R-Biopharm RIDA CUBE SCAN, User Manual

Page 1: ...2014 09 30 Page 1 of 34 R Biopharm AG...

Page 2: ...ive 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 limi...

Page 3: ...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 Ta...

Page 4: ...anufacturer calibration 10 Pictogramms Button Symbols 11 Tablet PC symbols and their functions 11 Getting started 12 The proper placement of the CUBE Laboratory Photometer 12 Transport lock 12 Connect...

Page 5: ...esults 24 Quality control 24 Choosing quality control QC materials 25 Handling the QC control materials 25 Frequency of QC testing 26 Cleaning instructions 27 Cleaning the touch display of the Tablet...

Page 6: ...r problems When not used according to the user manual the CUBE Instrument may be influenced or damaged We recommend that you familiarize yourself with these instructions before operating the RIDA CUBE...

Page 7: ...n of the Instrument to the manufacturer or before transport please repack the RIDA CUBE SCAN Instrument contents in the original packaging according to the illustration above Moreover please remember...

Page 8: ...ved 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 Instrument Interfaces RIDA CUBE SCAN Instrument...

Page 9: ...nded to use the USB cable connection How to handle the RIDA CUBE SCAN Laboratory Photometer The RIDA CUBE SCAN Instrument is operated solely by means of the Tablet PC All the basic operating steps are...

Page 10: ...ption of light rays is measured during this process and the measured value is then converted into the test result using mathematical methods The result is displayed on the Tablet PC Optionally results...

Page 11: ...e menu for test data entries Results Opens the result list screen CUBE Settings Opens the Configuration menu Edit Opens an entry or value so it can be edited Confirm Confirms the input Abort to main m...

Page 12: ...port lock and the original packaging In case of a defect the Instrument is to be returned in the original packaging see p 7 with the transport lock installed to prevent any damage during transportatio...

Page 13: ...onnecting the Tablet PC with the RIDA CUBE SCAN Instrument Tap Next to continue The RIDA CUBE SCAN app starts and the main menu appears Note while the RIDA CUBE SCAN Instrument is warming up indicated...

Page 14: ...to the socket This launches the Instrument s automatic start up and warm up processes Please wait for these to be completed approximately 10 minutes When operating the Instrument The door protects the...

Page 15: ...igure Swipe down to view all available options All following descriptions are examples The configuration of the RIDA CUBE SCAN Instrument models may vary depending on the tests used Note The normal va...

Page 16: ...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 Application menu 3 3 Operator menu Tap and a drop down menu op...

Page 17: ...t Note the screenshot above is for demonstration purposes only By default all boxes are unchecked 3 2a Host configuration password screen 3 2b Host configuration menu The service password is required...

Page 18: ...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 Datalogic Touch 65 barcode re...

Page 19: ...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 wi...

Page 20: ...xternal computer or send it via email see p 24 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...

Page 21: ...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 packag...

Page 22: ...t cartridge and close door Tap the desired input field e g Name the Tablet PC keyboard appears Enter the information and confirm with Done Next tap and select an entry from the drop down menu Tap to c...

Page 23: ...ding 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 openin...

Page 24: ...the Return Arrow Tap to open the filter options Tap to print mail or export Results can be filtered by date test type and Sample ID Tap to set the desired start date to set the desired end date Tap t...

Page 25: ...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 the control results fall within t...

Page 26: ...ot 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 l...

Page 27: ...o 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...

Page 28: ...tive 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 Nam...

Page 29: ...ement 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 witho...

Page 30: ...BE SCAN Instrument dealer for technical assistance Before asking for assistance please have the following information ready the serial number of your RIDA CUBE SCAN Instrument the test type the test l...

Page 31: ...ce RS232 USB Bluetooth Tolerance conditions 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 Powe...

Page 32: ...612 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 requireme...

Page 33: ...within the RIDA CUBE SCAN Instrument For the purpose of delivering the RIDA CUBE SCAN Instrument it is also required to protect the photometer with its original delivered packaging and packaging inse...

Page 34: ...9 30 Page 34 of 34 R Biopharm AG Manufacturer information R Biopharm AG An der neuen Bergstrasse 17 64297 Darmstadt Germany Tel 49 0 61 51 8102 0 Fax 49 0 61 51 8102 0 info r biopharm de www r biophar...