ROTEM delta Operating Manual Ver 2.2.0.01 EN May 2015

©2002, 2005, 2007, 2008, 2009, 2010, 2012 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

1.5.3.01.EN

1.5.3

08-2008

first version

1.6.0.01.EN

1.6.0

04-2009

actualization with new SW

1.6.0.02.EN

1.6.0

11-2010

actualization (including new company name and logo) and update with "important note EN_091013"

2.2.0.01.EN

2.2.0

05-2012

actualization with new software version

Manual Version:2.2.0.01.EN Software Version:2.2.0 Release Date: 05/2012 Reference Number:REF 200137-EN This User 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® delta Manual 2.2.0.01.EN 2012

Page 1 - 3

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

Help function...1-4

1.7

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

System description ...3-1

3.1

Scope of supply ...3-1

3.2

Hardware ...3-3

3.2.1 3.2.2

Components ... 3-3 Accessories ... 3-5

3.3

Software...3-6

3.3.1

Technical data ... 3-7

4

Basics ...4-1

4.1

Introduction ...4-1

© Tem Innovations GmbH ROTEM® delta Manual 2.2.0.01.EN 2012

Page 2 - 1

Table of contents

4.2

The ROTEM® measuring principle ... 4-1

4.3

Reaction curve and parameters in thromboelastometry... 4-3

4.3.1 4.3.2 4.3.3 4.3.4

Reaction curve...4-3 The most important routine parameters...4-4 Research parameters ...4-7 Reference ranges ...4-8

4.4

ROTEM® differential analysis ... 4-9

4.4.1

The citrated blood sample ...4-9

4.4.2

ROTEM® tests ...4-10

5

Measurement ...5-1

5.1

Introduction... 5-2

5.1.1 5.1.2

Usage of the pipette ...5-2 Sample handling ...5-3

5.2

Measurement preparation ... 5-4

5.2.1 5.2.2 5.2.3 5.2.4 5.2.5

Switching on the ROTEM® system ...5-4 Reagent preparation ...5-5 Refill cups and tips...5-6 Measuring cell preparation ...5-6 Sample preparation ...5-7

5.2.6 5.2.7 5.2.8 5.2.9

Adjust measurement temperature at the ROTEM®...5-7 Select Channel ...5-8 Select test ...5-8 Enter patient data ...5-8

5.3

Performing measurements ... 5-10

5.3.1 5.3.2 5.3.3 5.3.4

Start measurement ... 5-11 Graphics of measurement results...5-12 Warning messages during measurement ...5-13 Interpretation of measurement results ...5-14

5.4

Finish measurement... 5-14

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 ...5-14 Print measurement results...5-14 Clear channel...5-14 Discard Channel ...5-15 Remove measuring cells ...5-15 Log off the system ...5-16 Daily maintenance ...5-16 Switch off ...5-16

Page 2 - 2

ROTEM® delta Manual 2.2.0.01.EN 2012 © Tem Innovations GmbH

Table of contents

5.5

Quality control...5-17

5.5.1 5.5.2 5.5.3 5.5.4 5.5.5 5.5.6

Control intervals ... 5-17 Continuous self-monitoring when powered on ... 5-18 Preparation of quality control material... 5-18 Performance of the quality control... 5-19 Check quality control results ... 5-20 Suggested actions for QC out of range ... 5-21

5.6

Managing measurement results in the database ...5-22

5.6.1 5.6.2 5.6.3 5.6.4

Find a measurement / QC result ... 5-22 Print measurements / QC results ... 5-23 Export patient measurements or QC results to USB stick... 5-23 Backup ... 5-24

5.7

Troubleshooting ...5-25

5.7.1 5.7.2 5.7.3

Warning screen errors... 5-25 Errors during pipetting ... 5-26 Incorrect TEMograms... 5-26

6

System software ...6-1

6.1

Operating elements ...6-1

6.2

Measurement module ...6-2

6.2.1 6.2.2 6.2.3 6.2.4 6.2.5

Preparation... 6-2 Measurement ... 6-3 Multi-TEM ... 6-4 Screenshots ... 6-4 Overlays ... 6-4

6.3

Database ...6-4

6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 6.3.7

Database user interface ... 6-4 Manual selection of patient measurements / QC results ... 6-6 Selecting measurements (patients or QC) using the search form... 6-7 Making measurements (patients or QC) available for processing... 6-7 Printing ... 6-7 Exporting ... 6-8 Evaluating measurement or QC results ... 6-11

6.4

Setup ...6-15

6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6

User Setup ... 6-16 Online setup ... 6-17 Remote access ... 6-19 Printer setup ... 6-20 Test setup ... 6-21 Parameter setup... 6-23

© Tem Innovations GmbH ROTEM® delta Manual 2.2.0.01.EN 2012

Page 2 - 3

Table of contents

6.4.7

Comment setup ...6-24

6.5

Service ... 6-25

6.5.1 6.5.2

Information...6-25 Settings...6-25

6.6

Liquitrans... 6-27

6.7

File system ... 6-28

6.7.1 6.7.2

Admin Tools ...6-28 User ...6-32

6.8

USB stick... 6-32

6.8.1

Update ...6-33

6.8.2

Importing data from the USB stick into Excel® ...6-33

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...7-2

7.2

Installation ... 7-3

8

Maintenance, cleaning, disinfection ...8-1

8.1

Introduction... 8-1

8.2

Maintenance plan ... 8-1

8.2.1 8.2.2 8.2.3 8.2.4 8.2.5 8.2.6

Daily maintenance ...8-3 Weekly maintenance ...8-3 Quarterly maintenance ...8-3 Semi-annual maintenance ...8-7 Yearly maintenance ...8-8 Every 3 years...8-8

8.3

Maintenance of the ROTEM® electronic eLine pipette ... 8-9

8.3.1 8.3.2 8.3.3

Replacement of the pipette filter ...8-9 Cleaning of the pipette surface ...8-9 Cleaning and disinfection of individual parts...8-10

8.3.4

Check and calibrate ROTEM® eLine pipette...8-13

8.3.5 8.3.6 8.3.7

Functional check of the ROTEM® eLine pipette ...8-13 New calibration ...8-13 Troubleshooting ...8-14

9

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

9.1

Placing out of operation... 9-1

Page 2 - 4

ROTEM® delta Manual 2.2.0.01.EN 2012 © Tem Innovations GmbH

9.2

Transport... 9-1

9.3

Disposal ... 9-1

10

Appendix... 10-1

11

Index...11-1

© Tem Innovations GmbH ROTEM® delta Manual 2.2.0.01.EN 2012

Page 2 - 5

Introduction

1

Introduction This operating manual applies to the ROTEM® delta 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® delta.

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 system reagents and consumables are available for the ROTEM® delta 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® delta Manual 2.2.0.01.EN 2012

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

Signification

A(x) ACF AIDS AR(x) AUC CFR CFT CLR CT DB G HBsAg HCV HIV ID IFU INR IVD LAN LI(x) LIS LOT LT MA maxVel MCE MCF ML N P POC QC REF RO RW SN TEM t-MaxVel TPI VNC Į

Amplitude after (x) minutes Actual Clot Firmness Acquired Immune Deficiency Syndrome ARea under the curve at time (x) Area under the Curve (from the first derivative) Clot Formation Rate Clot Formation Time Clot Lysis Rate (Lyse Rate) Clotting Time Database Elastic shear modulus Hepatitis B Surface Antigen Hepatitis C Virus Humane Immunodeficiency Virus Identification (e.g.: patient ID, sample ID, etc. ) Instruction For Use International NormaliSed Ratio In Vitro Diagnostic Local Area Network Lysis Index (after (x) minutes) Laboratory Information System Lysis Onset Time Lysis Time Maximum Amplitude Maximum Velocity Maximum Clot Elasticity Maximum Clot Firmness Maximum Lysis Normal (for QC or blood samples) Pathological (for QC or blood samples) Point Of Care Quality Control Reference Number Read Only Read and Write Serial Number TEMogram Time to Maximum Velocity Thrombodynamic Potential Index Virtual Network Computing Alpha angle

Table 1-1: Used abbrevations

Page 1 - 2

ROTEM® delta Manual 2.2.0.01.EN 2012 ©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

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® delta Manual 2.2.0.01.EN 2012

Page 1 - 3

Introduction

1.6

Help function A help file is available in the MEASUREMENT MODULE and in the modules DATABASE, SETUP, SERVICE and LIQUITRANS. It explains, additional to this document, the handling of the equipment, handling of the reagents and in particular the interpretation of the results. A troubleshooting guide is also available in this menu.

1.7

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

Page 1 - 4

ROTEM® delta Manual 2.2.0.01.EN 2012 ©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 reagents. • Before performing measurements and quality controls, please read the instructions of the reagents 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). The diagnosis may not be based exclusively on the results of the ROTEM® system but has to be examined together with the patient's anamnesis, the clinical picture and, if necessary, further coagulations tests. The equipment is not evaluated to measure veterinary or other non-human samples. Non-intended usage means all other usage of the ROTEM® delta than described in this manual.

© Tem Innovations GmbH ROTEM® delta Manual 2.2.0.01.EN 2012

Page 2 - 1

Safety

2.3

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

+15 °C to +30 °C

Storage temperature

+0 °C to +50 °C

Relative humidity

20% to 85%

Pollution degree

2

Air pressure (Operating, Warehousing,

700 hPa to 1060 hPa

Transport) Operable to height above sea level

2000 m

Distance of examined, treated or monitored patients

1.5 m

Table 2-1: Ambient conditions

Page 2 - 2

ROTEM® delta Manual 2.2.0.01.EN 2012 ©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 61010-1:2001 Safety requirements for electrical equipment for measurement, control and laboratory use. Part 1: General requirements (IEC 61010-1:2001) 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 (EN 60601-1-2:2007) 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. During the EMC testing according to IEC 60601-1-2:2007, warning messages appeared during electrostatic discharge over the housing at an immunity test level of 6 kV. These warning messages occur due to a series of implausible data points, caused by the discharge. They have no influence on the continuing measurement and are therefore not critical. In the rare case warning messages caused by electrostatic discharge appear, they may be avoided by applying ESD safety measures (use of antistatic materials). For this purpose, the floors should be either wooden, made of concrete or covered with ceramic tiles. If the floor is covered with synthetic materials, the relative humidity should be 40 % or higher. 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® delta Manual 2.2.0.01.EN 2012

Page 2 - 3

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).

Page 2 - 4

ROTEM® delta Manual 2.2.0.01.EN 2012 ©Tem Innovations GmbH

Safety

2.6

Residual risks Adhere to following instructions for the safe usage of the ROTEM® delta: • • • •

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® delta 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® delta system. • Do not drop the equipment or expose to shocks. • Do not touch or stop the rotating axis with your hand.

© Tem Innovations GmbH ROTEM® delta Manual 2.2.0.01.EN 2012

Page 2 - 5

Safety

Page 2 - 6

ROTEM® delta Manual 2.2.0.01.EN 2012 ©Tem Innovations GmbH

System description

3

System description

3.1

Scope of supply The ROTEM® delta equipment is an integrated complete system containing the ROTEM® delta device and the respective system software.Table 3-1 lists components in the scope of supply. Amount

REF

Accessories box

1

400472

Adapter (<14 mm) sample preheater

1

400402

Barcode scanner 3000 (mounted)

1

400566

Barcode scanner 3000 holder (mounted)

1

400567

Barcode scanner 3000 cable

1

400568

Clean Ring Rod

1

400596

Colour printer, USB (optional)

1

400222

Connecting cable eLine

1

400324

Connection cable for printer, USB (optional)

1

400223

Cup holder pro

4

400016

Disc for cup ejector pin

1

400586

eLine electronic pipette

1

700030

eLine pipette filter

1

100048

eLine pipette tips for the system pipette

1x96

400041

Keyboard

1

400475-EN

Keyboard protection foil

1

400476

MC Rod pro

1

400045

Set MC Rod Holder delta

1

200175

Measuring cells (Cup&Pin pro)

1x20

200011

Operating manual ROTEM® delta

1

200137-EN

Parameter list

1

200086-EN

Pipette cable guide

1

500220

Pipette and Clean Ring Rod holder

1

200206

Plastic clip for cup holder plus

8 (4 on holders)

400482-4

Reagent rack delta

1

400484

ROTEM® delta

1

200090

ROTEM® delta power cable

1

700048-XX*

The package ROTEM® delta (REF 200100-XX*) contains

Table 3-1: Scope of supply ROTEM® delta

© Tem Innovations GmbH ROTEM® delta Manual 2.2.0.01.EN 2012

Page 3 - 1

System description

Amount

REF

ROTEM® delta Secure Viewer CD

1

200178

ROTEM® delta software

1

200140

ROTEM® system USB Stick

1

400221

Short user manual Single Use Reagents

1

200176-EN

Short user manual ROTEM® delta

1

200124-EN

Touch screen incl. power cable

1

400477

The package ROTEM® delta (REF 200100-XX*) contains

* Country specific; e.g. -EN (English), -DE (German). Table 3-1: Scope of supply ROTEM® delta

Page 3 - 2

ROTEM® delta Manual 2.2.0.01.EN 2012 ©Tem Innovations GmbH