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User Manual
Eurolyser Diagnostica GmbH
Bayernstraße 11a
5020 Salzburg, AUSTRIA
Tel: +43 662 432100
Fax: +43 662 432100 50
2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04
Page 1 of 43
Eurolyser Diagnostica GmbH

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  • Page 1 User Manual Eurolyser Diagnostica GmbH Bayernstraße 11a 5020 Salzburg, AUSTRIA Tel: +43 662 432100 Fax: +43 662 432100 50 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 1 of 43 Eurolyser Diagnostica GmbH...
  • Page 2: Symbols & Abbreviations

    SYMBOLS & ABBREVIATIONS The following symbols and abbreviations are used in the product labeling and instructions for the Eurolyser laboratory photometer. Symbol / Abbreviation Explanation Conformity marking according to the directive 2004/108/EC of the European Parliament and of the European Council...
  • Page 3 Personal Computer Identification HIS / LIS Hospital Information System / Laboratory Information System Alternating Current Direct Current RFID Radio Frequency Identification Table 1: Product Labelling and User Manual Symbols 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 3 of 43 Eurolyser Diagnostica GmbH...
  • Page 4: Table Of Contents

    TABLE OF CONTENTS SYMBOLS & ABBREVIATIONS ..............................2 TABLE OF CONTENTS ................................4 INTRODUCTION..................................7 Intended use of the Eurolyser CUBE-S/CUBE Laboratory Photometer ..................7 About this user manual ................................7 Inspecting the package contents ............................... 7 CUBE-S/CUBE packaging ................................8 SYSTEM DESCRIPTION ................................
  • Page 5 Connecting a barcode scanner ..............................20 Using a barcode scanner to scan patient ID and/or operator information ................21 How to wake the CUBE-S/CUBE Analyser up or switch it OFF ....................21 TEST PROCEDURES ................................22 Overview of the testing and measuring procedures ........................ 22 Operating safety precautions..............................
  • Page 6 Error messages and possible causes ............................38 Service information .................................. 39 TECHNICAL SPECIFICATIONS ..............................40 Eurolyser CUBE-S/CUBE Instrument ............................40 Power supply .................................... 40 Options ..................................... 40 DECLARATION OF CONFORMITY ............................41 SHUT DOWN AND WASTE MANAGEMENT ........................... 42 MANUFACTURER INFORMATION ............................43 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04...
  • Page 7: Introduction

    The CUBE-S/CUBE Instrument is highly compact and is designed as a point of care measuring Instrument for the ERS (Eurolyser Reagent System). It is easy to use and provides quick, reliable and accurate results.
  • Page 8: Cube-S/Cube Packaging

    CUBE-S/CUBE Instrument door before repacking (see Transport lock on page 13)! Note: The CUBE-S/CUBE Tablet PC is delivered in a separate package and must be returned in this if necessary.
  • Page 9: System Description

    SYSTEM DESCRIPTION Description of the Eurolyser CUBE-S/CUBE Analyser This section introduces the general characteristics of the Eurolyser CUBE-S/CUBE Instrument and Tablet PC. RFID Card Pit The RFID card is placed here Indicator Lights There are 3 LEDs on the front of the Instrument.
  • Page 10: Indicator Lights

    How to handle the Eurolyser CUBE-S/CUBE Laboratory Photometer The CUBE-S/CUBE Instrument is operated solely by means of the Tablet PC. All the basic operating steps are displayed as symbols. An overview of these symbols can be found in Table 1 (p. 3) and Table 2 (p.
  • Page 11: How The Eurolyser Cube-S/Cube Laboratory Photometer Works

    How the Eurolyser CUBE-S/CUBE Laboratory Photometer works The Eurolyser CUBE-S/CUBE Instrument is an open measuring system. This means that it is able to use various reagents from multiple manufacturers. To perform a test the CUBE-S/CUBE Instrument is loaded with an ERS cartridge filled with reagents from the respective reagent manufacturers. The Instrument can process endpoint tests, kinetic tests and coagulation tests.
  • Page 12: Pictogramms / Button Symbols

    Tapping one of these symbols on the Tablet PC activates the described function. Symbol Name Function CUBE-S/CUBE App Icon Starts the Eurolyser CUBE-S/CUBE app Browser Opens the Web Browser on the Tablet PC Android Settings Opens the Android settings menu...
  • Page 13: Getting Started

    GETTING STARTED The proper placement of the CUBE-S/CUBE Laboratory Photometer Place the Instrument on a dry, clean, stable and level surface. Make sure the Instrument has at least 10 cm of table surface and clearance on each side and that the Instrument can be easily disconnected from the power source.
  • Page 14: The Tablet Pc

    The Tablet PC The Eurolyser CUBE-S/CUBE Instrument is operated with a Tablet PC. Connect the Tablet PC to the USB port of the plugged-in Instrument and then turn on the Tablet PC. An independent Tablet PC manual is delivered with the Tablet PC. It describes in detail the operating of the Tablet PC, how to manage settings and the establishing of a Bluetooth or USB connection between the CUBE-S/CUBE and the Tablet PC.
  • Page 15: How To Switch The Eurolyser Cube-S/Cube Laboratory Photometer

    Note: the Eurolyser CUBE-S/CUBE application supports several languages. If you choose a language in the system settings that is not supported by the CUBE-S/CUBE app English will be used. How to switch the Eurolyser CUBE-S/CUBE Laboratory Photometer ON The Instrument is switched on by plugging the power cable into the socket. This launches the Instrument’s automatic start-up and warm-up processes.
  • Page 16: Configuring The Eurolyser Cube-S/Cube

    Swipe down to view all available options. All following descriptions are examples. The configuration of the Eurolyser CUBE-S/CUBE Instrument models may vary depending on the tests used. Note: The normal values, units and sample types for a test can only be displayed if the respective test RFID card has been placed on the Instrument and read.
  • Page 17: Setting Units

    Input menu. last used will always be selected. 3.2 Sampletype menu 3.3a Hematocrit menu (CUBE Analyser) 3.3b Hematocrit menu (CUBE-S Analyser) and a drop down menu Tap a desired hematocrit value Choose HCT Auto for an analyser-...
  • Page 18: Configuring Interfaces

    Note: the screenshot above is for The following descriptions are in demonstration purposes only. By the order of the interfaces in the default all boxes are unchecked. Interface menu. 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 18 of 43 Eurolyser Diagnostica GmbH...
  • Page 19 Password please contact your added Automatic dealer. transmission or standard manual transmission format. Note: the screenshot above is for demonstration purposes only. By default all boxes are unchecked. 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 19 of 43 Eurolyser Diagnostica GmbH...
  • Page 20: Optional Equipment

    RS232 cable to the RS232 socket at the Instrument (see illustration below). Always connect the power supply to the barcode scanner correctly before using it. If a printer should be installed simultaneously an adapter has to be interconnected (e.g. barcode-printer- interface-cable, Eurolyser order number: SZ0405). Eurolyser CUBE-S/CUBE Instrument Interfaces Power supply...
  • Page 21: Using A Barcode Scanner To Scan Patient Id And/Or Operator Information

    This screen only appears if the operator input has been enabled (see 3.4 on page 17)! How to wake the CUBE-S/CUBE Analyser up or switch it OFF When the Tablet PC displays the main menu, the “power safe” function dims the screen. Pressing the Lock Switch will re-illuminate the display to its customary level of brightness.
  • Page 22: Test Procedures

    Overview of the testing and measuring procedures Allow the ERS test cartridge to reach room temperature before use. If the CUBE-S/CUBE Instrument has been disconnected from the power supply, plug it in soon enough for it to be at the proper operating temperature when it is needed.
  • Page 23: Operating Safety Precautions

     Please refer to package insert provided with each test kit suitable for use with the Eurolyser CUBE-S/CUBE Instrument and follow all instructions regarding: o The proper temperature a cartridge must have before a test is performed o The exact amount of the sample volume o The regulations for the proper storage of the test cartridges 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04...
  • Page 24: Analysing A Patient Sample

    Hematocrit* to open the operator menu (see 3.4 on p. 17 for details). The manual input of hematocrit or automatic calculation via the input menu is only available to CUBE-S. This feature does not apply to CUBE. This screen only...
  • Page 25 Be sure the test cartridge is fully inserted into the proper opening in the Instrument  Use ONLY manufacturer-approved test cartridges! Otherwise serious damage to the CUBE-S/CUBE photometer and/or inaccurate test results may occur  Do not attempt to open the door manually! 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04...
  • Page 26: Viewing And Processing Test Results

    (see p. 18) the according data will be transferred to the printer or host system automatically and will appear on the printouts and/or the computer or host system. 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 26 of 43 Eurolyser Diagnostica GmbH...
  • Page 27: Eurolyser Online Services (Eos)

    Services (EOS) servers. Before test results can be synchronized a registration with the EOS is needed. The feature to synchronize data from the CUBE-S/CUBE app into the EOS account can be used according to the steps described on page 27, EOS Synchronization.
  • Page 28: Eos Synchronization

    Services account the registration or login Registration page mask will appear. respectively Eurolyser Online Service Login on page 30). After a successful registration or login the results will be synchronized. 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 28 of 43 Eurolyser Diagnostica GmbH...
  • Page 29: Eurolyser Online Services Registration

    Eurolyser Online Services Registration The Eurolyser CUBE-S/CUBE application asks the user to register or login to the EOS once before synchronizing. The following steps describe the process of a registration. 1. EOS Registration & Login Mask 2. Terms of Services 3.
  • Page 30: Eurolyser Online Service Login

    Eurolyser Online Service Login 1. EOS Registration & Login Mask 2. Login Mask Press to open the login mask. Provide your account information and tap to log in. Synchronizing a single result 1. Main Menu 2. Result List Screen 3. Result Detail Screen...
  • Page 31: Synchronizing A Filtered Result List

    Set a filter according to 2.1 Filter open the Result List. Options on page 26 4. Filtered Result List (e.g. CRP) in the upper right corner to synchronize the filtered test results. 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 31 of 43 Eurolyser Diagnostica GmbH...
  • Page 32: Eos Web Access

    (1) Email address which has been used for registration on the App (2) Password which has been used for registration on the App (3) Button to perform login after filling email address and password (4) Possible language switch 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 32 of 43 Eurolyser Diagnostica GmbH...
  • Page 33: Quality Control

    QUALITY CONTROL A quality control program should be performed on a regular basis to verify the Eurolyser CUBE-S/CUBE Instrument is working properly and providing reliable results. Data integrity can only be assured when controls and GCLP practices are used routinely. The frequency of performing QC differs from laboratory to laboratory;...
  • Page 34: Frequency Of Qc Testing

     when new personnel is being trained to use the equipment .  if local regulations require more frequent control testing than described above, then the number of control tests performed must comply with these regulations. 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 34 of 43 Eurolyser Diagnostica GmbH...
  • Page 35: Correlation

    Correlated as seen to be adjusted. Enter the factor in the test screen when starting a and the offset accordingly and tap measurement process. to accept the new correlation settings. 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 35 of 43 Eurolyser Diagnostica GmbH...
  • Page 36: Cleaning Instructions

    Cleaning the Exterior Do not clean the surface of the Tablet PC with isopropyl alcohol! The surface of the Eurolyser CUBE-S/CUBE Instrument should be cleaned with a clean, lint-free cloth only moistened with isopropyl alcohol. Wipe down the exposed surfaces.
  • Page 37: External Interface Description

    Date: 08-02-2007 Operat: Text Operat:Max Muster Optional Lot No: Value Lot No:4111 Optional Ser No: Value Ser No:Ba00001 Optional USB Interface The USB interface emulates the serial interface. 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 37 of 43 Eurolyser Diagnostica GmbH...
  • Page 38: Error Information And Troubleshooting

    The cartridges’ temperature is too Cartridge temperature error Repeat the test and refer to the low for a proper test. package inserts for proper cartridge use. 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 38 of 43 Eurolyser Diagnostica GmbH...
  • Page 39: Service Information

    Service information If the problem persists after the corrective actions are taken, contact your local CUBE-S/CUBE Instrument dealer for technical assistance. Before asking for assistance, please have the following information ready:  the serial number of your CUBE-S/CUBE Instrument  the test type ...
  • Page 40: Technical Specifications

    TECHNICAL SPECIFICATIONS Eurolyser CUBE-S/CUBE Instrument Photometer resolution 0.0001 ABS Reproducibility <1.5% CV at 1 OD 0.1000 – 3.0000 OD better than +/- 1.5% and +/- 0.01 OD Linearity Temperature control Electrical temperature control of the photometer unit to 37°C +- 2°C Fuse 2.5 A, self-healing...
  • Page 41: Declaration Of Conformity

    DECLARATION OF CONFORMITY The Eurolyser CUBE-S/CUBE Analyser consisting of the CUBE-S/CUBE Instrument and the CUBE- S/CUBE Tablet PC is in conformity with the directive 2004/108/EC of the European Parliament and the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC.
  • Page 42: Shut Down And Waste Management

    SHUT DOWN AND WASTE MANAGEMENT Before shutting down the CUBE-S/CUBE Instrument for the purpose of a repair or disposal it is necessary to ensure that there is no cartridge left within the CUBE-S/CUBE Instrument. For the purpose of delivering the CUBE-S/CUBE Instrument it is also required to protect the photometer with its original delivered packaging and packaging inserts.
  • Page 43: Manufacturer Information

    MANUFACTURER INFORMATION EUROLYSER DIAGNOSTICA GmbH Bayernstrasse 11a 5020 Salzburg AUSTRIA Tel: +43 662 432100 Fax: +43 662 432100-50 www.eurolyser.com Contact: Gerhard Bonecker, MBA 2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04 Page 43 of 43 Eurolyser Diagnostica GmbH...

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