipettor 364
11 Troubleshooting 374
11.1 Overview 374
11.1.1 Status alerts 374
11.1.2 Status light 375
11.2 Red status alerts 376
11.2.1 Connection problem (4) 376
11.2.2 Initialization problem (6) 376
11.2.3 Initialization problem with access door, consumables, or waste (8) 377
11.2.4 Problem with liquid waste pressure (9) 379
11.2.5 Software problem with CAN bus (12) 380
11.2.6 Initialization required: component <component name> (14) 380
11.2.7 Initialization problem: input wheel carries more than 6 items (16) 381
11.2.8 Initialization required (17) 382
11.2.9 Service required: component <component name> (19) 383
11.2.10 Leakage detected in analyzer. Fluid dripped into collection pan (22) 385
11.2.11 System on backup power (24) 385
11.2.12 Backup power used up, shutting down (25) 385
11.2.13 Probe not washed (27) 385
11.2.14 Housing lid or cuvette loader open (29) 386
11.2.15 Clog in aliquot probe cannot be removed (34) 386
11.2.16 Purified water used up (41) 386
11.2.17 Purging solution used up (44) 386
11.2.18 Purging solution container missing (45) 387
11.2.19 Probe cleaner container empty. Replace probe cleaner container (46) 387

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11.2.20 Probe cleaner reservoir empty. Replace probe cleaner container immediately
(47) 387
11.2.21 Cuvettes used up (49) 388
11.2.22 Stirrer bars used up (51) 388
11.2.23 Liquid waste container full (53) 388
11.2.24 Liquid waste container missing (54) 388
11.2.25 Cuvette waste container full (56) 388
11.2.26 Cuvette waste container missing or drawer open (57) 389
11.2.27 Probe cleaner not identified (58) 389
11.2.28 Probe cleaner expired (60) 390
11.2.29 Pumping of purified water not possible (63) 392
11.2.30 Probe cleaner not flowing (64) 392
11.2.31 Sample material required (70) 394
11.2.32 Calibrator or assigned value missing (73) 395
11.2.33 Reagent missing (76) 395
11.2.34 Control missing (94) 395
11.2.35 Temperature in LOCI reader out of range (<too high>/<too low>) (102) 396
11.2.36 Temperature sensor of LOCI reader defective (103) 396
11.2.37 Temperature in reagent storage out of range (<too high>/<too low>) (105) 396
11.2.38 Temperature sensor of reagent storage defective (106) 397
11.2.39 Temperature in absorbance reader out of range (<too high>/<too low>) (108)
397
11.2.40 Temperature sensor of absorbance reader defective (109) 398
11.2.41 Temperature in incubator out of range (<too high>/<too low>) (111) 398
11.2.42 Temperature sensor of incubator defective (112) 398
11.2.43 Temperature in pre-heater out of range (<too high>/<too low>) (114) 398
11.2.44 Temperature sensor of pre-heater defective (115) 399
11.2.45 Ambient temperature out of range (<too high>/<too low>) (117) 399
11.2.46 Ambient temperature sensor defective (118) 400
11.2.47 QC rule violation (120) 400
11.2.48 Control result not saved or rejected by QC software (122) 400
11.2.49 QC database capacity critical (123) 400
11.2.50 Calibration required (130) 401
11.2.51 Problem with compressed air pressure (<too high>/<too low>) (140) 402
11.2.52 During "Aliquotting speed reduced" only STAT racks will be processed <rack ID>
(10001) 402
11.2.53 Aliquotting not possible. No cap defined for rack <rack ID>-<rack position>
(10002) 402
11.2.54 Problem with component: <component name> (10009) 403
11.2.55 Incorrect wash program <wash program name> for component <component
name> (10010) 403
11.3 Yellow status alerts 404
11.3.1 Initializing (2) 404
11.3.2 Starting (3) 405
11.3.3 System shutting down. Do not switch off the analyzer (5) 405
11.3.4 Transportation problem at component <component name> (11) 405
11.3.5 Maintenance mode active (15) 411
11.3.6 Service recommended: component <component name> (18) 411
11.3.7 Updates available (20) 412
11.3.8 Clog detected during sample aspiration (21) 412
11.3.9 Cleaning of HIL cuvette required. HIL check not possible (23) 412
11.3.10 Maintenance due (26) 412
11.3.11 Aliquot probe reached maximum number of cap piercings (28) 413
11.3.12 Access door open (30) 413

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11.3.13 Purified water almost used up (40) 413

11.3.14 Purified water container missing (<Water front>/<Water rear>) (42) 413
11.3.15 Cuvettes almost used up (48) 414
11.3.16 Stirrer bars almost used up (50) 414
11.3.17 Liquid waste container almost full (52) 414
11.3.18 Cuvette waste container almost full (55) 414
11.3.19 Probe cleaner container missing (59) 414
11.3.20 Registered cuvettes used up (65) 415
11.3.21 Registered cuvettes almost used up (66) 415
11.3.22 Probe cleaner almost expired (67) 415
11.3.23 Aliquot not sufficient (72) 415
11.3.24 Calibrator not sufficient (75) 416
11.3.25 Reagent not sufficient (79) 416
11.3.26 Sample tubes with identical barcodes on rack <rack ID> (80) 416
11.3.27 Reagent storage full (83) 416
11.3.28 Aliquotting speed reduced (84) 417
11.3.29 Unidentified item on rack (85) 418
11.3.30 Rack not identified or rack barcode unreadable (86) 418
11.3.31 Problem rack re-loaded (87) 418
11.3.32 Unidentified item on input wheel (88) 419
11.3.33 Unloading of input wheel required (89) 420
11.3.34 Lot data missing (90) 420
11.3.35 Lot data conflict (92) 420
11.3.36 Item without evaporation cap on input wheel (93) 421
11.3.37 Control not sufficient (96) 422
11.3.38 Product expired (97) 422
11.3.39 Overfilled bottle or cartridge on input wheel (98) 423
11.3.40 Product almost expired (99) 423
11.3.41 Operating temperatures not yet reached (100) 424
11.3.42 Temperature in LOCI reader in warning range (<too high>/<too low>) (101)
424
11.3.43 Temperature in reagent storage in warning range (<too high>/<too low>)
(104) 425
11.3.44 Temperature in absorbance reader in warning range (<too high>/<too low>)
(107) 425
11.3.45 Temperature in incubator in warning range (<too high>/<too low>) (110) 426
11.3.46 Temperature in pre-heater in warning range (<too high>/<too low>) (113) 426
11.3.47 Ambient temperature in warning range (<too high>/<too low>) (116) 427
11.3.48 Required calibration running (129) 428
11.3.49 Required re-calibration running (131) 428
11.3.50 Re-calibration required (132) 429
11.3.51 Assay using calibration that is almost expired (133) 430
11.3.52 Service required: stirrer motors defective (10003) 430
11.3.53 Unknown sample tube type: barcode <barcode> on rack <rack ID>‑<rack
position> (10005) 430
11.3.54 Insufficient volume of sample, calibrator, or control on rack <rack ID>‑<rack
position> (10006) 431
11.3.55 Fan problem <fan number> (10007) 431
11.4 Component names in status alerts 432
11.5 Possible entries for <problem> 433
11.6 Other problems 435
11.6.1 Problem with software start 435
11.6.2 Stirrer bars filled into cuvette loader 435
11.6.3 Problem with analyzer 435

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11.6.4 Problem with peripherals 436

11.6.5 Problem with LAS connection 436
11.6.6 Removing cuvette blockings in the cuvette loader 439
11.7 Exporting troubleshooting data using remote services 450
11.7.1 Create system backup 450
11.7.2 Create troubleshooting data 450
11.7.3 Export data 451
12 Technical specifications 452

12.1 Analyzer 452
12.1.1 Operating conditions 455
12.1.2 Storage conditions 456
12.1.3 I/O ports 456
12.2 Computer 456
12.3 UPS (optional) 457
12.4 Consumables 457
12.5 Barcodes 457
12.5.1 Samples 457
12.5.2 Reagents, calibrators, and controls 458
12.5.3 Racks 459
12.5.4 Cuvette bag 459
12.6 Sample tubes 459
13 Appendix 461
13.1 Principle of operation 461
13.1.1 Sample handling 461
13.1.2 Reagent handling 465
13.1.3 Processing of assays 466
13.1.4 Results 468
13.2 Principle of measurement 468
13.2.1 HIL measurement principle 468
13.2.2 Absorbance measurement principle 469
13.2.3 LOCI measurement principle 471
13.2.4 Blank value 473
13.3 Calculation of results 473
13.3.1 Data reduction methods 474
13.3.2 Normalization methods 477
14 Revision Information 479
Index 481

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1 Introduction
1 Introduction
This chapter gives introductory information.
1.1 About this manual

This manual describes the use of the Atellica® COAG 360 System in clinical laboratories.
The description is limited to the primary operating functions and information required
at times when the system is off or when the online help is not available.
This manual is only valid in conjunction with other user manuals available electronically
on the system or in print.
Depending on the operating system, the selected languages, and regional settings,
screenshots in this manual can differ from the display on the screen.
1.2 User manuals

Certain user manuals are available on the system as PDF documents or online help.
Printed user manuals that are not delivered with the system can be ordered from Siemens
Healthineers service.
1.2.1 Viewing a PDF document

To view a PDF document, proceed as follows:
1 In the software, at the top, select Setup.
→ The dialog Setup is displayed.

2 In the area Tools, select Document viewer.
→ The dialog Document viewer is displayed. For more information on the dialog, see
( Page 137 Document viewer).
3 At the top left, select Manuals.
→ On the right, in the list Manuals, folders for the available languages are displayed.
4 Select the folder for the required language.
→ The available manuals are displayed.
5 Select the required manual.
6 Select the action button Show.
→ The first manual page is displayed.
→ Viewing a PDF document is completed.

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1 Introduction
1.2.2 Getting online help on a dialog

To get online help on the current dialog, proceed as follows:
◆ Select the action button Help.
→ The dialog Help is displayed, showing online help for the dialog.
→ Getting online help on a dialog is completed.
1.2.3 Getting online help on a status alert

To get online help on a status alert, proceed as follows:
1 Select the status alert.
There are several possibilities:
• The dialog where the problem can be resolved is displayed.
• The dialog Info > Alerts showing details of the status alert is displayed.
• If the corresponding dialog is already displayed, the dialog Help is displayed

showing the solution. For more information on the dialog, see ( Page 185 Help).
2 If the dialog Help is not yet displayed, select the status alert a second time.
→ Getting online help on a status alert is completed.
1.3 Orientation tips
Indicates a hint
Is used to provide information on how to avoid operating errors or information
emphasizing important details
Indicates the solution of a problem

Is used to provide troubleshooting information or answers to frequently
asked questions
Indicates a list item
Indicates a prerequisite
Is used for a condition that has to be fulfilled before starting a
particular procedure
Indicates a 1‑step procedure or procedural steps to solve a problem
Indicate steps within procedures
Indicates a link to related information as well as previous or next steps

• If used with "see": reference for further reading in case more information
is required
• If used with "go to": leave current procedure and continue at referred step
→ Indicates the result of a procedural step or a procedure

Print No. DCHS-G01.621.01.08.02 14
1 Introduction
Italic Is used for references
Bold Is used for table or figure titles and to identify window titles, menu items,
function names, buttons, and keys, for example, the button Enter
Menu > Menu item Is used for the navigation to a certain submenu entry
<(...)> Are used for generic placeholders in software texts

Represent additional parameters that are explained separately, if required
Orange Is used to emphasize particularly important sections of the text
1.4 Identification
The model numbers of the Atellica COAG 360 System are:
• 1AAA101A (REF), 10707173 (SMN) (stand-alone)
• 1AAA102A (REF), 10759658 (SMN) (automation)
The model numbers of accessories used with the system are:
• Behring Coagulation Cup: OVIS31 (REF), 10446526 (SMN)
• Cuvettes: 10642243 (REF/SMN)
• Evaporation caps (5 mL): 10642564 (REF/SMN)
• Evaporation caps (15 mL): 10642565 (REF/SMN)
• Stirrer bars: 10642244 (REF/SMN)
• SVS solution: 10873473 (REF/SMN)
1.5 Service
Siemens Healthineers and its representatives are available to repair the system during
customary local office hours. If service is required at any other time, contact Siemens
Healthineers service or a local Siemens Healthineers representative. In the following,
“Siemens Healthineers service” refers to both Siemens Healthineers service or any
local representative authorized by Siemens Healthineers. Information about how to
reach Siemens Healthineers service is provided when the system is installed, or visit
siemens-healthineers.com to find contact information.
Siemens Healthineers will provide information about the availability and cost of updates.
The scope of agreed service is included in the service contract.
1.6 Warranty
Siemens Healthineers and its representatives guarantee that the system shows no
defects after installation, and during operation if operated according to this manual. For
more information on warranty, contact Siemens Healthineers service. The warranty is
not valid for damage that occurs as a consequence of non-observance of this manual.
Only perform maintenance as described in this manual. Incorrect interventions on the
system void the warranty and can result in service charges.

Print No. DCHS-G01.621.01.08.02 15
1 Introduction
Repairs and servicing must only be carried out by persons authorized by

Siemens Healthineers.
Only use the system as intended. If the system is not used as intended, Siemens
Healthineers disclaims all liability for damage to the system.
1.7 Ordering information

Only use original Siemens Healthineers consumables, accessories, and spare parts.
Order these only from Siemens Healthineers. For ordering information, see the Siemens
Healthineers product catalog or contact Siemens Healthineers service.
1.8 Third-party software copyrights

This system includes open source software. Such software is provided by Siemens
Healthineers under the terms of the open source software licenses applicable to such
software, and is distributed without any warranty as set forth in the corresponding
licenses. Those terms require that Siemens Healthineers provide the following notices
and information to the purchaser of this system. Where required by the specific license
terms, Siemens Healthineers will make the source code for such open source software
available upon request from Siemens Healthineers in accordance with the terms of the
relevant open source license. Versions of the GNU General Public License (GPL) and
Lesser General Public License (LGPL) are available at www.gnu.org.
The MIT License is duplicated as follows:
Permission is hereby granted, free of charge, to any person obtaining a copy of this
software and associated documentation files (the “Software”), to deal in the Software
without restriction, including without limitation the rights to use, copy, modify, merge,
publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons
to whom the Software is furnished to do so, subject to the following conditions:
The above copyright notice and this permission notice shall be included in all copies or
substantial portions of the Software.
The software is provided “as is”, without warranty of any kind, express or implied,
including but not limited to the warranties of merchantability, fitness for a
particular purpose and noninfringement. In no event shall the authors or copyright
holders be liable for any claim, damages or other liability, whether in an action of
contract, tort or otherwise, arising from, out of or in connection with the software
or the use or other dealings in the software.
For JSON.NET v3.0 under the MIT License:
© 2007–2008 James Newton-King
For DotNetZip Library v1.9.1.8 under the Microsoft Public License (Ms-PL):
© 2006–2011 Dino Chiesa
For Prism Library v4.0 under the Microsoft Patterns & Practices License:
© 2008–2010 Microsoft Corp.
For Sumatra PDF Viewer v2.3.2 under the GNU GPL v3:
© 2006–2013 Krzysztof Kowalczyk
For libXML v2.9.2 under the MIT License:

Print No. DCHS-G01.621.01.08.02 16
1 Introduction
© 1998–2014 Daniel Veillard
For Ultra VNC v1.0.9.2 under the GNU GPL (no version specified):
© 2008 UltraVNC
© 2013 Siemens Healthcare Diagnostics Inc. (modifications)
For Task Scheduler Manager Wrapper v1.9.4 under the MIT License:
© 2003–2010 David Hall
The Atellica® COAG 360 System contains software components licensed from Comfort
Software Group. These products may only be used as part of and in connection with the
Atellica COAG 360 System.
1.9 Trademarks
Actin, Atellica, INNOVANCE, Innovin, LOCI, and PSI are trademarks of
All other trademarks are the property of their respective owners.
1.10 Manual version history
Manual Software
Version Date Changes Full version Release version
01 (1.0) 2014-06 First version 1.0 1
02 (2.0) 2016-03 Update 1.1 1
03 (2.1) 2016-08 Update and name change 1.1 1
04 (2.2) 2016-09 Update 1.1 1
06 (2.3) 2019-09 Update 1.3 1
07 (2.4) 2021-02 Update 1.7 1
08 2022-02 Update and layout change 1.7 1

Print No. DCHS-G01.621.01.08.02 17
2 Safe handling
2 Safe handling
This chapter describes the intended use of the system and gives general
safety instructions.
2.1 Intended use

The Atellica® COAG 360 System is a fully automated, blood coagulation system for in
vitro diagnostic use. The system uses human plasma for the measurement of diagnostic
parameters and different technologies or evaluation methods in order to obtain results
for the clinical laboratory by trained personnel. It can be used in combination with
defined IVD devices. The instrument is capable to use the following technologies:
clotting, chromogenic, immuno-chemical, optomechanical, aggregation as well as LOCI.
2.1.1 System functions

The system functions are:
• Identifying reagents, deficient plasmas, controls, calibrators, and samples by

barcode means
• Loading and disposing of system liquids, cuvettes, and stirrer bars
• Pipetting aliquots of samples, controls, and calibrators in single-use cuvettes
• Pipetting all required reagents, deficient plasmas, controls, calibrators, and samples
• If required, checking samples for hemolysis, icterus, and lipemia (HIL)
• Cooling of reagents, controls, and deficient plasmas in the reagent storage
• Preparing dilutions
• Performing control measurements and calibrations
• Measuring STAT samples
• Managing several lots and calibration curves for 1 reagent
• Incubating and measuring assay preparations in single-use cuvettes
• Performing photometry or LOCI measurements from single-use cuvettes
• Performing fixed-time, fixed-absorbance, or kinetic measurements using various

evaluation methods
• Calculating and analyzing the measurement results
• Communicating with the Laboratory Information System (LIS) and transferring results
to the LIS automatically
• Evaluating measurement results
• Storing results
• As an option, sampling from the Laboratory Automation System (LAS)

Print No. DCHS-G01.621.01.08.02 18
2 Safe handling
2.2 Intended user

The system is intended for laboratory professional use only.
2.3 Reporting of serious incidents

According to EU regulation 2017/746, any serious incident that has occurred in relation
to the device shall be reported to the manufacturer and the competent authority of the
EU Member State in which the user and/or patient is established.
2.4 General safety information

The system has been inspected for technical safety before distribution. To maintain this
status and to ensure hazard-free operation:
• Always follow the instructions in this manual.
• If an addendum or release information is published, read the addendum or the release

information. The information in the addenda and the release information reflects
the current status and supersedes other information in the corresponding manual,
if applicable.
• Keep this manual, the addenda, and the release information for future reference
unless a new version of this manual is published.
• Only use the system as intended. If the system is not used as intended, Siemens
Healthineers disclaims all liability for any personal injury and property damage.
• Only perform maintenance as described in this manual. If maintenance is not

performed as described or if maintenance other than described in this manual is
performed, Siemens Healthineers disclaims all liability for any personal injury and
property damage.
• The system must only be opened for maintenance or replacement work by specially
trained users.
• The tool that is required to open the housing for maintenance or replacement work
must be retained by the system owner. Access to the tool must be controlled.
• Always follow good laboratory practice.
• Make sure the operating and storage conditions are met, see ( Page 455 Operating
conditions) and ( Page 456 Storage conditions).
2.4.1 Operator qualification

Risk of death and serious injury due to lack of knowledge. To avoid this hazard:
• The system must be operated and maintained only by persons whose skills,
knowledge, and practical experience qualify them to do so, and who have been
trained in its operation and maintenance.
• For information on available training options and suggested duration and frequency
of such training, contact Siemens Healthineers service.

Print No. DCHS-G01.621.01.08.02 19
2 Safe handling
2.4.2 Electrical safety

Risk of electric shock when coming into contact with live parts. Even when the system is
switched off, some components, for example, capacitors, can be live as they can still be
electrically charged. Death or serious injury can result. To avoid this hazard:
• Connect the system only to a socket with a ground contact (earth).
• Only use double insulated extension cables with a protective conductor and
ground contact.
• Never disconnect the ground contacts from the line.
• Never interrupt the protective conductor inside or outside the system.
• Never remove protective guards or fused components.
• Ensure that all surfaces, including the floor, are dry when using and maintaining
the system.
• Make sure that the power switch is easily accessible.
• To de-energize the analyzer, unplug the supply cable from the power supply socket.
• Maintenance described in this manual that has to be carried out on the open analyzer
while connected to a power source must only be done by specially trained users.
Specially trained users must be familiar with the hazards associated with such action.
Risk of short-circuit by spilled liquids that can come into contact with live parts. Damage
to the system can result. To avoid this hazard:
• Never pour liquids or place containers with liquid on top of the system.
• Disconnect the mains plug immediately if liquid is spilled into the system.
Risk of malfunctions in nearby electrical devices due to radio interference. The system
complies with the emission and immunity requirements described in IEC 61326‑2‑6. The
analyzer has been designed and tested according to CISPR 11 Class A. In a domestic
environment, it can cause radio interference. To avoid this hazard:
• Assess the electromagnetic environment prior to operating the system.
• Use the cables supplied.
• Use shielded cables and plugs if external devices are connected, for example, a printer
or a network.
Risk of malfunctions of the system such as incorrect results due to radio interference
from other electrical devices. To avoid this hazard:
• Do not operate strong electromagnetic transmitters, for example, mobile phones,

walkie-talkies, door openers, or elevators, in the vicinity of the system.
• In places where the quality of the power supply line is poor or impacted by other
electrical devices, consider the use of an external uninterruptible power supply (UPS).
2.4.3 Mechanical safety

Risk of serious injury due to moving parts. To avoid this hazard:
• Never bypass or remove safety devices, for example, cover switches.

Print No. DCHS-G01.621.01.08.02 20
2 Safe handling
• Maintenance described in this manual that has to be carried out on the open analyzer
while connected to a power source must only be done by specially trained users.
Specially trained users must be familiar with the hazards associated with such action.
• Keep clear of moving parts when the system is in operation or maintenance is

performed. Long hair, necklaces, bracelets, and similar objects can get caught in
moving parts.
2.4.4 Operational safety

Risk of burns due to combustion of flammable liquids. Death or serious injury can result.
To avoid this hazard:
• Keep flammable liquids away from heat or open flame.

If a flammable liquid has been spilled, immediately take the following measures to
prevent combustion:
• Eliminate all sources of ignition.
• Remove flammable liquid with a non-combustible absorbent material.
• Vent the room.
Risk of explosion due to ignition caused by sparks generated by the switch contacts of
the system. Death or serious injury can result. To avoid this hazard:
• Never operate the system in an environment containing explosive mixtures of oxygen,

hydrogen, or other flammable gases.
Risk of property damage due to inaccurate handling of the system. Rough handling can
disturb or damage internal components. Improper interventions on the system void the
warranty and can result in service work having to be charged for. To avoid this hazard:
• Always handle the system with care.
• Switch off the system and secure it against accidental operation if there is visible
damage to the system or if safe operation is no longer possible. This may be assumed:
– If the analyzer is no longer working after a technical malfunction
– After an extended period of storage
– After being transported in harsh conditions
• Only carry out maintenance and repair work or replace parts as described in
this manual.
• Only use Siemens Healthineers spare parts.
• Only use liquids for rinsing, cleaning, and purging which have been authorized by
• Do not use solvents or abrasive cloths to clean the system.

Print No. DCHS-G01.621.01.08.02 21
2 Safe handling
2.4.5 Safe handling of samples, reagents, controls, calibrators,

and consumables
Risk of infection due to potentially infectious material. Samples, reagents, controls,
standards, calibrators, consumables, and parts of the system which have come into
contact with this material are potentially infectious. Death or serious injury can result. To
avoid this hazard:
• Wear appropriate personal protective equipment, that is, gloves, protective clothing,
safety glasses, and mask, according to national and local standards and regulations.
• Handle potentially infectious material in accordance with good laboratory practice, for
example, as described in CLSI documents available at www.clsi.org.
• Maintenance described in this manual that involves access to potentially infectious

parts of the system must only be carried out by specially trained users. Specially
trained users must be familiar with the hazards associated with such action.
• Avoid contact of the skin and mucosa with potentially infectious material.
• Follow all warning and safety symbols supplied with reagents, controls, calibrators,
and consumables.
• See the instructions for use of the reagents, controls, standards, and calibrators as well
as the application sheets.
• Check with local waste disposal authorities for specific requirements regarding
potentially infectious material.
• Discard potentially infectious material according to national and local standards

and regulations.
Risk of microbial contamination and particulate growth in the tubing that can lead to
incorrect results. Incorrect results can lead to misdiagnoses and incorrect treatment. To
avoid this hazard:
• Only use water with a low microbial content (≤ 100 CFU/mL) and particle content,
as described, for example, in PH.EUR.NT2000 or in the United States Pharmacopeia
(USP), monograph: Purified Water.
Risk of incorrect or no results. Incorrect results can lead to misdiagnosis and incorrect
treatment. To avoid this hazard:
• Only use approved Siemens Healthineers consumables.
• Only use purging agents recommended by Siemens Healthineers. Siemens

Healthineers assumes no liability for any damages or false test results caused by
the use of purging agents that are not recommended.
• If purified water is used as purging agent, additional maintenance must be performed,

see ( Page 342 Cleaning the purging solution container). Prior to the use of purified
water, make sure that the analyzer has been configured for this purging agent by
Siemens Healthineers service.
• When using third-party reagents, validate that Siemens Healthineers assays are not
affected by carry-over.
• Measure controls, see the instructions for use and ( Page 287 Measuring a control).
• Monitor the stability of reagents, controls, calibrators, probe cleaner, and wash
solutions, see the instructions for use.

Print No. DCHS-G01.621.01.08.02 22
2 Safe handling
• The analyzer must only be opened for maintenance or replacement work by specially
trained users when no orders are running.
Risk of irritation of the skin and mucous membranes due to liquids for cleaning and
purging. Minor or moderate injury can result. To avoid this hazard:
• Wear appropriate personal protective equipment, that is, gloves, protective clothing,
safety glasses, and mask, according to national and local standards and regulations.
• Pay attention to the information from the manufacturer regarding the compatibility of
the gloves with the materials and liquids used.
• Follow all product instructions from the manufacturer.
Risk of property damage due to incorrect handling of samples, reagents, controls,

standards, calibrators, and consumables. To avoid this hazard:
• Only use approved Siemens Healthineers consumables.
• See the instructions for use that are supplied with the reagents, controls, standards,
calibrators, and consumables.
• Only use the specified sample tube types, see the dialog Rack definition, subgroup
Sample tubes, list Type, or contact Siemens Healthineers service.
• When working with cap piercing, only use sample tubes specified for cap piercing. For
more information, contact Siemens Healthineers service.
Risk of pollution due to incorrect waste disposal. Damage to the environment can result.
To avoid this hazard:
• Discard waste material according to national and local standards and regulations.
2.4.6 Safe handling of personal data

The system processes personal data of both patients and laboratory staff. Personal data
of the patient includes the patient's name, sex, and age, the patient ID, sample ID, sample
results, notes, and other data. Some of these data are necessary for the use of the
system according to its intended purpose, for example, sample ID and sample result. The
personal data of the laboratory staff consists of their login data.
Risk of loss of privacy protection. To avoid this hazard:
• Before entering any personal data, consider carefully whether it is mandatory to enter
this data. Personal data must be adequate, relevant, and limited to what is necessary
in relation to the purposes for which they are processed.
• Only the field Patient name in the dialogs Jobs and Sample info is intended for
displaying personal data (as sent from the LIS).
• Only enter personal data in the fields explicitly provided for the respective type of input
(for example, name, age, sex), not in fields provided for other personal data or any
fields that allow free input. For example, the patient name must not be entered in the
sample ID field. Only under these conditions is this data protected by the software.
• Do not enter any personal data in input fields, for example, as sample ID, comment,
or in a file name.

Print No. DCHS-G01.621.01.08.02 23
2 Safe handling
• On shift change, log off the system to prevent unauthorized people from accessing
personal data and other sensitive data/information.
• When printing personal data, for example, from the patient or laboratory journal,
make sure that these printouts cannot be viewed by unauthorized persons.
2.5 IT security measures

This chapter describes the system's minimum IT networks and security requirements.
2.5.1 Hardware requirements

The system runs under the following minimum hardware requirements:
• Intel Core I5‑7500, 3.4 GHz
• 16 GB DDR4 RAM
• 500 GB SSD for the operating system and installed software and an additional 500 GB
SSD for long term storage of system log files and database backups
• Communication via CAN bus between subsystems and the main computer
2.5.2 IT network characteristics

This system communicates to an LIS or LAS using a serial RS‑232 connection or an
ethernet port (with crossover cable).
To connect with Smart Remote Services (SRS), a network connection is required.
In such cases, the following network controls are in place:
• The host-based firewall is configured to block all unsolicited inbound connections.
• Web browsing is disabled.
• Access to SMB shares is blocked by default.
• Remote access is controllable by the operator.
• IPv6 tunneling techniques are disabled.
• No wireless connectivity is built in.
• All unnecessary ports have been closed.
2.5.3 Security measures

The system is protected by the following security measures:
• McAfee Embedded Control allow lists provide protection against malware infections.
• Properly configured firewall blocks unwanted connections.
• Audit logging ensures transparency.
• Timely patching is available via SRS.

Print No. DCHS-G01.621.01.08.02 24
2 Safe handling
• Hardened operating system drastically reduces the attack surface.
• The SQL database is password protected.
Continuous vulnerability assessment and remediation is performed throughout the

complete product lifecycle by Siemens Healthineers.
Security and software/data updates are provided via the Document Library as secure
update packages. These packages can be manually installed by the system operator
using the dialog Secure download.
The system software logs all configuration changes to the protected audit log located in
the system database. This can be viewed using the built-in audit log viewer. The audit log
is contained in all system backups and stored for the lifetime of the system.
2.5.4 Protection against unauthorized access

The system software runs in a restricted kiosk-mode environment to prevent
unauthorized access to the operating system and protects it from tampering and
unintentional configuration changes.
The system includes role-based access, including separate accounts for routine
operation and service tasks with strong password enforcement.
2.5.5 Software-related measures to protect personal data

The system protects personal data in accordance with the principles of data minimization
and purpose limitation. Personal data are encrypted in the database of the system.
Using role-based access, patient data are only available to users having the appropriate
roles assigned. For Siemens Healthineers, only the sample ID and the sample result are
available for troubleshooting purposes.
When setting up the system, Siemens Healthineers service aids the user in changing
the passwords for all users defined in the system. This way, passwords will only be
known by the users of the system. For this reason, the password should be carefully
stored in accordance with the security guidelines of the system owner. This is the sole
responsibility of the system owner. If there is reason to suspect that the password has
become known to untrusted persons, the password may be changed at any time with the
assistance of Siemens Healthineers service.
2.5.6 Security whitepaper

For more information about specifications for software, hardware, network
characteristics, and security controls, see the security whitepaper. This technical
information is not part of the instruction manual and is intended for the IT professional.
2.6 Safety messages

All safety messages must be observed to avoid hazardous situations which can result in
death, injury, or damage to the equipment.
The following explains the signal words and their meanings.

Print No. DCHS-G01.621.01.08.02 25
2 Safe handling
Signal word Meaning
WARNING Indicates a hazardous situation which, if not avoided, could

result in death or serious injury
CAUTION Indicates a hazardous situation which, if not avoided, could

result in minor or moderate injury
NOTICE Indicates a hazardous situation which, if not avoided, could

result in potential damage to property
The following explains the structure of safety messages.
WARNING
This section states nature and source of the hazard.
This section states potential consequences of not avoiding the hazard. This
section can be combined with the previous section.
◆ This section lists preventive actions to avoid the hazard.
2.7 Symbols
This chapter describes symbols that may appear on the system and related products,
except symbols in the software.
Symbol Meaning
Atmospheric pressure limitation
Authorized representative in Switzerland
[LOT] Batch code
[REF] Catalog number
CE mark
China RoHS mark with environmental protection use period in years
Consult instructions for use
[CONTENTS] Contents
[CUVETTES] Cuvettes

Print No. DCHS-G01.621.01.08.02 26
2 Safe handling
Symbol Meaning
Disconnect main plug from socket
Do not fill stirrer bars into the cuvette loader
Do not re-use
Do not stack and do not place any load
[EVAP__ CAPS] Evaporation caps
Fragile, handle with care
Humidity limitation
[IVD] In vitro diagnostic medical device
Keep away from sunlight and heat
Keep dry
Liquid waste
Manufacturer
Maximum number of racks on the rack tray
Not dishwasher-proof
Placing of sample racks

Print No. DCHS-G01.621.01.08.02 27
2 Safe handling
Symbol Meaning
Position for aligning barcodes
Power off
Power on
Prescription device
Only applicable in the USA
Product line: Hemostasis
Protective earth, protective ground

Identifies any terminal which is intended for connection to an
external conductor for protection against electric shock in case of a
fault, or the terminal of a protective earth (ground) electrode.
Protective gloves must be worn
Purging solution
Purified water
Safety glasses must be worn
[SN] Serial number
[STIRRER__ BARS] Stirrer bars
SVS SVS solution
[SOLUTION]
[SYSTEM] System
Temperature limit
This way up
Store in upright position

Print No. DCHS-G01.621.01.08.02 28
2 Safe handling
Symbol Meaning
[TRACE] Traceable number for identification of consumables
Turn input wheel to next position
Ukraine mark
Unique device identification barcode
Use-by date
Vacuum
Warning: Assembly is susceptible to electrostatic charge
Warning: Biohazard
The labeled area can come into contact with potentially infectious
material. The safety instructions for infectious material must be
observed, see ( Page 22 Safe handling of samples, reagents,
controls, calibrators, and consumables).
Warning: Consult instructions for use for important cautionary infor‐

mation
Warning: Crushing and cutting of hands due to moving belt drive
Warning: Crushing of fingers
Warning: Crushing of hands
Warning: Electricity, possibility of electric shock
Warning: Puncturing of fingers

Print No. DCHS-G01.621.01.08.02 29
2 Safe handling
Symbol Meaning
Warning: Puncturing of hands due to sharp elements
[CUVETTES] Waste bags for cuvettes

[WASTE__ BAGS]
Waste electrical and electronic equipment

For more information, see ( Page 32 Disposal).
Symbols
2.8 Statutory provisions

The product bears a CE mark which certifies that the product meets the requirements of
the following European directives:
• In vitro diagnostic medical devices Regulation (EU) 2017/746
• Directive on restriction of hazardous substances 2011/65/EU
Unauthorized changes to this product are not covered by the CE mark and the related
Declaration of Conformity.
The product also meets the requirements of the following European directives:
• Directive on waste electrical and electronic equipment 2012/19/EU
• Battery Directive 2006/66/EC
The product has been developed, tested, and manufactured in accordance with
IEC 61010‑2‑101, ISO 14971, IEC 61326‑2‑6, IEC 62304, and IEC 62366.
The product has been tested in accordance with IEC 61326‑2‑6. The product corresponds
to CISPR 11 Class A regarding electromagnetic compatibility (EMC).
The product owner takes on the obligations arising from the national legislation about
the operation of in vitro diagnostic medical devices.

Print No. DCHS-G01.621.01.08.02 30
3 Life cycle
3 Life cycle
This chapter describes the stages the system goes through, from delivery to disposal, and
the requirements involved for the user with each stage.
3.1 Delivery
The system is delivered by Siemens Healthineers service.
For information on the scope of delivery, see the packing list delivered with the system.
To check the delivery, proceed as follows:
1 Check the transport containers for signs of external damage.
2 If the transport container shows any visible signs of damage, inform Siemens
Healthineers service immediately.
3.2 Installation
The system must be installed by Siemens Healthineers service.
WARNING
Incorrect installation of the system
Death or serious injury can result. Damage to the system can result.
◆ The system must only be installed by Siemens Healthineers service.

◆ Contact Siemens Healthineers service with regard to installation of the system.
3.3 Non-operation
3.3.1 Up to 2 weeks
For a period of up to 2 weeks of non-operation, proceed as follows:
◆ Purge the tubings once a week, see ( Page 344 Purging the tubings).
3.3.2 More than 2 weeks

To prepare the system for a period of more than 2 weeks of non-operation, proceed
as follows:
NOTICE
Incorrect storage of the system
Damage to the system can result.

◆ Contact Siemens Healthineers service with regard to storage of the system.

Print No. DCHS-G01.621.01.08.02 31
3 Life cycle
1 Perform the weekly maintenance tasks, see ( Page 342 Weekly maintenance).
2 Perform the monthly maintenance tasks, see ( Page 348 Monthly maintenance).
3 Remove the probe cleaner container and store or discard it, if applicable, see
( Page 270 Removing the probe cleaner container).
Siemens Healthineers recommends not to re-use the probe cleaner container to avoid
small amounts of probe cleaner dripping out.
4 Wash the probes, see ( Page 333 Washing the probes).
5 Contact Siemens Healthineers service with regard to non-operation of the system.
To resume operation, contact Siemens Healthineers service.
3.4 De-installation
The system must be de-installed by Siemens Healthineers service.
WARNING
Incorrect de-installation of the system
Death or serious injury can result.
◆ The system must only be de-installed by Siemens Healthineers service.

◆ Contact Siemens Healthineers service with regard to de-installation of
the system.
3.5 Movement
The system must be moved by Siemens Healthineers service.
WARNING
Incorrect movement of the system
Death or serious injury can result. Damage to the system can result.
◆ The system must only be moved by Siemens Healthineers service.

◆ Make sure the storage conditions are met, see ( Page 456 Storage conditions).
◆ Contact Siemens Healthineers service with regard to movement of the system.
3.6 Disposal
In the European Union, disposal of the system is regulated by Directive
2012/19/EU on waste electrical and electronic equipment (WEEE), and corresponding
national transpositions.

Print No. DCHS-G01.621.01.08.02 32
3 Life cycle
Siemens Healthineers is committed to taking back and recycling electrical and electronic
equipment in areas where the above mentioned directive is enforced.
In areas where the above mentioned directive is not enforced, contact Siemens
Healthineers service with regard to disposal of the system.
Depending on the applications, parts of the system may be contaminated with

biohazardous or hazardous chemical material.
To dispose of the system, proceed as follows:
WARNING
Infection due to contaminated material
◆ Treat contaminated material according to national and local standards

and regulations.
◆ Before movement or disposal, disinfect parts of the system that may be
contaminated according to national and local standards and regulations.
◆ To get assistance, contact Siemens Healthineers service.
NOTICE
Pollution due to improper waste disposal
Damage to the environment can result.
◆ Contact Siemens Healthineers service with regard to disposal of the system.

◆ Do not treat electrical and electronic equipment as unsorted municipal waste.
◆ Check with the local waste disposal contractor for specific requirements
regarding disposal.
◆ Collect waste electrical and electronic equipment separately, and return them to
Siemens Healthineers in areas where the above mentioned directive is enforced.
1 Contact Siemens Healthineers service with regard to de-installation and disposal of

the system, see ( Page 32 De-installation).
2 Dispose of the system according to national and local standards and regulations.

Print No. DCHS-G01.621.01.08.02 33
4 Description of the hardware

This chapter describes the operation and the functions of the hardware.
4.1 Analyzer
The analyzer is displayed in the 2 figures below.
1 2 3 4 5
10
6
Front view of the analyzer
(1) Touchscreen monitor

(2) Sample manager
(3) Reagent manager
(4) Stirrer bar loader
(5) Cuvette loader
(6) Accessories drawer
(7) Right drawer
(8) Bottom middle drawer
(9) Left drawer
(10) LAS connection (optional)

Print No. DCHS-G01.621.01.08.02 34
7 2
3
6
5 4
Rear view of the analyzer
(1) External connection for liquid waste

(2) External connection for vacuum supply
(3) External connection for purified water
(4) Connections for external devices
(5) Power supply
(6) Main power switch
(7) Air inlet
(8) XLR port for status light
4.1.1 Operating elements

This chapter describes the operating elements of the analyzer.
Touchscreen monitor The touchscreen monitor is displayed in the figure below.

Print No. DCHS-G01.621.01.08.02 35
3 2
Touchscreen monitor
(1) Monitor
(2) Monitor power switch
(3) Handheld barcode reader
The touchscreen monitor allows the user to perform routine functions without using the
keyboard or mouse. The virtual keyboard on the touchscreen can be used for quick input.
A keyboard and mouse in the accessories drawer can be used, for example, to enter
user-defined methods.
Behind the touchscreen monitor a USB port is provided. The USB port is used to connect
the handheld barcode reader.
Sample manager The sample manager is displayed in the figure below.
1 2
4
3
6 5
Sample manager
(1) Input lane

(2) Output lane
(3) Rack stops
(4) Unload button

Print No. DCHS-G01.621.01.08.02 36
(5) Reverse button

(6) Load button
The input lane is used to insert sample racks, or calibrator and control racks.
The output lane is used to remove the processed racks. Racks may not be moved
backwards manually on the output lane. This can block the rack transport inside the
analyzer and lead to a malfunction of the system.
The rack stops are used to stop the racks.
The load button is used to move racks into the analyzer.
The reverse button is used to pull out the racks and change the order of the racks in the
input lane. This functionality can be used to place STAT samples in a prioritized position.
The unload button is used to remove racks from the analyzer.
For more information, see ( Page 55 Racks).
Reagent manager The reagent manager is displayed in the figure below.
1
2
5 4
Reagent manager with open access door
(1) Illumination LED

(2) Access door
(3) Position button
(4) Status LED
(5) Carrier with bottle and evaporation cap in the input wheel
The reagent manager is used to insert bottles in carriers or cartridges into the analyzer
and to remove used bottles or cartridges.
For more information, see ( Page 59 Carriers).
Bottles or cartridges are replaced one at a time. Pushing the position button turns the
input wheel to the next position. Now the user can remove or insert the next bottle in a
carrier or the next cartridge.
Only while the access door is closed, is the input wheel accessible by the analyzer for
loading or unloading.
The status LED has different statuses. 1 of the following statuses is possible:
• On: Used bottle or cartridge must be removed.
• Off and position in the input wheel is empty: A new bottle or cartridge can be inserted.

Print No. DCHS-G01.621.01.08.02 37
• Off and a bottle or a cartridge is in the position in the input wheel: The bottle or the
cartridge must not be removed.
• Blinking: Problem message, see touchscreen monitor.
The illumination LED has different statuses. 1 of the following statuses is possible:
• Off: The system is off.
• On and full brightness: The system is on.
• Blinking and brightness dimmed to 50 %: The system is in eco mode.
Accessories drawer The accessories drawer is displayed in the figure below.
4 3 3 3
Open accessories drawer
(1) USB ports

(2) Mouse
(3) Compartment for consumables and accessories
(4) Keyboard
The accessories drawer serves as a storage for consumables and accessories, for
example, sample racks, carriers, and evaporation caps. The accessories drawer has
3 compartments.
If the accessories drawer is open, an additional drawer with a keyboard and a mouse
can be opened. The keyboard in the drawer can be used, for example, to enter
user-defined methods.
4 USB ports are near the right side of keyboard in the drawer. 2 of the 4 USB ports are
provided for external storage media. The other 2 USB ports are provided for the keyboard
and the mouse.
Left drawer The left drawer is displayed in the figure below.

Print No. DCHS-G01.621.01.08.02 38
7
3
7
4
Open drawer for liquid waste and probe cleaner
(1) Push button

(2) Rear liquid waste container
(3) Front liquid waste container
(4) Status LED of the probe cleaner container (in the frame to the left side)
(5) Probe cleaner container
(6) Opening tool for the probe cleaner container
(7) Status LEDs of the liquid waste containers
In the left drawer, the analyzer is equipped with 2 liquid waste containers and a probe
cleaner container. Beside each connection of the liquid waste containers are status LEDs.
The status LED indicates if the liquid waste container must be emptied. The push button
is used to disconnect the tubing from the liquid waste container. 1 of the liquid waste
containers can be emptied while the analyzer is operating. Instead of using liquid waste
containers, liquid waste can be pumped directly into a sink, see ( Page 35 Rear view of
the analyzer).
The probe cleaner container can be replaced while the analyzer is operating. The
opening tool is used to open the screw cap of the probe cleaner container, see
( Page 61 Opening tool). The status LED is on if the probe cleaner container is missing.
For more information on the system fluids, see ( Page 52 Fluid unit).
Bottom middle drawer The bottom middle drawer is displayed in the figure below.

Print No. DCHS-G01.621.01.08.02 39
5 2
5 3
5 4
Open drawer for water and purging solution
(1) Push button

(2) Stationary water container
(3) Purging solution container
(4) Front water container
(5) Status LED
In the bottom middle drawer, the analyzer is equipped with 2 water containers and a
purging solution container. Beside each connection of a container is a status LED. The
status LED indicates if the container must be re-filled. If the status LED of the stationary
water container is on, the container is re-filled automatically without any user action. The
push buttons are used to disconnect the tubings from the containers.
The purging solution container can be replaced while the analyzer is operating.
During the maintenance task Purge tubings the purging solution container must not
be replaced.
The stationary water container supplies the analyzer with purified water. When the filling
level of the stationary water container drops, the analyzer pumps the water from the
front water container to the stationary water container. The front water container can
be re-filled while the analyzer is operating. If the laboratory is equipped with a supply
for purified water, the analyzer can be connected directly to this supply via a hose, see
( Page 35 Rear view of the analyzer).
For more information on the system fluids, see ( Page 52 Fluid unit).
Right drawer The right drawer is displayed in the figure below.

Print No. DCHS-G01.621.01.08.02 40
2
3
4
Open drawer for cuvette waste
(1) Wake-up button (green button inside the drawer)

(2) Frame to hold the cuvette waste bag
(3) Cuvette waste bag
(4) Cuvette waste container
In the right drawer, the analyzer is equipped with the cuvette waste container. The
cuvette waste container holds a cuvette waste bag for approximately 4000 cuvettes.
While assays are being performed, the drawer is locked. If the cuvette waste bag needs
to be exchanged while the analyzer is running, current assays are completed before the
drawer is unlocked.
The wake-up button is used to start up the system from eco mode.
Cuvette loader The feed opening of the cuvette loader with an open cover is displayed in the
figure below.

Print No. DCHS-G01.621.01.08.02 41
1 2
Cuvette loader with an open cover
(1) Cover
(2) Feed opening
The bulk cuvettes are filled into the cuvette loader. The cuvette loader can store up to
1500 cuvettes.
Stirrer bar loader The feed opening of the stirrer bar loader with an open cover is displayed in the
figure below.

Print No. DCHS-G01.621.01.08.02 42
1 2
Stirrer bar loader with an open cover
(1) Cover
(2) Feed opening
For some assays, for example, optomechanical assays, a stirrer bar is automatically added
to the cuvette.
The bulk stirrer bars are filled into the stirrer bar loader. The stirrer bar loader can store
up to 1200 stirrer bars.
Status light The status light is displayed in the figure below.

Print No. DCHS-G01.621.01.08.02 43
Status light
(1) Red light

(2) Yellow light
(3) Green light
(4) XLR connector
As an option, a status light can be connected via an XLR port. The status light indicates
the overall status of the system, see ( Page 375 Status light).
Handheld barcode reader The handheld barcode reader is connected via a USB port. For details, see the instruction
manual of the handheld barcode reader.
Main power switch The main power switch is located at the right side of the analyzer, see ( Page 35 Rear
view of the analyzer).
The main power switch has the following positions:
• Position 0: The analyzer is off.
• Position I: The analyzer is on.
To avoid system problems that may require on-site servicing, do not power off the
system using the main power switch before shutdown is completed. The shutdown is
completed as soon as the status LED of the touchscreen monitor turns orange.
4.1.2 Components inside the analyzer

This chapter describes the components inside the analyzer.
Sample unit The sample unit loads and stores samples, calibrators, and controls.
The sample unit includes the following components as displayed in the figure below.

Print No. DCHS-G01.621.01.08.02 44
1 2
5 4
Sample unit
(1) Aliquot arm

(2) Aliquot storage
(3) HIL reader
(4) Sample manager
(5) Sample scanner
Sample manager The sample manager consists of 2 lanes and 3 buttons and performs the following tasks:
• Loading and unloading samples, calibrators, and controls
• Reading barcodes of racks, samples, calibrators, and controls
• Transporting samples, calibrators, and controls to sampling position
In the sampling position at the rear end of the 2 lanes, the barcodes are read and aliquots
are taken from the sample tubes, calibrator bottles, or control bottles. After that the racks
are transferred from the input lane to the output lane.

Print No. DCHS-G01.621.01.08.02 45
Sample scanner The sample scanner checks the loaded samples for compliance with the rack definition
performed by the user, for example, regarding sample tube type, bottle size, or caps
on tubes or bottles. The sample scanner also identifies the barcodes of the racks and
of the samples, calibrators, and controls in the racks. The barcodes give information
about the rack type, the sample ID, the material (sample, calibrator, or control), the lot
number, and the expiration date. The information is stored in the software and is used
to process assays.
If a barcode is unreadable or missing, a status alert is displayed at the monitor.
Aliquot arm When a rack is in sampling position, the aliquot arm aspirates 1 or more aliquots
depending on the number of requested assays. The aliquot arm transports the aliquot to
the aliquot storage and dispenses the aliquot into a cuvette. Optionally, the aliquot arm
transports a small volume of the aliquot to the HIL reader and dispenses this volume into
the measuring cell of the HIL reader.
Additionally the aliquot arm can pierce through caps on sample tubes with the aliquot
probe to aspirate the aliquot volume. This means it is not necessary to remove the caps
of sample tubes if caps suitable for cap piercing are used.
For directly processed assays, in direct mode, open sample tubes must be used. The
aliquot arm directly aspirates the required amount of sample for a test (up to 150 μL)
from a sample tube. In direct mode, HIL check is not performed.
Aliquot storage The aliquot storage can store up to 160 cuvettes. The aliquot storage receives empty
cuvettes from the cuvette distributor. The cuvettes receive the aliquots for open orders
and hold the remaining aliquots in case additional orders are requested. If the cuvettes
are no longer required, expired, or in case of high sample throughput (first in, first
out), they are removed from the aliquot storage and disposed of in the cuvette
waste container.
HIL reader Depending on the configuration in the software, the aliquot arm dispenses a part of the
aliquot volume into the HIL reader. A photometer in the HIL reader analyzes if and what
kind of HIL interference exists.
Reagent unit The reagent unit loads, unloads, and stores reagents, controls, and calibrators.
The reagent unit includes the following components as displayed in the figure below.

Print No. DCHS-G01.621.01.08.02 46
3
4
Reagent unit
(1) Reagent storage

(2) Carrier arm
(3) Reagent scanner
(4) Shaker
(5) Input wheel
Input wheel The input wheel has 8 positions for bottles in carriers or for cartridges. It is accessed
by the carrier arm. 7 positions can be used for loading bottles in carriers or for loading
cartridges. The 8th position is kept free for urgent analyzer access.
Carrier arm The carrier arm transports bottles or cartridges between the input wheel and the reagent
storage. The carrier arm places full bottles or cartridges into the reagent storage and
transports empty or expired bottles or cartridges back to the input wheel for unloading.
To load and unload the reagent storage, the carrier arm opens and closes the cover of the
reagent storage. Additionally, the carrier arm opens and closes the evaporation caps of
the bottles and cartridges.
Reagent scanner The reagent scanner identifies the barcodes of the bottles or cartridges during transport
from the input wheel to the reagent storage. The barcode gives information about the
reagent type, the size of the bottle or cartridge, the serial number, the lot, and the
expiration date. The barcode information is stored in the software and is used to process
assays. Additionally, the reagent scanner identifies if an evaporation cap is located on the
bottle or cartridge.
If a barcode is unreadable, missing, or a problem with an evaporation cap is detected,

the corresponding bottle or cartridge is automatically transported to the input wheel
for unloading.

Print No. DCHS-G01.621.01.08.02 47
Shaker The shaker receives a bottle or cartridge and shakes it to prevent sedimentation of
the reagent. The frequency and duration of shaking can be configured for each type
of reagent.
Reagent storage The reagent storage has 48 positions for bottles and cartridges. Only 47 positions can
be loaded, 1 position must stay empty and is therefore not accessible by the user. The
empty position is required to enable the analyzer to position the reagents for optimized
throughput. The temperature in the reagent storage is kept between 5–12 °C.
Consumables unit The consumables unit loads, stores, distributes, and disposes of cuvettes and stirrer bars.
The consumables unit includes the following components as displayed in the

figure below.
4
2
Consumables unit
(1) Stirrer bar loader

(2) Cuvette loader
(3) Waste station
(4) Cuvette distributor
Cuvette loader The cuvette loader stores, aligns, and separates the cuvettes. Then the cuvette loader
transports the cuvettes via a chute to the cuvette distributor.
Cuvette distributor The cuvette distributor takes empty cuvettes from the cuvette loader and places them
in the aliquot storage or in the pre-heater. For optomechanical assays the cuvette
distributor transports the empty cuvette first to the stirrer bar loader and then to the
aliquot storage or to the pre-heater. The cuvette distributor removes used cuvettes from
aliquot storage and disposes of them in the waste station.
In direct mode, the cuvette distributor also transports filled cuvettes from the aliquot
storage to the pre-heater.

Print No. DCHS-G01.621.01.08.02 48
Stirrer bar loader The stirrer bar loader stores, aligns, and separates the stirrer bars. Then the stirrer bars
are dispensed into a cuvette held by the cuvette distributor.
Reaction and measuring unit The reaction and measuring unit mixes samples and reagents in cuvettes, incubates and
measures these reaction mixtures, and disposes of the cuvettes.
The reaction and measuring unit includes the following components as displayed in the
2 figures below.
1 2
Reaction and measuring unit, part 1 of 2
(1) Pre-heater
(2) Front reagent arm
(3) Sample arm
(4) Rear reagent arm

Print No. DCHS-G01.621.01.08.02 49
1 2
8
7
6
4 5 4 3
Reaction and measuring unit, part 2 of 2
(1) Rear cuvette arm

(2) Front cuvette arm
(3) Absorbance reader
(4) Waste stations
(5) Cuvette mixer for front cuvette arm
(6) Cuvette mixer for rear cuvette arm
(7) Incubator
(8) LOCI reader
Sample arm The sample arm aspirates a sample volume from the cuvette in the aliquot storage or
material from the reagent storage. The sample arm dispenses this volume or material
into the cuvette positioned in the pre-heater.
Additionally, the sample arm pre-dilutes the samples, calibrators, and controls according
to the assay procedure definition.
Pre-heater The pre-heater has 30 positions for cuvettes. The pre-heater receives empty cuvettes
from the cuvette distributor. The pre-heater heats the cuvettes and samples up to 37 °C.
Cuvette arms The cuvette arms transport the cuvettes to different positions. Both arms can reach
the pre-heater and the incubator. The front cuvette arm transports cuvettes to the
absorbance reader and the rear cuvette arm transports cuvettes to the LOCI reader.

Print No. DCHS-G01.621.01.08.02 50
The front cuvette arm takes the cuvette containing the sample from the pre-heater and
transports it to the front pipetting position. There the reagent arm adds the reagent.
The cuvette arm moves the cuvette down to the mixer to mix the reagent and sample.
Afterwards the cuvette arm transports the cuvette to the absorbance reader. After
measuring the cuvette arm takes the cuvette and discards it in the waste station. The
front cuvette arm can also take a cuvette from the incubator and transport it either to the
front reagent arm or to the absorbance reader.
The rear cuvette arm takes the cuvette containing the sample from the pre-heater and
transports it to the rear pipetting position. There the reagent arm adds the reagent.
The cuvette arm moves the cuvette down to the mixer to mix the reagent and sample.
Afterwards the cuvette arm transports the cuvette to the LOCI reader. After measuring
the cuvette arm takes the cuvette and discards it in the waste station. For assays needing
an incubation time or more than 1 reagent, the rear cuvette arm transports the cuvette
after mixing the reagent and sample to the incubator.
Reagent arms The 2 reagent arms transport reagents from the reagent storage to the pipetting position
at the right end of the reagent arms. During transport the reagent is heated up to 37 °C.
At the pipetting position the reagent arms dispense the reagent into a cuvette.
Mixer The mixers are vortex mixers and they are located at the right end of each reagent
arm. After the reagent arm has dispensed the reagent into the cuvette, the cuvette arm
transports the cuvette to the mixer. The vortex mixer mixes the reagent and sample in
the cuvette.
Incubator The incubator has 36 positions for cuvettes and 2 stations between the LOCI reader and
the absorbance reader. The incubator is moved between these 2 stations. Each cuvette
arm has access to the incubator, if the incubator is at the corresponding station.
The incubator keeps the reaction mixture at a temperature of 37 °C.
Absorbance reader The absorbance reader is used to measure assays. It is accessible by the front cuvette
arm. The absorbance reader is equipped with 4 photometers and a cuvette ring with
25 cuvette positions. Cuvette position 25 is used as the reference for intensity readings.
4 of the remaining 24 cuvette positions can be used for stirring assays, for example,
an optomechanical assay or an aggregation assay. The photometers rotate along the
cuvette ring to measure the absorbance of the reaction mixture in the cuvettes. Up to
4 different wavelengths (340 nm, 405 nm, 630 nm, 850 nm) can be measured on each
cuvette position, depending on the assay definition.
Each photometer uses an LED as the light source. When passing through the cuvette,
the light beam is weakened due to absorption and/or scattering through particles
and aggregates in the solution. Behind the cuvette, stray light at higher solid angles
is blocked out by an aperture. Light passing through the aperture is measured with
a photodetector.
The absorbance reader is temperature controlled to keep the reaction mixture at a

temperature of 37 °C.
LOCI reader The LOCI reader is used to measure high-sensitivity immunoassays. It is accessible by
the rear cuvette arm. The LOCI reader is equipped with a photomultiplier and a position
for 1 cuvette. The photomultiplier measures the light emitted by the reaction mixture in
the cuvette.

Print No. DCHS-G01.621.01.08.02 51
The light source of the LOCI reader is an illumination LED with a wavelength of 680 nm.
The illumination LED flashes the cuvette that contains reaction mixture. After the
illumination LED is turned off, a shutter opens and the reaction mixture emits light.
Behind the cuvette, stray light is blocked out by a filter. The emitted light illuminates the
surface of the photomultiplier and is measured.
The LOCI reader keeps the reaction mixture at a temperature of 37 °C.
Fluid unit The fluid unit supplies the analyzer with system fluids, compressed air, and vacuum and
collects the liquid waste.
The fluid unit includes the following components as displayed in the figure below.
1 1 1 1
4
3
7 6 5
Fluid unit
(1) Wash stations

(2) Tubings
(3) System fluids
(4) Pump box
(5) Probe cleaner reservoir
(6) Liquid waste
(7) Pressure and vacuum box
System fluids System fluids are purified water, probe cleaner, and purging solution. They are used to
clean the probes and the tubings of the analyzer.
Purified water is used for normal rinsing of the probes.
Probe cleaner is used for special cleaning of the probes in the wash stations. The probe
cleaner is also used to clean the cuvette in the HIL reader.

Print No. DCHS-G01.621.01.08.02 52
Purging solution is used to purge the tubings of the analyzer. Purified water can be
used as purging solution. If purified water is used, additional maintenance must be
performed, see ( Page 342 Cleaning the purging solution container). Prior to the use of
purified water, make sure that the analyzer has been configured for this purging agent
by Siemens Healthineers service.
Probe cleaner reservoir The analyzer is equipped with a probe cleaner reservoir. The size of the probe cleaner
reservoir is 0.3 L and is designed so that the re-filling process of probe cleaner does
not interrupt the routine. The probe cleaner reservoir is equipped with a level sensor
that detects the filling height. If the probe cleaner container is empty and the probe
cleaner reservoir does not receive any more probe cleaner, the status alert Probe cleaner
container empty. Replace probe cleaner container (46) is displayed. If the probe
cleaner reservoir is empty, the system stops running, even for assays that do not require
probe cleaner. Detailed descriptions of the probe cleaner, its handling, applications, and
performance are provided in the corresponding instructions for use.
Liquid waste The liquid waste containers are used to collect liquid waste.
Tubings The tubings connect the aliquot pipettor, sample pipettor, and reagent pipettors and the
wash stations of these pipettors with the containers for system fluids and liquid waste.
Each pipettor has a separate fluid circuit.
Wash stations The aliquot arm, the sample arm, and the reagent arms have separate wash stations.
The probe of each arm dips into the wash station between the individual pipettings and
is cleaned by being rinsed inside and out. Purging solution is pumped into the wash
stations for special cleaning. The wash station has an overflow, and the purging solution
runs off through this. The aliquot probe is additionally dried by compressed air.
The probes are rinsed before aspirating a new aliquot, sample, or reagent to
prevent carryover.
Pressure and vacuum box The pressure and vacuum box has an internal compressor to provide compressed air
for the pneumatic components. Additionally the pressure and vacuum box supplies the
analyzer with internal vacuum. Optionally, the analyzer can be connected to an external
vacuum system, see ( Page 35 Rear view of the analyzer).
Pump box The pump box supplies the wash stations with purified water, probe cleaner, and
purging solution.
Computer The computer of the system is located behind the drawer for cuvette waste. The
computer controls all system functions and displays information, such as results, on the
touchscreen monitor.
4.2 External devices

The analyzer can be connected to several external devices. The connections displayed in
the figure below are provided with the analyzer.

Print No. DCHS-G01.621.01.08.02 53
Connections for external devices
(1) 2 RS-232 ports

(2) 2 Ethernet ports
(3) 2 USB ports
Additional 2 USB ports for external storage media are in the accessories drawer.
4.2.1 LIS
The analyzer can be connected to a laboratory information system (LIS) via a RS‑232 port
or an ethernet port. See the data interface manual.
The LIS sends orders to the analyzer and receives results.
4.2.2 LAS (optional)

The analyzer can be connected to a laboratory automation system (LAS) via an RS‑232
port or an ethernet port. The LAS is used to transport the sample tubes to the analyzer.
To use the LAS, a special configuration of the analyzer is needed. In this configuration the
aliquot arm reaches out of the analyzer housing to aspirate an aliquot at a defined point
in space.

Print No. DCHS-G01.621.01.08.02 54
A 2-part transparent cover closes the gap between the analyzer and the LAS, see the
figure below. The transparent cover can be lifted as a whole to troubleshoot problems
with the LAS connection.
LAS connection with transparent cover (LAS is not displayed)
(1) Transparent cover
4.2.3 UPS (optional)

The analyzer can be connected to an external uninterruptible power supply (UPS) via
a USB port. The UPS consists of a battery pack and a control unit and has to support
Windows power management. The UPS provides power as soon as the primary power
source fails. During power outage the UPS switches to battery operating mode and
communicates with the analyzer.
4.3 Consumables and accessories

This chapter lists the consumables and accessories for the analyzer.
Instructions for using the consumables and accessories are given in the
respective procedures.
4.3.1 Racks
2 types of racks are available:
• Sample rack, see ( Page 56 Sample rack)
• Calibrator and control rack, see ( Page 56 Calibrator and control rack)
Both rack types are equipped with steel plates on the bottom. The steel plates work with
the magnetic conveyor of the sample manager.

Print No. DCHS-G01.621.01.08.02 55
The barcode label on the right side provides a unique ID for each rack. The last 6 digits
of the barcode are the rack number and can be read by the user.
Sample rack The rack is displayed in the figure below.
1 2
Sample rack
(1) Rack number

(2) Color clip
(3) Handle
(4) Barcode
A sample rack can carry up 5 sample tubes. Each tube position is lettered from A to E. All
position labels are on the top of the rack. In a sample rack, primary or secondary tubes
can be loaded. The barcode labels of the tubes must be visible in the slot of the rack.
The color clips are used to mark racks according to their definitions, for example,
STAT racks.
The sample racks have been approved for centrifugation in a centrifuge equipped
with specific accessories, see ( Page 63 Third-party accessories for centrifugation of
samples in racks).
Calibrator and control rack The rack is displayed in the figure below.
Calibrator and control rack
(1) Rack number

(2) Handle
(3) Barcode
A calibrator and control rack can carry up 4 bottles with calibrators or controls. Each
bottle position is numbered from 1 to 4. All position labels are on the top of the rack. In a
calibrator and control rack, GW 2.5 bottles with adapters and GW 5 bottles can be loaded.
The bottles generally have to be opened before use. The barcode labels of the bottles
must be visible in the slots of the rack.

Print No. DCHS-G01.621.01.08.02 56
4.3.2 Adapters
2 types of adapters are available:
• Adapter for sample tube, see ( Page 57 Adapter for sample tube)
• Adapter for GW 2.5 bottle, see ( Page 57 Adapter for GW 2.5 bottle)
Adapter for sample tube The adapter is displayed in the figure below.
Adapter for sample tubes
The adapter is inserted in the sample rack and is used to process Eppendorf Safe-Lock
tubes or Eppendorf tubes 3810X, 1.5 mL (with or without cap).
Adapter for GW 2.5 bottle The adapter is displayed in the figure below.
Adapter for GW 2.5 bottle
The adapter is inserted in the calibrator and control rack to process calibrators or controls
in GW 2.5 bottles.
4.3.3 Rack tray

The rack tray is displayed in the figure below.
Rack tray
A rack tray is used to transport racks from the sample preparation to the sample manager
and vice versa. Each rack tray has a capacity of 10 sample racks or 8 calibrator and control
racks. With 1 rack tray, 50 samples or 32 calibrators and/or controls can be loaded into
the analyzer.
4.3.4 Evaporation caps

The evaporation caps are used to extend the on-board stability of the reagents.
Evaporation caps for bottles The evaporation caps for bottles are displayed in the figure below.

Print No. DCHS-G01.621.01.08.02 57
1 2
3 3
4 4
Evaporation caps for bottles
(1) Evaporation cap for GW 5 bottles

(2) Evaporation cap for GW 15 bottles
(3) Arrow
(4) Slider
The arrow on the evaporation cap and the arrow above the barcode on the label of the
bottle must be aligned.
Evaporation caps for cartridge An evaporation cap for a cartridge is displayed in the figure below.
1 2
Evaporation cap for cartridge
(1) Evaporation cap

(2) Slider
The evaporation cap for a cartridge is provided together with the cartridge.
NOTICE
Incorrect handling of evaporation caps for cartridges
Spoiled content of the cartridge by light can result.

◆ See the instruction for use of the cartridge for proper handling and mounting of
the evaporation cap.
4.3.5 Cartridge tool

The cartridge tool is displayed in the figure below.
Cartridge tool

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The cartridge tool is used to attach evaporation caps on cartridges, see instructions for
use of the cartridges.
4.3.6 Carriers
The carriers for bottles are displayed in the figure below.
1 2
Carriers
(1) Carrier for GW 5 bottles

(2) Carrier for GW 15 bottles
The carriers are used to hold bottles with evaporation caps. 1 carrier can carry 1 bottle.
4.3.7 Cuvette
A cuvette is displayed in the figure below.
Cuvette
The cuvettes store aliquots and hold samples and reagents for the measurement of
the analyte.
4.3.8 Stirrer bar

A stirrer bar is displayed in the figure below.
Stirrer bar
The stirrer bars are used for special assays, for example, optomechanical measurements.
4.3.9 Cuvette waste bag

A cuvette waste bag for used cuvettes is displayed in the figure below.

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2
1
2
3
Cuvette waste bag
(1) Cuvette waste bag

(2) Tunnel cord ends
(3) Tunnel cords
The cuvette waste bag can store up to 4000 used cuvettes.
4.3.10 Water containers

The water containers are displayed in the figure below.
1 1 2 1 2
4 3
Water containers
(1) Connector to the fluid unit

(2) Handle
(3) Front water container
(4) Stationary water container
The analyzer is equipped with 2 water containers, see ( Page 39 Bottom middle drawer).
4.3.11 Purging solution container

The purging solution container is displayed in the figure below.

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1 2
Purging solution container

(2) Handle
The analyzer is equipped with a purging solution container in the bottom middle drawer,
see ( Page 39 Bottom middle drawer).
4.3.12 Probe cleaner container

The probe cleaner container is displayed in the figure below.
Probe cleaner container
(1) Screw cap

The analyzer is equipped with a probe cleaner container in the left drawer. The probe
cleaner is a system fluid used, for example, in washing programs according to the
assay definitions, for maintenance, on system start, shutdown, and when switching to
eco mode.
4.3.13 Opening tool

The opening tool is displayed in the figure below.
Opening tool
The opening tool is used to open the screw cap of the probe cleaner container, see the
instructions for use of the probe cleaner.

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4.3.14 Liquid waste container

A liquid waste container is displayed in the figure below.
1 2
Liquid waste container
(1) Handle
(3) Connector to the tap
The analyzer is equipped with 2 liquid waste containers, which can be filled with up to
10 L liquid waste and emptied with the tap.
4.3.15 Tap
The tap is displayed in the figure below.
Tap to empty liquid waste container
(1) Push button

(2) Connector to the container
(3) Outlet tubing
The tap is used to empty the liquid waste container. The tap must be connected to the
liquid waste container. The push button of the tap is used to disconnect the tap from the
liquid waste container.
4.3.16 SVS solution

Detailed descriptions of the SVS solution, its handling, applications, and performance are
provided in the corresponding instructions for use.

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4.3.17 Third-party accessories for centrifugation of samples in racks

The sample racks have been approved for centrifugation with max. 2500 g in a centrifuge
equipped with specific accessories.
Centrifuge For details on the centrifuge’s make and model visit siemens-healthineers.com or
contact a Siemens Healthineers representative.
Accessories The following accessories are required for the centrifugation of samples in racks:
• 1 swing-out rotor, 2‑places
• 2 buckets for the swing-out rotor
• 2 stainless steel frames, to adapt the buckets to the length of the sample racks
• 2 polyurethane inserts for the stainless steel frames, to adapt the frames to the height
of the sample racks
4.4 Reagents, calibrators, and controls

Detailed descriptions of the reagents, calibrators, and controls, their handling,
applications, and performance are provided in the corresponding instructions for use.

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5 Description of the software

This chapter describes the operation of the software.
To reset user-specific settings to manufacturer settings, contact Siemens

5.1 Overview of the screen

An overview of the screen is displayed in the figure below.
1 2
Overview of the screen
(1) Tool bar

(2) Status area
(3) Buttons to access the routine functions
(4) Dialog
(5) Action bar with navigation buttons and action buttons
(6) Status alerts

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Elements of the screen are explained below.
Information Explanation
Tool bar The buttons in the tool bar are used to access less frequently used functions, for
example, setup or maintenance.
Status area For the displayed information, see ( Page 65 Status information).
Buttons to access the routine functions The buttons at the bottom are used to access the routine functions, for
example, in the job list and in the reagent overview.
Action bar The action bar is located on top of the dialogs.

On the left, the action bar displays the dialog title, and, if applicable, the
navigation buttons of related subdialogs.
On the right, the action bar displays action buttons, for example, for printing
or accessing online help. Depending on the dialog, different action buttons
are displayed.
Status alerts The status alerts in yellow or red inform the user about problems. For more
information on status alerts, see ( Page 374 Troubleshooting).
Elements of the screen
While measuring results, it is possible to access other dialogs. For example, depending
on access rights, the dialog Setup > Data definition can be displayed to get more
information on the used assays.
5.2 General elements

This chapter describes general elements of the software that are used in multiple dialogs.
5.2.1 Status information

The status information is explained in the 2 tables below.
System status, see ( Page 66 System statuses)
Name of the user logged in
Current date and time of day
Estimated walk-away time
The system is being controlled remotely by


Print No. DCHS-G01.621.01.08.02 65
The connection with the LIS is available.
The connection with the LIS is not available.
Status information
Information Explanation User action
Starting The system starts. Log on.

The user dialog is displayed. Start initialization, if applicable.
Initializing The system initializes. Wait for status Operating.
Operating The system is operating. Load reagents, perform analysis.
Operating The system will be in system status Operating Load reagents, wait for the displayed time.
in <mm:ss>a) after the displayed number of minutes and sec‐
onds.
If reagents are loaded, the bottles and car‐
tridges are processed as soon as the system
switches to the system status Operating.
Standby in <mm:ss>a) The system will switch to system status Load reagents, wait for status Standby.
Standby after the displayed number of
minutes and seconds.
If reagents are loaded, the bottles and car‐
tridges are processed as soon as the system
switches to the system status Operating.
Standby After 15 minutes without open orders, the Load reagents.

system switches to automatic standby mode.
The system automatically resumes from
Compared to Sleep, a shorter cleaning of the Sleep or Standby to Operating if an order
tubings is required to resume from the system is requested.
status Standby to Operating (approximately
To manually resume from Sleep or Standby to
1 minute).
Operating, select the button Resume in the
Sleep After 3:45 hours in Standby, the system dialog System.
switches to sleep mode.
Compared to Standby, a longer cleaning of
the tubings is required to resume from the sys‐
tem status Sleep to Operating (approximately
4:15 minutes).
Paused The system is not operating due to a problem, Resolve problem, or

for example, missing consumables, or
Empty cuvette waste.
The user paused the system to empty the cuv‐
To resume from Paused to Operating, select
ette waste.
the button Resume in the dialog System,
if required.

Print No. DCHS-G01.621.01.08.02 66
Information Explanation User action
Maintenance The system is in maintenance mode. Perform maintenance.

To resume from Maintenance to Operating,
select the button Resume in the dialog System,
if required.
Disconnected The system is not operating because the con‐ Resolve problem.
nection between the analyzer and its computer
is interrupted.
Shutting down The system finishes all open orders for which at Wait until:
least the first transfer step has been processed
(eco mode and shutdown) or aborts all open • The system is in eco mode, that is, the
orders (quick shutdown). illumination LED of the reagent manager
blinks slowly, or
The system switches to eco mode or
shuts down. • The system is shut down, that is, the status
LED of the touchscreen monitor turns orange.
Do not power off the system using the main
power switch before shutdown is completed.
System statuses
a) Placeholders: mm = minutes in 2 digits, ss = seconds in 2 digits
In system statuses Standby and Sleep, the system performs administrative tasks,
for example, an automatic compression of log files, and it is not possible to perform
maintenance tasks which require interaction with the software.
5.2.2 Automatic transmission

This chapter describes the information that is automatically transmitted between the
Atellica COAG 360 System and the laboratory information system (LIS), the laboratory
automation system (LAS), and the Smart Remote Services (SRS).
LIS communication The following information is transmitted to and from the LIS:
• Orders from the LIS (including patient information)
• Sample results with flags to the LIS
• Sample HIL index values and proper-fill values to the LIS, if configured
• Control results to the LIS
LAS communication The following information is transmitted to and from the LAS:
• Command requests from the LAS
• Command responses to the LAS
• Sample IDs and sample tube geometry from the LAS
• Analyzer and sample status information to the LAS

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Smart Remote Services (SRS) The following information is transmitted to and from the SRS via remote connection:
• Lot data and software updates provided by Siemens Healthineers from the SRS
• Analyzer properties, for example, status information, temperatures, and usage

counter to the SRS
• Released sample and control results, and calibrations to the SRS
• Analyzer events (a subset of the red status alerts) to the SRS
• Cost-per-reportable result (CPRR) to the SRS
• Remote control by Siemens Healthineers service, if accepted
5.2.3 Common display functions in dialogs

This chapter describes common display functions used in multiple dialogs.
Select In some dialogs, the user can select and de-select all items at once, see the table below.
Button Explanation
Selects all displayed items
De-selects all selected items
Select and de-select all displayed items
In the dialogs Jobs and Controls, the user can select and de-select cells as explained in
the table below.
Cells to be selected Action
Select 1 cell Select the cell
Select more cells Select the cells
De-select 1 cell Select the cell again
Select all cells for a sample ID or con‐ Select the sample ID or the product short name
trol lot
De-select all cells for a sample ID or a Select the sample ID or the product short name again
control lot
Select all cells for an assay Select the column header
De-select all cells for an assay Select the column header again
Select items
At the bottom left, the selection count n of m cells selected displays how many cells are
currently selected.
Scroll Some dialogs provide scroll functions, see the table below.

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Button or Explanation Action

slider
To the top Select
1 step up Select
Vertically Drag
1 step down Select
To the bottom Select
To the far left Select
1 step to the left Select
Horizontally Drag
1 step to the right Select
To the far right Select
Scroll
Sort In some dialogs, the user can sort the data in lists by selecting the header of the
required column.
Filter In some dialogs, the user can filter the displayed data. Filters are indicated by the
symbol . When a filter is applied to previously selected items, only those items
are displayed, which fulfill the filter criteria. All other previously selected items are
de-selected for safety reasons, for example, to prevent the unintended release of results.
Dates and times of orders Dates and times of orders are displayed in different colors as explained in the table below.
Color Explanation
Gray Date and time when the order was requested
Blue Estimated date and time when the order will be fin‐
ished

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Color Explanation
Black Date and time when the order was finished
Dates and times of orders
Master navigation Some subdialogs provide so-called master navigation. In the subdialog, the user can
browse the items of the master dialog. Master navigation is a shortcut for going back to
the master dialog, selecting a neighboring item, and displaying the subdialog again.
For example, the subdialog Sample result info provides buttons for master navigation
as explained in the table below.
Button Explanation
Selects the previous sample ID in the master dialog
Sample
Sample Selects the next sample ID in the master dialog
Selects the previous assay in the master dialog

Assay
Selects the next assay in the master dialog

Assay
Returns to the item selected when displaying the sub‐

dialog
Reset
Example for master navigation
Descriptive text for input In some dialogs descriptive text is displayed, for example, an input validation message for
fields input fields. Longer texts are reduced to 1 line. The full text will only be displayed when
the mouse pointer is moved over that line, for example, in the dialog Data definition.
1 2
Descriptive text
(1) Reduced descriptive text

(2) Full descriptive text

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Display of charts There are different ways to change the display of charts:
• Zoom in: drag a rectangle shape in the chart
• Change the display using buttons as explained in the table below
Button Dialog Explanation
Zoom in Jobs > Sample result info > Measurement curve Scales up the axes by 1 zoom‐
ing step
Jobs > Sample result info > Measurement curve
> Alternative wavelength
Data > Raw data > Measurement curve
Data > Raw data > Measurement curve

Controls > Control result info > Measurement curve
Control > Control result info > Measurement curve

Calibration > Calibration curve
Calibration > Calibration curve > Calibration curve info

> Measurement curve
Calibration > Calibration curve > Calibration curve info

> Measurement curve > Alternative wavelength
Zoom out See button Zoom in Scales down the axes by

1 zooming step
Auto See button Zoom in Adjusts the axes to the availa‐

ble data
Reset See button Zoom in Resets the axes to a

default scale
Show grid Calibration > Calibration curve Displays or hides grid lines
Swap axes Calibration > Calibration curve Swaps the axes
X-axis logarithmic Calibration > Calibration curve Changes between logarithmic

and linear scaling of the x-axis
Y-axis logarithmic Calibration > Calibration curve Changes between logarithmic

and linear scaling of the y-axis
Change the display of charts
Select files The dialog Select file is used to select and open a file, see the table below.
Information Explanation Action
(Folder list on the left) Available folders Select

If configured, the folder can be a shared folder, see ( Page 170 Shared folders)
(File list on the right) Available files of the file type selected below Select

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File type File type Select
Cancel Cancels the selection and closes the dialog Select
Open Opens the file Select

If a ZIP file contains more than 1 file, the simplified dialog Select file is displayed to
select and open a file from the ZIP file, see ( Page 72 Select file (for ZIP files))
Select file
(File list) Files available in the ZIP file Select
Cancel Cancels the selection and closes the dialog Select
Open Opens the file Select
Select file (for ZIP files)
Screenshot To create a screenshot, use the keys Ctrl + Alt + D.
5.2.4 Common action buttons

The action bar displays action buttons as appropriate to each dialog. Action buttons
common to various dialogs are explained in the table below.
Action button Dialog Explanation
Close Various dialogs Clears unsaved changes and closes the dialog
Help Various dialogs Displays the online help for the current dialog, see
( Page 185 Help)
Info Jobs > Sample result info See ( Page 95 Raw value info)
Calibration > Calibration curve info
Controls > Control result info
Data > Raw data
Data > Jobs > Sample result info
Print Jobs If no results are selected, a confirmation dialog is dis‐

played to print all results. If 1 or more results are selected,
Controls
a confirmation dialog is displayed to print the selected
Result history results. When confirmed, the dialog Print is displayed,
see ( Page 186 Print)
Various dialogs Displays the dialog Print, see ( Page 186 Print)
Reset Various dialogs Reverts to the previously saved values
Save Various dialogs Saves the values
Common action buttons

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If no printer is connected to the system, the action button Print creates an XPS file or
PDF file, as configured by Siemens Healthineers service. To display XPS files or PDF files
on the system, see ( Page 137 Document viewer). To export created XPS files or PDF
files to a USB storage device or to a shared folder, see ( Page 136 Export).
5.2.5 Flags
Flags can be displayed as comments and/or as symbols.
Flags with symbols Flags with symbols are explained in the table below. In the dialogs Jobs, Controls,
Calibration, Calibration curve, and Data > Raw data, only flag symbols are displayed.
In the dialogs Jobs and Controls, if more than 1 flag symbol is available for a result,
only the most important flag symbol according to an implemented hierarchy is displayed
(priority: 1 = most important, 9 = least important). In the table, the flags are sorted by
importance. Symbols with higher numbers in the column Priority are hidden by symbols
with lower numbers. In the dialogs Sample result info, Control result info, Calibration
curve info, Raw value info, and Archive viewer, all corresponding flag symbols and flag
comments are displayed.
Flag Explanation Symbol displayed in dialog
Comment Symbol Jobs Controls Priority
No resulta) No result can be determined, for exam‐ 1

ple, because no clot or color change has
been detected.
Result invalida) The sample or control result, calibration curve, or 2

supporting point is invalid.
- At least 1 of the sample’s HIL indices is higher - 3

than or equal to the assay-specific warning level.
The symbol can only be displayed in the
dialog Jobs and summarizes 1 or more of the
following flags:
• Above assay-specific hemolytic warning level
• Above assay-specific icteric warning level
• Above assay-specific lipemic warning level
Result The sample or control result is above the meas‐ >>> >>> 4
b)
above measure‐ urement range.
ment rangea)
Result The sample or control result is below the meas‐ <<< <<< 4
b)
below measure‐ urement range.
ment rangea)
Result doubtfula) The measurement curve, raw value, sample 5

or control result, calibration curve, or support‐
ing point is doubtful, for example, because an
unregistered cuvette or expired reagent or aged
sample has been used.

Print No. DCHS-G01.621.01.08.02 73
Relevant control At least 1 control result relevant for the sample - 6

result outside result is outside of the acceptance range or inva‐
acceptance range lid.
or invalidc)
Relevant control At least 1 control result relevant for the sample - 6

result doubtfulc) result is in the acceptance range, but doubtful.
Result above The control result is above the acceptance range. - 6

acceptance range
Result below The control result is below the acceptance range. - 6

acceptance range
Result above ref‐ The sample result is above the reference range. - 7
erence rangea)
Result above The sample result is above the customized refer‐ - 7

customized refer‐ ence range.
ence rangea)
Result below ref‐ The sample result is below the reference range. - 7
erence rangea)
Result below The sample result is below the customized refer‐ - 7

customized refer‐ ence range.
ence rangea)
Result above cut- The sample result is above the cut-off. - 7

off
Result above cus‐ The sample result is above the customized cut- - 7
tomized cut-off off.
Result below cut- The sample result is below the cut-off. - 7

off
Result below cus‐ The sample result is below the customized cut- - 7
tomized cut-off off.
Result in accept‐ The control result is in the acceptance range. - 8

ance range
Result converted The sample or control result has been converted - 9

to base dilution to the base dilution.
Relevant control The 2 control results relevant for the sample - - -

results in accept‐ result are valid and in the acceptance range.
ance range
Result released The sample result has been released. - - -
Above assay-spe‐ The sample’s hemolytic index is higher than or - -

cific hemolytic equal to the assay-specific warning level.
warning level

Print No. DCHS-G01.621.01.08.02 74
Above assay-spe‐ The sample’s icteric index is higher than or equal - -

cific icteric warn‐ to the assay-specific warning level.
ing level
Above assay-spe‐ The sample’s lipemic index is higher than or - -

cific lipemic warn‐ equal to the assay-specific warning level.
ing level
Flags with symbols
a) Transmitted to the LIS together with the result, if configured

b) This symbol is displayed only in the dialogs Sample result info and Control result info.
c) Transmitted to the LIS as Control result doubtful, outside acceptance range, or invalid together with the result, if configured
Flags without symbols Flags without symbols are explained in the table below. Flags without symbols give
additional information and do not have an implemented hierarchy. In the dialogs
Sample result info, Control result info, Calibration curve info, Raw value info, and
Archive viewer, all corresponding flag comments are displayed.
Comment Explanation
Aged sample, control, or calibra‐ The expiration warning period has started to elapse.
tor used
For aged samples, the flag Result doubtful is displayed additionally.
Aggregation curve doubtful The measured blank value of the platelet-poor plasma (PPP) is implausible or
does not match the expected ratio to the platelet-rich plasma (PRP) for 1 of the
following reasons:
• A high absorbance for the PPP sample due to interference substances
(hemoglobin, bilirubin, or lipids)
• A high absorbance due to loading a PRP sample instead of a PPP sample
• An implausibly low absorbance for the PRP sample due to a very low
platelet number
If the absorbance for the PPP sample is equal to or greater than 1000 mE, the
sample has to be checked for interference. If no interference is observed, a new
platelet-poor plasma sample from the same patient with the identical sample
ID has to be re-measured and the blank value is recalculated. In this case all
corresponding PRP results have to be selected and repeated in the dialog Jobs.
All single assay results not usable No single assay result is usable.
Antigen excess suspected The sample is suspected to have too much antigen.
Blank value doubtful The measured blank values of the platelet-poor plasma (PPP) and the platelet-
rich plasma (PRP) are implausible, for example, due to a mix-up of the PPP
sample and the PRP sample.
Calculation not possible The calculation is not possible.
Calculation of correlation coeffi‐ The evaluation method cannot determine the correlation coefficient.
cient failed
Calibration curve edited manually At least 1 supporting point of the calibration curve has been edited manually.

Print No. DCHS-G01.621.01.08.02 75
Comment Explanation
Calibration curve not monotonic The calibration curve is not monotonic.
Calibration curve outside accept‐ The calibration curve is outside the acceptance range.
ance range
Clog detected At least once a clog has been detected when loading the sample.
Cuvette may be contaminated The cuvette may be contaminated by a dropped cuvette, cartridge, or carrier
with bottle, or their respective contents.
Data problem A data problem occurred.
Data reduction not possible The data reduction is not possible.
Decreasing curve expected The evaluation method does not find the expected decreasing measure‐
ment curve.
Deviation of single measurements At least 1 single measurement deviates more than permitted.
too higha)
Expired calibration curve used An expired calibration curve has been used to evaluate the sample or con‐
trol result.
Expired reagent used An expired reagent has been used to process the order, that is, either the
assay-specific reagent on-board stability period, the general on-board stability
period or the expiration date has been exceeded.
Expired sample, control, or calibra‐ An expired sample, control, or calibrator has been used to process the order,
tor used that is,
• For a sample, the on-board time in aliquot storage has been exceeded. The
flag Result doubtful is displayed additionally.
• For a control, either the on-board stability period or the expiration date has
been exceeded.
• For a calibrator, the expiration date has been exceeded.
Extrapolation not possible The extrapolation of the calibration curve is not possible.
Fewer supporting points than defined The calibration curve has fewer supporting points than defined.
Increasing curve expected The evaluation method does not find the expected increasing measure‐
ment curve.
Insufficient change in signal The difference between the maximum absorbance and the minimum absorb‐
ance in the measurement curve is smaller than the defined value.
Kinetic curve is waveda) The check method has determined a waved measurement curve.
Measurement curve too short The measurement curve is too short for an evaluation, for example, because
the maximum signal difference has been exceeded too early.
Measurement curve without reactionb) At least 1 measurement curve does not show a reaction.
Measurement range exceeded The measurement range of the photometer has been exceeded.
Measurements from different dilutions At least 1 assay procedure has been processed with a different dilution.
Measurements with different lots At least 2 single measurements have been performed with different lots.

Print No. DCHS-G01.621.01.08.02 76
Comment Explanation
Minimum absorbance too higha) The minimum absorbance is greater than the defined value for the minimum
signal of a measurement curve.
No linear range The evaluation method cannot determine the linear range where the maximum
reaction velocity occurs.
No measurement No measurement has been performed.
No plateau The measurement curve has not reached a constant signal level at the end of
the reaction.
Not all single assay results usable At least 1 single assay result is not usable.
Not all single measurements usable At least 1 single measurement is not usable.
Not enough supporting points The calibration curve does not have enough supporting points.
Onset of coagulation doubtful The increase or decrease in signal at the time of coagulation onset does not
reach the defined minimum angle.
Pipettor problem A pipettor problem occurred.
Problem with incubation time A problem with the incubation time occurred.
Problem with measurement curve The measurement curve cannot be evaluated.
Problem with measuring module A problem with a measuring module occurred.
Problem with pipetting medium The volume of the pipetting medium was insufficient.
Problem with pipetting sequence A problem with the pipetting sequence occurred.
Quality criterion for the raw value can‐ The quality criterion for the raw value to characterize the Endogenous Throm‐
not be calculated bin Potential of an ascending measurement curve cannot be determined.
Quality criterion for the raw The quality criterion for the raw value to characterize the Endogenous Throm‐
value cannot be calculated; rising bin Potential of an ascending measurement curve cannot be determined.
curve expected
The evaluation method does not find the expected increasing measure‐
ment curve.
Quality criterion for the raw value The quality criterion for the raw value to characterize the Endogenous Throm‐
not fulfilled bin Potential of an ascending measurement curve is not fulfilled.
Quality criterion for the raw value not The quality criterion for the raw value to characterize the Endogenous Throm‐
fulfilled; rising curve expected bin Potential of an ascending measurement curve is not fulfilled.
The evaluation method does not find the expected increasing measure‐
ment curve.
Reaction curve has unacceptable cor‐ The correlation coefficient within the time interval is below the defined mini‐
relation mum.
Registered cuvettes used up The order has been processed with an unregistered cuvette.
Repeata) The sample result for this sample and assay has been re-measured, or
The result for the supporting point of the calibration curve has been re-meas‐
ured.
Result extrapolated to a higher value The sample or control result has been extrapolated to a higher value.
Result extrapolated to a lower value The sample or control result has been extrapolated to a lower value.

Print No. DCHS-G01.621.01.08.02 77
Comment Explanation
Result sent to LIS The sample result has been sent to the LIS.
Reversing measurement curve Toward the end of the reaction, a drop in signal against the maximum has been
determined that is greater than the defined value.
Sample tube overfilled The sample tube was overfilled when an aliquot was taken for the first time.
Sample tube underfilled The sample tube was underfilled when an aliquot was taken for the first time.
Significant drop in absorbance The check method has determined a significant drop in absorbance.
System problem A system problem occurred.
Temperature problem A temperature problem occurred.
Unexpected measurement curve The shape of the measurement curve is unexpected.
Flags without symbols
a) Transmitted to the LIS together with the result, if configured

b) Transmitted to the LIS as No result, if configured
5.3 Dialogs
This chapter describes every dialog of the software.
At the beginning of each dialog description, 1 or more paths are listed to find the dialog
within the software.
5.3.1 Loading
The following dialogs are used to manually identify samples, controls, and calibrators
loaded into the sample manager.
5.3.2 Problem racks

Path to the dialog:
• Loading > Problem racks
The dialog is used to view unidentified sample tubes and bottles loaded into the sample
manager and to manually identify them.
On the left, unidentified sample tubes and bottles are displayed, see the table below.
Problem Symbol representing the problem, see ( Page 79 Problems with

unidentified sample tubes and bottles)
Rack type Rack type
Rack-Position Rack ID and position of the sample, control, or calibrator on

the rack
Date and time Date and time when the rack was loaded

Print No. DCHS-G01.621.01.08.02 78
Status
, if Skip position or Assign to position has been selected,
see below
Unidentified sample tubes and bottles
Symbol Explanation
Barcode unreadable
Identical barcode
Barcode incorrect, or
Clog detected
Problems with unidentified sample tubes and bottles
When a sample, control, or calibrator is selected, the corresponding rack is displayed on

the right, see the figure below.
3 2
Problem rack (example)
(1) Sample ID or product data, and problem, if applicable

(2) Rack data
(3) Positions on the rack: 5 positions on a sample rack (A to E), 4 positions on a calibrator
and control rack (1 to 4)
Below, the user can resolve the problem. The displayed information corresponds to
the problem.
For unreadable barcodes , see the table below.
Sample ID (only for samples) Sample ID Enter

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Product name (only for controls and calibrators) Product short name Select
Lot number (only for controls and calibrators) Lot number Select
Bottle type (only for controls and calibrators) Bottle type Select
Serial number (only for controls and calibrators) Serial number Enter
Skip position Marks the position in the figure with a black circle Select
Marks the position in the list with a blue circle in the
column Status
Deletes the data associated with the position
Assign to position Marks the position in the figure with a black circle Select
column Status
Assigns the sample ID or product data to the position
Save rack (only if all problems on the rack have For manually identified positions: Select
been resolved)
• Saves the entered values
For skipped positions:
• Discards the aliquots, if applicable
• Aborts open orders, if applicable
• The user can correct the barcode and re-load the
sample, calibrator, or control.
Unreadable barcode
For identical barcodes , and incorrect barcodes and clogs in sample tubes ,
see the table below.
Skip position Marks the position in the figure with a black circle Select
column Status
Deletes the data associated with the position
Save rack (only if all problems on the rack have The user can correct the problem and re-load the sample. Select
been resolved)
Identical sample IDs and other problems
5.3.3 Pre-identification
Path to the dialog:
• Loading > Pre-identification
The dialog is used to manually identify samples before loading them into the sample
manager, see the table below.

Print No. DCHS-G01.621.01.08.02 80
Rack ID Rack IDs with the sample type in brackets Select or

scan
Instead of selecting the rack ID from the list, the user
can identify the rack by scanning the barcode using the
handheld barcode reader.
Position Sample positions on the selected rack Select

On the right, rack ID, sample type, and sample tube name
Sample ID Sample ID Enter
STAT Short turnaround-time Select
Automatic numbering Sample IDs for all following unidentified positions on Select
the selected rack are automatically completed with an
increasing numbering.
The selected assays are copied to all automatically num‐
bered positions.
Positions already identified manually or by barcode
are skipped.
Examples:
• Sample ID entered for position A: SAMP
Sample IDs on the rack: A = SAMP0, B = SAMP1,
C = SAMP2, D = SAMP3, E = SAMP4
• Sample ID entered for position C: SAMP
Sample IDs on the rack: C = SAMP0, D = SAMP1,
E = SAMP2
• Sample ID entered for position B: SAMP34
Sample IDs on the rack: B = SAMP34, C = SAMP35,
D = SAMP36, E = SAMP37
• Position B already barcoded or manually identified,
sample ID entered for position A: SAMP
Sample IDs on the rack: A = SAMP0, C = SAMP1,
D = SAMP2, E = SAMP3
Requested by Sender of the sample, for example, ward or laboratory Enter
Direct mode Requests an order in direct mode Select

When selecting Direct mode, make sure to select below,
under Assays, only those assays which are defined for
measurements in direct mode.
Otherwise, when trying to save the settings made in
the dialog Pre-identification, a dialog stating that not
all selected assays can be measured in direct mode is
displayed. The dialog does not specify the affected assays.
When selecting Cancel, there is the option to de-select
assays in an iterative approach.
Comment Comment on the sample, if applicable Enter

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Assays Assay short names and alternative dilutions dialog, Select

if applicable 1 or more
If the arrow to the right of an assay is selected, a list of Select

alternative dilutions is displayed. If an alternative dilution
has been selected from the list, the dilution is displayed
next to the assay short name.
Identification of samples
Action buttons For special action buttons, see the table below.
Action button Explanation
Save Saves the values and requests orders for the selected assays
Action buttons
5.3.4 Jobs
Path to the dialog:
• Jobs
The dialog is used to manage sample jobs and to display sample results.
The dialog displays the sample jobs in a table with sample IDs shown on the left and
assays shown at the top, see the figure below.
1 2 3 4 5 6
20 7
19 18 17 16 15 14 13 7 12 11 10 9
Details of the dialog Jobs (example)
(1) Number of sample IDs in the dialog Jobs

(2) Column Patient name with the patient names for the sample jobs, if available, see
( Page 83 Patient name)
(3)
Column with the estimated times of completions for the sample jobs, see
( Page 84 Estimated time of completion)
(4) Assay short name or customized assay name
(5) Unit of the result, if applicable
(6) Assay uses the sample type PRP (platelet-rich plasma)
(7) If more than 1 flag symbol is available for a result, only the most important flag
symbol according to an implemented hierarchy is displayed, see ( Page 73 Flags)
(8) No result, for example, no clot or color change has been detected

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(9) Raw value available, waiting for applicable calibration curve or assigned value
(10) Number of orders, if repeated
(11) Last result, the color of numerical results indicates the status of the result, see
( Page 83 Statuses of numerical results)
(12) Result obtained with a previous assay definition that has been changed in the
meantime so that the result is now incomparable to results using the new
assay version
(13) Open order
(14) See ( Page 85 Symbols <<< and >>>)
(15) At least 1 of the sample’s HIL indices is higher than or equal to the assay-specific
warning level
(16) Sample ID comprises both platelet-poor plasma and platelet-rich plasma
(17) See ( Page 84 PSI symbol)
(18) See ( Page 84 HIL symbol)
(19) Sample material is on-board
(20) Sample ID displayed in red: STAT sample
Color Status
Orange Doubtful
Black Not doubtful, but not yet released
Green Released and sent to the LIS, if applicable
Statuses of numerical results
With the symbol button at the bottom right of the dialog, between the
symbol buttons for search and zoom, the user can display or hide the columns Patient
name and , for example, to have more space for results, if required.
The user can define in the dialog Setup > Configuration > System if one or both
of the columns Patient name and can be displayed in the dialog Jobs, see
( Page 165 System (for general settings)).
Patient name The patient name is displayed in the format <last name>, <first name>.
The correct patient name can only be displayed if last name and first name have
been transferred from the LIS (configurable only for the protocol ASTM, see the data
interface manual).
It is not possible to directly enter a patient name in the column Patient name.
It is possible to search in the column Patient name if it is displayed.
It is also possible to sort samples by the column Patient name if it is displayed, see
( Page 85 Sort sample IDs).
If a patient name is displayed in the dialog Jobs, it is also included in the

corresponding printout.

Print No. DCHS-G01.621.01.08.02 83
To protect personal data, the patient name is anonymized:
• in the dialog Data > Result history
• when a service user is logged on
• when remote control by Siemens Healthineers service has been accepted
Estimated time of completion

The column displays the following information:
• The displayed time is an estimation for the completion of all orders requested for
the sample.
• As long as not all orders requested for the sample are already planned by the system, ...
(= three dots) is displayed.
• If no order has been requested or all orders have already been measured for a sample,
the column is empty.
The displayed time in the column is the current estimation and is permanently
updated, for example, when a new order for a STAT sample requires a re-scheduling of
the planned orders.
If a cell in the column is selected, the corresponding dialog Jobs > Sample
info is displayed showing details for the already estimated completions in the list
Running orders.
Platelet aggregation meta- Platelet aggregation meta-assays are used to select several platelet aggregation agonists
assays or agonist concentrations at once in the dialog Jobs. The result of the platelet
aggregation meta-assays will be set to 1 if all measurements are completed.
If an order for a platelet aggregation meta-assay result is deleted, all orders for the
corresponding single assays are also deleted (as long as the single assays are not
activated in the dialog Assay activation or used by another meta-assay order).
PSI symbol
The PSI symbol indicates at least 1 of the following conditions:
• The sample tube was under- or overfilled during the first aliquotation.
• At least 1 of the sample’s HIL indices is higher than or equal to the sample-specific
warning level.
• For at least 1 of the sample’s results, an assay-specific HIL warning is displayed.
HIL symbol
The HIL symbol indicates that at least 1 of the sample’s HIL indices could not be
measured or evaluated.

Print No. DCHS-G01.621.01.08.02 84
In case that the conditions for both, the PSI symbol and the HIL symbol, are fulfilled,
only the PSI symbol is displayed.
Symbols <<< and >>> To prevent the unintended release of results, the result is not displayed when outside the
measurement range:
• The symbol <<< indicates that no result is displayed because the result is below
measurement range.
• The symbol >>> indicates that no result is displayed because the result is above
measurement range.
Filter The user can filter the sample IDs, see the table below.
Filter Explanation
All samples All samples
Samples with request Samples with open orders
On-board samples Samples with material on-board
Sample material required Missing samples and samples with insufficient aliquot volume
Samples with unreleased results Samples with unreleased results
STAT samples Samples with short turnaround-time
Samples with PSI or HIL warning Samples:

• underfilled or overfilled during aliquotation, or
• with at least 1 HIL index higher than or equal to the sample-specific warning
level, or
• with at least 1 result with an assay-specific HIL warning, or
• with at least 1 HIL index that could not be measured or evaluated
Filters for sample IDs
Sort samples The user can sort the sample IDs, see the table below.
Setting Explanation
Numerically ascending, Numeri‐ Digits are sorted as whole numbers, even if a sample ID comprises both letters
cally descending and digits.
Letters are sorted alphabetically, character by character.
Example:
BC41
BC370
BC460

Print No. DCHS-G01.621.01.08.02 85
Setting Explanation
Alphanumerically ascending, Alpha‐ The sample IDs are sorted character by character.
numerically descending
Example:
BC370
BC41
BC460
Chronologically ascending, Chrono‐ The sample IDs are sorted by the date and time when a sample ID was created
logically descending on the system.
Ascending by patient name, Descend‐ The samples are sorted by the patient name.
ing by patient name
Sort sample IDs
Search The user can search for any part of a sample ID, see the table below.
Symbol or field Explanation Action
Opens and closes the search dialog Select
(Input field) The user can enter any part of a sample ID. Enter or
scan
Instead of entering a sample ID manually, the user can also search for a sample ID or
a control ID by scanning the barcode using the handheld barcode reader.
Both procedures select the first matching sample ID.
Selects the previous matching sample ID Select
Selects the next matching sample ID Select
(m) of (n) Selection count: there are n matching sample IDs, currently the m-th matching -
sample ID is selected
Clears the input field Select

De-selects the currently selected sample ID
Search for sample IDs
Zoom The user can zoom the dialog, see the table below.
Button Explanation
Small
Medium

Print No. DCHS-G01.621.01.08.02 86
Button Explanation
Large
Zoom
Multiple selection The user can display the measurement curves of 1 or more selected results with the
same sample ID in the multiple-selection dialog Measurement curve by selecting the
button . This is valid for both platelet-rich plasma (PRP) and platelet-poor
plasma (PPP). The symbol button is positioned at the bottom right in the
dialog Jobs.
The multiple-selection dialog Measurement curve is displayed above the dialog Jobs
and contains all elements required for the evaluation of platelet aggregation curves.
Subdialogs Subdialogs are available depending on the selected data, see the table below.
Selected Subdialog
1 sample ID Sample info
1 sample job Sample result info

Measurement curve
Subdialogs
New Requests a new order for each selected empty cell
Special order See ( Page 88 Special order)
Delete Displays a confirmation dialog to delete the selected samples and sample jobs

Print No. DCHS-G01.621.01.08.02 87
Repeat Requests a new order for each selected sample job.

If the sample job is for a meta-assay, 1 of the following 3 steps will be per‐
formed, namely the one for which the described preconditions are fulfilled:a)
• A new meta-assay result is calculated from the most recent single-assay
results utilized by the meta-assay. This is possible only if there exist
single-assay results that are more recent than the meta-assay result. In
this case, no single-assay will be requested again and the new result is
available immediately.
• Of all the single-assay results used by the meta-assay, only the invalid or
doubtful results will be requested again. In this case, a new result is released
by combining the valid single-assay results of the original result with the
results of the new requests, once measured.
• If there are no valid single-assay results at all, all single-assay results used
by the meta-assay result will be requested again. This will result in a
complete re-measurement.
Release Releases the last result of each selected sample job for transmission to the LIS
Send Sends the released last result of each selected sample job for transmission to
the LIS
Action buttons
a) For example, multi-material assays, multi-dilution assays, or meta-assays using the data reduction method Formula, for example, to calculate
a ratio.
The following needs to be observed with regard to repeating measurements:
• Repeating an assay result does not automatically re-request any meta-assay results
that use it. To re-calculate a meta-assay result that may be impacted by the repeated
single-assay result, the meta-assay result needs to be selected and repeated manually.
• To manually repeat only specific single-assays (for example, assays measuring a

specific sample type or a specific dilution) of a meta-assay result select only these
single-assay results in the dialog Jobs and repeat them. Then select and repeat the
meta-assay result. This will result in a repeated meta-assay result where only the
manually selected single assays are re-measured.
• Repeat orders can be requested at any time. If the action button Repeat is selected
for a meta-assay result, the result is re-calculated using the single assay results
already available.
5.3.5 Special order

Path to the dialog:
• Jobs > Special order
The dialog is only available for assays with 1 of the following settings:
• Measurement in direct mode is possible
• Alternative sample dilutions are defined
Sample tubes with caps are detected and will not be processed in direct mode.

Print No. DCHS-G01.621.01.08.02 88
The dialog is used to request an order in direct mode or with an alternative sample
dilution or both for 1 cell selected in the dialog Jobs, see the table below.
Special orders for pre-identified samples can directly be requested in the dialog
Loading > Pre-identification as well.
Direct mode
Measure in direct mode Aspirates sample material directly from the sample tube Select
without taking an aliquot
Dilution
(Value) Alternative sample dilutions defined for the assay Select
Request Requests the order and closes the dialog Select
Special order
5.3.6 Sample info

Path to the dialog:
• Jobs > Sample info
• Data > Result history > Sample info
The dialog is used to view and edit properties of a sample selected in the dialog Jobs or
in the dialog Data > Result history, see the table below.
Sample ID Sample ID -
The symbol indicates that the sample ID comprises

both platelet-poor plasma and platelet-rich plasma.
STAT Activates short turnaround-time for the sample Select
Created Date and time when the sample ID was created on the sys‐ -
tem
Requested by Sender of the sample, for example, ward or laboratory, Enter

if applicable
Comment Comment on the sample, if applicable or available from Enter

the LIS
Properties of a sample
Using the buttons for master navigation on the right, the user can browse the samples
in the dialog Jobs, see also ( Page 70 Master navigation).
Running orders The list Running orders displays the orders that are currently being measured, see the
table below.

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Assay Assay short name or customized assay name
Sample type PPP: platelet-poor plasma

PRP: platelet-rich plasma
Estimated completion Estimated time when the result will be available, or

Empty when the time is not yet scheduled, or
Waiting for result: The measurement has been finished, but the result is not
yet available.
Running orders
Aliquots The list Aliquots displays information on the aliquots, see the table below.
Sample type PPP: platelet-poor plasma -

The symbols on the left, if applicable, indicate
the following:
• : The aliquot probe has been washed using a

special wash program before taking the aliquot.
• The expiration status of the sample aliquot, see
( Page 91 Statuses of on-board aliquots) (only for
on-board aliquots).
Rack-Position Rack ID and sample position on the rack -
H, I, L The numbers in brackets display the sample-specific -

warning levels, see ( Page 169 HIL warning).
Hemolytic index (H), icteric index (I), and lipemic index
(L) of the sample, for the corresponding concentration
ranges see ( Page 469 HIL indices and the corresponding
concentration ranges), or
, if the index could not be measured or evalu‐

ated, or
Empty
• if HIL indices have not been measured because the
sample has been measured in direct mode or HIL
measurements are deactivated in the dialog Setup
> Configuration > System, or
• if another aliquot is taken for the same sample ID
within 4 hours
Level , if sample tube was overfilled during aliquotation -
, if sample tube was underfilled during aliquotation

Print No. DCHS-G01.621.01.08.02 90
Volume [μL] Aliquot volume, displayed in red when the aliquot -

has expired
On-board Date and time when the aliquot was taken -
Eject Select
: discards the aliquot (only for on-board ali‐

quots)
Aliquots
If a value is only available for the lipemic index (L) and is displayed for the
hemolytic index (H) and the icteric index (I), the sample has a high turbidity (with a
lipemic index higher than or equal to 6). For such samples, the hemolytic index (H) and
icteric index (I) cannot be evaluated.
If a sample has been loaded, but no aliquots have been taken, the sample is displayed
in the list Aliquots similar to aliquots that have already been discarded.
Symbol Explanation
The expiration warning period has not yet started to

elapse, or
(blue) The expiration warning period is not configured in the
dialog Setup > Configuration > Expiration warnings,
see ( Page 166 Expiration warnings).
The expiration warning period is elapsing or the aliquot

has expired.
(yellow)
Statuses of on-board aliquots
Print Displays the dialog Print, see ( Page 186 Print), to print a sample report.
The sample report includes also the results displayed in the dialog Sample
result info and patient data transmitted from the LIS, if applicable.
Action buttons
5.3.7 Sample result info

Path to the dialog:
• Jobs > Sample result info

Print No. DCHS-G01.621.01.08.02 91
The dialog is used to view information on all results for a sample job selected in the
dialog Jobs.
At the top, in the area Sample, the sample ID is displayed. The symbol indicates
that the sample ID comprises both platelet-poor plasma and platelet-rich plasma.
Below, the assay name is displayed. For a meta-assay, the dialog contains several pages:
The first page displays information on the meta-assay and the other pages display
information on the single assays.
Using the buttons for master navigation on the right, the user can scroll through the
samples and assays in the dialog Jobs, see ( Page 70 Master navigation).
The list Results displays information on all sample results, see the table below.
Date See ( Page 69 Dates and times of orders)
Time See ( Page 69 Dates and times of orders)
(Symbol)
Flag symbol or , if applicable
Result
Numerical result, or symbol or
Unit Unit of the result, if applicable
Raw value (not for meta-assays) Numerical raw value or symbol
Unit (not for meta-assays) Unit of the raw value, if applicable
Results
When selecting the tab of a single assay, the assay short name is displayed next to
Results, because due to reasons of space the assay short name in the tab itself is not
fully readable.
For the selected sample result, details are displayed, see the table below.
Comment Comments and flags, if applicable
Controls (only for finished orders of assays with Information on the Previous control, if applicable, and Suc‐
assigned controls) ceeding control, if applicable, see ( Page 93 Framing con‐
trols)
Calibration curve Identifier of the calibration curve (only for finished orders of
assays with calibration curve)
or
Lot data missing for calculation (only for assays, which use an
ISI, MNPT, or MNV value instead of a calibration curve) if any of
these values is missing in the lot data
Lots Lots used with the order, see ( Page 93 Lots used)

Print No. DCHS-G01.621.01.08.02 92
Single measurements (not for meta-assays) Information on the single measurements, see ( Page 93 Infor‐
mation on single measurements and single assays)
Single assay results (only for meta-assays) Information on the single assay results, see ( Page 93 Informa‐
tion on single measurements and single assays)
Details on results
If in the area Comment the flag Above assay-specific hemolytic warning level,
Above assay-specific icteric warning level, or Above assay-specific lipemic
warning level is displayed, at least 1 of the sample’s HIL indices is higher than
or equal to the assay-specific warning level.
The measured indices are displayed in the dialog Sample info. To display the dialog,
select Jobs, select the sample, and then select the navigation button Sample info.
To view the assay-specific warning levels for Siemens Healthineers assays, see the
reference guide.
Product name Product short name
Product ID Product code and lot number separated by a slash
On-board age Time period from loading the reagent bottle or car‐
tridge into the reagent storage until the measurement
for this result started
Remaining OBS Remaining on-board stability (OBS) period from when

the measurement for this result started until the
reagent bottle or cartridge expires
If the reagent has expired, the time is displayed in red
and with a minus sign.
Lots used
(Name) Product short name
(Product ID) Product code and lot number separated by a slash
(Date) Date when the control result was available
(Time) Time when the control result was available
Framing controls
Assay (only for meta-assays) Assay short name or customized assay name

Print No. DCHS-G01.621.01.08.02 93

Assay procedure (not for meta-assays) Assay procedure name
Wavelength (not for meta-assays) Wavelength used for the evaluation
On-board age Time period from scanning the sample tube barcode until the measurement for
this result started
Dilution Sample dilution
(Symbol) (only for meta-assays)

Flag symbol or , if applicable
Result (only for meta-assays)
Unit (only for meta-assays) Unit of the result, if applicable
Raw value
Unit Unit of the raw value, if applicable
Flag Flag symbol, if applicable
Information on single measurements and single assays
The system can only monitor the on-board age in the course of processing the sample.
The user is responsible for monitoring the actual sample age by adding the period of
time from blood draw until the sample is loaded into the sample manager.
Reagent and sample on-board ages and remaining on-board stability are also
displayed for meta-assays and their single assays.
Selected Subdialog
Result of an assay which is not a meta- Measurement curve

assay
Result of a meta-assay. For the con‐ Multi-dilution assay curve

ditions that need to be fulfilled, see
( Page 98 Multi-dilution assay curve).
Subdialogs

Print No. DCHS-G01.621.01.08.02 94
5.3.8 Raw value info

Path to the dialog:
• Data > Raw data > Info
The dialog is used to view details on the raw value of the selected result, see the
table below.
Assay procedure Assay procedure name
Material Sample ID and sample type PRP, if platelet-rich plasma, or

Product ID of the control or calibrator
Measured Date and time when the raw value was available
Details on raw values
5.3.9 Measurement curve

Path to the dialog:
• Jobs > Measurement curve (navigation button at the top of the dialog)
• Jobs > Sample result info > Measurement curve
• Calibration > Calibration curve info > Measurement curve
• Controls > Control result info > Measurement curve
• Data > Raw data > Measurement curve
• Jobs > (symbol button at the bottom right of the dialog)
The single-selection dialog Measurement curve is used to view the measurement

curves for the last measurement of a result selected in the dialog Jobs or up to 10 single
measurements selected in either of the dialogs Sample result info, Calibration curve
info, Control result info, or Raw data.
Depending on the way of access, the dialog Measurement curve

has a slightly different appearance and different functionality, see also
( Page 95 Measurement curve).
It is not possible to display a measurement curve for meta-assays.
The measurement curves are displayed in different colors. On the right, a key is displayed,
see the figure below. The user can select a measurement curve.

Print No. DCHS-G01.621.01.08.02 95
1 2 3 4 3 5 6
Key for the measurement curves
(1) Color and symbol for the displayed curve

(2) Sample ID
(3) Field separator
(4) Assay procedure name for the displayed curve
(5) Wavelength, if applicable
(6) Symbol for sample type platelet-rich plasma (PRP), if applicable
At the top, details on the selected measurement curve are displayed, see the table below.
Material Sample ID and sample type PRP, if platelet-rich plasma, or

Product ID of the calibrator or control
Measured Date and time when the result was available
Wavelength Wavelength used for the evaluation
Measurement curves
In the chart, the selected measurement curve is highlighted and markers depending on
the evaluation method are displayed as vertical and horizontal lines, for example, the
minimum signal or the clotting time.
Only for platelet aggregation assays: At the left of the chart, the user can select to
display either the underlying blank value measurement in mA, based on the patient’s
platelet-poor plasma (PPP), or the aggregation curve in %Agg based on the patient’s
platelet-rich plasma (PRP.)
Below the chart, the following display options are available, see the table below.
Display results for all curves At the bottom, the results for all curves are displayed, Select
see ( Page 97 Results for the assay procedures of
all curves).
Display smoothed curves (only for sample An additional smoothing is applied to the displayed per‐ Select
type PRP) cent aggregation curves (%Agg) to ease evaluation.
Show grid Displays or hides grid lines Select
Display options

Print No. DCHS-G01.621.01.08.02 96
Depending on the check box Display results for all curves, the information on the
displayed curves at the bottom differs:
• If the check box is not selected, the evaluation methods for the displayed curve and
their raw values are listed and additional information on markers is displayed, see the
table below.
• If 1 or more results for platelet aggregation assays are selected and the check
box is selected, the evaluation methods for all displayed curves are listed, see
( Page 97 Results for the assay procedures of all curves).
Evaluation method Evaluation method used
Raw value Raw value and unit, if applicable
Marker Name of the first marker defined in the evaluation method
X-value X-value and unit of the first marker
Y-value Y-value and unit of the first marker
Marker Name of the second marker defined in the evaluation method, if applicable
X-value X-value and unit of the second marker, if applicable
Y-value Y-value and unit of the second marker, if applicable
Evaluation methods
(Color) Color of the percent aggregation curve
(Evaluation method) Raw values for the displayed assay procedure. For details on the evaluation
methods used, see ( Page 222 PlateAgg).
Results for the assay procedures of all curves
To display the results for all curves, use the scroll bar at the right, if applicable.
Subdialog Subdialogs are available depending on the selected data, see the table below.
Selected Subdialog
Measurement curve for Alternative curves

1 result
Subdialogs
The subdialog Alternative curves is only available, if only 1 result has been selected
in the dialog Jobs.

Print No. DCHS-G01.621.01.08.02 97
Multiple-selection dialog The multiple-selection dialog Measurement curve is accessed by selecting Jobs
Measurement curve
> .
The dialog is used to view the mA or %Agg measurement curves for 1 or more results
selected in the dialog Jobs for the evaluation of platelet aggregation results.
The multiple-selection dialog Measurement curve provides in general the same options
as the single-selection dialog Measurement curve. Only the subdialog Alternative
curves is missing.
5.3.10 Alternative curves

Path to the dialog:
• Jobs > Measurement curve > Alternative curves
The dialog is only available if only 1 result has been selected in the dialog Jobs. The
dialog is used to view alternative curves for the measurement curve selected in the dialog
Measurement curve:
• For PPP measurement curves: all measurements recorded using different

wavelengths, see ( Page 95 Measurement curve). The wavelengths are additionally
displayed in the key for the measurement curves, see ( Page 96 Key for the
measurement curves).
Alternative wavelengths are measured as configured for the assay procedure in

the dialog Data definition, subgroups Assay definition > Assay groups > Assay
procedures > Evaluation methods for raw value, parameter Wavelength, see
( Page 206 Evaluation methods for raw value).
• For PRP measurement curves: the PPP (mA or %Agg) measurement curve for the
result, see ( Page 95 Measurement curve).
5.3.11 Multi-dilution assay curve

Path to the dialog:
• Jobs > Multi-dilution assay curve
• Jobs > Sample result info > Multi-dilution assay curve
The dialog is used to view the curve of a multi-dilution assay result selected in the dialogs
Jobs or Sample result info.
A multi-dilution assay is a meta-assay that meets the following conditions:
• All single assays use the same result unit and sample type, defined in the dialog Data
definition, subgroups Assay definition > Assay groups > Assays.
• All single assays use the same raw value unit, defined in the dialog Data definition,
subgroups Assay definition > Assay groups > Assays > Assay measurement.
• All single assay results are transformed to the minimum dilution (base dilution).
• Precisely 1 of the single assays is calibrated. All other assays use this calibration curve.

Print No. DCHS-G01.621.01.08.02 98
The curve can only be displayed for results that meet the following conditions:
• The result has a numerical value and is not flagged Result invalid, Not all single assay
results usable, or All single assay results not usable.
• The result comprises at least 2 single assay results.
• All single assay results use the same calibration curve.
At the top of the dialog, the meta-assay name and the sample ID are displayed. The
symbol indicates that the sample ID comprises both platelet-poor plasma and
platelet-rich plasma.
In the chart, 2 curves are displayed. The curve for the multi-dilution-assay (black) is
the linear regression of the single-assay results. The reference line (blue) is the linear
regression over the calibration points of the base assay. Scaling of the axes corresponds
to the transformation model used to calculate the calibration curve.
On the right, criteria for the quality of the result are displayed, see the table below.
Correlation Correlation coefficient of the transformed values (raw value/

target concentration)
Target gradient Gradient of the curve of the multi-dilution assay
Reference gradient Gradient of the reference line
Deviation Deviation of the target gradient from the reference gradient
Mean activity Average activity of the sample
Coefficient of variation Variation coefficient of the sample activity at the different dilu‐
tions
Multi-dilution assay curve
At the bottom, information on the single assay results is displayed, see the table below.
Ratio Dilution factor Single assay result

Dilution ratio = -------------------------------------------------------------------
-
Base dilution factor
Raw value Raw value
Concentration Result
Activity Dilution factor Single assay result

Result Corrected = Result Single assay result -------------------------------------------------------------------
-
Base dilution factor
Target concentration Base dilution factor

Dilution ratio Normalized = 100 ----------------------------------------------------------------------
Dilution factor Single assay result

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Dev. from base assay Result Corrected – Result At base dilution

Deviation From base dilution = 100 --------------------------------------------------------------------------------
-
Result At base dilution
Dev. from mean value Result Corrected – Result Mean

Deviation From mean = 100 ---------------------------------------------------------------
-
Result Mean
With:
ResultMean: Mean activity
Single assays
5.3.12 Analyzer
Path to the dialog:
• Analyzer
The dialog is used to display the system temperatures and the fill levels of consumables,
system fluids, and waste containers, see the figure below. The symbols are displayed in
different colors, see ( Page 101 Colors of symbols).
5
6
15 7
14 8
13 12 11 10 9
System temperatures and fill levels of consumables, system fluids, and waste containers
(example)
(1) System temperatures (Ambient air, Incubator, LOCI reader, Absorbance reader,
Pre-heater, Reagent storage), + (plus): the temperature exceeds the normal
range, - (minus): the temperature is below the normal range
(2) Fill level of the stirrer bar loader
(3) Displays the dialog Re-fill stirrer bars

Print No. DCHS-G01.621.01.08.02 100
(4) Fill level of the cuvette loader

(5) Number of registered cuvettes
(6) Displays the dialog Register cuvettes
(7) Fill level of the cuvette waste container
(8) Displays the dialog Empty cuvette waste
(9) Fill level of the rear water container
(10) Fill level of the purging solution container
(11) Fill level of the front water container
(12) Fill level of the rear liquid waste container
(13) Fill level of the front liquid waste container
(14) Displays the dialog Replace probe cleaner
(15) Fill levels of the probe cleaner container and the probe cleaner reservoir, lot
number and expiration date of the probe cleaner
Color Explanation
Light blue Running without problems
Yellow Temperature: in warning range

Fill level of consumable or system fluid: almost used up
Fill level of waste container: almost full
Red Temperature: out of range or problem with sensor

Fill level of consumable or system fluid: used up
Fill level of waste container: full
Transparent and crossed out The status is not available, for example, the right drawer for the
cuvette waste is open or a container is missing.
Colors of symbols
5.3.13 Re-fill stirrer bars

Path to the dialog:
• Analyzer > Re-fill stirrer bars

The dialog is used to load stirrer bars, see the table below.
Lot Lot number of the stirrer bars Scan or

enter
Finish Saves the values and closes the dialog Select
Cancel Resets the values and closes the dialog Select
Load stirrer bars
5.3.14 Register cuvettes

Path to the dialog:
• Analyzer > Register cuvettes

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The dialog is used to load and register cuvettes, see the table below.
(Cuvette bag ID) Scanned cuvette bag ID Scan
Register Registers the cuvettes and adds them to the counter Select
Registered cuvettes in the dialog Analyzer
Load cuvettes
The number of registered cuvettes does not automatically match the fill level. If the
number of registered cuvettes is 0 and more cuvettes are available than registered,
results measured with unregistered cuvettes are flagged Result doubtful.
5.3.15 Replace probe cleaner

Path to the dialog:
• Analyzer > Replace probe cleaner
The dialog is used to replace the probe cleaner container, see the table below.
Lot Lot number of the probe cleaner Scan or

enter
Expiration date Expiration date of the probe cleaner Scan or

select
Replace the probe cleaner container
5.3.16 Empty cuvette waste

Path to the dialog:
• Analyzer > Empty cuvette waste
The dialog is used to empty the cuvette waste container, see ( Page 271 Emptying the
cuvette waste container).
5.3.17 Reagents
The following dialogs are used to view on-board and required products, and to manually
identify products loaded into the reagent manager.
5.3.18 Overview
Path to the dialog:
• Reagents > Overview

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The dialog is used to view on-board and required reagents, controls, calibrators, and
wash solutions, see ( Page 103 On-board products and products required for all
open orders).
Products of the same lot are summarized. On the left, in the column Product name,
the product names for on-board products and required products are displayed in the
summary line. For on-board products, the user can display and hide additional lines with
details on each product, see the table below.
Button or check box Explanation
Hides the details for this line

(in a line)
Displays the details for this line

(in a line)
Show details (at the bot‐ Displays the details for all lines
tom left)
Display and hide details
Details are only available if the filter All or On-board is selected, see ( Page 104 Filters
for products).
Product name Summary: product name -

Details: symbol indicating the expiration status of the
product, see ( Page 104 Expiration statuses of products)
Product ID Product code and, if applicable, lot number separated by -

a slash
Expiration date Date the lot expires, if applicable -
Required [mL] Total volume required for all open orders -
On-board [mL] Summary: total on-board volume of this lot -

Details: volume in the bottle or cartridge
Sufficient for number of orders Estimated number of orders that can be measured with -
the on-board volume
The estimation is based on:
• The activated assay with the highest
reagent consumption
• The reagent consumption caused by multiple
measurements processed for a single order
—: For reagents that are only used as a wash solution
Required in addition [mL] Missing volume to measure all open orders, displayed -
in orange

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Inventory and expiration Summary: number of on-board bottles or cartridges, and -

up to 5 symbols indicating the expiration status of each
product, see ( Page 104 Expiration statuses of products)
Details: estimated on-board stability period of the prod‐
uct
(Free positions: <number>) Display of free positions (0–47) in the reagent storage
Eject Select
Summary: for the product: ejects all displayed

bottles or cartridges of the product lot
Details: for a single bottle or cartridge: ejects

the bottle or cartridge (= only the bottle or cartridge next
to the symbol)
On-board products and products required for all open orders
When the same product is displayed in 2 different lines, either another product or lot
data are missing to process an order.
Symbol Explanation
The expiration warning period has not yet started

to elapse.
(blue)
The expiration warning period is elapsing.
(yellow)
(red) The product has expired, that is, either the onboard sta‐
bility period or the expiration date has been exceeded.
Expiration statuses of products
The user can filter the products, see the table below.
Filter Explanation
All On-board products and products required for

open orders
Required Products required for open orders

The details are not available, see ( Page 103 On-board
products and products required for all open orders).
On-board On-board products

Print No. DCHS-G01.621.01.08.02 104
Filter Explanation
Not sufficient Products not sufficient for all open orders, either
onboard or not
The details are not available, see ( Page 103 On-board
products and products required for all open orders).
Expired or almost expired On-board products that are already expired or for
which the expiration warning period has started
to elapse
Filters for products
Eject all Displays a confirmation dialog to eject all bottles or cartridges in the
reagent storage
Action buttons
5.3.19 Loading
Path to the dialog:
• Reagents > Loading
The dialog is used to view products loaded into the reagent manager and to manually
identify them.
On the left, the wheel positions are displayed, see the figure below. At the bottom, a
legend for the loading statuses is shown.
2 3 4 5 6
Wheel positions (detail, example)
(1) Loading position (only when the access door is open)

(2) Symbol for the loading status, see ( Page 106 Loading statuses)

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(3) Wheel position number

(4) Product short name, if available
(5) Product ID, if available
(6) Loading status, see ( Page 106 Loading statuses)
(7) Wheel positions
Symbol Legend Loading status Explanation
Loading Loading Bottle or cartridge is being

loaded and identified by
(green) the system.
Loading (manually identi‐ Manually identified bottle or

fied) cartridge is being loaded.
Unloading Unloading Bottle or cartridge is availa‐

ble for unloading.
(black)
Problem Evaporation cap missing Bottle or cartridge does not

carry an evaporation cap.
(red)
Barcode incorrect Barcode is incorrect.
Barcode unreadable Barcode is unreadable.
Bottle overfilled Bottle is overfilled.
Empty Empty position Position is empty.
(transparent) Manually identified Bottle or cartridge is being

identified manually.
Loading statuses
On the right, the user can view and enter the product data of the bottle or cartridge in
the loading position when the access door is open.
For the statuses Unloading and Manually identified, the user can view the product
data, see the table below.
Product name Product short name
Bottle type Bottle type
Serial number Serial number, if applicable
Expiration date Date the lot expires, if applicable
Display of product data
For the status Empty, the user can enter the product data, see the table below.
Product name Product short name Select
Lot number Lot number Select

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Bottle type Bottle type Select
Serial number (if required) Serial number, if applicable Enter
Save Saves the values and changes the status to Man‐ Select
ually identified
Input of product data
5.3.20 Assays availability

Path to the dialog:
• Reagents > Assays availability
The dialog is used to view all products loaded into the reagent manager grouped
by the assays that use the products, see the table below. In the summary line, only
the assay short name is displayed. The user can also display and hide details, see
( Page 103 Display and hide details).
All active assays are displayed. If no reagents for an assay are loaded, no details can
be displayed.
Reagents not used by any active assay are not displayed in this dialog.
Assay / Product name Summary: assay short name -

Details: product name and one or more symbols indi‐
cating the expiration statuses of the products, see
( Page 104 Expiration statuses of products)
Product ID Product code and, if applicable, lot number separated by -

a slash
Remaining on-board stability For each bottle or cartridge of the product, the smaller -
value of either
• the estimated remaining on-board stability period
(assay-specific, if available, or general) or
• the remaining period until the expiration date of
the product
Defined on-board stability Assay-specific on-board stability for the product, if -

available, see ( Page 197 Assay procedures) and
( Page 202 Media), or
General on-board stability of the reagent, see
( Page 194 Product definition)
---: If the general on-board stability is Unlimited.
On-board [mL] Total on-board volume of this lot -

Volume in the bottle or cartridge

Print No. DCHS-G01.621.01.08.02 107
Sufficient for number of orders Estimated number of orders for the selected assay that -
can be measured with the on-board volume
Estimated number of orders that can be measured with
each bottle or cartridge
---: For reagents that are only used as a wash solution
Inventory and expiration Number of on-board bottles or cartridges, and up to -

5 symbols indicating the expiration status of each prod‐
uct, see ( Page 104 Expiration statuses of products)
For each bottle or cartridge of the product, symbol indi‐
cating the expiration status
(Free positions: <number>) Display of free positions (0–47) in the reagent storage
Eject Select
for the product: ejects the displayed number

of bottles or cartridges (= all bottles or cartridges of the
product lot that are used by the assay)
for a single bottle or cartridge: ejects the

bottle or cartridge (= only the bottle or cartridge next to
the symbol)
On-board products grouped by assays
The user can filter the products, see the table below.
Filter Explanation
All On-board products that are assigned to an activated

assay which is displayed in the job list
Expired or almost expired On-board products that are already expired or for
which the expiration warning period has started
to elapse
Filters for products grouped by assays
Action buttons For special action buttons, see ( Page 105 Action buttons).
5.3.21 Calibration
Path to the dialog:
• Calibration
The dialog is used to view and manage calibration curves and check curves.
On the left, the list Curves displays the identifiers of the available curves. For an
explanation of the symbols see ( Page 109 Symbols for curves). The colors distinguish
different curves, see the table below.

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Color Explanation
Red Expired curve
Blue Master curve
Green Check curve
Gray The calibration is running.
Black Measured or manually entered calibration curve which

has not expired
Colors of curves
Symbol Explanation
Calibration curve is active.
Calibration curve is used to evaluate results for a previous incompatible assay version.
Calibration curve is valid and not doubtful.

Calibration curve can be activated.
At least 1 supporting point of a measured or manually entered calibration curve has been
edited manually.
Symbols for curves
Using the button at the bottom, the user can filter the curves, see
( Page 111 Curve filter). When a filter is set, a green label Filter on is displayed
at the top right of the curve overview. Using the button at the bottom, the user
can remove the filter.
If precisely 1 curve is selected, details on the curve are displayed on the right, see the
table below.
Type Curve type, see ( Page 110 Curve types)
Version (only if the assay has been edited Date and time when the assay definition was published
after the curve was created on the sys‐
tem)
Created Date when the curve was created on the system
Time Time when the curve was created on the system
Slope (only for curves with 2 support‐ Slope of the line

ing points and the transformation model
lin/lin)

Print No. DCHS-G01.621.01.08.02 109
Expires If an expiration period has been defined for the calibration: date and time when
the curve expires, displayed in red when the curve has already expired
If the expiration period is unlimited: (Does not expire)
The warning period before a calibration expires can be configured in the dialog
Expiration warnings, see ( Page 166 Expiration warnings).
Time Time when the curve expires, if applicable
Lots See ( Page 110 Lots used)
Details on calibration curves and check curves
Curve type Explanation
Measured curve (status) Calibration curve with supporting points measured using a calibrator set or
calibrator dilutions prepared by the system
For an explanation of the statuses, see ( Page 110 Statuses of calibrations).
Manually entered curve Calibration curve with manually entered supporting points
Master curve Calibration curve provided by Siemens Healthineers
Check curve Check curve including acceptance range provided by Siemens Healthineers,
used to check measured and manually entered calibration curves
Curve types
Status Explanation
waiting for calibrator with assigned At least 1 calibrator with assigned value must first become available before the
value available calibration can proceed.
waiting for assigned value At least 1 calibrators’ assigned value is missing.
running The calibration is running.
completed The calibration has been finished.
Statuses of calibrations
Product name Product short name of the reagent or calibrator
Product ID Product code and, when available, lot number, separated by a slash
Assigned value Assigned value, if applicable
Lots used

Print No. DCHS-G01.621.01.08.02 110
Selected Subdialog
1 measured calibra‐ Calibration curve

tion curve
Calibration curve info
Measurement curve
Up to 3 curves with the Calibration curve

same units
Subdialogs
Activate Activates the selected curve, that is, the curve will be used to determine results
for the corresponding assay and lots
New Displays the dialog New calibration, see ( Page 112 New calibration)
Delete Displays a confirmation dialog to delete the selected curve (active or not active)
Action buttons
5.3.22 Curve filter

Path to the dialog:
• Calibration > Curve filter
The dialog is used to filter the curve overview for assays and curve types.
On the left, in the list Assays, the user can select 1 or more assays.
On the right, the user can select the curve types, see the table below.
Filter Explanation
Measured curves Measured calibration curves
Active curves only Active measured calibration curves

The filter is only available if Measured curves is selected.
Manually entered curves Manually entered calibration curves
Active curves only Active manually entered calibration curves

The filter is only available if Manually entered curves
is selected.
Master curves Calibration curves provided by Siemens Healthineers
Check curves Check curves provided by Siemens Healthineers
Apply Applies the filter and closes the dialog
Filters for curve types

Print No. DCHS-G01.621.01.08.02 111
5.3.23 New calibration

Path to the dialog:
• Calibration > New
The dialog is used to create a new calibration curve, see the table below. The user can
either request an order or enter supporting points manually.
Assay Assay short name or customized assay name Select
Curve identifier The software generates an identifier using the assay short Edit
name or customized assay name, the product short name
of the first calibrator, and the current date and time.
The user can edit the identifier.
(Calibration) Run calibration, see ( Page 112 Run calibration), or Select

Enter curve manually, see ( Page 113 Enter curve man‐
ually)
New calibration curve
Reagent lots Product short names of the required reagents Select
Reagent lots available in the software, : The lot is

on-board in the reagent storage, or
Any: Use any reagent lot on-board.
Calibrator lots Product short names of the required calibrators Select
Calibrator lots available in the software, : The lot is

on-board in the aliquot storage, or
Any: Use any calibrator lot on-board.
Start calibration Requests the order and closes the dialog Select
Run calibration
For calibrations using cartridges, only reagents from the same reagent lot are used.
Thus, the reagent lot must be selected for only 1 of the 3 reagents. The same reagent
lot is selected automatically for the other 2 reagents in the cartridge. To ensure
lot-dependency during calibration, the cartridge is automatically unloaded if 1 of the
reagents is empty.

Print No. DCHS-G01.621.01.08.02 112
Reagent lots Product short names of the required reagents Select
Reagent lots available in the software, : The lot is

on-board in the reagent storage.
(Supporting points) Result at the supporting point, displayed at the x-axis Enter
Unit of the result -
Raw value at the supporting point, displayed at the y-axis Enter
Unit of the raw value -
Adds input fields for a supporting point Select
Deletes the last supporting point Select
Save curve Saves the values and closes the dialog Select
Enter curve manually
5.3.24 Calibration curve

Path to the dialog:
• Calibration > Calibration curve
The dialog is used to view up to 3 curves with the same units selected in the
dialog Calibration.
The curves are displayed in different colors. At the top of the chart, a key is displayed, see
the table below.
Key Explanation
Calculated Blue, red, or green: curve calculated between the support‐

ing points
Supporting point Blue, red, or green: supporting points measured, manually

entered, or provided by Siemens Healthineers
Extrapolated Black: curve calculated to the extrapolation points
Extrapolation point Black: extrapolation points calculated to extend the calibra‐

tion range
Acceptance range Permitted deviation from the check curve
Key for calibration curves and check curves

Print No. DCHS-G01.621.01.08.02 113
If Check against acceptance range is selected for the assay in the dialog Assay
calibration and a check curve is available for the corresponding reagent lots, the
calibration curve is automatically checked against the acceptance range and the check
curve, see ( Page 211 Assay calibration). The acceptance range and the check curve
are saved with the calibration.
On the right, in the list Selected curve, the user can select a curve. Long identifiers can
be cropped. To view the complete identifier, the user can select the arrow on the right
to display the complete list. Curves provided by Siemens Healthineers and curves that
have already been used to evaluate results are marked with the green label (Cannot be
edited) below the list.
In the chart, the selected curve is highlighted and the values of the supporting points
are displayed.
If a check curve or a calibration curve with a check curve available is selected, the user can
activate Display acceptance range to display the acceptance range of the check curve.
If more than 1 check curve is displayed, only the acceptance range of the selected curve
is displayed.
The acceptance range is also displayed for the calibration curve if no check curve
is selected.
On the right and at the bottom, details on the selected curve are displayed, see the table
below and ( Page 114 Supporting points).
Created Date and time when the curve was created on the system
Calibration method Method used to calculate the curve
Transformation model Transformation applied to the supporting points before calculat‐

ing the curve
Factor (only for curves with 2 supporting points and the Slope of the line
transformation model lin/lin)
Correlation coefficient (only for curves using the Measure of quality for the regression
calibration methods Linear regression, Orthogonal
regression, or LogitLog5B)
Lots Lots used with the calibration, see ( Page 110 Lots used)
Curve properties
The list Supporting points displays the supporting points of the curve, see the
table below.
Concentration [unit] Result at the supporting point -
Dilution Calibrator dilution prepared by the system, if applicable -
Flag Flag symbol, if applicable -

Print No. DCHS-G01.621.01.08.02 114
Raw value [unit] Raw value at the supporting point Enter (only if the curve is not
provided by Siemens Healthi‐
: Raw value has been edited manually. neers and has not been used to
evaluate results)
Measured Measured result at the supporting point -

result [unit]
Bias [unit] Measured result deviation at the supporting point -
Supporting points
When the user edits a supporting point of an active calibration that has not yet been
used to evaluate results, the calibration curve is deactivated. When the user finishes
editing supporting points, the calibration curve must be activated manually. If a valid
calibration curve has been calculated, the calibration curve is displayed connecting
the supporting points. Calibration curves with valid re-measurements of the selected
supporting points are activated automatically.
Selected Subdialog
Measured calibration curve Calibration curve info

Measurement curve
Subdialogs
Repeat Requests the re-measurement of the selected supporting points (only if the
curve can be edited)
Calculate Displays the dialog Calibration calculator, see ( Page 115 Calibration calcu‐
lator)
Action buttons
5.3.25 Calibration calculator

Path to the dialog:
• Calibration > Calibration curve > Calibration calculator
The dialog is used to calculate results for entered raw values and vice versa for the
calibration curve selected in the dialog Calibration curve, see the table below.
# Running number -

Print No. DCHS-G01.621.01.08.02 115
Raw value [unit] The user can enter a raw value. The software displays the Enter or -
corresponding result.
(Range of available raw values)
Result [unit] The user can enter a result. The software displays the Enter or -
corresponding raw value.
(Range of available results)
Clear all Clears all raw values and results in the dialog Select
Calibration calculator
5.3.26 Calibration curve info

Path to the dialog:
• Calibration > Calibration curve > Calibration curve info
The dialog is used to display details on the calibration curve selected in the dialog
Calibration curve.
At the top left, the identifier is displayed.
The list Results displays the supporting points, see the table below.
Concentration [unit] Result at the supporting point
Raw value [unit] Final raw value at the supporting point
Supporting points
The area Comment displays comments and flags related to the selected supporting
point, if applicable.
The list Single measurements displays all single measurements for the supporting point
selected in the list Results, see the table below.
Material Product ID of the calibrator
Raw value Raw value for the single measurement
Unit Unit of the raw value, if applicable
Flag Flag symbol, if applicable
Single measurements

Print No. DCHS-G01.621.01.08.02 116
5.3.27 Controls
Path to the dialog:
• Controls
The dialog is used to manage control jobs and control results, similar to managing
samples in the dialog Jobs, see ( Page 82 Jobs).
The dialog displays the control jobs in a table with the controls lots shown on the left and
assays shown at the top. The display is similar to the dialog Jobs, see ( Page 82 Details
of the dialog Jobs (example)), with the following differences:
• For a control lot, the control short name and the product ID are displayed.
• The symbol in a cell indicates that either the control has not been
assigned to the assay, see ( Page 159 Control assignment), or no reagent
lot-independent assigned values and permitted deviations are available, see
( Page 178 Assigned values).
• The symbol for a result converted to base dilution is never displayed in this dialog.
• The symbol button is not available.
For more information on the displayed flag symbols, see ( Page 73 Flags).
The user can filter, search, and zoom in the dialog similar to the dialog Jobs.
Selected Subdialog
1 control job Control result info

Measurement curve
Subdialogs
New Requests new orders for the selected cells
Delete Displays a confirmation dialog to delete the selected control jobs. If any control
jobs with open orders are selected, only the open orders are deleted and all
control results are retained. If no control jobs with open orders are selected, all
selected control jobs and control results are deleted.
Action buttons
5.3.28 Control result info

Path to the dialog:
• Controls > Control result info

Print No. DCHS-G01.621.01.08.02 117
The dialog is used to view information on all results for a control job selected in the
dialog Controls.
At the top, the control short name and the product ID are displayed.
Using the buttons for master navigation on the right, the user can scroll through the
controls lots and assays in the dialog Controls, see ( Page 70 Master navigation).
The data displayed in the dialog is similar to the dialog Sample result info, see
( Page 91 Sample result info), with the following differences:
• In the list Results, in the column Deviation, the deviation of the control result from
the assigned value is displayed.
• To the right of the list Results, the assigned value and the acceptance range
are displayed.
Reagent and control on-board-ages and remaining on-board stability are also
displayed in the dialog Control result info. Control samples in sample tubes with 1D
barcodes are considered as samples, that is, the on-board age of control samples starts
with scanning the sample tube barcode.
Frame Uses the control result selected in the list Results as a framing result for all
relevant sample results in the dialog Jobs
Depending on the time when the results were available, the control result is
used as previous or succeeding control result.
Delete Displays a confirmation dialog to delete the selected order or control result
Action buttons
5.3.29 Info
The following dialogs are used to view system information.
5.3.30 Alerts
Path to the dialog:
• Info > Alerts
The dialog is used to view current and previous status alerts, see the table below.
Severity
; Red, or
: Yellow, see ( Page 374 Colors of status alerts)

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Category Problem category, see ( Page 119 Filters for the category of
status alerts), and unique ID for the status alert as described in
the area Description
Date and time Date and time when the problem occurred
Description Short description of the problem, see subchapters of

( Page 376 Red status alerts) and ( Page 404 Yellow sta‐
tus alerts)
Status alerts
Using the filters Filter and Category, the user can filter the status alerts, see the table
below and ( Page 119 Filters for the category of status alerts).
Filter Explanation
All All status alerts
Active Status alerts currently displayed in the status area
Last 24 hours Status alerts of the last 24 hours
Filters for the relevance of status alerts
Filter Explanation
All categories All status alerts
Analyzer Status alerts related to the analyzer
Reagent overview Status alerts related to the reagent overview
Loading Status alerts related to the sample manager
Jobs Status alerts related to sample jobs
Calibration Status alerts related to calibrations
Control Status alerts related to controls
Maintenance Status alerts related to maintenance
System Status alerts related to the system
Lot data Status alerts related to lot data
Reagent loading Status alerts related to the input wheel
QC Status alerts related to quality control
Component Status alerts related to the initialization of components
Updates Status alerts related to the installation of updates
Filters for the category of status alerts
When a status alert is selected, more information is displayed on the right, in the middle,

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Date and time Date and time when the problem occurred
Resolved Date and time when the problem was resolved, if applicable
Details Detailed description of the problem including the parameter, for example, the
product name of a missing reagent
Details on status alerts
5.3.31 Audit log

Path to the dialog:
• Info > Audit log
The dialog is used to view system events, for example, user logins, configuration
changes, and data updates, see the table below.
User name Name of the user who performed the action

Automatic: no user was logged on
Date and time Date and time when the system event occurred
Description Description of the system event, see ( Page 120 Sys‐

tem events)
Audit log
Adjustment performed System adjusted or calibrated in dialog Setup > Tools

> Service software
Assay customization settings modified Changes in dialog Assay customization or Assay activation
Calibration curve activated: identifier <curve identi‐ Calibration curve manually activated
fier>, <assay short name>
Calibration curve deactivated: identifier <curve iden‐ Calibration curve manually deactivated
tifier> for assay <assay short name>
Calibration curve deleted: identifier <curve identi‐ Calibration curve manually deleted
Calibration curve manually entered: identifier Calibration curve manually entered

<curve identifier>, <assay short name>
Calibration curve modified: identifier <curve identi‐ Calibration curve modified

Calibration curve released: identifier <curve identi‐ Unreleased calibration curve manually activated
Calibration requested: identifier <curve identifier>, Calibration requested

<assay short name>

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Control assignment created Control assignment to an assay group created in dialog Con‐
trol assignment
Control assignment deleted Control assignment to an assay group deleted in dialog Con‐
trol assignment
Control job deleted: control <product ID>, assay Control job deleted in dialog Controls
<assay short name>
Control job used for sample result framing: control Sample result framed by control
<control name>, assay <assay short name>
Cuvette bag ID registered New cuvette bag registered in dialog Register cuvettes
Definition created Definition created in dialog Data definition or Rack definition
Definition deleted Definition deleted in dialog Data definition or Rack definition
Definition modified Definition modified in dialog Data definition or Rack definition
Definition update loaded Updated definition loaded in dialog Definitions loader
Diagnosis performed System diagnosis performed in dialog Setup > Tools

> Service software
Installation of definitions file requested New definitions available for installation
Job deleted: sample <sample ID>, assay <assay Job deleted in dialog Jobs
short name>
Job requested: control <product ID>, assay <assay Job requested in dialog Controls
short name>
Job requested: sample <sample ID>, assay <assay Job requested in dialog Jobs
short name>
LIS configuration modified Changes in dialog LIS configuration
Lot data accepted by user after conflict Status alert Lot data conflict (92) resolved
Lot data deleted Lot data deleted in the dialog Data > Lot data
Lot data imported Lot data manually added from installed lot data files on the sys‐
tem
Lot data installed Lot data files provided by Siemens Healthineers installed on
the system
Lot data modified Lot data manually modified in dialog Data > Lot data
Lot data nominal values deleted Nominal values deleted in dialog Data > Lot data
Maintenance log entry was modified Performance of periodic maintenance task modified in dialog
Maintenance > Periodic tasks
Manual maintenance entry created Manual entry created to record aperiodic maintenance task
in dialog Maintenance > Maintenance log > Manual entry
(button New)
Mapping of control ID to LIS control ID modified Mapping of control IDs modified in dialog LIS configuration

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Periodic maintenance task created Periodic maintenance task created in dialog Setup
> Maintenance
Periodic maintenance task deleted Periodic maintenance task deleted in dialog Setup
> Maintenance
Periodic maintenance task modified Periodic maintenance task modified in dialog Setup
> Maintenance
Periodic maintenance task performed Performance of periodic maintenance task recorded in dialog
Setup > Maintenance
Probe cleaner container <lot number> identified New probe cleaner container identified in dialog Replace
probe cleaner
Product <product short name(s)> (<product code(s) Product loaded into reagent manager and manually identified in
or product ID(s)>) (manually identified) loaded dialog Reagents > Loading
Product <product short name(s)> (<product code(s) Product processed from sample manager and manually identi‐
or product ID(s)>) (manually identified) processed fied in dialog Loading > Problem racks
Product <product short name(s)> (<product code(s) Product loaded into reagent manager
or product ID(s)>) loaded
Product <product short name(s)> (<product code(s) Barcoded product loaded into reagent manager, manual identi‐
or product ID(s)>) loaded (manual identification as fication ignored
<product short name(s)> (<product code(s) or prod‐
uct ID(s)>) ignored)
Product <product short name(s)> (<product code(s) Product manually unloaded into reagent manager
or product ID(s)>) manually unloaded
Product <product short name(s)> (<product code(s) Product processed from sample manager
or product ID(s)>) processed
Reflex testing rule <rule name> activated Rule activated in dialog Reflex testing
Reflex testing rule <rule name> created Rule created in dialog Reflex testing
Reflex testing rule <rule name> deactivated Rule deactivated in dialog Reflex testing
Reflex testing rule <rule name> deleted Rule deleted in dialog Reflex testing
Reflex testing rule <rule name> modified Rule modified in dialog Reflex testing
Reflex testing rule <rule name> renamed to Rule renamed in dialog Reflex testing
<rule name>
Re-measurement for calibration supporting point Re-measurement requested for selected supporting points in the
requested: identifier <curve identifier>, assay <assay dialog Calibration (button Repeat)
short name>
Re-measurement requested: sample <sample ID>, New order requested for selected sample job in the dialog Jobs
assay <assay short name> (button Repeat)
Remote user logged off Remote user logoff successful
Remote user logged on Remote user logon successful

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Result released: sample <sample ID>, assay <assay Result released in dialog Jobs
short name>
Sample ID <sample ID> created Sample created by:

• an order from the LIS
• ordering a meta-assay for a sample type not already available
on the system in dialog Jobs
• manual identification in dialog Loading > Problem racks
• pre-identification in dialog Loading > Pre-identification

• loading a barcoded sample tube
• loading a non-barcoded sample tube (no sample ID available)
Sample ID <sample ID> deleted Selected sample deleted in the dialog Jobs
Sample information <sample ID> modified Sample information manually modified in dialog Sample info or
modified by loading sample on a STAT rack
Sample tube <sample ID> (manually identified) used Manually pre-identified sample tube loaded from sample man‐
ager
Sample tube <sample ID> processed Barcoded sample tube processed from sample manager
Sample tube <barcode> processed (manual identifi‐ Barcoded sample tube processed from sample manager, manual
cation as <sample ID> ignored) pre-identification ignored
Service action performed Service action performed in dialog Setup > Tools > Service
software (neither adjustment, calibration, nor diagnosis)
Siemens Healthineers service removed or added Sample or product manually removed from the system or added
sample or product manually to the system by Siemens Healthineers service
Stirrer bar lot data created Lot number of stirrer bars scanned or entered in dialog Re-fill
stirrer bars
System manually restored Backup restored in dialog Data manager
System settings modified Changes in 1 of the following dialogs:
• Setup > Configuration > Auto start
• Setup > Configuration > Barcodes
• Setup > Configuration > Expiration warnings
• Setup > Configuration > HIL warning
• Setup > Configuration > Printout
• Setup > Configuration > System
Task 'Clean aliquot probe' executed Maintenance task performed in dialog Maintenance
> Task execution
Task 'Clean HIL cuvette' executed Maintenance task performed in dialog Maintenance
> Task execution

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Task 'Drain probe cleaner' executed Maintenance task performed in dialog Maintenance
> Task execution
Task 'Initialization' executed Maintenance task performed in dialog Maintenance

> Task execution
Task 'Prime tubings' executed Maintenance task performed in dialog Maintenance

> Task execution
Task 'Purge tubings' executed Maintenance task performed in dialog Maintenance

> Task execution
Task 'Wash probes' executed Maintenance task performed in dialog Maintenance

> Task execution
Unidentified product loaded into sample man‐ Non-barcoded product loaded into sample manager with‐
ager ignored out pre-identification
Unidentified sample tube (incorrect bar‐ Unidentified sample tube not processed
code) ignored
Unidentified sample tube processed Non-barcoded sample tube processed with default profile, meas‐
urements can only be displayed after manual identification
Unidentified sample tube: loaded <barcode>, man‐ Unidentified sample tube loaded and manually identified in
ually identified as sample <sample ID> dialog Loading > Problem racks
User <user name> logon failed User logon failed
User <user name> logon failed: user account disa‐ User logon failed because user has been deactivated in dialog
bled by another user Setup > Tools > User administration
User <user name> logon failed: user account has User logon failed because user disabled, for example, by pass‐
been disabled by system word expiration
User <user name> logon failed: user account now User logon failed because password was mistyped 5 times
disabled by system
User account added or edited New user added or edited in dialog Setup > Tools
> User administration
User account deleted User deleted in dialog Setup > Tools > User administration
User account modified User modified in dialog Setup > Tools > User administration
User confirmed to keep products after temperature Products kept in dialog Reagent storage although conditions
in reagent storage was unknown of products were unknown due to system problem or after
quick shutdown
User logged off User logoff successful
User logged on User logon successful
System events
The user can filter the system events, see the table below.

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Filter Explanation
All All system events
Last 24 hours System events that occurred in the last 24 hours
Filters for system events
5.3.32 About
Path to the dialog:
• Info > About
The dialog is used to view the current version of the software and its components, see
the table below.
Component Name of the component
Version Version of the component
Date and time Date and time of the last changes
File Path and file name of the component
Software components
5.3.33 Setup
The following dialogs are used to set up the software.
5.3.34 Archive viewer

Path to the dialog:
• Setup > Tools > Archive viewer
The dialog is used to view sample results, control results, and audit logs deleted from the
system or exported from other systems.
At the top right, in the list Archive set, the user can select an archive set to be displayed.
The system searches the available archives and can combine them in an archive set.
At the top left, the user can select the data to be displayed, see the table below.
Sample or control (only active for results) The user can enter any part of a sample ID or con‐ Enter
trol name.
Assay (only active for results) The user can enter any part of an assay short name. Enter
Reagent lots The user can enter any part of a reagent lot. Enter
Start Displays a calendar to select a start date Select
End Displays a calendar to select an end date Select

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Selects the first matching result Select

Shows more buttons to search for results, if not yet
(only active for results) displayed, see ( Page 126 Buttons to search for results)
Results Displays the results in the archive set, see Select

( Page 126 Results)
Audit log Displays the audit log in the archive set, see Select
( Page 120 Audit log)
Select data
Button Explanation Action
Selects the previous matching result, if available Select
(m) of (n) Selection count, there are n matching results, currently -

the m‑th matching result is selected
Selects the next matching result, if available Select
Clears the search Select

Selects the first result in the archive set
Buttons to search for results
Results Results for a sample ID or control lot are summarized. The summary line displays the
sample ID or control lot and the number of orders. The user can display and hide
additional lines with details on the results, see the table below and ( Page 127 More
details on results).
Button Explanation
Displays the details
Hides the details
Display and hide details

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Sample or control Sample ID, and
symbol for a sample ID comprising both platelet-

poor plasma and platelet-rich plasma, if applicable, or
symbol for a sample ID comprising only platelet-

rich plasma, if applicable, or
Control name and control lot. For controls it is not pos‐
sible to differentiate between platelet-rich and platelet
poor plasma
Assay Assay short name
Result Numerical result and unit, if applicable, or sym‐
bol or
Flag symbol, if applicable
Raw value Numerical raw value and unit, or

---: no raw value is available
Details on results
On the right, more details are displayed for the selected result, see the table below. The
user can display and hide some details using the buttons and .
System
Name System that measured the raw value
Assay
Name Assay name
Number Assay number
Published Date and time when the assay definition was published
LIS request name Assay ID used by the LIS to request an order

After receiving an order, the system maps this assay ID to the assay number.
LIS result name Assay ID used by the LIS to receive a result

Before sending a result, the system maps the assay number to this assay ID.
In most cases, the LIS request name and the LIS result name are identical.

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Sample (only for samples)
Sample ID Sample ID, and
symbol for a sample ID comprising both platelet-poor plasma and

platelet-rich plasma, or
symbol for a sample ID comprising only platelet-rich plasma
Control (only for controls)
Name Control name
Assigned value Assigned value
Published Date and time when the product definition was published
LIS name Control name as defined by the LIS
Result
Result
Numerical result and unit, if applicable, or symbol or
Deviation (only for controls) Deviation of the control result from the assigned value
Acceptance range (only for controls) Permitted deviation from the acceptance range
Comment Comments and flags on the result, if applicable
Calibration
Name (only for calibrated assays) Calibration identifier
Measured (only for calibrated assays) Date and time when the calibration was finished
Raw value
Raw value Numerical raw value and unit, or

---: no raw value is available
Dilution Dilution used
Lots Lots used with the order
More details on results
At the bottom, buttons are available to display and hide samples, controls, and results,
All Displays the summary lines for both samples and controls Select
Samples Displays only the summary lines for samples Select

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Controls Displays only the summary lines for controls Select
Hide all details Hides the results for all displayed summary lines Select
Display and hide samples, controls, and results
5.3.35 ASCII converter

Path to the dialog:
• Setup > Tools > ASCII converter
The dialog is used to convert files exported from the dialog Result export to the export
format used in other systems, see the table below.
Select the file to create from the result File type, see ( Page 129 File types) Select
export file
(Status) Files and status of the last conversion -
Result export files
All files Converts the complete data in the result export file
C file (calibrations) Converts only the calibrations and generates a C file
S file (sample results and con‐ Converts only the sample and control results, and generates an S file
trol results)
R file (measurement curves) Converts only the measurement curves and generates an R file
File types
Export Converts the result export file, that is:

• Displays the dialog Select file to select a file exported from the dialog
Result export
• Converts the selected result export file and generates the selected file types
When exporting is finished, the converted files are displayed in the status list at
the bottom.
The system generates the file names as follows:
filetypeyyyy-mm-dd_nn.ACOAG360
For an explanation of the placeholders see ( Page 130 Placeholders in
file names).
Action buttons

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Placeholder Explanation
filetype File types, see ( Page 129 File types):
• C for C file
• S for S file
• R for R file
yyyy Year in 4 digits
mm Month in 2 digits
dd Day in 2 digits
nn Consecutive number for each day in 2 digits
Placeholders in file names
5.3.36 Assay statistics

Path to the dialog:
• Setup > Tools > Assay statistics
The dialog is used to view monthly assay statistics.

At the top, a user-defined header is displayed. To configure the header, see
( Page 131 Header setup).
In the list, the assay statistics are displayed, see the table below.
Assay number Assay number
Assay name Assay short name or customized assay name
Calibrations Number of supporting points measured
Repetitions Number of repetitions measured
Samples Number of samples measured
Controls Number of controls measured
Total per assay Total number of measurements
Assay statistics
At the bottom, in the line Total, the measurements for all assays are summed up.
New Displays the dialog New statistics, see ( Page 131 New statistics)
Setup Displays the dialog Header setup, see ( Page 131 Header setup)
Action buttons

Print No. DCHS-G01.621.01.08.02 130
5.3.37 New statistics

Path to the dialog:
• Setup > Tools > Assay statistics > New statistics
The dialog is used to generate assay statistics, see the table below.
Select month
Month Month to generate the assay statistics for Select
Select results
Released results only Generate assay statistics only for released results Select
All results Generate assay statistics for all results Select
Generate assay statistics
5.3.38 Header setup

Path to the dialog:
• Setup > Tools > Header setup
The dialog is used to configure the header of the assay statistics, see the table below.
Left header Information at the top left Enter
Middle header Information at the top, in the middle Enter
Right header Information at the top right Enter
Title Title of the assay statistics Enter

The software adds the month and year selected in the
dialog New statistics.
Label for creation date Subtitle of the assay statistics Enter

The software adds the date and time when the assay
statistics were generated.
Header of the assay statistics
5.3.39 Barcode maker

Path to the dialog:
• Setup > Tools > Barcode maker
The dialog is used to print new 2D barcodes or 1D barcodes if the barcode of a product is
unreadable or missing. To enter the product data and to make general barcode settings
for a 2D barcode, see the table below, or for a 1D barcode, see ( Page 132 Product data
and general barcode settings for a 1D barcode).

Print No. DCHS-G01.621.01.08.02 131
Product code Product code Enter

If unknown, the product code can be checked in the dialog Data definition,
see ( Page 194 Product definition).
Lot number Lot number Enter
Expiration date Date the lot expires Select
Bottle type Bottle type Select
Serial number Serial number, if applicable Enter

If no serial number is entered, the system uses 0000000 for every printed
label and the on-board-stability period cannot be evaluated correctly. Thus,
if no serial number is available for a third-party product or the serial number
cannot be entered, make sure to enter and manage unique generic serial
numbers instead.
If Number of labels is greater than 1, the system treats the entered serial
number as generic and increases the serial number for every printed label
by 1.
Include readable text Prints the product ID as readable text below the barcode Select
Number of labels Number of labels to be printed Select
Reagent name 1a) 2 lines of readable reagent identifier text, first line in bold type, printed above Enter
the product code, for example, for adding the name of the manufacturer and
Reagent name 2a) of the product
Additional info 1a) 3 lines of readable additional info, printed below the product code, for Enter
example, for adding the prepared dilution
Additional info 2a)
Additional info 3a)
Product data and general barcode settings for a 2D barcode
a) Cannot be printed on labels smaller than 20 × 40 mm
Lot number Lot number Enter
Include product ID as Prints the product ID as readable text below the barcode Select
readable text
Number of labels Number of labels to be printed Select
Product data and general barcode settings for a 1D barcode
Self-printed labels with 1D barcodes must only be used when measuring control
samples in secondary sample tubes on sample racks, see ( Page 288 Measuring
control samples). For the sample racks, the sample rack template Controls must
be defined.

Print No. DCHS-G01.621.01.08.02 132
Settings Displays the dialog Settings, see ( Page 133 Settings (for barcode maker))
Export Displays the dialog Save file to create a Barcode maker file that saves the
product data and general barcode settings, see ( Page 189 Save file)
Import Displays the dialog Select file to load a Barcode maker file with saved product
data and general barcode settings, see ( Page 71 Select file)
Action buttons
5.3.40 Settings (for barcode maker)

Path to the dialog:
• Setup > Tools > Barcode maker > Settings
The dialog is used to set the print layout, see the table below.
Columns
Number of labels in column Number of labels in a column Enter
Label height Height of the labels Enter
Top margin Top margin Enter
Lines
Number of labels in line Number of labels in a line Enter
Label width Width of the labels Enter
Left margin Left margin Enter
Print layout
5.3.41 Data manager

Path to the dialog:
• Setup > Tools > Data manager
The dialogs are used to create backups, restore backups, and export data from the system
to USB storage devices, to a shared folder, or to an upload folder.
In case of problems with USB storage devices or for assistance with other storage
media, contact Siemens Healthineers service.

Print No. DCHS-G01.621.01.08.02 133
5.3.42 Backup
Path to the dialog:
• Setup > Tools > Data manager > Backup
The dialog is used to create backups, see the table below.
System backup A backup file is created, including the system’s configura‐ Select
tion and data related to orders.
Troubleshooting data A file with troubleshooting data or hardware issues is Select

created, used by Siemens Healthineers service
Hardware issues
Depending on the selected time period, the creation of
the file can take a long time and the file size can be
very large.
Siemens Healthineers recommends to create files with
troubleshooting data or with hardware issues only if
requested by Siemens Healthineers service
File name The system generates the file names as follows: -

System backup:
ACOAG360_SN<serial number>_yyyy-mm-dd-hh-nn-
ss.dmta)
Troubleshooting data (for selected time period):
ss.erda)
Hardware issues (for selected time period):
ss[_yyyymm- dd hh-nn-ss]_Hardware_issues.xpsa)
The serial number of the system is added to the file names
of backups.
For an explanation of the other placeholders see
( Page 135 Placeholders in file names).
_ The user can add up to 30 additional characters to the Enter

file name.
Example:
ACOAG360_SN1234_2016-12-08-14-03-45_LabMan‐
ager.dmt
Select time period (only for troubleshooting data The file includes only data of the time period Select
and hardware issues) selected below.
From Day and hours when the time period starts Select
and select
To Day and hours when the time period ends Select

and select
Creating backups
a) New placeholder SN <serial number>: abbreviation for “serial number” plus serial number of the system in 5 digits

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dd Day in 2 digits
hh Hour in 2 digits
nn Minute in 2 digits
ss Second in 2 digits
Placeholders in file names
Start Creates the backup

At the bottom, the current status is displayed.
Action buttons
5.3.43 Restore
Path to the dialog:
• Setup > Tools > Data manager > Restore
The dialog is used to restore a backup, that is, the system’s configuration and data related
to orders are replaced with the data from a backup file, see the table below.
File name Displays the backup file selected for restoring -
Select file Displays the dialog Select file to select a backup file Select
Restoring backups
Start Restores the backup, that is:

• Creates a current backup
• Replaces the system’s data with the data from the selected backup file
• Re-starts the software
Action buttons

Print No. DCHS-G01.621.01.08.02 135
5.3.44 Export
Path to the dialog:
• Setup > Tools > Data manager > Export
The dialog is used to export data from the system to USB storage devices, to a shared
folder, or, if remote services are installed, to an upload folder for troubleshooting
purposes, and to delete export data from the system.
On the left, in the area Source, the user can select the type of data, see the table below.
Archive files Archive file created by the system, including all data Select
created on the system during the archiving period
ACOAG360 Data yyyy-mm-dd hh-nn-ss - yyyy-mm-
dd hh-nn-ss.archive
For an explanation of the placeholders, see
( Page 135 Placeholders in file names).
The first date is the start time, the second date is the end
time of the archiving period.
Backup files Backup files created in the dialog Setup > Data manager Select
> Backup:
• System backup
• Troubleshooting data
Export files Export files created in the dialog Setup > Result export Select
Printouts Printouts created as XPS file or PDF file in any dialog using Select
the action button Print
Screenshots Screenshot files created using the keys Ctrl + Alt + D Select
Hardware files Log files for hardware problems created by the system Select
Files with information on hardware issues created via
Setup > Data manager > Backup > Hardware issues
Types of data
In the middle, the user can select the files to export or delete, see the table below.
Files Available files of the selected type of data Select

1 or more
Size (MB) File size in megabytes -
Available files
On the right, in the area Target, the user can select the USB storage device, the shared
folder, or the upload folder to export the data to, see the table below.

Print No. DCHS-G01.621.01.08.02 136
Drive / free space
USB 1 (only if a USB USB storage device connected to the system and space available on the USB stor‐ Select
storage device is con‐ age device
nected to the system)
USB 2 (only if 2 USB Second USB storage device connected to the system and space available on the USB Select
storage devices are storage device
connected to the sys‐
tem)
Shared folder (only if Shared folder, see ( Page 170 Shared folders) Select
export folder is config‐
ured)
Upload folder (only Upload folder for troubleshooting purposes Select

if remote services
Files transferred to the upload folder are accessible for Siemens Healthineers service
are installed)
Estimated size Size of the selected files in megabytes -
USB storage device, shared folder, or upload folder
Start Copies the selected files to the selected USB storage device, the shared folder,
or the upload folder
When the export is finished, Export completed is displayed at the bottom left.
Show (only for screenshots) Displays the selected screenshot

To print the displayed screenshot, select the action button Print.
To close the screenshot view, select the action button Close.
Delete Deletes the selected files
Action buttons
5.3.45 Document viewer

Path to the dialog:
• Setup > Tools > Document viewer
The dialog is used to display PDF documents and XPS documents on the system.
On the left, the user can select the document type, see the table below.
Manuals User manuals provided by Siemens Healthineers Select
Printouts Printouts created by the user as XPS files or PDF files in any Select
dialog using the action button Print
Document types

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On the right, the user can select a document folder, if applicable, and the document to
display, see the figure below.
1
2
Overview of the document display (example)
(1) Menu bar, see ( Page 138 Menu bar)

(2) Tool bar, see ( Page 139 Tool bar)
(3) Document
(4) Bookmarks, if applicable
File
Properties Displays the dialog Document Properties Select
Exit Closes the document Select
View
Single Page Displays the document as single pages Select
Facing Displays the document as double pages Select
Book View Displays the document as double pages starting with a Select
single page
Show pages continuously Scrolls the pages line by line instead of page by page Select
Rotate Left Rotates the document counterclockwise Select
Rotate Right Rotates the document clockwise Select
Bookmarks Displays bookmarks to the left of the document, if availa‐ Select

ble
Show Toolbar Displays the tool bar below the menu bar Select
GoTo
Next Page Displays the next page Select
Previous Page Displays the previous page Select
First Page Displays the first page Select

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Last Page Displays the last page Select
Page Activates the area Page in the tool bar to enter a Select
page number
Back Displays the previously viewed page, if applicable Select
Forward Displays the subsequently viewed page, if applicable Select
Find Activates the area Find in the tool bar to enter a Select
search term
Zoom
Fit Page Displays the whole page Select
Actual Size Displays the document in its actual size Select
Fit Width Displays the document zoomed to the page width Select
Fit Content Displays the document zoomed to the page content Select
Custom Zoom Displays the dialog Zoom factor to select or enter a zoom Select
(Zoom) Displays the document using the selected zoom Select
Settings > Change Language Displays the dialog Change Language to set the lan‐ Select
guage of the document viewer
Help > About Displays a dialog to view the current version of the docu‐ Select
ment viewer
Menu bar
(Not active) -
(Not active) -
Displays the page corresponding to the entered page number Enter
Displays the previous page Select
Displays the next page Select
Displays the document zoomed to the page width and scrolls the pages line by line instead Select
of page by page
Displays the whole page Select
Displays the document zoomed 1 step smaller Select
Displays the document zoomed 1 step larger Select

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Displays a text passage containing the entered search term Enter
Displays the previously found text passage, if available Select
Displays the next found text passage, if available Select
Activates case-sensitive search Select
Tool bar
Show Displays the selected document
Action buttons
5.3.46 LAS connection

Path to the dialog:
• Setup > Tools > LAS connection
The dialogs are used to configure the system’s connection with the LAS, see the data
interface manual.
5.3.47 LIS connection

Path to the dialog:
• Setup > Tools > LIS connection

The dialogs are used to configure the system’s connection with the LIS, see the data
interface manual.
5.3.48 Quality control (optional)

Path to the dialog:
• Setup > Tools > Quality control
Selecting Quality control opens the quality control software, see the documentation of
the quality control software.
When using Advanced QC, printing to PDF files is deactivated on the system. Thus,
Siemens Healthineers recommends to continue printing to XPS files.

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5.3.49 Reflex testing

Path to the dialog:
• Setup > Tools > Reflex testing

The dialog is used to support the diagnosis with reflex assays for automated, rule-based
orders of other assays or of re-measurements. To manage rules, see the table below.
State Status of the rule, see ( Page 141 Statuses of rules)
Rule name Name of the rule
Rule set Group the rule belongs to
Rule application count Displays how many times the rule was used
Rule information
State Explanation
Active Rule is active.
Deactivated Rule is deactivated.
Incorrect Rule is incorrect.
Statuses of rules
Rules are applied to sample orders and results to request new orders or repeat
orders for samples that fulfill the rule’s criteria. Rules are never applied to control
or calibration materials.
The following applies to rules:
• New rules can cause re-measurements of existing results in the dialog Jobs.
• Rules can be used to refer to and measure or repeat both active and inactive assays,
see ( Page 155 Assay activation).
• A rule cannot order direct mode measurements to be automatically performed.
The following limitations apply to samples completely measured in direct mode in

connection with rules:
• Avoid reflex testing for measurements completely performed in direct mode. For
rules to simplify this, see ( Page 147 Examples) for an example of such a rule, or
• When measuring in direct mode and a sample is requested a second time by the
system due to a reflex testing rule, the sample has to be manually re-loaded.
New Displays the dialog New rule, see ( Page 142 New rule)
Edit Displays the dialog Edit rule, see ( Page 143 Edit rule)

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Delete Displays a confirmation dialog to delete the selected rule
Reset counts Resets all counts, not only the count of the selected rule
Copy Displays the dialog New rule with the information of the selected rule, see
( Page 142 New rule)
Close Closes the dialog
Action buttons
When selecting Close, the system stops running automatic reflex assays.
5.3.50 New rule

Path to the dialog:
• Setup > Tools > Reflex testing > New

The dialog New rule is used to add rule sets and rules, see the table below.
The dialog Edit rule is identical to the dialog New rule, except for the dialog name.
Rule set Name of the rule set Select or

enter
Rule set name Name of the new rule set Enter
Rule name Name of the rule Enter
Rule text Rule, see ( Page 143 Creating rules for reflex testing) Enter
Active Activates the rule Select
Add or edit rules
Save Saves the rule, checks if the rule is correct, and closes the dialog
Check Checks if the rule is correct
Action buttons
Make sure to save changes in the dialogs before logging off. Otherwise, the changes
are lost.

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5.3.51 Edit rule

Path to the dialog:
• Setup > Tools > Reflex testing > Edit

The dialog Edit rule is used to edit rules and is identical to the dialog New rule (except
for the dialog name) , see ( Page 142 New rule).
5.3.52 Creating rules for reflex testing

The software includes rules for reflex testing provided by Siemens Healthineers which
cannot be changed, but copied and modified to create new, user-defined rules, see
( Page 141 Reflex testing), ( Page 142 New rule), and ( Page 143 Edit rule).
The rules are simple if - then relationships and structured as follows:
if <condition> then <instruction>
The conditions, their different elements, and their notations are explained in the
table below.
Condition Elements of the condition Comment
<value><comparison operator><value> <value>: numerical value Example: 3.1415
<comparison operators>:
• < or is less than <value>
or
• <= or is less than or equal to <value>
or
• > or is greater than <value>
or
• >= or is greater than or equal
to <value>
<value><calculation operator><value> <value>: numerical value Example: 3.1415
<calculation operators>: Brackets are used to struc‐

ture 1 or more expressions.
• + or plus
See also ( Page 147 Exam‐
or ples)
• - or minus
or
• * or times
or
• / or divided by

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result for <assay><flag opera‐ <assay>: Example: 10100 (for PT

tor><flag> sec Innovin)
• Assay number
Example: "PT sec In"
or
(for PT sec Innovin)
• Assay short name in single quotes or in Example: "PT
double quotes sec Innovin"
or
• Assay name in single quotes or in
double quotes
Assay names are case-sensitive.
<flag operator>: -
• is or is flagged
or
• is not or is not flagged
or
• has flag or does not have flag

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<flag>: -
• released, or repeated, or doubtful,
or invalid
or
• "aspirated in direct mode" or
"converted to base dilution"
or
• "controls valid", or "control
doubtful", or "control invalid"
or
• "over cut-off", or "under cut-off",
or "over reference range", or "under
reference range"
or
• "over custom cut-off", or "under
custom cut-off", or "over custom
range", or "under custom range"
or
• "poor double determination"
or
• "minimum absorbance too high" or
"absorbance too high"
or
• "ambiguous reaction" or
"without reaction"
or
• "under measurement range" or "over
measurement range"
result for <assay><dilution opera‐ <assay>: see above -

tor><dilution>
<dilution operator>: The dilution needs to be
specified with an accuracy
• is diluted to or is at dilution of ±15 %.
<dilution>, for example, 1:5
Conditions
Conditions can be combined, see the table below.
Combined conditions Elements of the condition Comment
condition and condition It is possible to combine 2 conditions with and -

or or:
• && or and: both conditions apply
• || or or: at least 1 of the conditions applies

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Combined conditions Elements of the condition Comment
condition or condition
Combined conditions
The instructions, their different elements, and their notations are explained in the
table below.
Instruction Elements of the instruction Comment
measure <assay> <assay>: Ensures that the assay is

measured at least once. No
• Assay number repetitions are performed.
or
measure <assay> ; <assay> As above, but for multi‐
• Assay short name in single quotes or in ple assays. Repeat with
double quotes more semicolons for
more assays.
or
repeat <assay> Ensures that the assay is
• Assay name in single quotes or in
repeated at least once.
double quotes
No additional repetitions
Assay names are case-sensitive. are performed.
repeat <assay> ; <assay> As above, but for multi‐

ple assays. Repeat with
more semicolons for
more assays.
measure <assay> at dilution <dilu‐ <dilution>, for example, 1:5 Ensures that the assay is
tion> measured at least once,
When specifying dilutions, enter only dilutions using the stated dilution
measure <assay> with dilu- which are defined in the assay definition. Other‐ factor if a new measure‐
tion <dilution> wise, the system will automatically choose the ment is started.
next higher or lower dilution which is defined for
measure <assay> diluted <dilution> the assay.
measure <assay> diluted to <dilu‐ Assay names are case-sensitive.
tion>
repeat <assay> at dilution <dilu‐ Ensures that the assay is

tion> repeated at least once,
using the stated dilu‐
repeat <assay> with dilution factor.
tion <dilution>
repeat <assay> diluted <dilution>
repeat <assay> diluted to <dilu‐
tion>
Instructions
For reflex testing, the instruction Repeat has the same effect as selecting the action
button Repeat manually once. Reflex testing cannot perform more than exactly
1 repetition of an assay for a sample.
When a semicolon is used to measure or repeat multiple assays, additional spaces are
required before and after the semicolon to separate assay numbers, for example: If
result for 19000 > 40.0 then measure 19100 ; 19010

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For better understanding, the user can add comments in curly brackets or between /*
and */. The software ignores text in curly brackets and between /* and */.
Make sure not to use multiple spaces in rules. Otherwise, the rule cannot
be performed.
Examples If result for 13100 {Fib Multi U} is "under measurement range"

then measure 13102 {Fib Multi U low}
If result of 16001 {VWF Ac} is 'under measurement range' then

measure 16101 {VWF Ac low}
If result of 13100 {Fib Multi U} is less than 1.5 then measure

13102 {Fib Multi U low}
If result of 11100 {APTT Actin FS} is 'without reaction' then

repeat 11100 {APTT Actin FS}
If result of 10130 {PT INR Cal In} is 'without reaction' then

measure 10130 {PT INR Cal In}
If result for 19000 {LA Screening} > 40.0 then measure 19100 {LA
Confirmation} ; 19010 {LA Ratio}
If result of 13100 {Fib Multi U} is greater than 6 then repeat

13100 {Fib Multi U} with dilution 1:2
If result for 'Fib der In' is greater than 3.7 or result of 'Fib
der In' is less than 1.9 then measure 'Fib Multi U'
If (1.2 * result of 19100 {LA Confirmation} < result of 19000

{LA Screening}) then measure 10100 {PT Innovin}
Direct mode
To avoid reflex testing for samples measured in Direct mode, create a rule with a
condition similar to the following:
If result for 11100 {APTT Actin FS} is doubtful and result for
11100 is not "aspirated in direct mode" then repeat 11100
5.3.53 Remote services

Path to the dialog:
• Setup > Tools > Remote services
The dialog is used to display the status of the Smart Remote Services (SRS), see the data
interface manual.
5.3.54 Result export

Path to the dialog:
• Setup > Tools > Result export
The dialog is used to create export files with results, measurement curves, and
calibration curves in XML format.

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The list Select the assays to export results for displays details on the defined assays, see
the table below.
Assay number Assay number
Short name Assay short name or customized assay name
Name Assay name
Assay list
The user can select 1 or more assays in the list.
Export Creates the export file

ResultExport_yyyy-mm-dd_nn.ACOAG360
For an explanation of the placeholders see ( Page 148 Placeholders in export
file names).
Action buttons
dd Day in 2 digits
nn Consecutive number for each day in 2 digits
Placeholders in export file names
5.3.55 Secure download

Path to the dialog:
• Setup > Tools > Secure download
The dialog is used to load data provided by Siemens Healthineers on the system via a USB
storage device or a shared folder.
When a file on a USB storage device or in a shared folder has been selected using the
action button New, the user can view information on the file, see the table below.
File name File name
Content Type of data, for example, lot data
Created Creation date and time
File ID Unique ID of the file

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Creator Name of the creator
Comment Additional information on the file, if applicable
Secure download files
New Displays the dialog Select file to select a secure download file
Install (only if a file is selected) Installs the selected file
Action buttons
If a ZIP file is selected that contains more than 1 secure download file, the simplified
dialog Select file is displayed to select and open a secure download file from the ZIP
file, see ( Page 72 Select file (for ZIP files)). Each secure download file from the ZIP file
has to be installed separately.
5.3.56 Service software

Path to the dialog:
• Setup > Tools > Service software
The dialogs are used by Siemens Healthineers service and users with appropriate training
to perform special maintenance and service functions, see the figure below.

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Overview of the service software screen
(1) Part of the system software

(2) Service software
(3) Tool bar of the service software to access maintenance and service functions
(4) Dialog of the service software
The dialog displays maintenance and service functions depending on the button
selected in the tool bar.
Buttons shown grayed are not active and cannot be selected.
5.3.57 Definitions loader

Path to the dialog:
• Setup > Tools > Definitions loader
The dialog is used to view the installed assay definitions and product definitions provided
by Siemens Healthineers, and to install updates.

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Siemens Healthineers recommends to load definitions only in the system status

Maintenance. To set the status, select System > Pause. When loading definitions is
finished, select System > Resume.
At the top, details on the last update are displayed, see the table below.
Last update Identifier of the last update, or

---: after the first installation
Installed Date and time when the last update was installed, or
Last update
In the list Installed definitions, the installed assay definitions and product definitions are
displayed, see the table below.
Name Name of the assay group, or

Product name
Type Reagent: product in a bottle provided by Siemens

Healthineers, for example, reagent, control, or calibra‐
tor
Cartridge: product in a cartridge provided by Sie‐
mens Healthineers
Assay group: assay group provided by Sie‐
mens Healthineers
Reagent (UDM): user-defined product in a bottle
Assay group (UDM): user-defined assay group
Published Date and time when the definition was published
Installed Date and time when the definition was installed, or

Installed definitions
Install Displays the dialog Select file to select and install a file with assay definitions
and product definitions
Action buttons

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5.3.58 Installation info

Path to the dialog:
• Setup > Tools > Definitions loader > Installation info

The dialog is displayed to provide troubleshooting instructions for installing definitions,
if required, see the table below.
Name Definition causing a problem
Cause Description of the problem
Recommended action Action to solve the problem

When having performed all actions, re-install the
update in the dialog Definitions loader.
Troubleshooting instructions for installing definitions
5.3.59 User administration

Path to the dialog:
• Setup > Tools > User administration
The dialog displays the user accounts, see the table below.
User name User name
Role Defines the user’s access rights, see ( Page 152 User roles and access rights)
Password expiration Date the password expires, or

Never: The password does not expire.
Status Status of the user account, see ( Page 154 Statuses of user accounts)
User accounts
Task User role and access level
Night shift Routine Lab technician Lab supervi‐

operator sor
1 2 3 4
Request orders for samples and controls X X X X
Load and manage lot data – X X X
Perform calibrations –a) X X X
Delete calibrations – X X X
Define products and assays with the dialog – – – X

Data definition

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operator sor
1 2 3 4
Define sample tubes, racks, and sample rack tem‐ – – – X

plates with the dialog Rack definition
Manage definitions with the dialog Defini‐ – – – X

tions loader
Configure assay customization – – – X
Configure control assignment – – – X
Configure sample result processing – – – X
Configure HIL warning – – – X
Configure automatic display clean up – – X X
Perform display cleanup manually – X X X
Perform configurations in the following dialogs: – X X X

• Alerts
• Assay activation
• Language
• Printout
• Expiration warnings
• Assay statistics
• Shared folders
Perform configurations in the following dialogs: – – X X

• Auto start
• System (in Setup > Configuration)

• Barcodes
• LAS connection
• LIS connections
• Secure download
•
Configure maintenance – – X X
Perform maintenance – X X X
Perform maintenance tasks that require spe‐ – – X –

cial training
Perform backups and export data X X X X
Restore backed up data – – X X

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operator sor
1 2 3 4
Manage user accounts – – – X
Install updates – – X X
User roles and access rights
a) The system runs calibrations automatically, if configured.
Status Explanation
Enabled The user can work according to the assigned user role.
Disabled (by another user) A user with sufficient rights has disabled the user account.
Disabled (login failure) The system has disabled the user account after 5 consecutive login failures.
Expired The password has expired, the user must change the password when logging
in the next time.
Statuses of user accounts
New Displays the dialog New user, see ( Page 154 New user)
Edit Displays the dialog Edit user, see ( Page 155 Edit user)
Delete Displays a confirmation dialog to delete the selected user account
Action buttons
5.3.60 New user

Path to the dialog:
• Setup > Tools > User administration > New
The dialog New user is used to add a user account, see the table below.
Role Defines the user’s access rights, see ( Page 152 User roles Select
and access rights)
User name User name Enter
Password Password, the characters are displayed as dots Enter
Re-type password Repetition of the password, the characters are displayed Enter
as dots

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Password expiration Validity period of the password Select

Not available if Password does not expire is active
Status Status of the user account, see ( Page 154 Statuses of -

user accounts)
Password does not expire The password does not expire. Select
Account disabled Disables the user account, the user cannot log on Select
User account settings
5.3.61 Edit user

Path to the dialog:
• Setup > Tools > User administration > Edit

The dialog Edit user is used to edit the selected user account, see ( Page 154 User
account settings).
5.3.62 Language
Path to the dialog:
• Setup > Configuration > Language

The dialog is used to set the language of the software, see the table below.
Select a language. Restart from eco Available languages of the software Select
mode required.
Restart from eco mode required
Languages
5.3.63 Assay activation

Path to the dialog:
• Setup > Configuration > Assay activation

The dialog is used to activate assays in the software, see the table below.
Available assays Assays that are defined, but cannot be run on the system. Select
1 or more
The assays are not displayed in most dialogs.
Moves assays selected in the list Available assays to the Select

list Active assays
Moves assays selected in the list Active assays to the list Select
Available assays

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Active assays Assays that can be run on the system. Select

1 or more
The assays are displayed in all dialogs in the same order as
in this list.
Moves assays selected in the list Active assays 1 line up Select
Moves assays selected in the list Active assays Select

1 line down
Activation of assays
The settings in the dialog Assay activation have several consequences on the system:
• In the dialog Jobs, only activated assays are displayed.
• It is possible to load reagents and to export results for single assays that are not
activated but used by activated meta-assays.
• In the dialog Data > Lot data, only reagent lots and control lots required for the
activated assays are available.
• In the dialog Reagents > Loading, only reagents required for the activated assays
can be manually identified.
• In the dialog Setup > Tools > LIS connection, only LIS specific assay values for
activated assays can be configured.
5.3.64 Assay customization

Path to the dialog:
• Setup > Configuration > Assay customization

The dialog is used to customize the display and processing of assays.
On the left, in the list Assay, the user can select an assay.
On the right, the user can view details on the assay and customize the assay, see the
table below.
Assay name Assay long name -
Assay number Assay number -
Published Date and time when the assay version was published -
Display name Customized assay name which is displayed in the soft‐ Enter
ware instead of the assay short name defined in the dialog
Data definition
Empty: reverts to the assay short name

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Default profile Requests a sample order for the assay by default if the LIS Select
does not send any orders
The default profile is measured in addition to manual
orders in the dialog Jobs.
The default profile is measured in normal mode or in
direct mode, depending on the sample rack used and the
corresponding sample rack template.
Meta-assays using more than 1 sample type cannot be
measured as part of the default profile.
Display color for measurement curves
Display in selected color Applies the selected color to the measurement curves Select
(Color) Color picker to select a color, see ( Page 158 Color picker) Select
Additional assay-specific aliquot volume Defines an assay-specific aliquot volume that is taken in Enter
addition to the sample volume required for open orders,
if applicable
The assay-specific aliquot volume is only taken if it is
higher than the reserve aliquot volume defined for the
sample tube, see ( Page 190 Sample tube).
The assay-specific aliquot volume can be used for the
processing of assays in normal mode, for example, for
expected re-measurements with different dilutions or for
reflex testing.
Result display
Convert results Customizes the displayed results Select
Factor Factor to customize the displayed result Enter
Offset Offset to customize the displayed result Enter
Unit Unit of the customized result Enter
Decimal places Number of decimal places displayed for the custom‐ Select
ized result
Result flagging
Flag results Flags results if the defined condition is met. Select

When de-selected, results are flagged according to the
settings in the dialog Data definition.
(Condition) Outside reference range: flags results outside the refer‐ Select
ence range
Below cut-off: flags results below the cut-off
Above cut-off: flags results above the cut-off
(Value) Lower limit of reference range, or Enter

Cut-off
to (only for reference ranges) Upper limit of reference range Enter

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Calibration processing
Automatically calibrate new reagent lots The system runs required calibrations for new Select
reagent lots.
The setting is only effective if in the dialog Data def‐
inition, subgroups Assay definition > Assay groups
> Assay procedures > Process steps > Media, the
parameter Lot-dependent is activated for the reagent.
Re-calibrate automatically when calibration The system runs new calibrations for reagent lots when Select
curve expires the existing calibration curve has expired.
Customizing assays
If a sample rack For manual orders is used, the following applies for the settings in the
dialog Assay customization:
• If a Default profile is configured, the selected assays are measured in addition to

manual orders in the dialog Jobs.
• If an Additional assay-specific aliquot volume is entered for an assay, it is only

taken when the assay is ordered manually.
• If the Default profile and the Additional assay-specific aliquot volume are
configured, they will both be processed.
1 2 3 4 5
Color picker
(1) Automatic naming of the selected color

(2) Selected color
(3) Previously selected color
(4) Shade color field for the selected color
(5) Hue slider
(6) Color sliders and input fields for hue (H), saturation (S) and value/brightness (V)
(7) Input field for hexadecimal color value
5.3.65 Sample result processing

Path to the dialog:
• Setup > Configuration > Sample result processing

The dialog is used to configure automatic sample result framing and sample
result release.
On the left, in the list Assay, the user can select an assay.

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On the right, the user can make settings for the sample result framing and sample result
release, see the table below.
Sample result framing
Automatic framing The system uses control orders run before and after the Select
sample orders to frame the sample results.
With control results from the same reagent bot‐ The system uses framing control orders from the same Select
tles reagent bottles, if available.
The setting is only effective for products for which the
parameter Measure control for each new reagent bot‐
tle is activated in the dialog Data definition, subgroup
Product definition.
Sample result release
Automatic release The system releases sample results if the conditions Select
selected below are met.
Result-dependent
Release valid results The system releases only valid sample results. Select
Release valid and doubtful results The system releases valid and doubtful sample results. Select
Release all results The system releases all sample results. Select
Control-dependent
If framed by valid control results The system releases the sample results selected above Select
once they are framed by valid control results.
If a valid control result exists The system releases the sample results selected above as Select
soon as 1 valid control result is available.
Until an invalid or doubtful control result exists The system releases the sample results selected above Select
unless an invalid or doubtful control result is already avail‐
able.
Independent of control results The system releases the sample results selected above Select
independent of control results.
Apply for all active assays Applies the configuration for automatic sample result Select
framing and for sample result release to all assays in the
list Assay
Sample result framing and sample result release
5.3.66 Control assignment

Path to the dialog:
• Setup > Configuration > Control assignment

The dialog is used to assign controls to assay groups, set automatic control orders,
and deviations.
On the left, the user can select an assay group.

Print No. DCHS-G01.621.01.08.02 159
At the top right, the list Controls displays the control assignments, see the table below.
Product name Control name
Automatic scheduling Rule for automatic scheduling, see ( Page 161 Set control assignment)
New bottle Yes: the system runs a control order for each new reagent bottle
No: the system does not run control orders for new reagent bottles
Control assignments
At the bottom right, the list Assay parameters displays the deviations for the selected
control assignment, see the table below.
Assay Assay short name or customized assay name -
Level Level of the control -
Dilution Control dilution -

For some assays, a dilution needs to be entered, see the
reference guide for more information.
Max. deviation (default) Default value for the maximum permitted deviation of -
control results from the assigned value
The default value is used if neither user-defined devia‐
tions nor deviations provided by Siemens Healthineers
are available in the dialog Data > Lot data, see
( Page 176 Lot data).
Max. period deviation Maximum permitted deviation of control periods, -

checked by the quality control software
Edit assay parameters Displays the dialog Assay to edit the deviations, see Select
( Page 161 Assay)
Deviations
New Displays the dialog Control to add a control assignment, see ( Page 161 Con‐
trol)
Edit Displays the dialog Control to edit the automatic scheduling of controls, see
( Page 161 Control)
Delete Displays a confirmation dialog to delete the selected control assignment
Action buttons

Print No. DCHS-G01.621.01.08.02 160
5.3.67 Control
Path to the dialog:
• Setup > Configuration > Control assignment > New
• Setup > Configuration > Control assignment > Edit
The dialog is used to add control assignments to an assay and to edit the automatic
scheduling of controls, see the table below.
New Edit
Product name Control names Select -
Automatic scheduling
Never The system does not run control orders. Select Select
Every (n) samples The system runs a control order after every (n) samples. Select and Select and
enter enter
Every (n) hours The system runs a control order every (n) hours. Select and Select and
enter enter
For each new reagent bottle The system runs a control order for each new reagent Select Select
bottle when used for the assay for the first time.
The setting is only effective for all products for which the
parameter Measure control for each new reagent bot‐
tle is activated in the dialog Data definition, subgroup
Product definition.
Save Saves the values and closes the dialog Select Select
Set control assignment
5.3.68 Assay
Path to the dialog:
• Setup > Configuration > Control assignment > Edit assay parameters
The dialog is displayed using the button Edit assay parameters at the bottom of the
dialog Control assignment.
The dialog is used to set deviations for the control assignment selected in the list
Controls and the assay selected in the list Assay parameters, see the table below.
Assay Assay short name or customized assay name -
Control Control name -

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Settings
Level Level of the control: Select

• None: No controls are measured for the assay.
• High and Low: to distinguish between the normal
range and the pathological or therapeutic range
Dilution Control dilution Select
Max. deviation (default) Default value for the maximum permitted deviation of Enter
control results from the assigned value
The default value is used if neither user-defined devia‐
tions nor deviations provided by Siemens Healthineers
are available in the dialog Data > Lot data, see
( Page 176 Lot data).
Max. period deviation Maximum permitted deviation between control results in Enter
a control period, checked by the quality control software
Save Saves the values and closes the dialog Select
Set deviations
5.3.69 Alerts
Path to the dialog:
• Setup > Configuration > Alerts

The dialog is used to set acoustic signals for status alerts, see the table below.
Alert volume
Min … Max Volume of the acoustic signal Drag
Alerts
Yellow Enables acoustic signals for yellow status alerts Select
Red Enables acoustic signals for red status alerts Select
Acoustic signals for status alerts
5.3.70 Barcodes
Path to the dialog:
• Setup > Configuration > Barcodes

The dialog is used to make settings for transmitting 1-dimensional sample barcodes
between the system and the LIS.
On the left, the positions of the LIS sample ID and the sample barcode are displayed. Up
to 29 positions are transmitted.

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On the right, the sample barcode settings are displayed, see the table below.
Sample ID length Number of positions used for transmitting the sample ID Select
Include sample type None: The sample type is not encoded. Select
Barcode: The sample type is encoded in the sample barcode.
Barcode and LIS sample ID: The sample type is encoded in the
barcode and the LIS sample ID.
Sample type key length Number of positions used to encode the sample type Select
Sample type keys PPP: encoding for the sample type platelet-poor plasma Enter
PRP: encoding for the sample type platelet-rich plasma Enter
Display start and stop characters Displays start and stop characters for the barcode type Codabar. Select
(only for Codabar)
If selected, the start and stop characters are not interpreted as start
and stop characters but are displayed on the system and can be
transmitted to the LIS with the sample ID and, if configured, the
sample type key.
Use check characters Uses check characters to check the correct reading of barcodes (only Select
available for barcode types with check characters)
If the result of reading the barcode is that the check character does
not match the barcode, Barcode incorrect is displayed for the sample
tube in the dialog Loading > Problem racks.
Display check characters Displays the check characters Select

If selected, the check characters are not interpreted as check charac‐
ters but are displayed on the system and can be transmitted to the LIS
with the sample ID and, if configured, the sample type key.
The check box is only available if Use check characters is selected.
Sample barcode settings
On the left, the user can match the LIS sample ID and the sample barcode, see the
table below.
Start sample type (only if the sample Start positions of the sample type key Drag
type is included)
Must be positioned either before or after the sample ID
Start sample ID Start positions of the sample ID Drag
Last relevant Last relevant position of the LIS sample ID Drag
Match LIS sample ID and sample barcode
The status of a position is indicated by different colors, see the table below.
Color Explanation
Position of the sample ID
(blue)

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Color Explanation
Position of the sample type key
(green)
Problem: The LIS sample ID has fewer positions than

the sample barcode.
(red)
Problem: The positions of the sample ID and the sample

type key overlap.
(red cross)
Position of the LIS sample ID that is not evaluated (pla‐

ceholder)
(white)
Unused position
(gray)
Statuses of positions
5.3.71 Auto start

Path to the dialog:
• Setup > Configuration > Auto start

The dialog is used to select tools that are started and running together with the software,
LAS connection The system communicates permanently with the LAS. Select
LIS connection The system communicates permanently with the LIS. Select
Reflex testing The system runs automatic reflex assays. Select
Remote services The system communicates permanently with the SRS. Select
Auto start
Tools that are not selected can be started manually by displaying the corresponding
dialogs. The tools continue running if the dialog is left using a button in the tool bar or
a button to access another routine function. When the dialog is closed using the action
buttons Close or Exit, the tools are stopped.
5.3.72 Printout
Path to the dialog:
• Setup > Configuration > Printout

The dialog is used to configure printouts.
The header of a printout displays, in the middle, the name of the dialog printed and the
user logged in. The user can add information as explained in the table below.

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Left header Information at the top left in 2 lines Enter
Right header Information at the top right in 2 lines Enter
Header of printouts
For printouts of the dialog Jobs, the user can set the level of detail, see the table below.
Summary printout Prints information displayed in the dialog Jobs Select
Detailed printout Prints information displayed in the dialogs Jobs, Sample Select
info, and Sample result info
Level of detail for printouts of the dialog Jobs
5.3.73 System (for general settings)

Path to the dialog:
• Setup > Configuration > System

The dialog is used to make general system settings, see the table below.
On-screen keyboard
Activate When the user selects an input field, either an alpha- Select
numeric or a numeric keyboard is displayed, depending
on the input.
Eco mode settings
Wake-up time Activates automatic start from eco mode Select

Sets the time of day Select
Shutdown time Activates automatic switching to eco mode Select

Sets the time of day Select
All open orders, for which at least the first transfer step
has been processed, are finished before the system is
switched to eco mode.
HIL check. Restart from eco mode required.
Activate Activates measurements of hemolytic, icteric, and lipe‐ Select

mic indices
Restart from eco mode required, see ( Page 256 Deacti‐
vating and activating the HIL check)
LIS order settings. Restart from eco mode required.
Order waiting time Waiting time for orders from the LIS for identified samples Select

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(Value) Short: up to 7 s (default) Select

Medium: up to 14 s
Long: up to 21 s
The order waiting times Medium and Long can reduce
the throughput of the system.
Restart from eco mode required, see ( Page 394 Sample
material required (70))
Jobs
Use column 'Patient name' In the dialog Jobs, the column Patient name can be Select
displayed, if required.
Use column time of completion Select

In the dialog Jobs, the column (time of completion)
can be displayed, if required.
Eco mode settings
Wake-up time
Monday to Sunday Activates automatic start from eco mode for the Select
selected weekday
Select
Sets the time of day
Shutdown time
(Monday) to (Sunday) Activates automatic switching to eco mode for the Select
selected weekday
Select
Sets the time of day
All open orders, for which at least the first transfer step
has been processed, are finished before the system is
switched to eco mode.
General system settings
When activating Shutdown time, open orders are aborted at the selected time of day.
Make sure that all open orders are processed when selecting a shutdown time.
5.3.74 Expiration warnings

Path to the dialog:
• Setup > Configuration > Expiration warnings

The dialog is used to set expiration warnings, see the table below.

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Products in reagent storage Warning period in hours before a product in the reagent Enter or
storage expires, that is, either the on-board stability select
period or the expiration date is exceeded
When the warning period starts to elapse, the symbol
in the dialog Reagents > Overview, column Product
names which indicates the expiration status changes
from blue to yellow.
Probe cleaner Warning period in hours before the probe cleaner expires Enter or
select
When the warning period starts to elapse, the status alert
Probe cleaner almost expired (67) is displayed.
Aliquots Warning period in minutes before an aliquot expires Enter or

select
When the warning period starts to elapse, the symbol in
the dialog Jobs > Sample info, list Aliquots which indi‐
cates the expiration status changes from blue to yellow.
When the warning period has elapsed, the flag Aged
sample, control, or calibrator used is displayed when
performing measurements with these aliquots.
Independent of this setting after 4 hours all aliquots are
discarded, which means that no more measurements can
be performed with these aliquots.
Calibrations Warning period in days before a calibration expires Enter or

select
If a calibration expires the next day, the expiration warn‐
ing is displayed the day before starting at 0:00.
Expiration warnings
An assay-specific on-board stability period can be defined for aliquots, see

( Page 197 Assay procedures). The flag Aged sample, control, or calibrator used is
displayed for the general aliquot expiration warning described in the table above as
well as for the assay-specific expiration warning, see ( Page 197 Assay procedures).
5.3.75 Maintenance
Path to the dialog:
• Setup > Configuration > Maintenance

The dialog is used to view maintenance tasks, see the table below.
Task name Name of the maintenance task
Type Type of the maintenance task:

Required: defined by Siemens Healthineers
User: defined by the user and set active
User inactive: defined by the user and set inactive

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Interval Frequency of performance
Day (only for intervals in multiples of a week) Weekday to perform the maintenance task
Scheduled Time of day to perform the maintenance task
Description Description of the maintenance task
Maintenance tasks
The user can filter the maintenance tasks, see the table below.
Filter Explanation
All All maintenance tasks
Active Active maintenance tasks
Inactive Inactive maintenance tasks
Filters for maintenance tasks
New Displays the dialog Maintenance task to add a maintenance task, see
( Page 168 Maintenance task)
Edit Displays the dialog Maintenance task to edit a maintenance task, see
( Page 168 Maintenance task)
Delete Displays a confirmation dialog to delete the selected user-defined mainte‐

nance task
Action buttons
5.3.76 Maintenance task

Path to the dialog:
• Setup > Configuration > Maintenance > New
• Setup > Configuration > Maintenance > Edit
The dialog is used to add or edit maintenance tasks, see the table below.
Task defined by User-defined task

Siemens Healthi‐
neers
Name Name of the maintenance task - Enter or edit
Description Description of the maintenance task - Enter or edit
Settings See ( Page 169 Performance of maintenance tasks)

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Task defined by User-defined task

Siemens Healthi‐
neers
Save Adds or changes the maintenance task Select Select

and closes the dialog
Properties of maintenance tasks
Daily, Weekly Frequency of performance Select
Time Time of day to perform the maintenance task Select
Interval (only for weekly perform‐ Number of weeks between performances Select
ance)
Day (only for weekly performance) Weekday to perform the maintenance task Select
Active (only for user-defined main‐ Activates the maintenance task Select
tenance tasks)
Performance of maintenance tasks
For maintenance tasks defined by Siemens Healthineers, the frequency can only be
increased, not decreased.
5.3.77 HIL warning

Path to the dialog:
• Setup > Configuration > HIL warning

The dialog is used to activate the checks and to set the sample-specific warning
levels for hemolysis, icterus, and lipemia, see the table below. For information on the
concentration ranges corresponding to the HIL indices, see ( Page 469 HIL indices and
the corresponding concentration ranges). If at least 1 of the sample’s HIL indices is higher
than or equal to the sample-specific warning level, then the symbol is displayed next
to the sample ID in the dialog Jobs.
Hemolytic sample if index at least Activates the sample-specific check for hemolysis Select
(Value) Sample-specific warning level for hemolysis Select or

enter
Icteric sample if index at least Activates the sample-specific check for icterus Select
(Value) Sample-specific warning level for icterus Select or

enter
Lipemic sample if index at least Activates the sample-specific check for lipemia Select

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(Value) Sample-specific warning level for lipemia Select or

enter
Checks and warning levels for hemolysis, icterus, and lipemia
5.3.78 Updates
Path to the dialog:
• Setup > Configuration > Updates

The dialog is used to install software updates and to view the status of installed updates,
Update Name of the software or data update
Created Creation date and time of the update release
Installed Installation date and time of the update
Version Version of the update
Mandatory Yes: The update is mandatory and is installed automatically on the next full shutdown.
No: The update is optional and must be installed manually.
Status Update status:

Ready to be installed: The update can be installed.
Installed: The update has been installed successfully.
Failed: A problem occurred while installing the update.
---: The update is not applicable and cannot be installed. A newer or the same update
version is already installed.
Description Description of the update
Updates
Install Manually installs the selected software update and re-starts the system
Action buttons
5.3.79 Shared folders

Path to the dialog:
• Setup > Configuration > Shared folders

The dialog is used to enter the paths and the names of shared folders for file import or
file export, see the table below.

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Import folder Shared folder for file import Enter
Export folder Shared folder for file export Enter
Shared folders
5.3.80 Maintenance
The following dialogs are used to perform maintenance.
5.3.81 Periodic tasks

Path to the dialog:
• Maintenance > Periodic tasks
The dialog is used to view periodic maintenance tasks and to record the performance.
On the left, all periodic maintenance tasks are listed, see the table below.
Task name Name of the maintenance task
Date and time Date and time scheduled for the next performance
Periodic maintenance tasks
When a maintenance task is selected, details are displayed on the right and the user can
record the performance, see the table below.
(Task name) Name of the maintenance task -
Description Description of the maintenance task -
Scheduled Date and time scheduled for the next performance -
(Status) Prior to the scheduled time, the user can record the per‐ Select
formance:
OK: The maintenance task has been performed suc‐

cessfully.
Not OK: A problem occurred while performing the

maintenance task.
If the user does not record the performance on time, the
system records the status Not performed.
Comment Comment on the performance Enter
Recording periodic maintenance tasks
When the scheduled time has passed, the maintenance tasks are moved to the dialog
Maintenance log.
The user can filter the maintenance tasks, see the table below.

Print No. DCHS-G01.621.01.08.02 171
Filter Explanation
Today Maintenance tasks scheduled from now until the end

of the day
All All maintenance tasks
Filters for maintenance tasks
5.3.82 Maintenance log

Path to the dialog:
• Maintenance > Maintenance log
The dialog is used to view records of maintenance tasks.

On the left, the records are listed, see the table below.
Periodic maintenance task Aperiodic mainte‐

nance task
Status Status of the performance: Empty
: The maintenance task has been performed success‐

fully.
: A problem occurred while performing the mainte‐

nance task.
: No performance has been recorded.
Date and time Displayed in black: date and time when the user recorded Date and time when the
the performance user recorded the perform‐
ance
Displayed in red: date and time scheduled for the perform‐
ance, the user did not record the performance
Task name Name of the maintenance task Manual entry
Interval Frequency of performance ---
User name Name of the user who recorded the performance, or Name of the user who
recorded the performance
Automatic: The performance was not recorded on time.
Comment Empty
, if a comment is available
Records of maintenance tasks
When a record is selected, details are displayed on the right, see the table below.

Print No. DCHS-G01.621.01.08.02 172
Periodic maintenance task Aperiodic mainte‐

nance task
Status Status of the performance: ---
OK
Not OK
Not performed.
Name Name of the maintenance task Manual entry
Description Description of the maintenance task, if available Description of the mainte‐

nance task
Scheduled Date and time scheduled for the performance ---
Performed Date and time when the user recorded the performance, Date and time when the
if applicable user recorded the perform‐
ance
User name Name of the user who recorded the performance, or Name of the user who
recorded the performance
Automatic: The performance was not recorded on time.
Interval Frequency of performance ---
Comment Comment entered by the user, if available, or Empty

Not performed on time recorded by the system
Details on records
Using the filters Status and Time, the user can filter the records, see the table below and
( Page 173 Filters for recording periods).
Filter Explanation
All All records
Not OK
Records with the status Not OK
Not performed Records with the status Not performed
Manual entries Records of aperiodic maintenance tasks
Filters for the status of maintenance tasks
Filter Explanation
All All records
Last 24 hours Records of the last 24 hours
Last 7 days Records of the last 7 days
Last 30 days Records of the last 30 days
Filters for recording periods

Print No. DCHS-G01.621.01.08.02 173
New Displays the dialog Manual entry to record an aperiodic maintenance task, see
( Page 174 Manual entry)
Action buttons
5.3.83 Manual entry

Path to the dialog:
• Maintenance > Maintenance log > New
The dialog is used to record aperiodic maintenance tasks, see the table below.
Description Description of the maintenance task Enter
Save Adds a record named Manual entry to the dialog Main‐ Select
tenance log and closes the dialog
Recording aperiodic maintenance tasks
5.3.84 Task execution

Path to the dialog:
• Maintenance > Task execution
The dialog is used to start maintenance tasks.

On the left, in the list Tasks, the user can select the required maintenance task, see the
table below.
Task Explanation
Clean aliquot probea) Moves the aliquot arm to a parking position where the aliquot probe can
be cleaned
Clean HIL cuvette Cleans the HIL cuvette
Drain probe cleaner Empties the probe cleaner reservoir
Initialization Initializes selected components
Prime tubings Primes the tubings with purified water
Purge tubingsa) Purges the tubings with purging solution
Wash probesa) Washes all probes
Maintenance tasks
a) If the task has been performed successfully, the execution is automatically recorded in the maintenance log.
On the right, a description, parameters, and notes for the selected maintenance tasks are
displayed, if applicable, see the table below.

Print No. DCHS-G01.621.01.08.02 174
Task Explanation Action
Initialization Initialize Component to be initialized Select
Prime tubings Number of priming cycles Number of priming cycles Enter
Wash probes Intensity See ( Page 201 Wash programs) Select

Number of washing cycles Number of washing cycles Enter
Parameters
Start In the system status Operating:

• Finishes all open orders for which at least the first transfer step has
been processed
• Sets the system status to Maintenance
In the system status Maintenance:
• Starts the selected maintenance task
Action buttons
5.3.85 Data
The following dialogs are used to view and manage data available on the system.
5.3.86 Raw data

Path to the dialog:
• Data > Raw data
The dialog is used to view available and requested raw data, see the table below.
Date and time See ( Page 69 Dates and times of orders)
Material Sample ID, or

Product ID of the control or calibrator

Dilution Sample dilution, control dilution, or calibrator dilution
Wavelength Wavelength used for the evaluation

Alternative wavelength, if configured
Flag 1 Flag, resulting from the first evaluation method, if applicable

Print No. DCHS-G01.621.01.08.02 175
Value 1 Raw value or symbol, resulting from the first evaluation method
Unit 1 Unit of the raw value, resulting from the first evaluation method, if applicable
Flag 2 Flag, resulting from the alternative evaluation method, if applicable
Value 2 Raw value or symbol, resulting from the alternative evaluation method
Unit 2 Unit of the raw value, resulting from the alternative evaluation method, if applicable
More … (3 dots), if more than 2 evaluation methods have been used
Raw data
Using the filter Assay, the user can filter the raw data, see the table below.
Filter Explanation
All All raw data
(Assay short name or cus‐ Raw data for the selected assay
tomized assay name)
If a meta-assay is selected, all single assays are
also selected.
Filters for raw data
Selected Subdialog
Up to 10 raw data records Measurement curve

with the same units
Subdialogs
5.3.87 Lot data

Path to the dialog:
• Data > Lot data
The dialog is used to manage lot data.

On the left, the user can search for a product, see the table below.
Product names Product names Select
Show all product names If activated, all products defined on the system are dis‐ Select
played.
If deactivated, only products used with active assays
are displayed.
Search product name
(Input field) Any part of a product name Enter

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Clears the input field Select
Selects the next matching product name Select
Product names
On the right, the user can view and edit the lot data.
At the top, the list Lots displays the lots available in the software, see the table below.
Product ID Product code and lot number separated by -

a slash
: The lot is on-board.
Expiration date Date the lot expires Select (only if the lot is
not on-board and if the
expiration date has been
entered manually)
ISI (only for thromboplastin reagents) User-defined international sensitivity index Enter
Default ISI (only for thromboplas‐ International sensitivity index provided by Sie‐ -
tin reagents) mens Healthineers
MNPT (only for thromboplas‐ User-defined mean normal prothrombin time Enter
tin reagents)
Default MNPT (only for thromboplas‐ Mean normal prothrombin time provided by Sie‐ -
tin reagents) mens Healthineers
MNV (only for reagents) For assays using a reagent lot with mean normal Enter
value (MNV) and the calculation method Ratio,
all results are calculated as ratio to the mean
normal value.
The mean normal value has to be entered with‐
out a unit. The unit must match the result unit of
the assay, see ( Page 207 Assays).
Unit Unit of the mean normal prothrombin time -
Delete Marks the lot for deletion from the software Select
(only if the lot is not on-board)
Lots
At the bottom, the list Assigned values displays the assigned values for controls and
calibrators, see the table below.

Print No. DCHS-G01.621.01.08.02 177
Assigned value Reagent lot-independent user-defined assigned value, or

(…), if the assigned value differs for different reagents lots (only for controls)
Default value Reagent lot-independent assigned value provided by Siemens Healthineers, or

(…), if the assigned value differs for different reagent lots (only for controls)
Unit Unit of the assigned value, if applicable
Acceptance range (only for controls) Reagent lot-independent user-defined acceptance range, or
(…), if the acceptance range differs for different reagent lots
Default acceptance range (only for con‐ Reagent lot-independent acceptance range provided by Siemens Healthi‐
trols) neers, or
(…), if the acceptance range differs for different reagent lots
Unit (only for controls) Unit of the assigned value, if applicable, and of the acceptance ranges (only
for controls)
Assigned values
Selected Subdialog
Control or calibrator Assigned values
Subdialogs
Add lot Displays the dialog Add lot number, see ( Page 180 Add lot number)
Resolve (only if there is a conflict Displays the dialog Lot data to resolve the conflict, see ( Page 420 Lot data
between lot data provided by Siemens conflict (92))
Healthineers and previously entered
user-defined lot data)
Action buttons
5.3.88 Assigned values

Path to the dialog:
• Data > Lot data > Assigned values
The dialog is used to edit user-defined assigned values and deviations.

At the top, product data and the assay are displayed, see the table below.

Print No. DCHS-G01.621.01.08.02 178
Product name Product name
Product data and assay
In the list Assigned values, the user can edit user-defined assigned values and
acceptance ranges, see the table below.
(Product name) Any: the assigned values are independent of the reagent lot, or -
Product ID of the reagent
Assigned value User-defined assigned value Enter
Default value Assigned value provided by Siemens Healthineers -
Lower limita) User-defined lower limit for the acceptance range (only for controls) Enter
Default lower limit Lower limit for the acceptance range provided by Siemens Healthineers -
(only for controls)
Upper limita) User-defined upper limit for the acceptance range (only for controls) Enter
Default upper limit Upper limit for the acceptance range provided by Siemens Healthineers -
(only for controls)
Unit Unit of the assigned value, if applicable, and of the lower and upper limits -
(only for controls)
Edit assigned values
a) The acceptance ranges for control lots are defined by upper and lower limits as provided in the Tables of Assigned Values.
A reagent lot-independent assigned value and permitted deviation in the line Any
must always be available. Otherwise, the corresponding cell in the dialog Controls is
marked with the symbol and no orders can be requested.
New (only for controls) Displays the dialog New assigned value, see ( Page 180 New assigned value)
Delete Displays a confirmation dialog to delete the selected assigned value
Action buttons

Print No. DCHS-G01.621.01.08.02 179
5.3.89 New assigned value

Path to the dialog:
• Data > Lot data > Assigned values > New
The dialog is used to add reagent lots or lot combinations to the list Assigned values in
the dialog Assigned values.
At the top, in the area Reagent lots, the short names of the lot-dependent reagents are
displayed. The lists contain the lots with lot data available. The user can select a lot or a
lot combination.
At the bottom, the user can enter the user-defined assigned value and the limits of the
acceptance range, see the table below.
Assigned value User-defined assigned value Enter
Lower limit User-defined lower limit for the acceptance range Enter
Upper limit User-defined upper limit for the acceptance range Enter
Save Saves the values Select
Add reagent lots or lot combinations
5.3.90 Add lot number

Path to the dialog:
• Data > Lot data > Add lot
The dialog is used to add lot numbers to the software, either from the lot data storage
loaded using the Smart Remote Services (SRS) or the dialog Secure download or
manually from the instructions for use of the product, see the table below.
Product name Product name -
Lot number Lot number to be added to the software Enter or select among the lots
displayed in the area Lot data
in the data storage
Lot data in the data storage Lot data available in the lot data storage -
The lot data must be loaded on the system
using the Smart Remote Services (SRS) or the
dialog Secure download.
Add Adds the lot number to the software Select
Add lot number

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5.3.91 Result history

Path to the dialog:
• Data > Result history
The dialog is used to display the dialog Jobs for a date or time period in the past within
the record retention period.
At the bottom, in the middle, the user can select the date or time period in the list. The
date or time period is displayed as a watermark
The display of data in the dialog corresponds to the dialog Jobs, see ( Page 82 Jobs).
5.3.92 Display cleanup

Path to the dialog:
• Data > Display cleanup
The dialog is used to make settings for the deletion of data from the dialogs Jobs and
Controls, see the table below, and to delete the data.
Clean up automatically
On shutdown or eco mode The system deletes the data as follows: Select
• When the user selects Shutdown or Eco mode in the
dialog System
• When the system switches automatically to eco mode
On logoff The system deletes the data when a user logs off. Select
Cleanup 'Jobs'
All samples All sample IDs are deleted from the dialog Jobs. Select
Samples without open orders and all results Sample IDs without sample jobs, with open orders, and Select
sent to LIS with sample results that are not yet sent to the LIS remain
in the dialog Jobs.
No samples All sample IDs with their sample results and open orders Select
remain in the dialog Jobs.
Cleanup 'Controls'
Control results All control results and open orders are deleted from the Select
dialog Controls.
Automatic display cleanup settings
Start Displays a confirmation dialog to delete the selected data from the dialogs Jobs
and Controls, if applicable
Action buttons

Print No. DCHS-G01.621.01.08.02 181
5.3.93 User
Path to the dialog:
• User
The dialog is used to log on, log off, and change the password, see the table below.
User name User name Enter
Password Password Enter

Characters are displayed as dots.
Log on Closes the dialog and logs the user on Select
Log off Closes the dialog and logs the user off Select
Change password Displays a dialog to change the password, see Select

( Page 182 Password)
Close Closes the dialog Select
User
To change the password, see the table below.
Current user name User name -
Current password Password Enter

New password New password Enter

Re-type password Repetition of the new password Enter

OK Saves the values and closes the dialog Select
Cancel Closes the dialog Select
Password
5.3.94 Initialization
Path to the dialog:
• - (automatically displayed if the system has been started from cold)
The dialog is used to initialize the system, see the table below.

Print No. DCHS-G01.621.01.08.02 182
Information Explanation Use in the following cases Action
Smart initialization Aliquots remain on the system. After problems, short service Select
breaks, or short power outages
Products in the reagent storage are not re-
scanned as the information is still available.
Full initialization Unloads all aliquots After longer service breaks, longer Select
power outages, or longer periods
The dialog Reagent storage is displayed,
of non-operation
see ( Page 184 Reagent storage).
Re-scans all products in the reagent storage,
if the products are kept
Start initialization Starts the initialization - Select
Initialization
If a Smart initialization is performed directly after solving a problem of the type

Transportation problem at component <component name> (11), aliquots on the
system are automatically discarded, see ( Page 415 Aliquot not sufficient (72)).
5.3.95 System (for operating the system)

Path to the dialog:
• System
The dialog is used to pause and resume operation, and to shut down the system, see the
table below. Depending on the system status, different buttons are displayed.
Resume To manually resume from Paused, Sleep, or After performing maintenance, Select
Standby to Operating automatic sleep mode, or
standby mode
• Cleans the tubings with probe cleaner (only
for Paused and Sleep)
• Rinses the tubings with purified water
Pause Finishes all open orders for which at least the Before performing mainte‐ Select
first transfer step has been processed nance
Sets the system status to Maintenance
Shutdown (only if Finishes all open orders for which at least the Movement Select
the reagent storage first transfer step has been processed
Longer periods of non-opera‐
is empty)
Performs display cleanup, if configured tion
Shuts down
Switches the reagent cooling off
The illumination LED of the reagent manager
turns off.

Print No. DCHS-G01.621.01.08.02 183
Quick shutdown Aborts all open orders Service breaks Select

Shuts down Problems, for example, with
the initialization
Switches the reagent cooling off
turns off.
Eco mode Finishes all open orders for which at least the At night Select
first transfer step has been processed
On days-off
Performs display cleanup, if configured
Switches to eco mode
The reagent cooling remains switched on.
blinks slowly.
Close Closes the dialog - Select
Resume, pause, and shutdown
5.3.96 Reagent storage

Path to the dialog:
• - (automatically displayed if the conditions of the products are unknown)
The dialog is used to unload or keep the products in the reagent storage if the conditions
of the products are unknown after a system problem or after a quick shutdown, see the
table below.
Unload products Unloads the products in the reagent storage Select
Keep products Keeps the products in the reagent storage Select
Unload or keep the products in the reagent storage
If the products in the reagent storage are kept, Siemens Healthineers recommends to
measure controls, see ( Page 287 Measuring a control).
5.3.97 Temperature problem

Path to the dialog:
• - (automatically displayed if the temperatures of the products in the reagent storage

are unknown)
The dialog is used to unload or keep the products in the reagent storage if a temperature
problem occurred in eco mode, see the table below.

Print No. DCHS-G01.621.01.08.02 184
Unload products Unloads the products in the reagent storage Select
Keep products Keeps the products in the reagent storage Select
Unload or keep the products in the reagent storage
5.3.98 Cuvette waste counter

Path to the dialog:
• - (automatically displayed if the status of the cuvette waste counter is unclear)
The dialog is used to reset the cuvette waste counter if the cuvette waste container has
been emptied while the system was in eco mode, see the table below.
Reset Resets the cuvette waste counter Select
Do not reset Keeps the cuvette waste counter Select
Reset cuvette waste counter
5.3.99 Remote control

Path to the dialog:
• - (automatically displayed when Siemens Healthineers service requests

remote control)
The dialog is used to accept or reject a remote control request of Siemens Healthineers
service, see the table below.
Accept Accepts remote control Select
Reject Rejects remote control Select
Auto reject Automatically rejects remote control after the displayed -

number of seconds
Accept or reject remote control
5.3.100 Help
Path to the dialog:
• Help
The dialog displays the manual chapter for the current dialog as an online help. The user
can display other chapters and change the view of the dialog, see the table below.
Button Explanation
Back Displays the previously shown chapter

Print No. DCHS-G01.621.01.08.02 185
Button Explanation
Forward Displays the original chapter again
Refresh Displays the matching chapter if the dialog has been changed, or
Re-displays the matching chapter if the user has navigated in the help
Move Moves the dialog to the upper or lower part of the screen
Minimize Minimizes the dialog
Maximize Maximizes the dialog
Restore Restores the display after selecting Minimize or Maximize
Close Closes the dialog
Displays the chapter of contents and other buttons to navigate in the manual, see
( Page 186 Buttons to navigate in the manual)
Online help dialog
Button Explanation
Content Displays the table of contents on the left
Index Displays the index on the left
Search Displays a search area on the left
Closes the table of contents
Displays the previous chapter in the manual
Displays the next chapter in the manual
Displays the table of contents on the left
Buttons to navigate in the manual
5.3.101 Print
Path to the dialog:
• Print
The dialog is used to select a printer and to make print settings.

Print No. DCHS-G01.621.01.08.02 186
If no printer is connected to the system, the action button Print creates an XPS file or
PDF file, as configured by Siemens Healthineers service. To display XPS files or PDF files
on the system, see ( Page 137 Document viewer). To export created XPS files or PDF
files to a USB storage device or to a shared folder, see ( Page 136 Export).
At the top, the user can select a printer and the properties of the printer are displayed,
Name Available printers Select
Status Status of the selected printer -
Model Type of the selected printer -
Location Site of the selected printer -
Comment Comment on the selected printer -
Printer properties
At the bottom, the user can make print settings, see the table below.
All All pages are printed. Select
Pages A page range is printed. Select
From The first page that is printed Select or enter
To The last page that is printed Select or enter
Number of copies Number of copies Select or enter
Collate Print the copies collated one after another Select
Orientation Orientation of the printed pages Select
Paper size Paper size Select
Cancel Resets the values and closes the dialog Select
OK Starts printing and closes the dialog Select
Print settings
5.3.102 Working with the dialogs Data definition and Rack definition
Siemens Healthineers recommends operating the dialogs Data definition and Rack
definition using mouse and keyboard, not the touchscreen.
For input fields, an input validation message might be displayed to support correct
parametrization. If the displayed texts are too long, move the mouse pointer over the
input validation message to view the full text.

Print No. DCHS-G01.621.01.08.02 187
The data are arranged in groups with several levels of subgroups.
Display and hide The groups are displayed on the left. The user can display and hide the subgroups, see
the table below.
Button Explanation
Displays the subgroups
Hides the subgroups
Display and hide subgroups
Add and delete The user can add, copy, and delete subgroups, see the table below.
Button Explanation
Adds an empty subgroup

Only for assay procedures: adds one of the following process steps: Transfer, Incubation,
or Measurement
Adds a copy of the selected subgroup
Deletes the selected subgroup
Undoes a deletion
Add, copy, and delete subgroups
Search At the bottom left, the user can search for defined items, see the table below.
Symbol or field Explanation Action
Search The user can enter any part of a defined item. Enter
Selects the first matching item Select
Search
Edit When a subgroup shown in plain text is selected on the left, settings are displayed on
the right.
The user cannot edit assay and product definitions provided by Siemens Healthineers.
For information on the display of changes, see the table below.

Print No. DCHS-G01.621.01.08.02 188
Display Changes
Yellow frame or background Any change
Red frame Invalid setting
In italics New item
Dimmed Deleted items
Display of changes
Save The concept for saving changes is different from all other dialogs in the software. When
exiting the dialog Data definition or Rack definition, changes are saved, but not yet
active in the software. The user can re-edit the changes when re-opening the dialog Data
definition or Rack definition. To activate changes, that is, to write the changes to the
database, the user must publish them.
As long as there are unpublished changes in the dialog Data definition, the user cannot
open the dialog Rack definition, and vice versa.
Create file (only for the dialog Data def‐ Displays the dialog Save file to create a file that saves the assay definitions and
inition) the product definitions, see ( Page 189 Save file)
If an assay group has been selected, only the assay definitions of this single
assay group are saved.
With this file, assay definitions and, if available, product definitions can be
restored or installed on other systems using the dialog Definitions loader, see
( Page 150 Definitions loader).
Check Checks if an input is correct and, if yes, removes the corresponding red frames
Reset Displays a confirmation dialog to reset all changes since the last publishing
Publish Publishes all changes, that is, writes the changes to the database and activates
them in the software
Move up (only for process steps Moves the selected process step or medium 1 step up
and media)
Move down (only for process steps Moves the selected process step or medium 1 step down
and media)
Exit Closes the dialog Data definition or Rack definition
Action buttons
Save file The dialog Save file is used to save a file, see the table below.
(Folder list on the left) Available folders Select

If configured, the folder can be a shared folder, see
( Page 170 Shared folders).

Print No. DCHS-G01.621.01.08.02 189
(File list on the right) Existing files of the file type selected below Select
File name File name Enter
(File type) File type Select
Cancel Cancels the file creation and closes the dialog Select
Save Saves the file Select
Save file
5.3.103 Rack definition

Path to the dialog:
• Setup > Tools > Rack definition
The dialog is used to define sample tubes, racks, and rack templates.
5.3.104 Sample tubes

Path to the dialog:
• Setup > Tools > Rack definition > Sample tubes
For the parameters defining a sample tube, see the table below.
Sample tubes are pre-defined by Siemens Healthineers with suitable parameters. If

required, sample tube definitions must only be changed if the following conditions
are met:
• There are no unidentified sample tubes displayed in the dialog Loading

> Problem racks.
• The system is in the status Maintenance. To set the status, select System > Pause.
When changing sample tube definitions is finished, select System > Resume.
Parameter Explanation Action
Name Sample tube name - (for existing sam‐

ple tubes), or
Enter (for new sam‐
ple tubes)
Published Date and time of last publishing -
Type Permitted sample tube types Select
Offset (A) The user can set the maximum immersion depth of the Select
aliquot probe.
Sets the maximum immersion depth, measured from Enter

the bottom

Print No. DCHS-G01.621.01.08.02 190
Sample low-warning (B) Checks the sample tube for underfilling Select
Sets the underfilling level Enter

Samples below the underfilling level are flagged Sample
tube underfilled.
Sample high-warning (C) Checks the sample tube for overfilling Select
Sets the overfilling level Enter

Samples above the overfilling level are flagged Sample
tube overfilled.
Level detection limit (D) The user can set the upper limit for the level detection Select
Sets the upper limit for the level detection Enter

The upper limit is especially important for cap piercing, as
the level detection has to start below the cap.
Default aliquot volume From sample tubes on normal mode racks, the default Enter
aliquot volume is taken if no aliquots are on-board and no
orders are open.
Exception: A default aliquot is also taken from sample tubes
on normal mode racks if a special order for direct mode
is open.
The aliquot is taken, even if another aliquot of the sample
was onboard at an earlier point.
Example:
Samples:
• Samples A, B, and C have already been measured.
• All aliquots have already been disposed of.
• A new normal mode order is requested for sample A.
• No orders are requested for samples B and C.
• Samples A, B, and C are re-loaded on the same normal
mode rack.
• Default aliquot volumes are defined for the sample tubes
in which samples A, B, and C are re-loaded.
Aliquots:
• For sample A, the aliquot volume is taken depending on
the new order.
• For samples B and C, the default aliquot volume is taken.
Reserve aliquot volume Reserve aliquot volume that is taken in addition to the Enter
sample volume required for open orders, if applicable
The reserve aliquot volume is only taken if it is higher than
the assay-specific aliquot volume, see ( Page 156 Assay cus‐
tomization).
Sample tube

Print No. DCHS-G01.621.01.08.02 191
Sample low-warning (B) and Sample high-warning (C) activate the proper-fill check
only for the first time a primary sample tube is loaded into the system and an aliquot
is taken.
5.3.105 Calibrator and control racks

Path to the dialog:
• Setup > Tools > Rack definition > Calibrator and control racks
A calibrator and control rack is defined by the following parameters, see the table below.
Rack ID Rack ID - (for existing racks), or

Enter (for new racks)
Published Date and time of the last publishing -
5.3.106 Sample racks

Path to the dialog:
• Setup > Tools > Rack definition > Sample racks
A sample rack is defined by assigning a sample rack template to a rack ID, see the
table below.
Sample rack definitions must only be changed if the following conditions are met:

> Problem racks.
Sample rack
Rack ID Rack ID - (for existing racks), or

Enter (for new racks)
Template Sample rack templates, see ( Page 193 Sam‐ Select

ple rack template)

Print No. DCHS-G01.621.01.08.02 192
Sample rack settings Sample settings as defined in the sample rack -

template, see ( Page 193 Sample rack tem‐
plate)
Sample rack
5.3.107 Sample rack templates

Path to the dialog:
• Setup > Tools > Rack definition > Sample rack templates
With a sample rack template, the user can combine properties and processing options for
the samples placed on a sample rack, for example, if the samples are processed as STAT
samples or measured in direct mode.
A sample rack template is defined by the following parameters, see the table below.
Sample rack templates must only be changed if the following conditions are met:

> Problem racks.
Sample rack template
Name Name of the sample rack template Enter
Color Clip color to distinguish the different sample rack tem‐ -

plates
Use as default Yes: The system assigns this sample rack template to -
sample racks that are new to the system.
Sample rack settings
Sample type PPP: platelet-poor plasma Select

Control: Measures controls on a sample rack
For direct mode All samples on the rack are measured in direct mode, Select
even if in the dialog Data definition under Assay Groups
> Assays > Assay measurement > Settings the option
Measurement in direct mode possible is not selected.
For STAT samples Processes all samples on the rack with short turnaround- Select
time

Print No. DCHS-G01.621.01.08.02 193
For manual orders Processes all samples on the rack without requesting Select
orders from the LIS
For all samples, manual orders have to be requested in the
dialog Jobs, see ( Page 302 Loading barcoded sample
tubes on sample racks with the sample rack setting For
manual orders).
Sample tube Sample tube type permitted on the rack Select
Sample rack template
To define a sample rack template for direct mode, the selected sample tube must not
be defined for cap piercing. If cap piercing is defined for a sample tube, a generic
sample tube with the same geometry and defined without cap must be used instead.
Then, in the sample rack template for direct mode, the generic sample tube must
be selected. To measure the sample tube in direct mode, the cap must be removed
from the sample tube first. For assistance with the configuration, contact Siemens
To save sample material for sample racks with the sample rack setting For manual
orders, the sample rack setting For direct mode can be selected additionally. Thus the
HIL check is not performed for samples on this rack type.
5.3.108 Data definition

Path to the dialog:
• Setup > Tools > Data definition
The dialog is used to view definitions of products (reagents, controls, calibrators,

wash solutions), and assays (assay groups, assays, meta-assays) provided by Siemens
Healthineers, and to enter user-defined products and assays. Assay definitions provided
by Siemens Healthineers are using numbers greater than 10,000.
5.3.109 Product definition

Path to the dialog:
• Setup > Tools > Data definition > Product definition
The product definition comprises the following subgroups:
• Deficient plasma
• Thromboplastin
• Reagent
• Calibrator
• Control

Print No. DCHS-G01.621.01.08.02 194
• LOCI
• Wash solution
The products in the subgroups Deficient plasma, Thromboplastin, Reagent, and LOCI
are referred to as reagents in this manual.
Products are defined by the following parameters, see the table below.
Product
Name Product name Enter
Short name Product short name Enter
Comment Comment, if applicable Enter
Manufacturer Name of the manufacturer, if applicable Enter
Control ID (only for controls) The user can assign a control ID if controls are to be Enter
measured as samples. The control ID is used similarly to
the sample ID for the communication with the LIS.
Measure control for each new reagent bottle The system measures a control for each new reagent bot‐ Select
(only for reagents) tle.
The setting is only effective if in the dialog Control
assignment > Control, For each new reagent bottle
is selected.
Mean normal value required (only for reagents) It is possible to manually enter a mean normal value Select
(MNV) for reagents. Using this mean normal value, results
can be expressed as a ratio to the entered mean normal
value instead of as an absolute value with the defined
unit, for example, sec.
If the check box is selected, for all lots of the reagent
an MNV needs to be entered in the dialog Lot data to
calculate results.
To use the mean normal value, the calculation method
Ratio must be selected for all assays using the reagent,
see ( Page 211 Assay calibration).
Wash program (only for wash solutions) Wash program used with the wash solution Select
On-board stability
Unlimited The stability of the product in the reagent storage Select

is unlimited.
(Value) Value of the stability period Select

and enter
(hours, days, weeks) Unit of the expiration stability period in hours, days, Select
or weeks
Shaking parameters
Program Shaking rate Select

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Duration Duration of shaking Enter
Interval Frequency of shaking Enter
Shake after eco mode Shake the bottles after starting the system from eco mode Select
Product code
Product
The following applies to on-board stabilities:
• If an assay-specific reagent on-board stability is configured for an assay, the

general on-board stability (as defined in the dialog Data definition, subgroups
Product definition > Reagent) is not evaluated.
• It is possible to configure more than 1 assay-specific reagent on-board stability

for an assay, for example, different values in Media and in Assay procedures.
Siemens Healthineers strongly recommends to use the same value (otherwise, the
shortest of the assay-specific reagent on-board stabilities is determined and used
for evaluation).
• If an on-board stability is changed after measurement, the displayed on-board

stabilities may become implausible.
5.3.110 Assay definition and Assay groups

Path to the dialog:
• Setup > Tools > Data definition > Assay definition > Assay groups
Assays and meta-assays based on the same clinical parameter are grouped into assay
groups. Therefore, to define a new assay, it must be assigned to an existing assay group
or a new assay group must be created.
Assay groups are defined by the following parameters, see the table below.
Name Assay group name Enter
Assay group
Assay groups comprise the following subgroups:
• Assay procedures, see ( Page 197 Assay procedures)
• Assays, see ( Page 207 Assays)
• Meta-assay, see ( Page 213 Meta-assay)

Print No. DCHS-G01.621.01.08.02 196
A single assay group can be saved and restored. Existing assay groups are not
overwritten. To import assay definitions from the saved file, the existing assay group
first has to be deleted, if applicable.
5.3.111 Assay procedures

Path to the dialog:
• Setup > Tools > Data definition > Assay definition > Assay groups > <Assay group
name> > Assay procedures
An assay procedure is defined by the following parameters, see the table below.
Assay procedure
Name Assay procedure name Enter
Number Assay procedure number Enter
Dilution
Diluent Dilution medium Select
Assay-specific OBS (only for reagents as dilu‐ Assay-specific stability of the reagent as dilution medium Select
tion medium)
(Value) (only for reagents as dilution medium) Value of the stability period Enter
or weeks
Calibrator mixing Mixing of calibrator with diluent, see ( Page 199 Mixing) Select
Sample/control mixing Mixing of sample or control with diluent, see Select

( Page 199 Mixing)
Number of measurements
Calibration points
(Number of measurements) Number of measurements for a supporting point Enter
(Permitted deviation) Permitted deviation between the single raw values Enter
0 (zero) means that the check is deactivated.
(Unit of permitted deviations) Unit of the permitted deviations for calibrations, samples, Select
and controls
Samples and controls
(Number of measurements) Number of measurements for a sample or control result Enter

Print No. DCHS-G01.621.01.08.02 197
(Permitted deviation) Permitted deviation between the single raw values Enter
0 (zero) means that the check is deactivated
Data reduction method Mathematical method to determine the final raw value Select
from the single measurements, see ( Page 474 Arith‐
metic mean), ( Page 474 Standard deviation),
( Page 475 Coefficient of variation), ( Page 475 Ratio
1/n), ( Page 475 Minimum), ( Page 475 Maxi‐
mum), ( Page 475 Arithmetic mean with hyperbolic
coefficient of variation), ( Page 476 Median), and
( Page 476 Median with hyperbolic coefficient of varia‐
tion)
Constant for hyperbolic coefficient of variation See ( Page 475 Arithmetic mean with hyperbolic coef‐ Enter
(only for the data reduction methods Arithmetic ficient of variation) and ( Page 476 Median with hyper‐
mean with hyperbolic coefficient of variation bolic coefficient of variation)
and Median with hyperbolic coefficient of varia‐
tion)
Sample parameters
Sample type Platelet-rich plasma (PRP)a) Select

Platelet-poor plasma (PPP)
Aliquot expires after Defines an assay-specific time period, that triggers an Select
onboard stability expiration warning when it expires.
Additionally, a general expiration warning period can be
defined for all aliquots, see ( Page 166 Expiration warn‐
ings).
In both cases the flag Aged sample, control, or calibra‐
tor used is displayed when performing measurements
with these aliquots.
Independent of these settings after 4 hours all aliquots
are discarded, which means that no more measurements
can be performed with these aliquots.
(Duration) Time period in min after which the aliquots are flagged Enter
Kinetics pre-treatment (only for sample See ( Page 199 Kinetics pre-treatment (only for sample Select
type PRP) type PRP))
Assay procedure
a) For the platelet-rich plasma (PRP) of a platelet aggregation assay, a blank value needs to be measured for a sample with platelet-poor plasma (PPP)
from the same patient and with the same sample ID. The blank value is required as reference to calculate the percent aggregation curve.

Print No. DCHS-G01.621.01.08.02 198


for evaluation).

Mixing Explanation
Level 1 Short mixing at normal frequency
Level 2 Short mixing at high frequency
Level 3 Medium mixing at normal frequency
Level 4 Medium mixing at high frequency
Level 5 Long mixing at normal frequency
Level 6 Long mixing at high frequency
Jet Half of the volume is aspirated from the cuvette and

then dispensed back into the cuvette.
Mixing
Name Name of the kinetics pre-treatment method Select

The kinetics pre-treatment method Percent aggregation limits the
possible platelet numbers for the calculation of percent aggregation
curves (%Agg).
Minimum platelet number Minimum absorbance of platelet-rich plasma (PRP) in mA Enter
Maximum platelet number Maximum absorbance of platelet-rich plasma (PRP) in mA Enter
Upper limit of value for platelet- Upper limit for absorbance of platelet-poor plasma (PPP) in mA Enter
poor plasma
Kinetics pre-treatment (only for sample type PRP)
Assay procedures comprise the following subgroups:
• Process steps, see ( Page 200 Process steps)
• Evaluation methods for raw value, see ( Page 206 Evaluation methods for
raw value)

Print No. DCHS-G01.621.01.08.02 199
5.3.112 Process steps

Path to the dialog:
name> > Assay procedures > <Assay procedure name> > Process steps
The process steps performed by the analyzer comprise the subgroups explained in the
table below.
Process step Quantity Order
Transfer, see ( Page 200 Transfer) 1 or more Always the first step
Never the last step
Incubation, see ( Page 203 Incuba‐ 0 (zero) or more Never the first step
tion)
Never the last step
Measurement, see ( Page 204 Meas‐ 1 Always the last step

urement)
Process steps
5.3.113 Transfer
Path to the dialog:
name> > Assay procedures > <Assay procedure name> > Process steps > Transfer
A transfer is a pipetting cycle with aspirating steps for several media and 1 dispensing
step. A transfer is defined by the following parameters, see the table below.
Transfer arm Aliquot arm Select

Sample arm
Rear reagent arm
Front reagent arm
Washing before transfer Wash program that is performed before the transfer, see Select
( Page 201 Wash programs)
Washing after transfer Wash program that is performed after the transfer, see Select
( Page 201 Wash programs)

Print No. DCHS-G01.621.01.08.02 200
Mixing None: no mixing Select

Level 1: short mixing at normal frequency
Level 2: short mixing at high frequency
Level 3: medium mixing at normal frequency
Level 4: medium mixing at high frequency
Level 5: long mixing at normal frequency
Level 6: long mixing at high frequency
Transfer
For the aliquot arm, the following applies:
• The washing levels 3, 4, 5, or 6 must not be used.
• If the aliquot arm is used for the sample transfer, no mixing must be used.
• If the aliquot arm is used for the sample transfer, normal mode orders are
not processed.
For the sample arm, the following applies:
• If the washing level 3, 4, 5, or 6 are used for the sample transfer, direct mode orders
are not processed.
• If mixing is used for the sample transfer, direct mode orders are not processed.
For mixing, the following applies:
• The mixing levels 2, 4, and 6 (high frequency) must not be used for liquid volumes
greater than 150 μL.
• Depending on the mixing level, the start time or lag phase of the evaluation and
check methods must be prolonged to allow the reaction mixture to settle, see
( Page 201 Start time or lag phase depending on mixing levels).
Mixing levels Minimum start time or lag phase
1 and 2 3s
3 and 4 5s
5 and 6 6s
Start time or lag phase depending on mixing levels
Wash program Explanation
Level 1 Rinsing with purified water

Print No. DCHS-G01.621.01.08.02 201
Wash program Explanation

Cleaning with probe cleaner
Sitting
Rinsing with purified water
Level 3 Cleaning with probe cleaner


Washing with wash solution 1
Level 5 Reserved for additional wash solutions
Level 6 Reserved for additional wash solutions
None No washing
Wash programs
Within an assay procedure, the washing levels 4, 5, and 6 must not be combined.
Media The transferred media are defined by the following parameters, see the table below.
Action Aspirate Select

Dispense
Material (only for aspiration steps) Sample Select

Reagent
Air
Purified water
(Product name) (only for reagents) Reagent names Select
Assay-specific on-board stability (only Assay-specific stability of the aspirated reagent Select
for reagents)
(Value) (only for reagents) Value of the stability period Enter
or weeks
Lot-dependent (only for reagents) A calibration is required for each reagent lot. Select

Print No. DCHS-G01.621.01.08.02 202
Speed Aspirating or dispensing speed as required by the Select

viscosity of the material:
• Fast
• Medium
• Slow
Volume Volume aspirated or dispensed Enter
Media
Direct mode orders are not processed if purified water is transferred together with
the sample.


for evaluation).

5.3.114 Incubation
Path to the dialog:
• Setup > Tools > Data definition > Assay definition > Assay groups > <Assay
group name> > Assay procedures > <Assay procedure name> > Process steps
> Incubation
An incubation is defined by the following parameters, see the table below.
Incubator Pre-heater Select

Incubator
Incubation time Incubation time Enter
Incubation

Print No. DCHS-G01.621.01.08.02 203
5.3.115 Measurement
Path to the dialog:
group name> > Assay procedures > <Assay procedure name> > Process steps
> Measurement
A measurement is defined by the following parameters, see the table below.
Measurement principle Absorbance Select

Optomechanic
LOCI
Measurement time (only for the measurement Measurement time Enter

principles Absorbance and Optomechanic)
Stirring after (only for the measurement principle Optomechanic)a)
(Starting point) Starting point of stirring Enter
for Duration of stirring Enter
(Stirring speed) Stirring speed Enter
Stirring aftera) Second stirring Select
Stirring aftera) Third stirring Select
Pre-measurement (only for the measurement principle LOCI)
Activate Activates a pre-measurement that estimates the light Select

emission from a complete LOCI reaction to prevent the
photometer from overexposure during measurement
The result is used to activate the alternative measure‐
ment, if configured.
Cut-off Checks the pre-measurement value against a cut-off pho‐ Enter

ton count to proceed with measurement
If the cut-off is exceeded, the measurement is aborted or,
if configured, the alternative measurement is activated.
Pre-illumination (only for the measurement principle LOCI)
Activate Activates a pre-illumination without measuring to protect Select

the measurement from luminescence artifacts

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Delay Delay between pre-illumination and measurement to Enter

prevent an influence on the LOCI reaction
Illumination duration Duration of pre-illumination Enter
Measurement settings (only for the measurement principle LOCI)
Delay between illumination and measurement Delay between illumination and measurement to match Enter
the light emission with LOCI reader properties
Number of measurements Number of measurement cycles for default measurement Enter

or alternative measurement, if selected
Additional measurement cycles make the measurement
more robust.
Default measurement (only for the measurement principle LOCI)
Illumination duration Default illumination duration to initiate a proportional Enter

light emission
Measurement time Default measurement time Enter

A longer measurement time provides a better approxima‐
tion of the complete light emission.
Delay Default delay between measurements if Number of Enter

measurements is greater than 1
Use alternative measurement (only for the Alternative measurement if pre-measurement exceeds a Select
measurement principle LOCI) defined threshold
If pre-measurement value is greater than Threshold for the pre-measurement value Enter
If exceeded, alternative measurement is used.
Illumination duration Alternative illumination duration to initiate a propor‐ Enter

tional light emission
Measurement time Alternative measurement time Enter

A longer measurement time provides a better approxima‐
tion of the complete light emission.
Delay Alternative delay between measurements if Number of Enter

measurements is greater than 1
Measurement
a) Stirring speeds and the durations of stirring are automatically validated.
Make sure to match the measurement time with the time parameters of the
evaluation methods.

Print No. DCHS-G01.621.01.08.02 205
5.3.116 Evaluation methods for raw value

Path to the dialog:
name> > Assay procedures > <Assay procedure name> > Evaluation methods for
raw value
Evaluation methods for raw value define how a raw value is determined from a
measurement curve. An evaluation method for raw value is defined by the following
parameters, see the table below. To check the measurement curves for plausibility, the
user can assign check methods to an evaluation method for raw value.
Raw value evaluation
Name Name of the evaluation method for raw value Enter
Wavelength Wavelength used for the evaluation Select

The system records a measurement curve at each availa‐
ble wavelength.
Signal difference If required, the user can set the signal difference at which Enter
measurements are finished.
Correlation factor and offset of raw value If required, the user can adapt a system deviation of the Enter
raw values with a factor and an offset.
(Offset of raw value) - Enter
Correlation factor and offset of direct mode If required, the user can adapt an additional system Enter
deviation of the raw values in direct mode with a factor
and an offset.
(Offset of raw value in direct mode) - Enter
Evaluation method
Name Evaluation method used, see ( Page 215 Evalua‐ Select

tion methods)
Below, the parameters relevant for the selected evalu‐
ation method are displayed, see ( Page 215 Evalua‐
tion methods).
Evaluation method for raw value
Defining several evaluation methods for raw value can be used, for example, to
measure different wavelengths with the same evaluation method or to measure
different evaluation methods with the same wavelength. All the wavelengths defined
for an assay procedure are measured and displayed in the dialogs Alternative curves,
see ( Page 98 Alternative curves), and Raw data, see ( Page 175 Raw data).
Check methods A check method is defined by the following parameters, see the table below.

Print No. DCHS-G01.621.01.08.02 206
Check method
Name Check method used, see ( Page 223 Check methods) Select
Below, the parameters relevant for the selected check method are displayed, see
( Page 223 Check methods).
Check method
5.3.117 Assays
Path to the dialog:
name> > Assays
An assay is defined by the following parameters, see the table below.
Assay
Name Assay name, for example, the clinical parameter to Enter

be measured
Short name Assay short name Enter
Number Assay number - (for existing

assays), or
Enter (for new
assays)
Publishing changes makes all previous results After publishing, the following occurs to results Select
incomparable to new results evaluated using the previous assay version and, if
applicable, calibrations:
• In the dialog Jobs, … (3 dots) are displayed
instead of a result.
• Results are not used anymore to evaluate
other results.
• Calibrations are not used anymore to evaluate
new results.
Internal settings See ( Page 208 Internal settings) -
Result reporting See ( Page 208 Result reporting) -
Result flagging See ( Page 209 Result flagging) -
Sample
Hemolytic sample if index at least Activates the assay-specific check for hemolysis Select

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(Value) Assay-specific warning level for hemolysis Enter

If the sample’s index is higher than or equal to the
warning level, results are flagged.
For information on the concentration ranges corre‐
sponding to the HIL indices, see ( Page 469 HIL
indices and the corresponding concentra‐
tion ranges).
Icteric sample if index at least Activates the assay-specific check for icterus Select
(Value) Assay-specific warning level for icterus Enter

tion ranges).
Lipemic sample if index at least Activates the assay-specific check for lipemia Select
(Value) Assay-specific warning level for the lipemia Enter

tion ranges).
Assay
Correlation factor and offset for result If required, the user can adapt a system deviation of the Enter
results with a factor and an offset.
(Offset for result) - Enter
Result unit Unit of the result Enter
Result format Displayed places before and after the decimal separator Select
Internal settings
Never report results below Checks results against a minimum value Select
(Value) Minimum reported results Enter
Never report results above Checks results against a maximum value Select
(Value) Maximum reported results Enter
Result reporting

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None Results are not checked against a reference range Select
Reference range Checks results against a reference range Select
(Value for the lower limit) Lower limit of the reference range Enter
(Value for the upper limit) Upper limit of the reference range Enter
Cut-off Checks results against a cut-off value Select
(Setting) Above Select

Below
(Value) Cut-off value Enter
Result flagging
Assays comprise the following subgroups:
• Assay measurement, see ( Page 209 Assay measurement)
• Assay calibration, see ( Page 211 Assay calibration)
5.3.118 Assay measurement

Path to the dialog:
name> > Assays > <Assay name> > Assay measurement
An assay measurement is defined by the following parameters, see the table below.
Dilution
Base dilution: 1: Initial dilution Enter
Alternative dilutions
Adds an input field for an alternative dilution Select
(Value) Alternative dilution, which is available when requesting Enter

special orders and defining meta-assays
Needs a diluent to be defined, see ( Page 197 Assay pro‐
cedure)
Deletes the alternative dilution Select
Repeat measurement with different dilution
If result is below calibration range Repeats the measurement if the result is below the cali‐ Select
bration range
use dilution 1: Dilution for the re-measurement Enter

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If result is below Repeats the measurement if the result is below a compa‐ Select
rative value
(Value) Comparative value Enter
If result is above Repeats the measurement if the result is above a compa‐ Select
rative value
(Value) Comparative value Select
If result is above calibration range Repeats the measurement if the result is above the cali‐ Select
bration range
Settings
Measurement in direct mode possible Measurement in direct mode is available for special orders Select
or when using direct mode racks.
De-selecting this option does not disable measurements
in direct mode. If samples are placed on a rack defined
for direct mode, see ( Page 193 Sample rack templates),
they will be measured in direct mode, independent of the
selection made here.
Intensive aliquot probe washing before aspira‐ If the assay is requested for a sample, the aliquot probe Select
tion is washed using a special wash program before taking
the aliquot.
Aliquots taken without the special washing are not used
to measure the assay.
Used for high-sensitivity assays
Raw value unit Unit of the raw value Enter
Data reduction method
Name Mathematical method to determine the final raw value Select

for assays with several assay measurement assignments,
see ( Page 474 Arithmetic mean), ( Page 475 Mini‐
mum), ( Page 475 Maximum), ( Page 476 Median),
and ( Page 476 Formula)
Formula (only for the data reduction method For‐ See ( Page 476 Formula) Enter
mula)
Alternative raw value evaluation
If absorbance is high Uses the alternative evaluation method defined in the Select
assay measurement assignment if the absorbance is
too high
If raw value is (Above, Below) Uses the alternative evaluation method defined in the Select
assay measurement assignment if the raw value is above
or below a comparative value

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(Value) Comparative value Enter
Assay measurement
If a base dilution different from 1:1 is used and measurement in direct mode is
possible, then the second transfer step must be an incubation in the pre-heater.
The alternative raw value evaluation can be used for measuring an assay with an
alternative wavelength, see ( Page 211 Assay measurement assignment).
Assay measurements comprise 1 or more assay measurement assignments, see

( Page 211 Assay measurement assignment).
5.3.119 Assay measurement assignment

Path to the dialog:
group name> > Assays > <Assay name> > Assay measurement > Assay
measurement assignment
An assay measurement assignment is defined by the following parameters, see the

table below.
Assay procedure Assay procedures defined for the assay Select
Evaluation method for raw value Evaluation methods defined for the assay procedure, see Select
( Page 206 Evaluation methods for raw value)
Alternative Uses the alternative evaluation method if 1 of the condi‐ Select

tions defined in the assay measurement is met
Evaluation method for raw value Alternative evaluation methods defined for the assay Select
procedure, see ( Page 206 Evaluation methods for
raw value)
Assay measurement assignment
5.3.120 Assay calibration

Path to the dialog:
name> > Assays > <Assay name> > Assay calibration
The assay calibration is defined by the following parameters, see the table below.
Platelet aggregation assays cannot be calibrated.

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Calibration
Type Calibration types: Select

None: The assay is not calibrated.
Curve from a different assay: The assay uses the calibra‐
tion curve of another assay.
Master curve: The assay uses a calibration curve pro‐
vided by Siemens Healthineers.
Measured curve: The assay uses a measured calibra‐
tion curve.
Calculation method (only for the calibration type None)
Name Result calculation for assays that are not calibrated, see Select
( Page 213 Calculation methods for assays that are
not calibrated)
Assay (only for the calibration type Curve from a different assay)
Name The assay uses the calibration curve of another assay in Select
the assay group.
The list is only active if the assay group comprises at least
1 other assay that uses either the calibration type Master
curve or Measured curve.
Calibration method (only for the calibration types Master curve and Measured curve)
Name Calibration method used, see ( Page 228 Calibra‐ Select

tion methods)
Below, the parameters relevant for the selected calibra‐
tion method are displayed, see ( Page 228 Calibra‐
tion methods).
Expiration (only for the calibration types Master curve and Measured curve)
Expires after Never: The calibration does not expire, or Select

Time period after which the assay calibration expires, in Select
hours, days, or months and enter
Measurements (only for the calibration type Measured curve)
Use calibrator set Uses a pre-diluted calibrator set Select
Dilute standard automatically Uses calibrator dilutions prepared by the system Select
Calibrator Calibrator of a pre-diluted calibrator set, or Select

Calibrator (standard) to prepare dilutions from
Target concentration [unit] (only for Dilute Target concentration to be prepared by the system Enter
standard automatically)
Due to technical reasons, the actual concentration can
deviate slightly from the target concentration.
Adds a line for another calibrator and, if applicable, Select

target concentration

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Deletes the line Select
Re-measurements of invalid supporting point Maximum number of re-measurements of invalid sup‐ Enter
porting points
Check against acceptance range If a check curve is available for the assay and the cor‐ Select
responding reagent lot, any new calibration curve is
automatically checked against the check curve and the
acceptance range.
The check curve and the acceptance range are saved with
the calibration.
The user can display the acceptance range with the
calibration curve.
Permitted deviation Deviation used to calculate the acceptance range Enter
Assay calibration
Calculation method Explanation
Raw value = result The result equals the raw value.
Ratio See ( Page 477 Ratio)
INR See ( Page 477 INR)
Calculation methods for assays that are not calibrated
The calculation methods Ratio and INR must only be used for assays that use exactly
1 lot-dependent thromboplastin reagent or exactly 1 lot-dependent reagent that is
marked as requiring a mean normal value (MNV).
5.3.121 Meta-assay
Path to the dialog:
name> > Meta-assay
A meta-assay is an aggregation of several assays and defined by the following
parameters, see the table below.
Meta-assay
Name Meta-assay name Enter
Short name Meta-assay short name Enter

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Number Assay number - (for existing

assays), or
Enter (for new
assays)
Internal settings See ( Page 208 Internal settings) -
Result reporting See ( Page 208 Result reporting) -
Result flagging See ( Page 209 Result flagging) -
Single assays
Assay Single assay used in the meta-assay Select
Dilution Dilution used with the single assay Select
Adds a line for another single assay Select
Deletes the line Select
Result calculation
Transform all results to minimum dilution Each Assay of the Single assays is measured with Select
the selected Dilution:
• If Transform all results to minimum dilution
is not selected, the single-assay result is
transformed to the single assay’s base dilution.
• If Transform all results to minimum dilution is
selected, the single-assay result is transformed
to the minimum Dilution selected for any
single assay, disregarding the single assay’s
base dilution.
The meta-assay result is calculated from the trans‐
formed single-assay results.
If Repeat measurement with different dilution is
configured for a single assay and the corresponding
condition applies, the alternative dilution is meas‐
ured, see ( Page 209 Assay measurement):
• If Transform all results to minimum dilution

is not selected, the result is used instead of the
single-assay result.
• If Transform all results to minimum dilution is
selected, the result is discarded.

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Result usage Valid results: Only results without neither invalid Select
nor doubtful symbol are used for result calculation.
Valid results and doubtful results: Results with
invalid symbol are not used for result calculation,
but results with doubtful symbol are used in addi‐
tion to valid results.
Data reduction method
Method Calculation of the result of the meta-assay using the Select

results of the single assays, see ( Page 474 Arith‐
metic mean), ( Page 474 Mean value with check),
( Page 475 Minimum), ( Page 475 Maximum),
( Page 476 Median), and ( Page 476 Formula)
Permitted deviation(only for the data reduction The result of the meta-assay is flagged if the result Enter
method Mean value with check) of a single assay deviates from the arithmetic mean
more than the permitted deviation.
Formula (only for the data reduction method For‐ See ( Page 476 Formula) Enter
mula)
Example: "LA Confirmation"/"LA Screening"
Meta-assay
5.4 Evaluation methods

The following chapters describe the evaluation methods and their parameters.
Make sure to match the time parameters of the evaluation methods with the
measurement time.
Depending on the mixing level, the start time or lag phase must be prolonged to allow
the reaction mixture to settle, see ( Page 201 Start time or lag phase depending on
mixing levels).
For all evaluation methods, the parameter Dynamic change of threshold must be set
to 0 (= off).
5.4.1 Delta A
The evaluation method Delta A determines the absorbance difference of a measurement
curve between the minimum (maximum for the decreasing curve type) and a defined
end time point.
Start time Time point when to start searching for the minimum or maximum
Valid values ≥ 0 s
Stop time End time point of evaluation

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Valid values > Start time s
Expected curve slope 1 = rising, -1 = falling
5.4.2 Delta A per minute

The evaluation method Delta A per minute determines the mean slope of a
measurement curve in a defined time interval by a linear regression line.
Start time Start time point of the time interval.
Stop time End time point of the time interval.
Correlation coefficient Minimum coefficient of correlation. If the coefficient of correlation of the data points
within the time interval is lower, the curve is flagged.
0 ≤ valid values ≤ 1
5.4.3 Drifting baseline

The evaluation method Drifting baseline determines the onset of coagulation of a
measurement curve as the time point when the defined absorbance threshold between
a dynamic baseline is reached. The baseline is dynamically adjusted by a linear regression
line and is able to compensate steady and unspecific increases.
Lag phase Start time point of evaluation
Measurement time End time point of evaluation

Valid values > Lag phase + both window widths s
Threshold Absorbance threshold above the dynamic baseline which must be exceeded
for coagulation
Valid values ≥ 0 mA
Dynamic change of threshold 0 = off, 1 = on (must be set to 0)
Window width for regression Width of the regression window
Valid values > 0 s
Window width for Width of the time window to search for exceeding the threshold
transgression search
Valid values > 0 s
Maximum gradient of the Maximum for the slope of the baseline. If this value is exceeded, a horizontal baseline
baseline is used.
Valid values > 0 mA/min

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5.4.4 Absorbance
The evaluation method Absorbance determines the mean absorbance of a
measurement curve in a defined time interval by a linear regression line.
Start time Start time point of the time interval
Stop time End time point of the time interval
5.4.5 Fixed absorbance

The evaluation method Fixed absorbance determines the onset of coagulation of a
measurement curve as the time point when the defined absorbance threshold after the
minimum or maximum for the decreasing curve type is reached.
Lag phase Time point when to start searching for the minimum
Threshold Absorbance threshold above the minimum which must be exceeded for coagulation
Valid values ≠ 0 mA
5.4.6 Fixed Delta A

The evaluation method Fixed Delta A determines the absorbance difference of a
measurement curve between 2 defined time points.
Start time Start time point of the time interval
Stop time End time point of the time interval
5.4.7 Percent Delta A

The evaluation method Percent Delta A determines the onset of coagulation of a
measurement curve as the time point when the defined percentage of the absorbance
delta (difference between maximum and minimum absorbance) is reached.

Print No. DCHS-G01.621.01.08.02 217

Valid values > Lag phase s
Minimum change in signal Minimum difference between maximum and minimum absorbance. If this limit is not
reached, no evaluation is possible.
Percentage of signal Percentage of the absorbance delta which is used for the coagulation onset
0 ≤valid values ≤ 100 %
5.4.8 Point of inflexion

The evaluation method Point of inflexion determines the onset of coagulation of a
measurement curve as the time point of the inflexion point at which the maximum
reaction velocity is reached.
Valid values > Lag phase s
Minimum change in signal Minimum difference between maximum and minimum absorbance. If this limit is not
reached, no evaluation is possible.
Distance left limit Defines, together with Distance right limit, the width of the time window for calculating
the first derivative and the point of inflexion
Valid values: Distance left limit + Distance right limit ≥ 6 s
Distance right limit Defines, together with Distance left limit, the width of the time window for calculating
the first derivative and the point of inflexion
Valid values: Distance left limit + Distance right limit ≥ 6 s
Minimum speed of reaction Minimum for the maximum reaction velocity. If this value is not reached, the curve
is flagged.
Expected curve slope 1 = rising, -1 = falling, 0 = undetermined
5.4.9 VLin Integral

The evaluation method VLin Integral determines the maximum reaction velocity of a
measurement curve.

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Start time Start time point of evaluation
Variable start time 0 = off, 1 = on
Window width for rough slope Width of the time window for calculating the rough slope in order to increase the start
calculation time, if Variable start time is selected
0 ≤ valid values ≤ Stop time - Start time s
Maximum start time Maximum for adjusting the start time, if Variable start time is selected
Start time ≤ valid values ≤ Stop time s
Upper limit for rough slope Lower limit for the rough slope. The nearer the calculated rough slope is to this value, the
more the start time is increased.
Valid values ≥ 0 mA/min
Lower limit for rough slope Upper limit for the rough slope. The nearer the calculated rough slope is to this value, the
less the start time is increased.
Valid values > Upper limit for rough slope mA/min
Window width for minimum Width of the time window for searching for the minimum absorbance
search
0 ≤ valid values ≤ Stop time - Start time s
Degree of polynomial Degree of the polynomial function adjusted to the curve
2 ≤ valid values ≤ 9 (integer)
Area under 1st derivative of Linear range where the maximum reaction velocity occurs by defining the area under the
polynomial first derivative of the polynomial
Valid values > 0
Min. window width for Minimum width of the time window for calculation of the maximum reaction velocity by
calculation of max. gradient linear regression.
0 < valid values ≤ Stop time - Start time s
5.4.10 ETP_cmax, ETP_tmax, ETP_tlag, ETP_auc

The algorithm ETP consists of 4 different evaluation methods to characterize the
Endogenous Thrombin Potential of an ascending measurement curve.
The evaluation method ETP_cmax determines the maximum velocity of the

thrombin generation.
The evaluation method ETP_tmax determines the time point at which the thrombin
generation reaches its maximum velocity.

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The evaluation method ETP_tlag determines the time point at which the thrombin
generation starts, the reaction lag phase.
The evaluation method ETP_auc determines the delta of absorbance in the free
thrombin curve corresponding to the generated amount of thrombin by calculating the
area under the thrombin generation curve (= first derivative of the free thrombin curve).
Start time for determining the Time point when to start searching for the reaction lag phase
reaction lag phase
Valid values ≥ 0
Valid values: any
Start time for determining the Start time point for determination of the linear range and end time point for searching
linear range for the reaction lag phase
Valid values > Start time for determining the reaction lag phase
Min. width of the lin. range Minimum width for the linear range
0 < valid values ≤ Measurement time - Start time for determining the linear range
Epsilon Stop criterion for the iteration. The iteration stops if the searched value differs less than
Epsilon from the previous value.
Max. iterations Maximum number of iterations
1 ≤ valid values ≤ 10,000 (integer)
Max. coefficient of variation in Maximum coefficient of variation (CV) of thrombin values in the linear range. If this value
the linear range is exceeded, the curve is flagged.
0 < valid values ≤ 100 %
Number of measurement Number of points used to smooth the first derivative

points for smoothing the
3 ≤ valid values ≤ 39 (odd)
1st derivative
Percentage of the max. speed Percentage of the maximum velocity of the thrombin generation which defines the
of thrombin generation reaction lag phase
1 ≤ valid values ≤ 99 %
5.4.11 VMaxDyn
The evaluation method VMaxDyn determines the maximum reaction velocity of a
measurement curve. VMaxDyn is based on the evaluation method VMax_sabs and
determines the absolute maximum in the first derivative of the curve. The difference
is that the window width for regression to estimate the first derivative is adjusted
dynamically. For a steeply increasing curve a smaller window width is used than for a flat
curve shape.

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Valid values ≥ Start time + 10 s
Number of measurement Number of points used to smooth the curve

measurement curve
Window width for regression Width of the time window used for approximation of the maximum slope by
linear regression
2 ≤ valid values ≤ Stop time - Start time - 1 s
Adjustment factor of the Dynamically defines the width of the time window by linear regression
regression window
Valid values ≥ 0
If the value 0 is used, the window width is constantly fixed to 2 s.
Exponent for adjustment of Dynamically defines the width of the time window by linear regression
the regression window
Valid values ≤ 0
If the value 0 is used, the window width is constantly defined by the value of Factor for
adjustment of the regression window.
5.4.12 VMax_sabs, VMax_sfirst, VMax_ssec, VMax_tabs,

VMax_tfirst, VMax_tsec
The algorithm VMax determines the maximum reaction velocity of a measurement
curve. It consists of 6 different evaluation methods regarding the type of maximum,
that is, first, second, or absolute maximum, and the type of raw value, that is, the
velocity = maximum in the first derivative of the curve, and the time point at which the
maximum reaction velocity occurs.
• The evaluation method VMax_sabs determines the maximum reaction velocity of

a measurement curve by using the absolute maximum in the first derivative of
the curve.
• The evaluation method VMax_sfirst determines the maximum reaction velocity of a

measurement curve by using the first maximum in the first derivative of the curve.
• The evaluation method VMax_ssec determines the maximum reaction velocity of a

measurement curve by using the second maximum in the first derivative of the curve.
• The evaluation method VMax_tabs determines the time point of the maximum
reaction velocity of a measurement curve by using the absolute maximum in the first
derivative of the curve.

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• The evaluation method VMax_tfirst determines the time point of the maximum
reaction velocity of a measurement curve by using the first maximum in the first
• The evaluation method VMax_tsec determines the time point of the maximum
reaction velocity of a measurement curve by using the second maximum in the first
Number of measurement Number of points used to smooth the curve

measurement curve
Window width for regression Width of the time window used for linear regression
1 ≤ valid values ≤ Stop time - Start time - 1 s
Drop in speed of reaction Difference in velocity used to differentiate the first and second maximum
after the first maximum
0 ≤ valid values ≤ 200 mA/s
(not for VMax_sabs and
VMax_tabs)
5.4.13 PlateAgg
The algorithm PlateAgg allows the evaluation of a percent aggregation kinetic curve of
the platelet aggregation assay. It covers nine different evaluation methods to determine
a specific raw value each (unit in square brackets):
• PlateAgg Maximal Aggregation [%Agg]: Maximum aggregation of the smoothed

percent aggregation curve
• PlateAgg Shape Change [%Agg]: Minimum aggregation of the smoothed percent

aggregation curve (only before its maximum)
• PlateAgg End Aggregation [%Agg]: Aggregation at the end of the smoothed percent
aggregation curve
• PlateAgg Disaggregation [%Agg]: Difference between PlateAgg Maximal

Aggregation and PlateAgg End Aggregation of the smoothed percent
aggregation curve
• PlateAgg Lag Time [s]: Time point at which the smoothed percent aggregation
curve reaches or exceeds the given Signal threshold the first time. Otherwise, the
first time point at which the curve reaches its maximum if this is smaller than the
Signal threshold.
• PlateAgg AUC [%Agg × min]: Area under the positive values of the smoothed percent
aggregation curve

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• PlateAgg Second Wave: Rating whether there is a significant decrease (second wave
type) or not in the time frame between the PlateAgg Lag Time and the first time point
at which the curve reaches its maximum (PlateAgg Second Wave = 1 or 0).
• PlateAgg Vmax Absolute [%Agg/min]: Absolute maximum of the reaction velocity

(slope) of the smoothed percent aggregation curve in the time frame between the
PlateAgg Lag Time and the first time point at which the curve reaches its maximum
• PlateAgg 2nd Vmax [%Agg/min]: Relative maximum reaction of the velocity (slope)
of the smoothed percent aggregation curve before the first significant decrease, if
there is one (PlateAgg Second Wave = 1). Otherwise (PlateAgg Second Wave = 0),
the same as PlateAgg Vmax Absolute
Smoothing value for curve Number of measurement points used to smooth the curve
Valid values ≥ 1
Smoothing value for Number of measurement points used to smooth the 1st derivation of the curve
derivation
Valid values ≥ 1
Signal threshold [%Agg] Threshold defining the PlateAgg Lag Time as the time point at which the smoothed
percent aggregation curve reaches or exceeds this value the first time
0 ≤ valid values ≤ 100 %Agg
Percent threshold [%] Percentaged threshold for the quantity of a decrease in the time frame between the
PlateAgg Lag Time and the first time point at which the curve reaches its maximum. If
a decrease is found it will be checked for significance (see parameter Cut-off).
Valid values > 0 %
Cut-off Cut-off which defines a decrease to be significant. If the cut-off value is exceeded, the
curve will be classified as second wave type.
Valid values > 0
5.5 Check methods

The following chapters describe the check methods and their parameters.
Make sure to match the time parameters of the check methods with the
measurement time.
Depending on the mixing level, the start time or lag phase must be prolonged to allow
the reaction mixture to settle, see ( Page 201 Start time or lag phase depending on
mixing levels).
For all check methods, the parameter Dynamic change of threshold must be set to
0 (= off).

Print No. DCHS-G01.621.01.08.02 223
5.5.1 Angle
The check method Angle determines if there is no sufficient increase or decrease in
signal in a measurement curve at the time of coagulation onset determined by the
evaluation method Fixed absorbance. If, at this time point, the standardized angle
against the horizontal is smaller than the defined value, the curve is flagged.
Threshold Absorbance threshold above the minimum which must be exceeded for coagulation
Angle window width Width of the time window for calculating the slope using a linear regression
Valid values > 0 s
Minimum angle Minimum value for the standardized angle which must be reached at least. A negative
value is used for falling curves.
Valid values ≤ ±90°
5.5.2 Angle DB
The check method Angle DB determines if there is no sufficient increase or decrease
in signal in a measurement curve at the time of coagulation onset determined by the
evaluation method Drifting baseline. If, at this time point, the standardized angle
against the horizontal is smaller than the defined value, the curve is flagged.
Valid values > Lag phase + both window widths s
Threshold Absorbance threshold above the dynamic baseline which must be exceeded
for coagulation
Window width for regression Width of the regression window
Valid values > 0 s
Window width for Width of the time window to search for exceeding the threshold
transgression search
Valid values > 0 s

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Maximum gradient of the Maximum for the slope of the baseline. If this value is exceeded, a horizontal baseline
baseline is used.
Minimum angle Minimum value for the standardized angle which must be reached at least. A negative
value is used for falling curves.
Valid values ≤ ±90°
Angle window width Width of the time window for calculating the slope using a linear regression
Valid values > 0 s
5.5.3 Drop
The check method Drop determines if an increasing measurement curve has a drop in
signal toward the end of the reaction. The last absorbance is therefore compared to the
maximum signal. If the relative deviation from the maximum is greater than the defined
value, the curve is flagged.
Max. permitted drop in Maximum for the relative deviation from the maximum absorbance which must not
absorbance be exceeded.
5.5.4 Drop 2
The check method Drop 2 determines if an increasing measurement curve has a
significant drop in signal after the minimum signal which is determined at the beginning
of the reaction. Each decrease is compared to the total difference between maximum
signal and minimum signal. If a decrease is greater than the pre-defined proportion of
the total difference in signal, the curve is flagged.
Stop time for minimum search End time point of searching for the minimum
Start time + 3 s ≤ valid values ≤ Stop time - 1 s
Window width for regression Width of the time window used for searching for the minimum by linear regression
2 ≤ valid values ≤ Stop time minimum search -Start time - 1 s
Minimum slope Slope used for searching for the minimum

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Valid values ≥ 0 mA/s
Max. permitted drop in Maximum for the relative proportion of the total difference in signal which must not
absorbance be exceeded
5.5.5 AMaxMin
The check method AMaxMin determines if the minimum signal of a measurement curve
is too high. If the minimum absorbance is greater than the defined value, the curve
is flagged.
Limit for minimum Upper limit of absorbance for the minimum signal which must not be exceeded
absorbance
Valid values > 0 mA
5.5.6 Min Delta A

The check method Min Delta A determines if there is no substantial increase in
absorbance (or decrease for the decreasing curve type) in a measurement curve. If the
difference between the maximal and minimal absorbance is smaller than the defined
value, the curve is flagged.
Minimum change in Minimum delta in absorbance which must be reached

absorbance
Valid values > 0 mA
5.5.7 New wave

The check method New wave determines if a measurement curve is waved, that is,
if the defined absorbance threshold is exceeded before the reaction actually starts.
The evaluation method Fixed absorbance is therefore applied with various equidistant
threshold values in a defined range. The differences of the corresponding time points are
compared. If the ratio of the smallest and the preceding largest difference exceeds the
defined value, the curve is flagged.
Base threshold Absorbance threshold above the minimum which must be exceeded for coagulation

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Threshold factor Upper limit of the absorbance range used for evaluation by multiplying the
base threshold
Valid values > 1
Number of steps Number of equidistant threshold values within the absorbance range
Valid values > 0
Limit value Upper limit for the ratio of the largest and the subsequent smallest difference value
which must not be exceeded
Valid values > 0
Minimum amplitude Minimum absorbance used for evaluation by adding the base threshold
Valid values: product with Base threshold > 0
5.5.8 New wave 2

The check method New wave 2 determines if a measurement curve is waved, that
is, if the defined absorbance threshold is exceeded before the reaction actually starts.
The evaluation method Fixed absorbance is therefore applied with various equidistant
threshold values in a defined range. The differences of the corresponding time points are
compared. If the ratio of the smallest and the absolutely largest difference exceeds the
defined value, the curve is flagged.
New wave 2 is an advanced and generalized version of New wave, see ( Page 226 New
wave). It detects waves even in measurement curves showing the steepest increase
at the beginning. Both check methods have the same parameters and can be used
in parallel.
5.5.9 Plateau
The check method Plateau determines if a measurement curve has not reached a
constant signal level at the end of the reaction. In a defined time interval, the absorbance
change is calculated by linear regression. If the absolute absorbance difference is greater
than the defined value, the curve is flagged.
Start time Time point at which a constant signal must be reached
Width of plateau Width of the time window in which a constant signal must be existent
Valid values > 0 s
Max. change in absorbance Maximum change in absorbance which must not be exceeded within the time window

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5.5.10 Antigen excess check

The check method Antigen excess check determines if a sample has too much antigen.
The check method is intended for immunochemical assays. The mean slopes in a time
interval at the beginning and at the end of a measurement curve are compared. If the
ratio of the slopes is greater than the defined value, the curve is flagged.
Start time of 1st time window Beginning of the first time window
Valid values < corresponding Stop time s
Stop time of 1st time window End of the first time window
Valid values > corresponding Start time s
Start time of 2nd time Beginning of the second time window

window
Valid values < corresponding Stop time s
Stop time of 2nd time window End of the second time window
Valid values > corresponding Start time s
Bend point in limiting line Cutoff value in mA/min used for the break-point of the borderline
Valid values: any
Gradient of limiting line Slope of the borderline
Valid values: any
Axis intersection of limiting Intercept of the borderline

line
Valid values: any
5.6 Calibration methods

The following chapters describe the calibration methods and their parameters.
5.6.1 Akima
The calibration method Akima uses sectionally defined cubic polynomials for
n ≥ 3 strictly monotonous supporting points. It is based on the interpolation method by
H. Akima.
All supporting points lie on the calibration curve: yes
Transformation model Applied to the concentration and raw values of the supporting points before fitting the
curve (concentration/raw value)
Abbreviations: lin = linear, log = logarithmic, rec = reciprocal
Minimum raw value Smallest possible raw value in an asymptotic calibration curve. Useful for transformation
models as lin/log

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Valid values: any
Typical value: 0
Lower extrapolation factor Lower extrapolation limit by multiplying the lowest concentration of the
supporting points
0 < valid values ≤ 1
Typical value: 1, which means no lower extrapolation
Upper extrapolation factor Upper extrapolation limit by multiplying the highest concentration of the
supporting points
Valid values ≥ 1
Typical value: 1, which means no upper extrapolation
5.6.2 Akima II
The calibration method Akima II uses sectionally defined cubic polynomials for
n ≥ 2 strictly monotonous supporting points. It is based on the interpolation method
by H. Akima and is an improved method providing always a strictly monotonous
calibration curve.
Raw value offset Defines the smallest or largest possible raw value in an asymptotic calibration curve.
Useful for transformation models as lin/log
Valid values: any
Typical value: 0
supporting points
supporting points
Valid values ≥ 1
Extrapolation slope factor Slope limit in the extrapolation range. Factor = 0 uses the slope of the regression
line through the supporting points according to the classic Akima method. Factor = 1
continues the given curvature which leads to a smoothed curve ending.
Typical value: 0

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5.6.3 Point-to-point
The calibration method Point-to-point uses sectionally defined straight lines for
n ≥ 2 strictly monotonous supporting points.
models as lin/log
Valid values: any
Typical value: 0
supporting points
supporting points
Valid values ≥ 1
5.6.4 Linear regression

The calibration method Linear regression calculates a linear regression line for
n ≥ 2 supporting points.
All supporting points lie on the calibration curve: no
models as lin/log
Valid values: any
Typical value: 0
supporting points
supporting points

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Valid values ≥ 1
5.6.5 Orthogonal regression

The calibration method Orthogonal regression calculates an orthogonal regression line
for n ≥ 2 supporting points.
models as lin/log
Valid values: any
Typical value: 0
supporting points
supporting points
Valid values ≥ 1
5.6.6 LogitLog5B
The calibration method LogitLog5B calculates a 5-parameter logit-regression for
n ≥ 4 strictly monotonous supporting points.
supporting points
supporting points
Valid values ≥ 1
Raw value transformation Transformation model of the raw values applied before fitting the curve
Valid values: lin = linear, log = logarithmic, rec = reciprocal

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Rec is only valid for descending calibration curves.
Raw value offset Constant value added to all raw values before transformation
Valid values: any, exception for raw value transformation lin: 0
Typical value: 0
Raw value aggregation mode The parameter Raw value aggregation mode is not relevant. The software uses the data
reduction method set in the dialog Assay procedure, area Number of measurements,
list Data reduction method.
Lower limit for curve Lower limit for the curve parameter C4
parameter C4
Valid values: 0.01 ≤ Lower limit for curve parameter C4 < Upper limit for curve
parameter C4
Typical value: 0.01
Upper limit for curve Upper limit for the curve parameter C4
parameter C4
Valid values: Lower limit for curve parameter C4 < Upper limit for curve
parameter C4 ≤ 2
Typical value: 2
Upper limit for mean absolute Upper limit for the mean absolute relative deviation between the fitted curve and the
relative deviation (MARD) supporting points (quality criterion 1). If this criterion is not met, the curve is flagged.
Valid values > 0 %
Typical value: 5 %
Zero adjust Adjustment of the fitted curve at the first supporting point with the lowest concentration
Valid values: -1 no adjust, 0 exact fit, > 0 appropriate adjust for the absolute relative
deviation in percent
For Raw value transformation rec only 0 is valid.
Typical value: -1
Number of supporting points Number of expected supporting points and therefore the number of regression weights
Weight of 1st (lowest) Regression weight for the first supporting point with the lowest concentration
concentration
Valid values ≥ 0
Typical value: 1
Weight of 2nd concentration Regression weight for the second supporting point
Valid values ≥ 0
Typical value: 1
Weight of 3rd concentration Regression weight for the third supporting point
Valid values ≥ 0
Typical value: 1

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Weight of 4th concentration Regression weight for the fourth supporting point
Valid values ≥ 0
Typical value: 1
Weight of 5th concentration Regression weight for the fifth supporting point
Valid values ≥ 0
Typical value: 1
Weight of 6th concentration Regression weight for the sixth supporting point
Valid values ≥ 0
Typical value: 1
Weight of 7th concentration Regression weight for the seventh supporting point
Valid values ≥ 0
Typical value: 1
Weight of 8th concentration Regression weight for the eighth supporting point
Valid values ≥ 0
Typical value: 1
Weight of 9th concentration Regression weight for the ninth supporting point
Valid values ≥ 0
Typical value: 1
Weight of 10th (highest) Regression weight for the tenth supporting point with the highest concentration
concentration
Valid values ≥ 0
Typical value: 1
Upper limit for absolute Upper limit for the absolute relative deviation at the first supporting point with the lowest
relative deviation at 1st concentration (quality criterion 2). If this criterion is not met, the curve is flagged.
(lowest) concentration
Valid values > 0 %
Typical value: 99 %
Upper limit for absolute Upper limit for the absolute relative deviation at the second supporting point (quality
relative deviation at 2nd criterion 2). If this criterion is not met, the curve is flagged.
concentration
Valid values > 0 %
Typical value: 99 %
Upper limit for absolute Upper limit for the absolute relative deviation at the third supporting point (quality
relative deviation at 3rd criterion 2). If this criterion is not met, the curve is flagged.
concentration
Valid values > 0 %
Typical value: 99 %

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Upper limit for absolute Upper limit for the absolute relative deviation at the fourth supporting point (quality
relative deviation at 4th criterion 2). If this criterion is not met, the curve is flagged.
concentration
Valid values > 0 %
Typical value: 99 %
Upper limit for absolute Upper limit for the absolute relative deviation at the fifth supporting point (quality
concentration
Valid values > 0 %
Typical value: 99 %
Upper limit for absolute Upper limit for the absolute relative deviation at the sixth supporting point (quality
concentration
Valid values > 0 %
Typical value: 99 %
Upper limit for absolute Upper limit for the absolute relative deviation at the seventh supporting point (quality
concentration
Valid values > 0 %
Typical value: 99 %
Upper limit for absolute Upper limit for the absolute relative deviation at the eighth supporting point (quality
concentration
Valid values > 0 %
Typical value: 99 %
Upper limit for absolute Upper limit for the absolute relative deviation at the ninth supporting point (quality
concentration
Valid values > 0 %
Typical value: 99 %
Upper limit for absolute Upper limit for the absolute relative deviation at the tenth supporting point with
relative deviation at 10th the highest concentration (quality criterion 2). If this criterion is not met, the curve
(highest) concentration is flagged.
Valid values > 0 %
Typical value: 99 %

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6 Configuring the system

This chapter describes how to configure the system.
To reset user-specific settings to manufacturer settings, contact Siemens
6.1 Setting the language

To set the language, proceed as follows:
1 In the dialog Setup, in the area Configuration, select Language.

→ The dialog Language is displayed.
2 Select the language.
3 Select the action button Save.
→ The changes are saved.
4 Switch the system to eco mode, see ( Page 336 Switching to eco mode or shutting
down the system).
5 Start the system from eco mode, see ( Page 262 Starting the system from
eco mode).
→ Setting the language is completed.
6.2 Managing user accounts

To manage user accounts, proceed as follows:
1 In the dialog Setup, in the area Tools, select User administration.

→ The dialog User administration is displayed. For more information on the dialog,
select the action button Help or see ( Page 152 User administration).
2 Check the available user accounts:
• To add a user account, go to ( Page 235 Adding a user account).
• To edit a user account, go to ( Page 236 Editing a user account).
• To delete a user account, go to ( Page 236 Deleting a user account).
6.2.1 Adding a user account

To add a user account, proceed as follows:
1 In the dialog User administration, select the action button New.

→ The dialog New user is displayed. For more information on the dialog, select the
action button Help or see ( Page 154 New user).
2 Make the settings as required.

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→ The changes are saved. A confirmation dialog is displayed.

4 Select OK
→ Adding a user account is completed.
6.2.2 Editing a user account

To edit a user account, proceed as follows:
1 In the dialog User administration, select the user account.

2 Select the action button Edit.
→ The dialog Edit user is displayed. For more information on the dialog, select the
action button Help or see ( Page 155 Edit user).

→ The changes are saved. A confirmation dialog is displayed.
5 Select OK
→ Editing a user account is completed.
6.2.3 Deleting a user account

To delete a user account, proceed as follows:
1 In the dialog User administration, select the user account.

2 Select the action button Delete.
→ A confirmation dialog is displayed.
3 Select Delete.
→ The user account is deleted. A confirmation dialog is displayed.
4 Select OK
→ Deleting a user account is completed.
6.3 Configuring printouts

To configure printouts, proceed as follows:
1 In the dialog Setup, in the area Configuration, select Printout.

→ The dialog Printout is displayed. For more information on the dialog, select the
action button Help or see ( Page 164 Printout).

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CAUTION
Personal data may be visible for service technician. If user enters personal data
in input fields not intended for personal data, no encryption is applied.
Loss of privacy protection can result.
◆ Do not enter personal data in the input fields, for example, patient or user
name, date of birth.
2 In the input fields Left header and Right header, enter texts for the
respective headers.
→ Configuring printouts is completed.
6.4 Setting acoustic signals on status alerts

To set acoustic signals on status alerts, proceed as follows:
1 In the dialog Setup, in the area Configuration, select Alerts.

→ The dialog Alerts is displayed. For more information on the dialog, select the
action button Help or see ( Page 162 Alerts).

→ Setting acoustic signals on status alerts is completed.
6.5 Selecting the active assays

To select the active assays, proceed as follows:
1 In the dialog Setup, in the area Configuration, select Assay activation.

→ The dialog Assay activation is displayed. For more information on the dialog,
select the action button Help or see ( Page 155 Assay activation).
2 Check the list Active assays:
• To activate assays, go to ( Page 237 Activating assays).
• To deactivate assays, go to ( Page 238 Deactivating assays).
• To change the order of the active assays, go to ( Page 238 Changing the order of
the active assays).
6.5.1 Activating assays

To activate assays, proceed as follows:

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1 In the dialog Assay activation, in the list Available assays, select 1 or more assays.
2 Select .
→ The selected assays are moved to the end of the list Active assays.
→ Activating assays is completed.
6.5.2 Deactivating assays

To deactivate assays, proceed as follows:
1 In the dialog Assay activation, in the list Active assays, select 1 or more assays.
2 Select .
→ The selected assays are moved to the list Available assays.

→ Deactivating assays is completed.
6.5.3 Changing the order of the active assays

To change the order of the active assays in the dialog Jobs, proceed as follows:
1 In the dialog Assay activation, in the list Active assays, select 1 or more assays.
2 Select or .
→ The selected assays are moved 1 line up or 1 line down.
→ Changing the order of the active assays is completed.
6.6 Assigning the default template to a sample rack

✓ The required sample rack is available.
✓ A clip of the same color as the default rack template is available.
To assign the default template to a sample rack that is new to the system, proceed
as follows:
1 Take an empty sample rack with the handle facing to the right.
2 Place the sample rack behind the rack stoppers on the input lane of the sample
manager, see ( Page 298 Placing a sample rack).

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3 Press the load button.
→ The sample rack is loaded. The sample rack barcode is read. The default rack
template is assigned to the sample rack. The sample rack is moved to the output lane.
4 Attach a clip of the same color as the default rack template to the sample rack.
5 To assign the default template to other sample racks, go to the first step.
→ Assigning the default template to a sample rack is completed.
6.7 Making settings in the dialogs Rack definition and Data

definition
CAUTION
Personal data may be visible for service technician. If user enters personal data in
input fields not intended for personal data, no encryption is applied.
◆ Do not enter personal data in the input fields, for example, patient or user name,
date of birth.
The following chapters describe how to make settings in the dialogs Rack definition
and Data definition for different items. For more information on these dialogs, see
( Page 187 Working with the dialogs Data definition and Rack definition).
6.7.1 Defining a sample rack

To define a sample rack, proceed as follows:
1 Troubleshoot unidentified samples, see ( Page 314 Troubleshooting unidentified

samples or samples causing other problems).
2 Select System > Pause.
→ The system finishes all open orders for which at least the first transfer step has been
processed. The system status Maintenance is displayed.
3 In the dialog Setup, in the area Tools, select Rack definition.
4 Select Yes.
→ The dialog Rack definition is displayed.
5 On the left, display the subgroups of Rack definition.
6 Display the subgroups of Sample tubes.
7 Check the available sample tubes:
• To define a new sample tube, go to ( Page 240 Add sample tube).
• To use an existing sample tube, go to ( Page 240 Define sample rack template).

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Add sample tube

1 Select .
→ On the right, the corresponding parameters are displayed. For more information
on the dialog, select the action button Help or see ( Page 190 Sample tubes).
WARNING
False results due to incorrect assignment of sample tube parameters
Death or serious injury to the patient can result.
◆ Make sure to assign the correct parameters to the sample tubes.
2 In the input field Name, enter the sample tube name.

3 In the list Type, select the sample tube type.
A list of vendor sample tubes with suitable parameters predefined by Siemens

Healthineers is displayed. If the required sample tube is not available, a generic sample
tube can be created from a set of cylindric vials with various inner diameters and cap
piercing capabilities.
4 Select the check box Offset (A) and enter the maximum immersion depth of the
aliquot probe.
5 Select the check box Sample low-warning (B) and enter the underfilling level.
6 Select the check box Sample high-warning (C) and enter the overfilling level.
7 Select the check box Level detection limit (D) and enter the upper limit for the
level detection.
8 In the input field Default aliquot volume, enter the default aliquot volume.
9 In the input field Reserve aliquot volume, enter the reserve aliquot volume.
Define sample rack template 1 Display the subgroups of Sample rack templates.
2 Check the available sample rack templates:
• To re-define an existing sample rack template, skip the next 2 steps.
• To use an existing sample rack template, go to ( Page 240 Define sample

rack template).
• To define an additional sample rack template, go to the next step.
3 Select .
on the dialog, select the action button Help or see ( Page 193 Sample
rack templates).
6 colors are available for the different sample rack templates. Make sure to use a
durable, easily recognizable, unique mark to distinguish between additional rack types
and templates with identical clip color.

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4 Skip the next step.
5 Select the template to be re-defined.
on the dialog, select the action button Help or see ( Page 193 Sample
rack templates).
6 In the input field Name, enter or edit the template name, if required.
WARNING
False results due to false selection of sample type or due to false selection of
sample tube
◆ Carefully follow the instructions given below.
7 In the list Sample type, select the sample type.
To measure controls on a sample rack, select the sample type Control.
8 To define a rack template for direct mode, select For direct mode.
9 To define a rack template for STAT samples, select For STAT samples.
10 To define a rack template for samples with manual orders, select For manual orders.
11 In the list Sample tube, select the sample tube.
Define sample rack 1 Display the subgroups of Sample racks.
→ The available sample racks are displayed.
WARNING
False results due to incorrect assignment of rack parameters

◆ Make sure to assign the correct rack barcodes and rack IDs to the respective
rack type and rack template.
2 Check the available sample racks:
• To define a new sample rack, go to the next step.
• To re-define an existing sample rack, skip the next 3 steps.
3 Select .
→ A new sample rack is added and selected. On the right, the corresponding
parameters are displayed. For more information on the dialog, select the action
button Help or see ( Page 192 Sample racks).

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4 In the input field Rack ID, enter the sample rack ID or scan the rack barcode using the
handheld barcode reader.
5 Skip the next step.
6 Select a sample rack.
on the dialog, select the action button Help or see ( Page 192 Sample racks).
Assign a template to a 1 In the list Template, select the sample rack template.
sample rack
WARNING
False results due to incorrect rack identification when using more than 6 sample
rack templates
◆ Make sure to use a durable, easily recognizable, unique mark to distinguish

between additional rack types and templates with identical clip color.
2 Attach a clip of the same color as the rack template to the sample rack.
3 Select the action button Publish.
→ The yellow marked changes are published. The dialog Rack definition is displayed
with hidden subgroups.
4 Select System > Resume.
→ The system status Operating in <mm:ss> is displayed, followed by Operating.
→ Defining a sample rack is completed.
6.7.2 Defining a calibrator and control rack

To define a calibrator and control rack, proceed as follows:
1 In the dialog Setup, in the area Tools, select Rack definition.

2 Select Yes.
→ The dialog Rack definition is displayed.
3 On the left, display the subgroups of Rack definition.

4 Display the subgroups of Calibrator and control rack.
5 Select .
→ A new calibrator and control rack is added and selected. On the right, the
corresponding parameters are displayed. For more information on the dialog, select
the action button Help or see ( Page 192 Calibrator and control racks).
6 In the input field Rack ID, enter the calibrator and control rack ID or scan the rack
barcode using the handheld barcode reader.

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→ The yellow marked changes are published. The dialog Rack definition is displayed
→ Defining a calibrator and control rack is completed.
6.7.3 Defining a reagent

To define a reagent, proceed as follows:
1 In the dialog Setup, in the area Tools, select Data definition.

2 Select Yes.
→ The dialog Data definition is displayed. For more information on the dialog, select
the action button Help or see ( Page 194 Data definition).
3 On the left, display the subgroups of Product definition.
→ The available product groups are displayed.

4 Display the subgroups of either Deficient plasma, Thromboplastin, or Reagent.
→ The available reagents are displayed.
5 Select a similar reagent.
→ On the right, the corresponding parameters are displayed.
6 Select next to the reagent.
→ A copy of the reagent is added and selected.

7 In the input field Name, enter the product long name for the reagent.
8 In the input field Short name, enter the product short name for the reagent.
9 In the input field Product code, enter the reagent product code.
10 Make the other settings as required.
→ The yellow marked changes are published. The dialog Data definition is displayed
→ Defining a reagent is completed.
6.7.4 Defining a calibrator

To define a calibrator, proceed as follows:

2 Select Yes.

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4 Display the subgroups of Calibrator.

→ The available calibrators are displayed.
5 Select a similar calibrator.
6 Select next to the calibrator.
→ A copy of the calibrator is added and selected.

7 In the input field Name, enter the product long name for the calibrator.
8 In the input field Short name, enter the product short name for the calibrator.
9 In the input field Product code, enter the calibrator product code.
→ Defining a calibrator is completed.
6.7.5 Defining a control

To define a control, proceed as follows:

2 Select Yes.

4 Display the subgroups of Control.
→ The available controls are displayed.
5 Select a similar control.
6 Select next to the control.
→ A copy of the control is added and selected.

7 In the input field Name, enter the product long name for the control.
8 In the input field Short name, enter the product short name for the control.
9 In the input field Product code, enter the control product code.

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→ Defining a control is completed.
6.7.6 Defining an assay group

To define an assay group, proceed as follows:

2 Select Yes.
WARNING
False results due to incorrect assay definitions. Changes for user-defined

methods can influence assay performance or results.
◆ Validate the assay definitions to check the correct configuration.
3 On the left, display the subgroups of Assay definition.

→ Assay groups is displayed.
4 Display the subgroups of Assay groups.
→ The available assay groups are displayed.
5 Check the available assay groups:
• To define a new assay group, go to ( Page 245 Add assay group).
• To assign the new assay to an existing assay group, go to ( Page 251 Add assay
to assay group).
Add assay group

1 Select next to Assay groups.
→ A new assay group is added and selected. On the right, the corresponding
button Help or see ( Page 196 Assay definition and Assay groups).
2 In the input field Name, enter the assay group name.

3 In the input field Comment, enter a comment for the assay group, if required.
4 Define an assay procedure, see ( Page 246 Defining an assay procedure).
5 Define an assay, see ( Page 250 Defining an assay).
→ Defining an assay group is completed.

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6.7.7 Defining an assay procedure

To define an assay procedure, proceed as follows:
1 Display the subgroups of Assay procedures.

→ A new assay procedure is displayed.
WARNING
False results due to incorrect assay procedures. Changes for user-defined

methods can influence assay performance or results.
◆ Validate the assay procedures to check the correct configuration.
2 Select the assay procedure.
on the dialog, select the action button Help or see ( Page 197 Assay procedures).
3 In the area Assay procedure, in the input field Name, enter the assay
procedure name.
4 In the input field Number, enter the assay procedure ID.
5 In the input field Comment, enter a comment if applicable.
6 In the area Dilution, in the list Diluent, select a dilution medium.
WARNING
False results due to liquid spilled to the cuvette gripper leaking into the
next cuvette
◆ Do not use the mixing levels 2, 4, and 6 (high-frequency) for liquid volumes
7 In the list Calibrator mixing, select a mixing level.
WARNING
False results due to incorrect mixing. Stirrer can be hurled out.

◆ For the measurement principle Optomechanic, depending on the viscosity
of the sample material and the mixing level, Siemens Healthineers
recommends not to use mixing for liquid volumes lower than 150 μL or
◆ The mixing levels 2, 3, 4, 5, and 6 must not be used with the measurement
principle Optomechanic.
◆ Validate the process steps to check the correct configuration and the
functioning on the system.
8 In the list Sample/controls mixing, select a mixing level.

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9 In the field Sample parameters, in the list Sample type, select the sample type.
11 Display the subgroups of the assay procedure.
→ Process steps and Evaluation methods for raw value are displayed.
12 Display the subgroups of Process steps.
→ A process step Transfer is displayed. For more information on the dialog, select the
action button Help or see ( Page 200 Process steps).
Add and sort process steps ◆ Check the available process steps:
• To add a transfer process step, go to ( Page 247 Add transfer process step).
• To add an incubation process step, go to ( Page 248 Add incubation process step).
• To add a measurement process step, go to ( Page 248 Add measurement

process step).
• To change the order of the process steps, go to ( Page 249 Sort process steps).
• To continue with the other assay settings, go to ( Page 250 Defining an assay).
Add transfer process step

1 Select Transfer.
→ A transfer process step is added as the last process step.
2 Select the process step Transfer.
on the dialog, select the action button Help or see ( Page 200 Transfer).
3 In the list Transfer arm, select a transfer arm.

4 In the list Washing before transfer, select a wash program.
5 In the list Washing after transfer, select a wash program.
WARNING
False results due to liquid spilled to the cuvette gripper leaking into the
next cuvette
◆ Do not use the mixing levels 2, 4, and 6 (high-frequency) for liquid volumes
6 In the list Mixing, select a mixing level.

7 Display the subgroups of Transfer.
→ The subgroup Media is displayed.
8 Display the subgroups of Media.
→ A medium is displayed.
9 Select the medium.

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on the dialog, select the action button Help or see ( Page 202 Media).
Make media settings 1 Make the settings as required.
2 Check the available media:
• To add another medium, go to the next step.
• If the transfer process step is complete, go to ( Page 247 Add and sort
process steps).
3 Select next to Media.
→ A medium is added to the transfer process step and selected.

4 Go to ( Page 248 Make media settings).
Add incubation process step

1 Select Incubation.
→ An incubation process step is added as the last process step.

2 Select the process step Incubation.
on the dialog, select the action button Help or see ( Page 203 Incubation).
3 In the list Incubator, select the incubator.

4 In the input field Incubation time, enter the incubation time.
5 Go to ( Page 247 Add and sort process steps).
Add measurement
process step 1 Select Measurement.
→ A measurement process step is added as the last process step.

2 Select the process step Measurement.
on the dialog, select the action button Help or see ( Page 204 Measurement).
3 In the list Measurement principle, select the measurement principle.

4 Decide how to proceed:
• For the measurement principle Absorbance, go to the next step.
• For the measurement principle Optomechanic, skip the next 2 steps.
• For the measurement principle LOCI, go to ( Page 249 Make LOCI settings).
5 In the input field Measurement time, enter the measurement time.

7 In the input field Measurement time, enter the measurement time.

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WARNING
False results due to interference with particles. Abrasion caused by stirrer bar
scratching against the cuvette wall for too long at high speed can produce
plastic particles.
◆ Make sure that the stirring speed and duration do not lead to a critical
abrasion of plastic particles influencing the results.
◆ Validate the assay procedure to check the correct configuration.
WARNING
False results due to incorrect stirring of optomechanical assays. Depending on

the stirring speed, the stirrer motor needs a minimum duration of stirring to
detect if a problem occurred.
◆ Make sure that the stirring speed and duration of stirring result in at least
11 rotations to validate the correct functioning of the stirrer motor.
8 In the area Stirring after for the first stirring, enter a starting point and a duration of
stirring, and a stirring speed. The stirring speed and duration of stirring must result
in at least 11 rotations, see the table below.
Stirring speed Formula to determine Duration of stirring

the minimum duration
for 11 rotations
30 rpm (11 × 60 s)/30 rpm = 22 s Equal to or greater than

22 s
100 rpm (11 × 60 s)/100 rpm = 6.6 s Equal to or greater than 7 s
1000 rpm (11 × 60 s)/1000 rpm = Equal to or greater than 1 s

0.66 s
At least 11 rotations are required to validate the correct functioning of the stirrer
motor. Stirring speeds and the durations of stirring are automatically validated.
9 If required, select the check box Stirring after for the second stirring and enter a
starting point and a duration of stirring, and a stirring speed.
10 If required, select the check box Stirring after for the third stirring and enter a
starting point and a duration of stirring, and a stirring speed.
Make LOCI settings 1 Make the settings as required.
Sort process steps 1 Select the process step to be moved.

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2 To move the selected process step 1 line up, select the action button Move up.
– or –
To move the selected process step 1 line down, select the action button Move down.
3 To continue sorting, go to ( Page 249 Sort process steps).
Define evaluation methods for 1 Display the subgroups of Evaluation methods for raw value.
raw value
→ A new evaluation method is displayed. For more information on the dialog, select
the action button Help or see ( Page 206 Evaluation methods for raw value).
2 In the input field Name, enter a name for the raw value evaluation.
4 Display the subgroups of the evaluation method.
→ Check methods is displayed.
5 Select next to Check methods.

→ A check method is added and selected. On the right, the corresponding
button Help or see ( Page 223 Check methods).
→ Defining an assay procedure is completed.
6.7.8 Defining an assay

To define an assay, proceed as follows:
1 Display the subgroups of Assays.

→ A new assay is displayed.
2 Select the assay.
on the dialog, select the action button Help or see ( Page 207 Assays).
Define assay 1 In the input field Name, enter an assay long name.
2 In the input field Short name, enter an assay short name.
3 In the input field Number, enter an assay number.
Define assay measurement 1 Select Assay measurement.
on the dialog, select the action button Help or see ( Page 209 Assay measurement).

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NOTICE
Delay of non-optomechanical results due to optomechanical measurements

ordered in direct mode
A throughput reduction can result.
◆ Only use normal mode with the measurement principle Optomechanic.

3 Only for optomechanical assays: Deactivate Measurement in direct mode possible.
4 Display the subgroups of Assay measurement.
→ Assay measurement assignment is displayed.
Define assay 1 Display the subgroups of Assay measurement assignment.

measurement assignments
→ A new assay measurement assignment is displayed.
2 Select the assay measurement assignment.
on the dialog, select the action button Help or see ( Page 211 Assay
measurement assignment).
3 In the list Assay procedure, select the assay procedure.

4 In the list Evaluation method for raw value, select an evaluation method for the
raw value.
Define assay calibration 1 Select Assay calibration.
on the dialog, select the action button Help or see ( Page 211 Assay calibration).
2 In the area Calibration, in the list Type, select a calibration type.

→ Depending on the selected calibration type, different parameters are displayed.
3 For the calibration type None: In the area Calculation method, in the list Method,
select a calibration type. For more information on the dialog, select the action button
Help or see ( Page 213 Calculation methods for assays that are not calibrated).
– or –
For the calibration type From a different assay: In the area Validity, in the list Assay,
select the assay the calibration curve of which should be used.
– or –
For the calibration type Master or Measured curve: Make the settings as
required. For more information on the dialog, select the action button Help or
see ( Page 228 Calibration methods).
Add assay to assay group 1 Select the assay group to add the assay to.
2 Display the subgroups of the assay group.

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→ Assay procedures, Assays, and Meta-assays are displayed.

3 Display the subgroups of Assays.
→ The available assays are displayed.
4 Select a similar assay.
5 Select next to the assay.
→ A copy of the assay is added and selected.

6 Select the assay.
on the dialog, select the action button Help or see ( Page 207 Assays).
7 Make the settings as required, see ( Page 250 Define assay).
→ Defining an assay is completed.
6.8 Defining a default assay

To define a default assay, proceed as follows:
1 In the dialog Setup, in the area Configuration, select Assay customization.

→ The dialog Assay customization is displayed. For more information on the dialog,
select the action button Help or see ( Page 156 Assay customization).
2 In the list Assay, select a default assay.

3 In the area Default profile, activate Add to default profile.
→ Defining a default assay is completed.
6.9 Assigning controls

To assign controls, proceed as follows:
◆ In the dialog Setup, in the area Configuration, select Control assignment.

→ The dialog Control assignment is displayed. For more information on the dialog,
select the action button Help or see ( Page 159 Control assignment).
6.9.1 Select assay group

1 In the list Assay groups, select an assay group.

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→ In the list Controls, the product names of the controls that are currently assigned
to the assay group are displayed.
2 Select the action button New.
→ The dialog Control is displayed. For more information on the dialog, select the
action button Help or see ( Page 161 Control).
3 In the list Product name, select the required control.

To configure automatic control measurements, automatic scheduling and, if required,

For each new reagent bottle must be activated, see ( Page 253 Configuring
automatic control measurements).
5 Select Save.
→ The changes are saved. In the dialog Control assignment, the control is displayed
in the list Controls. The short names of the assays that are assigned to the assay
group are displayed in the list Assay parameters.
6.9.2 Edit assay parameters

◆ In the list Assay parameters, check the levels, dilutions, and deviations for the
different assays:
• To edit the level, dilution, and deviations for an assay, go to

( Page 253 Select assay).
• Otherwise, go to ( Page 253 Edit other assay group).
Select assay 1 Select the assay.
2 Select Edit assay parameters.

→ The dialog Assay is displayed. For more information on the dialog, select the
action button Help or see ( Page 161 Assay).
4 Select Save.

5 To edit the assay parameters for other assays, go to ( Page 253 Select assay).
Edit other assay group ◆ To add controls to other assay groups, go to ( Page 252 Select assay group).
→ Assigning controls is completed.
6.10 Configuring automatic control measurements

To configure automatic control measurements, proceed as follows:
1 Assign the required controls, see ( Page 252 Assigning controls).

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2 In the dialog Control assignment, in the list Controls, check if Automatic

scheduling and, if required, New bottle are activated for the required controls.
6.10.1 Configure sample result framing

1 In the dialog Setup, in the area Configuration, select Sample result processing.
→ The dialog Sample result processing is displayed. For more information on the
dialog, select the action button Help or see ( Page 158 Sample result processing).
2 In the list Assay, select the required assay.

3 To automatically measure a control before measuring the first sample, select
Automatic release in the area Sample result release and If framed by valid
control results in the area Control dependent.
Controls will be measured automatically only if there are requests for the
corresponding assay.
Manually requested control measurements are independent from automatic control

measurements. That means, if a manually requested control measurement is
performed shortly before the scheduled event of an automatic control measurement,
the automatic control measurement is not superseded by the manually requested
control measurement and will be performed anyway.
4 To automatically frame the sample results, select Automatic framing in the area
Sample result framing.
5 To automatically frame the sample results only with control results from the
same reagent bottles, if available, select With control results from the same
reagent bottles.
→ The sample results are automatically framed with the control result from the
previous control measurement. A succeeding framing is only used if a control
measurement from the same reagent bottle is available.
The selection is only effective if in the dialog Data definition, subgroup Product
definition, the parameter Measure control for each new reagent bottle is activated.
6 To apply the selections to all assays in the list Assay, select Apply for all
active assays.
7 Configure the sample result release, see ( Page 254 Configuring the sample
result release).
→ Configuring automatic control measurements is completed.
6.11 Configuring the sample result release

To configure the sample result release, proceed as follows:
1 In the dialog Setup, in the area Configuration, select Sample result processing.
→ The dialog Sample result processing is displayed. For more information on the
dialog, select the action button Help or see ( Page 158 Sample result processing).

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WARNING
Unintended release of results
◆ Make sure to configure the automatic sample result release correctly.
2 In the area Sample result release, select Automatic release.

→ For the 2 different release types below, several options become active for each.
3 In the area Result dependent, select the required release depending on sample
result flags:
• Release valid results: all results that are not flagged Result invalid or
Result doubtful
• Release valid and doubtful results: all results that are not flagged Result invalid,
but may be flagged Result doubtful
• Release all results: all results independent of flags Result invalid and
Result doubtful
4 In the area Control dependent, select the required release depending on the
availability of control results.
5 To apply the selections to all assays in the list Assay, select Apply for all
active assays.
6 Select Save.
→ Configuring the sample result release is completed.
6.12 Configuring automatic calibrations

To configure automatic calibrations, proceed as follows:
1 In the dialog Setup, in the area Configuration, select Assay customization.

→ The dialog Assay customization is displayed. For more information on the dialog,
select the action button Help or see ( Page 156 Assay customization).
2 In the list Assay, select the required assay.

3 To request a new calibration when a calibration curve has expired, select
Re-calibrate automatically when calibration curve expires in the area
Calibration processing.
4 To run a calibration for each new reagent lot, go to the next step.
– or –
Otherwise, skip the next step.
5 In the area Calibration processing, select Automatically calibrate new

reagent lots.

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The selection is only effective if in the dialog Data definition, subgroups Assay
definition > Assay groups > Assay procedures > Process steps > Media, the
parameter Lot-dependent is activated for the reagent.

→ Configuring automatic calibrations is completed.
6.13 Deactivating and activating the HIL check

To deactivate or activate the HIL check on the system, proceed as follows:
1 In the dialog Setup, in the area Configuration, select System.
→ The dialog Setup > System is displayed. For more information on the dialog, select
the action button Help or see ( Page 165 System (for general settings)).
2 To deactivate the HIL check for all samples on the system, go to

( Page 256 Deactivating the HIL check).
– or –
To activate the HIL check on the system, go to ( Page 257 Activating the HIL check).
The changes are only effective after a restart of the system.
6.13.1 Deactivating the HIL check

To deactivate the HIL check, proceed as follows:
WARNING
False results due to hemolytic, icteric, or lipemic sample material
◆ If the pre-analytical HIL check is deactivated on the system, the sample

integrity has to be checked by visual inspection, for example, turbidity, and
color, as described in CLSI documents available at www.clsi.org.
1 In the dialog Setup > System, in the area HIL check. Restart from eco mode
required., de-select Activate.
down the system).
eco mode).

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→ Deactivating the HIL check is completed.
6.13.2 Activating the HIL check

To activate the HIL check, proceed as follows:
1 In the dialog Setup > System, in the area HIL check. Restart from eco mode
required., select Activate.
WARNING
False results for hemolytic, icteric, or lipemic sample material due to ineffective
HIL check
◆ To re-start the system, carefully follow the instructions given below. To

re-start the system, carefully follow the instructions given below.
down the system).
eco mode).
→ Activating the HIL check is completed.
6.14 Configuring automatic display cleanup

To configure automatic display cleanup, proceed as follows:
1 In the dialog Data, select Display cleanup.

→ The dialog Display cleanup is displayed. For more information on the dialog,
select the action button Help or see ( Page 181 Display cleanup).
→ The action button Save becomes active.

→ Configuring automatic display cleanup is completed.
6.15 Making sample ID settings for barcodes and for the LIS
To make sample ID settings for barcodes and for the LIS, proceed as follows:
1 In the dialog Setup, in the area Configuration, select Barcodes.

→ The dialog Barcodes is displayed. For more information on the dialog, select the
action button Help or see ( Page 162 Barcodes).

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WARNING
False results due to incorrect barcode configuration
2 On the right, in the list Sample ID length, select the number of positions for the
sample ID.
→ In the figure, the positions are displayed in blue.
WARNING
False results or critical delay of results due to missing sample type information

◆ Include the sample type in the barcode if both, platelet-poor plasma and
platelet-rich plasma, are used on the system.
3 In the list Include sample type, select in which items the sample type is encoded.
→ On the left, in the figure, depending on the selected sample type encoding,
different sliders are displayed.
4 If the sample type encoding Barcode or Barcode and LIS sample ID is selected, go
to next step.
– or –
If the sample type encoding None is selected, go to ( Page 258 Using

additional characters).
5 In the list Sample type length, select the number of positions for the encoded
sample type.
→ In the figure, in the line Barcode, the positions are displayed in green, overlapping
and barred positions are displayed in red.
6 In the area Sample type keys, in the input fields PPP and PRP, enter the sample
type keys.
6.15.1 Using additional characters

1 To use start and stop characters for the barcode type Codabar, de-select Display start
and stop characters (only for Codabar).
→ The start and stop characters are not displayed or transmitted to the LIS.
2 Check the available barcode types:
• To check the correct reading of barcodes with check characters, go to

( Page 259 Use check characters).
• For barcodes without check characters, go to ( Page 259 De-select

check characters).

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Use check characters 1 Select Use check characters.

→ The check box Display check characters becomes active.
Siemens Healthineers recommends using barcodes with check characters. Using the
check characters significantly increases the reading reliability, especially of damaged
or dirty barcode labels. Otherwise, incorrect reading cannot be ruled out.
2 De-select Display check characters.
→ The check characters are not displayed or transmitted to the LIS.
3 Go to ( Page 259 Setting sliders).
De-select check characters 1 De-select Use check characters.

2 Go to ( Page 259 Setting sliders).
6.15.2 Setting sliders

1 On the left, in the figure, check the available sliders:
• For the sample type encoding Barcode and LIS sample ID, go to the next step.
• For the sample type encoding Barcode, skip the next step.
• For the sample type encoding None, skip the next 2 steps.
2 Above the line LIS sample ID, adjust the slider Start sample type.
3 Below the line Barcode, adjust the slider Start sample type.
4 Above the line LIS sample ID, adjust the sliders Start sample ID and Last relevant
without overlapping or barring.
→ If no position of the figure is displayed in red or marked with a red cross, the current
adjustment is permissible.
5 Below the line Barcode, adjust the slider Start sample ID without overlapping
or barring.
→ If no position of the figure is displayed in red or marked with a red cross, the current
adjustment is permissible.
down the system).
eco mode).
→ Making sample ID settings for barcodes and for the LIS is completed.

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6.16 Configuring shared folders

To configure folders for importing or exporting files from or to accordingly authorized,
existing folders in the laboratory network, proceed as follows:
1 In the dialog Setup, in the area Configuration, select Shared folders.

→ The dialog Shared folders is displayed. For more information on the dialog, select
the action button Help or see ( Page 170 Shared folders).
2 In the input fields Import folder and Export folder, enter the paths to the
corresponding folders.
→ The network folders are linked to the system and are accessible via Setup > Tools
> Data manager > Export > Target > Shared folder or Setup > Tools > Data
manager > Restore > Select file > Shared folder.
→ Configuring shared folders is completed.
6.17 Configuring the LIS connection

To configure the LIS connection, see the data interface manual.
WARNING
False results due to incorrect LIS connection

◆ Follow the instructions in the data interface manual of the system to configure
the LIS connection correctly.
◆ LIS configuration needs to be validated by the laboratory organization.

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7 Preparing for the analysis

This chapter describes how to prepare the system for the analysis.
7.1 Starting the system from cold

To start the system from cold, proceed as follows:
1 At the analyzer, on the right, set the main power switch to position I.
→ The analyzer and the software start. On the screen, the user dialog is displayed.
For more information on the dialog, see ( Page 182 User).
2 Log on, see ( Page 263 Logging on).
→ The dialog Initialization or the dialog Initializing is displayed.
The dialog Initialization is only displayed if a smart initialization is possible, see

( Page 182 Initialization). Otherwise, a full initialization is performed automatically.
3 Check the displayed dialog.
4 If the dialog Initialization is displayed, go to the next step.

– or –
If the dialog Initializing is displayed, skip the next 2 steps.
5 Select Smart initialization or Full initialization, as required, see

( Page 182 Initialization).
6 Select Start initialization.

7 Wait until the initialization is finished.
→ The dialog Initializing is displayed showing the status of the initialization.
The system status Initializing is displayed. This can take up to 30 minutes.
The illumination LED of the reagent manager turns on. The status Operating is
displayed in the status area. For Full initialization, the dialog Reagent storage is
displayed. For more information on the dialog, select the action button Help or see
( Page 184 Reagent storage).
WARNING
False results due to unknown or incorrect temperature conditions of products

after system problem or quick shutdown
◆ To check if the reagents are still usable, measure controls before performing
further measurements.
8 If the dialog Reagent storage is displayed, decide how to proceed:
• To keep the products in the reagent storage, select Keep products.
• To unload the products in the reagent storage, select Unload products.

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9 If the products in the reagent storage are kept, measure controls, see
( Page 287 Measuring a control).
→ Starting the system from cold is completed.
7.2 Starting the system from eco mode

To start the system from eco mode, proceed as follows:
The system can start automatically at a defined time of the day. The user can
configure the time control in the dialog Setup > System, see ( Page 165 System (for
general settings)).
1 Open the right drawer.
WARNING
Infection by infectious cuvette waste
Death or serious injury to the user can result.
◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask, according to local standards
and regulations.
◆ Handle the cuvette waste in accordance with good laboratory practice.
2 Next to the right drawer, at the top left, press the wake-up button.
→ On the screen, the message Starting from eco mode is displayed. The dialog
Initializing is displayed showing the status of the initialization. The system status
Initializing is displayed. The status alert Initializing (2) is displayed.
3 Wait until the initialization is finished.
→ The status alert Initializing (2) is cleared. The system status Operating in
<mm:ss> is displayed in the status area, followed by Operating. The illumination LED
of the reagent manager switches from slowly blinking to on.
4 Log on, see ( Page 263 Logging on).
5 If the dialog Temperature problem is displayed, check the displayed

temperature problem:
• To unload the on-board reagents, select Unload products.
• To keep the on-board reagents, select Keep products.

6 If the dialog Cuvette waste counter is displayed, check the status of the cuvette
waste container.

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WARNING
Infection by infectious cuvette waste due to overflow of cuvette

waste container
◆ Make sure to have emptied the cuvette waste container when resetting the
cuvette waste counter.
and regulations.
7 To reset the cuvette waste counter when the cuvette waste container has been
emptied, select Reset.
– or –
To keep the cuvette waste counter when the cuvette waste container has not been
emptied, select Do not reset.
WARNING

8 If the dialog Temperature problem has been displayed and the products in the
reagent storage have been kept, measure controls, see ( Page 287 Measuring
a control).
→ Starting the system from eco mode is completed.
7.3 Logging on
To log on, proceed as follows:
1 In the user dialog, in the input field User name, enter the user name.
2 In the input field Password, enter the password.
3 Select Log on.
→ The user name is displayed in the status area.
→ Logging on is completed.
7.4 Loading cuvettes

✓ A new cuvette bag is available.

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To load cuvettes, proceed as follows:
WARNING
False results due to re-use of cuvettes or due to use of cuvettes not approved by
Siemens Healthineers
◆ Only use approved Siemens Healthineers cuvettes.

◆ Use cuvettes only once.
◆ Do not use washed or recycled cuvettes.
◆ Wear gloves when handling cuvettes.
1 If displayed, select one of the following status alerts:
• Cuvettes almost used up (48)
• Cuvettes used up (49)
• Registered cuvettes almost used up (66)
• Registered cuvettes used up (65)
→ The dialog Analyzer is displayed.

2 In the dialog Analyzer, on the right, select Register cuvettes.
→ The dialog Register cuvettes is displayed.
3 Scan the barcode of the cuvette bag using the handheld barcode reader.
→ In the dialog Register cuvettes, the lot and serial numbers are displayed.
4 Select Register.
→ In the dialog Analyzer, in the area Cuvettes, the count Registered cuvettes is
updated. The status alert Registered cuvettes almost used up (66) or Registered
cuvettes used up (65) is cleared.
5 Open the cuvette bag.
6 Open the cover of the cuvette loader.
7 Fill the cuvettes into the cuvette loader.
→ The status alert Cuvettes almost used up (48) or Cuvettes used up (49) is
cleared. In the dialog Analyzer, the cuvette loader is displayed in blue.
Always fill the cuvette loader to the brim.
8 Close the cover of the cuvette loader.
9 Select Finish.
→ Loading cuvettes is completed.

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7.5 Loading stirrer bars

✓ A new stirrer bar bottle is available.
To load stirrer bars, proceed as follows:
NOTICE
No processing of assays using stirrer bars if stirrer bar loader is overfilled

◆ Re-fill stirrer bars only when the status alert Stirrer bars almost used up (50)
or Stirrer bars used up (51) is displayed.
◆ Make sure that all stirrer bars are filled into the funnel of the stirrer bar loader.
◆ Fill the contents of only 1 stirrer bar bottle at once into the stirrer bar loader,
and pay attention to the current fill level.
1 Select the status alert Stirrer bars almost used up (50) or Stirrer bars used up (51).
2 Select Re-fill stirrer bars.

→ The dialog Re-fill stirrer bars is displayed.
3 Scan the barcode of the stirrer bar bottle using the handheld barcode reader.
→ In the dialog Re-fill stirrer bars, the lot number is displayed. The button Finish
becomes active.
4 Select Finish.
WARNING
False results due to use of stirrers not approved by Siemens Healthineers
◆ Only use approved Siemens Healthineers stirrers.
5 Open the stirrer bar bottle.
6 Open the cover of the stirrer bar loader.
WARNING
False results if stirrer bars are filled into the cuvette loader
Death or serious injury to the patient can result. Damage to the system
can result.
◆ Fill stirrer bars only into the stirrer bar loader.
7 Fill the stirrer bars into the stirrer bar loader.
8 Close the cover of the stirrer bar loader.
→ After about a minute, the stirrer bar loader starts aligning the stirrer bars. The
status alert Stirrer bars almost used up (50) or Stirrer bars used up (51) is cleared.
In the dialog Analyzer, the stirrer bar loader is displayed in blue.

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→ Loading stirrer bars is completed.
7.6 Re-filling purified water

To re-fill purified water, proceed as follows:
1 If displayed, select the status alert Purified water almost used up (40) or Purified
water used up (41).
2 Open the bottom middle drawer.
NOTICE
System failure can occur if liquid is spilled into the system.

◆ Do not re-fill the container while inserted in the drawer.
3 At the connector of the front water container, press the push button.
→ The front water container is disconnected from the connector.
4 Before removing the front water container, carefully push aside the connector,
if required.
5 Take the front water container out of the holder.
→ The status alert Purified water container missing (Water front) (42) is displayed.
In the dialog Analyzer, the symbol for the front water container is crossed out.
6 Go to ( Page 266 Re-filling the container).
7.6.1 Re-filling the container

1 Unscrew the screw cap of the front water container.
2 Empty the front water container.

Print No. DCHS-G01.621.01.08.02 266
WARNING
False results due to disallowed or unpurified system liquids
◆ Only use water with a low microbial (≤ 100 CFU/mL is permitted) and particle
content, as described, for example, in the United States Pharmacopeia (USP),
monograph: Purified Water.
◆ Make sure not to mix-up system liquids.
◆ Observe the labels on the containers about their contents.
◆ Observe the connectors and their different shapes and positions at the
container, and match them with their counterpart at the frame.
NOTICE
System failure due to corrosion caused by disallowed water
◆ Only use purified water.
3 Re-fill the front water container with purified water.

4 Screw the screw cap on the front water container.
5 Place the front water container into the holder slightly pressing the right side.
→ The status LED turns off. The status alert Purified water container missing (Water
front) (42) is cleared.
6 Press the connector on the front water container until it locks audibly.
→ The status alert Purified water almost used up (40) or Purified water used up
(41) is cleared. If the fill level of the stationary water container is below the threshold,
purified water is pumped from the front water container to the stationary water
container. In the dialog Analyzer, the fill levels of the front water container and the
stationary water container are displayed.
7 Close the bottom middle drawer.
→ Re-filling purified water is completed.
7.7 Re-filling or replacing purging solution

✓ Purging agent is available.
✓ Maintenance task Purge tubings is not executed.
Purified water can be used as purging agent. For specifications for allowed purified
water, see ( Page 22 Safe handling of samples, reagents, controls, calibrators,
and consumables).
To re-fill or replace purging solution, proceed as follows:
1 If displayed, select the status alert Purging solution used up (44).

Print No. DCHS-G01.621.01.08.02 267
WARNING
False results due to disallowed system liquids
◆ For more information on the purging agent, see the instruction manual of
the purging agent.
2 Only for purging agents other than purified water: Prepare the purging solution
according to the instruction manual of the purging agent.
NOTICE

◆ Do not re-fill the container while inserted in the drawer.
4 At the connector of the purging solution container, press the push button.
→ The purging solution container is disconnected from the connector.

5 Before removing the purging solution container, carefully push aside the connector,
if required.
6 Take the purging solution container out of the holder.
→ The status alert Purging solution container missing (45) is displayed. In the
dialog Analyzer, the symbol for the purging solution container is crossed out.
7.7.1 Opening the purging solution container

1 Unscrew the screw cap of the purging solution container.
2 To re-fill the purging solution, go to ( Page 269 Re-filling the purging solution).
– or –
To replace the purging solution, go to ( Page 268 Replacing the purging solution).
7.7.2 Replacing the purging solution

1 Empty the purging solution container and discard the purging solution according to
national and local standards and regulations.
2 Only for purging agents other than purified water: Rinse the purging solution
container with some water.

Print No. DCHS-G01.621.01.08.02 268
3 Only for purging agents other than purified water: Empty the purging solution
container and discard the liquid according to national and local standards
and regulations.
4 Record the maintenance task, go to ( Page 341 Record periodic maintenance task).
5 Go to ( Page 269 Re-filling the purging solution).
7.7.3 Re-filling the purging solution

1 Re-fill the purging solution container with purging solution.
2 Screw the screw cap on the purging solution container.

3 Place the purging solution container into the holder slightly pressing the right side.
→ The status LED turns off. The status alert Purging solution container missing (45)
is cleared.
4 Press the connector on the purging solution container until it locks audibly.
→ The status alert Purging solution used up (44) is cleared. In the dialog Analyzer,
the fill level of the purging solution container is displayed.
→ Re-filling or replacing purging solution is completed.
7.8 Replacing the probe cleaner container

✓ A new probe cleaner container is available.
To replace the probe cleaner container, proceed as follows:
NOTICE
No processing of assays if probe cleaner reservoir is empty
On-site servicing can be required.

◆ Immediately replace the probe cleaner container when the status alert
Probe cleaner reservoir empty. Replace probe cleaner container
immediately (47) is displayed.
◆ Do not start the initialization of any wash station or of the complete system
when the status alert Initialization required: component <component
name> (14) and the status alert Probe cleaner reservoir empty. Replace
probe cleaner container immediately (47) are displayed at the same time.
1 If displayed, select the status alert Probe cleaner container empty. Replace probe
cleaner container (46), Probe cleaner reservoir empty. Replace probe cleaner
container immediately (47), or Probe cleaner almost expired (67).
Do not shut down the system when the status alert Probe cleaner container empty.
Replace probe cleaner container (46) or Probe cleaner reservoir empty. Replace
probe cleaner container immediately (47) is displayed.

Print No. DCHS-G01.621.01.08.02 269
2 In the dialog Analyzer, at the bottom left, select Replace probe cleaner.
→ The dialog Replace probe cleaner is displayed.
3 Remove the probe cleaner container, see ( Page 270 Removing the probe
cleaner container).
4 Insert the probe cleaner container, see ( Page 270 Inserting the probe
cleaner container).
→ Replacing the probe cleaner container is completed.
7.8.1 Removing the probe cleaner container

To remove the probe cleaner container, proceed as follows:
1 Open the left drawer.
CAUTION
Irritation of the skin and mucous membranes by cleaning agents
Minor or moderate injury to the user can result.

and regulations.
◆ Pay attention to the manufacturer’s information regarding the gloves’
compatibility with the materials and liquids used.
◆ When taking the probe cleaner container out of the holder, be careful of
◆ Do not shake probe cleaner container.
2 Carefully tighten the screw cap of the probe cleaner container.
3 Take the probe cleaner container out of the holder.
→ The status alert Probe cleaner container missing (59) is displayed. The dialog
Replace probe cleaner is updated.
4 Discard the probe cleaner container according to national and local standards
and regulations.
7.8.2 Inserting the probe cleaner container

To insert the probe cleaner container, proceed as follows:

Print No. DCHS-G01.621.01.08.02 270
WARNING
False results due to disallowed cleaning agents
◆ Do not use expired probe cleaner.

◆ Observe the instructions for use of the probe cleaner.
1 Scan the barcode of the new probe cleaner container using the handheld
barcode reader.
→ In the dialog Replace probe cleaner, the lot number and the expiration date are
displayed. The button Finish becomes active.
2 Holding the small opening downwards, place the probe cleaner container into
the holder.
→ The status alert Probe cleaner container missing (59) is cleared.
3 Take the opening tool for the probe cleaner container out of the left drawer.
4 Carefully unscrew the screw cap of the probe cleaner container by 1 full turn using
the opening tool.
→ The probe cleaner reservoir is filled.
5 Put the opening tool back in the provided space in the left drawer.
6 In the dialog Replace probe cleaner, select Finish.
→ The status alert Probe cleaner container empty. Replace probe cleaner
container (46), Probe cleaner reservoir empty. Replace probe cleaner container
immediately (47), or Probe cleaner almost expired (67) is cleared.
The lot number and the expiration date of the probe cleaner container are not
immediately updated in the dialog Analyzer. The displayed lot information reflects
that probe cleaner from the previous lot is still available in the probe cleaner reservoir.
7 Close the left drawer.
7.9 Emptying the cuvette waste container

✓ A new cuvette waste bag is available.
To empty the cuvette waste container, proceed as follows:
1 If displayed, select the status alert Cuvette waste container almost full (55) or
Cuvette waste container full (56).
The red status alert Cuvette waste container full (56) is displayed as soon as
approximately 250 more cuvettes are disposed of in the cuvette waste compared to
the yellow status alert Cuvette waste container almost full (55). If Cuvette waste
container full (56) is displayed, the system is no longer operating until the cuvette
waste is emptied.

Print No. DCHS-G01.621.01.08.02 271
2 At the bottom right, select Empty cuvette waste.

→ The dialog Empty cuvette waste is displayed.
3 Select Next.
processed. The system status Paused is displayed. The right drawer is unlocked.
→ The status alert Cuvette waste container missing or drawer open (57)
is displayed.
5 Go to ( Page 272 Removing the cuvette waste bag).
7.9.1 Removing the cuvette waste bag
WARNING

and regulations.
◆ Always use a single-use waste bag with the cuvette waste container.
1 Raise the frame of the cuvette waste container.
2 Fold up the upper portion of the cuvette waste bag.
3 Tighten the tunnel cord of the cuvette waste bag by pulling the tunnel cord ends on
both sides of the cuvette waste bag, see ( Page 60 Cuvette waste bag).
4 Remove the cuvette waste bag from the cuvette waste container.
5 Discard the cuvette waste bag in the biohazard waste container.
6 Insert a new cuvette waste bag into the cuvette waste container. Position the tunnel
cord ends opposite each other on the long sides of the container.
7 Fold the upper portion of the cuvette waste bag around the rim of the cuvette
waste container.
8 Close the frame of the cuvette waste container.
9 Close the right drawer.
→ The status alert Cuvette waste container missing or drawer open (57) is cleared.
10 In the dialog Empty cuvette waste, select Confirm.
→ The system is set into the status Operating. In the dialog Analyzer, the cuvette
waste container is displayed as empty. The status alert Cuvette waste container
almost full (55) or Cuvette waste container full (56) is cleared.
→ Emptying the cuvette waste container is completed.

Print No. DCHS-G01.621.01.08.02 272
7.10 Emptying the liquid waste container

✓ The tap is available.
To empty the liquid waste container, proceed as follows:
WARNING
Infection due to infectious liquid waste

clothing, safety glasses, and mask.
1 If displayed, select the status alert Liquid waste container almost full (52) or Liquid
waste container full (53).
→ The dialog Analyzer is displayed. The fill levels of the front liquid waste container
and the rear liquid waste container are displayed.
3 Inside the left drawer, check the status LEDs.
→ The status LEDs of all liquid waste containers that need to be emptied are on.
7.10.1 Emptying a container

1 At the connector to the liquid waste container, press the push button.
→ The liquid waste container is disconnected from the connector.
2 Before removing the liquid waste container, carefully push aside the connector,
if required.
3 Take the liquid waste container out of the holder.
→ The status LED remains on. The status alert Liquid waste container missing (54)
is displayed.
Empty liquid waste container 1 Place the liquid waste container next to a waste container according to national and
local standards and regulations.
→ The plug near the bottom of the liquid waste container points to the biohazard
waste container.
2 Connect the tap to the plug at the bottom of the liquid waste container until the
tap locks.
→ The liquid waste starts to flow off.
3 Wait until the liquid waste container is empty.
4 Slightly tilt the liquid waste container to empty residual liquid waste, if required.
5 Remove the tap from the liquid waste container.
6 Rinse the tap with water.
7 Store the tap for re-use.

Print No. DCHS-G01.621.01.08.02 273
8 At the liquid waste container, unscrew the connector to the fluid unit.
9 Rinse the liquid waste container with water.
10 Screw the connector to the fluid unit on the liquid waste container.
11 Place the liquid waste container back into the holder pressing the right side slightly.
→ The status alert Liquid waste container missing (54) is cleared. The status LED
turns off. The status alert Liquid waste container almost full (52) or Liquid waste
container full (53) is cleared.
12 Press the connector on the liquid waste container until it locks audibly.
13 To empty the other liquid waste container, go to ( Page 273 Emptying a container).
→ Emptying the liquid waste container is completed.
7.11 Loading data

✓ A separate computer with access to the internet and a USB port or access to a shared
folder is available, see ( Page 170 Shared folders).
✓ A USB storage device is available, if required.

To load data, for example, lot data, provided by Siemens Healthineers on the system,
proceed as follows:
1 When Siemens Healthineers releases information about new available data,

download the new data on the separate computer as described in the Document
Library Download instruction manual.
2 To use a USB storage device, go to ( Page 274 Loading data using a USB
storage device).
– or –
To use the shared folder, go to ( Page 275 Loading data using the shared folder).
7.11.1 Loading data using a USB storage device

To load data from a separate computer using a USB storage device:
1 Connect the USB storage device to one of the separate computer’s USB ports.
2 If applicable, delete old data from the USB storage device.
3 Copy the downloaded data to the USB storage device.
4 Safely remove the USB storage device from the separate computer, see the
documentation of the operating system.
5 At the analyzer, open the accessories drawer.
6 Connect the USB storage device to the port USB1 or USB2 above the
accessories drawer.
7 In the dialog Setup, in the area Tools, select Secure download.

Print No. DCHS-G01.621.01.08.02 274
→ The dialog Secure download is displayed. For more information on the dialog,
select the action button Help or see ( Page 148 Secure download).
Select file 1 Select the action button New.

→ The dialog Select file is displayed.
2 On the left, select USB 1 or USB 2.
→ On the right, the files that are available on the USB storage device are displayed.
3 Select the file with the downloaded data.
→ The button Open becomes active.
4 Check the displayed file:
• If the file type is ZIP and the file contains more than one data file, go to the
next step.
• Otherwise, skip the next 2 steps.
5 Select Open.
→ The simplified dialog Select file is displayed.

6 Select a data file.
7 Select Open.
→ In the dialog Secure download, the available information on the data file is
displayed. The action button Install becomes active.
8 Select the action button Install.
→ The data is loaded on the system. The current status is displayed. When loading
the data is finished, a corresponding message is displayed.
9 Select OK.
10 To install more data files from the ZIP file, go to ( Page 275 Select file).
– or –
Otherwise, go to the next step.
11 Select the action button Close.
12 Wait for 5 s.
13 Remove the USB storage device from the system’s USB port.
→ Loading data using a USB storage device is completed.
7.11.2 Loading data using the shared folder

To load data from a separate computer using the shared folder:
1 Copy the downloaded data to the shared folder.
2 In the dialog Setup, in the area Tools, select Secure download.

→ The dialog Secure download is displayed. For more information on the dialog,
select the action button Help or see ( Page 148 Secure download).

Print No. DCHS-G01.621.01.08.02 275
Select file 1 Select the action button New.

→ The dialog Select file is displayed.
2 On the left, select Shared folder.
→ On the right, the files that are available on the shared folder are displayed.
3 Select the file with the downloaded data.
→ The button Open becomes active.
4 Check the displayed file:
• If the file type is ZIP and the file contains more than one data file, go to the
next step.
5 Select Open.
→ The simplified dialog Select file is displayed.

6 Select a data file.
7 Select Open.
→ In the dialog Secure download, the available information on the data file is
displayed. The action button Install becomes active.
→ The data is loaded on the system. The current status is displayed. When loading
the data is finished, a corresponding message is displayed.
9 Select OK.
10 To install more data files from the ZIP file, go to ( Page 276 Select file).
– or –
Otherwise, select the action button Close.
→ Loading data using the shared folder is completed.

Print No. DCHS-G01.621.01.08.02 276
8 Performing the analysis

This chapter describes how to perform the analysis.
8.1 Preparing a bottle for loading into the reagent manager

✓ A reagent bottle, control bottle, calibrator bottle, or wash solution bottle is available.
✓ An evaporation cap for GW 5 or GW 15 bottle is available.
✓ A carrier for GW 5 or GW 15 bottle is available.
To prepare a bottle for loading into the reagent manager, proceed as follows:
1 Prepare the material according to the instructions for use of the product.
WARNING
False results due to incorrect barcode label
◆ Make sure to setup, print, and attach the correct barcode labels to the bottles
used for third-party reagents.
◆ When filling third-party reagents into bottles that are approved for the
analyzer, do not mix-up the reagents and the corresponding barcode-
labeled bottles.
NOTICE
Delay of results due to incorrect product identification
◆ Use 2D barcodes whenever available on a bottle.
2 Check if a label is attached to the bottle. If not, print a barcode label, see
( Page 331 Printing barcode labels), or use a blank label.
The system cannot safely identify products from 1D barcodes. All Siemens
Healthineers reagents for the system are delivered with 2D barcodes (Data matrix
codes). For third-party products, 2D barcodes can be printed in the dialog Barcode
maker. For detailed specifications, see the application sheets of these products.
Siemens Healthineers recommends to enter a unique serial number for each reagent
bottle or cartridge per lot, because otherwise the bottle specific on-board stability
cannot be monitored.
3 Unscrew the screw cap from the bottle.
4 Remove the stopper from the bottle, if required.

Print No. DCHS-G01.621.01.08.02 277
WARNING
False results due to re-use of evaporation caps
◆ Use single-use evaporation caps only once.

◆ Do not use washed or recycled single-use evaporation caps.
NOTICE
No processing of assays if the evaporation cap for a bottle or cartridge is

placed incorrectly
5 Place the evaporation cap on the bottle and align the arrow to the arrow on the label
of the bottle, see ( Page 57 Evaporation caps for bottles).
Self-printed barcode labels do not have the arrow for alignment with the evaporation
cap. For self-printed barcodes align the arrow on the evaporation cap with the center
of the 2D barcode.
6 Close the evaporation cap of the bottle, if applicable.
7 Place the bottle into the carrier.
WARNING
False results due to froth or lamellae causing incorrect level detection. Accurate
transfer of the reagent cannot be guaranteed.
◆ Remove froth and lamellae before loading the bottle.
8 If required, remove froth and lamellae.
9 Load the bottle placed in the carrier, see ( Page 278 Loading a bottle or a cartridge
into the reagent manager).
→ The bottle is loaded into the reagent manager.
→ Preparing a bottle for loading into the reagent manager is completed.
8.2 Loading a bottle or a cartridge into the reagent manager

✓ A prepared bottle or cartridge is available.
To load a bottle or a cartridge into the reagent manager, proceed as follows:

Print No. DCHS-G01.621.01.08.02 278
WARNING
False results due to spoiled content of the cartridge by light or by chamber to

chamber spill-over
◆ Use the cartridge only with the evaporation cap, see the instructions for use
of the reagent.
◆ Do not remove the evaporation cap from the cartridge.
◆ Do not open the slider of the evaporation cap.
◆ Do not tilt the cartridge.
1 Prepare the product:
• For bottles: See ( Page 277 Preparing a bottle for loading into the
reagent manager).
• For cartridges: See the instructions for use of the reagent.
For information on how many free positions are available in the reagent storage, select
Reagents > Overview. The number of free positions (0 to 47) in the reagent storage
is displayed in the column Inventory and expiration (Free positions: <number>).
2 If displayed, select the status alert Reagent missing (76) or Reagent not
sufficient (79).
The dialog Reagents > Loading displays which bottles or cartridges can be removed.
3 Open the access door.
→ The status alert Access door open (30) is displayed.
4 If required, remove the bottle or cartridge in the loading position, or press the
position button until an empty position in the input wheel is at the front.
5 Make sure that the evaporation cap of the bottle or cartridge is closed.
6 Place the bottle positioned in the carrier or the cartridge into the empty position.
→ The status LED of the reagent manager remains off.
7 Close the access door.
→ The status alert Access door open (30) is cleared. The bottle or cartridge is
loaded into the reagent manager and scanned. If configured, the bottle or cartridge
is shaken. As soon as the bottle or cartridge is in the reagent storage, the status alert
Reagent missing (76) or Reagent not sufficient (79) is cleared.
A bottle or cartridge without evaporation cap is detected and rejected by the system.

Print No. DCHS-G01.621.01.08.02 279
WARNING
False results due to incorrect preparation of reagents
◆ To detect reagent preparation problems, measure controls or control

samples for every new reagent bottle or cartridge.
8 For every new reagent bottle or cartridge, measure controls, see

→ Loading a bottle or a cartridge into the reagent manager is completed.
8.3 Identifying a bottle loaded into the reagent manager

To identify a bottle, proceed as follows:
1 If displayed, select the status alert Unidentified item on input wheel (88).
→ The dialog Reagents > Loading is displayed. The loading status Barcode
unreadable is displayed for the unidentified item.
3 If required, press the position button until the bottle is in the loading position.
→ The status LED of the reagent manager flashes. In the dialog Reagents > Loading,
the top line is displayed in red.
4 Take the bottle positioned in the carrier out of the loading position.
→ The status LED turns off. The status alert Unidentified item on input wheel (88)
is cleared.
5 Check the bottle:
• If there is no barcode or the barcode is illegible, go to ( Page 281 Identifying

the bottle).
• If the barcode is ok but the arrow is not aligned to the arrow on the label of the
bottle, go to ( Page 280 Re-positioning a bottle).
8.3.1 Re-positioning a bottle

1 Take the bottle out of the carrier.
2 Align the arrow on the evaporation cap to the arrow on the label of the bottle.
3 Place the bottle back into the carrier.
4 Place the carrier back into the same loading position as before.
→ The status LED remains off.


Print No. DCHS-G01.621.01.08.02 280
→ The status alert Access door open (30) is cleared. The bottle is loaded into the
reagent manager.
6 If the status alert Unidentified item on input wheel (88) is displayed again, go to
( Page 280 Identifying a bottle loaded into the reagent manager).
→ Identifying an incorrectly positioned bottle is completed.
8.3.2 Identifying the bottle
1 In the dialog Reagents > Loading, in the area Manual reagent identification, in the
list Product name, select a product name.
→ The list Lot number and the list Bottle type become active. For more information
on the dialog, select the action button Help or see ( Page 105 Loading).
WARNING
False results due to incorrect manual input of product data
2 In the list Lot number, select a lot number.

3 In the list Bottle type, select a bottle type.
If there is a mismatch between the bottle type entered and the bottle type detected by
the system, the bottle or cartridge is unloaded with the status Unloading.
4 In the input field Serial number, enter the serial number, if available.
5 Select Save.
→ The display on the left is updated. The reagent is identified.
6 Place the carrier back into the same loading position as before.
→ In the dialog Reagents > Loading, the loading status Loading (manually
identified) is displayed. The status LED remains off.
→ The status alert Access door open (30) is cleared. The bottle is loaded into the
reagent manager.
If the system can read the barcode of an already identified bottle, the system uses the
read barcode.
→ Manually identifying a bottle is completed.

Print No. DCHS-G01.621.01.08.02 281
8.4 Loading calibrator and control bottles into the sample

manager
✓ Calibrator bottles or control bottles are available.
✓ The required calibrator and control racks are available.
✓ Adapters for GW 2.5 bottles are available, if required.
To load calibrator and control bottles into the sample manager, proceed as follows:
1 Prepare the material according to the instructions for use of the calibrator and
control bottles.
2 Select one of the following status alerts:
• Calibrator or assigned value missing (73)
• Calibrator not sufficient (75)
• Control missing (94)
• Control not sufficient (96)
→ The dialog Reagents > Overview is displayed.

3 Remove the screw caps from the bottles.
4 If supplied with stoppers, remove the stoppers from the bottles.
WARNING
False results due to froth or lamellae causing incorrect level detection. Accurate
transfer of the calibrator cannot be guaranteed.
◆ Remove froth and lamellae (skin formation on liquid surfaces) before loading
the bottle.
5 If required, remove froth and lamellae.
6 If required, insert adapters into the calibrator and control rack positions, see the
figure below.
Using an adapter with a calibrator and control rack
(1) Calibrator and control rack

(2) Adapter

Print No. DCHS-G01.621.01.08.02 282
7 Place the bottles into the calibrator and control racks or into the adapters aligning the
barcodes towards the slots, see the figure below.
2
1 3
Placing a bottle with adapter into a calibrator and control rack
(1) Calibrator and control rack

(2) Bottle
(3) Adapter, if required
8 Take the calibrator and control rack with the handle facing to the right.
9 Place the calibrator and control rack behind the rack stoppers on the input lane of the
sample manager, see the figure below.
Placing a calibrator and control rack
(1) Rack stoppers
→ The calibrator and control racks are loaded. For each calibrator and control rack,
the barcode is read. For each bottle, the barcode is read and the material is taken. The
calibrator and control rack is moved to the output lane.
A bottle with screw cap or stopper is detected and rejected by the system.
→ Loading calibrator and control bottles into the sample manager is completed.

Print No. DCHS-G01.621.01.08.02 283
8.4.1 Unloading the calibrator and control rack

1 Remove the calibrator and control racks from the output lane.
2 Take the bottles out of the calibrator and control racks.
3 Store the calibrator and control racks and the adapters for re-use.
→ Unloading the calibrator and control rack is completed.
8.5 Adding lot data to the software

To add lot data to the software, proceed as follows:
1 In the dialog Data, select Lot data.

→ The dialog Lot data is displayed. For more information on the dialog, select the
action button Help or see ( Page 176 Lot data).
2 In the list Product names, select the product name.

→ In the list Lots and, if applicable, in the list Assigned values, lot data for the
selected product name is displayed.
There are several aids to find the product name:
• If the product name is not displayed, select Show all product names.
• If the list Product names contains many entries, use Search product name.
3 Select the action button Add lot.
→ The dialog Add lot number for the selected product name is displayed. In the area
Lot data in the data storage, the lots are displayed for which lot data is available in
the data storage.
4 In the input field Lot number, enter the lot number and select Add.
5 To add lot numbers for other lots, repeat the previous step.
→ In the list Lots, the product IDs of the entered lot numbers are displayed.
8.5.1 Selecting an expiration date

1 In the list Lots, select the product ID.
2 Select Select a date.
→ A calendar is displayed.
3 Select the expiration date.

Print No. DCHS-G01.621.01.08.02 284
8.5.2 Entering ISI and MNPT
WARNING
False results due to incorrect manual input of lot data. Failure to enter
the correct ISI value will cause incorrect International Normalization Ratio
(INR) results.
◆ Enter ISI values for prothrombin time assays directly as they appear on the
current reagent labeling.
◆ Any changes, for example, reagent lot changes, software upgrades, or major
servicing, require verification of the ISI value.
1 For a thromboplastin reagent, enter the corresponding values in the columns ISI
and MNPT.

8.5.3 Entering a mean normal value
WARNING
False results due to incorrect manual input of reagent lot data

◆ The mean normal value has to be determined and entered for each new
reagent lot.
◆ Make sure that the entered mean normal value matches the result unit of
the assay.
◆ Only enter the value itself without the unit.
◆ When using several reagents requiring a mean normal value, make sure not
to mix-up the mean normal values for the reagents.
1 For reagents requiring a mean normal value, enter the mean normal value in the
column MNV, see ( Page 176 Lot data).

8.5.4 Entering assigned values

For calibrators and controls, proceed as follows:

Print No. DCHS-G01.621.01.08.02 285
WARNING
False results due to incorrect manual input of lot data
1 In the list Assigned values, select the assay.

→ The dialog Assigned values is displayed.
2 In the list Assigned values, in the line Any, enter values for Assigned value, Lower
limit, and Upper limit (only for controls).
4 Check the available assigned values:
• To add a lot-dependent assigned value for the control lot, go to ( Page 286 Add
lot-dependent assigned value).
• Otherwise, go to ( Page 286 Add other assigned values).
Add lot-dependent 1 If the dialog New assigned value is not already displayed, select the action
assigned value button New.
→ The dialog New assigned value is displayed.
2 In the area Reagent lots, select a reagent lot.
3 In the input field Assigned value, enter the assigned value.
4 In the input field Lower limit, enter the lower limit for the acceptance range.
5 In the input field Upper limit, enter the upper limit for the acceptance range.
6 Select Save.
→ The lot-dependent assigned value is saved and displayed in the list Assigned
values in a separate table row for the lot-specific product ID. The assigned value is
only used for the combination of the control lot with the selected reagent lot.
7 To add lot-dependent assigned values for other reagent lots, go to ( Page 286 Add
lot-dependent assigned value).
Add other assigned values 1 Select the navigation button Lot data.
→ The dialog Lot data is displayed.
2 To edit the assigned values for other assays, go to ( Page 285 Entering
assigned values).
3 To enter lot data for other control lots, go to ( Page 284 Selecting an
expiration date).
→ Adding lot data to the software is completed.

Print No. DCHS-G01.621.01.08.02 286
8.6 Measuring a control

To measure a control, proceed as follows:
Siemens Healthineers recommends:
• Run assay-specific and lot-specific control measurements according to the valid

instructions for use.
• Perform accuracy and precision control measurements for assays in the normal
range and in the pathological or therapeutic range, and monitor accuracy
and precision.
• Check the functioning and the precision of the pipettors, see ( Page 358 Checking
the functioning and the precision of the pipettors).
• Configure automatic control measurements, see ( Page 253 Configuring

automatic control measurements).
As there are no Siemens Healthineers controls available for platelet aggregation

assays, controls for platelet aggregation always need to be measured as control
samples, for example, with platelet-rich plasma (PRP) from a healthy blood donor.
◆ Measure Siemens Healthineers controls, see ( Page 287 Measuring Siemens

Healthineers controls).
– or –
Measure control samples, see ( Page 288 Measuring control samples).
– or –
Measure third-party controls, see ( Page 289 Measuring third-party controls).
8.6.1 Measuring Siemens Healthineers controls

✓ Siemens Healthineers control bottles are available.
To measure a Siemens Healthineers control, proceed as follows:

1 In the dialog Controls, select the required control job.
→ The action button New becomes active. For more information on the dialog, select
the action button Help or see ( Page 117 Controls).

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Control orders can only be requested in the following cases:
• If the control has been assigned to the assay, see ( Page 252 Assigning
controls), and
• If in the dialog Data > Lot data > Assigned values, lot-independent assigned values
and permitted deviations in the line Any are available for the assay and the control
lot, see ( Page 284 Adding lot data to the software), or
• If in the dialog Data > Lot data > Assigned values, lot-dependent assigned values
and permitted deviations in the line of a product ID are available for the assay and
the control lot, see ( Page 284 Adding lot data to the software).

→ The order is requested.
3 If required, load the control bottle, see ( Page 278 Loading a bottle or a cartridge
into the reagent manager) or see ( Page 282 Loading calibrator and control bottles
into the sample manager).
→ The control is measured. In the dialog Controls, the result is displayed.
4 Evaluate the control results, see ( Page 290 Evaluating control results).
→ Measuring controls is completed.
8.6.2 Measuring control samples

✓ The control samples are available.
✓ Lot data for the control samples are available.
✓ Blank barcode labels are available.
✓ The required sample racks are available.
To measure a control sample, proceed as follows:
Siemens Healthineers has validated the provided Siemens Healthineers controls for
optimized product performance and for meeting the product specifications. User
defined controls are not supported by Siemens Healthineers as they may affect the
performance of the system and the release of test results.
1 Define a sample rack with the sample rack template Controls, see
( Page 242 Defining a calibrator and control rack). Make sure that the sample
type Control is selected in Sample rack settings.
2 Define a control, see ( Page 244 Defining a control).
3 Assign the control, see ( Page 252 Assigning controls).
4 Add lot data, see ( Page 284 Adding lot data to the software).
5 Print a 1D barcode label for the sample tube using the product data defined above,
see ( Page 331 Printing barcode labels).

Print No. DCHS-G01.621.01.08.02 288

8 If required, insert adapters into the sample rack.
9 Place the barcoded sample tubes with the control samples into the sample rack
aligning the barcodes towards the slots.
10 Take the sample rack with the handle facing to the right.
11 Place the sample rack behind the rack stoppers on the input lane of the
sample manager.
→ The sample rack is loaded. The sample rack barcode is read and, if applicable,
aliquots are taken. The aliquot volume depends on the control orders. In the
dialog Reagents > Overview, the control samples are displayed. The controls are
measured. The sample rack is moved to the output lane. In the dialog Controls, the
results are displayed.
→ Measuring control samples is completed.
8.6.3 Measuring third-party controls

✓ The third-party controls are available.
✓ Lot data for the third-party controls are available.
✓ Empty GW 5 bottles provided by Siemens Healthineers are available.

To measure a third-party control, proceed as follows:
Siemens Healthineers has validated the provided Siemens Healthineers controls for
optimized product performance and for meeting the product specifications. User
defined controls are not supported by Siemens Healthineers as they may affect the
performance of the system and the release of test results.
1 Define a control, see ( Page 244 Defining a control).
2 Assign the control, see ( Page 252 Assigning controls).
3 Add lot data, see ( Page 284 Adding lot data to the software).
4 Print a 2D barcode label for the bottle using the product data defined in the first step,
see ( Page 331 Printing barcode labels).
5 Fill the third-party controls into the labeled bottles.


Print No. DCHS-G01.621.01.08.02 289
8 Load the control bottle, see ( Page 278 Loading a bottle or a cartridge into the
reagent manager) or see ( Page 282 Loading calibrator and control bottles into the
sample manager).
→ The control is measured. In the dialog Controls, the result is displayed.
→ Measuring third-party controls is completed.
8.6.4 Evaluating control results

✓ Control results are available.
1 In the dialog Controls, select the result.

2 Select the navigation button Control result info.
→ The dialog Control result info is displayed.
3 In the list Comment, check the displayed flags:
• If the flag Relevant control results outside acceptance range or invalid is

displayed, go to the next step.
• If the flag Relevant control result doubtful is displayed, go to ( Page 290 Repeat
control measurement).
4 In the dialog Controls, select New to repeat the control measurement for the
selected control result.
5 If the flag Relevant control results outside acceptance range or invalid is still
displayed in the dialog Control result info, repeat the control measurement using
new control bottles.
displayed in the dialog Control result info, repeat the control measurement using
new reagent bottles.
displayed in the dialog Control result info, check the following:
• If a calibrated assay is used, go to the next step.
• Otherwise, go to ( Page 290 Identify further possible causes).
8 Perform a new calibration, see ( Page 328 Calibrating an assay).
Repeat control measurement ◆ In the dialog Controls, select New to repeat the control measurement.
Identify further 1 If the flag Relevant control results outside acceptance range or invalid or
possible causes Relevant control result doubtful is still displayed in the dialog Control result info,
check if the periodic maintenance and cleaning has been performed:
• If a periodic maintenance or cleaning has not been performed or needs to be

repeated, go to the next step.

Print No. DCHS-G01.621.01.08.02 290
2 Perform the maintenance task, see ( Page 340 Performing maintenance tasks).
3 In the dialog Controls, select New to repeat the control measurement.

4 If the flag Relevant control result doubtful or Relevant control results outside
acceptance range or invalid is still displayed in the dialog Control result info,
contact Siemens Healthineers service.
→ Evaluating control results is completed.
8.7 Ejecting a bottle or cartridge

To eject a bottle or cartridge, proceed as follows:
1 In the dialog Reagents, select Overview or Assays availability.
→ The dialog Reagents > Overview or Reagents > Assays availability is

displayed. For more information on the dialog, select the action button Help or
see ( Page 102 Overview) or ( Page 107 Assays availability).
The number of free positions (0 to 47) in the reagent storage is displayed in the column
Inventory and expiration (Free positions: <number>).
2 In the list Filter, select On-board, if required.

→ All on-board products are displayed.
3 At the bottom left, select Show details.
→ The details are displayed for all products on-board.
4 In the column Eject, select for the required bottle or cartridge.
→ The bottle or cartridge is transferred into the input wheel. The display is updated.
If displayed, the status alert Reagent storage full (83) is cleared.
Alternatively, the action button Eject all can be selected to eject all products in the
reagent storage.
→ Ejecting a bottle or cartridge is completed.
8.8 Unloading a bottle or cartridge

To unload a bottle or cartridge, proceed as follows:
1 If displayed, select the status alert Unloading of input wheel required (89).
→ The dialog Reagents > Loading is displayed.
2 Check the loading status of all bottles and cartridges on the input wheel.

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→ The loading status or is displayed for every bottle or

cartridge to be unloaded.
4 If required, press the position button until the bottle or cartridge is in the
loading position.
→ The status LED of the reagent manager is on.
5 Take the bottle or cartridge out of the loading position.
→ The status LED turns off. If displayed, the status alert Unloading of input wheel
required (89) is cleared.
WARNING
False results due to expired reagent. On-board stability periods cannot be

correctly monitored if reagents are loaded onto more than one analyzer.
◆ Only re-use bottles or cartridges on the same analyzer.

◆ Do not re-use bottles or cartridges on other analyzers.
6 Check the unloaded bottle or cartridge:
• To re-use a bottle, go to ( Page 292 Re-using a bottle).
• To discard a bottle, go to ( Page 292 Discarding a bottle).
• To discard a cartridge, go to ( Page 293 Discarding a cartridge).
8.8.1 Re-using a bottle

1 Store the bottle with the evaporation cap according to the instructions for use of
the product.
2 Go to ( Page 293 Finish unloading).
8.8.2 Discarding a bottle

1 Take the bottle with the evaporation cap out of the carrier.

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WARNING
False results due to re-use of evaporation caps
◆ Use single-use evaporation caps only once.

◆ Do not use washed or recycled single-use evaporation caps.
2 Discard the bottle together with the evaporation cap according to national and local
standards and regulations.
3 Store the carrier for re-use.
4 Go to ( Page 293 Finish unloading).
8.8.3 Discarding a cartridge

◆ Discard the cartridge together with the evaporation cap according to national and
Finish unloading ◆ Close the access door.
→ The status alert Access door open (30) is cleared.
→ Unloading a bottle or cartridge is completed.
8.9 Loading barcoded primary sample tubes

✓ Barcoded primary sample tubes are available.
✓ Adapters are available, if required.
To load barcoded primary sample tubes, proceed as follows:
WARNING
Infection due to infectious samples

and regulations.
◆ Handle samples in accordance with good laboratory practices.
1 If required, select System > Resume from standby to resume the system from
automatic standby mode or from sleep mode.

Print No. DCHS-G01.621.01.08.02 293
WARNING
False results due to incorrect sample material or due to aspiration of blood cells
from the sample tube
◆ Only use the required sample material. The primary sample for analysis
is the plasma component of human blood with added anticoagulant
(sodium citrate).
◆ Ensure that the sample volume and the volume of the supernatant plasma
above the packed cells are sufficient.
◆ Only use the sample tube with a sample rack defined for the sample tube.
◆ Do not use sample tubes with smaller inner diameters than specified on the
sample rack.
WARNING
False results due to exceeded sample on-board time in aliquot storage.

Depending on the assay, after 4 hours at the latest, all on-board aliquots
are discarded.
◆ Enable an assay-specific on-board stability expiration warning, see

( Page 197 Assay procedure), parameter Aliquot expires after.
◆ Enable a general on-board stability expiration warning for all aliquots, see
( Page 166 Expiration warnings).
◆ If no such warnings have been enabled, the time when an aliquot has been
placed on the analyzer can be checked in the dialog Sample info, in the field
Aliquots, in the column On-board.
WARNING
False results due to carryover. When using capped and uncapped sample
tubes on the same rack, the touchdown of the cap piercer on the opening
of an uncapped sample tube can lead to splashes wetting the cap piercer.
The contamination of the cap piercer can be transferred to other open
sample tubes.
◆ Do not mix capped and uncapped sample tubes on the same rack.
◆ Only use uncapped sample tubes on a sample rack defined for the sample
tube type without cap.

Print No. DCHS-G01.621.01.08.02 294
WARNING
False results or delay of results due to incorrect or missing PSI flag for sample
tubes with identical sample ID
◆ For correct proper-fill check, do not reuse sample IDs for different primary
sample tubes.
WARNING
False results due to no PSI flag transferred to LIS because first sample result
performed in direct mode
◆ For proper-fill check, only use normal mode.
NOTICE
Crash of the aliquot probe due to an inappropriate sample tube on a rack. The
aliquot probe might pierce the bottom of the sample tube.
Damage to the aliquot probe can result. Loss of the sample can result.
2 For each sample tube and sample rack, check the following:
• Is the sample material correct?
• When using PSI: Is normal mode used and is the sample ID unique?
• If not using proper-fill: Are the plasma volume and the plasma height sufficient?
• Is the sample tube correctly defined for the sample rack, for example, with or
without cap?
• Is the barcode legible and correctly placed?
Do not load samples with platelet-rich plasma (PRP) in barcoded primary sample
tubes. These samples must be loaded in secondary sample tubes.
The sample with platelet-poor plasma (PPP) for measuring the blank value can be
loaded in a barcoded primary sample tube.
3 If the sample tube is not specified for cap piercing, remove the stopper from the
sample tube.

Print No. DCHS-G01.621.01.08.02 295
WARNING
False results due to froth causing incorrect level detection. Accurate transfer of
the sample cannot be guaranteed.
◆ Remove froth before loading samples.
4 If required, remove froth.
WARNING
rack templates

5 If required, insert adapters into a suitable sample rack, see the figure below.
Using an adapter with a sample rack
(1) Sample rack

(2) Adapter
Do not use a sample rack with the sample rack setting For manual orders for samples
which are to be processed with LIS orders. LIS orders will not be processed for racks
with this sample rack setting.

Print No. DCHS-G01.621.01.08.02 296
WARNING
False results due to incorrect sample type or due to incorrect sample tube
◆ Use the sample racks only with the corresponding sample type, that is,
platelet-poor plasma or platelet-rich plasma.
◆ To ensure the correct function of proper-fill, make sure that the sample tube
is defined for the sample rack.
WARNING
False results due to or no results for hemolytic, icteric, or lipemic

sample material
◆ If the pre-analytical HIL check is not performed, for example, because

sample racks configured for direct mode are used or the HIL check is not
available, the sample integrity has to be checked by visual inspection, for
example, turbidity, and color, as described in CLSI documents available
at www.clsi.org.
6 Place the sample tubes into a suitable sample rack aligning the barcodes towards
the slots, see the figure below. For more information on sample handling, see
( Page 461 Sample handling). For more information on the pre-analytic sample
integrity check, see ( Page 462 Pre-analytic sample integrity check (PSI)).
2
3
1
Placing a primary sample tube with adapter into a sample rack
(1) Sample rack

(2) Sample tube
(3) Adapter, if required

Print No. DCHS-G01.621.01.08.02 297
manager, see the figure below.
Placing a sample rack
(1) Rack stoppers
→ The sample rack is loaded. The sample rack barcode is read. Each sample tube
is scanned and, if applicable, an aliquot is taken. The sample rack is moved to the
output lane.
If the sample rack is new to the system, the default template is assigned to the
sample rack.
→ Loading barcoded primary sample tubes is completed.
8.10 Loading STAT samples in barcoded primary sample tubes

✓ The required STAT sample racks are available.
To load STAT samples in barcoded primary sample tubes, proceed as follows:

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WARNING

and regulations.
WARNING
(sodium citrate).
sample rack.
WARNING
sample tubes.
WARNING
sample tubes.

Print No. DCHS-G01.621.01.08.02 299
WARNING
NOTICE
2 For each STAT sample tube and sample rack, check the following:
without cap?
sample tube.
WARNING
WARNING
rack templates

5 If required, insert adapters into a suitable sample rack, see ( Page 296 Using an
adapter with a sample rack).

Print No. DCHS-G01.621.01.08.02 300
WARNING
WARNING

sample material

at www.clsi.org.
6 Place the STAT sample tubes into a suitable sample rack aligning the barcodes
towards the slots. For more information on sample handling, see ( Page 461 Sample
handling). For more information on the pre-analytic sample integrity check, see
( Page 462 Pre-analytic sample integrity check (PSI)).
The system also processes STAT samples in other sample racks if ordered by the LIS.
7 If there are sample racks on the input lane, press the reverse button of the
sample manager.
→ The sample racks are moved back to the input lane.
8 Take the STAT sample rack with the handle facing to the right.

Print No. DCHS-G01.621.01.08.02 301
9 Place the STAT sample rack on the input lane in front of the other racks, see the
figure below.
Placing a STAT sample rack
(1) STAT sample rack
→ The STAT sample rack is loaded. The STAT sample rack barcode is read. Each STAT
sample tube is scanned and, if applicable, an aliquot is taken. The STAT sample rack
is moved to the output lane.
→ Loading STAT samples in barcoded primary sample tubes is completed.
8.11 Loading barcoded sample tubes on sample racks with the

sample rack setting For manual orders
✓ Barcoded sample tubes are available.
✓ A sample rack with the sample rack setting For manual orders is available.
To load barcoded sample tubes on sample racks with the sample rack setting For manual
orders, proceed as follows:
Similarly it is possible to load non-barcoded sample tubes using the dialog Loading
> Pre-identification. For more information on the dialog, see ( Page 80 Pre-
identification).

Print No. DCHS-G01.621.01.08.02 302
WARNING

and regulations.
WARNING

are discarded.

2 Load the required samples on a sample rack with the sample rack setting For
manual orders, see ( Page 293 Loading barcoded primary sample tubes) or
( Page 298 Loading STAT samples in barcoded primary sample tubes).
→ The sample rack is loaded. The sample rack barcode is read. Each sample tube is
scanned. If the rack type is configured For direct mode and no Default profile is
selected, no aliquot is taken. The sample rack is moved to the output lane.
3 In the dialog Jobs, select an empty cell for the required sample job.
the action button Help or see ( Page 82 Jobs).

→ The order is requested. The status alert Sample material required (70)
is displayed.

Print No. DCHS-G01.621.01.08.02 303
If the sample rack setting For direct mode is not selected for the sample rack, the
action button Special order can be used to request single orders in direct mode to save
sample material, see ( Page 88 Special order), or Direct mode can be selected in the
dialog Pre-identification, see ( Page 80 Pre-identification).
5 Re-load the rack.
→ The sample is measured. The sample rack is moved to the output lane. In the dialog
Jobs, the result is displayed.
→ Loading barcoded sample tubes on sample racks with the sample rack setting For
manual orders is completed.
8.12 Pre-identifying and loading samples and STAT samples in

non-barcoded secondary sample tubes
✓ Non-barcoded secondary sample tubes are available.
✓ The required adapters are available.
To pre-identify and load samples and STAT samples in non-barcoded secondary sample
tubes, proceed as follows:
WARNING

and regulations.

Print No. DCHS-G01.621.01.08.02 304
WARNING
(sodium citrate).
sample rack.
WARNING

are discarded.

• Is the sample tube correctly defined for the sample rack?
Load samples with platelet-rich plasma (PRP) only in secondary sample tubes.
WARNING

Print No. DCHS-G01.621.01.08.02 305
WARNING
rack templates

4 Insert adapters into a suitable sample rack, see ( Page 296 Using an adapter with a
sample rack).
WARNING
WARNING

sample material

at www.clsi.org.

Print No. DCHS-G01.621.01.08.02 306
5 Place the sample tubes into the sample rack using the adapters and fixing the
cap to the holder, if required, see the figure below. For more information on
sample handling, see ( Page 461 Sample handling). For more information on the
pre-analytic sample integrity check, see ( Page 462 Pre-analytic sample integrity
check (PSI)).
3
1
Placing a secondary sample tube with adapter into a sample rack
(1) Sample rack

(2) Sample tube with cap
(3) Adapter with cap holder
manager, see ( Page 298 Placing a sample rack).
8 In the dialog Loading > Pre-identification, in the list Rack ID, select the rack ID or
scan the rack barcode using the handheld barcode reader. For more information on
the dialog, select the action button Help or see ( Page 80 Pre-identification).
8.12.1 Identifying positions on the sample tube rack

1 In the figure Position, select the position of the sample tube.
WARNING
False results due to incorrect manual sample identification
Death or serious injury to the patient can result if sample tubes are
mixed up.
◆ Make sure to enter the correct sample ID.
2 In the input field Sample ID, enter the sample ID.

3 For STAT samples, activate STAT.

Print No. DCHS-G01.621.01.08.02 307
WARNING

sample material

at www.clsi.org.
4 If required, activate Direct mode, for example, when the available sample material
is low.
When selecting Direct mode, make sure to select below, under Assays, only those
assays which are defined for measurements in direct mode.
Otherwise, when trying to save the settings made in the dialog Pre-identification, a
dialog stating that not all selected assays can be measured in direct mode is displayed.
The dialog does not specify the affected assays. When selecting Cancel, there is the
option to de-select assays in an iterative approach. Another option is to check the
assay definitions.
5 Select Automatic numbering, if required.
CAUTION
6 In the input field Requested by, enter information about the sender of the sample.
7 In the input field Comment, enter a comment on the sample, if applicable.
8 If required, select 1 or more assays in the area Assays.
9 To identify other positions of the sample rack, go to ( Page 307 Identifying positions
on the sample tube rack).

→ In the dialog Jobs, the sample IDs are displayed and if applicable, the assays
are requested.
→ The sample rack is loaded. The sample rack barcode is read. Each sample tube
is scanned and, if applicable, an aliquot is taken. The sample rack is moved to the
output lane.

Print No. DCHS-G01.621.01.08.02 308
→ Pre-identifying and loading samples and STAT samples in non-barcoded secondary

sample tubes is completed.
8.13 Loading and unloading sample tubes using a rack tray

✓ Up to 10 sample racks are available.
✓ A rack tray is available.
To load and unload sample tubes using a rack tray, proceed as follows:
WARNING

and regulations.

Print No. DCHS-G01.621.01.08.02 309
WARNING
(sodium citrate).
sample rack.
WARNING

are discarded.

WARNING
sample tubes.

Print No. DCHS-G01.621.01.08.02 310
WARNING
sample tubes.
WARNING
NOTICE
without cap?
sample tube.
WARNING

Print No. DCHS-G01.621.01.08.02 311
WARNING
rack templates

WARNING

WARNING

sample material

at www.clsi.org.
5 Place the sample tubes into the sample racks aligning the barcodes towards the slots.

Print No. DCHS-G01.621.01.08.02 312
7 Place the sample racks on the rack tray, see the figure below.
Placing a sample rack on the rack tray
8 Carry the rack tray upright to the analyzer.
9 Push the rack tray into the input lane until it locks.
→ The rack stoppers are pushed aside by the tray.
10 Push the sample racks from the rack tray into the input lane.
→ The sample racks are loaded. The sample rack barcodes are read. Each sample tube
is scanned and, if applicable, an aliquot is taken. The sample racks are moved to the
output lane.
→ Loading sample tubes using a rack tray is completed.
8.13.1 Unloading sample tubes using a rack tray

1 Press the unload button, if required.
→ The sample racks are moved to the output lane.

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WARNING

and regulations.
2 Remove the empty rack tray from the input lane.
3 Push the rack tray into the output lane until it locks.
4 Push the sample racks from the output lane onto the rack tray.
5 Remove the rack tray from the output lane.
6 Carry the rack tray upright to the worktop.
7 Take the sample racks from the rack tray.
8 Handle the sample tubes according to the laboratory standards and regulations.
9 Store the sample racks for re-use.
→ Unloading sample tubes using a rack tray is completed.
8.14 Troubleshooting unidentified samples or samples causing

other problems
To troubleshoot unidentified samples or samples causing other problems, proceed
as follows:
◆ Select the status alert Unidentified item on rack (85), Sample tubes with identical
barcodes on rack <rack ID> (80), or Clog detected during sample aspiration (21).
→ The dialog Loading > Problem racks is displayed.
8.14.1 Selecting a sample position

1 In the list on the left, select a sample position.
→ The corresponding rack is displayed on the right.
2 Check the selected sample position:
• For an unreadable barcode , go to ( Page 315 Unreadable barcode).
• For identical barcodes , go to ( Page 316 Identical barcodes).
• For other problems , go to ( Page 316 Other problems).

Print No. DCHS-G01.621.01.08.02 314
8.14.2 Unreadable barcode
For an unreadable barcode :
◆ To assign a sample ID to the sample position, go to ( Page 315 Identify manually).
– or –
To check the barcode of the sample tube, go to ( Page 315 Skip position).
Identify manually CAUTION
1 On the right, below the figure, in the input field Enter sample ID, enter a sample ID
or scan the barcode using the handheld barcode reader. For more information on the
dialog, select the action button Help or see ( Page 78 Problem racks).
2 Select Assign to position.
→ In the figure, the sample position is marked with a black circle. In the list on the left,
a blue circle is displayed in the column Status.
3 Go to ( Page 315 Check figure).
Skip position ◆ On the right, below the figure, select Skip position.
Check figure 1 If the rack contains other unidentified samples, go to ( Page 314 Selecting a
sample position).
– or –
If a blue circle is displayed in the column Status for all sample positions on the rack,
go to the next step.
2 Select Save rack.
→ On the left, in the list, the corresponding sample positions are cleared. If there are
no other problem racks, the corresponding status alerts are cleared.
3 Check the barcodes of the unidentified sample tubes.
4 If the default aliquot is not available, re-load the unidentified sample tubes, see
( Page 293 Loading barcoded primary sample tubes).
→ Troubleshooting samples with an unreadable barcode is completed.

Print No. DCHS-G01.621.01.08.02 315
8.14.3 Identical barcodes
For identical barcodes :
1 Select a sample position with identical barcode.
2 On the right, below the figure, select Skip position.

3 Check the other problems on the rack:
• If there is another sample tube with the identical barcode, go to

( Page 316 Identical barcodes).
• If the rack contains other unidentified samples, go to ( Page 314 Selecting a

sample position).
• If a blue circle is displayed in the column Status for all sample positions on the rack,
4 Select Save rack.
5 Replace the required barcodes.
6 Re-load the unidentified sample tubes, see ( Page 293 Loading barcoded primary
sample tubes).
→ Troubleshooting samples with identical barcodes is completed.
8.14.4 Other problems
For other problems :
◆ In the figure, if the status Clog detected is displayed for the sample position, go to
( Page 316 Replace the sample with clog).
– or –
Otherwise, go to ( Page 316 Troubleshoot the problem rack).
Replace the sample with clog 1 Take the problem rack from the output lane.
2 Check the sample tubes with clogs.
3 Replace the sample tubes with new samples.
Troubleshoot the problem rack 1 On the right, below the figure, select Skip position.

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2 Check the figure:
• If the rack contains other unidentified samples, go to ( Page 314 Selecting a

sample position).
• If a blue circle is displayed in the column Status for all sample positions on the rack,
3 On the right, select Save rack.
4 Check the sample tubes.
5 Re-load the unidentified sample tubes, see ( Page 293 Loading barcoded primary
sample tubes).
→ Troubleshooting samples causing other problems is completed.
8.15 Unloading samples

To unload samples, proceed as follows:
1 Press the unload button, if required.
→ The sample rack is moved to the output lane of the sample manager.
WARNING

and regulations.
CAUTION
No processing of assays due to a blocking of the rack transport
◆ Do not push backwards sample racks on the output lane.
2 Take the sample rack from the output lane.
3 Handle the sample tubes according to the laboratory standards and regulations.

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4 To remove adapters from the sample rack, push the small knob of the adapter
upwards, see the figure below.
Removing an adapter from a sample rack
(1) Knob
5 Store the sample rack and the adapters for re-use.
→ Unloading samples is completed.
8.16 Displaying data in the job list

To display data in the job list, proceed as follows:
To display the job list:
1 Select Jobs.
→ The dialog Jobs or one of its subdialogs is displayed.

2 Select the navigation button Jobs, if required.
→ The dialog Jobs is displayed.
8.16.1 Display functions

Zoom To zoom the job list:
◆ At the bottom, on the right, select , , or .
→ The jobs are displayed in the selected zoom.
Filter To filter the sample IDs:
◆ At the bottom, in the list Filter, select a filter for sample IDs.
→ The selected filter is displayed. In the job list, only the samples which match the
filtered sample IDs are displayed.
Sort To sort the sample IDs:
◆ At the bottom, in the list Sort samples, select a sort sequence.
→ The sample IDs are displayed according to the selected sort sequence.
Reset selection To reset a selection:

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◆ At the bottom left, select .
→ All selected samples and jobs are deselected. The selection count is reset.
Scroll up or down To scroll up or down:
◆ On the right, move up or down.
Scroll left or right To scroll left or right:
◆ At the bottom, move left or right.
Screenshot To create a screenshot:
◆ Use the keys Ctrl + Alt + D.
→ Displaying data in the job list is completed.
8.17 Searching for a sample ID or a patient name

To search for a result, proceed as follows:
1 In the dialog Jobs, at the bottom, select .
→ The search dialog is displayed.
2 Scan the sample barcode using the handheld barcode reader.
→ The sample ID is automatically entered in the input field of the search dialog.
– or –
In the input field of the search dialog, enter the complete or part of the sample ID or
the patient name, if applicable.
→ In either case, the first matching sample ID is selected. A selection count m of n is

displayed. A selection count 0 of 0 with dimmed arrows indicates that no matching
sample ID has been found.
3 Browse through the matching sample IDs by selecting until the required
sample ID is selected.
4 Select .
→ The search dialog is closed.
→ Searching for a result is completed.

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8.18 Displaying results and navigating through assays and

samples
To display results and to navigate through assays and samples, proceed as follows:
◆ To display all results of a job, see ( Page 320 Displaying all results of a job).
– or –
To navigate through assays and samples, see ( Page 320 Navigating through assays
and samples).
8.18.1 Displaying all results of a job
1 In the dialog Jobs, check when the result is available in the column , if required.
2 Select a result.
3 Select the navigation button Sample result info.
→ The dialog Sample result info is displayed.
4 In the list Results, scroll down, if required.
→ The previous results are displayed.
8.18.2 Navigating through assays and samples

Navigate through assays To display results for the previous or the next assay using the same sample ID:
◆ In the dialog Sample result info, on the right, select Assay or Assay .
Navigate through samples To display results for the previous or the next sample ID using the same assay:
◆ In the dialog Sample result info, on the right, select Sample or
Sample .
Reset navigation To reset the navigation:
◆ In the dialog Sample result info, on the right, select Reset in the center of
the arrows.
→ The results that were selected when displaying the dialog are displayed.
→ Displaying results and navigating through assays and samples is completed.
8.19 Displaying a measurement curve

To display a measurement curve, proceed as follows:

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◆ To display the measurement curve of the latest result, see ( Page 321 Display current
measurement curve).
– or –
To display the measurement curve of any result, see ( Page 321 Display any
measurement curve).
– or –
To display multiple measurement curves of any result, see ( Page 321 Display
multiple measurement curves).
– or –
To customize the display of measurement curves, see ( Page 322 Customizing the
display of measurement curves).
8.19.1 Displaying curves

Display current 1 In the dialog Jobs, Controls, Calibrations, or Raw data, select the result.
measurement curve
→ In the action bar, the navigation button Measurement curve becomes active.
2 Select the navigation button Measurement curve.
→ The measurement curve of the latest result is displayed.
Display any 1 In the dialog Jobs, select the navigation button Sample result info.
measurement curve
→ The dialog Sample result info is displayed.
– or –
In the dialog Controls, select the navigation button Control result info.
→ The dialog Control result info is displayed.
2 In the list Results, scroll down, if required.

3 In the list Results, select the result.
4 Select the navigation button Measurement curve.
→ The measurement curve of the selected previous result is displayed.
Display multiple 1 In the dialog Jobs, select the results.

measurement curves
2 At the bottom right, select .
→ The dialog Measurement curve with all curves of the selected results is
displayed. For more information on the dialog, select the action button Help or
see ( Page 98 Multiple-selection dialog Measurement curve).
→ Displaying a measurement curve is completed.

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8.19.2 Customizing the display of measurement curves

Define display color To customize the display color of the measurement curve for an assay, proceed
as follows:
1 In the dialog Setup, select Configuration > Assay customization.

2 In the list Assay, select the assay.
3 In the area Display color for measurement curves, select Display in selected color.
4 Select the arrow to the right of the check box Display in selected color.
→ The color picker is displayed, see the figure below.
5 To select a color, decide how to proceed:
• Use the shade color field, see number 4 in the figure below.
• Use the hue slider, see number 5.
• Enter values for hue, saturation, and brightness in the respective input fields, see
number 6.
• Enter a hexadecimal color value in the respective input field, see number 7.
1 2 3 4 5
Color picker
(1) Automatic naming of the selected color

(2) Selected color
(3) Previously selected color
(4) Shade color field for the selected color
(5) Hue slider
(6) Color sliders and input fields for hue (H), saturation (S) and value/brightness (V)
(7) Input field for hexadecimal color value
Adjust axes To adjust the axes to the displayed measurement curves, proceed as follows:
◆ At the bottom, on the right, select Auto.

→ The axes are adjusted to the displayed measurement curves.
Show grid ◆ With the check box Show grid, a grid can be displayed, see
( Page 96 Display options).
→ Customizing the display of measurement curves is completed.

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8.20 Displaying the results of the PSI check for a sample and its
results
To display the results of the PSI check for a sample and its results, proceed as follows:
The PSI check is not performed for platelet-rich plasma (PRP).
The user can configure the PSI check as follows:
• Make sure that HIL measurements are activated in the dialog Setup
> Configuration > System, see ( Page 165 System (for general settings)). To
activate the HIL check, see ( Page 256 Deactivating and activating the HIL check).
• Set the sample-specific HIL warning levels in the dialog Setup > Configuration
> HIL warning, see ( Page 169 HIL warning).
• For user-defined assays, set assay-specific HIL warning levels in the dialog Setup
> Tools > Data definition, subgroups Assay definition > Assay groups > <Assay
group name> > Assays, see ( Page 207 Assays).
• Set the sample-low warning and the sample-high warning in the dialog Setup
> Tools > Rack definition > Sample tubes, see ( Page 190 Sample tubes).
WARNING
False results due to released results for hemolytic, icteric, or lipemic

sample material
◆ If a HIL check is not available, the sample integrity has to be checked by visual
inspection, for example, turbidity, and color, as described in CLSI documents
available at www.clsi.org.
◆ In the dialog Jobs, check the symbols next to the sample ID.
• If is displayed, go to ( Page 323 Proper fill).
• If is displayed, check the sample integrity by visual inspection.
8.20.1 Proper fill

1 Select the sample ID.
2 Select the navigation button Sample info.

→ The dialog Sample info is displayed. For more information on the dialog, select the
action button Help or see ( Page 89 Sample info).
3 Make sure that the sample tube has been in the correct sample rack when the sample
rack was loaded and the PSI flag was set.

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4 Check if is displayed for an overfilled sample tube or for an underfilled sample

tube during aliquotation.
If configured, a value for overfill or underfill is sent to the LIS.
CAUTION
5 In the input field Comment, enter a comment on the sample, if required.
8.20.2 HIL check

Check if HIL indices WARNING
are available
False results due to diagnostic interpretation of HIL indices. The concentration
ranges only serve as guidance to estimate if the sample material is suitable to
be used for measurements.
◆ Do not use the HIL indices obtained by the pre-analytic sample integrity
check to evaluate the actual concentrations of hemoglobin, bilirubin, or
lipoproteins/triglycerides.
◆ In the list Aliquots, check the columns H, I, and L:
• If a position is empty or is displayed, no HIL index has been measured or

the HIL index could not be evaluated. An error code has been sent to the LIS, if
configured. Check the sample integrity by visual inspection.
• If numerical values are displayed, go to ( Page 324 Sample-specific HIL check).
For information on the concentration ranges corresponding to the HIL indices, see
( Page 469 HIL indices and the corresponding concentration ranges).
Sample-specific HIL check ◆ Check if the measured HIL indices are higher than or equal to the corresponding
sample-specific warning level as displayed in brackets in the column header H, I,
and L.

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Sample results are released as configured in the dialog Sample result processing, see
( Page 158 Sample result processing), independent of the sample-specific HIL check.
If configured, HIL index values are also sent to the LIS.
Assay-specific HIL check 1 Select the navigation button Jobs.
→ The dialog Jobs is displayed.
2 Scroll through the sample results and check if the symbol is displayed next to a
sample result.
3 Select the sample result.
4 Select the navigation button Sample result info.
→ The dialog Sample result info is displayed. For more information on the dialog,
select the action button Help or see ( Page 91 Sample result info).
5 In the list Comment, check the assay-specific HIL comments.
Assay-specific HIL comments are supplemental information and do not affect the
release of results. Sample results are released as configured in the dialog Sample
result processing, see ( Page 158 Sample result processing). If configured, HIL index
values are also sent to the LIS.
6 To check other results for the sample, go to ( Page 325 Assay-specific HIL check).
→ Displaying the results of the PSI check for a sample and its results is completed.
8.21 Releasing results

To release results, proceed as follows:
As platelet aggregation curves are evaluated using the multiple-selection dialog

Measurement curves and its printout (not at the LIS), do not release results before
evaluation on the system. Thus, for platelet aggregation assays, it is not recommended
to configure an automatic sample result release.
1 In the dialog Jobs, at the bottom left, select .
→ All selected samples and jobs are de-selected. The selection count is reset.
WARNING
Unintended release of results

◆ Make sure to select only the results to be released.
2 Select 1 or more unreleased results.
→ The action button Release becomes active.

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3 To release the selected results, select the action button Release.
→ Releasing results is completed.
8.22 Printing results

To print results, proceed as follows:
The user can configure the printout in the dialog Setup > Configuration > Printout,
see ( Page 164 Printout).
◆ To evaluate and print results for percent platelet aggregation, see

( Page 326 Evaluating and printing results for percent platelet aggregation).
– or –
To print results for selected or all samples, see ( Page 327 Printing results for
selected or all samples).
8.22.1 Evaluating and printing results for percent platelet

aggregation
1 In the dialog Jobs, select the results required for evaluation.
2 At the bottom right, select .
→ The multiple-selection dialog Measurement curve is displayed.

3 Select the action button Print.
→ The dialog Comment for evaluation is displayed.
CAUTION
4 Enter a comment in the corresponding input field and select OK.
– or –
Leave the input field empty and select Cancel.

→ The dialog Print is displayed.
5 Make the settings as required, see ( Page 327 Printing results for selected or
all samples).
6 Select OK.
→ The following is printed:

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• The selected measurement curves
• A table with results, flag symbols, measurement time periods, and HIL values
(for PPP)
• The comment for evaluation, if applicable
→ Evaluating and printing results for percent platelet aggregation is completed.
8.22.2 Printing results for selected or all samples

1 In the dialog Jobs, check the selected sample IDs:
• To print only the results of selected samples, go to the next step.
• To print the results of all samples, skip the next step.
2 Select 1 or more sample IDs.

4 To insert additional page breaks, select Start a new page for each sample (only for
detailed printouts).
5 Select Yes.
→ The dialog Print is displayed. For more information on the dialog, see
( Page 186 Print).
7 Select OK.
→ Printing results for selected or all samples is completed.
8.23 Displaying and validating the control results for an assay in a

control period
See the documentation of the quality control software.
8.24 Displaying all results affected by an invalid control

To display all results affected by an invalid control, proceed as follows:
This procedure is only required if sample results are released without being framed by
valid control results, see ( Page 253 Configuring automatic control measurements).
1 In the dialog Data, select Raw data.

→ The dialog Raw data is displayed.
2 At the bottom, select the filter Assay.
→ The available assays are displayed.
3 Select the assay for which the control has been measured.

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→ The raw data for all measurements of the assay is displayed.
4 If the raw data is not sorted by time, select the header of the column Time.
→ The displayed raw data is sorted by the time when the measurement
was performed.
Controls defined by Siemens Healthineers can be easily identified in the column

Material by their consistent naming.
5 In the column Material, identify the last valid control measurement.
→ All sample results measured later than the last valid control measurement are
affected by the invalid control. In the column Material, the sample IDs of the affected
sample results are displayed.
The affected sample results may already have been transferred to the LIS.
→ Displaying all results affected by an invalid control is completed.
8.25 Calibrating an assay

✓ The calibrator bottles are available.
✓ The assigned values for the required calibrator lots are available.
To calibrate an assay, proceed as follows:
Platelet aggregation assays cannot be calibrated.
The user can configure an automatic calibration in the dialog Setup > Configuration
> Assay customization, see ( Page 156 Assay customization).
1 In the dialog Calibration, select the action button New.

→ The dialog New calibration is displayed.
→ The curve identifier is displayed.
3 Select Run calibration, if required.
4 In the area Reagent lots, select the required product IDs.
If Any is selected in the area Reagent lots, any reagent lot on-board of the required
reagent is used.

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In the dialog Assay customization, if Automatically calibrate new reagent lots is

not active and the current reagent lot is no longer available or should not be used
anymore, place the reagent with the new lot on the system and start a new calibration.
Otherwise, the 2 status alerts Reagent missing (76) and Calibration required (130)
will be displayed.
For calibrations using cartridges, only reagents from the same reagent lot are used.
Thus, the reagent lot must be selected for only 1 of the 3 reagents. The same reagent
lot is selected automatically for the other 2 reagents in the cartridge. To ensure
lot-dependency during calibration, the cartridge is automatically unloaded if one of
the reagents is empty.
5 In the area Calibrator lots, select the required product IDs.
If Any is selected in the area Calibrator lots, any calibrator lot on-board of the required
calibrator is used.
6 Select Start calibration.
→ The calibration is requested. If applicable, the status alerts Reagent missing (76)
and Calibrator or assigned value missing (73) are displayed.
7 If required, load reagents, see ( Page 278 Loading a bottle or a cartridge into the
reagent manager).
8 Load the required calibrators, see ( Page 277 Preparing a bottle for loading into
the reagent manager) and ( Page 278 Loading a bottle or a cartridge into the
reagent manager), or see ( Page 282 Loading calibrator and control bottles into the
sample manager).
When loading a calibrator set, load all bottles on the required number of calibrator and
control racks directly one after another.
9 Select Calibration.
→ When the calibration is finished, in the list Curve overview, the identifier of the
calibration curve is displayed in black. A valid and not doubtful calibration curve is
activated automatically, and in the list Curves, on the left of the identifier,
is displayed.
→ Calibrating an assay is completed.
8.25.1 Evaluating a calibration curve

1 Select the navigation button Calibration curve.
→ The dialog Calibration curve is displayed. For more information on the dialog,
select the action button Help or see ( Page 113 Calibration curve).
2 Check if the measured calibration curve is doubtful or not valid.

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3 To repeat the measurement of single supporting points, go to ( Page 330 Repeat

measurement of supporting point).
– or –
To repeat the measurement of the calibration, go to ( Page 330 Repeat

measurement of calibration).
– or –
To activate a doubtful calibration curve, go to ( Page 330 Activate doubtful or

previous calibration curve).
Repeat measurement of 1 In the list Supporting points, select the supporting point which is to be re-measured,
supporting point if required.
→ The action button Repeat becomes active.
Measurements of supporting points can only be repeated as long as the calibration

curve has not been used for evaluating results.
2 Select the action button Repeat.
→ The selected supporting point is re-measured.
3 To repeat the measurement for other supporting points, go to ( Page 330 Repeat
measurement of supporting point).

→ The changes are saved. A valid and not doubtful calibration curve is activated
automatically. In the list Curves, on the left of the identifier, is displayed. The
status alert is cleared.
5 To activate a doubtful calibration curve, go to ( Page 330 Activate doubtful or
previous calibration curve).
Repeat measurement 1 Unload the reagent bottles or the reagent cartridge used for the calibration, see
of calibration ( Page 291 Unloading a bottle or cartridge).
2 Load new reagent bottles or a new reagent cartridge, see ( Page 278 Loading a
bottle or a cartridge into the reagent manager).
3 Select the navigation button Calibration.

4 Go to ( Page 328 Calibrating an assay).
Activate doubtful or previous 1 In the dialog Calibration, select the measured curve.
calibration curve
→ On the right, the corresponding curve info is displayed. The action button Activate
becomes active.
2 Select the action button Activate.
→ If another calibration curve is active for the same lot or lot combination, a
confirmation dialog is displayed.
3 Select Yes.

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→ The calibration curve is activated. In the list Curves, on the left of the identifier,
is displayed.
Set curve filter
1 Select .
→ The dialog Curve filter is displayed.

2 Select Active curves only below Measured curves, if required.
3 Select Apply.
→ Only the active measured curves are displayed.
→ Evaluating a calibration curve is completed.
8.26 Printing barcode labels

✓ A printer connected to the system is available.
To print new barcode labels, proceed as follows:
WARNING
False results due to incorrect barcode label
◆ Make sure to setup, print, and attach the correct barcode labels to the bottles
used for third-party reagents.
◆ When filling third-party reagents into bottles that are approved for the
analyzer, do not mix-up the reagents and the corresponding barcode-
labeled bottles.
1 In the dialog Setup, in the area Tools, select Barcode maker.

→ The dialog Barcode maker is displayed. For more information on the dialog, select
the action button Help or see ( Page 131 Barcode maker).

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WARNING
False results due to exceeded reagent on-board stability period when using 1D
barcode on reagent bottle or cartridge
◆ Self-printed labels with 1D barcodes must only be used when measuring

control samples in secondary sample tubes on sample racks.
◆ If 1D barcodes are used, the on-board stability period will not be evaluated
correctly by the system. The user is responsible for monitoring the on-board
stability for all effected reagent bottles or cartridges.
◆ Siemens Healthineers highly recommends to use 2D barcodes for reagents.
2 To print a 2D barcode, select 2D barcode.

– or –
To print a 1D barcode, select 1D barcode.
CAUTION
3 For 2D barcodes, enter a reagent name and additional info in the respective
input fields.

→ The dialog Print is displayed. For more information on the dialog, see
( Page 186 Print).
7 Select OK.
→ The barcode labels are printed.
The barcode settings can lead to different print results, for example, due to the fact
that the printable area varies depending on the used printer, labels, paper formats, on
different paper, or if printed to file. If the print result is not as expected, change the
barcode settings or try to export a PDF file for subsequent printing.
→ Printing barcode labels is completed.

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9 Finishing the analysis

This chapter describes how to finish the analysis.
9.1 Washing the probes

To wash the probes, proceed as follows:
NOTICE
No processing of assays if reagent probe or sample probe is blocked or partially

blocked by an accumulation of substances
◆ Make sure to wash probes as a daily maintenance task.

1 In the dialog Maintenance, select Task execution.
→ The dialog Maintenance > Task execution is displayed. For more information on
the dialog, select the action button Help or see ( Page 174 Task execution).
2 In the list Tasks, select Wash probes.

→ On the right, a task description is displayed.
3 In the list Intensity, select Level 2.
4 In the input field Number of washing cycles, enter 3.
5 Select the action button Start.
→ The dialog Wash probes is displayed.
6 Select Next.
→ The system finishes all open orders for which at least the first transfer step has
been processed. The dialog Wash probes is updated. The status alert Maintenance
mode active (15) is displayed. The probes are washed for the entered number of
washing cycles.
7 Select Finish.
→ The status alert Maintenance mode active (15) is cleared. The tubings are
cleaned with probe cleaner and afterwards rinsed with purified water. The execution
of the maintenance task is automatically recorded in the maintenance log. The
system status Operating in <mm:ss> is displayed, followed by Operating.
→ Washing the probes is completed.
9.2 Cleaning up jobs and controls

To clean up jobs and controls, proceed as follows:

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◆ To delete off-board sample IDs manually from the job list, go to ( Page 334 Deleting
off-board sample IDs manually from the job list).
– or –
To start automatic display cleanup, go to ( Page 334 Starting automatic

display cleanup).
9.2.1 Deleting off-board sample IDs manually from the job list
To delete off-board sample IDs from the job list, proceed as follows:
1 In the dialog Jobs, at the bottom left, select .
→ All selected samples and jobs are de-selected. The selection count is reset.
2 Select the required sample IDs.
3 Make sure that no sample IDs with open orders are selected.
Sample IDs and results remain available in the dialog Data > Result history for the
record retention period.

→ A confirmation dialog is displayed showing the number of selected sample IDs.
5 Select Delete.
→ The sample IDs and their results are deleted.
→ Cleaning up jobs and controls manually is completed.
9.2.2 Starting automatic display cleanup

To start automatic display cleanup, proceed as follows:
The user can configure automatic display cleanup on shutdown, eco mode, and logoff,
see ( Page 257 Configuring automatic display cleanup).
1 In the dialog Data, select Display cleanup.

→ The dialog Display cleanup is displayed. For more information on the dialog,
select the action button Help or see ( Page 181 Display cleanup).

→ The dialog Display cleanup is displayed.
3 Select Next.
→ The dialog Display cleanup shows the current status. When the display cleanup
is finished, the button Finish becomes active.
4 Select Finish.
→ Cleaning up jobs and controls automatically is completed.

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9.3 Accepting or rejecting remote control

To accept or reject remote control of the system through Siemens Healthineers service,
proceed as follows:
WARNING
Risk of injury and infection due to unexpected movement of probes during

remote service via SRS
◆ Follow the instructions given by Siemens Healthineers service after

accepting remote control.
1 Check the displayed dialog Remote control.

2 To accept the remote control, select Accept.
– or –
To reject the remote control, select Reject.
After a defined duration the remote control is automatically rejected. The duration can
be changed by Siemens Healthineers service.
→ Accepting or rejecting remote control is completed.
9.4 Logging off

To log off, proceed as follows:
• Logging off and leaving the system running between shifts
• Switching the system to eco mode or shutting it down at least once a week, see
( Page 336 Switching to eco mode or shutting down the system)
1 Select User.
→ The user dialog is displayed.
2 Select Log off.
→ If configured, samples are moved from the job list to the dialog Data > Result
history and control results are moved from the control list to the archive. The user is
logged off. In the status area, the user name is cleared. Behind the user dialog, the
dialog Analyzer is displayed.
The user can configure automatic archiving on logoff in the dialog Data > Display
cleanup, see ( Page 181 Display cleanup).
→ Logging off is completed.

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9.5 Switching to eco mode or shutting down the system

To switch to eco mode or to shut down the system, proceed as follows:
To avoid system problems that may require on-site servicing, do not power off the
system using the main power switch before shutdown is completed. The shutdown is
completed as soon as the status LED of the touchscreen monitor turns orange.
• Logging off and leaving the system running between shifts, see
( Page 335 Logging off)
• Switching the system to eco mode or shutting it down at least once a week
NOTICE

1 Check if one of the following status alerts is displayed:
• Access door open (30)
• Cuvette waste container missing or drawer open (57)
• Cuvette waste container full (56)
• Cuvette waste container almost full (55)
• Liquid waste container full (53)
• Liquid waste container almost full (52)
• Probe cleaner reservoir empty. Replace probe cleaner immediately (47)
• Probe cleaner container empty. Replace probe cleaner container (46)
• Stirrer bars used up (51)
• Stirrer bars almost used up (50)
• Cuvettes used up (49)
• Registered cuvettes used up (65)
• Cuvettes almost used up (48)
• Registered cuvettes almost used up (66)

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Replace probe cleaner container (46) or Probe cleaner reservoir empty. Replace
probe cleaner container immediately (47) is displayed.
2 If at least one of the status alerts is displayed, resolve the corresponding problems,
see ( Page 374 Troubleshooting).
3 In the tool bar, select System.

→ The system dialog is displayed.
4 Select .
→ The shutdown types are displayed. For more information on the available
shutdown types, see ( Page 183 System (for operating the system)).
When Eco mode or Shutdown is selected even though there are still open orders,
those orders are aborted and sample material can be lost without receiving a result.
5 Wait until open orders are processed and results are available.
6 Select the shutdown type Eco mode.
→ The system status Shutting down is displayed. The status alert System shutting
down. Do not switch off the analyzer (5) is displayed. The system finishes all open
orders for which at least the first transfer step has been processed. The system
switches to eco mode. The illumination LED of the reagent manager blinks slowly.
– or –
Select the shutdown type Shutdown.
down. Do not switch off the analyzer (5) is displayed. The system finishes all open
orders for which at least the first transfer step has been processed. The system shuts
down. The illumination LED of the reagent manager turns off. The status LED of the
touchscreen monitor turns orange.
→ Switching to eco mode or shutting down the system is completed.

Print No. DCHS-G01.621.01.08.02 337
10 Performing maintenance and cleaning
10 Performing maintenance and

cleaning
This chapter describes how to perform maintenance and how to clean the system.
10.1 List of maintenance tasks

For a list of all maintenance tasks, see the table below.
Interval Maintenance task User level Reference
Daily Washing the probes Routine See ( Page 333 Washing the probes)
Weekly Only for purging agent purified Routine See ( Page 342 Cleaning the purging solu‐
water: Cleaning the purging solu‐ tion container)
tion containera)
Purging the tubingsb) Routine See ( Page 344 Purging the tubings)
Cleaning the water containers Routine See ( Page 345 Cleaning the water con‐
tainers)
Monthly Cleaning the aliquot probe Routine See ( Page 348 Cleaning the aliquot probe)
Backing up data Routine See ( Page 351 Backing up data)
Cleaning the racks, the adapters, and Routine See ( Page 352 Cleaning the racks, the
the carriers adapters, and the carriers)
Cleaning the cuvette waste container Routine See ( Page 353 Cleaning the cuvette
waste container)
Cleaning the liquid waste containers Routine See ( Page 356 Cleaning the liquid
waste containers)
Checking the functioning and the pre‐ Routine See ( Page 358 Checking the functioning
cision of the pipettors and the precision of the pipettors)
As needed Replacing the purging solution Routine See ( Page 267 Re-filling or replacing purg‐
ing solution)
Cleaning the surface of the ana‐ Routine See ( Page 360 Cleaning the surface of
lyzer, the handheld barcode reader, the analyzer, the handheld barcode reader,
the sample manager, and the the sample manager, and the reagent man‐
reagent manager ager)
Cleaning the touchscreen monitor Routine See ( Page 361 Cleaning the
touchscreen monitor)
Cleaning the keyboard and the mouse Routine See ( Page 362 Cleaning the keyboard and
the mouse)
Cleaning the accessories drawer Routine See ( Page 362 Cleaning the accesso‐
ries drawer)
Cleaning the HIL cuvette Routine See ( Page 363 Cleaning the HIL cuvette)
Priming the tubings Routine See ( Page 364 Priming the tubings)

Print No. DCHS-G01.621.01.08.02 338
Interval Maintenance task User level Reference
Draining expired probe cleaner Routine See ( Page 390 Probe cleaner expired (60))
Solving problems with the LAS con‐ Routine See ( Page 436 Problem with LAS connec‐
nection tion)
Removing a dropped item Routine See ( Page 405 Transportation problem at

component <component name> (11))
Removing a blocked cuvette Lab technician See ( Page 439 Removing cuvette block‐
ings in the cuvette loader)
Replacing the aliquot probe Lab technician See ( Page 364 Replacing the aliquot pipet‐
tor)
Maintenance tasks
a) Must be performed before purging the tubings.

b) Only for purging agent purified water: Take care to clean the purging solution container first.
10.2 Types of maintenance tasks

This chapter describes the types of maintenance tasks.
10.2.1 Automatic and semi-automatic maintenance tasks

Some maintenance tasks are started automatically by the software. For example, the
tubings and the probes are purged automatically with each shutdown.
Some maintenance tasks are semi-automatic, for example, checking the proper
functioning and precision of the probes. For this maintenance task, the user requests a
special assay and the system performs the assay.
10.2.2 Manual maintenance tasks

Some maintenance tasks are performed manually by the user. For example, the
following components of the system must be cleaned manually:
• Housing, including handheld barcode reader, sample manager, and reagent manager
• Touchscreen monitor
• Accessories (racks, adapter, carriers)
• Accessories drawer (keyboard, mouse)
• Cuvette waste container

Print No. DCHS-G01.621.01.08.02 339
10.3 Performing maintenance tasks
CAUTION
Personal data may be visible for service technician. If user enters personal data in
input fields not intended for personal data, no encryption is applied.
◆ Do not enter personal data in the input fields, for example, patient or user name,
date of birth.
This chapter describes how to perform maintenance tasks.
10.3.1 Performing periodic maintenance tasks

To perform periodic maintenance tasks, proceed as follows:
WARNING
False results due to insufficient or incorrect maintenance

◆ Perform all periodic and as needed maintenance tasks as described in

this manual.
1 In the dialog Maintenance, select Periodic tasks.

2 In the list Filter, select Today.
→ All periodic maintenance tasks scheduled for the rest of the day are displayed.
Perform periodic 1 In the list Task name, select a maintenance task.

maintenance task
→ On the right, details and the status of the performance are displayed.
2 Check the status of the performance:
• If the status is Not performed, go to the next step.
• If the status is OK or Not OK, select the next maintenance task.

3 Check the type of maintenance task:
• For an automatic or semi-automatic maintenance task, go to the next step.
• For a manual maintenance task, skip the next step.
4 Select Task execution.

5 Perform the selected maintenance task.

Print No. DCHS-G01.621.01.08.02 340
Record periodic 1 For the maintenance tasks Clean aliquot probe, Purge tubing, and Wash
maintenance task probes, go to ( Page 341 Finish automatic or semi-automatic maintenance
task). The execution of these maintenance tasks is automatically recorded in the
maintenance log.
– or –
For all other maintenance tasks, go to the next step.
2 In the dialog Maintenance, select Periodic tasks.

3 If the maintenance task has been performed successfully, select OK.
– or –
If a problem occurred while performing the maintenance task, select Not OK and
enter a comment.
Finish automatic or semi- 1 To perform more periodic maintenance tasks, go to ( Page 340 Perform periodic
automatic maintenance task maintenance task).
– or –
To finish the maintenance, go to the next step.
2 If the system status Maintenance is displayed, select System > Resume.
cleaned with probe cleaner and afterwards rinsed with purified water. The system
status Operating in <mm:ss> is displayed, followed by Operating.
→ Performing periodic maintenance tasks is completed.
10.3.2 Performing as needed maintenance tasks

To perform as needed maintenance tasks, proceed as follows:
WARNING
False results due to insufficient or incorrect maintenance
◆ Perform all periodic and as needed maintenance tasks as described in

this manual.
◆ Perform the required maintenance task, see ( Page 360 As needed maintenance).
Record as needed 1 In the dialog Maintenance, select Maintenance log.

maintenance task
→ The dialog Manual entry is displayed.
3 In the field Description, enter the maintenance task.

Print No. DCHS-G01.621.01.08.02 341
→ Manual entry is displayed in the dialog Maintenance log.
Finish automatic or semi- 1 To perform more periodic maintenance tasks, go to ( Page 341 Performing as
automatic maintenance task needed maintenance tasks).
– or –
To finish the maintenance, go to the next step.
2 If the system status Maintenance is displayed, select System > Resume.

cleaned with probe cleaner and afterwards rinsed with purified water. The system
status Operating in <mm:ss> is displayed, followed by Operating.
→ Performing as needed maintenance tasks is completed.
10.4 Weekly maintenance

This chapter describes the maintenance tasks that must be performed once a week.
10.4.1 Cleaning the purging solution container

This procedure is only required if purified water is used as purging solution.
✓ 70 % ethanol or 70 % isopropyl alcohol is available.
✓ Purified water is available.
✓ The system is in system status Maintenance, Standby, or Sleep, in eco mode, or off.
To clean the purging solution container, proceed as follows:
1 Check the system status.
2 If the system is in the status Maintenance, check that the maintenance task Purge
tubings is not executed.
WARNING
◆ For more information on the purging agent, see the instruction manual of
the purging agent.
4 At the connector of the purging solution container, press the push button.
→ The purging solution container is disconnected from the connector.

Print No. DCHS-G01.621.01.08.02 342
5 Before removing the purging solution container, carefully push aside the connector,
if required.
6 Take the purging solution container out of the holder.
→ The status LED turns on. In the dialog Analyzer, the symbol for the purging
solution container is crossed out and the status alert Purging solution container
missing (45) is displayed.
7 Unscrew the screw cap of the purging solution container.
8 Empty the purging solution container.
WARNING
◆ Only use 70 % ethanol or 70 % isopropyl alcohol.
WARNING
Risk of burns, serious eye irritation, drowsiness, or dizziness. 70 % ethanol and

70 % isopropyl are highly flammable liquids. 70 % isopropyl may cause serious
eye irritation, drowsiness, or dizziness.
Death or serious injury can result. Damage to the system or other

equipment can result.
◆ Keep 70 % ethanol and 70 % isopropyl away from sources of ignition, for

example, heat or open flame.
◆ Wear appropriate personal protective equipment; that is, gloves, protective
clothing, safety glasses and mask.
◆ Pay attention to the information from the manufacturer regarding the
compatibility of the gloves with the materials and liquids used.
◆ Due to no claim of completeness of these measures, follow all instructions
from the product manufacturer and observe the material safety data sheet.
9 Fill the purging solution container with approximately 300 mL of the

specified alcohol.
10 Slew the container until the entire inner surface has been wetted.
11 Allow the alcohol to take effect, according to the manufacturer’s instructions or for
at least 1 minute.
12 Discard the alcohol according to national and local standards and regulations.
13 Rinse the purging solution container thoroughly with purified water.

Print No. DCHS-G01.621.01.08.02 343
WARNING
14 Re-fill the purging solution container with purified water.

15 Screw the screw cap on the purging solution container.
16 Place the purging solution container into the holder slightly pressing the right side.
→ The status LED turns off. The status alert Purging solution container missing (45)
is cleared.
17 Press the connector on the purging solution container until it locks audibly.
→ In the dialog Analyzer, the fill level of the purging solution container is displayed.
19 Record and finish the maintenance task, go to ( Page 341 Record periodic
maintenance task).
→ Cleaning the purging solution container is completed.
10.4.2 Purging the tubings

✓ The system is in system status Operating or Maintenance.
WARNING
False results due to microbial contamination of the tubing
◆ If purified water is used as cleaning agent, clean the purging solution container
before purging the tubings.
For more information on how to clean the purging solution container, see
( Page 342 Cleaning the purging solution container).
To purge the tubings, proceed as follows:
1 In the list Tasks, select Purge tubings.


Print No. DCHS-G01.621.01.08.02 344
→ The dialog Purge tubings is displayed.

3 Select Next.
processed. The dialog Purge tubings is updated. The system status Maintenance is
displayed. The status alert Maintenance mode active (15) is displayed. The tubings
are purged with purging solution and afterwards rinsed with purified water. Once
Next is selected, the complete process can take up to 30 minutes.
4 Select Finish.
→ Purging the tubings is completed.
10.4.3 Cleaning the water containers

✓ Purified water is available.
✓ The system is in system status Maintenance, in eco mode, or off.

To clean the front water container and the stationary water container, proceed
as follows:
Take out water containers NOTICE

◆ When cleaning the water containers, make sure to take out the front water
container before taking out the stationary water container.

if necessary.
→ Only in system status Maintenance: In the dialog Analyzer, the symbol for the
front water container is crossed out and the status alert Purified water container
missing (Water front) (42) is displayed. The status LED turns on.
4 At both connectors of the rear (stationary) water container, press the push buttons.
→ The stationary water container is disconnected from the connectors.

Print No. DCHS-G01.621.01.08.02 345
5 Before removing the stationary water container, carefully push aside the connectors,
if necessary.
6 Take the stationary water container out of the holder.
→ Only in system status Maintenance: In the dialog Analyzer, the symbol for
the stationary water container is crossed out and the status alert Purified water
container missing (Water rear) (42) is displayed. The status LED turns on.
Clean water containers 1 Unscrew the screw cap of the water container.
2 Empty the water container.
WARNING
WARNING



3 Fill the water container with approximately 300 mL of the specified alcohol.
at least 1 minute.
WARNING
False results due to remaining alcohol in the water container

◆ Make sure to remove remaining alcohol when rinsing the water container.
7 Rinse the water container thoroughly with purified water.

Print No. DCHS-G01.621.01.08.02 346
WARNING
NOTICE
System failure due to corrosion caused by disallowed water
◆ Only use purified water.
8 Re-fill the container with purified water.

9 Screw the screw cap on the water container.
10 To clean the other water container, go to ( Page 346 Clean water containers).
Place water containers NOTICE
◆ When placing the water containers, make sure that the stationary water
container is placed in its holder first and connected before placing the front
water container into the holder.
1 Place the stationary water container into the holder slightly pressing the right side.
→ Only in system status Maintenance: The status LED turns off. The status alert
Purified water container missing (Water rear) (42) is cleared and the fill level of the
stationary water container is displayed.
2 Press the connectors on the stationary water container until they lock audibly.
→ Only in system status Maintenance: The status LED turns off. The status alert
Purified water container missing (Water front) (42) is cleared and the fill level of
the front water container is displayed.
Finish maintenance task 1 Close the bottom middle drawer.

Print No. DCHS-G01.621.01.08.02 347
2 If required, re-start the system, see ( Page 261 Starting the system from cold) or
( Page 262 Starting the system from eco mode).
3 Perform the maintenance task Prime tubings, see ( Page 364 Priming the tubings).
maintenance task).
→ Cleaning the water containers is completed.
10.5 Monthly maintenance

This chapter describes the maintenance tasks that must be performed once a month.
10.5.1 Cleaning the aliquot probe

✓ 1 cross-tip screwdriver, delivered by Siemens Healthineers, is available.
✓ Disposable, absorbent cloth, preferably a microfiber cloth is available.

To clean the aliquot probe, proceed as follows:
1 In the list Tasks, select Clean aliquot probe.
→ The dialog Clean aliquot probe is displayed.
3 In the dialog Clean aliquot probe, select Next.
→ The system finishes processing orders. This can take several minutes. The system
status Maintenance is displayed. The status alert Maintenance mode active (15) is
displayed. The system moves the aliquot arm to a parking position where the aliquot
probe can be cleaned.

Print No. DCHS-G01.621.01.08.02 348
WARNING
Infection by contaminated material and injury to hands due to moving

aliquot probe
◆ Do not open the cover until the dialog displays that the aliquot probe has
reached the parking position.
4 When the aliquot probe is in parking position, move the monitor to the left side, see
the figure below.
1 2
Cleaning the aliquot probe
(1) Mounting of the monitor

(2) Cover above sample manager
(3) Aliquot probe
5 With the cross-tip screwdriver, unscrew the cover above the sample manager.
6 Open the cover above the sample manager.

Print No. DCHS-G01.621.01.08.02 349
WARNING
Infection due to contaminated material and injury to hands due to sharp edges
◆ Only trained users are allowed to replace the probe assembly.

◆ Be especially careful of the sharp probe tip and other sharp edges.
◆ Handle parts of the system that have come into contact with potentially
infectious material in accordance with good laboratory practices.
WARNING

WARNING



7 Wipe the aliquot probe with the disposable, absorbent cloth soaked with the specified
alcohol from top to bottom.
at least 1 minute.
9 Dry remaining liquid with the disposable, absorbent cloth.
10 Close the cover above the sample manager.
11 With the cross-tip screwdriver, screw the cover above the sample manager.
12 Move back the monitor.
13 In the dialog Clean aliquot probe, select Finish.

Print No. DCHS-G01.621.01.08.02 350
→ Cleaning the aliquot probe is completed.
10.5.2 Backing up data

To backup data, proceed as follows:
1 In the dialog Setup > Tools > Data manager, select Backup.
2 Select System backup.
CAUTION
3 Complete the file name, if required.

5 Record and finish the maintenance task, go to ( Page 340 Performing periodic
maintenance tasks).
→ Backing up data is completed.
Export backup file To export the backup file from the system to a USB storage device or to a shared folder,
proceed as follows:
1 If required, plug a USB storage device into a USB port in the accessories drawer.
2 In the dialog Setup > Tools > Data manager, select Export.
3 In the area Source, select Backup.
4 Select the backup file.
5 In the area Target, select the USB storage device or the shared folder.
→ The export starts. When the export is finished, Export completed is displayed at
the bottom left.
Restore backup file If required, to restore a backup file, proceed as follows:

Print No. DCHS-G01.621.01.08.02 351
1 To restore a backup file from a USB storage device, plug the USB storage device into
a USB port in the accessories drawer.
– or –
To restore a backup file from a shared folder, copy the backup file to the import folder,
see ( Page 170 Shared folders).
2 In the dialog Setup > Tools > Data manager, select Restore.
3 Select Select file.
4 In the folder list on the left, select the folder where the backup file is saved.
5 In the file list on the right, select the backup file.
6 Select Open.
→ The backup file is displayed.
8 Select Yes.
→ An automatic backup is saved. The restore starts. When the restore is finished,
Restore completed is displayed at the bottom left. The system re-starts.
WARNING
Lot data of the probe cleaner is restored from the backup file. False results due
to expired probe cleaner if the probe cleaner container has been replaced since
saving the backup file
9 Replace the probe cleaner container, see ( Page 269 Replacing the probe
cleaner container).
10.5.3 Cleaning the racks, the adapters, and the carriers

✓ A lint-free cloth is available.
✓ Water is available.
To clean the racks, the adapters, and the carriers, proceed as follows:
1 Remove the racks, adapter, and carriers from the analyzer.
2 Check each rack, adapter, and carrier to see if it is broken.
3 If a rack, adapter, or carrier is broken, dispose of it.
4 Wipe the racks, adapter, and carriers with a lint-free cloth moistened with water.

Print No. DCHS-G01.621.01.08.02 352
WARNING
WARNING



5 If required, wipe the racks, adapter, and carriers with a lint-free cloth moistened with
the specified alcohol.
at least 1 minute.
7 Dry remaining liquid with a lint-free cloth.
maintenance task).
→ Cleaning the racks, the adapters, and the carriers is completed.
10.5.4 Cleaning the cuvette waste container

✓ A soft cloth is available.
✓ A new cuvette waste bag is available.
✓ The system is in system status Paused (using the dialog Empty cuvette waste, see
the first 3 steps of ( Page 271 Emptying the cuvette waste container)) or Standby,
Sleep, in eco mode, or off.

Print No. DCHS-G01.621.01.08.02 353
Siemens Healthineers recommends to perform this procedure in system

status Paused.
For all other system statuses the dialog Empty cuvette waste has to be used
afterwards anyway, because otherwise the system cannot recognize that the cuvette
waste has been emptied. As a result, the status alert Cuvette waste container full
(56) will be displayed, although the cuvette waste container is empty.
To clean the cuvette waste container, proceed as follows:
WARNING

and regulations.
◆ Always use a single-use waste bag with the cuvette waste container.
3 Raise the frame of the cuvette waste container.
4 Fold up the upper portion of the cuvette waste bag.
5 Tighten the tunnel cord of the cuvette waste bag by pulling the tunnel cord ends on
both sides of the cuvette waste bag, see ( Page 60 Cuvette waste bag).
6 Remove the cuvette waste bag from the cuvette waste container.
7 Discard the cuvette waste bag in the biohazard waste container.
8 On the narrow sides of the cuvette waste container, raise the clamps that hold the
cuvette waste container in position.
9 Take the cuvette waste container out of the holder.

Print No. DCHS-G01.621.01.08.02 354
WARNING
WARNING



10 Wipe the cuvette waste container with a soft cloth moistened with the
specified alcohol.
at least 1 minute.
12 Dry remaining liquid with a soft cloth.
13 Re-insert the cuvette waste container with the slightly longer end facing backwards.
14 Clamp the cuvette waste container with the clamps on the narrow sides of the
cuvette waste container.
15 Insert a new cuvette waste bag into the cuvette waste container. Position the tunnel
cord ends opposite each other on the long sides of the container.
16 Fold the upper portion of the cuvette waste bag around the rim of the cuvette
waste container.
17 Close the frame of the cuvette waste container.
19 If the cuvette waste container has been emptied in system statuses system off, eco
mode, standby, or sleep, go to the next step.
– or –
If the cuvette waste container has been emptied in system status Paused, go to
( Page 356 Finish maintenance task).

Print No. DCHS-G01.621.01.08.02 355
21 In the dialog Analyzer, at the bottom right, select Empty cuvette waste.
→ The dialog Empty cuvette waste is displayed.
22 Select Next.
→ The system status Paused is displayed. The right drawer is unlocked.
→ The status alert Cuvette waste container missing or drawer open (57)
is displayed.
→ The status alert Cuvette waste container missing or drawer open (57) is cleared.
Finish maintenance task 1 In the dialog Empty cuvette waste, select Confirm.
→ The system is set into the system status Operating. In the dialog Analyzer, the
cuvette waste container is displayed as empty.
maintenance task).
→ Cleaning the cuvette waste container is completed.
10.5.5 Cleaning the liquid waste containers

✓ The tap is available.
✓ Purging agent is available.
✓ A disposable, absorbent cloth is available.
✓ The system is in system status Operating (as long as 1 liquid waste container remains
in the system), Maintenance, Standby, or Sleep, in eco mode, or off.
To clean the front liquid waste container and the rear liquid waste container, proceed
as follows:
WARNING
Infection due to infectious liquid waste

Clean 1 liquid waste container 1 At the connector to the liquid waste container, press the push button.
→ The liquid waste container is disconnected from the connector.

2 Before removing the liquid waste container, carefully push aside the connectors,
if required.

Print No. DCHS-G01.621.01.08.02 356
3 Take the liquid waste container out of the holder.
→ Only in system statuses Operating, Maintenance, Standby, and Sleep: The

status LED turns on. In the dialog Analyzer, the symbol for the liquid waste container
is crossed out. The status alert Liquid waste container missing (54) is displayed.
4 Place the liquid waste container next to a waste container according to national and
→ The plug near the bottom of the liquid waste container points to the biohazard
waste container.
tap locks.
→ The liquid waste starts to flow off.
6 Wait until the liquid waste container is empty.
7 Slightly tilt the liquid waste container to empty residual liquid waste, if required.
8 Remove the tap from the liquid waste container and place it on a disposable,
absorbent cloth.
9 At the liquid waste container, unscrew the connector to the fluid unit.
WARNING
WARNING



10 Fill the liquid waste container with approximately 300 mL of the specified alcohol.
at least 1 minute.

Print No. DCHS-G01.621.01.08.02 357
tap locks.
→ The alcohol starts to flow off.
15 Remove the tap from the liquid waste container.
16 Rinse the tap with water.
17 Store the tap for re-use.
18 Discard the absorbent cloth according to national and local standards

and regulations.
19 If required by local standards or regulations, fill purging agent into the empty liquid
waste container.
20 Screw the connector to the fluid unit on the liquid waste container.
21 Place the liquid waste container back into the holder pressing the right side slightly.
22 Press the connector on the liquid waste container until it locks audibly.
→ Only in system statuses Operating, Maintenance, Standby, and Sleep: The

status LED turns off. The status alert Liquid waste container missing (54) is cleared.
Clean other liquid ◆ To clean the other liquid waste container, go to ( Page 356 Clean 1 liquid
waste container waste container).
Finish maintenance task 1 Close the left drawer.
maintenance task).
→ Cleaning the liquid waste containers is completed.
10.5.6 Checking the functioning and the precision of the pipettors

✓ SVS solution is available.
✓ 0.85 % natrium chloride solution is available.
✓ 4 Behring coagulation cups are available.
✓ The system is in system status Operating (no open orders).

To check the functioning and the precision of the pipettors, proceed as follows:

Print No. DCHS-G01.621.01.08.02 358
WARNING
Risk of very serious allergic effects if SVS solution is inhaled, gets in contact with
skin, or is swallowed

◆ Avoid contact with eyes and skin.
◆ Refer to the SVS solution labeling and to Material Safety Data Sheets for more
information on first aid measures. Material Safety Data Sheets are available from
1 Load SVS solution as reagent, see ( Page 278 Loading a bottle or a cartridge into the
reagent manager).
For more information on the SVS solution, see the instructions for use of the
SVS solution.
2 Fill 4 Behring coagulation cups with about 3 mL (= to the first line from below)
of 0.85 % natrium chloride solution and place them on a sample rack (no direct
mode rack).
3 Pre-identify each Behring coagulation cup with 1 of the 4 precision check assays,
see ( Page 304 Pre-identifying and loading samples and STAT samples in non-
barcoded secondary sample tubes):
• REL.Prec.Aliquot
• REL.Prec.Sample
• REL.Prec.Reag.Front
• REL.Prec.Reag.Back
4 Load the sample rack.
→ The precision checks will be performed. The sample is measured 20 times for each
precision check assay.
Depending on the available and used volume, re-loading the natrium chloride solution
may be required, as described.
5 For each of the 4 precision check assays, evaluate the results, see
( Page 359 Evaluate results).
→ Checking the functioning and the precision of the pipettors is completed.
Evaluate results 1 Print or note the results.

Print No. DCHS-G01.621.01.08.02 359
2 Check the results:
• If the CV (coefficient of variation) of the 20 test results is ≤ 5, the precision check is

passed. Go to ( Page 341 Record periodic maintenance task), then proceed with
the next precision check assay.
• If the CV (coefficient of variation) of the 20 test results is > 5, the precision check
has failed. Continue with the next step.
4 Repeat the precision check and check the results again:
• If the precision check is passed, record and finish the maintenance task, go to
( Page 341 Record periodic maintenance task), then proceed with the next
precision check assay.
• Otherwise, contact Siemens Healthineers service.
10.6 As needed maintenance

This chapter describes the maintenance tasks that must be performed as needed.
10.6.1 Cleaning the surface of the analyzer, the handheld barcode

reader, the sample manager, and the reagent manager
✓ The system is in system status Maintenance, Standby, or Sleep, in eco mode, or off.
To clean the surface of the analyzer, the handheld barcode reader, the sample manager,
and the reagent manager, proceed as follows:
1 Check the system status and make sure that the aliquot pipettor is not cleaned or
replaced at the same time.

Print No. DCHS-G01.621.01.08.02 360
WARNING
WARNING



2 Wipe the analyzer, the handheld barcode reader, the sample manager, and the
reagent manager with a soft cloth moistened with the specified alcohol.
at least 1 minute.
4 Dry remaining liquid with a soft cloth, preferably a microfiber cloth.
6 Record and finish the maintenance task, go to ( Page 341 Record as needed
maintenance task).
→ Cleaning the surface of the analyzer, the handheld barcode reader, the sample
manager, and the reagent manager is completed.
10.6.2 Cleaning the touchscreen monitor

✓ Special screen clean is available.
✓ The system is in eco mode or off.
To clean the touchscreen monitor, proceed as follows:
2 Wipe the touchscreen monitor with a soft cloth moistened with special screen clean.
3 Dry remaining liquid with a soft cloth, preferably a microfiber cloth.

Print No. DCHS-G01.621.01.08.02 361
4 Re-start the system, see ( Page 261 Starting the system from cold) or
maintenance task).
→ Cleaning the touchscreen monitor is completed.
10.6.3 Cleaning the keyboard and the mouse

To clean the keyboard and the mouse, proceed as follows:

2 Open the accessories drawer.
3 Clean the keyboard and the mouse with a lint-free cloth.
4 Close the accessories drawer.
5 Re-start the system, see ( Page 261 Starting the system from cold) or
maintenance task).
→ Cleaning the keyboard and the mouse is completed.
10.6.4 Cleaning the accessories drawer


To clean the accessories drawer, proceed as follows:
2 Open the accessories drawer.
3 Clean the accessories drawer with a lint-free cloth.

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WARNING
WARNING



4 If required, wipe the accessories drawer with a lint-free cloth moistened with the
specified alcohol.
at least 1 minute.
6 Dry remaining liquid with a lint-free cloth.
7 Close the accessories drawer.

maintenance task).
→ Cleaning the accessories drawer is completed.
10.6.5 Cleaning the HIL cuvette

To clean the HIL cuvette, proceed as follows:
2 In the list Tasks, select Clean HIL cuvette.
→ The dialog Clean HIL cuvette is displayed.

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4 Select Next.
been processed. This can take several minutes. The system status Maintenance is
displayed. The status alert Maintenance mode active (15) is displayed. The cuvette
of the HIL reader is cleaned.
5 Select Finish.
maintenance task).
→ Cleaning the HIL cuvette is completed.
10.6.6 Priming the tubings

To prime the tubings, proceed as follows:
→ The dialog Maintenance > Task execution is displayed. For more information on
the dialog, select the action button Help or see ( Page 174 Task execution).
2 In the list Tasks, select Prime tubings.

3 In the input field Number of priming cycles, enter 2.
→ The dialog Prime tubings is displayed.
5 Select Next.
been processed. The dialog Prime tubings shows the current status. The status alert
Maintenance mode active (15) is displayed. For the entered number of priming
cycles, the tubings are rinsed with purified water, cleaned with probe cleaner, and
rinsed with purified water.
6 Select Finish.
maintenance task).
→ Priming the tubings is completed.
10.6.7 Replacing the aliquot pipettor

The aliquot pipettor needs to be replaced after 40,000 cap piercings by a specially
trained user.
Siemens Healthineers recommends customers to have a spare aliquot pipettor

in stock.
To replace the aliquot pipettor, proceed as follows:

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Order aliquot pipettor Aliquot pipettors can be ordered via the customer’s established way of ordering
consumables or via Siemens Healthineers service.
Unpack and check delivery 1 Before opening, check the transport container for signs of external damage.
2 If the transport container shows any visible signs of damage, file a complaint with the
carrier immediately.
3 Open the transport container.
4 Check the content for completeness and intact condition.
The delivery includes:
• 1 aliquot pipettor
5 If the aliquot pipettor is missing or damaged, inform the Siemens Healthineers

service immediately.
Access service software 1 In the system software, in the dialog Setup, in the area Tools, select
Service software.
→ The user dialog of the service software is displayed.
2 In the user dialog, in the input field User name, enter the user name.
3 In the input field Password, enter the password.
4 Select Log on.
Replace aliquot pipettor ✓ A disposable, absorbent cloth is available.
✓ 1 new aliquot pipettor is available.
✓ Optional: A flashlight is available.
WARNING
Infection due to contaminated material and injury to hands due to sharp edges

◆ Only trained users are allowed to replace the probe assembly.
◆ Be especially careful of the sharp probe tip and other sharp edges.
◆ Handle parts of the system that have come into contact with potentially
1 In the tool bar of the service software, select Utilities.
2 In the dialog, select Fluid unit.
3 On the left, select Part exchange.

→ The dialog Utilities - Part exchange is displayed.
4 In the area Selection, select Aliquot arm.
→ In the area Additional parameters, Replace aliquot pipettor is selected.

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5 In the area Commands, select Start.

→ The aliquot pipettor moves to the parking position.
6 Wait until a dialog box is displayed.
Do not select OK until the new aliquot pipettor is installed.
7 Move the touchscreen monitor to the left so that the cover above the sample
manager can be lifted.
8 With the cross-tip screwdriver, release the locking of the cover and raise the
cover completely.
9 Place a disposable, absorbent cloth beneath the aliquot pipettor so that spilled liquid
is absorbed.
10 In front of the green mounting, loosen the knurled nut, see the figure below.
1
2
5
6
De-installing the aliquot pipettor
(1) Mounting
(2) Knurled nut
(3) Supply tube
(4) Electrical connector
(5) Metallic rollers
(6) Hook-shaped holder
(7) Aliquot pipettor
11 Disconnect the electrical connector by pinching the small nose at the top side of the
electrical connector and carefully pulling the electrical connector out of the socket.

Print No. DCHS-G01.621.01.08.02 366
→ The aliquot pipettor is disconnected.
Remove aliquot pipettor 1 Carefully bend the supply tube to the side.
2 Grasp the hook-shaped holder and carefully pull the aliquot pipettor forward.
→ The aliquot pipettor slides over the 2 metallic rollers next to the holder, thus
coming loose.
Dispose of aliquot pipettor 1 Dispose of the used aliquot pipettor, see ( Page 373 Dispose of used
aliquot pipettor).
2 Remove the disposable, absorbent cloth and dispose of it according to national and
Remove green cover ◆ Remove the green oblong cover beneath the aliquot pipettor, see the figure below.
Removing the green oblong cover
(1) Aliquot pipettor

(2) Green oblong cover

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Install new aliquot pipettor 1 Carefully bend the supply tube to the side so it cannot be damaged by the threaded
connector, see the figure below.
2
9
3
5
7
6
Installing the aliquot pipettor
(1) Supply tube

(2) Threaded connector
(3) Clamping fixtures
(4) Cylinders
(5) Metallic rollers
(6) Guidings
(7) Hook-shaped holder
(8) Printed circuit board
(9) Mounting
2 Grasp the hook-shaped holder.
NOTICE
System failure due to damaged printed circuit board

◆ Take special care not to scratch the printed circuit board with the threaded
connector or any other part of the aliquot pipettor during installation.
3 Carefully insert the 2 cylinders at the top side of the new aliquot pipettor in the
clamping fixtures on both sides of the mounting.
4 Carefully push the aliquot pipettor upward and backward.

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→ The aliquot pipettor slides over the 2 metallic rollers next to the holder. 2 guidings
on each side of the metallic rollers direct the aliquot pipettor into its correct position.
5 At the right side of the aliquot pipettor, check if the locking lever is positioned directly
beneath the slide of the hydraulic cylinder, see the figure below.
Checking the position of the locking lever
(1) Hydraulic cylinder

(2) Slide
(3) Locking lever
(4) Aliquot probe
• If the locking lever is not positioned directly beneath the slide of the hydraulic
cylinder, repeat the steps explained in ( Page 367 Remove aliquot pipettor), as
well as the previous steps in this chapter.
• If the locking lever is positioned directly beneath the slide of the hydraulic cylinder,
6 Carefully grasp the aliquot probe between 2 fingers and move it upward
approximately 3 mm.
7 Release the aliquot probe and check if the aliquot probe moves back down:
• If the aliquot probe does not move back down, repeat the steps explained in
( Page 367 Remove aliquot pipettor), as well as the previous steps in this chapter.
• If the aliquot probe moves back, go to the next step.

Print No. DCHS-G01.621.01.08.02 369
NOTICE
System failure due to short-circuit by spilled liquids that can come into contact
with live parts
◆ Take care that the knurled nut is screwed hand-tight to the

threaded connector.
8 Screw the knurled nut hand-tight to the threaded connector, see the figure below.
1
4
2
3
Connecting the aliquot pipettor
(1) Knurled nut

(2) Electrical connector
(3) Printed circuit board
(4) Supply tube
(5) Aliquot pipettor tube
9 If the supply tube and aliquot pipettor tube are stuck, carefully free them.
– or –
If the supply tube and aliquot pipettor tube are free to move, go to the next step.
10 With the small nose of the electrical connector pointing upward, carefully plug the
electrical connector into the socket on the printed circuit board.
If the socket is hard to locate, use a flashlight to illuminate the setting.

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Initialize new aliquot pipettor 1 Empty the liquid waste container as initialization produces approximately 1 L of
liquid waste. For more information on emptying the liquid waste container, see
( Page 273 Emptying the liquid waste container).
2 In the service software, in the dialog box, select OK.
→ The new aliquot pipettor is being initialized and checked. This can take
several minutes.
3 Wait until the color of the status area changes from yellow to green or to red, see the
figure below.
Service software, Result view, example
(1) Status area

(2) Result view area
4 If the color of the status area changes to red or for 1 or more actions the column
Validation displays not OK, go to ( Page 372 Re-initialize aliquot pipettor).
– or –
If the color of the status area changes to green and for all actions the column
Validation displays OK, go to ( Page 371 Insert green cover).
Insert green cover 1 With the arching handle facing toward you, insert the green oblong cover in the
oblong opening beneath the aliquot pipettor.
2 Close the cover above the sample manager.
3 With the cross-tip screwdriver, lock the cover.
4 Move the touchscreen monitor back into its usual position.
5 In the dialog Utilities - Part exchange, in the upper right corner, select Close.
→ The dialog is closed.
6 In the service software, in the upper right corner, select Exit.
7 Wait until the service software is closed.

Print No. DCHS-G01.621.01.08.02 371
→ The system software is displayed. The aliquot pipettor is initialized. The system
status Operating in <mm:ss> is displayed.
Re-initialize aliquot pipettor 1 In the dialog Utilities - Part exchange, in the area Commands, select Start.
→ A dialog box is displayed.
2 Do not follow the instructions in the dialog but select OK.
→ The new aliquot pipettor is initialized and checked. This can take several minutes.
3 Wait until the color of the status area changes from yellow to green or to red, see
( Page 371 Service software, Result view, example).
4 If the color of the status area changes to red or for 1 or more actions the column
Validation displays not OK, contact Siemens Healthineers service immediately.
– or –
If the color of the status area changes to green and for all actions the column
Validation displays OK, go to ( Page 372 Insert green cover).
Insert green cover ◆ Insert the green cover, see ( Page 371 Insert green cover).
Perform precision check To check the functioning and precision of the aliquot arm:
WARNING
Risk of very serious allergic effects if SVS solution is inhaled, gets in contact with
skin, or is swallowed

◆ Avoid contact with eyes and skin.
◆ Refer to the SVS solution labeling and to Material Safety Data Sheets for more
information on first aid measures. Material Safety Data Sheets are available from
1 Load SVS solution as reagent, see ( Page 278 Loading a bottle or a cartridge into the
reagent manager).
For more information on the SVS solution, see the instructions for use of the
SVS solution.
2 Pre-identify and load a Behring coagulation cup with 0.85 % natrium chloride
solution, see ( Page 304 Pre-identifying and loading samples and STAT samples in
non-barcoded secondary sample tubes).
3 Request the assay REL.Prec.Aliquot for the natrium chloride solution.

→ The sample is measured 20 times.
4 Print or note the results, see ( Page 326 Printing results).

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5 Check the results:
• If the CV (coefficient of variation) of the 20 test results is ≤ 5, the precision check

is passed.
• If the CV of the 20 test results is > 5, the precision check has failed. Go to the
next step.
7 Repeat the precision check and check the results again:
• If the precision check is passed, proceed working with the analyzer.
Dispose of used aliquot Depending on the applications, the aliquot pipettor can be contaminated with
pipettor biohazardous or hazardous chemical material.
WARNING
Infection due to contaminated material

◆ Treat contaminated material according to national and local standards
and regulations.
◆ Before movement or disposal, disinfect parts of the system that may be
contaminated according to national and local standards and regulations.
◆ To get assistance, contact Siemens Healthineers service.
1 De-install the aliquot pipettor, see ( Page 367 Remove aliquot pipettor).
2 Dispose of the aliquot pipettor according to national and local standards

and regulations.
3 For more information, contact Siemens Healthineers service with regard to disposal
of the aliquot pipettor.
→ Replacing the aliquot pipettor is completed.

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11 Troubleshooting
11 Troubleshooting
This chapter describes the troubleshooting of the system.
11.1 Overview
The troubleshooting is based on status alerts displayed in the status area of the software.
Each status alert indicates a specific problem and has a unique status alert ID. In addition,
the status light indicates the overall status of the system.
11.1.1 Status alerts

Status alerts are displayed below the tool bar and the status area, see
( Page 64 Overview of the screen), number 6. An example of the status alert display is
shown in the figure below.
1 2 3 1 2 3
4 4
5 5
Example of the status alert display
(1) Problem category

(2) Status alert ID related to the short description
(3) Time when the problem occurred
(4) Short description of the problem
(5) Parameter, if applicable
The status alerts are displayed from left to right in the order of severity. Red status alerts
are most important. The colors are explained in the table below.
Color Explanation Example Parameter
Red The system is not operating, or Cuvettes used up (49) Not applicable
No more orders can be processed for at least Calibration Assay short name
1 sample or assay. required (130)
Yellow If the user does not resolve the problem, a red Reagent not suffi‐ Reagent short name (prod‐
status alert will be displayed soon, or cient (79) uct ID, if applicable)
Specific condition which is resolved by the system Initializing (2) Not applicable
Colors of status alerts

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11 Troubleshooting
If a status alert occurs more than once at the same time, there are 3 possibilities how the
similar status alerts are displayed:
• All instances of the status alert are displayed and must be resolved separately,
if required.
• Only the first instance of the status alert is displayed. When the first instance is
resolved, the next unsolved instance is displayed.
• Only one instance of the status alert with several parameters in the short description is
displayed. The status alert is updated with each solved parameter and displayed until
all parameters are resolved.
When the user selects a status alert, there are several possibilities:
• The dialog where the problem can be resolved is displayed, or
• The dialog Info > Alerts is displayed, or
• If the corresponding dialog is already displayed, the dialog Help is displayed showing
the solution for the problem. The dialog Help is also displayed when the user selects
the status alert a second time.
In the dialog Info > Alerts, the user can view details on all status alerts, see
( Page 118 Alerts).
Depending on the number of status alerts, their height can be minimized. Changing
between the minimized and the expanded display is explained in the table below.
Action Select on the right
Show expanded display
Show minimized display
Show expanded or minimized display
In the expanded display, … (3 dots) indicate that the space available is not sufficient to
show all parameters. The user can view all parameters in the dialog Info > Alerts, in the
detailed descriptions of the problems.
11.1.2 Status light

The status light indicates the overall status of the system, see the table below.
Status light display Explanation
Red User action is required, the system is not operating
Yellow User action is recommended, but the system is still operating
Yellow blinking Specific condition which is resolved by the system
Green Running without problems
Status light display

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11 Troubleshooting
11.2 Red status alerts

The following chapters describe how to troubleshoot red status alerts.
11.2.1 Connection problem (4)

Problem:
The connection between the analyzer and its computer is interrupted. The system
is not operating.
Solution:
1 Wait to see if the status alert is displayed for more than 30 s.
2 If the status alert is still displayed, select System > Quick shutdown.
down. Do not switch off the analyzer (5) is displayed. The system shuts down. The
illumination LED of the reagent manager turns off.
3 Re-start the system, see ( Page 261 Starting the system from cold).
4 If the status alert is still displayed, contact Siemens Healthineers service.
11.2.2 Initialization problem (6)

Problem:
An initialization problem occurred: <error code>. The system is not operating.
Solution:
1 If the status alert Problem with compressed air pressure (<too high>/<too low>)
(140) is displayed, go to ( Page 402 Problem with compressed air pressure (<too
high>/<too low>) (140)).
2 If the status alert Unloading of input wheel required (89) and the error code
AssemblyOccupied are displayed, go to ( Page 377 Unload input wheel).
3 Select the status alert Initialization problem (6).
→ If the problem has been resolved, the status alert is cleared.
4 If the status alert is still displayed, select System > Quick shutdown.
5 Re-start the system with Smart initialization, see ( Page 261 Starting the system
from cold).
→ The dialog Reagent storage is displayed. For more information on the dialog, see

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11 Troubleshooting
WARNING

6 To keep the products in the reagent storage, select Keep products.

– or –
To unload the products in the reagent storage, select Unload products.
If the restart fails, for example, due to missing consumables, the corresponding status
alert is displayed and must be resolved.
Unload input wheel 1 Select System > Quick shutdown.
3 If required, turn the input wheel manually until a bottle or cartridge is in the
loading position.
4 Take 1 bottle or cartridge out of the loading position.
11.2.3 Initialization problem with access door, consumables, or

waste (8)
Problem:
An initialization problem occurred: The access door of the reagent manager is open,
cuvettes, stirrer bars, or probe cleaner are used up or almost used up, the cuvette
waste container or liquid waste container is full or almost full, or the right drawer
is open. The system is not operating.
Solution:
1 Check if the access door of the input wheel and the right drawer are closed.
2 If the status alert is still displayed, select it.

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11 Troubleshooting
NOTICE
3 Check if status alerts for consumables or for waste are displayed:
• To load cuvettes, see ( Page 263 Loading cuvettes).
• To load stirrer bars, see ( Page 265 Loading stirrer bars).
• To re-fill purified water, see ( Page 266 Re-filling purified water).
• To re-fill purging solution, see ( Page 267 Re-filling or replacing purging solution).
• To replace the probe cleaner container, see ( Page 269 Replacing the probe
cleaner container).
• To empty the cuvette waste container, see ( Page 271 Emptying the cuvette
waste container).
• To empty the liquid waste container, see ( Page 273 Emptying the liquid
waste container).
4 Select System > Quick shutdown.
from cold).
WARNING


– or –

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11 Troubleshooting
If the restart fails, for example, due to missing consumables, the corresponding status
alert is displayed and must be resolved.
11.2.4 Problem with liquid waste pressure (9)

Problem:
A problem with the liquid waste pressure occurred. The system is not
operating correctly.
Solution:
◆ If the system uses the external connection for liquid waste, go to ( Page 379 Check
external connection for liquid waste).
– or –
If the system uses the liquid waste containers in the left drawer, go to
( Page 379 Check liquid waste containers).
Check external connection for 1 At the rear side of the analyzer, check if the external connection for liquid waste is
liquid waste correctly connected and re-connect it, if required.
2 Check if the used tube is clogged or if it is connected to an external connection
more than 3 m above the external connection for liquid waste at the rear side of
the analyzer.
3 Re-start the system, go to ( Page 379 Re-start system).
Check liquid waste containers 1 Open the left drawer.

2 Inside the left drawer, check the status LEDs.
→ The status LEDs of all liquid waste containers that need to be emptied are on, see
3 Check if the connectors to the liquid waste containers are correctly locked and re-lock
them, if required.
5 Re-start the system, go to ( Page 379 Re-start system).
Re-start system 1 Shut down the system, see ( Page 336 Switching to eco mode or shutting down
the system).

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11 Troubleshooting
11.2.5 Software problem with CAN bus (12)

Problem:
A software problem with the CAN bus occurred. The system is not operating.
Solution:
◆ Contact Siemens Healthineers service.
11.2.6 Initialization required: component <component name> (14)

Problem:
A component requires initialization: <component name>. The system is not

Solution:
1 Select the status alert Initialization required: component <component

name> (14).
→ The dialog Maintenance > Task execution is displayed.
For a list of all possible component names in this status alert, see
( Page 432 Component names in status alerts).
2 In the list Tasks, select Initialization.

3 In the list Initialize, select the required component.
NOTICE


→ The component is initialized. If the initialization is successful, the status alert
is cleared.

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11 Troubleshooting
5 If the status alert Transportation problem at component <component name> (11)

is displayed, go to ( Page 405 Transportation problem at component <component
name> (11)).
– or –
If the status alert Initialization required: component <component name> (14) is

still displayed, go to the next step.
6 In the dialog Info > Alerts, in the list Category, select Component.
7 Look for the latest status alert Initialization required: component <component
name> (14).
8 Select the latest nearby status alert Problem <problem>.
If the component name is Fluid unit and the selected status alert is Problem
"WastePressure" (5007), the liquid waste containers might be incorrectly connected.
◆ Check the connection to the liquid waste containers and re-connect them,
if applicable.
◆ If the liquid waste containers have been re-connected, repeat the initialization of
the fluid unit, see ( Page 380 Initialization required: component <component
name> (14)).
◆ For more information on the status alert Problem "WastePressure" (5007), see
( Page 433 Possible entries for <problem>).
If the selected status alert is Problem "ResourceJam" (5026), cuvette blockings need
to be removed.
◆ For information on how to remove cuvette blockings, see ( Page 439 Removing
cuvette blockings in the cuvette loader).
For a list of possible entries for <problem>, see ( Page 433 Possible entries
for <problem>).
9 On the right, in the area Details, if the component name matches the component
name displayed in the status alert Initialization required: component <component
name> (14), contact Siemens Healthineers service indicating the information in the
area Details.
– or –
Otherwise, select another nearby status alert Problem <problem> and repeat
the step.
11.2.7 Initialization problem: input wheel carries more than 6 items

(16)
Problem:
An initialization problem occurred: The input wheel carries more than 6 items.
Solution:
1 Unload 1 or 2 bottles or cartridges, see ( Page 291 Unloading a bottle or cartridge).

Print No. DCHS-G01.621.01.08.02 381
11 Troubleshooting
from cold).
WARNING


– or –
If the restart, for example, due to missing consumables, the corresponding status alert
is displayed and must be resolved.
11.2.8 Initialization required (17)

Problem:
The system requires initialization. The system is not operating.
Solution:
1 If the status alert Problem with compressed air pressure (<too high>/<too low>)
(140) is displayed, go to ( Page 402 Problem with compressed air pressure (<too
high>/<too low>) (140)).
from cold).

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11 Troubleshooting
WARNING


– or –
If the restart, for example, due to missing consumables, the corresponding status alert
is displayed and must be resolved.
11.2.9 Service required: component <component name> (19)

Problem:
A component requires service: <component name>. The system is not

Solution:
1 In the dialog Info > Alerts, in the list Category, select Analyzer.
2 Look for the latest status alert Service required: component <component
name> (19).
For a list of possible entries for <problem>, see ( Page 433 Possible entries
for <problem>).
4 On the right, in the area Details, check the displayed component name:
• If the component name matches the component name displayed in the status alert
Service required: component <component name> (19), go to the next step.
• Otherwise, select another nearby status alert Problem <problem> and repeat
the step.

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11 Troubleshooting
5 If the component name is HIL reader, go to ( Page 384 Component name is

HIL reader).
– or –
If the component name is Sample manager, go to ( Page 384 Component name is

Sample manager).
– or –
Otherwise, follow the instructions in the area Details.
Component name is HIL reader WARNING
No results for hemolytic, icteric, or lipemic sample material
◆ If the pre-analytical HIL check is not performed, for example, because the
HIL check is not available, the sample integrity has to be checked by visual
inspection, for example, turbidity, and color, as described in CLSI documents
available at www.clsi.org.
◆ For all new samples, check the sample integrity by visual inspection.
Component name is 1 Check the nearby status alerts:

Sample manager
• If the status alert Problem "SensorError" (5021) is displayed, go to the next step.
• Otherwise, go to ( Page 384 Contact service).
2 On the right, in the area Details, check the displayed component name:
• If the component is Sample manager, go to the next step.
• Otherwise, go to ( Page 384 Contact service).
3 Take the racks from the output lane of the sample manager.
4 Press the unload button to remove all remaining racks.
6 In the list Tasks, select Initialization.
7 In the list Initialize, select the component Sample manager.
→ The component is initialized. If the initialization is successful, the status alert

is cleared.
9 If the status alert is still displayed, go to ( Page 384 Contact service).
Contact service ◆ Contact Siemens Healthineers service indicating the problem in the area Details.

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11 Troubleshooting
11.2.10 Leakage detected in analyzer. Fluid dripped into collection

pan (22)
Problem:
A leakage is detected in analyzer. Fluid dripped into the collection pan.
Solution:
11.2.11 System on backup power (24)

Problem:
The system is on backup power. New samples are rejected.
Solution:
1 Check if the system’s power cord is plugged into the power outlet.
2 If the status alert is still displayed, check the power supply of the laboratory.
3 Wait until the power connection is re-established.
→ The status alert is cleared.
11.2.12 Backup power used up, shutting down (25)

Problem:
The backup power is used up. Running orders are aborted. The system shuts down.
Solution:
1 Wait until the power connection is re-established.
11.2.13 Probe not washed (27)

Problem:
A probe has not been washed.
Solution:
1 Check if status alerts for system liquids or for the liquid waste are displayed:
• To re-fill purified water, see ( Page 266 Re-filling purified water).
• To re-fill purging solution, see ( Page 267 Re-filling or replacing purging solution).
• To replace the probe cleaner container, see ( Page 269 Replacing the probe
cleaner container).
• To empty the cuvette waste container, see ( Page 271 Emptying the cuvette
waste container).
• To empty the liquid waste container, see ( Page 273 Emptying the liquid
waste container).

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11 Troubleshooting
11.2.14 Housing lid or cuvette loader open (29)

Problem:
At least one housing lid is open or the cuvette loader is pulled out.
Solution:
1 If a housing lid is open or the cover of the cuvette loader is pulled out for routine tasks
or for maintenance tasks, perform the required tasks.
2 When finished, close all open housing lids and the cuvette loader.
→ The status alert is cleared. Measuring and aliquotting continue.
11.2.15 Clog in aliquot probe cannot be removed (34)

Problem:
The system cannot remove the clog in the aliquot probe.
Solution:
1 Clean the aliquot probe, see ( Page 348 Cleaning the aliquot probe).
2 If the status alert is still displayed, replace the aliquot probe, see
( Page 364 Replacing the aliquot pipettor).
11.2.16 Purified water used up (41)

Problem:
The purified water is used up. The system is not operating.
Solution:
◆ Re-fill purified water, see ( Page 266 Re-filling purified water).
11.2.17 Purging solution used up (44)

Problem:
The purging solution is used up.
Solution:
◆ Re-fill purging solution, see ( Page 267 Re-filling or replacing purging solution).

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11 Troubleshooting
11.2.18 Purging solution container missing (45)

Problem:
The purging solution container is missing.
Solution:
◆ Re-fill purging solution and re-insert the purging solution container, see
( Page 268 Opening the purging solution container).
11.2.19 Probe cleaner container empty. Replace probe cleaner

container (46)
Problem:
The probe cleaner container is empty. Replace the probe cleaner container.
Solution:
NOTICE

◆ Replace the probe cleaner container, see ( Page 269 Replacing the probe
cleaner container).
Replace probe cleaner container (46) is displayed.
11.2.20 Probe cleaner reservoir empty. Replace probe cleaner

container immediately (47)
Problem:
The probe cleaner reservoir is empty. Replace the probe cleaner container. The
system is not operating.
Solution:
cleaner container).

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11 Troubleshooting
Do not shut down the system when the status alert Probe cleaner reservoir empty.
Replace probe cleaner container immediately (47) is displayed.
11.2.21 Cuvettes used up (49)

Problem:
The cuvettes are used up. The system is not operating.
Solution:
◆ Load cuvettes, see ( Page 263 Loading cuvettes).
11.2.22 Stirrer bars used up (51)

Problem:
The stirrer bars are used up.
Solution:
◆ Load stirrer bars, see ( Page 265 Loading stirrer bars).
11.2.23 Liquid waste container full (53)

Problem:
The liquid waste container is full. The system is not operating.
Solution:
◆ Empty the liquid waste container, see ( Page 273 Emptying the liquid
waste container).
11.2.24 Liquid waste container missing (54)

Problem:
The liquid waste container is missing.
Solution:
◆ Empty and re-insert the liquid waste container, see ( Page 273 Empty liquid
waste container).
11.2.25 Cuvette waste container full (56)

Problem:
The cuvette waste container is full. The system is not operating.
Solution:
◆ Empty the cuvette waste container, see ( Page 271 Emptying the cuvette
waste container).

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11 Troubleshooting
11.2.26 Cuvette waste container missing or drawer open (57)

Problem:
The cuvette waste container is missing or the right drawer is open. The system is
not operating.
Solution:
◆ If required, empty and re-insert the cuvette waste container, and close the right
drawer, see ( Page 272 Removing the cuvette waste bag).
11.2.27 Probe cleaner not identified (58)

Problem:
The probe cleaner has not been identified.
Solution:
1 Select the status alert Probe cleaner not identified (58).

2 At the bottom left, select Replace probe cleaner.
CAUTION

and regulations.
Replace probe cleaner is updated. The status alert Probe cleaner not identified
(58) is cleared.
6 Scan the barcode of the probe cleaner container using the handheld barcode reader.
the holder.

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11 Troubleshooting
→ The status alert Probe cleaner container missing (59) is cleared. The status alert
Probe cleaner not identified (58) is displayed.
the opening tool.
→ The status alert Probe cleaner not identified (58) is cleared.
11.2.28 Probe cleaner expired (60)

Problem:
The probe cleaner has expired. The system is not operating.
Solution:
2 In the list Tasks, select Drain probe cleaner.
→ The dialog Drain probe cleaner is displayed.
4 Select Next.
→ The status alert Maintenance mode active (15) is displayed. The dialog Drain
probe cleaner is updated.
CAUTION

and regulations.

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11 Troubleshooting
→ The status alert Probe cleaner container missing (59) is displayed. The
dialog Drain probe cleaner shows the current status. The probe cleaner reservoir
is emptied.
8 Discard the probe cleaner container according to national and local standards
and regulations.
9 Wait until the probe cleaner reservoir is empty. This can take up to 20 minutes.
WARNING
False results due to disallowed cleaning agents
◆ Do not use expired probe cleaner.

◆ Observe the instructions for use of the probe cleaner.
barcode reader.
→ In the dialog Drain probe cleaner, the lot number and the expiration date
are displayed.
the holder.
the opening tool.
15 In the dialog Drain probe cleaner, select Next.
→ The dialog Drain probe cleaner is updated.
17 Wait until the probe cleaner reservoir is filled. This can take approximately 6 minutes.
→ The dialog Drain probe cleaner shows the current status. The status alert Probe
cleaner expired (60) is cleared.
18 Select Finish.
cleaned with probe cleaner and afterwards rinsed with purified water.

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11.2.29 Pumping of purified water not possible (63)

Problem:
A problem with the water containers occurred: The front or rear water container is
not correctly connected or the water pump is defective.
Solution:

if required.
→ The status alert Purified water container missing (Water front) (42) is displayed.
→ The status alert Purified water container missing (Water front) (42) is cleared.
The status LED goes off.
7 At both connectors of the rear (stationary) water container, press the push buttons.
→ The stationary water container is disconnected from both connectors.
8 Before removing the stationary water container, carefully push aside both
connectors, if required.
9 Take the stationary water container out of the holder.
→ The status alert Purified water container missing (Water rear) (42) is displayed.
10 Place the stationary water container into the holder slightly pressing the right side.
→ The status alert Purified water container missing (Water rear) (42) is cleared.
The status LED goes off.
11 Press the connectors on the stationary water container until they lock audibly.
11.2.30 Probe cleaner not flowing (64)

Problem:
The probe cleaner does not flow: The screw cap of the probe cleaner container is not
opened, the probe cleaner is used up, or the connection to the fluid unit is clogged.
Solution:

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11 Troubleshooting
CAUTION

and regulations.
3 Check if the screw cap of the probe cleaner container is not opened:
• If the screw cap is not opened, go to ( Page 393 Screw cap locked).
• Otherwise, go to ( Page 393 Probe cleaner used up or connection clogged).
Screw cap locked 1 In the dialog Analyzer, at the bottom left, select Replace probe cleaner.
Replace probe cleaner is updated.
barcode reader.
the holder.
the opening tool.
7 Check the displayed status alerts:
• If the status alert Probe cleaner not flowing (64) is still displayed after 5 minutes,
go to ( Page 393 Probe cleaner used up or connection clogged).
• Otherwise, go to ( Page 394 Finish troubleshooting).
Probe cleaner used up or 1 Unscrew the screw cap of the probe cleaner container using the opening tool.
connection clogged

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2 Check if the probe cleaner is used up:
• If the probe cleaner is used up, replace the probe cleaner container, go to
( Page 269 Replacing the probe cleaner container).
Finish troubleshooting 1 Put the opening tool back in the provided space in the left drawer.
11.2.31 Sample material required (70)

Problem:
Sample material required: <sample ID>. If the sample type is platelet-rich plasma,
'(PRP)' is displayed.
Solution:
1 If required, in the dialog Jobs, search for missing samples by using the filter Sample
material required at the bottom left.
2 In the special case the identified sample tubes are permanently unloaded without
having been processed due to orders sent too late from the LIS, go to the next step.
– or –
Otherwise, go to ( Page 395 Load sample).
3 In the dialog Setup, in the area Configuration, select System.
→ The dialog Setup > System is displayed.
4 In the area LIS order settings. Restart from eco mode required., select the check
box Order waiting time.
NOTICE
Delay of results due to incorrect LIS order settings

◆ Only select an order waiting time other than default Short if identified
sample tubes are permanently unloaded without having been processed due
to orders sent too late from the LIS.
5 To increase the order waiting time, select Medium (or, if the problem persists: Long)
in the list.
down the system).
eco mode).

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Load sample ◆ Load the sample with the displayed sample ID into the sample manager, see
11.2.32 Calibrator or assigned value missing (73)

Problem:
A calibrator or its assigned value is missing: <product short name(s)> (<product

code(s) or product ID(s)>).
Solution:
1 Select the status alert Calibrator or assigned value missing (73).
2 Check the available calibrators:
• If the calibrator is displayed with missing volume, load the displayed calibrator into
the sample manager, see ( Page 282 Loading calibrator and control bottles into
the sample manager).
• Otherwise, add the missing calibrator lot data to the software, see
( Page 284 Adding lot data to the software).
11.2.33 Reagent missing (76)

Problem:
A reagent is missing: <product short name(s)> (<product code(s) or product ID(s)>).
Solution:
1 Select the status alert Reagent missing (76).
2 Load a bottle or cartridge of the displayed reagent and, if applicable, of the displayed
lot into the reagent manager, see ( Page 278 Loading a bottle or a cartridge into the
reagent manager).
11.2.34 Control missing (94)

Problem:
A control is missing: <product short name(s)> (<product code(s) or product ID(s)>).
Solution:
1 Select the status alert Control missing (94).
2 Load the displayed control, see ( Page 278 Loading a bottle or a cartridge into the
reagent manager) or see ( Page 282 Loading calibrator and control bottles into the
sample manager).

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11 Troubleshooting
11.2.35 Temperature in LOCI reader out of range (<too high>/<too

low>) (102)
Problem:
The temperature in the LOCI reader is out of range (<too high>/<too low>).
Solution:
1 Select the status alert Temperature in LOCI reader out of range (<too high>/<too
low>) (102)
2 Check if the status alert Ambient temperature out of range (<too high>/<too
low>) (117) is displayed:
• If the ambient temperature is too high, check if the system’s louvers are occluded
and if the solar radiation can be reduced.
• If the ambient temperature is too low, check if the room temperature can be
re-established in the laboratory as specified.
3 If the status alert is still displayed after 15 minutes, shut down the system, see
( Page 336 Switching to eco mode or shutting down the system).
4 Wait for 10 minutes.

11.2.36 Temperature sensor of LOCI reader defective (103)

Problem:
The temperature sensor of the LOCI reader is defective.
Solution:
11.2.37 Temperature in reagent storage out of range (<too high>/

<too low>) (105)
Problem:
The temperature in the reagent storage is out of range (<too high>/<too low>). The
Solution:
1 Select the status alert Temperature in reagent storage out of range (<too high>/
<too low>) (105)

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11.2.38 Temperature sensor of reagent storage defective (106)

Problem:
The temperature sensor of the reagent storage is defective. The system is

not operating.
Solution:
11.2.39 Temperature in absorbance reader out of range (<too high>/

<too low>) (108)
Problem:
The temperature in the absorbance reader is out of range (<too high>/<too low>).
Solution:
1 Select the status alert Temperature in absorbance reader out of range (<too
high>/<too low>) (108)

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11.2.40 Temperature sensor of absorbance reader defective (109)

Problem:
The temperature sensor of the absorbance reader is defective.
Solution:
11.2.41 Temperature in incubator out of range (<too high>/<too

low>) (111)
Problem:
The temperature in the incubator is out of range (<too high>/<too low>). The
Solution:
1 Select the status alert Temperature in incubator out of range (<too high>/<too
low>) (111)

11.2.42 Temperature sensor of incubator defective (112)

Problem:
The temperature sensor of the incubator is defective. The system is not operating.
Solution:
11.2.43 Temperature in pre-heater out of range (<too high>/<too

low>) (114)
Problem:
The temperature in the pre-heater is out of range (<too high>/<too low>). The

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11 Troubleshooting
Solution:
1 Select the status alert Temperature in pre-heater out of range (<too high>/<too
low>) (114)
11.2.44 Temperature sensor of pre-heater defective (115)

Problem:
The temperature sensor of the pre-heater is defective. The system is not operating.
Solution:
11.2.45 Ambient temperature out of range (<too high>/<too low>)

(117)
Problem:
The ambient temperature is out of range (<too high>/<too low>). The system is
not operating.
Solution:
1 Select the status alert Ambient temperature out of range (<too high>/<too
low>) (117)
2 Check the system temperature Ambient air.
3 Using a separate thermometer, countercheck the ambient air temperature measured

near the air inlet, see ( Page 35 Rear view of the analyzer), number 7.

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11.2.46 Ambient temperature sensor defective (118)

Problem:
The ambient temperature sensor is defective. The system is not operating.
Solution:

2 Contact Siemens Healthineers service.
11.2.47 QC rule violation (120)

Problem:
A quality control rule has been violated: <rule name>, control: <control name>,
lot: <lot number>, assay: <assay short name>, level: <level of the control>. Results
are flagged.
Solution:
◆ See the documentation of the quality control software.
11.2.48 Control result not saved or rejected by QC software (122)

Problem:
A control result has not been saved or has been rejected by the quality control
software, control: <control name>, lot: <lot number>, assay: <assay short name>,
level: <level of the control>.
Solution:
11.2.49 QC database capacity critical (123)

Problem:
The capacity of the quality control database has reached a critical level of <capacity
level> %. Archiving is required.
Solution:

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11 Troubleshooting
11.2.50 Calibration required (130)

Problem:
A calibration is required for assay: <assay short name>.
Solution:
1 Select the status alert Assay using calibration that is almost expired (133).
→ The dialog Calibration is displayed.
2 In the list Curves, check the available curves:
• If a calibration curve that has not expired is available but not active, go to
( Page 401 Activate calibration curve).
• If a new calibration curve has to be measured, go to ( Page 328 Calibrating

an assay).
• If a new calibration curve has to be entered manually, go to

( Page 401 Calibration required (130)).
Activate calibration curve 1 Select the inactive calibration curve.
becomes active.
→ In the list Curves, on the left of the identifier, is displayed. The status alert
is cleared.
Enter curve 1 Select the action button New.
→ The dialog New calibration is displayed.
→ The curve identifier is displayed.
3 Select Enter curve manually.
→ The dialog Enter curve manually is displayed.
4 In the area Reagent lots, select the required product IDs.
Enter supporting point
1 Select .
→ The input fields for the supporting point are added.
2 In the left input field, enter the result for the supporting point.
3 In the right input field, enter the raw value for the supporting point.
4 To enter other supporting points, go to ( Page 401 Enter supporting point).
5 Select Save curve.
→ The identifier of the calibration curve is displayed in the list Curves. The calibration
curve is activated automatically. The status alert is cleared.

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11 Troubleshooting
11.2.51 Problem with compressed air pressure (<too high>/<too

low>) (140)
Problem:
A problem with the compressed air pressure occurred (<too high>/<too low>). The
Solution:
11.2.52 During "Aliquotting speed reduced" only STAT racks will be

processed <rack ID> (10001)
Problem:
When the alert "Aliquotting speed reduced" is displayed, only STAT racks will be
processed (<rack ID>).
Solution:
1 Select the status alert During "Aliquotting speed reduced" only STAT racks will be
processed <rack ID> (10001).
2 For STAT samples, go to the next step.
– or –
For all other samples, wait until some jobs are performed before reloading the rack,
see ( Page 417 Aliquotting speed reduced (84)).
3 Check if the rack with the displayed rack ID is a STAT rack.
4 If applicable, use a STAT rack instead.
5 Press the reverse button of the sample manager.

7 Place the STAT sample rack on the input lane in front of the other racks, see
( Page 302 Placing a STAT sample rack).
11.2.53 Aliquotting not possible. No cap defined for rack <rack ID>-
<rack position> (10002)
Problem:
Aliquotting is not possible because a cap has been detected. No cap is defined for
the rack <rack ID>-<rack position>.

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11 Troubleshooting
Solution:
1 Check the sample tube on the rack with the displayed rack ID and sample position on
the rack.
2 To re-load the sample tube with cap, go to the next step.
– or –
To re-load the sample tube without cap, skip the next 2 steps.
3 Place the sample tube on another rack defined for the sample tube with cap piercing.
4 Skip the next step
5 Remove all caps from the sample tubes on the rack with the displayed rack ID.
6 Load the sample rack.
7 Select the status alert Aliquotting not possible. No cap defined for rack <rack
ID>-<rack position> (10002).
11.2.54 Problem with component: <component name> (10009)

Problem:
A problem with a component occurred: <component name>. The system is

not operating.
Solution:
11.2.55 Incorrect wash program <wash program name> for

component <component name> (10010)
Problem:
Incorrect wash program <wash program name> is defined for component

<component name>.
Solution:
1 Select the status alert Incorrect wash program <wash program name> for
component <component name> (10010).

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11 Troubleshooting

3 Select Yes.
4 On the left, display the subgroups of Assay definition.

→ Assay groups is displayed.
5 Display the subgroups of Assay groups.
→ The available assay groups are displayed.
6 Display the subgroups of the assay group.
7 Display the subgroups of Assay procedures.
8 Display the subgroups of the assay procedure.
→ Process steps and Evaluation methods for raw value are displayed.
9 Display the subgroups of Process steps.
Select Transfer 1 Select a process step Transfer.
on the dialog, select the action button Help or see ( Page 200 Transfer).
The wash program Level 3, for example, must not be used with the aliquot arm in
direct mode.
2 If required, in the list Washing before transfer, select a wash program that can be
used with the component.
3 If required, in the list Washing after transfer, select a wash program that can be used
with the component.
4 On the left, check if there are more transfer process steps:
• If there is another process step Transfer, go to ( Page 404 Select Transfer).
• Otherwise, go to the next step.
11.3 Yellow status alerts

The following chapters describe how to troubleshoot yellow status alerts.
11.3.1 Initializing (2)

Problem:
The system is initializing.
Solution:

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11 Troubleshooting
◆ Wait until the status alert is cleared.
11.3.2 Starting (3)

Problem:
The system is starting.
Solution:
◆ Wait until the status alert is cleared.
11.3.3 System shutting down. Do not switch off the analyzer (5)
Problem:
The system switches to eco mode or shuts down.
The system may switch to eco mode because an automatic shutdown time is
configured in the dialog Setup > Configuration > System, see ( Page 165 System (for
general settings)).
Solution:
1 Wait until the system has shut down.

→ The user interface is locked. The system finishes all open orders for which at least
the first transfer step has been processed (for eco mode and for shutdown). The
software closes. The illumination LED of the reagent manager turns off (for shutdown
or quick shutdown) or blinks slowly (for eco mode).
11.3.4 Transportation problem at component <component name>

(11)
Problem:
A cuvette, carrier with bottle, or cartridge has been dropped at component

<component name>. Results are flagged.
Solution:

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11 Troubleshooting
WARNING
Infection by contaminated material and injury to hands due to moving parts or

due to sharp edges
◆ Only trained users are allowed to perform maintenance as described in

this chapter.
◆ Take special care of the sharp probe tip and other edges during maintenance.
and regulations.
◆ Handle parts of the system which have come into contact with potentially
NOTICE
No processing of assays if dropped item causes initialization problems
1 Carefully note down the exact name of the component stated in the status alert. This
information is required later in this procedure.
All results processed while the status alert Transportation problem at component
<component name> (11) is displayed, are flagged Result doubtful and Cuvette may
be contaminated, see ( Page 73 Flags).
2 Check the system status and the displayed status alerts:
• If the system is off, go to ( Page 406 Open housing).
• If the status alert Initialization required: component <component name> (14)

is displayed, skip the next step.
3 Otherwise, if there are open orders that need to be processed before performing a
quick shutdown, wait until the orders are processed and the results are available.
→ The system status Shutting down is displayed. The system aborts all open orders.
All aliquots in cuvettes on-board are automatically discarded. The reagent cooling is
switched off. The illumination LED of the reagent manager turns off.
Open housing 1 Retrieve the hex key that is provided by Siemens Healthineers.

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11 Troubleshooting
2 At the bottom edge of the cuvette loader cover, insert the hex key into the locking,
see the figure below.
4 2
Releasing the locking of the cuvette loader
(1) Cuvette loader

(2) Right cover
(3) Locking
(4) Left cover
3 Turn the hex key counter clockwise by 90° and hold the hex key in that position.
4 While still holding the hex key, carefully pull the cuvette loader forward.
5 Remove the hex key from the locking.
6 Behind the bottom right edge of the left cover, pull the metallic lever to unlock the
left cover, see the figure below.
Unlocking the left cover (detail view)
(1) Metallic lever

(2) Left cover
7 Carefully raise and hold the left cover.

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11 Troubleshooting
8 Pull the support bar out of the clip on the underside of the left cover, see the
figure below.
Support bar of the left cover
(1) Left cover

(2) Support bar
(3) Clip
(4) Frame
(5) Small opening
(6) Cuvette loader
9 Insert the free end of the support bar into the small opening in the black frame.
10 Behind the bottom left edge of the right cover, pull the metallic lever to unlock the
right cover, see the figure below.
Unlocking the right cover (detail view)
(1) Metallic lever

(2) Right cover

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11 Troubleshooting
11 Carefully raise and hold the right cover.
12 Pull the support bar out of the clip on the underside of the right cover, see the
figure below.
4
5
Support bar of the right cover
(1) Right cover

(2) Support bar
(3) Clip
(4) Frame
(5) Small opening
(6) Cuvette loader
13 Insert the free end of the support bar into the opening in the black frame.
14 Starting at the component displayed in the status alert Transportation problem

at component <component name> (11) and searching in the direction of the
component which transported the item before, look for dropped cuvettes, carriers
with bottles, or cartridges. The following table relates the abbreviated component
name to the component name generally used in this document. Furthermore,
the table provides information on related components, which are accessed by the
component stated in the status alert.

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11 Troubleshooting
Abbreviated component Component name in Related components

name in status alert 11 this manual
TRZ_Cplx_Gripper Cuvette distributor The cuvette distributor moves between the cuvette loader,
(Hall sensor) the aliquot storage, the pre-heater, and the front left cuvette
waste station. For more information, see ( Page 48 Consum‐
TRZ_DInp_CuvDet Cuvette distributor ables unit).
(light barrier)
TXYZB_Cplx_Gripper Rear cuvette arm (Hall sen‐ The rear cuvette arm moves between the pre-heater, the rear
sor) cuvette mixer, the incubator, the LOCI reader, and the rear cuv‐
ette waste station. For more information, see ( Page 49 Reac‐
TXYZB_DInp_CuvSensor Rear cuvette arm tion and measuring unit).
(light barrier)
TXYZF_Cplx_Gripper Front cuvette arm The front cuvette arm moves between the pre-heater, the front
(Hall sensor) cuvette mixer, the incubator, the absorbance reader, and the
front right cuvette waste station. For more information, see
TXYZF_DInp_CuvSensor Front cuvette arm ( Page 49 Reaction and measuring unit).
(light barrier)
TXZRC_DInp_GripSensor Carrier arm (light barrier) The carrier arm transfers cartridges and carriers with bottles
between the input wheel and the reagent storage. For more
information, see ( Page 46 Reagent unit).
Possible component names in status alert 11
15 Remove all dropped cuvettes, carriers with bottles, or cartridges from inside
the analyzer.
16 Raise the right cover slightly and remove the support bar from the opening in
the frame.
17 Hold the right cover and push the free end of the support bar into the clip on the
underside of the right cover, see ( Page 409 Support bar of the right cover).
18 Carefully lower the right cover until it perceptibly rests against the metallic lever.
19 Carefully push the right cover back until it locks audibly.
20 Raise the left cover slightly and remove the support bar from the opening in
the frame.
21 Hold the left cover and push the free end of the support bar into the clip on the
underside of the left cover, see ( Page 408 Support bar of the left cover).
22 Carefully lower the left cover until it perceptibly rests against the metallic lever.
23 Carefully push the left cover back until it locks audibly.
24 Insert the hex key into the locking of the cuvette loader, see ( Page 407 Releasing
the locking of the cuvette loader).
26 While still holding the hex key, carefully slide the cuvette loader backward to the
end position.
27 To lock the cuvette loader cover, turn the hex key clockwise by 90° and remove the
hex key.
28 Start the system from cold, see ( Page 261 Starting the system from cold).
→ The status alert Transportation problem at component <component name>

(11) is cleared. Results from new cuvettes are no longer flagged.

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11.3.5 Maintenance mode active (15)

Problem:
The system is in maintenance mode.
Solution:
1 In the dialog Maintenance > Task execution, perform the required maintenance
task, see ( Page 338 List of maintenance tasks).
→ The status alert is cleared. The tubings are cleaned with probe cleaner and
afterwards rinsed with purified water. The system status Operating in <mm:ss> is
displayed, followed by Operating.
11.3.6 Service recommended: component <component name> (18)

Problem:
Service is recommended for a component: <component name>.
Solution:
◆ Check the displayed component name:
• If the component name is Absorbance reader, go to ( Page 411 Component

name is Absorbance reader).
• Otherwise, go to ( Page 411 All components).
Component name is ◆ If the status alert Service required: stirrer motors defective (10003) is displayed
Absorbance reader in addition to the status alert Service recommended: component Absorbance
reader (18), go to ( Page 430 Service required: stirrer motors defective (10003)).
– or –
Otherwise, contact the Siemens Healthineers service.
All components 1 In the dialog Info > Alerts, in the list Category, select System.
2 Look for the latest status alert Service recommended: component <component
name> (18).
Check details ◆ On the right, in the area Details, check the displayed component name.
• If the component name matches the component name displayed in the status
alert Service recommended: component <component name> (18), follow the
instructions in the area Details.
• Otherwise, select another status alert Problem <problem> and go to

( Page 411 Check details).

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11 Troubleshooting
11.3.7 Updates available (20)

Problem:
Updates are available.
Solution:
1 Select the status alert Updates available (20).

→ The status alert Updates available (20) is cleared. The dialog Updates is
displayed. For more information on the dialog, select the action button Help or see
( Page 170 Updates).
2 Select 1 or more updates.

4 Select Yes.
processed. The system shuts down. The selected updates are installed. If required,
the system re-starts during the installation (1 or more times). When the updates are
finished, the system re-starts.
5 Log on, see ( Page 263 Logging on), and initialize the system, see
( Page 182 Initialization).
6 Select Setup > Updates.

→ The dialog Updates is displayed showing the installed updates.
11.3.8 Clog detected during sample aspiration (21)

Problem:
A clog has been detected during sample aspiration.
Solution:
◆ Troubleshoot all samples with clog on the displayed rack, see

( Page 314 Troubleshooting unidentified samples or samples causing
other problems).
11.3.9 Cleaning of HIL cuvette required. HIL check not possible (23)
Problem:
Cleaning of the HIL cuvette is required. The HIL check is not possible.
Solution:
◆ Clean the HIL cuvette, see ( Page 363 Cleaning the HIL cuvette).
11.3.10 Maintenance due (26)

Problem:
Maintenance is due.

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Solution:
1 Select the status alert Maintenance due (26).
→ The dialog Maintenance > Periodic tasks is displayed. The status alert
Maintenance due (26) is cleared.
2 Perform the required maintenance task, see ( Page 340 Performing

maintenance tasks).
11.3.11 Aliquot probe reached maximum number of cap piercings

(28)
Problem:
The aliquot probe has reached the maximum number of cap piercings.
Solution:
◆ Replace the aliquot probe, see ( Page 364 Replacing the aliquot pipettor).
11.3.12 Access door open (30)

Problem:
The access door of the reagent manager is open.
Solution:
1 Load or unload bottles and cartridges, if required. For loading, see

( Page 278 Loading a bottle or a cartridge into the reagent manager). For
unloading, see ( Page 291 Unloading a bottle or cartridge).
11.3.13 Purified water almost used up (40)

Problem:
The purified water is almost used up.
Solution:
◆ Re-fill purified water, see ( Page 266 Re-filling purified water).
11.3.14 Purified water container missing (<Water front>/<Water

rear>) (42)
Problem:
The purified water container is missing (<Water front>/<Water rear>).
Solution:
◆ Re-fill purified water, if required, and re-insert the purified water container, see
( Page 266 Re-filling the container).

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11.3.15 Cuvettes almost used up (48)

Problem:
The cuvettes are almost used up.
Solution:
11.3.16 Stirrer bars almost used up (50)

Problem:
The stirrer bars are almost used up.
Solution:
◆ Load stirrer bars, see ( Page 265 Loading stirrer bars).
11.3.17 Liquid waste container almost full (52)

Problem:
The liquid waste container is almost full.
Solution:
◆ Empty the liquid waste container, see ( Page 273 Emptying the liquid
waste container).
11.3.18 Cuvette waste container almost full (55)

Problem:
The cuvette waste container is almost full.
Solution:
◆ Empty the cuvette waste container, see ( Page 271 Emptying the cuvette
waste container).
The red status alert Cuvette waste container full (56) is displayed as soon as
approximately 250 more cuvettes are disposed of in the cuvette waste. If Cuvette
waste container full (56) is displayed, the system is no longer operating until the
cuvette waste is emptied.
11.3.19 Probe cleaner container missing (59)

Problem:
The probe cleaner container is missing.
Solution:
1 If the dialog Replace probe cleaner is not yet displayed, in the dialog Analyzer,
select Replace probe cleaner.

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11 Troubleshooting
2 Replace or re-insert the probe cleaner container, see ( Page 270 Inserting the probe
cleaner container).
11.3.20 Registered cuvettes used up (65)

Problem:
The registered cuvettes are used up. Results are flagged.
Solution:
11.3.21 Registered cuvettes almost used up (66)

Problem:
The registered cuvettes are almost used up.
All results measured using unregistered cuvettes receive the flag Results doubtful.
Solution:
11.3.22 Probe cleaner almost expired (67)

Problem:
The probe cleaner has almost expired.
Solution:
cleaner container).
The user can configure a warning period before expiration in the dialog Setup
> Expiration warnings, see ( Page 166 Expiration warnings).
11.3.23 Aliquot not sufficient (72)

Problem:
The volume of an aliquot is not sufficient: <sample ID>.
Solution:
1 If required, in the dialog Jobs, search for samples with insufficient aliquot volume by
using the filter Sample material required at the bottom left.
2 Re-load the sample with the displayed sample ID, see ( Page 293 Loading barcoded
primary sample tubes).

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Proper-fill is not performed for the re-loaded sample tube, see ( Page 462 Pre-analytic
sample integrity check (PSI)).
11.3.24 Calibrator not sufficient (75)

Problem:
The volume of a calibrator is not sufficient: <product short name(s)> (<product

Solution:
◆ Load a new bottle of the displayed calibrator and, if applicable, of the displayed lot,
see ( Page 282 Loading calibrator and control bottles into the sample manager) or
( Page 282 Loading calibrator and control bottles into the sample manager).
11.3.25 Reagent not sufficient (79)

Problem:
The volume of a reagent is not sufficient: <product short name(s)> (<product

Solution:
◆ Load a new bottle of the displayed reagent and, if applicable, of the displayed lot
into the reagent manager, see ( Page 278 Loading a bottle or a cartridge into the
reagent manager).
11.3.26 Sample tubes with identical barcodes on rack <rack ID> (80)
Problem:
Sample tubes on rack <rack ID> have identical sample IDs and identical sample
types, if applicable.
Solution:
◆ Troubleshoot all unidentified samples on the displayed rack, see

other problems).
11.3.27 Reagent storage full (83)

Problem:
The reagent storage is full.
Solution:
1 Select the status alert Reagent storage full (83).

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11 Troubleshooting
2 Unload bottles or cartridges with the loading status or , see

( Page 291 Unloading a bottle or cartridge).
3 Select Overview.
4 In the list Filter, select On-board.
→ All on-board products are displayed.
The dialog Reagents > Overview indicates which products will soon be ejected
automatically, depending on the open orders.
Additionally, in the column Inventory and expiration (Free positions: <number>),

the number of free positions (0 to 47) in the reagent storage is displayed.
5 Check the displayed dialog:
• If the status alert Reagent missing (76) or Control missing (94) is displayed, go
to ( Page 291 Ejecting a bottle or cartridge).
• Otherwise, go to the next step.
6 Wait until the system ejects 1 or more of the displayed products.
11.3.28 Aliquotting speed reduced (84)

Problem:
The aliquotting speed is reduced to match the measurement speed and to prevent
aliquots from exceeding their maximum on-board time in aliquot storage.
Solution:
1 For STAT samples, go to the next step.
– or –
For all other samples, go to ( Page 418 Wait).
2 Press the reverse button of the sample manager.

4 Place the STAT sample rack on the input lane in front of the other racks, see
( Page 302 Placing a STAT sample rack).

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Only a STAT rack can be loaded and prioritized. If another rack is loaded, the rack
is moved to the output lane without taking aliquots and the status alert During
"Aliquotting speed reduced" only STAT racks will be processed <rack ID> (10001)
is displayed.
Wait ◆ Wait until some jobs are performed.
→ The status alert is cleared. The aliquotting continues. More samples can be loaded.
11.3.29 Unidentified item on rack (85)

Problem:
A rack carries an unidentified item: <rack ID>.
Solution:

other problems).
11.3.30 Rack not identified or rack barcode unreadable (86)

Problem:
The rack loaded at this time of the day has not been identified or the rack barcode
was unreadable: <time of day>.
Solution:
1 Check the barcode of the rack.
2 Re-load the rack.
3 If the status alert is still displayed, decide how to proceed:
• Use another rack with a correct barcode.
• For a calibrator and control rack: Define the calibrator and control rack, see
( Page 242 Defining a calibrator and control rack).
11.3.31 Problem rack re-loaded (87)

Problem:
A problem rack has been re-loaded without resolving the problem in the software:
<rack ID>.
Solution:

other problems).

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11.3.32 Unidentified item on input wheel (88)

Problem:
The input wheel carries an unidentified item.
Solution:
NOTICE
No processing of assays if the evaporation cap for a bottle or cartridge is

placed incorrectly
◆ Make sure that the evaporation cap on the bottle or cartridge is

placed correctly.
1 Identify the item:
• For a bottle: Identify the bottle, see ( Page 280 Identifying a bottle loaded into
the reagent manager).
• For a cartridge: Go to the next step.
2 Select the status alert Unidentified item on input wheel (88).
→ The dialog Reagents > Loading is displayed. The loading status Barcode
unreadable is displayed for the unidentified item.
3 Unload the unidentified cartridge, see ( Page 291 Unloading a bottle or cartridge).
4 Check and, if required, replace the barcode of the item, see ( Page 331 Printing
barcode labels).
5 Re-load the cartridge, see ( Page 278 Loading a bottle or a cartridge into the
reagent manager).
6 In the dialog Reagents > Loading, in the area Manual reagent identification, in the
list Product name, select the product name.
→ The list Lot number and the list Bottle type become active. For more information
on the dialog, select the action button Help or see ( Page 105 Loading).
WARNING
False results due to incorrect manual input of product data
7 In the list Lot number, select a lot number.

8 In the list Bottle type, select Cartridge.
9 In the input field Serial number, enter the serial number, if required.
10 Select Save.
→ The display on the left is updated. The reagent is identified.

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11.3.33 Unloading of input wheel required (89)

Problem:
The input wheel requires unloading.
Solution:
◆ Unload all bottles and cartridges, see ( Page 291 Unloading a bottle or cartridge).
11.3.34 Lot data missing (90)

Problem:
Lot data are missing: <product short name(s)> (<product code(s) or product ID(s)>).
Solution:
◆ Add lot data, see ( Page 284 Adding lot data to the software).
11.3.35 Lot data conflict (92)

Problem:
Lot data provided by Siemens conflicts with previously entered user-defined lot
data: <product short name(s)> (<product code(s) or product ID(s)>).
Solution:
◆ Select the status alert Lot data conflict (92).
→ The dialog Data > Lot data is displayed. Products, lots, and, if applicable, assigned
values with conflicts are marked in yellow. For more information on the dialog, select
the action button Help or see ( Page 176 Lot data).
The selected product, lot, and, if applicable, assigned value are marked in blue. The
conflicts can be hidden by the selection. By selecting another line, the yellow marked
conflicts become visible.
Resolve conflict 1 In the list Product names, select a product with a conflict.
→ On the right, the lists Lots and, if applicable, Assigned values are displayed.
2 For thromboplastins: Go to the next step.
– or –
For controls: Go to ( Page 421 Check assigned values).
3 In the list Lots, select a product ID with a conflict.

→ The action button Resolve becomes active.

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11 Troubleshooting
4 Check the values ISI, Default ISI, MNPT, and Default MNPT:
• To keep the previously entered user-defined lot data, go to ( Page 421 Keep
lot data).
• To use the lot data provided by Siemens Healthineers, go to ( Page 421 Accept
new lot data).
Check assigned values 1 In the list Assigned values, select an assay with a conflict.
→ The action button Resolve becomes active.
2 Check the values Assigned value, Default value, Acceptance range, and Default
acceptance range:
• To keep the previously entered user-defined lot data, go to ( Page 421 Keep
lot data).
• To use the lot data provided by Siemens Healthineers, go to ( Page 421 Accept
new lot data).
Keep lot data 1 Select the action button Resolve.

2 Select Keep existing.
→ The previously entered user-defined lot data is kept. The yellow marking is cleared.
When all conflicts have been resolved, the status alert is cleared.
3 Go to ( Page 421 Continue troubleshooting).
Accept new lot data 1 Select the action button Resolve.

2 Select Accept new.
→ The lot data provided by Siemens Healthineers is used. The yellow marking is
cleared. When all conflicts have been resolved, the status alert is cleared.
Continue troubleshooting ◆ If the status alert is still displayed, go to ( Page 420 Resolve conflict).
11.3.36 Item without evaporation cap on input wheel (93)

Problem:
The input wheel carries an item without evaporation cap.
Solution:
1 Select the status alert Item without evaporation cap on input wheel (93).
2 Check the loading status of all bottles and cartridges on the input wheel.
→ The loading status Evaporation cap missing is displayed for the bottle or cartridge
without evaporation cap.

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11 Troubleshooting
3 Unload the bottle or cartridge without evaporation cap, see ( Page 291 Unloading
a bottle or cartridge).
4 Place a suitable evaporation cap on the bottle or cartridge:
• For bottles: Align the arrow to the arrow on the label of the bottle, see
( Page 57 Evaporation caps).
• For cartridges: See ( Page 57 Evaporation caps) and the instructions for use of
the reagent.
5 Re-load the bottle or cartridge, see ( Page 278 Loading a bottle or a cartridge into
the reagent manager).
11.3.37 Control not sufficient (96)

Problem:
The volume of a control is not sufficient: <product short name(s)> (<product code(s)
or product ID(s)>).
Solution:
◆ Load a new bottle of the displayed control and, if applicable, of the displayed lot,
see ( Page 278 Loading a bottle or a cartridge into the reagent manager) or
( Page 282 Loading calibrator and control bottles into the sample manager).
11.3.38 Product expired (97)

Problem:
For a reagent, control, or calibrator in the reagent storage, either the on-board
stability period or the expiration date has been exceeded. Results are flagged.
The status alert Product expired (97) is displayed if one of the following conditions
is fulfilled:
• For the activated assays, the shortest configured assay-specific reagent onboard-
stability has been exceeded.
• No assay-specific reagent onboard-stability is defined but the general reagent

onboard-stability has been exceeded.
• Assay-specific reagent onboard-stabilities are defined, but not for all assays. For at
least one assay, the general reagent onboard-stability has been exceeded.
• The expiration date has been exceeded.
Solution:
1 Select the status alert Product expired (97).
→ The dialog Reagents > Assays availability is displayed.
2 If the details are hidden, select Show details.
3 In the list Filter, select Expired or almost expired.

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4 Check the displayed Remaining on-board stability:
• To prevent further results to be flagged doubtful, go to the next step.
• Otherwise, the system continues using the expired reagent, control, or calibrator.
Results measured with the expired product are flagged.
Alternatively, the expiration date for the expired product can be checked in the dialog
Reagents > Overview.
5 Eject the expired reagent, control, or calibrator, see ( Page 291 Ejecting a bottle
or cartridge).
Only reagents, controls, or calibrators without open orders can immediately be

ejected. Thus, Siemens Healthineers recommends not to request further orders for
assays which are using the expired product. For products with open orders, ejecting
may take longer.
A product defined as Wash solution will not be used if expired. A bottle with expired
wash solution is automatically ejected from the reagent wheel.
6 Unload the expired reagent, control, calibrator, or wash solution, see

( Page 291 Unloading a bottle or cartridge).
11.3.39 Overfilled bottle or cartridge on input wheel (98)

Problem:
The input wheel carries an overfilled bottle or cartridge.
Solution:
1 Select the status alert Overfilled bottle or cartridge on input wheel (98).
→ The dialog Reagents > Loading is displayed. For an overfilled bottle, the loading
status Bottle overfilled is displayed. For an overfilled cartridge, the loading status
Unloading is displayed.
2 Unload the overfilled bottle or cartridge, see ( Page 291 Unloading a bottle
or cartridge).
3 Load a new bottle or cartridge of the reagent, control, or wash solution, see
( Page 278 Loading a bottle or a cartridge into the reagent manager).
11.3.40 Product almost expired (99)

Problem:
The reagent, control, or calibrator has almost expired.

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The user can configure the warning period for products in the reagent storage in the
dialog Expiration warnings, see ( Page 166 Expiration warnings). When the product
expires, the status alert Product expired (97) is displayed and all results measured
using the expired reagent receive the flag Result doubtful.
Only a product defined as Wash solution will not be used if expired. A bottle with
expired wash solution is automatically ejected from the reagent wheel.
Solution:
1 Select the status alert Product almost expired (99).
→ The dialog Reagents > Assays availability is displayed.
2 If the details are hidden, select Show details.
3 In the list Filter, select Expired or almost expired.
4 Check if the open orders require the displayed product.
5 To prevent results to be flagged doubtful, go to the next step.
– or –
Otherwise, the system continues using the almost expired reagent, control, or
calibrator without flagging results doubtful until the status alert Product expired
(97) is displayed.
6 Eject the almost expired reagent, control, or calibrator, see ( Page 291 Ejecting a
bottle or cartridge).
7 Unload the almost expired reagent, control, or calibrator, see ( Page 291 Unloading
a bottle or cartridge).
8 Load a new bottle or cartridge of the reagent, control, or calibrator, see

( Page 278 Loading a bottle or a cartridge into the reagent manager).
11.3.41 Operating temperatures not yet reached (100)

Problem:
The system has not yet reached its operating temperatures.
Solution:
1 Wait until the status alert is cleared. This can take up to 30 minutes.
11.3.42 Temperature in LOCI reader in warning range (<too high>/

<too low>) (101)
Problem:
The temperature in the LOCI reader is in the warning range (<too high>/<too low>).
Solution:
1 Select the status alert Temperature in LOCI reader in warning range (<too high>/
<too low>) (101)

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11.3.43 Temperature in reagent storage in warning range (<too

Problem:
The temperature in the reagent storage is in the warning range (<too high>/
<too low>).
Solution:
1 Select the status alert Temperature in reagent storage in warning range (<too
11.3.44 Temperature in absorbance reader in warning range (<too

Problem:
The temperature in the absorbance reader is in the warning range (<too high>/
<too low>).
Solution:

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1 Select the status alert Temperature in absorbance reader in warning range (<too
11.3.45 Temperature in incubator in warning range (<too high>/<too

low>) (110)
Problem:
The temperature in the incubator is in the warning range (<too high>/<too low>).
Solution:
1 Select the status alert Temperature in incubator in warning range (<too high>/
<too low>) (110)
11.3.46 Temperature in pre-heater in warning range (<too high>/

<too low>) (113)
Problem:
The temperature in the pre-heater is in the warning range (<too high>/<too low>).

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Solution:
1 Select the status alert Temperature in pre-heater in warning range (<too high>/
<too low>) (113)
11.3.47 Ambient temperature in warning range (<too high>/<too

low>) (116)
Problem:
The ambient temperature is in the warning range (<too high>/<too low>).
Solution:
1 Select the status alert Ambient temperature in warning range (<too high>/<too
low>) (116)
2 Check the system temperature Ambient air.


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11.3.48 Required calibration running (129)

Problem:
An assay with request is being calibrated: <assay short name>.
Solution:
1 Select the status alert Required calibration running (129).

2 Check if status alerts for reagents or calibrators related to the assay are displayed.
3 If required, load the reagent, if applicable, of the displayed lot into the reagent
manager, see ( Page 278 Loading a bottle or a cartridge into the reagent manager).
4 If required, load the calibrator, if applicable, of the displayed lot into the sample
manager, see ( Page 282 Loading calibrator and control bottles into the
sample manager).
5 Wait until the calibration is finished.
→ In the list Curves, the identifier is displayed in black. The status alert is cleared. A
valid and not doubtful calibration curve is activated automatically.
11.3.49 Required re-calibration running (131)

Problem:
An assay uses an expired calibration: <assay short name>. The assay is being re-
calibrated.
Solution:
1 Select the status alert Required re-calibration running (131).

The system continues to use an active calibration curve until a new calibration curve
is available. The affected sample results are flagged, but may already have been
transferred to the LIS. If required, new sample orders have to be requested using a
newly measured calibration curve or using another existing calibration curve.
2 Check if status alerts for reagents or calibrators related to the assay or related to the
assay, by which the calibration curve is used, are displayed.
3 If required, load the reagent, if applicable, of the displayed lot into the reagent
manager, see ( Page 278 Loading a bottle or a cartridge into the reagent manager).
4 If required, load the calibrator, if applicable, of the displayed lot into the sample
manager, see ( Page 282 Loading calibrator and control bottles into the
sample manager).
5 Wait until the calibration is finished.
→ In the list Curves, the identifier is displayed in black. The status alert is cleared. A
valid and not doubtful calibration curve is activated automatically.

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11.3.50 Re-calibration required (132)

Problem:
A re-calibration is required for assay: <assay short name>.

Solution:
1 Select the status alert Re-calibration required (132).

The system continues to use an active calibration curve until a new calibration curve
is available. The affected sample results are flagged, but may already have been
transferred to the LIS. If required, new sample orders have to be requested using a
newly measured calibration curve or using another existing calibration curve.
2 In the list Curves, check the available curves:
• To delete the expired calibration curve, go to ( Page 429 Delete expired

calibration curve).
• To activate another curve, which has not expired, go to ( Page 429 Activate
calibration curve).
• To measure a new calibration curve, go to ( Page 328 Calibrating an assay).
Delete expired 1 Select the expired calibration curve.

calibration curve
→ The action button Delete becomes active.
3 Select Delete.
→ The expired calibration curve is deleted. If another valid and not doubtful
calibration curve is available for the assay and, if applicable, for the same lot or lot
combination, the calibration curve is activated. The status alert is cleared.
Activate calibration curve 1 Select the inactive calibration curve.
becomes active.
→ If another calibration curve is active for the same lot or lot combination, a
confirmation dialog is displayed.
3 Select Yes.
→ The calibration curve is activated. In the list Curves, on the left of the identifier,
is displayed. The status alert is cleared.

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11.3.51 Assay using calibration that is almost expired (133)

Problem:
An assay is using a calibration that is almost expired: <assay short name>.
Solution:
◆ Calibrate the assay, see ( Page 328 Calibrating an assay).
The status alert is displayed:
• until all expired calibrations are re-measured and/or
• until no calibration is within the expiration warning period
The user can configure a warning period before expiration in the dialog Setup
> Configuration > Expiration warnings, see ( Page 166 Expiration warnings).
11.3.52 Service required: stirrer motors defective (10003)

Problem:
One or more defective stirrer motors require service. The throughput for
optomechanical assays is reduced. Other assays are not affected.
Solution:
◆ If no optomechanical assays are used on the system, the status alert can be ignored.
The stirrer motors will be replaced during the next on-site servicing by Siemens
– or –
Otherwise, contact Siemens Healthineers service to arrange a quick replacement.
If a stirrer motor is defective, the corresponding cuvette position for stirring assays
is deactivated. The photometer continues processing assays from the remaining
cuvette positions.
11.3.53 Unknown sample tube type: barcode <barcode> on rack

<rack ID>‑<rack position> (10005)
Problem:
The sample tube type for the sample tube with the barcode <barcode> on rack <rack
ID>‑<rack position> is unknown.
Solution:
1 Check the displayed sample tube on the displayed rack.
2 Select the status alert Unknown sample tube type: barcode <barcode> on rack
<rack ID>‑<rack position> (10005).

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3 Re-load the rack.
4 If the status alert is displayed again, use another sample tube instead of the sample
tube with the displayed barcode.
11.3.54 Insufficient volume of sample, calibrator, or control on rack

<rack ID>‑<rack position> (10006)
Problem:
The volume of a sample on a rack or of a calibrator or control on a calibrator and

control rack is insufficient (<rack ID>‑<rack position>).
Solution:
1 Check if one of the following status alerts is displayed:
• If the status alert Sample material required (70) or Aliquot not sufficient (72) is
displayed, load sufficient volume of the sample with the displayed sample ID, see
• If the status alert Calibrator or assigned value missing (73) or Calibrator not
sufficient (75) is displayed, load a new bottle of the displayed calibrator and, if
applicable, of the displayed lot, see ( Page 277 Preparing a bottle for loading into
the reagent manager) and ( Page 278 Loading a bottle or a cartridge into the
reagent manager), or see ( Page 282 Loading calibrator and control bottles into
the sample manager).
• If the status alert Control missing (94) or Control not sufficient (96) is displayed,
load a new bottle of the displayed control and, if applicable, of the displayed lot,
see ( Page 282 Loading calibrator and control bottles into the sample manager).
• Otherwise, wait for one of the status alerts to be displayed and repeat the first step.
• If none of the above mentioned status alerts is displayed, go to the next step.
For samples measured in direct mode, the status alert Insufficient volume of
sample, calibrator, or control on rack <rack ID>‑<rack position> (10006) might
be displayed because a default aliquot volume or a default profile is configured, see
( Page 466 Processing of assays).
2 Select the status alert Insufficient volume of sample, calibrator, or control on rack
<rack ID>‑<rack position> (10006).
11.3.55 Fan problem <fan number> (10007)

Problem:
A fan problem occurred (<fan number>).
Solution:
1 Select the status alert Fan problem <fan number> (10007).
→ The dialog Info > Alerts is displayed. If the problem has been resolved, the status
alert is cleared.

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2 If the status alert is still displayed, check if the system’s louvers are occluded and
remove obstructions of the air flow, if applicable.
11.4 Component names in status alerts

The following table lists the possible contents of the variable <components> for status
alerts using this variable. The contents of the variable for the status alert Transportation
problem at component <component name> (11) are explained separately, see
( Page 405 Transportation problem at component <component name> (11)).
<component name> Used in status alert with ID:
14a) 18b) 19c) 10009d) 10010e)
Aliquot storage × × × × –
Cuvette loader × × × × –
HIL reader × × × × ×
Incubator × × × × –
LOCI reader × × × × –
Cuvette mixer for rear cuvette arm × × × × –
Cuvette mixer for front cuvette arm × × × × –
Absorbance reader × × × × –
Pre-heater × × × × –
Sample manager × × × × –
Reagent manager × × × × –
Reagent storage (including cooling unit) × × × × –
Reagent shaker × × × × –
Stirrer bar loader × × × × –
Fluid unit × × × × –
Aliquot arm × × × × ×
Carrier arm × × × × –
Rear cuvette arm × × × × –
Front cuvette arm × × × × –

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11 Troubleshooting
<component name> Used in status alert with ID:
14a) 18b) 19c) 10009d) 10010e)
Cuvette distributor × × × × –
Rear reagent arm × × × × ×
Front reagent arm × × × × ×
Sample arm × × × × ×
Access door × × × × –
Wash station for aliquot arm × × × × ×
Wash station for rear reagent arm × × × × ×
Wash station for front reagent arm × × × × ×
Wash station for sample arm × × × × ×
Component names
a) Initialization required: component <component name> (14)

b) Service recommended: component <component name> (18)
c) Service required: component <component name> (19)
d) Problem with component: component <component name> (10009)
e) Incorrect wash program for component <component name> (10010)
11.5 Possible entries for <problem>

The following table lists the possible contents of the variable <problem> for status alerts
Problem <problem>.
ID Message Measure
5000 Problem "DevErrCntExceeded" Report the message and ID to Siemens Healthineers service.
5001 Problem "AssErrCntExceeded"
5002 Problem "MeasFailue"
5003 Problem "TemperatureError"
5004 Problem "NoFreePos"
5005 Problem "CompressedAir"
5006 Problem "ClogDetected"

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11 Troubleshooting
ID Message Measure
5007 Problem "WastePressure" Check the connection to the liquid waste containers and
re-connect them, if applicable. The problem might be that
1 liquid waste container is full and cannot be emptied
due to the incorrect connection. For more information, see
If the liquid waste containers have been re-connected, repeat
the initialization of the fluid unit, see ( Page 380 Initializa‐
tion required: component <component name> (14)).
If the status alerts are still displayed, report the message and
ID to Siemens Healthineers service.
5008 Problem "CrashDetected" Report the message and ID to Siemens Healthineers service.
5009 Problem "MeasChnFailure"
5010 Problem "PosUnusable"
5011 Problem "CalibRecommended"
5012 Problem "InitFailed"
5013 Problem "MechDisplacement"
5014 Problem "StateChangeFailed" Check the sample integrity manually. Report the message and
ID to Siemens Healthineers service.
5015 Problem "DrainingTestFailed"
5016 Problem "FlushingTestFailed"
5017 Problem "CleaningFailed"
5018 Problem "NotEmpty"
5019 Problem "MeasUnitChngRequired"
5020 Problem "CalibNeeded" Do not restart the system. Report the message and ID to
5021 Problem "SensorError" Problem "SensorError", component {0}

If the component is 'Sample manager', proceed as follows:
1. Take the racks from the output lane of the sample manager.
2. Press the unload button to remove all remaining racks.
3. In the dialog 'Maintenance', select 'Task execution'. -> The
dialog 'Maintenance' > 'Task execution' is displayed.
4. In the list 'Tasks', select 'Initialization'. -> On the right, a task
description is displayed.
5. In the list 'Initialize', select the component 'Sample manag‐
er'.
6. Select the action button 'Start'. -> The component is ini‐
tialized. If the initialization is successful, the status alert
is cleared.
Otherwise, contact Siemens Healthineers service indicating
the problem in the area 'Details'.
5022 Problem "LeakageFluidSystem" Report the message and ID to Siemens Healthineers service.

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11 Troubleshooting
ID Message Measure
5023 Problem "WasteOverfilled" Report the message and ID to Siemens Healthineers service.
5024 Problem "ClogNotReleased"
5025 Problem "PotentialVesselLoss" Do not restart the system. Report the message and ID to
5026 Problem "ResourceJam" For information on how to remove cuvette blockings,

see ( Page 439 Removing cuvette blockings in the cuv‐
ette loader).
Possible entries for <problem>
11.6 Other problems

The following chapters describe problems that are not indicated by status alerts.
11.6.1 Problem with software start

Problem:
The software does not start correctly. A dialog with the buttons Retry, Service logon,
and Shutdown is displayed.
Solution:
1 Select Retry.
2 If the dialog is still displayed, select Shutdown.

3 Contact Siemens Healthineers service.
11.6.2 Stirrer bars filled into cuvette loader

Problem:
Stirrer bars have accidentally been filled into the cuvette loader. Stirrer bars affect the
correct functioning of the system. False results and damage to the system can result.
Solution:
11.6.3 Problem with analyzer

Problem:
The analyzer does not function properly, for example, it does not start.
Solution:
2 If the problem persists, contact Siemens Healthineers service.

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11 Troubleshooting
11.6.4 Problem with peripherals

Problem:
A peripheral device does not function properly, for example, the touchscreen monitor,
the mouse, the keyboard, the virtual keyboard, or the handheld barcode reader.
Solution:
1 If an additional USB device has been connected before the problem occurred, remove
the USB device.
down the system).
eco mode).
11.6.5 Problem with LAS connection

Problem:
The sample tube is not in the defined aliquotting position of the LAS connection, or
another problem occurred during aliquotation from the LAS connection.
Solution:
1 Check if the sample processing status Unknown error is displayed for the analyzer in
the LAS control software.
For more information on LAS problems, see the documentation of the LAS.
2 Select System > Pause.
processed. The system status Maintenance is displayed.

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11 Troubleshooting
WARNING
Infection by contaminated material and injury to hands due to moving aliquot

probe or due to sharp edges at LAS access
◆ Only trained users are allowed to perform maintenance as described in

this chapter.
◆ Take special care of the sharp probe tip and other edges during maintenance.
and regulations.
◆ Do not open the cover until the system is in the system status Paused and
the aliquot probe has reached the parking position.
◆ Handle parts of the system which have come into contact with potentially
3 Unscrew the transparent cover of the LAS connection, see the figure below.
3
2
1
Unscrewing the transparent cover of the LAS connection (LAS is not displayed)

(2) Screws (one on the rear side)
(3) Recesses (one on the rear side)

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11 Troubleshooting
4 Lift the transparent cover of the LAS connection upwards until the 2 screws are close
to the top of the recesses.
3
2
1
Lifting the transparent cover of the LAS connection (LAS is not displayed)

(2) Recesses (one on the rear side)
(3) Screws (one on the rear side)
5 Screw the transparent cover of the LAS connection close to the top of the recesses.
6 If required to access the problem, unscrew the top cover of the LAS and remove it.
7 Check if one or several of the following steps can resolve the problem:
• Check if the stop gate of the LAS connection is free to move.
• Remove any mechanical blocking at the LAS connection.
• Check if the sample tube is correctly placed into the carrier.
• Check if the sample tube is clogged.
• For further causes, see the documentation of the LAS.
9 If applicable, place the top cover of the LAS in its correct position and screw it.
10 Unscrew the transparent cover of the LAS connection close to the top of the recesses.
11 Move the transparent cover of the LAS connection downwards until the 2 screws are
at the bottom of the recesses.
12 Screw the transparent cover of the LAS connection at the bottom of the recesses.
→ The system status Operating in <mm:ss> is displayed, followed by Operating.

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11 Troubleshooting
11.6.6 Removing cuvette blockings in the cuvette loader

To remove cuvette blockings in the cuvette loader, the following procedures need to be
followed in the given order until an initialization resolves the cuvette blocking.
✓ A dry, soft, disposable, lint-free cloth is available.
✓ 1 hex key, delivered by Siemens Healthineers, is available.
Initialize cuvette loader 1 In the system software, in the tool bar, select Maintenance > Task execution.
For more information on the dialog, select the action button Help or see
( Page 174 Task execution).
2 On the left, select Initialization.
3 On the right, select .
→ A list of hardware components is displayed.

4 Select Cuvette loader.
5 At the top right, select Start.

→ The dialog Initialization is displayed.
6 Select Next.
→ The cuvette loader is initialized. After initialization is completed, a message

is displayed.
7 If the message Initialization of 'Cuvette loader' completed is displayed, go to the

next step.
– or –
If the message Initialization of 'Cuvette loader' failed is displayed, go to

( Page 439 Remove cuvette blockings in upper part of cuvette loader).
8 Select Finish.
→ The cuvette blocking is resolved.
Remove cuvette blockings in 1 Select Finish.

upper part of cuvette loader
→ The message Initialization of 'Cuvette loader' failed is closed.

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11 Troubleshooting
2 Open the cover of the cuvette loader, see the figure below.
1 2
Removing cuvette blockings in the upper part of the cuvette loader
(1) Cover
(2) Separating plate
3 On the right side of the cuvette loader, slide a hand down the side to the lower edge
of the separating plate.
4 Carefully stir the cuvettes by hand. Do not use any tool.
5 Initialize the cuvette loader, see ( Page 439 Initialize cuvette loader).

next step.
– or –

( Page 440 Remove cuvette blockings in bottom part of cuvette loader).
7 Select Finish.

8 Close the cover of the cuvette loader.

bottom part of cuvette loader

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11 Troubleshooting
2 Remove the cuvettes from the upper part of the cuvette loader by hand, see the
figure below.
Locking of the cuvette loader
(1) Cuvette loader

(2) Cuvette loader cover
(3) Locking
3 At the bottom edge of the cuvette loader cover, insert the hex key into the locking.
5 While still holding the hex key, carefully pull the cuvette loader forward.
→ The status alert Housing lid or cuvette loader open (29) is displayed.
6 Remove the hex key from the locking.

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11 Troubleshooting
7 At the right side of the cuvette loader assembly, push the access lid of the cuvette
loader slightly upward, see the figure below.
3 2
Opening the access lid of the cuvette loader
(1) Access lid

(2) Cuvette loader
(3) Cuvette loader assembly
8 Open the access lid of the cuvette loader.

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11 Troubleshooting
9 Carefully loosen the 2 clamps securing the separating plate to the cuvette loader, see
the figure below.
1 1
3
4
Removing the separating plate
(1) Clamps
(3) Cuvette loader
(4) Access lid
10 Carefully move the separating plate upward while holding the clamps until the
clamps come free of the cuvette loader.
11 Carefully remove the separating plate.
12 Remove all cuvettes and possible foreign bodies from the cuvette loader.
13 Clean the inside of the cuvette loader with a dry, soft, disposable, lint-free cloth. Do
not use any liquid.
CAUTION
Injury to fingers, hands, and other body parts by moving parts inside the system
◆ Keep clear of moving parts when the system is initialized while open. Long
hair, necklaces, bracelets, and similar objects can get caught in moving parts.

next step.
– or –

( Page 444 Remove cuvette blockings in feed hopper):
16 Select Finish.

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11 Troubleshooting
17 Hold the separating plate as displayed in the figure below.
2 2
Orientation of separating plate

(2) Clamps
18 Carefully insert the separating plate into the cuvette loader above the opening left by
the access lid.
19 Carefully move the 2 clamps down over the top rim of the cuvette loader.
20 Carefully move the separating plate down until the clamps lock audibly on either side
in their original position.
21 Close the access lid of the cuvette loader.
22 Carefully slide the cuvette loader assembly backward.
23 Insert the hex key into the locking of the cuvette loader, see ( Page 441 Locking of
the cuvette loader).
25 While still holding the hex key, carefully slide the cuvette loader backward to the
end position.
26 To lock the cuvette loader cover, turn the hex key clockwise by 90° and remove the
hex key.
27 Load cuvettes, see ( Page 263 Loading cuvettes).

feed hopper

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11 Troubleshooting
2 At the left side of the cuvette loader assembly, carefully turn the metal bar below the
feed hopper several times by hand in both directions, see the figure below.
Removing cuvette blockings in the feed hopper
(1) Feed hopper

(2) Metal bar
The metal bar can be turned in both directions. While turning, a slight resistance of the
motor can be felt.
3 If the metal bar cannot be turned or if the resistance from the motor is substantial,
contact Siemens Healthineers service. Otherwise, skip this step.
CAUTION

next step.
– or –

( Page 446 Remove cuvette blockings in chute and escapement).
6 Select Finish.

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11 Troubleshooting
2 2

(2) Clamps
the access lid.
13 At the bottom edge of the cuvette loader cover fasten the locking with the hex key.

chute and escapement

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11 Troubleshooting
2 Behind the cuvette loader, loosen the captive knurled screw that holds the
transparent cover of the chute, see the figure below.
2
3
6 5
Removing cuvette blockings in the chute
(1) Cuvette loader

(2) Nose of the transparent cover
(4) Captive knurled screw
(5) Cables
(6) Chute
NOTICE
System failure due to damaged cables and electronic parts

◆ Take special care while removing the transparent cover.
3 Carefully remove the transparent cover. Take care not to loosen or break the cables
attached to the transparent cover and to the chute.
4 Remove all cuvettes and possible foreign bodies from the chute.

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11 Troubleshooting
5 Clean the chute, see the figure below, with a dry, soft, disposable, lint-free cloth. Do
not use any liquid.
1 2 3
9 7 8 7
Removing cuvette blockings in the escapement
(1) Chute
(2) Screw hole
(3) Escapement
(4) Spring clip
(5) Locking screw
(6) Knurled screw
(7) Cables
(9) Nose of the transparent cover
6 At the right side of the escapement, grasp the spring clip of the locking screw.
7 Unlock the locking screw and turn the escapement assembly from the chute.
8 Turn the escapement in both directions and remove all cuvettes and possible
foreign bodies.
9 Clean the inside of the escapement with a dry, soft, disposable, lint-free cloth. Do not
use any liquid.
10 Turn the escapement assembly back to the chute and secure it with the locking screw.
11 Swivel the spring clip in.

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11 Troubleshooting
CAUTION
NOTICE
System failure due to damaged cables and electronic parts
◆ Take special care while removing the transparent cover.
12 Carefully slide the nose of the transparent cover under the feed hopper until the
captive knurled screw is placed above the screw hole. Take care not to loosen or break
the cables attached to the transparent cover and to the chute.
13 Screw the knurled screw hand-tight to fit the transparent cover to the chute.

next step.
– or –
If the message Initialization of 'Cuvette loader' failed is displayed, contact Siemens

16 Select Finish.
2 2

(2) Clamps
the access lid.

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11 Troubleshooting
23 At the bottom edge of the cuvette loader cover fasten the locking with the hex key.
→ Removing cuvette blockings in the cuvette loader is completed.
11.7 Exporting troubleshooting data using remote services

To export troubleshooting data if the remote services are installed, proceed as follows:
1 In the dialog Setup, in the area Tools, select Data manager.

2 To create a system backup, go to ( Page 450 Create system backup).
– or –
To create troubleshooting data or troubleshooting data only for hardware issues, go
to ( Page 450 Create troubleshooting data).
– or –
If the files to be exported are already created, go to ( Page 451 Export data).
11.7.1 Create system backup

1 If required, select Backup.
→ The dialog Backup is displayed. For more information on the dialog, select the
action button Help or see ( Page 134 Backup).
2 Select System backup.

→ The file is created.
4 Go to ( Page 451 Export data).
11.7.2 Create troubleshooting data

1 If required, select Backup.
→ The dialog Backup is displayed. For more information on the dialog, select the
action button Help or see ( Page 134 Backup).
2 Select Troubleshooting data or Hardware issues.

→ The file is created.

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11 Troubleshooting
5 Go to ( Page 451 Export data).
11.7.3 Export data

1 Select Export.
→ The dialog Export is displayed. For more information on the dialog, select the
action button Help or see ( Page 136 Export).
2 On the left, in the area Source, select the source type, for example, Backup files.
→ In the middle, the available backup files are displayed.
3 Select the files to be exported.
4 On the right, in the area Target, select Upload.
→ The action button Start becomes active.
→ The selected files are exported to the upload folder. The upload status is displayed
at the bottom.
6 When Export completed is displayed, contact Siemens Healthineers service

indicating the uploaded files.
→ The dialog is closed.

Print No. DCHS-G01.621.01.08.02 451
12 Technical specifications
This chapter describes the specifications of the system and the
environmental conditions.
12.1 Analyzer
Dimensions and weight
Dimensions (W x H x D) 1858 mm x 1415 mm x 1042 mm

(73.15 in x 55.71 in x 41.02 in) without
LAS connection
2156 mm x 1415 mm x 1042 mm
(84.88 in x 55.71 in x 41.02 in) with
LAS connection
Required space for ventilation 300 mm (12 in) on the right side and on
the rear side
Required working space 800 mm (31 in) on the front side
Required space for service (may overlap 800 mm (31 in) on the right side and on
with other working spaces) the rear side
Weight 600 kg (1322 lbs) without LAS connec‐

tion
617 kg (1360 lbs) with LAS connection
Dimensions and weight
Sample unit
Sample types Platelet-poor plasma

Platelet-rich plasma
Calibrator
Control
Rack types Sample rack

Bottle types on calibrator and control rack GW 2.5 (with adapters)

GW 5
Typical residual volume in bottles GW 2.5 bottle: ≤300 μLa)

GW 5 bottle: ≤300 μL
Material and rack identification By barcode
Aliquot pipetting volume Depends on the requested orders

Print No. DCHS-G01.621.01.08.02 452
Throughput (examples using HIL check PT sec Innovin or APTT Actin FSL:
and cap piercing) ≥ 200 results/hour
PT sec Thromborel S and APTT Pathromtin
SL: ≥ 350 results/hour
PT sec Thromborel S, APTT Pathromtin SL,
and Antithrombin INNOVANCE (Anti Xa):
≥ 330 results/hour
PT sec Thromborel S, APTT Pathromtin SL,
Antithrombin INNOVANCE (Anti Xa), and
D-Dimer INNOVANCE: ≥ 310 results/hour
Maximum on-board time in aliquot stor‐ 4 hours

age
Sample unit
a) There may be variation in the stated residual volume due to differences in reagent types and due to
variation from bottle to bottle. When performing calibrations from a calibrator and control rack the
residual volumes may be significantly higher due to safety margins.
Reagent unit
Bottle types GW 5
GW 15
Cartridge
Material and bottle or cartridge identifica‐ By barcode

tion
Reagent storage 48 positions for up to 47 bottles or car‐

tridges
Cooling in reagent storage 5–12 °C
Reagent pipetting volume 10–180 μL
Typical residual reagent volume GW 5 bottle: ≤300 μLa)

GW 15 bottle: ≤300 μLa)
Cartridge: ≤150 μL
Reagent unit
a) There may be variation in the stated residual volume due to differences in reagent types and due to
variation from bottle to bottle.
Cuvettes and stirrer bars
Supply capacity Cuvettes: 1500

Stirrer bars: 1200
Waste capacity 4000 cuvettes
Cuvettes and stirrer bars

Print No. DCHS-G01.621.01.08.02 453
Reaction and measuring unit
Sample pipetting volume 2–150 μL
Reagent pipetting volume 10–180 μL
Fill volume of a cuvette 120–250 μL
Temperature In the pre-heater: 37 °C

In the incubator: 37 °C
Incubation time Programmable up to a maximum of

1800 s
Reaction and measuring unit
Absorbance reader
Light sources LEDs
Wavelengths 340 nm , 405 nm, 630 nm, 850 nm
Wavelength tolerance ± 3 nm
Full width at half maximum (FWHM) 16 nm
Measurement frequency 2 Hz
Measurement temperature 37 °C
Measurement positions 24
4 of the 24 measurement positions can be
used for stirring assays
Absorbance reader
LOCI reader
Light source LED
Wavelength 680 nm
Wavelength tolerance ± 5 nm
Measurement temperature 37 °C
LOCI reader
HIL reader
Light sources LEDs
Wavelengths 365 nm , 415 nm, 470 nm, 645 nm
Measurement temperature Room temperature
HIL reader
Fluid unit
Liquid waste volume 2 × 10 L
Probe cleaner volume 1 × 2.3 L

Print No. DCHS-G01.621.01.08.02 454
Purging solution volume 1 × 10 L
Purified water volume 2 × 10 L
Fluid unit
Performance data
Measurement time Programmable up to a maximum of

1800 s
Performance data
12.1.1 Operating conditions

Electrical conditions
Operating voltage 200–240 V, ACa)
Main frequency 50–60 Hza)
Circuit breaker 240 V / 16 A
Power consumption 1000 W
Degree of ingress protection IP 11
Surge voltage protection Class II
Electrical conditions
a) In places where the quality of the power supply is poor, impacted by other electrical devices, or voltage
and/or frequency are above or below the required range, an external uninterrupted power supply
(UPS) is recommended.
Water conditions
Purified water ≤ 100 CFU/mL
Water pressure for external supply 0.15–2 bar (15–200 kPa)
Water temperature for external supply 15–25 °C
Water consumption Approximately 2 L/ha)
Water conditions
a) Depending on the job list
Environmental conditions
Altitude 0–2000 m
On special request up to 2500 m
Ambient temperature 18–30 °C
Ambient humidity 20–80 % (non-condensing)

Print No. DCHS-G01.621.01.08.02 455
Sound level during operation (distance to Standby: 55 dB(A) at the front side and
the analyzer: 1 m (39.37 in) 61 dB(A) at the rear side
Measurement mode: 62 dB(A) at the front
side and 64 dB(A) at the rear side
Eco mode: 55 dB(A)
Reagent unit, illumination LED Low risk according to IEC 62471
Pollution degree 2
Other environmental conditions Only indoor use

No direct sunlight
Vacuum conditions
External vacuum supply –0.65––0.90 bar (–65––90 kPa) against

environment pressure
Vacuum conditions
12.1.2 Storage conditions
Ambient temperature 5–45 °C
Ambient humidity 10–85 % (non-condensing)
12.1.3 I/O ports
1 AC power input Power connection
1 XLR port Status light
2 RS‑232 ports Legacy LIS or LAS
2 Ethernet ports LIS, LAS, or remote connectivity
7 USB ports UPS, handheld barcode reader, external

storage media, printer
Specifications of I/O ports
12.2 Computer
Operating system Windows 10
Specifications of the computer

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12.3 UPS (optional)
Battery time > 15 minutes
Interface USB
Supported operating system Windows 10
Nominal power > 1200 W
Specifications of the UPS (optional)
12.4 Consumables
Storage conditions (ambient tempera‐ 2–30 °C

ture)
Evaporation caps
12.5 Barcodes
This chapter describes the specifications of the barcodes.
12.5.1 Samples
Parameter 1D barcodes
Barcode size ≤ 75 mm (including quiet zone)
Module width ≥ 0.19 mm
Barcode types • Code 39 (with and without check digit)

• Interleaved 2/5 (with and without check digit)
• Codabar
• Code 128
Number of characters 4–29
Limit area on the label ≥ 3 mm blank area at both ends of the barcode zone
Specifications for barcodes on sample tubes
Barcodes must be attached to sample tubes as displayed in the figure below.

Print No. DCHS-G01.621.01.08.02 457
Attaching barcodes to sample tubes
(1) Distance top of sample tube to barcode placement area: 14 mm (0.55 in)
(2) Barcode placement area
(3) Center of barcode label and barcode placement area
(4) Distance bottom of sample tube to barcode placement area: 20 mm (0.79 in)
To measure controls in sample tubes, 1D barcodes have to be printed in the dialog

Barcode maker, which fulfill the following conditions:
• Barcode type: Interleaved 2/5
4 uppercase letters for Product code

6 digits for Lot number. The lot number can contain zeros.
12.5.2 Reagents, calibrators, and controls

The following barcode types can be used for reagents, calibrators, and controls:
• Interleaved 2/5 (1D barcode, for calibrators and controls: only with check digit)
• Data matrix code (2D barcode)
On a 1D barcode, digits 1 to 6 from the left are the lot number. The lot number can
contain zeros. Digit 7 represents the bottle size. Digit 8 is a check digit.
For controls to be measured in sample tubes, see ( Page 457 Samples).
Barcodes must be attached to bottles as displayed in the figure below.

Print No. DCHS-G01.621.01.08.02 458
5 3
Attaching barcodes to bottles
(1) Screw cap of the bottle

(2) Tapered section of the bottle
(3) Barcode placement area
(4) Bottom of the bottle
(5) Barcode label
• The barcode label must be inside the barcode placement area.
• The barcode label must not come into the tapered section of the bottle.
• The barcode label must not protrude beyond the bottom of the bottle.
12.5.3 Racks
Both rack types, sample racks and calibrator and control racks, have a barcode label with
9 digits on the right side. Digits 1 to 3 are used by the analyzer to indicate the rack type.
Digits 4 to 9 are the rack ID. These digits can be read by the user.
12.5.4 Cuvette bag

Each cuvette bag has a barcode label to indicate the cuvette bag. The used barcode type
is a 2D barcode.
12.6 Sample tubes

Primary sample tubes:
Primary sample tubes used with caps must have the following dimensions:
• 65–108 mm height
• 8–13 mm outer diameter
Primary sample tubes used without caps must have the following dimensions:
• 8–13 mm outer diameter
For more information, contact Siemens Healthineers service.

Print No. DCHS-G01.621.01.08.02 459
Secondary sample tubes:
Secondary sample tubes can be used if they have the following dimensions:
• 8–15 mm outer diameter (no conical shape)
For proper configuration, contact Siemens Healthineers service.

In addition, the following secondary sample tube types are permitted:
• Eppendorf: Safe-Lock tube or tube 3810X, 1.5 mL, with adapter (with or without cap)
• Siemens Healthineers: Behring Coagulation Cup
Further secondary sample tubes can be implemented if needed. For more information,
contact Siemens Healthineers service.

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13 Appendix
13 Appendix
This chapter describes the principle of operation, the principles of measurement, and the
calculation of results.
13.1 Principle of operation

The system is equipped with the following measuring units for the determination of
hemostasis parameters in blood plasma samples:
• HIL reader
• Absorbance reader
• LOCI reader
The measurements on the HIL reader and the absorbance reader are based on
the method of absorption spectroscopy. The measurements on the LOCI reader are
based on the induced emission of photons. For information on these principles, see
( Page 468 Principle of measurement).
The system can run the following assays:
• Clotting assays
• Chromogenic assays
• Immuno-chemical assays
• Optomechanical assays
• Aggregation assays
• LOCI-based immunoassays
The commonly used methods measure either the coagulation time, reaction rate, or the
level of the total signal.
13.1.1 Sample handling

Samples are transported in sample tubes. A sample rack carries up to 5 sample tubes.
Calibrators and controls are transported in bottles. A calibrator and control rack carries
up to 4 bottles.
A rack is loaded on the input lane of the sample manager. When the load button is
pushed, the rack is moved into the analyzer. More racks can be loaded without pushing
the load button again. Based on the sample barcode and information from the LIS,
sample processing starts. If default profiles or default aliquot volumes are defined,
sample processing also starts without orders. The processed racks move to the output
lane where they can be removed from the analyzer.

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To minimize the use of sample volume, the following 2 parameters must

be deactivated:
• If Default aliquot volume is configured, the aliquot volume is taken in addition to

the direct mode volume, see ( Page 190 Sample tubes).
• If Default profile is configured, the default profile is measured in addition to the

direct mode order, see ( Page 156 Assay customization).
Non-barcoded samples Non-barcoded samples are assigned and processed according to the entries made in the
dialog Loading > Pre-identification of the software.
Unreadable barcodes If a barcode is unreadable or missing, the dialog Loading > Problem racks shows
the rack and the position of the unidentified tube or bottle on the rack. The ID of
the unidentified tube or bottle must be checked and any missing information must be
entered manually.
Alternatively, the required barcodes can be printed using the dialog Barcode maker.
Sample dilution Sample dilutions are performed automatically depending on the assay. All requested
samples, calibrators, and controls are diluted according to the assay procedure
definition. The maximum dilution is 1:1000.
Multiple sample A sample can be measured up to 20 times per order as defined in the assay procedure.
measurements The method to calculate the raw value of all measurements can be defined by the user.
The individual measured values can deviate from the mean only by a defined percentage.
Otherwise, the result is flagged as doubtful.
Pre-analytic sample integrity The sample integrity is checked prior to processing orders. PSI evaluates the actual
check (PSI) sample tube fill level and the measured H, I, and L concentration ranges for interfering
substances. PSI is in effect, if one or both of the following conditions apply:
• The maximum and minimum fill height must be defined for the relevant sample tube
types, see ( Page 190 Sample tubes).
• The HIL measurement must be activated and the sample type is appropriate for HIL
measurement, see ( Page 468 HIL measurement principle).
Unique sample IDs When using PSI, Siemens Healthineers recommends:
• Use a unique sample ID for each sample tube whenever possible.

When measuring a blank value for platelet-aggregation, the same sample ID can still
be used, as proper-fill can handle multi-material assays (PPP and PRP).
• If a sample tube with new sample material should re-use the sample ID, delete the
sample in the dialog Jobs before re-loading the new sample with the same sample ID.
• However, if the sample ID is re-used, check the list Aliquots for proper-fill check results
in the dialog Sample info: Further proper-fill checks are not evaluated for flagging
results but the symbol is displayed for an overfilled sample tube or for an
underfilled sample tube during aliquotation.
Proper-fill Proper-fill checks the sample volume in a primary sample tube in normal mode each time
an aliquot is taken.

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13 Appendix
The proper-fill check result is only evaluated using flags the first time a sample ID is
aliquoted by the system.
The following proper-fill check results can be displayed:
• The sample tube is underfilled during aliquotation, but the sample can be measured.
The sample is pipetted and measured according to the orders in the job list. A symbol
is displayed in the dialog Jobs, a flag is displayed in the dialog Jobs > Sample result
info, and a symbol is displayed in the column Level in the dialog Jobs > Sample info.
• The sample tube is overfilled during aliquotation, but the sample can be measured.
The sample is pipetted and measured according to the orders in the job list. A symbol
is displayed in the dialog Jobs, a flag is displayed in the dialog Jobs > Sample result
info, and a symbol is displayed in the column Level in the dialog Jobs > Sample info.
If configured, the proper-fill result is sent to the LIS at the same time as the first sample
result of the sample ID. But no proper-fill results are sent to the LIS for further aliquots
with the same sample ID if the first sample result has been measured in direct mode.
The proper-fill check only provides a statement on the volume of the sample, but not
directly on the citrate-to-blood ratio. If the sample volume is insufficient and no volume
has been taken from the sample before the proper-fill check, it can be assumed, that the
citrate-to-blood ratio is incorrect.
HIL For more information on the HIL measurement principle, see ( Page 468 HIL
measurement principle). The following HIL check results can be displayed:
• If a HIL index cannot be measured or evaluated, the symbol or, if the sample tube
was also under- or overfilled during aliquotation, is displayed in the dialog Jobs and
is sent to the LIS. Otherwise, the HIL indices are sent to the LIS.
• If a HIL index is higher than or equal to the assay-specific warning level, the symbol
is displayed in the dialog Jobs next to the result, the symbol is displayed for the
sample, and a flag is displayed in the dialog Jobs > Sample result info.
• If a HIL index is higher than or equal to the sample-specific warning level, the symbol
is displayed in the dialog Jobs. In the dialog Jobs > Sample info, the sample-specific
warning levels are displayed in brackets in the column headers H, I, and L, and
can easily be compared with the measured indices in the columns. Sample-specific
warning levels can be entered in the dialog Setup > HIL warning.
If configured, the HIL check results are sent to the LIS at the same time as the first sample
result of the sample ID. But no HIL check results are sent to the LIS for further aliquots
with the same sample ID if the first sample result has been measured in direct mode.
Clot detection The clot detection is a pre-analytical check for sample clots in the aliquot probe. The
clot detection measures the pressure of the air in the aliquot arm before the sample is
aspirated and after the aspiration. The measured pressures are compared and a clot is
indicated if the difference of the values is above a defined threshold. The following clot
detection results are possible:

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13 Appendix
• The status alert Clog detected during sample aspiration (21) is displayed. In the
dialog Loading > Problem racks, the status Clog detected is displayed for a rack
position. All results measured for the sample receive the flag Clog detected and can
be re-sent to the LIS manually, if required. For more information on the status alert
Clog detected during sample aspiration (21), see ( Page 412 Clog detected during
sample aspiration (21)). For more information on the dialog Problem racks, see
( Page 78 Problem racks).
• The status alert Initialization required: component Aliquot arm (14) is displayed.
In the dialog Maintenance > Task execution, the user has to start the maintenance
task Initialization for the component Aliquot arm manually. The system rinses the
aliquot probe to remove the clog and re-initializes the aliquot arm. If successful, the
status alert is cleared. Otherwise, the status alert Clog in aliquot probe cannot be
removed (34) is displayed. For more information on the status alert Initialization
required: component <component name> (14), see ( Page 380 Initialization
required: component <component name> (14)). For more information on the status
alert Clog in aliquot probe cannot be removed (34), see ( Page 386 Clog in aliquot
probe cannot be removed (34)).
When using cap piercing, the clot detection is not active.
Calibration Calibrations are performed following the pre-sets in the assay definition. Either
calibrators or calibrator sets can be used. Required dilutions of calibrators are calculated
and performed automatically. The dilutions depend on the calibrator concentration and
the required support points of the curve.
Calibrators from Siemens Calibrators from Siemens Healthineers are pre-defined. For some parameters, calibrator
Healthineers sets are available. These consist of ready-made pre-dilutions with pre-determined
assigned values, for example, PT, Fibrinogen. The individual calibrators can also be
defined in the software.
Curves provided by Siemens For Siemens Healthineers assays, suitable measurement points have been pre-selected.
Healthineers The system uses 1 curve per lot to calculate the results. If more than 1 curve per lot is
available, the user can activate the required curve.
The following curves are provided by Siemens Healthineers:
• Check curves with acceptance range. These curves are intended to check if a measured
calibration curve fits with the expectations of the reagent lot. These curves are not
used to calculate results.
• Master curves are provided to calculate the derived fibrinogen. These curves cannot
be measured.
User-defined method (UDM) User-defined methods can be used on the system. To calibrate a user-defined method,
calibrators must be defined. The measurement points must be entered as well as the lot
data. Accordingly, the system creates the required dilutions for the calibration curve.
Control measurements Controls serve to validate sample results and calibration curves. Controls need to be
assigned to assays before control measurements can be requested. Control orders are
requested automatically or manually.

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The system performs accuracy checks and precision controls. Other evaluations of the
control results, such as the creation of pre-periods, trend analyses, or multi-rate checks,
can be performed with the QC software.
13.1.2 Reagent handling

Reagents are transported in bottles or, in the case of LOCI reagents, in cartridges. Every
reagent cartridge comprises 3 reagents. To load bottles into the analyzer, they must be
placed in carriers. Carriers and cartridges are loaded via the input wheel of the reagent
manager. The reagent manager is accessed by the carrier arm. The carrier arm transports
full bottles in carriers, and cartridges from the reagent manager to the reagent storage.
During the transport, the reagent scanner identifies the reagents. Additionally the
reagent scanner identifies if an evaporation cap is located on the bottle or cartridge
and attached properly. If a barcode is unreadable, missing, or a problem with a cap is
detected, the corresponding bottle or cartridge is automatically ejected.
When the reagent barcode is identified, the system recognizes by the serial number if this
bottle was previously on the system and if the on-board stability of this bottle is expired
or not. The system also compares the reference numbers and lot numbers with those that
are already stored in the software. If the system does not recognize a lot number, the lot
data is requested from the lot data storage and transferred to the software.
The carrier arm opens the evaporation cap of the reagent when the pipettor needs
access for level detection or taking reagent. The evaporation caps of the cartridges are
closed if there is no open order 15 minutes after the last access of the pipettor. The
evaporation caps of bottles and cartridges are closed when the system switches to eco
mode. Depending on the reagent, a shaker at the carrier arm shakes the reagents to
prevent sedimentation. Empty bottles and cartridges are moved back to the input wheel.
A status LED indicates when to remove an empty bottle or cartridge.
Non-barcoded reagents If non-barcoded reagents are used, the required barcodes can be printed using the dialog
Barcode maker. For these reagents the lot data must be entered manually.
Unreadable barcodes If a barcode is unreadable or is missing, the unidentified reagent is automatically ejected.
The dialog Reagents > Loading shows the unidentified bottle or cartridge. The ID of the
unidentified bottle or cartridge must be checked and any missing information must be
entered manually.
Alternatively, the required barcodes can be printed using the dialog Barcode maker.
Reagent lot numbers Reagents can contain additional lot dependent information. The software checks if
additional information for an inserted reagent lot is available in the database. If not, the
information is requested from a special lot information file which is provided by Siemens
Healthineers frequently.
Multiple lot management The system can store the calibration curves for several lots of the same reagent. This
enables the user to work with several different lots of a reagent in parallel.
If more than 1 bottle from the same lot is placed on the analyzer, the bottle with the
lowest volume is used up first for sample determinations.
The system checks if the required calibration curves are available when it reads the
barcode. If no calibration curve is available but there is at least 1 measurement to
be performed, the system recommends to perform a calibration, or it requests and
records any required calibration curves automatically. Whether the system recommends
or requests a calibration depends on the configuration.

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The software controls which reagent lot is used and evaluates the raw values on the
relevant calibration curve. When a lot is changed, the correct calibration is automatically
used. The software prevents a wrong calibration curve from being used and incorrect
results being calculated.
Third-party reagents Third-party reagents can be used on the system. These reagents must be defined and
the lot data must be entered. Siemens Healthineers does not provide check curves and
master curves for third-party reagents. Calibration curves that have been recorded using
third-party reagents cannot be checked using a check curve with confidence range.
They must be checked manually. Since the original barcodes of such reagents cannot be
detected, Siemens Healthineers recommends to print appropriate barcodes by using the
dialog Barcode maker.
Siemens Healthineers assays have been validated to ensure that carry-over does not
affect test results when only approved Siemens Healthineers reagents are used. When
using third-party reagents, validate that Siemens Healthineers assays are not affected
by carryover.
13.1.3 Processing of assays

The processing of assays starts when a rack is loaded on the sample manager and the
sample barcode is read.
If the analyzer is connected to an LIS, the orders for the respective samples are requested
by means of the sample barcodes.
If the analyzer is not connected to an LIS, the sample IDs are entered in the job list after
reading the sample barcodes. Then the orders must be entered manually.
Normal mode In normal mode, the aliquot arm aspirates one or more aliquots depending on the
number of requested assays and dispenses them to empty cuvettes in the aliquot
storage. Optionally, a proper-fill check can be performed and/or the aliquot arm
transports aliquot to the HIL reader and dispenses aliquot volume to the measuring cell
of the HIL reader. From the cuvette in the aliquot storage, the sample arm aspirates a
defined amount of sample (up to 150 μL) according to the assay definition. Then the
sample arm dispenses the sample into an empty cuvette in the pre-heater.
The other steps are the same as described in the second paragraph of direct mode.
Direct mode The direct mode can be used when the available sample material is low.
The proper-fill check is only performed for the first aliquot from a primary sample tube
in normal mode, not in direct mode.
In direct mode, the aliquot arm aspirates sample material (up to 150 μL) from the
open sample tube and dispenses it to an empty cuvette in the aliquot storage. No
aliquot volume is dispensed into the measuring cell of the HIL reader. No HIL indices are
measured and no proper-fill check can be performed. The cuvette is taken by the cuvette
distributor and is transported from the aliquot storage to the pre-heater.

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In the pre-heater, a pre-heating of the sample takes place at 37 °C. The cuvette is taken
by one of the cuvette arms and a reagent is added by one of the reagent arms. Then the
cuvette is mixed on the mixer. Now the cuvette is either transported to the measuring
unit (absorbance reader) or to the incubator for assays needing an incubation time or
more than 1 reagent. If an assay requires more than 1 reagent, additional reagents are
added as described before.
After measuring, the cuvette arm takes the cuvette and discards it in the waste station.
The recorded measurements are evaluated and a result is calculated.
A sample is measured in direct mode if the following conditions are met:
• In the dialog Data definition, subgroups Assay definition > Assay groups > Assays
> Assay measurement, Measurement in direct mode possible must be activated for
the assay, see ( Page 209 Assay measurement), and
• The sample is loaded on a sample rack with a sample rack template defined For direct
mode, see ( Page 193 Sample rack templates), or
• Measure in direct mode is activated for the sample in the dialog Special order, see
( Page 88 Special order), or
• Direct mode is activated for the sample in the dialog Loading > Pre-identification.
Meta-assay and ratio assay A meta-assay is an aggregation of several assays, see ( Page 213 Meta-assay),
for example:
• combining multiple materials, as platelet-poor plasma (PPP) and platelet-rich plasma

(PRP) for platelet aggregation
• combining multiple dilutions of the same base assay
• combining separate assays to a common result by some mathematical calculation

(using a formula), for example, a ratio assay
A ratio assay can also be defined in the dialog Assay measurement, see
( Page 209 Assay measurement). Ratio assays defined as meta-assays show some
differences compared to ratio assays defined in Assay measurement, see the
table below.
Action Meta-assay, for example, ratio assay Ratio assay (Assay measurement)
Define a meta-assay or ratio assay By single assays By assay procedures (that may also be
used by other assays)
Request an order Orders for single assays are requested. Orders for other assays are
not requested.
If raw values for other assays are avail‐
able, the result for the ratio assay is
directly displayed.
Display in dialog Jobs Orders and results for the meta assay Orders and results for the ratio assay
and for single assays are displayed (if are displayed. For other assays, orders
the single assays are activated in dialog and results are only displayed if
Assay activation). requested separately.
Display in dialog Sample result info • Single assays are displayed as tabs. Raw values are displayed in the list
Single measurements.
• Results are displayed in the list
Single assay results.

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Action Meta-assay, for example, ratio assay Ratio assay (Assay measurement)
Delete an order for the meta-assay or Orders for single assays Orders for other assays
the ratio assay remain unchanged. remain unchanged.
Delete a result for a single assay or the The meta-assay result is still displayed. The ratio assay result
other assays It is not marked that a referred single remains unchanged.
assay result has been deleted.
Delete a result for the meta-assay or Results for single assays Results for other assays remain
ratio assay remain unchanged. unchanged. Raw values are still availa‐
ble for other assays.
Repeat a result for the meta-assay or Some or all single assay results are Some or all raw values are auto‐
the ratio assay automatically repeated, if required. matically re-measured, if required.
All raw values for other assays
remain unchanged.
Repeat a result of a single assay or the If subsequently the result for the meta- If subsequently the result for the
other assays assay is repeated, it is re-calculated ratio assay is repeated, it is re-calcu‐
using the new single assay result. lated using the latest raw values from
other assays.
Differences between meta-assays, for example, a ratio assay, and ratio assays defined in Assay
measurement
13.1.4 Results
Sample results are displayed in the job list and flagged, if applicable. Explanation of the
flags and more information on the results can be viewed in the dialog Jobs > Sample
result info. From this dialog, the measurement curves for each individual measurement
can be opened (only available for measurements in the absorbance reader).
If configured, released sample results are sent to the LIS automatically.
For information on the calculation of results, see ( Page 473 Calculation of results).
13.2 Principle of measurement

The system is equipped with different measuring units. The HIL reader is used for
pre-analytics of untreated sample material. The absorbance reader and the LOCI reader
are used for analysis with assays.
The measurements on the absorbance reader and on the LOCI reader are performed
independently of each other.
The measurement principles of each reader are described in the following chapters.
13.2.1 HIL measurement principle

The HIL reader performs an initial check of untreated samples relative to hemolysis,
icterus, and lipemia. A photometer in the HIL reader checks the presence and the type
(H, I, or L) of interference in the sample.
The HIL check is not performed for samples containing platelet-rich plasma (PRP).

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HIL indices The HIL reporting feature provides a numerical index for each interference attribute:
• H = hemoglobin resulting from lysis of red blood cells
• I = icterus resulting from endogenous bilirubin
• L = lipemia or turbidity caused by insoluble lipids
HIL indices classify concentration levels of the interference substances hemoglobin,

bilirubin, and lipids.
Absorbance measurements at 365 nm, 415 nm, 470 nm, and 645 nm are used to
generate the HIL indices, see the table below.
HIL index Hemoglobin (H) Bilirubin (I) Lipids (L)

mg/dL mg/dL mg/dL
1 < 20 <2 < 120
2 20–< 60 2–< 5 120–< 200
3 60–< 90 5–< 10 200–< 300
4 90–< 140 10–< 15 300–< 400
5 140–< 180 15–< 20 400–< 500
6 180–< 220 20–< 25 500–< 650
7 220–< 260 25–< 30 650–< 800
8 260–< 300 30–< 35 800–< 1000
9 ≥ 300 ≥ 35 ≥ 1000
HIL indices and the corresponding concentration ranges
The concentration ranges for the HIL indices specified above are approximate
values for plasmas with added hemoglobin, bilirubin (conjugated), and intralipid,
respectively. The concentration ranges only serve as guidance for a qualitative
check to estimate potential interferences of substances. The HIL indices obtained
by the pre-analytic sample integrity check must not be used to evaluate the actual
concentrations of hemoglobin, bilirubin, or lipoproteins/triglycerides.
Conditions for HIL HIL indices are measured for all samples containing platelet-poor plasma (PPP). The
measurements following general conditions are required for HIL to be processed:
• HIL measurement must be activated in the dialog Setup > System.
• Sample must be measured in normal mode.
• Sample is aliquoted for the first time.
13.2.2 Absorbance measurement principle

In the absorbance reader, the measurements are performed using the light absorbance
effect at selected wavelengths. Photodetectors measure the intensity of the light having
passed the cuvette and its content, and convert it to electrical signals.

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The assembly with the LEDs and the photodetectors rotates along the 25 cuvette
positions. Every 500 ms an absorbance measurement is performed for each cuvette
position. At each cuvette position a scan of up to 1000 data points is recorded for each
full rotation of the assembly. The scan data is used to determine cuvette position and
intensity levels.
An empty cuvette position is used for a reference measurement.
The total time of a measurement for an assay depends on the assay definition. During
the coagulation process, the sample becomes increasingly turbid. The intensity of the
light passing through the cuvette is therefore weakened due to extinction (absorption
and/or scattering) by particles or formation of aggregates in the sample. In the case of
chromogenic assays, a dye is activated during the reaction, which adds to the absorbance
of the sample at a defined wavelength.
Measurement methods On the absorbance reader, the following measurement methods are distinguished:
• Clotting time
• Reaction rate
• Absolute difference
• Absorbance
Clotting time This method is used to determine the clotting time of the sample. The formation of a
fibrin clot leads to an increase in the turbidity and thus to an increase of absorption. The
registration of the clotting time starts with the dispensation of the last reagent (starting
reagent) of an assay to the cuvette. The registration ends when a defined amount of
increase of absorbance is achieved. The result is given in clotting time in seconds.
Reaction rate Kinetic methods and immunochemical methods can be distinguished:
• Kinetic methods: This method is used to determine the enzyme activity, or specific
inhibitors. The sample reacts with enzymatic assays with use of chromogenic
substrates. The reaction leads to a formation of a dye and thus to a change
in absorbance. The kinetic rate of the reaction is detected with the result delta
absorbance per minute.
• Immunochemical methods: This method is used to measure the concentration of a

protein. The sample reacts with antibodies which, for example, are bound to a latex
particle. The aggregates thus formed lead to a change in the turbidity. The rate of the
change is detected with the result delta absorbance per minute.
Absolute difference This method is used to determine the difference in absorbance of a measurement curve.
Therefore the basic absorbance is subtracted from the final absorbance. The method
can be used to calculate the fibrinogen concentration from a PT measurement curve, for
example. The result is given in delta absorbance.
Absorbance This method is used to determine the precision of the system by use of dyes. The result
is given in absorbance.

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13.2.3 LOCI measurement principle

The LOCI measurement principle is based on the proximity effect of 2 different particle
reagents. This effect induces a fluorescence that is detected by a photomultiplier and
converted to electrical signals. Check methods and evaluation methods are used to
calculate results.
The first particle, called chemibead (CB), is coated with analyte-specific antibodies.
The chemibead particle contains an olefin that reacts with singlet oxygen and emits
light at 612 nm wavelength. The second particle, called sensibead (SB), is coated with
streptavidin. The sensibead particle contains a photosensitive dye that produces singlet
oxygen when flashed with light at 680 nm wavelength. Since singlet oxygen has a half
life of 4 μs, the chemibead needs to be in close proximity to the sensibead to be able
to emit light at 612 nm wavelength. If chemibeads and sensibeads are not in close
proximity, no light will be emitted. The light, measured in the unit, is either proportional
or inversely proportional to the concentration of analyte (in mg/L) in the sample.
Measurement methods 3 measurement methods are available on the LOCI reader:
• Measurement of sandwich assay formats to detect antigens in samples
• Measurement of sandwich assay formats to detect antibodies in samples
• Measurement of competitive assay formats to detect antibodies as well as antigen

in samples
In the following, a LOCI assay protocol describes the determination of an antigen
(analyte) using a sandwich assay format.
LOCI assays use reagent cartridges, each with the 3 reagents, for example:
• Chemibead particle coated with analyte-specific antibodies
• Biotinylated analyte receptor (antibody)
• Sensibead particle coated with streptavidin
LOCI assays are performed in 4 steps, see the table below and ( Page 472 LOCI
assay protocol).
Step Explanation
1 Pipetting and first incubation Chemibeads, coated with analyte-specific antibodies, are pipetted into a cuv‐
ette together with biotinylated antibodies and sample. During the incubation,
the antibodies (on the chemibead and the biotinylated one) react with the
analyte contained in the sample. The antigen contained in the sample is bound
between 2 different antibodies. An antibody-antigen-complex is formed.
2 Second incubation Sensibeads, coated with streptavidin, are added. The cuvette is incubated again
to enable streptavidin to react with the biotin of the biotinylated antibody.
3 Illumination The cuvette is illuminated by light at 680 nm for up to 1 s (assay-specific).

The sensibead absorbs the light and generates singlet oxygen from the dis‐
solved oxygen in the reaction mixture.
4a Measurement a If the specific antigen is present in the sample, a immunoreaction takes place.
Sensibead and chemibead are in close proximity to each other. After illumina‐
tion the produced singlet oxygen diffuses to the chemibead, that generates
light. The generated light is detected at 612 nm wavelength.

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Step Explanation
4b Measurement b If no specific antigen is present in the sample, no immunoreaction takes place.

Therefore, sensibead and chemibead are not in close proximity to each other.
After illumination the produced singlet oxygen decays before it can reach the
chemibead. No light is generated.
Steps of the LOCI assay protocol
1 216 s
+ + 37 °C
CB B CB
2 360 s
+ 37 °C
SB SB CB
3
SB CB
680 nm / 0.1 ... 1.0 s
4a 3O 1O2 1O τ = 4 µs
2 2
SB CB
612 nm / 1.0 s
4b 3O 1O2 τ = 4 µs
2
3O
2
SB CB
LOCI assay protocol
Sample
Coated chemibead
Biotinylated antibody
Coated sensibead
Streptavidin
Incubation
Antibody-antigen bond
Immunocomplex bond
Light flash

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Light emission
13.2.4 Blank value

For the platelet-rich plasma (PRP) of a platelet aggregation assay, a blank value needs
to be measured for a sample with platelet-poor plasma (PPP) from the same patient and
with the same sample ID. The blank value is required as reference to calculate the percent
aggregation curve.
13.3 Calculation of results

This chapter shows how the result is calculated, for example, an analyte concentration
or the activity of a coagulation subsystem. The calculation is performed in several steps.
Not all the steps are applied depending on assay.
According to the assay definition, the system can perform a number of measurements
corresponding to different assay procedures. Some or all of them can be performed
as replicate measurements. The final sample result or control result is then calculated
according to the steps in the table below.
Step Explanation
1 Curve smoothinga) The measurement curve is mathematically smoothed to provide more robust‐
ness for the subsequent steps, curve evaluation, and curve checking.
2 Curve evaluationa) A raw value is calculated from the measurement curve by means of an
evaluation method. This raw value is a single numerical value generated from
the measurement curve or directly from the absorbance reader.
Different evaluation methods are available, see ( Page 215 Evaluation meth‐
ods).
3 Curve checkinga) The check methods are used to check the plausibility of the measurement
curves and to verify if certain requirements for the evaluation method are met.
The result is then flagged appropriately.
Some of the check methods are freely selectable and others are already
integrated in evaluation methods, for example, plateau formation.
Different check methods are available, see ( Page 223 Check methods).
4 Blank value subtraction For assay procedures that perform blank value subtraction, each raw value
obtained is corrected for possible fluctuations over time by subtracting an
up-to-the-minute reference value measured on the system itself.
5 Replicate summarization For replicate measurements, the raw values obtained from separate meas‐
urements are summarized to a single, intermediate raw value using a data
reduction method. The single, intermediate raw values are converted into
results according to the assay procedure.
Different data reduction methods are available, see ( Page 474 Data reduc‐
tion methods).
6 Measurement method summari‐ When measurements according to different measurement methods are used to
zation obtain a compound assay result, a final raw value is calculated from the meas‐
urement method’s intermediate raw values using a data reduction method.
Different data reduction methods are available, see ( Page 474 Data reduc‐
tion methods).

Print No. DCHS-G01.621.01.08.02 473
13 Appendix
Step Explanation
7 Normalization The final raw value can be normalized by calibration or other means to generate
the result.
Different normalization methods are available, see ( Page 477 Normaliza‐
tion methods).
Steps for the calculation of results
a) These steps are only applied to assays measured in the absorbance reader.
The steps that require more details are described in the following chapters.
13.3.1 Data reduction methods

The following data reduction methods are available:
• Arithmetic mean
• Mean value with check
• Standard deviation
• Coefficient of variation
• Ratio 1/n
• Minimum
• Maximum
• Arithmetic mean with hyperbolic coefficient of variation
• Median
• Median with hyperbolic coefficient of variation
• Formula
Arithmetic mean The arithmetic mean over a set of values is calculated as follows:
å v (i )
i=1
v = ------------------
-
n
With:
n: Number of values
v(i): i‑th value
Mean value with check The method Mean value with check calculates the arithmetic mean and checks if any
of the values deviates from the arithmetic mean more than the permitted deviation.
Standard deviation The standard deviation of a set of values is calculated as follows:

Print No. DCHS-G01.621.01.08.02 474
13 Appendix
n
1 2
s = ------------
n –1 å (v (i ) – v )
i=1
With:
n: Number of values
v(i): i‑th value
v: Arithmetic mean, see ( Page 474 Arithmetic mean)
Coefficient of variation The coefficient of variation, given in percent, over a set of values is calculated as follows:
s
cv [%] = -- 100%
v
With:
s: Standard deviation, see ( Page 474 Standard deviation)

The method checks if the coefficient of variation is larger than the permitted deviation.
The method is mainly used for precision assays.
Ratio 1/n The method Ratio 1/n calculates the ratio of the first value over the last value. The ratio
is useful as an indicator for any possible change over time in values measured under
identical conditions.
Minimum The method Minimum determines the smallest of a set of values.
Maximum The method Maximum determines the largest of a set of values.
Arithmetic mean with For the method Arithmetic mean with hyperbolic coefficient of variation, the
hyperbolic coefficient of hyperbolic coefficient of variation, given in percent, is calculated as follows:
variation
n
1 ( v ( i ) – v )2
------------ å
n –1
i=1
cv mean hyp -------------------------------------------------------- 100%
[%] = -------------------------------------------------------
2 2
c +v
With:
n: Number of values
v(i): i‑th value
c: Constant for hyperbolic coefficient of variation

With c = 0, the normal coefficient of variation is obtained.
The method checks if the hyperbolic coefficient of variation is larger than the
permitted deviation.

Print No. DCHS-G01.621.01.08.02 475
13 Appendix
The method is mainly used for high-sensitivity assays.
Median The median of a set of values is determined as follows:
if n is odd
ì væ n + 1 ö
2 ø
-
ï è ------------ if n is even
ï
ṽ = í v n + v n
ï æè --2- öø æ --- + 1 ö
è2 ø
ï ------------------------------
î 2
With:
n: Number of values
v1, v2, …, vn: the values in ascending order (v1: smallest value, vn: largest value)
Median with hyperbolic For the method Median mean with hyperbolic coefficient of variation, the hyperbolic
coefficient of variation coefficient of variation, given in percent, is calculated as follows:
n
1 ( v ( i ) – ṽ ) 2
------------ å
n –1
i=1
cv med hyp [%] = -------------------------------------------------------
-------------------------------------------------------- 100%
2 2
c + ṽ
With:
n: Number of values
v(i): i‑th value
c: Constant for hyperbolic coefficient of variation
ṽ: Median, see ( Page 476 Median)

The method checks if the hyperbolic coefficient of variation is larger than the
permitted deviation.
The method is mainly used for high-sensitivity assays.
Formula The method Formula calculates the final value with a user-defined formula using the
following elements:
• Assay procedures names or assay short names in quotation marks "
• The operators +, -, /, *
• Numbers
• Parentheses
Example:
"ProC Ac R Activator"/"ProC Ac R OVB"
With:
ProC Ac R Activator, ProC Ac R OVB: Assay procedure names

Print No. DCHS-G01.621.01.08.02 476
13 Appendix
13.3.2 Normalization methods

Depending on the assay definition, the final raw value is normalized to generate the
result, or, in other words, the parameter concentration. Some assays do not require a
normalization, that is, the final raw value is the result.
The purpose of normalization is to allow comparison of results obtained by different

systems and laboratories. Some assays yield results in SI units like analyte concentration
in g/L, some not, like analyte activity in % of norm.
There are 4 normalization methods available:
• Ratio
• INR
• Calibration with a measured calibration curve
• Calibration with a curve from a different assay
Ratio The ratio method is used to express the relation of the measured value of a sample to a
pre-measured, normalized value for the reagent used in the sample measurement: The
assay result is expressed as the ratio of the sample raw value to the normalized value for
the reagent.
This ratio is applied to PT assays with the mean normal prothrombin time (MNPT) of
the single thromboplastin reagent lot used in the sample measurement, and to other
assays with the mean normal value (MNV) of a single reagent lot used in the sample
measurement that is marked as requiring and supplying such a value. The result is
calculated as follows:
Result = Raw value/MNPT or
Result = Raw value/MNV
If the raw value is already available from another measurement, no measurement needs
to be performed for this order. The value is calculated.
INR The INR (International Normalized Ratio) method is an extension of the ratio. As well
as the MNPT value, the ISI (International Sensitivity Index) value is also required. With a
thromboplastin lot, the ISI value is part of the lot data. The result is calculated as follows:
Result = (Raw value/MNPT)ISI
If the raw value is already available from another measurement, no measurement needs
to be performed for this order. The value is calculated.
Calibration with a measured In order to normalize the final raw value to obtain an assay result, an assay can be
calibration curve calibrated. A calibration curve for mapping raw values to assay results can be provided by
Siemens Healthineers for the assay and reagent lots used. The calibration curve can also
be measured and calculated on the system itself, using calibrators and assigned values
provided by Siemens Healthineers or third parties.
Different standard calibration methods are used for assay calibration, see
( Page 228 Calibration methods). The calibration method selected depends on
the assay.

Print No. DCHS-G01.621.01.08.02 477
13 Appendix
Calibration with a curve from A raw value can also be normalized through use of a calibration curve originally provided
a different assay for, or measured on the system for another assay. This can be useful in cases where
multiple assays produce comparable final raw values and assay results, and separate
calibration curves for the assays can reasonably be dispensed with.

Print No. DCHS-G01.621.01.08.02 478
14 Revision Information
The revision information lists topics that have changed since the previously published
version of this document.
Topic Link
Orientation tips ( Page 14 Orientation tips)
Identification ( Page 15 Identification)
Manual version history ( Page 17 Manual version history)
Electrical safety ( Page 20 Electrical safety)
Safe handling of personal data ( Page 23 Safe handling of per‐

sonal data)
IT security measures ( Page 24 IT security measures)
Symbols ( Page 26 Symbols)
Cleaning the purging solution container ( Page 342 Cleaning the purging solu‐
tion container)
Cleaning the water containers ( Page 345 Cleaning the water contain‐
ers)
Cleaning the aliquot probe ( Page 348 Cleaning the aliquot probe)
Cleaning the racks, the adapters, and ( Page 352 Cleaning the racks, the
the carriers adapters, and the carriers)
Cleaning the cuvette waste container ( Page 353 Cleaning the cuvette
waste container)
Cleaning the liquid waste containers ( Page 356 Cleaning the liquid
waste containers)
Checking the functioning and the preci‐ ( Page 358 Checking the functioning
sion of the pipettors and the precision of the pipettors)
Cleaning the surface of the analyzer, ( Page 360 Cleaning the surface of
the handheld barcode reader, the sample the analyzer, the handheld barcode
manager, and the reagent manager reader, the sample manager, and the
reagent manager)
Cleaning the accessories drawer ( Page 362 Cleaning the accesso‐

ries drawer)
Perform precision check ( Page 372 Perform precision check)
Updated topics
Topic Link
Safe handling ( Page 18 Safe handling)
Reporting of serious incidents ( Page 19 Reporting of serious incidents)

Print No. DCHS-G01.621.01.08.02 479
Topic Link
Statutory provisions ( Page 30 Statutory provisions)
Introduced topics
Topic Link
Safe handling –
Intended purpose –
Reporting of serious incidents –
Statutory provisions –
Revision information –
Removed topics

Print No. DCHS-G01.621.01.08.02 480
Index
1, 2, 3 ... Aggregation curve doubtful, flag 75 Assay

Akima II, calibration method 229 Calculate result 473
<...> 14
Calibration 328, 477
<<<, symbol 85 Akima, calibration method 228
Definition 250
<component name> 432 Alerts (acoustic signal), dialog 162 Dialog 161
<problem> 433 Alerts (view), dialog 118 General processing 466
LOCI assay 471
>>>, symbol 85 Aliquot arm 46
Type 461
Cleaning probe 348
1D barcode 131 Assay activation, dialog 155
Aliquot not sufficient (72), status alert 415
2D barcode 131 Assay calibration
Aliquot pipettor
3rd-party Dialog 211
Connection 368
Control 289 Normalization method 477
Delivery 365
Reagent 466 Assay customization, dialog 156
Disconnect 365
Disposal 367, 373 Assay definition, dialog 196
A Initialize 371
Assay group, definition 245
About, dialog 125 Installation 368
Ordering information 365 Assay groups, dialog 196
Above assay-specific hemolytic warning level,
flag 73 Precision check 372 Assay measurement assignment, dialog 211
Re-initialize 372 Assay measurement, dialog 209
Above assay-specific icteric warning level,
Remove 367
flag 73 Assay procedure, definition 246
Time to replace 364
Above assay-specific lipemic warning level, Assay procedures, dialog 197
Aliquot probe reached maximum number of
flag 73 Assay statistics, dialog 130
cap piercings (28), status alert 413
Absolute difference, measurement Assay using calibration that is almost expired
Aliquot storage 46
method 470 (133), status alert 430
Aliquot volume
Absorbance Assays availability, dialog 107
Default 190
Evaluation method 217
Reserve 190 Assays, dialog 207
Measurement method 470
Aliquotting not possible. No cap defined Assigned values, dialog 178
Absorbance reader 51
for rack <rack ID>-<rack position> (10002),
Measurement method 470 Audit log, dialog 120
status alert 402
Measurement principle 469 Audit trail
Reference measurement 469 Aliquotting speed reduced (84), status
see Audit log, dialog
Specifications 452 alert 417
Auto start, dialog 164
Wavelength 452 All single assay results not usable, flag 75
Automatic calibration 255
Absorption spectroscopy 461 Alternative curves, dialog 98
Automatic control measurement 253
Access door 37 Alternative wavelength 98
Axes 322
Access door open (30), status alert 413 AMaxMin, check method 226
Accessories drawer 38 Ambient temperature in warning range (<too B
Cleaning 362 high>/<too low>) (116), status alert 427
Backup
Accessory 55 Ambient temperature out of range (<too Dialog 134
Adapter 57 high>/<too low>) (117), status alert 399 Restoring 351
Carrier 59 Ambient temperature sensor defective (118),
Cartridge tool 58 Backup power used up, shutting down (25),
status alert 400 status alert 385
Centrifugation 63
Analyte receptor, LOCI reagent 471 Barcode
Liquid waste container 62
Opening tool 61 Analyzer 34 Calibrator 458
Rack 55 Cleaning 360 Control 458
Rack tray 57 Dialog 100 Cuvette bag 459
Tap 62 Problem 435 Missing 462, 465
Acoustic signal 237 Angle DB, check method 224 Rack 459
Reagent 458, 465
Action button 72 Angle, check method 224
Sample 457, 462
Active assay 237 Antigen excess check, check method 228 Settings 257
Adapter 57 Antigen excess suspected, flag 75 Specifications 457
Calibrator bottle 57 Archive viewer, dialog 125 Unreadable 462, 465
Cleaning 352 Barcode label, printing 331
Arithmetic mean 474
Control bottle 57 Barcode maker, dialog 131
GW 2.5 bottle 57 Arithmetic mean with hyperbolic coefficient
Sample tube 57 of variation 475 Barcode reader, handheld 44
Add lot number, dialog 180 As needed maintenance 360 Barcode reader, reagent
ASCII converter, dialog 129 see Reagent scanner
Aged sample, control, or calibrator used,
flag 75

Print No. DCHS-G01.621.01.08.02 481
Index
Barcode reader, sample Carrier 59 Safe handling 22

see Sample scanner Cleaning 352 Stirrer bar 59
Barcoded sample tube 293 Carrier arm 47 Water container 60
Barcodes, dialog 162 Cartridge Consumables unit 48
Battery Directive 30 Ejecting 291 Consumption, electrical power 455

Evaporation cap 58 Contact information 15
Biotinylated analyte receptor, LOCI
Loading 278
reagent 471 Container
Unloading 291
Blank value doubtful, flag 75 Liquid waste 62
Cartridge tool 58 Liquid waste container cleaning 356
Blank value, PRP 473
CE conformity 30 Probe cleaner 61
Bottle see Declaration of Conformity Purging solution 60
Barcode attaching 458
Centrifugation accessory 63 Control 63
Ejecting 291
Check method 223 Adapter for bottle 57
Evaporation cap 57
Barcode 458
Loading 278 Checking, overview of calculation steps 473
Definition 244
Preparation 277 Chemibead, LOCI reagent 471 Dialog 161
Unloading 291
Cleaning 338 Invalid 327
Bottom middle drawer 39 Accessories drawer 362 Measurement 287
Adapter 352 Measurement on sample rack 240
C Aliquot probe 348 Safe handling 22
Calculation Analyzer 360 Control assignment 252
Overview of steps 473 Automatic procedure 339 Dialog 159
Result 473 Carrier 352
Control bottle, loading 282
Cuvette waste container 353
Calculation not possible, flag 75 Control measurement, automatic 253
Handheld barcode reader 360
Calculation of correlation coefficient failed, HIL cuvette 363 Control missing (94), status alert 395
flag 75 Keyboard 362 Control not sufficient (96), status alert 422
Calibration 328 Liquid waste container 356
Control rack
Assay 477 Manual procedure 339
Definition 242
Automatic 255 Mouse 362
Loading 282
Curve from different assay 478 Purging solution container 342
Curve, provided by Siemens Rack 352 Control result info, dialog 117
Healthineers 464 Reagent manager 360 Control result not saved or rejected by QC
Dialog 108 Sample manager 360 software (122), status alert 400
Using calibrator set 464 Touchscreen monitor 361
Control result, evaluation 290
Using standard plasma 464 Water container 345
Using user-defined method 464 Control sample 288
Cleaning of HIL cuvette required. HIL check
Calibration calculator, dialog 115 not possible (23), status alert 412 Controls, dialog 117
Calibration curve edited manually, flag 75 Clog detected during sample aspiration (21), Curve filter, dialog 111
Calibration curve info, dialog 116 status alert 412 Cuvette 59

Clog detected, flag 75 Loading 263
Calibration curve not monotonic, flag 75
Clog in aliquot probe cannot be removed Cuvette arm 50
Calibration curve outside acceptance range,
flag 75 (34), status alert 386 Cuvette bag
Clot detection 463 Barcode, technical specifications 459
Calibration curve, dialog 113
Clotting time, measurement method 470 Cuvette blockings 439
Calibration method 228 Bottom part (cuvette loader) 440
Calibration required (130), status alert 401 Coefficient of variation 475
Chute 446
Calibrator 63 Communication 67 Escapement 446
Adapter for bottle 57 Competitive format, measurement Feed hopper 444
Barcode 458 method 471 Upper part (cuvette loader) 439
Definition 243 Component name, status alert 432 Cuvette distributor 48
Safe handling 22 Cuvette loader 41, 48
Computer 53
Calibrator and control rack 56 Technical specifications 456 Troubleshooting 435
Calibrator and control racks, dialog 192 Conformity 30 Cuvette may be contaminated, flag 75
Calibrator bottle, loading 282 Connection problem (4), status alert 376 Cuvette waste bag 59
Calibrator not sufficient (75), status alert 416 Consumable 55 Cuvette waste container 40
Calibrator or assigned value missing (73), Cuvette 59 Cleaning 353
status alert 395 Cuvette waste bag 59 Emptying 271
Calibrator rack Evaporation cap 57 Cuvette waste container almost full (55),
Definition 242 Probe cleaner 61 status alert 414
Loading 282 Purging solution container 60

Print No. DCHS-G01.621.01.08.02 482
Index
Cuvette waste container full (56), status Direct mode 466 Export
alert 388 Directive on restriction of hazardous Dialog 136
Cuvette waste container missing or drawer substances 30 Troubleshooting data 450
open (57), status alert 389 Directive on waste electrical and electronic External device 53
Cuvette waste counter, dialog 185, 262 equipment 30 Extrapolation not possible, flag 75
Cuvettes almost used up (48), status Display cleanup 257
alert 414 Dialog 181 F
Cuvettes used up (49), status alert 388 Disposal 32 Fan problem <fan number> (10007), status
Aliquot pipettor 367 alert 431
D Distilled water Fewer supporting points than defined, flag 75
Data see Purified water Fixed absorbance, evaluation method 217
Dialog 175 Document viewer, dialog 137 Fixed Delta A, evaluation method 217
Job list 318 Drawer Flag 73
Loading 274 Cleaning of accessories 362 With symbol 73
Lot data 176 Cuvette waste 40 Without symbol 75
Raw data 175 Liquid waste 38
Fluid unit 52
Data backup 351 Probe cleaner 38
Specifications 452
Data definition, dialog 187, 194 Purging solution 39
Purified water 39 Footprint, analyzer 452
Data manager, dialog 133
Drifting baseline, evaluation method 216 Formula, calculate final value 476
Data problem, flag 75
Drop 2, check method 225 Framing 253
Data protection 23
Drop, check method 225
Data protection by means of system G
software 25 During "Aliquotting speed reduced" only STAT
racks will be processed <rack ID> (10001), Green cover
Data reduction 474 Insert 371
status alert 402
Arithmetic mean 474 Remove 367
Arithmetic mean with hyperbolic
E Grid 322
coefficient of variation 475
Coefficient of variation 475 Eco mode
Formula 476 System shutdown 336 H
Maximum 475 System start 262 Handheld barcode reader 44
Mean value with check 474 Edit rule, dialog 143 Cleaning 360
Median 476 Hardware requirements 24
Edit user, dialog 155
Median with hyperbolic coefficient of
Electrical safety 20 Header setup, dialog 131
variation 476
Minimum 475 Electromagnetic compatibility 30 Help 14
Ratio 1/n 475 Help, dialog 185
Emergency sample 298
Standard deviation 474
Empty cuvette waste, dialog 102 Hemolysis, interference check 468
Data reduction not possible, flag 75
ETP_auc, evaluation method 219 HIL (hemolysis, icterus, lipemia)
De-installation 32 Calculate index value 469
ETP_cmax, evaluation method 219
Declaration of Conformity 30 Determination 469
ETP_tlag, evaluation method 219 Measurement principle 468
Decreasing curve expected, flag 75
ETP_tmax, evaluation method 219 Result 323
Default aliquot volume 190
European directives 30 HIL check 463
Default assay 252 Activate 256
Evaluation
Default profile 156 Deactivate 256
Overview of calculation steps 473
Default rack template 238 Result 323
Raw value 473
Definitions loader, dialog 150 HIL cuvette, cleaning 363
Evaluation method 215
Delivery 31 HIL index 469
Evaluation methods for raw value, dialog 206
Delta A per minute, evaluation method 216 HIL reader 46
Evaporation cap
Specifications 452
Delta A, evaluation method 215 Bottle 57
Wavelength 452
Cartridge 58
Determination
Technical specifications 457 HIL result 323
HIL 469
HIL indices 469 Expiration warnings, dialog 166 HIL symbol 84
Steps for result 473 Expired calibration curve used, flag 75 HIL warning, dialog 169
Deviation of single measurements too high, Expired reagent used, flag 75 Housing lid or cuvette loader open (29),
flag 75 status alert 386
Expired sample, control, or calibrator used,
Dilution, sample 462 flag 75 Humidity 456
Dimensions, analyzer 452

Print No. DCHS-G01.621.01.08.02 483
Index
I Invalid control 327 Loading (samples), dialog 78

I/O ports 456 ISI (International Sensitivity Index) 284 LOCI (luminescent oxygen channeling
IT security 24 immunoassay)
Icterus, interference check 468
Measurement principle 471
Identification Item without evaporation cap on input wheel
Measurement step 471
Accessory 15 (93), status alert 421
Settings 200
Bottle 280 IVDR
LOCI assay, measurement 471
Sample 314 see In vitro diagnostic medical devices
System 15 Regulation LOCI reader 51
Measurement method 471
Illumination LED, reagent manager 37
Specifications 452
Illumination, LOCI assay 471 J
Wavelength 452
Immunochemical, measurement method 470 Job list
LOCI reagent
Cleanup 333
In vitro diagnostic medical devices Analyte receptor 471
Functions 318
Regulation 30 Chemibead 471
Navigation 320
Inactive assay 238 Sensibead 471
Jobs, dialog 82
Incorrect wash program <wash program Locking lever, checking position 368
name> for component <component name> K LogitLog5B, calibration method 231
(10010), status alert 403 Logoff 335
Keyboard 35, 38
Increasing curve expected, flag 75 Cleaning 362 Logon 263
Incubation time, maximum 452 Kinetic curve is waved, flag 75 Lot
Incubation, dialog 203 Management of multiple lots 465
Kinetic curve, check 473
Incubator 51 Reagent 465
Kinetic rate, measurement method 470
Induced emission of photons 461 Lot data
Adding to software 284
Infection, safe handling 22 L Dialog 176
Info, dialog 118 Language Loading 274
Initialization problem (6), status alert 376 Dialog 155 Lot data conflict (92), status alert 420
Setting 235
Initialization problem with access door, Lot data missing (90), status alert 420
consumables, or waste (8), status alert 377 LAS (laboratory automation system) 54
Communication 67 Lot data missing for calculation, message 91
Initialization problem: input wheel carries Luminescent oxygen channeling
more than 6 items (16), status alert 381 LAS connection 54
Dialog 140 immunoassay (LOCI), measurement
Initialization required (17), status alert 382 principle 471
Troubleshooting 436
Initialization required: component
Leakage detected in analyzer. Fluid dripped
<component name> (14), status alert 380 M
into collection pan (22), status alert 385
Initialization, dialog 182 Main power switch 44
Left drawer 38
Initialize Maintenance 338
Life cycle 31
Aliquot pipettor 371 As needed 360
Cuvette loader 439 Linear regression, calibration method 230 Automatic procedure 339
Initializing (2), status alert 404 Lipemia, interference check 468 Data backup 351
Liquid waste 38, 53 Dialog 167, 171
Input lane 36
Container 62 List 338
Input wheel 47 Manual procedure 339
Tap for emptying 62
INR (International Normalization Ratio) Monthly 348
Liquid waste container 62
Adding lot data 284 Periodic 338
Cleaning 356
Normalization method 477 Weekly 342
Emptying 273
Installation 31 Maintenance due (26), status alert 412
Liquid waste container almost full (52), status
Aliquot pipettor 368 Maintenance log, dialog 172
alert 414
Installation info, dialog 152 Maintenance mode active (15), status
Liquid waste container full (53), status
Insufficient change in signal, flag 75 alert 388 alert 411
Insufficient volume of sample, calibrator, or Liquid waste container missing (54), status Maintenance task 338
control on rack <rack ID>‑<rack position> alert 388 Dialog 168
(10006), status alert 431 Record 341
LIS (laboratory information system) 54
Select 340, 341
Intended purpose Communication 67
see Intended use Configuration 260 Manual entry, dialog 174
Intended use 18 Sample ID settings 257 Manual identification
LIS connection, dialog 140 Bottle 280
Intended user 19
Sample tube 314
Interference check, HIL 468 Load button, sample manager 36
Manual order, sample rack setting 302
International standards 30 Loading (reagents), dialog 105
Maximum 475

Print No. DCHS-G01.621.01.08.02 484
Index
Mean value with check 474 No measurement, flag 75 Pipettor, check functioning and precision 358
Measurement No plateau, flag 75 Placeholder 14
Control measurement 464 No result, flag 73 PlateAgg, evaluation method 222
Dialog 204
Non-barcoded sample tube 304 Plateau, check method 227
LOCI assay 471
Multiple sample measurement 462 Non-operation 31 Platelet aggregation meta-assay 84
Principle 468 Normal mode 466 Platelet-rich plasma (PRP), blank value 473
Reference 469
Normalization Plausibility, kinetic curve 473
Measurement curve Final result 477 Point of inflexion, evaluation method 218
Color 322 Overview of calculation steps 473
Dialog 95 Point-to-point, calibration method 230
Normalization method
Display 320 Position button, reagent manager 37
Assay calibration 477
Display customization 322 Power consumption 455
INR 477
Multiple 321
Ratio 477 Power switch 44
Measurement curve too short, flag 75
Not all single assay results usable, flag 75 Pre-heater 50
Measurement curve without reaction, flag 75
Not all single measurements usable, flag 75 Pre-identification
Measurement method 470 Bottle 280
Not enough supporting points, flag 75
Measurement range exceeded, flag 75 Dialog 80
Measurement time, maximum 452 O Sample 304
Measurements from different dilutions, Online help 14 Precision check 358, 372
flag 75 Status alert 14 Pressure and vacuum box 53
Measurements with different lots, flag 75 Onset of coagulation doubtful, flag 75 Primary sample tube 293
Mechanical safety 20 Opening tool 61 Prime tubings 364
Median 476 Operating conditions 455 Principle of operation 461
Median with hyperbolic coefficient of Operating element 35 Print screenshot 137
variation 476 Operating temperatures not yet reached Print, dialog 186
Meta-assay (100), status alert 424 Printing 326
Description 467 Operation, general principle 461 Barcode label 331
Dialog 213
Operational safety 21 Printout
Method Configuration 236
Data reduction 474 Operator qualification 19
Dialog 164
Normalization 477 Ordering information 16
Aliquot pipettor 365 Probe cleaner 38
Min Delta A, check method 226 Container 61
Minimum 475 Orthogonal regression, calibration Opening tool 61
method 231
Minimum absorbance too high, flag 75 Probe cleaner almost expired (67), status
Output lane 36 alert 415
Mixer 51
Overfilled bottle or cartridge on input wheel Probe cleaner container 61
Mixing 197, 200 (98), status alert 423 Replace 269
MNPT (Mean Normal Prothrombin Time) 284 Overview Probe cleaner container empty. Replace probe
Model number 15 Analyzer 34 cleaner container (46), status alert 387
Monitor 35 Dialog 102
Software 64 Probe cleaner container missing (59), status
Cleaning 361
alert 414
Monthly maintenance 348
P Probe cleaner expired (60), status alert 390
Mouse, cleaning 362
Patient name 83 Probe cleaner not flowing (64), status
Movement 32 alert 392
PDF document, display 13
Multi-dilution assay curve, dialog 98 Probe cleaner not identified (58), status
Percent Delta A, evaluation method 217
alert 389
N Periodic tasks, dialog 171
Probe cleaner reservoir 53
Network characteristics 24 Peripheral, problem 436
Probe cleaner reservoir empty. Replace probe
New assigned value, dialog 180 Personal data protection 23 cleaner container immediately (47), status
New calibration, dialog 112 Personal data protection by means of system alert 387
software 25 Probe not washed (27), status alert 385
New rule, dialog 142
Personal health information (PHI) 23 Probe washing 333
New statistics, dialog 131
Personally identifiable information (PII) 23 Problem <problem>, status alert 433
New user, dialog 154
PHI (Personal health information) 23 Problem rack re-loaded (87), status alert 418
New wave 2, check method 227
PII (Personally identifiable information) 23 Problem racks, dialog 78
New wave, check method 226
Pipettor problem, flag 75
No linear range, flag 75

Print No. DCHS-G01.621.01.08.02 485
Index
Problem with component: <component Qualification of operator 19 Reagent manager 37

name> (10009), status alert 403 Quality control, dialog 140 Cleaning 360
Problem with compressed air pressure (<too Quality criterion for the raw value cannot be Reagent missing (76), status alert 395
high>/<too low>) (140), status alert 402 calculated, flag 75 Reagent not sufficient (79), status alert 416
Problem with incubation time, flag 75 Quality criterion for the raw value cannot be Reagent scanner 47
Problem with liquid waste pressure (9), status calculated; rising curve expected, flag 75 Reagent storage 48
alert 379 Quality criterion for the raw value not Dialog 184
Problem with measurement curve, flag 75 fulfilled, flag 75 Reagent storage full (83), status alert 416
Problem with measuring module, flag 75 Quality criterion for the raw value not Reagent unit 46
Problem with pipetting medium, flag 75 fulfilled; rising curve expected, flag 75 Specifications 452
Problem with pipetting sequence, flag 75 Reagents, dialog 102
R
Process step, definition 250 Rear water container
Rack 55 see Stationary water container
Process steps, dialog 200 Barcode, technical specifications 459
Processing Calibrator 56 REF
Assay in direct mode 466 Cleaning 352 Accessory 15
Assay in normal mode 466 Control 56 System 15
Reagent 465 Sample 56 Reference measurement, absorbance
Sample 461 Rack definition reader 469
Product almost expired (99), status alert 423 Dialog 187, 190 Reflex testing
Product definition, dialog 194 Sample rack 239 Dialog 141
Rack not identified or rack barcode Rule 143
Product expired (97), status alert 422
unreadable (86), status alert 418 Register cuvettes, dialog 101
Proper-fill 462
Rack tray 57 Registered cuvettes almost used up (66),
Protection, personal data 23
Loading and unloading 309 status alert 415
by means of system software 25
Ratio 1/n 475 Registered cuvettes used up (65), status
Protection, unauthorized access 25
Ratio assay 467 alert 415
PSI (Pre-analytic sample integrity)
Ratio, normalization method 477 Registered cuvettes used up, flag 75
HIL check 463
Proper-fill 462 Raw data, dialog 175 Release, sample result 254
Sample check 462 Raw value info, dialog 95 Relevant control result doubtful, flag 73
PSI check 323 Raw value, evaluation 473 Relevant control result outside acceptance
PSI symbol 84 range or invalid, flag 73
Re-calibration required (132), status alert 429
Pump box 53 Relevant control results in acceptance range,
Re-fill cuvettes flag 73
Pumping of purified water not possible (63), see Register cuvettes, dialog
status alert 392 Remote control 335
Re-fill stirrer bars, dialog 101 Dialog 185
Purge tubings 344 Re-initialize Remote services, dialog 147
Purging solution 39 Aliquot pipettor 372
Container 60 Remove
Reaction and measuring unit 49 Aliquot pipettor 367
Re-filling or replacing 267
Reaction curve has unacceptable correlation, Repair 15
Purging solution container 60 flag 75
Purging solution container missing (45), Repeat, flag 75
Reaction rate, measurement method 470
status alert 387 Replace aliquot pipettor 364
Reaction unit, specifications 452
Purging solution used up (44), status Replace probe cleaner, dialog 102
alert 386 Reagent 63
Barcode, technical specifications 458 Replicate summarization
Purified water 22, 39, 60, 266 Definition 243 Data reduction 474
Container 60 Lot management 465 Overview of calculation steps 473
Re-filling 266 Lot number 465 Report serious incident 19
Requirements 22 Multiple lot 465 Required calibration running (129), status
Purified water almost used up (40), status Non-barcoded 465 alert 428
alert 413 Other manufacturer 466
Required re-calibration running (131), status
Purified water container missing (<Water Processing 465
alert 428
front>/<Water rear>) (42), status alert 413 Safe handling 22
Third-party 466 Reserve aliquot volume 190
Purified water used up (41), status alert 386
Reagent arm 51 Restore backup 351
Q Reagent bottle Restore, dialog 135

Loading 278 Result
QC database capacity critical (123), status
Preparation 277 Calculation steps 473
alert 400
Reagent cartridge, loading 278 Display and navigation 320
QC rule violation (120), status alert 400

Print No. DCHS-G01.621.01.08.02 486
Index
Invalid control 327 Sample Security measures 24

Manual release 325 Barcode 457 Security whitepaper 25
Printing 326 Dilution 462
Sensibead, LOCI reagent 471
Sample 468 Multiple measurement 462
Non-barcoded 462 Serious incident 19
Result above acceptance range, flag 73
Processing 461 Service
Result above customized cut-off, flag 73
Result 468 Contact information 15
Result above customized reference range, Safe handling 22 Remote control 335
flag 73 Troubleshooting 314
Service recommended: component
Result above cut-off, flag 73 Unloading 317
<component name> (18) 411
Result above measurement range, flag 73 Sample arm 50
Service required: component <component
Result above reference range, flag 73 Sample barcode, technical specifications 457 name> (19), status alert 383
Result below acceptance range, flag 73 Sample ID, settings 257 Service required: stirrer motors defective
Result below customized cut-off, flag 73 Sample info, dialog 89 (10003) 430
Result below customized reference range, Sample manager 36, 45 Service software 365
flag 73 Cleaning 360 Dialog 149
Initialize aliquot pipettor 371
Result below cut-off, flag 73 Sample material required (70), status
Re-initialize aliquot pipettor 372
alert 394
Result below measurement range, flag 73 Replace aliquot pipettor 365
Sample rack 56
Result below reference range, flag 73 Set language 235
Definition 239
Result converted to base dilution, flag 73 Rack tray 309 Settings (for barcode maker), dialog 133
Result doubtful, flag 73 Sample rack templates, dialog 193 Setup, dialog 125
Result export, dialog 147 Sample racks, dialog 192 Shaker, for reagents 48
Result extrapolated to a higher value, flag 75 Sample report Shared folder 260
Result extrapolated to a lower value, flag 75 see Sample info, dialog Shared folders, dialog 170
Result framing 253 Sample result framing 253 Shift change
Result history, dialog 181 Sample result info, dialog 91 see Logoff
Result in acceptance range, flag 73 Sample result processing, dialog 158 Short turnaround time (STAT) 298
Result invalid, flag 73 Sample result release 254 Shutdown 336
Result release 254, 325 Sample scanner 46 Significant drop in absorbance, flag 75
Result released, flag 73 Sample tube Smart Remote Services (SRS) 335
Adapter 57 Communication 67
Result sent to LIS, flag 75
Barcode problem 314 SMN
Reverse button, sample manager 36
Definition 239 Accessory 15
Reversing measurement curve, flag 75 Loading 293 System 15
Right drawer 40 Pre-identification without barcode 304
Software problem with CAN bus (12), status
Technical specifications 459
RoHS alert 380
see Directive on restriction of hazardous Sample tube overfilled, flag 75
Software start, problem 435
substances Sample tube underfilled, flag 75
Software text placeholder 14
Sample tubes with identical barcodes on rack
S Software-related measures to protect
<rack ID> (80), status alert 416
personal data 25
Safety information Sample tubes, dialog 190
Calibrator 22 Spare parts 16
Sample unit 44
CAUTION, meaning 25 Special order, dialog 88
Specifications 452
Consumable 22 Specifications
Control 22 Sandwich format 471
Electrical safety 20 Scanner Analyzer 452
General 19 Reagent scanner 47 Barcode 457
Infection 22 Sample scanner 46 Computer 456
Mechanical safety 20 Scope of delivery 31 Consumable 457
NOTICE, meaning 25 Fluid unit 452
Operational safety 21 Screenshot
HIL reader 452
Operator qualification 19 Create 72
I/O ports 456
Personal data 23 Creating 319
LOCI reader 452
Reagent 22 View or print 137
Operating conditions 455
Safety messages, structure 25 Search Reaction unit 452
Sample 22 Patient name 319 Reagent unit 452
Symbols 26 Sample ID 319 Sample tube 459
WARNING, meaning 25 Secondary sample tube 304 Sample unit 452
Secure download, dialog 148

Print No. DCHS-G01.621.01.08.02 487
Index
Storage conditions 456 Technical specifications 452 Time of completion 84

Technical 452 Analyzer 452 Touchscreen monitor 35
Spectroscopy 461 Barcode 457 Cleaning 361
Barcode for user-defined control
SRS (Smart Remote Services) 335 Transfer step 200
sample 457
Standard deviation 474 Computer 456 Transfer, dialog 200
Standards, statutory requirements 30 Cuvette bag barcode 459 Transport 32
Evaporation cap 457
Starting (3), status alert 405 Transportation problem at component
I/O ports 456
STAT (short turnaround time) 298 <component name> (11), status alert 405
Operating conditions 455
STAT sample, loading 298 Rack barcode 459 Troubleshooting via remote services 450
Stationary water container 60 Reagent barcode 458 Tubing system 53

Sample barcode 457 Tubings 53
Status alert, color 374
Sample tube 459 Prime 364
Status LED, reagent manager 37 Storage conditions 456 Purge 344
Status light 43, 375 UPS 457
Statutory requirements Temperature 456 U
CE conformity 30 Temperature in absorbance reader in warning Unexpected measurement curve, flag 75
Electromagnetic compatibility 30 range (<too high>/<too low>) (107), status
European directives 30 Unidentified item on input wheel (88), status
alert 425
International standards 30 alert 419
Temperature in absorbance reader out of
Sticky Unidentified item on rack (85), status
range (<too high>/<too low>) (108), status
see Status alert, color alert 418
alert 397
Stirrer bar 59 Unidentified sample 314
Temperature in incubator in warning range
Loading 265 (<too high>/<too low>) (110), status Uninterruptible power supply (UPS) 55
Troubleshooting 435 alert 426 Technical specifications 457
Stirrer bar loader 42, 49 Temperature in incubator out of range (<too Unknown sample tube type: barcode
Stirrer bars almost used up (50), status high>/<too low>) (111), status alert 398 <barcode> on rack <rack ID>-<rack position>
alert 414 (10005), status alert 430
Temperature in LOCI reader in warning
Stirrer bars used up (51), status alert 388 range (<too high>/<too low>) (101), status Unload button, sample manager 36
alert 424 Unloading of input wheel required (89),
Storage 31
Aliquot 46 Temperature in LOCI reader out of range status alert 420
Reagent 48 (<too high>/<too low>) (102), status Unloading sample 317
alert 396 Updates available (20), status alert 412
Storage conditions 456
Temperature in pre-heater in warning Updates, dialog 170
SVS solution 62, 358
range (<too high>/<too low>) (113), status
Symbols, meaning 26 alert 426 UPS (uninterruptible power supply) 20, 55
System (for general settings), dialog 165 Technical specifications 457
Temperature in pre-heater out of range (<too
System (for operating the system), dialog 183 high>/<too low>) (114), status alert 398 User account 235
System event 120 Temperature in reagent storage in warning User administration, dialog 152
System fluid range (<too high>/<too low>) (104), status User-defined control sample
Probe cleaner 52 alert 425 Barcode, technical specifications 457
Purging solution 52 Temperature in reagent storage out of User, dialog 182
Purified water 52 range (<too high>/<too low>) (105), status
System identification 15 alert 396 V
System on backup power (24), status Temperature problem Vacuum supply 53
alert 385 Dialog 184, 262
Validation 358
Flag 75
System problem, flag 75 SVS solution 62
Temperature sensor of absorbance reader
System shutdown 336 View screenshot 137
defective (109), status alert 398
System shutting down. Do not switch off the VLin Integral, evaluation method 218
Temperature sensor of incubator defective
analyzer (5), status alert 405 VMax_sabs, evaluation method 221
(112), status alert 398
System start 261, 262 VMax_sfirst, evaluation method 221
Temperature sensor of LOCI reader defective
System status 65 (103), status alert 396 VMax_ssec, evaluation method 221
Temperature sensor of LOCI reader defective VMax_tabs, evaluation method 221
T (106), status alert 397 VMax_tfirst, evaluation method 221
Tap, accessory for emptying liquid waste 62 Temperature sensor of pre-heater defective VMax_tsec, evaluation method 221
Task execution, dialog 174 (115), status alert 399
VMaxDyn, evaluation method 220
Technical safety 19 Third-party control 289
Third-party reagent 466

Print No. DCHS-G01.621.01.08.02 488
Index
W
Wake-up button 40
Warranty 15
Wash program 200
Wash station 53
Waste bag, cuvette 59
Water
see Purified water
Water container 60
Cleaning 345
Wavelength
Alternative raw value evaluation 98
HIL reader 452
LOCI reader 452
WEEE
see Directive on waste electrical and
electronic equipment
Weekly maintenance 342
Weight, analyzer 452
X
XPS document, display 137

Print No. DCHS-G01.621.01.08.02 489
optimize product performance and meet product specifications. User
defined modifications are not supported by Siemens Healthineers as
Siemens Healthineers has validated the provided instructions, reagents, they may affect performance of the system and test results.
instrument, software and customizable features for this system to
Siemens Healthineers Headquarters Legal Manufacturer

Siemens Healthcare GmbH Siemens Healthcare Diagnostics
Henkestr. 127 Products GmbH
91052 Erlangen Emil-von-Behring-Str. 76
Germany 35041 Marburg
Phone: +49 9131 84-0 Germany
siemens-healthineers.com
Material No. 10987749

Published by Siemens Healthineers / Print No. DCHS-G01.621.01.08.02 / © Siemens Healthineers, 2014 - 2022
Date of first issue: 2014-06 / Revision date: 2022-02

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Atellica COAG 360 System

4 Description of the hardware 34

Instruction Manual Atellica COAG 360 System | 2022-02

4.2 External devices 53

5 Description of the software 64

Instruction Manual Atellica COAG 360 System | 2022-02

5.3.22 Curve filter 111

Instruction Manual Atellica COAG 360 System | 2022-02

5.3.76 Maintenance task 168

Instruction Manual Atellica COAG 360 System | 2022-02

5.4.8 Point of inflexion 218

6 Configuring the system 235

Instruction Manual Atellica COAG 360 System | 2022-02

6.12 Configuring automatic calibrations 255

7 Preparing for the analysis 261

8 Performing the analysis 277

Instruction Manual Atellica COAG 360 System | 2022-02

8.8 Unloading a bottle or cartridge 291

9 Finishing the analysis 333

Instruction Manual Atellica COAG 360 System | 2022-02

10 Performing maintenance and cleaning 338

Instruction Manual Atellica COAG 360 System | 2022-02

Instruction Manual Atellica COAG 360 System | 2022-02

11.3.13 Purified water almost used up (40) 413

Instruction Manual Atellica COAG 360 System | 2022-02

11.6.4 Problem with peripherals 436

12 Technical specifications 452

14 Revision Information 479

Instruction Manual Atellica COAG 360 System | 2022-02

1.1 About this manual

1.2 User manuals

1.2.1 Viewing a PDF document

1 In the software, at the top, select Setup.

→ The dialog Setup is displayed.

3 At the top left, select Manuals.

→ The available manuals are displayed.

5 Select the required manual.

6 Select the action button Show.

→ The first manual page is displayed.

→ Viewing a PDF document is completed.

Instruction Manual Atellica COAG 360 System | 2022-02

1.2.2 Getting online help on a dialog

◆ Select the action button Help.

1.2.3 Getting online help on a status alert

1 Select the status alert.

There are several possibilities:

• The dialog where the problem can be resolved is displayed.

• If the corresponding dialog is already displayed, the dialog Help is displayed

1.3 Orientation tips

Indicates the solution of a problem

Indicates a list item

Indicates a 1‑step procedure or procedural steps to solve a problem

Indicate steps within procedures

Indicates a link to related information as well as previous or next steps

→ Indicates the result of a procedural step or a procedure

Instruction Manual Atellica COAG 360 System | 2022-02

Italic Is used for references

<(...)> Are used for generic placeholders in software texts

Orange Is used to emphasize particularly important sections of the text

• 1AAA101A (REF), 10707173 (SMN) (stand-alone)

• 1AAA102A (REF), 10759658 (SMN) (automation)

The model numbers of accessories used with the system are:

• Behring Coagulation Cup: OVIS31 (REF), 10446526 (SMN)