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2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04

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Eurolyser Diagnostica GmbH

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

Содержание Cube

Страница 1: ...664 e5f4 4907 bab1 9f7c76e7d9ef DP10 0 2016 07 04 Page 1 of 43 Eurolyser Diagnostica GmbH User Manual Eurolyser Diagnostica GmbH Bayernstraße 11a 5020 Salzburg AUSTRIA Tel 43 662 432100 Fax 43 662 432100 50 ...

Страница 2: ...rking 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...

Страница 3: ...er Diagnostica GmbH LED Light Emitting Diode PC Personal Computer ID Identification HIS LIS Hospital Information System Laboratory Information System AC Alternating Current DC Direct Current RFID Radio Frequency Identification Table 1 Product Labelling and User Manual Symbols ...

Страница 4: ...UBE 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...

Страница 5: ...sing 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 cont...

Страница 6: ...Eurolyser Diagnostica GmbH 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 ...

Страница 7: ...ts 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 accompa...

Страница 8: ...er 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 ...

Страница 9: ...ges 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 conn...

Страница 10: ... 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 ...

Страница 11: ...ms the tests automatically according to that data Numerous types of tests can be selected and performed automatically The sample and the reagent are automatically mixed within the Instrument The photometer unit performs the analysis with a light diode The absorption of light rays is measured during this process and the measured value is then converted into the test result using mathematical method...

Страница 12: ...main menu Measurement Opens the menu for test data entries Results Opens the result list screen CUBE S CUBE Settings Opens the Configuration menu Edit Opens an entry or value so it can be edited Confirm Confirms the input Abort to main menu Cancels an action and returns to the main menu Start analysis Starts the test process Print Opens the print export mail dialogue Filter Opens the Filter Option...

Страница 13: ... Note keep both the transport lock and the original packaging In case of a defect the Instrument is to be returned in the original packaging see p 8 with the transport lock installed to prevent any damage during transportation Connecting the power supply Eurolyser CUBE S CUBE Instrument Interfaces Power supply USB Socket for connecting a PC for data transfer Tablet PC Lock eyelet Bluetooth on off ...

Страница 14: ... the flashing green LED on the front the Measurement Button is grey and inactive The Eurolyser CUBE S CUBE Launcher Eurolyser CUBE S CUBE Launcher When the Tablet PC is not connected to the Instrument or by pressing the Home Button the Eurolyser CUBE S CUBE Launcher appears Tapping Browser opens the Android web browser Tapping Eurolyser CUBE S CUBE starts the CUBE S CUBE app Tapping Settings opens...

Страница 15: ...r protects the analysis system from dust dirt and humidity Empty the door s cartridge chamber after every analysis and keep it closed when the Instrument is not in use The door opens automatically Do not attempt to open the door manually If an error message appears during an analysis please consult the Troubleshooting section on page 38 The automatic start up and warm up processes 1 Warm up menu 2...

Страница 16: ...ding 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 Setting normal values and limits 1 Settings menu 2 Normal values limits menu e g CRP 2 1 Normal values limits menu e g PT Tap Normal Values to open the Normal Values Limits menu To change a limit tap the value and change i...

Страница 17: ... drop down menu Select which gender is to be used as the standard default Last used means that the gender last used will always be selected 3 2 Sampletype menu 3 3a Hematocrit menu CUBE Analyser 3 3b Hematocrit menu CUBE S Analyser Tap and a drop down menu opens select which type of sample should be selected by default Last used means the sample type last used will be selected Confirm with Press t...

Страница 18: ...menu then tap Configuring interfaces 1 Configuration menu 2 Interface menu 3 1 Printer configuration menu Tap Interface in the Configuration menu The Interface menu appears Tap an interface to configure and the respective configuration menu appears The following descriptions are in the order of the interfaces in the Interface menu Tap a checkbox next to an option to select or de select it Note the...

Страница 19: ...nfiguration menu opens If you do not know the Service Password please contact your dealer Tap a checkbox next to an option to select or de select it Checking Automatic transmission allows for automatic transmission of the standard information of a measurement result after the measurement is done via USB or serial port Operator ID lot number and serial number are additional information that can be ...

Страница 20: ... All optional equipment must be connected before such leakage current can be measured If the Instrument is not used according to the instruction manual then the provided levels of safety will be lowered Connecting a barcode scanner To install the barcode reader see Technical specifications section on page 40 please connect the RS232 cable to the RS232 socket at the Instrument see illustration belo...

Страница 21: ...dge and close door On this screen an operator can now be selected by scanning the operator barcode and tapping to continue If new information is scanned i e the operator has not been created in the operator menu yet a new operator will be created automatically The door opens automatically Insert the cartridge and close the door The test procedure starts automatically 1 This screen only appears if ...

Страница 22: ...t the result with an optional external printer or send it via email see p 26 How to run a control test Place the provided RFID card from the test kit on the Instrument Prepare the control serum according to the instructions on the control package insert Enter the lot number instead of the patient data Prepare the test just like a patient sample and start the analysis The result is displayed on the...

Страница 23: ...or manually When handling a test cartridge Do not use test cartridges after their expiration date or when the test cartridges have not been stored in accordance with the regulations Do not use the test cartridge if the packaging is damaged or if fluids have leaked The test cartridge must reach room temperature 20 28 C 68 82 5 F before use Use gloves when handling and disposing the test cartridges ...

Страница 24: ...onfirm with Done Next tap and select an entry from the drop down menu When using a CUBE S CUBE S analyser additional options are available when selecting Hematocrit 1 When tapping the desired setting for hematocrit the value can be set manually when choosing HCT Manual HCT Auto allows for automatic calculation of the HCT value by the device s software Tap to confirm the input or to return to the m...

Страница 25: ...ing process varies by test type Mixing Incubating Measuring Be sure to handle the test cartridge according to the instructions on the package insert Be sure the test cartridge is properly sealed before inserting it into the Instrument 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...

Страница 26: ... 1 Filter Options Tap in the main menu to open the Result List The stored results can be browsed by swiping up and down Tap a result to open the result screen see above to return to the result list from a result screen press the Return Arrow Tap to open the filter options Tap to print mail or export Results can be filtered by date test type and Patient ID Tap to set the desired start date to set t...

Страница 27: ...S account can be used according to the steps described on page 27 EOS Synchronization The synchronized data can be viewed by using a web browser on e g a PC or tablet A description of the possibilities of the EOS Web Access and an explanation of the user interface can be found on page 31 EOS Web Access Sensitive data is encrypted by using industry standard cryptographic algorithms following ENISA ...

Страница 28: ...a filtered measurement result list Synchronizing all test results 1 Main Menu 2 Result List Screen 3 EOS Registration Login Mask Tap in the main menu to open the Result List Tap in the upper right corner to synchronize all test results When not logged in with an EOS account the registration or login mask will appear Use to register a new EOS account or to log in with an already existing EOS user s...

Страница 29: ...g with the EOS system the terms of services need to be read and accepted Please read through the terms of services thoroughly The terms of services are accepted by ticking the Accept checkbox and pressing Register with the EOS system by providing an e mail address and a strong and secret password Accept the account information by pressing The registration confirmation appears 4 Registration Confir...

Страница 30: ...tration Login Mask 2 Login Mask Press to open the login mask Provide your EOS account information and tap to log in Synchronizing a single result 1 Main Menu 2 Result List Screen 3 Result Detail Screen Tap in the main menu to open the Result List Tap a result to open the result detail screen Tap to synchronize the result currently viewed ...

Страница 31: ...nizing a filtered result list 1 Main Menu 2 Login Mask 3 Filter Options Tap in the main menu to open the Result List Tap to open the filter options Set a filter according to 2 1 Filter Options on page 26 4 Filtered Result List e g CRP Tap in the upper right corner to synchronize the filtered test results ...

Страница 32: ...shown in the table below It is not recommended to use a browser which is not listed Windows Internet Explorer 10 or higher Mozilla Firefox 24 or higher Google Chrome 33 or higher Linux Mozilla Firefox 24 or higher Mac Mozilla Firefox 24 or higher Always use the most recent version of a browser to make sure that the latest security updates are applied Older browsers might not provide all functions ...

Страница 33: ...s Please refer to the package insert provided with each control kit for detailed instructions on storage and handling of control materials Follow the instructions in the Analysing a patient sample sections starting on p 24 on how to properly perform a control test The measured values must be within the range of target values specified on the control vial label or in the control package insert If t...

Страница 34: ...ts is about to be used a new lot is about to be used if it s possible that the test cartridges have not been properly stored if an unexpected patient result is obtained 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 ...

Страница 35: ... the settings menu Tap Correlation to open the correlation menu Enter the password The default setting is 3010 4 Correlation menu 5 Test Screen Tapping opens a drop down menu Select which parameter is to be adjusted Enter the factor and the offset accordingly and tap to accept the new correlation settings An active correlation adjustment is marked by Correlated as seen in the test screen when star...

Страница 36: ...oid damage do not spill too much water on the Tablet PC Cleaning the Door Cartridge Area Clean the door with a clean lint free cloth moistened with isopropyl alcohol Wipe down the surface The cartridge area may be cleaned with a cotton swab moistened with isopropyl alcohol Cleaning the Exterior Do not clean the surface of the Tablet PC with isopropyl alcohol The surface of the Eurolyser CUBE S CUB...

Страница 37: ... value or text Data fields are concluded with one carriage return and line feed Data sets are concluded with three carriage returns and line feeds Data Fields Identifier Format Example Remarks Name Text Name John Doe ID Text ID 1234 Sex Male Female Child Control Sex Male Sample Serum Blood Sample Blood Optional HCT Value HCT 40 Optional Testname Value and unit CRP 2 48 mg dl Calculatedname Value a...

Страница 38: ... value lies outside the measuring range e g a cold cartridge has been used Repeat the test using a new cartridge Blank error The photometric measurement value is outside the measuring range without the cartridge Repeat the test after restarting the Instrument Temperature error The temperature is outside the range Repeat the test after restarting the Instrument Wrong sampletype The wrong sample typ...

Страница 39: ... 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 the test lot number the control lot number the control results obtained so far a description of the problem including any of the CUBE S CUBE s error messages ...

Страница 40: ...nditions Work space 20 28 C relative humidity 10 85 Transport Storage 0 50 C relative humidity 5 85 Work surface A dry clean level surface Avoid direct sunlight Power usage 12V DC 2A Power supply Manufacturer Globtek Type GTM21097 5012 Mains adapter A separate AC to DC mains adapter with double insulation Input 90 264V AC 47 63 Hz Output 12V DC 4 17A Power usage Max 30 VA Options Thermo printer Se...

Страница 41: ... 89 336 EEC The standards EN 13612 2002 Performance evaluation of in vitro diagnostic medical devices IEC 61010 1 2001 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements IEC 61010 2 101 2002 Safety requirements for electrical equipment for measurement control and laboratory use Part 2 101 Particular requirements for in vitro diagnost...

Страница 42: ...sure 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 For proper waste management according to the directive 2002 96 EG please contact your local dealer Used cartridges need to be disposed with laboratory waste and accor...

Страница 43: ... DP10 0 2016 07 04 Page 43 of 43 Eurolyser Diagnostica GmbH 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 ...

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