Viva-ProE Operators Guide US

Viva-ProE ™ System Operator’s Guide
Copyright © 2014 Siemens Healthcare Diagnostics.

All rights reserved.
This publication, the software, and the reports generated by the software have
been provided pursuant to the following agreement containing restrictions on
their use. They are also protected by federal regulations and cannot be copied,
distributed, transmitted, transcribed, or translated into any human or
computer language, in any form or by any means, to any third parties, without
the express written consent of Siemens Healthcare Diagnostics, Tarrytown, NY
10591.
Siemens has validated the provided instructions, reagents, instrument,
software, and customizable features for this system to optimize product
performance and meet product specifications. User defined modifications are
not supported by Siemens as they may affect performance of the system and
test results. It is the responsibility of the user to validate any modifications
made to these instructions, instruments, reagents, or software provided by
Siemens.
The material in this manual is believed adequate for the intended use of the
system. If the system or its individual components are used for purposes other
than those specified herein, confirmation of their validity and suitability must
be obtained; otherwise, Siemens does not guarantee results and assumes no
obligation or liability. Siemens warrants that the material itself does not
infringe any United States patents. No further warranty is expressed or
implied.
Viva-ProE is a trademark of Siemens Healthcare Diagnostics.
i-2 2014/07
2014/07 i-3
i-4 2014/07
Chapter 1: System Features . . . . . . . . . . . . . . . . . . . . . . 1-1

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
System Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Hardware Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Cuvette Rotor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Reagent and Sample Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Sample Rotor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Reagent Rotor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Pipettor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Water and Waste Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Concentrated Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Quartz-iodine Lamp Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Cooling Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Internal Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
External Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Keyboard and Trackball . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
System Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Windows Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
System Software Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Superuser Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
User Interface Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Start of Day Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Reagent Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Reagent Rotor Image Status Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Reagent Rotor Image Size Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Reagent Info Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Load Calibration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Request Calibration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
Request Calibration Screen (Detailed View Information) . . . . . . . . . . . . . . . . . . . . . 1-27
Load Controls Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Request Controls Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Request Controls Screen (Control and Test Information) . . . . . . . . . . . . . . . . . . . . . 1-31
Load Patients Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32
Rotor Status Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Request Patient Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-34
Results Screen - Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36
Results Screen - Calibration and Controls . . . . . . . . . . . . . . . . . . . . . . . 1-38
Unload Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-41
End of Day Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42
Events Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43
Chapter 2: System Operation . . . . . . . . . . . . . . . . . . . . . 2-1

Precautions for Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Precautions before Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Precautions during Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2014/07 Table of Contents- 1

Preparing Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Using Gel Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Using Pediatric Sample Cups . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Sample Barcode Label Properties and Placement . . . . . . . . . . 2-5
Sample Barcode Symbology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Daily Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Turning on the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Start of Day Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Emptying Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Filling Treated Water Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Emptying Concentrated Waste Container . . . . . . . . . . . . . . . . . . . . . . . 2-10
Checking Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Checking Cuvette Blank Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Manually Accepting Cuvette Blank Results . . . . . . . . . . . . . . . . . . . . . . 2-12
Rejecting Cuvette Blank Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Excluding Cuvette Blank Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Checking/Refilling 10% Cleaning Solution (Sodium Hypochlorite) . . . . 2-13
Viewing/Printing Daily Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
End of Day Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Emergency Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Stopping the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Restarting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Shutting down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Turning on the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Chapter 3: Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Checking Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Replacing a Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Loading a Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Unloading a Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Extending the Validity of a Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Switching the Reagent Rotor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Removing the Reagent Rotor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Installing the Reagent Rotor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Chapter 4: Sample Management . . . . . . . . . . . . . . . . . . 4-1

Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Requesting and Loading Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
Manually Accepting or Rejecting Control Measurements . . . . . . . . . . . 4-3
Unloading Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Unloading All Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Requesting Patient Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Editing Patient Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Loading and Processing Sample Tubes (with Internal Barcode Reader) 4-6
Loading and Processing Sample Tubes (without Internal Barcode Reader) 4-7
Manually Processing Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Processing STAT (Short Turn Around Time) Samples . . . . . . . . . . . . . . 4-9
Table of Contents- 2 2014/07

Pausing Sample Processing and Resuming Measurements . . . . . . . . . 4-10

Evaluating Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Searching Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Unloading a Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Unloading All Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Chapter 5: Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Loading Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Performing Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Editing Automatically Requested Calibrations . . . . . . . . . . . . . . . . . . . 5-2
Extending the Validity of a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Manually Accepting or Rejecting Results . . . . . . . . . . . . . . . . . . . . . . . 5-3
Unloading Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Unloading All Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Chapter 6: Quality Control . . . . . . . . . . . . . . . . . . . . . . . 6-1

Quality Control Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Viewing Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Chapter 7: Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
General Care and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Maintenance - Daily . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Emptying Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Filling Treated Water Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Emptying Concentrated Waste Container . . . . . . . . . . . . . . . . . . . . . . . 7-8
Checking Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Checking Cuvette Blank Measurements . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Checking/Refilling 10% Cleaning Solution (Sodium Hypochlorite) . . . 7-10
Viewing/Printing Daily Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Checking 0.1N HCl Cleaning Solution . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Priming the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Checking Reagent Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Archiving Results Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Maintenance - Weekly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Rinsing the Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Maintenance - Monthly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Cleaning the Treated Water and Waste Containers . . . . . . . . . . . . . . . 7-13
Cleaning the Concentrated Waste Container . . . . . . . . . . . . . . . . . . . . 7-15
Maintenance - Every 3 Months . . . . . . . . . . . . . . . . . . . . . . . . 7-17
Replacing the Drying Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
Maintenance - Every 6 Months . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
Replacing the Stirrer Belt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
Replacing the Water Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20
Cleaning the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
Maintenance - Yearly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23
Replacing Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23

Replacing the Photometer Lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26

Adjusting the Lamp Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-29
Maintenance - Every 10,000 Tests . . . . . . . . . . . . . . . . . . . . . . 7-32
Replacing the Cuvette Rotor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-32
Maintenance - As Needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-34
Cleaning the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-34
Cleaning the Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-34
Cleaning the Reagent Rotor Compartment . . . . . . . . . . . . . . . . . . . . . . 7-34
Filling the Cooling Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-37
Maintenance Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-39
Daily Maintenance Log (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-41
Weekly Maintenance Log (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-45
Monthly Maintenance Log (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-46
Every 3 Months Log (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-47
Every 6 Months Maintenance Log (1) . . . . . . . . . . . . . . . . . . . . . . . . . . 7-48
Yearly Maintenance Log (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-49
Every 10,00 Tests Maintenance Log (1) . . . . . . . . . . . . . . . . . . . . . . . . 7-50
As Needed Maintenance Log (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-51
Chapter 8: Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 8-1

Troubleshooting Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Troubleshooting Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Error Signaling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Audible Error Signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
General Error Condition Icons . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Test Related Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Hardware Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Unblocking the Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Chapter 9: Data Management . . . . . . . . . . . . . . . . . . . . 9-1

Backing Up the System Database . . . . . . . . . . . . . . . . . . . . . . . 9-2
Configuring Database Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Manually Backing Up the System Database . . . . . . . . . . . . . . . . . . . . . .9-2
Transferring a Backup Database to External Media Device . . . . . . . . . . 9-3
Archiving Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Manually Archive Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-4
Restoring a Backup Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Exporting Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Importing Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Chapter 10: System Configuration . . . . . . . . . . . . . . . . . 10-1

Configuration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Dependencies on Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Recommended Work Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Accessing the Configuration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Accessing the Configure Tests Screen . . . . . . . . . . . . . . . . . . . 10-4

Viewing Tests - General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

Viewing Tests - Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Viewing Tests - Measurement (Kinetic Tests) . . . . . . . . . . . . . . . . . . . . 10-7
Viewing Tests - Measurement (Endpoint Tests) . . . . . . . . . . . . . . . . . . 10-8
Viewing Tests - Measurement (Two Point Tests) . . . . . . . . . . . . . . . . . 10-9
Viewing Tests - Absorbance Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
Viewing Tests - Sample Blank Absorbance Checks . . . . . . . . . . . . . . . . 10-11
Viewing Tests - Result Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12
Viewing Tests - Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14
Viewing Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Viewing Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Viewing, Adding, and Editing Controls . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Creating a Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Adding a Test to Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Editing Test Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18
Deleting a Test from a Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18
Deleting a Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-19
Viewing, Adding, and Editing Calibrator Lot . . . . . . . . . . . . . . . . . . . . . 10-19
Creating a Calibrator Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20
Editing a Calibrator Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20
Viewing, Adding, and Editing Control Lot . . . . . . . . . . . . . . . . . . . . . . . 10-21
Creating a Control Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21
Editing a Control Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-22
Viewing, Adding, and Editing Probe Incompatibilities . . . . . . . . . . . . . 10-22
Adding Probe Incompatibilities or Links . . . . . . . . . . . . . . . . . . . . . . . . 10-23
Editing Probe Incompatibilities or Links . . . . . . . . . . . . . . . . . . . . . . . . 10-24
Deleting a Probe Incompatibility or Link . . . . . . . . . . . . . . . . . . . . . . . . 10-24
Viewing, Adding, and Editing Test Incompatibilities . . . . . . . . . . . . . . 10-24
Adding Test Incompatibilities or Links . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25
Editing Test Incompatibilities or Links . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25
Deleting a Test Incompatibility or Link . . . . . . . . . . . . . . . . . . . . . . . . . 10-26
Viewing a Test Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Editing a Test Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Accessing System Menu Screens . . . . . . . . . . . . . . . . . . . . . . . 10-28
Configuration Instrument Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-28
Configuring Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-28
Configuring Laboratory Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-29
Configuring Audible Notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-29
Configuring User Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-30
Activating or Deactivating the Internal Barcode Reader . . . . . . . . . . . . . . . . . . . . . . 10-30
Configuring Reagent Rotors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-31
Configuring Daily Operation Times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-31
Configuring Start of Day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-32
Configuring Database Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-33
Configuring Printed Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-33
Configuring Export Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-34
Configuring the Laboratory Information System (LIS) Connections . . . . . . . . . . . . 10-35
Configuring Sample Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-36
Configuring Category Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-36
Editing Category Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-37
Configuring Calculated Test Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-37
Editing Calculated Test Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-37
Configuring Service Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-38
Configuring Operator Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-38
Editing Operator Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-38
Accessing the Flag Customization Screen . . . . . . . . . . . . . . . . . . . . . . . 10-39
Configuring Flag Customization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-39

Editing Flag Customization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-40

Configuring Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-40
Adding a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-40
Resetting User Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-41
Deactivating a User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-41
Appendix A: Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Protection from Biohazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
Instrument and Waste Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
Protection from Barcode Scanner Lasers . . . . . . . . . . . . . . . . . . . . . . . . 11-4
Mechanical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Biological Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Appendix B: Warranty and Support . . . . . . . . . . . . . . . . 12-1

Limited Instrument Warranty and Service Delivery Policy . . . . 12-2
Warranty Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Service Calls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Warranty and Service Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Appendix C: Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1

Cleaning Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2
System Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2
System Cleaning Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2
0.1 N HCl Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
0.1N NaOH Volumetric Solution (Sodium Hydroxide) . . . . . . . . . . . . . . 13-3
Appendix D: Specifications . . . . . . . . . . . . . . . . . . . . . . . 14-1

System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2
Dimensions and Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2
Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3
Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3
Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-6
Internal Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-6
External Barcode Reader (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-6
Accuracy and Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-7
Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-7
Predefined Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-8
Appendix E: Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-1

System Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-2
Appendix F: Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-1

Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-2
Absorbance Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-3
Measuring Absorbance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-3
Measurement Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-4
Calculating Concentrations from Absorbances . . . . . . . . . . . . . . . . . . . 16-5
Measurement with Reagent Blank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-5
Measurement with Reagent Blank and Sample Blank . . . . . . . . . . . . . . . . . . . . . . . 16-5
Bichromatic Endpoint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-6
Interpolation on Calibration Curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-6
Calibration Algorithms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-7
Standard Cubic Spline Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-7
Modified Cubic Spline Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-8
NLLS Algorithms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-8
4 Parameter Logit-log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-8
5 Parameter Logit-log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-8
5 Parameter Exponential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-9
Linear Regression and Point-to-Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-9
Explanation of System Features . . . . . . . . . . . . . . . . . . . . . . . . 16-10
Integrity Checking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-10
Absorbance Check for Calibrated Tests . . . . . . . . . . . . . . . . . . . . . . . . . 16-10
Westgard Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-10
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1


Viva-ProE ™ System Operator’s Guide System Features
Chapter 1: System Features
2014/07 1-1
System Features Viva-ProE ™ System Operator’s Guide
Intended Use
ELITech Clinical system Viva-ProE ™ is an automated clinical chemistry system
intended for use in clinical laboratories. It is intended to be used for a variety of
assay methods that have been applied to spectrophotometric techniques. The
system has a spectrophotometric system for measurement of analytes using
spectrophotometric techniques, such as end point, rate and turbidimetric
assays.
WARNING: An incorrectly measured result may lead to an error in

diagnosis thereby posing a danger to the patient.
Note: Do not use the computer for anything other than running the
pre-installed control software. The use of any other software
might cause failures in the analyzer.
Usage
The Viva-ProE ™ System is intended for use in clinical chemistry laboratories
with low to medium workload and must be operated by qualified and trained
personnel.
The analytical results depend on both correct operation of the system and a
variety of external influences beyond the control of the manufacturer. This
system is intended for professional use in a laboratory environment only. Tests
performed using this system are intended for In Vitro diagnostic use. A
definitive clinical diagnosis should not be based on the results of a single test,
but should only be made by the physician after all clinical and laboratory
findings have been evaluated.
1-2 2014/07
System Users
This Operator’s Guide provides information for the following clinical laboratory
professionals who use the system:
Table 1-1: System Users
User Description
Operator Performs daily operating tasks such as start of day tasks, calibration and
control measurements, loading and unloading reagents and samples,
examining test results, and basic maintenance.
Supervisor In addition to the Operator functions, the Supervisor can also accept or
reject flagged results, accept or reject pending calibration results, and add
comments to a QC history controlled result.
Administrator In addition to the Supervisor functions, the Administrator can create new or
edit existing controls, create new calibrators, lots, and tests, enable or
disable tests, edit test and instrument parameters, extend expired control
results, override Westgard rules, and exclude controls from the QC history.
2014/07 1-3
Hardware Overview
Figure 1-1: Viva-ProE ™ System
1 Reagent Rotor
2 Probes
3 Cuvette Rotor
4 Sample Rotor
5 Computer and Touchscreen
6 Pipettor (inside side cabinet)
7 Treated Water and Waste Containers (inside cabinet)
8 Cooling Unit (inside cabinet)
9 Lamp Unit (inside cabinet)
10 Concentrated Waste Container (inside cabinet)
1-4 2014/07
Cuvette Rotor
The cuvette rotor contains 48 cuvettes. The system requires a measuring
volume between 200 µL - 400 µL. The cuvette rotor uses a heater installed
below the rotor and a heated cover to keep the cuvettes at
37 °C (98.6 F).
The stirrer stirs the reaction mixture. It operates by lowering the probe into the
eccentric washer; the eccentric washer vibrates the probe in the reaction
mixture. The cuvette rotor then rotates the sample until it reaches the
measurement position. Once the system completes all measurements, the
wash arm washes and dries the cuvette, then deposits the waste into the
waste container.
Figure 1-2: Cuvette Rotor
1 Cuvette Rotor
2 Wash Arm
3 Stirrer
Reagent and Sample Probes

The Viva-ProE ™ System is equipped with a reagent and sample probe. During
the aspiration of either the reagent or sample, the probes are lowered through
one of the openings in the reagent or sample covers. The reagent or sample is
then dispensed into the cuvettes through the openings in the cuvette rotor
cover. After the reagent or sample has been dispensed, the rinsing stations
clean the probes with treated water.
2014/07 1-5
Figure 1-3: Reagent and Sample Probes
1 Reagent Arm
2 Reagent Probe
3 Reagent Rotor
4 Cuvette Rotor Cover
5 Rinsing Stations
6 Sample Arm
7 Sample Probe
8 Sample Rotor
1-6 2014/07
Sample Rotor
The sample rotor holds the sample tubes. All positions are numbered and
displayed on the rotor screens. The samples are divided over three rings.
The sample rotor is covered to protect the samples from light and other
ambient influences. The cover has openings to let the sample probe pass
through.
Figure 1-4: Sample Rotor
2014/07 1-7
Reagent Rotor
The reagent rotor is designed to hold both 14 mL and 28 mL reagent bottles.
An optional adapter is also available that allows 14 mL bottles to be used in a
28 mL position. Reagent positions are defined in the system software.
The reagent rotor is covered to protect the reagent from light, heat, and other
ambient influences. The cover has openings to let the reagent probe pass
through. The base of the reagent rotor is cooled.
Figure 1-5: Reagent Rotor
1 28 mL Position
2 14 mL Position
1-8 2014/07
Pipettor
The pipettor unit uses a 1 mL syringe for pipetting reagent and a 100 µL
syringe for pipetting sample materials.
Figure 1-6: Pipettor
1 Probe Connection
2 Valve
3 Sample Syringe
4 Plunger Handle
5 Reagent Syringe
6 Water Connection
2014/07 1-9
Water and Waste Systems

Figure 1-7: Water and Waste Systems
1 Waste Container Cap
2 Float Switch
3 Waste Container
4 Water Filter
5 Treated Water Container
6 Treated Water Container Cap
1 - 10 2014/07
Concentrated Waste Container

Figure 1-8: Concentrated Waste Container
1 Cap
2 Float Switch
3 Concentrated Waste Container
2014/07 1 - 11
Quartz-iodine Lamp Unit

The lamp unit is located inside the main cabinet. It uses a quartz-iodine lamp,
which uses light of various wavelengths to measure the absorbance in sample
tests. The system uses one of its eight filters to filter light from the
quartz-iodine lamp. The filter wheel drive automatically places the appropriate
filter into position.
The Viva-ProE ™ System tests the quality of the light source. If the system
detects degradation in the performance of the quartz-iodine lamp, it displays
an error message on the system screen.
Figure 1-9: Quartz-iodine Lamp Unit
1 Filter
2 Quartz-iodine Lamp
3 Filter Wheel Drive
1 - 12 2014/07
Cooling Unit
The Viva-ProE ™ System uses a cooling unit to extend the on-board stability of
reagents on the system. The cooling unit keeps the reagent’s temperature
between 8 - 12 °C (46 - 53 °F), up to an ambient temperature of 25° C (77° F).
Above 25° C (77° F) the reagent temperature increases relative to the ambient
temperature. The cooling unit is located behind the front panel of the system.
The cooling unit uses a pump to circulate the cooling liquid and has a sight
window with markers that indicate minimum and maximum cooling liquid
levels.
Figure 1-10: Cooling Unit
1 Cap
2 Maximum Level Indicator
3 Minimum Level Indicator
2014/07 1 - 13
Internal Barcode Reader

The Viva-ProE ™ System is equipped with an internal barcode reader. The
barcode reader is located in the outer compartment behind the sample rotor.
Figure 1-11: Internal Barcode Reader
1 Internal Barcode Reader
2 Sample Rotor
1 - 14 2014/07
External Barcode Reader

A hand-held barcode reader can be connected to a USB port on the computer
for use in loading barcoded sample tubes.
WARNING: The hand-held barcode reader emits laser light. Do

not look directly at the laser or its reflection from a shiny
surface. This causes damage to the eyes.
Note: Barcode readers must be programmed before use to
recognize barcodes labels. Barcode readers purchased from
the manufacturer or one of its distributors are shipped with
the appropriate programming instructions. The manufacturer
cannot guarantee correct functioning of a barcode reader
that is purchased elsewhere.
Figure 1-12: External Barcode Reader
2014/07 1 - 15
Computer
The Viva-ProE ™ System includes a Personal Computer (PC) on an adjustable
mounting arm. The panel PC runs the Microsoft® Windows® operating system
and the user interface software for the system. The mechanical components of
the system are controlled by electronic boards located in the back of the
system.
The touchscreen offers an easy-to-use direct user interface to the system
functions.
Note: Ensure the operator’s fingers or gloves are clean when
touching the screen. A clean, plastic stylus may also be used.
CAUTION: Never use metal or sharp objects to touch the screen.

Note: The mouse pointer should jump to the location where the
operator touches the screen. If the mouse pointer
consistently fails to locate the touch point, recalibrate the
touchscreen. Contact the nearest Siemens representative for
support.
Figure 1-13: Panel Personal Computer
1 - 16 2014/07
Keyboard and Trackball

A US-international mini keyboard with an integrated trackball is supplied for
entering data when needed.
Note: The customer may replace the keyboard with another USB
enabled keyboard. When connecting a keyboard with
another key layout, change the keyboard settings in the
Windows control panel.
Figure 1-14: Keyboard
2014/07 1 - 17
Software Overview
System Access
The Viva-ProE ™ System software requires authentication by the operator. The
operator must have a user name and password to access the system. The
operator must login to the system using the following access screens:
• Windows Login
• System Software Login
Windows Login
In the Windows system, the following user accounts are available:
Table 1-2: Windows Login Account Types
Account Type User
Analyzer Operator
Maintenance Field Service Engineer
System Software Login

In the system software, the following user levels are available:
Table 1-3: System Login User Accounts
User Description
Operator Performs daily operations of the system, such as start of day tasks, calibration
and control measurements, loading reagents and samples, requesting and
running tests, examining test results, and repeat or re-running tests for some
flagged results.
Supervisor In addition to the Operator functions, the Supervisor accepts or rejects flagged
test results.
Administrator In addition to the Supervisor functions, the Administrator configures the

system, extends validity of reagents, calibrators, and controls, and authorizes
deviations from standard operating procedures.
Superuser Login
Switching to another user is possible without logging out the previous user.
This login allows a supervisor to temporarily login to perform tasks requiring
supervisor level access.
Logging In or Out a Superuser

Note: Only users with Supervisor access or above can perform this
procedure.
1. From the Home screen, select Logout to open the User Logout screen.
2. Select Switch User to open the Login Dialog screen.
1 - 18 2014/07
3. Enter Username and Password, then select Login.

4. The name of the Superuser will be displayed in Red at the top of the
Home screen and a Logout Superuser symbol will be displayed.

5. Select Logout to logout the Superuser and login the previous user.
2014/07 1 - 19
User Interface Screens

Home Screen
Figure 1-15: Home Screen Components
1 11
Start of Day Screen Icon Print Screen Icon
2 12
Reagents Screen Icon Help Screen Icon
3 13
Load Calibration Screen Icon Events Screen Icon
4 14
Load Controls Screen Icon Quality Control Screen Icon
5 Scan, Process, Pause or 15

Resume Icon Configure Screen Icon
6 16
Load Patients Screen Icon Tasks Screen Icon
7 17
Results Screen Icon Reset Icon
8 18
Unload Screen Icon System Stopped Icon
9 19
End of Day Screen Icon Stop System Icon
10 20
Login / Logout Icon Open or Close Information Panel window icon
1 - 20 2014/07
Start of Day Screen

Displays a list of tasks that must be performed at the start of each working day.
Figure 1-16: Start of Day Screen Components
1 Start of Day
2 Description
3 Status
2014/07 1 - 21
Reagent Screen
The Reagent screen displays the status of reagents and is used for loading,
unloading, replacing, and extending reagents.
Figure 1-17: Reagent Screen Components
1 Clear
2 Reagent Rotor
3 Print
4 Reagent Info
5 Switch Rotor
6 Extend
7 Replace
8 Unload
9 Load
Reagent Rotor Image Status Colors

The positions on the Reagent Rotor image changes color based on the current
system status.
Table 1-4: Reagent Rotor Image Colors and Status
Color Status
Blue Reagent Loaded
Dark Blue Special Fluid Loaded
Red Reagent Empty or Expired
Gray Open or Empty Position
Blue Outer Circle A loaded Reagent that has been selected
1 - 22 2014/07
Reagent Rotor Image Size Indicators

The size of the circle displayed on the Reagent Rotor screen is an indicator of
the size of the reagent bottle that can be loaded.
Table 1-5: Reagent Rotor Image Size Indicators
Indicator Description
Small Circle 14 mL Bottle Load Position
Large Circle 28 mL Bottle Load Position
2014/07 1 - 23
Reagent Info Screen

The Reagent Info screen displays the following information:
Table 1-6: Reagent Info List Box Section
Item Displays
POS The position of the reagent on the rotor.
Tests The test for which the reagent is used.
Reagent The role of the reagent, such as first (R1), second (R2), or third
(R3).
Note: For special fluids, the name of the fluid will be displayed.
Status The current state of the reagent. See Table 1-8 “Reagent Status
Icons” for more information.
Lot Number The lot number of the on-board reagent.
Lot Expiration The expiration date of the reagent.
Onboard Stability The remaining time during which the reagent can still be used
when it is kept on the system.
Remaining Volume The remaining volume in the reagent bottle.

Note: If the reagent bottle is refilled or replaced the system will
automatically reset the volume.
Remaining Tests The number of tests that can be performed with the amount of
remaining reagent.
Completed Tests The number of tests that were performed using the current
reagent bottle.
Table 1-7: Reagent Status Icons
Icon Description
Reagent Level Low
Reagent Empty
Reagent Expiration date Extended
Reagent Expired
1 - 24 2014/07
Load Calibration Screen

The Load Calibration screen displays the status of requested calibrations and is
used for loading or unloading calibrators on the Sample Rotor.
Figure 1-18: Load Calibration Screen
1 Load
2 Unload
3 Sample Rotor
4 Review
The Load Calibration screen displays the following information:

Table 1-8: Load Calibration List Box Section
Item Displays
Calibrator The position of the reagent on the rotor.
Tests The name of the test for the requested Calibration and or
Reagent Blank.
Calibrator Lot The lot number and lot expiration of the Calibrator.
Note: The lot number is listed on the package label of the
Calibrator. Do not use beyond the expiration date.
Level The number of Calibrator levels.
Pos The position of the Calibrator on the rotor.
2014/07 1 - 25
Request Calibration Screen

The Request Calibration screen displays all tests for which calibrations and
reagent blanks are defined and is used to request calibrations. The Summary
view displays two sets of request buttons. Calibrations are displayed on the left
side of the screen and Reagent Blanks are displayed on the right side of the
screen.
Figure 1-19: Request Calibration Screen (Summary View)
1 Summary
2 Details
3 Calibration
4 Reagent Blank
5 Cancel
6 Accept
7 Close
Note: Reagent Blank function shown, but not used.
1 - 26 2014/07
Request Calibration Screen (Detailed View Information)

The Request Calibration Screen Details View displays a list of tests with detailed
calibration and reagent blank information.
Table 1-9: Request Calibration Screen List Box Section (Detailed View)
Item Displays
Tests The name of the test for the requested Calibration and or
Reagent Blank.
Calibrator The name of the calibrator.
Reagent Stability The time remaining before the reagent expires.
Blank Expiration The time remaining before the reagent blank expires.
Calibration Expiration The time remaining before the calibration measurement expires
Note: If N/A is displayed, no calibration was performed and was
not required for the test requested.
Calibrator Lot Number The lot number of the calibrator.
Calibrator Lot Expiration The expiration date of the calibrator.
Level The number of calibrator levels.
Concentration The concentration of the calibrator level.
Note: Reagent Blank function shown, but not used.
2014/07 1 - 27
The following function buttons are available in the detailed view:

Table 1-10: Request Calibration Screen Buttons - Detailed View
Button Description
Use Previous Discards the calibration and revert to the previous calibration
results.
Extend Extends the Calibration and or Reagent Blank validity.
Calibrate Schedules calibration for the current test.
Close Returns to the Load Calibration Screen.

Note: Only be available if no changes were made.
Accept Confirms the request and opens the Load Calibration screen.
Cancel Cancels all changes.
Table 1-11: Calibration and Reagent Blank Status Icons
Icon Description
Test unable to be performed; select Details for more information.
Calibrator loaded; request to change a test cannot not be made at this time.
Calibration and or Reagent Blank has expired.
Calibration and or Reagent Blank validity has been extended.
1 - 28 2014/07
Load Controls Screen

The Load Controls screen displays the status of the requested controls and is
used to request and load controls on the sample rotor.
Figure 1-20: Load Controls Screen
1 Load
2 Unload
3 Sample Rotor
4 Review
The Load Controls screen displays the following information:

Table 1-12: Load Controls Screen List Box Section
Item Displays
Control The name of the Control.
Tests The name of the test for which the Control is requested.
Control Lot The Control lot number.
Pos The position of the control on the rotor.
2014/07 1 - 29
Request Controls Screen

The Request Controls screen displays all configured controls and is used to
request control measurements for particular tests.
Figure 1-21: Request Controls Screen
1 Summary
2 Details
3 Cancel
4 Accept
5 Close
6 Extend
The Request Controls screen displays the following information:

Table 1-13: Request Controls Screen List Box Section (Summary View)
Item Displays
1 - 30 2014/07
The Request Controls screen displays the following information:

Table 1-14: Request Controls Screen List Box Section (Details View)
Item Displays
Reagent Stability The time remaining before the Reagent expires.
Control Expiration The time remaining before the Control Measurement expires.
Note: The Control Expiration displays when the Control
Measurement expires, not when the Control lot expires. The date
is displayed as Expiration in the control information section to
the right of the tests list.
Request Controls Screen (Control and Test Information)

Control and Test information is displayed on the right side of the Request
Controls Screen.
The Request Controls screen Control and Test section displays the following
information:
Table 1-15: Request Controls Screen List Box Section (Details View)
Item Displays
Lot The Lot number of the Control.
Expiration The expiration date of the Control.
Reagent The Reagents for the selected test.
Lot The Reagent Lot number.
Expiration The expiration date of the Reagent.
2014/07 1 - 31
Load Patients Screen

The Load Patients screen displays a list of samples awaiting processing and an
image of the Sample rotor. Use this screen to load samples onto the Sample
rotor.
Figure 1-22: Load Patients Screen
1 Delete
2 Edit
3 Create
4 Load
5 Unload
6 Sample Rotor
7 Print List
The Load Patients screen displays the following information:

Table 1-16: Load Patients List Box Screen
Item Displays
Search ID A text box used to enter a new patient or search for an existing
patient identification number.
Comment The comment text box.
ID The sample identification.
Patient Name The patient name.
Pos The position of the sample on the rotor.
1 - 32 2014/07
Rotor Status Icons

Table 1-17: Rotor Status Icons
Icon Description
Open or empty rotor position.
The sample has been loaded onto the rotor and is ready for processing.
A STAT sample has been loaded.
The system is processing the sample.
Sample processing complete and can now be unloaded.
Attention required. Measurements cannot be completed and display

flagged results. Operator attention is required to complete processing of
the Sample, Control, or Calibrator.
Calibrator or Reagent Blank. Shows a Calibrator, or Reagent currently

processing, has completed processing, or flagged and in error state.
Control that is currently processing, completed processing, or flagged in

error state.
Special fluid loaded in the rotor (cleaning solution).
2014/07 1 - 33
Request Patient Screen

The Request Patient screen displays administrative information. The
information displayed is for an individual sample record and is used to request
tests for that sample.
Figure 1-23: Request Patient Screen
1 Routine 10 Female
2 ASAP (As Soon As Possible) 11 Male
3 STAT (Short Turn Around Time) 12 Comment
4 Replicates 13 Category
5 Collection Date 14 Sample Type
6 Cancel 15 Birth Date
7 Accept 16 Physician
8 * Repeat Mode 17 Name
9 Pediatric 18 MR# (Medical Record Number)
Note: * If selected, remembers the last test selection for use with
the next sample.
1 - 34 2014/07
The Request Patient screen displays the following information:

Table 1-18: Request Patient List Box Screen
Item Displays
Sample ID The patient sample identification number.
Position The position of the sample on the rotor.
Test The individual tests that can be performed on a patient sample.

Note: If the test button displays a red flag, the test has an error.
The error must be resolved before the test can be performed.
2014/07 1 - 35
Results Screen - Patients

In the Patients view, the Results screen is used to view test results for samples.
Figure 1-24: Results Screen - Patients
1 Reagent Blanks
2 Loaded
3 Recent
4 Calibration and Controls
5 Patients
6 Search
7 Cancel
8 Reject
9 Accept
10 Dilute
11 Repeat
12 Export
13 Resend to LIS
14 Print
15 Summary Report
1 - 36 2014/07
The following buttons are displayed but not shown:

Table 1-19: Results Screen - Patients Buttons (Additional)
Button Description
View Test Displays the test parameters.
View Calibration Views the last calibration results for a desired test.
View Blank Views the last reagent blank results for a desired test.
The Results Screen - Patients screen displays the following information:

Table 1-20: Results Screen - Patient List Box Screen
Item Displays
ID Sample identification.
Name Patient name.
Status Time the sample tests were completed.
Test Name Name of the test performed on the sample.

Note: To view, select the triangle icon in front of the test name.
Value Result of the test and individual measurement, if available.
Flags Errors according to the automatic checking mechanisms in the

system software.
Note: A description of the flags are given to the right of the
sample details. Individual measurements can be viewed as a
graph or table by selecting the triangle icon in front of the test
name.
Table 1-21: Results Screen - Patient Status Icons
Icon Description
Blue Circle Sample processing
Blue Check Mark Sample processing complete
Orange Flag Error during processing
2014/07 1 - 37
Results Screen - Calibration and Controls

In the Calibration and Controls view, the Results screen is used to view and
accept or reject calibration and control measurement results.
Note: Selecting Details expands the window and displays
measurement details for that Calibration or Control.
Figure 1-25: Results Screen - Calibration and Controls (Summary View)
1 Reagent Blanks
2 Calibration and Controls
3 Patients
4 Search
5 Print
6 Export
1 - 38 2014/07
The following buttons are displayed only in the Detailed view:

Table 1-22: Results Screen - Calibration and Controls Buttons
Button Description
Accept Curve Accepts the selected calibration curve.
Reject Curve Rejects the selected calibration curve.
Repeat Requests a repeat for the selected measurement.
Dilute Requests a repeat with a diluted sample for the selected

measurement.
Accept Accepts the selected measurement.

Note: Only available if the result has not been accepted or
rejected automatically.
Reject Rejects the selected measurement.

Note: Only available if the result has not been accepted or
rejected automatically.
Cancel Cancels a pending calibration or control.

Note: The Cancel button is only available when calibration or
control measurements are in progress or are interrupted.
Note: Dilute function shown, but not used.
2014/07 1 - 39
The Results Screen - Calibrations and Controls details screen displays the
following information:
Table 1-23: Results Screen - Calibrations and Controls List Box Screen
Item Displays
Level The calibrator level.
Value The concentration of the calibrator at this level.
Abs, dAbs, or dAbs/m The unit of measurement (measured absorbance, measured

delta absorbance, or measured delta absorbance per minute).
Flags (Calibration) Errors according to the automatic checking mechanisms in the

system software.
name.
Control The name of the control.
Result The Measurement results.
Range The Acceptance range for the control.
Flags (Controls) Errors according to the automatic checking mechanisms in the

system software.
name.
Table 1-24: Results Screen - Calibrations and Controls Status Icons
Icon Description
Blue Circle Processing calibration and controls.
Blue Circle with Blue Processing complete and ready to be unloaded.

Check Mark
Blue Check Mark Processing complete and Calibrator or Control unloaded.
Red Clock Expired Calibrator and or Control.
Red Exclamation Operator attention required.

Mark
1 - 40 2014/07
Unload Screen
The Unload screen displays a list of currently loaded samples and an image of
the sample rotor. The screen is used to unload completed samples.
Note: Only validated samples can be unloaded. If one or more tests
results for the sample are flagged, operator intervention is
required before the sample can be released for unloading.
Figure 1-26: Unload Screen
1 Type
2 Name
3 Sample ID/Level
4 Pos
5 Unload All
6 Unload
7 Rotor
2014/07 1 - 41
End of Day Screen

Displays a list of tasks that must be performed at the end of each working day.
Figure 1-27: End of Day Screen Components
1 End of Day
2 Description
3 Status
1 - 42 2014/07
Events Screen
The Events screen lists all events that were recorded and is used to
acknowledge events and or silence the audio alarm. The list displays the time
and date of each event with a description and information about a possible
action that was performed.
Figure 1-28: Events Screen
1 Silence Alarm
2 Stop Instrument
3 Acknowledge
4 Reconnect LIS
5 Stay Disconnected
The Events screen displays the following information:

Table 1-25: Events Screen List Box Section
Item Displays
Time Date and time when the event was registered.
Description Error code and description of the event.
Action Action performed in reaction to the event.
User User who performed the action.
2014/07 1 - 43
1 - 44 2014/07
Viva-ProE ™ System Operator’s Guide System Operation
Chapter 2: System Operation
2014/07 2-1
System Operation Viva-ProE ™ System Operator’s Guide
Precautions for Operation

Follow these precautions and requirements when operating the Viva-ProE ™
System. Failure to do so could cause damage to the system and may negatively
affect test results.
Precautions before Operation

Before operating the Viva-ProE ™ System:
• Read this Operator’s Guide thoroughly to understand the full functionality
of the system and associated hazards.
• Read the sections of the reagent manufacturer’s assay-specific
documentation (for example, IFU or reagent application sheet) that are
associated with warnings and precautions.
WARNING: Biohazard - Wear personal protective equipment. Use

universal precautions. See “Protection from Biohazards” on
page 3 of Appendix A Safety for recommended precautions
when working with biohazardous materials.
Precautions during Operation

While operating the Viva-ProE ™ System:
• Keep all covers, doors, and safety shields closed unless instructed
otherwise.
• Do not disconnect any electrical connection while the power is on.
• If there are bubbles or foam present in any reagent or samples carefully
remove using a disposable pipette.
2-2 2014/07
Preparing Samples
The quantity of patient sample needed to perform the desired tests is a
combination of sample volume per test, buffer volume per test, and dead
volume per test.
The following is a definition of the Buffer and Dead Volumes:
• The buffer volume is a small amount of the sample aspirated prior to
testing to remove water from the interior wall lining of the sample probe.
• The dead volume is the patient sample material that remains in the sample
tube or cup after testing is completed.
CAUTION: Do not use the remaining sample volume material; what remains
is too low to be accurately aspirated by the system.
Use the table below to determine volume requirements for the sample tubes
or cups.
Table 2-1: Sample Volume Requirements
Sample Volume Per Test* Buffer Volume Per Test Dead Volume Per Test**
1 - 10 µL 5 µL 250 µL
10 - 20 µL 10 µL 250 µL
20 - 30 µL 15 µL 250 µL
* Note: This is the sample volume required for each test, as specified in the reagent package insert.
** Note: When using pediatric cups with the pediatric adaptors, the dead volume is ~ 100 µL.
CAUTION: Ensure that the sample/reagent mixture does not contain any
bubbles, blood clots, dust, or other insoluble contaminants.
Insoluble contaminants contained within a sample may
negatively affect patient results.
Using Gel Tubes

Gel tubes can be used on the system. The gel tubes must contain at least
10 mm of serum above the gel layer. Do not process a gel tube with less than
10 mm of liquid above the gel layer as gel can clog the sample probe. If less
than 10 mm of liquid remains, transfer the liquid to a secondary tube or
sample cup.
2014/07 2-3
Using Pediatric Sample Cups

Note: Only use pediatric sample cups with the silver-colored
pediatric adapter.
Figure 2-1: Pediatric Sample Cup and Sample Cup Adapter
1 Pediatric Sample Cup
2 Pediatric Sample Cup Adapter
1. Insert the pediatric cup into the silver pediatric adapter.

2. Insert the combined pediatric cup and adaptor into the sample rotor.
2-4 2014/07
Sample Barcode Label Properties and Placement

Adhere to the following practices when affixing the barcode label:
• Affix the barcode label vertically along the length of the sample tube in a
“ladder” orientation, where the printed bars are horizontal. Do not wrap
the label horizontally around the tube.
• Position the label vertically as straight as possible. Do not place the label at
an angle on the tube.
• Affix the label so that the barcode and the minimum quiet zone is 14 mm
(0.55 inch) below the top of the tube, excluding the cap.
• Affix the label so that the barcode and the minimum quiet zone is no lower
than 20 mm (0.79 inch) from the bottom of the sample tube to ensure that
the entire label is visible to the barcode reader when the tube is loaded into
the rotor.
• Siemens recommends that “quiet zones” at least 3.5 mm (0.14 inch) wide
be included before the first bar of the barcode and follow the last bar.
• “Quiet zones” must contain no lines or marks that could be interpreted as a
bar by the barcode reader.
Figure 2-2: Barcode Label Placement
1 Quiet Zone
2 Barcode Symbol Placement Zone
3 Label Placement Zone
4 Symbol Barcode Height 10 mm (0.39 inch) – Minimum Height Required
• Ensure that the label does not touch the tube closure.
• Ensure that the label is not transparent to prevent reading the barcode on
an underlying label.
• Ensure that the label has no creases.
• Do not place clear tape over the label.
• Ensure that the label is free of moisture.
• Ensure that the adhesive is strong enough to prevent the label from
peeling loose or becoming partially detached from the tube.
2014/07 2-5
WARNING: The operator is responsible for placing the correct barcode

label on the sample tube to ensure proper sample
identification.
WARNING: When a new barcode label is added to a sample tube, ensure

that the original label is covered entirely by the new barcode
label.
Sample Barcode Symbology

The sample barcode should be as followed:
• Code 128 is the preferred symbology.
• Minimum height of the barcode symbol is 10 mm (0.40 inch).
• Minimum width of the narrow bar is 0.191 mm (0.007 inch).
• Minimum width of the quiet zone is 10 x width of the narrow bar
(10 x 0.191mm).
• The barcode must include a minimum of three data characters.
• Minimum acceptable ANSI grade is C.
Note: Siemens recommends “quiet zones” at least 3.5 mm
(0.14 inch) wide.
Note: Siemens recommends using a symbology that uses check
digits.
2-6 2014/07
Daily Setup
Turning on the System
1. On the back of the system, turn main disconnect switch On.
2. Turn the system PC On.
3. From the Windows screen, select Analyzer.
4. Double-select the Pro Series Software icon.

5. Select Start Application Software.
Login
1. From the Home screen, select the Login icon.
2. Enter Username and Password then select Login.
Start of Day Procedures

1. Select the Start of Day icon.
Note: The screen displays a list of tasks that must be performed at
the start of each day.
2. Perform all tasks that show an orange flag or exclamation mark.
3. Select the checkbox next to the task to mark as complete.
2014/07 2-7
Emptying Waste Container

Figure 2-3: Waste Container
1 Cap
2 Float Switch
3 Waste Container

Note: Skip this procedure if the system is equipped with an external
waste kit. The external waste kit diverts liquid waste directly
into a drain outside of the system.
1. Open the Waste Container door using the handle at the bottom to pull
the door outward.
2. Remove the Waste Container cap.
3. Slide the Waste Container out of the system.
4. Empty the Waste Container following standard laboratory operating
procedures.
5. Push the Waste Container inside the system and ensure that it is in the
proper position.
6. Replace and tighten the cap; close the cabinet door.
7. From the Home screen, select the Events icon.
2-8 2014/07
8. Select Waste Full.

9. Select Acknowledge to stop the alarm signal.
Filling Treated Water Container

Figure 2-4: Treated Water Container
1 Cap
3 Water Filter
1. Open the Treated Water Container door using the handle at the bottom
to pull the door outward.
2. Remove the Treated Water Container cap.
3. Slide the Treated Water Container out of the system.
4. Fill the Treated Water Container with 12.5 mL of system solution and 5 L
of distilled or purified water (ASTM Type II Grade or above).
5. Push the Treated Water Container inside the system and ensure that it is
in the proper position.
2014/07 2-9
Emptying Concentrated Waste Container

1 Cap
2 Float Switch

1. Open the Concentrated Waste Container door using the handle at the
bottom to pull the door outward.
2. Remove the Concentrated Waste Container cap.
3. Slide the Concentrated Waste Container out of the system.
4. Empty the Concentrated Waste Container following standard laboratory
operating procedures.
5. Push the Concentrated Waste Container inside the system and ensure
that it is in the proper position.
2 - 10 2014/07
Checking Syringes
Figure 2-6: Reagent and Sample Syringes
1 Probe Connection
2 Valve
3 Sample Syringe
4 Probe Connection
5 Reagent Syringe
6 Water Connection
1. Open the Pipettor door using the handle at the bottom to pull the door
outward.
2. Inspect the Reagent and Sample syringes and verify that no air bubbles or
leaks are present.
Checking Cuvette Blank Measurements

1. From the Home screen, select Start of Day > Check cuvette blank.
2. Verify the following:
2014/07 2 - 11
a. Cuvette blanks status and value information.

b. Expiration date. If the cuvette blank has expired or is about to
expire, proceed to step 3.
3. Select Run to perform a cuvette blank.
4. Select Yes at The cuvette blank operation will take some time to
complete, during which the instrument will be unavailable for tests.
Do you wish to continue? prompt.
Note: When the cuvette blank results are within the defined
acceptance ranges, the measurement is automatically
accepted and the information on the screen updated. No
further action is required.
Manually Accepting Cuvette Blank Results

procedure.
2. Select the desired Cuvette Blank Measurement then select Accept.
Rejecting Cuvette Blank Results

procedure.
2. Select the desired Cuvette Blank Measurement then select Reject.
Excluding Cuvette Blank Results

procedure.
2. Select Edit.
3. Select the desired Cuvette Blank Measurement then select Disable.
4. Select Accept to accept the remaining cuvette blank measurements.
Note: Up to 5 cuvettes can be excluded before the cuvette rotor
must be replaced. Excluded cuvettes will not be used by the
system. If an excluded cuvette is selected, selecting Enable
reactivates the cuvette for use with the next cuvette blank
measurement.
2 - 12 2014/07
Checking/Refilling 10% Cleaning Solution (Sodium

Hypochlorite)
1. From the Home screen, select Start of Day > Check/refill 10% cleaning
solution.
2. Check the following:
a. Inventory levels
b. Expiration date
Note: If the 10% Cleaning Solution has expired, proceed to step 3.
3. Select Replace.
4. Enter the following:
a. Lot Number
b. Lot Expiration date
5. Select Accept.
6. Place the new tube with the Sodium Hypochlorite solution into the same
rotor position.
Viewing/Printing Daily Report

1. From the Home screen, select Start of Day > Check daily report.
2. The report screen will display the following information:
• Cuvette blank
• Calibrator and control planning
• Maintenance planning
• Expiring reagents
• Expiring calibrator lots
• Expiring control lots
3. Select Daily Report to print a copy of the report.
2014/07 2 - 13
End of Day Procedures

1. Verify all measurements are completed.
2. Unload all completed samples.
3. From the Home screen, select the End of Day icon. The screen
displays a list of tasks that must be performed at the end of each day.
4. Perform all tasks that show an orange flag or exclamation mark.
5. Select the checkbox next to the task to mark as complete.
2 - 14 2014/07
Emergency Shutdown
When the Viva-ProE ™ System must be turned off immediately to ensure the
safety of personnel and equipment and a controlled shutdown is not possible,
use the following procedures to perform an emergency shutdown.
CAUTION: Selecting Stop will immediately halt all sample processing and
testing, which could result in the loss of patient data.
CAUTION: The power to the system is not switched off when an emergency
stop is performed. If the electrical power to the system must be
interrupted completely, go to the back of the system and turn the
main disconnect switch Off and or disconnect the Power Cable.
WARNING: Opening the system cover while the system is working does
Not stop pipetting and may cause injuries or damages by
touching a moving probe or rotor. Do not open the analyzer
cover unless the system is stopped or paused.
Stopping the System

1. Select the Stop icon.
2. At the Are you sure that you want to stop the instrument? prompt,
select Stop.
Restarting the System

1. Select the Reset icon. The system will reset and return to a stand-by
state.
Note: Reset can take 1 to 2 minutes to complete.
2. Select whether to Cancel or Reschedule any testing scheduled prior to
shutdown.
3. Select the Processing icon to resume testing.
Shutting down the System

1. Select the Logout icon.
2. Select Shutdown.
3. At the Are you sure you want to shutdown? prompt, select Yes.
4. On the back of the system, turn the main disconnect switch Off.
Turning on the System

1. On the back of the system, turn the main disconnect switch On.
2. Turn the system PC On.
3. From the Windows Start screen, select Analyzer.
2014/07 2 - 15
4. From the Windows desktop, double-select the Pro Series Software icon.
5. Select Start Application Software.
6. From the Home screen, select the Login icon.
7. Enter Username and Password then select Login.
2 - 16 2014/07
Viva-ProE ™ System Operator’s Guide Reagents
Chapter 3: Reagents
2014/07 3-1
Reagents Viva-ProE ™ System Operator’s Guide
Reagents

Note: If bubbles are present in reagent bottles carefully remove
them using a disposable pipette.
Note: If reagents bottles are stored in a refrigerator, it is
recommended to let them equilibrate to instrument
temperature prior to use.
Note: Do not overfill reagent bottles. Do not fill above the neck of
the bottle.
Checking Reagents
1. From the Home screen, select the Reagents icon.

2. Ensure the correct rotor is installed.
Note: The Viva-ProE ™ System is capable of using multiple rotors,
with each rotor holding a different set of reagents. The
expected rotor is shown in the top right corner of the
Reagents screen.
WARNING: The use of multiple reagent rotors requires strict handling

procedures. The system cannot detect whether the correct
reagent rotor in installed. If multiple reagent rotors must be
used, include verification of rotor configuration as part of the
operator’s standard laboratory procedures.
3. Select Reagent Info to display the Reagents information screen then
check the following information fields:
a. Lot Expiration
b. Remaining Volume
3-2 2014/07
c. Status
Table 3-1: Reagent Status Icons
Icon Description
Reagent Level Low
Reagent Empty
Reagent Expiration date Extended
Reagent Expired
4. Select Hide Info to return to the Reagents screen.
Replacing a Reagent


2. Select the desired Reagent.
3. Select Replace.
4. Remove the old Reagent bottle.
5. Enter the new Reagent bottle (lot number, expiration date) in the
appropriate fields.
6. Remove the Reagent bottle cap and insert the bottle into the desired
rotor position.
7. Select Accept.
Note: If the Reagent bottle is from a different lot of reagent, a
Calibration must be performed. Even if the new reagent
bottle is of the same lot, performing a calibration and control
measurement is highly recommended.
2014/07 3-3
Loading a Reagent
Figure 3-1: Load Reagent Screen
1 Reagent 7 Lot Expiration (Date Field)
2 Special Fluid 8 Lot Number
3 Barcode Information Text Box 9 Bottle Size
4 Clear 10 Reagent Position
5 Cancel 11 Test
6 Accept


2. Select an empty Reagent position that can accommodate the size of the
Reagent bottle.
3. Select Load.
4. Select the Reagent Radio button.
5. Select the desired Test.
6. Select the desired Reagent (R1 or R2) position.
7. Select the Reagent Bottle Size (14 mL or 28 mL).
8. Enter a lot number into the Lot Number field.
9. Enter a lot expiration date into the Lot Expiration field.
3-4 2014/07
10. Remove the Reagent bottle cap and insert the bottle into the desired
rotor position.
11. Select Accept.
Note: When loading probe rinse or acid solution fluid, select
Special Fluid radio button, than follow steps 7 through 11.
Unloading a Reagent


3. Select Unload then remove the Reagent bottle from the rotor.
Extending the Validity of a Reagent

procedure.
Note: The validity of a reagent will be extended by one day.

3. Select Extend.
4. Enter a reason for the extension in the Enter comment field then select
OK.
Note: All comments will be logged in the audit trail.
Switching the Reagent Rotor

Note: The Viva-ProE ™ System does not have an auto-detect feature
to identify the reagent rotor type. When replacing a reagent
rotor, inspect the rotor to ensure the correct rotor is being
installed.
Removing the Reagent Rotor

1. Remove the Reagent Rotor cover.
2. Recap any reagents that remain on the Reagent Rotor.
3. Remove the Flange from the center of the Reagent Rotor.
(See figure 3-2).
2014/07 3-5
Figure 3-2: Reagent Rotor with Flange Shown
4. Set the Flange aside and carefully lift the Reagent Rotor out of the
system.
5. Store the reagents and rotor following the standard laboratory operating
procedures.
3-6 2014/07
Installing the Reagent Rotor

1. Carefully lower the Reagent Rotor and align the white dot on the Reagent
Rotor[2] with the white dot on the driving axle [1]. (See Figure 4-9).
Figure 3-3: Properly Aligned Reagent Rotor
2. Slightly rotate the Reagent Rotor left and right until it falls over the
positioning pin and locks into place.
3. Reinstall the Flange.

5. Select Switch Rotor.
Note: Switching rotor will unload the currently loaded bottles and
automatically reload the bottles that were last loaded on the
selected rotor. Any test results requiring the currently loaded
bottles may be negatively affected.
6. Select from the following Reagent Rotor types:
• Standard
• Auxiliary
• Maintenance
7. Select OK.
8. Reinstall the Reagent bottles.
9. Install the Reagent Rotor cover.
2014/07 3-7
3-8 2014/07
Viva-ProE ™ System Operator’s Guide Sample Management
Chapter 4: Sample Management
2014/07 4-1
Sample Management Viva-ProE ™ System Operator’s Guide
Controls
Requesting and Loading Controls

1. From the Home screen, select the Control icon.

2. Select Review to open the Request Controls screen.
3. Select the desired Control, number of replicates and select or deselect
the test(s) being edited for that Control.
4. Repeat the steps 2 and 3 for each Control.
5. Select Accept.
6. Select the desired Control on the Load Control screen.
7. Choose from one of the recommended positions or select any open
position on the Rotor.
8. Select Load.
9. Place the Control into the selected Rotor position.
10. Repeat the above procedure until all of the Controls are loaded.
11. Select the Process icon.
4-2 2014/07
Manually Accepting or Rejecting Control Measurements

procedure.
1. From the Home screen, select the Results icon.

2. Select Review to open the Calibration and Controls screen.
3. Select Tests.
4. Select Details.
5. Verify Result, if flagged, select (!) Exclamation Mark.
Table 4-1: Control Measurement Status Icons
Icon Description
Unable to perform test; select Details for more

information.
Control loaded; request to change a test cannot

not be made at this time.
Control Expiration date Extended
Control Expired
6. If the Result is flagged, select from the following options:

a. Select Repeat to rerun the Control Measurement.
b. Select Accept to accept the Control Measurement Results.
c. Select Reject to reject the Control Measurement Results.
Note: Control Test Results without flags are automatically
accepted.
Note: If a patient test is ordered when the control is out, the system
will not allow the patient to be processed. The control must
be rerun and pass.
Note: If Repeat is selected, the Viva-ProE ™ System will average the
results of both replicates. Siemens recommends selecting
Reject, and then rerun the Control.
7. Select Close.
2014/07 4-3
Unloading Controls

1. From the Home screen, select the Unload icon.

2. Select the desired Control or Sample from the rotor image or the unload
list.
3. Select Unload then remove the Control or Sample from the rotor.
Unloading All Controls

2. Select Unload All then remove all finished Controls and Samples from
the rotor.
4-4 2014/07
Patients
Requesting Patient Tests
1. From the Home screen, select the Patients icon.

2. Select Search ID then using the keyboard or hand held scanner enter a
new Sample ID into the Sample ID text box.
3. Select Create to open the Request Patients screen.
4. Select the Request Type.
5. Complete the following Patient Data fields:
a. MR#: Medical Record Number (optional)
b. Name: Patient Name (optional)
c. Physician: Name of the primary physician (optional)
d. Birth Date (optional)
e. Replicates
f. Sample Type
g. Collection Date (optional)
h. Sex: Male, Female, or Pediatric
i. Category
j. Comment (optional)
6. Select the desired Tests.
7. If desired, select the following options:
a. Panels
b. Calculated Tests
c. Repeat Programming Mode
8. Select Accept to save changes.
9. Repeat steps 2 through 8 for all Patients.
Editing Patient Tests

2. Select Search ID then enter the Sample ID into the Sample ID text box.
3. Select the desired Sample Record.
4. Select Edit to open the Request Patient screen.
5. Make the desired changes then select Accept to save.
2014/07 4-5
Loading and Processing Sample Tubes (with Internal

Barcode Reader)

1. Using only the outer two load positions of the Sample Rotor, place the
Sample Tubes on the rotor with the barcodes labels facing out.
Figure 4-1: Sample Rotor with Internal Barcode Shown
2. Repeat the above procedure until all of the Sample Tubes are loaded.
3. Install the Sample Rotor cover.
4. Close the system cover.
5. Select the Scan icon.
4-6 2014/07
Loading and Processing Sample Tubes (without Internal

Barcode Reader)


2. Enter the Sample Tube information using one of the following methods:
a. Scan the barcode label on the sample tube with a hand-held
barcode reader.
b. Select Search ID then using the keyboard enter the Sample ID into
the Sample ID text box.
c. Use the work list to locate an open sample position.
3. Select the desired Sample Tube.
position on the Sample Rotor.
5. Select Load.
WARNING: It is recommended to place the sample in the selected rotor

position immediately to avoid sample mix-ups.
WARNING: If bubbles are present on top of the sample tubes carefully

remove them prior to processing the sample.
6. Place the Sample Tube into the selected Rotor position.
7. Repeat steps 1 through 5 until all of the Sample Tubes are loaded.
9. Close the System cover.
10. Select the Scan icon.
2014/07 4-7
Manually Processing Samples


2. Select Search ID then using the keyboard or hand held scanner enter a
new Sample ID into the Sample ID text box.
3. Select Create to open the Request Patients screen.
4. Select the Request Type.
e. Replicates
f. Sample Type
h. Sex: Male, Female, or Pediatric (optional)
i. Category (optional)
7. If desired, select Repeat Programming Mode.
8. Select Accept to save changes.
9. Repeat steps 2 through 8 for all Patients.
10. Select Load.
WARNING: It is recommended to place the sample in the selected rotor

position immediately to avoid sample mix-ups.
WARNING: If bubbles are present on top of the sample tubes carefully

remove them prior to processing the sample.
12. Repeat steps 1 through 11 until all of the Sample Tubes are loaded.
14. Close the System cover.
4-8 2014/07
Processing STAT (Short Turn Around Time) Samples

WARNING: Opening the system cover while the system is working does
NOT stop pipetting and may cause injuries or damage by
touching a moving probe or rotor. Do not open the system
cover unless the system has stopped or paused.
1. From the Home screen, select the Pause icon.

Note: When a Pause is requested, the system will not start any new
tests. However, the measurements for tests, which have
already begun pipetting, are continued. It can take up to
several minutes for the system to pause.
2. Select the STAT icon to open the Request Patient screen.

3. Select STAT located next to the Request Type field.
e. Replicates
f. Sample Type
h. Sex: Male, Female, or Pediatric
i. Category
7. Select the Resume icon to resume processing samples.

Note: Select the Info icon on the Home screen to display the time to
completion of STAT samples.
2014/07 4-9
Pausing Sample Processing and Resuming Measurements

WARNING: Opening the system cover while the system is operating does
NOT stop pipetting and may cause injuries or damage if a
moving probe or rotor is touched. Do not open the system
cover unless the system has stopped or is paused.
1. From the Home screen, select the Pause icon.

Note: When a Pause is requested, the system will not start any new
tests. However, the measurements for tests, which have
already begun pipetting, are continued. It can take up to
several minutes for the system to pause.
2. Select the STAT icon, if desired.
3. Load additional Sample Tubes, if desired.
4. Add additional Tests Requests, if desired.
5. Select the Resume icon to resume processing samples.

Note: Tests are resumed based on assigned priorities. If STAT and
ASAP samples were loaded, the tests on these new samples
will be performed before remaining Routine samples.
Evaluating Patient Results

2. Select the Patients radio button to open the Patients view.
3. Select the desired sample to view the test results.
4. Select the Triangle icon and Measurement to view detailed information.
Note: If there are no flags on a test result, the result is
automatically accepted by the system software.
5. Select Print to print test results.
6. Select Summary Report to print a summary report which contains
results details for multiple patients.
7. Select Export to create a CSV file.
8. Select Resend to resend the test result to the LIS.
4 - 10 2014/07
9. Select Repeat.
Note: Only users with Supervisor access or above can perform
step 10 of this procedure.
10. Select Accept to accept or Reject to reject flagged results.
Searching Patient Results

2. Select the Search radio button to open the Search view.
3. Enter the search criteria in one or more of the search text boxes.
4. Select Search.
Note: Select the double arrow in the Search section of the screen to
hide or unhide the search fields section.
5. Select the desired sample.
Note: Select the double arrow in the Options section of the screen
to hide or unhide the Option buttons.
6. Select Print to print the selected test result.
7. Select Print all to print all of the search results.
8. Select Export to export the selected test result.
9. Select Export all to export all of the test results.
10. Select Resend to resend the selected test result to the LIS.
11. Select Resend all to LIS to resend all of the test results to the LIS.
Unloading a Sample

1. From the Home screen then select the Unload icon.

2. Select the desired sample.
3. Select Unload, remove the sample tube from the rotor.
2014/07 4 - 11
Unloading All Samples


2. Select Unload All then remove all the completed sample tubes from the
rotor.
Note: All flagged results must be resolved, prior to unloading
samples.
4 - 12 2014/07
Viva-ProE ™ System Operator’s Guide Calibration
Chapter 5: Calibration
2014/07 5-1
Calibration Viva-ProE ™ System Operator’s Guide
Calibration
Loading Calibrators

1. From the Home screen, select the Calibration icon.

2. Select the desired Calibrator or Review.
position on the Rotor.
4. Select Load.
5. Place the Calibrator(s) into the selected Rotor position.
Performing Calibrations

2. Select Review to open the Request Calibration screen and view the
statuses of the Calibration.
Table 5-1: Calibration Status Icons
Icon Description
Unable to perform test; select Details for more

information.
Calibrator loaded; request to change a test

cannot not be made at this time.
Calibration has expired.
Note: When Calibrations are expired, the system automatically

enters requests in the list.
Editing Automatically Requested Calibrations

2. Select Review to open the Request Calibration screen.
3. Select the desired Calibration.
5-2 2014/07
Viva-ProE ™ System Operator’s Guide Calibration
Extending the Validity of a Calibration

procedure.
Note: This procedure extends validity of a calibration by one day.

2. Select Review to open the Request Calibration screen.
3. Select Details to open the Details screen.
4. Select the desired Calibration.
5. Select Extend.
6. Enter a reason for the extension in the Enter comment field then select
OK.
Note: All comments will be logged in the audit trail.
Manually Accepting or Rejecting Results

procedure.

2. Select Calibration and Controls.
3. Select the desired test to view the Calibration Curve results.
4. If Results are flagged, select Details to view additional information.
Select one from the following to resolve the error condition:
a. Select Repeat to repeat the selected Control measurement.
b. Select Accept to accept the Control measurement.
c. Select Reject to reject the Control measurement.
5. Select Accept Curve to accept or Reject Curve to reject results.
Unloading Calibrators


2. Select the desired Calibrator from the rotor image or unload list.
3. Select Unload then remove the Calibrator from the rotor.
2014/07 5-3
Calibration Viva-ProE ™ System Operator’s Guide
Unloading All Calibrators


2. Select Unload All then remove all finished Calibrators, Controls, and
Samples from the rotor.
5-4 2014/07
Viva-ProE ™ System Operator’s Guide Quality Control
Chapter 6: Quality Control
2014/07 6-1
Quality Control Viva-ProE ™ System Operator’s Guide
Quality Control Screen

The Quality Control screen displays the statistical and graphical information of
control measurements.
Figure 6-1: Quality Control Screen
Table 6-1: Quality Control Screen
1 Controls Displays Controls.
2 Tests Displays Tests.
3 Reset Westgard Rules Resets the Westgard Rules for a control-test combination.
Note: Available only if the Control uses Westgard Rules.
4 Override Rules Overrides the rules (Westgard or Basic) for the control-test
combination.
6-2 2014/07
Viva-ProE ™ System Operator’s Guide Quality Control
The following function buttons are available but not shown:

Table 6-2: Quality Control Screen Buttons
Button Description
Print Prints the quality control information.
Previous Returns to the previous page of graphs.
Next Advances to the next page of graphs.
Comment Enters a comment for the selected point.
Exclude Excludes the selected point.

Note: If a point is excluded, it will no longer be included in the
Average, SD, and CV calculations.
< Selects the previous point.
> Selects the next point.
The Quality Control screen displays the following information:

Table 6-3: Quality Control Screen List Box Section
Item Displays
QC Rules Rules that apply to Westgard, Basic, or Separation rules.

Note: Rules only apply for Qualitative Tests.
Average Average test result over the included Control Results.
SD Standard deviation over the included Control Result.
CV Standard deviation divided by the average Control Result.
N Number of measurements that are included.
Target Value that should be obtained in the measurements.
2014/07 6-3
Quality Control Viva-ProE ™ System Operator’s Guide
Viewing Quality Control

1. From the Home screen, select the QC icon.
2. Select from the following:
a. Select Controls to display QC Controls.
b. Select Tests to display QC Tests.
3. Select the desired Control or Test to view the Control Measurement
History.
4. Select from the following:
a. Select Graph to view the Levey-Jennings Graph.
b. Select Table to view QC in a table format.
5. Select Exclude to exclude a individual point.
6. Select Comment to comment on a individual point.
6-4 2014/07
Viva-ProE ™ System Operator’s Guide Maintenance
Chapter 7: Maintenance
2014/07 7-1
Maintenance Viva-ProE ™ System Operator’s Guide
Introduction
As an important part of a complete quality assurance program, proper service
and maintenance:
• Minimizes down time
• Provides optimal performance
• Preserves records for inspection and accreditation
Note: Some maintenance work may be performed by service
engineers of the system supplier.
7-2 2014/07
General Care and Cleaning

Observe the following warnings and guidelines for care and cleaning:
WARNING: To avoid sample contamination and potential erroneous

patient results, do not place bleach solution or soapy water
containers on the system.
WARNING: Biohazard - Wear personal protective equipment.

Use universal precautions. See the recommended safety
information section when working with biohazardous
materials.
WARNING: To avoid sample contamination and potential erroneous

patient results, remove all sample tubes from the area before
performing cleaning procedures.
Note: Maintenance should only be performed by qualified
personal. The level of training that is required may differ by
procedure. When in doubt contact a superior.
WARNING: Maintenance should never be performed when the

system is working. Perform maintenance work only when all
patient sample, calibrators, and controls are unloaded and
there are no pending test requests.
WARNING: Opening the system cover when maintenance actions

are being performed may cause injuries or damages by
touching a moving probe or rotor. Stay out of reach of moving
parts. Keep the system cover closed when possible. Do not
open the system cover unless the system is stopped.
2014/07 7-3
Maintenance Schedule
Table 7-1 indicates the recommended frequency of preventative maintenance
procedures. It can be used as a Maintenance Quick Reference Guide.
Table 7-1: Recommended Maintenance Task Frequency
Frequency Procedure
Daily • Emptying Waste

• Filling Treated Water Container
• Emptying Concentrated Waste Container
• Checking Syringes
• Checking Cuvette Blank
• Checking / Refilling 10% Cleaning Solution
• Checking Daily Report
• Check 0.1N HCl Cleaning Solution
• Priming System
• Checking Reagent Inventory
• Archiving Results Database
Weekly Rinsing Probes
Monthly • Cleaning the Treated Water and Waste Containers

• Cleaning the Concentrated Waste Container
Every 3 Months Replacing Drying Block
Every 6 Months • Replacing Stirrer Belt

• Replacing Water Filter
• Cleaning the System
Yearly • Replacing Syringes

• Replacing the Photometer Lamp
Every 10,000 Tests Replacing Cuvette Rotor
As Needed • Cleaning the system

• Filling the Cooling Fluid
• Cleaning Reagent Rotor Compartment
Note: Reagent cooling causes condensation fluid to build
up in the reagent compartment and effect system
operation. Depending on environmental conditions,
condensation fluid can accumulate in a period of days or
weeks.
7-4 2014/07
Maintenance - Daily
Note: It may be necessary to perform these procedures more than
once daily, depending on the laboratory workload.
• Emptying Waste
• Filling Treated Water Container
• Emptying Concentrated Waste Container
• Checking Syringes
• Checking Cuvette Blank
• Checking / Refilling 10% Cleaning Solution
• Checking Daily Report
• Checking 0.1N HCl Cleaning Solution
• Priming the System
• Checking Reagent Inventory
• Archiving Results Database

2014/07 7-5
Emptying Waste Container

Figure 7-1: Waste Container
1 Cap
2 Float Switch
3 Waste Container

Note: Skip this procedure if the system is equipped with an external
waste kit. The external waste kit diverts liquid waste directly
into a drain outside of the system.
1. Open the Waste Container door using the handle at the bottom to pull
the door outward.
2. Remove the Waste Container cap.
3. Slide the Waste Container out of the system.
4. Empty the Waste Container following standard laboratory operating
procedures.
5. Push the Waste Container inside the system and ensure that it is in the
proper position.
6. Replace and tighten the cap then close the cabinet door.
7. From the Home screen, select the Events icon.
7-6 2014/07
8. Select Waste Full.

9. Select Acknowledge to stop the alarm signal.
Filling Treated Water Container

Figure 7-2: Treated Water Container
1 Cap
3 Water Filter
1. Open the Treated Water Container door using the handle at the bottom
to pull the door outward.
2. Remove the Treated Water Container cap.
3. Slide the Treated Water Container out of the system.
4. Fill the Treated Water Container with 12.5 milliliters of system solution
and 5 liters of distilled or purified water.
5. Push the Treated Water Container inside the system and ensure that it is
in the proper position.
2014/07 7-7
Emptying Concentrated Waste Container

1 Cap
2 Float Switch

5. Push the Concentrated Waste Container inside the system and ensure
that it is in the proper position.
7-8 2014/07
Checking Syringes
Figure 7-4: Reagent and Sample Syringes
1 Probe Connection
2 Valve
3 Sample Syringe
4 Probe Connection
5 Reagent Syringe
6 Water Connection
1. Open the Pipettor door using the handle at the bottom to pull the door
outward.
2. Inspect the Reagent and Sample syringes and verify that no air bubbles or
leaks are present.
Checking Cuvette Blank Measurements

a. Cuvette blanks status and value information.
2014/07 7-9
b. Expiration date.
Note: If the cuvette blank has expired or about to expire, proceed to
step 3.
3. Select Run to perform a cuvette blank.
4. Select Yes at The cuvette blank operation will take some time to
complete, during which the instrument will be unavailable for tests.
Do you wish to continue? prompt.
Note: When the cuvette blank results are within the defined
acceptance ranges, the measurement is automatically
accepted and the information on the screen updated. No
further action is required.
Checking/Refilling 10% Cleaning Solution (Sodium

Hypochlorite)
1. From the Home screen, select Start of Day > Check/refill 10% cleaning
solution.
a. Inventory levels
b. Expiration date
Note: If the 10% Cleaning Solution has expired, proceed to step 3.
3. Select Replace.
a. Lot Number
5. Select Accept.
6. Place the new tube with the Sodium Hypochlorite solution into the same
rotor position.
Viewing/Printing Daily Report

1. From the Home screen, select Start of Day > Check daily report.
2. The report screen will display the following information:
• Cuvette blank
• Calibrator and control planning
• Maintenance planning
• Expiring reagents
• Expiring calibrator lots
• Expiring control lots
3. Select Daily Report to print a copy of the report.
7 - 10 2014/07
Checking 0.1N HCl Cleaning Solution

1. From the Home screen, select Start of Day > Check 0.1N HCl Cleaning
Solution.
a. Inventory levels
b. Expiration date
3. Select Replace.
a. Lot Number
5. Select Accept.
Priming the System
1. From the Home screen, select Tasks icon.

2. Select Maintenance.
3. Select Prime and Drain.
4. Select Prime System.
Checking Reagent Inventory
1. From the Home screen, select Reagents icon.

2. Select Reagent Info.
Archiving Results Database
1. From the Home screen, select Tasks icon.

2. Select Backup and Archive.
3. Select Archive All.
2014/07 7 - 11
Maintenance - Weekly

Rinsing the Probes

Table 7-2: Rinsing the Probes - Supplies Needed
Item Description
Supplies 10% Cleaning Solution

Note: Ensure 10% cleaning (Sodium Hypochlorite) solution is available
on the Sample rotor.
Probe Rinse Solution

Note: Ensure 10% cleaning (Sodium Hypochlorite) solution is loaded on
the Reagent rotor.
1. From the Home screen, select the Tasks icon.

3. Select Clean Cuvette/Rinse Probe.
4. Select Probe Rinse.
Note: The system will begin the process of rinsing the probes. The
process may take up to 5 minutes to complete.
7 - 12 2014/07
Maintenance - Monthly
• Cleaning the Treated Water and Waste Containers
• Cleaning the Concentrated Waste Container

Cleaning the Treated Water and Waste Containers

Table 7-3: Cleaning the Treated Water and Waste Containers - Supplies Needed
Item Description
Supplies System Solution

Note: See Specification - “System Solution” for more information.
Distilled or Purified Water (ASTM Type II Grade)
0.1N NaOH

Figure 7-5: Treated Water and Waste Containers
2014/07 7 - 13
1 Cap - Waste Container
2 Float Switch
3 Waste Container
4 Water Filter
6 Cap - Treated Water Container
1. Open the Treated Water and Waste Container door using the handle at
the bottom to pull the door outward.
2. Remove both the Treated Water and Waste Container caps.
3. Slide the Treated Water and Waste Containers out of the system.
4. Empty the Treated Water and Waste Containers following standard
laboratory operating procedures.
5. Pour a small amount of 0.1N NaOH solution (enough to cover the
bottom) into the Treated Water and Waste Containers.
6. Swirl the 0.1N NaOH solution around the container then empty the
Treated Water and Waste Containers following standard laboratory
7. Rinse both containers three times using distilled or purified water.
8. Fill the Treated Water Container with 12.5 mL of system solution and 5
liters of distilled or purified water.
9. Push the Treated Water and Waste Containers inside the system and
ensure they are in the proper position.
10. Replace and tighten the container caps then close the cabinet door.

13. Select Clean Waste and Treated Water Container.
14. Select Confirm.
7 - 14 2014/07
Cleaning the Concentrated Waste Container

Table 7-4: Cleaning the Concentrated Waste Container - Supplies Needed
Item Description
Supplies Distilled or Purified Water (ASTM Type II Grade)
0.1N NaOH

1 Cap
2 Float Switch
2014/07 7 - 15

5. Pour a small amount of 0.1N NaOH solution (enough to cover the
bottom) into the Concentrated Waste Container.
6. Swirl the 0.1N NaOH solution around the container then empty the
Concentrated Waste Container following standard laboratory operating
procedures.
7. Rinse the container three times using distilled or purified water.
8. Push the Concentrated Container inside the system and ensure it is in the
proper position.
9. Replace and tighten the container cap then close the cabinet door.

12. Select Clean Waste and Treated Water Container.
13. Select Confirm.
7 - 16 2014/07
Maintenance - Every 3 Months

Replacing the Drying Block

Figure 7-7: Replacing the Drying Block
1 Positioning Block Screw 4 Cuvette Rotor
2 Tubing to Drying Block 5 Needle Plate Unit
3 Drying Block 6 Positioning Block

2014/07 7 - 17
3. Select Replace Drying Block to open the Replace Drying Block screen.
4. Select Replace Drying Block.
5. Disconnect the tubing [2] from the front end of the Drying Block and
move the tubing aside.
6. Remove the Positioning Block Screw [1], using caution not drop the
screw into the system.
7. Remove the Positioning Block [6] by pulling it up and off the
Needle Plate [5].
8. Remove the Drying Block [3] by pulling it up and to the right.
9. Place the new Drying Block [3] into the slit and press down into the bush.
10. Reinstall the Positioning Block [6].
11. Replace the Positioning Block Screw [1] but do not tighten.
12. Select Continue.
13. Tighten the Positioning Block Screw [6].
14. Reattach the tubing [2] to the Drying Block [3].
16. Select the Reset icon to reset the system and return to a stand-by
state.
17. Install the Cuvette Rotor Cover.
7 - 18 2014/07
Maintenance - Every 6 Months

• Replacing the Stirrer Belt
• Replacing the Water Filter

Replacing the Stirrer Belt

Figure 7-8: Replacing the Stirrer Belt
1 Pulley
2 Stirrer Belt
3 Eccentric Pulley
1. Starting from the Pulley [1], use a pair of tweezers to pull the
Stirrer Belt [2] off the Pulley [1].
2. Starting from the Eccentric Pulley [3], use the same tweezers to pull the
new Stirrer Belt [2] around the Pulley [1].

2014/07 7 - 19
5. Select Replace Stirrer Belt.

6. Select Confirm.
state.
Replacing the Water Filter

Figure 7-9: Replacing the Water Filter
1 Cap
3 Tubing
4 Filter Holder
5 Water Filter
1. Open the Treated Water door using the handle at the bottom to pull the
door outward.
2. Remove the Treated Water Container cap [1].
7 - 20 2014/07
3. Remove the tubing [3] with the filter out of the container.
4. Unscrew the filter [5] from the filter holder [4].
5. Screw the new filter [5] onto the filter holder [4].
6. Place the tubing with the filter into the Treated Water Container.
7. Push the Treated Water Container inside the system and ensure it is in
the proper position.
8. Replace and tighten the container cap then close the cabinet door.

11. Select Replace Water Filter.
12. Select Confirm.
state.
Cleaning the System

Note: Operator assistance is required during this entire procedure.
The system software will prompt the operator to perform a
task and wait for confirmation after each step. This
procedure can take up to 4 hours to complete.

3. Select Clean System.
4. Empty the Waste Container.
5. Detach the Water Intake Tube from the Treated Water Container.
6. Select Clean System.
7. Fill a container with approximately 500 mL of Sodium Hypochlorite
Cleaning Solution.
8. When prompted, insert the Water Intake Tube into the Sodium
Hypochlorite Cleaning Solution container.
9. Select Continue.
10. When prompted, remove the Water Intake Tube out of the Sodium
Hypochlorite Cleaning Solution container.
2014/07 7 - 21

12. Clean the Treated Water Container.
Note: See “Cleaning the Treated Water and Waste Containers” on
page 13 of this chapter.
13. When prompted, insert the Water Intake Tube into the Filled Treated
Water Container.
15. When prompted, remove the Water Intake Tube from the Treated Water
Container.
Note: The system will prompt the Operator to repeat steps 13
through 16 three times. Once the process has completed, the
system will automatically return to a Stand-by state.
Note: Perform a system Prime and check Syringes for air bubbles.
7 - 22 2014/07
Maintenance - Yearly
• Replacing Syringes
• Replacing the Photometer Lamp
Note: Customers with a Siemens maintenance contract will have
these services performed by a Siemens service technician.
Replacing Syringes
Figure 7-10: Replacing Syringes
1 Valve Block
2 End Cap
3 Glass Barrel
4 Plunger Handle
5 Screw
6 Drive Pin
2014/07 7 - 23
CAUTION: HANDLE WITH CARE. The syringes are fragile.

3. Select Replace Syringes, to open the Replace Syringes screen.
4. Select Replace Syringes.
5. Remove the Screw [5] and set it aside.
6. Unscrew the End Cap [2] from the Valve Block [1].
7. Push down the Glass Barrel [3] until it is out of the Valve Block [1].
8. Pull the Syringe off the Drive Pin [6].
9. Push the Plunger into the Syringe; ensure the tip of the Plunger is aligned
with the top of the Syringe.
Note: Readjust the Plunger alignment, if needed.
10. Moisten the inside of the Syringe’s Glass Barrel with water.
11. Pull water into the Syringe.
12. Remove the air bubbles from the tip of the Plunger by carefully tapping
the Glass Barrel or by emptying and refilling the Syringe with water.
Note: There must be at least 2cm of water on top of the Plunger,
with no air bubbles displayed.
13. Inspect the Valve Block to ensure the Gasket is present. (See Figure 7-11)
Figure 7-11: Valve Block with the Gasket Displayed
14. Insert the Plunger into the Syringe.

15. Insert the Plunger Handle [4] of the Syringe over the Drive Pin [6].
7 - 24 2014/07
16. Reattach the Screw [5].

17. Carefully pull the Glass Barrel [3] up until the End Cap touches the Valve
Block.
18. Reattach the End Cap [2] into the Valve Block [1].
state.

23. Select Prime and Drain to open the Prime and Drain screen.
24. Select Prime System.
Note: If air bubbles are present in the Tubing and Syringes repeat
step 24.
2014/07 7 - 25
Replacing the Photometer Lamp
WARNING: The lamp gets very hot when switched on. Ensure the
lamp has cooled down before removing it from the system.
CAUTION: Wear latex gloves when replacing the lamp. Quartz -iodine lamps
are very sensitive. Touching the lamp with your hands will
dramatically reduce its lifetime.
Figure 7-12: Replacing the Photometer Lamp
1 Quartz-iodine Lamp
2 Lamp Holder
3 Mounting Screw
7 - 26 2014/07
1. Turn off the System.

2. Remove the Front Panel by lifting up the panel from the bottom and
pulling it forward.
3. Remove the Lamp Unit Cover:
Figure 7-13: Removing the Lamp Unit Cover
1 Lamp Unit Cover
2 Screw
a. Loosen the Screw [2].

b. Slide the Cover [1]to the left and forward.
2014/07 7 - 27
4. Remove the Lamp Bracket:

Figure 7-14: Removing the Lamp Bracket
1 Lamp
2 Fastening Screw
3 Tapped Hole
a. Remove the Fastening Screw [2] from the Lamp Bracket.

b. Install the Fastening Screw [2] into the Tapped Hole [3] to use as a
handle.
c. Remove by pulling the Lamp Bracket forward.
5. Remove the old Lamp [1].
6. Install the new Lamp.
Note: Ensure the new lamp is pressed firmly into the Lamp Holder.
7. Reinstall the Mounting Bracket:
a. Place the Mounting Bracket into position.
b. Place the Fastening Screw [2] into the top hole; install the
Fastening Screw but do NOT tighten.
8. Turn on the System.
7 - 28 2014/07
9. Proceed to “Adjusting the Lamp Unit” on page 29 of this chapter to

complete.
Adjusting the Lamp Unit
WARNING: Looking into the lamp can hurt the Operator’s eyes.
Avoid looking directly into the lamp while it is switched on.
Figure 7-15: Adjusting the Lamp Unit
1 Fastening Screw
2 Vertical Adjustment
3 Horizontal Adjustment
pulling it forward.
2. Remove the Lamp Unit Cover:
2014/07 7 - 29
Figure 7-16: Removing the Lamp Unit Cover
1 Lamp Unit Cover
2 Screw
a. Loosen the Screw [2].

b. Slide the Cover [1]to the left and forward.

5. Select Adjust Lamp to open the Adjust Lamp screen.
6. Select Start Adjust Lamp then wait until the countdown timer
reaches 0:00.
7. Loosen the Fastening Screw [1] (See Figure 7-14).
8. Use the Vertical [2] and Horizontal [3] Adjustment screws to set the
Cuvette and Lamp Absorbance levels.
9. Turn the Vertical [2] and Horizontal [3] Adjustment screws until both
absorbances reach their minimum levels.
Note: The absorbances must be within the valid (green) range. If
the absorbances cannot be set within the valid range, replace
the Lamp.
10. Tighten the Fastening Screw [1].
11. Select Stop Adjust Lamp.
12. Install the Lamp Cover.
13. Install the system Front Panel.
7 - 30 2014/07
state.
15. Perform a Cuvette Blank Measurement.
2014/07 7 - 31
Maintenance - Every 10,000 Tests

Replacing the Cuvette Rotor

3. Remove the Cuvette Rotor Cover.
4. Select Replace Cuvette Rotor, to open the Replace Cuvette Rotor screen.
5. Select Replace Cuvette Rotor.
Figure 7-17: Replacing the Cuvette Rotor
1 Stirrer Knob
2 Center Knob
CAUTION: Wear latex gloves when replacing the Cuvette Rotor. Hold the
Cuvette Rotor by the Center Knob [2] only. Do not touch the
Cuvettes.
6. Use the Knob [1] to pull the Stirrer Unit up.
7. Use the Center Knob [2] to remove the Cuvette Rotor.
7 - 32 2014/07
8. Install the new Cuvette Rotor by carefully aligning the four notches of the
new Cuvette Rotor above the slits on the Rotor Holder.
9. Push down the Stirrer Knob [1].
11. Select Yes at the “Reset Cuvette Rotor Counter” prompt.
state.
13. Replace the Cuvette Rotor Cover.
14. Perform a Cuvette Blank.
2014/07 7 - 33
Maintenance - As Needed
Perform the following procedures as needed:
• Cleaning the Reagent Rotor Compartment
• Filling the Cooling Fluid

Cleaning the System

Clean the system using a damp cloth and a mild detergent solution to wipe all
panels and the worktable. Dry the panels and the worktable with a clean dry
cloth.
Cleaning the Touchscreen

1. Logout the System software.
2. Clean the Touchscreen using a clean, soft, nonabrasive cloth to wipe the
screen.
CAUTION: To avoid damaging electronic components, ensure no liquid gets

into the Panel PC while cleaning the touchscreen.
Cleaning the Reagent Rotor Compartment

1. Complete all current measurements.
2. Recap any reagents that remain on the Reagent Rotor.
3. Store the reagents and rotor following standard laboratory operating
procedures.
4. Remove the Reagent Rotor:
a. Remove the Reagent Rotor cover.
b. Remove the Flange from the center of the Reagent Rotor. (See
figure 7-18.)
7 - 34 2014/07
Figure 7-18: Reagent Rotor with Flange Shown
c. Set the Flange aside and carefully lift the Reagent Rotor out of the
system.
5. Clean the Reagent Rotor:
a. Pour all condensation fluid out of the rotor.
b. Dry the rotor on the inside and outside with paper tissue or a clean,
dry cloth.
6. Dry the Stator (base on which the rotor rests) with a paper tissue or a dry,
clean cloth.
7. Reinstall the Reagent Rotor:
a. Carefully lower the Reagent Rotor ensuring to align the white dot
on the Reagent Rotor[2] with the white dot on the driving axle [1].
(See Figure 4-9.)
2014/07 7 - 35
Figure 7-19: Properly Aligned Reagent Rotor
b. Slightly rotate the Reagent Rotor left and right until it falls over the
positioning pin and locks into place.
c. Reinstall the Flange.
8. Reinstall the Reagent bottles.
9. Install the Reagent Rotor cover.
7 - 36 2014/07
Filling the Cooling Fluid

Figure 7-20: Cooling Fluid Level Gauge
1 Cooling Fluid Fill Cap
2 Maximum Fill Marker
3 Minimum Fill Marker
pulling it forward.
2. Check the Cooling Fluid Level. The level should be between the
Minimum [3] and Maximum [2] markers.
Note: If the cooling fluid level is below the Minimum [3] marker,
proceed to step 3.
Note: Cooling liquid must be diluted with distilled water. Use 1 part
cooling liquid on 4 parts distilled water.
3. Fill the Cooling Fluid:
a. Remove the Cooling Fluid Fill Cap [1].
b. Add Cooling Fluid until the level is just below the Maximum [2]
marker.
c. Wait a few minutes and then recheck the Cooling Fluid level. If the
Cooling Fluid level is between Minimum [3] and Maximum [2],
proceed to step D.
2014/07 7 - 37
d. Reattach the Cooling Fluid Fill Cap [1].

4. Install the Front Panel.
7 - 38 2014/07
Maintenance Logs
Use the Maintenance Logs on the following pages to record Daily, Weekly, and
Monthly, Every 3 Months, Every 6 Months, Yearly, Every 10,000 Tests, and As
Needed maintenance procedures. Recording these tasks helps track
instrument performance. Complete each column for each task completed.
2014/07 7 - 39
7 - 40 2014/07
Daily Maintenance Log (1)

Month/Year:____________________
Serial Number:___________________________
Table 7-5: Daily Maintenance Log (1)
Empty Waste Fill Treated Water

Date Check Syringes Initials
Containers Container
2014/07 7 - 41

Month/Year:____________________
Serial Number:___________________________
Check / Refill 10%

Date Check Cuvette Blank Check Daily Report Initials
Cleaning Solution
7 - 42 2014/07

Month/Year:____________________
Serial Number:___________________________
Check 0.1N HCl Check Reagent

Date Prime System Initials
Cleaning Solution Inventory
2014/07 7 - 43

Month/Year:____________________
Serial Number:___________________________
Archive Results
Date Initials
Database
7 - 44 2014/07
Weekly Maintenance Log (1)

Month/Year:____________________
Serial Number:___________________________
Table 7-9: Weekly Maintenance (1)
Date Perform Rinse Probe procedure Initials
2014/07 7 - 45
Monthly Maintenance Log (1)

Month/Year:____________________
Serial Number:___________________________
Table 7-10: Monthly Maintenance (1)
Clean Treated Water Clean Concentrated

Date Initials
and Waste Containers Waste Container
7 - 46 2014/07
Every 3 Months Log (1)

Month/Year:____________________
Serial Number:___________________________
Table 7-11: Every 3 Months Maintenance Log (1)
Date Replace Drying Block Initials
2014/07 7 - 47
Every 6 Months Maintenance Log (1)

Month/Year:____________________
Serial Number:___________________________
Table 7-12: Every 6 Months Maintenance Log (1)
Replace Water Clean the

Date Replace Stirrer Belt Initials
Filter System
7 - 48 2014/07
Yearly Maintenance Log (1)

Month/Year:____________________
Serial Number:___________________________
Table 7-13: Yearly Maintenance Log (1)
Date Replace Syringes Replace Photometer Lamp Initials
2014/07 7 - 49
Every 10,00 Tests Maintenance Log (1)

Month/Year:_______________________
Serial Number:________________________
Table 7-14: Every 10,000 Tests Maintenance Log (1)
Replace Cuvette Rotor after Every 10,000 Tests

Date or after receiving SD errors on the Daily Rotor Initials
Blank
7 - 50 2014/07
As Needed Maintenance Log (1)

Month/Year:____________________
Serial Number:___________________________
Table 7-15: As Needed Maintenance Log (1)
Clean Exterior of the Clean Reagent Rotor

Date Fill Cooling Fluid Initials
Instrument Compartment
2014/07 7 - 51
7 - 52 2014/07
Viva-ProE ™ System Operator’s Guide Troubleshooting
Chapter 8: Troubleshooting
2014/07 8-1
Troubleshooting Viva-ProE ™ System Operator’s Guide
Troubleshooting Overview
This chapter describes Viva-ProE ™ System errors and provides instructions on
possible causes and solutions for resolving them.
Note: Only trained operators can perform these procedures.
8-2 2014/07
Troubleshooting Error Codes

If an error occurs during processing, the error code is displayed on the Events
screen.
Use this procedure to access the Events screen:
1. Select the Events icon.

2. Select the desired event then choose the appropriate option.
Error Signaling
A variety of error conditions may occur. Each error code is signaled differently
depending on the type of error condition. The following is a list of error and
system states:
• Audible Signal
• Dialog Signal
• Icon Signal
Audible Error Signals

Error and system states may be signaled by an Audible Signal. The following is
a list of Audible Signals.
Table 8-1: Audible Error Signals
Error Cause Resolution
Repetitive Audio Alert A Critical Error has Resolve the critical event then perform
occurred. the following procedure:
1. Select Events.
2. Select Silence Alarm.
Single Audio Alert A Non-Critical Error has No action required. Open the Events
occurred. screen to view the event.
2014/07 8-3
General Error Condition Icons

A number of General Error Conditions are signaled via icons, which appear at
the top of the User screen. Table 8-1 provides a more detailed description of
each of the Error Condition Icons.
Table 8-1: Error Condition Icons
Icon Description Resolution
Reagent cooling temperature out of range. Check the Cooling Liquid level.
See “Filling the Cooling Fluid” on page 37 of
chapter 7.
Waste full. Empty the Waste Container(s).

See “Emptying Waste Container” on page 6 of
chapter 7.
Treated water running low. Fill the Treated Water Container as soon as
possible.
See “Filling Treated Water Container” on
page 7 of chapter 7.
Treated Water Container is empty. Fill the Treated Water Container.

See “Filling Treated Water Container” on
page 7 of chapter 7.
System cover open. Close the cover.
LIS connection failed. Contact a Service Engineer.
Printer problem. Contact a IT Technician.
8-4 2014/07
Test Related Errors

When errors occur during measurement, the test results are flagged . The
flagged results are listed on the Results screen and included on printed
reports.
Table 8-2: Test Related Error Codes, Code Description, Cause, and Resolution
Code Code Description Cause Resolution
a Reagent Absorbance Limit • The reagent absorbance is out of • Check to ensure reagents are stored in
Violation range. the proper rotor positions.
• Poor reagent quality. • Refresh reagent.
• Reagents were placed in the
wrong rotor positions.
A Calibrator Limit Violation • A calibrator measurement is out • Check calibration parameters with data
of range. on the test package insert.
• Incorrect calibration parameters. • Ensure calibrators are stored in the
• Poor calibrator quality. proper rotor positions.
• Calibrators were placed in the • Refresh calibrators.
wrong rotor positions. • Refresh reagent.
• Poor reagent quality.
B Barcode Not Matching • Incorrect placement of the • Ensure the barcode label is clearly
barcode label. readable and facing outward.
• Sample was moved to a different • Ensure the sample tube is in the correct
rotor position. rotor position.
• Redo the entire test request procedure
for the sample.
C, c Control Limit Violation • A control measurement is out of • Check control parameters with data on
range. the test package insert.
• Incorrect control parameters. • Refresh controls.
• Poor control quality. • Refresh reagent.
• Poor reagent quality.
D Reagent Absorbance Deviation • The reagent absorbance Select Dilute to rerun the test using a diluted
Error / Substrate Depletion Error deviation is out of range. sample.
• Reaction was too rapid to be
measured (very high
concentration of analyte in
sample).
E Result Near Cut-off The test result is within the cut-off None
deviation range (only applies to
qualitative tests).
G General Hardware Error This error is often triggered in • Check the Error History screen for
combination with other errors. previously unresolved errors.
• Reset the system.
• If the problem persists, contact the
distributor or system support
department of the manufacturer.
k, K Results Exceeds Calibration The test result was below the lowest None
Limits calibration standard (k) or above the
highest calibration standard (K).
L Cuvette Blank Error / Lamp Error • Stained cuvette. • Perform a cuvette blank; exclude
• Poor lamp quality. cuvettes if required.
• Adjust or replace the lamp.
2014/07 8-5
m, M Low / High Absorbance Limit The test result was below the lower None
Violation absorbance limit (m) or above the
upper absorbance limit (M).
o, O Cuvette Blank Error / Over Range • Stained cuvette. • Perform a cuvette blank; exclude
Reference Detector / Over Range • Poor lamp quality. cuvettes if required.
• Electronic circuit board failure. • Adjust or replace the lamp.
• Contact supplier’s service department.
r Rerun The test was repeated with the rerun None

parameters.
R- Insufficient Reagent • Reagent bottle is empty or • Fill or replace the reagent bottle.
missing. • If bubbles have formed in the reagent,
• The liquid detection system is carefully remove bubbles using a
malfunctioning. disposable pipette.
• Ensure the correct reagent rotor is
installed.
R+ Reagent Not Taken • The fill level of the reagent is too • Remove some reagent; ensure the fill
high. level is below the neck of the bottle.
• Bubbles have formed on the • If bubbles have formed in the reagent,
reagent. carefully remove bubbles using a
disposable pipette.
T Cuvette Temperature Error • The ambient temperatures are • Ensure the ambient temperature is
out of range. within the specified working range.
• The cuvette rotor cover is • Ensure the cuvette rotor is properly
installed incorrectly. installed.
• The cuvette temperature control • Contact customer service.
system is malfunctioning.
u, U Cuvette Blank Error / Under • Stained cuvette. • Perform a cuvette blank; exclude
Range Reference Detector / • Poor lamp quality. cuvettes if required.
Under Range • Electronic circuit board failure. • Adjust or replace the lamp.
• Contact supplier’s service department.
v Negative The result is negative relative to the None

cur-off value and direction.
V Positive The result is positive relative to the None

cut-off value and direction.
W, w Westgard Rules Limit Violation None • Compare all quality control results for
that test.
• Prepare fresh controls.
• Rerun calibrations.
• Prepare fresh reagent.
x, X Concentration Limit Error The results is below the analytical None

sensitivity (x) or above the
concentration limit (X).
y, Y Reference Panic Limit Error The result is below the lower panic None
limit (y) or above the upper panic limit
(Y).
8-6 2014/07
Z Duplicate Difference Limit Error The difference between the results or None
repeated tests are above the limit.
* Non-linearity Error The linearity of the measurements is out None

of range.
# Insufficient Sample • The sample tube is empty or • Ensure the sample tube is present
missing. and has sufficient sample volume.
• The liquid detection system is • Ensure the sample has not clotted
malfunctioning. and remove any bubbles that are
present.
• Ensure no air bubbles are blocking
the sample aspiration.
!c Analysis Failure Concentration could not be calculated • Follow the !i resolution process.
due to one of the following: • Re-measure the sample to
confirm.
• Test was interrupted (combined • Re-measure the failed
with !i). photometric test.
• Interpolation on the low end of the
calibration curve was not possible.
• Measurement result of a
photometric test used in a
calculated test was not available or
did not meet the condition of the
calculated test.
!i Test Interrupted By System • The reagent probe could not be • Ensure acid solution (HCI) is
cleaned. loaded on the rotor and check the
• A hardware error has occurred. fill level.
• Check the error code and resolve
the problem.
!u Test Interrupted By User An emergency stop performed. • Resolve the reason for the
emergency stop.
• Reset the system.
2014/07 8-7
Hardware Errors
Table 8-3: Hardware Error Codes, Code Description, Cause, and Resolution
E02 System Emergency Halt The arm touched during Reset the system.
measurement.
E05 No Clean Cuvette The system was reset but the cuvettes Perform the following procedure:
were not emptied.
1. Remove the Cuvette Rotor.
2. Clean and Empty the Cuvettes.
3. Reset the system.
E07 System Reset Incomplete System errors preventing the system Open the Events screen and resolve any
from resetting. system errors.
E10 No Vacuum • Vacuum tube is bent or • Check the tubing.

obstructed. • Reset the system.
• Vacuum tube has a leak.
E11 Waste Full Waste container full. Empty the waste container.
E12 Water Running Out Treated water container empty. Fill the treated water container.
E13 Lamp Failure Lamp is near the end of its lifetime. Replace the lamp.
E16 Concentrated Waste Full Concentrated waste container full. Empty the concentrated waste container.
E17 Insufficient Treated Water Treated water container empty. Fill the treated water container.
E125 No Cuvettes Cuvette rotor not installed. Install cuvette rotor.
8-8 2014/07
Procedures
Unblocking the Probe
Figure 8-1: Unblocking the Probe
1 Inner Tube
2 Inner Probe Tube
3 Probe
CAUTION: Handle with care. The Probe Head and Probe are both fragile and
vital components of the system.
Note: Only use the piercing rod this is included in the analyzer
accessories kit to unblock the probe. Any other will cause
irreparable damage to the probe. Clean and store the
piercing rod after use.
1. Remove the tubing by pulling the Outer and Inner Tube [1] off the Probe
Head.
Note: Use care when pulling off the tubes. If the Inner Tube slides
too far into the Outer Tube, it may be difficult to properly
reconnect the tubing.
2. Carefully insert the Piercing Rod into the Inner Probe Tube [2]. Push
down the Piercing Rod until it comes out of the lower tip of the Probe [3].
3. Move the Piercing Rod up and down several times.
4. Using a lint free cloth remove all dirt from the lower tip of the Probe.
5. Remove the Piercing Rod.
6. Reattach the tubing by pushing the Inner and Outer Tubes over the Probe
Tip on the Sample and or Reagent Head. Ensure both the Inner and Outer
tubing slightly touch the Silicon Sealing Ring.
Note: Do not push the tubing into the Sample or Reagent Head
cover.
2014/07 8-9
state.

10. Select Clean Cuvette/Rinse Probe.
11. Select Probe Rinse.
Note: The system will begin the process of rinsing the probes. The
process may take up to 5 minutes to complete.
8 - 10 2014/07
Viva-ProE ™ System Operator’s Guide Data Management
Chapter 9: Data Management
2014/07 9-1
Data Management Viva-ProE ™ System Operator’s Guide
Backing Up the System Database

All settings, test parameters, and test results are stored in the system database.
Siemens recommends creating daily backups of the database then copying the
backup files to an external media device.
Configuring Database Backup

Note: Only users with Administrator access can perform these
procedures.
Table 9-1: Database Backup
Item Description
Enable Daily Automatic Performs an automatic daily backup of the database.

Backup
Number of Backups to Retain Keeps the number of backup databases selected.

Note: When the automatic backup checkbox is selected, the
system creates an automatic backup of the database at the time
specified in the Daily Rollover Time parameter. When the
maximum number of backups is reached, the oldest one is
overwritten.
1. From the Home screen, select the Configure icon.

2. Select System to display the System view.
3. Select Instrument.
4. Select Daily Operations.
5. Select Edit.
6. Navigate to the Database Backup section of the screen.
7. Make the desired changes.
8. Select Accept to save.
Manually Backing Up the System Database

Makes a copy of the system database which can then be placed in another
directory. The file name of the backup contains the date and time when the
backup file was created.
procedures.

2. Select Routine Tasks.
4. Select Backup Now.
5. Select Yes at the Perform backup? screen prompt.
9-2 2014/07
Transferring a Backup Database to External Media Device

In order to keep the backup files safe, it is recommended to place a copy of the
backup database file into an external media device. This will prevent the files
from being lost in the event the hard disk crashes on the PC.
procedures.

4. Select View Backup Files to open the Database Backups window.
5. Select the desired Backup Database.
6. Select Edit > Copy To Folder to open the Copy Items window.
7. Select the desired file transfer location.
8. Select Copy.
9. Select X to close the window.
Archiving Patient Results

The test results are stored in the system database and kept in an archive
database until they are moved manually or automatically. This also applies
when the system is connected to a LIS.
Archiving the database serves the following purposes:
• Reduces the database size
• Protects the privacy of patients by removing historical results
• Keeps the review of historical data manageable
Note: When records are archived, they are only available via the
Search functionality in the Results screen.
Note: When archiving the system database, backup files remain
unchanged. Restoring an old backup will put back the old
records into the system database. At the next time of
archiving, these old records are moved to the archive
database.
procedures.

4. Navigate to the Archive section of Screen.
5. Select the Auto Archive checkbox to enable or deselect to disable auto
archiving.
2014/07 9-3
6. In the Archive record older than text box, enter the number of days
after which the records should be archived.
7. In the Archive frequency text box, enter the number of days for the
frequency of the automatic archive.
Manually Archive Patient Results

procedures.

4. Navigate to the Archive section of Screen.
5. Select Archive All.
Restoring a Backup Database

Note: Restoring from a previous backup will overwrite the current
database including all settings, test parameters, and test
results. Any data that need to be saved must be exported
before restoring a backup.
procedures.

3. Select Close Software.
4. Select Yes at the Are you sure you want to close the software? screen
prompt.
5. At the Pro Series Software window, select Restore From Backup.
6. Select Yes at the Are you sure you want to perform file restore?
Current file will be overwritten by the selected file. screen prompt.
7. Select the desired database file.
8. Select Open.
9. Check the System state.
Note: All information in the system database is overwritten by the
backup. Some information (for example, cuvette blank,
reagent information, calibrations, and controls) will not be
valid. Also, the backup may contain samples and fluids on
the sample rotor which were removed after the backup was
created. The following steps should be performed prior to
resuming normal operation of the system.
a. Cancel all pending Tests.
9-4 2014/07
b. Unload all Samples (both physically and within the software).

c. Run a Cuvette Blank.
d. Replace all Reagents and Special Fluids.
e. Run Calibrations and Controls.
Exporting Data
procedures.

3. Select Export and Import.
4. Select a Page from the following:
a. Test
b. Calibrators
c. Controls
d. Results
e. Other (user defined)
5. Select the checkboxes next to the data to be included.
6. Select Export.
7. Select Yes at the Are you sure that you want to export these items?.
screen prompt.
8. Select OK at the Export was successful to directory. screen prompt.
Importing Data
procedures.

3. Select Export and Import.
4. Select a Page from the following:
a. Test
b. Calibrators
c. Controls
d. Results
e. Other (user defined)
5. Select the checkboxes next to the data to be included.
6. Select Import.
7. Select the desired Import Data.
8. Select OK at the Import was successful. screen prompt.
2014/07 9-5
9-6 2014/07
Viva-ProE ™ System Operator’s Guide System Configuration
Chapter 10: System Configuration
2014/07 10 - 1
System Configuration Viva-ProE ™ System Operator’s Guide
Configuration Screen
Figure 10-1: Configuration Screen
1 Configure
2 System
3 Tests
4 Configuration Option Buttons
Note: Only users with Administrator access can edit or delete

configuration settings.
10 - 2 2014/07
Dependencies on Parameters
Parameters cannot be changed when items that depend on these parameters
are in use. For example the Edit button is disabled for tests when their
reagents are loaded on the reagent rotor. The parameters can be viewed but
not changed until all their reagents are unloaded.
Prior to making any changes to the configuration of tests or instrument
configuration items, it is recommended to check the following:
• All pending test requests were completed.
• All patient samples were unloaded.
• All issues with controls, calibrators, and blanks were resolved.
• All reagents were unloaded.
Note: Instead of unloading all reagents to unlock configuration
options, the operator can temporarily switch to an empty
reagent rotor (e.g. the Maintenance rotor) to unlock
configuration items.
Recommended Work Order

For open channels, the following work order is recommended.
1. Define Calibrators.
2. Program Tests.
3. Define Controls.
4. Define Calibrator Lots.
5. Define Control Lots.
Accessing the Configuration Screen

2. Select from the following options:
a. Select System to access the System Configuration screens.
b. Select Tests to access the Test Configuration screens.
2014/07 10 - 3
Accessing the Configure Tests Screen

Note: Only users with Administrator access can edit or delete Tests
settings.
Note: Tests in predefined systems cannot be edited; however, they
can be deleted.

2. Select Tests to display the Tests view.
The following function buttons are available in the Tests view:
Table 10-1: Configure Screen- Tests Buttons
Button Description
Tests Tests configuration screen
Calculated Test Calculated Test configuration screen
Panels Panels configuration screen
Calibrators Calibrators configuration screen
Controls Controls configuration screen
Calibrator Lot Calibrator Lot configuration screen
Control Lot Control Lot configuration screen
Probe Incompatibilities Probe Incompatibilities configuration screen
Test Incompatibilities Test Incompatibilities configuration screen
Test Order Test Order configuration screen
10 - 4 2014/07
Viewing Tests - General

Note: Only users with Administrator access can view
Tests - General settings.

3. Select Tests.
5. Select General.
Table 10-2: Tests -General
Item Description
Test Code A code used to represent the test in the system software.
Note: Codes starting with the digit 9 are used for user-definable
channels and cannot be edited.
Revision The revision number used for test definitions.

Note: For user-definable channels, this number can be edited.
Name The test that is displayed in printed reports.
Abbreviation A unique abbreviated test name in this system.

Note: Maximum length is 4 characters. The name is displayed in
lists, buttons, and other places where space is limited.
Mode A drop-down list that displays all available test methods.
Reagent Onboard The time period during when reagent can be used after it has
Stability been placed on the rotor.
Note: The On-board Stability is usually defined in the reagent
package insert.
Reagent Low Vol The percentage at which a reagent low level warning is
Warning displayed.
Service Test The test that, when selected, is not included in communications
with the LIS (the test cannot be requested from and no results
passed to the LIS when requested manually).
Note: Used only for service or maintenance of the system.
Suppress Test Results The test results that, when selected, are excluded from reports
and are not sent to the LIS.
Sample Types A list of available sample types that can be used for testing.
Note: The Disabled option is a user defined option that is
configured in the Instrument Configuration screen.
Access The minimum required user level to edit a test.

can be deleted.
Note: The common function buttons Edit, Delete, New, Cancel,
and Accept are available on this screen.
2014/07 10 - 5
Viewing Tests - Processing

Tests - Processing settings.

3. Select Tests.
5. Select Processing.
Table 10-3: Tests -Processing
Item Description
Replicates The number of times the test will be performed for each sample.
The results of these tests are averaged.
Sample Blank The measurement performed on a reagent with a blank sample

(for example, distilled water or any solution that does not
contain target material).
Note: View only, cannot be edited.
Sample Volume Any value between 1- 30 µL in increments of 0.1 µL.

Note: When Predilution is used, the maximum sample volume is
15 µL.
Reagent Volume The volumes as defined in the package insert.
Diluent The diluent to be used.

Note: A test diluent is specific for the test, whereas Saline and
Distilled Water can be shared with other tests.
Note: Currently not in use.

can be deleted.
10 - 6 2014/07
Viewing Tests - Measurement (Kinetic Tests)

Tests - Measurement (Kinetic Tests) settings.

3. Select Tests.
5. Select Measurement.
Table 10-4: Tests -Measurement (Kinetic Tests)
Item Description
Wavelength The filter selected for use in measuring tests.
Delay The delay between pipetting the sample (or the last reagent in
case of multi-reagent tests) and the first measurement.
Min Time The minimum duration covered by the kinetic measurement

(from the time specified to the Delay to the last measurement.

can be deleted.
2014/07 10 - 7
Viewing Tests - Measurement (Endpoint Tests)

Tests - Measurement (Endpoint Tests) settings.

3. Select Tests.
Table 10-5: Tests -Measurement (Endpoint Tests)
Item Description

Note: For bichromatic endpoint tests, two filters must be
selected.
Incubation Time The time between pipetting the sample (or the last reagent in
case of multi-reagent tests) and the measurement.

can be deleted.
10 - 8 2014/07
Viewing Tests - Measurement (Two Point Tests)

Tests - Measurement (Two Point Tests) settings.

3. Select Tests.
Table 10-6: Tests -Measurement (Two Point Tests)
Item Description
Point 1, Point 2 The two required measurements that must be selected, the
points are measured from the moment the sample is pipetted.

can be deleted.
2014/07 10 - 9
Viewing Tests - Absorbance Checks

Tests - Abs Check settings.

3. Select Tests.
5. Select Abs Check.
Table 10-7: Tests -Absorbance Checks
Item Description
Absorbance Limit When the result is flagged, the measured absorbance has fallen
outside this range.
Reagent Abs Limit When the result is flagged, the reagent measurement has fallen
outside this range. This measurement is performed shortly
before the sample is added.
Reaction Direction Select Increasing (Kinetic) or Decreasing (Two Points Tests)

absorbance.
Substrate Depletion The determination if the result is compromised due to substrate

depletion.
Note: Valid range is -3.0 to 3.0 Abs. Displayed for Kinetic and
Two Point Tests with more than one reagent, and where the first
reagent volume is 220 µL or more.
Slope Blank If selected, the Delay for the slope blank must also be set (Kinetic
Tests or Two Point Tests using reagent R1 and R3).
Alinearity Limit Any result that exceeds the alinearity limit will be flagged
(Kinetic Tests).

can be deleted.
10 - 10 2014/07
Viewing Tests - Sample Blank Absorbance Checks

Note: This feature is only available when the Sample Blank
parameter of the Processing tab is set to Yes or No.
Tests - Abs Check settings.

3. Select Tests.
5. Select Abs Check.
Table 10-8: Tests -Sample Blank Absorbance Checks
Item Description
Absorbance Limit When the result is flagged, the measured absorbance has fallen
outside this range.
Reagent Abs Limit When the result is flagged, the reagent measurement has fallen
outside this range. This measurement is performed shortly
before the sample is added.
Reagent Abs Deviation Used to determine if the result is compromised due to depletion
or substrate in the reagent (Kinetic or Two Point Tests with one
reagent).
Substrate Depletion The factor used to determine if the result is compromised due to
substrate depletion.
Note: Valid range is -3.0 to 3.0 Abs. Displayed for Kinetic and
Two Point Tests with more than one reagent where the first
reagent volume is 220 µL or more.

can be deleted.
2014/07 10 - 11
Viewing Tests - Result Calculation

Tests - Result Calculation settings.

3. Select Tests.
5. Select Result Calculation.
Table 10-9: Tests -Result Calculation (Result Type and Units Section)
Item Description
Result Type The result type must be selected from either Quantitative or
Qualitative; depending on the selected type, additional
parameters are displayed.
• Qualitative Mode: Select either Increasing or Decreasing.
If increasing tests is selected, a test result above the cut-off
absorbance will be marked as positive. If decreasing tests is
selected, a test result below the cut-off absorbance will be
marked as positive.
• Qualitative Uncertainty Deviation: Sets the range in
which the test result is flagged to be viewed by the
operator. This value is used both below and above the
cut-off absorbance.
Primary Units The primary units in which test results are expressed.
Note: If None is selected, the absorbance is reported and the
secondary units are disabled.
Unit Conversion Factor A The factor used when converting values from primary to
secondary units. The primary units are converted to their base
unit, then the secondary value is calculated as A (primary base)
plus B. If both factors are set to 0, conversion to secondary units
occurs.
Unit Conversion Factor B The factor used when converting values from primary to
secondary units. When a test is configured in a user-definable
channel, the primary units equal the secondary units. For tests in
a predefined channel, a primary unit is predefined. To report test
results in another unit, a secondary unit can be defined.
10 - 12 2014/07
Item Description
Decimals The number of decimal places (0 to 4) used for measurement

results.
Table 10-10: Tests -Result Calculation (Reference Ranges Section)
Item Description
Reference Ranges The reference ranges that can be enabled and set separately for
each available sample type.
Available Sample Types A list of available sample types. Select the double arrow to open
or close the sample type setting section.
Available sample types are Serum, Urine, Whole Blood, CSF, or
User Defined.
Note: Only the sample types enabled on the Tests-General
section are displayed.
Table 10-11: Tests -Result Calculation (Concentration Limits Section)
Item Description
Concentration Limits The concentration limits that can be enabled and set separately
for each available sample type.
Available Sample Types A list of available sample types. Select the double arrow to open
or close the sample type setting section.
Note: Available sample types are Serum, Urine, Whole Blood,
CSF or User Defined.
Note: Only the sample types enabled on the Tests-General
section are displayed.
Limits The measurement concentrations outside the range that trigger

a flag of the sample.

can be deleted.
2014/07 10 - 13
Viewing Tests - Calibration

Tests - Calibration settings.

3. Select Tests.
5. Select Calibration.
Table 10-12: Tests -Calibration (General Settings Section)
Item Description
Calibration Type The calibration type that must be selected from either Calibrator
or Factor; depending on the selected type, additional parameters
are displayed.
Note: If the Calibration Type is set to Calibrator, tests must be
calibrated prior to running patient tests.
Calibration Factor The factor for calibration.

Note: Will only appear if the Factor calibration type is selected.
Correlation The Factor and Offset fields that are used to match results of
multiple systems in the same laboratory to each other.
Calibrator Name A list of available calibrators.

Note: This feature is only available when Calibration Type is set
to Calibrator.
Replicates The calibration measurements that can be performed up to 3

times. The average results are then used for the calibration
result.
Expiration Time The number of days an accepted calibration measurement is

valid.
Note: The maximum number of days is 90.
10 - 14 2014/07

can be deleted.
Table 10-13: Tests -Calibration (Calibration Algorithm Section)
Item Description
Number of Points The number of calibration points to be measured. This number is

preset to the number of levels defined for the selected calibrator.
Algorithm The list that displays the available calibration methods for the
number of calibration points selected.
Note: Depending on the algorithm selected, additional
parameters may appear or disappear.
Extended Absorbance The values that determine how far the area of the measured
Limits points can be extrapolated below the lowest and above the
highest measured calibration point.
Extended Concentration The values that determine how far the area of the measured
Limits concentrations can be extrapolated below the lowest and above
the highest measured calibration concentration.
Algorithm Inaccuracy The algorithm that determines how much the modified cubic
spline is allowed to deviate from the perfect fitting curve through
all calibration points.

can be deleted.
Note: The Calibration Points section is only displayed when
Calibration Type is set to Calibrator.
Table 10-14: Tests -Calibration (Calibration Points Section)
Item Description
Label The identifier of the measurement.
Calibrator Level If selected, the calibrator level that is used.

can be deleted.
2014/07 10 - 15
Viewing Panels
Note: Only users with Administrator access can view or delete
Panels settings.

3. Select Panels.
4. Select the desired Panels.
can be deleted.
Viewing Calibrators
Note: Only users with Administrator access can view or delete
Calibrators settings.

3. Select Calibrators.
4. Select the desired Calibrator.
Table 10-15: Calibrators
Item Description
Calibrator List of defined calibrators.
Name The name of the calibrator (enter for new calibrators).
Levels The number of calibrator levels available for use.
Level Names The names of the calibrator levels.

can be deleted.
Note: The common function buttons New, Cancel, and Accept are
available on this screen.
Viewing, Adding, and Editing Controls

Note: Only users with Administrator access can edit, add, or delete
Controls settings.

3. Select Controls.
10 - 16 2014/07
4. Select the desired Control.

Table 10-16: Controls
Item Description
Name The name of the control (enter for new controls, edit for existing
controls).
Test The test for which the control is used.
Rule Type The method used to determine if the control measurement is

valid.
Sample Type The sample type for the control.
Expiration The number of days the control measurement will be valid.

Note: After the validation period, the control measurement will
have to be repeated. Alternatively, the validity of the control
measurement can be extended to the next day. A comment text
is required and will be logged in the audit trail.

can be deleted.
Note: The common function buttons New, Cancel, and Accept are
Creating a Control
Note: Only users with Administrator access or above can perform
these procedures.

3. Select Controls.
4. Select New.
5. Select Add.
7. Select Rule Type.
8. Select Sample Type.
9. Enter the Expiration period.
Adding a Test to Control

these procedures.

3. Select Controls.
2014/07 10 - 17

5. Select the Edit button next to the Control field.
7. Select the Edit button next to the Test Field.
8. Select the Rule Type.
9. Select the Sample Type.
10. Enter the Expiration period.
Editing Test Parameters

these procedures.

3. Select Controls.
7. Select the Edit button next to the Test Field.
Deleting a Test from a Control

these procedures.
Note: Patient samples related to test or control must be unloaded
before control can be deleted. An error flag will appear on
the Unload tab and the control cannot be deleted until the
patient sample is unloaded.

3. Select Controls.
7. Select the Delete button next to the Test Field.
10 - 18 2014/07
Deleting a Control
these procedures.
Note: Verify that all tests associated with the control have been
removed before performing this procedure.

3. Select Controls.
5. Select the Delete button next to the Control field.
Viewing, Adding, and Editing Calibrator Lot

Note: Only users with Administrator access can edit or add
Calibrator Lot settings.

3. Select Calibrator Lot.
Table 10-17: Calibrator Lot
Item Description
Calibrator A drop-down list of available calibrators.
Lot The lot number as specified on the package insert.
Expiration The date when the calibrator lot expires.

Note: After this date, calibrators from this lot will no longer be
accepted and a new lot must be entered.
Test The name of the test for which the calibrator level is shown.
Level The number of calibrator levels.
Concentration The concentration of the calibrator level.
Auto-Accept Range The limits for the calibration level that a calibration must fall
within to be automatically accepted.
Note: These values are only displayed when the check box next
to Auto Acceptance Limits is selected.
2014/07 10 - 19
Item Description
Dup-diff The maximum difference allowed between replicates of the

calibration measurement on this level. Replicates are defined in
the Calibration page of the test settings.
Note: These values are only displayed when the check box next
to Duplicate Difference is selected and the numbers of
replicates is either 2 or 3.
Note: The common function buttons Edit Lot, New Lot, Cancel,
Creating a Calibrator Lot

these procedures.
Note: A new lot or an existing lot cannot be created unless all
samples associated with its calibration have been both
unloaded and its flagged results addressed.

5. Select New Lot.
6. Fill in all the required fields.
Editing a Calibrator Lot

these procedures.
Note: A new lot or an existing lot cannot be edited unless all
samples associated with its calibration have been both
unloaded and its flagged results addressed.

5. Select Edit Lot.
10 - 20 2014/07
Viewing, Adding, and Editing Control Lot

Note: Only users with Administrator access can edit or add
Control Lot settings.

3. Select Control Lot.
Table 10-18: Control Lot
Item Description
Control A drop-down list of available controls.
Lot The lot number as specified on the package insert.
Expiration The date when the control lot expires.

Note: After this date, calibrators from this lot will no longer be
accepted and a new lot must be entered.
Test The name of the test for which the control targets are shown.
Rule Type The method used to determine if the control measurement is

valid.
Expiration The date when the control measurement expires.
Separation The minimum difference between the cut-off value and the
control result.
Target The concentration that should be measured on the control with

the test.
SD The standard deviation used in the Westgard Rules.
Low, High When the control is flagged, the control measure has fallen
outside these limits.
Note: These parameter are available only for the Basic QC Rules.
Note: The common function buttons Edit Lot, New Lot, Cancel,
Creating a Control Lot

these procedures.

5. Select New Lot.
2014/07 10 - 21
Editing a Control Lot

these procedures.

5. Select Edit Lot.
Viewing, Adding, and Editing Probe Incompatibilities

This screen is used to prevent the aspiration of a reagent immediately
following the aspiration of another reagent (incompatibility). Alternatively this
screen can force aspiration of a reagent to immediately follow aspiration of
another reagent, if available (link).
Note: If the linked reagent is unavailable, acid solution is aspirated.
If acid solution is unavailable, treated water is aspirated
instead.
Note: Only users with Administrator access can edit, delete, or add
Probe Incompatibilities settings.

3. Select Probe Incompatibilities.
Table 10-19: Probe Incompatibilities
Item Description
Test The test for which the probe incompatibilities or links are
defined.
Type The following types are displayed:

• Link - The link forces subsequent aspiration of the listed
fluids in order from the top to the bottom of the list.
• Incompatibility - Prohibits aspiration of any fluids listed
under reagent.
Reagent The list of reagents or special fluids that are linked or

incompatible.
Note: The list is defined separately for each reagent.
Note: The common function buttons Edit, Add, Delete, Cancel,

10 - 22 2014/07
Adding Probe Incompatibilities or Links

these procedures.
Note: These procedures can only be performed in Open Channels.

4. Select the desired Test, Reagent, or Special Fluid for which the Probe
Incompatibility or Link need to be defined.
5. Select Add.
2014/07 10 - 23
Editing Probe Incompatibilities or Links

these procedures.

4. Select the desired Test, Reagent, or Special Fluid for which the Probe
Incompatibility or Link need to be defined.
5. Select Edit.
6. Select the desired Incompatibility or Link type definition.
Deleting a Probe Incompatibility or Link

these procedures.

4. Select the desired Test, Reagent, or Special Fluid.
5. Select Delete.
Viewing, Adding, and Editing Test Incompatibilities

This screen is used to prevent one test from immediately following another
test in the same cuvette (incompatibility). Alternatively this screen can be used
to force a test to immediately follow another test in the same cuvette, if
available (link).
Note: If the linked test is unavailable, acid solution is performed. If
acid solution is unavailable, treated water is performed.
Note: Only users with Administrator access can edit, delete, or add
Test Incompatibilities settings.

3. Select Test Incompatibilities.
10 - 24 2014/07

Table 10-20: Probe Incompatibilities
Item Description
Test The test for which the test incompatibilities or links are defined.
Type The following types are displayed:

• Link - The link forces subsequent execution of the listed
tests in order from the top to the bottom of the list.
• Incompatibility - Prohibits tests from immediately
following the test which the incompatibility is defined in the
same cuvette.
Reagent The list of reagents or special fluids that are linked or

incompatible.
Note: The list is defined separately for each reagent.
Note: The common function buttons Edit, Add, Delete, Cancel,

Adding Test Incompatibilities or Links

these procedures.

4. Select Test Incompatibility or Link.
5. Select the desired incompatible or linked Test
6. Select Add.
Editing Test Incompatibilities or Links

these procedures.

6. Select Edit.
2014/07 10 - 25
Deleting a Test Incompatibility or Link

these procedures.

6. Select Delete.
10 - 26 2014/07
Viewing a Test Order

This screen is used to define the order in which the Tests, Calculated Tests, and
Panels are displayed on the Request Patient screen.
Note: Only users with Administrator access can edit
Test Order settings.

3. Select Test Order.
Table 10-21: Test Order
Item Description
Test, Calculated Tests, The category for which the order of buttons is defined.
Panels
Calculated Tests
Panels
Note: The common function buttons Edit, Cancel, Accept,

Move Right, Move Left, Move Down, and Move Up are
Editing a Test Order

these procedures.

3. Select Test Order.
4. Select Tests, Calculated Tests, or Panels.
5. Select Edit.
6. Select the desired button.
7. Using the direction buttons below, move the highlighted (Test,
Calculated Tests or Panels) button to the desired location.
2014/07 10 - 27
Accessing System Menu Screens

Note: Only users with Administrator access can edit or delete
System Menu settings.

The following function buttons are available in the System view:
Table 10-22: Configure Screen- Tests Buttons
Button
Instrument
Flag Customization
Users
Configuration Instrument Functions

Use the Configuration function buttons to set preferences in the system.
Table 10-23: Configure Screen- System (Instrument) Buttons
Button
System Parameters
Daily Operations
Result Reporting
Sample Types
Categories
Calculated Test Parameters
Service Configuration
Reminders
Configuring Language
Select Language to choose the local interface language.
these procedures.

4. Select System Parameters.
5. Navigate to the General section of the screen.
6. Select Edit.
10 - 28 2014/07
7. Select Language from the drop-down menu.

9. Shut down, then restart the system software.
Configuring Laboratory Name

Indicates the name of the laboratory that should be printed on all printouts,
log files, and reports.
these procedures.

5. Navigate to the General section of the screen.
6. Select Edit.
Note: The maximum number of characters is 32.
Configuring Audible Notifications

these procedures.
Table 10-24: Audible Notifications
Item Description
Pause/Complete Audio File The sound that plays when processing is Paused or Completed.
Event Audio File The sound that plays when an event has occurred.
Alert Audio File The sound that plays when an Alert appears on the screen.
Interval The pause between repetitions of event sounds that require

acknowledgement.
Duration The maximum period of repetitions.

5. Select Edit.
6. Navigate to the Audible Notification section of the screen.
2014/07 10 - 29

Note: The Interval and Duration parameters apply to the alert
signal only. This signal is given when operator attention is
required. The Pause/Complete and Event signals only sound
once.
Note: The sound files to be played must have the WAV format and
be located in the following directory:
C:\Program Files\ELITech Clinical Systems\Pro Series
Software|Alarms.
Note: The filenames of the alert sounds cannot be changed.
Configuring User Management

these procedures.
Table 10-25: User Management
Item Description
Automatic Login The selected user will be automatically logged in when the
system starts.
User ID The name of the automatically logged in user.
Inactivity Time Out The current user is automatically logged out after a defined
period of inactivity.

5. Select Edit.
6. Navigate to the User Management section of the screen.
Activating or Deactivating the Internal Barcode Reader

these procedures.

5. Select Edit.
10 - 30 2014/07
6. Navigate to the Hardware Configuration section of the screen.

7. Select the checkbox to enable or deselect the checkbox disable this
feature.
Configuring Reagent Rotors

these procedures.
Table 10-26: Reagent Rotors
Item Description
Number of user-definable The amount of tests that can be fully configured.

channels Note: This field is shown but cannot be edited.
Pre Batch Clean When enabled, the additional tests with acid solution that are
scheduled before a batch of tests.
Note: This field is shown but cannot be edited.

5. Select Edit.
6. Navigate to the Reagent Rotors section of the screen.
Configuring Daily Operation Times

these procedures.
Note: If this system is configured for Daylight Savings Time, avoid
setting daily operations during the time of changeover
(typically 2AM to 3AM).
Table 10-27: Daily Operation Times
Item Description
Daily Rollover Time Performs an automatic database backup.
Start of Day Time Un-checks the tasks on the Start of Day screen.
End of Day Time Un-checks the tasks on the End of Day screen.
2014/07 10 - 31

5. Select Edit.
6. Navigate to the Daily Operation Times section of the screen.
Configuring Start of Day

these procedures.
Table 10-28: Start of Day
Item Description
Automatic Cuvette Blank Performs an automatic cuvette blank at the start of day time
when selected.
Max Cuvette SD Automatically accepts the cuvette blank measurements if it

remains below the standard deviation. Otherwise, an alert is
given and operator attention is required.
Note: If the last cuvette blank is older than 28 hours, a new cuvette
blank is required before any tests can be processed.
Note: Cuvette Blank will not perform automatically if the Treated
water container is empty or the Waste container is full.

5. Select Edit.
6. Navigate to the Start of Day section of the screen.
10 - 32 2014/07
Configuring Database Backup

these procedures.
Table 10-29: Database Backup
Item Description
Enable Daily Automatic Performs an automatic daily backup of the database if selected.
Backup
Number of Backups to Retain Keeps the selected number of backup databases.

Note: When the automatic backup checkbox is selected, the
system creates an automatic backup of the database at the time
specified in the Daily Rollover Time parameter. When the
maximum number of backups is reached, the oldest backup is
overwritten.

5. Select Edit.
6. Navigate to the Database Backup section of the screen.
Configuring Printed Reports

these procedures.
Table 10-30: Printed Reports
Item Description
Print Enabled Enables print when Yes is selected and disables print when No is
selected.
Automatic Results Report Enables automatic printing to test result reports.
Patient Report Template Enables printing of test reports for individual patient samples.
Choose between the Internal (detailed report) or External
patient reports template.
Summary Report Template Enables printing of summary test result reports. The report
includes all loaded samples for finished tests and validated test
results. Choose between the Extensive or Detailed report.

2014/07 10 - 33
4. Select Result Reporting.

5. Select Edit.
6. Navigate to the Printed Reports section of the screen.
Configuring Export Parameters

these procedures.
Table 10-31: Export Parameters
Item Description
Export Type Select which type of data to export.
Export Patient Names Select the checkbox to Include or deselect to Exclude patient
names from the exported data.

5. Select Edit.
6. Navigate to the Export Parameters section of the screen.
10 - 34 2014/07
Configuring the Laboratory Information System (LIS) Connections

these procedures.
Table 10-32: Laboratory Information System (LIS)
Item Description
LIS Connection • None - Disable LIS Connection

• RS232 - Connect using RS232 Connection
• TCP/IP - Connect using TCP/IP Connection
Collated Results • Yes - Send test results for a sample when all tests are
finished and no flags remain.
• No - Send individual test results for a sample as soon as they
become available.
Extended Results Absorbance values for kinetic measurement points that can be
selected to include in the results communicated to the LIS host.
Device ID Six-digit alphanumeric code used to identify the LIS host

computer. Used when more than one device communicates to
the same host.
Host ID Six-digit alphanumeric code used to identify the LIS host

computer. Used when more than one LIS host system is available
to the network.
Port Number The port number on the LIS host computer over which the LIS
(TCP/IP option) communication is handled.
Data Bits The number of data bits per character.

(RS232 option)
Stop Bits The duration of the stop period.

(RS232 option)
Parity The type of parity bit, if applicable.

(RS232 option)
Flow Control Flow control option, if applicable.

(RS232 option)

5. Select Edit.
6. Navigate to the LIS Parameters section of the screen.
2014/07 10 - 35
Configuring Sample Types

these procedures.
Table 10-33: Sample Types
Item Description
Sample Types Select to enable or deselect to disable one of more of the

following sample types:
• Serum
• Urine
• Whole Blood
• CSF
• User Defined Sample Type (User Definable Sample Type)
Automatically Increment Select to enable automatic incrementation of the sample ID in

Sample ID the Request Patients screen.
Note: The sample types appear in the Request Patients screen.
For each included sample type, reference values and absorbance
limits can be defined in the test parameters.

4. Select Sample Types.
5. Select Edit.
Configuring Category Types

Various configuration screens include the option to define category-dependent
data. Only the categories which are enabled and named in this screen are
displayed. When at least one category is enabled, the category option is
enabled on the request screen for patient samples.
these procedures.

4. Select Categories.
5. Select one of the Checkboxes to open a text box field.
6. Enter a Category type.
10 - 36 2014/07
Editing Category Types

these procedures.

4. Select Categories.
5. Select the desired Category Type.
6. Select Edit.
Configuring Calculated Test Parameters

Calculated test formulas may include physical parameters.
these procedures.

4. Select Calculated Test Parameters.
5. Select one of the Checkboxes to open a text box fields.
6. Enter a Name and Unit measurement.
Editing Calculated Test Parameters

these procedures.

4. Select Calculated Test Parameters.
5. Select the desired Calculated Test Parameter.
6. Select Edit.
2014/07 10 - 37
Configuring Service Configuration

Note: View only, can only be changed by Siemens Service
personnel.
Configuring Operator Reminders

Calculated test formulas may include physical parameters.
these procedures.

4. Select Reminders.
5. Select one of the checkboxes to open a text box fields.
6. Enter a user defined reminder in the Start of Day or End of Day text box
fields.
Editing Operator Reminders

these procedures.

4. Select Reminders.
5. Select the desired Start of Day or End of Day Reminder.
6. Select Edit.
10 - 38 2014/07
Accessing the Flag Customization Screen

these procedures.

3. Select Flag Customization.
Table 10-34: Flag Customization
Item Description
Flag Lists the flags that may appear for test results.
Flag Name Describes briefly the error condition that is flagged.
Print on Report If selected, enables printing the flag on result reports when the
(if LIS disabled) LIS is disabled.
Print on Report If selected, enables printing the flag on result reports when the
(if LIS enabled) LIS is enabled.
Send to LIS If selected, enables sending the flag to the LIS
Automatic Re-Run If selected, enables an automatic rerun of the test to occur when
the result is flagged.
Custom Evaluation Option Selects one of the automatic evaluation options from the list.
Note: When the Supervisor option is selected, a supervisor must
evaluate the flagged result to complete the test before the
sample can be unloaded.
CAUTION: Some flags allow an automatic Accept action. Selecting this

action may cause such flagged results to pass unnoticed
(especially when the flags are not included in reports). Validate
these settings according to laboratory procedures.
Note: When the flagged result has been accepted or rejected
automatically, it is no longer possible to request Repeat for
this test.
Note: The common function buttons Edit, Restore Defaults,
Set To Supervisor, Accept, and Cancel are available on this
screen.
Configuring Flag Customization

these procedures.

4. Select Edit.
2014/07 10 - 39

Editing Flag Customization

these procedures.

4. Select Edit.
Configuring Users
these procedures.

3. Select Users.
Table 10-35: Users
Item Description
User The name of the current user.
Username The name to be used in the login dialog box. This name is also
registered for actions recorded in the events log.
Role The roles that determine access privileges for screens and
functions.
Password The user’s access password.
Repeat Password Confirms the previous password was entered correctly.
Active If selected, enables a user to access the system or, when

deselected, disables a user from accessing the system.
Adding a User
these procedures.

3. Select User.
4. Select New.
10 - 40 2014/07
5. Type the User Name.

6. Select the User Role (Operator, Supervisor, or Administrator).
7. Type the User Password.
8. Retype the User Password.
9. Select the Active check box to activate the User.
Resetting User Passwords

these procedures.

3. Select User.
4. Select the desired User.
5. Select Edit.
6. Type in a new User Password.
7. Retype the new User Password.
Deactivating a User
these procedures.

3. Select User.
4. Select the desired User.
5. Select Edit.
6. Deselect the Active check box.
2014/07 10 - 41
10 - 42 2014/07
Viva-ProE ™ System Operator’s Guide Safety
Appendix A: Safety
2014/07 11 - 1
Safety Viva-ProE ™ System Operator’s Guide
General Safety
Instrument operators must be proficient in operation and maintenance
procedures. To ensure safety, follow these basic precautions:
• Observe all warnings and cautions in the guide.
• Remove safety guards only if specifically instructed in the procedures.
Replace all guards after completing the procedures.
• For more information on the Emergency Power Shutdown procedure, see
“Emergency Shutdown” on page 15 of Chapter 2: System Operation.
• Stow cables and tubing properly to eliminate tripping hazards.
• Use only specified cleaners and follow specified cleaning procedures.
Incorrect test results or damage to system components could result if these
procedures are not followed.
WARNING: Using this equipment in a manner not specified by the

manufacturer may result in injury to lab personnel, harm to
the environment, incorrect test results, or damage to the
equipment.
Warnings, Cautions, and Notes

Warnings, cautions, and notes provide safety notices and important
information that require the operator’s attention.
WARNING: Warning statements indicate the risk of personal injury

or loss of life if operating procedures are not strictly
observed.
CAUTION: Caution statements indicate the possibility of damage to

equipment or data if operating procedures are not strictly
observed.
Note: Note statements alert the operator to important information
that requires attention.
11 - 2 2014/07
This summary is based on the guidelines developed by the Centers for Disease
Control, the Clinical and Laboratory Standards Institute Document M29-A3,
Protection of Laboratory Workers from Occupationally Acquired Infections, and
the Occupational Safety and Health Administration’s Bloodborne Pathogens
Standard. 1-3
Protection from Biohazards

CAUTION: Use this summary for general information only. It is not intended
to replace or supplement the laboratory or hospital biohazard
control procedures.
A biohazardous condition is any situation involving infectious agents biological
in nature, such as the hepatitis B virus, the Human Immunodeficiency Virus
(HIV), and the tuberculosis (TB) bacterium. These infectious agents may be
present in human blood or blood products and other body fluids.
The following are the major sources of contamination when handling
potentially infectious agents:
• Needlesticks
• Hand-to-mouth contact
• Hand-to eye contact
• Direct contact with superficial cuts, open wounds, and other skin
conditions that may permit absorption into subcutaneous skin layers
• Splashes or aerosol contact with skin and eyes
To prevent accidental contamination in a clinical laboratory, strictly adhere to
the following procedures:
• Wear gloves while servicing parts of the instrument that have contact with
body fluids such as serum, plasma, urine, or whole blood.
• Wash your hands before going from a contaminated area to a
noncontaminated area, or when removing or changing gloves.
• Perform procedures carefully to minimize aerosol formation.
• Wear facial protection when splatter or aerosol formation is possible.
• Wear personal protective equipment such as safety glasses, gloves, lab
coats, or aprons when working with possible biohazards contaminants.
• Keep your hands away from your face.
• Cover all superficial cuts and wounds before starting any work.
• Dispose of contaminated materials according to the laboratory’s biohazard
control procedures.
• Keep the work area disinfected.
• Disinfect tools and other items that have been near any part of the
instrument sample path or waste area with 10% solution of bleach.
• Do not eat, drink, smoke, apply cosmetics, or handle contact lenses while
in the laboratory.
• Do not use your mouth to pipette any liquid, including water.
• Do not place tools or other items in your mouth.
2014/07 11 - 3
• Do not use the biohazard sink for personal cleaning such as rinsing coffee
cups or washing hands.
To prevent needlestick injures, needles should not be recapped, purposely
bent, cut, broken, removed from disposable syringes, or otherwise
manipulated by hand.
References
1. Centers for Disease Control. 1988. Update: Universal precautions for
prevention of transmission of human immunodeficiency virus, hepatitis B
virus and other bloodborne pathogens in healthcare settings. MMWR,
37:377-382, 387, 388.
2. Clinical and Laboratory Standards Institute (formerly NCCLS). Protection of
Laboratory Workers from Occupationally Acquired Infections; Approved
Guidelines - Third Edition. CLSI Document M29-A3. [ISBN 1-56238-567-4].
Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898 USA 2005.
3. Federal Occupational Safety and Health Administration. Bloodborne
Pathogens Standard. 29 CFR 1819. 1030.
Instrument and Waste Removal

Please contact a Siemens Healthcare Diagnostics representative for instrument
removal for repair or disposal.
The product meets the requirements of the environmental protection

guidelines (2002/95/EC, 2002/96/EC, 2003/108/EC) and must be disposed of
properly at the end of its life cycle.
WARNING: Fluid and solid consumables are potential biohazards.

Dispose of all waste produced during instrument operation
according to local, state, and country regulations.
Protection from Barcode Scanner Lasers
WARNING: To avoid damage to the eyes, never look directly at

the laser beam or at its reflection from a shiny surface. Never
point a hand-held barcode scanner at anyone.
11 - 4 2014/07
Mechanical Hazards
WARNING: Pinch Point - Do not touch moving parts of the analyzer

(rotor, arms, etc.) while they are in motion.
WARNING: Sharp Edges - Do not touch reagent or sample probes

at any time.
WARNING: Hot Surface - Do not touch the reagent probe. The

reagent probe is heated and may be hot.
WARNING: Hot Surface - Do not touch the lamp when it is switch on.
If the lamp must be replaced, wait until it has cooled off
before replacing.
Biological Hazards
WARNING: Biohazard - Patient samples, controls, calibrators, and

liquid waste are potential biohazards. Handle these
substances according to national and international laboratory
safety regulations. This also applies to components of the
analyzer that are exposed to such substances. If any liquid is
spilled on the analyzer, wipe it up immediately and clean the
contaminated surface with a disinfectant.
WARNING: Biohazard - None of the fluids used in the analyzer are

fit for consumption.
Chemical Hazards
WARNING: Take Care - Specific hazards may be associated with the

use of clinical laboratory chemicals, such as reagents.
Recommendations to prevent such hazards are given in the
package inserts or material safety data sheets. All
recommendations must be followed.
2014/07 11 - 5
11 - 6 2014/07
Viva-ProE ™ System Operator’s Guide Warranty and Support
Appendix B: Warranty and Support
2014/07 12 - 1
Warranty and Support Viva-ProE ™ System Operator’s Guide
Limited Instrument Warranty and Service Delivery Policy

Siemens and its authorized distributors may provide customers who acquire
new Siemens instruments with a limited warranty either in a specific
agreement or in standard language on their invoices. This limited warranty is
designed to protect customers from the cost associated with repairing
instruments that exhibit malfunctions due to defects in materials and/or
workmanship during the warranty period.
Siemens, at its election, will provide warranty service either by providing repair
service of the instrument on site, or by exchanging the defective instrument or
component, subject to the limitations and exclusions set forth in Replacement
of Parts and Warranty and Service Exclusions, repairs, replacements or
exchanges of instruments or components provided during the warranty or any
additional service period, will not extend the warranty or service period
beyond the initially agreed upon period.
When the customer calls for service, the Siemens representative or authorized
distributor will inform the customer of the type of service available for the
customer’s instrument, and will instruct the customer as to how to obtain that
service.
Warranty Period
The limited warranty period generally commences upon installation of the
original instrument at the customer’s location and extends for a period of one
year thereafter, unless otherwise specifically agreed to by and between
Siemens (or its authorized distributors) and customer in a writing signed by
duly authorized representatives of both parties (sales representatives are
generally not authorized representatives of Siemens for these purposes).
Service Calls
The customer may obtain service for instruments during normal business
hours by contacting the nearest Siemens technical support provider or
authorized distributor.
Warranty or service calls generally include onsite repair or exchange of
instruments or components, travel to the location of the instrument, and
onsite labor during normal business hours. A warranty or service call is
initiated by the customer by following the instructions on how to obtain
service for the customer’s instrument. The service call is considered complete
when any defects in material or workmanship have been corrected by repair or
replacement and the instrument conforms to the applicable specifications.
When service is complete, the customer receives a copy of the documentation
detailing all work performed by the Siemens representative or authorized
distributor.
12 - 2 2014/07
Viva-ProE ™ System Operator’s Guide Warranty and Support
Customers, with some exceptions, may also request service to be delivered or

an exchange to be initiated outside normal business hours, including
evenings, weekend days, or nationally observed holidays, by contacting the
nearest Siemens location or authorized distributor. Service performed outside
normal hours is subject to a surcharge unless the customer has in place a
service product option that provides service at the time requested.
Warranty and Service Exclusions

The following exclusions are in addition to any exclusions provided for in any
written warranty or service agreement.
If any of the following events occur, the warranty or service provisions do not
apply:
1. Repairs or modifications have been made to the instrument by someone
other than an authorized Siemens representative.
2. The instrument has been operated using accessories and supplies other
than Siemens brand accessories, or consumable supplies and/or reagents
not having the same grade, quality, and composition as defined in the
system operator’s manuals.
3. Siemens has notified customers of a change that improves the
performance or reliability of their instrument and customer has not agreed
to retrofit or make design changes to the instrument.
4. Customer did not purchase the instrument from Siemens or one of its
authorized distributors.
5. The instrument has not been installed within 90 days of shipment to the
customer’s facility unless otherwise specified.
6. The customer has not performed appropriate customer maintenance
procedures, as outlined in the system operator’s manuals.
7. The instrument has been misused or used for a purpose for which it was
not intended.
8. The instrument has been damaged in transit to the customer or damaged
by the customer while moving or relocating it without supervision by a
Siemens representative.
9. Damage was caused by floods, earthquakes, tornados, hurricanes, or other
natural or man-made disasters.
10. Damage was caused by Acts of War, vandalism, sabotage, arson, or civil
commotion.
11. Damage was caused by electrical surges or voltages exceeding the
tolerances outlined in the system operator’s manuals.
12. Damage was caused by water from any source external to the instrument.
13. The customer has purchased an alternative agreement whose terms of
warranty or service supersede these provisions.
Siemens or its authorized distributors will invoice customers, at current
standard labor and parts rates, for instruments repaired to correct damage or
malfunctions due to any of the reasons listed above.
2014/07 12 - 3
Warranty and Support Viva-ProE ™ System Operator’s Guide
OTHER THAN AS STATED ABOVE, THERE ARE NO OTHER WARRANTIES, EXPRESS

OR IMPLIED WITH RESPECT TO THE INSTRUMENT, ITS SALE TO THE CUSTOMER,
ITS LEASE TO THE CUSTOMER, OR THE SALE OF THE INSTRUMENT TO THE
CUSTOMER AT THE EXPIRATION OR TERMINATION OF THE LEASE AGREEMENT.
SIEMENS SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE. SIEMENS
LIABILITY FOR BREACH OF ANY WARRANTY OR SERVICE AGREEMENT SHALL BE
LIMITED ONLY TO THE REPAIR OR REPLACEMENT OF DEFECTIVE EQUIPMENT
AND SHALL NOT INCLUDE ANY DAMAGES OF ANY KIND, WHETHER DIRECT,
INDIRECT, INCIDENTAL, CONTINGENT, OR INCONSEQUENTIAL. SIEMENS SHALL
NOT BE LIABLE FOR DELAY FROM ANY CAUSE IN PROVIDING REPAIR OR
EXCHANGE SERVICE.ANY LIMITATIONS OR OTHER PROVISIONS NOT
CONSISTENT WITH APPLICABLE LAW IN PARTICULAR JURISDICTIONS OR A
SPECIFIC WRITTEN AGREEMENT DO NOT APPLY TO CUSTOMERS IN THOSE
JURISDICTIONS OR SUBJECT TO THOSE AGREEMENTS.
12 - 4 2014/07
Viva-ProE ™ System Operator’s Guide Supplies
Appendix C: Supplies
2014/07 13 - 1
Supplies Viva-ProE ™ System Operator’s Guide
Cleaning Solutions
All cleaning solutions are European Commission (EC) marked according to
directive 98/79/EC. They are for professional use only and intended for in vitro
diagnostic devices.
Note: If the solution is cloudy, discard according to local regulations
regarding waste disposal.
System Solution
• Reference (Part Number) - 10445247
• Distributed - Siemens
• Intended Use - Washing cuvettes and probes; also used for the pipetting
system (wetting effect for system fluidics)
• Preparation - Dilute with distilled water at 1/400 (12.5 mL system solution
in 5 L of distilled water)
• Composition - Aqueous solution with a detergent containing sodium azide
(<0.1%)
• Precautions - None
System Cleaning Solution

• Intended Use - Cleaning sample and reagent probes; also used in the
system cleaning procedure
• Preparation - Dilute with distilled water at 1/10 for probe rinsing; use
undiluted for the system cleaning procedure
• Composition - Aqueous solution of Sodium hypochlorite (<2% of active
chlorite) and Sodium hydroxide (<5.4%)
• Precautions - Corrosive (C)
• R 35 - Causes severe burns
• S 26 - In case of contact with eyes, rinse immediately with plenty of water
and seek medical attention
• S 28 - In case of contact with skin, wash immediately with plenty of water
• S 36 / 37 / 39 - Wear suitable protective clothing, gloves and eye / face
protection
• S 45 - In case of accident or if you don’t feel well, seek medical advice
immediately (if possible show the package label)
13 - 2 2014/07
Viva-ProE ™ System Operator’s Guide Supplies
0.1 N HCl Solution

• Intended Use - Cleaning the reagent probes; also used in the
incompatibility procedure for tests
• Preparation - Solution is ready for use
• Composition - Aqueous solution of hydrochloric acid (<0.5%)
• Precautions - Irritant (Xi)
• R 36 / 37 / 38 - Irritating to eyes, respiratory system and skin
0.1N NaOH Volumetric Solution (Sodium Hydroxide)

• Intended Use - Cleaning the System
• Preparation - Solution is ready for use
• Precautions - Corrosive (C)
• R 35 - Causes severe burns
• S 28 - In case of contact with skin, wash immediately with plenty of water
• S 36 / 37 / 39 - Wear suitable protective clothing, gloves and eye / face
protection
• S 45 - In case of accident or if you don’t feel well, seek medical advice
immediately (if possible show the package label)
2014/07 13 - 3
Supplies Viva-ProE ™ System Operator’s Guide
13 - 4 2014/07
Viva-ProE ™ System Operator’s Guide Specifications
Appendix D: Specifications
2014/07 14 - 1
Specifications Viva-ProE ™ System Operator’s Guide
System Specifications
This section summarizes the system design specifications.
Dimensions and Weight

Figure 14-1: Dimensions and Weight
Table 14-1: Dimensions and Weight
1 Distance required to access and remove the rear cover 20 cm (7.9 inches)
2 Depth 62 cm (24.4 inches)
3 Distance required to open the side door 30 cm (11.8 inches)
4 Width 125 cm (49.2 inches)
5 Distance required to open the side door 30 cm (11.8 inches)
6 Height (excluding monitor) 75 cm (29.5 inches)
7 Maximum total height 85 cm (33.5 inches)
Weight (excluding monitor arm and panel PC 93 Kg (205 lbs)
14 - 2 2014/07
Environmental
Table 14-2: System Environmental Specifications
Ambient Operating Temperature 15 - 32 °C (59 to 90 °F)
Relative Humidity 15 - 85% (non condensing)
Maximum Altitude 2000 Meters / 6500 Feet
Pollution Degree 2 (in accordance with IEC 664)
Electrical Requirements
Table 14-3: System Electrical Requirements
Line Voltage 110 - 240 V
Line Frequency 50 or 60 Hz
Maximum Power Consumption 400 VA (includes panel PC)
Installation Category II (in accordance with IEC664)
Main Fuses Two 5 Amp Slow Blow Fuses
Note: Do not use the system in close proximity to sources of strong

electromagnetic radiation (e.g. unshielded intentional RF
sources), as these may interfere with proper functioning of
the system.
Note: The manufacturer advises the user to evaluate the
electromagnetic environment prior to operation of the
Viva-ProE ™ System.
Approvals
Table 14-4: Approvals
Approvals Description
CE European Conformity
CB Cartes Bancaires
UL Underwriters Laboratory
ICE 61326-2-6 The system complies with the emission and immunity
requirements described in the IEC 61326-2-6.
CISPR 11 Class A This equipment has been designed and tested to CISPR
11 Class A. In a domestic environment, it may cause
radio interference in this instance, it may be necessary
to take measures to mitigate the interference.
Note: The approvals listed here refer only to the instrument and
operator console, not to additional devices. For the approvals
for these devices, see the corresponding manuals.
2014/07 14 - 3
Technical Specifications
Table 14-5: Product Specification
Product Specification Description
Maximum Throughput 133 Tests/Hour
Accuracy See “Accuracy and Precision” on page 7 of Chapter 14:

Precision See “Accuracy and Precision” on page 7 of Chapter 14:

Programmable Tests 120 per rotor configuration
Quality Control 6 per parameter

(120 controls programmable per rotor configuration)
Sample Processing Prioritized in the following order: STAT, Pediatric,

Normal
Table 14-6: Sample Handling
Sample Handling Description
Positions on Outer 50 positions for barcoded tubes (See Note)

Rings
Positions on Inner Ring 1 blank position

1 wash position
12 positions for tubes without barcodes (See Note)
Sample Tubes Diameter 13 mm

Height 75 mm
Pediatric Cups and Adapters (See “Using Pediatric
Sample Cups” on page 4 of chapter 2)
Probe Level detector and integrated stirrer
Pipetting Capacity 1 to 30 µL (increments of 0.1 µL)
Syringe 100 µL
Note: All positions can be used for patient samples (normal, ASAP,
and STAT), calibrators, Blank, and Controls. Normally,
controls and calibrators are placed on the inner ring and
patient samples are loaded on the two outer rings (readable
by the internal barcode scanner).
14 - 4 2014/07
Table 14-7: Reagent Handling
Reagent Handling Description
Reagent Rotor 26 positions

13 x 14 mL bottles; 13 x 28 mL bottles
Volumes Per Test Reagent 1: 110 to 399 µL

Reagent 2: 10 to 289 µL
Reagent 3: 10 to 289 µL
Refrigeration 8 - 12 °C (Absolute up to 25 °C ambient temperature)
Probe Heated, with level detector and integrated stirrer
Pipetting Capacity 400 µL (increments of 1 µL)
Syringe 1000 µL
Table 14-8: General Specifications
General Specification Description
Cuvette Rotor Multi-use disposable rotor with 48 positions
Path Length 6.8 mm
Volume Range 220 µL to 400 µL (total volume of sample and reagents)
Wash Station Fully automated with overflow level detector
Cuvette Rinsing 4 x 500 µL treated water
Light Source Quartz Iodine lamp 12 volts 20 watts
Wavelengths 340, 415, 505, 546, 570, 600, 660, and 700 nm
Wavelength ± 2nm
Uncertainty
Spectral Half-width 10 ± 2 nm
Value
Measuring Range 0 - 3.0 Abs.
Temperature 37 ° C ± 0.2 °C
Cycle Time 27 seconds
2014/07 14 - 5
User Interface
Table 14-9: Computer System (minimal requirements)
Computer System Description
CPU Intel Celeron M 575 2 GHz
RAM DDR-RAM / SO-DIMM 2 GB
Hard Disk 500 GB
Monitor Touchscreen Monitor 15.6 inch, 1366 x 768 pixels
Operating System MS Windows
Serial Port 1 x RS232 (for the system)
USB Ports 4 (USB 2.0)
Ethernet 1 x 100 Mbps (Host Connection)
Internal Barcode Reader

Table 14-10: Internal Barcode Reader System
Barcode System Description
Version Built-in device
Technology CCD
Barcodes Code 39, Code 93, Code 128, Codabar, and Code 2
of 5 family
Note: Other barcodes can be configured when required. A total of 5

barcodes can be programmed for the internal barcode
reader. Contact the Siemens service for more information.
External Barcode Reader (optional)

Table 14-11: External Barcode Reader
Barcode Reader Description
Version Hand-held Device
Technology CCD
Barcodes Code 39, Code 128, Codabar, and Code 2 of 5

family
Note: Other barcodes can be configured when required. See the

configuration manual provided with the hand-held barcode
reader. Contact the system support department of the
supplier for more information.
14 - 6 2014/07
Accuracy and Precision

The chemical performance of clinical chemistry systems, in terms of accuracy
and precision depends on the characteristics of the instrument, the
measurement techniques, and the materials used. Therefore, the chemical
performance characteristics of a clinical chemistry system can only be
established and postulated in terms of the following: the analyte, the specific
reagent kit and calibrator(s) used, the type and constitution of the specimens
involved, etc.
The analyzers are designed as user-definable systems, implying most clinical
chemistry tests and techniques that require photometric measurement can be
adapted on the system. Only the test parameters for a specific test need to be
adjusted. The operator must establish the required test parameter settings to
achieve satisfactory results, utilizing appropriate methods. The methods are
based on international guidance documents, such as CLSI guidelines. Contact
the local representative or the reagent manufacturer for more information on
the chemical performance of their reagents.
Disclaimer
The manufacturer assumes no responsibility for erroneous test results caused
by reagents kits and or test parameters that are not explicitly provided or
recommended by the manufacturer.
2014/07 14 - 7
Predefined Systems
The Viva-ProE ™ System is supplied as a predefined system (designed for
Siemens reagents). In predefined systems, the test parameters are
pre-programmed and 10 open channels can be fully configured.
can be deleted.
14 - 8 2014/07
Viva-ProE ™ System Operator’s Guide Symbols
Appendix E: Symbols
2014/07 15 - 1
Symbols Viva-ProE ™ System Operator’s Guide
System Symbols
This section describes the symbols that can appear on the interior or exterior of
the system, or on the system packaging. The symbols on the system identify
the location of certain components and, where necessary, display warnings for
proper operation. The symbols on the system packaging also provide other
important information.
Table 15-1: System Symbols
Symbol Description
An activity that may present a safety-related hazard and advises

the operator to consult the associated caution or warning
instructions provided.
An activity or area where operators may be exposed to potentially

infectious material.
A reference to the Viva-ProE ™ System Operator’s Guide before the

operator performs procedures on the system.
An activity or area where the operator may be exposed to hot

surfaces (> 70 °C/158 °F).
A possible electrical shock if procedural or engineering controls are

not observed.
An area containing cutting parts.

Note: Follow the instructions in this Operator’s Guide when
performing maintenance.
A warning against direct viewing of the laser beam or reflection

from the laser beam. Avoid eye exposure to laser light. Do not
stare into the beam.
A pinch hazard opening or closing mechanical parts.
15 - 2 2014/07
Viva-ProE ™ System Operator’s Guide Symbols
Symbol Description
The WEEE symbol indicates that this equipment is classified as

Waste Electrical and Electronic Equipment under the European
WEEE Directive. It must be recycled or disposed of in accordance
with applicable local requirements.
This symbol indicates the name and location of the product

manufacturer.
This symbol indicates that the product complies with the

applicable directives of the European Union.
2014/07 15 - 3
Symbols Viva-ProE ™ System Operator’s Guide
15 - 4 2014/07
Viva-ProE ™ System Operator’s Guide Theory
Appendix F: Theory
2014/07 16 - 1
Theory Viva-ProE ™ System Operator’s Guide
Theory
This chapter contains the theoretical foundations for the measurements
performed by the instrument. It includes formulas for all measurement types,
as well as calibration algorithms and explanations of some advanced integrity
checking features.
16 - 2 2014/07
Absorbance Measurements
Measuring Absorbance
Parameters are measured as spectral absorbance relative to a zero-adjustment
on water. The measured absorbance is related to the concentration following
Beers-Lambert law:
Item Description
Abs Absorbance
e Molar Extinction Coefficient
d Length of the light path
c Concentration
T Transmission
Figure 16-1: Light is absorbed by the fluid in the cuvette
2014/07 16 - 3
Measurement Types
When samples and reagents are mixed, a reaction takes place. In general, this
reaction follows a profile as shown in the diagram below. In the first section of
the curve, there is a linear relationship between time and change in
concentration (absorbance). In the second linear relationship between time
and change in concentration (absorbance). In the second section, the reaction
slows down until it reaches a stable endpoint, when all of the sample or
reagent is consumed.
Figure 16-2: Absorbance Versus Time Graph
The time for the reaction to reach a stable endpoint varies greatly. As the time
frame available for measurements on the system is limited, three available
types of measurements are the following:
Table 16-1: Measurement Types
Type Description
Kinetic Tests The time frame for measurement on the system corresponds to section 1 of
the curve. This measurement type assumes that the change in absorbance is
linear during the entire measurement period.
Endpoint Tests A stable endpoint is reached within the measurement time frame.
Two Point Tests The absorbance values at two points are compared, irrespective of which part
of the curve corresponds to the measurement time frame.
16 - 4 2014/07
Calculating Concentrations from Absorbances

The following three options are available for calculating from measured
absorbances:
• Fixed factor
• Calculated factor based on a calibration measurement
• Interpolation on a calibration curve obtained with multiple calibration
measurements
The first two options can be described with the following set of formulas:
The factor “F” is either fixed value supplied with the reagent kit or is calculated
as follows:
Measurement with Reagent Blank
Measurement with Reagent Blank and Sample Blank
2014/07 16 - 5
Bichromatic Endpoint
The factor calculation and the formulas for bichromatic endpoints with
reagent blank and sample blank are identical to those used in the standard
endpoint method.
Interpolation on Calibration Curves

The third option for obtaining the concentration from measured absorbance is
based on interpolation on a calibration curve through three or more reference
points. The curve can be calculated using a number of the following different
algorithms:
• Linear Regression
• Standard Cubic Spline
• Smooth Cubic Spline
• Modified Cubic Spline
• Point to Point
• 4-Parameter Logit-Log (requires at least 4 points)
• Syva 4-Parameter Logit-Log (requires at least 4 points)
• 5-Parameter Logit-Log (requires at least 5 points)
• 5-Parameter Exponential (requires at least 5points)
• Syva 5-Parameter Logit-Log (requires at least 5 points)
• Syva 5-Parameter Exponential (requires at least 5points)
Note: It is possible that not all of the algorithms in this section are
available on the system.
16 - 6 2014/07
Calibration Algorithms
Standard Cubic Spline Method
Item Description
Ai measured absorbance value for calibration point i
Ci Concentration for calibration point i
Am Measured absorbance value for the sample
Cm Calculated concentration
ai Factor determined by the curve-fit algorithm
Note: The value of Ai and Ai + 1 is given by the following:
2014/07 16 - 7
Modified Cubic Spline Method

The modified cubic spline is similar to the standard cubic spline method.
The difference is the constraint of the curve that passes through all data points
is lifted. This is achieved by introducing a smoothing factor that determines
the balance between the smoothness of the curve and the proximity to the
data points. In extreme situations, this method reduces to either the linear
regression line (smoothest line) or the normal cubic spline (closest to the data
points). In the current implementation, the smoothing factor is optimized
based on a configurable maximum deviation of the curve from the data points.
The modified cubic spline is a variant of the smooth cubic spline.
See Smoothing by spline functions by C.H. Reinsch, published in Numerische
Mathematik 10, 177-183, 1967.
NLLS Algorithms
4 Parameter Logit-log
Item Description
x0 K a b Factors determined by the curve-fit algorithm
5 Parameter Logit-log
Item Description
x0 K a b c Factors determined by the curve-fit algorithm
16 - 8 2014/07
5 Parameter Exponential
Item Description
x0 K a b c Factors determined by the curve-fit algorithm
Linear Regression and Point-to-Point
Item Description
Slope Factor determined by the algorithm
Intercept Factor determined by the algorithm
2014/07 16 - 9
Explanation of System Features

Integrity Checking
The Viva-ProE™ System can perform a number of checks on the integrity of the
measurements. Some methods are explained in this paragraph. When an
integrity check fails, an error flag is set for the measurement result. The error
flags are displayed next to the measurement results on the screen.
Absorbance Check for Calibrated Tests

After a non-linear calibration, an automatic rate check is initiated. The
following limits are set:
• Low Rate Limit - Lowest Calibrator Rate - 1% of Calibrator Range
• High Rate Limit - Highest Calibrator Rate - 1% of Calibrator Range
The calibrator range in the above formulas equals the highest calibrator rate
minus the lowest calibrator rate.
When a calibration violates these limits, the k or K flag is raised and one of the
following results are shown:
• 0.00 - result is lower than the lowest standard
• 9999.0 - result is higher than the highest standard
Note: These limits are calibrator related and do not display in the
test parameters. Do not confuse them with the general
absorbance limits which are method related and displayed as
flagged results (m or M).
Note: The manufacturer recommends setting concentration limits
when a test is calibrated. When a high concentration limit is
set at 300 mg/dl all results above this limit (also 9999.0) are
present in the form “>300 mg/dl”.
Westgard Rules
The Westgard rules can only be used for single controls. When the Westgard
option is selected, the high and low limits are automatically set from the
standard deviation that is entered by the operator.
The Westgard rules are violated if one or more of the following conditions
apply:
• 1 control result is more than 3 standard deviations from the target.
• The last 2 control results are more than 2 standard deviations from the
target in the same direction (+ or -).
• The last 4 control results are more than 1 standard deviation from the
target in the same direction (+ or -).
• The last 10 control results are all located either on the “+” or the “-” side to
the target.
Note: The Westgard rules are not violated in any other case.
16 - 10 2014/07
Viva-ProE ™ System Operator’s Guide Index
A
accept control measurements 4-3
accessing configuration screen 10-3
accessing configure tests screen 10-4
accessing flag customization screen 10-39
accessing system menu screens 10-28
accuracy and precision 14-7
acid solution 13-3
activate internal barcode reader 10-30
add calibrator lot 10-19
add control lot 10-21
add probe incompatibilities 10-22
add probe incompatibilities or links 10-23
add test incompatibilities 10-24
add test incompatibilities or links 10-25
add test to a control 10-17
add user 10-40
adding controls 10-16
adjusting lamp unit 7-29
administrator 1-3
approvals 14-3
archive patient results 9-3
archiving results database 7-11
as needed 7-34
audible error signals 8-3
B
backup system database 9-2
barcode symbology 2-6
C
calculated tests 10-16
calibration 5-1
cautions 11-2
check 0.1N HCl cleaning solution 7-11
check 10% cleaning solution 2-13, 7-10
check cuvette blank measurements 7-9
checking 10% cleaning solution 2-13, 7-10
checking cuvette blank measurements 2-11
checking reagent inventory 7-11
checking reagents 3-2
checking syringes 2-11, 7-9
clean system 7-21
clean touchscreen 7-34
cleaning concentrated waste container 7-15
cleaning solutions 13-2
cleaning system 7-34
cleaning the touchscreen 7-34
cleaning touchscreen 7-34
computer 1-16
concentrated waste container 1-11
configuration 10-16
configuration screen 10-2
2014/07 Index - 1
Index Viva-ProE ™ System Operator’s Guide
configure audible notifications 10-29

configure calculated test parameters 10-37
configure category types 10-36
configure daily operation times 10-31
configure database backup 9-2, 10-33
configure export parameters 10-34
configure flag customization 10-39
configure laboratory information system connections 10-35
configure laboratory name 10-29
configure language 10-28
configure operator reminders 10-38
configure printed reports 10-33
configure reagent rotors 10-31
configure service configuration 10-38
configure start of day tasks 10-32
configure user management 10-30
configure users 10-40
configuring sample types 10-36
controls 4-2
cooling unit 1-13
create calibrator lot 10-20
create control lot 10-21
creating controls 10-17
cuvette rotor 1-5
D
daily setup 2-7
data management 9-1
deactivate internal barcode reader 10-30
deactivate user 10-41
delete control 10-19
delete probe incompatibilities or links 10-24
delete test from a control 10-18
delete test incompatibilities or links 10-26
dimensions and weight 14-2
E
edit calculated test parameters 10-37
edit calibrations and reagent blanks 5-2
edit calibrator lot 10-20
edit category types 10-37
edit control lot 10-21, 10-22
edit flag customization 10-40
edit operator reminders 10-38
edit patient tests 4-5
edit probe incompatibilities 10-22
edit probe incompatibilities or links 10-24
edit test incompatibilities 10-24
edit test incompatibilities or links 10-25
edit test order 10-27
editing controls 10-16
editing test parameters 10-18
electrical requirements 14-3
Index - 2 2014/07
emergency shutdown 2-15

empty concentrated waste container 2-10, 7-8
empty waste container 7-6
emptying waste container 2-8
end of day 2-14
end of day screen 1-42
environmental 14-3
error signaling 8-3
evaluate patient results 4-10
events screen 1-43
exclude cuvette blank results 2-12
export data 9-5
extend validity of a reagent 3-5
extend validity of calibrations or reagent blanks 5-3
external barcode reader 1-15
F
fill treated water container 2-9, 7-7
filling cooling fluid 7-37
G
general care and cleaning 7-3
general error condition icons 8-4
H
hardware errors 8-8
hardware overview 1-4
home screen 1-20
I
import data 9-5
install reagent rotor 3-7
Instrument Removal 11-4
intended use 1-2
internal barcode reader 1-14, 14-6
K
keyboard 1-17
L
lamp unit 1-12
load and process sample tubes with internal barcode reader 4-6
load and process sample tubes without internal barcode reader 4-7
load calibration screen 1-25
load calibration screen detailed view 1-27
load calibrators 5-2
load controls screen 1-29
load patients screen 1-32
load reagent 3-4
load reagent blanks 5-2
login 2-7
login superuser 1-18
logout superuser 1-18
2014/07 Index - 3
M
maintenance 7-1, 7-34
maintenance - as needed 7-34
maintenance - daily 7-5
maintenance - every 10,000 tests 7-32
maintenance - every 3 months 7-17
maintenance - every 6 months 7-19
maintenance - monthly 7-13
maintenance - weekly 7-12
maintenance - yearly 7-23
maintenance logs 7-39
maintenance schedule 7-4
manually accept cuvette blank results 2-12
manually accept results 5-3
manually archive patient results 9-4
manually backup system database 9-2
manually process samples 4-8
manually reject results 5-3
N
notes 11-2
O
operator 1-3
P
patients 4-5
pause sample processing 4-10
perform calibrations and reagent blanks 5-2
pipettor 1-9
precautions for operation 2-2
preparing samples 2-3
prime system 7-11
print daily report 2-13, 7-10
process STAT samples 4-9
Q
quality control 6-1
quality control screen 6-2
R
reagent info screen 1-24
reagent probe 1-5
reagent rotor 1-8
reagent rotor image size indicators 1-23
reagent rotor image status colors 1-22
reagent screen 1-22
reagents 3-1
refill 10% cleaning solution 2-13, 7-10
refilling 10% cleaning solution 2-13, 7-10
reject control measurements 4-3
reject cuvette blank results 2-12
remove reagent 3-5
Index - 4 2014/07
remove reagent rotor 3-5

removing reagent 3-5
replace drying block 7-17
replace reagent 3-3
replace stirrer belt 7-19
replace water filter 7-20
replacing cuvette rotor 7-32
replacing photometer lamp 7-26
replacing syringes 7-23
request calibration screen 1-26
request controls 4-2
request controls screen 1-30
request controls screen control and test information 1-31
request patient screen 1-34
request patient tests 4-5
reset user password 10-41
restarting the system 2-15
restore backup database 9-4
results screen - calibration and controls 1-38
results screen - patients 1-36
resume measurements 4-10
rinse probes 7-12
rotor status Icons 1-33
S
safety 11-1
sample barcode label properties and placement 2-5
sample management 4-1
sample probe 1-5
sample rotor 1-7
search patient results 4-11
service 12-1
service calls 12-2
sodium hydroxide 13-3
software overview 1-18
specifications 14-1
start of day 2-7
start of day screen 1-21
stopping the system 2-15
superuser login 1-18
supervisor 1-3
supplies 13-1
support 12-1, 12-2
switch reagent rotor 3-5
switch user 1-18
system access 1-18
system cleaning solution 13-2
system configuration 10-1
system operation 2-1
system shutdown 2-15
system software login 1-18
system solution 13-2
system specifications 14-2
system symbols 15-2
2014/07 Index - 5
system users 1-3
T
technical specifications 14-4
test related errors 8-5
tests 10-16
theory 16-2
touchscreen 1-16
transfer backup database to external media device 9-3
troubleshooting 8-1
troubleshooting error codes 8-3
turn on system 2-7
turn on the system 2-15
U
unblocking the probe 8-9
unload all calibrators 5-4
unload all controls 4-4
unload all reagent blanks 5-4
unload all samples 4-12
unload calibrators 5-3
unload controls 4-4
unload reagent 3-5
unload reagent blanks 5-3
unload sample 4-11
unload screen 1-41
unloading reagent 3-5
unloading reagents 3-5
user accounts 1-18
user interface 14-6
user interface screens 1-20
using gel tubes 2-3
using pediatric sample cups 2-4
V
view calibrator lot 10-19
view control lot 10-21
view daily report 2-13, 7-10
view probe incompatibilities 10-22
view quality control 6-4
view test incompatibilities 10-24
view test order 10-27
viewing calibrators 10-16
viewing controls 10-16
viewing tests 10-5
viewing tests - absorbance checks 10-10
viewing tests - calibration 10-14
viewing tests - measurement endpoint tests 10-8
viewing tests - measurement kinetic tests 10-7
viewing tests - measurement two point tests 10-9
viewing tests - processing 10-6
viewing tests - result calculation 10-12
viewing tests - sample blank absorbance checks 10-11
Index - 6 2014/07
W
warnings 11-2
warranty 12-1, 12-2
waste system 1-10
water system 1-10
windows login 1-18
2014/07 Index - 7
Index - 8 2014/07

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Viva-ProE ™ System Operator’s Guide

Copyright © 2014 Siemens Healthcare Diagnostics.

Viva-ProE ™ System Operator’s Guide

Chapter 1: System Features . . . . . . . . . . . . . . . . . . . . . . 1-1

Chapter 2: System Operation . . . . . . . . . . . . . . . . . . . . . 2-1

2014/07 Table of Contents- 1

Preparing Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Checking Cuvette Blank Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Chapter 3: Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Chapter 4: Sample Management . . . . . . . . . . . . . . . . . . 4-1

Table of Contents- 2 2014/07

Pausing Sample Processing and Resuming Measurements . . . . . . . . . 4-10

Chapter 5: Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Chapter 6: Quality Control . . . . . . . . . . . . . . . . . . . . . . . 6-1

Chapter 7: Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

2014/07 Table of Contents- 3

Replacing the Photometer Lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26

Chapter 8: Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 8-1

Chapter 9: Data Management . . . . . . . . . . . . . . . . . . . . 9-1

Chapter 10: System Configuration . . . . . . . . . . . . . . . . . 10-1

Table of Contents- 4 2014/07

Viewing Tests - General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

2014/07 Table of Contents- 5

Editing Flag Customization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-40

Appendix A: Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Appendix B: Warranty and Support . . . . . . . . . . . . . . . . 12-1

Appendix C: Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1

Appendix D: Specifications . . . . . . . . . . . . . . . . . . . . . . . 14-1

Appendix E: Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-1

Appendix F: Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-1

Table of Contents- 6 2014/07

2014/07 Table of Contents- 7

Table of Contents- 8 2014/07

Chapter 1: System Features

WARNING: An incorrectly measured result may lead to an error in

Table 1-1: System Users

5 Computer and Touchscreen

6 Pipettor (inside side cabinet)

7 Treated Water and Waste Containers (inside cabinet)

8 Cooling Unit (inside cabinet)

9 Lamp Unit (inside cabinet)

10 Concentrated Waste Container (inside cabinet)

Reagent and Sample Probes

Figure 1-3: Reagent and Sample Probes

4 Cuvette Rotor Cover

Water and Waste Systems

1 Waste Container Cap

5 Treated Water Container

6 Treated Water Container Cap

Concentrated Waste Container

3 Concentrated Waste Container

Quartz-iodine Lamp Unit

3 Filter Wheel Drive

2 Maximum Level Indicator

3 Minimum Level Indicator

Internal Barcode Reader

1 Internal Barcode Reader

External Barcode Reader

WARNING: The hand-held barcode reader emits laser light. Do

CAUTION: Never use metal or sharp objects to touch the screen.

Keyboard and Trackball

Account Type User

Maintenance Field Service Engineer

System Software Login