En - HDSD L00600370 Rev 02

User Manual
ROTEM® sigma P/N 000600370

Rev. 02 September 2022
Tem Innovations GmbH, Martin-Kollar-Strasse 15, 81829 Munich, Germany

©2022 Tem Innovations GmbH, a Werfen company. All rights reserved.
No part of this manual may be reproduced in any way nor edited, copied or distributed electronically (by printing,
photocopying or any other method) without written consent of the publisher.
ROTEM® is a trademark of Tem Innovations GmbH in Europe, in the USA and in other countries.
Other product names marked with ® are trademarks of their trademark owners.
Revision History
Manual Version Software Version Date Changes
REV. 00 5.1.2 02-2022 Initial release
REV. 01 5.2.0 07-2022 Administrative updates and alignment to software revision
REV. 02 5.2.0 09-2022 Correct Power Input level displayed in Table 4-6
Tem Innovations GmbH

Martin-Kollar-Strasse 15
81829 Munich, Germany
www.werfen.com
This user manual is published by the manufacturer.

All rights reserved.
This manual reflects the technical specifications at the time of printing. Major amendments will be included in a new issue
of the user manual. Any data sheets included with this product represent the latest information update.
The right to make amendments of the technical development without explicit reference is reserved.
Patents
Instruments, cartridges, reagents, and other parts of the products may be covered by one or more patents in the U.S. and
in other jurisdictions including China, Japan, Australia, Germany, U.K., France, and etc.
Selected U.S. patents: https://www.werfen.com/na/en/trademarks-and-patents
Table of Contents
1 Introduction 4
2 Safety 7
3 Initiation and installation 11
4 System description 12
5 Basics 17
6 Measurement 28
7 System software 45
8 Maintenance, cleaning, disinfection 73
9 Shipping, Removal from use and Disposal 76
10 Appendix 77
P/N 000600370 Rev. 02 · ROTEM® sigma User Manual 3 of 98

1 Introduction
This user manual applies to the ROTEM sigma system with the respective ROTEM software. It is part of the product and
describes the intended use and safety considerations during the whole product life cycle.
In this document, the terms ROTEM and ROTEM system always refer to the ROTEM sigma.
1.1 Subject to change and validity

The information in this manual includes the technical specifications at the time of printing. Significant amendments will be
revised in a new edition of the manual. Any data sheets accompanying this manual contain the most current information
regarding the product. The document and version number of this manual are included in the footer.
1.2 Completeness
This user manual is only complete with the respective cartridge and control instructions for use (IFU). Instructions for use
for ROTEM sigma cartridges and controls are included in Appendices H-K of this manual.
1.3 Depository
This manual must be kept within reach and always accessible near the ROTEM system.
1.4 Further applicable documents

A range of cartridges, controls and consumables are available for the ROTEM sigma thromboelastometry system.
Please refer to the respective IFU’s for the cartridges and control kits regarding specific sample requirements, execution,
limitations and interpretation of results.
Additionally, follow your own local and internal regulations and policies.
Safety Data Sheets (SDS) for ROTEM sigma cartridges and controls can be requested through your local Customer
Support or online at www.werfen.com
1.5 Safety information

Immediately report any serious incident that occurs in relation to this device to both the manufacturer and the EU
Competent Authority of the Member State in which your facility is located or, if outside the EU, your local Regulatory
Agency.
For your local IL representative contact information, go to: www.werfen.com

1 Introduction
1.6 Typographical conventions

This section shows the applied abbreviations, symbols and textual accentuations.
1.6.1 Used abbreviations

Table 1-1 shows used abbreviations in this document.
Abbreviation Applied for

A(x) Amplitude after (x) minutes
AIDS Acquired Immunodeficiency Syndrome
CT Clotting Time
DB Database
HBsAg Hepatitis B Surface Antigen
HCV Hepatitis C Virus
HIV Human Immunodeficiency Virus
ID Identification (e.g.: patient ID, sample ID, etc.)
IFU Instructions For Use
INR International Normalized Ratio
IVD In Vitro Diagnostic
LAN Local Area Network
LI60 Lysis Index after 60 minutes
LIS Laboratory Information System
LOT Lysis Onset Time
MCF Maximum Clot Firmness
ML Maximum Lysis
POC Point Of Care
QC Quality Control
REF Reference Number
RO Read Only
RW Read and Write
SN Serial Number
Table 1-1: Used abbreviations
1.6.2 Text conventions

Table 1-2 shows applied accentuations in this document.
Identification Applied for Example

<> Keyboard entries <Enter>
Small capitals Surface texts D ATABASE
Bold Buttons Exit
Italic Input field Patient ID
Table 1-2: Text conventions

1 Introduction
1.6.3 Warning concept

Warning messages in this document are constructed as follows:
SIGNAL WORD
Danger
Consequences
4 Precautions
The respective symbol is shown if it is a matter of biohazard (Table 1-3).
Symbol Applied in Relevance

Information Refers to information.
Warning message Refers to danger. The level of danger is labelled by the signal word.
Warning message Refers to biohazard.
Table 1-3: Applied symbols in the warning concept
1.6.4 Strategic concept

Operation procedure instructions in this document are constructed as follows:
Purpose of action
P Assumption of action (optional)
1. Action undertaken
9 Intermediate result (optional)
2. Action undertaken
...
Action result (optional)
1.7 Intended User

The ROTEM sigma thromboelastometry system is intended to be used by trained medical professionals only. It is intended
for use in the point of care (near-patient test) and laboratory settings.

2 Safety
2.1 General safety instructions

This manual contains important information for the safe and appropriate installation, operation, transport, storage and
maintenance of the ROTEM system.
Please read the user manual carefully to familiarize yourself with the equipment.
Special attention should be paid to the information provided in this chapter.
Please refer to the instructions mentioned in Appendix A regarding the applied symbols for the system and
cartridges.
Before performing measurements and quality control, please read the IFU of the cartridges and controls.
2.2 Intended use

ROTEM sigma is a fully integrated and automated thromboelastometry system designed to monitor and analyze a patient’s
coagulation status by measuring the viscoelastic properties of a 3.2% citrated venous or arterial whole blood sample.
The ROTEM sigma system is indicated for use where a semi-quantitative evaluation of a hospitalized patient's blood
coagulation properties is desired, in the point of care (near-patient test) and laboratory settings. Coagulation evaluations
with the ROTEM sigma system are used to assess hemorrhage and/or thrombosis in clinical settings such as organ
transplantation, cardiovascular surgery, trauma, orthopedics, and obstetrics.
The ROTEM sigma system includes the following assays contained in single use, multi-channel cartridges; ROTEM sigma
complete (INTEM C, EXTEM C, FIBTEM C, APTEM C) and ROTEM sigma complete + hep (INTEM C, EXTEM C, FIBTEM C,
HEPTEM C):
INTEM C is used for the assessment of coagulation via the intrinsic pathway in citrated whole blood samples.
EXTEM C is used for the assessment of coagulation via the extrinsic pathway in citrated whole blood samples.
FIBTEM C is used for the assessment of coagulation via the extrinsic pathway in citrated whole blood samples, after
blocking platelet contribution to clot firmness.
APTEM C is used for the assessment of coagulation via the extrinsic pathway in citrated whole blood samples, after
blocking fibrinolysis.
HEPTEM C is used for the assessment of coagulation via the intrinsic pathway in citrated whole blood samples, after
inactivating heparin.
Results from the ROTEM sigma should not be the sole basis for a patient diagnosis; ROTEM sigma results should be
considered along with a clinical assessment of the patient’s condition and other laboratory tests.
For in vitro Diagnostic Use.
For use by healthcare professionals only.

2 Safety
2.3 Ambient conditions

For the proper operation of the ROTEM sigma, please note the following environmental requirements:
Operating temperature 18 °C - 30 °C
Storage temperature range 0 °C - 50 °C
Relative humidity range (transport, storage) 20% - 85%
Relative humidity range (operating) 15% - 60%
Air pressure (operating) 700 hPa - 1060 hPa
Operable to height above sea level 3000 m
Distance from examined, treated or monitored patients > 1.5 m
Pollution degree 2
Overvoltage Category II
Voltage fluctuation +/- 10%
Table 2-1: Ambient conditions
2.4 Certifications
Applicable standards:
EMC Standards:
IEC 61326-1 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1:
General requirements
IEC 61326-2-6 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6:
Particular requirements - In vitro diagnostic (IVD) medical equipment
FCC Title 47 Part 15 Sub-part B & Japan EMC VCCI V-3
Safety standards:
IEC 61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1:
General requirements
IEC 61010-2-101: Safety requirements for electrical equipment for measurement, control, and laboratory use -
Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61010-2-010 Safety requirements for electrical equipment for measurement, control and laboratory use -
Part 2-010: Particular requirements for laboratory equipment for the heating of materials
Certified to CAN/CSA-C22.2 #s 61010-1-12, 61010-2-010, 61010-2-101-15
Conforms to UL 61010-1, 61010-2-010, 61010-2-101
The main label on the back of the instrument contains markings indicating that the ROTEM sigma instrument has been
certified to the applicable standards for the United States and Canada.
Other Certification
RoHS
The manufacturer certifies that the ROTEM sigma thromboelastometry system is in compliance with the Directive
2011/65/EU of the European Parliament and of the Council of June 8, 2011 on the restriction of the use of certain
hazardous substances in electrical and electronic equipment (RoHS 2).

2 Safety
CEI/IEC 61010-1
The ROTEM sigma meets CEI/IEC 61010-1 for the following:
External surface temperature
Flame resistance
Internal air flow and temperature
Audible noise
Product labeling
The ROTEM sigma instrument shipping crate complies with the International Safe Transit Packaging Testing Procedure
(ISTA-2A).
2.5 Personal protection

2.5.1 Biohazards
WARNING
Risk of infection
Testing of patient blood samples poses inherent operator risk, including possible exposure to infectious
material.
4 Use of the system by anyone other than trained medical professionals may result in increased risk of exposure
of the operator to infectious material.
4 Always wear personal protective equipment such as laboratory coat, gloves and eye protection when handling
samples.
4 Always treat test samples as a potential biohazard and ensure proper handling and disposal of the samples.
4 Adhere to local statutory provisions for proper disposal (general recommendation available in Laboratory
Biosafety Manual World Health Organization, 2020).
4 Failure of system components may increase risk of exposure.
2.5.2 Electrical hazard
WARNING
Risk of Serious Injury or Death
Misuse of electrical equipment can cause electrocution or death by burning.
4 Always adhere to basic safety precautions for electrical equipment.
4 Never touch the patient and the instrument at the same time.
4 Any adjustments, service or repairs that have to be carried out while the equipment is powered on may only be
performed by qualified service personnel for ROTEM systems.
4 The equipment is supplied with an external grounded power cable. Connect the equipment only to an
grounded power socket. Any utilized adapters must also be grounded.
4 Keep equipment dry. If the equipment gets wet, unplug it before touching.
4 Use only components supplied by Instrumentation Laboratory/Werfen / Tem Innovations GmbH.
4 Do not switch the equipment on if it is damaged. Contact qualified service personnel.
4 If the power cable (instrument plug) is lost or damaged, it must be replaced by an original power cable
(Appendix F).

2 Safety
2.6 Cautions or Warnings

Adhere to the following instructions for the safe use of the ROTEM sigma:
Do not use the equipment if it is not working properly or damaged.
Do not leave the equipment unattended if it is used near those who require supervision.
Use the equipment only for the purposes described in this user manual (Chapter 2.2).
Liquids may damage the internal components of the equipment. Do not spill liquids over or into the ROTEM system.
Do not immerse the equipment in water or other liquids.
Only qualified service personnel may access internal components of the ROTEM system.
If safe operation of the ROTEM system cannot be guaranteed, discontinue use of the system and prevent further
use.
Do not let the equipment or its power cable come into contact with surfaces that are too warm to touch.
Do not cover air openings nor place equipment on a soft surface which might block them. Keep air openings free
from lint, hair, dust, etc.
Do not place anything on top of the equipment, except the accessories recommended by the manufacturer.
Unless specified in the user manual, do not stuff or put anything into the openings, tubes or couplings of the
equipment.
Do not use the ROTEM sigma near or in flammable or explosive atmospheres.
The equipment is designed for indoor use only.
Only software explicitly supplied by Tem Innovations GmbH may be installed on the ROTEM sigma system.
Do not drop the equipment or expose to physical shocks.
Only use qualified ROTEM sigma system material.

3 Initiation and
installation
3.1 Site installation requirements

Before using the ROTEM sigma for the first time, make sure you read and understand all information in the
User Manual. Particular attention should be paid to Chapter 2, where important information is provided
regarding risks, safety standards, operating conditions, and handling of reagents, samples and controls.
For the proper usage of the ROTEM sigma, a site has to fulfill the following requirements:
Ensure that the on/off switch is always accessible and that the power cable can always be removed to disconnect
the power socket in case of emergency.
Place the ROTEM sigma on an even, clean and robust surface. The operation of the equipment on a robust cart is
possible but strong physical shocks to the system during measurement should be avoided.
Ensure that the place where the equipment is set up is capable of supporting the weight of the system (28 kg) and
that two grounded power outlets are available (ROTEM sigma, optional printer).
Avoid placing the equipment near open windows, air vents, radiators or other instruments that produce heat or
strong vibrations.
Ensure sufficient ventilation of the ROTEM sigma, leaving a minimum distance of 20 cm between other instruments
and walls.
Ensure that the ventilation openings at the rear side of the equipment are not blocked.
Additionally, please note the instruction for ambient conditions listed in Chapter 2.3.
3.2 Installation
CAUTION
Measurement errors
After installation functionality of the instrument should be checked by performing a QC measurement.
4 Perform a control measurement after each installation of the equipment (Chapter 6.5).
CAUTION
Damage to equipment or loss of data
Inappropriate installation and operation of the ROTEM may lead to damage to equipment or loss of data.
4 The ROTEM instrument should be installed by IL/Werfen trained personnel only.
4 Never remove the printer cable with the system switched on.
4 Never press the main switch while software is running.
ROTEM sigma installation:

P The touch screen has been mounted on the ROTEM sigma.
1. Place the ROTEM sigma on an even robust surface.
2. Connect the optional printer to the USB port at the rear of the ROTEM sigma.
3. Connect the printer to the power outlet (See printer manual for details).
4. Connect the ROTEM sigma power cable to the power outlet.
5. Switch on the ROTEM sigma and the (optional) printer.
6. If necessary, calibrate the touch screen (Chapter 7.5).
7. If required, configure the software (Chapter 7.3).

4 System description
The ROTEM sigma system consists of (Appendix F)(Appendix G):

1. ROTEM sigma instrument
2. ROTEM sigma cartridges
– ROTEM sigma complete
– ROTEM sigma complete + hep
3. ROTEM sigma system QC (Quality Control) cartridge
4. ROTEM sigma controls
– ROTEM sigma ROTROL N
– ROTEM sigma ROTROL P
List of Materials Provided With the Instrument
P/N Material
211000 ROTEM sigma Instrument
555504 ROTEM sigma system QC
000600370 ROTEM sigma User Manual
000216318 ROTEM live
Table 4-1: List of Materials Provided with the Instrument
List of Materials Required but Not Provided With the Instrument
P/N Material
555501 ROTEM sigma complete
555502 ROTEM sigma complete + hep
555201 ROTEM sigma ROTROL N
555202 ROTEM sigma ROTROL P
Table 4-2: List of Materials Required but Not Provided With the Instrument

4.1 Hardware
4.1.1 System Overview
Shows components of the ROTEM sigma, Table 4-3 shows their description.
Figure 4-1: Components of the ROTEM sigma
No. System Overview Description

1 Touch screen The software is controlled by the touch screen.
2 Cartridge slot The cartridge slides into this slot.
3 Barcode reader The barcode reader scans blood samples and ROTROL vials.
4 On/off button The blue button on the right side of the instrument turns the
ROTEM sigma on (The button lights up blue as soon as the device has
been switched on).
5 USB port A USB stick can be connected for data export and backup purposes.
6 ROTEM sigma System QC slot When not in use, the ROTEM sigma system QC cartridge is stored in the
system QC slot.
7 Serial number label (not visible) The type label provides information on model, serial number, date of
manufacture, required patient distance, power data, IVD designation,
regional mark, SGS mark and manufacturer. The symbols are described
in Appendix A.
8 Peripheral Ports Sockets on the rear side of the instrument for the connection of LAN
cable, USB devices, and VGA connection.
9 Air openings The air openings ensure the appropriate ventilation of the instrument.
Table 4-3: Components of the ROTEM sigma

4.1.2 Test cartridges

The ROTEM sigma test cartridges are a part of the ROTEM sigma system and contain reagents for the assessment of
coagulation and its interaction with platelets in citrated whole blood.
Cartridges should be kept in their sealed pouches and are stable until the expiration date shown on the label when stored
unopened at room temperature (15 - 25° C).
Figure 4-2: ROTEM sigma test cartridge
A sample tube / control vial (tube types see Chapter 6.1.1) can be inserted into the Sample Tube Port without the need to
use a pipette or syringe.
The ROTEM sigma instrument automatically handles the transfer of the blood sample (or control) from the sample tube to
the cartridge measurement cells and runs the measurement.
This is done through transport of the samples through fluidic channels where measured quantities are mixed with the
lyophilized reagent beads in the reagent mixing chamber using a mixing ball. The sample is then moved to the
measurement cell where the thromboelastometry measurement is taken using the cup and pin.
The cartridge barcode contains lot specific information regarding test selection, expiration date and test calibration
(e.g., system-specific factors).
Four assays are measured with one ROTEM sigma test cartridge.
4.1.3 Additional Items

Item Description
User manual This manual contains comprehensive information on handling of the equipment. Please
store it near the instrument.
ROTEM sigma System QC The ROTEM sigma system QC cartridge is used to check the system.
cartridge
Table 4-4: Additional Items. For order information please refer to Appendix F.
4.1.3.1 Printer (optional)

In case a printer is connected to the system, it is possible to print numeric results and TEMograms. The installation of the
printer is described in Chapter 7.5.

4.2 Software
The software is preset to show the log in screen when switching on the instrument. After the log in process,
the measurement module is shown. After quitting the measurement module, the main screen is shown.
The ROTEM sigma software supports the user through intuitive guidance during performance, interpretation and
management of measurements. From the main screen, the user can open seven modules using the touch screen
(Figure 4-3). Table 4-5 shows an overview of the modules. Chapter 7 gives a detailed description of the modules.
Figure 4-3: Main screen of the system software
Module Description Details

Measurement module In the MEASUREMENT module, the user can start and interpret tests. Chapter 7.1
Database In the D ATABASE module, the user can manage patient and QC results and further Chapter 7.2
evaluate them.
File Manager In the FILE MANAGER module data can be transferred with a USB stick. Chapter 7.6
Device Setup In the D EVICE SETUP module and in the sub modules SETUP and LOGS , the user can Chapter 7.5
manage system settings, authorized users and data backup. The user can also
calibrate the touch screen or prepare the instrument for transport in this menu.
This module can only be accessed with the appropriate user rights.
Service The SERVICE module provides the user an overview of the technical condition of Chapter 7.4
the device and the technical operations performed on the system.
Setup In the SETUP module, the user can change system settings, conditional that the Chapter 7.3
user has the appropriate user rights.
Table 4-5: Modules of the system software

4.3 Specifications and Performance Characteristics

Measurements and Length 60 cm
weight Width 37 cm
Height 31 cm without touch screen
approx. 65 cm including touch screen
Weight approx. 25.2 kg without touch screen
approx. 28 kg including touch screen
Power supply Input 110/240 VAC; 2.0/1.0 A; 60/50 Hz
instrument Power input Max. 230 VA
Installation Installation category I
Noise level Amplitude 55 dB
(according to ISO 3774, Second Edition 1994/05/01 and
7779, Third Edition, 2010/09/22 below 80 dB)
Ambient conditions Operating temperature 18 °C - 30 °C
Storage temperature range 0 °C - 50 °C
Relative humidity range (transport, 20% - 85%
storage)
Relative humidity range (operating) 15% - 60%
Air pressure (operating, storage, 700 hPa - 1060 hPa
transport)
Operable to height above sea level 3000 m
Distance from examined, treated or > 1.5 m
monitored patient
Pollution degree 2
Temperature control Measuring station Measurement temperature 37.0 °C ± 1.0 °C
Specifications Measuring principle Thromboelastometry
Angular deflection detection Optical system with CCD sensor
Heater Cartridge and measurement position are heated
Number of channels Four channels
Connections Power supply Original ROTEM power cable (country specific)
See also Table 4-3. Touch screen Three original ROTEM connection cables come out of the
ROTEM sigma
Data backup USB stick Allows to export data to other media.
Printer (optional) Supported printer Printers with USB port are supported. Please ensure that
required drivers are available in the system (Chapter 7.3.5).
Connectivity Data Input USB (See Chapter 7.5.1)
Data Output USB, LAN, VGA (See Chapter 7.3.2)
Table 4-6: Technical data
Note: Refer to the appropriate appendix section for Performance Characteristics specific to: ROTEM sigma complete
(Appendix H), ROTEM sigma complete + hep (Appendix I), ROTEM sigma ROTROL N (Appendix J), and ROTEM sigma
ROTROL P (Appendix K).

5 Basics
5.1 Introduction
The ROTEM system is a further development of classical thromboelastography developed by Hartert.1
The ROTEM sigma thromboelastometry system is designed for in vitro diagnostic use in the Point of Care (POC)
(near-patient test) or in laboratory settings. The system is intended to provide a semi-quantitative indication of the
coagulation state of a blood sample. The system records the kinetic changes in a citrated whole blood sample during clot
formation as well as when the sample clot retracts and/or lyses. Different parameters are measured and reported for this
purpose. The graphical presentation reflects the various physiological results, which describe the interaction between
coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain
drugs influencing coagulation, in particular some anticoagulants (e.g. heparin), can be detected.
5.2 The ROTEM measuring principle

The patented ROTEM technology is based on a fixed cylindrical cup and an oscillating vertical axis (Figure 5-1).
The axis is supported by a high precision ball bearing and oscillates back and forth through an angle of 4.75°. The rotation
of the axis is driven by a motor that is connected to the axis via a spring.
For the measurement, the channel’s measurement axis moves down into the plastic pin (6 mm diameter) in the disposable,
heated cartridge. After the blood sample is mixed with the reagent beads, the blood sample fills the cartridge cup (8 mm
diameter), immersing the plastic pin.
The oscillation of the pin is detected optically via a mirror plate at the upper end of the axis, using a diode light source and
light sensitive sensor (CCD Chip). If no clotting occurs, the movement of the pin is not obstructed. As a clot forms and
attaches between the pin and cup surfaces, the pin's movement becomes increasingly obstructed.
The result is a balance between the spring tension and the tension of the clot. As the clot becomes firmer, the rotational
amplitude of the axis is reduced.
The rotational amplitude is processed with special software and displayed graphically and numerically (Chapter 7).
1 Hartert, H. Blutgerinnungsstudien mit der Thrombelastographie. Cent Eur J Med. 1948;26:577–83

5 Basics
Figure 5-1: Principle of thromboelastometry with ROTEM sigma
1 Axis (4.75 °) 7 Cartridge cup filled with blood

2 Spring 8 Fibrin fibers and platelet aggregate
3 Light source/diode 9 Heated cartridge
4 Mirror 10 Ball bearings
5 Light Sensitive Sensor 11 Data processing
6 Pin
5.3 Reaction curve and parameters in thromboelastometry

As in classical thromboelastography, the ROTEM system generates a reaction curve and calculates different numeric
(kinetic and firmness) parameters in a mathematical analysis of that curve.
5.3.1 Reaction curve

The ROTEM software utilizes a highly developed curve smoothing algorithm and noise filtering which prevents potential
errors due to mechanical or electrical noise. The parameters are determined in real time during the tests, calculated, and are
represented graphically as TEMograms.
The rotation amplitude of the pin is converted into a graphical amplitude, thus the following definition applies for the
ROTEM system:
Graphical amplitude in mm Rotation of the pin Clotting

0 free rotation of the pin no clotting
100 no rotation of the pin maximum possible clot firmness
Table 5-1: Definition of the amplitude

5 Basics
Figure 5-2 shows parameters in a TEMogram.
Figure 5-2: Example of a ROTEM sigma reaction curve (TEMogram)
5.3.2 Routine parameters

Generally, the measurement results are interpreted with routine parameters. Figure 5-3 shows these routine parameters.
The y-axis shows the amplitude in mm, the x-axis shows the time in minutes.
Figure 5-3: The most important routine parameters
These routine parameters are described in the following sections.

5 Basics
Clotting Time (CT), [s]

Definition The CT is the time from the beginning of the test from addition of the activator until the
time when an amplitude of 2 mm is achieved.
The CT parameter is not reported for the FIBTEM C assay.
Description The CT describes how fast fibrin formation occurs. This parameter is analogous to the
clotting time in a standard coagulation test. However, they are not identical, as more fibrin
is created and has to be stabilized in order to achieve a sufficient clot firmness to connect
the two parts of the measuring cell.
Main influencing factors Clotting factors, heparin (sensitivity is dependent on the test)
Clinical application The CT parameter facilitates the decision to substitute clotting factors or to reverse
heparin anticoagulation.
Table 5-2: Routine parameter – CT
CAUTION
Misinterpretation of graphical display
The cartridge barcode contains lot specific information regarding test selection, expiration date and test
calibration (e.g., system-specific factors). The TEMogram’s time axis is not adjusted by this calibration.
Therefore, CT values on the TEMogram may appear longer or shorter compared to the displayed numerical
CT values.
4 Only numerical CT values can be used for interpretation.
4 The TEMogram CT must not be used for clinical interpretation.
Maximum Clot Firmness (MCF), [mm]

Definition The MCF is a measure of the firmness of the clot and therefore clot strength. It is the
maximum amplitude that is reached before the clot is dissolved by fibrinolysis and clot
firmness begins to decrease.
Main influencing factors Platelets, fibrinogen (concentration and the ability to polymerize) and the presence of
fibrinolysis.
Clinical application A low MCF indicates a low clot firmness. The MCF value is used to facilitate the decision
for substitution therapy with platelets or fibrinogen1 .
Table 5-3: Routine parameter – MCF
1- Mulder MB, Proctor KG, Valle EJ, Livingstone AS, Nguyen DM, Van Haren RM. Hypercoagulability After Resection of Thoracic Malignancy: A Prospective Evaluation. World J
Surg. 2019 Dec;43(12):3232-3238.
- Kamel Y, Hassanin A, Ahmed AR, Gad E, Afifi M, Khalil M, Görlinger K, Yassen K. Perioperative Thromboelastometry for Adult Living Donor Liver Transplant Recipients with a
Tendency to Hypercoagulability: A Prospective Observational Cohort Study. Transfus Med Hemother. 2018 Nov;45(6):404-412.
- Akay OM. The Double Hazard of Bleeding and Thrombosis in Hemostasis From a Clinical Point of View: A Global Assessment by Rotational Thromboelastometry (ROTEM).
Clin Appl Thromb Hemost. 2018 Sep;24(6):850-858.
- Türk SM, Cansu DÜ, Teke HÜ, Kaşifoğlu T, Meltem Akay O, Bilgin M, Korkmaz C. Can we predict thrombotic tendency in rheumatoid arthritis? A thromboelastographic
analysis (with ROTEM). Clin Rheumatol. 2018 Sep;37(9):2341-2349.
- Anıl H, Kılıç Yıldırım G, Harmancı K, Bozkurt Turhan A, Akay OM, Bör Ö, Aydoğdu S, Kocak A. Thromboelastogram as a Tool to Predict Hypercoagulability in Children With
Cystic Fibrosis. Clin Appl Thromb Hemost. 2018 Mar;24(2):348-352.
- Binay C, Bozkurt Turhan A, Simsek E, Bor O, Akay OM. Evaluation of Coagulation Profile in Children with Type 1 Diabetes Mellitus Using Rotational Thromboelastometry.
Indian J Hematol Blood Transfus. 2017 Dec;33(4):574-580.
- Zanetto A, Senzolo M, Vitale A, Cillo U, Radu C, Sartorello F, Spiezia L, Campello E, Rodriguez-Castro K, Ferrarese A, Farinati F, Burra P, Simioni P. Thromboelastometry
hypercoagulable profiles and portal vein thrombosis in cirrhotic patients with hepatocellular carcinoma. Dig Liver Dis. 2017 Apr;49(4):440-445.
- Hincker A, Feit J, Sladen RN, Wagener G. Rotational thromboelastometry predicts thromboembolic complications after major non-cardiac surgery. Crit Care. 2014 Oct 8;18
(5):549.
- Rossetto V, Spiezia L, Senzolo M, Rodriguez- Castro KI, Maggiolo S, Simioni P. Whole blood rotation thromboelastometry (ROTEM®) profiles in subjects with
non-neoplastic portal vein thrombosis. Thromb Res. 2013 Aug;132(2):e131-4.
A(x)-values, [mm]
Definition A(x)-values represent clot firmness. An A(x)-value is the amplitude after a certain time x
after CT (e.g. A10 after 10 min).
Main influencing factors Platelets, fibrinogen (concentration, ability to polymerize).
Clinical application See MCF.
Table 5-4: Routine parameter – A(x)-values

5 Basics
Lysis index at 60 min (LI60), [%]

Definition LI60 represents fibrinolysis 60 min after CT. It is the relation of the amplitude to the
maximum clot firmness (% remaining clot firmness).
Clinical application Due to the high concentration of fibrinolysis inhibitors, almost no fibrinolysis can be
observed in samples from healthy persons. An abnormal LI60 value typically indicates
hyperfibrinolysis. In certain cases, hyperfibrinolysis may develop relatively late.
Table 5-5: Routine parameter – LI60
Maximum lysis (ML), [%]

Definition Maximum lysis (ML) describes the degree of fibrinolysis relative to maximum clot firmness
(MCF) achieved during the measurement. (% clot firmness lost).
Description A ML of 5% means that, at the period of observation, the MCF has decreased by 5%.
As the maximum lysis is not calculated at a fixed time point, but is defined as % lysis at
the end of the measurement, the total runtime and the time after maximum clot formation
should always be considered.
Clinical application See LI60
Table 5-6: Routine parameter – ML
Lysis Onset Time (LOT), [s]

Definition The time span from CT to the start of significant lysis in s. Significant lysis is defined as a
decrease of the amplitude of 15% as compared to MCF.1
Table 5-7: Parameter - LOT
1 Dekker SE, Viersen VA, Duvekot A, de Jong M, van den Brom CE, van de Ven PM, Schober P, Boer C. Lysis onset time as diagnostic rotational thromboelastometry
parameter for fast detection of hyperfibrinolysis. Anesthesiology. 2014 Jul;121(1):89-97.
5.3.3 Reference ranges

Reaction curves and parameters of each patient sample can be compared with the results of a healthy reference
population.
Results for each of the test cartridges are indicated in Appendix H and Appendix I. Due to the many variables which affect
ROTEM results, each laboratory should determine its own normal range. Reference ranges may not be identical to setting-
specific values for clinical decision making.

5 Basics
5.4 ROTEM differential analysis

5.4.1 ROTEM tests
5.4.1.1 Introduction
Acute bleeding during or after surgery requires rapid differentiation between surgically induced bleeding and coagulation
disorders. The combination of the ROTEM sigma with additional diagnostic methods facilitates goal-directed treatment
strategies.
Figure 5-4: Differentiation of surgical bleeding and coagulation disorder with ROTEM analysis and the principle of the ROTEM analysis
ROTEM tests
You will find detailed information regarding the specific requirements for samples, limitations, interfering
substances, current test characteristics, limits of the method and interpretation of results, in each ROTEM
system cartridge IFU (Appendix H-I).
The following name conventions are applied:
Tests are referred to as INTEM C, EXTEM C, FIBTEM C, HEPTEM C and APTEM C.
The associated cartridges are referred to as
– ROTEM sigma complete: INTEM C, EXTEM C, FIBTEM C and APTEM C (REF 555501) and
– ROTEM sigma complete + hep: INTEM C, EXTEM C, FIBTEM C and HEPTEM C (REF 555502).

5 Basics
5.4.2 General principles of ROTEM sigma tests

The following sections describe the general principles of the available ROTEM sigma tests.
INTEM C
Principle: Intrinsic coagulation activation
Application area: Global analysis of coagulation in conjunction with HEPTEM C (see below)
Sensitive to: Most affected ROTEM parameters:
Factor deficiency (intrinsic and common pathways) CT
Anticoagulant effects (e. g. heparin) CT
Platelet contribution to clot firmness MCF, A(x)
Fibrin polymerization (and fibrinogen concentration) MCF, A(x)
Hyperfibrinolysis ML, LI60
Table 5-8: INTEM C

5 Basics
HEPTEM C
Principle: Intrinsic coagulation activation after inactivating heparin.
Application area: Global analysis of coagulation after the elimination of the influence of heparin
In comparison to INTEM C: Qualitative assay for the presence of heparin
Factor deficiency (intrinsic and common pathways) CT
Note: The combination of INTEM C and HEPTEM C can confirm the presence of heparin in
the sample. It also provides information on alterations in coagulation potential, with
elimination of any heparin effect.
Table 5-9: HEPTEM C

5 Basics
EXTEM C
Principle: Extrinsic coagulation activation
Application area: Global analysis of coagulation
Largely heparin insensitive
In conjunction with FIBTEM C and APTEM C (see below)
Factor deficiency (extrinsic and common pathways) CT
Table 5-10: EXTEM C

5 Basics
FIBTEM C
Principle: Extrinsic coagulation activation in the presence of platelet inhibitors.
Application area: Detection of fibrinogen deficiency and/or fibrin polymerization disorders or
hyperfibrinogenemia
Compared to EXTEM C: indirect evaluation of platelet contribution to clot firmness
Sensitive to: Mostly affected ROTEM parameters:
Note: In contrast to the measurement of only platelet count or fibrinogen concentration, the
ROTEM system captures the ability of fibrin and cellular components to form a stable
clot. FIBTEM C clot firmness generally correlates with fibrinogen concentration.
However, a fibrin polymerization disorder will give a pathological result in spite of a
reasonably high fibrinogen concentration in the sample.1
The CT parameter is not reported for the FIBTEM C assay.
Table 5-11: FIBTEM C

1 Innerhofer P., Fries D., Margreiter J., Klingler A., Kuhbacher G., Wachter B., Oswald E., Salner E., Frischhut B., Schobersberger W.:The effects of perioperatively administered
colloids and crystalloids on primary platelet-mediated hemostasis and clot formation. Anesth Analg 2002;95(4):858–65.

5 Basics
APTEM C
Principle: Extrinsic coagulation activation in the presence of a fibrinolysis inhibitor.
Application area: Confirmation of hyperfibrinolysis in comparison to EXTEM C
Assessment after treatment with anti-fibrinolytic drugs
Factor deficiency (extrinsic and common pathways) CT
Note: If the typical pattern of hyperfibrinolysis (spindle shaped, total lysis of the clot firmness)
is seen in EXTEM C (and INTEM C and FIBTEM C), and hyperfibrinolysis is not present
in APTEM C, then hyperfibrinolysis can be confirmed.
The APTEM C result represents the in vitro response after blocking fibrinolysis.
Table 5-12: APTEM C

6 Measurement
CAUTION
Measurement errors
Inappropriate storage of materials may lead to measurement errors.
4 Always store cartridges and controls according to the environmental conditions as recommended on the
package insert sheets.
CAUTION
Damage to the touch screen
Inappropriate handling of the touch screen may lead to damage.
4 Do not use sharp objects on the touch screen (e.g. pencils).
6.1 Introduction
The ROTEM sigma system software supports the user during measurements through a step-by-step menu.
This chapter defines how different ROTEM tests are conducted. It is essential to read the other chapters of
this manual thoroughly.
6.1.1 Sample handling

6.1.1.1 Blood sample collection
Collect a 3.2% citrated venous or arterial whole blood sample according to the references below:
CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard-Seventh
Edition. CLSI document GP41-A6. Wayne, PA: Clinical and Laboratory Standards Institute; 2017.
CLSI. Procedures for the Collection of Arterial Blood Specimens; Approved Standard-Fourth Edition. CLSI document
GP43-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2004.
Blood sample tube type
The following blood sample tubes (3.2% buffered sodium citrate) have been tested on the ROTEM sigma:
BD Vacutainer®: 2.7 mL, 4.5 mL
Greiner Bio-One Vacuette®: 3.5 mL, 5 mL
Sarstedt S-Monovette®: 3 mL, 4.3 mL (only in combination with Vial Adapter ROTEM sigma, REF 415502 or
Sarstedt adapter REF 14.1216)
Kabe Primavette: 2.9 mL (only in combination with Sarstedt adapter REF 14.1216)
Any larger volume sample tube can also be used.
Note: Make sure that the blood sample tubes are filled properly.
Note: It is recommended to verify and confirm the proper function of tubes used for measurements.

6 Measurement
6.1.1.2 Transport of samples
CAUTION
Measurement errors
Inappropriate sample transport may lead to measurement errors.
4 Do not shake samples.
4 Do not roll the sample tube.
4 Prior to use, pneumatic tube transportation systems need to be validated according to your local policies and
procedures.
4 Samples should be stored at room temperature.
4 Do not store samples on ice.
6.2 Measurement preparation

Note: Obtain and process samples according to the instructions.
6.2.1 Switching on the ROTEM system

P The cartridge from the previous measurement has been removed.
1. Switch on the printer (optional).
2. If required, turn on the ROTEM system with the blue on/off button on the right hand side of the instrument.
9 The ROTEM system software starts automatically and checks the system.
9 The connection between the ROTEM system and the optional printer is established.
9 The log in screen is loaded.
3. Log into the system.
– Touch the screen if the screen saver is active.
– Select user.
– Enter password.
9 Measurement start screen is shown (Figure 6-1).
9 Heating of the instrument to operating temperature. This procedure may take up to 30 minutes.
Note: In case the Information button becomes available, touch it and act accordingly.
4. The system displays QC and maintenance reminders according to the preset QC (Chapter 7.3.9) and maintenance
schemes (Chapter 8.2).
5. Perform QC measurements (Chapter 6.5) and maintenance as prompted by the reminder and confirm.

6 Measurement
Figure 6-1: Details of the measurement start screen
The color of the status (see number 4 Figure 7-3) line below each channel provides information on the channel status.
Color Status
Grey Channel ready to use
Blue Channel not ready, initialization may be active
Green Measurement is running
Yellow Warning message during measurement
Red Error, measurement is stopped
Table 6-1: Colors of the status line
6.3 Performing patient measurements

6.3.1 Start measurement
WARNING
Danger of injury
Inappropriate handling
4 Always avoid touching the needle in the cartridge sample position
1. Start the sequence with the START button (Figure 6-2).

6 Measurement
Figure 6-2: Measurement module - ready to measure
2. Follow the menu navigation.

3. If required, confirm the step on the screen (Figure 6-3).
Figure 6-3: Confirm patient data
Note: If patient demographics are entered manually, this can be done during the cartridge preparation time before
inserting the blood sample in the cartridge.
9 The measurements are started.
9 The Multi-TEM view with 4 TEMograms is shown (Figure 6-5).
Note: In case of emergency, a measurement can also be started without patient data. However, some functions will
be restricted, e.g. patient overlays or remote view.
WARNING
Risk of Result Misidentification
Missing or incorrect patient demographic data may result in misidentification of test results.
4 Always confirm patient demographic data is correct before interpreting results or saving/clearing a
measurement.
6.3.2 Change/complete patient data during measurement

Patient data is assigned to the channels and to each measurement. Patient data contains patient ID, patient name
(first name, last name), sample ID, comment, date of birth and gender. In the SETUP module, it is defined which fields are
available and if these are mandatory or optional (Chapter 7.3.1). It is also possible to select a normal range profile specific
to the patient (e.g. pregnant).
1. Touch one of the four channels/TEMograms.
9 The Multi-TEM view is changed into the channel view.

6 Measurement
2. Press the Patient data button.

9 In the upper part of the screen, entry fields for patient data are displayed (Figure 6-4).
Figure 6-4: Entry fields for patient data
3. Touch the respective entry field.

4. Enter/change the required patient data.
Note: Alternatively, patient data may be read using a barcode reader.
Note: Mandatory fields are displayed in blue.
5. Choose a normal values profile for the patient.
9 Normal values from this profile are used for this patient.
9 The profile overlay TEMogram is formed with these normal values.
Note: All entries, except Comment are automatically copied into all other channels
6. If required, copy the Comment into the other channels with Copy and Paste or Copy to all.
7. Press the Multi-TEM button to resume normal measurement viewing (Figure 6-4).
6.3.2.1 Conventions for entry
Consider the following conventions when entering patient data to sort the measurements in the database logically and to
avoid failures.
Enter names with first and last name. Datasets can be sorted consistently by names.
Do not use special characters like /, \, #, * ,, „, ?, < . Errors may occur when exporting data containing these
characters.
6.3.2.2 Simplification when entering data
The system provides user support during patient data entry.
If a patient ID already contained in the database is re-entered or read in, the fields containing Patient name, Date of
birth, and Gender are filled in automatically with the respective patient data. Automatic entries cannot be changed.
Note: Patient data are transmitted to the database when the respective measurement is saved/cleared
(Chapter 6.4.3).
All patient data of a channel can be deleted with the Reset data button.
6.3.3 Graphics of measurement results

During measurement, the Multi-TEM view displaying all four channels is active (Figure 6-5). The current measurement
results of the test parameters are shown. Some of the coagulation parameters are shown as “preliminary values” in the
display while a clot is developing. These values are based on a limited amount of data and are replaced by the final values
as soon as the appropriate amount of data points are available. Preliminary results are marked with an asterisk (*).
With Profile overlay , a TEMogram of the same test within the normal range of the selected patient profile is displayed over
the currently measured TEMogram.
Note: With Patient overlay , the last 4 TEMograms of the same test and the same patient already saved (during the last
48 hours) in the database are displayed. With each overlaid TEMogram, the starting time of the according measurement is
displayed in color.

6 Measurement
Note: Patient overlays are only possible with measurements measured with the same cartridge type and lot as the one in
use for the current measurement.
For measurements that run longer than 60 minutes, it is possible to view the graph from 60-120 minutes by double-
touching the graph.
CAUTION
Misinterpretation of graphical display
The cartridge barcode contains lot specific information regarding test selection, expiration date and test
calibration (e.g., system-specific factors). The TEMogram time axis is not adjusted by this calibration.
Therefore, CT values may appear longer or shorter compared to the displayed numerical CT values.
4 Only numerical CT values can be used for interpretation.
4 The TEMogram CT must not be used for clinical interpretation.
WARNING
Risk of Result Misinterpretation
Interpretation of wrong TEMogram may result in incorrect assessment or treatment.
4 Always confirm test name before interpreting TEMogram or numerical results.
Figure 6-5: 4 TEMograms in the measurement module
6.3.4 Warning messages during measurement

Typically the Warning button is hidden and only appears if a system error occurs. When activated, the status line directly
under the respective channel turns yellow and the Warning button flashes red.
1. Touch Warning button.
9 The channel with the error is displayed in red.

6 Measurement
2. Note the error caption in case it is needed for reference by the service provider (e. g. CCD invalid).
3. Read the descriptions and instructions under the caption.
Note: Messages are shown with a short coded error message and a longer description of the cause as well as
troubleshooting of the problem. The messages in the warning windows are self explanatory. See Table 6-4 for
additional help for troubleshooting.
4. Check if the TEMogram is plausible and decide if the measurement should be continued (Ignore) or cancelled (Stop ).
Note: In case of uncertainty, stop and repeat measurements.
5. Please contact your service provider if the error occurs again during the next measurement.
6.4 Finish measurement

A measurement is finished in several steps described in the sections from Chapter 6.4.1 to Chapter 6.4.8. The following
actions can be performed after touching any TEMogram on the Multi-TEM screen.
9 The Multi-TEM screen is closed.

9 The measurement screen is shown.
6.4.1 Stop measurement
A measurement can be stopped automatically or manually.
A patient measurement is stopped automatically after 2 hours.
A QC measurement is stopped automatically after 1.5 hours.
Stop all stops the measurements manually.
A single channel may be stopped with Stop channel.
6.4.2 Print (to PDF) measurement results

P Channel is not yet saved/cleared or discarded.
P Patient data has been entered.
1. Select Print button.
2. Select number of TEMograms (measurements) per page.
– Print 1 (1 TEMogram over 60 min and additionally the same TEMogram over 2 hours)
– Print 4 (4 different TEMograms of 60 min each)
– PDF 1 (Creation of a PDF with a TEMogram, saved in FILE MANAGER - PDF)
9 If normal values (or QC target ranges) have been entered, they are printed as well.
9 Overlays are printed when selected on the MEASUREMENT screen and when pre-set in SETUP - PRINTER SETUP .
9 The normal range profile for the patient is printed.
Note: If a warning message was displayed during a run, the respective printout will be marked with “check plausibility”.
Check the data for irregularities and completeness and determine whether measurement results should be discarded.
Note: Patient or control results that are out of range are flagged with an arrow up or down. Patient measurements run after
missing yearly maintenance are flagged. Patient measurements run after missing or out of range QC are similarly flagged.
Note: Alternatively, a screenshot can be printed in the Multi-TEM view via Print Screenshot.
6.4.3 Save and clear measurement

When a channel is saved and cleared, the data is transmitted to the database and is accessible there for printing
(Chapter 7.2.5) or exporting. Verify the patient ID and the sample ID before transmitting the measurement to the database.
For safety reasons, data cannot be changed after a measurement has been finished and transmitted to the database.
1. Select Save/clear all.
9 The measurements are removed from the screen.
9 The measurements are saved in the database.
Note: A single channel may be saved/cleared with Save/clear channel.
2. Remove the cartridge from the slot when prompted on the screen.

6 Measurement
6.4.4 Discard measurement

An erroneous measurement may be discarded. For safety reasons, it will still be present in the database after discarding.
It will however only be shown in light grey. In case of a connection with the LIS or HIS, it will not be transferred. It cannot
be used for patient overlays.
1. Select Discard channel.
2. Enter comment.
3. Press Accept.
9 The measurement is removed from the screen.
9 The measurement is saved in the database but greyed out on the database display.
6.4.5 Remove cartridge
CAUTION
Blocked system
Removing the cartridge before it is released may lead to system damage.
4 Remove the cartridge only when the screen prompts its removal.
Dispose of the cartridge with the blood sample still attached.

Do not tilt the cartridge.
Always avoid touching the needles in the cartridge sample position.
Follow local regulations for disposal of biohazardous material.
6.4.6 Log off the system

1. Leave measurement module with the Quit button.
2. Confirm with Yes.
3. Select Logout.
9 The log in screen is shown.
6.4.7 Daily maintenance
A detailed description of the necessary maintenance actions can be found in (Chapter 8).
The system automatically reminds the user to perform maintenance. The user is responsible for ensuring the maintenance
plan is followed.
The following maintenance must be performed daily on the ROTEM sigma.
1. Clean and disinfect the outer surface of the ROTEM sigma with a lint free cloth.
2. Wipe the barcode reader with a dry lint free cloth.
6.4.8 Switch off

Normally the instrument should remain powered.
Note: Finish running software before switching the instrument off, to avoid damage to the database.
1. Select Quit button in the measurement module.
9 The main menu is shown.
2. Press blue on/off button on the right side of the instrument.
9 The software is being shut down.
9 The instrument is switched off.

6 Measurement
6.5 Quality control

Instrumentation Laboratory/Werfen has designed QC features into the ROTEM sigma system (instrument, cartridges and
controls) to ensure that the system functions as intended. This includes internal system quality control features for
instrument and cartridge (Chapter 6.5.1, Chapter 6.5.2, Chapter 6.5.3) as well as the ROTEM sigma system QC cartridge
(Chapter 6.5.4) for more extensive system functionality testing.
Cartridges and controls are manufactured with in-process controls to ensure lot-to-lot reproducibility and performance.
Production samples are tested and confirmed to be working to specifications before each lot is released.
A detailed description of the necessary maintenance actions can be found in maintenance, cleaning, disinfection
(Chapter 8).
6.5.1 Continuous self-monitoring when powered on:

The instrument continuously checks the functions of the system. Channel status information is displayed automatically if
a self-test failure is detected (See Table 6-2). If the impacted component is critical for sample measurement, system
operation is blocked automatically.
Errors Display in the status line Consequence
Channels are not ready for blue START button is not active. Measurement cannot be started.
use before measurement
Channel fails during yellow Warning is displayed.
measurement Measurement is marked with "check plausibility" on the
printout and with an error code in the database.
Continue or stop measurement.
Table 6-2: Measurement channel status
Additionally, the AD Module Service Values are a measure of the quality of the analytical system and are checked during
quarterly maintenance (See “Control AD Module Service Values” on page 75).
6.5.2 Cartridge-check:
Upon cartridge insertion into the instrument, a barcode reader identifies expiration date and cartridge type. The barcode
information is verified for correctness. The system additionally checks and confirms the cartridge integrity and usability.
If the cartridge does not pass all checks, an error message will be displayed and the measurement cannot be started.
6.5.3 During testing:

Every critical step is closely monitored and checked:
when the sample is aspirated into the cartridge
when the reagents are mixed with the sample
during the actual measurement
The user will be informed of faulty blood drawing and further measurement will be prevented. If an error occurs during
measurement, the channel is marked with "check plausibility" on the screen and on the printout. The corresponding error
code is transferred to the database and the LIS (Chapter 6.7.2). User review of the affected measurement is mandatory
before it can be saved or discarded (Chapter 6.7).
6.5.4 System QC
The ROTEM sigma system QC cartridge is available for more extensive system functionality testing. It should be run
weekly or in accordance with local regulations.
P A ROTEM sigma system QC cartridge is available (in its slot on the right side of the system).
1. Press Start system QC.
2. Follow carefully the instructions on the screen.
3. When the system QC is finished, store the cartridge in its slot.
Note: In case the Information button becomes available, press it and act accordingly.
9 The buttons START and Start ROTROL become available.
Note: If the ROTEM sigma system QC Cartridge is not available, any other unused cartridge can be used for System QC.
In order to ensure the ROTEM sigma is not damaged, it is important to use a new cartridge when performing the
system QC.

6 Measurement
6.5.5 External QC with ROTEM sigma ROTROL N / P

6.5.5.1 Control intervals
The internal system quality control features for instrument and cartridge (Chapter 6.5.1, Chapter 6.5.2, Chapter 6.5.3) as
well as the ROTEM sigma system QC cartridge (Chapter 6.5.4) ensure the ROTEM sigma system is operating correctly.
Instrumentation Laboratory/Werfen recommends the use of two levels of external quality control (ROTROL N and
ROTROL P) for every new cartridge lot, every new cartridge delivery and after system maintenance/repair. The use of
additional external quality control outside of these circumstances (e.g. during daily, weekly, or monthly routine use) is not
required.
Instrumentation Laboratory/Werfen also recommends the user establishes an Individualized Quality Control Plan (IQCP)
for the system, based on these recommendations as well as local and internal regulations and/or policies.
6.5.5.2 Preparation of ROTROL QC material
WARNING
Danger of infection
This kit contains material of human and animal origin and may transmit infectious agents and should be
handled with extreme caution. No known test method can offer complete assurance that products derived
from human sources will not transmit infectious agents.
All donor animals were sourced from BSE-free herds. The cattle received ante- and post-mortem health
inspection by a veterinarian and were apparently free from infectious and contagious material.
The human derived material in this product was tested and found nonreactive for Hepatitis B Surface
Antigen (HBsAg), HCV, and HIV antibodies at the donor stage. Handle as if potentially infectious.
4 Always wear personal protective equipment such as laboratory coat, gloves and goggles when handling
samples.
4 Always follow guidelines for infectious materials.
The control materials are easy to prepare. Pipetting is not required.

P Allow control material to reach room temperature (15 - 25 °C).
1. To dissolve, pour the contents of the Dil vial into the Lyo vial. (Figure 6-6).
Note: Do not use a pipette.
2. Attach the screw-on adapter.
3. Gently swirl the lyophilisate to dissolve it.
Note: Make sure of the complete reconstitution of the product. Small particles may remain after reconstitution.
These particles are not a sign of deterioration of the control and have no influence on control results.
4. Keep the control at room temperature (15 - 25 °C) for 15 minutes.
5. Invert and swirl 10 times before use.
The control is ready for use.
Figure 6-6: Reconstitution of ROTROL N (or P)

6 Measurement
6.5.5.3 Performance of ROTROL QC

Quality control is always performed for all 4 tests of the ROTEM cartridge.
A new ROTEM cartridge is required to perform the QC.
1. Press Start ROTROL.
2. Scan the ROTROL vial.
– In case the lot has never been measured before, confirm to put it in use.
– In case a new lot is scanned, scan the ROTROL box.
9 The target values for this lot are automatically saved.
3. Alternatively, choose ROTROL Type (N or P) and select the respective Lot from the list.
– In case the lot has never been measured before, confirm to put it in use.
4. Press OK.
5. Follow the starting sequence.
6. Let the QC measurement run until parameter A20 has been reached.
Note: Reaching the parameter A20 is necessary to pass the ROTROL control.
In case a daily, weekly, or monthly external QC is required, the QC reminder can be activated (Chapter 7.3.9) and will be
displayed on the screen:
1. Press OK to run QC.
– Select ROTROL lot from the list or scan ROTROL vial.
2. Follow the starting sequence.
3. Let the QC measurement run until parameter A20 has been reached.
Note: Reaching the parameter A20 is necessary to pass the ROTROL control.
The only difference between routine tests and quality control tests, is that instead of a blood sample, control
material is used. The control measurements are saved in the dedicated QC database (Chapter 6.6.1).
Control Range of Cartridge QC Test Equivalent patient test

material control
ROTROL N level 1 ROTEM sigma complete QCinN C, QCexN C, INTEM C, EXTEM C,
QCfibN C, QCapN C FIBTEM C, APTEM C
ROTROL N level 1 ROTEM sigma QCinN C, QCexN C, INTEM C, EXTEM C,
complete + hep QCfibN C, QChepN C FIBTEM C, HEPTEM C
ROTROL P level 2 ROTEM sigma complete QCinP C, QCexP C, INTEM C, EXTEM C,
QCfibP C, QCapP C FIBTEM C, APTEM C
ROTROL P level 2 ROTEM sigma QCinP C, QCexP C, INTEM C, EXTEM C,
complete + hep QCfibP C, QChepP C FIBTEM C, HEPTEM C
Table 6-3: Available QC tests
The ROTEM sigma ROTROL quality control materials are adapted to test the activating agent in each control test, not
heparin inhibitors (FIBTEM C, EXTEM C, APTEM C and HEPTEM C), fibrinolysis inhibitors (APTEM C) or platelet inhibitors
(FIBTEM C).
6.5.5.4 Check quality control results
The ROTEM QC materials should produce repeatable results in the range specified on the ROTROL control sheet.
The target values for a specific ROTROL lot are automatically saved in the system after scanning the barcode of the
ROTROL box or control sheet (either in the MEASUREMENT menu or in SETUP - ROTROL SETUP (Chapter 7.3.9)). Alternatively,
the target values of the according tests for each new ROTROL lot can be entered manually in SETUP - ROTROL SETUP (e. g. for
QCinN C).
9 QC results deviating from the target values are highlighted in red on the screen.
9 All patient results obtained after any out of range (or missing) QC result are flagged in the database and on
printouts. In the database they are also highlighted yellow.

6 Measurement
If no target values are available in the system, QC results have to be compared with the accompanying
control sheet.
6.5.5.5 Suggested actions for QC out of range
QC results are evaluated by the system as a cartridge 4-test QC quartet.
If a QC result is outside the expected range, examine the potential reasons.
1. Rerun the QC tests.
2. In case the new QC tests are within the target range, patient samples may be tested again and valid results can be
expected.1
3. In case a new QC test is again outside the target range, contact your local service provider for further
troubleshooting.
6.6 Managing measurement results in the database

The following sections describe the most important steps to find, print and export patient and QC results in the database.
Chapter 7.2 contains more detailed information on these topics.
Patient results should be interpreted as soon as they become available.
The database should only be used as a documentation tool, not for result interpretation.
6.6.1 Find a patient / QC result

1. Quit measurement module.
3. Open D ATABASE module.
4. Select either the patient database or the QC database with the Patients/QC button.
5. Select the requested patient or QC result either by touching its line in the list on the upper left side or by entering
the search criteria into the search form and pressing Start search (Figure 6-7).
9 The located measurements are highlighted in the list.
9 The respective TEMograms are overlaid in the TEMogram window.
1 Literature: CSLI. Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline-Third Edition.
CLSI document C24-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2006.

6 Measurement
Figure 6-7: Select measurement
6. Add selected patient/QC results with the Add button to the selection box on the lower left for further processing.
7. To search further patient/QC results, clear search criteria by clear search and search to add further measurements.
8. To remove single patient/QC results, highlight the measurements in the selection window and select Remove.
9. To clear all patient/QC results from the selection window, select Reset.
6.6.2 Print patient / QC results

Normally, measurement results are printed immediately after the measurement. Additionally, results may be printed directly
from the database.
1. Select and add patient / QC results.
2. Select Print.
3. Select number of TEMograms (measurements) per page.
– Print 1 (1 TEMogram over 60 min and additionally the same TEMogram over 2 hours)
– Print 4 (4 different TEMograms of 60 min each)
9 Flags and errors are printed together with TEMogram and numerical results.
6.6.3 Export patient or QC results to USB stick
Special characters (*, /, &, etc.) are not accepted in file names when copied from the internal hard disk to
an USB stick. Please do not use any such characters when renaming a file during the export function.
1. Select and add patient / QC results.
2. Select Accept button.
9 Evaluation screen is opened (Figure 6-8).

6 Measurement
Figure 6-8: Evaluation screen
3. Touch and select a maximum of 4 TEMograms for the export.

9 The 4 TEMograms are displayed overlaid on the right side.
4. Select Export 4 TEM.
9 The TEMograms are saved in a picture on the hard drive in the FILE MANAGER.
5. Enter a title if required.
6. Confirm with OK.
7. Optionally, change the file name of the exported file.
8. Confirm with OK.
9. Repeat action until all required TEMograms are exported.
10. Quit the D ATABASE module.
12. Open the FILE MANAGER.
13. Select GRAPHE XPORT.
9 If the exported data are not password protected (in D EVICE SETUP - USER MANAGEMENT - OPTIONS ), a preview of the
stored and exported TEMograms is displayed (max 4 per screen).
14. Insert a USB stick.
15. Drag & drop the exported pictures with your finger to the left side into the USB stick window.
16. Copy or Move the pictures.
9 The pictures are now saved onto the USB stick.
17. Remove USB stick.
9 The TEMograms are now available for further processing on a Windows computer.
6.6.4 Backup
In case the remote backup feature has not been implemented, backup the database and the settings at least once a week.
1. Quit measurement module.
3. Insert a USB stick.
4. Open D EVICE SETUP .

6 Measurement
5. Select Backup/Restore.
6. Select Start USB Backup .
7. Confirm with OK.
9 a message appears: Backup was created successfully. The USB stick can be removed now.
8. Confirm with Finish.
9. Remove the USB stick.
Chapter 7.5.1 describes how to restore the backup data in case of data loss.
6.7 Troubleshooting
The ROTEM sigma thromboelastometry system is designed for simple, trouble-free operation. However, in the case of a
system warning or error, a user message is displayed specifying the error type. The following table provides additional
information on commonly encountered system errors and describes basic troubleshooting steps a user may take to
resolve them.
Other errors not included on this list may be resolved by restarting the system. In the event of a reoccurring error that is
not resolved with the below troubleshooting steps or via a system restart, please contact your service provider for further
technical support.
For your local IL representative contact information, go to: www.werfen.com
Error Error Description Troubleshooting Steps

Cartridge barcode could not be read This error may display if the Check if the cartridge has been inserted
internal barcode scanner cannot correctly
read the barcode on the rear side of Check that the correct ROTEM sigma
the ROTEM sigma cartridge. cartridge and not the transport cartridge
is inserted
Check that the barcode does not show
printing anomalies or has been damaged
Run a measurement with a new cartridge
CARTRIDGE_INSERTED_EARLY This error may display if a cartridge Check that no cartridge is inserted right
is inserted right after starting the after starting the ROTEM sigma system
ROTEM sigma system, without
starting a measurement.
CARTRIDGE_TOO_COLD This error may display if the Check that the cartridge is inserted at
CARTRIDGE_TOO_HOT cartridge temperature after correct temperature as specified in the
insertion is too high or too low. instructions for use (IFU)
Check that the cartridge is stored at
correct temperature as specified in the
instructions for use (IFU)
Check that no cartridge is inserted before
being prompted by the system
CLAMP_CARTRIDGE No description available. Ensure the cartridge is all the way
CLAMP_CARTRIDGE_SUBSTATE inserted
UNCLAMP_CARTRIDGE_SUBSTATE Restart the ROTEM sigma system
CONTROL_PROTECT_ This error may display when the Restart the ROTEM sigma system
DIFFERENCE_QC measured temperature difference Run a measurement with a new cartridge
between the sensors within the
sample handler is too great.
DELIVER_CHAN This error may display if sample Run the ROTEM sigma system QC
cannot be delivered to the cartridge Run a measurement with a new cartridge
cups.
Table 6-4: Error Troubleshooting

6 Measurement
Error Error Description Troubleshooting Steps

DRAW_BLOOD_1 This error may display if a sample Check that a sample has been inserted in
has not bee inserted in the the cartridge
cartridge.
DRAW_BLOOD_2 This error may display if, after Check that the blood sample was inserted
blood is drawn into the cartridge, onto the cartridge correctly
the cartridge sensors don’t detect Check that no bubbles are inside the
blood. sample tube
Ensure proper sample volume
Run a measurement with a new cartridge
DROP_CHAN This error may display if sample Run the ROTEM sigma system QC
cannot be delivered to the cartridge Run a measurement with a new cartridge
mixing chamber.
MIXER_PARK_SUBSTATE This error may display if there is an Restart the ROTEM sigma system
error during mixer parking during
startup or reset.
MIX_CHAN_1 This error may display if there is an Restart the ROTEM sigma system
MIX_CHAN_2 error during the mixing in one of Run the ROTEM sigma system QC
MIX_CHAN_3 the cartridge channels. The error Run a measurement with a new cartridge
indicates which channel is
MIX_CHAN_4
affected.
MIX_CHAN_5
LOWER_AD This error may display in case the Restart the ROTEM sigma system
RAISE_AD AD platform cannot move into the Run the ROTEM sigma system QC
STEPPER_INIT_SUBSTATE correct position.
STEPPER_LOWER_AD_SUBSTATE
STEPPER_RAISE_AD_SUBSTATE
RTD_BOUNDARY_VALUE_CHECK This error may display if the Check that no cold cartridge was inserted
ROTEM sigma system was unable during system warm-up
to reach target temperature in the Check that the ROTEM sigma system is
appropriate time. located in a room within the specified
operating temperature (Chapter 2.3)
Restart the ROTEM sigma system after it
has reached room temperature
SOLENOID_FAULT This error may display if there is a Restart the ROTEM sigma system
SOLENOID_DRIVER_FAULT solenoid-related error. Run a measurement with a new cartridge
SOLENOID_DROP_FAULT This error may display if there is a Run a measurement with a new cartridge
solenoid-related error.
TEST_CART_NO_PRES This error may display if the sample Run the ROTEM sigma system QC
TEST_CART_PRES_LEAK handler could not create the Run a measurement with a new cartridge
TEST_CART_PRES_NO_FIL necessary vacuum or a pressure
change was noted.
USED_CART_DETECTED This error may display if after Ensure placement of sample tube only
insertion of the cartridge, liquid is when prompted
detected on a cartridge sensor. Run a measurement with a new cartridge
This could be due to utilization of a
used cartridge or early attachment
of the sample collection tube.
Table 6-4: Error Troubleshooting

6 Measurement
6.7.1 Incorrect TEMograms

In case of abnormal TEMograms a warning message is displayed for the affected channel. Follow the instructions of the
warning menu.
6.7.2 Warning screen errors

These are potential hardware errors and their possible causes. There are other errors or warnings that are possible but in
those cases the description is provided on screen.
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CCD_DARK 1003 T T T T T
CCD_BRIGHT 1013 T T T T T
CCD_NOISE 1023 T T T
CCD_INVALID 1033 T T T T T
POS_TIMEOUT 2013 T T
CARRIER_SPIKE 3003 T T T
CARRIER_LOST 3013 U
CARRIER_INVALID 3023 T T
CARRIER_TIMEOUT 3033 U
MOTION_VANISH 4003 T
MOTION_DRIFT 4013 T T
MOTION_BAD 4023 T T U T T T T
MOTION_TIMEOUT 4033 T
AMPL_JUMP_HIGH 5003 T
AMPL_JUMP_LOW 5013 T
AMPL_BAD_IDLE_LOW 5023 T T
AMPL_BAD_IDLE_HIGH 5033 T T
AMPL_BAD_SAMPLE 5043 T T
TGM_SPLINE 6003 T
TGM_BASELINE 6013 T T U
TGM_NOISE 6023 T T U
TGM_DRYING 6033 T
TGM_DRY_PARA 6043 T
TEMPHIGH 10013 T
TEMPLOW 10023 T
DISCARDED 10033 U
QCMISSING 10043 U
QCOOUTORNG 10053 U
WMNOVERDUE 10063 U
QMNOVERDUE 10073 U
YMNOVERDUE 10083 U
SYNCLOST 10093 T
HWCHANNELBLOCK 11003 T
* - a U in the table above denotes that a user may perform troubleshooting activities, a T denotes that a trained service technician is required to troubleshoot.
Table 6-5: Error codes

7 System software
The ROTEM sigma software provides you with intuitive user guidance when performing, evaluating and managing
measurements. General operating elements and the modules are described in this chapter. The main screen is described in
Chapter 4.2.
7.1 Measurement module

The measurement module guides the user through the measurement preparation, the measurement itself and the
management of the patient data.
This chapter covers the user interface. Chapter 6 gives a detailed description of the measurement.
7.1.1 Start screen

After log in, the start screen is opened (Figure 7-1).
Figure 7-1: Measurement module – start screen (without reminders)
With the START button, patient measurements can be started.

With Start ROTROL, QC measurements with ROTROL are started.
With Start system QC, the system is tested with the ROTEM sigma system QC cartridge.

7 System software
7.1.2 Multi-TEM
Once the measurements have started, the Multi-TEM view is shown (Figure 7-2). This view is especially suitable for remote
transmission of the results.
Figure 7-2: Measurement module - Multi-TEM
Area Content
1 Main menu Buttons Print Screenshot, Screenshot, Profile overlay , Patient overlay , and Quit. The button
Warning is only visible when errors occur.
2 TEMogram area A TEMogram is shown for each channel.
3 Result area Numeric parameter values. The order of the parameters is determined in the menu SETUP -
PARAMETER SETUP (Chapter 7.4.2).
Out of range results are displayed in red.
Table 7-1: Measurement module – sub areas of the Multi-TEM screen
Note: Touching any TEMogram twice on the screen displays measurements run up to 120 minutes.

7 System software
7.1.3 Measurement
Touching one of the TEMograms in the Multi-TEM view opens the measurement window with its six areas (Figure 7-3),
(Table 7-2):
Figure 7-3: Measurement module – measurement
Area Content
1 Action area Entry fields for patient data (upper half of the screen) and the buttons Reset data, Copy ,
Copy to all and Paste.
While running a measurement: the current TEMogram is displayed.
2 Main menu Buttons Multi-TEM, Screenshot, Profile overlay , Patient overlay , and Quit. The Warning button
is only visible when errors occur.
3 Sub menu Buttons to Print, enter Patient data, return to the TEM-view, Stop the measurements.
After stopping a measurement, the buttons to Save/clear or Discard become active.
4 Status line Date and time, QC status, user, serial number and software version. In addition, one month
before the due date, the date of the next annual maintenance.
5 TEMogram display Channel 1 to 4 from left to right. The selected and therefore active channel is highlighted in
blue. The appropriate parameter values are shown under the particular channel.
6 Test line Color coded test.
Table 7-2: Measurement module – sub areas of the measurement screen

7 System software
7.1.4 Screenshots
The measurement and service modules provide the possibility to capture the current screen content as a graphic file in .jpg
format. These screenshots can be viewed and processed in every graphical software that can read .jpg files.
Select Screenshot.
9 The file is saved in the folder FILE MANAGER - SCREENSHOTS under the name Screenshot_yyyymmddThhmmss.png
(e. g. Screenshot_20070413T174652.png). These files are automatically deleted 60 days after creation.
Chapter 7.6 contains further information regarding the FILE MANAGER.
7.1.5 Overlays
With Profile overlay, a TEMogram of the same test within the normal range of the selected patient profile is displayed over
the currently measured TEMogram.
With Patient overlay, the last 4 TEMograms of the same test and the same patient already saved (during the last 48 hours)
in the database are displayed. With each overlaid TEMogram, the starting time of the respective measurement is displayed
in color.
Note: Patient overlays are only possible with measurements measured with the same cartridge type and lot as the one in
use for the current measurement.
Note: Patient overlays are only possible with measurements that have already been saved/ cleared. In case a new
measurement is saved/cleared (possibly on another ROTEM sigma instrument), this measurement will only become
available for the patient overlay on the original instrument after pressing the Patient overlay button twice.
7.2 Database
All measurements (patient and QC) are saved in the database. They are available for later retrieval and for export to other
programs. Measurements may be selected manually or by using a search form (Chapter 7.2.2), (Chapter 7.2.3).
Note: To avoid the loss or unwanted editing of data, it is not possible to delete, change or add data sets to the database.
Measurements that have been previously discarded (instead of saved/cleared) in the measurement menu are displayed grey
but are still present.
Note: Measurements with flags (e.g. QC missing) are highlighted in yellow.
7.2.1 Database user interface

The database module contains 2 databases:
1. the patient database
2. the QC database
The required database can be selected by toggling the button Patients/QC.

7 System software
The database module user interface consists of five areas (Figure 7-4), (Table 7-3):
Figure 7-4: Database module
Area Content
1 Database buttons Selection of patient or QC database, show or hide discarded measurements
2 Database window List of performed patient or QC results
3 TEMogram window According to the selection in the database window either one single or overlaid
TEMograms
4 Search form Entry fields for the filtering of measurement results
Search buttons
5 Selection screen List of selected measurements
Table 7-3: Database module
Additionally there are further buttons for the handling of the database module available at the right margin. These are
described in the relevant sections 7.2.2, 7.2.3, 7.2.4, 7.2.5, 7.2.6, 7.2.7.
7.2.2 Manual selection of patient / QC results

7.2.2.1 Sorting data sets
By default, data sets are sorted according to the start time of the measurements, beginning with the newest measurement.
By touching the column caption, a sorting criterion can be set. By touching the same column caption again, the sort order
is inverted.
The selection view can be adjusted with the horizontal and vertical scroll bar.
7.2.2.2 Hiding/unhiding discarded measurements
With the button Hide discarded it is possible to hide all the discarded measurements from the database view. With the
button Show all they are shown again.

7 System software
7.2.2.3 Selecting measurements

A measurement is selected by touching its line. Sliding down will highlight the measurements below.
9 The lines of the measurements are highlighted.

9 The selected measurements are shown overlaid in the TEMogram window.
Proceed as described in Chapter 7.2.4 for further processing of the selected results.
7.2.3 Selecting patient / QC results using the search form

The database module provides the possibility to filter the measurements and to select them for further review.
It is possible to enter placeholder characters "?" for single characters and "*" for multiple characters in the
search form of the database. For example searching for "M??er" retrieves the results for Meier, Meyer,
Maier etc. Searching for "*er" retrieves the results for all patient names ending with "er".
1. In the patient database: Specify at least one of the search criteria patient ID, sample ID, patient name, comment, lot,
date range or test in the SIMPLE SEARCH FORM.
2. In the QC database: Specify at least one of the search criteria QC lot, expiry date, comment, date range or test in the
SIMPLE SEARCH FORM.
3. Select Start search.
9 The database is scanned for the required entries.
9 The results complying with the given criteria are highlighted in the database window.
9 The results are shown in the TEMogram window.
Note: If the search does not provide the requested results, delete the entered sorting criteria using the button
Clear search.
Note: If necessary, selected QC measurements can be discarded with Discard QC.
9 The discarded QC measurements are displayed in grey.
4. Proceed as described in Chapter 7.2.4 for processing of the results.
7.2.4 Making patient / QC results available for processing

1. Select Add button.
9 The highlighted measurement results are copied to the selection screen and are available for printing and
exporting (Chapter 7.2.5), (Chapter 7.2.6).
Note: A maximum of 20 overlays can be displayed in the TEMogram window.
Table 7-4 shows an overview of the buttons used in the selection screen.
Button Function
Remove Remove the highlighted search results from the selection screen
Reset Remove all search results from the selection screen
Table 7-4: Buttons for selection screen
7.2.5 Printing
The settings for the printer are determined in the menu SETUP - PRINTER SETUP.
Patient and QC results can be printed from the respective databases.

P A printer is connected to the system.
P The measurements to be printed are added to the selection screen.
1. Select Print button.
9 The SELECT PRINT STYLE window is opened.
2. Determine the number and type of TEMograms (Print on paper or PDF creation) to be printed per page.
3. If required, change the name of the PDF file.
4. Confirm with OK.

7 System software
7.2.6 Exporting
A timeout can occur when transferring extensive data sets via network to an external information system.
Do not export more than a thousand measurements at once.
P The measurements to be exported have been added to the selection screen.
1. Select Export button.
9 A configuration window is shown (Figure 7-5).
2. Determine export destination and type:
– Online (Chapter 7.2.6.1):
When no real-time automatic transmission is possible, this export function allows measurement results to be
batched as XML and transmitted to the LIS or transmitted as PDF or txt file to a folder within the network.
Configurations for online export are possible (Chapter 7.3.2).
– Hard drive (Chapter 7.2.6.2):
Measurement results can be exported to the FILE MANAGER on the hard drive. From there the results can be
transferred to a USB stick and made available for evaluation in other software like Microsoft Excel. This also acts
as a data backup feature.
Note: For every measurement, the exported .txt file contains a hyperlink (Chapter 7.3.2) to the corresponding TEMogram
image. This hyperlink is only active when the folder containing the .jpg TEMogram files and the .txt file are saved in the
same location on your computer.
Figure 7-5: Export options
7.2.6.1 Online export

P Export destination ONLINE is selected.
1. Select where the measurement results should be sent to:
– the LIS/HIS
– the local network (pdf)
– the local network (text)
2. Confirm with OK.
9 A message about the transfer duration appears.
3. Confirm with OK.
9 The measurements are transferred to the chosen destination.

7 System software
7.2.6.2 Hard disk

P Export destination HARD DISK is selected.
1. Mark the option E XPORT WITH TEMOGRAM, when not only the numeric measurement results but also the corresponding
TEMograms should be exported.
9 The two options for selecting the graphical format are active (Figure 7-6).
Figure 7-6: Export options for TEMograms
2. Select requested graphical format:

– .bmp for maximum resolution (450 kB/file)
– .jpg if multiple TEMograms should be exported (70 kB/file)
3. Confirm with OK.
4. Enter a new name for the export file if necessary.
5. Confirm with OK.
9 The measurement results are exported.
9 A pop up confirms the successful export.
6. Confirm the successful export with OK.
Naming conventions during the export of the measurement results to the file manager
The numeric measurement results are saved in a .txt file and the TEMograms are saved as separate single files, in a folder
with the same name as the .txt file.
By default the system assigns names for the .txt files according to following conventions:
TEM-Export date (yyyy-mm-dd)_Export time (hh-mm-ss).txt
(e.g. TEM-2018-06-18_13-44-53.txt).
The file name may be changed but must have the extension ".txt" for import into Microsoft Excel.
The file names for the single TEMograms are composed of:
Patient name (15 characters)_Name of the test_Date (yymmdd)time (hhmmss).jpg or
Patient name (15 characters)_Name of the test_Date (yymmdd)time (hhmmss).bmp.
e. g. Miller-John_INTEM_080618134453.jpg.
Note: In case exports are password protected (in D EVICE SETUP - USER MANAGEMENT - OPTIONS ), exports are saved in password
protected .zip folders.

7 System software
Exported parameter of the numeric measurement results (.txt)

With the export of numeric measurement results, 30 parameters are exported (Table 7-5). If TEMograms are exported
additionally, the 29th parameter is the name of the folder containing those TEMograms. The 30th shows a hyperlink to the
corresponding TEMogram image. This hyperlink is only active when the folder containing the .jpg TEMogram files and the
.txt file are saved in the same location on your computer.
Content
1. Patient ID 11. Starter 21. A10
2. Sample ID 12. Stopper 22. A20
3. Patient name 13. Saved by 23. MCF
4. Sex 14. Error code 24. LI30
5. Birth date 15. Flags 25. LI45
6. Comment 16. Lot 1 26. LI60
7. Test name 17. Serial nr. cartridge 27. ML
8. Start time 18. Profile 28. LOT
9. Run time 19. CT 29. Image file name
10. Channel 20. A5 30. TEMogram link
Table 7-5: Exported parameters
Note: The exported .txt file is available for evaluation of measurement result only. In case of multiple error codes during
the measurement, only 1 error code is reported. Lot numbers (cartridges and QC) are not reported. Error codes and lots
can be viewed in the database module.
7.2.7 Evaluating patient or QC results

The database module offers the possibility to view and compare stored measurement results in the patient or the QC
database.
P The required measurement results have been added into the selection screen.
1. Select Accept.
9 The measurement results are prepared for evaluation.
During the data transfer, the user is informed about the progress in a status pop up. The transmission can
be stopped with Cancel.
9 The measurement results can be interpreted in a new screen (Figure 7-7).

7 System software
Figure 7-7: Measurement result evaluation screen
7.2.7.1 User interface of the evaluation screen

The evaluation screen consists of three areas:
Area Content
Area 1 Thumbnails of the TEMograms
Area 2 TEMograms in larger view
Area 3 Numeric measurement results (color coded)
Table 7-6: Areas evaluation Screen
By using the Back button, the evaluation screen is closed and the first database screen is shown.
Selecting TEMograms
In area 1 the TEMograms for evaluation are selected:
Touch the required TEMograms in area 1
9 The background changes from grey to white.
9 Explicit colors are assigned to the TEMograms.
If more then 4 TEMograms are selected, all other TEMograms are shown in black by default. With the Color
button at the lower part of the screen, further colors can be defined and assigned (Section Define and assign
colors).
9 In area 2 the TEMograms are shown in these colors.

9 The numeric measurement results are shown in area 3 and are highlighted with color bars in these colors.
Define and assign colors
Additional to the automatic assignment of colors, colors may be manually assigned to TEMograms:
1. Select the TEMogram to which the color is to be assigned.
2. Select Color button.
9 The color selection window is opened.

7 System software
3. Select one of the basic colors

or
Add a user-defined color
4. Confirm with OK.
9 The color is assigned to the TEMogram.
Evaluating numeric measurement results
According to the settings in the menu SETUP - PARAMETER SETUP - LARGE TEM, the numeric measurement results are shown in
area 3 (Chapter 7.3.7).
The heading shows the patient name, patient ID, the comment and the executed test from the measurement.
If normal values have been entered for the parameters, all values outside the reference range will be highlighted with a red
background.
If multiple TEMograms are selected, it is possible to scroll between the different measurements with the arrow buttons at
the bottom of the screen.
Evaluating TEMograms
It may be necessary to overlay not only multiple TEMograms but also their first or second derivative.
Table 7-7 shows possible combinations for the overlay of curves.
Number of selected TEMograms TEMogram 1. Derivative 2. Derivative

1 X X X
>1 X
Table 7-7: Combinations for overlay
The first and second derivative are scaled proportionally to the scale of the firmness curves (y-axis). Both scale factors are
shown at the bottom left of the TEMograms.
Printing TEMograms and overlays
The evaluation screen offers the possibility to print TEMograms and overlays.
For the purpose of clarity, the number of printable curves is limited to four curves.
P At least one but not more than four curves are selected (TEMograms and/or derivative).
Select Print overlay .
or
Select Print 4 TEM and enter title.
Figure 7-8 shows an example from a printout of 4 overlay TEMograms.

7 System software
Figure 7-8: Printout of 4 overlay TEMograms
Export TEMograms and overlay

Selecting Export overlay , PDF overlay or Export 4 TEM copies the curves as .jpg or PDF files into the FILE MANAGER. From
there they can be transmitted to a USB stick.

7 System software
7.3 Setup
The ROTEM system has preset factory settings and is ready for testing after installation. However, some ROTEM sigma
settings can be changed.
The authorization to change settings requires the appropriate user rights. If these user rights are not given,
the settings can only be viewed.
1. Select Setup button in the main menu.
9 The ROTEM SETUP module is opened (Figure 7-9).
2. Customize settings. The setting possibilities are described in the following sections.
3. Save changes using the Quit button.
4. Confirm to save the changes.
Figure 7-9: Setup - User setup
7.3.1 User Setup

The following entry and list fields are displayed in the upper area of the screen (Figure 7-9):
Field Content
Device name Name for identification on printouts when multiple instruments are utilized
Location, institute Information for the correct inscriptions on the printouts
Date, time System date and time, save with Set clock
Table 7-8: User Setup, general settings
The lower part of the screen allows additional configurations:
In the area ADDITIONAL SETTINGS I, you define which patient data can be optionally entered (AVAILABLE) and which is
required to be entered (MANDATORY ).
Note: At least one field has to be selected for the identification of the measurement in the database (preferably the
patient ID or the patient name). Fields that are not selected are then not available in the measurement module.

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In the area ADDITIONAL SETTINGS II, Results barcode, On-screen keyboard default and User Lockout can be selected.
9 with Results barcode selected, a barcode containing the measurement results of all running and stopped patient
measurements will be displayed in the measurement module.
9 with On-screen keyboard default selected, the on-screen keyboard is always displayed when touching an entry
field.
9 with User Lockout selected, only trained and authorized personnel can log in and the user is locked out when
their training has expired.
In the TIME ZONE / NTP SETTINGS area, the time zone can be selected and an NTP server can be set up to synchronize the
time.
9 The correct TIME ZONE can be selected from the drop down menu
9 For the NTP setup, please enter the NTP-server IP-address
7.3.2 Online setup

ONLINE SETUP contains the settings for the connection between the ROTEM sigma and the LIS.
The window consists of five areas (Figure 7-10):
Figure 7-10: Setup - Online setup
7.3.2.1 Transmission parameters (area 1)

Area 1 allows you to enter the IP address for ROTEM live, GEMweb live, or a middleware. Do not change the standard port
setting.
7.3.2.2 Transfer measurement results (area 2)
In area 2 you can determine:
– if the measurement results should be transmitted automatically to the LIS after saving/clearing the
measurement (Chapter 6.4.3).
– whether the patient data is automatically retrieved from the LIS when the patient ID is scanned
(ROTEM XMLv2 protocol).

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7.3.2.3 Select transmission protocol (area 3)

In area 3 select the protocol for data transmission. Currently the following communication protocols are implemented:
– ROTEMXMLv1: With this protocol all demographic data and all numeric measurement values are
transmitted.
– ROTEMXMLv1+JPEG: With this protocol all demographic data and all numeric measurement values are
transmitted. The XMLv1 file includes an additional tag (TEMJPEG) which contains the TEMogram as hex
encoded JPEG.
– ROTEMXMLv2: With this protocol demographic data, numeric values and TEMograms are transmitted.
7.3.2.4 Network diagnostics (area 4)
In area 4, a network diagnosis can be started. This checks the connection with the network as well as all IT-related
configurations in the ROTEM (e.g. concerning LIS/HIS, remote view, middleware, PDF export, text export, network printer,
remote backup/restore).
The results of this diagnostic test can be stored as a .txt file in the FILE MANAGER - SERVICE folder.
7.3.2.5 GEMweb Plus configuration (area 5)
A connection to GEMweb Plus can be established in area 5. Please enter the IP-address and port to setup the connection.
If the GEMweb Plus configuration is checked, the port settings in area 1 and settings of area 3 are deactivated and grayed
out. In addition, measurements are automatically sent to GEMweb Plus, therefore the first check box in area 2 is activated
and greyed out.
Note: Please contact your local service provider for the current version of the interface description before programming
the access to the laboratory information system.
7.3.3 Export setup

E XPORT SETUP contains the settings for the connection between the ROTEM sigma and the laboratory information system
(LIS).
The window consists of two areas (Figure 7-11):
7.3.3.1 PDF export (area 1)
In area 1, the necessary configurations to send a .pdf file to a folder on the local network can be made. Automatic sending
of each measurement after having been saved/cleared in the MEASUREMENT module can be activated.
Note: For PDF export, at least Patient ID or sample ID need to be filled out.
7.3.3.2 Text Export (area 2)
In area 2, the necessary settings can be made to send a text file (and TEMogram) with the measurement results to a folder
in the network.

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Figure 7-11: Setup - Export setup
7.3.4 Remote access

The system software of the ROTEM sigma offers the possibility to transfer the current screen view to another computer
within the same LAN.
In the menu REMOTE ACCESS , settings for the connection can be found (Figure 7-12).
If the server is running, select Stop server button to change the settings.
If required, adjust the update interval (default 10 sec. / adjustable from 5-60 sec.).
Figure 7-12: Setup – Remote access

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Note: In case a measurement from patient X is saved/cleared on the ROTEM sigma while that same patient X is being
remote-viewed on an external computer, this measurement will not be available for patient overlays.
Note: In the very rare case a programmer from Instrumentation Laboratory/Werfen requests access to the instrument,
select Allow SSH-Service access.
Note: Activate Ping service to test the reachability of the ROTEM sigma on an Internet Protocol (IP) network.
Activation will be disabled after reboot.
7.3.5 Printer setup

Measurement results can be sent to a printer. Under PRINTER SETUP the according configuration window opens
(Figure 7-13).
If you are directly connecting a printer via USB to the instrument, ensure that the printer is of medical grade
or appropriate for the environment the instrument is operating in.
Note:
Figure 7-13: Setup – Printer setup
7.3.5.1 Select printer and set as default

P A printer is connected to the system.
1. Select printer from the list.
2. Set the selected printer as default printer.
3. Confirm with OK.
7.3.5.2 Add new printer driver
P The printer is not in the printer driver list.
P A printer is connected to your system.
1. Select Install new printer.
2. Confirm with Next.
3. Select the appropriate printer and confirm with Next.
4. Select the manufacturer and mark corresponding to the necessary printer driver.
5. Confirm your selection with Next.
6. Enter a name for the printer.
Note: The printer name does not allow spaces.
7. Confirm with Next.

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8. Wait until the printer installation is complete and confirm with Finish.
9 The printer has been added as the default driver.
7.3.5.3 Options: Including normal values (or target ranges) on the printout
P In the settings for the test (or QC test), normal values (or target ranges) are provided.
1. Highlight the option NORMAL VALUES .
9 The normal values (or target ranges) of the tests (or QC tests) are displayed together with the measurement
values.
9 Measurement values outside the ranges are marked with an arrow up or down.
7.3.5.4 More options:
Print Test Page can be used to check the print image or the function of the printer.
Delete print queue clears the printer spooler and thus the open print jobs.
DIN A4 or Letter format can be selected in Paper size.
Color or black-and-white printing can be selected in Color mode.
Uninstall Printer deletes the selected printer.
7.3.6 Test setup

In the menu Test setup normal values can be entered and special patient profiles can be created.
Figure 7-14: Setup – Test setup
7.3.6.1 Defining normal values

For the evaluation of measurement results, comparison with the reference ranges of the tests may be helpful.
These ranges are entered in the menu TEST SETUP - SIGMA NORMAL VALUES (Figure 7-14).
Note: It is possible to enter normal values for different patient profiles (e.g. pregnant patients). These normal values will be
taken in account to form the profile overlay in the MEASUREMENT menu. By default, an empty Demo profile is available.
1. Select or create the required patient profile (e.g. "demo") in the list CURRENT PROFILE:
2. Select the required test in the list NORMAL VALUES FOR:
3. Enter the reference values for each parameter in the columns LOWER LIMIT and UPPER LIMIT
4. Confirm each entry by touching any other entry field.

7 System software
By using the Clear button all normal values are deleted for the selected test.
5. Select Enable overlay if the entered normal values should be used for the profile overlay in the MEASUREMENT menu.
6. In case the new profile should be the standard profile in MEASUREMENT module select Preselect current profile as
default profile.
Note: For this feature, values for all parameters between brackets must be filled out. All values and the curve must be
checked for correctness before confirmation.
7.3.6.2 Creating a new patient normal range profile
1. Press New.
2. Enter the new profile name (max. 10 characters).
3. Confirm with OK.
4. Select the new name in the drop-down list.
5. Enter the new normal values for each required test as described above.
6. Check the correctness of the entered values.
7. Check the correctness of the curve.
8. Select Enable overlay if the entered normal values should be used for the profile overlay in the MEASUREMENT menu.
It is possible to create a new profile with a copy of existing normal values with Copy .
After selecting an existing profile in the drop-down list, it is possible to Rename or Delete it.
9. In case the new profile should be the standard profile in MEASUREMENT module select Preselect current profile as
default profile.
7.3.7 Parameter setup

When displaying the TEMograms, the appropriate parameters are shown in the order determined in the menu PARAMETER
SETUP .
1. Select PARAMETER SETUP .

9 The window for the determination of the order of the parameters for the SMALL TEM, the LARGE TEM, the MULTI-TEM
and the PRINTER TEM is opened (Figure 7-15).
2. With <Arrow up > and <Arrow down>, highlight parameters and move as required.
Note: The maximum number of parameters shown at the screen or the printout is stated in brackets.

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Figure 7-15: Setup – Parameter setup
7.3.8 Comment setup

Under the menu item COMMENT SETUP , additional information for reutilization, like clinical studies and diagnoses, may be
entered. These text items then become available in the measurement module in the list box Comment.
1. Select Comment setup .
9 The window for the entry of comments opens.
2. Enter text (max. 126 characters).
3. Confirm with <Enter>.
9 The text is adopted to the list.
4. With the <Arrow up > and <Arrow down>, highlight comments and move them as required.
By using the Delete button, highlighted comments are removed from the list.
7.3.9 ROTROL setup

In the ROTROL SETUP menu (Figure 7-16), external control material can be:
Scanned (control name, lot number, expiration date and target ranges are transferred to the system)
Added (the scanned control can be added to the control list)
Put in use (this is done automatically when the user first uses the control)
Deactivated (when the control should not be available in the MEASUREMENT menu)
Activated again (in order to become available in the MEASUREMENT menu)

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Figure 7-16: Setup - ROTROL setup
The list in the upper part of the screen displays all controls, their different lots and their actual status (new, activated, in
use or deactivated). Viewing just one control is possible by selecting the desired control type in the upper Control field.
The list in the lower part of the screen displays the history of all actions (when, by which user, etc.) taken for each lot.
Pressing the required column header, allows to sort the data in both lists. The lower list can be printed out with Print Lot
History .
7.3.9.1 Entering a new control

P The control has not expired.
P The control has not been entered yet.
1. Press SCAN.
2. Scan the control box or control sheet barcode.
9 Control type, lots, expiry date and TEM Code are displayed on top of the screen.
3. Press Add Control.
9 The control lot is now added to the upper list.
9 In its STATUS column, it is shown as " ACTIVATED" .
9 In the lower history list ACTION column, it is shown as "added".
9 The target ranges for the control lot are saved and can be viewed in SETUP - ROTROL SETUP - TARGET RANGES .
9 The lot becomes available for the user in the MEASUREMENT screen.
Note: Scanned but expired controls will not be added to the list.
Note: The first time the user selects this lot in the MEASUREMENT menu, the ACTION in the lower history list becomes
"put in use".
7.3.9.2 Entering a new control manually
In case the barcode scanner is not available, control data can be entered the following way:
1. Select control type.
2. Type lot numbers, expiration date and TEM code (refer to control sheet) in the corresponding fields.
Note: Each ROTROL batch has three lot numbers: one for the complete kit, one for the Lyo vial and one for the
Dil vial.

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3. Press Add Control.

9 The new control now appears in the upper list.
4. Select the new control.
5. Press Target ranges.
6. Select the test QCinN C (or QCinP C) in the drop-down menu.
7. Enter the lower and upper limit for each test result parameter (to be found on the control sheet from the control’s
package insert).
8. Press Save your changes.
9. Repeat the whole procedure for every QC test (e.g. QCexN C, etc.).
10. Press Quit to leave the SETUP menu.
7.3.9.3 QC reminder
If required, the user is reminded to run quality control on a regular basis (daily, weekly, or monthly).
1. Press the button Reminder.
2. Select the QC reminder interval (e.g. weekly on a particular day).
3. Select the time the user wishes to be reminded.
4. Choose if you wish the system to be blocked for patient measurements after 3 consecutive QC runs with out of
range results.
Note: The current status of the last QC run can be checked in the menu SERVICE-INFORMATION (Chapter 7.4.1).
Note: This feature can only be disabled by service engineers with Service user rights.
5. Press Close.
9 A reminder in the MEASUREMENT menu automatically prompts the user when to run QC.
7.4 Service Module

The authorization to change settings requires the appropriate user rights. If these user rights are not given,
the settings can only be viewed.
7.4.1 Information
The menu item INFORMATION contains a list of the current version numbers of the installed software components and MAC
address.
The menu also indicates the QC status (Number 5 on the screen):
1. OK: all QC tests have been successfully performed.
2. Out of range (1x, 2x or 3x): at least one parameter from the last QC run(s) is out of range.
3. Missing: QC has not been performed yet.
4. Blocked: the system has been blocked after 3 consecutive QC runs with out of range results.
Figure 7-17: Service – Information

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7.4.2 Settings
In the menu SETTINGS , the graphical illustration of the recorded data streams allows an evaluation of the raw data
generation. If the curve is displayed in red (superimposed on black), the data stream is recorded correctly. If the red and
black lines are not superimposed exactly, it is a sign of a technical defect.
Note: The technical values are balanced and ready for evaluation about 3 minutes after entering the screen.
Calibration values (gains) of the channels are factory set. Phase shift, amplitude, center, variance and period are
parameters providing information on the mechanical and optical functions of the system. They are helpful for service
personnel to determine if ball bearings or other components of the system are in need of exchange or repair
(Chapter 8.2.3).
Screenshots can be made by using the Screenshot button (Chapter 7.1.4).
The button Print Screenshot captures the screen on a printout that can be forwarded to ROTEM technical service for
further evaluation.
The buttons ADM 1, ADM 2, ADM 3 and ADM 4 show technical data concerning each channel.
Figure 7-18: Service – Settings
7.4.3 Log book

The log book contains 3 information screens:
The user can view the History of service interventions (e.g. repairs, SW installation, maintenance...) (Figure 7-19).
The service engineer can enter his service actions under Report.
The Reminder informs the user when the next yearly preventive maintenance is due. The date can be set by the
service representative or is set automatically after adding a yearly maintenance in Report.
9 The user will be informed through a reminder in the MEASUREMENT menu one month before the yearly preventive
maintenance is due.
9 All measurements run when the yearly maintenance is 30 days overdue will be flagged and colored yellow in the
database and flagged on printouts.

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Figure 7-19: Service - Log book - History
7.5 Instrument Setup

The authorization to work with the individual menus requires the appropriate user rights (Table 7-8).
This menu is divided in the tabs SETUP and LOGS .
7.5.1 Setup
In this menu, the instrument can be configured, the touch screen can be calibrated, users can be managed, a backup or
restoration can be performed and the instrument can be secured for transport.
7.5.1.1 Backup/Restore
A database backup should be performed at regular intervals.
Please follow local, state and federal regulatory guidelines regarding backup frequency. Always keep the
two most recent backup files.
Automatic backups can be performed using the Remote Backup tool.
Backup with a USB stick
1. Select Backup / Restore.
2. Insert USB stick.
3. Select Start USB Backup .
4. Confirm with OK.
9 A backup of the database and all settings of the instrument is made.
9 A message appears: Backup was created successfully. The USB stick can be removed now.
9 The backup is saved under the name "Backup_Serialnumber_Date_Time.sigma" on the USB stick.
5. Confirm with Finish.

7 System software
Restore with a USB stick

The function RESTORE permits restoration of a saved database.
Restoration of the database will overwrite the existing data and is always associated with a loss of the data
generated between the last backup and the restoration. Therefore it should only be applied if absolutely
necessary.
Databases can only be restored if the backup file has its original name "backup_serialnumber_yyyymmdd_
hhmmss.sigma". If necessary, rename the file, remove the USB stick and reconnect it.
P The backup file to be restored belongs to the same ROTEM sigma system.
P If the backup file is not from the same system (e.g. replacement system during repair period), the file has been
taken from a ROTEM sigma with the same SW version.
2. Insert USB stick.
3. Select Start USB Restore.
4. Confirm with OK.
5. Select required backup file (e.g. the one with the most recent date).
Note: The backup file must be stored in the main directory of the USB stick.
6. Confirm with OK.
7. Select one of the following ROTEM restore options:
– Everything
Note: This option also includes data from SHOW LOGS .
– Everything except instrument configurations
– Measurement database only
– User management only
8. Confirm with OK.
9. Confirm again with OK.
9 The database is restored.
9 A window informs you that the save is successful.
10. Complete the process with Finish.
12. Login in again.
Remote server setup
To setup this feature, configuration by IT personnel is required:
P The ROTEM sigma is connected to the local area network.
1. Create a password protected network folder in your local network.
2. Grant access rights to users who may need to access this folder.
3. Select Remote server setup .
– Enter the Domain/user name of the network folder.
– Enter the password to access the network folder.
– Enter the path to the CIFS server share (// IP address / folder name).
Note: Use the slash /, not the backslash \.
– Enter the number of backup files (per ROTEM sigma) to be saved in the network folder.
9 The oldest backup file will be overwritten, once the maximum number is reached.
4. Select the option Automatic remote backup activated .
5. Select Quit.
6. Confirm to save changes with Yes.
9 The remote backup is made automatically.
7. Open the network folder on a remote computer.
9 The backup file (e.g. backup_serialnumber_yyyymmdd_hhmmss.sigma) can be found in the folder.

7 System software
Remote backup
This feature allows automatic backup transfer to a remote computer via the network. A backup is automatically transferred
when shutting down the system and whenever the screen saver is activated for 4 hours.
Note: During shut down, it is possible to cancel the automatic backup.
Note: When the screen saver is active for 4 hours, the remote backup is only performed if new (saved/cleared or discarded)
measurements are available in the database.
2. Select Start remote backup .
3. Confirm with OK.
9 A backup of the database and all instrument settings is made.
9 A window confirms the successful backup.
9 The backup is saved under the name "backup_serialnumber_yyyymmdd_hhmmss.sigma" in the network folder.
4. Finish action with Finish.
Remote restore
Restoration of the database will overwrite the existing data and is always associated with a loss of the data
generated between the last backup and the restoration. Therefore it should only be applied if absolutely
necessary.
2. Select Start remote restore.
3. Confirm with OK.
4. From the list, select the required backup file (e.g. the one with the same serial number and the most recent date).
5. Confirm with OK.
6. Select one of the following ROTEM restore options:
– Everything
Note: This option also includes data from SHOW LOGS
– Everything without instrument configurations
– Measurement database only
– User management only
7. Confirm with OK.
8. Confirm again with OK that the existing data will be replaced with the ones from the backup
9 The database is restored.
9 A window confirms the successful restoration.
9. Finish action with Finish.
10. Reboot the system.
7.5.1.2 Setup
This menu allows the administrator to set the IP address, subnet mask, default gateway, ROTEM remote password,
language and layout of the default keyboard.
To install a new language, insert a USB stick with the corresponding language file:
1. Press on Install New Language.
2. Confirm with OK in the next text box.
3. Select the language that should be installed.
4. After successful installation, the USB stick can be removed. Click Finish.
5. In the next text field, confirm with Yes if you want to change to the newly installed language.
6. Select the default keyboard layout in the next text box.
7.5.1.3 Touch screen
If the entry fields of the touch screen cannot be smoothly operated, the screen has to be re-calibrated.
1. Follow the instructions on the screen.

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7.5.1.4 Transport lock

When the ROTEM sigma has to be transported, an unused cartridge must be used to secure the instrument for transport.
1. Select D EVICE SETUP .
2. Select the SETUP tab.
3. Select Transport lock.
4. Insert the cartridge when prompted.
9 The unused cartridge is inserted into the instrument.
5. Confirm to clamp to cartridge.
6. Wait until the cartridge has been clamped.
Note: This can take up to 15 minutes.
7. Shut down the instrument.
7.5.1.5 User management
In USER MANAGEMENT, new users and their passwords can be set. Passwords of existing users can be reset or changed.
In Lockout, the administrator can select each user and set the user’s training status (last training date, required training
interval):
P In SETUP - USER SETUP User Lockout is selected.
9 When a user's training expires soon, a message appears at log in.
9 When a user's training has expired, the user is locked after 30 days.
In Options:
Log in via barcode can be selected.
Password rules can be selected (ON) or not (OFF)
Note: The password rule requires a password with at least 1 number and a minimum of 8 characters. In addition, the
service user can activate password protection for the data export and, if necessary, assign a password requested by
the user.
Under Options - Data export, all exported data can be protected with a password. The default password may be used
or an alternative password (with the password rule described above) may be chosen.
Note: Only a service engineer is authorized to change the password protection of exported data.
Table 7-9 gives an overview of the hierarchy of user rights and the management of passwords.
Normal User Administrator Service
Measurement X X X
Database X X X
Setup (read only) X X X
Setup (read and write) X X
Setup (System blocked after 3 x QC OR) X X
Service (read only) X X X
Service (Gains) X X
Service (read and write) X
File Manager X X X
Backup X X X
Restore X X
Device Setup - Setup: everything except SN X X
Device Setup - Setup: serial number X
Touchscreen (calibration) X X X
User Management X X
Table 7-9: Hierarchy of user rights

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Note: Only administrators can add new users, set new passwords and remove users.
7.5.2 Logs
7.5.2.1 Get Logs
If a general system diagnosis is necessary, instrument log files with or without patient data can be saved to a USB stick for
a user-defined period of time via this button. This data can be sent per e-mail for analysis.
7.5.2.2 Get Logs-SH
If a special hardware diagnosis is necessary, log files can be saved to a USB stick for a user defined period of time via this
button. These data can be sent for analysis.
7.5.2.3 Show Logs
The log in this list gives information about the people who used the equipment, any configuration changes and backup or
restore procedures at a given time.
With the button Filter, it is possible to sort the logged data.
With Export USB data is copied directly onto a USB stick.
7.6 File Manager

The FILE MANAGER contains different buttons for operations. The menu ROTEM on the left contains the folders DataExport,
GraphExport, PDF, Screenshots and Service:
7.6.1 DataExport
All exported data is saved in this folder (Chapter 7.2.6).
7.6.2 GraphExport
All evaluations that were created in the evaluation window of the database and exported from there are saved in this folder
(Chapter 7.2.7).
7.6.3 PDF
The folder PDF contains the PDF exports from the MEASUREMENT module and the D ATABASE.
7.6.4 Screenshots
All screenshots are saved in this folder (Chapter 7.1.4).
7.6.5 Service
All exports from SERVICE-LOG BOOK are saved in this folder.
The menu USB stick on the right shows the content of the connected USB stick and allows to transfer data from the
ROTEM menu to the connected USB stick with the buttons Copy , Cut and Paste or by drag/drop with the touch screen.
7.6.6 Update
The USB stick is also used to update the system with new software. Smaller updates are usually copied to a USB stick.
P A software update has been copied to the USB stick.
1. Connect USB stick to one of the USB interfaces.
2. Select FILE MANAGER.
9 The USB menu is opened.
3. Select the update file.
9 Update starts.
4. Please follow any operation instructions appearing on the screen.
5. Reboot the system after the update has been completed.

8 Maintenance,
cleaning, disinfection
8.1 Introduction
Maintenance must be performed in order to guarantee correct operation of the system.
The system reminds you automatically when to perform maintenance.
The ROTEM system requires only minor maintenance, if used as intended.
Tem Innovations GmbH recommends to follow the maintenance schedule as outlined below (Chapter 8.2) to ensure
serviceability.
WARNING
Danger of infection
Exposure to residual reagents/blood within the device may lead to biohazard exposure.
4 Always wear gloves when cleaning the equipment.
4 Always follow guidelines for infectious materials.
4 Carefully disinfect surfaces that have been in contact with potential contaminated material.
4 Follow local maintenance procedures for the cleaning of such surfaces.
8.2 Maintenance plan

The maintenance plan contains a daily, weekly, quarterly and yearly maintenance work scheme. The user is prompted to
perform maintenance in the MEASUREMENT menu.
CAUTION
Damage to equipment
Inappropriate maintenance may lead to equipment damage by exposure of the system to liquids.
4 Ensure that no liquids enter the equipment.
4 Use only damp or dry, lint free cloths for cleaning.
The following can be used to disinfect the ROTEM sigma:

A solution of 50% 1-propanol, 50% water
A solution of 0.5-1% sodium hypochlorite (bleach), 99% water.*
Any other disinfectant containing the same percentage of the active ingredients
*This solution should not be used on the touchscreen.
8.2.1 Daily maintenance

Table 8-1 shows the maintenance to be performed daily.
Instrument to maintain Action

Outer surface of the ROTEM sigma Clean and disinfect with lint-free cloth.
ROTEM sigma barcode reader Wipe with a dry lint free cloth.
Table 8-1: Daily maintenance work

8 Maintenance, cleaning, disinfection
8.2.2 Weekly maintenance

In addition to the daily maintenance described in Table 8-1, ROTEM sigma system QC should be performed every week
(Chapter 6.5.4).
In case the automatic remote backup feature is not used, perform a system backup (Chapter 7.5).
8.2.3 Quarterly maintenance

In addition to the daily and weekly maintenance, the fan filter on the rear of the instrument should be dusted and the
instrument AD Module service values should be evaluated quarterly.
8.2.3.1 Dusting the filter
1. Switch off the system.
2. Remove the fan cover together with the fan filter (Figure 8-1).
Figure 8-1: Removing the fan filter and cover from the system
3. Remove the fan filter from the cover (Figure 8-2).
Figure 8-2: Removing the fan filter from the fan cover

8 Maintenance, cleaning, disinfection
4. Wipe any dust off the fan filter with your (clean and dry) hand (Figure 8-3).
Figure 8-3: Dusting the fan filter with your hand
5. Reseat the fan filter with the fan cover on the system.
8.2.3.2 Control AD Module Service Values
The AD Module Service Values are a measure of the quality of the analytical system.
1. Open menu SERVICE > SETTINGS .
2. Wait until the curves appear and the values stabilize (approx. 3 min).
3. Read and take a note of the values for AMPLITUDE, CENTER and V ARIANCE.
If a printer is connected to the instrument, you can print these values with the button Print Screenshot. It is
recommended to print out this report regularly and to file it.
The values included in the table below are continuously measured by the system that monitors the performance of the axis
movement and sensors. The values should be within their target ranges:
Value Definition Target range

Amplitude Measurement of the movement of the axis and function of the supporting ball bearings 4400 to 5100
Center Measurement indicating the location of the amplitude on the CCD chip -832 to 708
Variance Measurement providing information about the mechanical status of each channel <12,000
Table 8-2: Acceptable range for the AD Module Service Values
The internal monitoring validates the proper functioning of the axis on each channel and the performance of the
instrument optics as depicted in the SERVICE menu channel graphs:
1. Black curve depicts the actual light beam from the CCD.
2. Red curve depicts the calculated light beam from the CCD.
Note: In case the values for one particular channel are not within specifications, contact your service provider.
8.2.4 Yearly maintenance

The system reminds the user when to schedule the yearly maintenance 30 days before the due date.
Maintenance of the ROTEM sigma system must be performed on a yearly basis by authorized service personnel.
Please contact your local service provider for yearly maintenance or ask for a maintenance contract.
If the preventative maintenance is not performed within the year, all measurements performed 30 days after the due date
will be flagged and highlighted in yellow in the database (yearly maintenance overdue). In the MEASUREMENT menu, Service!
lights up in red in the lower left corner of the screen.

9 Shipping, Removal
from use and Disposal
9.1 Shipping
CAUTION
Damage to instrument
Inappropriate transport may cause damage to the instrument.
4 Please contact service if you have a need to ship the instrument.
4 Lift the instrument only by holding the lower side.
4 Shipping the ROTEM sigma only in the original cardboard shipping boxes.
4 Secure the instrument with the Shipping cartridge or any unused cartridge (except ROTEM sigma System QC
cartridge).
4 Ship touch screen separately.
9.2 Placing out of operation

Disinfect the ROTEM sigma when taking it out of operation (Chapter 8.2) and protect it from dust until re-installation.
9.3 Disposal
The life cycle of the ROTEM sigma system is five years when maintained as described in this manual.
Instrumentation Laboratory/Werfen is committed to meeting or exceeding the conditions of the WEEE Directive
(2012/19/EU) and being a good environmental partner.
In compliance with the WEEE Directive, beginning with product shipped after August 13, 2005, all instruments are labeled
with the symbol shown below.
Disposing of this product correctly helps to prevent potential negative consequences for the environment and for human
health. Recycling conserves natural resources. Penalties may be applicable for incorrect disposal of this waste, in
accordance with national (European) legislation.
Please call your local Instrumentation Laboratory/Werfen distributor for information regarding the disposal of end-of-life
instruments.
Figure 9-1: WEEE disposal symbol
For equipment which came into contact with blood or other biological contaminants prior to end-of-life, separate
directives apply. This equipment is marked with a biohazard symbol and has to be disposed of according to local
regulations for biohazardous equipment.
Figure 9-2: Symbol for biohazard
Data Disposal
Instrumentation Laboratory/Werfen recommends to customers the ROTEM sigma hard drive be purged of all data prior to
system disposal. IL recommends following the recommendations as published by NIST Special Publication 800-88 for
data and hard drive sanitization.

10 Appendix
Appendix A: Marks, labels and symbols

Symbol Symbol Title Description Reference1
Manufacturer Indicates the medical device manufacturer. ISO 15223-1
REF 5.1.1
Date of manufacture Indicates the date when the medical device ISO 15223-1
was manufactured. REF 5.1.3
Delta Indicates change(s) to section since previous N/A

revision.
Consult instructions Indicates the need for the user to consult the ISO 15223-1
for use instructions for use. REF 5.4.3
Device for near-patient Indicates that the device is to be used in a near MedTech Europe New IVD
testing patient setting by a health professional symbols for compliance with
the IVDR
Do not re-use Indicates a medical device that is intended for ISO 15223-1
one use, or for use on a single patient during a REF 5.4.2
single procedure.
In vitro diagnostic Indicates a medical device that is intended to ISO 15223-1
medical device be used as an in vitro diagnostic medical REF 5.5.1
device.
Use-by date Indicates the date after which the medical ISO 15223-1
device is not to be used. REF 5.1.4
Batch code Indicates the manufacturer’s batch code so ISO 15223-1

that the batch or lot can be identified. REF 5.1.5
Serial number Indicates the manufacturer’s serial number so ISO 15223-1
that a specific medical device can be identified. REF 5.1.7
Catalogue number Indicates the manufacturer’s catalogue number ISO 15223-1
so that the medical device can be identified. REF 5.1.6
CE mark Indicates conformity to the European Regulation (EU) 2017/746
regulations as stated in the respective Regulation (EC) 1907/2006
Declaration of Conformity. Includes the
Notified Body number (BSI: 2797) for devices
in classes B, C, and D.
Control Indicates a control material that is intended to ISO 15223-1
verify the performance characteristics of REF 5.5.2
another medical device.
Caution Indicates the need for the user to consult the ISO 15223-1
instructions for use for important cautionary REF 5.4.4
information such as warnings and precautions
that cannot, for a variety of reasons, be
presented on the medical device itself.
Contains sufficient for Indicates the total number of IVD tests that can ISO 15223-1
<n> tests be performed with the IVD. REF 5.5.5
Table 10-1: Markings, symbols and labels

10 Appendix

Temperature limit Indicates the temperature limits to which the ISO 15223-1
medical device can be safely exposed. REF 5.3.7
Humidity limitation Indicates the range of humidity to which the ISO 15223-1
medical device can be safely exposed. REF 5.3.8
Atmospheric pressure Indicates the range of atmospheric pressure to ISO 15223-1

limitation which the medical device can be safely REF 5.3.9
exposed.
Fragile, handle with Indicates a medical device that can be broken ISO 15223-1
care or damaged if not handled carefully. REF 5.3.1
Keep dry Indicates a medical device that needs to be ISO 15223-1

protected from moisture. REF 5.3.4
This way up On transport packaging. To indicate the IEC TR 60878
correct upright position. REF 0623
Alternating current To indicate on the rating plate that the IEC TR 60878
equipment is suitable for alternating current REF 5032
only; to identify relevant terminals.
General warning sign To signify a general warning. ISO 7010
REF W001
Warning; Biological To warn of a biological hazard. ISO 7010

Hazard REF W009
Biological risks Indicates that there are potential biological ISO 15223-1
risks associated with the medical device. REF 5.4.1
Warning; Sharp To warn of a sharp element. ISO 7010

element REF W022
Minimum distance Minimum Distance of 1.5 m / 4.9 ft between N/A

device and patient is obligatory
Recycle: Electronic Marking of Electrical and Electronic Equipment EN 50419

Equipment in accordance with Article 14(4) of Directive
2012/19/EU (WEEE).

10 Appendix

Universal Serial Bus To identify a port or plug as meeting the ISO 7000
(USB), port/plug generic requirements of the Universal Serial REF 3650
Bus (USB). To indicate that the device is
plugged into a USB port or is compatible with
a USB port.
"ON"/"OFF" To indicate connection to or disconnection IEC TR 60878
(push-push) from the mains, at least for mains switches or REF 5010
their positions, and all those cases where
safety is involved.
Each position, "ON" or "OFF", is a stable
position.
1 Referencesto international standards are in short form. The full references are:
- ISO 15223-1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
- ISO 7010 Graphical symbols — Safety colours and safety signs — Registered safety signs
- ISO 7000 Graphical symbols for use on equipment
- IEC TR 60878 Graphical symbols for electrical equipment in medical practice
- EN 50419 Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE)
- 21 CFR 809.10 Labeling for in vitro diagnostic products
Appendix B: Warranty
Manufacturer responsibility for safety and performance
Instrumentation Laboratory (IL), a Werfen company is responsible for the safety and electrical performance of this
equipment if and only if:
Persons authorized by IL carry out assembly operations, extensions, adjustments, modifications, or repairs.
The ROTEM sigma system is repaired by authorized IL personnel and/or persons authorized by IL.
The electrical installation of the room complies with the local, state, or national requirements (including power
supply circuit with independent grounding).
The equipment is used in accordance with the instructions for use contained in this manual.
IL brand products are used; non-IL branded products are not covered.
Warranty information
The following language applies to all warranties listed in this manual.
Excluded from all warranties are any defects caused by misuse, accidental damage, or unauthorized repair of the product.
Those parts which deteriorate or which are in any case considered consumables or those parts or “items” which by their
nature are normally required to be replaced periodically consistent with normal maintenance are not covered by the
analyzer warranty. The warranty is limited to the replacement, at no cost to the purchaser, of any component or accessory
found to be defective during the period in which the warranty is in effect. Product functionality must be determined per
the manufacturer’s instructions prior to reporting patient results.
The warranty is expressly in lieu of all other warranties, expressed or implied, including any implied warranty of
merchantability or fitness for a particular purpose. It is the responsibility of the purchaser to determine the suitability of
this product for any particular application, and to take any necessary actions to determine the fitness of the product at
time of use.
The purchaser agrees that any liability against IL for a breach of a warranty shall be limited to the replacement of any
defective part. No other remedy including, but not limited to, incidental or consequential damages or lost profits, lost
sales, injury to person or property, or any other incidental or consequential loss shall be available to the purchaser.
No agent or employee of IL is authorized to extend any other warranty or to assume for IL any liability except as above set
forth.
Exceptions to any of the warranties listed in this manual must be generated by an Instrumentation Laboratory corporate
office or authorized distributor corporate office.

10 Appendix
ROTEM sigma Analyzer Warranty

IL declares to the original purchaser that each ROTEM sigma system manufactured and sold by IL or sold by an authorized
IL distributor shall be free from defects in material and workmanship and, under normal and proper use conditions,
warrants it for a period of one year from installation and no more than 13 months from the shipping date, except as
otherwise provided in writing.
IL’s obligation is limited to repairing, replacing, or modifying (at IL’s undisputed judgment) at IL’s factory, or elsewhere as
designated by IL, the material whose defects have been verified, on condition that the purchaser has informed IL of any
defects found within 10 days from receipt, or 10 days of discovery in case of defects which may not be identified in the
normal inspection. Damages caused by or connected to transport are excluded. Transport to an IL facility or authorized IL
distributor will be at purchaser’s charge and risk.
Replacements, repairs, or alterations will in no case determine extension to the warranty period.
The warranty does not cover those parts which deteriorate or which are in any case considered consumables or those
parts or “items” which by their nature are normally required to be replaced periodically consistent with normal
maintenance. It is also understood that following the purchase and delivery of the instrument, the purchaser shall be
deemed liable for any losses, damages, or complaints concerning persons or things incurred by the use or misuse of the
instrument on behalf of the purchaser, its employees, co-operators, or others.
IL does not assume any obligation or warranty engagement concerning precision and/or accuracy of the measurements as
well as for any damage to the instrument directly or indirectly resulting from the use of reagents and/or consumables
different from those produced by IL specifically for its own instruments and for the same properly tested.
Warranty will not apply to those defective instruments or materials showing defects or damage arising from the following
causes:
Insufficient or negligent care by the purchaser.
Insufficient or negligent maintenance by the purchaser in relation to the instructions contained in the manuals prepared by
IL for this purpose; tampering or alterations of the instruments or in any case interventions or repairs made by any person
not duly authorized by IL.
Misuse due to carelessness, negligence, or inexperience.
Employment of materials under heavier conditions than those for which they have been designed and manufactured and
use of the same in combination with incompatible or dangerous products.
Non-observance of the regulations relevant to installation, power supply, and operation of the instruments.
For more extensive coverage, service contracts may be available for purchase. Please contact your local distributor for
additional information.
Appendix C: Repair
In the event that the ROTEM sigma system requires repair, contact your local IL/Werfen Technical Support department.
For your local representative contact information, go to: www.werfen.com
Appendix D: Software license

The ROTEM system contains proprietary software modules of Tem Innovations GmbH (measurement module, database
module, service module, setup module, hardware-software interface, calculation module). Furthermore, it contains free
software/open source software. Only the free software/open source software is licensed under the free software licenses.
The source code of all modules licensed under free software licenses and the respective license texts can be found on the
CD-ROM that is delivered along with the ROTEM.
As long as the Software is only used as embedded software of the ROTEM, there is no requirement to comply with the
additional conditions as set forth by the free software licenses. In order to obtain additional rights, the user may, at his
option, agree to these license agreements with the licensor of the respective software modules.

10 Appendix
Compliance with the license conditions of the free software licenses entitles the user to use the free software as provided
by the relevant license. Any modification of the Free Software embedded in the ROTEM system has the effect that any
warranty for the ROTEM system is lost and that the user becomes liable for any damage arising in connection with the use
of the ROTEM system. The ROTEM system is not designed for any kind of modifications by the user, including but not
limited to modifications of the embedded software. All public authorizations will automatically terminate with any
intervention in the integrity of the ROTEM system.
Appendix E: Passwords
Table 10-2 lists the ROTEM standard passwords.
Function Password
Login administrator admin
Standard password encryption SigmaSN (SN = serial number)
Table 10-2: Standard passwords
Standard passwords should be changed following local, state and federal regulatory guidelines.
Appendix F: Ordering Information

Following items can be ordered with their according catalogue numbers (Table 10-3).
Article Description REF No.

Tem Innovations
ROTEM sigma ROTEM sigma instrument 211000
User manual ROTEM sigma User manual 000600370
ROTEM sigma fan filter Replacement filter for the fan 418704S
ROTEM sigma power cable Power cable for the ROTEM sigma Contact local
representative
ROTEM sigma Software Software for ROTEM sigma 216300S
ROTEM system USB Stick ROTEM system USB stick 400221S
Touch screen Touch screen for the ROTEM sigma system 418707S
Table 10-3: Available additional Items
Appendix G: Ordering Information, Cartridges and Controls

The following cartridges and controls can be ordered with their according catalogue numbers (Table 10-4).
Article Description REF No.

Tem Innovations
ROTEM sigma complete Cartridge with test panel EXTEM C, INTEM C, FIBTEM C 555501
and APTEM C
ROTEM sigma complete + hep Cartridge with test panel EXTEM C, INTEM C, FIBTEM C 555502
and HEPTEM C
ROTEM sigma ROTROL N Control material level 1 555201
ROTEM sigma ROTROL P Control material level 2 555202
ROTEM sigma system QC cartridge Cartridge to check the functionality of the system 555504
Table 10-4: Available Cartridges and Controls

10 Appendix
Appendix H: ROTEM sigma complete, Instructions for Use

REF 555501
Intended Use
HEPTEM C):
Summary and principle
4 assays are measured with one ROTEM sigma complete cartridge:
INTEM C: recalcification of a sample and activation of the intrinsic coagulation pathway.
EXTEM C: recalcification of a sample and activation of the extrinsic coagulation pathway.
FIBTEM C: recalcification of a sample, activation of the extrinsic pathway, and in vitro platelet inhibition.
APTEM C: recalcification of a sample, activation of the extrinsic coagulation pathway, and in vitro inhibition of fibrinolysis.
In a thromboelastometric measurement, clotting is continuously monitored. ROTEM results describe coagulation inclusive
of clot initiation, firmness, and stability. Deviation of results from established reference ranges may indicate a potential
disturbance in coagulation.
Abnormal results may be observed in the following situations1 :
INTEM C, EXTEM C, FIBTEM C: deficiency of coagulation factors or hypercoagulability

INTEM C, EXTEM C, FIBTEM C: fibrinogen deficiency and/or fibrin polymerization disorder (differentiation from
platelet deficiency possible by comparing EXTEM C and FIBTEM C amplitudes), or hyperfibrinogenemia
INTEM C, EXTEM C, FIBTEM C: thrombocytopenia (differentiation from hypofibrinogenemia possible by comparing
EXTEM C and FIBTEM C amplitudes)
INTEM C, EXTEM C, FIBTEM C, APTEM C: hyperfibrinolysis (confirm by FIBTEM C or by comparing EXTEM C with
APTEM C) or hypofibrinolysis/fibrinolysis shutdown
ROTEM-guided bleeding management algorithms have been found to be effective in reducing transfusion requirements,
healthcare cost, complication rates, and mortality1 . Several randomized clinical trials, meta-analyses, and health
technology assessments have provided evidence that use of ROTEM-guided algorithms in bleeding patients improves
patient safety and outcomes, including peri-operative morbidity and mortality1-6 .

10 Appendix
Composition
ROTEM sigma complete (Cat. No. 555501): 20 single-use ROTEM sigma complete cartridges
Constituents:
INTEM C: Ellagic acid, phospholipids, calcium chloride, preservatives, and buffer.
EXTEM C: Recombinant tissue factor, heparin inhibitor, phospholipids, calcium chloride, preservatives, and buffer.
FIBTEM C: Recombinant tissue factor, platelet inhibitors, heparin inhibitor, phospholipids, calcium chloride,
preservatives, and buffer.
APTEM C: Recombinant tissue factor, fibrinolysis inhibitor, heparin inhibitor, phospholipids, calcium chloride,
Precautions and Warnings
Precautions:
Intended to be used by trained medical professionals only. For single use only. Do not reuse.
Human blood should be handled with care, following the precautions recommended for biohazardous material7 .
Do not touch the needle in the sample position of the cartridge.

Warnings:
Hazard Class:
None
Hazard Statements:
None
Precautionary Statements:
P501: Dispose of contents/container in accordance with local/regional/national/international regulation.
EUH208: Contains 1,2-benzisothiazolin-3-one (BIT)(2634-33-5). May produce an allergic reaction.
EUH210: Safety Data Sheets (SDS) for ROTEM sigma cartridges and controls can be requested through your local
Customer Support or online at www.werfen.com.
The Summary of Safety and Performance can be located on the EUDAMED website under BASIC UDI-DI
4260160470310R5 Reference ec.europa.eu/tools/eudamed.
Preparation
No preparation required. The ROTEM sigma complete cartridge is ready-to-use.
Storage and stability
Store at room temperature.
Unopened cartridges are stable until the expiration date shown on the label when stored at 15 - 25°C. Cartridges should
be used within 10 minutes of opening the sealed pouch.
Instrument/test procedures
Refer to section 6 of this User Manual for complete test procedure instructions.
Specimen collection and preparation
Nine parts of freshly drawn whole blood are collected into one part trisodium citrate. Refer to Clinical & Laboratory
Standards Institute (CLSI) Document GP41 or GP43 for further instructions on specimen collection, handling and
storage8,9 . Sample storage time has not been found to influence measured parameters for up to 4 hours after blood
collection10 . Store citrated blood at room temperature, do not refrigerate.

10 Appendix
Additional materials
The following are not supplied and must be purchased separately.
Material Cat. No.

ROTEM sigma instrument 211000
ROTEM sigma ROTROL N 555201
ROTEM sigma ROTROL P 555202
Sarstedt blood collection tube vial adapter 415502
Table 10-5: Additional Materials
Quality Control
Two levels of controls are recommended for a complete quality control program11,12 . ROTEM sigma ROTROL N and
ROTEM sigma ROTROL P are designed for this program. Each laboratory should establish a quality control program to
monitor testing.
Results
Parameter CT A5 A10 A20 MCF LI60 LOT ML

Unit of Measure seconds mm mm mm mm % s %
Table 10-6: Results
Limitations/interfering substances
ROTEM results may be affected by many commonly administered drugs and supplements13-23 and further studies should
be made to determine the source of unexpected abnormal results. ROTEM sigma complete results are not affected by
tranexamic acid up to 60 µg/mL, ε-aminocaproic acid up to 600 µg/mL, acetylsalicylic acid up to 3 mg/dL, ticagrelor up to
0.1881 mg/dL, and lupus anticoagulant with a dRVVT screen/confirm ratio up to 1.34.
Heparin responsiveness:
No interference up to:
Unfractionated Heparin Low Molecular Weight Heparin

EXTEM C 5 U/mL 3 U/mL
FIBTEM C 5 U/mL 3 U/mL
APTEM C 5 U/mL 3 U/mL
Table 10-7: Heparin responsiveness
Most primary coagulation disorders (e.g. von Willebrand disease, platelet function disorders) are not detected in INTEM C,
EXTEM C, FIBTEM C, and APTEM C24-26 .
Local, non-systemic fibrinolysis may not be detected in INTEM C, EXTEM C, FIBTEM C, and APTEM C27 .
A significantly elevated or lowered hematocrit can influence thromboelastometry measurements28 .
In specific patient populations and clinical settings, parameters obtained with the ROTEM sigma system may show
different results as compared to the ROTEM delta system.
Serious incident reporting
Agency.

10 Appendix
Expected values
A normal range study was performed using 120 normal donor samples on the ROTEM sigma. Due to the many variables
which affect ROTEM results, each laboratory should determine its own normal range. Reference ranges may not be
identical to setting-specific values for clinical decision making1 .
INTEM C EXTEM C FIBTEM C APTEM C

CT (seconds) 139 - 202 48 - 72 N/A 50 - 73
A5 (mm) 37 - 55 33 - 51 5 - 14 30 - 49
A10 (mm) 47 - 64 44 - 61 5 - 15 41 - 59
A20 (mm) 54 - 70 53 - 68 5 - 16 49 - 66
MCF (mm) 55 - 71 54 - 70 5 - 17 52 - 68
LI60 (%) 93 - 100 94 - 100 100 95 - 100
ML* (%) 0-7 0-6 0 0-5
*ML data was calculated 60 minutes after CT.
Performance characteristics
Precision:
Precision was assessed over multiple runs using three lots of ROTEM sigma complete cartridges and three lots of
ROTEM sigma complete + hep cartridges with whole blood from normal donors. The highest CV % or standard deviation
(SD) values from this testing are recorded below:
INTEM C EXTEM C FIBTEM C APTEM C

CV % CV % CV % CV %
CT (seconds) ≤ 9.1 ≤ 9.9 N/A ≤ 8.0
A5 (mm) ≤ 7.3 ≤ 5.0 ≤ 10.2 ≤ 5.2
A10 (mm) ≤ 4.4 ≤ 3.3 ≤ 9.7 ≤ 3.9
A20 (mm) ≤ 2.9 ≤ 2.6 ≤ 7.6 ≤ 3.3
MCF (mm) ≤ 1.9 ≤ 2.3 ≤ 9.8 ≤ 2.7
LI60 (%) ≤ 1.5 ≤ 1.4 ≤ 0.0 ≤ 0.6
SD SD SD SD
ML* (%) ≤ 1.4 ≤ 1.3 ≤ 0.0 ≤ 0.6

10 Appendix
Method comparison
In external studies, the following data were obtained using ROTEM sigma cartridges on the ROTEM sigma compared to
the same assays performed on the ROTEM delta.
Test Parameter N Slope Intercept r

INTEM C CT (seconds) 396 1.08 -5.2 0.621
A5 (mm) 396 0.95 3.4 0.925
A10 (mm) 396 0.93 4.9 0.948
A20 (mm) 396 0.95 3.9 0.961
MCF (mm) 396 0.97 2.6 0.966
LI60 (%) 462 1.00 2.0 0.987
ML* (%) 462 1.00 -2.0 0.987
EXTEM C CT (seconds) 434 1.07 -1.3 0.812
A5 (mm) 434 0.88 8.2 0.932
A10 (mm) 434 0.86 10.1 0.946
A20 (mm) 434 0.88 9.7 0.953
MCF (mm) 434 0.93 6.9 0.959
LI60 (%) 506 1.00 2.0 0.986
ML* (%) 506 1.00 -2.0 0.986
FIBTEM C A5 (mm) 431 0.89 -0.3 0.917
A10 (mm) 431 0.91 -0.4 0.906
A20 (mm) 431 0.92 -0.3 0.900
MCF (mm) 431 1.00 -2.0 0.902
LI60 (%) 505 0.94 6.4 0.963
ML* (%) 505 0.94 0.0 0.963
APTEM C CT (seconds) 227 1.04 -3.3 0.801
A5 (mm) 227 0.82 8.5 0.925
A10 (mm) 227 0.83 10.3 0.945
A20 (mm) 227 0.86 10.1 0.958
MCF (mm) 227 0.91 7.9 0.966
Mean Percent
N
Difference Difference
LI60 (%) 213 2.3 2.4%
ML* (%) 216 -2.8 37.7%
These precision and correlation results were obtained using specific lots of cartridges.
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10 Appendix
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experimental pilot study in healthy volunteers. BMC Complement Altern Med. 2016; 16.
24. Schmidt DE, Majeed A, Bruzelius M, et al. A prospective diagnostic accuracy study evaluating rotational
thromboelastometry and thromboelastography in 100 patients with von Willebrand disease. Haemophilia. 2016;
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patients undergoing off-pump coronary artery bypass graft surgery: A prospective randomized study. PLoS One.
2017; 12.
26. Holck MH, Christensen TD, Hvas A-M. Influence of selected antithrombotic treatment on thromboelastometric
results. Scand J Clin Lab Invest. 2017; 78: 11-17.

10 Appendix
27. Raza I, Davenport R, Rourke C, et al. The incidence and magnitude of fibrinolytic activation in trauma patients. J
Thromb Haemost. 2013; 11: 307-14.
28. Solomon C, Rahe-Meyer N, Schöchl H, et al. Effect of haematocrit on fibrin-based clot firmness in the FIBTEM test.
Blood Transfus. 2012; 11: 412-18.
Appendix I: ROTEM sigma complete + hep, Instructions for Use

REF 555502
Intended Use
HEPTEM C):
4 assays are measured with one ROTEM sigma complete + hep cartridge:
INTEM C: recalcification of a sample and activation of the intrinsic coagulation pathway.
EXTEM C: recalcification of a sample and activation of the extrinsic coagulation pathway.
FIBTEM C: recalcification of a sample, activation of the extrinsic pathway, and in vitro platelet inhibition.
HEPTEM C: recalcification of a sample, activation of the intrinsic coagulation pathway, and in vitro heparin inactivation.
In a thromboelastometric measurement, clotting is continuously monitored. ROTEM results describe coagulation inclusive
of clot initiation, firmness, and stability. Deviation of results from established reference ranges may indicate a potential
disturbance in coagulation.
Abnormal results may be observed in the following situations1 :
INTEM C, EXTEM C, FIBTEM C: deficiency of coagulation factors or hypercoagulability

INTEM C, EXTEM C, FIBTEM C: fibrinogen deficiency and/or fibrin polymerization disorder (differentiation from
platelet deficiency possible by comparing EXTEM C and FIBTEM C amplitudes), or hyperfibrinogenemia
INTEM C, EXTEM C, FIBTEM C: thrombocytopenia (differentiation from hypofibrinogenemia possible by comparing
EXTEM C and FIBTEM C amplitudes)
INTEM C, HEPTEM C: presence of unfractionated heparin (compare INTEM C CT and HEPTEM C CT)

10 Appendix
ROTEM-guided bleeding management algorithms have been found to be effective in reducing transfusion requirements,
healthcare cost, complication rates, and mortality1 . Several randomized clinical trials, meta-analyses, and health
technology assessments have provided evidence that use of ROTEM-guided algorithms in bleeding patients improves
patient safety and outcomes, including peri-operative morbidity and mortality1-6 .
Composition
ROTEM sigma complete + hep (Cat. No. 555502): 20 single-use ROTEM sigma complete + hep cartridges
Constituents:
INTEM C: Ellagic acid, phospholipids, calcium chloride, preservatives, and buffer.
EXTEM C: Recombinant tissue factor, heparin inhibitor, phospholipids, calcium chloride, preservatives, and buffer.
FIBTEM C: Recombinant tissue factor, platelet inhibitors, heparin inhibitor, phospholipids, calcium chloride,
HEPTEM C: Ellagic acid, heparin inhibitor, phospholipids, calcium chloride, preservatives, and buffer.
Precautions:
Human blood should be handled with care, following the precautions recommended for biohazardous material7 .
Do not touch the needle in the sample position of the cartridge.

Warnings:
Hazard Class:
None
Hazard Statements:
None
4260160470327RN Reference ec.europa.eu/tools/eudamed.
Preparation
No preparation required. The ROTEM sigma complete + hep cartridge is ready-to-use.
Store at room temperature.
Unopened cartridges are stable until the expiration date shown on the label when stored at 15 - 25°C. Cartridges should
be used within 10 minutes of opening the sealed pouch.
Refer to section 6 of this User Manual for complete test procedure instructions.
Specimen collection and preparation
Nine parts of freshly drawn whole blood are collected into one part trisodium citrate. Refer to Clinical & Laboratory
Standards Institute (CLSI) Document GP41 or GP43 for further instructions on specimen collection, handling and
storage8,9 . Sample storage time has not been found to influence measured parameters for up to 4 hours after blood
collection10 . Store citrated blood at room temperature, do not refrigerate.

10 Appendix
Material Cat. No.

Sarstedt blood collection tube vial adapter 415502
Quality Control
Two levels of controls are recommended for a complete quality control program11,12 . ROTEM sigma ROTROL N and
ROTEM sigma ROTROL P are designed for this program. Each laboratory should establish a quality control program to
monitor testing.
Results
Parameter CT A5 A10 A20 MCF LI60 LOT ML

Unit of Measure seconds mm mm mm mm % s %
Table 10-9: Results
ROTEM results may be affected by many commonly administered drugs and supplements13-23 and further studies should
be made to determine the source of unexpected abnormal results. ROTEM sigma complete + hep results are not affected
by tranexamic acid up to 60 µg/mL, ε-aminocaproic acid up to 600 µg/mL, acetylsalicylic acid up to 3 mg/dL, ticagrelor up
to 0.1881 mg/dL, and lupus anticoagulant with a dRVVT screen/confirm ratio up to 1.34.
Heparin responsiveness:
No interference up to:
Unfractionated Heparin Low Molecular Weight Heparin

EXTEM C 5 U/mL 3 U/mL
FIBTEM C 5 U/mL 3 U/mL
HEPTEM C 7 U/mL 3 U/mL
Table 10-10: Heparin responsiveness
Most primary coagulation disorders (e.g. von Willebrand disease, platelet function disorders) are not detected in INTEM C,
EXTEM C, FIBTEM C, and HETEM C24-26 .
Local, non-systemic fibrinolysis may not be detected in INTEM C, EXTEM C, FIBTEM C, and HEPTEM C27 .
A significantly elevated or lowered hematocrit can influence thromboelastometry measurements28 .
In specific patient populations and clinical settings, parameters obtained with the ROTEM sigma system may show
different results as compared to the ROTEM delta system.
Agency.

10 Appendix
Expected values
A normal range study was performed using 120 normal donor samples on the ROTEM sigma. Due to the many variables
which affect ROTEM results, each laboratory should determine its own normal range. Reference ranges may not be
identical to setting-specific values for clinical decision making1
INTEM C EXTEM C FIBTEM C HEPTEM C

CT (seconds) 139 - 202 48 - 72 N/A 141 - 215
A5 (mm) 37 - 55 33 - 51 5 - 14 33 - 51
A10 (mm) 47 - 64 44 - 61 5 - 15 44 - 61
A20 (mm) 54 - 70 53 - 68 5 - 16 52 - 67
MCF (mm) 55 - 71 54 - 70 5 - 17 54 - 69
LI60 (%) 93 - 100 94 - 100 100 94 - 100
ML* (%) 0-7 0-6 0 0-6
Precision:
Precision was assessed over multiple runs using three lots of ROTEM sigma complete cartridges and three lots of
ROTEM sigma complete + hep cartridges with whole blood from normal donors. The highest CV % or standard deviation
(SD) values from this testing are recorded below:
INTEM C EXTEM C FIBTEM C HEPTEM C

CV % CV % CV % CV %
CT (seconds) ≤ 9.1 ≤ 9.9 N/A ≤ 3.9
A5 (mm) ≤ 7.3 ≤ 5.0 ≤ 10.2 ≤ 5.7
A10 (mm) ≤ 4.4 ≤ 3.3 ≤ 9.7 ≤ 3.9
A20 (mm) ≤ 2.9 ≤ 2.6 ≤ 7.6 ≤ 2.9
MCF (mm) ≤ 1.9 ≤ 2.3 ≤ 9.8 ≤ 2.5
LI60 (%) ≤ 1.5 ≤ 1.4 ≤ 0.0 ≤ 1.4
SD SD SD SD
ML* (%) ≤ 1.4 ≤ 1.3 ≤ 0.0 ≤ 1.3

10 Appendix
Method comparison
In external studies, the following data were obtained using ROTEM sigma cartridges on the ROTEM sigma compared to
the same assays performed on the ROTEM delta.
Test Parameter N Slope Intercept r

INTEM C CT (seconds) 396 1.08 -5.2 0.621
A5 (mm) 396 0.95 3.4 0.925
A10 (mm) 396 0.93 4.9 0.948
A20 (mm) 396 0.95 3.9 0.961
MCF (mm) 396 0.97 2.6 0.966
LI60 (%) 462 1.00 2.0 0.987
ML* (%) 462 1.00 -2.0 0.987
EXTEM C CT (seconds) 434 1.07 -1.3 0.812
A5 (mm) 434 0.88 8.2 0.932
A10 (mm) 434 0.86 10.1 0.946
A20 (mm) 434 0.88 9.7 0.953
MCF (mm) 434 0.93 6.9 0.959
LI60 (%) 506 1.00 2.0 0.986
ML* (%) 506 1.00 -2.0 0.986
FIBTEM C A5 (mm) 431 0.89 -0.3 0.917
A10 (mm) 431 0.91 -0.4 0.906
A20 (mm) 431 0.92 -0.3 0.900
MCF (mm) 431 1.00 -2.0 0.902
LI60 (%) 505 0.94 6.4 0.963
ML* (%) 505 0.94 0.0 0.963
HEPTEM C CT (seconds) 203 1.17 -20.3 0.797
A5 (mm) 203 0.92 3.0 0.883
A10 (mm) 203 0.93 3.6 0.903
A20 (mm) 203 0.96 2.4 0.920
MCF (mm) 203 1.00 1.0 0.946
LI60 (%) 238 0.91 11.4 0.990
ML* (%) 238 0.91 -2.3 0.990
These precision and correlation results were obtained using specific lots of cartridges.
Bibliography
1. Görlinger K, Pérez-Ferrer A, Dirkmann D, et al. The role of evidence-based algorithms for rotational
thromboelastometry-guided bleeding management. Korean J Anesthesiol. 2019; 72: 297-322.
2. Weber CF, Görlinger K, Meininger D, et al. Point-of-care testing: a prospective, randomized clinical trial of efficacy in
coagulopathic cardiac surgery patients. Anesthesiology. 2012; 117: 531-47.
3. Whiting P, Al M, Westwood M, et al. Viscoelastic point-of-care testing to assist with the diagnosis, management and
monitoring of haemostasis: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2015;
19: 1-228.
4. Deppe A, Weber C, Zimmermann J, et al. Point-of-care thromboelastography/ thromboelastometry-based
coagulation management in cardiac surgery: a meta-analysis of 8332 patients. J Surg Res. 2016; 203: 424-33.
5. Wikkelsø A, Wetterslev J, Møller AM, Afshari A. Thromboelastography (TEG) or thromboelastometry (ROTEM) to
monitor haemostatic treatment versus usual care in adults or children with bleeding. Cochrane Database of Syst
Rev. 2016(8):CD007871.

10 Appendix
6. Brohi K, Eaglestone S. Traumatic coagulopathy and massive transfusion: improving outcomes and saving blood.
Southampton (UK): NIHR Journals Library; 2017.
National Institutes of Health; 2007
8. CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard-Seventh
9. CLSI. Procedures for the Collection of Arterial Blood Specimens; Approved Standard-Fourth Edition.
CLSI document GP43-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2004.
10. Bohner J, von Pape KW. Method Dependent Reference Values and Pre-analytical Influences in Rotation
Thromboelastography. Ann Haematol. 2003; 82: 13.
11. CLSI. One Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved
Guideline – Second Edition. CLSI Document H47-A2. Wayne, PA: Clinical and Laboratory Standards Institute;
2008.
12. Zucker S, Cathey MH, West B. Preparation of Quality Control Specimens for Coagulation. Am J Clin Pathol. 1970;
53: 924-27.
13. Mittermayr M, Velik-Salchner C, Stalzer B, et al. Detection of Protamine and Heparin After Termination of
Cardiopulmonary Bypass by Thrombelastometry (ROTEM®): Results of a Pilot Study. Anesth Analg. 2009;
108: 743-50.
14. Vonk AB, Veerhoek D, Brom CE, et al. Individualized Heparin and Protamine Management Improves Rotational
Thromboelastometric Parameters and Postoperative Hemostasis in Valve Surgery. J Cardiothorac Vac Anesth. 2014;
28: 235-41.
15. Mittermayr M, Margreiter J, Velik-Salchner C, et al. Effects of protamine and heparin can be detected and easily
differentiated by modified thrombelastography (Rotem®): an in vitro study. Br J Anaesth. 2005; 95: 310-16.
16. Beiderlinden M, Werner P, Bahlmann A, et al. Monitoring of argatroban and lepirudin anticoagulation in critically ill
patients by conventional laboratory parameters and rotational thromboelastometry – a prospectively controlled
randomized double-blind clinical trial. BMC Anesthesiol. 2018; 18.
17. Comuth WJ, Henriksen LØ, Kerkhof DVD, et al. Comprehensive characteristics of the anticoagulant activity of
dabigatran in relation to its plasma concentration. Thromb Res. 2018; 164: 32-9.
18. Escolar G, Arellano-Rodrigo E, Lopez-Vilchez I, et al. Reversal of Rivaroxaban-Induced Alterations on Hemostasis by
Different Coagulation Factor Concentrates. Circ J. 2015; 79: 331-38.
19. Fontana P, Alberio L, Angelillo-Scherrer A, et al. Impact of rivaroxaban on point-of-care assays. Thromb Res. 2017;
153: 65-70.
20. Henskens YMC, Gulpen AJW, Oerle RV, et al. Detecting clinically relevant rivaroxaban or dabigatran levels by routine
coagulation tests or thromboelastography in a cohort of patients with atrial fibrillation. Thrombosis. 2018; 16.
21. Schmidt DE, Holmström M, Majeed A, et al. Detection of elevated INR by thromboelastometry and
thromboelastography in warfarin treated patients and healthy controls. Thromb Res. 2015; 135: 1007-11.
22. Taune V, Wallén H, Ågren A, et al. Whole blood coagulation assays ROTEM and T-TAS to monitor dabigatran
treatment. Thromb Res. 2017; 153: 76-82.
23. Bagge A, Schött U, Kander T. Effects of naturopathic medicines on Multiplate and ROTEM: a prospective
experimental pilot study in healthy volunteers. BMC Complement Altern Med. 2016; 16.
24. Schmidt DE, Majeed A, Bruzelius M, et al. A prospective diagnostic accuracy study evaluating rotational
thromboelastometry and thromboelastography in 100 patients with von Willebrand disease. Haemophilia. 2016;
23: 309-18.
25. Lee J, Jung C-W, Jeon Y, et al. Effects of preoperative aspirin on perioperative platelet activation and dysfunction in
patients undergoing off-pump coronary artery bypass graft surgery: A prospective randomized study. PLoS One.
2017; 12.
26. Holck MH, Christensen TD, Hvas A-M. Influence of selected antithrombotic treatment on thromboelastometric
results. Scand J Clin Lab Invest. 2017; 78: 11-17.
27. Raza I, Davenport R, Rourke C, et al. The incidence and magnitude of fibrinolytic activation in trauma patients.
J Thromb Haemost. 2013; 11: 307-14.
28. Solomon C, Rahe-Meyer N, Schöchl H, et al. Effect of haematocrit on fibrin-based clot firmness in the FIBTEM test.
Blood Transfus. 2012; 11: 412-18.

10 Appendix
Appendix J: ROTEM sigma ROTROL N, Instructions for Use

REF 555201
Intended Use
ROTEM sigma ROTROL N is a Level 1 quality control intended for the assessment of accuracy and precision of INTEM C,
EXTEM C, FIBTEM C, APTEM C, and HEPTEM C on the ROTEM sigma system.
For use in the point of care (near-patient test) and laboratory settings.
ROTEM sigma ROTROL N may be used with ROTEM sigma cartridges to verify reagent performance. Quality control
performed with ROTEM sigma ROTROL N may be used to verify appropriate handling and storage after each new
shipment of ROTEM sigma cartridges, or at intervals specified by the institutional quality control program. A control sheet
provided with each kit includes target ranges against which the user should compare results.
Composition
Each ROTEM sigma ROTROL N kit consists of:
ROTEM sigma ROTROL N Lyo (Cat. No. 555203): 5 x 4 mL vials of lyophilized human plasma with stabilizers and
buffers.
ROTEM sigma ROTROL N Dil (Cat. No. 555205): 5 x 4 mL diluent vials with preservatives and buffer.
ROTEM sigma ROTROL adapter (Cat. No. 415501): 5 adapters to fit the control vial onto the test cartridge.
Precautions:
This kit contains material of human and animal origin and may transmit infectious agents and should be handled with
extreme caution. No known test method can offer complete assurance that products derived from human sources will not
transmit infectious agents.
All donor animals were sourced from BSE-free herds. The cattle received ante- and post-mortem health inspection by a
veterinarian and were apparently free from infectious and contagious material.
The human derived material in this product was tested and found nonreactive for Hepatitis B Surface Antigen (HBsAg),
HCV, and HIV antibodies at the donor stage. Handle as if potentially infectious1 .
Warnings:
Hazard Class:
None
Hazard Statements:
None
4260160470341RG Reference ec.europa.eu/tools/eudamed.

10 Appendix
Preparation
Allow the control material to reach room temperature (15 - 25 °C). To dissolve, pour the contents of the Dil vial into the
Lyo vial. Attach the screw-on adapter and swirl to dissolve. Make sure of the complete reconstitution of the product. Small
particles may remain after reconstitution. These particles are not a sign of deterioration of the control and have no
influence on control results. Keep the control at room temperature for 15 minutes. Invert and swirl 10 times before use.
Unopened ROTEM sigma ROTROL N is stable until the expiration date when stored at 2 - 8 °C.
Reconstituted ROTEM sigma ROTROL N is stable for 8 hours at 2 - 8 °C.
After reconstitution, ROTEM sigma ROTROL N should be handled in the same manner as a whole blood sample. Refer to
Section 6.5.5 for complete instructions on performing a measurement. Measurement of quality control samples should be
continued until results for A5, A10, and A20 are obtained.
Material Cat. No.

ROTEM sigma complete 555501
ROTEM sigma complete + hep 555502
The control is subjected to the limitations of the assay system. Deviations may indicate possible problems with one or
more components in the test system.
ROTEM sigma ROTROL N quality control material is designed to assess the activator in each assay. The function of
heparin inhibitors (FIBTEM C, EXTEM C, APTEM C, and HEPTEM C), fibrinolysis inhibitors (APTEM C), and platelet
inhibitors (FIBTEM C) is not assessed with this control material.
Agency.
Expected values
Each lot of ROTEM sigma ROTROL N is supplied with lot-specific target ranges. Any properly functioning ROTEM sigma
system should yield values within these target ranges.
Within run and total precision was assessed over multiple runs using specific lots of reagents and controls.
The coefficient of variation for all parameters (CT, A5, A10, A20) was <10% for INTEM C, EXTEM C, FIBTEM C, and
HEPTEM C, and <12.5% for APTEM C.
Bibliography
National Institutes of Health; 2007.

10 Appendix
Appendix K: ROTEM sigma ROTROL P, Instructions for Use

REF 555202
Intended Use
ROTEM sigma ROTROL P is a Level 2 quality control intended for the assessment of accuracy and precision of INTEM C,
EXTEM C, FIBTEM C, APTEM C, and HEPTEM C on the ROTEM sigma system.
For use in the point of care (near-patient test) and laboratory settings.
ROTEM sigma ROTROL P may be used with ROTEM sigma cartridges to verify reagent performance. Quality control
performed with ROTEM sigma ROTROL P may be used to verify appropriate handling and storage after each new
shipment of ROTEM sigma cartridges, or at intervals specified by the institutional quality control program. A control sheet
provided with each kit includes target ranges against which the user should compare results.
Composition
Each ROTEM sigma ROTROL P kit consists of:
ROTEM sigma ROTROL P Lyo (Cat. No. 555204): 5 x 4 mL vials of lyophilized human plasma with stabilizers and
buffers.
ROTEM sigma ROTROL P Dil (Cat. No. 555206): 5 x 4 mL diluent vials with preservatives and buffer.
ROTEM sigma ROTROL adapter (Cat. No. 415501): 5 adapters to fit the control vial onto the test cartridge.
Precautions:
This kit contains material of human and animal origin and may transmit infectious agents and should be handled with
extreme caution. No known test method can offer complete assurance that products derived from human sources will not
transmit infectious agents.
All donor animals were sourced from BSE-free herds. The cattle received ante- and post-mortem health inspection by a
veterinarian and were apparently free from infectious and contagious material.
The human derived material in this product was tested and found nonreactive for Hepatitis B Surface Antigen (HBsAg),
HCV, and HIV antibodies at the donor stage. Handle as if potentially infectious1 .
Warnings:
Hazard Class:
None
Hazard Statements:
None
4260160470358RZ Reference ec.europa.eu/tools/eudamed.

10 Appendix
Preparation
Allow the control material to reach room temperature (15 - 25 °C). To dissolve, pour the contents of the Dil vial into the
Lyo vial. Attach the screw-on adapter and swirl to dissolve. Make sure of the complete reconstitution of the product. Small
particles may remain after reconstitution. These particles are not a sign of deterioration of the control and have no
influence on control results. Keep the control at room temperature for 15 minutes. Invert and swirl 10 times before use.
Unopened ROTEM sigma ROTROL P is stable until the expiration date when stored at 2 - 8 °C.
Reconstituted ROTEM sigma ROTROL P is stable for 8 hours at 2 - 8 °C.
After reconstitution, ROTEM sigma ROTROL P should be handled in the same manner as a whole blood sample. Refer to
Section 6.5.5 for complete instructions on performing a measurement. Measurement of quality control samples should be
continued until results for A5, A10, and A20 are obtained.
Material Cat. No.

ROTEM sigma complete 555501
ROTEM sigma complete + hep 555502
The control is subjected to the limitations of the assay system. Deviations may indicate possible problems with one or
more components in the test system.
ROTEM sigma ROTROL P quality control material is designed to assess the activator in each assay. The function of
heparin inhibitors (FIBTEM C, EXTEM C, APTEM C, and HEPTEM C), fibrinolysis inhibitors (APTEM C), and platelet
inhibitors (FIBTEM C) is not assessed with this control material.
Agency.
Expected values
Each lot of ROTEM sigma ROTROL P is supplied with lot-specific target ranges. Any properly functioning ROTEM sigma
system should yield values within these target ranges.
Within run and total precision was assessed over multiple runs using specific lots of reagents and controls. The
coefficient of variation for all parameters (CT, A5, A10, A20) was <10% for INTEM C, EXTEM C, FIBTEM C, APTEM C, and
HEPTEM C.
Bibliography
National Institutes of Health; 2007.

User Manual
ROTEM® sigma P/N 000600370
Rev. 02 September 2022
Tem Innovations GmbH, Martin-Kollar-Strasse 15, 81829 Munich, Germany

En - HDSD L00600370 Rev 02

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User Manual

ROTEM® sigma P/N 000600370

Tem Innovations GmbH, Martin-Kollar-Strasse 15, 81829 Munich, Germany

Manual Version Software Version Date Changes

REV. 00 5.1.2 02-2022 Initial release

REV. 01 5.2.0 07-2022 Administrative updates and alignment to software revision

Tem Innovations GmbH

This user manual is published by the manufacturer.

P/N 000600370 Rev. 02 · ROTEM® sigma User Manual 3 of 98

1.1 Subject to change and validity

1.4 Further applicable documents

1.5 Safety information

P/N 000600370 Rev. 02 · ROTEM® sigma User Manual 4 of 98

1.6 Typographical conventions

1.6.1 Used abbreviations

Abbreviation Applied for

1.6.2 Text conventions

Identification Applied for Example

P/N 000600370 Rev. 02 · ROTEM® sigma User Manual 5 of 98

1.6.3 Warning concept

The respective symbol is shown if it is a matter of biohazard (Table 1-3).

Symbol Applied in Relevance

Warning message Refers to biohazard.

Table 1-3: Applied symbols in the warning concept

1.6.4 Strategic concept

1.7 Intended User

P/N 000600370 Rev. 02 · ROTEM® sigma User Manual 6 of 98

2.1 General safety instructions

2.2 Intended use

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2.3 Ambient conditions

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2.5 Personal protection

2.5.2 Electrical hazard

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2.6 Cautions or Warnings

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3.1 Site installation requirements

ROTEM sigma installation:

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The ROTEM sigma system consists of (Appendix F)(Appendix G):

List of Materials Required but Not Provided With the Instrument

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Figure 4-1: Components of the ROTEM sigma

No. System Overview Description

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4.1.2 Test cartridges

Figure 4-2: ROTEM sigma test cartridge

4.1.3 Additional Items

4.1.3.1 Printer (optional)

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Figure 4-3: Main screen of the system software

Module Description Details

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4.3 Specifications and Performance Characteristics

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5.2 The ROTEM measuring principle

1 Hartert, H. Blutgerinnungsstudien mit der Thrombelastographie. Cent Eur J Med. 1948;26:577–83

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Figure 5-1: Principle of thromboelastometry with ROTEM sigma

1 Axis (4.75 °) 7 Cartridge cup filled with blood

5.3 Reaction curve and parameters in thromboelastometry

5.3.1 Reaction curve

Dispose of the cartridge with the blood sample still attached.