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Thermo Scientific BRAHMS direct Reader User Manual
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Thermo Scientific BRAHMS direct Reader User Manual

Thermo Scientific BRAHMS direct Reader User Manual

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B·R·A·H·M·S direct Reader
User Manual | Version R06 EN
Date: 07.11.2018

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Summary of Contents for Thermo Scientific BRAHMS direct Reader

  • Page 1 B·R·A·H·M·S direct Reader User Manual | Version R06 EN Date: 07.11.2018...
  • Page 2 B·R·A·H·M·S GmbH B·R·A·H·M·S direct Reader User Manual | Version R06 EN Page 2 of 65...
  • Page 3 Contents Front and Rear View..................6 Keypad and Symbols ..................7 Software Menu Structure ................. 8 Introduction ..................9 1.1. Description ........................9 1.2. About the Manual ......................9 1.2.1. Content Changes Versus Previous Version ............... 9 1.2.2. The Following Symbols are Used in This Manual ............ 10 Measurement Principle: Lateral Flow Immunoassay .....
  • Page 4 5.1. Lot Registration ......................24 5.1.1. Registration of Test Lot .................... 24 5.1.2. Registration of Liquid QC Lot (e.g. B·R·A·H·M·S PCT direct QC) ......24 5.1.3. Registration of B·R·A·H·M·S direct Reader Control Lot ......... 25 5.2. Show Lot Lists ......................25 5.2.1.
  • Page 5 8.6.1. Set Up a Reader Name ....................48 8.6.2. Software Update ......................48 Maintenance and Troubleshooting ..........49 9.1. Maintenance ....................... 49 9.2. Database Backup ....................... 49 9.3. Error Messages and Troubleshooting ..............50 Attachments ..................61 10.1. Reader, Reagents and Accessories ................61 10.2.
  • Page 6 Front and Rear View Printer Display Function Keys Drawer Power Supply 2x USB Connection Connection for Barcode Scanner, LAN Interface, USB Stick and/or external keyboard RJ45 type On-Off Switch B·R·A·H·M·S GmbH B·R·A·H·M·S direct Reader User Manual | Version R06 EN Page 6 of 65...
  • Page 7 Keypad and Symbols LED indicates the measurement of the test Line feed button Eject button to unload the test Print button Pushing the “soft key” button confirms the Navigation activity shown directly button above on the display Switch between numbers and letters Delete User Interface Symbols...
  • Page 8 Software Menu Structure B·R·A·H·M·S GmbH B·R·A·H·M·S direct Reader User Manual | Version R06 EN Page 8 of 65...
  • Page 9 1. Introduction 1.1. Description The B·R·A·H·M·S direct Reader is an instrument for in vitro diagnostic use for the quantitative and rapid determination of various analytes in human whole blood. It is indicated to be used in combination with B·R·A·H·M·S direct immuno-chromatographic test sets in point-of-care settings. The B·R·A·H·M·S direct Reader is for professional use only.
  • Page 10 Changed “Logon” into the correct wording as “Login” in all corresponding content  Chapter 1,1; 3,7; 9;1 and front page: Deleting of the name “Thermo Scientific” before the product name “B·R·A·H·M·S direct Reader” 1.2.2. The Following Symbols are Used in This Manual ...
  • Page 11 2. Measurement Principle: Lateral Flow Immunoassay After application of the sample to the test device, the device is inserted into the drawer. Once the drawer is closed, the device is fixed and the plunger opens the buffer blister. Subsequently buffer moves over the membrane in order to allow reproducible test conditions.
  • Page 12 3. System Specification 3.1. Used Symbols for B·R·A·H·M·S direct Reader and Related Accessories Symbol Explanation Consult instructions for use In vitro diagnostic medical device Manufacturer Date of manufacture Serial number The CE mark attached on Reader indicates the conformity with the IVD (in vitro diagnostics medical devices) directive 98/79/EC Catalogue number Temperature limitation...
  • Page 13 Symbol Explanation Humidity limitation Keep away from sunlight Do not reuse Use only the power supply that is shipped with the instrument Contents Fragile, handle with care Keep dry This way up Handle with care Page 13 of 65 B·R·A·H·M·S direct Reader User Manual | Version R06 EN B·R·A·H·M·S GmbH...
  • Page 14 Symbol Explanation Green dot according to German law The instrument is approved by a Nationally Recognized Testing Laboratory (NRTL). Batch code Use by date Laser, danger to eyes Location: Barcode Scanner This product should be disposed of and recycled at the end of its useful life in accordance with the Directive 2002/96/EC (WEEE) on Waste Electrical and Electronic Equipment.
  • Page 15 3.2. Technical Specification Height 115 mm Width 172 mm Length 245 mm Weight 1500 g Power Supply 4.16A power supply; 100 to 240V AC at 50 Hz to 60Hz Consumption <50VA Light Source LED (light emitting diode) Reader Head CMOS line detector Printer Internal thermal printer Display...
  • Page 16 3.5. Warnings and Precautions You are obliged to pay attention to all warnings and safety instructions of this manual. Safety instructions given in this manual help the user to avoid personal accidents, material damage and environmental contamination. Read the safety instructions very carefully before operating the system.
  • Page 17 3.5.2. Electrical Safety The instrument must only be operated with the supplied power supply unit (Class I protection). Do not operate the instrument in an environment containing explosive gases since its components could generate sparks. Avoid spilling fluids on or into the instrument at any time. All spills should be wiped up promptly.
  • Page 18 3.7. Decontamination/Cleaning Procedure The following decontamination or disinfection procedure has to be performed to ensure safe use by the user and prior to any physical intervention by a supplier/transport worker or service personnel. If the device is contaminated with radioactive, chemical, biological, infectious substances or if the device needs to be returned to Thermo Fisher Scientific, perform the following cleaning process (please refer also to chapter Maintenance).
  • Page 19 4. Starting 4.1. Installation Remove the transport package and check the package integrity at receipt. Important Place the instrument on a stable, flat and dry area. Protect the system from extremes of temperature, high atmospheric humidity and bright and direct light sources (direct sunlight, spot lamps, etc.).
  • Page 20 4.1.3. Connection of Power Supply and Barcode Scanner  Connect the power supply (in Reader box, provided by B·R·A·H·M·S) to its connection on the rear side of the instrument. Use only the provided cable! Use the international plug adapter from the package only if required.
  • Page 21  Ensure that a part of the paper sticks out of the slot.  Close the cover. 4.1.5. Switching the Instrument On and Off  Follow instructions when placing the instrument (refer to chapter Installation).  Start or switch off the instrument by pushing the On/Off switch on its back side for a few seconds.
  • Page 22 4.1.6. Select the Language > Main Menu | Administration | Settings | Internal Settings | Language The instrument is delivered with factory settings, ready to use. The default language is English. The following chapter guides you to change the language (please refer also to chapter 8.3.1.9 Language).
  • Page 23 4.1.6.2. Modification of Barcode Scanner Settings when Changing from French to Another Language  Select a language.  Confirm by OK.  Scan all barcodes in the sequence shown below. Steps Function Barcode Scan Language scan  The scanning process is now possible. Page 23 of 65 B·R·A·H·M·S direct Reader User Manual | Version R06 EN B·R·A·H·M·S GmbH...
  • Page 24 5. Lot Management > Main Menu | Lot Management By registration of test lots and QC lots you ensure that all relevant information to use the instrument in routine work is present. 5.1. Lot Registration 5.1.1. Registration of Test Lot >...
  • Page 25  Data of the registered lot are displayed.  Select Display to see the control ranges.  Confirm by OK.  Select Main Menu to return. 5.1.3. Registration of B·R·A·H·M·S direct Reader Control Lot > Main Menu | Lot Management | Scan Barcode Sheet Use the barcode sheet that is supplied with the B·R·A·H·M·S direct Reader Control.
  • Page 26 5.2.2. Liquid QC Lots > Main Menu | Lot Management | Show Lot Lists | Show Liquid QC Lots Select Show Liquid QC Lots to get a list of already registered Liquid QC (e.g. B·R·A·H·M·S PCT™ direct QC) lots. No information appears if there are no lots registered. The Liquid QC lots are sorted by their expiry dates.
  • Page 27 6. Run Test > Main Menu | Run Test You have to login with your 4 digits PIN, except when Auto Login is activated (refer to chapter 8.3.1.1 Auto Login Function), if the instrument setup requires that. Only a Supervisor is allowed to change the login rules.
  • Page 28 6.2. Measurement > Main Menu | Run Test | Enter Sample ID | Apply Sample to Test Apply the sample to the test following the IFU of the test. Place the device on a table and close it by applying slight pressure on the body in the area of the capillary until you hear it click.
  • Page 29 7. Quality Control > Main Menu | Quality Control (QC) We strongly recommend measuring a Liquid QC and a B·R·A·H·M·S direct Reader Control before starting routine measurements to ensure the proper function of the instrument. Follow your local guidelines to define the frequency of control measurements. Important If unacceptable control values are obtained, please avoid further proceeding and contact customer service.
  • Page 30 7.2. B·R·A·H·M·S direct Reader Control > Main Menu | Quality Control (QC) | Run Reader Control The intended use of the B·R·A·H·M·S direct Reader Control is a physical control of the Reader function. The B·R·A·H·M·S direct Reader Control is reusable, it must be stored in the provided reclosable pouch.
  • Page 31 7.3. QC Lockout > Main Menu | Run Test | Enter Sample ID As Supervisor you define the QC lock in the QC setup (refer to chapter 7.3.1 QC Setup). In case of missing QC measurements, the Supervisor can define a certain number of patient samples that is allowed to be measured prior to lockout.
  • Page 32 7.3.1.2. Intervals for QC with B·R·A·H·M·S direct Reader Control > Main Menu | Administration | Settings | QC Setup | Set Intervals of Reader Control  Select the Interval for Reader Control, using  or . By default, the interval is set to none.
  • Page 33 This will be requested by the B·R·A·H·M·S direct Reader with “Reader Control lockout” (error code 118,119) and “Liquid QC lockout” (error code 107). After unlocking the B·R·A·H·M·S direct Reader via the middleware software, the Reader can be used normally again. Page 33 of 65 B·R·A·H·M·S direct Reader User Manual | Version R06 EN B·R·A·H·M·S GmbH...
  • Page 34 8. Administration 8.1. Result History > Main Menu | Administration | Result History You have the possibility to look-up previous patient results from the archive. The results are sorted by date/time. More recent results are displayed on the top of the list. To display further results, scroll down the screen.
  • Page 35 When the instrument is not connected to a middleware or LIS or the LIS or middleware connection is not enabled you will receive an error message. 8.3. Settings 8.3.1. Internal Settings > Main Menu | Administration | Settings | Internal Settings Internal Settings are only accessible if you are logged in as Supervisor.
  • Page 36 8.3.1.2. Auto Logout Function > Main Menu | Administration | Settings | Internal Settings | Auto Logout Activate the Auto Logout function to enable the automatic logout of the instrument after a certain time. The automatic logout can help to protect the instrument from unauthorized use. Auto Logout is set to off by default.
  • Page 37 8.3.1.4. User Identification > Main Menu | Administration | Settings | Internal Settings | User Identification Here, you can determine if entering of a User ID is required prior to running a test or a QC. Not required is set by default. ...
  • Page 38 8.3.1.7. Printer Setup > Main Menu | Administration | Settings | Internal Settings | Printer Printer function is activated by default.  Select YES to print the test results as well as QC results automatically at the end of the measurement. ...
  • Page 39 8.3.1.9. Language > Main Menu | Administration | Settings | Internal Settings | Language The default language is English. The predefined languages are:  English  German  French  Spanish  Italian  Japanese  Chinese  Not all of these languages are displayed on the screen. Scroll down to select your preferred language from the list.
  • Page 40  Plug the USB stick into the USB port on the rear side of the instrument.  Select Add Language.  Click OK.  Choose the required language.  Confirm by OK.  If this is the 7 language, it is directly stored in the software.
  • Page 41 8.3.1.10. Network Connection > Main Menu | Administration | Settings | Internal Settings | Network Connection On this menu you define the interface parameter for connection to middleware, LIS or HIS. Important To avoid electric discharge please connect a ferrite (e.g. STAR-TEC Snap Ferrite with safety key technology 7427111S) at your network cable.
  • Page 42  Select Enable Manual Reader Config.  Click OK.  Enter the Reader IP address.  Navigate by  to the next field.  Enter the Subnet mask in the second field.  Navigate by  to the next field. ...
  • Page 43 8.4.1. Registration of a New User > Main Menu | Administration | User Administration | Add new User By Login with a User PIN you have limited access to the administration menu (refer to chapter 4.1.5 Switching the Instrument On and Off).
  • Page 44 8.4.3. Registration of a New Supervisor > Main Menu | Administration | Supervisor Administration | Add new Supervisor By Login with a Supervisor PIN you have full access to the administration menu (refer to chapter 4.1.5 Switching the Instrument On and Off).
  • Page 45 8.4.5. Change Supervisor PIN > Main Menu | Administration | Supervisor Administration | Change Supervisor PIN You are currently logged in as Supervisor and you want to change your own PIN.  Enter your old PIN.  Navigate by  to the next field. ...
  • Page 46 8.5.2. Export Liquid QC (e.g. B·R·A·H·M·S PCT direct QC) Results > Main Menu | Administration | Export/Import Data | Export Liquid QC Results  Plug in a formatted FAT32 USB stick.  Select the field Export QC Results by using . ...
  • Page 47 8.5.4. Export User ID’s > Main Menu | Administration | Export/Import Data | Export User ID’s  Plug in a formatted FAT32 USB stick.  Select the field Export User ID`s by using .  Wait until the step “Export User ID`s to USB Stick”...
  • Page 48 8.6. About My Reader > Main Menu | Administration | About my Reader Here, general information about the B·R·A·H·M·S direct Reader is available. As Supervisor, you may set up a Reader name and install a software update. 8.6.1. Set Up a Reader Name >...
  • Page 49 9. Maintenance and Troubleshooting 9.1. Maintenance The B·R·A·H·M·S direct Reader needs only a minimum of maintenance. The following decontamination or disinfection procedure has to be performed to ensure safe use by the user and prior to any physical intervention by a supplier/transport worker or service personnel. If the device is contaminated with radioactive, chemical, biological, infectious substances or if the device needs to be returned to Thermo Fisher Scientific, perform the following cleaning process (please refer also to chapter...
  • Page 50 9.3. Error Messages and Troubleshooting Error Message Possible Cause Solution Code In case of electrostatic Switch the B·R·A·H·M·S direct Reader discharge it is possible off and on again to restore that the Barcode Scanner communication. does not communicate with the B·R·A·H·M·S direct Reader any longer.
  • Page 51 Error Message Possible Cause Solution Code  Switch the instrument off. Reader failure Mechanical failure.  Restart the instrument (refer to chapter 4.1.5).  If restart fails again, contact customer service.  Switch the instrument off. Motor failure 1. Error reaching ...
  • Page 52 Error Message Possible Cause Solution Code  In QC setup the QC  To run the required control, select Liquid QC lockout lock is activated. So Main Menu and go to Quality Liquid QC (e.g. Control (QC), Run Liquid QC. ...
  • Page 53 Error Message Possible Cause Solution Code  Confirm by OK to return to the Barcode not 1. The barcode on the legible test is damaged previous screen. The drawer is 2. No test is loaded. opened up.  Remove the test. ...
  • Page 54 Error Message Possible Cause Solution Code  In QC setup the QC  You are obliged to run the Reader Control lockout lock is activated. So a B·R·A·H·M·S direct Reader Control B·R·A·H·M·S direct before you can continue with sample Reader Control measurement.
  • Page 55 Error Message Possible Cause Solution Code  Ensure that the barcodes on the No information You registered lot entered information by barcode barcode sheet are not damaged and scanner. No or the printing is ok, without gaps. Check incomplete information that the barcode scanner is plugged in are read from the properly.
  • Page 56 Error Message Possible Cause Solution Code  Either no USB stick is  Please insert a FAT32 formatted USB USB Stick write Error plugged in or the USB stick.  Select OK to return to the previous stick is not FAT32 Insert a formatted.
  • Page 57 Error Message Possible Cause Solution Code  Click on OK to return to the previous Reader Control The lot of the expired B·R·A·H·M·S direct screen.  Select Back, Main Menu. Reader Control that is  Register a new B·R·A·H·M·S direct currently used is already expired.
  • Page 58 Error Message Possible Cause Solution Code  Select OK to return to the previous No USB stick In order to load a new detected software version, you are screen. Check on the label of the USB requested to plug in the stick that you have the proper one USB stick.
  • Page 59 Error Message Possible Cause Solution Code  Select OK to return to the previous No language 1. To load an additional USB stick language, you shall screen.  Go to the Main Menu. detected. connect the USB stick.  Plug the USB stick containing the Ensure that the 2.
  • Page 60 Error Message Possible Cause Solution Code  You are not allowed to change the This is not the You intend to change the PIN of an PIN of another Supervisor PIN of another Supervisor. You can existing but not yours. only change your own PIN.
  • Page 61 10. Attachments 10.1. Reader, Reagents and Accessories Product Order No. Number/Content Reader B·R·A·H·M·S direct Reader 107074 Reagents B·R·A·H·M·S PCT direct 126.025 25 tests B·R·A·H·M·S PCT direct QC 12692 2x1 control sample, ready to use Accessories Thermal printer paper 105933 2 rolls B·R·A·H·M·S direct Reader Control 106005 Power supply, incl.
  • Page 62 10.2. Decontamination Certificate B·R·A·H·M·S direct Reader Decontamination Certificate Instrument/Module: ............Serial Number: ............Instrument/Module was in contact with the following substance(s):  radioactive material  chemical substances  biological substances  infectious substances  I confirm, that the specified Instrument/Module was cleaned/decontaminated. ...
  • Page 63 10.3. Return Form B·R·A·H·M·S direct Reader Decontamination Certificate Serial Number: ............Installation Date: ............Date of Return: ............Delivery Address: Customer Service B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) Neuendorfstr. 25 16761 Hennigsdorf Germany Sender: ................................................................................................................
  • Page 64 10.4. Glossary Abbreviation Explanation C1, C2 Control 1, Control 2 Liquid QC B·R·A·H·M·S PCT direct QC CMOS Complementary Metal Oxide Semiconductor = semiconductor for conversion of light signals into electrical signals Config. Configuration DHCP Protocol for the assignment of the network configuration (Dynamic Host Configuration Protocol) Gateway A switch address in the network...
  • Page 65 B·R·A·H·M·S GmbH Neuendorfstr. 25 16761 Hennigsdorf Germany Customer Service B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) Neuendorfstr. 25 16761 Hennigsdorf GERMANY +49 (0)3302 883-300 +49 (0)3302 883-388 fax service.brahms@thermofisher.com Date: 07.11.2018 Clinical Diagnostics Thermo Fisher Scientific +49 (0)3302 883 0 B·R·A·H·M·S GmbH +49 (0)3302 883 100 fax Neuendorfstr.