Eurolyser CUBE-S Manual de usuario

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User Manual

Eurolyser Diagnostica GmbH

Bayernstraße 11a

5020 Salzburg, AUSTRIA

Tel: +43 662 432100

Fax: +43 662 432100 50

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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

Catalogue number / Order number

Lot number

Serial number

Bluetooth

Connection

Power Supply / Device Readiness

Use by

Temperature limitations

Relative humidity limitations

Manufacturer

Production date

Sterile

Warnings and precautions, see accompanying documents

Operator's action

Refer to the user’s manual and follow the instructions

Do not dispose with household waste

ERS TC

ERS Testing Cartridge

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LED

Light Emitting Diode

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

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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............................................................................................................................................................9

Description of the Eurolyser CUBE-S/CUBE Analyser .................................................................................................................9

CUBE-S/CUBE Instrument Interfaces..........................................................................................................................................9

Indicator lights .........................................................................................................................................................................10

How to handle the Eurolyser CUBE-S/CUBE Laboratory Photometer ......................................................................................10

How the Eurolyser CUBE-S/CUBE Laboratory Photometer works ............................................................................................11

Manufacturer calibration.........................................................................................................................................................11

PICTOGRAMMS / BUTTON SYMBOLS ...................................................................................................................................12

Tablet PC symbols and their functions .....................................................................................................................................12

GETTING STARTED ............................................................................................................................................................... 13

The proper placement of the CUBE-S/CUBE Laboratory Photometer ......................................................................................13

Transport lock ..........................................................................................................................................................................13

Connecting the power supply...................................................................................................................................................13

The Tablet PC ...........................................................................................................................................................................14

Starting & Operating the Tablet PC .........................................................................................................................................14

The Eurolyser CUBE-S/CUBE Launcher .....................................................................................................................................14

Changing the language of the Eurolyser CUBE-S/CUBE application ........................................................................................14

How to switch the Eurolyser CUBE-S/CUBE Laboratory Photometer ..............................................................................ON

The automatic start-up and warm-up processes .....................................................................................................................15

CONFIGURING THE EUROLYSER CUBE-S/CUBE .....................................................................................................................16

Setting normal values and limits..............................................................................................................................................16

Setting units .............................................................................................................................................................................17

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Configuring inputs (Sex, Sampletype, Hematocrit, Operator)..................................................................................................17

Configuring interfaces..............................................................................................................................................................18

OPTIONAL EQUIPMENT........................................................................................................................................................20

Printer, barcode scanner or PC.................................................................................................................................................20

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...................................................................................................................................................23

Analysing a patient sample......................................................................................................................................................24

Viewing and processing test results .........................................................................................................................................26

Eurolyser Online Services (EOS) ...........................................................................................................................................27

EOS Synchronization ................................................................................................................................................................28

Synchronizing all test results ...............................................................................................................................................28

Eurolyser Online Services Registration ................................................................................................................................29

Eurolyser Online Service Login ............................................................................................................................................30

Synchronizing a single result ...............................................................................................................................................30

Synchronizing a filtered result list .......................................................................................................................................31

EOS Web Access .......................................................................................................................................................................32

Recommended web-browsers.............................................................................................................................................32

Login Mask...........................................................................................................................................................................32

QUALITY CONTROL ..............................................................................................................................................................33

Choosing quality control (QC) materials ..................................................................................................................................33

Handling the QC control materials...........................................................................................................................................33

Frequency of QC testing ...........................................................................................................................................................34

CORRELATION ......................................................................................................................................................................35

Performing a parameter correlation adjustment.....................................................................................................................35

CLEANING INSTRUCTIONS.................................................................................................................................................... 36

Cleaning the touch display of the Tablet PC.............................................................................................................................36

Cleaning the Door & Cartridge Area ........................................................................................................................................36

Cleaning the Exterior................................................................................................................................................................36

EXTERNAL INTERFACE DESCRIPTION .................................................................................................................................... 37

Serial Interface .........................................................................................................................................................................37

USB Interface ...........................................................................................................................................................................37

ERROR INFORMATION AND TROUBLESHOOTING.................................................................................................................38

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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

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INTRODUCTION

Intended use of the Eurolyser CUBE-S/CUBE Laboratory Photometer

The Eurolyser CUBE-S/CUBE Analyser consisting of the CUBE-S/CUBE Instrument laboratory

photometer and the CUBE-S/CUBE Tablet PC is intended as a general purpose laboratory instrument

for the quantitative determination of clinical wet chemistry parameters.

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.

About this user manual

This user manual will guide you through the installation, operation and maintenance of your Eurolyser

CUBE-S/CUBE Instrument. The user manual also explains how the photometer works, describes the

quality assurance system and assists you in troubleshooting any errors or problems. When not used

according to the user manual the CUBE-S/CUBE Instrument may be influenced or damaged.

We recommend that you familiarize yourself with these instructions before operating the Eurolyser

CUBE-S/CUBE Instrument. Some of the information in this user manual is marked with following

symbols:

Operator's action

Warnings and precautions; see accompanying documents

Refer to the user manual or test kit package insert and follow the given instructions

Inspecting the package contents

When unpacking the CUBE-S/CUBE Analyser, check the contents against the list below and examine

the components for signs of shipping damage (see illustration on the following page).

The CUBE-S/CUBE package contains:

-the Eurolyser CUBE-S/CUBE Instrument

-a main adapter

-a power cable

-this user Manual (on a CD)

-the Quick Reference

-a Test-Kit Rack

-a Tablet Stand

If any part of the package is missing or damaged, please report this to your supplier immediately.

It is recommended to keep the original packaging, in case the Instrument ever needs to be transported.

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CUBE-S/CUBE packaging

In case of returning the CUBE-S/CUBE Instrument to the manufacturer and/or before transporting the

Instrument, please repack the CUBE-S/CUBE Instrument contents in the original packaging according to

the following illustration:

1. Tablet Stand

2. Test-Kit Rack

3. Power Cable

4. Main Adapter

5. CUBE-S/CUBE Instrument

Note: In case of a necessary return of the Instrument to the manufacturer or before transport please

repack the CUBE-S/CUBE Instrument contents in the original packaging according to the illustration

above!Moreover, please remember to reinsert the white transport lock into the 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.

WARNING: Wrong packing and/or the use of inappropriate

packaging can cause severe damage to the Instrument!

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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.

For a detailed description

refer to page 10

Door Test cartridges are inserted

and then removed here.

Note: do not attempt to open

door manually!

Tablet PC The Tablet PC is the main

user interface to operate the

Instrument & process the

results

CUBE-S/CUBE Instrument Interfaces

.Eurolyser CUBE-S/CUBE Instrument Interfaces

Power supply

USB Socket for connecting a

PC (for data transfer)

Tablet PC-Lock eyelet

Bluetooth on/off switch

(left: Bluetooth OFF)

USB Port for connecting a

Tablet PC

RS 232 socket for connecting a

printer, a barcode reader or a

PC (for data transfer)

Do not use liquid cleaners on the Instrument or Tablet PC! Use a lint-free,

slightly damp cloth only!

Do not attempt to open the door manually

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LEDs

Indicator lights

Eurolyser CUBE-S/CUBE front

LEDs on the Eurolyser CUBE-S/CUBE Instrument

This green LED indicates the readiness of the photometer

Flashing: the Instrument is warming up and testing cannot be

started yet (Note: this takes approximately 10 min.)

Constantly lit: the Instrument is warmed up and ready for use

Off: the Instrument is not plugged in

This blue LED indicates a connection to a Tablet PC

Constantly lit: a connection with a Tablet PC is established

Off: the Tablet PC is not connected

This blue LED indicates a Bluetooth connection to Tablet PC

Constantly lit: a connection with a Tablet PC is established

Flashing: Bluetooth is activated on the photometer but no

Tablet PC is connected via Bluetooth

Off: Bluetooth is switched off

Note: The Bluetooth connection is operational with Tablet PCs

with serial numbers Tb##### or higher. To keep the Tablet PC

constantly powered it is recommended to use the USB cable

connection.

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. 12). To activate a symbol tap it with a finger.

In order to perform a test, the RFID card enclosed in the test kit must first be placed on the Instrument.

This card contains all the data needed to perform the tests. No analysis can be started without the RFID

test card!

The door opens automatically once a test is initiated by pressing the button. After entering all the

requested data on the Tablet PC and inserting the ERS cartridge into the slot, close the door and the

testing procedure begins automatically. After the analysis is completed, the door opens automatically

and the test cartridge is to be removed.

The door prevents ambient light, dust, dirt and humidity from entering the Instrument during the testing

process and when the Instrument is not in use.

Please make sure the door is closed whenever the Instrument is not in use.

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