ROTEM sigma Operating Manual Ver 3.2.0.01 sw 3.2.0 and higher July 2015

©2015 Tem Innovations GmbH. 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

3.2.0.01.EN

3.2.0 and higher

07-2015

first version

Manual Version: 3.2.0.01.EN Software Version: 3.2.0 Release Date: 07/2015 Reference Number: REF 216001-EN This operating manual is published by the manufacturer. Tem Innovations GmbH Martin-Kollar-Str. 13-15 D-81829 Munich/Germany 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 Operating 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 DE4437 475 C1 US5777215 A WO96/12954

Printed in Germany

© Tem Innovations GmbH ROTEM® sigma Manual 3.2.0.01.EN 2015

ROTEM® sigma Manual 3.2.0.01.EN 2015 ©Tem Innovations GmbH

Table of contents

Table of contents 1

Introduction...1-1

1.1

Subject to change and validity ...1-1

1.2

Completeness...1-1

1.3

Depository...1-1

1.4

Further applicable documents ...1-1

1.5

Typographical conventions ...1-2

1.5.1 1.5.2 1.5.3 1.5.4

Used abbrevations ... 1-2 Text conventions ... 1-3 Warning concept ... 1-3 Strategic concept... 1-3

1.6

Target group...1-4

2

Safety...2-1

2.1

General safety instructions ...2-1

2.2

Intended use ...2-1

2.3

Ambient conditions ...2-2

2.4

Safety standards ...2-3

2.5

Personal protection...2-4

2.5.1 2.5.2

Biohazards ... 2-4 Electrical hazard... 2-4

2.6

Residual risks ...2-5

3

Basics ...3-1

3.1

Introduction ...3-1

3.2

The ROTEM® measuring principle...3-1

3.3

Reaction curve and parameters in thromboelastometry ...3-3

3.3.1 3.3.2 3.3.3

Reaction curve ... 3-3 The most important routine parameters ... 3-4 Reference ranges... 3-7

3.4

ROTEM® differential analysis...3-7

3.4.1

The citrated blood sample ... 3-8

3.4.2

ROTEM® tests ... 3-8

© Tem Innovations GmbH ROTEM® delta Manual 3.2.0.01.EN 2015

Table of contents

4

System description ...4-1

4.1

Scope of supply... 4-1

4.2

Hardware... 4-2

4.2.1 4.2.2

Components ...4-2 Accessories ...4-3

4.3

Software ... 4-4

4.3.1

Technical data...4-5

5

Measurement ...5-1

5.1

Introduction... 5-1

5.1.1

Sample handling ...5-2

5.2

Measurement preparation ... 5-3

5.2.1

Switching on the ROTEM® system ...5-3

5.3

Performing patient measurements ... 5-4

5.3.1 5.3.2 5.3.3 5.3.4

Start measurement ...5-4 Change/complete patient data during measurement...5-5 Graphics of measurement results...5-6 Warning messages during measurement ...5-7

5.4

Finish measurement... 5-8

5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7 5.4.8

Stop measurement ...5-8 Print measurement results...5-8 Save and clear measurement...5-8 Discard measurement...5-9 Remove cartridge ...5-9 Log off the system ...5-9 Daily maintenance ...5-9 Switch off ...5-10

5.5

Quality control ... 5-10

5.5.1 5.5.2 5.5.3

Control intervals... 5-11 Continuous self-monitoring when powered on... 5-11 System QC ... 5-11

5.5.4

QC with ROTEM® sigma ROTROL N / P ...5-12

5.6

Managing measurement results in the database... 5-14

5.6.1 5.6.2 5.6.3 5.6.4

Find a patient / QC result...5-14 Print patient / QC results...5-15 Export patient or QC results to USB stick...5-16 Backup...5-17

ROTEM® delta Manual 3.2.0.01.EN 2015 © Tem Innovations GmbH

Table of contents

5.7

Troubleshooting ...5-18

5.7.1 5.7.2

Warning screen errors... 5-18 Incorrect TEMograms... 5-19

6

System software ...6-1

6.1

Operating elements ...6-1

6.2

Measurement module ...6-1

6.2.1 6.2.2 6.2.3 6.2.4 6.2.5

Start screen ... 6-2 Multi-TEM ... 6-2 Measurement ... 6-4 Screenshots ... 6-5 Overlays ... 6-5

6.3

Database ...6-5

6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 6.3.7

Database user interface ... 6-5 Manual selection of patient / QC results... 6-7 Selecting patient / QC results using the search form ... 6-7 Making patient / QC results available for processing ... 6-8 Printing ... 6-8 Exporting ... 6-8 Evaluating patient or QC results... 6-11

6.4

Setup ...6-16

6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 6.4.7 6.4.8

User Setup ... 6-17 Online setup ... 6-18 Remote access ... 6-20 Printer setup ... 6-21 Test setup ... 6-23 Parameter setup... 6-24 Comment setup ... 6-25 ROTROL setup ... 6-25

6.5

Service...6-28

6.5.1 6.5.2 6.5.3

Information ... 6-28 Settings ... 6-28 Log book ... 6-29

6.6

File system...6-31

6.6.1 6.6.2

Admin Tools... 6-31 User... 6-36

6.7

USB stick ...6-36

6.7.1

Update... 6-37

6.7.2

Importing data from the USB stick into Excel® ... 6-37

© Tem Innovations GmbH ROTEM® delta Manual 3.2.0.01.EN 2015

Table of contents

7

Initiation and installation ...7-1

7.1

Initiation ... 7-1

7.1.1 7.1.2 7.1.3

Open package ...7-1 Touch screen preparation ...7-1 Site installation requirements...7-1

7.2

Installation ... 7-3

8

Maintenance, cleaning, disinfection ...8-1

8.1

Introduction... 8-1

8.2

Maintenance plan ... 8-2

8.2.1 8.2.2 8.2.3 8.2.4 8.2.5

Daily maintenance ...8-3 Weekly maintenance ...8-3 Quarterly maintenance ...8-3 Yearly maintenance ...8-6 Every 3 years...8-6

9

Placing out of operation, transport and disposal...9-1

9.1

Placing out of operation... 9-1

9.2

Transport ... 9-1

9.3

Disposal... 9-1

10

Appendix ...10-1

ROTEM® delta Manual 3.2.0.01.EN 2015 © Tem Innovations GmbH

Introduction

1

Introduction This operating manual applies to the ROTEM® sigma system with the respective ROTEM® software. It is part of the product and describes the intended use and safe exposure during the whole product life cycle. In this document the terms ROTEM® and ROTEM® system always refer to ROTEM® sigma.

1.1

Subject to change and validity The information in this manual concerns the approved technical specifications at the time of printing. Significant amendments will be considered 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 mentioned in the footer.

1.2

Completeness This operationd manual is only complete with further applicable documents for the respective application.

1.3

Depository This manual as well as further applicable documents for the respective application have to be kept within reach and always accessible near by 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 instructions for use (IFU = Instruction for use) for the reagents and control kits regarding specific sample requirements, execution of tests, limits of the method and of interpretation of the results. Furthermore please refer to the universally valid, legal or other binding regulations of european and national law, as well as to the effective regulations for prevention of accidents and environmental protection applicable in your country.

© Tem Innovations GmbH ROTEM® sigma Manual 3.2.0.01.EN 2015

Page 1 - 1

Introduction

1.5

Typographical conventions This section shows the applied abbrevations, symbols and textual accentuations.

1.5.1

Used abbrevations Table 1-1 shows used abbrevations in this document. Abbreviation

Applied for

A(x)

Amplitude after (x) minutes

AIDS

Acquired Immune Deficiency Syndrome

CFT

Clot Formation Time

CT

Clotting Time

DB

Database

HBsAg

Hepatitis B Surface Antigen

HCV

Hepatitis C Virus

HIV

Humane Immunodeficiency Virus

ID

Identification (e.g.: patient ID, sample ID, etc. )

IFU

Instructions For Use

INR

International Normalised Ratio

IVD

In Vitro Diagnostic

LAN

Local Area Network

LI(x)

Lysis Index (after (x) 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

TEM

TEMogram

α

Alpha angle

Table 1-1: Used abbrevations

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ROTEM® sigma Manual 3.2.0.01.EN 2015 ©Tem Innovations GmbH

Introduction

1.5.2

Text conventions Table 1-2 shows applied accentuations in this document. Indentification

Applied for

Example

<>

Keyboard entries

<Enter>

Small capitals

Surface texts

DATABASE

Bold

Buttons

Exit

Italic

Input field

Patient ID

Table 1-2: Text conventions

1.5.3

Warning concept Warning messages in this document are constructed as follows:

Danger Consequences  Precautions

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

Symbol

Applied in

Relevance

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

1.5.4

Strategic concept Operation procedure instructions in this document are constructed as follows: Purpose of action

 Assumption of action (optional) 1. Action undertaken  Intermediate result (optional) 2. Action undertaken ... Action result (optional)

© Tem Innovations GmbH ROTEM® sigma Manual 3.2.0.01.EN 2015

Page 1 - 3

Introduction

1.6

Target group This document is adressed to qualified hospital staff, working in the field of haemostasis. • Physicians (mostly anaesthesists and laboratory physicians) • Laboratory technicians • Perfusionists and others

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ROTEM® sigma Manual 3.2.0.01.EN 2015 ©Tem Innovations GmbH

Safety

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 operating manual carefully to acquaint yourself with the equipment. • Special attention should be paid to the information provided in this chapter. • Please note the instructions mentioned in Appendix A regarding the applied symbols for the equipment and catridges. • Before performing measurements and quality controls, please read the instructions of the cartridges and controls.

2.2

Intended use ROTEM® Thromboelastometry systems are designed for in vitro diagnostics in the POC (Point of Care) field and in hospital laboratories. The ROTEM® system is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample. Different parameters of coagulations are measured, analysed, monitored and interpreted (constitution of clot) for this purpose. Additionally, the ROTEM® system records the kinetic changes in a sample of citrated whole blood as the sample clot retracts and/or lyses (breaks apart). 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 coagulation laboratory tests. The equipment is not evaluated to measure veterinary or other non-human samples. Non-intended usage means all other usage of the ROTEM® sigma than described in this manual.

© Tem Innovations GmbH ROTEM® sigma Manual 3.2.0.01.EN 2015

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Safety

2.3

Ambient conditions For the proper operating of the ROTEM® sigma please note the requirements within the work environment as follows: Operating temperature

+18 °C to +30 °C

Storage temperature range

+0 °C to +50 °C

Relative humidity range (transport, storage)

0% to 85%

Relative humidity range (operating)

0% to 65%

Air pressure (operating, storage,

700 hPa to 1060 hPa

transport) Operable to height above sea level

3000 m

Distance from examined, treated or monitored patients

> 1.5 m

Pollution degree

2

Table 2-1: Ambient conditions

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ROTEM® sigma Manual 3.2.0.01.EN 2015 ©Tem Innovations GmbH

Safety

2.4

Safety standards The in-vitro diagnostic equipment of the ROTEM® category has been manufactured in compliance with EC Directive 98/79/EC of October 27, 1998 (including Corrigendum to Directive 98/79/EC) regarding in-vitro diagnostic equipment (IVD guideline). The equipment has been manufactured in accordance with the following standards: IEC 61010-1:2010 Safety requirements for electrical equipment for measurement, control and laboratory use. Part 1: General requirements (EN 61010-1:2010) IEC 61010-2-081:2001 + A1:2003 Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes IEC 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (EN 61010-2-101:2002) IEC 60601-1-2:2007 (Modified) Medical electrical equipment. Part1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests excluding chapter 5: Markings, Inscriptions and Accompanying Documents (EN 60601-1-2:2007) IEC 61326-1:2012 Electrical equipment for measurement, control and laboratory use EMC requirements - Part 1: General requirements (EN 61326-1:2013) IEC 61326-2-6:2005 Electrical equipment for measurement, control and laboratory use EMC requirements. Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (EN 61326-2-6:2006) The equipment uses RF energy only for its internal function. Therefore, its RF-emissions are very low and are not likely to cause any interference in nearby electronic equipment. This equipment is suitable for use in all establishments other than domestic. The equipment fulfils this safety requirements when it is leaving the manufacturing site1.

1

See Declaration of conformity (Appendix D)

© Tem Innovations GmbH ROTEM® sigma Manual 3.2.0.01.EN 2015

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Safety

2.5

Personal protection

2.5.1

Biohazards Always treat test samples as a potential biohazard and ensure proper handling and disposal of the samples. • Always use personal protective equipment, such as laboratory coat, gloves and goggles when handling samples. • Adhere to local statutory provisions for proper disposal (general recommendation, available in Laboratory Biosafety Manual World Health Organization, 1984).

2.5.2

Electrical hazard

Danger of life Misuse of electrical equipment can cause electrocution or death by burning.  Always adhere to basic safety precautions for electrical equipment.  Don’t touch the patient and the device at the same time.  Any adjustments, service or repairs that have to be carried out while the equipment is energised, may only be performed by qualified service personnel for ROTEM® systems.  Do not leave the equipment unattended while it is plugged in.  The equipment is supplied with an external grounded power cable. Connect the equipment only to an grounded power socket. Utilised adaptors have to be grounded, equally.  Keep equipment dry. If equipment gets wet, unplug it before touching.  Utilise only original accessories (Appendix G).  Do not switch the equipment on if it is damaged. Contact qualified service personnel.  If the power cable (instrument plug) is lost or damaged, it must be replaced by an original power cable (Appendix G).

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ROTEM® sigma Manual 3.2.0.01.EN 2015 ©Tem Innovations GmbH

Safety

2.6

Residual risks Adhere to following instructions for the safe usage 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 children or disabled persons. Use the equipment only for purposes described in this operating 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® systems. • If safe operation is not guaranteed, usage of the ROTEM® system has to be discontinued and further usage has to be prevented. • 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 operating manual, do not stuff or put anything into the openings, tubes or couplings of the equipment. • Do not use the ROTEM® sigma near 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 shocks.

© Tem Innovations GmbH ROTEM® sigma Manual 3.2.0.01.EN 2015

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Safety

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ROTEM® sigma Manual 3.2.0.01.EN 2015 ©Tem Innovations GmbH

Basics

3

Basics

3.1

Introduction The ROTEM® system is a further development of classical thromboelastography developed by Hartert. The ROTEM® sigma Thromboelastometry systems are designed for in vitro diagnostics in the POC (Point of Care) field or in hospital laboratories. The system is intended to provide a quantitative and qualitative indication of the coagulation state of a blood sample. The system records the kinetic changes in a sample of citrated whole blood during clot formation as well as when the sample clot retracts and/or lyses (breaks apart). Different parameters of the clotting are measured, analysed, monitored, interpreted, and charted for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between components like coagulation factors and inhibitors, fibrinogen, thrombocytes, and the fibrinolysis system. Additionally, the effect of certain drugs influencing haemostasis, in particular anticoagulants, can be detected.

3.2

The ROTEM® measuring principle The patented ROTEM® technology is based on a fixed cylindrical cup and a permanently oscillating vertical axis (Figure 3-1). The axis is supported by a high precision ball bearing and oscillates to the left and to the right through an angle of 4.75 °. The rotation of the axis is driven by a motor that is connected to the axis via an elastic spring. For the measurement, the channel’s measurement axis moves down into the plastic pin (6 mm diameter) in the disposable cartridge. The blood sample is filled into the cartridge cup (8 mm diameter). Hence, the plastic pin is immersed into the blood sample. The rotation is detected optically via a mirror plate at the upper end of the axis, a diode as light source and a light sensitive sensor (CCD Chip). If no clotting takes place, the movement is not obstructed. When a clot is formed and attaches itself between pin and cup surfaces, the movement is 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 results of the measurement are interpreted with special software (Chapter 6).

© Tem Innovations GmbH ROTEM® sigma Manual 3.2.0.01.EN 2015

Page 3 - 1

Basics

Figure 3-1: Principle of thromboelastometry with ROTEM® sigma 1 2 3 4 5 6

Page 3 - 2

Axis (~4.75 °) Spring Light source/diode Mirror Detection device (electric camera) Sensor pin

7 8 9 10 11

Cartridge cup filled with blood Fibrin fibres and thrombocyte aggregate Heated cartridge Ball bearings Data processing

ROTEM® sigma Manual 3.2.0.01.EN 2015 ©Tem Innovations GmbH