Human HumaFIA User Manual
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Human HumaFIA User Manual

Semi-automated time-resolved fluorescence immunoassay analyser
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  • Page 1 Produktinformation Diagnostik & molekulare Diagnostik Laborgeräte & Service Zellkultur & Verbrauchsmaterial Forschungsprodukte & Biochemikalien Weitere Information auf den folgenden Seiten! See the following pages for more information! Lieferung & Zahlungsart Lieferung: frei Haus Bestellung auf Rechnung SZABO-SCANDIC HandelsgmbH Lieferung ab € 30,- Quellenstraße 110, A-1100 Wien Erstbestellung Vorauskassa T.
  • Page 2 HumaFIA │User Manual Cat. No. 16090/1 REF 16090/1...
  • Page 3 HumaFIA | User manual...

  • Page 4: Humafia

    No part of this documentation may be reproduced in any form, nor processed, copied or distributed by means of electronic systems, without prior permission of HUMAN Wiesbaden or HUMAN China in writing. Since all precautionary measures were taken into account in producing these operating instructions, the manufacturer accepts no responsibility for any errors or omissions.
  • Page 5 HumaFIA | User manual...

  • Page 6: Table Of Contents

    2.3 Technical data ............................. 14 2.4 Method: time-resolved fluorescent immunoassay ................15 2.4.1 Fluorescent immunoassay lateral flow cartridge ................15 2.4.2 The time-resolved technology of HumaFIA .................. 15 2.5 Installation ............................16 2.5.1 Turning the instrument ON ......................17 2.5.2 Turning the instrument OFF ......................17 2.6 Software user interface........................
  • Page 7 4.7 Selection of data fields in the database ....................43 4.8 Settings to establish connectivity channels ..................44 4.9 Service and maintenance ........................44 4.9.1 Run Standard Cartridge as quality check ..................44 5 TROUBLESHOOTING..........................47 6 LATEST INFORMATION/UPDATES ......................49 HumaFIA | User manual...
  • Page 8 Table of Contents HumaFIA | User manual...

  • Page 10: Safety Instructions

    The HUMAN representative shall be relieved of any liability under this warranty if the product is not used in accordance with the manufacturer instructions, altered in any way not specified by HUMAN, not regularly maintained, used with equipment not approved by HUMAN or used for purposes for which it was not designed.

  • Page 11: Disposal Management Concept

    1.6 Biohazard warning Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls which should be considered at least potentially infectious. Therefore, every part and accessory of the respective instrument which may have come into contact with such samples must equally be considered as potentially infectious.

  • Page 12: System Description

    The instrument is a closed system intended to be used only in combination with HumaFIA SR reagents, as an aid to diagnosis, for screening or monitoring. For laboratory professional use only.

  • Page 13: Humafia Calibration Card

    2.2.4 HumaFIA power bank The HumaFIA power bank (73 Wh) is an optional accessory that allows the analyser to run for several hours even when no mains power is available. It can be combined with a solar panel to function as a stand‑alone power system.

  • Page 14: Humafia Data Cable

    Insert the cartridge with the sample port end first into the analyser, as indicated by the arrow. Figure 2-5 Cartridges of various parameters, with barcode containing LOT information 2.2.6 HumaFIA data cable Figure 2-6 Data cable, to connect HumaFIA with a PC for data exchange HumaFIA | User manual...

  • Page 15: Humafia Standard Cartridge

    HumaFIA optical system. Figure 2-7 Standard Cartridge, REF: 16090/510 To run the Standard Cartridge on HumaFIA, first insert the corresponding calibration card. Run the Standard Cartridge in the QC module, see chapter 3.3 QC module.

  • Page 16: Method: Time-Resolved Fluorescent Immunoassay

    Stable dry reagent cartridges are ready to use (4-30 °C) for easy storage and transportation. Whole blood, serum and plasma are supported sample types. Refer to the corresponding IFU for each parameter. 2.4.2 The time-resolved technology of HumaFIA The highly sensitive time-resolved fluorescent immunoassay (TR-FIA) technology is based on fluorescent europium Eu chelates, with large Stokes shifts, narrow emission bands and long fluorescence lifetimes.

  • Page 17: Installation

    Figure 2-9 TR-FIA method explanation, graph for illustration purposes only 2.5 Installation This chapter provides instructions for the unpacking and installation of the HumaFIA analyser. Follow the procedures below to ensure proper operation and service. Carefully read and follow all the instructions in this User Manual before operating the analyser.

  • Page 18: Turning The Instrument On

    Select the user level, type in the password, and click Login to enter the home screen (see chapter 2.6.1.4 Home screen). 2.5.2 Turning the instrument OFF After completing the tests, turn off the power switch at the back of the instrument. HumaFIA | User manual...

  • Page 19: Software User Interface

    The user interface of the HumaFIA analyser is designed to be intuitive and easy to use and provide access to all user level functions. The user can interact with the HumaFIA by using only the touch screen and the virtual on-screen keypad, or by using an external keyboard.

  • Page 20: Menu Tree

    Settings module: for settings of date and time, but also of flags, reference values, printer settings, connectivity, and database selection for review of results. Access the home screen from any screen on the analyser by pressing on the HUMAN logo in the upper left corner of the permanent header.
  • Page 21 Table 2-2 Meaning of the symbols shown in the status line of the permanent header Use the scroll bar on the right side of most screens to reach more patient results or data if they are not initially displayed. Pressing on the HUMAN logo always directs to the home screen. HumaFIA | User manual...

  • Page 22: Routine Utilization And Measurement

    3 ROUTINE UTILIZATION AND MEASUREMENT 3.1 Instrument operation and sample preparation The HumaFIA analyser is a semi-automated instrument. The user must prepare the sample, incubate the cartridge (automatically inside the analyser or manually outside), insert a sample cartridge in the analyser at the Cassette input slot of the analyser, and start the reading of the results.

  • Page 23: Calibration

    Safety Notes: All patient specimens, calibrators and controls should be handled as potentially infectious. All donor units of human origin have been tested for HBsAg, HIV and HCV-antibodies and found to be non- reactive using approved methods. All materials of animal origin avoid many risks associated with the use of human serum (e.g.

  • Page 24: Sampling Modes

    3 ROUTINE UTILIZATION AND MEASUREMENT 3.2 Sampling modes The HumaFIA software provides 3 modes to run a sample. a) Auto sample mode b) STAT sample mode Fast mode 3.2.1 Auto sample mode, with internal incubation Upon selection of Auto sample, the following screen is displayed: Figure 3-1 Auto-sample mode for automated incubation and reading of tests Auto sample mode allows the automated sampling for a test.

  • Page 25: Stat Sample Mode, Flexible Testing

    Note: 3-in-1 tests, like cTnI/Myo/CK-MB are displayed in 3 lines. Each parameter of the 3-in-1 cartridge is shown in a separate line on the screen. The parameter names start and end with two dots (e.g, ..cTnI.., or ..Myo..). HumaFIA | User manual...

  • Page 26: Fast Mode Sampling

    Now the user has 10 seconds to insert the cartridge into the analyser and press the Read button. For valid results, press the Read button when the timer is equals 00. Reading takes only a few seconds, then the result of this parameter is displayed. HumaFIA | User manual...
  • Page 27 Note: 3-in-1 tests, like cTnI/Myo/CK-MB are displayed in 3 lines. Each parameter of the 3-in-1 cartridge is shown in a separate line on the screen. The parameter names start and end with two dots (e.g, ..cTnI.., or ..Myo..). HumaFIA | User manual...

  • Page 28: Add Sample, Patient Data And Parameter Type

    Incubation and reading can be initiated on the next screen. 3.2.4.2 Add an ID To add a new patient sample, press Add ID to assign an ID number. A new ID number is then generated automatically. HumaFIA | User manual...
  • Page 29 There are two ways to add patient data: A) manually by keyboard B) via the optional barcode reader Once the patient data is added successfully, the Family name, Given name, Birthday and Gender are shown in the light grey fields. HumaFIA | User manual...

  • Page 30: Qc Module

    Run controls in Fast mode: This option is recommended if control materials of various levels and parameters need to be run in a short time. Figure 3-6 Quality control main screen HumaFIA | User manual...

  • Page 31: Upload Of New Control Material

    Select the level of the control. Type in the LOT number. Select the Expiration date. Type in the target value (according to the units of parameter). To complete the upload of new controls, press the Add button. HumaFIA | User manual...

  • Page 32: Run Controls In Auto Mode

    Note: The red Exp flag in the column LOT indicates that this LOT of control material is expired and must be replaced by a new LOT. HumaFIA | User manual...

  • Page 33: Run Controls In Fast Mode

    A new line is added and if there is an available time-slot to read a control after incubation time, Next Con. is shown in this line, further details below. Figure 3-10 Worklist of controls to be run in Fast mode HumaFIA | User manual...
  • Page 34 LOT, date and time of the reading, control low and high target values, control level and the recorded result of a control parameter. Note: A red number in the Timer column indicates an incorrect incubation time. The measurement must be repeated with another cartridge. HumaFIA | User manual...

  • Page 35: Database In The Qc Module

    Datasets can be deleted by pressing the dark grey button of the dataset to be deleted. Note: Only calibration cards of parameters are shown. The Standard Cartridge is not displayed here. HumaFIA | User manual...

  • Page 36: Database Interface

    Some fields, for example in the column Printed or Exported, are set to no by default. Pressing the field changes this setting to yes. To delete a complete data set, press the wastebasket icon next to the patient’s name. Figure 3-13 Review of recorded results in Database HumaFIA | User manual...

  • Page 37: Filter Functions Of The Database

    • Family name • Given name • Patient ID • Parameter • Result flags • Comment on correct/wrong reading times • • Sample type • Expired or non-expired readings • Flagged results out of linearity range HumaFIA | User manual...

  • Page 38: Advanced Operation

    Connectivity: definition of IP address and ports for communication channels Note: The Connectivity button can be reached by swiping upwards on the buttons on the right side. It is below the Reset factory settings button. Each module is explained below in a separate chapter. HumaFIA | User manual...

  • Page 39: Settings For The Test Procedure

    If Auto-print every result (external printer) is activated, the printout to an external printer is activated. However, this option is only available if a printer driver for an external printer is loaded. This function is currently not available. Exit applies the selected settings and closes the window. HumaFIA | User manual...

  • Page 40: General (Date, Time, Language, Brightness, Temperature, Delete)

    Confirm by warning: If this option is enabled, a warning will show up to confirm the deletion of data. • The Test/Control confirm option enables all the warnings related to the use of tests and controls, such as a hint for an expired reagent. Exit applies the selected settings and closes the window. HumaFIA | User manual...

  • Page 41: Selection Of Parameter List

    The name of the new parameter is neo12h. Any name can be chosen. Then, the range for normal values is set to be 0.5 to 8.0 ng/ml. Pressing Add on the pop-up window creates the new parameter with a customised reference range. The last step is to define a priority for the new parameter. HumaFIA | User manual...

  • Page 42: Settings To Enable Flags

    L, N and H flags are shown if Low, normal, high, to classify sample result is activated. Tx and Cx flags are shown if Cartridge/test expired Control expired is activated, indicating the test LOT (Tx) or the control LOT (Cx) is expired. HumaFIA | User manual...

  • Page 43: General (2) Settings, Software Update, Auto-Warnings

    Note: Only the USB ports next to the serial-connection port can be used to upload a software update. Show software version opens a screen that shows the current software version running on the system. Exit applies the selected settings and closes the window. HumaFIA | User manual...

  • Page 44: Selection Of Data Fields In The Database

    The database is quite big and stores many data fields. This setting page allows the user to customise what is displayed in the database or printed by activating (✓) or disabling (x) the options on the corresponding data field. Exit applies the selected settings and closes the window. HumaFIA | User manual...

  • Page 45: Settings To Establish Connectivity Channels

    If the setting Serial port (PC interface) is enabled, the system starts the data transfer via the HumaFIA data cable with the PC the HumaFIA is connected to, automatically after the start of the instrument.
  • Page 46 Press Load new Standard Cartridge in the QC module screen to access the following screen. Then press STD-test which leads to the pop-up window showing the LOT of the Standard Cartridge. Next to Gradient, select the level of the Standard Cartridge that should be used next. Figure 4-12 Read Standard Cartridges (STD) HumaFIA | User manual...
  • Page 47 LOT. Compare the uploaded target values to the values on the target value sheet in the kit to ensure that they have been uploaded correctly. If the problem remains, contact a service engineer. HumaFIA | User manual...

  • Page 48: Troubleshooting

    Faulty optical components, contact a service engineer. 5 levels. Red number in column Timer in Auto- Monitoring of the incubation time by HumaFIA revealed an sample or in Fast mode. A red number incorrect timing. IL: Incubation time too long, IS: Incubation like 02:11 and an IL or IS flag are time too short.
  • Page 49 5 TROUBLESHOOTING Warning 100 HumaFIA has a temperature sensor which monitors the Ambient temperature out of ambient temperature. If the temperature is out of the specified specifications. range, all results will be flagged, and a warning is shown. The Please re-run sample at 18 to 28 °C...

  • Page 50: Latest Information/Updates

    If the information about the latest versions is not accessible via internet, it can be obtained free of charge from your local distributor. If the installed software is not the latest one, contact your local distributor. If you cannot download the latest manual, contact your local distributor. HumaFIA | User manual...
  • Page 51 6 LATEST INFORMATION/UPDATES HumaFIA | User manual...
  • Page 53 HUMAN Diagnostics Product (Beijing) Co., Ltd. Address: Unit 703, Yongchang Industry Park, No.3 Yongchang North Road, Beijing Economic and Technological Department Area, Beijing 100176, China Tel：+86-10-63579937, E-Mail: customerservice@human-china.com...

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