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by PHẠM THỊ
THU HÀ
Date:
2022.05.01
20:45:26
+07'00'

Atellica NEPH 630 System

 
Instruction Manual
2021-10

siemens-healthineers.com
 Table of contents

1 Introduction 8
1.1 About this manual 8
1.2 Orientation tips 8
1.3 Identification 9
1.4 Service 9
1.5 Warranty 9
1.6 Ordering information 9
1.7 Third-party software copyrights 10
1.8 Trademarks 13
1.9 Manual version history 13

2 Safe handling 14
2.1 Intended use 14
2.1.1 System functions 14
2.2 Intended user 14
2.3 Reporting of serious incidents 14
2.4 General safety information 14
2.4.1 Operator qualification 15
2.4.2 Electrical safety 15
2.4.3 Mechanical safety 16
2.4.4 Operational safety 16
2.4.5 Safe handling of samples, reagents, controls, standards, and consumables 18
2.4.6 Limitations of the quantitative determination of proteins 19
2.4.7 Safe handling of personal data 20
2.4.8 IT security measures 20
2.4.9 Security whitepaper 21
2.5 Safety messages 21
2.6 Symbols 22
2.7 Statutory provisions 25

3 Life cycle 26
3.1 Delivery 26
3.2 Installation 26
3.3 Non-operation 26
3.4 De-installation 27
3.5 Movement 27
3.6 Disposal 28

4 Description of the hardware 29

4.1 Overview of the analyzer 29
4.2 Functional units 30
4.2.1 Covers 30
4.2.2 LEDs 30
4.2.3 Sample rotor 31
4.2.4 Reagent rotor 31
4.2.5 Dilution station 32
4.2.6 Wet station 33
4.2.7 Cuvette rotor 34
4.2.8 Transfer arm and probe 35
4.2.9 Syringe 37
4.2.10 Power module 37

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4.3 Components inside the analyzer 38

4.3.1 Air bubble detector 38
4.3.2 Barcode reader 38
4.3.3 Dilutor 39
4.4 External and peripheral devices 39
4.4.1 Peripheral devices 40
4.4.2 LIS (optional) 40
4.5 Consumables and accessories 41
4.5.1 Sample rotor segments 41
4.5.2 Reagent rotor segments 44
4.5.3 N Cuvette segments for BN ProSpec 45
4.5.4 Dilution strips 46
4.5.5 N Evaporation Caps for Control Vials (2.5 mL) and N Evaporation Caps for
Reagent Vials (5 mL) 46
4.5.6 Liquid containers, level sensors, and tubing 47
4.5.7 Probe cleaner bottle 49
4.6 Reagents, standards, and controls 49

5 Description of the software 50

5.1 Overview of the screen 50
5.2 General elements 51
5.2.1 Status buttons 51
5.2.2 Common display functions in dialogs 52
5.2.3 Common action buttons 54
5.2.4 Flags and symbols 54
5.2.5 Function keys 57
5.3 Dialogs 58
5.3.1 About 58
5.3.2 Access cuvette segments and dilution strips 58
5.3.3 Access reagents 60
5.3.4 Access samples 60
5.3.5 Add request 60
5.3.6 Calibration 63
5.3.7 Check probe 65
5.3.8 Clean probe 65
5.3.9 Configuration 66
5.3.10 Control details 72
5.3.11 Definitions 73
5.3.12 Hardware check - probe 80
5.3.13 Help 80
5.3.14 Initialize analyzer 81
5.3.15 Kinetics - Measurement curves 81
5.3.16 Kinetics - Reference curve 82
5.3.17 Lab journal 83
5.3.18 Loading cuvette segments and dilution strips 86
5.3.19 Loading reagents 88
5.3.20 Loading reagents, graphic overview 89
5.3.21 Loading reagents, identify reagents and controls 92
5.3.22 Loading samples 94
5.3.23 Log on 99
5.3.24 Logbook 100
5.3.25 Message window 101
5.3.26 New 102
5.3.27 Open lot data file 104

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5.3.28 Pre-loading 105

5.3.29 Print preview 106
5.3.30 Print raw data 108
5.3.31 Purge tubings 108
5.3.32 QC 109
5.3.33 Remote control 109
5.3.34 Repeat 110
5.3.35 Replace syringe 111
5.3.36 Replace system liquids and empty waste container 111
5.3.37 Request controls 112
5.3.38 Rinse system 113
5.3.39 Sample details 113
5.3.40 Select path for backup file 114
5.3.41 Show curve 115
5.3.42 Special dilution 117
5.3.43 Status 118
5.3.44 System 123

6 Configuring the system 127

6.1 Adding a standard lot 127
6.2 Configuring cyclic control measurements 127
6.3 Deactivating cyclic control measurements for an assay 128
6.4 Adding a user-defined control 128
6.5 Adding an assay to a user-defined control 130
6.6 Editing assay settings in a user-defined control 131
6.7 Deleting a user-defined control 133
6.8 Adding a control lot 133
6.9 Deleting a control lot 134
6.10 Adding a profile 135
6.11 Adding an assay to a profile 135
6.12 Removing an assay from a profile 135
6.13 Deleting a profile 136
6.14 Adding a sample rotor segment ID 136
6.15 Deleting a sample rotor segment ID 137
6.16 Configuring the immersion depth for cups used with a cup-in-tube segment 137
6.17 Configuring unit and reference range of an assay 139
6.18 Setting automatic re-measurement and automatic release 140
6.19 Configuring printouts 141
6.20 Setting the display of results in the lab journal 141
6.21 Setting the default sort sequence in the lab journal 141
6.22 Setting the language 142
6.23 Configuring significant digits of the sample ID 142
6.24 Configuring the LIS connection 143

7 Preparing for the analysis 144

7.1 Starting the system 144
7.2 Emptying the waste container 145
7.3 Replacing system liquids 146
7.4 Loading cuvette segments and dilution strips 147
7.5 Loading lot data 149
7.6 Preparing reagents and controls 149
7.7 Loading reagents and controls 152
7.8 Preparing a sample rotor segment for use 154

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8 Performing the analysis 157

8.1 Identifying a reagent or control 157
8.2 Loading standards and user-defined controls 158
8.3 Measuring a control 160
8.4 Repeating a control measurement 161
8.5 Loading barcoded samples 162
8.6 Assigning STAT status to a barcoded sample 165
8.7 Pre-identifying non-barcoded samples and non-barcoded STAT samples 166
8.8 Loading non-barcoded samples and non-barcoded STAT samples 167
8.9 Loading sample rotor segments 170
8.10 Identifying a sample or standard with unreadable barcode 171
8.11 Requesting a job for a sample manually 172
8.12 Repeating a job for a sample manually 173
8.13 Refilling a sample tube 174
8.14 Unloading samples 175
8.15 Unloading standards 176
8.16 Unloading reagents and controls 177
8.17 Displaying data in the lab journal 178
8.18 Displaying sample and control details 179
8.19 Displaying measurement curves 179
8.20 Releasing results 179
8.21 Printing results 180
8.22 Sending control results for evaluation 180
8.23 Measuring the reference curve for an assay 181
8.24 Repeating the measurement of a reference curve 182
8.25 Displaying a reference curve 183
8.26 Activating an invalid reference curve 184
8.27 Deleting a sample ID from the lab journal 184
8.28 Removing previous assignments of sample IDs 185
8.29 Using cup-in-tube segments 186
8.30 Using Eppendorf cup segments 189
8.31 Using Hitachi cup segments 192
8.32 Using cup-behind-tube segments 194

9 Finishing the analysis 198

9.1 Rinsing the system 198
9.2 Creating a backup 198
9.3 Shutting down the system 199
9.4 Emptying the waste container 201

10 Performing maintenance and cleaning 202

10.1 List of tasks 203
10.2 Weekly tasks 204
10.2.1 Checking the functioning of the probe 204
10.2.2 Cleaning the probe 205
10.2.3 Cleaning the wet station 207
10.2.4 Cleaning the reagent rotor and the reagent rotor housing 209
10.2.5 Checking the syringe for leaks 210
10.2.6 Cleaning the water container 211
10.2.7 Checking the tubing of the containers 212
10.2.8 Checking the tubing of the probe 212
10.3 Monthly tasks 214
10.3.1 Purging the tubing 214
10.3.2 Replacing the water filter 216

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10.3.3 Cleaning the level sensors 217

10.4 Yearly tasks 220
10.4.1 Replacing the syringe 220
10.4.2 Replacing the tubing of the containers 224
10.5 As needed tasks 228
10.5.1 Shutting down the system for maintenance 228
10.5.2 Cleaning the surface of the system 228
10.5.3 Cleaning the sample rotor and the sample rotor housing 228
10.5.4 Cleaning the segments 230
10.5.5 Cleaning the dilution station, the cuvette rotor, and the cuvette rotor housing
230
10.5.6 Cleaning the waste container 233
10.5.7 Cleaning the peripheral devices 233
10.5.8 Replacing the probe cleaner bottle 234
10.5.9 Preparing the purging solution 235
10.5.10 Preparing the hypochlorite solution 235
10.6 Atellica® NEPH 630 System maintenance log 237

11 Troubleshooting 239
11.1 Carrying out troubleshooting 239
11.2 Hardware troubleshooting 240
11.2.1 Hardware troubleshooting chart 240
11.2.2 Inserting reagent rotor segments 241
11.2.3 Checking the level of samples visually 242
11.2.4 Checking the level of reagents or controls 243
11.2.5 Checking the geometry of the probe 245
11.2.6 Replacing the fuses 245
11.2.7 Replacing the probe assembly 248
11.2.8 Troubleshooting the syringe 264
11.3 Software troubleshooting 265
11.3.1 Message window 265
11.3.2 Status bar 269
11.3.3 Dialog Status 276
11.3.4 Dialog Lab journal 276
11.3.5 Dialog Loading 282
11.3.6 Dialog Calibration 291
11.3.7 Dialog System 291
11.3.8 General software problems 294
11.4 Entering a logbook entry 298
11.5 Exporting logbook entries 299

12 Technical specifications 300

12.1 Analyzer 300
12.1.1 Operating conditions 302
12.1.2 Storage conditions 303
12.1.3 I/O ports 303
12.2 Computer 303
12.3 Consumables 303
12.3.1 Sample rotor segments 304
12.3.2 Reagent rotor segments 305
12.3.3 Cuvette segments 305
12.3.4 Dilution strips 305
12.3.5 Evaporation caps 305

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12.4 Sample tubes, cups, and vials 305

12.4.1 Sample tubes 306
12.4.2 Special cups and vials 306
12.5 Adapters 306
12.6 Barcodes 306
12.6.1 Sample and user-defined control barcodes 307
12.6.2 Reagent barcodes 308

13 Appendix 309
13.1 Principle of operation 309
13.1.1 Handling of samples 309
13.1.2 Handling of reagents 309
13.1.3 Handling of standards 310
13.1.4 Handling of controls 311
13.1.5 Dilutions 311
13.1.6 Handling of lot data and calibration data 312
13.1.7 Calibration 312
13.1.8 Processing of assays 314
13.1.9 Processing of reference curves 317
13.1.10 Processing of control measurements 319
13.1.11 Plausibility check 319
13.1.12 Formula test 320
13.2 Principle of measurement 320
13.2.1 Nephelometry 320
13.2.2 Optical path of beam 321
13.2.3 Principle of immunochemical protein determination 323
13.2.4 Methods of determining the protein concentration at different times 326
13.3 Communications 327

14 Revision information 328

Index 329

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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® NEPH 630 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 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

→ Indicates the result of a procedural step or a procedure

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

Orange Is used to emphasize particularly important sections of the text

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 1 Introduction

1.3 Identification
The model number is: 11239861 (SMN), OVLI02 (REF)

The model numbers of accessories used with the system are:

• N Predilution Wells: OVIC11 (REF), 10446521 (SMN)

• N Cuvettes Segments for BN ProSpec: OVLK31 (REF), 10446539 (SMN)

• N Evaporation Caps for Control Vials (2.5 ml): OVLC21 (REF), 10446534 (SMN)

• N Evaporation Caps for Reagent Vials (5 ml): OVLC31 (REF), 10446535 (SMN)

1.4 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.

1.5 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.

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.

1.6 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.

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 1 Introduction

1.7 Third-party software copyrights

This device 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 device. 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. Versions of the
Apache License are available at http://www.apache.org/licenses/.
The Apache License Version 2.0 reads:

Terms and conditions for use, production, and distribution.

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 1 Introduction

“Contribution” shall mean any work of authorship, including the original version of the
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 1 Introduction

d. If the Work includes a “NOTICE” text file as part of its distribution, then any Derivative
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nothing herein shall supersede or modify the terms of any separate license agreement
you may have executed with Licensor regarding such Contributions.

6. Trademarks.

This License does not grant permission to use the trade names, trademarks, service
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7. Disclaimer of Warranty.

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8. Limitation of Liability.

In no event and under no legal theory, whether in tort (including negligence), contract,
or otherwise, unless required by applicable law (such as deliberate and grossly negligent
acts) or agreed to in writing, shall any Contributor be liable to You for damages,
including any direct, indirect, special, incidental, or consequential damages of any
character arising as a result of this License or out of the use or inability to use the Work
(including but not limited to damages for loss of goodwill, work stoppage, computer
failure or malfunction, or any and all other commercial damages or losses), even if such
Contributor has been advised of the possibility of such damages.

9. Accepting Warranty or Additional Liability.

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 1 Introduction

While redistributing the Work or Derivative Works thereof, You may choose to offer, and
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may act only on Your own behalf and on Your sole responsibility, not on behalf of any
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harmless for any liability incurred by, or claims asserted against, such Contributor by
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End of terms and conditions

For Linux Kernel v3.13.5 under the GNU GPL v2:

© 2014 Linux Community

© 2015 Richard Theil (modifications regarding patches br-0001-Config, linux-0001-

ehcixinc, linux-0002-r4sig, linux-0003-ngpio, linux-0004- pselect, linux-0005-
cmdforce, linux-0006-xelitex, linux-0007-binimgdts, linux-0009-emilxdefconfig
and linux-0011-timerns)

© 2015 Siemens Healthcare Diagnostics Products GmbH, Xilinx Inc. and Michal Simek
(modifications regarding patch linux-0008-emilxdtb)

© 2015 Siemens Healthcare Diagnostics Products GmbH (modifications regarding

patch linux-0010-bdideviceremove)

For u-boot Universal Boot Loader, v2014.01 under the GNU GPL v2:

© 2014 Wolfgang Denk, DENX Software Engineering

For log4net, v1.2 under the Apache Software License, Version 2.0:

© 2004–2015 Apache Software Foundation

1.8 Trademarks
Atellica and Advia are trademarks of Siemens Healthineers.

All other trademarks are the property of their respective owners.

1.9 Manual version history

Manual Software

Version Date Changes Full version Release version

1.0 (not published) 2016-10 First version 1.0.0 1

1.1 (not published) 2017-01 Update 1.0.0 1

1.2 2017-04 Update 1.0.0 1

1.3 2018-04 Update 1.1.0 1

01 2021-10 Update 1.1.1 1

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 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® NEPH 630 is a system for the quantitative determination of proteins in
serum, plasma, urine, and CSF.

The system is intended for in vitro diagnostic use in clinical laboratories by

trained personnel.

2.1.1 System functions

The system functions are:

• Preparation of pre-dilutions in the dilution cups for samples, standards, and controls

• Pipetting (dispensing) of all required reagents, samples, and sample dilutions

• Reaction incubation in the rotor cuvettes

• Optical measurement of the rotor cuvettes

• Calculation and flagging, if required, of the measurement results

The Atellica NEPH 630 system is a walk-away analyzer. After entering the job list
and loading the analyzer with the necessary reagents, standards, and controls,
up to 45 samples can be loaded simultaneously onto the analyzer. Processing
occurs automatically.

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.

• Keep this manual for future reference unless you obtain a new version of the manual.

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 2 Safe handling

• If an addendum is published, read the addendum. The information in the addenda

reflects the current status and supersedes other information in the corresponding
manual, if applicable.

• 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 and in the instruction manual
of the system. If maintenance is not performed as described or if maintenance
other than described in this manual and in the instruction manual of the system is
performed, Siemens Healthineers disclaims all liability for any personal injury and
property damage.

• 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 302 Operating
conditions) and ( Page 303 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.

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:

• To de-energize the analyzer, unplug the supply cable from the power supply socket.

• 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.

• Only use checked cables for the connection between the analyzer and the associated
computer and monitor.

• 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.

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• If the system needs to be opened for maintenance or replacement, follow the

instructions given in the relevant procedures.

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.

• 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.

• Place the system in a well-ventilated area.

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.

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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 damage to the eyes due to the laser beam of the barcode reader. Minor or
moderate injury can result. To avoid this hazard:

• Do not look directly into the laser beam of the barcode reader.

• Do not place any reflective objects in front of the laser beam of the barcode reader.

The system uses a covered laser beam to identify the barcode labels on tubes and vials.
The beam of the used laser is protected from possible directly viewing.

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.

• 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
Siemens Healthineers.

• Do not use solvents or abrasive cloths to clean the system.

• Only open the covers of the system as displayed below.

Risk of property damage due to organic solvents, acids, alkalis, or other inorganic
solvents affecting parts of the system. To avoid this hazard:

• Only use agents for cleaning and purging as described in this manual.

Modifications of the system software can affect the operation of the analyzer. To avoid
this hazard:

• Do not modify the system software, for example, do not update the operating system
or install any software not authorized by Siemens Healthineers.

• Only use virus-free USB flash drives or other data carriers with the computer.

Steam, solvents, and acid vapors can affect the operation of the system. To avoid
this hazard:

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 2 Safe handling

• Select a place to set up the system where it will be least affected by steam, solvents,
and acid vapors.

Risk of the reagent rotor overheating due to blocked air inlet and outlet area of the
reagent rotor cooler. To avoid this hazard:

• Make sure the required space for ventilation is sufficient, see ( Page 300 Dimensions
and weight).

2.4.5 Safe handling of samples, reagents, controls, standards, and

consumables
Risk of infection due to potentially infectious material. Samples, reagents, controls,
standards, 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.

• Only open covers as described in this manual.

• Avoid contact of the skin and mucosa with potentially infectious material.

• See the instructions for use of the reagents, controls, and standards 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 results due to incorrect level detection. Incorrect results can lead to
misdiagnoses and incorrect treatment. To avoid this hazard:

• Ensure that the water used has a conductivity of > 30 μS/cm.

• In the case of water with a lower conductivity, for example, purified water, water for
injections, or Siemens Healthineers purified water diluent, add 10 mL system diluent
to 10 L water.

Risk of incorrect results. Incorrect results can lead to misdiagnosis and incorrect
treatment. To avoid this hazard:

• Do not use whole-blood samples.

• When using third-party reagents, validate that Siemens Healthineers assays are not
affected by carry-over.

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 2 Safe handling

• Measure controls for each assay.

• Monitor the stability of samples, reagents, controls, and washing solution, see the
instructions for use.

• Do not store system liquids in the refrigerator. For more information, see the
instructions for use of the buffer and diluent.

• Do not pool or refill buffer and diluent.

Risk of irritation of the skin and mucous membranes due to reagents, standards, controls,
and 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, and consumables. To avoid this hazard:

• Only use approved Siemens Healthineers consumables.

• Keep all sample or reagent segments and any dilution frames away from sunlight
and heat.

• See the instructions for use that are supplied with the reagents, controls, standards,
and consumables.

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 Limitations of the quantitative determination of proteins

Immunochemical techniques are subject to the limitations imposed by the Heidelberger-
Kendall curve, whereby 2 different concentrations can be responsible for a single
measurement signal.

In the case of fixed time nephelometry, the ascending branch of the Heidelberger-
Kendall curve is extended by optimizing the course of the reaction so that most plasma
proteins’ measurement signals fall at the left side of the Heidelberger-Kendall curve,
even at very high concentrations, see ( Page 323 Heidelberger-Kendall curve).

In individual cases, a very high protein concentration in the sample, for example, urine,
could lead to questionable results. If this is the case, additional measurements must
be taken (total protein determination, protein test strips, measurements using higher
dilutions) in order to exclude the possibility that an antigen excess has occurred. The
analyzer performs a pre-reaction for several assays. Samples in which an antigen excess
is detected in the pre-reaction are automatically re-measured at a higher dilution.

Turbidity and particles in the samples can interfere with measurements. Particles that
have been formed in incompletely coagulated serum and/or plasma or through the
denaturization of proteins, or that may be present in urine and CSF samples (crystals,
cells) must be removed by centrifugation before measurement.

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Control sample and inter laboratory test sample results can vary depending on the
measurement method used, since the techniques used to prepare them may differ or the
samples may be old. It may therefore be required to evaluate these results according to
method-specific target values.

Rheumatoid factors In individual cases, the reaction could be disturbed by very high concentrations of
rheumatoid factors (RF). The rheumatoid factors bind to the antibodies in the antigen-
antibody complexes, leading to an increase in the size of the aggregates. The addition of
special supplementary reagents can reduce this effect.

For more information on the RF concentration up to which the measurements are valid,
see the instructions for use of the reagents.

Monoclonal immunoglobulins Since monoclonal immunoglobulins (paraproteins) react differently with the antibodies
used in the assays because of their structure, implausible results should be checked with
other techniques (immunofixation, immunoelectrophoresis).

In immunochemical measurement methods, such samples can give different results at

different dilutions.

2.4.7 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 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 this condition can protective measures implemented in the
software become effective.

• When printing personal data, for example, from the laboratory journal, make sure that
these printouts cannot be viewed by unauthorized persons.

• When exporting personal data, make sure that these exported data cannot be
accessed by unauthorized persons.

2.4.8 IT security measures

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

Hardware requirements The device runs under the following minimum hardware requirements: Intel Celeron
G540 Dual 2.5 GHZ 2M SKT, 8GB DDR3 SDRAM, 256 GB hard drive (or SSD) for
the operating system and installed software. Communication via Can bus between
subsystems and the main computer.

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IT network characteristics This product communicates to a LIS system using a serial RS-232 connection. To connect
to the Smart Remote Services (SRS) infrastructure, 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

Security measures The following security measures are in place:

• McAfee Embedded Control allow lists provide protection against malware infections

• Properly configured firewall blocks unwanted connections

• Audit logging ensures transparency (operating system only)

• Timely patching is available via SRS

• Hardened operating system drastically reduces the attack surface

Security and software/data updates are provided via the document library as secure
update packages. These packages can be manually installed by the device operator using
the Secure Download software. Continuous vulnerability assessment and remediation is
performed throughout the complete product lifecycle by Siemens Healthineers.

Protection against System includes role-based access, including separate accounts for routine operation
unauthorized access and service tasks with strong password enforcement

2.4.9 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.

2.5 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.

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

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Signal word Meaning

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.

2.6 Symbols
This chapter describes all symbols except symbols in the software.

Symbol Meaning

Accessories

[ANALYZER] Analyzer

Authorized representative in Switzerland

[BUFFER] Buffer

SMN Catalog number

CE mark

China RoHS marking

The number in the center indicates the environmental
protection use period (in years).

[COMPUTER] Computer

Consult instructions for use

Content is fragile and must be handled with care

[CONTENTS] Contents

[CUVETTES] Cuvettes

Date of manufacture

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Symbol Meaning

Unique device identification barcode

[DILUENT] Diluent

Do not re-use

EAC marking

[EVAP__ CAPS] Evaporation caps

Federal (USA) law restricts this device to sale by or on

the order of a licensed healthcare professional.

Handle with care

[IVD] In vitro diagnostic medical device

Indicates correct upright position of the transport pack‐

age

Keep away from sunlight and heat

Keep dry

Keyboard

[LOT] Lot data

Manuals

Manufacturer

Only open covers of the system as displayed

Prescription device
Only applicable in the USA

Product line: Plasma Proteins

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Symbol Meaning

Power off

Power on

[PREDIL__ _ WELLS] Predilution wells

Protective earth, protective ground

Identifies any terminal which is intended for connec‐
tion to an external conductor for protection against
electric shock in case of a fault, or the terminal of a
protective earth (ground) electrode.

[REF] Registration reference number

Remove caps from sample tubes before loading.

Stacking of the transport package is not allowed and no

load should be placed on the transport package.

[SYSTEM] System

Temperature limit

Ukraine mark

Warning: Assembly is susceptible to electro‐

static charge

Warning: Biological risks

The labeled area can come into contact with potentially
infectious material. The safety instructions for infec‐
tious material must be observed, see ( Page 18 Safe
handling of samples, reagents, controls, standards,
and consumables).

Warning: Consult instructions for use for important

cautionary information

Warning: Laser beam

[WASTE__ BAGS] Waste electrical and electronic equipment

For more information, see ( Page 28 Disposal).

Symbols

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2.7 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.

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 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 Quick Starter manual 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 containers show 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.

The system is supplied without any power supply cables. Power supply cables that
correspond to the requirements of the particular country must be used, for example,
VDE, CSA‑C22.2, No. 21, or CSA‑C22.2, No. 49, see ( Page 302 Electrical conditions).

3.3 Non-operation
To prepare the system for a period of more than 1 week of non-operation, proceed
as follows:

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WARNING

When the system is shut down for more than 2 hours, the buffer in the tubing and
in the buffer reservoir can crystallize. The concentration of the buffer can change.
False results can occur.

Death or serious injury to the patient can result.

◆ Before the system is shut down for more than 2 hours, rinse the system
with water.
◆ Insert the level sensor of the buffer container into a container with at least 1 L
of water.

Crystallization of the buffer in the tubing and in the buffer reservoir can change the
concentration of the buffer. Delay of results can occur.

1 Clean the system, see ( Page 202 Performing maintenance and cleaning).

2 Contact Siemens Healthineers service with regard to non-operation of the system.

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.

CAUTION

Incorrect movement of the system

Minor or moderate injury can result. Damage to or misalignment of the
system can result.

◆ The system must only be moved by Siemens Healthineers service.

◆ Make sure the storage conditions are met.
◆ Contact Siemens Healthineers service with regard to movement of the system.

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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.

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

Death or serious injury can result.

◆ 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 De-install the system, see ( Page 27 De-installation).

2 Contact Siemens Healthineers service with regard to disposal of the system.

3 Dispose of the system according to national and local standards and regulations.

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 4 Description of the hardware

4 Description of the hardware

This chapter describes the operation and the functions of the hardware.

4.1 Overview of the analyzer

The analyzer is displayed in the figure below.

1 1 2 3

4
5

11

10 9 8 7 6

Front view of the analyzer

(1) Covers
(2) Power module (hidden)
(3) Display windows for LEDs
(4) Probe
(5) Wet station
(6) Cuvette rotor
(7) Dilution station
(8) Probe cleaner bottle
(9) Reagent rotor
(10) Sample rotor
(11) Syringe (hidden)

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 4 Description of the hardware

4.2 Functional units

This chapter describes the functional units of the analyzer.

4.2.1 Covers
The covers protect the operator from injury that could be caused by moving parts
inside of the system. Both covers are equipped with sensors that detect the opening of
the covers.

When opening of the covers is requested via the software, routine processing is
interrupted for a defined period. During this time reagents and some consumables can
be loaded onto the system. A message indicates that the covers can be opened.

Right cover The right cover gives access to the reagent rotor, the dilution station, the wet station, the
cuvette rotor, and the probe.

When the right cover is opened without access being requested via the software, a stop
function is triggered and routine processing is interrupted.

Do not open the cover without access being requested via the software.

The system does not resume processing until the right cover has been closed. After the
right cover has been closed, the system performs the following tasks:

• The stop function is canceled.

• Interrupted pre-dilutions are repeated automatically.

Left cover The left cover gives access to the sample rotor.

When the left cover is opened without access being requested via the software, no stop
function is triggered, but:

• The sample rotor stops moving.

• The probe no longer moves to the sample rotor.

Do not open the cover without access being requested via the software.

4.2.2 LEDs
3 LEDs are located in the upper right corner at the front of the analyzer. The LEDs indicate
the overall status of the system, see the table below.

Color and marking Explanation

Green The system is running without problems.

Yellow The system is initializing or is in its warming up phase.

– or –
The system is continuing processing but cannot
complete processing.

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 4 Description of the hardware

Color and marking Explanation

Red A problem has occurred. The system cannot

continue processing.

Explanation of the LED colors

4.2.3 Sample rotor

The sample rotor is located at the left side of the analyzer, behind the left cover, see the
figure below.

3
1
2

Sample rotor

(1) Sample rotor

(2) Sample rotor segment
(3) Handwheel
The sample rotor can hold 3 segments with tubes for samples, standards and user-
defined controls, or special cups. The segment positions are consecutively numbered
from 1–3. A maximum of 45 samples can be placed. The sample rotor is fixed to the
analyzer by a handwheel.

When the left cover is closed, the sample rotor turns, bringing the barcode strips
of the sample rotor segments into the scanning area of the barcode reader, see
( Page 41 Sample rotor segments).

The barcode reader scans which positions for sample rotor segments are occupied, see
( Page 38 Barcode reader).

4.2.4 Reagent rotor

The reagent rotor is located in the center of the analyzer, behind the right cover, see the
figure below.

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 4 Description of the hardware

4
3 1

Reagent rotor

(1) Reagent rotor

(2) Reagent rotor segment
(3) Handwheel
(4) Reagent rotor cover
(5) Access lid of the reagent rotor cover

The reagent rotor can hold 15 segments for reagents and controls. The segment
positions are consecutively numbered from 1–15. The reagent rotor is fixed to the system
by a handwheel.

The reagent rotor is cooled to approximately 8 °C. The reagent cooler is positioned
underneath the reagent rotor. When the system is used continuously, reagents and
controls do not have to be removed and stored in the refrigerator. Condensation in the
reagent rotor is drained into the waste container.

The reagent rotor is covered to ensure constant temperature. The reagent rotor cover has
an access lid for loading reagent rotor segments during routine processing. The access
lid is fitted with a sensor. If the access lid is not closed properly, the system will not
start processing.

When the access lid of the reagent rotor is opened, a timing device is started. When
the opening time of the access lid exceeds 10 minutes, the reagent cooler turns off.
After the access lid has been closed, the reagent rotor must be cooled down again to
approximately 8 °C. Routine operation is resumed once the temperature is reached.
When the access lid of the reagent rotor cover has been closed, the reagent rotor turns,
bringing the reagent rotor segments into the scanning area of the barcode reader, see
( Page 44 Reagent rotor segments).

The barcode reader scans if the reagent rotor segment is a reagent segment or a control
segment, see ( Page 38 Barcode reader).

Reagent and control vials must be fitted with evaporation caps before they are loaded in
the reagent rotor. When a reagent or control is required, the relevant vial is moved to the
pipetting position. The system opens the evaporation cap, the probe aspirates liquid, and
the system closes the evaporation cap, see ( Page 46 N Evaporation Caps for Control
Vials (2.5 mL) and N Evaporation Caps for Reagent Vials (5 mL)).

4.2.5 Dilution station

The dilution station is located between the reagent rotor and the cuvette rotor, behind
the right cover, see the figure below.

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Dilution station

(1) Dilution station

(2) Cuvette rotor cover
(3) Dilution frame
(4) Reagent rotor cover

The dilution station consists of a dilution frame in which the dilution strips are inserted.
The dilution frame can hold a maximum of 2 x 8 dilution strips. The dilution frame does
not need to be fully loaded, see ( Page 46 Dilution strips).

When the right cover is closed, a light barrier is used to check whether the dilution frame
has been inserted. The system checks whether dilution strips are present by moving
the probe to the relevant position and following the outline of the dilution cup. If no
outline is detected, no dilution strip is present. The amount of liquid in the dilution cups
is determined by a filling level check executed by the probe.

In order to prepare pre-dilutions, the system moves the dilution frame so the required
dilution cup is positioned in the pipetting position.

4.2.6 Wet station

The wet station is located between the dilution station and the cuvette rotor, behind the
right cover, see the figure below.

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 4 Description of the hardware

3
4
5

Wet station

(1) Wet station

(2) Cuvette rotor cover
(3) Fountain area
(4) Dispensing area
(5) Buffer reservoir
(6) Dilution station

The wet station is connected to the buffer container, the diluent container, the water
container, and the waste container. Excess liquid is discharged to the waste container.

In the fountain area, the probe is cleaned externally with water by immersion through an
injection ring. Excess water is discharged to the waste container. When the probe is not
in operation, the probe is dipped into the fountain area to prevent it from drying out.

In the dispensing area, the probe dispenses liquid waste and performs internal cleaning
with diluent. Liquid waste is discharged to the waste container.

The buffer reservoir contains the buffer required for certain assays. The buffer reservoir is
supplied with buffer from the buffer container so that the re-filling process of buffer does
not interrupt the routine. The filling level in the buffer container is checked by the level
detection of the probe.

4.2.7 Cuvette rotor

The cuvette rotor is located at the right side, behind the right cover, see the figure below.

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1
2

Cuvette rotor

(1) Cuvette rotor

(2) Cuvette segments
(3) Handwheel
The cuvette rotor can hold 10 cuvette segments, each comprising 9 cuvettes. The
segment positions are consecutively numbered from 0–9. The cuvette rotor is fixed to the
system by a handwheel, see ( Page 45 N Cuvette segments for BN ProSpec).

The cuvette rotor is heated to approximately 37 °C. The cuvette rotor is surrounded by
an insulator.

The cuvette rotor is covered to ensure constant temperature. The cuvette rotor cover has
a hole for pipetting. The cuvette rotor cover is fitted with a sensor. If the cuvette rotor
cover is not closed properly, the system will not start processing.
When the right cover is closed, the system scans the cuvette segments. The
differentiation between unused cuvettes and used cuvettes is performed through blank
readings. Measurements are taken during the movement phases of the cuvette rotor.

4.2.8 Transfer arm and probe

The transfer arm with the probe is located in the upper part of the analyzer. The transfer
arm moves along a guide rail stretching the width of the housing, see the figure below.

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2
4
3

Transfer arm

(1) Transfer arm

(2) Probe
(3) Reagent rotor cover
(4) Guide rail
The transfer arm can move horizontally and vertically. The transfer arm has a fitting for
mounting the probe and is flexibly mounted to prevent damage. Sensors on the probe
detect when the tip contacts a hard object.

When evaporation caps of reagents and controls have to be opened, the lower part of the
transfer arm pushes down on 1 out of 2 cylindrical pins on the reagent rotor cover. The
evaporation cap is then opened by rotation of the reagent rotor.

The probe is mounted to the transfer arm. The probe performs the following tasks:

• Pipetting samples, controls, and standards into the dilution cups

• Preparing pre-dilutions in the dilution cups

• Pipetting reagents, buffer, and pre-dilutions into the cuvettes

• Mixing liquids in the dilutions cups and cuvettes through vibration of the probe

• Pipetting undiluted samples into the cuvettes

• Heating liquids to approximately 37 °C within the probe

• Checking for loaded dilution strips

• Determination of the filling level of liquid in a sample, standard, control, or reagent

container, in the dilution cups, the cuvettes, the probe cleaner bottle, and the
buffer reservoir

The probe is cleaned after every transfer step.

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4.2.9 Syringe
The syringe is located at the left side, behind the sample rotor, see the figure below.

Syringe

(1) Syringe

The syringe has a volume of 500 μL. The syringe is connected to the probe and supplies
the probe with diluent and water. Valves control which liquid is supplied to the probe or
aspirated by the probe.

4.2.10 Power module

The power module is located at the right side of the alayzer, see the figure below.

Power module

(1) Fuse holder

(2) Main switch
(3) Power supply socket

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The fuse holder contains 2 fuses.

The main switch has the following positions:

• Position 0: The system is off.

• Position I: The system is on.

The system has to be connected to a wall outlet that meets the electrical conditions, see
( Page 302 Electrical conditions).

4.3 Components inside the analyzer

This chapter describes the components inside the analyzer.

4.3.1 Air bubble detector

The air bubble detector is located at the left side of the analyzer, next to the syringe.
When air bubbles are detected in the diluent tubing, the system rinses the diluent tubing.
If air bubbles are still detected, the system stops processing. Then the diluent has to
be replaced.

4.3.2 Barcode reader

The barcode reader is located between the sample rotor and the reagent rotor. The
barcode reader is mounted in a way that it can turn either to the sample rotor or to the
reagent rotor.

The barcode reader is active only during scanning.

The barcode reader performs the following tasks:

• Identifying sample rotor segments: The barcode reader scans the barcode label at
the left side of the sample rotor segments and thus identifies sample, standard,
cup-in-tube, cup-behind-tube, Eppendorf cup, and Hitachi cup segments.

• Identifying empty positions in sample rotor segments: The barcode reader scans every
position of the sample rotor segments. If the position in front is empty, the barcode
strip on the sample rotor segment is scanned.

• Identifying samples and standards in sample rotor segments: The barcode reader
scans every position of the sample rotor segments. If a vial with a barcode is present,
the vial is identified. If no barcode is present or if the barcode cannot be scanned, the
sample or standard information has to be entered manually.

• Identifying reagent rotor segments: The barcode reader scans every position of the
reagent rotor segments. If a position is empty, the barcode on the back of the segment
is scanned and thus the segment is either identified as a reagent or a control segment.
If all positions are occupied, the barcodes on the vials are scanned and thus the
segment is either identified as a reagent or a control segment. If no barcode is present
on the vials or if the barcode cannot be scanned, the reagent or control information
has to be entered manually.

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If no barcode on any vial of a reagent rotor segment can be scanned, the positions are
displayed as empty in the dialog Loading reagents. The barcodes of the vials cannot
be entered manually. To enter the reagent or control information manually, separate
the vials on different reagent rotor segments.

For more information on the barcode reader, see ( Page 301 Barcode reader)

4.3.3 Dilutor
The dilutor is located at the left side of the analyzer, on the rear side of the syringe. The
dilutor consists of pumps and valves.

The dilutor is connected to the following components:

• Liquid containers (water, buffer, diluent, waste)

• Syringe

• Wet station

• Reagent rotor

The dilutor transfers and regulates liquids as follows:

• Diluent from the diluent container to the probe

• Water from the water container to the probe and to the wet station

• Buffer from the buffer container to the wet station

• Liquid waste from the wet station and from the reagent rotor to the waste container
A valve next to the syringe regulates the flow of liquids:

• When the valve is open, the syringe is without function. The system dispenses diluent
via the probe to the diluent station or rinses the probe with water.

• When the valve is closed, the syringe builds up excess pressure or low pressure so the
probe dispenses or aspirates sample, reagent, standard, control, or buffer.

4.4 External and peripheral devices

The system can be connected to several external and peripheral devices. The
connections are located at the right side of the analyzer, beside the power module, see
the figure below.

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Connections for external devices

(1) Power module

(2) Ethernet port

The power module consists of multiple elements, see ( Page 37 Power module).

The serial ports can be used for additional devices, for example, LIS.

The Ethernet port is used to connect the system to a computer.

4.4.1 Peripheral devices

Peripheral devices include:

• Computer

• Monitor

• Keyboard

• Mouse

• Printer (optional)
The system is connected to a computer. The computer performs the following tasks:

• Enabling communication between operator and system

• Enabling dialog selections

• Enabling the input of sample information

• Printing dialogs

• Communication with the LIS, if available

4.4.2 LIS (optional)

The system can be connected to a laboratory information system (LIS) via a serial RS‑232
port. For more information, see the data interface manual.

The LIS sends orders to the system and receives results.

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4.5 Consumables and accessories

This section lists consumables and accessories for the system. For ordering information,
see the Siemens Healthineers product catalog or contact Siemens Healthineers service.

Instructions for using the consumables and accessories are given in the
respective procedures.

4.5.1 Sample rotor segments

The various types of sample rotor segments are identified by differently colored plain
text labels located on the grip of the sample rotor segment. These plain text labels have
numbers, the segment IDs, corresponding to the barcode label located at the left side
of the sample rotor segment. The first 2 digits of the segment ID identify the type of
sample rotor segment, the next 2 digits identify the running number within the type of
the sample rotor segment. The running number on the plain text label is copied in larger
type size.

The barcode label is attached vertically at the left side of the sample rotor segment and
contains an additional empty digit and check digit. The plain text label and the barcode
label are delivered on barcode sheets in pairs and must be attached as such.

Each sample rotor segment is fitted with adapters to hold different kinds of cups, tubes,
and vials. Behind the adapters, a barcode strip is attached for the barcode reader to
identify empty positions, see ( Page 38 Barcode reader).

The adapters ensure that the cups, tubes, and vials are always centered in their position.
This reduces the residual volume. For each type of sample rotor segment, a maximum
probe immersion depth is defined in the software.

Barcode labels on cups, tubes, or vials must be aligned towards the outer edge of the
sample rotor segment. Adapters have openings so the barcodes can be scanned.

Sample segment 01 02 1

3
2

Sample segment

(1) Plain text label

(2) Barcode strip
(3) Barcode label

Sample segments are fitted with adapters to hold up to 15 sample tubes, see
( Page 304 Sample rotor segments).

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Standard segment 20 01 1

3
2

Standard segment

(1) Plain text label

(2) Barcode strip
(3) Barcode label

Standard segments are fitted with adapters to hold up to 6 standard vials. Only
positions 3, 5, 7, 9, 11, and 13 must be used, see ( Page 304 Sample rotor segments).

Cup-in-tube segment 1

3
2

Cup-in-tube segment

(1) Plain text label

(2) Barcode strip
(3) Barcode label

Cup-in-tube segments are identical in construction to sample segments. Cup-in-tube

segments are fitted with adapters to hold up to 15 sample tubes. All common cups,
including Dimension cups from Siemens Healthineers, can be used within the tubes, see
( Page 304 Sample rotor segments).

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Eppendorf cup segment 61 01 1

3
2

Eppendorf cup segment

(1) Plain text label

(2) Barcode strip
(3) Barcode label

Eppendorf cup segments are fitted with adapters to hold up to 15 Eppendorf cups, see
( Page 304 Sample rotor segments).

Hitachi cup segment 81 01 1

3
2

Hitachi cup segment

(1) Plain text label

(2) Barcode strip
(3) Barcode label

Hitachi cup segments are fitted with adapters to hold up to 15 Hitachi cups, see
( Page 304 Sample rotor segments).

Cup-behind-tube segment 81 04 1

3
2

Cup-behind-tube segment

(1) Plain text label

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(2) Barcode strip

(3) Barcode label
Cup-behind-tube segments are fitted with 2 rows of adapters to hold up to 7 sample
tubes and 7 cups. The lower row holds empty sample tubes with barcodes that identify
the sample behind. The upper row holds the cups with the sample material, see
( Page 304 Sample rotor segments).

False bottom tube segment 81 01 1

3
2

False bottom tube segment

(1) Plain text label

(2) Barcode strip
(3) Barcode label

False bottom tube segments are fitted with adapters to hold up to 15 False bottom tubes,
see ( Page 304 Sample rotor segments).

4.5.2 Reagent rotor segments

2 types of reagent rotor segments are identified by differently colored grips and different
barcode labels. The barcode labels are attached vertically at the back of every position for
reagent or control vials for the barcode reader to scan the type of reagent rotor segment,
see ( Page 38 Barcode reader).

Reagent and control vials are positioned at an 11° angle to allow optimal reagent and
control consumption. Reagent and control vials must be fitted with evaporation caps
before they are placed in the reagent rotor segments, see ( Page 46 N Evaporation
Caps for Control Vials (2.5 mL) and N Evaporation Caps for Reagent Vials (5 mL)).

Barcode labels on reagent and control vials must be positioned in the direction of the
outer edge of the reagent rotor segment. The reagent rotor segments have openings so
the barcodes can be scanned.

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Reagent segment
1

Reagent segment

(1) White grip

(2) Locked position
(3) Positions for reagent vials
The reagent segment has 2 positions for reagent vials in the outer area. The inner
position is locked, see ( Page 305 Reagent rotor segments).

Control segment
1

Control segment

(1) Yellow grip

(2) Positions for control vials

The control segment has 3 positions for control vials:

• 2 outer positions

• 1 inner position

For more information, see ( Page 305 Reagent rotor segments).

4.5.3 N Cuvette segments for BN ProSpec

This product is suitable for Atellica NEPH 630 analyzers.

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2
1

Cuvette segment

(1) Grip
(2) Cuvettes
(3) Cuvette segment
Each cuvette segment consists of 9 cuvettes and is wrapped in a plastic pouch. The
cuvettes hold dilutions, reagents, and buffer for the measurement of the protein
concentration in the cuvette rotor.

The cuvette segments have a grip with which they can be handled without touching the
surfaces of the cuvettes, see ( Page 305 Cuvette segments).

4.5.4 Dilution strips

Dilution strip

(1) Dilution cups

(2) Dilution strip

Each dilution strip consists of 6 dilution cups. The dilution cups are used to prepare
pre-dilutions of samples, controls, and standards, see ( Page 305 Dilution strips).

4.5.5 N Evaporation Caps for Control Vials (2.5 mL) and

N Evaporation Caps for Reagent Vials (5 mL)

This product is suitable for Atellica NEPH 630 analyzers.

Evaporation cap

(1) Evaporation cap

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(2) Slider
(3) Vertical striation
Evaporation caps are used to minimize evaporation and to extend the on-board stability
of reagents and controls. The vertical striation on the evaporation cap and the barcode
on the label of the vial must be aligned, see ( Page 305 Evaporation caps).

4.5.6 Liquid containers, level sensors, and tubing

The liquid containers are connected to the left side of the system, see the figure below.

8 5

7
6

Liquid containers, level sensors, and tubing

(1) Colored marking

(2) Tubing
(3) Spiral tube
(4) Level sensor
(5) Waste container
(6) Water container
(7) Buffer container
(8) Diluent container

The filling levels of the 4 liquid containers are checked by level sensors attached to the
tubing and inserted into the liquid containers. Insufficient filling levels of water, buffer,
and diluent as well as a too high filling level of liquid waste are displayed by the software.

When a container is empty or, in the case of the waste container, full, a stop function is
triggered. The software requests to refill the liquid or empty the waste container. When
the liquid is refilled or the waste container is emptied, the tubing is automatically rinsed
after confirmation.

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The liquid containers are supplied in 5 L or 10 L volumes. The tubing bears differently
colored markings, see the table below.

Liquid Volume Color Liquid delivered to

Diluent 5L Blue Probe

Buffer 5L Red Wet station

Water 10 L White Probe and wet station

Waste 10 L Green -

Characteristics of the liquid containers

Spiral tubes are fitted around the tubing and cable to prevent bends in the tubing.

The distance between the liquid containers and the table edge is restricted to 80 cm. The
restriction can only be changed by Siemens Healthineers service.

Buffer container
1

Buffer container

(1) Screw cap

(2) Buffer container

Buffer is required to prepare the dilution for certain assays. Detailed descriptions of the
buffer, its handling, and its applications are provided on the label of the buffer container.

Diluent container
1

Diluent container

(1) Screw cap

(2) Diluent container

Diluent is required to prepare pre-dilutions and to rinse the inside of the probe. Detailed
descriptions of the diluent, its handling, and its applications are provided on the label of
the diluent container.

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4.5.7 Probe cleaner bottle

Probe cleaner bottle

(1) Screw cap

(2) Probe cleaner bottle

Probe cleaner is required to clean the probe after every transfer step for assays with
extremely adhesive proteins. The probe cleaner bottle is located between the reagent
rotor and the dilution station. Detailed descriptions of the probe cleaner, its handling,
and its applications are provided in the corresponding instructions for use.

4.6 Reagents, standards, and controls

Detailed descriptions of the reagents, standards, and controls, their handling, their
applications, and the performance of the reagents 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.

5.1 Overview of the screen

The figure below shows an example of a lab journal, displaying all information levels.

The example uses the decimal separators of the English software version. Note that
the representation of the decimal separators varies by country.

Overview of the screen

(1) Title bar

(2) Navigation bar
(3) Status bar
(4) Status line
(5) Dialog
(6) Action bar

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Elements of the screen are explained in the table below.

Information Explanation

Title bar The title bar displays the title of the active dialog, corresponding to the selected
routine and action.

Navigation bar The navigation bar is used to access the dialogs of the system via
routine buttons.
The routine button displayed with a white icon is inactive. The corresponding
routine is currently displayed in the dialog.

Status bar The status buttons in the status bar display the status of various
parts of the system. For more information on the status buttons, see
( Page 51 Status buttons).

Status line The status line displays date, time, the action currently performed by the
system, and details of the job last finished by the system.

Dialog The dialog displayed is dependent on the active routine.

Action bar The action bar displays action buttons as appropriate to each dialog.
Action buttons displayed with white icons are inactive. The corresponding
action is not available.

Elements of the screen

5.2 General elements

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

5.2.1 Status buttons

The status buttons are displayed to the right of most dialogs. The status buttons are
explained in the table below.

Button Explanation

Walk-away time Estimated walk-away time

– or – – or –
Unfinished jobs Number of unfinished jobs
The user can change the displayed text by clicking the button.

Samples & Standards Status of the level of samples and standards loaded in the sample rotor

Reagents & Controls Status of the level of reagents and controls loaded in the reagent rotor

Cuv. seg. & dil. strips Status of cuvette segments loaded in the cuvette rotor and dilution strips
loaded in the dilution station

Ref. curves & Contr. results Status of the required reference curves and control results

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Button Explanation

Information Status of the following environmental conditions and parts of the system:
• Temperatures (ambient temperature, temperature in the reagent rotor,
temperature in the cuvette rotor, temperature in the probe)
• Left cover, right cover, access lid of the reagent rotor cover, and cuvette
rotor cover
• Filling levels of the system liquids
• Filling level of the waste container
• Connection to the analyzer

Status buttons

The status buttons display the status of various parts of the system by means of colors. If
multiple problems for a specific part of the system are detected, the color of the problem
with the highest priority is displayed first. The colors are explained in the table below.

Color Explanation

Red The requested jobs cannot be processed. The system is

not operating.

Yellow The requested jobs cannot be completely processed. If the user does
not resolve the problem, the status button will change to red soon.
– or –
The system is warming up.

Blue All material required is available and valid, the system is operating.
All requested jobs can be processed.

Colors of status buttons

When the user places the mouse pointer over a red or yellow status button, a tool tip text
specifying the problem is displayed. Only after a problem is solved, the next problem is
displayed in the tool tip text.

When the user clicks a red or yellow status button, there are 2 possibilities:

• The dialog where the problem can be resolved is displayed.

• The dialog Logbook that provides detailed information on the problem is displayed.

5.2.2 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 rows, dilution strips, or cuvette
segments, see the table below.

Selection Action

Select 1 row, dilution strip, or Click the row, dilution strip, or cuvette segment.
cuvette segment.

De-select 1 row, dilution strip, or Hold the Ctrl key, then click the row, dilution strip, or cuvette segment again.
cuvette segment.

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Selection Action

Select a series of consecutive rows, Click the first row, dilution strip, or cuvette segment, then hold the Shift key
dilution strips, or cuvette segments. while clicking the last row, dilution strip, or cuvette segment.

De-select a series of consecutive rows, Hold the Shift key, then click the last row, dilution strip, or cuvette segment that
dilution strips, or cuvette segments. should be included in the new selection.

Select multiple rows, dilution strips, or Click the first row, dilution strip, or cuvette segment, then hold the Ctrl key
cuvette segments. while clicking every row, dilution strip, or cuvette segment.

De-select multiple rows, dilution strips, or Hold the Ctrl key, then click the rows, dilution strips, or cuvette segments again.
cuvette segments.

Select all rows, dilution strips, or Only in the dialog Lab journal: Hold theCtrl key, then press the key A.
cuvette segments.

Select rows, dilution strips, or cuvette segments

Scroll Some dialogs provide scroll functions, see the table below.

Button or slider Explanation Action

Scroll up Click or click and hold

Scroll down Click or click and hold

Scroll left Click or click and hold

Scroll right Click or click and hold

Slide vertically Drag

or horizontally

Scroll functions

Adjust column widths In some dialogs, the user can adjust column widths by clicking the left or right border of
the table heading and dragging it to the left or to the right. The user can reset the default
column width with a right-click on the mouse within the dialog.

Sort In some dialogs, the user can sort the data in tables by clicking in the heading of the
corresponding column.

Filter In some dialogs, the user can filter the displayed data. Filters are indicated by an arrow

right of a drop-down list, for example, .

Master navigation Some dialogs provide so-called master navigation. In the dialog, the user can browse the
items of the master dialog, that is, the higher-level dialog from which the current dialog
was displayed via an action button. Master navigation is a shortcut for going back to the
master dialog, selecting a neighboring item, and displaying the current dialog again, see
the table below.

Button Explanation

Selects the previous item in the master dialog

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Button Explanation

Selects the next item in the master dialog

Selects the first item in the master dialog

Selects the last item in the master dialog

Master navigation

5.2.3 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 Explanation

Apply Saves the data in the dialog

Cancel Cancels the current process

Close Closes the dialog without saving

Delete In the dialog Lab journal: Deletes results permanently or deletes sample or
control IDs permanently which are no longer on-board
In all other dialogs: Deletes all selected items finally

De-select all De-selects all items in the dialog

Print Prints the selected data with or without a preview, see

( Page 106 Print preview)

Save Saves data and closes the dialog

Select all Selects all items in the dialog

Common action buttons

5.2.4 Flags and symbols

Flags and other symbols in various dialogs and on printed pages are explained in the
table below.

Flag /  Printed Dialog Column Explanation

symbol pages

STAT Lab journal Left column The sample is processed as a STAT sample.

M Lab journal Left column Jobs are requested for the sample but the sample is missing.

M Lab journal Left column Jobs are requested for the control but the control is missing.

- Loading Left column This is a reagent.

reagents

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Flag /  Printed Dialog Column Explanation

symbol pages

- Loading Left column This is a control.

reagents

- Calibration Flag Controls: The control is empty or insufficient.

Reagents: The reagent is empty or insufficient.

… Lab journal Status Samples: The sample is being measured.

Controls: The control is being measured.

- Calibration Flag Assays: A new reference curve has been requested or is

being measured.
Reagents: The reference curve has been requested.

E Lab journal Flag A hardware problem has occurred or a resource was low
during processing of the sample. The measurement was
canceled. This flag is called a technical flag.

E Lab journal Flag A hardware problem has occurred or a resource was low
during processing of the control. The measurement was
canceled. This flag is called a technical flag.

M Lab journal Status The sample is missing.

M Lab journal Status The control is missing.

- Calibration Flag Assays: At least 1 valid reference curve is active but not all
relevant reagents are onboard.
Reagents: The reference curve is valid and active but not all
relevant reagents are onboard.
– or –
The reference curve is not active.

- Lab journal Left column All jobs for the sample have been processed.

- Lab journal Left column All jobs for the control have been processed.

R Lab journal Status The sample result has been released.

R Lab journal Status The control result has been released.

- Calibration Flag Assays: At least 1 valid reference curve is active, all relevant
reagents are on-board.
Reagents: The reference curve is valid and active, all
relevant reagents are on-board.

- Calibration Flag Assays: All reference curves are invalid.

Reagents: The reference curve is invalid.

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Flag /  Printed Dialog Column Explanation

symbol pages

- Calibration Flag Assays: A new reference curve was measured but another
reference curve is valid and active.
Reagents: The reference curve was measured but is
not valid.

< (value) < Lab journal Result/Unit Samples: The sample result is below the
measurement range.
Controls: The control result is below the
measurement range.

> (value) > Lab journal Result/Unit Samples: The sample result is above the
measurement range.
Controls: The control result is above the
measurement range.

? Lab journal MP Different manual pre-dilutions of the sample were detected

by the system.

a Lab journal AD The dilution used for the measurement of the sample is 1 : 1
and differs from the initial dilution.

a Lab journal AD The dilution used for the measurement of the control is 1 : 1
and differs from the initial dilution.

A Lab journal MP The sample is manually pre-diluted 1 : 5.

b Lab journal AD The dilution used for the measurement of the sample is 1 : 5
and differs from the initial dilution.

b Lab journal AD The dilution used for the measurement of the control is 1 : 5
and differs from the initial dilution.

B Lab journal MP The sample is manually pre-diluted 1 : 20.

c Lab journal AD The dilution used for the measurement of the sample is
1 : 20 and differs from the initial dilution.

c Lab journal AD The dilution used for the measurement of the control is
1 : 20 and differs from the initial dilution.

d Lab journal AD The dilution used for the measurement of the sample is
1 : 100 and differs from the initial dilution.

d Lab journal AD The dilution used for the measurement of the control is
1 : 100 and differs from the initial dilution.

e Lab journal AD The dilution used for the measurement of the sample is
1 : 400 and differs from the initial dilution.

e Lab journal AD The dilution used for the measurement of the control is
1 : 400 and differs from the initial dilution.

f Lab journal AD The dilution used for the measurement of the sample is
1 : 2,000 and differs from the initial dilution.

f Lab journal AD The dilution used for the measurement of the control is
1 : 2,000 and differs from the initial dilution.

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Flag /  Printed Dialog Column Explanation

symbol pages

g Lab journal AD The dilution used for the measurement of the sample is
1 : 8,000 and differs from the initial dilution.

g Lab journal AD The dilution used for the measurement of the control is
1 : 8,000 and differs from the initial dilution.

h Lab journal AD The dilution used for the measurement of the sample is
1 : 32,000 and differs from the initial dilution.

h Lab journal AD The dilution used for the measurement of the control is
1 : 32,000 and differs from the initial dilution.

h Lab journal Flag The control result is above confidence range.

H Lab journal Flag The sample result is above reference range.

S Lab journal Status The sample result has been sent to the LIS, if available.

S Lab journal Status The control result has been sent to the LIS, if available.

i Lab journal AD The dilution used for the measurement of the sample is no
standard dilution.

i Lab journal AD The dilution used for the measurement of the control is no
standard dilution.

l Lab journal Flag The control result is below confidence range.

L Lab journal Flag The sample result is below reference range.

O Lab journal Flag The formula test of the sample cannot be evaluated.

P Lab journal Flag The manual pre-dilution of the sample is doubtful.

X Lab journal Flag The turbidity of the sample is above the defined threshold.

X Lab journal Flag The turbidity of the control is above the defined threshold.

Y Lab journal Flag The level of the cup-in-tube sample cannot be found.

No flag - Calibration Flag No released reference curve is available for the assay,
reagent, or supplementary reagent.

Flags and symbols in dialogs

5.2.5 Function keys

Some actions can be accessed by pressing function keys on the keyboard, see the
table below.

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Function key Button Dialog Explanation

F1 Help Various dialogs Displays the online help, see ( Page 80 Help)

Alt + F4 Exit Status Shuts down the system

Function keys

5.3 Dialogs
This chapter describes every dialog of the software.

At the beginning of each dialog description, 1 or more paths to find the dialog within the
software are specified.

5.3.1 About
Path to the dialog:

• System > About

The dialog is used to view the current version of the software and its components, see
the table below.

Information Explanation

SIEMENS ANEPH630 Version of the system software

Revision Revision number

ComServer Internal version of the communication software

Viewer Internal version of the viewer software

NSAAnalyser Internal version of the control software

Software components

5.3.2 Access cuvette segments and dilution strips

Paths to the dialog:

• Loading > Cuv. seg. & dil. strips > Access

• System > Cuv. seg. & dil. strips

The dialog is used to access the cuvette rotor and the dilution frame. The user has to
follow the instructions displayed during the process.

The dialog is divided into 2 areas, see the table below.

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Information Explanation

Dilution strips Graphic of the dilution frame with dilution strips and the single dilution cups
Letters and digits in the graphic correspond with the letters and digits affixed
to the dilution frame.
When access was obtained via the action button Access, the action button
Dilution strips, or the action button Cuv. seg. & dil. strips, the user can select
and de-select replaced dilution strips in the graphic or use common action
buttons, see ( Page 52 Select) and ( Page 54 Common action buttons).
The colors and markings of the dilution strips and single dilution cups have
different meanings, see ( Page 59 Colors and markings of the dilution strips
and dilution cups).

Cuvettes Graphic of the cuvette segments with the single cuvettes

Digits in the graphic correspond with the digits affixed to the cuvette rotor.
When access was obtained via 1 of the action buttons Access, Cuvettes, or
Cuv. seg. & dil. strips, the user can select and de-select replaced cuvette
segments in the graphic or use common action buttons, see ( Page 52 Select)
and ( Page 54 Common action buttons).
The colors and markings of the cuvette segments and single cuvettes have
different meanings, see ( Page 59 Colors and markings of the cuvette
segments and cuvettes).

Areas in the dialog Access cuvette segments and dilution strips

Color and marking Explanation

Dark blue, no marking The dilution cup is in use or has been assigned to a
requested job.

Light blue, no marking No dilution strip is placed in this row.

White, no marking The dilution cup is available.

White, X The dilution cup is no longer required. When all dilution

cups in a dilution strip are marked with an X, the
dilution strip can be removed.

Colors and markings of the dilution strips and dilution cups

Color and marking Explanation

Dark blue, no marking The cuvette is in use or has been assigned to a

requested job.

Light blue, no marking No cuvette segment is loaded in this row.

White, no marking The cuvette is available.

White, X The cuvette is no longer required.

– or –
The blank value of the empty cuvette is above the limit.
The cuvette is refused.
When all cuvettes in a cuvette segment are marked
with an X, the cuvette segment can be removed.

Colors and markings of the cuvette segments and cuvettes

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Action buttons The special action buttons are only available by using this path to the dialog:

• System > Cuv. seg. & dil. strips

For special action buttons, see the table below.

Action button Explanation

Cuvettes Gives access to cuvette segments

Dilution strips Gives access to dilution strips

Cuv. seg. & dil. strips Gives access to cuvette segments and dilution strips

Special action buttons

5.3.3 Access reagents

Paths to the dialog:

• Loading > Loading reagents > Access

• System > Reagents

The dialog is used to request access to the reagent rotor.

After the system displays a corresponding message, the user can open the right cover to
access the reagent rotor.

5.3.4 Access samples

Paths to the dialog:

• Loading > Loading samples > Access

• System > Samples

The dialog is used to request access to the sample rotor.

After the system displays a corresponding message, the user can open the left cover to
access the sample rotor.

5.3.5 Add request

Path to the dialog:

• Lab journal > Add request

The dialog is used to manually. Enter sample data and patient data for an existing
sample ID. To request jobs, see the table below.

Sample data

Sample ID Sample ID -

STAT Short turnaround time Select

Dilutions already in the cuvette rotor are measured, then the STAT sample is prepared
and measured.

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Sample data

Number of Number of assays selected in the list of assays below -

selected assays

Manually pre-diluted Manual pre-dilution of the sample, see ( Page 62 Manual pre-dilution) Select
The user can only select a manual pre-dilution if no job has been requested. The
system automatically incorporates the manual pre-dilution into the calculated result.

Patient data

First name First name Enter

Maximum 20 characters

Initial Abbreviation of the middle name Enter

1 character

Last name Last name Enter

Maximum 20 characters

Date of birth Date of birth Enter

The format of the date depends on the settings of the operating system of
the computer.

Practice assigned ID ID assigned by the referring practice Enter

Maximum 30 characters

Laboratory ID assigned by the laboratory Enter

assigned ID
Maximum 20 characters

Additional Patient ID Any additional ID assigned by the laboratory Enter

Maximum 20 characters

Comment Any additional comment on the patient Enter

Maximum 100 characters

Assays

Specimen type Filters the assays in the list of assays below by specimen type, see Select
( Page 62 Specimen type)

- The list below the specimen type displays assays available for the selected specimen. Select
The colors in the list of assays have different meanings, see ( Page 62 Colors in the
list of assays).

Profile Available profiles, see ( Page 75 Profiles) Select

The user can add profiles to the job list by selecting the corresponding table cell.
Selected profiles are highlighted dark blue.

Profile no. Running number of the profile Select

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Assays

Assays Assays assigned to the profile Select

The user can add assays to the job list by selecting the corresponding table cell.

Sample and patient data

Information Explanation

1:1 Sample is not manually pre-diluted, default setting.

1:5 Sample is manually pre-diluted 1 : 5.

1 : 20 Sample is manually pre-diluted 1 : 20.

Manual pre-dilution

Information Explanation

(All) Assays for use in all specimen types

Serum Assays for use in serum only

Urine Assays for use in urine only

CSF Assays for use in CSF only

Plasma Assays for use in plasma only

Specimen type

Color Explanation

White Assay has not been requested.

Dark blue Assay has been requested but is not yet applied.

Light blue Assay has been requested but was not yet processed.

Colors in the list of assays

Navigation The user can scroll through the selected sample IDs by using the buttons for master
navigation in the top left corner, see ( Page 53 Master navigation).

Action buttons For special action buttons, see the table below.

Action button Explanation

Special dilution Displays the dialog Special dilution, see

( Page 117 Special dilution)

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Action button Explanation

Host job list Requests the job list from the LIS, if available, for the
selected sample IDs
A job list is only sent back by the LIS and added to the
lab journal when the following conditions are met:
• A connection to the LIS is established.
• A job list for the selected sample ID exists with
the LIS.

Special action buttons

5.3.6 Calibration
Path to the dialog:

• Calibration

The dialog is used to view, manage, and check reference curves.

The dialog is divided into 3 areas, see the table below.

Information Explanation

Assays Assays that have been defined and are active are
displayed in a table, see ( Page 63 Assays).

Reagents When the user selects an assay in the area Assay,

the reagent lots that are on-board, were used or are
required to measure the reference curve are displayed
in a table. The system stores up to 3 lots for each
reagent, see ( Page 64 Reagents).

Supplementary reagents When the user selects an assay in the area Assay,
the supplementary reagents that were used or
are required to measure the reference curve, if
applicable, are displayed in a table. The system
stores 1 lot for each supplementary reagent, see
( Page 64 Supplementary reagents).

Calibration

Information Explanation

Flag Flag, if applicable, see ( Page 54 Flags and symbols)

Assay no. Assay number

The assay number is provided by Siemens Healthineers.

Assay Abbreviation of the assay

No. of curves Number of reference curves available for the assay

Assays

The user can filter the entries in the table by using the 2 filters above the table, see the
table below.

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Filter Setting Explanation

Specimen type (All) Assays for use in all specimen types

Serum Assays for use in serum only

Urine Assays for use in urine only

CSF Assays for use in CSF only

Plasma Assays for use in plasma only

Status ref. curve (All) All assays

Invalid Assays with invalid reference curves

In process Assays with reference curves that are

being measured

Missing Assays with missing reference curves

Filter for assays

Information Explanation

Flag Flag, if applicable, see ( Page 54 Flags and symbols)

Reagent Abbreviation of the reagent

Lot no. Reagent ID

An ID comprises 6 characters, 4 characters for the identifier
number and 2 characters for the lot number. If the lot number is
replaced by --, the reagent is not on-board.

Reagents

When the user changes the lot of a reagent, the measurement of the reference curve
must be repeated.

Reference curves for which 2 reagents are required must be deleted before a newly
measured reference curve can be activated.

Information Explanation

Flag Flag, if applicable, see ( Page 54 Flags and symbols)

Reagent Abbreviation of the supplementary reagent

Only supplementary reagents are displayed whose change of lot
does not affect the validity of the reference curve.

Lot no. ID of the supplementary reagent

An ID usually comprises 6 characters, 4 characters for the
identifier number and 2 characters for the lot number. For
supplementary reagents, the lot number is not displayed,
as a change of the lot does not affect the validity of the
reference curve.

Supplementary reagents

Action buttons For special action buttons, see the table below.

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Action button Explanation

Delete Deletes the reference curve measured with the reagent lot
selected. Jobs using the deleted reference curve will be
canceled. Jobs using a deleted curve cannot be evaluated.
If the reference curve of an affected assay is measured with
2 reagents, both reagent lots need to be replaced before the
existing reference curve can be deleted.

Show curve Displays the dialog Show curve, see ( Page 115 Show curve)

Measure Measures the reference curve for an assay with the selected
reagent lot
The action button is deactivated when 3 valid reference curves
are available for a reagent.

Repeat Repeats the measurement of the reference curve for an assay

with the selected reagent lot. Repeating the measurement of
a valid reference curve will cancel all jobs using this valid
reference curve.
Only 1 valid reference curve of a specific reagent lot can be
used by the system. If a valid reference curve is repeated and
the new reference curve is also valid, the new reference curve
will be used. The original reference curve is retained. If the new
reference curve is deleted, the original reference curve will be
used again.

Special action buttons

5.3.7 Check probe

Path to the dialog:

• System > Check probe

The dialog is used to check the probe for possible blockage and correct shape. The user
has to follow the instructions displayed during the process.

Action buttons For special action buttons, see the table below.

Action button Explanation

Check Checks the probe for possible blockage and correct shape

Special action buttons

5.3.8 Clean probe

Path to the dialog:

• System > Clean probe

The dialog is used to clean the probe. The user has to follow the instructions displayed
during the process.

Action buttons For special action buttons, see the table below.

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Action button Explanation

Park probe for cleaning Moves the transfer arm to a parking position where the
probe can be cleaned

Special action buttons

5.3.9 Configuration
Path to the dialog:

• System > Configuration

The dialog is used to configure the software, to define new sample rotor segments, and
to delete defined sample rotor segments.

The dialog is divided into 8 tabs, see the table below.

Information Explanation Default setting Action

Language Available languages of the software English Select

Logbook entries entered before a change of
language are not updated. Logbook entries entered
after a change of language are displayed in the
new language.

Connection Configuration of the connection between analyzer See Enter and

and computer ( Page 67 Informati select
on on the tab
The connection is configured during the installation
Connection)
of the system by Siemens Healthineers service, see
( Page 67 Information on the tab Connection). The
user should not change the configuration.

Host Configuration of automatic re-measurements, See Select

automatic release of results, and sample ID settings ( Page 68 Informati
for barcodes and for the LIS, if available, see on on the tab Host)
( Page 68 Information on the tab Host)

Password Configuration of password check during the start of De-activated Select or

the system and management of user accounts de-select
User accounts and password check are configured
during the installation of the system by Siemens
Healthineers service. The user should not change
the configuration.
The user’s access rights are only defined by the user
account. An audit trail is not possible. For more
information, see ( Page 99 Log on).

Sample segments Definition of new sample rotor segments and See Enter
deletion of existing sample rotor segments, ( Page 71 Informati
see ( Page 71 Information on the tab on on the tab Sample
Sample segments) segments)

Address / Analyzer Name and address of the laboratory and analyzer ID See Enter
( Page 71 Informati
Data entered on the tab is displayed and printed as
on on the tab
a header, see ( Page 71 Information on the tab
Address / Analyzer)
Address / Analyzer).

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Information Explanation Default setting Action

User settings User settings, see ( Page 71 Information on the tab See Select
User settings) ( Page 71 Informati
on on the tab User
settings)

Result report Deactivates or activates the extended result report De-activated Select or
de-select
The extended result report can be useful for Siemens
Healthineers service in case of system problems.
The extended result report is not required during
normal operation.
The setting becomes active only after the software
is restarted.

Configuration

Connection On the tab Connection, the connection between analyzer and computer is set.

The connection between analyzer and computer is configured during the installation
of the system by Siemens Healthineers service. The user should not change the
configuration, see the table below.

Timeout

Timeout for Length of time the computer waits for an answer from 60 Enter
confirmation [sec.] the analyzer

Timeout for event [sec.] Length of time a single component of the computer 30 Enter
waits for an answer from another component

Interface

TCP/IP Connection established via an Ethernet cable Activated Select

Serial Connection established via a serial cable (RS‑232) De-activated Select

Connection

IP address IP address of the analyzer 192.168.35.20 Enter

IP port IP port of the analyzer 35001 Enter

Check connection Interval in which the system checks the connection 60 Enter
after [sec.] between analyzer and computer
The interval is not changed immediately. A re-start of
the viewer software is required.

Information on the tab Connection

Host On the tab Host, the user can activate and deactivate automatic re-measurements and
automatic release of results, see the table below.

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Information Explanation Default setting Action

Automatic remeasurement Automatic repetition of measurements that are Activated Select

outside the measurement range
Re-measurements are done with the next higher or
lower dilution for as long as the measurement result
is outside the measurement range.
Measurements from a cup-in-tube segment cannot be
repeated automatically.

Automatic release Automatic release of valid results and subsequent De-activated Select
sending to the LIS, if available
Results inside the reference range are automatically
released and sent to the LIS. Automatic release is only
active when Automatic remeasurement is selected.
Automatic release is indicated by flags and symbols,
see ( Page 68 Automatic release of results).

Significant digits of sample ID

2 rows of digits The digits represent the numbers 1–29 and identify - -
the position of the rectangles below, for example,
both rectangles on the left have the number 1, both
rectangles on the right have the number 29.
Each number represents 1 of the 29 characters of a
sample ID for barcoded samples.

Host The rectangles represent the digits in the sample ID. All rectangles selected Select or
de-select
The digits are sent from the LIS to the system together
with the job list.
The colors of the rectangles have different meanings,
see ( Page 70 Colors of the rectangles).

Barcode The rectangles represent the digits in the sample ID. All rectangles selected Select or
de-select
The digits are sent from the system to the LIS together
with the results. They are always a subset of the
digits selected in the line Host. When the user
selects or deselects rectangles in the line Barcode,
the corresponding rectangles in the line Host are
automatically updated by the system.
The colors of the rectangles have different meanings,
see ( Page 70 Colors of the rectangles).

Information on the tab Host

Flag/symbol Explanation Automatic release

A hardware problem has occurred or a resource No

was low during processing of the sample. The
Result can be released manually but will
measurement was canceled.
be defined as invalid by the LIS, if availa‐
ble.

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Flag/symbol Explanation Automatic release

A hardware problem has occurred or a resource No

was low during processing of the control. The
Result can be released manually but will
measurement was canceled.
be defined as invalid by the LIS, if availa‐
ble.

< (Value) The sample or control result is below the meas‐ Yes
urement range.

> (Value) The sample or control result is above the meas‐ Yes
urement range.

The dilution used for the measurement of the Yes

sample is 1 : 1 and differs from the initial dilu‐
tion.

The dilution used for the measurement of the Yes

control is 1 : 1 and differs from the initial dilu‐
tion.

The dilution used for the measurement of the Yes

sample is 1 : 5 and differs from the initial dilu‐
tion.

The dilution used for the measurement of the Yes

control is 1 : 5 and differs from the initial dilu‐
tion.

The dilution used for the measurement of the Yes

sample is 1 : 20 and differs from the initial dilu‐
tion.

The dilution used for the measurement of the Yes

control is 1 : 20 and differs from the initial dilu‐
tion.

The dilution used for the measurement of the Yes

sample is 1 : 100 and differs from the initial dilu‐
tion.

The dilution used for the measurement of the Yes

control is 1 : 100 and differs from the initial dilu‐
tion.

The dilution used for the measurement of the Yes

sample is 1 : 400 and differs from the initial dilu‐
tion.

The dilution used for the measurement of the Yes

control is 1 : 400 and differs from the initial dilu‐
tion.

The dilution used for the measurement of the Yes

sample is 1 : 2,000 and differs from the ini‐
tial dilution.

The dilution used for the measurement of the Yes

control is 1 : 2,000 and differs from the ini‐
tial dilution.

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Flag/symbol Explanation Automatic release

The dilution used for the measurement of the Yes

sample is 1 : 8,000 and differs from the ini‐
tial dilution.

The dilution used for the measurement of the Yes

control is 1 : 8,000 and differs from the ini‐
tial dilution.

The dilution used for the measurement of the Yes

sample is 1 : 32,000 and differs from the ini‐
tial dilution.

The dilution used for the measurement of the Yes

control is 1 : 32,000 and differs from the ini‐
tial dilution.

The control result is above confidence range. Yes

The sample result is above reference range. Yes

The dilution used for the measurement of the Yes

sample is no standard dilution.

The dilution used for the measurement of the Yes

control is no standard dilution.

The control result is below confidence range. Yes

The sample result is below reference range. Yes

The turbidity of the sample is above the No

defined threshold.
Result can be released manually.

The turbidity of the control is above the No

defined threshold.
Result can be released manually.

Automatic release of results

Color Explanation

Dark blue Information in this position represents a part of the sample ID

and is sent between the system and LIS.

Light blue Information in this position is not being sent between the
system and LIS.

White Information in this position is additional information and is sent

from the LIS to the system.

Red This position is invalid because it is selected in the line Barcode

but is not a subset of the line Host.

Colors of the rectangles

Sample segments On the tab Sample segments, the user can define new sample rotor segments and
delete existing sample rotor segments, see the table below.

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Information Explanation Default setting Action

New segment New segment ID of a sample rotor segment Empty input field Enter
The segment ID must comprise 6 digits, see
( Page 304 Sample rotor segments).

Segment list List of existing sample rotor segments All entries deselected Select

Information on the tab Sample segments

Address / Analyzer On the tab Sample segments, the user can define new sample rotor segments and
delete existing sample rotor segments, see the table below.

Information Explanation Default setting Action

Name of laboratory Name of the laboratory or company Empty input field Enter
Maximum 255 characters, letters and digits, no
special characters

Street Street name and number, if applicable Empty input field Enter
Maximum 255 characters, letters and digits, no
special characters

Zip code Zip code Empty input field Enter

Maximum 6 characters, digits only

City City or town Empty input field Enter

Maximum 255 characters, letters and digits, no
special characters

Country / State Country Empty input field Enter

Maximum 255 characters, letters and digits, no
special characters

Phone Phone number Empty input field Enter

Maximum 29 characters, digits only

Analyzer ID Analyzer ID Empty input field Enter

5 characters, letters and digits, no special characters

Information on the tab Address / Analyzer

Data entered on the tab Address / Analyzer is displayed in the header of the
printed pages.

User settings On the tab User settings, the user can change various settings, see the table below.

Information Explanation Default setting Action

Show results The user can define whether all results or only the All results Select
most recently measured result is displayed in the
lab journal.
When the user selects Only last result, all results are
only displayed in the dialog Sample details.

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Information Explanation Default setting Action

Sort sequence in the The user can define the default sort sequence in the Entry Select
lab journal lab journal.
Various options are available, see ( Page 85 Sorting
order in the lab journal).

Display assays The user can define whether assays are sorted by assay Assay no. Select
number or alphabetically.

Print The user can activate or deactivate the print preview, With preview Select
see ( Page 71 User settings).
If printing without preview is selected, the data is
printed directly.

Replacement of cuvette The user can define whether the closing of Terminate by closing Select
segments or dilution strips the right cover already serves as a confirmation the cover
for replacement or if a confirmation procedure
is followed.

Information on the tab User settings

Action buttons For special action buttons, see the table below.

Action button Explanation

Add Adds a new segment ID to the list of existing sample rotor seg‐
ments
The button is displayed when the tab Sample segments
is selected.

Basic settings Deactivates or activates the extended result report

The button is displayed when the tab Result report is selected.

Special action buttons

5.3.10 Control details

Path to the dialog:

• Routine button Lab journal > double-click a line with a requested job or a
measurement result for a control

The dialog is used to view details of a control measurement.

In the top left corner, the control ID and the control name are displayed, preceded by a
symbol, if applicable. For more information, see ( Page 54 Flags and symbols).

The table displays details for all control measurements. Column headings are explained
in the table below.

Information Explanation

Status Status of measurements, represented by symbols, if applicable,

see ( Page 54 Flags and symbols)

Assay Abbreviation of the assay

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Information Explanation

Result/Unit Measurement result and corresponding unit

If a measurement result is above the measurement range, the
upper limit is displayed additionally, with the symbol >, for
example, > 16.3 g/L. If a measurement result is below the
measurement range, the lower limit is displayed additionally,
with the symbol <, for example, < 0.1439 g/L.

Flag Flag, if applicable, see ( Page 54 Flags and symbols)

Deviation Deviation from the reference value in %

If the deviation from the reference value is exceeded, the control
result is outside the confidence range. The permitted deviation
is defined in the dialog Definitions, on the tab Controls, see
( Page 75 Controls).

AD Not applicable for controls

Time Time at which the job was finished

Column headings

Every control result is compared to the confidence range and the reference range of the
selected method. If the control result is outside of at least 1 of these 2 ranges, the control
result will be displayed as invalid in the dialog Lab Journal.

Control results, which are displayed as invalid in the dialog Lab Journal and are not

flagged or , are inside the confidence range and can be considered as valid.

Action buttons For special action buttons, see the table below.

Action button Explanation

Repeat Displays the dialog Repeat, see ( Page 110 Repeat)

Kinetics Displays the dialog Kinetics, see ( Page 81 Kinetics -

Measurement curves)

Special action buttons

5.3.11 Definitions
Path to the dialog:

• System > Definitions

The dialog is used to establish or change definitions for profiles, controls, standards,
units, and cups.

The dialog is divided into 6 tabs, see the table below.

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Information Explanation

Profiles Definition of profiles

Profiles define a set of assays that will be requested
when the profile is manually assigned to a sample ID,
see ( Page 75 Profiles).

Controls Definition of controls provided by Siemens

Healthineers and user-defined controls, see
( Page 75 Controls)

Units Definition of units, see ( Page 78 Units)

Immersing depth Definition of the immersing depth for cup-in-tube

segments, see ( Page 78 Immersing depth)

Control lots Definition of control lots, see ( Page 79 Control lots)

Standard lots Definition of standard lots, see

( Page 80 Standard lots)

Definitions

Action buttons For special action buttons, see the table below.

Action button Explanation

New Profiles:
Adds a new row to the table
The user can enter a name for the new profile in the left
table cell and add assays to the profile by selecting the
corresponding table cell.
Profile name: Maximum 255 characters, letters and
digits, no special characters
Controls:
If the name of a user-defined control is selected in
the table: The user can add any assay to the user-
defined control via the dialog Control details, see
( Page 76 Components of the dialog Control details
for controls provided by Siemens Healthineers).
If no control name is selected in the table: The user
can add a new user-defined control to the table via the
dialog Control details, see ( Page 77 Components of
the dialog Control details for user-defined controls).
The action button is only visible on the tabs
Profiles and Controls, see ( Page 75 Profiles) and
( Page 75 Controls).

Change depth Displays a confirmation dialog and, after

confirmation, a table and a graphic, see
( Page 78 Immersing depth)
The action button is only visible on the tab Immersing
depth, see ( Page 78 Immersing depth).

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Action button Explanation

Reset Resets the variable Z of the selected cup-in-tube

segment to the default setting
The action button is only visible on the tab Immersing
depth after the value of the variable Z has been
changed, see ( Page 78 Immersing depth).

Lot ID Control lots: Adds a new control lot of the selected

control to the table
Standard lots: Adds a new standard lot of the selected
standard to the table
The user can enter the new lot ID in the left table
cell and enter reference values by selecting the
corresponding table cell.
Lot ID: 2 digits
Reference value: Maximum 11 digits including
decimal point
The action button is only visible on the tabs Control
lots and Standard lots, see ( Page 79 Control lots)
and ( Page 80 Standard lots).

Special action buttons

Profiles On the tab Profiles, the user can add, edit, and delete profiles.

Profiles are displayed in a table. The table heading lists all available assays by their
abbreviation. The left column lists the existing profiles. The colors and markings of the
table cells are explained in the table below.

Color and marking Explanation

White, no marking Assay is not assigned to the corresponding profile.

White, X Assay is assigned to the corresponding profile.

Colors and markings of table cells

The user can select and de-select profile names. When the user selects profile names, the
corresponding table rows are highlighted dark blue, see ( Page 52 Select).

The user can add assays to and remove assays from existing profiles by selecting or
de-selecting the corresponding table cell.

Controls On the tab Controls, the user can view and edit detailed information on assays assigned
to controls provided by Siemens Healthineers, and add and delete user-defined controls.

Controls are displayed in a table. The table heading lists all available assays by their
abbreviation. The left column lists the existing controls. The colors and markings of the
table cells are explained in the table below.

Color and marking Explanation

Dark gray, no marking Assay is not assigned to the corresponding control.

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Color and marking Explanation

White, X Assay is assigned to the corresponding control.

Colors and markings of table cells

The user can select and de-select control names. When the user selects control names,
the corresponding table rows are highlighted dark blue, see ( Page 52 Select).

The names of controls provided by Siemens Healthineers are displayed in green. The
user can view and edit detailed information on assays assigned to a control in the dialog
Control details by clicking the corresponding table cell. The components of the dialog
Control details are explained in the table below.

Information Explanation Default setting Action

Name Control name - -

ID Identifier number of the control - -

Assay Abbreviation of the assay and assay number - -

Permitted deviation Permitted deviation from the reference value in % 15 Enter

The value entered defines the confidence range
for the assay. If a control result is outside the
confidence range, it is flagged in the lab journal, see
( Page 54 Flags and symbols).

Dilution Dilution used for the measurement of the assay Depending on Select
the assay

At the beginning A control measurement is performed before the De-selected Select or

system processes requested jobs for this assay. de-select
This component is used to define cyclic
control measurements.

all … measurements A control measurement is performed after the No entry Enter

entered number of requested jobs for this assay.
Example: When 50 is entered in the input field,
50 requested jobs are measured for this assay. The
51st measurement is a control measurement.
This component is used to define cyclic
control measurements.

At the end A control measurement is performed after the system De-selected Select or
has processed the requested jobs for this assay. de-select
This component is used to define cyclic
control measurements.

Precision The control results are sent to the quality De-selected Select
control software. For more information, see the
documentation of the quality control software.

Accuracy The control results are sent to the quality Selected Select
control software. For more information, see the
documentation of the quality control software.

Components of the dialog Control details for controls provided by Siemens Healthineers

The names of user-defined controls are displayed in black.

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Identifier numbers 9900 to 9999 are reserved for user-defined controls by the system.

Siemens Healthineers recommends to use only these identifier numbers for user-
defined controls.

The user can add and delete user-defined controls, and view and edit detailed
information on assays assigned to a user-defined control in the dialog Control details by
clicking the corresponding table cell. The components of the dialog Control details are
explained in the table below.

Information Explanation Default setting Action

Name Control name - Enter

Maximum 255 characters, letters and digits, no
special characters

ID Identifier number of the control - Enter

Digits 9900 to 9999

Treat sample as user- Sample IDs starting with the entered identifier Selected Select or
defined control number will automatically be treated as user-defined de-select
controls by the system, if selected.

Assay Abbreviation of the assay and assay number - Select

Permitted deviation Permitted deviation from the reference value in % 0 Enter

The value entered defines the confidence range
for the assay. If a control result is outside the
confidence range, it is flagged in the lab journal, see
( Page 54 Flags and symbols).

Dilution Dilution used for the measurement of the assay Depending on Select
the assay

At the beginning A control measurement is performed before the Selected Select or

system processes requested jobs for this assay. de-select
This component is used to define cyclic
control measurements.

all … measurements A control measurement is performed after the 1 Enter

entered number of requested jobs for this assay.
Example: When 50 is entered in the input field,
50 requested jobs are measured for this assay. The
51st measurement is a control measurement.
This component is used to define cyclic
control measurements.

At the end A control measurement is performed after the system De-selected Select or
has processed the requested jobs for this assay. de-select
This component is used to define cyclic
control measurements.

Precision The control results are sent to the quality Selected Select
control software. For more information, see the
documentation of the quality control software.

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Information Explanation Default setting Action

Accuracy The control results are sent to the quality De-selected Select
control software. For more information, see the
documentation of the quality control software.

Components of the dialog Control details for user-defined controls

Units On the tab Units, the user can assign units and reference ranges to assays.

Units and reference ranges are displayed in a table. Column headings are explained in the
table below.

Information Explanation Default setting Action

- Abbreviation of the assay - -

Unit Unit of the assay Depending on Select

the assay
Depending on the assay, the user can select different
units. When the user saves a changed unit, the lower
limit of the reference range and the upper limit of the
reference range are converted accordingly.

Lower limit of Lower limit of the reference range of the assay Depending on Enter
reference range the assay
The lower limit is provided by Siemens Healthineers
and can be changed by the user to a value suitable for
the laboratory.
If a result for this assay is below the reference
range, the result is flagged in the lab journal, see
( Page 54 Flags and symbols).

Upper limit of Upper limit of the reference range of the assay Depending on Enter
reference range the assay
The upper limit is provided by Siemens Healthineers
and can be changed by the user to a value suitable for
the laboratory.
If a result for this assay is above the reference
range, the result is flagged in the lab journal, see
( Page 54 Flags and symbols).

Information on the tab Units

Immersing depth On the tab Immersing depth, the user can edit the immersion depth of the probe into
cups held in cup-in-tube segments. The number on the plain text label of cup-in-tube
segments starts with 51.

After clicking the action button Change depth and a confirmation, a table and a graphic
are displayed in the dialog. In the table, the user can change the value of the variable Z for
all defined cup-in-tube segments that are not on-board. Column headings are explained
in the table below.

Information Explanation Default setting Action

Segment ID Segment ID of the cup-in-tube segment - -

The colors of the segment ID texts are explained in the
table below.

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Information Explanation Default setting Action

Z [mm] Distance from the bottom edge of the cup-in-tube 3.9 Enter
segment to the inner base of the cup
Digits 3.9–99.9
When the user changes this value, the
distance representing Z displayed in the graphic
changes accordingly.

Information on the tab Immersing depth

Color Explanation

Black Variable Z has not been adapted.

Blue Variable Z has been adapted.

Colors of the segment ID texts

The graphic displays a cup inserted into a tube. The graphic illustrates that the immersion
depth depends on the variable Z. The higher the value of the variable Z, the smaller
becomes the immersion depth.

A default value for the variable Z is provided by Siemens Healthineers for all defined
cup-in-tube segments. The user has to adapt the default value to the cups used with a
cup-in-tube segment before this cup-in-tube segment is loaded in the sample rotor. Only
1 type of cup can be used in a specific cup-in-tube segment, as the immersion depth must
be the same for all cups.

Control lots On the tab Control lots, the user can view and edit lot data for existing control lots and
add new control lots.

Lot data is displayed in a table. The table heading lists all available assays by their
abbreviation and the assigned unit. The left column lists all control lots by their
abbreviation and the control ID. An ID comprises 6 digits, 4 digits for the identifier
number and 2 digits for the lot number. If the lot number is replaced by --, no reference
values have been defined for this control.
The colors and content of the table cells are explained in the table below.

Color and content Explanation

Gray, no content Assay is not assigned to the corresponding control, see

( Page 75 Controls).

White, no content Assay is assigned to the corresponding control but no

reference value is defined for the assay.
The user can only enter reference values for control lots
with lot numbers.

White, (Value) Assay is assigned to the corresponding control, the

value is the defined reference value for the assay.
The user can edit the reference value by selecting the
table cell and editing the value.

Colors and content of table cells

The user can select and de-select control lots by clicking the control name. When the user
selects a control lot, the table row is highlighted dark blue.

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Standard lots On the tab Standard lots, the user can view and edit lot data for existing standard lots
and add new standard lots.

Lot data is displayed in a table. The table heading lists all available assays by their
abbreviation with the assigned unit. The left column lists all standard lots by their
abbreviation and the standard ID. An ID comprises 6 digits, 4 digits for the identifier
number and 2 digits for the lot number. If the lot number is replaced by --, no reference
values have been defined for this standard.

The colors and content of the table cells are explained in the table below.

Color and content Explanation

Gray, no content Assay is not assigned to the corresponding standard.

White, no content Assay is assigned to the corresponding standard but no

reference value is defined for the assay.
The user can only enter reference values for standard
lots with lot numbers.

White, (Value) Assay is assigned to the corresponding standard, the

value is the defined reference value for the assay.
The user can edit the reference value by selecting the
table cell and editing the value.

Colors and content of table cells

The user can select and de-select standard lots by clicking the standard name. When the
user selects a standard lot, the table row is highlighted dark blue.

5.3.12 Hardware check - probe

Path to the dialog:

• System > Hardware check

The dialog is used to check if the probe is bent or not properly adjusted.

The user has to follow the instructions displayed during the process.

5.3.13 Help
Path to the dialog:

• Help
The dialog displays the online help. The online help is displayed in a browser window.

Depending on the user settings, the dialog is either split in 2 columns or not split. The
user can display other chapters and change the view of the dialog, see below.

Buttons displayed when the dialog is split in 2 columns

Content Displays the table of contents on the left

Index Displays the index on the left

Search Displays a search area on the left

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Buttons displayed when the dialog is split in 2 columns

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

Button displayed when the dialog is not split

Displays the chapter of contents and other buttons to navigate

in the manual

Buttons of the online help

When the dialog is split in 2 columns, the user can adjust column widths by clicking the
middle border of the columns and dragging it to the left or to the right.

5.3.14 Initialize analyzer

Path to the dialog:

• (automatically displayed)
The dialog is displayed during the start of the viewer software and indicates that the
viewer software is waiting for a response from the analyzer.

5.3.15 Kinetics - Measurement curves

Paths to the dialog:

• Sample details > Kinetics

• Control details > Kinetics

The dialog is used to view the measurement curves of results. Details on the
measurement are displayed above and below the measurement curve, see the
table below.

Information Explanation

ID Samples: Sample ID
Controls: Control ID

Dilution Dilution used for the measurement

Assay Abbreviation of the assay and assay number

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Information Explanation

- Date and time of the measurement

Pre-value Value of the pre-reaction

If no pre-reaction has occurred, the detail is not displayed.

Start value Start value of the reaction

Difference value Difference between the end value and the start value of
the reaction

Reagents Abbreviation of the reagents used for the measurement and

reagent IDs
An ID comprises 6 digits, 4 digits for the identifier number and
2 digits for the lot number.

Calibration Date and time of the calibration

Kinetics

Navigation between The user can scroll through the selected results by using the buttons for master
measurement curves navigation in the top left corner, see ( Page 53 Master navigation).

5.3.16 Kinetics - Reference curve

Path to the dialog:

• Calibration > Show curve > Kinetics

The dialog is used to view the kinetics of a reference curve at the various dilution steps
for the assay displayed in the dialog Show curve.

Details on the measurement are displayed above and below the graph, see the
table below.

Information Explanation

ID Standard ID
An ID comprises 6 digits, 4 digits for the identifier
number and 2 digits for the lot number.

Dilution Dilution used for the measurement

Assay Abbreviation of the assay and assay number

- Date and time of the measurement

Pre-value Value of the pre-reaction

If no pre-reaction has occurred, the detail is
not displayed.

Start value Start value of the reaction

Difference value Difference between the end value and the start value of
the reaction

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Information Explanation

Reagents Abbreviation of the reagents used for the

measurement and reagent IDs
An ID comprises 6 digits, 4 digits for the identifier
number and 2 digits for the lot number.

Details on the measurement

Navigation between dilution The user can scroll through the dilution steps by using the buttons for master navigation
steps in the top left corner, see ( Page 53 Master navigation).

5.3.17 Lab journal

Path to the dialog:

• Lab journal

The dialog is used to manage jobs and to display results in a table, see the table below.

1 1 2 1

Details of the dialog Lab journal (example)

(1) Filters
(2) Sorting
(3) Table
Information on samples, STAT samples, controls, assays, and results is displayed in a
table. Column headings are explained in the table below.

Information Explanation

- Common information on samples and controls, represented by

symbols, if applicable, see ( Page 54 Flags and symbols)

ID Samples: Sample ID
A sample ID comprises 1–29 characters.
Controls: Control ID
A control ID comprises 6 digits, 4 digits for the identifier number
and 2 digits for the lot number.
Only controls that are on-board and identified are displayed.

Name Samples: Patient name, if available

Controls: Control name

MP Manual pre-dilution of samples, represented by symbols, if

applicable, see ( Page 54 Flags and symbols)

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Information Explanation

AD Assay dilution: Requested special dilution of samples,

represented by symbols, if applicable, see ( Page 54 Flags
and symbols)

Assay Abbreviation of the requested assay

Result/Unit Samples: Measurement result and corresponding unit

Controls: Measurement result, corresponding unit, and
deviation from the reference value in %
If a measurement result is above the measurement range,
the upper limit is displayed additionally, with the symbol >,
for example, > 16.3 g/l. If a measurement result is below the
measurement range, the lower limit is displayed additionally,
with the symbol <, for example, < 0.1439 g/l.

Flag Flag, if applicable, see ( Page 54 Flags and symbols)

Status Status of the requested job for samples and controls,

represented by symbols, if applicable, see ( Page 54 Flags
and symbols)

Column headings

Filters in the lab journal The user can filter the entries in the lab journal by using the 3 filters above the table, see
the table below.

Filter Setting Explanation

Selection (All) Jobs for all samples and controls

Samples Jobs for all samples

STATs Jobs for STAT samples only

Controls Jobs for controls

View by (All) Jobs for all samples and controls

Out of Jobs whose result is out of measurement range

measurement range

Out of Jobs whose result is out of reference range

reference range
When the user selects this filter setting, the filter Selection
is automatically set to Samples. The filter Selection is not re-
set automatically.

Invalid controls Invalid control measurements

When the user selects this filter setting, the filter Selection
is automatically set to Controls. The filter Selection is not re-
set automatically.

Missing Missing samples and/or controls, depending on the setting of the

filter Selection

Not sufficient Jobs for which the volume of the sample or control is not sufficient

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Filter Setting Explanation

Samples on-board Samples that are on-board but for which no jobs are requested
without jobs
When the user selects this filter setting, the filter Selection
is automatically set to Samples. The filter Selection is not re-
set automatically.

Samples on-board Samples that are on-board

When the user selects this filter setting, the filter Selection
is automatically set to Samples. The filter Selection is not re-
set automatically.

Samples with result Jobs for samples that already have a result
When the user selects this filter setting, the filter Selection
is automatically set to Samples. The filter Selection is not re-
set automatically.

Pending requests Jobs for samples and controls that have not yet been processed

Date Today Jobs and results for all samples and controls that have been requested or
measured today

(Date) Results for all samples and controls that have been measured on the
selected date
The results for the last 14 days can be displayed.

Filter for entries in the lab journal

Sorting order in the lab The user can sort the entries in the lab journal, see the table below.
journal
Information Explanation

ID The samples and controls are sorted by ascending ID.

IDs comprising blocks of letters and digits are first sorted
alphabetically by the block of letters and subsequently
numerically by the block of digits.
IDs of the same length comprising only digits are
sorted numerically.

Status The samples and controls are sorted by their processing status.
Succession:
• Samples and controls that have finished processing
• Samples and controls whose jobs have been partly processed
or whose jobs are still in process
• Samples and controls that are not on-board
Within each group, samples and controls are sorted by
ascending ID, see above.

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Information Explanation

Position The sample and control IDs are sorted by their position on the
sample rotor segments.
Succession:
• Sample rotor segment 1, positions 1–15
• Sample rotor segment 2, positions 1–15
• Sample rotor segment 3, positions 1–15
• Samples that are not on-board

Entry The sample and control IDs are sorted by the date and time
when an ID was created on the system.

Sorting samples and controls

The default sort sequence is set in the dialog Configuration, on the tab User settings,
see ( Page 71 User settings).

Action buttons For special action buttons, see the table below.

Action button Explanation

New Displays the dialog New, see ( Page 102 New)

Add request Displays the dialog Add request, see

( Page 60 Add request)

Repeat Displays the dialog Repeat, see ( Page 110 Repeat)

Release Releases selected results and sends selected results to

the LIS, if available

Request control Displays the dialog Request controls, see

( Page 112 Request controls)

Special action buttons

5.3.18 Loading cuvette segments and dilution strips

Path to the dialog:

• Loading > Cuv. seg. & dil. strips

The dialog is used to give an overview of the cuvette segments and the dilution strips.

The dialog is divided into 2 areas, see the table below.

Information Explanation

Dilution strips Graphic of the dilution frame with dilution strips and the single dilution cups
Letters and digits in the graphic correspond with the letters and digits affixed
to the dilution frame.
The colors and markings of the dilution strips and single dilution cups have
different meanings, see ( Page 87 Colors and markings of the dilution strips
and dilution cups).

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Information Explanation

Cuvettes Graphic of the cuvette segments with the single cuvettes

Digits in the graphic correspond with the digits affixed to the cuvette rotor.
The colors and markings of the cuvette segments and single cuvettes have
different meanings, see ( Page 87 Colors and markings of the cuvette
segments and cuvettes).

Areas in the dialog Loading cuvette segments and dilution strips

Color and marking Explanation

Dark blue, no marking The dilution cup is in use or has been assigned to a
requested job.

Light blue, no marking No dilution strip is placed in this row.

White, no marking The dilution cup is available.

White, X The dilution cup is no longer required. When all dilution

cups in a dilution strip are marked with an X, the
dilution strip can be removed.

Colors and markings of the dilution strips and dilution cups

Color and marking Explanation

Dark blue, no marking The cuvette is in use or has been assigned to a

requested job.

Light blue, no marking No cuvette segment is loaded in this row.

White, no marking The cuvette is available.

White, X The cuvette is no longer required.

– or –
The blank value of the empty cuvette is above the limit.
The cuvette is refused.
When all cuvettes in a cuvette segment are marked
with an X, the cuvette segment can be removed.

Colors and markings of the cuvette segments and cuvettes

Action buttons For special action buttons, see the table below.

Action button Explanation

Samples Displays the dialog Loading samples, see

( Page 94 Loading samples)

Reagents Displays the dialog Loading reagents, see

( Page 88 Loading reagents)

Access Displays the dialog Access cuvette segments and dilution

strips, see ( Page 58 Access cuvette segments and
dilution strips)

Special action buttons

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5.3.19 Loading reagents

Path to the dialog:

• Loading > Loading reagents

The dialog displays an overview of the reagents and controls loaded in the reagent rotor
segments via a table.

Column headings of the table are explained in the table below.

Information Explanation

- Common information on reagents and controls, represented by

symbols, if applicable, see ( Page 54 Flags and symbols)

Reagent Abbreviation of the reagent or control

Lot no. ID of the reagent or control

An ID comprises 6 digits, 4 digits for the identifier number and
2 digits for the lot number.
If a reagent or control could not be identified, a ? is displayed.

Required [μl] Volume of the reagent or control required for requested jobs

Available [μl] Available volume of the reagent or control

Seg / Pos Number of the reagent rotor segment and number of the
position on the reagent rotor segment where the reagent or the
control is loaded

Status Status of the reagent or control, see ( Page 88 Status of

reagents and controls)

Column headings

Information Explanation

Available Reagents and controls that are on-board and not empty

Empty Reagents and controls that are empty

To be identified Reagents and controls that are on-board but could not
be identified

Not required Reagents and controls that are on-board but are not
required for requested jobs

Insufficient Reagents and controls that are on-board but whose

volume is not sufficient for requested jobs

Missing Reagents and controls that are required for requested

jobs but are not on-board

Status of reagents and controls

The user can filter the entries in the table by using the 2 filters above the table, see the
table below.

Filter Setting Explanation

Selected by (All) Reagents and controls

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Filter Setting Explanation

Controls Controls only

Reagents Reagents only

Reagent status (All) Reagents and controls that are on-board or are required for
requested jobs

To be identified Reagents and controls that are on-board but could not
be identified

Not required Reagents and controls that are on-board but are not required
for requested jobs

Insufficient Reagents and controls that are on-board but whose volume
is not sufficient for requested jobs

Missing Reagents and controls that are required for requested jobs
but are not on-board

Filter for reagents and controls

Action buttons For special action buttons, see the table below.

Action button Explanation

Samples Displays the dialog Loading samples, see

( Page 94 Loading samples)

Graphic Displays a graphical overview of the reagent rotor and

the reagent rotor segments, see ( Page 89 Loading
reagents, graphic overview)

Cuv. seg. & dil. strips Displays the dialog Loading cuvette segments and
dilution strips, see ( Page 86 Loading cuvette
segments and dilution strips)

Identify Displays the dialog Loading reagents with a list

of reagents and controls, see ( Page 92 Loading
reagents, identify reagents and controls)

Access Displays the dialog Access reagents, see

( Page 60 Access reagents)

Special action buttons

5.3.20 Loading reagents, graphic overview

Path to the dialog:

• Loading > Loading reagents > Graphic

The dialog displays an overview of the reagents and controls loaded in the reagent rotor
segments via a graphic.

The dialog is divided into a graphic and a corresponding table, see the figure below.

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2 3 2

Graphic overview of the dialog Loading reagents (example)

(1) Graphic
(2) Navigation buttons
(3) Diagram of the reagent rotor
(4) Diagram of the selected reagent rotor segment
(5) Vial position
(6) Table
The table below the graphic provides additional information on the reagents or controls.
This information is displayed for the reagent rotor segment selected in the diagram of the
reagent rotor. The components of the dialog are explained in the table below.

Graphic

Navigation buttons Select the next reagent rotor segment to the left or to the right Click

Diagram of the reagent rotor Schematic overview of the 15 segments of the reagent rotor Select
The numbers in the schematic overview correspond with the digits
affixed to the reagent rotor. If a reagent rotor segment is selected, its
number is enlarged in the schematic. If at least 1 position of the reagent
rotor segment is empty, the reagent rotor segment is marked with a
black dot.
The colors of the reagent rotor segments have different meanings, see
( Page 91 Colors of the reagent rotor segments).

Diagram of the selected Schematic overview of the selected reagent rotor segment with -
reagent rotor segment all positions
The digits in the schematic overview correspond with the digits affixed to
the reagent rotor.

Vial position The number of positions depends on the type of the Select
reagent rotor segment, see ( Page 45 Reagent segment) and
( Page 45 Control segment).
The selected position is framed by blue lines and highlighted in the table
below. If a reagent or control could not be identified, a ? is displayed in
the position.
The colors and markings of the vial positions have different meanings,
see ( Page 91 Colors and markings of the vial positions).

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Table

Vial position Number of the position on the reagent rotor segment where the reagent -
or the control is loaded

Reagent Abbreviation of the reagent or control -

Lot no. ID of the reagent or control -

An ID comprises 6 digits, 4 digits for the identifier number and 2 digits for
the lot number.
If a reagent or control could not be identified, a ? is displayed.

Required [μl] Volume of the reagent or control required for requested jobs -

Available [μl] Available volume of the reagent or control -

If a reagent or control with 2 different lot numbers is on-board, the
volume for the second lot number is displayed as 0. The correct volume
of the second lot number is only displayed when the first lot number has
been used up.

Status Status of the reagent or control, see ( Page 88 Loading reagents) -

Graphic overview of the dialog Loading reagents

Color Explanation

Blue All positions have been identified.

Yellow At least 1 position could not be identified.

- No reagent rotor segment is loaded.

– or –
A reagent rotor segment is loaded but no position could
be identified.

Colors of the reagent rotor segments

Color and marking Explanation

Dark blue, no marking Position is empty.

Completely filled with white The reagent or control is identified. The level is above
wavy lines, no marking 500 μL.

Completely filled with white The reagent or control is unidentified. The level is above
wavy lines, ? 500 μL.

Blue and partly filled The reagent or control is identified. The level is below
with white wavy lines, 500 μL.
no marking

Blue and partly filled with The reagent or control is unidentified. The level is
white wavy lines, ? below 500 μL.

Colors and markings of the vial positions

Action buttons For special action buttons, see the table below.

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Action button Explanation

Samples Displays the dialog Loading samples, see

( Page 94 Loading samples)

Reagents Displays the dialog Loading reagents, see

( Page 88 Loading reagents)

Cuv. seg. & dil. strips Displays the dialog Loading cuvette segments and
dilution strips, see ( Page 86 Loading cuvette seg‐
ments and dilution strips)

Identify Displays the dialog Loading reagents with a list

of reagents and controls, see ( Page 92 Loading
reagents, identify reagents and controls)

Access Displays the dialog Access reagents, see

( Page 60 Access reagents)

Special action buttons

5.3.21 Loading reagents, identify reagents and controls

Path to the dialog:

• Loading > Loading reagents > Identify

The dialog is used to manually identify reagents and controls that are already on-board
but whose barcode could not be read. After the manual identification, the assigned data
is retained unless the reagent rotor segment is removed from the system.

The dialog is divided into 3 areas, see the figure below.

1 2 3

Identify reagents and controls (example)

(1) Reagent list

(2) Data area
(3) Graphic of the reagent rotor segment

The areas of the dialog are explained in the table below.

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Information Explanation Action

Reagent list

Lot no. ID of the identified reagent or control Select

An ID comprises 6 digits, 4 digits for the identifier number and 2 digits for the
lot number.

Reagent Abbreviation of the reagent or control Select

Data area

Lot number ID of the reagent or control that has to be identified manually Enter
An ID comprises 6 digits, 4 digits for the identifier number and 2 digits for the
lot number.

- Reagent or Control Select

Graphic of the reagent rotor segment

- Reagent rotor segment with at least 1 unidentified reagent or control, see Select
figure below.

Information in the areas of the dialog

The data for an unidentified reagent or control can be selected in the Reagent list or
entered in the data area.

Graphic of the reagent rotor segment

(1) Reagent rotor segment

(2) Vial position
(3) Number of the reagent rotor segment

The components of the graphic are explained in the table below.

Information Explanation

Reagent rotor segment Schematic overview of the reagent rotor segment with
all positions

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Information Explanation

Vial position The number of positions depends on the type of the reagent
rotor segment, see ( Page 45 Reagent segment) and
( Page 45 Control segment).
The selected position is framed by blue lines. If a reagent
or control could not be identified, a ? is displayed in
the position.
The colors and markings of the vial positions have different
meanings, see ( Page 94 Colors and markings of the
vial positions).

Number of the reagent Number of the reagent rotor segment

rotor segment
The digit corresponds with the digits affixed to the
reagent rotor.

Components of the graphic

Color and marking Explanation

Dark blue, no marking Position is empty.

Completely filled with white The reagent or control is identified. The level is above
wavy lines, no marking 500 μL.

Completely filled with white The reagent or control is unidentified. The level is above
wavy lines, ? 500 μL.

Blue and partly filled The reagent or control is identified. The level is below
with white wavy lines, 500 μL.
no marking

Blue and partly filled with The reagent or control is unidentified. The level is
white wavy lines, ? below 500 μL.

Colors and markings of the vial positions

5.3.22 Loading samples

Path to the dialog:

• Loading

• Loading > Loading samples

The dialog is used to manually identify samples, standards, and user-defined controls and
to give an overview of the sample rotor segments. The dialog is divided into 3 areas, see
the figure below.

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Overview of the dialog Loading samples (example)

(1) Left area

(2) Top right area
(3) Bottom right area

The areas of the dialog are explained in the table below.

Information Explanation

Left area Schematic overview of the sample rotor and the sample
rotor segments, see figure below
Components of the left area are explained in the table
( Page 96 Components of the dialog).

Top right area Manual identification or entry of new samples,

standards, or user-defined controls
Components of the top right area are explained in the
table ( Page 96 Components of the dialog).

Bottom right area IDs of samples or standards that have been created
in the lab journal but have not yet been loaded on a
sample rotor segment
Components of the bottom right area are explained in
the table ( Page 96 Components of the dialog).

Loading samples

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1 2 3 4

Left area of the dialog Loading samples (example)

(1) Segment ID
(2) Diagram of the selected sample rotor segment
(3) Position on the selected sample rotor segment
(4) ID of the loaded sample, standard, or user-defined control
(5) Status of the selected sample rotor segment
(6) Diagram of the sample rotor

Information Explanation Action

Components of the left area

Segment ID Segment ID of the selected sample rotor segment Select

The list contains all sample rotor segments defined in the dialog
Configuration, on the tab Sample segments. The selected sample
rotor segment is displayed on the right, see ( Page 70 Sample segments)
and ( Page 41 Sample rotor segments).

Diagram of the selected Schematic overview of the selected sample rotor segment with -
sample rotor segment all positions

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Information Explanation Action

Components of the left area

Position on the selected The selected position is framed by blue lines. Select
sample rotor segment
The number of positions depends on the type of the sample rotor
segment. The positions in the schematic overview correspond with the
digits affixed to the sample rotor segment, see ( Page 41 Sample
rotor segments).
If a sample, standard, or user-defined control could not be identified, a ?
is displayed in the position.
The colors of the positions on the sample rotor segment have different
meanings, see ( Page 97 Colors and markings of the positions on the
sample rotor segment).

ID of the loaded If a sample, standard, or user-defined control is loaded in a position of the -

sample, standard, or user- sample rotor segment, its ID is displayed to the right of the position.
defined control

Status of the selected sample Status of the selected sample rotor segment -
rotor segment
The sample rotor segment can be on-board or not on-board.

Diagram of the sample rotor Schematic overview of the 3 positions of the sample rotor Select
The digits in the schematic overview correspond with the digits affixed to
the sample rotor. If a sample rotor segment is selected, the number of its
position is enlarged in the schematic.
The colors of the sample rotor segments have different meanings, see
( Page 98 Colors of the sample rotor segments).

Components of the top right area

- Samples, Standards, or Controls Select

Enter ID ID of the sample, standard, or user-defined control Enter

Enter the ID of the sample, standard, or user-defined control that could
not be identified.
– or –
Enter a new sample.
Maximum 29 characters, letters and digits, no special characters

Man. predil. Manual pre-dilution of the sample Select

Components of the bottom right area

Type Filter by STAT samples, samples, or standards Select

ID ID of samples or standards that have not yet been loaded Select

Components of the dialog

Color and marking Explanation

Dark blue, no marking Position is empty.

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Color and marking Explanation

Completely filled with white The sample, standard, or control is identified. The cup,
wavy lines, no marking tube, or vial is full.

Completely filled with white The sample, standard, or control is unidentified. The
wavy lines, ? cup, tube, or vial is full.

Blue and partly filled The sample, standard, or control is identified. The cup,
with white wavy lines, tube, or vial is not full.
no marking

Blue and partly filled with The sample, standard, or control is unidentified. The
white wavy lines, ? cup, tube, or vial is not full.

Blue, no marking Position is pre-loaded but the sample rotor segment

is not yet on-board the system, see ( Page 105 Pre-
loading).

Colors and markings of the positions on the sample rotor segment

Color Explanation

Blue At least 1 sample, standard, or user-defined control is

still required.
The sample rotor segment should not be removed.

Blue and yellow At least 1 sample, standard, or user-defined control is still

required. At least 1 position could not be identified.
The sample rotor segment should not be removed.

Green All jobs relating to the samples, standards, or user-defined

controls loaded on the sample rotor segment have
been processed.
The sample rotor segment can be removed.

Green and yellow At least 1 sample, standard, or user-defined control could not
be identified.
The sample rotor segment can be removed nonetheless.

Dark gray The sample rotor segment is on-board but no sample, standard,
or user-defined control is loaded.

- No sample rotor segment is loaded in this position.

Colors of the sample rotor segments

Action buttons For special action buttons, see the table below.

Action button Explanation

Reagents Displays the dialog Loading reagents, see

( Page 88 Loading reagents)

Cuv. seg. & dil. strips Displays the dialog Loading cuvette segments and
dilution strips, see ( Page 86 Loading cuvette
segments and dilution strips)

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Action button Explanation

Auto loading Displays the dialog Pre-loading for the selected

samples, see ( Page 105 Pre-loading)

Level detection Measures the level of the selected sample, standard, or

user-defined control
The detected level is displayed via colors, see
( Page 97 Colors and markings of the positions on the
sample rotor segment).

Access Displays the dialog Access samples, see

( Page 60 Access samples)

Special action buttons

5.3.23 Log on
Path to the dialog:

• (automatically displayed on log on)

If a password check was configured during the installation of the system by Siemens
Healthineers service, the dialog is displayed after the start of the viewer software.

With the password check it is possible to assign different users different user roles. The
user can work according to the assigned user role, see ( Page 99 User role).

The components of the dialog are explained in the table below.

Information Explanation Action

Name User name Enter

Password Password, the characters are displayed as asterisks Enter

Components of the dialog Log on

User role User role Access Access rights

level

Lab technician 1 Request orders for samples and controls

Perform backups
The system runs calibrations automatically,
if configured.
Load and manage lot data
Perform maintenance
Configure specific settings
Configure maintenance
Restore backed up data

Lab manager 2 All

User roles and access rights

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5.3.24 Logbook
Path to the dialog:

• System > Logbook

The dialog is used to view system entries and manual entries in the logbook.

The logbook entries are displayed in a table, see the table below.

Information Explanation

Date/Time Date and time when an event or a problem occurred or

when a manual entry was made
A rectangle is displayed left of the date. The
colors of the rectangle have different meanings, see
( Page 100 Colors in the logbook).

Source Source of the logbook entry

Category Category of the logbook entry

Error code Error code of logbook entries

The error code of manual entries is always 0.

Description Short description of the problem or text of the

manual entry

Logbook entries

The color of the rectangle displayed left of the date in the logbook is explained in the
table below.

Color Explanation

Red Problem that leads to the system not operating

The requested jobs cannot be processed.

Yellow Problem that will lead to the system not operating

The requested jobs cannot be completely processed. If the
user does not resolve the problem, the status button will soon
change to red.

Green Problem that does not lead to the system not operating
All requested jobs can be processed.

Colors in the logbook

When a system entry is selected, more information is displayed below the table, see the
table below.

Information Explanation

Explanation Instructions on how to resolve the problem

Details on system entries

The user can filter the logbook entries by using the 2 filters above the table, see the
table below.

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Filter Setting Explanation

Period Today Logbook entries from today

Last 7 days Logbook entries from the last 7 calendar days

(All) Logbook entries from the last 14 calendar days

Gravity (All) All logbook entries

Red + yellow System entries of category 1 and 2, see ( Page 100 Log‐
book entries)

Red System entries of category 2, see ( Page 100 Log‐

book entries)

Stop error System entries due to a hardware problem that prevented

the system from working

Filter for logbook entries

Action buttons For special action buttons, see the table below.

Action button Explanation

Manual entry Displays the confirmation dialog Entry

The user can enter information on system-relevant issues in the
text field, for example, to record the replacement of the syringe.
Maximum 255 characters, entries with more than
255 characters will not be displayed.

Export Exports all logbook entries filtered by the selected period to the
file LogBook.asc

Special action buttons

5.3.25 Message window

Path to the dialog:

• (automatically displayed)
The message window is an information dialog which displays system messages. If
multiple problems are detected, the system message regarding the problem that
occurred first is displayed first.
The components of the message window are explained in the table below.

Information Explanation Action

Messages Number of unacknowledged system messages -

Date Date when the system message was generated -

Time Time when the system message was generated -

Cause Cause of the system message -

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Information Explanation Action

Explanation Recommendation on how to respond to the -

system message

Ok Acknowledges the current system message Click

The system message is closed. If there are further
system messages, the next system message
is displayed.

Message window

The message window is always displayed in the front. The user can move the message
window anywhere on the screen and continue working.

System messages that have not been acknowledged before the system is shut down are
displayed again after restart of the system.

5.3.26 New
Path to the dialog:

• Lab journal > New

The dialog is used to manually assign sample data and patient data to samples before
loading them in the sample rotor. The dialog is also used to request jobs, see the
table below.

Sample data

Sample ID Sample ID Enter

A sample ID for non-barcoded samples comprises 1–29 characters, letters and digits,
no special characters, spaces at the beginning or at the end of the sample ID
are ignored.

Batch input The user can enter groups of samples for serial analyses. The same assays are Enter
requested for all samples. The sample ID is followed by a sequentially-assigned
batch number.
A maximum number of 99 can be entered.

STAT Short turnaround time Select

Dilutions already in the cuvette rotor are measured, then the STAT sample is prepared
and measured.

Number of Number of assays selected in the list of assays below -

selected assays

Manually pre-diluted Manual pre-dilution of the sample, see ( Page 103 Manual pre-dilution) Select
The system automatically incorporates the manual pre-dilution into the
calculated result.

Patient data

First name First name Enter

Maximum 20 characters

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Patient data

Initial Abbreviation of the middle name Enter

1 character

Last name Last name Enter

Maximum 20 characters

Date of birth Date of birth Enter

The format of the date depends on the settings of the operating system of
the computer.

Practice assigned ID ID assigned by the referring practice Enter

Maximum 30 characters

Laboratory ID assigned by the laboratory Enter

assigned ID
Maximum 20 characters

Additional Patient ID Any additional ID assigned by the laboratory Enter

Maximum 20 characters

Comment Any additional comment on the patient Enter

Maximum 100 characters

Assays

Specimen type Filters the assays in the list of assays below by specimen type, see Select
( Page 103 Specimen type)

- The list below the specimen type displays assays available for the selected specimen. Select
Selected assays are highlighted dark blue.

Profile Available profiles, see ( Page 75 Profiles) Select

The user can add profiles to the job list by selecting the corresponding table cell.
Selected profiles are highlighted dark blue.

Profile no. Running number of the profile Select

Assays Assays assigned to the profile Select

The user can add assays to the job list by selecting the corresponding table cell.

Sample and patient data

Information Explanation

1:1 Sample is not manually pre-diluted, default setting

1:5 Sample is manually pre-diluted 1 : 5

1 : 20 Sample is manually pre-diluted 1 : 20

Manual pre-dilution

Information Explanation

(All) Assays for use in all specimen types

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Information Explanation

Serum Assays for use in serum only

Urine Assays for use in urine only

CSF Assays for use in CSF only

Plasma Assays for use in plasma only

Specimen type

Action buttons For special action buttons, see the table below.

Action button Explanation

Special dilution Displays the dialog Special dilution, see

( Page 117 Special dilution)

Host job list Requests the job list from the LIS, if available
A job list is only sent back by the LIS when the following
conditions are met:
• A sample ID is entered.
• A connection to the LIS is established.
• A job list for the selected sample ID exists with
the LIS.
The lab journal does not automatically display the data
from the job list.

Special action buttons

5.3.27 Open lot data file

Path to the dialog:

• System > Lot data file

The dialog is used to load lot data to the system from a lot data file provided by
Siemens Healthineers.

The dialog is divided into 3 areas, see the figure below.

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2
3

Open lot data file

(1) Drive
(2) Files
(3) Path

The areas of the dialog are explained in the table below.

Information Explanation Action

Drive Drive names of the computer Select

Files Selected path Double-click

The lot data is loaded from a lot data file in the
selected folder.

Path Files with the extension .txt, .zip, or .sd Select

Areas of the dialog

The user can select the drive and path where the lot data is stored. The lot data contains
the current lot numbers and assigned values of controls and standards provided by
Siemens Healthineers.

For information on downloading the lot data, see the Document Library Download
Instruction Manual.

Lot data for each control lot can be viewed in the dialog Definitions, on the tab Control
lots, see ( Page 79 Control lots).

Lot data for each standard lot can be viewed in the dialog Definitions, on the tab
Standard lots, see ( Page 80 Standard lots).

5.3.28 Pre-loading
Path to the dialog:

• Loading > Auto loading

The dialog is used to assign non-barcoded samples to sample rotor segments that are not
on-board, see the table below.

The dialog is only available for samples that are displayed in the lab journal but are not
assigned to a sample rotor segment.

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Information Explanation Action

Number of positions to Number of samples that were selected in the dialog Loading samples -
be loaded

Segment ID Segment ID of sample rotor segments that are not on-board Select
The user can select 1 or more sample rotor segments to which the
selected samples will be assigned by the system.

Free positions Number of positions available on the sample rotor segment Select

Pre-loading

The user must manually load non-barcoded samples on the selected sample rotor
segments according to the assignment. This assignment is also called pre-loading.

5.3.29 Print preview

Path to the dialog:

• Print

The action button is available in several dialogs.

If printing with preview is selected in the dialog Configuration, on the tab User settings,
a print preview is displayed every time the user clicks Print. The print preview displays the
pages as they will be printed.

If printing without preview is selected in the dialog Configuration, on the tab User
settings, data is printed directly, see ( Page 71 User settings).

The information displayed in the header of the print preview is explained in the
table below.

Information Explanation

- Dialog name of which the print preview is displayed

SIEMENS ANEPH630 System name

Laboratory Name and address of the laboratory or

company entered in the dialog Configuration, see
( Page 71 Address / Analyzer)

Phone Phone number of the laboratory or company

entered in the dialog Configuration, see
( Page 71 Address / Analyzer)

Serial no. Analyzer ID entered in the dialog Configuration, see

( Page 71 Address / Analyzer)

Version Version of the system software

Operator User name used for logging on, if applicable

Printing date Printing date

Printing time Printing time

Header of the print preview

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In the footer of the print preview, the number of the current page and the total number
of pages is displayed.

The user can scroll through the pages, print or export 1 or more pages, and zoom the
pages in and out, see the table below.

Button Explanation

Displays the first page

Displays the previous page

Displays the next page

Displays the last page

Stops the transfer of data (spooling)

Displays the print settings, see ( Page 107 Print settings)

Displays the export settings, see ( Page 108 Export settings)

Zooms the pages in or out

Buttons of the print preview

Information Explanation Action

Printer Available printers Select

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

Copies Number of copies Select or

enter

Collate Copies Print the copies collated 1 after another Select

OK Starts printing and closes the dial Click

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Information Explanation Action

Cancel Closes the dialog without printing Click

Print settings

Information Explanation Action

Format Format of the exported data Select

Destination Destination of the exported data Select

OK Starts the export and closes the dialog Click

Cancel Closes the dialog without exporting Click

Export settings

To the right of the buttons, information on the data sets in the print preview is displayed.

5.3.30 Print raw data

Path to the dialog:

• System > Print raw data

When printing with preview is selected in the dialog Configuration, on the tab User
settings, a print preview for raw data is displayed every time the user clicks Print raw
data. Raw data is displayed in a list, see the table below.

Information Explanation

Cuv. Number of the cuvette used for the measurement

Date Date of the measurement

Time Time of the measurement

Assay Abbreviation of the assay

Identification Sample ID, standard ID with abbreviation of the stand‐

ard, or control ID with abbreviation of the control

Dil. Dilution used for the measurement

Start Start value of the reaction, measured after 7.5 s

Value End value of the

PrerVal. Value of the pre-reaction

If no pre-reaction has occurred, the value is 0.

Flag Flag, see ( Page 54 Flags and symbols)

Information in the print preview for raw data

5.3.31 Purge tubings

Path to the dialog:

• System > Purge tubings

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The dialog is used to purge the tubing. The user has to follow the instructions displayed
during the process.

Action buttons For special action buttons, see the table below.

Action button Explanation

Start purging Starts the purging of the tubing

Start rinsing Starts the rinsing of the tubing

Special action buttons

5.3.32 QC
Path to the dialog:

• QC
The button QC is deactivated if the quality control software is not installed. If the quality
control software is installed, the button is active. Clicking the button opens the quality
control software, see the documentation of the quality control software.

5.3.33 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 or the Atellica Process Manager, see the table below.

Information Explanation Action

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

The user can distinguish a remote control request by Siemens Healthineers service or
Atellica Process Manager by means of the displayed information, see the table below.

Information Explanation

Accept or reject remote control by Remote control request by Siemens

Siemens Healthineers service? Healthineers service

Accept or reject remote control by Remote control request by a user of

Atellica Process Manager? Atellica Process Manager

When the dialog is activated for a remote control from the Atellica Process Manager,
the confirmation requests have to be accepted for every single remote control. After
deactivating the dialog for a remote control from the Atellica Process Manager, the
confirmation requests will be accepted automatically.

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If a remote control is running, a notification is displayed in front of the screen. The

notification is flagged with the string Remote control. The user can drag and drop the
notification anywhere on the screen.

The dialog for a remote control by the Atellica Process Manager can be deactivated by
Siemens service.

5.3.34 Repeat
Paths to the dialog:

• Re-measure assays for samples:

Lab journal > Repeat

Sample details > Repeat

• Re-measure 1 assay for a control:

Lab journal > Repeat

Control details > Repeat

The dialog is used for the following:

• Definition of special dilutions and new dilution series for re-measurements of multiple
assays of multiple samples

• Definition of special dilutions and new dilution series for the re-measurement of
1 assay of 1 control

If a measurement is repeated, it is given priority processing. The parts of the dialog are
explained in the table below.

Information Explanation Action

Sample ID / Assay Samples: Sample ID and selected assays -

Controls: Control ID and selected assay

Special dilution Special dilutions for the selected assay, see ( Page 111 Spe‐ -
cial dilution)
The colors and markings of the table cells have differ‐
ent meanings, see ( Page 111 Colors and markings of
table cells).

New dilution series If the check box is selected, new dilutions are prepared for Select
the re-measurement.
If the check box is de-selected and dilutions prepared previ‐
ously are still valid according to the defined dilution stabili‐
ties, these dilutions are used for the re-measurement.
If the check box is de-selected and the corresponding dilu‐
tion is already expired, a new dilution is prepared by default.

Repeat

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Information Explanation Action

- Special dilutions available for the assay selected in -

the list Sample ID / Assay

(Assay) Abbreviation of the assay Select

Measurement Measurement range for the special dilution -

range

Special dilution

Color and marking Explanation

Dark gray, no marking Special dilution is not available for the assay.

White, no marking Special dilution is available but not assigned to the job.

White, X Special dilution is available and assigned to the job.

Yellow, no marking Initial dilution for the assay, not assigned to the job
The initial dilution is provided by Siemens Healthineers.

Yellow, X Initial dilution for the assay, assigned to the job

The initial dilution is provided by Siemens Healthineers.

Colors and markings of table cells

5.3.35 Replace syringe

Path to the dialog:

• System > Replace syringe

The dialog is used to replace the syringe. The user has to follow the instructions displayed
during the process.

5.3.36 Replace system liquids and empty waste container

Path to the dialog:

• System > System liquid & waste

The dialog is used to confirm the replacement of system liquids and the draining of the
waste container, see the table below.

Information Explanation Action

Replaced system liquid System liquid that has been replaced Select
The selected system liquids are used to rinse the system
after confirmation. The number of rinsing cycles required is
determined by the system.

Waste container Waste container has been emptied Select

Replace system liquids and empty waste container

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5.3.37 Request controls

Path to the dialog:

• Lab journal > Request controls

The dialog is used to request control measurements via a table. The parts of the dialog
are explained in the table below.

Information Explanation Action

Table heading All assays with at least 1 valid reference curve -

Left column of Controls defined in the dialog Definitions, on the tab Controls -
the table
The colors and markings of the table cells have different meanings, see
( Page 112 Colors and markings of table cells).

New dilution series If the check box is selected, new dilutions are prepared for the re-measurement. Select
If the check box is de-selected, the dilutions prepared previously are used for
the assay.

Request controls

The user can assign assays to a job by clicking the corresponding table cell. The colors and
markings of the table cells are explained in the table below.

Color and marking Explanation

Dark gray, no marking Assay is not available in the control.

White, no marking Assay is not assigned to the job.

White, X Assay is assigned to the job.

Colors and markings of table cells

If multiple lots of a control are on-board, a dialog is displayed in which the user can select
the required lot by clicking it.

If valid reference curves for multiple lots of a reagent are available, a dialog is displayed
in which the user can select the required lot by clicking it.

Action buttons For special action buttons, see the table below.

Action button Explanation

Cyclic control Activates cyclic control measurements

Cyclic control measurements can only be activated
after the corresponding components are defined in
the dialog Definitions, on the tab Controls, see
( Page 75 Controls).
Jobs for cyclic control measurements persist when
control measurements are requested manually via the
action button Measure.

Measure Requests the selected control measurements

Special action buttons

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5.3.38 Rinse system

Path to the dialog:

• System > Rinse system

The dialog is used to rinse the system.

Information in the dialog is explained in the table below.

Information Explanation Action

System liquid System liquid to be used for rinsing Select

Number of rinsing cycles Number of rinsing cycles Enter

The maximum number of rinsing
cycles is 5.

Rinse system

5.3.39 Sample details

Path to the dialog:

• Routine button Lab journal > double-click a line with a requested job or a
measurement result of a sample

The dialog is used to view patient data and information on all sample results.

In the top left corner, the sample ID is displayed, preceded by a symbol, if applicable, see
( Page 54 Flags and symbols).

Area Patient data The area Patient data displays information on the patient, if available, see the
table below.

Information Explanation

First name First name

Initial Abbreviation of the middle name, if applicable

Last name Last name

Date of birth Date of birth

The format of the date depends on the settings of the
operating system of the computer.

Practice assigned ID ID assigned by the referring practice

Laboratory assigned ID ID assigned by the laboratory

Additional Patient ID Any additional ID

Comment Any additional comment on the patient

Patient data

Table below the area Patient The table below the area Patient data displays details for all sample results, for example,
data repeated measurements. Column headings are explained below.

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Information Explanation

Status Status of results, represented by symbols, if applicable, see

( Page 54 Flags and symbols)

Assay Abbreviation of the assay

Result/Unit Measurement result and corresponding unit

If a measurement result is above the measurement range, the
upper limit is displayed additionally, with the symbol >, for
example, > 16.3 g/L.
If a measurement result is below the measurement range, the
lower limit is displayed additionally, with the symbol <, for
example, < 0.1439 g/L.

Flag Flag, if applicable, see ( Page 54 Flags and symbols)

Dilution Dilution used for the measurement

AD Assay dilution: Requested special dilution of the assay,

represented by symbols, if applicable, see ( Page 54 Flags
and symbols)

Time Time at which the job was finished

Column headings

Action buttons For special action buttons, see the table below.

Action button Explanation

Repeat Displays the dialog Repeat, see ( Page 110 Repeat)

Kinetics Displays the dialog Kinetics, see ( Page 81 Kinetics -

Measurement curves)

Special action buttons

5.3.40 Select path for backup file

Path to the dialog:

• System > Backup

The dialog is used to create backups of all data required for operation, for example,
calibration data and system configuration.

The dialog is divided into 3 areas, see the figure below.

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2
3

Select path for backup file

(1) Drive
(2) Files
(3) Path

The areas of the dialog are explained in the table below.

Information Explanation Action

Drive Drive names of the computer Select

Files Selected path Double-click

The backup is created in the selected folder.

Path Files with the extension .txt -

Areas of the dialog

The user can select the drive and path where the backup will be created. The path is
displayed in the dialog.

Backup data can only be restored by Siemens Healthineers service.

5.3.41 Show curve

Path to the dialog:

• Calibration > Show curve

The dialog is used to check the reference curves of an assay or a reagent lot selected in
the dialog Calibration.

The system tags the supporting points with red crosses and calculates the resulting
reference curve.

The reference curve is displayed double-logarithmically. The concentration at which the

supporting point was measured is displayed at the x-axis. The value at the supporting
point is displayed at the y-axis. The user can change the measurement unit of the
concentration in the dialog Definitions, on the tab Units, see ( Page 78 Units).

If an assay was selected in the dialog Calibration, the user can scroll through the
reference curves relating to this assay by using the buttons for master navigation in the
top left corner, see ( Page 53 Master navigation).

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Details on the reference curve are displayed above and below the graph, see the
table below.

Above the graph

Assay Abbreviation of the assay and assay number

- Date and time of the last measurement for the reference curve

- Remark on the reference curve, for example, if the curve has

been released automatically or manually

Mean deviation Mean deviation of all supporting points of the reference curve

Below the graph

Standard Standard used for the measurement with its ID

An ID comprises 6 digits, 4 digits for the identifier number and
2 digits for the lot number.

Reagents Abbreviation of the reagents and supplementary reagents used

for the measurement and reagent IDs
An ID comprises 6 digits, 4 digits for the identifier number and
2 digits for the lot number.

Table of Information on the supporting points of the reference curve is

supporting points given in the table below.

Details on the reference curve

Information Explanation

No. Running number of the supporting point

Dilution Dilution at which the result was measured

Conc. [unit] Concentration at which the result was measured

Prereact. [Bit] Value of the pre-reaction

First value [Bit] First value

Value [Bit] Value at the supporting point

Dev. [%] Deviation of the value at the supporting point from the
calculated reference curve

Supporting points of the reference curve

Navigation between If an assay was selected in the dialog Calibration, the user can scroll through the
measurement curves reference curves relating to this assay by using the buttons for master navigation in the
top left corner, see ( Page 53 Master navigation).

Action buttons For special action buttons, see the table below.

Action button Explanation

Repeat Repeats the measurement of the reference curve for the

displayed assay

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Action button Explanation

Release Releases reference curves that deviate from the validity criteria
Validity criteria are defined in the assay protocols.

Kinetics Displays the dialog Kinetics, see ( Page 82 Kinetics -

Reference curve)

Special action buttons

5.3.42 Special dilution

Paths to the dialog:

• New > Special dilution

• Add request > Special dilution

The dialog is used for the following:

• When accessed via the dialog New: Entering special dilutions for a job via a table

• When accessed via the dialog Add request: Entering special dilutions for a sample via
a table

In this case, in the top left corner, the sample ID is displayed.

Special dilutions cannot be assigned to jobs already requested.

The table heading lists all available assays. The left column lists all available
dilution steps.

The colors and markings of the table cells are explained in the table below.

Color and marking Explanation

Dark gray, no marking Special dilution is not available for

the assay.

White, no marking Special dilution is available but not

assigned to the job.

White, X Special dilution is available and assigned

to the job.

Yellow, no marking Initial dilution for the assay, not assigned

to the job
The initial dilution is provided by Sie‐
mens Healthineers.

Yellow, X Initial dilution for the assay, assigned to

the job
The initial dilution is provided by Sie‐
mens Healthineers.

Colors and markings of table cells

The user can enter special dilutions by clicking the corresponding field in the table. When
the user places the mouse pointer over a field, a tool tip text with the corresponding
measurement range is displayed.

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Samples with a relatively low or high concentration should be measured at a lower or

higher dilution, different from the initial dilution.

5.3.43 Status
Path to the dialog:

• Status

The dialog is used to display the status of various parts of the system, see the
figure below.
1

Details of the dialog Status (example)

(1) Background
(2) Dialog area (example)
(3) Buttons (examples)
(4) Estimated walk-away time (information only)

Colors of the background The background is displayed in different colors representing the existence of problems
and their seriousness. If multiple problems for a specific part of the system are detected,
the color for the problem with the highest priority is displayed first. The colors are
explained in the table below.

Color Explanation

Red The requested jobs cannot be processed. The system is not

operating. Follow the directions given by the system to continue
routine processing.

Yellow The requested jobs cannot be completely processed. If the user

does not resolve the problem, the color will change to red soon.
– or –
The system is warming up.

Blue All material required is available and valid, operating conditions

are ok, the system is operating. All requested jobs can
be processed.

Colors of the background

Colors of the buttons The buttons within the dialog areas are displayed in different colors, see the table below.

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Dialog area Button Color Explanation

All areas All buttons Blue The material required is available and valid.
Operating conditions are ok.

Samples Not sufficient Red Required samples are empty.

and standards
Required standard are empty.

Samples Not sufficient Yellow Required samples are empty but the system can process
and standards other requested jobs.
Required standards are empty but the system can
process other requested jobs.

Samples Missing Red Required samples are missing.

and standards
Required standards are missing.

Samples Missing Yellow Required samples are missing but the system can process
and standards other requested jobs.
Required standards are missing but the system can
process other requested jobs.

Reagents Not sufficient Red Required reagents are empty.

Reagents Not sufficient Yellow Required reagents are empty but the system can process
other requested jobs.

Reagents Missing Red Required reagents are missing.

Reagents Missing Yellow Required reagents are missing but the system can
process other requested jobs.

Controls Not sufficient Red Required controls are empty.

Controls Not sufficient Yellow Required controls are empty but the system can process
other requested jobs.

Controls Missing Red Required controls are missing.

Controls Missing Yellow Required controls are missing but the system can process
other requested jobs.

Cuvettes Used Red All available cuvettes are used.

Cuvettes Used Yellow More than 81 cuvettes are used and further jobs
are requested.

Cuvettes Available Yellow Less than 10 cuvettes are available and further jobs
are requested.

Dilution cups Used Yellow All dilution cups are used or spared for potential re-
measurements and STAT samples.

Dilution cups Available Yellow Less than 7 dilution cups are available and further jobs
are requested.

Reference curves Missing Yellow Reference curves for requested jobs are missing.

Reference curves Invalid Yellow At least 1 reference curve for requested jobs is invalid,
the mean deviation is outside the defined range.

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Dialog area Button Color Explanation

Information Temperatures Red At least 1 monitored temperature is outside the defined

temperature range. The defined temperature range was
not reached within a defined period of time.

Information Temperatures Yellow At least 1 monitored temperature is outside the defined

temperature range. The system will resume operation
when the defined temperature range is reached.

Information Covers Red The covers have been opened during operation without
access being requested via the software.
– or –
The covers have not been closed correctly.
– or –
The reagent rotor or cuvette rotor covers have not been
inserted correctly.
– or –
The dilution frame has not been inserted correctly.

Information System liquids Red Water, diluent, buffer, or probe cleaner is used up.
– or –
The level sensors have not been inserted properly into
the corresponding containers.

Information System liquids Yellow Water, diluent, buffer, or probe cleaner is almost used up.
– or –
Water, diluent, buffer, or probe cleaner is used up but no
further jobs are requested.

Information Waste Red The waste container is full and further jobs
are requested.

Information Waste Yellow The waste container is full but no further jobs
are requested.
– or –
The waste container is almost full.

Information Analyzer status Red An internal problem has occurred.

Colors of the buttons in dialog areas

When the user places the mouse pointer over a red or yellow button, a tool tip text
specifying the problem is displayed.

When the user clicks a red or yellow button, there are 2 possibilities:

• The dialog where the problem can be resolved is displayed.

• The dialog Logbook providing detailed information on the problem is displayed.

Information on the buttons The buttons within the dialog areas display varying information according to changing
operating conditions, see the table below.

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Dialog area Button Information Explanation

Samples On-board (Number) The number of samples and standards loaded in the
and standards sample rotor is displayed.

Samples Not sufficient (Number) The system constantly calculates the required volumes
and standards of samples and standards for requested jobs. The
number of samples and standards with insufficient
volumes is displayed.

Samples Missing (Number) The system constantly checks the samples required to
and standards perform requested jobs. The number of missing samples
is displayed.
Missing standards are not displayed because a reference
curve cannot be requested when the standard is missing.

Reagents On-board (Number) The number of reagents loaded in the reagent rotor
is displayed.

Reagents Not sufficient (Number) The system constantly calculates the required volumes
of reagents for requested jobs. The number of reagents
with insufficient volumes is displayed.

Reagents Missing (Number) The system constantly checks the reagents required
to perform requested jobs. The number of missing
reagents is displayed.

Controls On-board (Number) The number of controls loaded in the reagent rotor
is displayed.

Controls Not sufficient (Number) The system constantly calculates the required volumes
of controls for requested jobs. The number of controls
with insufficient volumes is displayed.

Controls Missing (Number) The system constantly checks the controls required to
perform requested jobs. The number of missing controls
is displayed.

Cuvettes Used (Number) The system constantly tracks the use of cuvettes. The
number of used cuvettes is displayed.

Cuvettes Available (Number) The system constantly tracks the use of cuvettes. The
number of available cuvettes is displayed.

Dilution cups Used (Number) The system constantly tracks the use of dilution cups.
The number of used dilution cups is displayed.

Dilution cups Available (Number) The system constantly tracks the use of dilution cups.
The number of available dilution cups is displayed.
The system reserves dilution cups for possible re-
measurements and for STAT samples. These cups are
not shown as available.

Reference curves Missing (Number) The number of missing reference curves is displayed.
A reference curve is missing when it is not available or is
being processed at the time a job is requested.

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Dialog area Button Information Explanation

Reference curves Invalid (Number) The number of invalid reference curves is displayed.
A reference curve is invalid when the value of at least
1 supporting point cannot be determined or when the
mean deviation of the reference curve exceeds the
defined deviation. Invalid reference curves are not used
for the evaluation of results.

Information Temperatures ! At least 1 monitored temperature is outside the defined

temperature range. The defined temperature range was
not reached within a defined period of time

Information Temperatures ? At least 1 monitored temperature is outside the defined

temperature range. The system will resume operation
when the defined temperature range is reached.

Information Temperatures ok All monitored temperatures are in the defined

temperature range.

Information Covers ! The covers have been opened during operation without
access being requested via the software.
– or –
The covers have not been closed correctly.
– or –
The reagent rotor or cuvette rotor covers have not been
inserted correctly.
– or –
The dilution frame has not been inserted correctly.

Information Covers ok All covers and lids are closed correctly. The dilution
frame is inserted correctly.

Information System liquids ! Water, diluent, buffer, or probe cleaner is used up.

Information System liquids ? Water, diluent, buffer, or probe cleaner is almost used up.
– or –
Water, diluent, buffer, or probe cleaner is used up but no
further jobs are requested.

Information System liquids ok All system liquids required are available.

Information Waste ! The waste container is full and further jobs

are requested.

Information Waste ? The waste container is full but no further jobs

are requested.
– or –
The waste container is almost full.

Information Waste ok The waste container can hold the estimated volume of
liquid waste from the requested jobs.

Information Analyzer status ! An internal problem has occurred.

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Dialog area Button Information Explanation

Information Analyzer status ok The system is operating.

Information on the buttons in dialog areas

Monitored temperatures The following temperatures are monitored:

• Ambient temperature

• Temperature in the reagent rotor

• Temperature in the cuvette rotor

• Temperature in the probe

Walk-away time In the dialog area Information, the field Walk-away timedisplays the estimated walk-
away time.

Action buttons For special action buttons, see the table below.

Action button Explanation

Exit Displays a confirmation dialog

The buttons of the confirmation dialog are explained in the
table below.

Special action buttons

Button Explanation Action

Yes Aborts running jobs Click

Rinses the system
Switches off the reagent cooler
Shuts down the system
Closes the software

No Closes the software Click

Cancel Closes the confirmation dialog without shutting Click

down the system

Buttons of the confirmation dialog

5.3.44 System
Path to the dialog:

• System

The dialog is used to perform maintenance, to request access, to check and initialize
hardware components, to update and backup the software, and to reset the system.

The dialog is divided into areas, see the table below.

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Information Explanation Action

Maintenance Starts maintenance on different parts of the system, see Click

( Page 124 Buttons in the area)

Access Requests access to different parts of the system, see Click

( Page 124 Buttons in the area )

Hardware check Requests a hardware check of the probe, see Click

( Page 80 Hardware check - probe)

Initialization Requests the initialization of different parts of the system, Click

see ( Page 125 Buttons in the area)

Update and back up software Updates lot data, creates backups, and prints requested and Click
available raw data, see ( Page 125 Buttons in the area)

About Displays the current versions of the software and its Click
components, see ( Page 58 About)

Reset analyzer Requests a reset of the system Click

Dialog System

Maintenance Button Explanation

Check probe Displays the dialog Check probe, see

( Page 65 Check probe)

Clean probe Displays the dialog Clean probe, see

( Page 65 Clean probe)

Replace syringe Displays the dialog Replace syringe, see

( Page 111 Replace syringe)

Purge tubings Displays the dialog Purge tubings, see

( Page 108 Purge tubings)

Rinse system Displays the dialog Rinse system, see

( Page 113 Rinse system)

Buttons in the area

Access Button Explanation

System liquid & waste Displays the dialog Replace system liquids and empty
waste container, see ( Page 111 Replace system
liquids and empty waste container)

Cuv. seg. & dil. strips Displays the dialog Access cuvette segments and
dilution strips, see ( Page 58 Access cuvette
segments and dilution strips)

Samples Displays the dialog Access samples, see

( Page 60 Access samples)

Reagents Displays the dialog Access reagents, see

( Page 60 Access reagents)

Buttons in the area

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Hardware check Button Explanation

Probe Displays the dialog Probe.

Buttons in the area

Initialization Button Explanation

Probe Initializes the probe

Syringe Initializes the syringe

Reagent rotor Initializes the reagent rotor

Sample rotor Initializes the sample rotor

Cuvette rotor Initializes the cuvette rotor

Dilution frame Initializes the dilution frame

Hardware Initializes all hardware components

Buttons in the area

Update and back up software Button Explanation

Lot data file Displays the dialog Open lot data file, see
( Page 104 Open lot data file)

Backup Displays the dialog Select path for backup file, see
( Page 114 Select path for backup file)

Print raw data Prints raw data

Buttons in the area

About Button Explanation

About Displays the dialog About.

Buttons in the area

Reset analyzer Button Explanation

Reset analyzer Displays the dialog Reset analyzer.

Buttons in the area

Action buttons For special action buttons, see the table below.

Action button Explanation

Configuration Displays the dialog Configuration, see

( Page 66 Configuration)

Logbook Displays the dialog Logbook, see

( Page 100 Logbook)

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Action button Explanation

Definitions Displays the dialog Definitions, see

( Page 73 Definitions)

Special action buttons

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6 Configuring the system

This chapter describes how to configure the system.

6.1 Adding a standard lot

✓ Reference values for assays assigned to the standard are available.

✓ The system is in standby or routine mode.

To add a standard lot, proceed as follows:

1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed.

2 Click the tab Standards lots.

→ The tab Standard lots is displayed. For more information on the tab, click the
action button Help or see ( Page 80 Standard lots).

3 Select the standard for which a lot is to be added.

→ The corresponding table row is highlighted dark blue. The action button Lot ID
becomes active.

4 Click Lot ID.

→ A new table row is added to the table.

5 Enter the lot ID in the left table cell.

6 Enter the reference values for the corresponding assays. Reference values can be
found in the instructions for use of the standard.

Reference values can only be entered in white table cells.

7 After entering all reference values, click outside of the table cells.

→ The action button Save becomes active.

8 Click the action button Save.

→ The dialog System is displayed. The standard lot is added.

→ Adding a standard lot is completed.

6.2 Configuring cyclic control measurements

✓ The system is in standby or routine mode.

To configure cyclic control measurements, proceed as follows:

1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed.

2 Click the tab Controls.

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→ The tab Controls is displayed. For more information on the tab, click the action
button Help or see ( Page 75 Controls).

3 Click a control name for which cyclic control measurements will be configured.

→ The corresponding table row is highlighted dark blue.

4 In the highlighted row, click an assay for which cyclic control measurements will
be configured.

→ The dialog Control details is displayed.

Cyclic control measurements can only be defined for assays marked with an X.

5 Configure when control measurements will be performed.

6 Click the action button Save.

→ In the dialog Definitions, the tab Controls is displayed. Changes are saved.

7 Click the action button Close.

→ The dialog System is displayed.

Defining cyclic control measurements does not activate the cyclic control
measurement automatically. Cyclic control measurement has to be requested
manually in the dialog Request controls for each assay, see ( Page 112 Request
controls). For more information on the dialog, click the action button Help.

→ Configuring cyclic control measurements is completed.

6.3 Deactivating cyclic control measurements for an assay

✓ The system is in standby or routine mode.
To deactivate cyclic control measurements for an assay of a control, proceed as follows:

1 Select a control result of the affected assay in the lab journal.

2 Click the action button Delete.

→ The control result is deleted from the lab journal. Cyclic control measurements for
the assay are deactivated but settings for cyclic control measurements are retained
by the system.

→ Deactivating cyclic control measurements for an assay is completed.

6.4 Adding a user-defined control

✓ The system is in standby or routine mode.

To add a user-defined control, proceed as follows:

1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed.

2 Click the tab Controls.

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→ The tab Controls is displayed. For more information on the tab, click the action
button Help or see ( Page 75 Controls).

3 Click the action button New.

→ The dialog Control details is displayed, see the figure below.

1 2

Areas of the dialog Control details

(1) Cyclic control measurement area

(2) Quality control area

4 In the input field Name, enter the name of the user-defined control.

5 In the input field ID, enter the 4‑digit identifier number of the user-defined control.

The 4‑digit identifier number of the user-defined control must not correspond to the
identifier number of a reagent or standard. Otherwise the system will not accept the
user-defined control.

Identifier numbers 9900–9999 are automatically specified as user-defined controls by

the system.

6 Select the check box Treat sample as user-defined control.

7 In the list Assay, select an assay which will be assigned to the user-defined control.

8 In the input field Permitted deviation, enter the permitted deviation from the
reference value.

9 In the list Dilution, select the dilution that will be used for the measurement of
the assay.

Ensure that the selected dilution is appropriate for the assay.

10 Make other settings as required.

11 Click the action button Apply.

→ The user-defined control is saved.

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An information dialog is displayed by the system

◆ Click OK.
◆ In the input field ID, enter a different 4‑digit identifier number that does not
correspond to the identifier number of a reagent or standard.
◆ Click the action button Apply.

12 Click the action button Close.

→ In the dialog Definitions, the tab Controls is displayed. In the left column, the new
user-defined control is displayed.
13 To completely define the user-defined control, add a control lot, see
( Page 133 Adding a control lot).

14 Click the action button Close.

→ The dialog System is displayed.

→ Adding a user-defined control is completed.

6.5 Adding an assay to a user-defined control

✓ The system is in standby or routine mode.
To add an assay to a user-defined control, proceed as follows:

1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed.

2 Click the tab Controls.

→ The tab Controls is displayed. For more information on the tab, click the action
button Help or see ( Page 75 Controls).

The names of user-defined controls are displayed in black.

3 Click the control name of the user-defined control.

→ The corresponding table row is highlighted dark blue.

4 Click the action button New.

→ The dialog Control details is displayed, see the figure below.

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1 2

Areas of the dialog Control details

(1) Cyclic control measurement area

(2) Quality control area

5 In the list Assay, select an assay which will be assigned to the user-defined control.

6 In the input field Permitted deviation, enter the permitted deviation from the
reference value.

7 In the list Dilution, select the dilution that will be used for the measurement of
the assay.

Ensure that the selected dilution is appropriate for the assay.

8 Make other settings as required.

9 Click the action button Apply.

→ Changes are saved.

10 Click the action button Close.

→ In the dialog Definitions, the tab Controls is displayed. All assays assigned to the
user-defined control are marked with an X.

11 Click the action button Close.

→ The dialog System is displayed.

Assays cannot be deleted from any control. If an assay is no longer required in a user-
defined control, the user-defined control must be deleted, see ( Page 133 Deleting a
user-defined control). Then a new user-defined control must be created instead, see
( Page 128 Adding a user-defined control).

→ Adding an assay to a user-defined control is completed.

6.6 Editing assay settings in a user-defined control

✓ The system is in standby or routine mode.

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To edit assay settings in a user-defined control, proceed as follows:

1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed.

2 Click the tab Controls.

→ The tab Controls is displayed. For more information on the tab, click the action
button Help or see ( Page 75 Controls).

The names of user-defined controls are displayed in black.

3 Click the control name of the user-defined control.

→ The corresponding table row is highlighted dark blue.

4 Click the action button New.

→ The dialog Control details is displayed, see the figure below.

1 2

Areas of the dialog Control details

(1) Cyclic control measurement area

(2) Quality control area

5 In the list Assay, select the assay whose settings need to be edited.

6 Make other settings as required.

7 Click the action button Apply.

→ Changes are saved.

8 Click the action button Close.

→ In the dialog Definitions, the tab Controls is displayed.

9 Click the action button Close.

→ The dialog System is displayed.

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Assays cannot be deleted from any control. If an assay is no longer required in a user-
defined control, the user-defined control must be deleted, see ( Page 133 Deleting a
user-defined control). Then a new user-defined control must be created instead, see
( Page 128 Adding a user-defined control)

→ Editing assay settings in a user-defined control is completed.

6.7 Deleting a user-defined control

✓ The user-defined control to be deleted is not on-board.

✓ The system is in standby or routine mode.

To delete a user-defined control, proceed as follows:

1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed.

2 Click the tab Controls.

→ The tab Controls is displayed. For more information on the tab, click the action
button Help or see ( Page 75 Controls).

The names of user-defined controls are displayed in black.

3 Click the control name of the user-defined control.

→ The corresponding table row is highlighted dark blue.

4 Click the action button Delete.

→ A confirmation dialog is displayed.

5 Click Yes.

→ The user-defined control is deleted.

6 Click the action button Close.

→ The dialog System is displayed.

→ Deleting a user-defined control is completed.

6.8 Adding a control lot

✓ Reference values for assays assigned to the control are available.

✓ The system is in standby or routine mode.

To add a control lot, proceed as follows:

1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed.

2 Click the tab Control lots.

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→ The tab Control lots is displayed. For more information on the tab, click the action
button Help or see ( Page 79 Control lots).

3 Select a control for which a lot is to be added.

→ The corresponding table row is highlighted dark blue. The action button Lot ID
becomes active.

4 Click Lot ID.

→ A new table row is added to the table.

5 Enter the lot ID in the left table cell.

6 Enter the reference values for the corresponding assays. Reference values for
controls provided by Siemens Healthineers can be found in the instructions for use
of the corresponding controls.

Reference values can only be entered in white table cells.

7 After entering all reference values, click outside of the table cells.

→ The action button Save becomes active.

8 Click the action button Save.

→ The dialog System is displayed. The control lot is added.

→ Adding a control lot is completed.

6.9 Deleting a control lot

Only control lots with a lot number can be deleted. If the lot number is replaced by --,
no reference values have been defined for this control. This control cannot be deleted.

✓ The control lot to be deleted is not on-board.

✓ Reference values for assays assigned to the control are available.

✓ The system is in standby or routine mode.

To delete a control lot, proceed as follows:

1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed.

2 Click the tab Control lots.
→ The tab Control lots is displayed. For more information on the tab, click the action
button Help or see ( Page 79 Control lots).

3 In the first column of the table, click the affected lot of the control.

→ The corresponding table row is highlighted dark blue.

4 Click the action button Delete.

→ A confirmation dialog is displayed.

5 Click Yes.

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→ In the left column, the affected lot of the control is deleted.

6 Click the action button Close.

→ The dialog System is displayed.

→ Deleting a control lot is completed.

6.10 Adding a profile

✓ The system is in standby or routine mode.

To add a profile, proceed as follows:

1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed. For more information on
the tab, click the action button Help or see ( Page 75 Profiles).

2 Click the action button New.

→ An empty row is added to the table.

3 In the left table cell, enter the profile name.

4 In the table cells to the right of the profile name, select all assays required.
→ Selected assays are marked with an X.

5 Click the action button Save.

→ The dialog System is displayed. The new profile is added.

→ Adding a profile is completed.

6.11 Adding an assay to a profile

✓ The system is in standby or routine mode.
To add an assay to a profile, proceed as follows:

1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed. For more information on
the tab, click the action button Help or see ( Page 75 Profiles).

2 In the table cells to the right of the profile name, select all assays required.
→ Selected assays are marked with an X.

3 Click the action button Save.

→ The dialog System is displayed. Changes are saved.

→ Adding an assay to a profile is completed.

6.12 Removing an assay from a profile

✓ The system is in standby or routine mode.

To remove an assay from a profile, proceed as follows:

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1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed. For more information on
the tab, click the action button Help or see ( Page 75 Profiles).

2 In the table cells to the right of the profile name, de-select all assays required.

→ The X is removed from de-selected assays.

3 Click the action button Save.

→ The dialog System is displayed. Changes are saved.

→ Removing an assay from a profile is completed.

6.13 Deleting a profile

✓ The system is in standby or routine mode.
To delete a profile, proceed as follows:

1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed. For more information on
the tab, click the action button Help or see ( Page 75 Profiles).

2 In the left column, click the profile name.

3 Click the action button Delete.

→ A confirmation dialog is displayed.

4 Click Yes.
→ The profile is deleted from the table.

5 Click the action button Save.

→ The dialog System is displayed.

→ Deleting a profile is completed.

6.14 Adding a sample rotor segment ID

✓ The system is in standby or routine mode.
To add a sample rotor segment ID, proceed as follows:

1 In the dialog System, click the action button Configuration.

→ In the dialog Configuration, the tab Language is displayed.

2 Click the tab Sample segments.

→ The tab Sample segments is displayed. For more information on the tab, click the
action button Help or see ( Page 70 Sample segments).

3 Make the settings as required.

4 Click the action button Add.

→ The sample rotor segment ID is added to the list Segment list.

5 Click the action button Save.

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→ The dialog System is displayed.

→ Adding a sample rotor segment ID is completed.

6.15 Deleting a sample rotor segment ID

✓ The system is in standby or routine mode.

To delete a sample rotor segment ID, proceed as follows:

1 In the dialog System, click the action button Configuration.

→ In the dialog Configuration, the tab Language is displayed.

2 Click the tab Sample segments.

→ The tab Sample segments is displayed. For more information on the tab, click the
action button Help or see ( Page 70 Sample segments).

3 In the list Segment list, select a sample rotor segment ID to be delete.

4 Click the action button Delete.

→ The sample rotor segment ID is deleted from the list Segment list.

5 Click the action button Save.

→ The dialog System is displayed.

→ Deleting a sample rotor segment ID is completed.

6.16 Configuring the immersion depth for cups used with a cup-
in-tube segment
✓ A cup-in-tube segment is available.

✓ A tube of the type that will be used with the cup-in-tube segment is available.
✓ A cup of the type that will be used with the cup-in-tube segment is available.

✓ A folding rule or a tape measure is available.

✓ The system is in standby or routine mode.

To configure the immersion depth for cups used with a cup-in-tube segment, proceed
as follows:

NOTICE

A default value for the variable Z is provided by Siemens Healthineers for all defined
cup-in-tube segments. If the default value is not adapted to the cups used with a
specific cup-in-tube segment, the probe can crash on the inner base of the cup.

Damage to the system can result.

◆ Adapt the default value to the cups used with a cup-in-tube segment before this
cup-in-tube segment is loaded in the sample rotor.

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If the default value is not adapted to the cups used with a specific cup-in-tube segment,
the probe cannot aspirate sample volume. Delay of results can occur.

1 Place the cup-in-tube segment on a level surface.

2 Place the tube in 1 of the adapters on the cup-in-tube segment.

3 Place the cup in the tube.

4 Hold the folding rule or tape measure in front of the cup, see the figure below.

11
10
9
8
7
6

1
5
4
3
2
1

Determining the immersion depth (example)

(1) Inner base or intermediate base of the cup

(2) Bottom edge of the cup-in-tube segment

Make sure that the zero mark of the folding rule or tape measure is aligned with the
bottom edge of the cup-in-tube segment.

5 Measure the distance from the bottom edge of the cup-in-tube segment to the inner
base or intermediate base of the cup.
6 Add 1 mm to the measured value as a safety allowance.

→ The calculated value corresponds to the value Z displayed in the dialog

Definitions, on the tab Immersing depth.

Example:

The distance measured from the bottom edge of the cup-in-tube segment to the
inner base of the cup is 55 mm.

Z = 55 mm + 1 mm = 56 mm

where Z is the calculated value.

7 In the dialog System, click the action button Definitions.

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→ In the dialog Definitions, the tab Profiles is displayed.

8 Click the tab Immersing depth.

→ The tab Immersing depth is displayed. For more information on the tab, click the
action button Help or see ( Page 78 Immersing depth).

9 Click the action button Change depth.

→ An information dialog is displayed.

The immersion depth can only be edited for defined cup-in-tube segments that are
not on-board.

10 Click Ok.
→ A table and a graphic are displayed.

11 In the column Z [mm], enter the previously calculated value for the corresponding
cup-in-tube segment.

12 Click outside of the table cells.

→ The action buttons become active. The distance representing Z displayed in the
graphic changes accordingly. The text in the corresponding table row is displayed
in blue.

13 Click the action button Save.

→ In the dialog Definitions, the tab Immersing depth is displayed. The immersion
depth is saved.

Siemens Healthineers recommends labeling the cup-in-tube segment to indicate what

type of cup can be used with the cup-in-tube segment.

→ Configuring the immersion depth for cups used with a cup-in-tube segment
is completed.

6.17 Configuring unit and reference range of an assay

✓ The system is in standby or routine mode.
To configure unit and reference range of an assay, proceed as follows:

WARNING

When the unit of an assay is changed, the values for the reference range are
automatically converted to the new unit after saving. If the user has already
entered the values for the reference range in the new unit, the values for the
reference range will be wrong. False results can occur.

Death or serious injury to the patient can result.

◆ Change the unit of the assay first.

◆ Save the new unit before editing the reference range.

1 In the dialog System, click the action button Definitions.

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→ In the dialog Definitions, the tab Profiles is displayed.

2 Click the tab Units.

→ The tab Units is displayed. For more information on the tab, click the action button
Help or see ( Page 78 Units).

3 In the column Unit of the corresponding assay, select a unit, if required.

4 Click outside of the table cells.

→ The action button Save becomes active.

5 Click the action button Save.

→ The changes are saved. The dialog System is displayed.

6 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed.

7 Click the tab Units.

→ The tab Units is displayed.

8 In the column Lower limit of reference range and in the column Upper limit of
reference range of the corresponding assay, enter a value, if required.

9 Click outside of the table cells.

→ The action button Save becomes active.

10 Click the action button Save.

→ The changes are saved. The dialog System is displayed.

→ Configuring unit and reference range of an assay is completed.

6.18 Setting automatic re-measurement and automatic release

✓ The system is in standby or routine mode.
To set automatic re-measurement and automatic release, proceed as follows:

1 In the dialog System, click the action button Configuration.

→ In the dialog Configuration, the tab Language is displayed.

2 Click the tab Host.

→ The tab Host is displayed. For more information on the tab, click the action button
Help or see ( Page 67 Host).

3 Select Automatic re-measurement, if required.

Re-measurements are done with the next higher or lower dilution for as long as the
measurement result is outside the measurement range.

4 Select Automatic release, if required.

Results inside the reference range are automatically released and sent to the LIS,
if available.

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5 Click the action button Save.

→ The changes are saved. The dialog System is displayed.

→ Setting automatic re-measurement and automatic release is completed.

6.19 Configuring printouts

✓ The system is in standby or routine mode.
To configure printouts, proceed as follows:
1 In the dialog System, click the action button Configuration.

→ In the dialog Configuration, the tab Language is displayed.

2 Click the tab Address / Analyzer.

→ The tab Address / Analyzer is displayed. For more information on the tab, click the
action button Help or see ( Page 71 Address / Analyzer).

3 Make the settings as required.

4 Click the action button Save.

→ The dialog System is displayed. Printouts are configured.

→ Configuring printouts is completed.

6.20 Setting the display of results in the lab journal

✓ The system is in standby or routine mode.
To set the display of results in the lab journal, proceed as follows:

1 In the dialog System, click the action button Configuration.

→ In the dialog Configuration, the tab Language is displayed.

2 Click the tab User settings.

→ The tab User settings is displayed. For more information on the tab, click the
action button Help or see ( Page 71 User settings).

3 To the right of Show results, make the settings as required.

4 Click the action button Save.

→ The dialog System is displayed. The display of results in the lab journal is
changed immediately.

→ Setting the display of results in the lab journal is completed.

6.21 Setting the default sort sequence in the lab journal

✓ The system is in standby or routine mode.

To set the default sort sequence in the lab journal, proceed as follows:

1 In the dialog System, click the action button Configuration.

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→ In the dialog Configuration, the tab Language is displayed.

2 Click the tab User settings.

→ The tab User settings is displayed. For more information on the tab, click the
action button Help or see ( Page 71 User settings).

3 To the right of Sort sequence in the lab journal, make the settings as required.

4 Click the action button Save.

→ The dialog System is displayed. The default sort sequence in the lab journal is
changed immediately.

→ Setting the default sort sequence in the lab journal is completed.

6.22 Setting the language

✓ The system is in standby or routine mode.
To set the language, proceed as follows:

1 In the dialog System, click the action button Configuration.

→ In the dialog Configuration, the tab Language is displayed. For more information
on the tab, click the action button Help or see ( Page 66 Configuration).

2 Select a language.

3 Click the action button Save.

→ The language is changed immediately. The dialog System is displayed in the
selected language.

Entries already existing in the logbook are not translated.

→ Setting the language is completed.

6.23 Configuring significant digits of the sample ID

✓ The system is in standby or routine mode.

To configure significant digits of the sample ID, proceed as follows:

1 In the dialog System, click the action button Configuration.

→ In the dialog Configuration, the tab Language is displayed.

2 Click the tab Host.

→ The tab Host is displayed. At the bottom of the tab, 2 rows of digits are displayed.
For more information on the tab, click the action button Help or see ( Page 67 Host).

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3 Make the settings in the 2 rows of digits as required.

Examples:

Significant digits of the sample ID (default setting)

In the default setting, the LIS sends the 29 digits of the barcode to the system
together with the job list. The system sends the 29 digits of the barcode to the LIS
together with the results.

Significant digits of the sample ID (example)

In the example, the LIS sends digits 1–14 of the barcode and digits 15–26 with
additional information to the system together with the job list. The system sends
digits 1–14 of the barcode to the LIS together with the results.

4 Click the action button Save.

→ The dialog System is displayed.

→ Configuring significant digits of the sample ID is completed.

6.24 Configuring the LIS connection

To configure the LIS connection, see the data interface manual of the system.

WARNING

False results due to incorrect LIS connection

Death or serious injury to the patient can result.

◆ 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

✓ The system is off.

To start the system, proceed as follows:

NOTICE

Failure of electrical parts of the system can result if the system is re-started too soon
after a shutdown.

Damage to the system can result.

◆ Wait at least 10 seconds before restarting the system after a shutdown.

1 Switch on the printer, if appropriate.

2 Make sure that the reagent rotor and cuvette rotor covers are inserted correctly and
that the covers are closed correctly.

3 Check if the waste container is empty.

→ The waste container is empty.

The waste container is not empty.

◆ Empty the waste container, see ( Page 145 Emptying the waste container).

4 Make sure that the filling level of the system liquids is sufficient.

The filling level of at least 1 system liquid is low.

◆ Replace the system liquid, see ( Page 146 Replacing system liquids).

5 If the sensor of the buffer container is inserted into a container filled with water:
Re-insert the level sensor into the buffer container. Otherwise skip this step.

6 Check that each level sensor is inserted properly in the corresponding container.

Make sure that the level sensor is inserted at an angle into the corresponding
container. The free end of the level sensor inside the container must point away from
the opening in the container so that the floater at the end of the level sensor can move
up and down freely.

The tubing bears differently colored markings, see ( Page 47 Liquid containers, level
sensors, and tubing).

7 At the right side of the system, set the main switch to position I.
→ The system starts.

8 Switch on the monitor.

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9 Switch on the computer.

→ The computer starts.

10 In the dialog for the log on to the operating system, enter user name and password,
if appropriate.

11 Click Ok, if appropriate.

→ The operating system starts.

12 Wait until the 3 LEDs in the upper right corner at the front of the system are on.
13 In the desktop screen, click Atellica NEPH 630 Viewer.

→ The viewer software starts. The dialog Initialize analyzer is displayed. This can
take up to 10 minutes.

14 Wait until the dialog Status is displayed.

→ The system is operating.

The dialog Log on is displayed.

◆ Enter user name and password.

◆ Click Ok.

→ Starting the system is completed.

7.2 Emptying the waste container

✓ The system is in standby or routine mode.

To empty the waste container, proceed as follows:

WARNING

Infection due to infectious waste

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle parts of the system that have come into contact with potentially
infectious material in accordance with good laboratory practices.

NOTICE

If containers are placed on or above the system, system liquids can flow over or into
the system.

Damage to the system can result.

◆ Place containers on the same level as or a lower level than the system.

1 In the dialog System, in the area Access, click System liquid & waste.

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→ In the dialog Replace system liquids and empty waste container, a progress
bar is displayed. The system finishes current operations. This can take several
minutes. For more information on the dialog, click the action button Help or see
( Page 111 Replace system liquids and empty waste container).

2 Wait until the progress bar is no longer displayed.

3 Pull the level sensor 1–2 cm out of the waste container.

4 Unscrew the cap from the waste container. The level sensor remains in the cap.

5 Dispose of the liquid waste according to national and local standards and regulations.

6 Screw the cap back on to the waste container.

7 Push the level sensor back into the waste container.

8 Place the 2 pegs on the level sensor in the notches on the cap.

9 In the dialog Replace system liquids and empty waste container, in the area Waste
container, select Emptied.

→ The action button Save becomes active.

10 Click the action button Save.

→ The dialog System is displayed.

→ Emptying the waste container is completed.

7.3 Replacing system liquids

✓ 1 new buffer container is available, if required.

✓ 1 new diluent container is available, if required.

✓ Water is available, if required.

✓ The system is in standby or routine mode.

To replace system liquids, proceed as follows:

NOTICE

If containers are placed on or above the system, system liquids can flow over or into
the system.

Damage to the system can result.

◆ Place containers on the same level as or a lower level than the system.

1 In the dialog System, in the area Access, click System liquid & waste.

→ In the dialog Replace system liquids and empty waste container, a progress
bar is displayed. The system finishes current operations. This can take several
minutes. For more information on the dialog, click the action button Help or see
( Page 111 Replace system liquids and empty waste container).

2 Wait until the progress bar is no longer displayed.

3 Remove the sealing cap with the level sensor from the corresponding container.

4 Replace the container with the corresponding liquid.

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5 Press the sealing cap with the inserted level sensor onto the opening of the container.

Make sure that the level sensor is inserted at an angle into the corresponding
container. The free end of the level sensor inside the container must point away from
the opening in the container so that the floater at the end of the level sensor can move
up and down freely.

The tubing bears differently colored markings, see ( Page 47 Liquid containers, level
sensors, and tubing).

WARNING

Air bubbles in the tubing can distort the mixing ratio in the cuvettes. False
results can occur.

Death or serious injury to the patient can result.

◆ Carefully follow the instructions given below.

6 Check for air bubbles in the tubing.

7 In the dialog Replace system liquids and empty waste container, in the area
Replaced system liquid, select the replaced system liquids and system liquids whose
tubing contains air bubbles.

→ The action button Save becomes active.

8 Click the action button Save.

→ The tubing of the selected system liquids is rinsed.

9 Wait until the dialog System is displayed.

→ Rinsing is completed.

→ Replacing system liquids is completed.

7.4 Loading cuvette segments and dilution strips

✓ Unused cuvette segments, in original packaging, are available.

✓ Unused dilution strips are available.

✓ The system is in standby or routine mode.

To load cuvette segments and dilution strips, proceed as follows:

WARNING

Infection due to infectious material in used cuvette segments and dilution strips
Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle used cuvette segments and dilution strips in accordance with good
laboratory practices.

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1 In the dialog System, in the area Access, click Cuv. seg. & dil. strips.

→ The dialog Access cuvette segments and dilution strips is displayed. For more
information on the dialog, click the action button Help or see ( Page 58 Access
cuvette segments and dilution strips).
2 Click the action button Cuv. seg. & dil. strips.

→ In the dialog Access cuvette segments and dilution strips, a progress bar is
displayed. The system finishes current operations. This can take several minutes.

3 Wait until a message is displayed.

No processing of jobs when the right cover is opened without access being requested
via the software. The stop function is triggered, the system's operation is interrupted,
and existing pre-dilutions may be rejected by the system. Delay of results can occur.

• Always request access through the right cover via the software.

• If the right cover was opened without access being requested, immediately close
the right cover.

4 Open the right cover.

5 Remove the cuvette rotor cover.

6 Remove used cuvette segments from the cuvette rotor, if required.

7 Dispose of used cuvette segments according to national and local standards

and regulations.

WARNING

The measurement signal can be misinterpreted due to polluted cuvette

segments or dilution strips or due to re-use of cuvette segments or dilution
strips. False results can occur.

Death or serious injury to the patient can result.

◆ Wear gloves when handling cuvette segments.

◆ Touch cuvette segments only by the grip.
◆ Make sure that cuvette segments are not scratched.
◆ Use cuvette segments only once.
◆ Do not use washed or recycled cuvette segments.
◆ Make sure that cuvette segments and dilution strips are free from dust and
dirt particles.
◆ Store cuvette segments and dilution strips in the original packaging in a dust
free place.

NOTICE

The probe can collide with cuvette segments that are inserted tilted.
Damage to the system can result.

◆ Make sure that the cuvette segments are inserted correctly.

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8 Load unused cuvette segments into the cuvette rotor.

When removed from plastic bags, cuvette segments and dilution strips can carry a
static charge. The system will not use electrically charged cuvette segments or dilution
strips. A delay of results can occur. After removing cuvette segments and dilution strips
from plastic bags, brush the cuvette segments and dilution strips with an anti-static
brush with carbon fibers.

The cuvette rotor does not need to be fully loaded.

9 Replace the cuvette rotor cover.

10 Remove used dilution strips from the dilution frame, if required.

11 Dispose of used dilution strips according to national and local standards

and regulations.

12 Load unused dilution strips in the dilution frame.

The dilution frame does not need to be fully loaded.

13 In the dialog Access cuvette segments and dilution strips, in the area Cuvettes,
select the loaded cuvette segments.

14 In the area Dilution strips, select the loaded dilution strips.

15 Click the action button Save.

→ Another message is displayed.

16 Close the right cover.

→ The system detects the loaded dilution strips. The system measures the blank
values of the loaded cuvette segments. The dialog System is displayed. Cuvette
segments and dilution strips are available.

→ Loading cuvette segments and dilution strips is completed.

7.5 Loading lot data

To load lot data see the Secure Download software instruction manual of the system.

7.6 Preparing reagents and controls

✓ White evaporation caps for reagent vials with a capacity of 5 mL are available.

✓ Yellow evaporation caps for control vials with a capacity of 2.5 mL are available.

✓ Soft, lint-free cloth is available.

✓ Water is available.

✓ The system is in standby or routine mode.

To prepare reagents and controls provided by Siemens Healthineers in the reagent rotor,
proceed as follows:

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WARNING

Infection due to potentially infectious reagents and controls

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle reagents and controls in accordance with good laboratory practices.

WARNING

False results due to uncooled or expired reagents and controls can occur.

Death or serious injury to the patient can result.

◆ Do not leave reagents and controls uncooled.

◆ Make sure that reagents and controls are thoroughly cooled before preparing.
◆ If reagents and controls are warm before preparing, store them in the
refrigerator for 15 minutes.
◆ Load reagents and controls in the reagent rotor immediately after preparing.
◆ Make sure that the reagents and controls have not expired.

Pooling of reagents or controls can cause overfilling of the vials. No liquid aspiration
can be processed due to overfilled vials. Delay of results can occur. Do not pool any
reagents or controls.

1 Prepare the reagents and controls according to the instructions for use of
the product.

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WARNING

False results due to sedimented reagents. False results due to froth or lamellae
causing incorrect level detection. Accurate transfer of the reagent or control
cannot be guaranteed.

Death or serious injury to the patient can result.

◆ Check reagents for sedimenting.
◆ Dispose of sedimented reagents according to national and local standards
and regulations.
◆ Remove froth and lamellae before placing evaporation caps on reagent and
control vials.

NOTICE

The probe cannot penetrate any seals, caps, or stoppers. The probe tip can be
damaged after collision with seals, caps, or stoppers.

Damage to the system can result.

◆ Remove any seals, caps, or stoppers from reagent, standards, and

control vials.

Delay of results can occur due to damaged probe tip after collision with caps
or stoppers.

2 Check the outside of the reagent and control vials for adhering substances and clean
them with a soft, lint-free cloth moistened with water, if required.

WARNING

Concentration of reagents and controls can increase due to evaporation out of

open reagent or control vials. False results can occur.

Death or serious injury to the patient can result.

◆ Carefully follow the instructions given below.

◆ For more information on on-board stability of reagents and controls, see
the separate document assay protocols and the instructions for use of
the product.

WARNING

False results due to re-use of evaporation caps

Death or serious injury to the patient can result.

◆ Use single-use evaporation caps only once.

◆ Do not use washed or recycled single-use evaporation caps.

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3 Place evaporation caps on the reagent and control vials, see the figure below.

2
4
3

Placing evaporation caps

(1) Evaporation cap

(2) Vertical striation
(3) Barcode
(4) Reagent or control vial

The vertical striation on the evaporation cap and the barcode on the label of the vial
must be aligned, see ( Page 152 Placing evaporation caps).

Do not tilt reagent and control vials with evaporation caps on. Evaporation caps do not
prevent liquid from spilling.

→ Preparing reagents and controls is completed.

7.7 Loading reagents and controls

✓ Reagents are prepared, see ( Page 149 Preparing reagents and controls).

✓ Controls are prepared, see ( Page 149 Preparing reagents and controls).

✓ Reagent segments with white grips are available.

✓ Control segments with yellow grips are available.

✓ The system is in standby or routine mode.

To load reagents and controls provided by Siemens Healthineers in the reagent rotor,
proceed as follows:

WARNING

Infection due to potentially infectious reagents and controls

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle reagents and controls in accordance with good laboratory practices.

1 Load reagent and control vials in the appropriate reagent rotor segments, see
( Page 305 Reagent rotor segments).

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Alternatively, a reagent or control vial can be loaded in a free position of a reagent

segment or control segment that is already on-board.

Take care to press the reagent and control vials down to the bottom of the reagent
rotor segment.

2 In the dialog System, in the area Access, click Reagents.

→ In the dialog Access reagents, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access reagents).

3 Wait until a message is displayed.

4 Open the left and right covers.

→ Another message is displayed.

5 Remove the reagent rotor cover.

6 Place the small end of each reagent rotor segment over a free position of the
reagent rotor.

7 Take care that the small end of the reagent rotor segment slides easily in the guide
rails below the handwheel.

8 Carefully push down each reagent rotor segment next to the handwheel.
→ A clicking noise indicates that the reagent rotor segment is inserted correctly.

WARNING

False results due to uncooled reagents and controls

Death or serious injury to the patient can result.

◆ Do not leave reagents and controls uncooled.

◆ After placing reagents and controls in the reagent rotor, replace the reagent
rotor cover immediately.

9 Close the left and right covers.

→ The action button Close is displayed.

10 Click the action button Close.

→ The dialog System is displayed. The barcode reader scans the barcodes of the vials
in the reagent rotor. Reagents and controls are available.

No barcode on any vial of a reagent rotor segment can be scanned, the positions are
displayed as empty in the dialog Loading reagents. The barcodes of the vials cannot
be entered manually.

◆ Separate the vials on different reagent rotor segments.

◆ Enter the reagent or control information manually, see ( Page 157 Identifying a
reagent or control).

→ Loading reagents and controls is completed.

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7.8 Preparing a sample rotor segment for use

To prepare a sample segment, you will need:

• A new sample segment

• 15 black adapters or 15 white adapters from an adapter set for sample segments

• 1 plain text label with the number 01 for the first 2 digits from an adapter set for
sample segments

• 1 barcode label corresponding to the plain text label from an adapter set for
sample segments

To prepare a cup-in-tube segment, you will need:

• A new cup-in-tube segment

• 15 black adapters or 15 white adapters from an adapter set for sample segments

• 1 plain text label with the number 51 for the first 2 digits from a barcode sheet for
cup-in-tube segments

• 1 barcode label corresponding to the plain text label from a barcode sheet for
cup-in-tube segments

To prepare a cup-behind-tube segment, you will need:

• A new cup-behind-tube segment

• 7 black adapters or 7 white adapters, delivered with the cup-behind-tube segment

• 1 plain text label with the number 81 for the first 2 digits, delivered with the
cup-behind-tube segment

• 1 barcode label corresponding to the plain text label, delivered with the cup-behind-
tube segment

✓ The system is in standby or routine mode or is off.

To prepare a sample rotor segment for use, proceed as follows:

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1 Attach the plain text label to the grip of the sample rotor segment, see the
figure below.

1 2 3

4
7

6 5

Preparing a sample rotor segment for use (example)

(1) Sample rotor segment

(2) Plain text label
(3) Grip
(4) Barcode strip
(5) Groove
(6) Nose
(7) Adapter
(8) Barcode label

WARNING

If the plain text label and the barcode label do not match and if samples
are manually identified, samples can be interchanged in the dialog Loading
samples. Results will be assigned to the wrong patient.

Death or serious injury to the patient can result.

◆ The plain text label and the corresponding barcode label are delivered on
barcode sheets in pairs. Always attach both labels as a pair.

2 Attach the corresponding barcode label vertically at the level of the barcode strip to
the left side of the sample rotor segment, next to the left edge.

3 Carefully insert the corresponding adapters into the openings of the base plate of the
sample rotor segment.

Align the nose at the back of each adapter with the groove in the openings of the
base plate.

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4 Push the adapters down until a clicking sound is heard.

→ Preparing a sample rotor segment for use is completed.

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8 Performing the analysis

This chapter describes how to perform the analysis.

8.1 Identifying a reagent or control

✓ The system is in standby or routine mode.

To identify a reagent or control loaded in the reagent rotor, proceed as follows:

1 In the dialog Loading, click the action button Reagents.

→ In the dialog Loading reagents, the table view is displayed. For more information
on the dialog, click the action button Help or see ( Page 88 Loading reagents).

2 In the list Reagent status, select To be identified.

→ In the table, the reagents and controls that need to be identified are displayed.

3 Click an entry in the table. The segment number and position are displayed in
the table.

4 Click the action button Access.

→ In the dialog Access reagents, a progress bar is displayed. The system finishes
current operations. This can take several minutes. The system moves the affected
reagent rotor segment to the position below the access lid of the reagent rotor
cover. For more information on the dialog, click the action button Help or see
( Page 60 Access reagents).

No processing of jobs when the right cover is opened without access being requested
via the software. The stop function is triggered, the system's operation is interrupted,
and existing pre-dilutions may be rejected by the system. Delay of results can occur.

• Always request access through the right cover via the software.

• If the right cover was opened without access being requested, immediately close
the right cover.

5 Wait until a message is displayed.

6 Open the right cover.

→ Another message is displayed.

7 Open the access lid of the reagent rotor cover.

8 Remove the corresponding vial.

9 If a barcode is attached to the vial, align the vertical striation on the evaporation cap
and the barcode on the label of the vial.

10 Re-load the vial at the same position.

11 Close the access lid of the reagent rotor cover.

12 Close the right cover.

→ The action button Close is displayed.

13 Click the action button Close.

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→ The dialog Loading reagents is displayed. The barcode reader scans the barcodes
of the vials in the reagent rotor.
14 Check the entries displayed in the table.

→ If the entry is no longer displayed, identifying the reagent or control is completed.

The entry is still displayed.

◆ Go to the next step.

15 Click an entry in the table.

16 Click the action button Identify.

→ In the dialog Loading reagents, a list of reagents and controls and a graphic of
a reagent rotor segment is displayed. The position of the unidentified reagent or
control is marked with a ?. For more information on the dialog, click the action button
Help or see ( Page 92 Loading reagents, identify reagents and controls).

17 In the graphic, click the position that is marked with a ?.

18 In the input field Lot reference, enter the identifier number and the lot number of the
reagent or control.

19 Left of the graphic, select if the material is a reagent or a control.

20 Click the action button Save.

→ The dialog Loading reagents is displayed. The barcode reader scans the barcodes
of the vials in the reagent rotor.

→ Identifying a reagent or control is completed.

8.2 Loading standards and user-defined controls

Pooling of standards and user-defined controls can cause overfilling of the vials. No
liquid aspiration can be processed due to overfilled vials. Delay of results can occur. Do
not pool any standards or user-defined controls.

✓ Standard segments are available.

✓ Sample segments are available.

✓ The system is in standby or routine mode.

To load standards and user-defined controls in the sample rotor, proceed as follows:

WARNING

Infection due to potentially infectious standards and user-defined controls

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle standards and user-defined controls in accordance with good
laboratory practices.

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WARNING

False results due to expired standards and user-defined controls

Death or serious injury to the patient can result.

◆ Make sure that the standards and user-defined controls have not expired.

1 Prepare the standards and user-defined controls according to the instructions for use
of the product.

WARNING

False results due to froth or lamellae causing incorrect level detection. Accurate
transfer of the standard or user-defined control cannot be guaranteed.
Death or serious injury to the patient can result.
◆ Remove froth and lamellae before loading the standards and user-
defined controls.

NOTICE

The probe cannot penetrate any stoppers. The probe tip can be damaged after
collision with caps or stoppers.
Damage to the system can result.
◆ Remove caps from standard and user-defined control vials.
◆ Remove stoppers from standard and user-defined control vials.

The probe tip can be damaged after collision with caps or stoppers. Delay of patient
result can occur.

After removing caps, Siemens Healthineers recommends marking standard caps with
the respective abbreviation to prevent cross-contamination.

2 Load standards in a standard segment aligning the barcodes towards the outer edge
of the standard segment. Alternatively, a standard vial can be loaded in an empty
position of a standard segment that is already on-board.

3 Load user-defined controls in a suitable sample segment aligning the barcodes

towards the outer edge of the sample segment. Alternatively, a user-defined control
vial can be loaded in an empty position of a suitable sample segment that is
already on-board.

The system identifies user-defined controls by the first 6 digits of the barcode. Further
digits are not taken into account.

4 Load the sample rotor segments, see ( Page 170 Loading sample rotor segments).

→ The dialog System is displayed. The standards and user-defined controls are
loaded. The barcode reader scans the barcodes in the sample rotor. The system adds
the standard IDs and user-defined control IDs to the lab journal.

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→ Loading standards and user-defined controls is completed.

8.3 Measuring a control

Siemens Healthineers recommends running assay-specific and lot-specific control

measurements according to the valid instructions for use.

✓ Valid reference curves for all requested assays are available, see
( Page 181 Measuring the reference curve for an assay).

✓ Controls to be measured are on-board, see ( Page 152 Loading reagents

and controls).

✓ Lot data for controls provided by Siemens Healthineers is loaded, see

( Page 149 Loading lot data).

✓ Lot data for user-defined controls is added to the system, if required, see
( Page 128 Adding a user-defined control).

✓ The system is in standby or routine mode.

To measure a control, proceed as follows:

1 In the dialog Lab journal, click the action button Request control.

→ The dialog Request controls is displayed. For more information on the dialog, click
the action button Help or see ( Page 112 Request controls).

The system identifies user-defined controls by the first 6 digits of the barcode. Further
digits are not taken into account.

2 In the table, in the corresponding row, select the required assays.

→ The action button Measure becomes active.

An information dialog is displayed warning the user that the required control is
not on-board.

◆ Load the appropriate control, see ( Page 152 Loading reagents and controls).

3 Click OK.

→ The dialog Request controls is displayed.

4 When a dialog is displayed in which you can select from different control lots or
reagent lots: Click the required control lot or reagent lot and the action button Save.

→ The dialog Request controls is displayed.

5 If new dilutions have to be prepared for the control measurements: Below the table,
select New dilution series.

If New dilution series is de-selected, the dilutions prepared previously are used for the
control measurements.

6 Click the action button Measure.

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→ The job is requested. The control is measured. In the dialog Lab journal, the
control results are displayed.
7 Check the control results.

→ The control results are inside the confidence range.

At least 1 control result is outside the confidence range and therefore flagged or .
◆ Repeat the control measurement, see ( Page 161 Repeating a
control measurement).

→ Measuring a control is completed.

8.4 Repeating a control measurement

✓ A control was measured and the control results are displayed in the dialog
Lab journal.

✓ Valid reference curves for all requested assays are available, see
( Page 181 Measuring the reference curve for an assay).

✓ Controls to be measured are on-board, see ( Page 152 Loading reagents

and controls).
✓ Lot data for controls provided by Siemens Healthineers is loaded, see
( Page 149 Loading lot data).

✓ Lot data for user-defined controls is available, if required.

✓ The system is in standby or routine mode.

To repeat a control measurement, proceed as follows:

1 In the dialog Lab journal, select the affected control result.

→ The action button Repeat becomes active.

2 Click the action button Repeat.

→ The dialog Repeat is displayed. For more information on the dialog, click the action
button Help or see ( Page 110 Repeat).

3 Make the settings as required.

4 Click the action button Save.

→ The job is requested. In the dialog Lab journal, the control result is displayed.
5 Check the control result.
→ If the control result is inside the confidence range, repeating the control
measurement is completed.

The control result is outside the confidence range.

◆ Go to the next step.

6 Repeat the control measurement twice using a new control vial.

7 Check both control results.

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→ If both control results are inside the confidence range, repeating the control
measurement is completed.

1 or both control results are still outside the confidence range.

◆ Go to the next step.

8 Check if the affected reagents, the buffer, and diluent have expired and replace them,
if required.
9 Measure a new reference curve for the affected assay, see ( Page 181 Measuring the
reference curve for an assay).

10 Measure the control, see ( Page 160 Measuring a control).

11 Check the control result.

→ The control result is inside the confidence range.

The control result is still outside the confidence range.

◆ Contact Siemens Healthineers service.

→ Repeating a control measurement is completed.

8.5 Loading barcoded samples

Each laboratory should determine the acceptability of blood collection tubes

and serum separation products used. Variations in these products exist between
manufacturers and, at times, from lot to lot. For more information, contact Siemens
Healthineers service.

✓ Valid reference curves for all requested assays are available, see
( Page 181 Measuring the reference curve for an assay).

✓ Controls for all requested assays have been measured, see ( Page 160 Measuring
a control).

✓ Sample rotor segments suitable for the present sample tubes are available.

✓ The system is in standby or routine mode.

To load barcoded samples, proceed as follows:

WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

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WARNING

False results due to incorrect sample material or due to aspiration of packed cells
from the sample tube.

Death or serious injury to the patient can result.

◆ Only use the required sample material, that is, serum, plasma, urine, or CSF.
◆ In the instructions for use of the product to be measured, check what kind of
sample material must be used.
◆ If using centrifuged samples or tubes with separating gel, ensure that the
volume of supernatant serum or plasma above the packed cells or separating gel
is sufficient. Approximately 10 mm of supernatant serum or plasma above the
packed cells or separating gel is required. If using 75 mm x 12 mm sample tubes,
450–500 μL plasma is required.

1 Check that the sample material is the required material and that it is of
sufficient volume.

2 Slowly warm frozen samples up to room temperature, if applicable.

3 Mix frozen samples thoroughly after thawing, if required.

WARNING

Clogging of the probe can lead to interferences with the processing of assays
and to contamination of assays. False results can occur.

Death or serious injury to the patient can result.

◆ Centrifuge thawed samples, turbid (lipemic) samples, urine and CSF
samples, and serum and plasma samples that contain blood cells or fibrin
strands. For more information, see the instructions for use of the assay to
be measured.

4 Visually check centrifuged samples and repeat centrifugation, if required.

5 Prepare a manual pre-dilution using diluent, if required.

No processing of assays with duplicate sample IDs. Jobs for duplicate sample IDs will
not be processed by the system. Delay of results can occur. Only use unique sample IDs.

6 Check the barcodes of the samples and replace barcode labels that are illegible or
incorrectly placed, see ( Page 307 Sample and user-defined control barcodes).

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WARNING

False results due to froth causing incorrect level detection. Accurate transfer of
the sample cannot be guaranteed.

Death or serious injury to the patient can result.

◆ Remove froth before loading samples.

NOTICE

The probe cannot penetrate any stoppers. The probe tip can be damaged after
collision with stoppers.

Damage to the system can result.

◆ Remove any stoppers from the sample tubes.

Delay of results can occur due to damaged probe tip after collision with stoppers.

7 Load the sample tubes in the sample rotor segment aligning the barcodes towards
the outer edge of the sample rotor segment.

NOTICE

The probe can collide with sample tubes that are not completely pressed down.
Damage to the system can result.

◆ Make sure to press the sample tubes down to the bottom of the sample
rotor segment.

8 In the dialog System, in the area Access, click Samples.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

In case of loading the job list for samples from the LIS, make sure that the job list is
available before samples are loaded.

9 Wait until a message is displayed.

10 Open the left cover.

→ Another message is displayed.

11 Holding the sample rotor segment at its grip and with the sample tubes facing
towards the outer edge, place the sample rotor segment over an empty position of
the sample rotor.

12 Take care that the sample rotor segment slides easily in the guide rails below
the handwheel.

13 Carefully push down the sample rotor segment next to the handwheel.

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14 Close the left cover.

→ The action button Close is displayed.

15 Click the action button Close.

→ The dialog System is displayed. The samples are loaded. The barcode reader scans
the barcodes in the sample rotor. The system adds the sample IDs to the lab journal.

When the system is connected to the LIS, requested jobs for the sample IDs are added
to the lab journal. When the system is not connected to the LIS, the user can add jobs
manually, see ( Page 172 Requesting a job for a sample manually).

→ Loading barcoded samples is completed.

8.6 Assigning STAT status to a barcoded sample

When the system is connected to the LIS, the user cannot assign STAT status to
sample IDs with requested jobs.

✓ Valid reference curves for all requested assays are available, see
( Page 181 Measuring the reference curve for an assay).

✓ Controls for all requested assays have been measured, see ( Page 160 Measuring
a control).

✓ The system is in standby or routine mode.

To assign STAT status to a barcoded sample, proceed as follows:

1 Load the STAT sample, see ( Page 162 Loading barcoded samples).

2 If the system is not connected to the LIS, in the dialog Lab journal, in the table, select
the sample ID of the STAT sample.

3 Click the action button Add request.

→ The dialog Add request is displayed. For more information on the dialog, click the
action button Help or see ( Page 60 Add request).

4 At the top left, click STAT.

→ STAT status is assigned to the sample ID. The area STAT is highlighted.

5 Make other settings as required.

6 In the area Assays, select 1 or more assays or profiles.

7 Click the action button Apply.

→ The assays are assigned to the sample ID.

8 Click the action button Close.

→ The dialog Lab journal is displayed. STAT status is assigned to the sample ID. The
assays are displayed in the lab journal. The system processes the requested jobs.

→ Assigning STAT status to a barcoded sample is completed.

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8.7 Pre-identifying non-barcoded samples and non-barcoded

STAT samples
✓ Valid reference curves for all requested assays are available, see
( Page 181 Measuring the reference curve for an assay).

✓ Controls for all requested assays have been measured, see ( Page 160 Measuring
a control).
✓ The sample rotor segment to which the sample IDs will be assigned is not on-board.

✓ The system is in standby or routine mode.

To pre-identify non-barcoded samples and non-barcoded STAT samples, proceed

as follows:

1 In the dialog Lab journal, click the action button New.

→ The dialog New is displayed. For more information on the dialog, click the action
button Help or see ( Page 102 New).

2 In the input field Sample ID, enter the sample ID.

No processing of assays with duplicate sample IDs. Jobs for duplicate sample IDs will
not be processed by the system. Delay of results can occur. Only use unique sample IDs.

3 If the sample is a STAT sample: At the top left, click STAT.

→ STAT status is assigned to the sample ID. The area STAT is highlighted.

4 Fill in further required information.

5 Make other settings as required.

6 In the area Assays, select 1 or more assays or profiles.

7 Click the action button Apply.

→ The assays are assigned to the sample ID.

8 To add another sample ID, repeat these steps.

9 Click the action button Close.

→ The dialog Lab journal is displayed. The sample ID and assays are added to the lab
journal and flagged.

WARNING

If sample IDs were manually assigned to a sample rotor segment, the

assignments are not automatically removed. The system identifies newly
loaded non-barcoded samples with the manually assigned sample IDs. Results
are incorrectly assigned.

Death or serious injury to the patient can result.

◆ Remove previous assignments of sample IDs from the sample rotor segment.

10 In the navigation bar, click Loading.

→ The dialog Loading samples is displayed. For more information on the dialog, click
the action button Help or see ( Page 94 Loading samples).

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11 In the bottom right area, right of ID, select all sample IDs to be assigned to a sample
rotor segment.
12 Click the action button Auto loading.

→ The dialog Pre-loading is displayed. For more information on the dialog, click the
action button Help or see ( Page 105 Pre-loading).

13 In the table, select the segment ID of a suitable sample rotor segment.

If the number of positions on the sample rotor segment is not sufficient for the number
of sample IDs, several segment IDs can be selected in the table, see ( Page 52 Select).

14 Click the action button Save.

→ The dialog Loading samples is displayed. The sample IDs are assigned to the
positions on the sample rotor segment.

Alternatively, in the dialog Loading samples, single sample IDs can be dragged from
the list at the bottom right and dropped on any unoccupied position in the graphic of
a sample rotor segment that is not on-board.

15 At the top left, select the segment ID of the sample rotor segment with the assigned
sample IDs.

16 Click the action button Print.

→ The data is printed. For more information, click the action button Help or see
( Page 71 User settings).

→ Pre-identifying non-barcoded samples and non-barcoded STAT samples is completed.

8.8 Loading non-barcoded samples and non-barcoded STAT

samples

Each laboratory should determine the acceptability of blood collection tubes

and serum separation products used. Variations in these products exist between
manufacturers and, at times, from lot to lot. For more information, contact Siemens
Healthineers service.

✓ Samples are pre-identified, see ( Page 166 Pre-identifying non-barcoded samples

and non-barcoded STAT samples).
✓ Required sample rotor segments are not on-board.

✓ A sample rotor segment suitable for the present sample tubes is available.

✓ A print-out of the assignment of sample IDs to the positions on the sample rotor
segment is available.
✓ The system is in standby or routine mode.

To load non-barcoded samples and non-barcoded STAT samples, proceed as follows:

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WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

WARNING

False results due to incorrect sample material or due to aspiration of packed cells
from the sample tube.

Death or serious injury to the patient can result.

◆ Only use the required sample material, that is, serum, plasma, urine, or CSF.
◆ In the instructions for use of the product to be measured, check what kind of
sample material must be used.
◆ If using centrifuged samples or tubes with separating gel, ensure that the
volume of supernatant serum or plasma above the packed cells or separating gel
is sufficient. Approximately 10 mm of supernatant serum or plasma above the
packed cells or separating gel is required. If using 75 mm x 12 mm sample tubes,
450–500 μL plasma is required.

1 Check that the sample material is the required material and that it is of
sufficient volume.

2 Slowly warm frozen samples up to room temperature, if applicable.

3 Mix frozen samples thoroughly after thawing, if required.

WARNING

Clogging of the probe can lead to interferences with the processing of assays
and to contamination of assays. False results can occur.

Death or serious injury to the patient can result.

◆ Centrifuge thawed samples, turbid (lipemic) samples, urine and CSF

samples, and serum and plasma samples that contain blood cells or fibrin
strands. For more information, see the instructions for use of the assay to
be measured.

4 Visually check centrifuged samples and repeat centrifugation, if required.

5 Prepare a manual pre-dilution using diluent, if required.

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WARNING

False results due to froth causing incorrect level detection. Accurate transfer of
the sample cannot be guaranteed. False results due to swapped samples.

Death or serious injury to the patient can result.

◆ Remove froth before loading samples.

◆ Load the sample tubes in the sample rotor segment to which the sample IDs
are assigned exactly as they are displayed in the print‑out.

NOTICE

The probe cannot penetrate any stoppers. The probe tip can be damaged after
collision with stoppers.

Damage to the system can result.

◆ Remove any stoppers from the sample tubes.

Delay of results can occur due to damaged probe tip after collision with stoppers.

6 Load the sample tubes in the sample rotor segment to which the sample IDs
are assigned.

NOTICE

The probe can collide with sample tubes that are not completely pressed down.
Damage to the system can result.

◆ Make sure to press the sample tubes down to the bottom of the sample
rotor segment.

7 Carefully press the sample tubes down to the bottom of the sample rotor segment.

8 In the navigation bar, click Loading.

→ The dialog Loading samples is displayed. For more information on the dialog, click
the action button Help or see ( Page 94 Loading samples).

9 Click the action button Access.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

10 Wait until a message is displayed.

11 Open the left cover.

→ Another message is displayed.

12 Holding the sample rotor segment at its grip and with the sample tubes facing
towards the outer edge, place the sample rotor segment over an empty position of
the sample rotor.

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13 Take care that the sample rotor segment slides easily in the guide rails below
the handwheel.
14 Carefully push down the sample rotor segment next to the handwheel.

15 Close the left cover.

→ The action button Close is displayed.

16 Click the action button Close.

→ The dialog System is displayed. The samples are loaded. The system processes the
requested jobs.

→ Loading non-barcoded samples and non-barcoded STAT samples is completed.

8.9 Loading sample rotor segments

✓ Sample rotor segments suitable for the present sample tubes are available.

✓ The system is in standby or routine mode.

To load sample rotor segments, proceed as follows:

WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

1 In the dialog System, in the area Access, click Samples.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

In case of loading the job list for samples from the LIS, make sure that the job list is
available before samples are loaded.

2 Wait until a message is displayed.

3 Open the left cover.

→ Another message is displayed.

4 Holding the sample rotor segment at its grip and with the sample tubes or vials facing
towards the outer edge, place the sample rotor segment over an empty position of
the sample rotor.

5 Take care that the sample rotor segment slides easily in the guide rails below
the handwheel.

6 Carefully push down the sample rotor segment next to the handwheel.

7 Close the left cover.

→ The action button Close is displayed.

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8 Click the action button Close.

→ The dialog System is displayed. The barcode reader scans the barcodes in the
sample rotor.

→ Loading sample rotor segments is completed.

8.10 Identifying a sample or standard with unreadable barcode

✓ The system is in standby or routine mode.

To identify a sample or standard with unreadable barcode, proceed as follows:

WARNING

Infection due to infectious samples and standards

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle samples and standards in accordance with good laboratory practices.

1 In the navigation bar, click Loading.

→ The dialog Loading samples is displayed. A schematic overview of the sample

rotor is displayed. Sample rotor segments with unidentified samples and standards
are colored green and yellow. For more information on the dialog, click the action
button Help or see ( Page 94 Loading samples).

2 On the left, in the overview of the sample rotor, click the position of a sample rotor
segment that is colored green and yellow.

→ A schematic overview of the sample rotor segment is displayed. Unidentified

positions are displayed with a ?.

3 Click the action button Access.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

4 Wait until a message is displayed.

5 Open the left cover.

→ Another message is displayed.

6 Remove the sample tube or standard vial from the unidentified position.

7 Close the left cover.

8 Note the sample ID or standard ID.

9 In the dialog Loading samples, in the input field Enter ID, enter the sample ID or
standard ID.

10 If a standard ID was entered: At the top right, select Standards. Otherwise skip
this step.

11 Make other settings as required.

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12 Drag the sample ID or standard ID from the input field and drop it on the
corresponding position with the ?.
13 Click the action button Apply.

→ The system assigns the sample ID or standard ID to the position. The system adds
the sample ID or standard ID to the lab journal.

14 Open the left cover.

15 Load the sample tube or standard vial in the same position of the sample
rotor segment.
16 Close the left cover.

→ The action button Close is displayed.

17 Click the action button Close.

→ The dialog Loading samples is displayed. The barcode reader scans the barcodes
in the sample rotor. The sample ID or standard ID is assigned.

→ Identifying a sample or standard with unreadable barcode is completed.

8.11 Requesting a job for a sample manually

✓ Sample is loaded and identified, see ( Page 162 Loading barcoded samples) and
( Page 167 Loading non-barcoded samples and non-barcoded STAT samples).

✓ Valid reference curves for all requested assays are available, see
( Page 181 Measuring the reference curve for an assay).

✓ Controls for all requested assays have been measured, see ( Page 160 Measuring
a control).

✓ The system is in standby or routine mode.

To request a job for a sample manually, proceed as follows:

1 In the navigation bar, click Lab journal.

→ The dialog Lab journal is displayed. For more information on the dialog, click the
action button Help or see ( Page 83 Lab journal).

2 In the table, select a sample ID.

WARNING

False results due to aspiration of packed cells from the sample tube
Death or serious injury to the patient can result.

◆ If using centrifuged samples or tubes with separating gel, ensure that the
volume of supernatant serum or plasma above the packed cells or separating
gel is sufficient. Approximately 10 mm of supernatant serum or plasma
above the packed cells or separating gel is required. If using 75 mm x 12 mm
sample tubes, 450–500 μL plasma is required.

3 Check that the sample material is the required material and that it is of
sufficient volume.

4 Click the action button Add request.

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→ The dialog Add request is displayed. For more information on the dialog, click the
action button Help or see ( Page 60 Add request).

5 In the area Assays, select the required profiles and assays.

6 Make other settings as required.

When the sample is manually pre-diluted 1 : 20 and the initial dilution for the assay is
1 : 5, the system rejects the job and a message is displayed.

7 Click the action button Apply.

→ The system applies the job to the sample ID. The system measures the assays
applied to the job.

8 Click the action button Close.

→ The dialog Lab journal is displayed.

→ Requesting a job for a sample manually is completed.

8.12 Repeating a job for a sample manually

✓ Sample is loaded and identified, see ( Page 162 Loading barcoded samples) and
( Page 167 Loading non-barcoded samples and non-barcoded STAT samples).

✓ Results for the sample are displayed in the dialog Lab journal.

✓ Valid reference curves for all requested assays are available, see
( Page 181 Measuring the reference curve for an assay).

✓ Controls for all requested assays have been measured, see ( Page 160 Measuring
a control).
✓ The system is in standby or routine mode.

To repeat a job for a sample manually, proceed as follows:

1 In the navigation bar, click Lab journal.

→ The dialog Lab journal is displayed. For more information on the dialog, click the
action button Help or see ( Page 83 Lab journal).

2 In the table, select a result.

WARNING

False results due to aspiration of packed cells from the sample tube
Death or serious injury to the patient can result.

◆ If using centrifuged samples or tubes with separating gel, ensure that the
volume of supernatant serum or plasma above the packed cells or separating
gel is sufficient. Approximately 10 mm of supernatant serum or plasma
above the packed cells or separating gel is required. If using 75 mm x 12 mm
sample tubes, 450–500 μL plasma is required.

3 Check that the sample material is the required material and that it is of
sufficient volume.

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4 Click the action button Repeat.

→ The dialog Repeat is displayed. For more information on the dialog, click the action
button Help or see ( Page 110 Repeat).

5 Make the settings as required.

Siemens Healthineers recommends repeating measurements from new

dilution series.

To repeat a measurement previously measured at a special dilution, select the previous

special dilution again in the table Special dilution.

6 Click the action button Save.

→ The dialog Lab journal is displayed. The system applies the job to the sample ID.
The system re-measures the assay applied to the job.

→ Repeating a job for a sample manually is completed.

8.13 Refilling a sample tube

✓ The sample tube is on-board.

✓ Sample material of the same pre-dilution is available.

✓ The barcode reader is not scanning the barcodes in the sample rotor.

✓ The system is in standby or routine mode.

To refill a sample tube, proceed as follows:

WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

1 In the dialog Loading samples, in the schematic overview of the sample

rotor segment, click the position of the sample tube to be refilled, see
( Page 94 Loading samples).

→ The selected position is framed by blue lines. The action button Level detection
becomes active. For more information on the dialog, click the action button Help.

2 Click the action button Level detection.

→ The probe detects the level in the sample tube. The position in the schematic
overview of the sample rotor segment is colored and marked according to the
level detected.

3 Click the action button Access.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

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4 Wait until a message is displayed.

5 Open the left cover.

→ Another message is displayed.

6 Remove the affected sample tube.

7 Refill the sample tube with an appropriate amount of the same sample material with
the same pre-dilution.

8 Load the sample tube in the same position of the sample rotor segment.
9 Close the left cover.

→ The action button Close is displayed.

10 Click the action button Close.

→ The dialog Loading samples is displayed. The barcode reader scans the barcodes
in the sample rotor.

→ Refilling a sample tube is completed.

8.14 Unloading samples

Do not unload a sample until all results of all requested jobs are available in the
lab journal.

✓ The system is in standby or routine mode.

To unload samples, proceed as follows:

WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

1 In the dialog System, in the area Access, click Samples.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

2 Wait until a message is displayed.

3 Open the left cover.

→ Another message is displayed.

4 Remove samples and sample rotor segments that are no longer required.

5 Dispose of samples and sample tubes according to national and local standards
and regulations.

6 Close the left cover.

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→ The action button Close is displayed.

7 Click the action button Close.

→ The dialog System is displayed.

→ Unloading samples is completed.

8.15 Unloading standards

✓ The system is in standby or routine mode.

To unload standards, proceed as follows:

WARNING

Infection due to infectious standards

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle standards in accordance with good laboratory practices.

1 In the dialog System, in the area Access, click Samples.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

2 Wait until a message is displayed.

3 Open the left cover.

→ Another message is displayed.

4 Remove standards and sample rotor segments that are no longer required.
5 Replace stoppers and caps to the standard vials.

WARNING

False results due to uncooled standards

Death or serious injury to the patient can result.

◆ Do not leave standards uncooled.

◆ Store standards that are no longer used in the refrigerator immediately
after unloading.

6 Dispose of empty standard vials according to national and local standards

and regulations.
7 Close the left cover.

→ The action button Close is displayed.

8 Click the action button Close.

→ The dialog System is displayed.

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→ Unloading standards is completed.

8.16 Unloading reagents and controls

✓ The system is in standby or routine mode.

To unload reagents and controls, proceed as follows:

WARNING

Infection due to potentially infectious reagents and controls

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle reagents and controls in accordance with good laboratory practices.

1 In the dialog System, in the area Access, click Reagents.

→ In the dialog Access reagents, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access reagents).

2 Wait until a message is displayed.

3 Open the left and right covers.

→ Another message is displayed.

4 Remove the reagent rotor cover.

5 Remove reagent rotor segments and reagent or control vials that are no
longer required.

WARNING

False results due to uncooled reagents and controls

Death or serious injury to the patient can result.

◆ Do not leave reagents and controls uncooled.

6 Store reagents and controls in the refrigerator immediately after unloading.

7 Dispose of empty reagent and control vials and of evaporation caps that are no longer
required according to national and local standards and regulations.

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WARNING

If reagents or controls were manually identified, the assignments to a reagent

rotor segment are not automatically removed. In case of the same number
of occupied positions in the reagent rotor segment, the system identifies non-
barcoded reagents or controls with the previous IDs. False results can occur.

Death or serious injury to the patient can result.

◆ Delete manual identifications before loading reagent and control vials in the
reagent rotor segment the next time.

8 Replace the reagent rotor cover.

9 Close the left and right covers.

→ The action button Close is displayed.

10 Click the action button Close.

→ The dialog System is displayed.

→ Unloading reagents and controls is completed.

8.17 Displaying data in the lab journal

✓ The system is in standby or routine mode.

To display data in the lab journal, proceed as follows:

1 In the navigation bar, click Lab journal.

→ The dialog Lab journal is displayed. For more information on the dialog, click the
action button Help or see ( Page 83 Lab journal).

2 To filter entries: Above the table, select a setting in 1 or more of the 3 filters, see the
figure below.

1 2 3 4

Filtering and sorting entries in the lab journal

(1) Filter Selection

(2) Filter View by
(3) List Sorted by
(4) Filter Date

→ In the filters, the selected settings are displayed. In the lab journal, only the entries
that match the settings are displayed.

3 To sort entries: Above the table, in the list Sorted by, select a sort sequence.

→ In the list, the selected sort sequence is displayed. In the lab journal, entries are
displayed according to the selected sort sequence.

4 To scroll, use scroll functions, see ( Page 53 Scroll).

→ Displaying data in the lab journal is completed.

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8.18 Displaying sample and control details

✓ The system is in standby or routine mode.

To display sample and control details, proceed as follows:

1 To display patient data and information on all sample results of a specific sample: In
the dialog Lab journal, in the table, double-click a line that belongs to the sample ID.

→ The dialog Sample details is displayed. For more information on the dialog, click
the action button Help or see ( Page 113 Sample details).

2 To display details of a control measurement: In the dialog Lab journal, in the table,
double-click a line that belongs to the control ID.
→ The dialog Control details is displayed. For more information on the dialog, click
the action button Help or see ( Page 72 Control details).

→ Displaying sample and control details is completed.

8.19 Displaying measurement curves

✓ The system is in standby or routine mode.
To display measurement curves, proceed as follows:

1 In the dialog Lab journal, in the table, double-click a line that belongs to the sample
ID or control ID.

→ For samples, the dialog Sample details is displayed, see ( Page 113 Sample
details). For controls, the dialog Control details is displayed, see ( Page 72 Control
details). For more information on the respective dialog, click the action button Help.

2 In the table, select 1 or more results.

→ The action button Kinetics becomes active.

3 Click the action button Kinetics.

→ The measurement curve of the first selected result is displayed.

4 To navigate between the measurement curves of the selected results, use the
navigation buttons at the top left, see ( Page 53 Master navigation).

→ Displaying measurement curves is completed.

8.20 Releasing results

✓ The system is in standby or routine mode.

To release results, proceed as follows:

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WARNING

Unintended release of results by the user

Death or serious injury to the patient can result.

◆ Make sure to select only the results to be released.

◆ Results flagged or must be checked and validated separately,

if required.

1 In the dialog Lab journal, in the table, select 1 or more unreleased results.

→ The action button Release becomes active.

2 Click the action button Release.

→ In the column Status, the symbol is displayed with sample results and the

symbol is displayed with control results. The selected results are released.

3 If the system is connected to an LIS: Released results are sent to the LIS.

→ In the column Status, the symbol is displayed with sample results and the

symbol is displayed with control results.

→ Releasing results is completed.

8.21 Printing results

✓ The system is in standby or routine mode.

To print results, proceed as follows:

1 In the dialog Lab journal, in the table, select those results that will be printed. If no
result is selected, all results will be printed

2 Click the action button Print.

→ The results are printed directly.

If no result was selected, all results are printed directly.

In the dialog Configuration, on the tab Address / Analyzer, the header of the printed
pages can be configured, see ( Page 71 Address / Analyzer).

→ Printing results is completed.

8.22 Sending control results for evaluation

✓ Controls have been measured, see ( Page 160 Measuring a control).

✓ The system is in standby or routine mode.

To send control results for evaluation, proceed as follows:

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1 In the dialog Lab journal, above the table, set the filter Selection to Controls.

→ In the lab journal, only controls are displayed. Control results outside the
confidence range are flagged.
2 In the table, select control results to be evaluated.

3 In the navigation bar, click QC, if available, see ( Page 109 QC). For more information
on the dialog, click the action button Help.

→ Control results are sent to the quality control software and can be evaluated there.

Control results of deleted controls are not sent to the quality control software.

– or –

In the action bar, click the action button Release.

→ Control results are sent to the LIS software and can be evaluated there.

→ Sending control results for evaluation is completed.

8.23 Measuring the reference curve for an assay

✓ Required reagents are on-board, see ( Page 152 Loading reagents and controls).

✓ Required standards are on-board, see ( Page 158 Loading standards and user-
defined controls).

✓ No reference curve is available for the selected reagent lot.

✓ The system is in standby or routine mode.

To measure the reference curve for an assay, proceed as follows:

1 In the dialog Calibration, in the area Assays, select an assay.

2 In the area Reagents, select the appropriate reagent lot.

3 Click the action button Measure.

→ In the table Assays, the affected assay is flagged . The system measures the
reference curve, see ( Page 54 Flags and symbols).

The action button Measure is inactive.

◆ If the action button Repeat is active, repeat the measurement of the reference
curve, see ( Page 182 Repeating the measurement of a reference curve).
◆ If neither the action button Measure nor the action button Repeat is active, select
another reagent lot.

Then click the action button Measure.

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An information dialog is displayed warning the user that a required standard is

not on-board.
◆ Load the appropriate standard, see ( Page 158 Loading standards and user-
defined controls).
◆ Re-start this procedure.

An information dialog is displayed warning the user that the required reagent is
not on-board.

◆ Load the appropriate reagent, see ( Page 152 Loading reagents and controls).
◆ Re-start this procedure.

4 In the navigation bar, click any other routine button as displayed data is not
updated automatically.

5 In the navigation bar, click Calibration.

→ Calibration data is updated. The assay is flagged by a different symbol. A valid

reference curve is activated automatically by the system. The affected reagent lot is

flagged .

→ Measuring the reference curve for an assay is completed.

8.24 Repeating the measurement of a reference curve

✓ Required reagents are on-board, see ( Page 152 Loading reagents and controls).

✓ Required standards are on-board, see ( Page 158 Loading standards and user-
defined controls).

✓ A reference curve for the selected reagent lot is available.

✓ The system is in standby or routine mode.

To repeat the measurement of a reference curve, proceed as follows:

1 In the dialog Calibration, in the area Assays, select an assay.

2 In the area Reagents, select the appropriate reagent lot.

3 Click the action button Repeat.

→ A confirmation dialog is displayed warning the user that all jobs using the reference
curve will be deleted.

The action button Repeat is inactive.

◆ If the action button Measure is active, measure the reference curve, see
( Page 181 Measuring the reference curve for an assay).
◆ If neither the action button Measure nor the action button Repeat is active, select
another reagent lot.

Then click the action button Repeat.

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An information dialog is displayed warning the user that a required standard is

not on-board.
◆ Load the appropriate standard, see ( Page 158 Loading standards and user-
defined controls).
◆ Re-start this procedure.

4 To cancel the measurement of the reference curve, click Cancel.

→ The measurement of the reference curve is canceled.

– or –

To continue, click OK.

→ Another confirmation dialog is displayed.

Canceled jobs must be requested again, see ( Page 172 Requesting a job for a
sample manually).

5 If new dilutions have to be prepared for the measurement, click Yes.

→ The measurement of the reference curve is repeated with new dilutions. In the

table Assays, the affected assay is flagged . The system measures the reference
curve, see ( Page 54 Flags and symbols).

– or –

If dilutions prepared previously should be used for the measurement, click No.

→ The measurement of the reference curve is repeated with dilutions prepared

previously. In the table Assays, the affected assay is flagged . The system
measures the reference curve, see ( Page 54 Flags and symbols).

An information dialog is displayed warning the user that the required reagent is
not on-board.

◆ Load the appropriate reagent, see ( Page 152 Loading reagents and controls).
◆ Re-start this procedure.

6 In the navigation bar, click any other routine button as displayed data is not
updated automatically.

7 In the navigation bar, click Calibration.

→ Calibration data is updated. The assay is flagged by a different symbol. A valid

reference curve is activated automatically by the system. The affected reagent lot is

flagged .

→ Repeating the measurement of a reference curve is completed.

8.25 Displaying a reference curve

✓ A reference curve for the selected assay is available.

✓ The system is in standby or routine mode.

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To display a reference curve, proceed as follows:

1 In the dialog Calibration, in the area Assays, select an assay.

2 If more than 1 reagent lot is displayed in the area Reagents, select the appropriate
reagent lot.

3 Click the action button Show curve.

→ The dialog Show curve is displayed. For more information on the dialog, click the
action button Help or see ( Page 115 Show curve).

If the reference curve is invalid and should not be activated, do not delete the
invalid reference curve but repeat the measurement with a new dilution series, see
( Page 182 Repeating the measurement of a reference curve).

If the reference curve is invalid because the mean deviation is outside the defined
range but the reference curve should be used nevertheless, activate the invalid
reference curve, see ( Page 184 Activating an invalid reference curve).

→ Displaying a reference curve is completed.

8.26 Activating an invalid reference curve

All reference curves with a mean deviation within the permissible range are
accepted automatically.

In case a reference curve is not accepted automatically, it can still be accepted

manually by the user. The decision to use such reference curves is the sole
responsibility of the user.

✓ The system is in standby or routine mode.

To activate an invalid reference curve, proceed as follows:

1 Display the affected reference curve, see ( Page 183 Displaying a reference curve).

2 Click the action button Release.

→ The reference curve is activated. The affected reagent lot is flagged , see
( Page 54 Flags and symbols).

→ Activating an invalid reference curve is completed.

8.27 Deleting a sample ID from the lab journal

✓ The system is in standby or routine mode.
To delete a sample ID from the lab journal, proceed as follows:

1 In the dialog Lab journal, in the table, select all requested jobs and all results
belonging to the affected sample ID.

2 Click the action button Delete.

→ A confirmation dialog is displayed.

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3 Click Yes.

→ The sample ID, all requested jobs, and all results belonging to the sample ID
are deleted.

The sample ID is not deleted from the lab journal.

As long as the sample is on-board, the sample ID cannot be deleted.

◆ Unload the sample, see ( Page 175 Unloading samples).

→ Deleting a sample ID from the lab journal is completed.

8.28 Removing previous assignments of sample IDs

✓ The system is in standby or routine mode.
To remove previous assignments of sample IDs from a sample rotor segment, proceed
as follows:

1 In the dialog Loading samples, in the left area, below Segment ID, select the
segment ID of the affected sample rotor segment, see ( Page 94 Loading samples).
For more information on the dialog, click the action button Help.

→ A diagram of the sample rotor segment is displayed. The status Not placed is
displayed for the sample rotor segment.

The status On-board is displayed.

◆ Unload the sample rotor segment, see ( Page 175 Unloading samples).
◆ Re-start this procedure.

2 In the diagram of the sample rotor segment, double-click an assigned position with
the right mouse button.

→ An information dialog is displayed.

3 Click Yes.

→ All previous assignments of sample IDs are removed from the affected sample rotor
segment. In the bottom right area, right of ID, the affected sample IDs are displayed.

Double-clicking an assigned position with the left mouse button removes the
assignment of only this sample ID from the sample rotor segment.

After the affected sample IDs are removed from the lab journal, they are no longer
displayed in the bottom right area.

→ Removing previous assignments of sample IDs is completed.

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8.29 Using cup-in-tube segments

Each laboratory should determine the acceptability of blood collection tubes, see
( Page 306 Sample tubes), and cups used, see ( Page 306 Special cups and vials).
Variations in these products exist, at times, from lot to lot. For more information,
contact Siemens Healthineers service.

✓ Immersion depth for the cups used is defined, see ( Page 137 Configuring the
immersion depth for cups used with a cup-in-tube segment).
✓ Only 1 type of cups is used with the specific cup-in-tube segment.

✓ Tubes used are barcoded.

✓ Valid reference curves for all requested assays are available, see
( Page 181 Measuring the reference curve for an assay).

✓ Controls for all requested assays have been measured, see ( Page 160 Measuring
a control).

✓ A cup-in-tube segment suitable for the present cup type is available but not on-board.

✓ Suitable tubes are available.

✓ The system is in standby or routine mode.

To use cup-in-tube segments, proceed as follows:

WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

WARNING

False results due to incorrect sample material or due to aspiration of packed cells
from the sample tube

Death or serious injury to the patient can result.

◆ Only use the required sample material, that is, serum, plasma, urine, or CSF.
◆ In the instructions for use of the product to be measured, check what kind of
sample material must be used.
◆ If using centrifuged samples, ensure that the volume of supernatant serum or
plasma above the packed cells is sufficient. Approximately 10 mm of supernatant
serum or plasma above the packed cells is required.

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NOTICE

If the immersion depth is not defined for the cups used, the probe can collide with
the bottom of the cups.

Damage to the system can result.

◆ Define the immersion depth for the cups used before working with cup-in-tube
segments, see ( Page 137 Configuring the immersion depth for cups used with
a cup-in-tube segment).

1 Check that the sample material is the required material and that it is of
sufficient volume.

2 Slowly warm frozen samples up to room temperature, if applicable.

3 Mix frozen samples thoroughly after thawing, if required.

WARNING

Clogging of the probe can lead to interferences with the processing of assays
and to contamination of assays. False results can occur.
Death or serious injury to the patient can result.
◆ Centrifuge thawed samples, turbid (lipemic) samples, urine and CSF
samples, and serum and plasma samples that contain blood cells or fibrin
strands. For more information, see the instructions for use of the assay to
be measured.

4 Visually check centrifuged samples and repeat centrifugation, if required.

5 Prepare a manual pre-dilution using diluent, if required.

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NOTICE

The probe cannot penetrate any caps or stoppers. The probe tip can be
damaged after collision with caps or stoppers.

Damage to the system can result.

◆ Remove any caps or stoppers from the cups.

Delay of results can occur due to damaged probe tip after collision with caps
or stoppers.

No processing of assays with duplicate sample IDs. Jobs for duplicate sample IDs will
not be processed by the system. Delay of results can occur. Only use unique sample IDs.

Removing any caps and stoppers from cups (example)

6 Check the barcodes on the tubes and replace barcode labels that are illegible or
incorrectly placed, see ( Page 307 Sample and user-defined control barcodes).

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WARNING

False results due to froth causing incorrect level detection. Accurate transfer of
the sample cannot be guaranteed. False results due to swapped samples. When
loading cups in a cup-in-tube segment, cups can easily be mixed up and thus
misplaced in a tube with the wrong barcode. Results will be assigned to the
wrong patient.

Death or serious injury to the patient can result.

◆ Remove froth before loading cups.
◆ Take special care to load the correct cup in the barcoded tube in the
cup-in-tube segment.

NOTICE

The probe can collide with cups that are inserted tilted or not completely
pressed down.

Damage to the system can result.

◆ Make sure that the cups are completely pressed down and centered when
inserted into the barcoded tubes.
◆ Make sure to press the barcoded tubes down to the bottom of the cup-in-
tube segment.

7 Load the barcoded tubes in the cup-in-tube segment aligning the barcodes towards
the outer edge of the cup-in-tube segment.

8 Load the cup-in-tube segments in the sample rotor, see ( Page 170 Loading sample
rotor segments).

Measurements from a cup-in-tube segment cannot be repeated automatically. Re-

measurements must be requested manually, see ( Page 172 Requesting a job for a
sample manually).

→ Using cup-in-tube segments is completed.

8.30 Using Eppendorf cup segments

Each laboratory should determine the acceptability of blood collection cups used, see
( Page 306 Special cups and vials). Variations in these products exist, at times, from
lot to lot. For more information, contact Siemens Healthineers service.

✓ Only 1 type of Eppendorf cups is used with the Eppendorf cup segment.

✓ Valid reference curves for all requested assays are available, see
( Page 181 Measuring the reference curve for an assay).

✓ Controls for all requested assays have been measured, see ( Page 160 Measuring
a control).

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✓ An Eppendorf cup segment is available but not on-board.

✓ The system is in standby or routine mode.

To use Eppendorf cup segments, proceed as follows:

WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

1 Pre-identify the sample IDs of the Eppendorf cups, see ( Page 166 Pre-identifying
non-barcoded samples and non-barcoded STAT samples).

WARNING

False results due to incorrect sample material or due to aspiration of packed

cells from the sample tube
Death or serious injury to the patient can result.
◆ Only use the required sample material, that is, serum, plasma, urine, or CSF.
◆ In the instructions for use of the product to be measured, check what kind of
sample material must be used.
◆ If using centrifuged samples, ensure that the volume of supernatant serum
or plasma above the packed cells is sufficient. Approximately 10 mm of
supernatant serum or plasma above the packed cells is required.

2 Check that the sample material is the required material and that it is of
sufficient volume.

3 Slowly warm frozen samples up to room temperature, if applicable.

4 Mix frozen samples thoroughly after thawing, if required.

WARNING

Clogging of the probe can lead to interferences with the processing of assays
and to contamination of assays. False results can occur.

Death or serious injury to the patient can result.

◆ Centrifuge thawed samples, turbid (lipemic) samples, urine and CSF

samples, and serum and plasma samples that contain blood cells or fibrin
strands. For more information, see the instructions for use of the assay to
be measured.

5 Visually check centrifuged samples and repeat centrifugation, if required.

6 Prepare a manual pre-dilution using diluent, if required.

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NOTICE

The probe cannot penetrate any caps or stoppers. The probe tip can be
damaged after collision with caps or stoppers. The probe can collide with cups
that are inserted tilted.

Damage to the system can result.

◆ Remove any caps or stoppers from the cups.

Delay of results can occur due to damaged probe tip after collision with caps
or stoppers.

Removing any caps and stoppers from Eppendorf cups (example)

WARNING

False results due to froth causing incorrect level detection. Accurate transfer of
the sample cannot be guaranteed. False results due to swapped samples.

Death or serious injury to the patient can result.

◆ Remove froth before loading cups.
◆ Load the cups in the Eppendorf cup segment to which the sample IDs are
assigned exactly as they are displayed in the print-out.

NOTICE

The probe can collide with cups that are inserted tilted or not completely
pressed down.

Damage to the system can result.

◆ Make sure to press the cups completely down.

7 Load the Eppendorf cup segment in the sample rotor, see ( Page 170 Loading
sample rotor segments).

Measurements from an Eppendorf cup segment cannot be repeated automatically.

Re-measurements must be requested manually, see ( Page 172 Requesting a job for
a sample manually).

→ Using Eppendorf cup segments is completed.

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8.31 Using Hitachi cup segments

Each laboratory should determine the acceptability of blood collection cups used, see
( Page 306 Special cups and vials). Variations in these products exist, at times, from
lot to lot. For more information, contact Siemens Healthineers service.

✓ Valid reference curves for all requested assays are available, see
( Page 181 Measuring the reference curve for an assay).

✓ Controls for all requested assays have been measured, see ( Page 160 Measuring
a control).

✓ A Hitachi cup segment is available but not on-board.

✓ The system is in standby or routine mode.

To use Hitachi cup segments, proceed as follows:

WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

WARNING

False results due to incorrect sample material or due to aspiration of packed cells
from the sample tube

Death or serious injury to the patient can result.

◆ Only use the required sample material, that is, serum, plasma, urine, or CSF.
◆ In the instructions for use of the product to be measured, check what kind of
sample material must be used.
◆ If using centrifuged samples, ensure that the volume of supernatant serum or
plasma above the packed cells is sufficient. Approximately 10 mm of supernatant
serum or plasma above the packed cells is required.

1 Check that the sample material is the required material and that it is of
sufficient volume.

2 Slowly warm frozen samples up to room temperature, if applicable.

3 Mix frozen samples thoroughly after thawing, if required.

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WARNING

Clogging of the probe can lead to interferences with the processing of assays
and to contamination of assays. False results can occur.

Death or serious injury to the patient can result.

◆ Centrifuge thawed samples, turbid (lipemic) samples, urine and CSF

samples, and serum and plasma samples that contain blood cells or fibrin
strands. For more information, see the instructions for use of the assay to
be measured.

4 Visually check centrifuged samples and repeat centrifugation, if required.

5 Prepare a manual pre-dilution using diluent, if required.

6 Check the barcodes on the cups and replace barcode labels that are illegible or
incorrectly placed, see ( Page 307 Sample and user-defined control barcodes).

No processing of assays with duplicate sample IDs. Jobs for duplicate sample IDs will
not be processed by the system. Delay of results can occur. Only use unique sample IDs.

NOTICE

The probe cannot penetrate any caps or stoppers. The probe tip can be
damaged after collision with caps or stoppers. The probe can collide with cups
that are inserted tilted.

Damage to the system can result.

◆ Remove any caps or stoppers from the cups.

Delay of results can occur due to damaged probe tip after collision with caps
or stoppers.

Removing any caps and stoppers from cups (example)

WARNING

False results due to froth causing incorrect level detection. Accurate transfer of
the sample cannot be guaranteed.

Death or serious injury to the patient can result.

◆ Remove froth before loading cups.

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NOTICE

The probe can collide with cups that are inserted tilted or not completely
pressed down.

Damage to the system can result.

◆ Make sure to press the cups completely down.

7 Load the barcoded cups in the Hitachi cup segment. Align the barcodes towards the
outer edge of the Hitachi cup segment so the barcodes can be scanned through the
opening in the adapters.

8 Load the Hitachi cup segment in the sample rotor, see ( Page 170 Loading sample
rotor segments).

Measurements from a Hitachi cup segment cannot be repeated automatically. Re-

measurements must be requested manually, see ( Page 172 Requesting a job for a
sample manually).

→ Using Hitachi cup segments is completed.

8.32 Using cup-behind-tube segments

Each laboratory should determine the acceptability of blood collection tubes, see
( Page 306 Sample tubes), and cups used, see ( Page 306 Special cups and vials).
Variations in these products exist, at times, from lot to lot. For more information,
contact Siemens Healthineers service.

✓ Tubes used are barcoded.

✓ Valid reference curves for all requested assays are available, see
( Page 181 Measuring the reference curve for an assay).

✓ Controls for all requested assays have been measured, see ( Page 160 Measuring
a control).

✓ A cup-behind-tube segment is available but not on-board.

✓ Suitable tubes are available.

✓ The system is in standby or routine mode.

To use cup-behind-tube segments, proceed as follows:

WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

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WARNING

False results due to incorrect sample material or due to aspiration of packed cells
from the sample tube

Death or serious injury to the patient can result.

◆ Only use the required sample material, that is, serum, plasma, urine, or CSF.
◆ In the instructions for use of the product to be measured, check what kind of
sample material must be used.
◆ If using centrifuged samples, ensure that the volume of supernatant serum or
plasma above the packed cells is sufficient. Approximately 10 mm of supernatant
serum or plasma above the packed cells is required.

1 Check that the sample material is the required material and that it is of
sufficient volume.

2 Slowly warm frozen samples up to room temperature, if applicable.

3 Mix frozen samples thoroughly after thawing, if required.

WARNING

Clogging of the probe can lead to interferences with the processing of assays
and to contamination of assays. False results can occur.
Death or serious injury to the patient can result.
◆ Centrifuge thawed samples, turbid (lipemic) samples, urine and CSF
samples, and serum and plasma samples that contain blood cells or fibrin
strands. For more information, see the instructions for use of the assay to
be measured.

4 Visually check centrifuged samples and repeat centrifugation, if required.

5 Prepare a manual pre-dilution using diluent, if required.

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NOTICE

The probe cannot penetrate any caps or stoppers. The probe tip can be
damaged after collision with caps or stoppers.

Damage to the system can result.

◆ Remove any caps or stoppers from the cups.

Delay of results can occur due to damaged probe tip after collision with caps
or stoppers.

Removing any caps and stoppers from cups (example)

No processing of assays with duplicate sample IDs. Jobs for duplicate sample IDs will
not be processed by the system. Delay of results can occur. Only use unique sample IDs.

6 Check the barcodes on the tubes and replace barcode labels that are illegible or
incorrectly placed, see ( Page 307 Sample and user-defined control barcodes).

WARNING

False results due to froth causing incorrect level detection. Accurate transfer of
the sample cannot be guaranteed. False results due to swapped samples. When
loading cups in a cup-behind-tube segment, cups can easily be mixed up and
thus misplaced behind a tube with the wrong barcode. Results will be assigned
to the wrong patient.

Death or serious injury to the patient can result.

◆ Remove froth before loading cups.

◆ Take special care to load the correct cup behind the barcoded tube in the
cup-behind-tube segment.

7 Load the barcoded tubes in the lower row of the cup-behind-tube segment.

8 Align the barcodes towards the outer edge of the cup-behind-tube segment.

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NOTICE

The probe can collide with cups that are inserted tilted or not completely
pressed down.

Damage to the system can result.

◆ Make sure that the cups are completely pressed down.

◆ Make sure to press the barcoded tubes down to the bottom of the cup-
behind-tube segment.

9 Load the cups in the upper row behind the appropriate barcoded tubes.

10 Load the cup-behind-tube segment in the sample rotor, see ( Page 170 Loading
sample rotor segments).

Measurements from a cup-behind-tube segment cannot be repeated automatically.

Re-measurements must be requested manually, see ( Page 172 Requesting a job for
a sample manually).

→ Using cup-behind-tube segments is completed.

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9 Finishing the analysis

This chapter describes how to finish the analysis.

9.1 Rinsing the system

✓ The system is in standby or routine mode.

To rinse the system, proceed as follows:

WARNING

The filling level of the waste container is not checked by the system before the
rinsing starts. Potentially infectious material in the waste container can overflow
during rinsing. Potentially infectious material can be released.

Death or serious injury to the user can result. Property damage and damage
to the surroundings can result.
◆ Empty the waste container before rinsing the system.

1 In the dialog System, in the area Maintenance, click Rinse system.

→ In the dialog Rinse system, a progress bar is displayed. The system finishes current
operations. This can take several minutes. For more information on the dialog, click
the action button Help or see ( Page 60 Add request).

2 Wait until the progress bar is no longer displayed.

3 Select the system liquids for rinsing, usually buffer, diluent, and water
(washing liquid).

4 Enter the number of rinsing cycles for each selected system liquid.

5 Click the action button Save.

→ The system starts rinsing.

6 Wait until an information dialog is displayed.

7 Click Ok.

→ Rinsing the system is completed.

9.2 Creating a backup

After the backup is created, the system is shut down automatically.

Backup data can only be restored by Siemens Healthineers service.

✓ The system is in standby or routine mode.

To create a backup, proceed as follows:

1 In the dialog System, in the area Update and back up software, click Backup.

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→ In the dialog System, the area Select path for backup file is displayed. For more
information on the dialog, click the action button Help or see ( Page 114 Select path
for backup file).

NOTICE

Backup data will be added to an already existing backup file. Frequent backups
can thus create a backup file of a size that cannot be restored.

Loss of data can result.

◆ Create a new folder for each backup via the operating system of
the computer.
◆ Delete the backup file frequently via the operating system of the computer
before creating a new backup.

2 Select the drive and path where the backup will be created.

3 Click the action button Save.

→ A confirmation dialog is displayed.

4 Click Ok.

→ The system creates a backup in the selected folder. Another confirmation dialog
is displayed.

5 Click Ok.

→ Another confirmation dialog is displayed.

6 Click Ok.

→ The system is shut down.

7 At the right side of the system, set the main switch to position O.

→ The system is off.

8 Shut down the computer.

9 Switch off the monitor.

10 Switch off the printer.

→ Creating a backup is completed.

9.3 Shutting down the system

Siemens Healthineers recommends:

• Not shutting down the system for an extended period, for example, over night or
over the weekend.

• Shutting down and restarting the system at least once a week.

✓ 1 container with at least 1 L of water is available if the system is shut down for more
than 2 hours.

✓ The system is in standby or routine mode.

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To shut down the system, proceed as follows:

WARNING

When the system shuts down, the reagent cooler is switched off. False results
can occur due to uncooled reagents and controls. When the system is shut down
for more than 2 hours, the buffer in the tubing and in the buffer reservoir can
crystallize. The concentration of the buffer can change. False results can occur.

Death or serious injury to the patient can result.

◆ If the system is shut down for more than 2 hours, remove reagent and
control vials, including evaporation caps, from the system and return them
to the refrigerator.
◆ Before the system is shut down for more than 2 hours, rinse the system with
water, see ( Page 198 Rinsing the system).
◆ If the system is shut down for more than 2 hours, insert the level sensor of the
buffer container into a container with at least 1 L of water.

Delay of results can occur due to changed concentration of buffer.

1 If the system is shut down for more than 2 hours: Remove the level sensor of the
buffer container.

2 If the system is shut down for more than 2 hours: Insert the level sensor of the buffer
container into a container with at least 1 L of water.

3 If the system is shut down for more than 2 hours: Rinse the system with buffer. Enter
3 as the Number of rinsing cycles, see ( Page 198 Rinsing the system).

4 In the dialog Status, click the action button Exit.

→ A confirmation dialog is displayed.

5 Click Yes.

→ The system is rinsed with water. The system is shut down. The viewer
software closes.

6 Wait until the 3 LEDs in the upper right corner at the front of the system are off.

7 Unload reagent and control vials from the system and return them to the refrigerator,
if required, see ( Page 177 Unloading reagents and controls).

8 Empty the waste container, see ( Page 201 Emptying the waste container).

9 At the right side of the system, set the main switch to position O.

→ The system is off.

10 Shut down the computer.

11 Switch off the monitor.

12 Switch off the printer.

→ Shutting down the system is completed.

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9.4 Emptying the waste container

✓ The system is in standby or routine mode or is off.

To empty the waste container, proceed as follows:

WARNING

Infection due to infectious waste

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle parts of the system that have come into contact with potentially
infectious material in accordance with good laboratory practices.

NOTICE

If containers are placed on or above the system, system liquids can flow over or into
the system.

Damage to the system can result.

◆ Place containers on the same level as or a lower level than the system.

1 If the system is in standby or routine mode: In the dialog System, in the area Access,
click System liquid & waste.

→ In the dialog Replace system liquids and empty waste container, a progress
bar is displayed. The system finishes current operations. This can take several
minutes. For more information on the dialog, click the action button Help or see
( Page 111 Replace system liquids and empty waste container).

2 If the system is in standby or routine mode: Wait until the progress bar is no
longer displayed.

3 Pull the level sensor 1–2 cm out of the waste container.

4 Unscrew the cap from the waste container. The level sensor remains in the cap.

5 Dispose of the liquid waste according to national and local standards and regulations.

6 Screw the cap back on to the waste container.

7 Push the level sensor back into the waste container.

8 Place the 2 pegs on the level sensor in the notches on the cap.

9 If the system is in standby or routine mode: In the area Waste container,

select Emptied.

→ The action button Save becomes active.

10 If the system is in standby or routine mode: Click the action button Save.

→ The dialog System is displayed.

→ Emptying the waste container is completed.

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10 Performing maintenance and

cleaning
This chapter describes how to perform maintenance and how to clean the system.

WARNING

Risk of burns by combustion of highly flammable liquid and vapour. 70% ethanol
and 70% isopropanol are highly flammable.

Death or serious injury can result.

◆ Keep 70% ethanol and 70% isopropanol away from sources of ignition, for
example, heat or open flame.
◆ Due to no claim of completeness of these measures, follow all instructions from
the product manufacturer and observe the material safety data sheet.

WARNING

Risk of serious eye irritation through contact with 70% isopropanol. Risk of
drowsiness or dizziness through inhalation of 70% isopropanol.

Serious injury can result.

◆ 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.

NOTICE

Purging agents, purging solutions, and alcohol dissolve the film of oil on
ball bearings, guides, and tracks. Purging agents and purging solutions can
cause short-circuits.

Damage to the system can result.

◆ Do not use purging agents, purging solutions, or alcohol on ball bearings,
guides, and tracks.
◆ Do not use purging agents or purging solutions near printed circuit boards and
light barriers.

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NOTICE

Pollution by improper waste disposal.

Damage to the environment can result.

◆ Dispose of ethanol, isopropanol, and containers according to laboratory

standards and national and local standards and regulations.
◆ Due to no claim of completeness of these measures, follow all instructions from
the product manufacturer and observe the material safety data sheet.

10.1 List of tasks

Maintenance and cleaning tasks are listed in the table below.

Weekly task See

Checking the functioning of the probe ( Page 204 Checking the functioning of the probe)

Cleaning the probe ( Page 205 Cleaning the probe)

Cleaning the wet station ( Page 207 Cleaning the wet station)

Cleaning the reagent rotor and the ( Page 209 Cleaning the reagent rotor and the reagent rotor housing)
reagent rotor housing

Checking the syringe for leaks ( Page 210 Checking the syringe for leaks)

Cleaning the water container ( Page 211 Cleaning the water container)

Checking the tubing of the containers ( Page 212 Checking the tubing of the containers)

Checking the tubing of the probe ( Page 212 Checking the tubing of the probe)

Shutting down the system ( Page 199 Shutting down the system)

Starting the system ( Page 144 Starting the system)

Monthly task See

Purging the tubing ( Page 214 Purging the tubing)

Replacing the water filter ( Page 216 Replacing the water filter)

Cleaning the level sensors ( Page 217 Cleaning the level sensors)

Yearly task See

Replacing the syringe ( Page 220 Replacing the syringe)

Replacing the tubing of the containers ( Page 224 Replacing the tubing of the containers)

As needed task See

Rinsing the system ( Page 198 Rinsing the system)

Cleaning the surface of the system ( Page 228 Cleaning the surface of the system)

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As needed task See

Cleaning the sample rotor and the sample ( Page 228 Cleaning the sample rotor and the sample rotor housing)
rotor housing

Cleaning the segments ( Page 230 Cleaning the segments)

Cleaning the dilution station, the cuvette ( Page 230 Cleaning the dilution station, the cuvette rotor, and the cuvette
rotor, and the cuvette rotor housing rotor housing)

Cleaning the waste container ( Page 233 Cleaning the waste container)

Cleaning the peripheral devices ( Page 233 Cleaning the peripheral devices)

Replacing the probe cleaner bottle ( Page 234 Replacing the probe cleaner bottle)

Preparing the purging solution ( Page 235 Preparing the purging solution)

Preparing the hypochlorite solution ( Page 235 Preparing the hypochlorite solution)

Have Siemens Healthineers service carry out maintenance tasks defined in the
maintenance contract.

10.2 Weekly tasks

This section describes the maintenance and cleaning tasks that must be performed once
a week.

10.2.1 Checking the functioning of the probe

✓ The system is in standby or routine mode.
To check the functioning of the probe, proceed as follows:

1 In the dialog System, in the area Initialization, click Probe.

→ A confirmation dialog is displayed.

2 Click Yes.

→ The system initializes the probe.

3 Wait until the information dialog Initialization of probe completed is displayed.

4 Click Ok.

→ The dialog System is displayed.

5 In the area Maintenance, click Check probe.

→ In the dialog Check probe, a progress bar is displayed. The system finishes current
operations. This can take several minutes.
6 Wait until a message is displayed.

7 Click the action button Check.

→ The probe emits diluent straight into the dispensing area.

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The jet of diluent exits diagonally, is split or fanned, or the probe drips.
◆ Click the action button Close.
◆ Click Ok.
◆ Rinse the system, see ( Page 198 Rinsing the system).

8 If the system was rinsed: In the dialog System, in the area Maintenance, click
Check probe.

→ In the dialog Check probe, a progress bar is displayed. The system finishes current
operations. This can take several minutes.

9 If the system was rinsed: Wait until a message is displayed.

10 If the system was rinsed: Click the action button Check.

→ The probe emits diluent straight into the dispensing area.

The jet of diluent exits diagonally, is split or fanned, or the probe drips.

◆ Click the action button Close.

◆ Click Ok.
◆ Replace the probe assembly, see ( Page 248 Replacing the probe assembly).

11 If the probe assembly was replaced: In the dialog System, in the area Maintenance,
click Check probe.

→ In the dialog Check probe, a progress bar is displayed. The system finishes current
operations. This can take several minutes.

12 If the probe assembly was replaced: Wait until a message is displayed.

13 If the probe assembly was replaced: Click the action button Check.
→ The probe emits diluent straight into the dispensing area.

The jet of diluent exits diagonally, is split or fanned, or the probe drips.

◆ Contact Siemens Healthineers service.

14 Click the action button Close.

→ A confirmation dialog is displayed.

15 Click Ok.
→ Checking the functioning of the probe is completed.

10.2.2 Cleaning the probe

✓ Soft, lint-free cloth is available.

✓ 70 % ethanol or 70 % isopropyl alcohol is available.

✓ The system is in standby or routine mode.

To clean the probe, proceed as follows:

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WARNING

Infection due to contaminated material and injury to hands due to sharp edges.

Death or serious injury to the user can result.

◆ Be especially careful of the sharp probe tip and other sharp edges.
◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle parts of the system that have come into contact with potentially
infectious material in accordance with good laboratory practices.

1 In the dialog System, in the area Maintenance, click Clean probe.

→ In the dialog Clean probe, a progress bar is displayed. The system finishes current
operations. This can take several minutes. For more information on the dialog, click
the action button Help or see ( Page 65 Clean probe).

2 Wait until a message is displayed.

3 Click the action button Park probe for cleaning.

→ The probe moves to the parking position.

4 Wait until another message is displayed.

→ The probe is in the parking position.

No processing of jobs when the right cover is opened without access being requested
via the software. The stop function is triggered, the system's operation is interrupted,
and existing pre-dilutions may be rejected by the system. Delay of results can occur.

• Always request access through the right cover via the software.

• If the right cover was opened without access being requested, immediately close
the right cover.

5 Open the right cover.

NOTICE

Sharp edges can damage the inside of the probe.

Damage to the system can result.

◆ Do not use cleaning wires to clean the inside of the probe.

6 Wipe the probe from top to bottom with a soft, lint-free cloth moistened with the
specified alcohol.

7 Close the right cover.

→ The action button Close becomes active.

8 Click the action button Close.

→ An information dialog is displayed.

9 Click Ok.

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→ Cleaning the probe is completed.

10.2.3 Cleaning the wet station

✓ Soft, lint-free cloth is available.

✓ 70 % ethanol or 70 % isopropyl alcohol is available.

✓ The system is in standby or routine mode.

To clean the wet station, proceed as follows:

WARNING

Infection due to contaminated material and injury to hands due to sharp edges.

Death or serious injury to the user can result.

◆ Be especially careful of the sharp probe tip and other sharp edges.
◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle parts of the system that have come into contact with potentially
infectious material in accordance with good laboratory practices.

1 In the dialog System, in the area Maintenance, click Clean probe.

→ In the dialog Clean probe, a progress bar is displayed. The system finishes current
operations. This can take several minutes. For more information on the dialog, click
the action button Help or see ( Page 65 Clean probe).

2 Wait until a message is displayed.

3 Click the action button Park probe for cleaning.

→ The probe moves to the parking position.

4 Wait until another message is displayed.

→ The probe is in the parking position.

No processing of jobs when the right cover is opened without access being requested
via the software. The stop function is triggered, the system's operation is interrupted,
and existing pre-dilutions may be rejected by the system. Delay of results can occur.

• Always request access through the right cover via the software.

• If the right cover was opened without access being requested, immediately close
the right cover.

5 Open the right cover.

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WARNING

Contamination of the buffer reservoir can cause dilution of the buffer used for
measurement. Buffer can become unusable. False results can occur.

Death or serious injury to the patient can result.

◆ Do not contaminate the buffer reservoir during cleaning.

6 Wipe the surface of the wet station with a soft, lint-free cloth moistened with the
specified alcohol, see the figure below.

2
3
4

Cleaning the wet station

(1) Wet station

(2) Fountain area
(3) Dispensing area
(4) Buffer reservoir
(5) Dilution frame

7 Remove the dilution frame.

8 Wipe the dispensing area, including the inside, with a soft, lint-free cloth moistened
with the specified alcohol.

9 Insert the dilution frame.

10 Moisten a cotton bud with the specified alcohol.

11 Clean the internal upper section of the fountain area using circular downwards
movements (approx. 8 mm deep).
12 Close the right cover.

→ The action button Close becomes active.

13 Click the action button Close.

→ An information dialog is displayed.

14 Click Ok.

15 Rinse the system with buffer only, see ( Page 198 Rinsing the system).

→ Cleaning the wet station is completed.

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10.2.4 Cleaning the reagent rotor and the reagent rotor housing
✓ Soft, lint-free cloth is available.

✓ Water is available.

✓ Purging solution is available.

✓ The system is in standby or routine mode.

To clean the reagent rotor and the reagent rotor housing, proceed as follows:
1 Prepare the purging solution according to the instruction manual of the purging
agent or contact Siemens Healthineers service.
2 In the dialog System, in the area Access, click Reagents.

→ In the dialog Access reagents, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access reagents).

3 Wait until a message is displayed.

4 Open the left and right covers.

→ Another message is displayed.

5 Remove the reagent rotor cover.

6 Remove all reagent segments and control segments.

7 Loosen the handwheel of the reagent rotor, see the figure below. The handwheel
cannot be completely unscrewed.

Cleaning the reagent rotor

(1) Handwheel
(2) Reagent rotor
(3) Reagent rotor housing
(4) Window of the barcode reader

8 Remove the reagent rotor by the handwheel.

9 Wipe the reagent rotor and the reagent rotor housing, especially the window of the
barcode reader, with a soft, lint-free cloth moistened with water.

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Do not use any purging agent or purging solution to clean the reagent rotor and the
reagent rotor housing.

10 Wipe the reagent rotor cover with a soft, lint-free cloth moistened with
purging solution.

11 Allow the purging solution to take effect, according to the instructions from
the manufacturer.
12 Place the reagent rotor back. Turn the reagent rotor slightly in both directions until it
locks in place.
13 Tighten the handwheel.

14 Clean the segments, see ( Page 230 Cleaning the segments).

15 Load reagent segments and control segments on the reagent rotor as required.

16 Replace the reagent rotor cover.

17 Close the left and right covers.

→ The action button Close is displayed.

18 Click the action button Close.

→ The dialog System is displayed.

→ Cleaning the reagent rotor and the reagent rotor housing is completed.

10.2.5 Checking the syringe for leaks

✓ Soft, lint-free cloth is available.

✓ The system is in standby or routine mode.

To check the syringe for leaks, proceed as follows:

1 In the dialog System, in the area Maintenance, click Replace syringe.

→ In the dialog Replace syringe, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 111 Replace syringe).

2 Wait until a confirmation dialog is displayed.

3 Click Yes.

4 Wait until a message is displayed.

5 Open the left cover.

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6 Check if there is liquid in the straining ring, see the figure below.

Checking the syringe for leaks

(1) Syringe
(2) Straining ring

→ No liquid is in the straining ring

There is liquid in the straining ring.

◆ Troubleshoot the syringe, see ( Page 264 Troubleshooting the syringe).

→ Checking the syringe for leaks is completed.

10.2.6 Cleaning the water container

✓ 70 % ethanol or 70 % isopropyl alcohol is available.
✓ Water is available.

✓ The system is in standby or routine mode.

To clean the water container, proceed as follows:

1 Remove the sealing cap with the level sensor from the water container.

2 Empty the water container.

3 Fill 1/10 of the water container with the specified alcohol.

4 Slew the water container until the entire inner surface has been wetted.

5 Allow the alcohol to take effect, according to the instructions from the manufacturer.

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6 Dispose of the alcohol according to national and local standards and regulations.

7 Rinse the water container thoroughly with water.

8 Refill the water container with water.

9 Press the sealing cap with the inserted level sensor onto the opening of the container.

Make sure that the level sensor is inserted at an angle into the corresponding
container. The free end of the level sensor inside the container must point away from
the opening in the container so that the floater at the end of the level sensor can move
up and down freely.
The tubing bears differently colored markings, see ( Page 47 Liquid containers, level
sensors, and tubing).

10 If the system is in standby mode: Rinse the system with water (washing liquid), see
( Page 198 Rinsing the system).

→ Cleaning the water container is completed.

10.2.7 Checking the tubing of the containers

✓ The system is in standby or routine mode.
To check the tubing of the containers, proceed as follows:

◆ Check if the tubing between the system and the containers is bent or contains
any debris.

→ The tubing between the system and the containers is not bent and does not
contain any debris.

The tubing between the system and the containers is bent.

◆ Replace the tubing, see ( Page 224 Replacing the tubing of the containers).

The tubing between the system and the containers contains any debris.

◆ Purge the tubing, see ( Page 214 Purging the tubing).

→ Checking the tubing of the containers is completed.

10.2.8 Checking the tubing of the probe

✓ The system is in standby or routine mode.

To check the tubing of the probe, proceed as follows:

1 In the dialog System, in the area Maintenance, click Clean probe.

→ In the dialog Clean probe, a progress bar is displayed. The system finishes current
operations. This can take several minutes. For more information on the dialog, click
the action button Help or see ( Page 65 Clean probe).

2 Wait until a message is displayed.

3 Click the action button Park probe for cleaning.

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→ The probe moves to the parking position.

4 Wait until another message is displayed.

→ The probe is in the parking position.

5 Open the right cover.

6 Visually check if the tubing of the probe is bent or damaged, see the figure below.

Checking the tubing of the probe

(1) Tubing of the probe

(2) Probe

→ The tubing of the probe is not bent or damaged.

The tubing of the probe is bent or damaged.

◆ Contact Siemens Healthineers service.

7 Close the right cover.

→ The action button Close becomes active.

8 Click the action button Close.

→ An information dialog is displayed.

9 Click Ok.

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→ The dialog System is displayed.

→ Checking the tubing of the probe is completed.

10.3 Monthly tasks

This section describes the maintenance and cleaning tasks that must be performed once
a month.

10.3.1 Purging the tubing

Depending on the kind of container used to hold the 2–3 % hypochlorite solution,
variable volumes are required to purge the tubing, see the table below.

Container Design Required volume

Small bottle, 500 mL Narrow bottom 250 mL

Container, 5000 mL Wide bottom 1000 mL

Examples for the required volume of hypochlorite solution

✓ 2–3 % hypochlorite solution is available.

✓ 1 empty container with a capacity of 500–5000 mL to hold the 2–3 % hypochlorite

solution is available.
✓ Water is available.

✓ 1 empty, unused container with a capacity of 5–10 L to hold the water is available.

✓ The system is in standby or routine mode.

To purge the tubing, proceed as follows:

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WARNING

Hypochlorite solution can cause damage to the respiratory system through

inhalation. Hypochlorite solution can cause severe skin burns and eye damage if it
comes into contact with skin and eyes.

Death or serious injury to the user and bystanders can result.

◆ 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.
◆ Observe the instructions from the manufacturer regarding handling of
hypochlorite solution.
◆ Store and handle in a well ventilated area.
◆ Avoid breathing fume.
◆ Avoid contact with eyes and skin.
◆ Wash thoroughly after handling.
◆ In case of contact with eyes or skin, immediately rinse the affected area with
plenty of water for several minutes.
◆ In the event of an accident or if you feel unwell, seek medical advice immediately
and show the label if possible.

NOTICE

Hypochlorite solution is very toxic to aquatic life when released.

Environmental damage can result.

◆ Dispose of sodium hypochlorite solution and containers according to national

and local standards and regulations.

1 Fill an empty container with the required volume of the 2–3 % hypochlorite solution.

WARNING

False results due to hypochlorite solution contaminating the water container

and entering the tubing

Death or serious injury to the patient can result.

◆ Do not use the routinely installed water container to purge the tubing.

2 Fill an empty, unused 5 L or 10 L container with at least 2 L of water.

3 In the dialog System, in the area Maintenance, click Purge tubings.

→ In the dialog Purge tubings, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or , see ( Page 108 Purge tubings).

4 Wait until a confirmation dialog is displayed.

5 Click Yes.

→ A message is displayed.

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6 Remove the level sensor from the routinely installed water container.

7 Place the level sensor in the extra container holding the hypochlorite solution.
8 Click the action button Start purging.

→ In the status line, the process steps are displayed.

9 Wait until an information dialog is displayed.

10 Click Ok.

→ A progress bar is displayed. The purging time is 15 minutes. During countdown the
remaining time is displayed in seconds starting at 900.
11 Wait until a message is displayed.

12 Remove the level sensor from the extra container holding the hypochlorite solution.

13 Rinse the outside of the level sensor thoroughly with water.

WARNING

False results can occur due to hypochlorite solution contaminating the water
container and entering the tubing.

Death or serious injury to the patient can result.

◆ Do not use the routinely installed water container to rinse the tubing.

14 Place the level sensor in the extra container holding water.

15 Click the action button Start rinsing.

→ The system rinses the tubing.

16 Wait until the information dialog Rinsing process completed is displayed.

17 Click Ok.

→ Another information dialog is displayed.

18 Rinse the routinely installed water container with water.

19 Remove the level sensor from the extra container holding water.

20 Place the level sensor in the routinely installed water container.

21 Click Ok.

→ The dialog System is displayed.

22 Rinse the system with buffer, diluent, and water (washing liquid), see
( Page 198 Rinsing the system).

→ Purging the tubing is completed.

10.3.2 Replacing the water filter

✓ Soft, lint-free cloth is available.

✓ 1 new water filter is available.

✓ The system is in standby or routine mode or is off.

To replace the water filter, proceed as follows:

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1 Disconnect the Luer lock fittings from the water filter, see the figure below.

1 1 2

3
4
3

Replacing the water filter

(1) Female Luer lock fittings

(2) Connection fitting of the system
(3) Male Luer lock fittings
(4) Water filter
(5) Water container

2 Dispose of the used water filter according to national and local standards
and regulations.
3 Insert the new water filter between the female and the male Luer lock fittings such
that the arrow points in the direction of flow of the water.
4 If the system is off: Start the system, see ( Page 144 Starting the system).

5 Rinse the system with water, see ( Page 198 Rinsing the system).

→ No air bubbles appear in the water tubing.

Air bubbles appear in the water tubing.

◆ Repeat rinsing until no more air bubbles appear in the water tubing.

→ Replacing the water filter is completed.

10.3.3 Cleaning the level sensors

To clean the level sensors, proceed as follows:

1 Clean the level sensors of the buffer, diluent, and water container, see
( Page 218 Clean level sensors of buffer, diluent, and water containers).

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2 Clean the level sensor of the waste container (green marking), see ( Page 219 Clean
level sensor of waste container).

→ Cleaning the level sensors is completed.

Clean level sensors of buffer,

diluent, and water containers

Clean the level sensors 1 at a time.

✓ Soft, lint-free cloth is available.

✓ 70 % ethanol or 70 % isopropyl alcohol is available.

✓ The system is in standby mode or is off.

To clean the level sensors of the buffer, diluent, and water containers, proceed as follows:

1 Pull the level sensor out of the cap, see the figure below.

1
2

Removing the cap

(1) Level sensor

(2) Cap
(3) Container
2 Pull the cap from the container.

3 Wipe the surface of the level sensor with a soft, lint-free cloth moistened with the
specified alcohol.
4 Allow the alcohol to take effect, according to the instructions from the manufacturer.

5 Over a sink, rinse the level sensor with clean water.

6 Wipe the surface of the cap with a soft, lint-free cloth moistened with the
specified alcohol.
7 Allow the alcohol to take effect, according to the instructions from the manufacturer.

8 Press the cap onto the opening of the container.

9 Insert the level sensor back into the container.

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Make sure that the level sensor is inserted at an angle into the corresponding
container. The free end of the level sensor inside the container must point away from
the opening in the container so that the floater at the end of the level sensor can move
up and down freely.

The tubing bears differently colored markings, see ( Page 47 Liquid containers, level
sensors, and tubing).

10 Repeat the procedure for the level sensors of the buffer, diluent, and
water containers.

11 Clean the level sensor of the waste container, see ( Page 219 Clean level sensor of
waste container).

→ Cleaning the level sensors of the buffer, diluent, and water containers is completed.

Clean level sensor of ✓ Soft, lint-free cloth is available.

waste container
✓ 70 % ethanol or 70 % isopropyl alcohol is available.

✓ The system is in standby mode or is off.

To clean the level sensor of the waste container, proceed as follows:

1 Pull the level sensor out of the cap, see the figure below.

1
2

Removing the cap

(1) Level sensor

(2) Cap
(3) Container

2 Unscrew the cap from the container.

3 Wipe the surface of the level sensor with a soft, lint-free cloth moistened with the
specified alcohol.

4 Allow the alcohol to take effect, according to the instructions from the manufacturer.

5 Over a sink, rinse the level sensor with clean water.

6 Wipe the surface of the cap with a soft, lint-free cloth moistened with the
specified alcohol.

7 Allow the alcohol to take effect, according to the instructions from the manufacturer.

8 Screw the cap back onto the waste container.

9 Place the 2 pegs on the level sensor of the waste container in the notches of the cap.

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10 Lower the level sensor back into the waste container.

11 Rinse the system with buffer, diluent, and water (washing liquid), see
( Page 198 Rinsing the system).

→ Cleaning the level sensor of the waste container is completed.

10.4 Yearly tasks

This section describes the maintenance and cleaning tasks that must be performed once
a year.

10.4.1 Replacing the syringe

Besides the yearly maintenance, it may be required to replace the syringe due to
leaking. This can be caused by dirt or deposits at low temperatures or the creep
characteristics of Teflon causing parts of the plunger to shrink.

✓ Disposable, absorbent cloth is available.

✓ 1 new syringe is available.

✓ The system is in standby or routine mode.

To replace the syringe, proceed as follows:

1 In the dialog System, in the area Maintenance, click Replace syringe.

→ In the dialog Replace syringe, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 111 Replace syringe).

2 Wait until a confirmation dialog is displayed.

3 Click Yes.
→ The plunger of the syringe moves to a position that enables replacing of
the syringe.

4 Wait until a message is displayed.

5 Open the left cover.

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6 Hold the used syringe by the handle, see the figure below.

1 2 1

4
7
6 5

Removing the used syringe

(1) Tubing
(2) Screw
(3) Handle
(4) Plunger
(5) Head of plunger
(6) Knurled nut
(7) Straining ring

7 Loosen the knurled nut.

8 Push the plunger upward until the head of the plunger is above the straining ring.

9 Loosen the screw.

10 Have disposable, absorbent cloth available to absorb spilled liquid.

11 Remove the used syringe from the straining ring.

12 Unscrew the tubing from the handle.

13 Dispose of the used syringe according to national and local standards

and regulations.

14 Fill the new syringe with diluent to moisten the inside.

15 Empty the new syringe again.

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WARNING

False results due to bent tubing can occur. Measurements must be repeated.

Death or serious injury to the patient can result.

◆ Check that the tubing of the new syringe is not bent.

16 With the scale facing away from the screw, screw the tubing to the handle of the new
syringe, see the figure below.

1 2 1

Screwing the tubing to the new syringe

(1) Tubing
(2) Screw
(3) Square
(4) Handle
(5) Scale

17 Insert the square of the new syringe below the screw.

18 Tighten the screw.

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19 Position the head of the plunger in the straining ring, see the figure below.

1
5
4 2

Installing the new syringe

(1) Plunger
(2) Head of the plunger
(3) Syringe platform
(4) Knurled nut
(5) Straining ring

20 Push the plunger slightly downward while screwing the knurled nut tight to secure
the head of the plunger.
21 Check the amount of play between the head of the plunger and the syringe platform.

→ There is no play between the head of the plunger and the syringe platform.

There is any amount of play between the head of the plunger and the syringe platform.
◆ Loosen the knurled nut a little.
◆ Push the plunger slightly more downward while screwing the knurled nut tight.
◆ Repeat this step.

22 Click the action button Close.

→ The system rinses the tubing.

23 Wait until an information dialog is displayed.

24 Click Ok.

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WARNING

Air bubbles in the tubing can distort the mixing ratio in the cuvettes. False
results can occur.

Death or serious injury to the patient can result.

◆ Carefully follow the instructions given below.

25 Rinse the system with diluent and water (washing liquid), see ( Page 198 Rinsing
the system).

→ No air bubbles appear in the syringe or in the tubing.

Air bubbles appear in the syringe or in the tubing.

◆ Repeat this step.

26 Close the left cover.

→ A confirmation dialog is displayed.

27 Click Ok.

→ The dialog System is displayed.

→ Replacing the syringe is completed.

10.4.2 Replacing the tubing of the containers

Siemens Healthineers recommends replacement of the tubing of the containers by

Siemens Healthineers service.

With the tubing set, the tubing of the containers is supplied in 1 piece. The current tubing
to each container bears a colored marking that is assigned to a specific liquid, see the
table below.

Liquid Color

Diluent Blue

Buffer Red

Water White

Waste Green

Color assignment of the tubing of the containers

The current tubing of the water container contains a filter in addition.

✓ Disposable, absorbent cloth is available.

✓ 1 new tubing set is available.

✓ 1 side cutter is available.

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✓ 1 folding rule or tape measure is available.

✓ 1 new water filter is available.

✓ The system is off.

To replace the tubing of the containers, proceed as follows:

Replace the tubing of each container 1 at a time.

1 Have disposable, absorbent cloth available to absorb spilled liquid.

2 Cut the new tubing according to the lengths of the current, used tubing, see the
figure below.

9 2
3
4
2
5

7
8

Replacing the tubing

(1) Knurled screw with sealing ring

(2) Colored marking
(3) Tubing
(4) Cable
(5) Connector
(6) Spiral tube
(7) Cable ties
(8) Level sensor
(9) Water filter

3 Slide the new colored markings over both sides of the cut, new tubing according to
the colored markings of the used tubing.
4 With the side cutter, cut the cable ties fastening the spiral tube to the level sensor.

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5 Push the spiral tube away from the level sensor.

6 Loosen the used tubing from the connectors between tubing and cable.
7 Unscrew the knurled screw at both ends of the used tubing and pull it back.

8 Carefully pull off the used tubing from the system and the level sensor so it
cannot drip.

9 Remove the knurled screws and the sealing rings from the used tubing and set
them aside.

10 Remove the spiral tube from the used tubing and the cable.

11 Hold the new tubing in such a way that the openings do not touch the floor.

12 Slide the spiral tube over the new tubing and the cable.

13 Dispose of the used tubing according to national and local standards and regulations.

14 Fit a knurled screw and then a sealing ring to the end of the new tubing near the
system. The wider end of the sealing ring must face in the direction of the tubing end.
Approximately 1 mm of the tubing end should be visible.

15 Put this end of the tubing into the connection fitting of the system.

Make sure to put the tubing in the similarly colored connection fitting. When fitting the
water tubing, take care to fit the tubing end with the water filter into the connection
fitting of the system.

16 Tighten the knurled screw.

17 Fit the other knurled screw and then the sealing ring to the other end of the tubing.
The wider end of the sealing ring must face in the direction of the tubing end.
Approximately 1 mm of the tubing end should be visible.

18 Put this end of the tubing into the connection fitting of the level sensor.

Make sure to put the tubing in the connection fitting of the correct level sensor.

19 Tighten the knurled screw.

20 Insert the tubing into the connectors of the tubing and cable.

WARNING

Bends in the tubing can distort the mixing ratio in the cuvettes. False results
can occur.

Death or serious injury to the patient can result.

◆ Take care that the tubing is not bent.

◆ Fit a spiral tube around the tubing and cable to prevent bends in the tubing.

21 Fit the spiral tube around the upper part of the level sensor.

22 Fasten the spiral tube to the level sensor with 2 cable ties.

23 Check that the tubing is connected properly.

24 Repeat the procedure up to this step for each tubing.

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→ The tubing is replaced. A new water filter has to be inserted.

25 Cut the tubing of the water container (white markings) approximately 10 cm from
the connection fitting of the system, see the figure below.

1 1 2

3
4
3

Inserting the water filter

(1) Female Luer lock fittings

(2) Connection fitting of the system
(3) Male Luer lock fittings
(4) Water filter
(5) Water container

26 Fit the conical part of a female Luer lock fitting up to the flange in the tubing that
leads to the water container.

27 Fit the conical part of a male Luer lock fitting up to the flange in the tubing that leads
to the connection fitting of the system.

28 Insert the new water filter between the female and the male Luer lock fittings such
that the arrow points in the direction of flow of the water.

29 Start the system, see ( Page 144 Starting the system).

30 Rinse the system with buffer, diluent, and water (washing liquid), see
( Page 198 Rinsing the system).

→ No air bubbles appear in the buffer, diluent, and water tubing.

Air bubbles appear in the buffer, diluent, or water tubing.

◆ Repeat rinsing until no more air bubbles appear in the buffer, diluent, and
water tubing.

→ Replacing the tubing of the containers is completed.

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10.5 As needed tasks

This section describes the maintenance and cleaning tasks that must be performed
as needed.

10.5.1 Shutting down the system for maintenance

✓ The system is in standby or routine mode.

To shut down the system for maintenance, proceed as follows:

1 In the dialog Status, click the action button Exit.

→ A confirmation dialog is displayed.

2 Click Yes.

→ The system is rinsed with water. The system is shut down. The viewer
software closes.

3 Wait until the 3 LEDs in the upper right corner at the front of the system are off.

→ The system is shut down.

→ Shutting down the system for maintenance is completed.

10.5.2 Cleaning the surface of the system

Purging agents that contain alcohol affect acrylic glass surfaces, for example, the cover
windows. Do not use purging agents or purging solutions that contain alcohol to clean
acrylic glass surfaces.

✓ Soft, lint-free cloth is available.

✓ Purging solution is available.

✓ The system is in standby or routine mode or is off.

To clean the surface of the system, proceed as follows:

1 Prepare the purging solution according to the instruction manual of the purging
agent or contact Siemens Healthineers service.

2 Wipe the surface of the system with a soft, lint-free cloth moistened with
purging solution.

3 Allow the purging solution to take effect, according to the instructions from
the manufacturer.

→ Cleaning the surface of the system is completed.

10.5.3 Cleaning the sample rotor and the sample rotor housing
✓ Soft, lint-free cloth is available.

✓ Purging solution is available.

✓ The system is in standby or routine mode.

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To clean the sample rotor and the sample rotor housing, proceed as follows:

1 Prepare the purging solution according to the instruction manual of the purging
agent or contact Siemens Healthineers service.
2 In the dialog System, in the area Access, click Samples.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

3 Wait until a message is displayed.

4 Open the left cover.

→ Another message is displayed.

5 Remove all sample rotor segments.

6 Loosen the handwheel of the sample rotor, see the figure below. The handwheel
cannot be completely unscrewed.

Cleaning the sample rotor

(1) Handwheel
(2) Sample rotor
(3) Sample rotor housing

7 Remove the sample rotor by the handwheel.

8 Wipe the sample rotor and the sample rotor housing with a soft, lint-free cloth
moistened with purging solution.

9 Allow the purging solution to take effect, according to the instructions from
the manufacturer.

10 Place the sample rotor back. Turn the sample rotor slightly in both directions until it
locks in place.

11 Tighten the handwheel.

12 Clean the segments, see ( Page 230 Cleaning the segments).

13 Load sample rotor segments on the sample rotor as required, see

( Page 170 Loading sample rotor segments).

14 Close the left cover.

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→ The action button Close is displayed.

15 Click the action button Close.

→ The dialog System is displayed.

→ Cleaning the sample rotor and the sample rotor housing is completed.

10.5.4 Cleaning the segments

✓ Soft, lint-free cloth is available.

✓ Purging solution is available.

✓ The system is in standby or routine mode or is off.

To clean the segments, proceed as follows:

1 Prepare the purging solution according to the instruction manual of the purging
agent or contact Siemens Healthineers service.

2 Wipe the segments with a soft, lint-free cloth moistened with purging solution.

– or –

Spray the segments with purging solution and wash them in a dishwasher.

3 Allow the purging solution to take effect, according to the instructions from
the manufacturer.

→ Cleaning the segments is completed.

10.5.5 Cleaning the dilution station, the cuvette rotor, and the
cuvette rotor housing

During cleaning, dilution strips and cuvette segments have to be replaced. Existing
pre-dilutions in dilution strips and sample dilutions in cuvette segments are lost. No
assays for those pre-dilutions and sample dilutions will be processed. A delay of results
can occur. Only clean the dilution station, the cuvette rotor and the cuvette rotor
housing after all jobs have been processed.

✓ Soft, lint-free cloth is available.

✓ Purging solution is available.

✓ Unused dilution strips are available.

✓ Unused cuvette segments in original packaging are available.

✓ The system is in standby or routine mode.

To clean the dilution station, the cuvette rotor, and the cuvette rotor housing, proceed
as follows:

1 Prepare the purging solution according to the instruction manual of the purging
agent or contact Siemens Healthineers service.

2 In the dialog System, in the area Access, click Cuv. seg. & dil. strips.

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→ The dialog Access cuvette segments and dilution strips is displayed. For more
information on the dialog, click the action button Help or see ( Page 58 Access
cuvette segments and dilution strips).

No processing of jobs when the right cover is opened without access being requested
via the software. The stop function is triggered, the system's operation is interrupted,
and existing pre-dilutions may be rejected by the system. Delay of results can occur.

• Always request access through the right cover via the software.

• If the right cover was opened without access being requested, immediately close
the right cover.

3 Click the action button Cuv. seg. & dil. strips.

→ A progress bar is displayed. The system finishes current operations. This can take
several minutes.

4 Wait until a message is displayed.

5 Open the right cover.

→ Another message is displayed.

6 Remove the dilution frame, see the figure below.

3 2

Cleaning the dilution station

(1) Dilution frame

(2) Dilution strips
(3) Base plate

7 Remove the dilution strips from the dilution frame.

8 Wipe the base plate and the dilution frame with a soft, lint-free cloth moistened with
purging solution.

9 Allow the purging solution to take effect, according to the

manufacturer’s instructions.

10 Load unused dilution strips in the dilution frame.

11 Place the dilution frame back on the system.

12 Remove the cuvette rotor cover.

13 Remove all cuvette segments.

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14 Loosen the handwheel of the cuvette rotor, see the figure below. The handwheel
cannot be completely unscrewed.

3 2

1
4
2

0
5
6

9
7 8

Cleaning the cuvette rotor

(1) Handwheel
(2) Cuvette rotor
(3) Cuvette rotor housing

15 Remove the cuvette rotor by the handwheel.

16 Wipe the cuvette rotor and the cuvette rotor housing with a soft, lint-free cloth
moistened with purging solution.

17 Allow the purging solution to take effect, according to the

manufacturer’s instructions.

18 Place the cuvette rotor back. Turn the cuvette rotor slightly in both directions until it
locks in place.

19 Tighten the handwheel.

20 Load unused cuvette segments in the cuvette rotor.

21 Replace the cuvette rotor cover.

22 Click the action button Select all.

23 Click the action button Save.

→ A message is displayed.

24 Close the right cover.

→ The action button Close is displayed.

25 Click the action button Close.

→ The dialog System is displayed. The system detects the dilution strips and cuvette
segments. The system measures the blank values of the cuvette segments.

→ Cleaning the dilution station, the cuvette rotor, and the cuvette rotor housing
is completed.

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10.5.6 Cleaning the waste container

✓ 70 % ethanol or 70 % isopropyl alcohol is available.

✓ Optional: Purging agent is available.

✓ The system is off.

To clean the waste container, proceed as follows:

WARNING

Infection due to infectious waste

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle parts of the system that have come into contact with potentially
infectious material in accordance with good laboratory practices.

1 Pull the level sensor of the waste container 1–2 cm out of the waste container.

2 Unscrew the cap from the waste container. The level sensor remains in the cap.

3 Dispose of liquid waste according to national and local standards and regulations.

4 Fill 1/10 of the waste container with the specified alcohol.

5 Slew the waste container until the entire inner surface has been wetted.

6 Allow the alcohol to take effect, according to the instructions from the manufacturer.

7 Dispose of the alcohol according to national and local standards and regulations.

Siemens Healthineers recommends filling the waste container with some purging
agent to prevent unpleasant odors. Handle the purging agent according to the
instructions from the manufacturer.

8 Screw the cap back onto the waste container.

9 Push the level sensor back into the waste container.

10 Place the 2 pegs on the level sensor in the notches of the cap.

→ Cleaning the waste container is completed.

10.5.7 Cleaning the peripheral devices

Peripheral devices are, for example, the computer, the monitor, the keyboard, the
mouse, or a printer.

✓ Soft, lint-free cloth is available.

✓ Purging solution is available.

✓ The system is in standby or routine mode or is off.

To clean the peripheral devices, proceed as follows:

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1 Prepare the purging solution according to the instruction manual of the purging
agent or contact Siemens Healthineers service.
2 Close the viewer software, see ( Page 298 Closing viewer software).

3 Wipe the peripheral devices with a soft, lint-free cloth moistened with
purging solution.

4 Allow the purging solution to take effect, according to the

manufacturer’s instructions.

5 Start the viewer software, see ( Page 297 Starting viewer software).

→ Cleaning the peripheral devices is completed.

10.5.8 Replacing the probe cleaner bottle

The residual volume in the probe cleaner bottle is 3.9 mL.

✓ 1 new probe cleaner bottle is available.

✓ The system is in standby or routine mode.

To replace the probe cleaner bottle, proceed as follows:

1 In the dialog System, in the area Access, click System liquid & waste.
→ In the dialog Replace system liquids and empty waste container, a progress
bar is displayed. The system finishes current operations. This can take several
minutes. For more information on the dialog, click the action button Help or see
( Page 111 Replace system liquids and empty waste container).

2 Wait until the progress bar is no longer displayed.

No processing of jobs when the right cover is opened without access being requested
via the software. The stop function is triggered, the system's operation is interrupted,
and existing pre-dilutions may be rejected by the system. Delay of results can occur.

• Always request access through the right cover via the software.

• If the right cover was opened without access being requested, immediately close
the right cover.

3 Open the right cover.

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WARNING

Hardware problem due to froth on the probe cleaner. The probe may not be
sufficiently cleaned. False results can occur.

Death or serious injury to the patient can result.

◆ Do not shake the probe cleaner bottle.

◆ Do not pool probe cleaner bottles.
◆ If froth has formed, remove it.

Delay of results can occur due to froth on the probe cleaner.

4 Remove the cap from the new probe cleaner bottle.

5 Replace the empty probe cleaner bottle with the new probe cleaner bottle.

Do not replace dilution strips or cuvette segments while loading probe cleaner, as the
system would not update the status of the dilution strips or cuvette segments.

6 Close the right cover.

7 In the area Replaced system liquid, select Cleaner bottle replaced.

→ The action button Save becomes active.

8 Click the action button Save.

9 Wait until the dialog System is displayed.

→ Replacing the probe cleaner bottle is completed.

10.5.9 Preparing the purging solution

Prepare the purging solution according to the instruction manual of the purging agent
or contact Siemens Healthineers service.

10.5.10 Preparing the hypochlorite solution

✓ Sodium hypochlorite solution is available.

✓ Water is available.
✓ An alkali-resistant container is available.

✓ The system is in standby or routine mode or is off.

To prepare the hypochlorite solution, proceed as follows:

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WARNING

Hypochlorite solution can cause damage to the respiratory system through

inhalation. Hypochlorite solution can cause severe skin burns and eye damage if it
comes into contact with skin and eyes.

Death or serious injury to the user and bystanders can result.

◆ 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.
◆ Observe the instructions from the manufacturer regarding handling of
hypochlorite solution.
◆ Store and handle in a well ventilated area.
◆ Avoid breathing fume.
◆ Avoid contact with eyes and skin.
◆ Wash thoroughly after handling.
◆ In case of contact with eyes or skin, immediately rinse the affected area with
plenty of water for several minutes.
◆ In the event of an accident or if you feel unwell, seek medical advice immediately
and show the label if possible.

NOTICE

Hypochlorite solution is very toxic to aquatic life when released.

Environmental damage can result.

◆ Dispose of sodium hypochlorite solution and containers according to national

and local standards and regulations.

1 Calculate the required amount of the initial sodium hypochlorite solution depending
on the required amount of the 2–3 % hypochlorite solution.

V1 = (V2 ⋅ c2) / c1

With:

V1: Required amount of the initial sodium hypochlorite solution

c1: Concentration of the initial sodium hypochlorite solution

V2: Final volume of the 2–3 % hypochlorite solution

c2: Final concentration of the 2–3 % hypochlorite solution

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2 Calculate the required amount of purified water to make up the final volume of the
2–3 % hypochlorite solution.

VW = V2 – V1

With:

VW: Required amount of water

V2: Final volume of the 2–3 % hypochlorite solution

V1: Required amount of the initial sodium hypochlorite solution

3 Fill the required amount of water into an alkali-resistant container.

4 Add the required amount of the initial sodium hypochlorite solution to the water.

→ Preparing the hypochlorite solution is completed.

Example The initial sodium hypochlorite solution is concentrated to 14 %. The required amount
of a 2 % hypochlorite solution is 1000 mL.

The required amount of the initial sodium hypochlorite solution is calculated as follows:

V1 = (V2 ⋅ c2) / c1 = (1000 mL ⋅ 2 %) / 14 % = 143 mL

The required amount of water is calculated as follows:

VW = V2 – V1 = 1000 mL - 143 mL = 857 mL

1 Fill an alkali-resistant container with 857 mL of water.

2 Add 143 mL of the 14 % initial sodium hypochlorite solution to make up 1000 mL of

a 2 % hypochlorite solution.

10.6 Atellica® NEPH 630 System maintenance log

Analyzer ID:

Weekly maintenance Week 1 Week 2 Week 3 Week 4 Week 5

1. Functioning of
the probe
checked

2. Probe cleaned

3. Wet station
cleaned

4. Reagent rotor
and reagent rotor
housing cleaned

5. Syringe checked
for leaks

6. Water container
cleaned

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Weekly maintenance Week 1 Week 2 Week 3 Week 4 Week 5

7. Tubing of the
containers
checked

8. Tubing of the
probe checked

9. System shut
down

10. System started

Remark:

Date:

Signature:

Monthly maintenance

1. Tubing purged

2. Water filter replaced

3. Level sensors cleaned

Remark:

Date:

Signature:

Yearly maintenance

1. Syringe replaced

2. Tubing replaced

Remark:

Date:

Signature:

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 11 Troubleshooting

11 Troubleshooting
This chapter describes the troubleshooting of the system.

11.1 Carrying out troubleshooting

To carry out troubleshooting, proceed as follows:

1 Check if the problem is a hardware problem.

The problem is a hardware problem.

◆ Check if the problem is described in the hardware troubleshooting chart, see

( Page 240 Hardware troubleshooting chart).

The problem is not a hardware problem.

◆ Go to the next step.

2 Check if a Message window is displayed.

A Message window is displayed.

◆ Follow the instructions given in the Message window, below Explanation.

◆ In the Message window, click OK.
◆ If the problem is not solved, check if a description and appropriate corrective
measures to the problem is available, see ( Page 265 Software troubleshooting).

No Message window is displayed.

◆ Go to the next step.

3 Check if a status button is highlighted.

A status button is highlighted.

◆ Place the mouse pointer over the highlighted status button.

◆ Register the displayed tool tip text that specifies the problem.
◆ Click the highlighted status button.
◆ If the dialog Logbook is displayed, click the most recent entry that corresponds
to the tool tip text and follow the instructions on how to solve the problem,
see ( Page 100 Logbook). For more information on the dialog, click the action
button Help.
◆ If the dialog where the problem can be solved is displayed, solve the problem that
was specified in the tool tip text.

No status button is highlighted.

◆ Check if a description and appropriate corrective measures to the problem is

available, see ( Page 265 Software troubleshooting).

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 11 Troubleshooting

4 If none of the above mentioned corrective measures solves the problem, contact
Siemens Healthineers service.

→ Troubleshooting is completed.

11.2 Hardware troubleshooting

This chapter lists possible hardware problems that could occur during operation of the
system together with probable causes and corrective measures. If the recommended
measures do not solve the problem, contact Siemens Healthineers service.

11.2.1 Hardware troubleshooting chart

The chart below describes possible hardware problems and probable causes. To solve a
problem, follow the instructions described in the right column of the chart.

Problem Probable cause Corrective measure

System does not start when the main Supply cable is not plugged into Plug the supply cable into the power
switch is set to position I. the power module at the right side module at the right side of the system.
of the system.

Supply cable is not plugged Plug the supply cable into a wall outlet
into a wall outlet meeting the meeting the electrical conditions, see
electrical conditions. ( Page 302 Electrical conditions).

Supply cable is damaged. At the right side of the system, set the
main switch to position O and replace the
supply cable.

Circuit breaker in electrical circuit Reset the circuit breaker.

of building is tripped.

Fuses are blown. Replace the fuses, see

( Page 245 Replacing the fuses).

Electrical failure of the system. Contact Siemens Healthineers service.

3 LEDs in the upper right corner at the Electrical failure of the system. Re-start the system. If the 3 LEDs
front of the system do not light up after still do not light up, contact Siemens
the main switch has been set to position I. Healthineers service.

Computer, monitor, or printer does not Supply cable is not plugged Plug the supply cable into the power
start when switched on. into the power module of the module of the computer, monitor,
computer, monitor, or printer. or printer.

Supply cable of the computer, Plug the supply cable of the computer,
monitor, or printer is not plugged monitor, or printer into a wall outlet
into a wall outlet meeting the meeting the electrical conditions, see
electrical conditions. ( Page 302 Electrical conditions).

Supply cable of the computer, Switch off the computer, monitor, or

monitor, or printer is damaged. printer and replace the supply cable.

Circuit breaker in electrical circuit Reset the circuit breaker.

of building is tripped.

Electrical failure of the computer, Contact Siemens Healthineers service.

monitor, or printer.

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Problem Probable cause Corrective measure

Probe is bent. Probe has collided with a Replace the probe assembly, see
solid object. ( Page 248 Replacing the
probe assembly).

Air bubbles appear in the tubing. Valve is leaking or tubing is bent • Check if the external tubing is
or leaking. bent and ensure that the tubing is
connected properly.
• Rinse the system, see
( Page 198 Rinsing the system).

• If air bubbles still appear, contact

Siemens Healthineers service.

Liquid accumulates within the system. Tubing of the probe or syringe has Re-tighten the tubing of the probe
not been tightened correctly. and syringe.

Probe leaks. Replace the syringe, see

( Page 220 Replacing the syringe).

Tubing leading to the waste Replace the tubing, see

container is bent. ( Page 224 Replacing the tubing of
the containers).

Liquid accumulates under the system. - Contact Siemens Healthineers service.

Reagent rotor makes scratching noises. 1 or more reagent rotor segments Insert the reagent rotor segments
have not been inserted correctly. correctly, see ( Page 241 Inserting
reagent rotor segments).

Too much ice has built up in the • Shut down the system, see
reagent rotor. ( Page 199 Shutting down
the system).
• Wait until the ice has
melted completely.
• Re-start the system, see
( Page 144 Starting the system).

Dilution cups or cuvettes remain empty Probe is blocked, for example, by a Check the functioning of the probe, see
even though the system processes jobs. clot that has been aspirated. ( Page 204 Checking the functioning of
the probe).

Other hardware problem with the Electrical or mechanical failure Contact Siemens Healthineers service.
system, computer, monitor, or printer has occured.
has occurred.

Hardware troubleshooting chart

11.2.2 Inserting reagent rotor segments

When the reagent rotor makes scratching noises, reagent rotor segments may not be
inserted correctly. In this case, reagent rotor segments have to be inserted correctly.

✓ The system is in standby or routine mode.

To insert reagent rotor segments, proceed as follows:

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1 In the dialog System, in the area Access, click Reagents.

→ In the dialog Access reagents, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access reagents).

2 Wait until a message is displayed.

3 Open the left and right covers.

→ Another message is displayed.

4 Remove the reagent rotor cover.

5 Push down the white and yellow parts of all reagent rotor segments next to
the handwheel.
→ A clicking noise indicates that a reagent rotor segment was not inserted correctly
but is now in the correct position.

6 Replace the reagent rotor cover.

7 Close the left and right covers.

→ The action button Close is displayed.

8 Click the action button Close.

→ The dialog System is displayed. The barcode reader scans the barcodes of the vials
in the reagent rotor. The reagent rotor segments have been inserted correctly if no
more scratching noises occur.

→ Inserting reagent rotor segments is completed.

11.2.3 Checking the level of samples visually

✓ The system is in standby or routine mode.
To check the level of samples visually, proceed as follows:

WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

1 In the dialog System, in the area Access, click Samples.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

2 Wait until a message is displayed.

3 Open the left cover.

→ Another message is displayed.

4 Remove the affected sample tube.

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5 Check that the sample material is of sufficient volume.

Approximately 10 mm of supernatant serum or plasma above the packed cells or

separating gel is required. If using 75 mm x 12 mm sample tubes, 450–500 μL plasma
is required.

6 Refill the sample tube with an appropriate amount of the same sample material,
if required.

WARNING

False results due to froth causing incorrect level detection. Accurate transfer of
the sample cannot be guaranteed.

Death or serious injury to the patient can result.

◆ Remove froth before loading samples.

7 Load the sample tube in the same position of the sample rotor segment. Carefully
push down the sample tube until it touches the base of the sample rotor segment.

8 Close the left cover.

→ The action button Close is displayed.

9 Click the action button Close.

→ The dialog System is displayed. The samples are loaded. The barcode reader scans
the barcodes in the sample rotor.

→ Checking the level of samples visually is completed.

11.2.4 Checking the level of reagents or controls

✓ The system is in standby or routine mode.
To check the level of reagents or controls, proceed as follows:

WARNING

Infection due to potentially infectious reagents and controls

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle reagents and controls in accordance with good laboratory practices.

1 In the dialog System, in the area Access, click Reagents.

→ In the dialog Access reagents, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access reagents).

2 Wait until a message is displayed.

3 Open the left and right covers.

→ Another message is displayed.

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4 Remove the reagent rotor cover.

5 Remove the affected reagent or control vial.

6 Remove the evaporation cap from the reagent or control vial.

7 Check that the reagent or control material is of sufficient volume.

WARNING

False results due to froth or lamellae causing incorrect level detection. Accurate
transfer of the reagent or control cannot be guaranteed. False results due to
increased concentration of reagents and controls. Concentration can increase
due to evaporation out of open reagent or control vials.

Death or serious injury to the patient can result.

◆ Remove froth and lamellae before placing evaporation caps on reagent and
control vials.
◆ Carefully follow the instructions given below.
◆ For more information on on-board stability of reagents and controls, see
the separate document assay protocols and the instructions for use of
the product.

8 Replace evaporation caps on the reagent and control vials, see the figure below.

2
4
3

Placing evaporation caps

(1) Evaporation cap

(2) Vertical striation
(3) Barcode
(4) Reagent or control vial

The vertical striation on the evaporation cap and the barcode on the label of the vial
must be aligned.

Do not tilt reagent and control vials with evaporation caps on. Evaporation caps do not
prevent liquid from spilling.

9 Reload the reagent or control vial in the same position of the reagent rotor segment.

10 Replace the reagent rotor cover.

11 Close the left and right covers.

→ The action button Close is displayed.

12 Click the action button Close.

→ The dialog System is displayed. The barcode reader scans the barcodes of the vials
in the reagent rotor.

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→ Checking the level of reagents or controls is completed.

11.2.5 Checking the geometry of the probe

When the probe has collided with a solid object, for example, an evaporation cap, the
geometry of the probe must be checked.

✓ The system is in standby or routine mode.

To check the geometry of the probe, proceed as follows:

1 In the dialog System, in the area Initialization, click Probe.

→ A confirmation dialog is displayed.

2 Click Yes.

→ The system initializes the probe.

3 Wait until the information dialog Initialization of probe completed is displayed.

4 Click Ok.

→ The dialog System is displayed.

5 In the area Hardware check, click Probe.

→ In the dialog Hardware check - probe, a progress bar is displayed. The system
finishes current operations. This can take several minutes.

6 Wait until a confirmation dialog is displayed.

7 Click Yes.

→ The geometry of the probe is checked. The probe moves in a predefined track along
the inside of the dispensing area. An information dialog is displayed saying that the
checking is complete.

An information dialog is displayed saying that the checking has been canceled.

If the probe is bent, it will touch the inside of the dispensing area. The system will
display an information dialog accordingly.

◆ Click Ok.
◆ Replace the probe assembly, see ( Page 248 Replacing the probe assembly).

8 Click Ok.

→ The dialog System is displayed

→ Checking the geometry of the probe is completed.

11.2.6 Replacing the fuses

If the fuses are blown, replace the fuses with the same type, see
( Page 302 Electrical conditions).

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✓ 1 set of replacement fuses is available.

✓ 1 small, blade-type screwdriver is available.

✓ The system is off.

To replace the fuses, proceed as follows:

WARNING

Electric shock due to contact with live parts. Even when the system is shut
down, some components, for example, capacitors, can be live as they can still be
electrically charged.

Death or serious injury to the user can result.

◆ Unplug the supply cable from the power supply socket before replacing
the fuses.

WARNING

When the fuses are blown, the reagent cooler is off. False results can occur due to
uncooled reagents and controls.
Death or serious injury to the patient can result.
◆ If the system is not re-started immediately, remove reagent and control vials,
including evaporation caps, from the system and return them to the refrigerator.

1 Pry open the fuse holder by lifting the clip at the bottom using a small, blade-type
screwdriver, see the figure below.

2
3
230

Removing the fuse holder

(1) Power module

(2) Fuse holder
(3) Window
(4) Clip

2 Pull the fuse holder out of the power module.

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NOTICE

Malfunctions and electrical failure due to inadequate fuses

Damage to the system can result.

◆ Only use fuses whose electrical rating matches the number displayed in the
window of the fuse holder.

3 Check the electrical rating of the replacement fuses.

→ The electrical rating of the replacement fuses matches the number displayed in
the window of the fuse holder. For example, the electrical rating of 230 V of the
replacement fuses matches 230 in the window.

The electrical rating of the replacement fuses does not match the number displayed
in the window of the fuse holder.

◆ Provide replacement fuses that match the number displayed in the window of the
fuse holder, see ( Page 302 Electrical conditions).

NOTICE

Malfunctions and electrical failure due to incorrectly inserted gray inset

Damage to the system can result.

◆ Do not remove the gray inset from the fuse holder.

4 Remove the used fuses from the gray inset within the fuse holder, see the
figure below.

1 1

3
230

Removing the fuses

(1) Fuses
(2) Gray inset
(3) Fuse holder
(4) Clip

5 Insert replacement fuses with the appropriate electrical rating into the gray inset.

6 With the clip facing downward, push the fuse holder into the power module until a
clicking sound is heard.

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→ The fuse holder is inserted correctly.

7 At the right side of the system, plug the supply cable in the power supply socket.
8 Start the system, see ( Page 144 Starting the system).

→ Replacing the fuses is completed.

11.2.7 Replacing the probe assembly

No processing of jobs when the right cover is opened without access being requested
via the software. The stop function is triggered, the system's operation is interrupted,
and existing pre-dilutions may be rejected by the system. Delay of results can occur.

• Always request access through the right cover via the software.

• If the right cover was opened without access being requested, immediately close
the right cover.

✓ Disposable, absorbent cloth is available.

✓ 70 % ethanol or 70 % isopropyl alcohol is available.

✓ 1 new probe assembly is available.

✓ The system is in standby or routine mode.

To replace the probe assembly, perform the following tasks:

WARNING

Infection due to contaminated material and injury to hands due to sharp edges
Death or serious injury to the user can result.

◆ Only trained users are allowed to replace the probe assembly.

◆ Be especially careful of the sharp probe tip and other sharp edges.
◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle parts of the system that have come into contact with potentially
infectious material in accordance with good laboratory practices.

1 Clean the dispensing area, see ( Page 249 Clean dispensing area).

2 Shut down the system, see ( Page 250 Shut down system).

3 Re-start the system, see ( Page 251 Re-start system).

4 Prepare the de-installation of the used probe assembly, see ( Page 252 Prepare
de-installation of used probe assembly).

5 De-install the used probe assembly, see ( Page 253 De-install used probe assembly).

6 Install the new probe assembly, see ( Page 257 Install new probe assembly).

7 Shut down the system, see ( Page 263 Shut down system).

8 Re-start the system, see ( Page 263 Re-start system).

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→ Replacing the probe assembly is completed.

Clean dispensing area To clean the dispensing area, proceed as follows:

NOTICE

Crystals in the dispensing area can cause the failure of the automatic adjustment
of the probe

Damage to the system can result.

◆ Thoroughly follow the instructions given below.

1 In the dialog System, in the area Maintenance, click Clean probe.

→ In the dialog Clean probe, a progress bar is displayed. The system finishes current
operations. This can take several minutes. For more information on the dialog, click
the action button Help or see ( Page 65 Clean probe).

2 Wait until a message is displayed.

3 Click the action button Park probe for cleaning.

→ The probe moves to the parking position.

4 Wait until another message is displayed.

→ The probe is in the parking position.

5 Open the right cover.

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WARNING

Contamination of the buffer reservoir can cause dilution of the buffer used for
measurement. Buffer can become unusable. False results can occur.

Death or serious injury to the patient can result.

◆ Do not contaminate the buffer reservoir during cleaning.

6 Wipe the surface of the wet station with a soft, lint-free cloth moistened with the
specified alcohol, see the figure below.

2
3
4

Cleaning the wet station

(1) Wet station

(2) Fountain area
(3) Dispensing area
(4) Buffer reservoir
(5) Dilution frame

7 Remove the dilution frame.

8 Wipe the dispensing area, including the inside, with a soft, lint-free cloth moistened
with the specified alcohol.

9 Close the right cover.

→ The action button Close becomes active.

10 Click the action button Close.

→ An information dialog is displayed.

11 Click Ok.

12 Shut down the system, see ( Page 250 Shut down system).

→ Cleaning the dispensing area is completed.

Shut down system To shut down the system, proceed as follows:

1 In the dialog Status, click the action button Exit.

→ A confirmation dialog is displayed.

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2 Click Yes.

→ The system is rinsed with water. The system is shut down. The viewer
software closes.
3 Wait until the 3 LEDs in the upper right corner at the front of the system are off.

WARNING

When the system shuts down, the reagent cooler is switched off. False results
can occur due to uncooled reagents and controls.

Death or serious injury to the patient can result.

◆ If the system is shut down for more than 2 hours, remove reagent and
control vials, including evaporation caps, from the system and return them
to the refrigerator.

4 At the right side of the system, set the main switch to position O.

→ The system is off.

5 Pull the level sensor of the waste container 1–2 cm out of the waste container.

6 Unscrew the cap from the waste container. The level sensor remains in the cap.

7 Dispose of the liquid waste according to national and local standards and regulations.

8 Screw the cap back on to the waste container.

9 Push the level sensor back into the waste container.

10 Place the 2 pegs on the level sensor in the notches on the cap.

11 Re-start the system, see ( Page 251 Re-start system).

→ Shutting down the system is completed.

Re-start system To re-start the system, proceed as follows:

NOTICE

If the system is re-started too soon after a shutdown, failure of electrical parts of
the system can result.

Damage to the system can result.

◆ Wait at least 10 sbefore re-starting the system after a shutdown.

1 Make sure that the reagent rotor and cuvette rotor covers are inserted correctly and
that the covers are closed correctly.

2 Check that the filling level of the system liquids is sufficient.

→ The filling level of the system liquids is sufficient.

The filling level of at least 1 system liquid is low.

◆ Replace the affected system liquids, see ( Page 146 Replacing system liquids).

3 Check that each level sensor is inserted properly in the corresponding container.

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Make sure that the level sensor is inserted at an angle into the corresponding
container. The free end of the level sensor inside the container must point away from
the opening in the container so that the floater at the end of the level sensor can move
up and down freely.

The tubing bears differently colored markings, see ( Page 47 Liquid containers, level
sensors, and tubing).

4 At the right side of the system, set the main switch to position I.
→ The system starts.

5 Wait until the 3 LEDs in the upper right corner at the front of the system are on.

6 At the bottom left of the desktop screen, click > All Programs > ANEPH630
> ANEPH 630 ISP.

→ The instrument support program starts. The dialog Log on is displayed.

7 Enter user name and password.

8 Click Login.

→ The dialog Instrument Support Program is displayed. An information dialog

is displayed.
9 Click Ok.

10 Prepare the de-installation of the used probe assembly, see ( Page 252 Prepare
de-installation of used probe assembly).

→ Re-starting the system is completed.

Prepare de-installation of used To prepare the de-installation of the used probe assembly, proceed as follows:
probe assembly
1 At the bottom of the instrument support program, in the area BASIC, click
Probe exchange.

→ The dialog Probe Exchange is displayed.

2 On the left, click Exchange probe.

→ An information dialog is displayed. The probe moves to the wash station.

3 Open the right cover.

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4 Remove the dilution frame, see the figure below.

Removing the dilution frame

(1) Dilution frame

5 Close the right cover.

6 Click Ok.
→ Another information dialog is displayed. The probe moves to the parking position.

Do not select OK again until the new probe assembly is installed.

7 De-install the used probe assembly, see ( Page 253 De-install used probe assembly).

→ Preparing the de-installation of the used probe assembly is completed.

De-install used probe assembly To de-install the used probe assembly, proceed as follows:

WARNING

During the time the instrument support program is running, protective guards can
be switched off and the probe can start moving even though the covers are open.
Infection due to contaminated material can occur. Injury to hands due to sharp
edges can occur.

Death or serious injury to the user can result.

◆ Be especially careful of the sharp probe tip and other sharp edges.
◆ Secure the probe tip of the used and the new probe assembly while handling
probe assemblies. A protective sleeve is delivered with the new probe assembly.

1 Open the right cover.

2 Place a disposable, absorbent cloth beneath the used probe assembly so that spilled
liquid will be absorbed.

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3 Loosen the knurled nut, see the figure below.

Disconnecting the used probe assembly

(1) Knurled nut

(2) Electrical connector
(3) Bracket
(4) Printed circuit board

4 Position the knurled nut in the bracket with the opening pointing upward.

5 Wipe the probe with an absorbent cloth to remove liquid from the tip of the probe.

6 Carefully pull the electrical connector out of the socket on the printed circuit board.

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7 With 1 hand, hold the gearwheel left of the probe assembly, see the figure below.

Loosening the used probe assembly

(1) Gearwheel
(2) Printed circuit board
(3) Holder

8 With the other hand, grasp the holder on both sides of the probe.

NOTICE

System failure due to damaged printed circuit board

Damage to the system can result.

◆ Take special care not to scratch the printed circuit board with any part of the
used probe assembly during de-installation.

9 Hold the gearwheel steady and carefully pull the used probe assembly a little
toward you.

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10 Secure the probe tip of the used probe assembly with the protective sleeve.

Securing the probe tip

(1) Wedge
(2) Notch
(3) Spring
(4) Protective sleeve
(5) Probe tip
11 Carefully push the used probe assembly upward, against the force of the spring.

→ The wedges come free of the notches.

12 Carefully pull the used probe assembly forward and tilt it slightly, if required.

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13 Still holding the used probe assembly, place the bolt on the bolt tray, see the
figure below.

Placing the bolt on the bolt tray

(1) Notches
(2) Bolt
(3) Bolt tray

14 Carefully remove the used probe assembly from the system.

15 Remove the protective sleeve from the used probe assembly and set it aside for
further use.

16 Dispose of the used probe assembly according to national and local standards
and regulations.

17 Install the new probe assembly, see ( Page 257 Install new probe assembly).

→ De-installing the used probe assembly is completed.

Install new probe assembly To install the new probe assembly proceed as follows:

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WARNING

During the time the instrument support program is running, protective guards can
be switched off and the probe can start moving even though the covers are open.
Infection due to contaminated material can occur. Injury to hands due to sharp
edges can occur.

Death or serious injury to the user can result.

◆ Be especially careful of the sharp probe tip and other sharp edges.
◆ Secure the probe tip of the used and the new probe assembly while handling
probe assemblies. A protective sleeve is delivered with the new probe assembly.

NOTICE

System failure due to damaged probe assembly

Damage to the system can result.

◆ Grasp the new probe assembly only at the holder on both sides of the probe.

1 Secure the probe tip of the new probe assembly with the protective sleeve.
2 With 1 hand, hold the gearwheel steady throughout the installation of the new
probe assembly.

3 With the other hand, grasp the new probe assembly at the holder on both sides of the
probe, see the figure below.

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NOTICE

System failure due to damaged printed circuit board

Damage to the system can result.

◆ Take special care not to scratch the printed circuit board with any part of the
used probe assembly during installation.

4 Hold the new probe assembly vertically and tilt it slightly, if required, to avoid collision
with the wet station, see the figure below.

5
6

Picking up the bolt from the bolt tray

(1) Gearwheel
(2) Printed circuit board
(3) Holder
(4) Bolt
(5) Recess
(6) Bolt tray
(7) Spring

5 Pick up the bolt from the bolt tray using the recess at the back of the holder.

→ The spring attached to the bolt is extended.

6 Carefully push the new probe assembly upward, against the force of the spring.

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7 Carefully place the wedges at the back of the new probe assembly in the notches, see
the figure below.

Mounting the new probe assembly

(1) Wedge
(2) Notch
(3) Holder
(4) Spring
8 Slowly let go of the holder.

→ The spring brings the new probe assembly into the correct position.

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9 Carefully plug the electrical connector into the socket on the printed circuit board, see
the figure below.

1 2

3
4
5

Connecting the new probe assembly

(1) Threaded connector

(2) Printed circuit board
(3) Socket
(4) Knurled nut
(5) Bracket
(6) Electrical connector

The electrical connector is shaped in such a way that it is not possible to plug it into the
socket the wrong way. If the electrical connector cannot be plugged into the socket,
turn it 180° and try again.

Ensure that the cable routing of the electrical connector is correct. First the cable runs
down, then it turns up 180°. The cable must run behind the knurled nut.

10 Remove the knurled nut from the bracket.

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WARNING

If the knurled nut is incorrectly screwed to the threaded connector, liquids can
leak from the tubing. False results can occur. Spilled liquids can come into
contact with live parts. System failure due to short-circuit can occur.

Death or serious injury to the patient can result. Damage to the system
can result
◆ Screw the knurled nut hand-tight to the threaded connector.

11 If the tubing of the probe is stuck, for example, on the edge of the printed circuit
board, carefully free it, see the figure below.

1
2

Freeing the tubing

(1) Printed circuit board

(2) Tubing
(3) Protective sleeve

12 Remove the disposable, absorbent cloth beneath the new probe assembly.

13 Carefully remove the protective sleeve from the new probe assembly.

14 Close the right cover.

15 In the information dialog, click OK.

→ The dialog Probe Exchange is displayed. Adjustment of the probe starts

automatically. Different checks are carried out successively. At the right of the
dialog, check boxes are checked off successively. This can take up to 20 minutes.

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16 Wait until all check boxes are checked off.

→ On the right, the button Close becomes active.

Not all check boxes are checked off and an information dialog is displayed.
◆ Contact Siemens Healthineers service immediately.

17 On the right, click Close.

→ A confirmation dialog is displayed.

18 Click Yes.

→ The dialog Instrument Support Program is displayed.

19 On the left, click Exit.

→ A confirmation dialog is displayed.

20 Click Ok.

→ An information dialog is displayed.

21 Click Ok.

→ The instrument support program is closed. The desktop screen is displayed.

22 Shut down the system, see ( Page 263 Shut down system).

→ Installing the new probe assembly is completed.

Shut down system To shut down the system, proceed as follows:

1 At the right side of the system, set the main switch to position O.
→ The system is off.

2 Open the right cover.

3 Replace the dilution frame.

4 Close the right cover.

5 Re-start the system, see ( Page 263 Re-start system).

→ Shutting down the system is completed.

Re-start system To re-start the system, proceed as follows:

NOTICE

If the system is re-started too soon after a shutdown, failure of electrical parts of
the system can result.

Damage to the system can result.

◆ Wait at least 10 sbefore re-starting the system after a shutdown.

1 Make sure that the reagent rotor and cuvette rotor covers are inserted correctly and
that the covers are closed correctly.
2 Check that the filling level of the system liquids is sufficient.

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→ The filling level of the system liquids is sufficient.

The filling level of at least 1 system liquid is low.

◆ Replace the affected system liquids, see ( Page 146 Replacing system liquids).

3 Check that each level sensor is inserted properly in the corresponding container.

Make sure that the level sensor is inserted at an angle into the corresponding
container. The free end of the level sensor inside the container must point away from
the opening in the container so that the floater at the end of the level sensor can move
up and down freely.

The tubing bears differently colored markings, see ( Page 47 Liquid containers, level
sensors, and tubing).

4 At the right side of the system, set the main switch to position I.

→ The system starts.

5 Wait until the 3 LEDs in the upper right corner at the front of the system are on.

6 Start the viewer software, see ( Page 297 Starting viewer software).

→ Re-starting the system is completed.

11.2.8 Troubleshooting the syringe

✓ Soft, lint-free cloth is available.

✓ The system is in standby or routine mode.

To troubleshoot the syringe, for example, if there is liquid in the straining ring, proceed
as follows:

1 In the dialog System, in the area Maintenance, click Replace syringe.

→ In the dialog Replace syringe, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 111 Replace syringe).

2 Wait until a confirmation dialog is displayed.

3 Click Yes.

4 Wait until a message is displayed.

5 Open the left cover.

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6 If there is liquid in the straining ring, dry the straining ring with a soft, lint-free cloth,
see the figure below.

Troubleshooting the syringe

(1) Tubing
(2) Syringe
(3) Straining ring

7 Re-tighten the tubing on both sides of the syringe.

8 Rinse the system with diluent only, see ( Page 198 Rinsing the system).

→ No liquid is in the straining ring

There is liquid in the straining ring.

◆ Replace the syringe, see ( Page 220 Replacing the syringe).

→ Troubleshooting the syringe is completed.

11.3 Software troubleshooting

This chapter lists possible software problems that could occur during system operation
together with probable causes and corrective measures. If the recommended measures
do not solve the problem, contact Siemens Healthineers service.

11.3.1 Message window

This chapter describes software problems displayed in the Message window.

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Position without barcode Probable cause:

detected on sample rotor
• A sample that was identified manually has been removed. Another sample is loaded
in the same position and the barcode cannot be read. The Message window displays
that a position without barcode has been detected and that the previous assignment
will be used.

Corrective measure:
1 In the Message window, click OK.

→ The previous assignment is applied to the affected position.

2 Remove the previous assignment of the sample ID from the affected position of
the sample rotor segment, see ( Page 185 Removing previous assignments of
sample IDs).

3 In the navigation bar, click Loading.

→ The dialog Loading samples is displayed. For more information on the dialog, click
the action button Help or see ( Page 94 Loading samples).

4 Click the action button Access.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

5 Wait until a message is displayed.

6 Open the left cover.

→ Another message is displayed.

7 Holding the sample rotor segment at its grip and with the sample tubes facing
towards the outer edge, place the sample rotor segment over an empty position of
the sample rotor.

8 Take care that the sample rotor segment slides easily in the guide rails below
the handwheel.

9 Carefully push down the sample rotor segment next to the handwheel.

10 Close the left cover.

→ The action button Close is displayed.

11 Click the action button Close.

→ The dialog System is displayed.

12 Identify the sample manually, see ( Page 171 Identifying a sample or standard with
unreadable barcode).

→ The sample is identified.

The problem is not solved.

◆ Contact Siemens Healthineers service.

→ Troubleshooting is completed.

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Position without barcode Probable cause:

detected on reagent rotor
• A reagent or control that was identified manually is empty. Another reagent or control
is loaded in the same position and the barcode cannot be read. The Message window
displays that a position without barcode has been detected and that the previous
assignment will be used.

Corrective measure:

No processing of jobs when the right cover is opened without access being requested
via the software. The stop function is triggered, the system's operation is interrupted,
and existing pre-dilutions may be rejected by the system. Delay of results can occur.

• Always request access through the right cover via the software.

• If the right cover was opened without access being requested, immediately close
the right cover.

1 In the Message window, click OK.

→ The previous assignment is applied to the affected position.

2 In the dialog Loading, click the action button Reagents.

→ In the dialog Loading reagents, the table view is displayed. For more information
on the dialog, click the action button Help or see ( Page 88 Loading reagents).

3 Click the action button Graphic.

→ In the dialog Loading reagents, the graphic overview is displayed.

4 In the diagram of the reagent rotor, click the affected reagent rotor segment.
→ A diagram of the reagent rotor segment is displayed on the right. The action button
Access becomes active.

5 Click the action button Access.

→ In the dialog Access reagents, a progress bar is displayed. The system finishes
current operations. This can take several minutes. The system moves the affected
reagent rotor segment to the position below the access lid of the reagent rotor
cover. For more information on the dialog, click the action button Help or see
( Page 60 Access reagents).

6 Wait until a message is displayed.

7 Open the right cover.

→ Another message is displayed.

8 Open the access lid of the reagent rotor cover.

9 Remove the affected reagent rotor segment.

10 Close the access lid of the reagent rotor cover.

11 Close the right cover.

→ The action button Close is displayed.

12 Click the action button Close.

→ In the dialog Loading reagents, the table view is displayed. The previous
assignment to the reagent rotor segment is deleted.

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13 Click the action button Graphic.

→ In the dialog Loading reagents, the graphic overview is displayed.

14 In the diagram of the reagent rotor, click the affected reagent rotor segment.

→ The action button Access becomes active.

15 Click the action button Access.

→ In the dialog Access reagents, a progress bar is displayed. The system finishes
current operations. This can take several minutes. The system moves the affected
reagent rotor segment to the position below the access lid of the reagent rotor
cover. For more information on the dialog, click the action button Help or see
( Page 60 Access reagents).

16 Wait until a message is displayed.

17 Open the right cover.

→ Another message is displayed.

18 Open the access lid of the reagent rotor cover.

19 Replace the affected reagent rotor segment.

20 Close the access lid of the reagent rotor cover.

21 Close the right cover.

→ The action button Close is displayed.

22 Click the action button Close.

→ The dialog Loading reagents is displayed. The barcode reader scans the barcodes
of the vials in the reagent rotor.

23 In the list Reagent status, select To be identified.

→ In the table, the reagent or control that needs to be identified is displayed.

24 Click the action button Identify.

→ In the dialog Loading reagents, a list of reagents and controls and a graphic of
a reagent rotor segment is displayed. The position of the unidentified reagent or
control is marked with a ?. For more information on the dialog, click the action button
Help or see ( Page 92 Loading reagents, identify reagents and controls).

25 In the graphic, click the position that is marked with a ?.

26 In the input field Lot reference, enter the identifier number and the lot number of the
reagent or control.

27 Left of the graphic, select if the material is a reagent or a control.

28 Click the action button Save.

→ The dialog Loading reagents is displayed. The barcode reader scans the barcodes
of the vials in the reagent rotor. The reagent or control is identified.

The problem is not solved.

◆ Contact Siemens Healthineers service.

→ Troubleshooting is completed.

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11.3.2 Status bar

This chapter describes software problems related to the buttons in the status bar.

Status button Samples & Check first:

Standards is yellow or red
• In the dialog Loading samples, in the schematic overview of the sample rotor
segment, at least 1 position is marked with a ?.

Probable cause:

• A sample tube carries a static charge. The level of the affected sample cannot
be measured.

Corrective measure:

1 In the dialog Loading samples, in the schematic overview of the sample

rotor segment, click the position of the affected sample tube, see
( Page 94 Loading samples).

→ The selected position is framed by blue lines. The action button Level detection
becomes active. For more information on the dialog, click the action button Help.

2 Click the action button Level detection.

→ The probe detects the level in the sample tube. The affected position is no longer
marked with a ?. The static charge has dissipated. Troubleshooting is completed.

The affected position is still marked with a ?.

◆ Check the level of the sample visually, see ( Page 242 Checking the level of
samples visually).
◆ In the dialog Loading samples, in the schematic overview of the sample rotor
segment, click the position of the affected sample tube.

The selected position is framed by blue lines. The action button Level detection
becomes active.
◆ Click the action button Level detection.

The probe detects the level in the sample tube. The affected position is no longer
marked with a ?.

The affected position is still marked with a ?.

◆ Contact Siemens Healthineers service.

→ Troubleshooting is completed.

Status button Ref. curves & Probable cause:

Contr. results remains yellow
• An invalid control result is present. Deleting the invalid control result is not sufficient
to solve the problem. The status button remains yellow until a valid result has been
measured with the control lot.

Corrective measure:
1 In the dialog Lab journal, delete the invalid control result, see ( Page 83 Lab
journal). For more information on the dialog, click the action button Help.

2 Close the viewer software, see ( Page 298 Closing viewer software).

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3 Re-start the viewer software, see ( Page 297 Starting viewer software).

→ The status button Ref. curves & Contr. results is blue.

4 Re-measure the control, see ( Page 160 Measuring a control).

The problem is not solved.

◆ Contact Siemens Healthineers service.

→ Troubleshooting is completed.

Status button Information is Probable cause:

red directly after starting
• A problem occurred during the start of the system.
viewer software
Corrective measure:

1 Place the mouse pointer over the status button Information.

→ A tool tip text that specifies the problem is displayed.

2 Register the displayed tool tip text that specifies the problem.

3 Click the status button Information.

→ The dialog where the problem can be solved is displayed.

The dialog Logbook is displayed.

For more information on the dialog, see ( Page 100 Logbook) or click the action
button Help.

◆ Click the most recent entry that corresponds to the tool tip text.
◆ Follow the instructions on how to solve the problem.
◆ If the problem is not solved, in the dialog System, on the bottom right, click
Reset analyzer.
◆ In the confirmation dialog, click Ok.
During reset, the mouse pointer is changed.
◆ Wait until the mouse pointer has changed back to an arrow.
◆ If the problem is not solved, contact Siemens Healthineers service.

4 In the dialog, solve the problem that was specified in the tool tip text.
→ The status button Information is blue.

The status button Information is still red.

◆ In the dialog System, on the bottom right, click Reset analyzer.
◆ In the confirmation dialog, click Ok.

During reset, the mouse pointer is changed.

◆ Wait until the mouse pointer has changed back to an arrow.
◆ If the problem is not solved, contact Siemens Healthineers service.

→ Troubleshooting is completed.

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Status button Information is

red

There are multiple probable causes for the problem.

1 Decide which of the following causes would be the most probable and follow the
appropriate link.

• A cover is not properly closed, see ( Page 271 Cover not properly closed).

• Right cover was open too long, see ( Page 271 Right cover open too long).

• The heating of the probe has stopped, see ( Page 272 Heating of probe
has stopped).

• The cooling of the reagent rotor has stopped, see ( Page 273 Cooling of reagent
rotor has stopped).

• A level sensor is not inserted properly, see ( Page 274 Level sensor not
inserted properly).

• The water filter is blocked, see ( Page 274 Water filter blocked).

• The probe is blocked, see ( Page 275 Probe blocked).

2 If the problem is not solved, follow the link to the next probable cause until the
problem is solved.

3 If the problem is not solved with the linked procedures, contact Siemens
Healthineers service.

→ Troubleshooting is completed.

Cover not properly closed Check first:

• In the dialog Status, in the area Information, the button Covers is red.
Probable cause:

• When 1 cover was opened, the other cover was slightly opened with it unintentionally.
After closing 1 cover, the other cover stays slightly open.

Corrective measure:

◆ Make sure that both covers are completely closed.

→ The system is operating. The status button Information is blue.

→ Troubleshooting is completed.

Right cover open too long Check first:

• In the dialog Status, in the area Information, the button Covers is red. The tool tip
text displays The right cover is open. The system does not resume working although
the right cover is properly closed.

Probable cause:

• The right cover was open for more than 30 minutes.

Corrective measure:

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1 In the dialog System, on the bottom right, click Reset analyzer.

→ A confirmation dialog is displayed.

2 Click Ok.

→ The mouse pointer changes. The system is reset. This can take several minutes.

3 Wait until the mouse pointer has changed back to an arrow.

→ The system is operating. The status button Information is blue.

→ Troubleshooting is completed.

Heating of probe has stopped Check first:

• In the dialog Status, in the area Information, the button Temperatures is red.

Probable cause:

• The heating of the probe has stopped. The temperature of the probe is too low.

Corrective measure:

WARNING

Infection due to contaminated material and injury to hands due to sharp edges.

Death or serious injury to the user can result.

◆ Be especially careful of the sharp probe tip and other sharp edges.
◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle parts of the system that have come into contact with potentially
infectious material in accordance with good laboratory practices.

No processing of jobs when the right cover is opened without access being requested
via the software. The stop function is triggered, the system's operation is interrupted,
and existing pre-dilutions may be rejected by the system. Delay of results can occur.

• Always request access through the right cover via the software.

• If the right cover was opened without access being requested, immediately close
the right cover.

1 In the dialog System, in the area Maintenance, click Clean probe.

→ In the dialog Clean probe, a progress bar is displayed. The system finishes current
operations. This can take several minutes. For more information on the dialog, click
the action button Help or see ( Page 65 Clean probe).

2 Wait until a message is displayed.

3 Click the action button Park probe for cleaning.

→ The probe moves to the parking position.

4 Wait until another message is displayed.

→ The probe is in the parking position.

5 Open the right cover.

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6 Carefully touch the probe in the upper half.

→ The probe is warm to the touch.

The probe is cold to the touch.

◆ Close the right cover.
◆ Click the action button Close.
◆ In the information dialog displayed then, click Ok.
◆ Replace the probe assembly, see ( Page 248 Replacing the probe assembly).

7 Close the right cover.

→ The action button Close is displayed.

8 Click the action button Close.

→ An information dialog is displayed.

9 Click Ok.
→ The dialog System is displayed. The status button Information is blue.

→ Troubleshooting is completed.

Cooling of reagent rotor Check first:

has stopped
• In the dialog Status, in the area Information, the button Temperatures is red.
Probable cause:

• The reagent cooler has stopped working because the opening time of the access lid
of the reagent rotor cover has exceeded 10 minutes. The temperature in the reagent
rotor is too high.

Corrective measure:

No processing of jobs when the right cover is opened without access being requested
via the software. The stop function is triggered, the system's operation is interrupted,
and existing pre-dilutions may be rejected by the system. Delay of results can occur.

• Always request access through the right cover via the software.

• If the right cover was opened without access being requested, immediately close
the right cover.

1 In the dialog System, in the area Maintenance, click Reagents.

→ In the dialog Access reagents, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access reagents).

2 Wait until a message is displayed.

3 Open the right cover.

4 Check that the access lid of the reagent rotor cover is closed correctly.

5 Close the right cover.

→ The action button Close is displayed.

6 Click the action button Close.

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→ An information dialog is displayed.

7 Click Ok.

→ The dialog System is displayed. The barcode reader scans the barcodes of the
vials in the reagent rotor. The reagent cooler starts working. The status button
Information stays red for some time.
8 If the button Temperatures is still red after 45 minutes, contact Siemens
Healthineers service.

If the ambient temperature is above 25 °C, the system can take longer to cool down
the reagent rotor.

→ Troubleshooting is completed.

Level sensor not Check first:

inserted properly
• In the dialog Status, in the area Information, the button System liquids is red
although the filling levels of the system liquids are not too low.

Probable cause:

• The level sensors are not inserted properly into the corresponding containers.

Corrective measure:
1 Remove the level sensors 1 after another from the containers.

2 Check that the floater at the end of each level sensor can move up and down freely.

3 Insert each level sensor into the corresponding container.

→ The system is operating. The status button Information is blue.

Make sure that the level sensor is inserted at an angle into the corresponding
container. The free end of the level sensor inside the container must point away from
the opening in the container so that the floater at the end of the level sensor can move
up and down freely.

The tubing bears differently colored markings, see ( Page 47 Liquid containers, level
sensors, and tubing).

→ Troubleshooting is completed.

Water filter blocked Check first:

• In the dialog Status, in the area Information, the button System liquids is red
although the filling levels of the system liquids are not too low and the level sensors
are inserted properly into the corresponding containers.

Probable cause:

• The water filter is blocked.

Corrective measure:

◆ Replace the water filter, see ( Page 216 Replacing the water filter).

→ The system is operating. The status button Information is blue.

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→ Troubleshooting is completed.

Probe blocked Check first:

• In the dialog Status, in the area Information, the button System liquids is red
although the filling levels of the system liquids are not too low and the level sensors
are inserted properly into the corresponding containers. The water filter has been
replaced recently.

Probable cause:

• The probe is blocked, for example, by a clot that has been aspirated.

Corrective measure:

◆ Check the functioning of the probe, see ( Page 204 Checking the functioning of
the probe).

→ The system is operating. The status button Information is blue.

→ Troubleshooting is completed.

Status button Information Check first:

is yellow
• In the dialog Status, in the area Information, the button Temperatures is yellow.
Probable cause:

• The system had been idle for more than 20 minutes and changed to standby mode.
The heating of the cuvette rotor was turned off. The system automatically changes
back to routine mode when new jobs are requested. The heating is then switched on
again, and the status button Information turns blue after a maximum of 5 minutes.
Then the requested jobs are processed.
◆ A corrective measure is not required.

→ Troubleshooting is completed.

Status button Information is Check first:

frequently yellow
• In the dialog Status, in the area Information, the button System liquids is frequently
yellow although the filling levels of the system liquids are not too low and the level
sensors are inserted properly into the corresponding containers.

Probable cause:

• The conductivity of the water is too low. The system cannot always detect the correct
filling level in the wet station. Error numbers 3046 and 3053 are displayed frequently.

The water used must meet the water specifications, see

( Page 303 Water specifications).

Corrective measure:

◆ Replace the water, see ( Page 146 Replacing system liquids).

→ The status button Information is blue.

→ Troubleshooting is completed.

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11.3.3 Dialog Status

This chapter describes software problems related to the dialog Status.

Dialog Status displays Probable cause:

incorrect numbers
• Updating of the dialog Status can take up to 10 minutes.

Corrective measure:
◆ Wait a few minutes until the dialog has been updated.

→ Correct numbers are displayed.

→ Troubleshooting is completed.

11.3.4 Dialog Lab journal

This chapter describes software problems related to the dialog Lab journal.

Lab journal empty Probable cause:

• The entries in the lab journal are filtered.

Corrective measure:

◆ Reset the 3 filters above the table. For more information on the dialog Lab journal,
see ( Page 83 Lab journal) or click the action button Help.

→ Lab journal data is displayed.

→ Troubleshooting is completed.

Lab journal data not updated Probable cause:

• If the entries in the lab journal are filtered, data is not updated automatically.
Corrective measure:

1 In the navigation bar, click any other routine button.

2 In the navigation bar, click Lab journal.

→ Lab journal data is updated.

→ Troubleshooting is completed.

Unknown character string as Probable cause:

sample ID
• A sample tube without a label was loaded. Through the sample tube, the barcode
reader scans parts of the barcode strip attached to the sample rotor segment, see
( Page 41 Sample rotor segments).

The system interprets the fragmentary barcode as a character string, for example,
mpty or xty. The correct sample ID cannot be identified manually.

Corrective measure:

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WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

1 In the dialog System, in the area Access, click Samples.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

2 Wait until a message is displayed.

3 Open the left cover.

→ Another message is displayed.

4 Remove the affected sample tube.

5 Attach a blank label to the sample tube.

6 Re-load the sample tube.

7 Close the left cover.

→ The action button Close is displayed.

8 Click the action button Close.

→ The dialog System is displayed.

9 Identify the sample manually, see ( Page 171 Identifying a sample or standard with
unreadable barcode).

→ The correct sample ID is displayed in the lab journal.

The problem is not solved.

◆ Contact Siemens Healthineers service.

→ Troubleshooting is completed.

Jobs not displayed when job

list is imported from LIS

There are multiple probable causes for the problem.

1 Decide which of the following causes would be the most probable and follow the
appropriate link.

• The lab journal was not updated, see ( Page 278 Lab journal not updated).

• The job list was not sent by the LIS, see ( Page 278 Job list not sent by LIS).

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2 If the problem is not solved, follow the link to the next probable cause until the
problem is solved.
3 If the problem is not solved with the linked procedures, contact Siemens
Healthineers service.

→ Troubleshooting is completed.

Lab journal not updated Probable cause:

• When the job list is imported from the LIS, the lab journal is not updated automatically.

Corrective measure:
1 In the navigation bar, click any other routine button.

2 In the navigation bar, click Lab journal.

→ Lab journal data is updated.

→ Troubleshooting is completed.

Job list not sent by LIS Probable cause:

• The LIS has not sent the job list.

Corrective measure:
1 In the dialog Lab journal, in the table, select all sample IDs without requested jobs.

→ The action button Add request becomes active.

2 Click the action button Add request.

→ The dialog Add request is displayed. For more information on the dialog, click the
action button Help or see ( Page 60 Add request).

3 Click the action button Host job list.

→ The job list is requested from the LIS for the samples selected.

4 In the navigation bar, click any other routine button.

5 In the navigation bar, click Lab journal.

→ Lab journal data is updated. Requested jobs are displayed.

No requested jobs are displayed.

◆ Repeat the complete procedure.

Requested jobs are not sent simultaneously by the LIS but little by little.

→ Troubleshooting is completed.

Jobs not processed after Probable cause:

reference curve has been re-
• If the reference curve for an assay is re-measured with a different lot while jobs are
measured
requested for this assay, these jobs are not evaluated. The new reference curve is
not used.

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Corrective measure:

1 Delete the affected jobs in the lab journal.

2 Request the affected assays again, see ( Page 172 Requesting a job for a
sample manually).

→ The jobs are processed.

→ Troubleshooting is completed.

Results marked with a Probable cause:

technical flag
• If a hardware problem has occurred or if a resource was low during processing of a

sample, the measurement cannot be processed. The result is flagged .

If a hardware problem has occurred or if a resource was low during processing of a

control, the measurement cannot be processed. The result is flagged .

Probable hardware problems are:

• The right cover was opened during measurement.

• The cuvette rotor cover opened unintentionally during measurement.

• The temperature in the reagent rotor was too high during measurement.

• The temperature in the cuvette rotor was too low during measurement.
Corrective measure:

1 In the dialog Logbook, click the most recent entry that corresponds to the probable
hardware problems listed above, see ( Page 100 Logbook). For more information on
the dialog, click the action button Help.

2 Follow the instructions on how to solve the problem.

3 Request the affected assays again, see ( Page 172 Requesting a job for a
sample manually).

→ The jobs are processed.

→ Troubleshooting is completed.

Results of a cup-in-tube sample Probable cause:

marked with a Y flag
• The system could not detect the level in the cup of a cup-in-tube segment when
aspirating the sample. The results are flagged Y.

Corrective measure:

1 Check whether there was a sufficient amount of sample material in the cup.

2 If required, refill the cup with a sufficient amount of sample material, approximately
100–350 μL and request the affected assays again.

→ The jobs are processed.

3 If the results are still marked with a Y flag, check if the results are outside the
measurement range.

→ If the results are not outside the measurement range, the results can be released.

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The results are outside the measurement range.

◆ Go to the next step.

4 Check if the remaining sample volume is still sufficient.

5 If required, refill the cup with a sufficient amount of sample material, approximately
100–350 μL.

No more sample is available.

◆ The result is doubtful.

6 Request the affected assays again from a new dilution.

→ The jobs are processed. Results are no longer flagged with a Y flag.

→ Troubleshooting is completed.

Requested job for a control

not processed

There are multiple probable causes for the problem.

1 Decide which of the following causes would be the most probable and follow the
appropriate link.

• A reference value is missing, see ( Page 280 Missing reference value).

• Cyclic control measurements are defined, see ( Page 281 Cyclic control
measurements defined).
2 If the problem is not solved, follow the link to the next probable cause until the
problem is solved.
3 If the problem is not solved with the linked procedures, contact Siemens
Healthineers service.

→ Troubleshooting is completed.

Missing reference value Probable cause:

• If a requested job for a control is not processed even though a reference curve for the
affected assay is available, the reference value for the assay is missing.

Corrective measure:

1 In the dialog System, click the action button Definitions.

→ In the dialog Definitions, the tab Profiles is displayed.

2 Click the tab Control lots.

→ The tab Control lots is displayed. For more information on the tab, click the action
button Help or see ( Page 79 Control lots).

3 Select the control and the lot ID for which the reference value is to be entered.

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→ The corresponding table row is highlighted dark blue. The action button Lot ID
becomes active.
4 Enter the reference values for the corresponding assays. Reference values for
controls provided by Siemens Healthineers can be found in the instructions for use
of the corresponding controls.

Reference values can only be entered in white table cells.

5 Click outside of the table cells.

→ The action button Save becomes active.

6 Click the action button Save.

→ The changes are saved. The dialog System is displayed.

7 Request the affected assays again, see ( Page 172 Requesting a job for a
sample manually).

→ The jobs are processed.

→ Troubleshooting is completed.

Cyclic control Probable cause:

measurements defined
• Cyclic control measurements are defined. As long as there are cyclic control
measurements to be carried out, no manually requested control measurements
will be processed, see ( Page 127 Configuring cyclic control measurements).

Corrective measure:

1 Delete the request for cyclic control measurements in the lab journal, see
( Page 128 Deactivating cyclic control measurements for an assay).

2 Request the affected assays again, see ( Page 172 Requesting a job for a
sample manually).

→ The jobs are processed.

→ Troubleshooting is completed.

Assay not displayed for Probable cause:

control measurement
• No valid reference curve is available for the assay.
Corrective measure:
1 Measure the reference curve for the assay, see ( Page 181 Measuring the reference
curve for an assay).

2 In the dialog Lab journal, measure the control again, see ( Page 160 Measuring
a control).

→ Troubleshooting is completed.

All results of dilution Probable cause:

series deleted
• A measurement was repeated from the same dilution series but at a higher dilution.
When the result of this re-measurement is deleted, all results of the same dilution
series are deleted.

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Corrective measure:

◆ Repeat the measurement at an appropriate dilution, see ( Page 172 Requesting a

job for a sample manually).

→ The result is displayed in the lab journal.

→ Troubleshooting is completed.

11.3.5 Dialog Loading

This chapter describes software problems related to the dialog Loading.

Sample barcode cannot be

scanned

There are multiple probable causes for the problem.

1 Decide which of the following causes would be the most probable and follow the
appropriate link.

• The sample barcode is not visible, see ( Page 282 Sample barcode not visible).

• The barcode label is damaged, see ( Page 283 Barcode label damaged).

• The quiet zone on the barcode label is too small, see ( Page 283 Quiet zone on
the barcode label too small).

• The barcode label is incorrectly placed, see ( Page 284 Barcode label
incorrectly placed).

• The barcode type used is not specified, see ( Page 284 Barcode type used
not specified).

• The left cover was closed too early, see ( Page 284 Left cover closed too early).

• The barcode reader is incorrectly adjusted, see ( Page 284 Barcode reader
incorrectly adjusted).

2 If the problem is not solved, follow the link to the next probable cause until the
problem is solved.

3 If the problem is not solved with the linked procedures, contact Siemens
Healthineers service.
→ Troubleshooting is completed.

Sample barcode not visible Probable cause:

• The barcodes of sample tubes must be aligned towards the outer edge of the sample
rotor segment. If this is not the case, the barcode reader cannot scan the barcode.

Corrective measure:

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WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

1 In the dialog System, in the area Access, click Samples.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

2 Wait until a message is displayed.

3 Open the left cover.

→ Another message is displayed.

4 Make sure that the barcodes of all sample tubes are aligned towards the outer edge
of the sample rotor segment.

5 Close the left cover.

→ The action button Close is displayed.

6 Click the action button Close.

→ The dialog System is displayed. The barcode reader scans the barcodes in the
sample rotor. The system adds the sample IDs to the lab journal.

→ Troubleshooting is completed.

Barcode label damaged Probable cause:

• The barcode label is damaged or the barcode is scratched. The barcode reader cannot
scan the barcode.

Corrective measure:

◆ Identify the sample manually, see ( Page 171 Identifying a sample or standard with
unreadable barcode).

→ Troubleshooting is completed.

Quiet zone on the barcode Probable cause:

label too small
• The quiet zone on the barcode label is too small. The barcode reader cannot scan the
barcode, see ( Page 307 Sample and user-defined control barcodes).

Corrective measure:

◆ Identify the sample manually, see ( Page 171 Identifying a sample or standard with
unreadable barcode).

→ The system adds the sample ID to the lab journal.

→ Troubleshooting is completed.

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Barcode label Probable cause:

incorrectly placed
• The barcode reader can only scan a specified area of the sample tube. If the barcode
label is incorrectly placed or if the barcode is tilted, the barcode reader cannot scan
the barcode.

Corrective measure:
◆ Place the barcode according to the specifications, see ( Page 307 Sample and
user-defined control barcodes).

→ The barcode reader scans the barcodes in the sample rotor. The system adds the
sample ID to the lab journal.

The sample ID is not added to the lab journal.

◆ Identify the sample manually, see ( Page 171 Identifying a sample or standard
with unreadable barcode).

→ Troubleshooting is completed.

Barcode type used Probable cause:

not specified
• The barcode reader can only interpret specified barcode types. If the barcode type used
is not specified, the barcode reader cannot scan the barcode, see ( Page 307 Sample
and user-defined control barcodes).

Corrective measure:

1 Identify the sample manually, see ( Page 171 Identifying a sample or standard with
unreadable barcode).

→ The system adds the sample ID to the lab journal.

2 In the future, use only specified barcode types.

→ Troubleshooting is completed.

Left cover closed too early Probable cause:

• If the left cover is open for less than 6 seconds, the barcode reader does not scan the
sample barcodes.

Corrective measure:

1 Open the left cover.

2 Wait at least 6 seconds.

3 Close the left cover.

→ The barcode reader scans the barcodes in the sample rotor. The system adds the
sample IDs to the lab journal.

→ Troubleshooting is completed.

Barcode reader Probable cause:

incorrectly adjusted
• The barcode reader can only scan a specified area of the sample tube. If the barcode
reader is incorrectly adjusted, the barcode reader cannot scan the barcode.

Corrective measure:

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◆ Contact Siemens Healthineers service.

→ Troubleshooting is completed.

Reagent or control barcode

cannot be scanned

There are multiple probable causes for the problem.

1 Decide which of the following causes would be the most probable and follow the
appropriate link.

• The barcode is not visible, see ( Page 285 Barcode not visible).

• The barcode label is damaged, see ( Page 286 Barcode label damaged).

2 If the problem is not solved, follow the link to the next probable cause.

3 If the problem is not solved with the linked procedures, contact Siemens
Healthineers service.

→ Troubleshooting is completed.

Barcode not visible Probable cause:

• The barcode reader scans reagent and control barcodes through an opening in the
reagent rotor segment. To ensure that the barcode is visible through the opening, the
vertical striation on the evaporation cap and the barcode on the label of the vial must
be aligned, see the figure below. If this is not the case, the barcode reader cannot scan
the barcode.

2
4
3

Placing evaporation caps

(1) Evaporation cap

(2) Vertical striation
(3) Barcode
(4) Reagent or control vial

Corrective measure:

1 In the dialog System, in the area Access, click Reagents.

→ In the dialog Access reagents, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access reagents).

2 Wait until a message is displayed.

3 Open the left and right covers.

→ Another message is displayed.

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4 Remove the reagent rotor cover.

5 Remove the reagent or control vial from the reagent rotor segment.

Do not tilt reagent and control vials with evaporation caps on. Evaporation caps do not
prevent liquid from spilling.

6 Align the vertical striation on the evaporation cap and the barcode on the label of
the vial.
7 Load the reagent or control vial correctly in the reagent rotor segment.

8 Replace the reagent rotor cover.

9 Close the left and right covers.

→ The action button Close is displayed.

10 Click the action button Close.

→ The dialog System is displayed. The barcode reader scans the barcodes of the vials
in the reagent rotor. Reagents and controls are available.

→ Troubleshooting is completed.

Barcode label damaged Probable cause:

• The barcode label is damaged or the barcode is scratched. The barcode reader cannot
scan the barcode.

Corrective measure:
1 In the dialog Loading, click the action button Reagents.

→ In the dialog Loading reagents, the table view is displayed. For more information
on the dialog, click the action button Help or see ( Page 88 Loading reagents).

2 In the list Reagent status, select To be identified.

→ In the table, the reagents and controls that need to be identified are displayed.

3 Click an entry in the table.

→ The segment number and position are displayed in the table.

4 Click the action button Identify.

→ In the dialog Loading reagents, a list of reagents and controls and a graphic
of a reagent rotor segment is displayed. For more information on the dialog, click
the action button Help or see ( Page 92 Loading reagents, identify reagents
and controls).

5 In the graphic, click the position that is marked with a ?.

6 In the input field Lot number, enter the identifier number and the lot number of the
reagent or control.

7 Left of the graphic, select if the material is a reagent or a control.

8 Click the action button Save.

→ The dialog Loading reagents is displayed. The barcode reader scans the barcodes
of the vials in the reagent rotor. The reagent or control is identified.

→ Troubleshooting is completed.

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Reagent or control in the Probable cause:

reagent rotor not used
• During preparing of the reagent or control, the evaporation cap was placed incorrectly
on the reagent or control vial or the reagent or control vial was loaded incorrectly in
the reagent rotor segment. Therefore, the probe collided with the evaporation cap or
with the reagent or control vial. The system cannot detect the level of the reagent or

control. The assay is flagged in the lab journal.

Corrective measure:
1 In the dialog System, in the area Access, click Reagents.

→ In the dialog Access reagents, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access reagents).

2 Wait until a message is displayed.

3 Open the left and right covers.

→ Another message is displayed.

4 Remove the reagent rotor cover.

5 Remove the reagent or control vial from the reagent rotor segment.

6 Place the evaporation cap correctly on the reagent or control vial.

2
4
3

Placing evaporation caps

(1) Evaporation cap

(2) Vertical striation
(3) Barcode
(4) Vial

Do not tilt reagent and control vials with evaporation caps on. Evaporation caps do not
prevent liquid from spilling.

The vertical striation on the evaporation cap and the barcode on the label of the vial
must be aligned, see the figure above.

7 Load the reagent or control vial correctly in the reagent rotor segment.

8 Replace the reagent rotor cover.

9 Close the left and right covers.

→ The action button Close is displayed.

10 Click the action button Close.

→ The dialog System is displayed. The barcode reader scans the barcodes of the vials
in the reagent rotor. The reagent or control can be used.

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→ Troubleshooting is completed.

Segment ID of sample rotor

segment not displayed in the
dialog Loading samples

Each type of sample rotor segment is identified by a colored plain text label with a
number located on the grip of the sample rotor segment. This number corresponds
to the barcode label located at the left side of the sample rotor segment, see
( Page 41 Sample rotor segments).

✓ 1 new plain text label corresponding to the sample rotor segment is available.

✓ 1 new barcode label corresponding to the plain text label is available.

Probable cause:

• The barcode label at the left side of the sample rotor segment is damaged or the
barcode is scratched. The barcode reader cannot scan the barcode.

Corrective measure:

WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

1 In the dialog System, in the area Access, click Samples.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

2 Wait until a message is displayed.

3 Open the left cover.

→ Another message is displayed.

4 Remove the sample rotor segment.

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5 Remove the current plain text label and barcode label from the sample rotor segment,
see the figure below.
1 2 3 4

Replacing the barcode of a sample rotor segment (example)

(1) Barcode label

(2) Sample rotor segment
(3) Plain text label
(4) Grip
(5) Barcode strip

WARNING

If the plain text label and the barcode label do not match and if samples
are manually identified, samples can be interchanged in the dialog Loading
samples. Results will be assigned to the wrong patient.

Death or serious injury to the patient can result.

◆ The plain text label and the corresponding barcode label are delivered on
barcode sheets in pairs. Always attach both labels as a pair.

6 Attach the plain text label to the grip of the sample rotor segment.

7 Attach the corresponding barcode label vertically at the level of the barcode strip to
the left side of the sample rotor segment, next to the left edge.

8 Replace the sample rotor segment.

9 Close the left cover.

→ The action button Close is displayed.

10 Click the action button Close.

→ The dialog System is displayed.

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→ Troubleshooting is completed.

Segment ID of sample rotor Probable cause:

segment not displayed in the
• Non-barcoded samples were pre-identified and loaded using the dialog Pre-loading.
dialog Pre-loading
In the dialog, only segment IDs of sample rotor segments that are not on-board are
displayed and can be selected.

Corrective measure:

WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective
clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

1 In the dialog Pre-loading, select the segment ID of a suitable sample rotor segment
that is not on-board.

– or –

If this is not possible, click the action button Access.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

2 Wait until a message is displayed.

3 Open the left cover.

→ Another message is displayed.

4 Remove the sample rotor segment.

5 Close the left cover.

→ The action button Close is displayed.

6 Click the action button Close.

→ The dialog Loading samples is displayed. The segment ID of the sample rotor
segment is displayed.

→ Troubleshooting is completed.

Segment ID of reagent Probable cause:

segment not displayed in the
• When reagent vials are loaded in both positions of a reagent segment, the barcode
dialog Loading reagents
reader scans both reagent barcodes. If neither reagent barcode can be scanned, for
example, because they are damaged, the system assumes that no vials are loaded.
As the barcode labels attached to the back of every position of the reagent segment
cannot be scanned through the reagent vials, the system assumes that no reagent
segment is loaded in this position. Therefore, the reagent segment is not displayed in
the dialog Loading reagents.

Corrective measure:

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1 In the dialog System, in the area Access, click Reagents.

→ In the dialog Access reagents, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access reagents).

2 Wait until a message is displayed.

3 Open the left and right covers.

→ Another message is displayed.

4 Remove the reagent rotor cover.

5 Remove 1 reagent vial from the affected reagent segment.

6 Load the reagent vial in another reagent segment.

7 Load a reagent vial with a readable barcode in the affected reagent segment.

8 Replace the reagent rotor cover.

9 Close the left and right covers.

→ The action button Close is displayed.

10 Click the action button Close.

→ The dialog System is displayed. The barcode reader scans the barcodes of the vials
in the reagent rotor. The segment ID of the reagent segment is displayed.

→ Troubleshooting is completed.

11.3.6 Dialog Calibration

This chapter describes software problems related to the dialog Calibration.

Valid reference curve cannot Probable cause:

be displayed
• For some assays, negative bit values are possible and valid at the lowest dilution step.
Negative bit values cannot be displayed in the double-logarithmic representation of
the reference curve. The assay or reagent is flagged as valid but cannot be displayed
or printed. The affected reference curve is only used for evaluation.

Corrective measure:

• No corrective measure is possible.

11.3.7 Dialog System

This chapter describes software problems related to the dialog System.

Unknown character string in Probable cause:

raw data
• If a technical problem or a problem with a reagent occurred during measurement, a
specific character string, for example, 1E+30 is displayed in the raw data. In the lab
journal, – is displayed instead of a result.

Corrective measure:

1 In the dialog Lab journal, in the table, select the respective row.

→ The action button Repeat becomes active.

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2 Click the action button Repeat.

→ The dialog Repeat is displayed. For more information on the dialog, click the action
button Help or see ( Page 110 Repeat).

3 Make the settings as required.

4 Click the action button Save.

→ The dialog Lab journal is displayed. The result is displayed in the table.

– is still displayed in the table instead of a result.

◆ Contact Siemens Healthineers service.

→ Troubleshooting is completed.

Logbook entry not Probable cause:

displayed completely
• The logbook entry is longer than the available space in the column of the
logbook table.

Corrective measure:

1 In the dialog Logbook, select the logbook entry.

2 Click the action button Print.

→ The logbook entry is printed and can be read completely.

→ Troubleshooting is completed.

Logbook entry displays a level Probable cause:

outside limits
• The level in a part of the system was detected incorrectly due to impurities, froth,
or lamellae.

Corrective measure:

1 In the dialog Logbook, read the entries immediately following.

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2 If the following entries mention samples, check the samples visually, see
( Page 242 Checking the level of samples visually).

– or –

If the following entries mention reagents or controls, check the level of the reagents
and controls, see ( Page 243 Checking the level of reagents or controls).

– or –

If the following entries mention cuvettes or dilution cups, replace the affected
cuvette segments or dilution strips, see ( Page 147 Loading cuvette segments and
dilution strips).
– or –

If the following entries mention the buffer, clean the wet station. Afterwards clean
the level sensor of the buffer container, see ( Page 207 Cleaning the wet station) and
( Page 218 Clean level sensors of buffer, diluent, and water containers).

– or –

If the following entries mention wash station or wet station, clean the wet station.
Afterwards replace the water filter, see ( Page 207 Cleaning the wet station) and
( Page 216 Replacing the water filter).

→ Troubleshooting is completed.

Immersion depth for cup- Probable cause:

in-tube segment cannot
• The immersion depth for a cup-in-tube segment cannot be defined while the affected
be defined
cup-in-tube segment is on-board.

Corrective measure:

WARNING

Infection due to infectious samples.

Death or serious injury to the user can result.

◆ Wear appropriate personal protective equipment, that is, gloves, protective

clothing, safety glasses, and mask.
◆ Handle samples in accordance with good laboratory practices.

1 In the dialog System, in the area Access, click Samples.

→ In the dialog Access samples, a progress bar is displayed. The system finishes
current operations. This can take several minutes. For more information on the
dialog, click the action button Help or see ( Page 60 Access samples).

2 Wait until a message is displayed.

3 Open the left cover.

→ Another message is displayed.

4 Remove the cup-in-tube segment.

5 Define the immersion depth, see ( Page 137 Configuring the immersion depth for
cups used with a cup-in-tube segment).

6 Replace the cup-in-tube segment.

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7 Close the left cover.

→ The action button Close is displayed.

8 Click the action button Close.

→ The dialog System is displayed. The immersion depth is defined.

→ Troubleshooting is completed.

Progress bar of purging of

tubing stops at 0:00

Avoid purging of the tubing after 10:00 PM.

Probable cause:

• If purging of the tubing is started before midnight, the progress bar stops at 0:00 and
the remaining time is no longer visible. No message is displayed in the dialog Purge
tubings. The purging of the tubing cannot be continued automatically.

Corrective measure:

1 Shut down the system, see ( Page 199 Shutting down the system).

2 Wait at least 10 seconds.

3 Start the system, see ( Page 144 Starting the system).

4 Purge the tubing, see ( Page 214 Purging the tubing).

→ Troubleshooting is completed.

11.3.8 General software problems

This chapter describes general software problems not related to a specific area or dialog.

Password cannot be entered Probable cause:

when starting system
• A technical problem may have occurred.
Corrective measure:

1 Shut down the computer.

2 Wait at least 5 seconds.

3 Re-start the computer.

→ The password can be entered.

The password cannot be entered.

◆ Contact Siemens Healthineers service.

→ Troubleshooting is completed.

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System does not respond Probable cause:

• A technical problem may have occurred.

Corrective measure:

WARNING

When the system shuts down, the reagent cooler is switched off. False results can
occur due to uncooled reagents and controls.

Death or serious injury to the patient can result.

◆ If the system is not re-started immediately, remove reagent and control vials,
including evaporation caps, from the system and return them to the refrigerator.

1 In the dialog Status, click the action button Exit.

→ A confirmation dialog is displayed.

2 Click Yes.
→ The system is rinsed with water. The system is shut down. The viewer
software closes.

3 Wait until all LEDs are off.

4 At the right side of the system, set the main switch to position O.

→ The system is off.

NOTICE

Failure of electrical parts of the system can result if the system is re-started too
soon after a shutdown.

Damage to the system can result.

◆ Wait at least 10 seconds before restarting the system after a shutdown.

5 At the right side of the system, set the main switch to position I.

→ The system starts.

6 Wait until the 3 LEDs in the upper right corner at the front of the system are on.

7 Start the viewer software, see ( Page 297 Starting viewer software).

→ The system is operating.

The system does not respond.

◆ Contact Siemens Healthineers service.

→ Troubleshooting is completed.

System does not continue Probable cause:

working after standby mode
• The ambient temperature has fallen significantly.
Corrective measure:

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1 In the dialog System, on the bottom right, click Reset analyzer.

→ A confirmation dialog is displayed.

2 Click Ok.

→ The system is reset. The mouse pointer changes. In the status line, Resetting
analyzer is displayed. This can take several minutes.

3 Wait until the mouse pointer has changed back.

→ The system is operating.

→ Troubleshooting is completed.

Viewer software does Probable cause:

not respond
• If the viewer software does not respond to the click of buttons, the viewer software
may have crashed.

Corrective measure:
1 On the keyboard, press Ctrl + Alt + Del.

→ An operating system screen is displayed.

2 Click Start Task Manager.

→ The dialog Windows Task Manager is displayed.

3 Click the tab Applications.

→ All programs that are currently running are displayed.

4 In the list, select Siemens ANEPH 630 - <dialog>.

5 At the bottom, click End Task.

6 Close the dialog Windows Task Manager.

7 Close all open programs.

8 In the desktop screen, click Atellica NEPH 630 Viewer.

→ The viewer software starts.

The viewer software does not start.

◆ Switch off the computer.
◆ Wait at least 10 seconds.
◆ Switch on the computer.
◆ In the dialog for the log on to the operating system, enter user name and password.
◆ Click Ok.
◆ In the desktop screen, click Atellica NEPH 630 Viewer.
◆ If the viewer software does not start, contact Siemens Healthineers service.

9 Enter user name and password, if required.

10 Click Ok, if required.

11 Wait until the dialog Status is displayed.

→ The viewer software is running.

→ Troubleshooting is completed.

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Incorrect context in a dialog

There are multiple probable causes for the problem.

1 Decide which of the following causes would be the most probable and follow the
appropriate link.

• Dialogs are not updated automatically, see ( Page 297 No automatic update
of dialogs).

• Dialogs were changed too fast, see ( Page 297 Dialogs changed too fast).

2 If the problem is not solved, follow the link to the next probable cause until the
problem is solved.

3 If the problem is not solved with the linked procedures, contact Siemens
Healthineers service.

→ Troubleshooting is completed.

No automatic update Probable cause:

of dialogs
• The system only updates data in a dialog when opening the dialog.

Corrective measure:

1 In the navigation bar, click any other routine button.

2 In the navigation bar, click the routine button for the required dialog.
→ Data in the required dialog is updated.

→ Troubleshooting is completed.

Dialogs changed too fast Probable cause:

• When the user changes between dialogs too fast, the display may not be
updated correctly.

Corrective measure:

1 In the navigation bar, click Status.

2 Wait at least 3 seconds.

3 In the navigation bar, click the routine button for the required dialog.
→ Data in the required dialog is updated.
→ Troubleshooting is completed.

Starting viewer software ✓ The system is on.

✓ The computer is on.

To start the viewer software, proceed as follows:

1 In the desktop screen, click Atellica NEPH 630 Viewer.

→ The viewer software starts. The dialog Initialize analyzer is displayed. This can
take up to 10 minutes.

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2 Wait until the dialog Status is displayed.

→ The system is operating.

The dialog Log on is displayed.

◆ Enter user name and password.
◆ Click Ok.

→ Starting the viewer software is completed.

Closing viewer software

Results measured while the viewer software is closed are stored in the system’s
memory. Capacity of the system’s memory is low. Results can be lost. Do not close the
viewer software while jobs are still processing.

✓ The system is in standby or routine mode.

To close the viewer software, proceed as follows:

1 In the dialog Status, click the action button Exit.

→ A confirmation dialog is displayed.

2 Click No.

→ The viewer software closes and the desktop is displayed. The system is
still running.

Do not switch off the system in this condition. Results stored in the system’s memory
will be lost. The system will not be rinsed.

→ Closing the viewer software is completed.

Printing problem during Probable cause:

print preview
• Printer settings may be incorrect.

Corrective measure:
1 On the keyboard, press Alt + Tab to bring the dialog Save As in front of the screen.

2 If the problem is not solved, contact Siemens Healthineers service.

→ Troubleshooting is completed.

11.4 Entering a logbook entry

To enter a logbook entry, proceed as follows:

1 In the dialog System, click the action button Logbook.

→ The dialog Logbook is displayed. For more information on the dialog, click the
action button Help or see ( Page 100 Logbook).

2 Click the action button Manual entry.

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→ The dialog Entry is displayed.

3 In the text box, enter text.

4 Click Ok.

→ The entry is stored in the logbook.

5 To view the entry, set the filter Gravity to (All).

→ The entry is displayed in the logbook.

→ Entering a logbook entry is completed.

11.5 Exporting logbook entries

To export logbook entries, proceed as follows:

1 In the dialog System, click the action button Logbook.

→ The dialog Logbook is displayed. For more information on the dialog, click the
action button Help or see ( Page 100 Logbook).

2 Above the table, set the filters Period and Gravity as required.

→ Entries in the logbook are filtered.

3 Click the action button Export.

→ Displayed logbook entries are exported to the file LogBook.asc.

→ Exporting logbook entries is completed.

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12 Technical specifications
This chapter describes the specifications of the system and the
environmental conditions.

12.1 Analyzer

Dimensions (W x H x D) 1070 mm x 600 mm x 630 mm (42.1 in x

23.6 in x 24.8 in), closed
1070 mm x 880 mm x 630 mm (42.1 in x
34.7 in x 24.8 in), open

Required space for ventilation 100 mm (4 in) on all sides

Required working space 300 mm (12 in) above

Footprint (W x H x D) 1070 mm x 900 mm x 750 mm (67 in x

36 in x 30 in) for analyzer, computer, and
liquid containers

Required space for service (W x H x D) 1 m (39.4 in) on all sides

(may overlap with other working spaces)

Weight 115 kg (254 lbs)

Dimensions and weight

Sample types Serum

Plasma
Urine
CSF

Types of sample tubes, cups, and vials For more information on sample tubes,
see ( Page 306 Sample tubes).
For more information on cups and vials,
see ( Page 306 Special cups and vials).

Capacity 3 segment positions for a maximum of

45 samples

Temperature Room temperature

Sample rotor

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Vial types 2.5 mL

5 mL

Capacity 15 segment positions for a maximum of

30 reagents or 45 controls

Temperature • If the room temperature is ≤ 28 °C, the

temperature in the reagent rotor is 8 °C.
• If the room temperature is > 28 °C,
the temperature in the reagent rotor
is 20 °C lower than the actual
room temperature.

Reagent rotor

Capacity 16 dilution strips with 6 dilution cups

each for a maximum of 96 pre-dilutions

Dilution station

Rinse volumes per washing cycle Inside rinse with system liquids:
(depending on assay) Approximately 1500–4000 μL
Outside rinse with water: Approximately
8 mL

Wet station

Capacity 10 segments with 9 cuvettes each for a

maximum of 90 dilutions

Temperature Approximately 37 °C

Cuvette rotor

Light source LED

Wavelength 840 nm ± 10 nm

Detector Hybrid diode (silicon photo diode with

integrated pre-amplifier)

Angle of measurement 13°–24°

Optics

Syringe volume 500 μL

Valves 2‑way and 3‑way valves

Syringe

Light source For single barcode reader: class 2 laser

(according to IEC 60825-1:2007)
For overall classification of the system:
class 1 laser (according to IEC
61010-1:2001 (second edition)

Wavelength 655 nm

Barcode reader

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Assays Up to 15 different assays at the same time

Performance data

12.1.1 Operating conditions

Operating voltage 100 V rating: 90–110 V, AC

120 V rating: 108–132 V, AC
230 V rating: 207–253 V, AC

Main frequency 50/60 Hz

Fuses 100 V rating: 100/120 V, 5.0 AT, 5 mm x

20 mm
120 V rating: 100/120 V, 5.0 AT, 5 mm x
20 mm
230 V rating: 230 V, 5.0 AT, 5 mm x
20 mm

Power consumption 500 VA

Degree of ingress protection IP20

Surge voltage protection Class II

Voltage fluctuations in the Not higher than ± 10 % of the

supply network nominal voltage

Transient overvoltage As normal in the supply network

Supply cables Type H 03 VV‑F, country-specific, for

example, VDE, CSA C22.2 No. 21, CSA
C22.2 No. 49
Length: 1.5 m
Minimum cross-section: 3 x 0.75 mm2
Analyzer: Plug according to
IEC 60320 C13

Electrical conditions

Altitude 0–2000 m

Ambient temperature 18–32 °C

Ambient humidity < 85 % (non-condensing)

Sound level 55 dB(A), at operator’s position

Pollution degree 2

Angle of installation ± 1° (horizontal)

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Distance between liquid containers and 80 cm

table edge

Other environmental conditions Only indoor use

No direct light and sunlight

Environmental conditions

Water with a low microbial content, for ≤ 100 CFU/mL

example, purified water

Conductivity > 30 μS/cm

Water consumption Dependent on the selected job list

Water specifications

12.1.2 Storage conditions

Ambient temperature 5–45 °C

Ambient humidity < 85 % (non-condensing)

Environmental conditions

12.1.3 I/O ports

1 AC input socket Power supply

1 Ethernet port Computer

2 RS‑232 ports LIS, for example

Specifications of I/O ports

12.2 Computer

Operating system Windows operating system

Weight Approximately 20 kg (44 lbs), depending

on the computer type

Specifications of the computer

12.3 Consumables
This chapter describes the specifications of consumables.

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12.3.1 Sample rotor segments

Specifications of sample segments:

• White plain text label

• Numbers 01 or 02 for the first 2 digits on the plain text label

• 15 positions
Specifications of standard segments:

• Orange plain text label

• Number 20 for the first 2 digits on the plain text label

• 6 positions

Specifications of cup-in-tube segments:

• Identical in construction to sample segment

• Gray plain text label

• Number 51 for the first 2 digits on the plain text label

• 15 positions

• For use with all common cups, including Dimension cups from Siemens Healthineers

• Maximum total height of cup and tube: 110 mm

Specifications of cup-behind-tube segments (optional):

• Green plain text label

• Number 81 for the first 2 digits on the plain text label

• 7 positions
Specifications of Eppendorf cup segments (optional):

• Yellow plain text label

• Number 61 for the first 2 digits on the plain text label

• 15 positions
Specifications of Hitachi cup segments (optional):

• Green plain text label

• Number 81 for the first 2 digits on the plain text label

• 15 positions
Specifications of False bottom tube segments (optional):

• Green plain text label

• Number 81 for the first 2 digits on the plain text label

• 15 positions

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12.3.2 Reagent rotor segments

Specifications of reagent segments:

• White grip

• Letter R on the barcode labels

• 2 positions for reagent vials

Specifications of control segments:

• Yellow grip

• Letter C on the barcode labels

• 3–positions for control vials

12.3.3 Cuvette segments

Storage conditions 2–25 °C

(ambient temperature)

Shelf life Unlimited

Specifications of cuvette segments

12.3.4 Dilution strips

Storage conditions 2–25 °C

(ambient temperature)

Shelf life Unlimited

Specifications of dilution strips

12.3.5 Evaporation caps

Types of evaporation caps White evaporation caps for reagent vials

with a capacity of 5 mL
Yellow evaporation caps for control vials
with a capacity of 2.5 mL

Storage conditions 2–25 °C

(ambient temperature)

Shelf life Unlimited

Specifications of evaporation caps

12.4 Sample tubes, cups, and vials

This chapter describes the specifications of sample tubes, cups, and vials to be used with
sample rotor segments.

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12.4.1 Sample tubes

Sample tubes must have the following dimensions:

• 65–100 mm height

• 11–16 mm outer diameter

Sample tubes must be used with differently colored adapters:

• Sample tubes of 11–13 mm outer diameter must be used with white adapters.

• Sample tubes of 13–16 mm outer diameter must be used with black adapters.

12.4.2 Special cups and vials

The following special cups and vials can be used with the specified sample
rotor segments:

• 0.5 mL or 1.0 mL standard vials can be used with a standard segment.

• All common cups, including Dimension cups from Siemens Healthineers, can be used
together with empty sample tubes with a cup-in-tube segment. The total height of
sample tube and inserted cup must not exceed 110 mm.

• Standard Eppendorf cups, 1.5 mL, with conical shaped bottom, can be used with an
Eppendorf cup segment.

• Advia cups, Sample cup 16 mm Ezee-Nest, can be used with a Hitachi cup segment.

• Advia cups, Sample cup 16 mm Ezee-Nest, can be used with a cup-behind-

tube segment.

• Hitachi cups, can be used with a Hitachi cup segment.

• Hitachi cups, can be used with a cup-behind-tube segment.

• False bottom tubes, like the Sarstedt Screw cap tube, working volume: 3.5 ml, (LxØ):
92 x 13 mm, rounded base shape can be used with a false bottom tube segment.

12.5 Adapters
Adapters for sample tubes have different colors depending on the outer diameter of the
sample tubes

• White adapters must be used for sample tubes of 11–13 mm outer diameter.

• Black adapters must be used for sample tubes of 13–16 mm outer diameter.
Standard segments are fitted with black adapters to hold 0.5 mL or 1 mL standard vials.

Control segments are fitted with black adapters to hold 0.5 mL or 1 mL control vials.

12.6 Barcodes
This chapter describes the specifications of barcodes.

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12.6.1 Sample and user-defined control barcodes

Barcode types • Interleaved 2 of 5

• Codabar
• Code 39
• Code 93
• Code 128

Required quality of barcodes According to ISO/IEC 15416:2000

(ANSI X3.182‑1990):
• Grade 4 (ANSI grade A)
• Grade 3 (ANSI grade B)
• Grade 2 (ANSI grade C)

Barcode size Height ≤ 72 mm

Module width (width of the smallest ≥ 0.2 mm

element within the barcode type)

Number of digits 4–29

Barcode orientation Vertically

Specifications of sample and user-defined control barcodes

Barcodes must be attached to sample tubes as displayed in the figure below.

4 1

Attaching barcodes to sample tubes

(1) Barcode placement area: 16–98 mm from bottom of sample tube

(2) Distance from bottom of sample tube to barcode placement area: 16 mm
(3) Quiet zones on the barcode label: ≥3 mm of blank area
(4) Barcode label (example)

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12.6.2 Reagent barcodes

Barcode types Interleaved 2 of 5

Required quality of barcodes According to ISO/IEC 15416:2000

(ANSI X3.182‑1990):
• Grade 4 (ANSI grade A)
• Grade 3 (ANSI grade B)
• Grade 2 (ANSI grade C)

Barcode size Height ≤ 12.9 mm

Width ≤ 8 mm

Module width (width of the smallest ele‐ ≥ 0.19 mm

ment within the barcode type)

Number of digits 8
Digits 1–6 from the left represent the
lot number. The lot number can con‐
tain zeros.
Digit 7 represents the vial size.
Digit 8 is a check digit.

Barcode orientation Vertically

Specifications of reagent barcodes

Barcodes must be attached to reagent vials as displayed in the figure below.

3 1

Attaching barcodes to reagent vials

(1) Barcode placement area: 3–16 mm from bottom of reagent vial

(2) Distance from bottom of reagent vial to barcode placement area: 3 mm
(3) Barcode label (example)

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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 provides a quantitative determination of plasma proteins by means of
nephelometric analysis of serum, plasma, urine, and CSF, see ( Page 320 Principle
of measurement).

The system can perform precipitation and agglutination reactions (latex).

13.1.1 Handling of samples

The system processes jobs sample-oriented. This means that all requested jobs for a
sample are started before the system moves on to process jobs for the next sample.

The barcode reader scans every position of the sample rotor segments every time the
left cover has been closed after being open for more than 6 seconds. If a barcode is
missing or unreadable, a message window is displayed. The ID of the unidentified sample
must be checked and any missing information must be entered in the dialog New, see
( Page 102 New).

Based on the sample barcode and information from the LIS, sample dilution starts. The
level in the sample tube is detected. If an assay is to be measured at a specific dilution,
the sample is pre-diluted. Further pre-dilutions are prepared from the first pre-dilution in
additional dilution cups. If an assay is to be measured undiluted, the sample remains in
the sample tube unprocessed.

The usual sequence is as follows:

• The required amount of diluent is aspirated by the syringe and supplied to the probe.

• The required amount of sample is aspirated by the probe.

• Sample and diluent are dispensed into a dilution cup.

• The pre-dilution is mixed by the probe.

• The probe is cleaned inside and outside.

Controls are processed in the same way.

13.1.2 Handling of reagents

The barcode reader scans every position of the reagent rotor segments after system start
and every time the reagent rotor cover or the access lid of the reagent rotor cover are
closed. If a barcode is missing or unreadable, a message window is displayed. The ID of
the unidentified reagent must be checked and any missing information must be entered
in the dialog Loading reagents via a list of reagents and controls, see ( Page 92 Loading
reagents, identify reagents and controls).

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When a reagent lot is identified, the system reads the lot data. The system checks
if additional information for the reagent lot is available in the database. If not, the
information is requested from a special lot information file which is frequently provided
by Siemens Healthineers.

Based on the requested job, reagent processing starts.

If an assay requires only 1 reagent, the sequence can be as follows:

• The required amount of reagent is aspirated by the probe.

• The required amount of sample is aspirated by the probe, either from the sample tube
or from the dilution cup.

• Sample and reagent are dispensed into a cuvette in the cuvette rotor.

• Sample and reagent are mixed, the reaction starts.

If an assay requires the addition of a supplementary reagent or buffer, the sequence can
be as follows:

• The required amount of supplementary reagent or buffer is aspirated by the probe.

• The required amount of sample is aspirated by the probe, either from the sample tube
or from the dilution cup.

• Sample and supplementary reagent or buffer are dispensed into a cuvette in the
cuvette rotor.

• The required amount of reagent is aspirated by the probe.

• The reagent is dispensed into the cuvette.

• Sample, supplementary reagent or buffer, and reagent are mixed, the reaction starts.

As the processing sequence of an assay depends on the assay definition provided by

Siemens Healthineers, sequences described above are only example sequences.

While the reagent is being transferred, it is heated in the probe to approximately 37 °C

so that a constant temperature is maintained in the cuvette directly after pipetting. The
temperature is kept constant by the heated cuvette rotor during the entire reaction time.

13.1.3 Handling of standards

Calibrations are performed following the pre-sets in the assay definition using standards.
Required dilutions of standards are calculated and performed automatically. The
dilutions depend on the standard concentration and the required support points of
the curve.

Missing reference curves should be measured for the assays before samples
are processed.

The sample rotor turns the standard into the pipetting position. The level of the required
standard is checked. Standard is pipetted into the dilution cups. The probe is cleaned
after each pipetting.

The dilution cups are brought into the pipetting position. A level detection of each cup
is performed. If the cup is empty, the pre-dilution is created and then mixed. The next
empty cuvette is turned to the pipetting position.

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The standard dilution is pipetted into the cuvette. The reagent rotor turns the required
reagent into the pipetting position. The probe pipettes the reagent into the cuvette that
contains the standard.

In the case of an assay that is prepared with supplementary reagent or buffer, first
supplementary reagent or buffer is aspirated and then the diluted standard is aspirated
and dispensed into the cuvette and mixed. Then the next pre-dilution is created,
dispensed into a cuvette, and reagent is added.

If you require a different lot for a kit reagent, delete the old reference curve.
Request a new reference curve with the required lots of, for example, reagent and
supplementary reagent.

13.1.4 Handling of controls

Controls serve to validate sample results and calibration curves. Controls need
to be assigned to assays before control measurements can be requested. Control
measurements are requested automatically or manually.

The sample or reagent rotor turns the control into the pipetting position. The probe
pipettes the control into the dilution cups. The required pre-dilutions are created and
mixed. The probe is cleaned after each pipetting. The diluted control is dispensed into the
cuvette. Reagent is added and mixed.

In the case of an assay that is prepared with supplementary reagent or buffer, first
supplementary reagent or buffer is aspirated and then the diluted control is aspirated and
dispensed into the cuvette and mixed.

The system performs accuracy checks and precision controls. If the quality control
software is installed, other evaluations of the control results can be performed on the
system. For more information, see the documentation of the quality control software.

If the system is connected to an LIS system, the control results can also be sent to the LIS
for evaluations of the control results.

13.1.5 Dilutions
The system dilutes standards, samples, and controls.

Sample dilution Sample dilutions are automatically created with diluent, in multiple dilution steps if
required. Sample dilutions are 1 : 5, 1 : 20, 1 : 100, 1 : 400, 1 : 2,000, 1 : 8,000, and
1 : 32,000.

Samples can also be manually pre-diluted 1 : 5 or 1 : 20. This can be required, for
example, in the case of pediatric samples with only little serum volumes available.
The manual pre-dilution factor must be entered in the software. When processing
this sample, the manual pre-dilution for creating the required sample dilution (initial
dilution) is taken into account, and the results will not need to be subsequently
converted manually. Manually pre-diluted samples are flagged in the job list.

Dilution of standards The system is able to create a dilution series of the standard serum with a maximum of
15 dilution steps, from 1 : 2.5 up to 1 : 20,480, including 1 : 1. Dilutions are made with
diluent. The number of dilution steps depends on the protein to be determined.

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A basic dilution is created, from which the required dilutions will be created, each in a
new dilution cup. Basic dilutions of 1 : 2.5, 1 : 5, 1 : 10, 1 : 20, 1 : 40, and 1 : 80 can
be created. The number of dilutions required for a calibration is specified according to
the assay.

Dilution of controls Controls are diluted in the same way as samples.

13.1.6 Handling of lot data and calibration data

Lot data contains lot numbers and assigned values for Siemens Healthineers standards
and controls within shelf life. Lot data is regularly updated by Siemens Healthineers. They
can either be downloaded from the Document Library or can be loaded from a CD ROM
sent by Siemens Healthineers. Lot data is stored on the hard drive after loading and are
retrieved as required. Missing lot data can also be entered manually from the table of
assigned values.

The reagent lots are read automatically via the barcode on the reagent vial and stored.
Up to 3 lots of a reagent for an assay can be stored. 1 reference curve can be evaluated
for each reagent lot of an assay. That means that a maximum of 3 valid reference curves
for 3 different reagent lots can be stored for an assay. With the third valid reference curve
measured for an assay, the action button Measure is deactivated until at least 1 of the
stored reference curves has been deleted.

The system stores lot data for only 1 lot of supplementary reagents.

If a valid reference curve for a reagent lot is repeated, the original reference curve
is retained in the background. If the newly measured reference curve is also valid, it
is automatically used by the system. If the system shall continue to use the original
reference curve, the newly measured reference curve has to be deleted.

13.1.7 Calibration
In order to evaluate an immunonephelometric measurement quantitatively, a reference
curve is required for each assay. The reference curve is obtained with the help
of standards.

Multiple point calibration Since there is no proportional relationship between the measurement signal and
the protein concentration, several measurement points of a standard at different
dilutions with a known antigen concentration must be measured. The reference curve
is calculated by fitting the theoretical curve to the measured supporting points. The
measurement signals of samples with unknown antigen concentrations are compared
with those of the standard dilutions, and the relevant concentration is read from the
reference curve.

The reference curves measured by multiple point calibration are stored by the system.
They remain stored until they are replaced by new reference curves. Depending on
the assay definition, a reference curve can be measured with a minimum of 5 and
a maximum of 8 dilution steps. A new reference curve can be measured any time
as required.

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Reference curves are valid until the reagent lot changes, as long as the control results
measured with the respective reagent lot are within the confidence range. If 2 or more
of the controls measured are outside the confidence range, a new reference curve has to
be measured or fresh reagent has to be used, because the reagent may have expired or
may be spoiled. If only 1 control is outside the confidence range, this control has to be
measured again. If the result of the repeat measurement is also outside the confidence
range, a new reference curve has to be measured or fresh reagent has to be used.

The validity of the reference curves is stated in the corresponding instruction for use.

Siemens Healthineers recommends to measure multilevel controls several times a day.

Methods for reference curve The relationship of the scattered light signal or the rate of the reaction to the protein
calculation concentration is described by the so-called logit log function. The system stores
calibration data and evaluates the measurement signals of the samples on the basis of
the corresponding reference curves.

A reference curve shows the relationship between the measured scattered light intensity
or rate of reaction Y and the diluted standard concentration C specific to the assay.
A double logarithmic representation is chosen. This function has a mathematically
continuous progression, which fits the signal progression of the individual assays.

The following applies:

R - y0
ln(C) = a ln( )+b
ymax - R

With:

R … Raw value (measured scattered light or rate of reaction)

C … Concentration

y0 … Lowest calculated signal

ymax … Highest calculated signal

a … Gradient

b … Intersection of the axis

y0, ymax, a, and b are parameters that are calculated by the system. The course of the
reference curve is described by these 4 parameters.

Logit log function The logit log function ensures a reliable, quick, and compact calculation of the
concentration. The calculation method is therefore superior to other evaluation
methods. A short section of the course of the reference curve changes to a straight line
when the following expression is applied to the Y axis instead of Y:

R - y0
ln( )
ymax - R

With:

R … Raw value (measured scattered light or rate of reaction)

y0 … Lowest calculated signal

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ymax … Highest calculated signal

The parameters a and b describe the gradient or the intersection of the axis. The
fitting of the reference curve to the measured values is optimized by determining the
4 parameters of the reference curve calculation using a stepwise approximation method.

In order to determine the validity of the reference curve, the percentage deviation of the
mathematically fitted curve from the actually measured signals of the standard dilutions
is calculated. If the mean value of this percentage deviation lies above a maximum value
as defined in the assay definition the reference curve is invalid and must be repeated. The
maximum value for Siemens Healthineers assays is usually 5 %.
The percentage deviation of the individual points is displayed on the screen. Reference
curves whose percentage deviation is above 5 % can be released manually via
the software.

13.1.8 Processing of assays

Before processing any assays, all required preparations have to be completed, see
( Page 144 Preparing for the analysis).

Verification of lot data After reagents, controls, and standards were loaded, the barcode reader scans the
barcodes in the reagent rotor and in the sample rotor. The scanned identifier numbers
and lot numbers of reagents, controls, and standards are compared with those stored in
the system's memory and thus verified. If a reagent with a new lot is loaded, lot data is
read and stored automatically.

Loading samples After samples were loaded and the left and right covers are closed, the barcode reader
scans the barcodes in the sample rotor. Opening the left cover does not trigger the
stop function and the system continues operation. Samples can be re-loaded any time.
Sample rotor segments that are no longer required can be removed or can be re-loaded
with new samples. STAT status can be assigned to samples to process emergency
analyses. STAT samples are flagged STAT and are given priority processing.

Processing of job list A job list containing the assays to be measured can be entered manually or can be
received from an LIS. At a minimum, the job list requires a sample ID and a requested
job for 1 assay. If the system is connected to an LIS, the requests for the relevant
samples are transferred between system and LIS. If the LIS driver is operating in auto
host mode, the system requests the job list from the LIS and automatically sends the
results back to the LIS. If the system is not connected to an LIS, sample IDs are entered
automatically in the lab journal after the sample barcodes have been scanned. Jobs have
to be entered manually in the lab journal. Processing of the job list starts. The system is
in routine mode.

While the job list is being processed, reagent lots can be changed if a valid reference
curve is available for all lots.

Checking of liquid levels To check liquid levels, the probe employs capacitive resistance to determine the level of
liquid in a sample tube or cup, in a standard, control, or reagent vial, in the cuvettes, the
dilution cups, the probe cleaner bottle, and the buffer reservoir. When the probe enters
the liquid, the capacitance between the probe and bottom of the sample rotor or reagent
rotor, which constitutes the counter electrode, changes. The system determines whether
or not there is sufficient volume of liquid in the containers to process requests.

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Before the first job is processed, the system checks the liquid levels in the reagent vials. If
the quantities of reagents loaded are insufficient for the current job list, this is indicated
in the status bar. The level in standard or control vials is not checked until the standard
or control is pipetted.

Aspirating of volumes A maximum volume of 450 μL, including diluent, can be aspirated per transfer. The probe
dips into the sample tube or reagent vial until it reaches a depth at which it can aspirate
the required amount of liquid.

Aspirating volumes:

• Sample: ≥ 5 μL

• Reagent: ≥ 5–400 μL

All required pre-dilutions are prepared in the dilution cups and then pipetted into
the cuvettes.

The required amount of sample is aspirated by the syringe from a sample tube or from
a dilution cup and dispensed into a cuvette. When a reagent is required, the relevant
reagent vial is moved to the pipetting position. The system opens the evaporation cap,
the probe aspirates the reagent, and the system closes the evaporation cap. The probe
dispenses the liquid into the cuvettes.

When a reference curve is measured, the required amount of diluent is aspirated by the
syringe, then the standard is aspirated from the vial and the liquid is pipetted into the
dilution cups. It is then pipetted into a cuvette.

The cuvettes in the cuvette rotor are used consecutively. If a cuvette is not usable
due to high blank value, the system automatically rejects it. The reaction solutions are
measured while the rotor is turning. The measurement results are saved by the system
and sent to the LIS.

Documentation of The measurement usually takes about 6 minutes, depending on the assay. After a
measurement results measurement is complete, the result is displayed in the lab journal. Measurement results
are continually transferred from the system to the computer and displayed in the lab
journal. Measurement results can be printed or sent to the LIS. Additional requests are
possible at any time. When the processing of the job list has finished, the system goes
into standby mode.

Example: processing of All reference curves are available. Assays are processed 1 after the other.
1 sample

Example:

• IgA and CRP are requested for a sample.

Processing in detail is as follows:

• The probe determines the filling level of the sample. If the volume of the sample is not
sufficient for the pending job list, no sample is aspirated.

• The outside and the inside of the probe are cleaned.

Processing of IgA starts.

• The probe is filled with the amount of diluens required to create the sample dilution
required for IgA.

• The probe aspirates the amount of sample required to create the sample dilution
required for IgA.

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• The probe dispenses sample and diluens into an empty dilution cup.

• The probe mixes sample and diluens in the dilution cup.

• The outside and the inside of the probe are cleaned.

• The probe aspirates the amount of buffer required for the diluted sample.

• The outside of the probe is cleaned.

• The probe aspirates the amount of diluted sample required for measurement.

• The probe dispenses diluted sample and buffer into an empty cuvette.

• The outside and the inside of the probe are cleaned.

• The probe aspirates the amount of buffer required for the reagent.

• The outside of the probe is cleaned.

• The probe aspirates the amount of IgA reagent required. Simultaneously, the probe
determines the filling level of the IgA reagent.

• The probe dispenses buffer and IgA reagent into the cuvette.

• The probe mixes the content of the cuvette.

Reaction time starts.

• The outside and the inside of the probe are cleaned.

Processing of CRP starts.

• The probe is filled with the amount of diluens required to create the first sample
dilution step required for CRP.

• The probe aspirates the amount of sample required to create the first sample dilution
step required for CRP.

• The probe dispenses sample and diluens into an empty dilution cup.

• The probe mixes sample and diluens in the dilution cup.

• The outside and the inside of the probe are cleaned.

• The probe is filled with the amount of diluens required to create the second sample
dilution step required for CRP.

• The probe aspirates the amount of diluted sample required to create the second
sample dilution step required for CRP.

• The probe dispenses diluted sample and diluens into another empty dilution cup.

• The probe mixes diluted sample and diluens in the dilution cup.

• The outside and the inside of the probe are cleaned.

• The probe aspirates the amount of supplementary reagent required.

• The outside of the probe is cleaned.

• The probe aspirates the amount of diluted sample required for measurement.

• The probe dispenses supplementary reagent and diluted sample into an

empty cuvette.

• The outside and the inside of the probe are cleaned.

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• The probe is filled with the amount of diluens required for the CRP latex reagent.

• The probe aspirates the amount of CRP latex reagent required. Simultaneously, the
probe determines the filling level of the CRP latex reagent.

• The probe dispenses diluens and CRP latex reagent into the cuvette.

• The probe mixes the content of the cuvette.

Reaction time starts.

• The outside and the inside of the probe are cleaned.

The next requested job can be processed.

Example: routine processing All reference curves are available. All requested jobs for a sample are started before the
system moves on to process jobs for the next sample. Assays for a sample are processed
1 after the other.

Example:

• Sample 1: IgA and CRP are requested.

• Sample 2: IgG and IgA are requested.

• Sample 3: IgG is requested.

Processing in general is as follows:

• IgA and CRP of sample 1 are processed as described above in detail, see
( Page 315 Example: processing of 1 sample).

• IgG of sample 2 is processed. 2 dilution steps are created for IgG.

• IgA of sample 2 is processed. The first dilution created for IgG of sample 2 is used
for measurement.

• IgG of sample 3 is processed. 2 dilution steps are created for IgG.

The next requested job can be processed.

13.1.9 Processing of reference curves

Processing in detail is as follows:

• The probe determines the filling level of the required standard.

• The outside and the inside of the probe are cleaned.

Processing of the first standard dilution step starts.

• The probe is filled with the amount of diluens required to create the first standard
dilution step.

• The probe aspirates the amount of standard required to create the first standard
dilution step.

• The probe dispenses standard and diluens into an empty dilution cup.

• The probe mixes standard and diluens in the dilution cup.

• The outside and the inside of the probe are cleaned.

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• Depending on the assay, the probe aspirates the amount of either buffer or
supplementary reagent required.

• The outside of the probe is cleaned.

• The probe aspirates the amount of diluted standard required for measurement.

• The probe dispenses buffer or supplementary reagent and diluted standard into an
empty cuvette.

• The outside and the inside of the probe are cleaned.

• Depending on the assay, the probe is filled with the amount of either buffer or
diluens required.

• The probe aspirates the amount of reagent required. Simultaneously, the probe
determines the filling level of the reagent.

• The probe dispenses buffer or diluens and reagent into the cuvette.

• The probe mixes the content of the cuvette.

Reaction time for the first dilution step starts.

• The outside and the inside of the probe are cleaned.

Processing of the second standard dilution step starts.

• The probe is filled with the amount of diluens required to create the second standard
dilution step.

• The probe aspirates the amount of diluted standard required to create the second
standard dilution step.

• The probe dispenses diluted standard and diluens into another dilution cup.

• The probe mixes diluted standard and diluens in the dilution cup.

• The outside and the inside of the probe are cleaned.

• Depending on the assay, the probe aspirates the amount of either buffer or
supplementary reagent required.

• The outside of the probe is cleaned.

• The probe aspirates the amount of diluted standard required for measurement.

• The probe dispenses buffer or supplementary reagent and diluted standard into an
empty cuvette.

• The outside and the inside of the probe are cleaned.

• Depending on the assay, the probe is filled with the amount of either buffer or
diluens required.

• The probe aspirates the amount of reagent required. Simultaneously, the probe
determines the filling level of the reagent.

• The probe dispenses buffer or diluens and reagent into the cuvette.

• The probe mixes the content of the cuvette.

Reaction time for the first dilution step starts.

Further required standard dilution steps are processed in the same way.

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13.1.10 Processing of control measurements

Processing in detail is as follows:

• The probe determines the filling level of the required control.

• The outside and the inside of the probe are cleaned.

Processing of the control starts.

• The probe is filled with the amount of diluens required to create the control dilution.

• The probe aspirates the amount of control required to create the control dilution.

• The probe dispenses control and diluens into an empty dilution cup.

• The probe mixes control and diluens in the dilution cup.

• The outside and the inside of the probe are cleaned.

• Depending on the assay, further control dilution steps are created likewise.

• Depending on the assay, the probe aspirates the amount of either buffer or
supplementary reagent required.

• The outside of the probe is cleaned.

• The probe aspirates the amount of diluted control required for measurement.

• The probe dispenses buffer or supplementary reagent and diluted control into an
empty cuvette.

• The outside and the inside of the probe are cleaned.

• Depending on the assay, the probe is filled with the amount of either buffer or
diluens required.

• The probe aspirates the amount of reagent required. Simultaneously, the probe
determines the filling level of the reagent.

• The probe dispenses buffer or diluens and reagent into the cuvette.

• The probe mixes the content of the cuvette.

Reaction time starts.

• The outside and the inside of the probe are cleaned.

The next requested job can be processed.

13.1.11 Plausibility check

If a result is below the measuring range, for example, < 0.46 g/L in the 1 : 20 dilution,
the measurement is repeated from the 1 : 5 dilution if automatic re-measurement is
configured. If the result of the 1 : 5 dilution deviates more than 15 % from the result of the
1 : 20 dilution, for example, 0.46 g/L + 15 %, the plausibility check causes the result of the
1 : 20 measurement to be displayed. That means that in the lab journal, the same result
is shown for the 1 : 5 dilution and for the 1 : 20 dilution. No further re-measurement
is started.

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13.1.12 Formula test

A formula test is a combination of 2 assays. The measurement results of the 2 assays are
determined first. If both measurement results are valid, the result of the formula test is
calculated from these measurement results according to a defined formula. If 1 of the
measurement results is invalid, this assay is re-measured until the result is valid. Manually
repeated measurements of the 2 assays are not taken into account.

Example The user requests the formula test kap_lam.

The system processes the assays kap and lam. The result for kap is 0.0911 g/L, the
result for lam is 0.0651 g/L. Both results are valid. The system calculates the result of the
formula test kap_lam as follows:
kap_lam = kap / lam = 0.0911 g/L / 0.0651 g/L = 1.399

Changing the units of the 2 assays has no impact on the result of the formula test.

13.2 Principle of measurement

This section describes the physical principles of measurement.

13.2.1 Nephelometry
Nephelometry is the most commonly used measurement principle for the
immunochemical determination of protein in serum, urine, and other body fluids.
In this method, the light scattered by the antigen-antibody complexes is measured.

If a sample containing antigen and the corresponding antiserum are put into a cuvette,
antigen-antibody complexes are formed. When the antibody is in excess, the intensity of
the measured light scatter is proportional to the amount of the antigenantibody complex
in the sample. At a constant antibody concentration, the signal is proportional to the
antigen concentration. A reference curve is created from a standard with known antigen
concentrations. The scattered light signal of the samples can then be read from this curve
as an antigen concentration.

The scattered light signal is considerably amplified by the adherence of antibodies or

antigens to latex particles. This makes sensitive measurements of trace proteins possible.

A light beam is generated by means of an LED and sent through the cuvette. The
light is scattered by the antigen-antibody complexes that are present. The intensity
distribution of the scattered light depends on the relationship of the particle size of the
antigen-antibody complex to the wavelength.

Rayleigh or Mie scattering can occur:

• If the particle diameter is small in comparison to the wavelength of the light, Rayleigh
scattering occurs. The light is scattered to all sides almost symmetrically. The light
efficiency for the measurement is reduced, see below.

• If the particle diameter is large in comparison to the wavelength of the light,

Mie scattering occurs. With increasing particle size, the light is mainly scattered in
the forward direction. This allows improved light efficiency for the measurement,
see below.

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Rayleigh scattering

Mie scattering

Due to the use of latex particles, among other things, the diameter of the antigen-
antibody complexes is of the order of magnitude d > 1000 nm. The diode used in
the system radiates light with a wavelength of 840 nm ± 20 nm. The particles are
generally larger than the wavelength and therefore Mie scattering occurs primarily, with
a correspondingly higher signal yield.

13.2.2 Optical path of beam

The diode emits a beam with a wavelength of 840 nm. The beam of light is practically
parallel and falls on the cuvette. The light is scattered by the particles in the cuvette. The
scattered light is measured at an angle of 13°–24° with a hybrid diode (detector). The
primary beam is filtered out. The primary beam is the light beam that was not scattered
by the antigen-antibody complexes or latex aggregates. The scattered light is focused
on a detector by means of a system of lenses. The optimum measurement angle is
determined by the wavelength of the incident light of the diode and the particle size of
the antigen-antibody complex at the time of measurement, see below.

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4 6

8
2

1
9

Optical system

(1) Diode
(2) Microscope lens
(3) Primary beam
(4) Tilted mirror
(5) Cuvette
(6) Tilted mirror
(7) Primary beam mask
(8) Scattered light
(9) Detector

Due to the geometrical arrangement of the detector, only a part of the scattered light is
detected. The detector converts the incident scattered light into an electrical signal. The
protein concentration in the sample measured is derived from the difference between
the signal before the start of the reaction and the signal after the start of the reaction,
using a mathematical procedure and by means of comparison with the reference curve.
Due to the intense, forwardly inclined scattered light signal, post-amplification with a
photomultiplier is not required.

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13.2.3 Principle of immunochemical protein determination

This chapter describes protein determination. This includes:

• Heidelberger-Kendall curve

• Pre-reaction

• Turbidity check
The determination of the protein concentration is achieved by means of the quantitative
evaluation of an immunochemical reaction.

Heidelberger-Kendall curve The Heidelberger-Kendall curve shows the relationship between the antigen
concentration and the measurement signal at a constant antibody concentration, see
the figure below.

Y 3 4 5

1 2
x x

Heidelberger-Kendall curve

X Antigen concentration
Y Precipitation/measurement signal
1 Point 1
2 Point 2
3 Antibody excess
4 Equivalence range
5 Antigen excess

The Heidelberger-Kendall curve can be divided into 3 areas: antibody excess,

equivalence range, and antigen excess. For an explanation of the 3 areas, see the
table below.

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Information Explanation

Antibody excess In this area there is an antibody excess, i.e. there are many free binding
sites. Each antigen that is added is immediately bound and leads to a further
cross-linking. The solubility decreases as the amount of crosslinking increases.
In this area of the curve, the relationship between antigen concentration and
measurement signal is proportional.

Equivalence range At approximately equal concentrations of antigens and antibodies, this area of
the curve is called the equivalence range. Here the cross-linking is strongest
and the solubility of the antigen-antibody complex is at its lowest.

Antigen excess In the case of an antigen excess, the solubility of the immune complex
increases again because the number of antibodies no longer suffices to bind
all antigens. This means that the measurement signal becomes less than in the
equivalence range.
In the evaluation on the Heidelberger-Kendall curve, 2 antigen concentrations
could therefore be responsible for a particular measurement signal:
• Point 1 lies on the ascending branch in the antibody excess range (low
antigen concentration)
• Point 2 lies on the descending branch in the antigen excess range (high
antigen concentration)
Through optimization of the reaction conditions on the system, the maximum
of the Heidelberger-Kendall curve has been shifted in the direction of higher
antigen concentrations to such an extent that the measurement signals still fall
on the left branch of the curve, even at high protein concentrations, see the
figure below.

Y 2 3
10 000

1000

100
5

10
X
0.1 1 10 100

Measurement range on the optimized Heidelberger-Kendall curve

X Concentration in g/L

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Y Scattered light intensity

1 Maximum allowed signal range
2 Allowed concentration range
3 Safety margin
4 Pathological threshold
5 Normal range

In order to guarantee antigen excess reliability - even in the case of proteins that are
present in high concentrations, or that display great biological variance, for example,
urine proteins - certain assays have a pre-reaction performed.

Pre-reaction In the pre-reaction, a fraction of the sample is prepared with the complete amount
of reagent. If, during the pre-reaction, a defined threshold is not exceeded, the usual
amount of sample is dispensed and the measurement is performed. The calculated raw
value is evaluated on the reference curve.

If there is a significant increase in the signal that exceeds the defined threshold, this
measurement is repeated automatically at the next higher dilution if automatic repeat
measurement has been configured. A pre-reaction is also measured for this new dilution.

If there is again a significant increase, the sample is prepared at the next dilution and
checked by means of a pre-reaction. This procedure is repeated until the result of the
pre-reaction lies below the stated threshold or until the system has reached the limits of
the permitted dilutions.

If a result cannot be obtained, it remains flagged > (value).

Pre-reaction measurement methods are available, for example, for the following assays:

• IgM/Serum

• Albumin/Urine

• Ig/L-chain type lambda in urine

For more information, see the respective assay definition.

Turbidity check If a measurement signal exceeds the defined threshold, the result for a sample is flagged

, the result for a control is flagged , the so-called turbidity flags. The turbidity
check is performed on the basis of 2 criteria, see the table below.

Criterion Explanation

1 The difference between the start value, that is, the first measured
value, typically after 7.5 s, and the cuvette blank value is higher
than typically 1800 bit. The 1800 bit value is called the general
turbidity threshold.
This criterion records samples with a very high intrinsic turbidity,
for example, lipemic samples, or a fast reaction, for example,
monoclonal immunoglobulins.

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Criterion Explanation

2 The difference between the start value, that is, the first measured
value, typically after 7.5 s, and the cuvette blank value is higher than
typically 800 bit plus 15 % of the difference between the second
measured value and the start value.
This criterion was developed in order to exclude non-specific
turbidities, or atypical reaction courses with a small measurement
signal difference between the second measured value and the
start value.

Criteria of turbidity check

The 800 bit value is called the turbidity threshold, the 15 % is called the turbidity factor.
Siemens Healthineers calculates the general turbidity threshold and general turbidity
factor and provides them as standard values.

If non-specific reactions occur, the affected sample has to be removed from the system
and centrifuged. Lipemic samples, for example, can be centrifuged for 10 minutes at
15,000 × g. After re-loading, the sample will be processed without a further check for a
non-specific reaction.

13.2.4 Methods of determining the protein concentration at

different times
The light scattered by the antigen-antibody complexes can be measured in
different ways:

• After the reaction has finished: end point method

• As the difference between the signals at 2 defined points in time: fixed time
kinetic method

• Across the whole course of the reaction: VLinIntegral

End point method The end point method is only used for certain selected assays. The maximum turbidity
of the reaction dilution is measured.

Fixed time kinetic method With the fixed time kinetic method the measurement signal is calculated of the difference
between 2 measured values that are obtained at different times.

After all components of the reaction have been pipetted into the cuvette, the first signal,
that is, the start value, is measured after approximately 7.5 s, depending on the assay
definition. The second value is measured after an incubation time of 6 minutes or longer,
depending on the assay definition. The increase in scattered light calculated from these
values is processed and can be output in different concentration units, for example, g/L
or lU/mL.

The advantage of this measurement method lies in the calculation of the result from
the signal difference. The fundamental scattering, which occurs when light is passed
through the cuvette containing the reaction partners, even when no antigen-antibody
complex is formed, is subtracted.

VLinIntegral VLinIntegral is a mathematical algorithm for the evaluation of agglutination reactions

such as particle enhanced immunoassays or precipitation tests via the maximum rate
of reaction.

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With the help of this algorithm, 1 or more of the following characteristics that vary
depending on the particular assay can be influenced:

• The analytical sensitivity is increased.

• The measuring range is extended.

• The antigen excess reliability is improved.

• The measurement time is reduced.

With this method, the change in scattered light intensity per time interval is determined.
In order to determine the maximum change in the rate of the reaction, both the width of
the time window and its location are dynamically determined by means of the kinetics.

This evaluation method uses the kinetics to ascertain how many measuring points are to
be included for the calculation of the line of regression.

The maximum rate of reaction (value/min) determined in this manner is proportional

to the protein concentration and is evaluated, like the other methods, on the basis of a
reference curve.

13.3 Communications
The viewer software is installed on the computer and gives the user access to the
analyzer. The user can, for example, enter a job list in the viewer software. The job list is
sent to the system with the help of a driver. The system processes the job list. The results
are sent back to the computer.

With a modem, lot data or update versions can be downloaded. Remote service
actions are also possible. Problems can be dealt with in this manner, for example, with
remote accessing.

The LIS is the interface for the laboratory information system. The analyzer can be
connected to a laboratory information system using communications drivers.

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14 Revision information
The revision information lists topics that have changed since the previously published
version of this document.

Due to a change in layout and a change in the authoring tool, the content of the
manual had to be slightly revised compared to the previous version. However, this
revision did not result in any significant changes in content.

In addition to the editorial changes, the following changes in content have

been implemented.

• The manual has been updated to meet the requirements of the in vitro diagnostic
medical devices Regulation (EU) 2017/746.

• The Addendum version 1.0 has been implemented.

• False bottom tube segment and suitable cups have been implemented, see
( Page 44 False bottom tube segment).

• Chapter Power module has been updated, see ( Page 37 Power module).

• The light source and wavelength of the barcode reader have been corrected, see
( Page 300 Analyzer).

• Additional information about remote control, see ( Page 109 Remote control).

• Reference to the Secure Download software instruction manual has been inserted, see
( Page 149 Loading lot data).

• Additional hint for activating an invalid reference curve, see ( Page 184 Activating an
invalid reference curve).

• New content for online help, see ( Page 80 Help).

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 Index

A CE conformity 25 Diluent 48
see Declaration of Conformity Replace tubing 224
About, dialog 58
Check Waste 47
Access cuvette segments and dilution strips, Water 47
Control level 243
dialog 58
Functioning of probe 204 Control 49
Access reagents, dialog 60 Probe geometry 245 Check level 243
Access samples, dialog 60 Reagent level 243 Configure cyclic control
Accessories 41 Sample level, visually 242 measurement 127
Syringe for leak 210 Deactivate cyclic measurement 128
Action buttons, common 54 Tubing of container 212 Definition 75
Adapter, technical specifications 306 Tubing of probe 212 Display details 179
Add Check probe, dialog 65 Display measurement curve 179
Sample ID to lab journal 166 Evaluate result 180
Clean
STAT sample ID to lab journal 166 Handling by system 311
Cuvette rotor and housing 230
Identify 157
Add request, dialog 60 Dilution station 230
Load 152
Adjust column width, display function 53 Level sensor 217
Measure 160
Peripheral device 233
Air bubble detector 38 Prepare 149
Probe 205
Analyzer 29 Repeat measurement 161
Reagent rotor and housing 209
Safe handling 18
Analyzer ID, configuration 71 Sample rotor and housing 228
Unload 177
As needed maintenance task 228 Segment 230
Surface of system 228 Control details, dialog 72
Assay Waste container 233 Control lot
Activate invalid reference curve 184 Water container 211 Add 133
Configure reference range 139 Wet station 207 Definition 79
Configure unit 139 Delete 134
Display reference curve 183 Clean probe, dialog 65
Measure a reference curve 181 Close, viewer software 298 Control measurement, processing by
Processing by system 314 system 319
Color
Repeat a reference curve 182 Buttons in dialog areas 118 Control segment 45
Assign STAT status 165 Container 47 Cover 30
Atellica Process Manager 109 Dialog background 118 Create backup 198
Grip, control segment 45
Automatic re-measurement 140 CSF (cerebrospinal fluid) 14
Grip, reagent segment 45
Automatic release 140 LED 30 Cup
Plain text label 41 Configure immersion depth 137
B Immersion depth, definition 78
Communication 327
Special cups, technical
Backup Computer 40 specifications 306
Create 198 Technical specifications 303
Select path for backup file, dialog 114 Cup-behind-tube segment 43
Condensation, reagent rotor 31 Use segment 194
Barcode label
Configuration Cup-in-tube segment 42
Control vial 44
Analyzer ID 71 Configure immersion depth 137
Reagent rotor segment 44
Connection 67 Use segment 186
Reagent vial 44
Cyclic control measurement 127
Sample rotor segment 41 Cuvette rotor 34
Dialog 66
Barcode reader 38 Clean 230
Host 67
Reagent rotor 31 Cover 34
Laboratory address 71
Sample rotor 31 Language 66 Cuvette segment 34, 45
Battery Directive 25 LIS connection 143 Access cuvette segments and dilution
Password 66 strips, dialog 58
Bottle, probe cleaner 49
Printout 141 Load 147
Buffer container 48 Result report 66 Technical specifications 305
Buffer reservoir 33 Sample rotor segment 70
Buffer, replace 146 User settings 71 D
Conformity 25 Data protection 20
C Connection, configuration 67 Data, display in lab journal 178
Calibration Consumable 41 De-installation 27
Dialog 63 Safe handling 18 Declaration of Conformity 25
Kinetic 82 Technical specifications 303
Show reference curve 115 Definitions
Contact information 9 Control lots 79
Valid reference curve cannot be
displayed 291 Container Controls 75
Buffer 48 Dialog 73
Calibration data, handling by system 312 Check tubing 212 Immersion depth 78

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 Index

Profiles 75 H Data not updated 276

Standard lots 80 Delete sample ID 184
Handwheel
Units 78 Dialog 83
Cuvette rotor 34
Delete sample ID from lab journal 184 Display data 178
Reagent rotor 31
Display result 141
Delivery 26 Sample rotor 31
Empty lab journal 276
Diluent container 48 Hardware check - probe, dialog 80 Job for control not processed 280
Diluent, replace 146 Hardware troubleshooting 240 Job list from LIS not displayed 277
Heidelberger-Kendall curve, principle 323 Jobs not processed with re-measured
Dilution cup 32
reference curve 278
Dilution frame 32 Help, dialog 80 New 102
Dilution station 32 Hitachi cup segment 43 Result with technical flag 279
Clean 230 Use segment 192 Set sort sequence 141
Dilution strip 32, 46 Host, configuration 67 Unknown character string 276
Access cuvette segments and dilution Hypochlorite solution, prepare 235 Laboratory address, configuration 71
strips, dialog 58 Language
Load 147 I Configuration 66
Technical specifications 305 Set 142
I/O port 303
Dilutor 39 LED 30
Identification
Directive on restriction of hazardous Level sensor 47
System 9
substances 25 Clean 217
Identify
Directive on waste electrical and electronic Limitations of nephelometry 19
Control 157
equipment 25
Reagent 157 Liquid container 47
Dispensing area 33 Sample with unreadable barcode 171
LIS (laboratory information system) 40
Display Standard with unreadable barcode 171
Configure connection 143
Control details 179 Immersion depth
Load
Measurement curve 179 Configure 137
Barcoded sample 162
Sample details 179 Definition 78
Control 152
Disposal 28 Immunochemical protein determination, Cuvette segment 147
Distilled water 18 principle 323 Dilution strip 147
In vitro diagnostic medical devices Non-barcoded sample 167
E Regulation 25 Non-barcoded STAT sample 167
Reagent 152
Electrical safety 15 Incorrect context in a dialog 297
Sample rotor segment 170
Electromagnetic compatibility 25 Infection, safe handling 18 Standard 158
Empty waste container 201 Initialize analyzer, dialog 81 User-defined control 158
End point method 326 Insert reagent rotor segment 241 Loading
Eppendorf cup segment 43 Installation 26 Reagent or control barcode cannot be
Use segment 189 scanned 285
Intended purpose
Reagent or control not used 287
European directives 25 see Intended use
Sample barcode cannot be scanned 282
Evaluate control result 180 Intended use 14 Segment ID of reagent segment not
Evaporation cap 46 Intended user 14 displayed 290
Technical specifications 305 Segment ID of sample rotor segment not
International standards 25
displayed 288
External device 39 IT security 20 Segment ID of sample rotor segment not
IVDR displayed in dialog Pre-loading 290
F see In vitro diagnostic medical devices Loading cuvette segments and dilution strips,
False-bottom-tube segment 44 Regulation dialog 86
Filter, display function 53 Loading reagents, dialog 88
Fixed time kinetic method 326
K Graphic overview 89
Flag, symbol 54 Kinetics, dialog Identify reagents and controls 92
Measurement curve 81 Loading samples, dialog 94
Formula test 320 Reference curve 82
Fountain area 33 Log on, dialog 99

Function key 57 L Logbook

Dialog 100
Fuse holder 37 Lab journal
Enter entry 298
Fuse, replace 245 Add request 60
Export entry 299
Add sample ID 166
All results of dilution series deleted 281 Logit log function 313
Assay not displayed for control 281
Cup-in-tube result with Y flag 279

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 Index

Lot data PHI (Personal health information) 20 Q

Handling by system 312 PII (Personally identifiable information) 20 QC, dialog 109
Open lot data file, dialog 104
Plain text label 41 Qualification of the operator 15
Verification 314
Plausibility check 319
M Port 39 R
Main switch 37 Power module 37 Raw data, print preview for raw data,
dialog 108
Maintenance Power supply socket 37
As needed task 228 Re-measurement 110
Pre-identify
List of tasks 203 Set 140
Non-barcoded sample 166
Monthly task 214 Non-barcoded STAT sample 166 Reagent 49
Weekly task 204 Access reagents, dialog 60
Pre-loading, dialog 105
Yearly task 220 Barcode, technical specifications 308
Pre-reaction, principle 325 Check level 243
Maintenance log 237
Prepare Handling by system 309
Maintenance task 203
Control 149 Identify 157
Measure control 160 Hypochlorite solution 235 Load 152
Measurement curve Purging solution 235 Prepare 149
Details 81 Reagent 149 Unload 177
Display 179 Sample rotor segment 154 Reagent cooler 31
Mechanical safety 16 Principle Reagent rotor 31
Message window 101 Control dilution 312 Access lid 31
Position without barcode on reagent Heidelberger-Kendall curve 323 Barcode reader 31
rotor 267 Immunochemical protein Clean 209
Position without barcode on sample determination 323 Cover 31
rotor 266 Multiple point calibration 312 Insert segment 241
Pre-reaction 325 Position without barcode detected 267
Model number 9 Sample dilution 311 Reagent cooler 31
Monthly maintenance task 214 Standard dilution 311
Reagent rotor segment 44
Movement 27 Turbidity check 325
Insert 241
Print preview for raw data, dialog 108 Technical specifications 305
N Print preview, dialog 106 Reagent segment 45
Navigate, display function 53 Print result 180 Reagent, safe handling 18
Nephelometry 320 Printing problem 298 Reference curve
Nephelometry, limitations 19 Printout, configure 141 Activate invalid reference curve 184
New, dialog 102 Probe 35 Calculation 313
Check functioning 204 Display 183
Non-operation 26
Check geometry 245 Kinetic 82
Check probe, dialog 65 Measure 181
O Processing by system 317
Check tubing 212
Online help 80 Clean 205 Repeat 182
Open lot data file, dialog 104 Clean probe, dialog 65 Show curve 115
Operating conditions 302 Hardware check - probe, dialog 80 Reference range, configure 139
Replace probe assembly 248 Refill sample tube 174
Operational safety 16
Probe cleaner Release result 179
Operator qualification 15
Bottle 49
Optical path of beam 321 Release, set 140
Replace bottle 234
Ordering information 9 Remote control, dialog 109
Profile
Overview Add 135 Repair 9
Analyzer 29 Add assay 135 Repeat control measurement 161
Software 50 Definition 75
Repeat job manually 173
Delete 136
Remove assay 135 Repeat, dialog 110
P
Protection, personal data 20 Replace
Password cannot be entered 294
Fuse 245
Password, configuration 66 Purge tubing 214
Probe assembly 248
Peripheral device 40 Purge tubings, dialog 108 Probe cleaner bottle 234
Clean 233 Purging solution, prepare 235 Tubing of container 224
Water filter 216
Personal data protection 20 Purified water 18
Replace syringe 220
Personal health information (PHI) 20
Dialog 111
Personally identifiable information (PII) 20

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 Index

Replace system liquids and empty waste Load standard 158 Standard lot
container, dialog 111 Load user-defined control 158 Add 127
Report serious incident 14 Position without barcode detected 266 Definition 80

Request controls, dialog 112 Sample rotor segment 41 Standard segment 42

Add segment ID 136 Standard, safe handling 18
Request job manually 172
Configuration 70
Result Standards, statutory requirements 25
Delete segment ID 137
Evaluate control result 180 Load 170 Start
Print 180 Prepare 154 System 144
Release 179 Technical specifications 304 Viewer software 297
Set display in lab journal 141 Use cup-behind-tube segment 194 STAT sample
Result report, configuration 66 Use cup-in-tube segment 186 Barcoded sample, assign status 165
Use Eppendorf cup segment 189 Load non-barcoded STAT sample 167
Rinse system 198
Use Hitachi cup segment 192 Pre-identify non-barcoded STAT
Dialog 113
Sample segment 41 sample 166
RoHS
see Directive on restriction of hazardous Sample tube Status
substances Refill 174 Dialog 118
Technical specifications 306 Incorrect numbers 276
S Scroll, display function 53 Status button 51
Safety information Security whitepaper 21 Status button Information
CAUTION, meaning 21 Frequently yellow 275
Segment
Consumable 18 Red 271
Clean 230
Control 18 Red directly after start 270
Control segment 45
Electrical safety 15 Yellow 275
Cup-behind-tube segment 43, 194
General 14 Cup-in-tube segment 42, 186 Status button Ref. curves & Contr. results
Infection 18 Cuvette rotor 34 Remains yellow 269
Mechanical safety 16 Eppendorf cup segment 43, 189 Status button Samples & Standards
Nephelometry, limitations 19 False-bottom-tube segment 44 Yellow or red 269
NOTICE, meaning 21 Hitachi cup segment 43, 192
Operational safety 16 Statutory requirements
Reagent rotor segment 44
Operator qualification 15 CE conformity 25
Reagent segment 45
Personal data 20 Electromagnetic compatibility 25
Sample rotor segment 41
Reagent 18 European directives 25
Sample segment 41
Safety messages, structure 21 International standards 25
Standard segment 42
Sample 18 Storage 26
Select path for backup file, dialog 114
Standard 18 Storage conditions 303
Symbol 22 Select, display function 52
Symbol
WARNING, meaning 21 Serious incident 14
Flag 54
Sample Service Meaning 22
Access samples, dialog 60 Contact information 9
Syringe 37
Assign STAT status 165 Set Check for leak 210
Check level visually 242 Automatic re-measurement 140 Replace 220
Display details 179 Automatic release 140 Replace syringe, dialog 111
Display measurement curve 179 Display result in lab journal 141 Troubleshooting 264
Handling by system 309 Language 142
Identify 171 System
Sort sequence in lab journal 141
Load barcoded sample 162 Clean surface 228
Load non-barcoded sample 167 Show curve, dialog 115 Dialog 123
Pre-identify non-barcoded sample 166 Shutdown 199 Does not respond 295
Refill sample tube 174 Maintenance 228 Does not work after standby 295
Repeat job manually 173 Rinse 198
Significant digits, sample ID 142
Request job manually 172 Rinse system, dialog 113
SMN, system 9 Shut down 199
Safe handling 18
Unload 175 Software version, information 58 Start 144
Sample barcode, technical specifications 307 Software, troubleshooting 265 System (dialog)
Sort, display function 53 Immersion depth cannot be defined 293
Sample details, dialog 113
Logbook entry displays level outside
Sample ID Spare parts 9
limits 292
Delete from lab journal 184 Special dilution, dialog 117 Logbook entry not displayed
Remove previous assignment 185 Standard 49 completely 292
Significant digits 142 Handling by system 310 Progress bar of purging of the tubing
Sample rotor 31 Identify 171 stops at 0:00 294
Barcode reader 31 Load 158 Unknown character string in raw
Clean 228 Unload 176 data 291

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 Index

System identification 9 User-defined control

System liquid Add 128
Replace 146 Add assay 130
Replace system liquids and empty waste Barcode, technical specifications 307
container, dialog 111 Delete 133
Edit assay settings 131
Load 158
T
Technical safety 14 V
Technical specifications
Vial, technical specifications 306
Adapter 306
Analyzer 300 Viewer software
Barcode for user-defined control 307 Close 298
Computer 303 Does not respond 296
Consumable 303 Start 297
Cuvette segment 305 VLinIntegral, method 326
Dilution strip 305
Evaporation cap 305 W
I/O port 303
Walk-away time 123
Operating conditions 302
Reagent barcode 308 Warranty 9
Reagent rotor segment 305 Waste container 47
Sample barcode 307 Clean 233
Sample rotor segment 304 Empty 145, 201
Sample tube 306 Replace system liquids and empty waste
Special cup 306 container, dialog 111
Storage conditions 303 Water
Vial 306 Replace 146
Temperature, monitoring 123 Requirement 18
Training see Distilled water
see Operator qualification see Purified water
Transfer arm 35 Water container 47
Clean 211
Transport
see Movement Water filter, replace 216
Troubleshooting 239 WEEE
Hardware 240 see Directive on waste electrical and
Software 265 electronic equipment
Syringe 264 Weekly maintenance task 204
Tubing 47 Wet station 33
Check tubing of container 212 Clean 207
Check tubing of probe 212
Purge 214 Y
Purge tubings, dialog 108
Yearly maintenance task 220
Replace tubing of container 224
Turbidity check, principle 325

U
Uninterruptible power supply 15
Units
Configure 139
Definition 78
Unload
Control 177
Reagent 177
Sample 175
Standard 176
UPS
see Uninterruptible power supply
User role 99
User settings, configuration 71

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 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. 11211543

Published by Siemens Healthineers / Print No. DCSI-B04.621.01.01.02 / © Siemens Healthineers, 2016 - 2021
Date of first issue: 2016-10 / Revision date: 2021-10