HTI BioChem FC-360 Operator's Manual
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HTI BioChem FC-360 Operator's Manual

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High Technology, Inc.
109 Production Road, Walpole MA 02081 USA
Automatic Chemistry Analyzer
Document Number
Revision Level
Effective Date
HTI BioChem FC-360
Operator's Manual
:
OM-E-FC-360-30
:
Rev. 3
:
8/15/2016
HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

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  • Page 1 High Technology, Inc. 109 Production Road, Walpole MA 02081 USA Automatic Chemistry Analyzer HTI BioChem FC-360 Operator’s Manual Document Number OM-E-FC-360-30 Revision Level Rev. 3 Effective Date 8/15/2016 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL...

  • Page 3: Table Of Contents

    J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Contents INTENDED USE ................................ 1 TRANSPORTATION, STORAGE AND UNPACKING ..................4 TRANSPORTATION AND STORAGE ....................... 4 UNPACKING INSTRUCTIONS ........................5 INSTALLATION ..............................7 ELECTRICAL REQUIREMENTS .......................
  • Page 4 J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 BASIC OPERATIONS ............................. 27 INITIAL CONFIGURATION OF THE PROGRAM ..................27 DAILY OPERATION ..........................27 PROGRAMMED MAINTENANCE ......................28 SOFTWARE TABS ............................29 MAIN WINDOW OF THE SOFTWARE ....................
  • Page 5 Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 General Tab (ISE) ..........................94 Factor tab (ISE) ..........................96 Special Tab (ISE) ..........................97 Advanced tab (ISE) .......................... 98 REAGENTS IN USE AND PROFILES ....................100 SAVING METHODS ..........................
  • Page 6 J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 12.8.1.1 Photometer calibration ....................... 145 12.8.1.2 Cuvettes calibration ........................146 Diluter purge ........................... 146 Washer purge ..........................147 Initialize ............................147 ISE (Optional) ..........................147 12.8.5.1 Start up ............................
  • Page 7 Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 MAINTENANCE PROGRAM ........................175 DAILY MAINTENANCE .......................... 175 Before starting daily operation ....................... 175 Maintenance  Instrument  Diluter Purge ..................... 175 During the daily operation ......................176 Upon finishing with the daily operation...................
  • Page 8 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 PREPARING SOLUTIONS ........................191 WASH SOLUTION..........................191 Washing solution for probe and cuvettes ..................191 Washing solution for probe and cuvettes when running turbidimetric methods ......192 TIP CLEANING SOLUTION ........................

  • Page 9: Intended Use

    8/15/2016 Operator’s Manual: HTI BioChem FC-360 INTENDED USE BioChem FC-360 is a photometric analyzer for clinical chemistry, it is meant to perform automated analytic procedures for “in vitro” diagnosis. Terms of use 1. The instrument must be installed by trained personnel.
  • Page 10 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Chemical risks Always wear protective apparel when operating the analyzer (gloves, safety glasses, etc.). Follow specific recommendations on the bottles of each reagent or washing solution. Read safety information of materials provided by manufacturers to be aware of possible danger and to learn how to prevent it.
  • Page 11 Warranty Terms HTI warrants the instrument for a period of 12 months as of the date the instrument leaves the factory. This warranty is only effective as long as the pertinent warranty card together with the installation record with all the data is duly completed and sent to us by certified mail.

  • Page 12: Transportation, Storage And Unpacking

    Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 HTI RESERVES THE RIGHT TO MODIFY THE INSTRUMENTS WITHOUT AFFECTING THEIR OPERATING PARAMETERS. NOTE: The following elements are not covered by warranty terms: halogen lamps, fuses, cuvettes, reagents bottles, tubes and tubing.

  • Page 13: Unpacking Instructions

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Unpacking instructions Warning: Unpacking shall be carried out by trained personnel. Carefully unpack the instrument to prevent damage. Labels indicating this operation are found on each side of the packaging box.
  • Page 14 S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 NOTE: Instrument remains fastened to the bottom. Remove the instrument from the bottom of the box as shown in Figure 1-2 and as explained below. On the upper part of the instrument you will find an Allen wrench Nº 6, which will be used to remove the screws joining the bottom to the instrument.

  • Page 15: Installation

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 1-5 Once the screws have been removed and the instrument is released, the protective Styrofoam is removed and the instrument can be placed on the working surface.

  • Page 16: Environmental Requirements

    Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Environmental requirements Operating temperature: 20°C ~25°C Operating Humidity: 20~85% (no condensation) Storage Temperature: 0°C~50°C Storage Humidity: ≤80% Moving the instrument Avoid hitting the instrument as well as subjecting it to any kind of vibration while moving it.

  • Page 17: Wires And Tubing Connection

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Connect the instrument to the computer and its peripherals before connecting to the supply line. If the above requirements are not met, the quality of results may be affected. Warning: Make sure that ground connection in the line meets the standard requirements for its operating power.
  • Page 18 S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 If necessary, soak the reference electrode in warm water until the lumen of the electrode has been cleared of salt build-up. 6. Depress the compression tray to install electrodes in position (as shown in Figure 2-2) Figure 2-2 7.

  • Page 19: Washing Solution

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 2-3 Warning: The tubing with the biggest diameter (waste funnel) must be kept straight downwards without curves to allow free drain of fluids. Washing solution Warning: Containers must be placed under the analyzer.

  • Page 20: Washing Solution For Probe And Cuvettes When Running Turbidimetric Methods

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 2.7.1.2 Washing solution for probe and cuvettes when running turbidimetric methods In those cases where latex reagents are used (most turbidimetric methods), is highly recommended to use the following washing solutions: Washing solution for probe: use only DI water Washing solution for cuvettes: dilute 3 ml of wash concentrate in 1 liter of distilled water.

  • Page 21: Analyzer Setup

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Analyzer setup Place the cuvettes in the reaction tray. Warning: Do not touch the external surface of the cuvette. Warning: avoid dropping the metal nuts into the interior of the instrument during this procedure.

  • Page 22: Analyzer Technical Specifications

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 For instruments that don’t have ISE Module installed, the analyzer is now ready to use. Otherwise go to step 15. Run Reagent Kit Replacement command. (Maintenance Instrument ISE Reagent Kit Replacement) Run Calibrant A and B purge if necessary.

  • Page 23: General Specifications

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 General specifications Average throughput with ISE: 450 test/hour Average throughput without ISE: 300 test/hour Automatic: Sample and reagents are taken and dispensed without the user's intervention. This also applies to the reading of reactions.

  • Page 24: Dispensing Arm And Hydraulic System

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Dispensing Arm and Hydraulic System Samples and reagents preheated to 37ºC. High precision diluter Maximum aspiration volume: 500 µl (physical capacity of the diluter) Internal and external washing of the probe through liquid diaphragm pump Volume detection...

  • Page 25: Software

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Software Easy access menu, with buttons and icons. Continuous loading of patients, calibrators, controls and reagents during work sequence. Stat samples Unlimited number of methods in memory Statistics for controls, calibrators and patients Levy-Jennings...

  • Page 26: Types Of Samples

    Colorimetric Kinetics Turbidimetric Ion Selective Electrode (ISE) (Optional) GENERAL FUNCTIONS Main parts or modules BioChem FC-360 Auto analyzer can be divided into the following main parts: Sample/ Reagent Tray Dispensing Arm and Probe Cuvette/Reaction Tray Cuvette Washer Hydraulic System Optical System...

  • Page 27: Sample/Reagent Tray

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Sample/Reagent Tray Figure 4-1 This tray can hold up to 60 refrigerated reagents, in 30 tray positions. Each reagent bottle can be single or double-mouthed. Only one tray position is occupied in methods with two reagents.

  • Page 28: Dispensing Arm And Probe

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Dispensing Arm and Probe Figure 4-2 The dispensing arm transports the reagents and samples through the probe to a cuvette in the reaction tray. Reagents and samples are preheated in this arm before being dispensed.
  • Page 29 S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 4-3 This is where the reactions are carried out and read. It has 100 separate cuvettes, grouped in 10 strips of 10 cuvettes. The cuvettes are made of PMMA, which allows a good transmittance in the UV range.

  • Page 30: Cuvette Washer

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Cuvette Washer Figure 4-4 Its function is to wash cuvettes once the reactions have been measured. This washing is also performed as required by dispensing: each time a new sample is dispensed by the probe, the washing system operates, and cuvettes are washed automatically and sequentially.

  • Page 31: Hydraulic System

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Hydraulic System Figure 4-5 Its main components are the liquid diaphragm pump, the solenoid valve and the diluter, the washing station and the tubing that connects the wash solution container to the probe.

  • Page 32: Optical System

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Optical System Light source: a 12-Volt 20-Watt krypton-halogen lamp is used which has a high emission in the UV range (320 nm-380 nm) Collimating lenses: 3 plane-convex lenses are used.

  • Page 33: Ise Module (Optional)

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 ISE Module (Optional) Figure 4-7 ISE Module includes ion selective electrodes and three peristaltic pumps. The ISE module measures the concentration of Li+, Na+, K+, Cl- in serum, plasma, and diluted urine.

  • Page 34: Reaction Preparation Cycle

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Reaction Preparation Cycle The dispensing arm moves to the sample/reagent tray, and the probe places itself over the reagent to be aspirated. The arm lowers until the sensor of the probe finds liquid level and it aspirates the programmed reagent volume.

  • Page 35: Basic Operations

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 BASIC OPERATIONS In this chapter, the necessary steps for operating the instrument are described, including initial configuration, daily operation and programmed maintenance. Initial configuration of the program Before beginning with the operation of the equipment, it is necessary to configure the following items: 1.

  • Page 36: Programmed Maintenance

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 14) Run the ISE calibration and ISE cleaning each time the system ask to (every 8 hours or every 50 samples). 15) Evaluate the obtained results. 16) Print results and/or reports.

  • Page 37: Software Tabs

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 SOFTWARE TABS Main window of the software The following window will be displayed when opening the software. Figure 6-1 The menu will be accessed by the mouse or from the keyboard with the help of shortcut keys. These become active by pressing Alt on the keyboard.

  • Page 38: Operations Tab

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Operations Tab The software has tabs in which patients’ results, calibrators and/or controls, as well as samples and reagent positions will be observed. It has a main tab Operations, where process and status of determinations will be shown. These tabs can be accessed by selecting them with the mouse.

  • Page 39: Operator's Manual: Hti Biochem Fc

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 6-5 Process Number This symbol represents the number assigned by the software to each sample when requested. This number corresponds to the time when the request is made. It is unique and it cannot be changed and has...
  • Page 40 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Absence of any of these signs means that there are no selected methods for the process, and the frame will be Pending Samples. Type In this column are the types of process like samples, patients, calibrators and/or controls. They are identified with different symbols for a quick reference.

  • Page 41: Reagents Trays Tab

    J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 6-6 Reagents Trays Tab Reagent position Reagent tray positions are configured in this tab. Figure 6-7 Numbers 1 to 30 on the left of each box correspond to the reagent positions on the tray.
  • Page 42 S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 6-8 Once all reagents have been positioned, type a name within the Tray File field and press Save. An indefinite number of tray files may be created, each with difference names, and then press Save.

  • Page 43: Pat Results Tab

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 6-11 Reload the volume reagent bottle(s), press Reloaded button in the Tray and then press Pause again to continue with the pending work. Figure 6-12 Warning: probe arm robot will move if reagent 2 has to be dispensed.
  • Page 44 Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 When you open the software and you access this tab, results will not be shown until you press the key With the following keys, different search processes of patients’ results, methods, calibrators and controls can be carried out.

  • Page 45: Patient Results Search

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Patient results search To see patients’ results follow these steps: When the software is opened, results will not be shown. The screen will look like this: Figure 6-15 First: Press the key “Make a new search”...
  • Page 46 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 6-16 Second: To see results corresponding to each patient, first select the patient in the box on the upper part of the window. Results corresponding to the selected patient can be seen in the box on the lower part of the window.
  • Page 47 Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 6-18 This “Extended Information” box will appear differently depending on the type of reaction. It will show whether the technique is bichromatic and/or if it is reagent blank.

  • Page 48: Advanced Search

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 6-20 Absorbances, time of measurements, readings plot, delta abs/min, redilutions, will be reported Advanced search Patients can be searched in different ways, such as: By process date:...
  • Page 49 Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 6-22 Advanced search parameters are shown or hidden by pressing this key both for a patient’s name and a method result. It has the same function in the CAL Results and CON Results tab. By pressing the same key these parameters will be hidden.
  • Page 50 S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 The search keys in the lower part of the page work in the same way in the upper part and allow for the search for a specific assay or patient result.
  • Page 51 S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Search results will be shown in the window box. Other advanced search parameters will operate in the same way. Warning: When the advanced search is not being used, REMOVE the check mark from the search parameter box.

  • Page 52: Cal Results Tab

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 CAL Results Tab Figure 6-26 Calibration results and factors are shown in this tab. They can be sorted by process number, alphabetically (by calibrator name), or by method.

  • Page 53: Con Results Tab

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 6-27 Searches can be made by process date, name of calibrator, method, or by patient report. Warning: Remove check marks from search parameters before closing advanced searches.
  • Page 54 S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 6-29 2. Result in control concentration is shown In the Report column Results will be reported with the text Right if the result is within the programmed control range, or Error if the result falls outside the programmed control range.

  • Page 55: Sample Positions Tab

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Sample Positions Tab Figure 6-31 This tab corresponds to the positions on the sample tray. Positions of tubes can be found here and identified by ID number or name.

  • Page 56: Operations Menu

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 OPERATIONS MENU Basic functions for the operation of the instrument are described in the Operations Menu, which can also be accessed from shortcut icons (Figure 7-1) Figure 7-1...

  • Page 57: Add Sample

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Add Sample Patients, Calibrators and Controls samples can be carried out in two ways: from the Operations Menu (Figure 7-2) or from the icon Add New Sample (Figure 7-3) Figure 7-3 On the Operations Menu select Add ...

  • Page 58: 7.1.1.1 Add Patient

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 7.1.1.1 Add Patient Select Patient on the screen Add Process. The fields Name, Surname, PID (Personal Identification), Age, Sex, ID, Tube, Doctor and Bed will appear. ID is the only mandatory field that has to be completed in order to save the request. The other fields can be completed so that patients’...
  • Page 59 Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Press Add to save the request, or Cancel if the operation is not carried out. If the Clear After Adding box is selected, the Add Process screen will be cleared after clicking on the Add button.

  • Page 60: 7.1.1.2 Add Calibrator

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 7.1.1.2 Add Calibrator Select Calibrator on the Add Process screen. All calibrators configured according to Chapter 9 point 9.1 will be displayed. Select the desired calibrator on the left column. The methods to be calibrated with the selected calibrator will appear in the right column since they have a configured concentration (Figure 7-8).

  • Page 61: Add Methods

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Patient Figure 7-9 Add Methods Methods can be added to samples already requested, Patients, Calibrators or Controls. This can be carried out in two ways: from the Operations Menu (Figure 7-2) or from the Add New Method to Sample icon (Figure 7-10).

  • Page 62: Modify Sample

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 7-11 Modify Sample Patients’ data that has already been requested can be edited in two ways: from the Operations Menu (Figure 7-12) or from the Edit Sample icon (Figure 7-13)

  • Page 63: Delete Samples And Methods

    Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Warning: These processes can only be carried out before the entered samples are on the sample tray. Once in process, or when the process has finished, it is not possible to modify patients’ data or the Stat condition.

  • Page 64: Delete Sample

    Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Delete Sample An entered sample can be deleted in two ways: from the Operations Menu (Figure 7-16) or from the Delete Sample icon. (Figure 7-17) Figure 7-17 Select the sample to be deleted on the Operations Tab and press Operations Delete Sample or...

  • Page 65: Delete Selected Method

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 7-19 Delete Selected Method A requested method for a Patient, Calibrator or Control sample can be deleted in two ways: from the Operations Menu (Figure 7-16) or from the Delete Method icon (Figure 7-20)

  • Page 66: Pending: Save, Load And Import Pending Requests

    Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 7-21 Figure 7-22 Pending: save, load and import pending requests Pending requests lists can be loaded, saved and imported from the Pending submenu in the Operations Menu.

  • Page 67: Save Pending

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Save Pending Samples which are not processed in the current run remain pending and can be saved in a file with the extension *.aop. This file can later be used in a new run to enter new requests into the system without the need to create them again (see 7.4.2).

  • Page 68: Import From Csv

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Warning: When sample requests are re-loaded from a saved file, the system will assign a new process number to each sample. Import from CSV Sample requests can be entered in the software from a laboratory information system software through a file with a standard CSV (comma, space, value) format.
  • Page 69 Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 -Non-correlative samples: Holding the Control key on the keyboard, select each sample with the mouse. Either all or some of the requested samples can be selected; the remaining samples can be left for later process.
  • Page 70 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 7-29 4. Select the execution options: by Selection, by Patients or by Reagents: Selection: This is the fastest option. The software organizes and establishes the work sequence, ordering of the methods and samples, optimizing processing speed.

  • Page 71: Samples To Tray (Barcode) (Optional)

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 7. Press Verify Selected or Do not verify. If the option Do Not Verify is selected, the methods that are checked will not be verified. Warning: This is the last screen where processing of requested samples can be cancelled.
  • Page 72 Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 and stop the scanning process after finishing in position 10. If a barcode can’t be read by the analyzer, the sample corresponding to that barcode won’t be found, therefor the analyzer will continue scanning until it reaches position 60.
  • Page 73 S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 3. Check that the actual positioning of samples on the tray corresponds to what appears on the Samples Position screen. Sample positions can be modified by using the drop down window in the Position column.
  • Page 74 S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 with a check mark. It is recommended that the selected reagents be verified to ensure the integrity of the reagents before processing samples. Methods where the verification time has not elapsed can also be verified by selecting them on this screen.

  • Page 75: Wash Cuvettes

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Wash Cuvettes Cuvette washing processes are carried out from the Operations Menu, Wash Cuvettes submenu or from the Wash Cuvettes icon on the main screen of the system (Figure 7-33)

  • Page 76: Start

    Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 7-40 Start Operation of the instrument can be started from the Start submenu of the Operations Menu or from the Start icon (Figure 7-35)

  • Page 77: Stop

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Stop The instrument can be completely stopped by pressing Stop on the Operations Menu or the Stop icon (Figure 7-36). The processing of samples and the reading of reagents in process will stop completely as a result.
  • Page 78 109 Production Road, Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 7-39 Pause is used:  to add samples on the samples tray  to refill reagents bottles ...

  • Page 79: Print Results

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Print Results Patients, calibrators and controls results can be printed from the Operations Menu, Print PAT, CAL or CON Results or from the Icon Print View (Figure 7-45).
  • Page 80 Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 By pressing Preview the Patient Report or Technical Report format can be viewed on screen. By pressing Filter a new window will appears, through this window some results can be remove from printout process.
  • Page 81 109 Production Road, Prepared by J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 7-43 Press Preview, Print or Cancel. HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 73 of 222...

  • Page 82: Repeat Results

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Repeat Results A method with a result already reported by the instrument can be repeated by pressing Repeat under the Operations Menu or the Repeat icon (Figure 7-41)

  • Page 83: Reload Samples

    J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Reload Samples Upon detection of insufficient sample an error notice will appear. The sample process identification is provided. Figure 7-50 Figure 7-51 A No Sample notice can be seen on the Operation Tab, Status field (Figure 7-43).

  • Page 84: Methods Menu

    Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 METHODS MENU In the menu bar select “Methods” to display the Method Menu (Figure 8-1) Figure 8-1 Settings: Methods Configuration Test parameters are programmed in this menu, including: reaction types, wavelengths, sample and reagent volumes, incubation times, etc.

  • Page 85: General Tab

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 General Tab Figure 8-3 Write the method’s name in the blank field on the top of the window (to the left of the Add button) then press Add. The method will appear in the field to the left of the Delete button, included in the general list of methods.
  • Page 86 High Technology, Inc. 109 Production Road, Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360  End Point Reagent Blank  End Point Sample Blank  Kinetics  Fixed Time Kinetics ...

  • Page 87: Factor Tab

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Verification time: Enter the time (in hours) that is desired for checking the reagent deterioration index. Sixteen hours is recommended. NOTE: Always press the Modify and OK buttons if any change is made in the method configuration.
  • Page 88 S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 If the calibration curve has more than one point repeat the previous steps until reaching the desired number of points. This step connects in the software the “Methods” window with the “Calibrators” window, where the calibrator concentration must be entered.
  • Page 89 S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 8-5 To know which interpolation suits the best for that set of calibrators, click on Curve and you’ll see the following chart, where each colored curve represents each type of interpolation and in black circles are marked the calibration points.

  • Page 90: Reference Values Tab

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Reference Values Tab In the Reference Values tab (Figure 8-4) complete the fields with the corresponding values given by the reagent manufacturer or a population mean obtained from each laboratory. These reference values are listed in the patient and technical reports.

  • Page 91: Specials Tab

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Specials Tab In the Specials tab enter the incubation times, minimum repetition and maximum re-dilution values, etc. The fields shown in this tab will depend on the type of reaction selected in the General tab. Each method has four different options (Figure 8-5).
  • Page 92 Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Interval between blanks: Enter the maximum possible time interval for the run of the reagent blank. 72 hours is recommended. The reagent blank should be run each time the reagent bottle is refilled, the reagent batch is changed, or the method is calibrated.

  • Page 93: 8.1.4.2 End Point Sample Blank

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 8.1.4.2 End Point Sample Blank In this type of measurement, the instrument takes a blank reading for each sample to be measured and the result is subtracted from the absorbance of the final reaction. The sample blank reading and reaction reading are run in the same cuvette.
  • Page 94 Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Factor programmed or obtained by the method calibration Concentration Sample Volume Reagent 1 Volume Reagent 2 Volume Dilution Factor = (V ) / (V C = (Am –...

  • Page 95: 8.1.4.3 Kinetics

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 8.1.4.3 Kinetics In this type of reaction, a set of readings through a specified period is taken by the instrument, as programmed by the user. This method monitors the initial substrate consumption, and calculates by least squares the slope of the straight line that the Δabs/min determines.
  • Page 96 Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Linearity: This is the linear correlation coefficient of the absorbance readings according to the time of the reaction. If the coefficient is less than that programmed, the instrument will dilute the sample. It is recommended to enter a value between 0.8 and 0.95...

  • Page 97: 8.1.4.4 Fixed Time Kinetics

    J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 ΔA/min • F Bichromatic Reading Absorbance Reading of the Sample Absorbance Reading of the Sample Absorbance Reading of the Sample ΔA/min = change per minute of the sample absorbance calculated by linear regression over “n”...
  • Page 98 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 8.1.4.4.1 Entering Times and Values Time to start Readings: Enter the total time in seconds for the first absorbance reading. Time between Readings: Enter the total time in seconds after the first absorbance reading, for the second absorbance reading.

  • Page 99: Advanced Tab

    J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Concentration ’ Ai = A ’  C = (Af – Ai) • F Af = A NOTE: Always press the Modify and OK buttons if any change is made in the method configuration.
  • Page 100 Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Gap Reagent/Sample: A volume of air drawn in by the diluter. It is used to minimize contact between the reagent and the sample. The default value is 0 µl. 2 µl are recommended.
  • Page 101 S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 8-15 Washings to avoid Interference: Extra wash cycles of the probe can be programmed to prevent interference between reagents of different methods. This extra wash can be up to 2.

  • Page 102: Ise Methods Settings (Optional)

    Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 The same options are available for washings between different reagents. Select from the general list of methods the one that is causing the interference. Then click in the Washing field, enter the extra number of washes, press Enter.

  • Page 103: Document Number Om-E-Fc

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 8-17 After adding the ISE type method a new check box and drop down list with the new ISE methods (Li, Na, K, Cl) appears. Figure 8-18...

  • Page 104: Factor Tab (Ise)

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Sample Volume: For serum sample is 70 µl for urine sample is 140 µl (diluted urine) Press Modify button NOTE: Always press the Modify and OK buttons if any change is made in the method configuration, if no parameter is changed, exit by pressing the OK button.

  • Page 105: Special Tab (Ise)

    Prepared by J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Exponential: (a • Abs + b) Conc = e Polynomial: • Abs + a • Abs + … + a •...

  • Page 106: Advanced Tab (Ise)

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Cx = Concentration of ion in the sample Cs = Concentration of ion in the calibrant solution “S”, the slope, is determined during calibration using Calibrants A and B, which have known levels of lithium, sodium, potassium, and chloride.
  • Page 107 S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Initial Gap Speed: The speed with which the diluter draws in the initial air gap. The default value is 500 µl / second. Gap Reagent/Sample: A volume of air drawn in by the diluter. It is used to minimize contact between the reagent and the sample.

  • Page 108: Reagents In Use And Profiles

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Reagents in Use and Profiles Figure 8-21 Within the Methods menu, select Reagents in Use and Profiles (Figure 8-16). Every time a method is programmed, it will appear on the In Use listing.

  • Page 109: Saving Methods

    The configured methods in the software can be saved in a file or location different from that which the software uses. They are saved with the extension *.amf. This extension is only used for the BioChem FC-360 program, and is not able to be opened with any other application. This operation is unavailable while processing patients, calibrators and/or controls.

  • Page 110: Loading Methods

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 8-23 Loading Methods Methods are loaded from a different location than that used by the program. Only files with the *.amf extension are able to be loaded. This operation is unavailable while processing patients, calibrators and/or controls.

  • Page 111: Saving Profiles

    The created profiles can be saved in a different location than that used by the program. They are saved with the extension *.aef. This extension is used for the BioChem FC-360 program. This operation is unavailable while processing patients, calibrators and/or controls.

  • Page 112: Calibrators Menu

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 CALIBRATORS MENU Calibrator parameters settings as well as calibrator files handling can be carried out from the Calibrators Menu. There is also a shortcut to parameters setting from the icon Calibrators Parameters (Figure 9-1)
  • Page 113 Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 9-2 The remove a calibrator already entered, select the calibrator in the column Calibrator and press Delete and then OK. To modify a concentration already entered, place the cursor on the data and modify it. Then press Enter on the keyboard and OK to save modifications.

  • Page 114: Saving Calibrators Files

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Saving Calibrators Files Calibrators configuration data in use can be saved through the submenu Save. By pressing Calibrators Menu Save, an exploration window is displayed. Select the folder or location where the data will be saved.

  • Page 115: Settings

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Settings Controls parameters are set on the Settings submenu. This operation is unavailable while processing patients, calibrators and/or controls. Press Settings on the Controls Menu or Controls Parameters shortcut icon. The configuration screen will then be displayed (Figure 10-2) and the data of the control is entered first in the pertinent fields: Name, Brand, Lot and Expiration date, in this format: dd/mm/yyyy.

  • Page 116: Saving Controls Files

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Saving Controls Files Controls configuration data in use can be saved from the submenu Save. By pressing Controls Menu Save, an exploration window is displayed. Select the folder or location where the data will be saved.
  • Page 117 S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 John, Last Name: Smith. The search can also be performed by Age, Sex, Protocol, Doctor or Bed 3. Select the data obtained, press Statistics Menu Levy-Jennings of Patients or press the shortcut Levy-Jennings Plot icon.

  • Page 118: Levy-Jennings Of Calibrators

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 11-4 Levy-Jennings of Calibrators Levy-Jennings plots can be made to represent values obtained in the same calibrator for a certain analyte. To do this, data must be previously ordered in the CAL Results Tab, performing an advanced search by Calibrator and Method.

  • Page 119: Levy-Jennings Of Controls

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 11-5 The graph obtained is a Levy-Jennings Plot where the results obtained for each point are indicated. The CV% and the Average for the data are also reported. In the plot, different lines can be observed, which show the values corresponding to the average and +/- SD per line (Figure 11-4).

  • Page 120: Quality Control

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 11-6 The graph obtained is a Levy-Jennings Plot where the results obtained for each point are indicated. The CV% and the Average for the data are also reported. In the plot, different lines can be observed, which show the values corresponding to the average and +/- SD per line (Figure 11-4).
  • Page 121 Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 11-7 The results of the controls will have to be selected before being drawn. Figure 11-8 If more than one method is selected, a method selection window will appear.
  • Page 122 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 11-11 In the upper side of the graph, control settings are shown. Figure 11-12 To the right side, the statistical information and the concentrations of the selected controls are shown.

  • Page 123: 12 Maintenance Menu

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 In the lower left side, the quality control graph is shown. Programmed control values are shown in solid line: Gray = Mean value (this value is the average value between the programmed maximum and minimum control values) Green = ±...

  • Page 124: Settings

    J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 12-1 Settings Serial Port Tab Figure 12-2 Communication port configuration data is preset in the Serial Port Tab (Figure 12-2). Available Serial Port: the PC Communication Port is accessed by the software and communication is established between them.
  • Page 125 Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 The log files are communication reports between the instrument and the PC. They contain a history of actions that have occurred every time there is an error message in the system. They have HTML format and they are used by technical support to determine the causes of errors whenever there is a failure.

  • Page 126: Database Tab

    Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Database Tab Figure 12-4 The name and address of the results file in use with the extension *.adb appear in the Database tab (Figure 12-4) File location: by pressing Browse the exploration window will be displayed, and the file in use folder is shown.
  • Page 127 S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 12-5 The next screen allows selecting date and time or process numbers from/to save information range (Figure 12-6). Choose the required option/s, complete the initial and final data to be saved and then press Selection.

  • Page 128: Ages Tab

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Press Yes to confirm or No to go back to the previous window. The latest calibration is saved in the configuration of methods and configuration data regarding calibrators, controls and method is not modified.

  • Page 129: Reports Tab

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 12-9 Reports Tab The printout formats of Patient Reports and Technical Reports are configured in this tab (Figure 12-9) Figure 12-10 The Patient Report has an easy-to-read format designed to be delivered directly to patients or doctors.
  • Page 130 S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 By clicking on the box Patient’s Report/Page Heading, the different sections of the Patient’s Report/Technical Report to be configured are displayed (Figure 12-10). The configuration language is HTML. The final format appears at the bottom of the screen. The configuration is written in the text box in the middle of the page.

  • Page 131: Memory Tab

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 12-13 Figure 12-14 Memory Tab The technical data in the internal memory of the instrument can be viewed and modified in the Memory tab (Figure 12-14) In this tab the status of the variables related to each module of the instrument is shown.

  • Page 132: Language/ Style Tab

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Language/ Style Tab In this tab the language and the style are selected (Figure 12-15). Language: Click on the desired language and press OK. For the language changes to be loaded in the system, close the software and open it again.

  • Page 133: Access Control Tab

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Access Control Tab Access control can be changed by the software administrator. Admin: password to enter in Settings of Maintenance menu. Methods: password to enter in Settings of Methods, Calibrators and Controls menu.
  • Page 134 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 -Washing 3: Aspiration of liquid and dispensing of washing solution -Washing 4: Aspiration of liquid and dispensing of washing solution -Washing 5: First drying step -Washing 6: Second drying step Light Blue: In Use Gray: Unknown status Cuvettes status is constantly refreshed as operations are carried out in the cuvettes tray.

  • Page 135: Containers Status

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Containers Status By clicking on Maintenance and selecting Containers Status, a screen will appear which shows the volume of liquid in each container, expressed as a percentage of its total capacity.

  • Page 136: Tip Cleaning

    Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 12-20 TIP Cleaning This process consists in the internal and external washing of the TIP or probe which aspirates and dispenses samples and reagents.

  • Page 137: Communications

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Communications By clicking on Maintenance and selecting Communication, two communication options between the PC and the instrument are displayed: Commands Console and Serial Port Log (Figure 12-21) Figure 12-22 Commands Console This screen allows selecting working commands.

  • Page 138: Serial Port Log

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Serial Port Log All the operations between the instrument and the PC are registered by the Serial Port Log screen (Figure 12-23). This registration only occurs when the screen is open and the command AutoRef is active.

  • Page 139: Validations

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Validations By clicking on Maintenance and selecting Validations, some validation tests are displayed which are used to control how the components of the instrument are working (Figure 12-24). The spectrophotometer, the diluter and the washer are controlled through these tests.

  • Page 140: Stray Light

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Stray Light Stray light is any electromagnetic radiation of a different wavelength from that selected wavelength reached by the detector and which is registered by the instrument. This test is based on the absorbance measurement of a Sodium Nitrite solution. The solutions of this substance absorb all wavelength radiation lower than 390 nm, that is why they are called optically opaque to UV light.

  • Page 141: Photometer Precision

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Photometer Precision Photometric precision is the measurement of the dispersion of absorbance measurements around the mean and it is expressed as a variation coefficient. This measurement is always made in the same cuvette.

  • Page 142: Photometric Accuracy

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Photometric Accuracy Photometric Accuracy means similarity between the absorbance unit and the real absorbance of a specific certified solution measured using reference standards. The error while reading the absorbance of this solution regarding the certified value is called Photometric inaccuracy.

  • Page 143: Photometric Linearity

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 12-31 Figure 12-32 Photometric Linearity Photometric linearity means the photometric capacity to make absorbance readings proportional to concentration changes for solutions of increasing concentrations of a substance which follows Beer’s law.
  • Page 144 Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Acceptable photometric linearity: higher tha 0.9995 Figure 12-33 Figure 12-34 Figure 12-35 Figure 12-36 Figure 12-37 Page 136 of 217...

  • Page 145: Diluter Precision

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Diluter Precision This test allows to determine volume precision of the diluter hydraulic system by making repeated dilutions and readings of the same reaction at 340 nm. Required materials: Sample solution: Potassium Dichromate solution 5g/l in Perchloric Acid 0.001 N...
  • Page 146 High Technology, Inc. 109 Production Road, Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 ADAPTATION GENERAL SPECIALS Name Dichromate Time for Reagent blank Type End Point R.Blank Interval between blanks...

  • Page 147: Precision Test P150 And P250

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Precision test P150 and P250 The precision study is used to determine the repeatability of the measured parameters under unchanged conditions. You will test P150 and P250 as a sample, using DI water for the Reagent for these precision tests Using the Precision Test Dye solution program the methods referring to section 12.7.6.1 and 12.7.6.2.
  • Page 148 S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 The P150 CV% should be equal to or less than 1.5% and The P250 CV% should be equal to or less than 2.5% The following is an example of a precision study...

  • Page 149: P150 Method

    J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 12.7.6.1 P150 Method Program the P150 Method settings by the following screens. Figure 12-40 Figure 12-41 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL...
  • Page 150 High Technology, Inc. 109 Production Road, Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 12-42 Figure 12-43 Page 142 of 217 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL...

  • Page 151: P250 Method

    J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 12.7.6.2 P250 Method Program the P250 Method settings by the following screens. Figure 12-44 Figure 12-45 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL...
  • Page 152 High Technology, Inc. 109 Production Road, Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 12-46 Figure 12-47 Page 144 of 217 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL...

  • Page 153: Instrument

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Instrument By clicking on Maintenance and selecting Instrument, the options Calibration, Diluter Purge, Washer Purge, Initialize and ISE are displayed (Figure 12-48) Figure 12-48 Calibration This option allows to calibrate the optical system, both photometer and cuvettes.

  • Page 154: Cuvettes Calibration

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 12.8.1.2 Cuvettes calibration Choose Calibrate Cuvettes and select the Initial Cuvette and Final Cuvette range to be calibrated. Also select the position of the solution to be used for the calibration in Use solution in reagent pos.

  • Page 155: Washer Purge

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Washer purge The washing of the first 10 cuvettes is carried out during this cycle, which allows the filling of all tubing of the washer circuit and the elimination of bubbles.

  • Page 156: Start Up

    Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 12-51 12.8.5.1 Start up During this cycle, a volume of Calibrant A and Calibrant B is pumped through the ISE module. This procedure eliminates bubbles from the tubing. Then pumps calibration will be done (place a tube with pumps calibration solution and indicate the position).

  • Page 157: Calibrant A Purge

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 12.8.5.2 Calibrant A purge During this cycle, a volume of Calibrant A is pumped through the ISE module. This procedure eliminates bubbles from the tubing.

  • Page 158: Clean

    Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 This cycle must be carried out: every 8 hours after each Clean Cycle if the QC sample results do not repeatedly fall within the proper ranges 12.8.5.5...

  • Page 159: Bubble Sensor Calibration

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 12.8.5.7 Bubble Sensor Calibration The Bubble Cal command is used to allow the module to reestablish a baseline for detecting air-liquid interfaces. Figure 12-58...

  • Page 160: Reagent Kit Replacement

    Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 12-59 12.8.5.9 Reagent Kit Replacement Reagent kit should be replaced any time the system asks to, when controls do not fall within the range and/or when the calibration of the module shows error.

  • Page 161: Reconnect

    J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 12-61 Finally Start up procedure starts automatically. Figure 12-62 12.8.5.10 Reconnect This cycle is used to power on ISE module after maintenance procedure (Electrode Replacement)
  • Page 162 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Page Heading Results Heading Result Result’s Imprint Page’s Imprint The difference between Patient’s Report and Technical Report is that the first one prints the results corresponding to the selected patients as a constant list, whereas the second one does it printing a patient per sheet.
  • Page 163 Revision Level Rev. 3 High Technology, Inc. 109 Production Road, Prepared by J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 dateiso datetext protocol name lastname methodname methodtecname unit limdown limup...

  • Page 164: File Exchange

    J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 id_time id_timeiso id_timetext File Exchange When the software is installed for the first time on the PC, the method files, calibrators, controls, and results, will be automatically generated in the start-up register, each with its own characteristic extension.

  • Page 165: Exporting Results To The Administration Program

    Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 The file is a text-type separated by commas; each line of the file must contain a Patient, a Calibrator or a Control along with all the methods to be used for the process.
  • Page 166 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Example: “this is a value that have \”quotationmarks\”,”Value1”,”Value2”,…,”ValueN” The inverted bars (\) should be replaced by the sequence \\ Example: “this is an \\inverted\\ bar” The exported fields are the following ones: (The values in quotation are fixed data)
  • Page 167 High Technology, Inc. 109 Production Road, Prepared by J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 “” “” “” “” Report Blank (1 blank, 0 determination) Number of re-dilutions Calibrators:...
  • Page 168 Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Process Number Order number Method’s name Determination Type ("PAC", “CAL” or “CON”) Method Type (“EPRB”, “EPSB”, “K” or “FTK”) Concentration...

  • Page 169: Determination Of Precision Of An Analytic Method

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Bichromatic Absorbance The export of the results can be done automatically. Contact Technical Support for more information. Determination of precision of an analytic method For the validation of an analytic method, one of the parameters that should be stipulated is the CV% that estimates the imprecision of the methods for a given concentration.
  • Page 170 S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Press the button on the right that says Execute 5) Select photoSetFilter (Figure 13-1) from the commands list, enter in the Parameters field the desired filter for carrying out the reading and press Execute. This way the photometer will be positioned in the chosen filter.

  • Page 171: Ise Module: Description And Operation (Optional)

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 13-2 14 ISE MODULE: DESCRIPTION AND OPERATION (OPTIONAL) ISE Module includes ion-selective electrodes and three peristaltic pumps. The ISE Module measures the concentration of Li+, Na+, K+, and Cl- in serum, plasma and diluted urine.

  • Page 172: Electrodes

    Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 14-1 Electrodes Electrodes are maintenance-free. In their package the user will find the “Install-by date.” A pump calibration should be performed each day.

  • Page 173: Fluid Management

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Cleaning solution should be used at least once a day at the end of the work day to minimize protein build- up in the fluid lines and electrodes. Fluid Management The sample is aspirated by the analyzer from the sample tube and dispensed into the sample entry port on top of the ISE Module.

  • Page 174: Sample Handling And Collection

    Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Sample Handling and Collection 14.3.1.1 Serum Serum may be analyzed immediately, stored at 4°C for 24 hours, or frozen at -20°C for up to one week.

  • Page 175: Reagent Kit Electronic Key

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Surfactants. Virtually all surfactants can irreversibly harm ISE electrodes. Most oils, emulsions, many organic chemicals, as well as certain inorganic chemicals and buffers, can also harm the electrodes (sometimes QC Materials.
  • Page 176 S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 The ISE Module Calibration Cycle performs two successive calibrations. The slopes should be repeatable within 1.5 mV/decade change; if not, a message error will be shown. Typical slopes are approximately 55 mV/decade for Li+, Na+ and K+ and 45 mV/decade for Cl-.

  • Page 177: Clean Cycle

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Clean Cycle This cycle is used to remove protein build-up from the ISE Module electrodes. The ISE Module positions cleaning solution in front of the electrodes for a period of time which will allow the enzyme to remove protein build-up on the electrodes.

  • Page 178: Pump Calibration Cycle

    50 patient samples, whichever is first. Clean the sample inlet port with a cotton swab and DI water once per month. All other parts and expendables are replacement items (see schedule below). Use only HTI approved components. Page 170 of 217...

  • Page 179: Shutdown Procedure

    Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Shutdown Procedure Preparing the ISE Module for Storage if the laboratory plans to store the ISE Module, the following steps should be performed: Before removing the electrodes, they should be cleaned using the cleaning solution and then 3 Purge A cycles should be run.

  • Page 180: Document Number Om-E-Fc

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 When the ISE Module is not operating properly, approach troubleshooting as a logical sequence of events. Isolate the problem area to avoid unnecessary component replacement and down time. Troubleshooting can be categorized into three main areas. These areas are: Fluid delivery, electrode stability, and communication.
  • Page 181 Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 It is also necessary to replace the Reference Electrode every six months or when the red ball indicator no longer floats in the internal electrode solution, whichever comes first. Failure to replace the Reference Electrode at this interval will cause all three of the errors mentioned.
  • Page 182 J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Drift Error Flag Multiple May occur when new Purge Calibrant A and recalibrate. electrodes electrode or Reagent Kit is installed on system.

  • Page 183: 15 Maintenance Program

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Ensure that all electrodes and O-rings are properly installed. Ensure tubing between reagent kit and sample entry port is connected properly. Replace tubing between reagent kit and sample entry port.

  • Page 184: During The Daily Operation

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 the liquid in the cuvettes Operations  Wash cuvettes  Cuvette range  1 to 10  Wash During the daily operation Run the washing program every time the message appears on the instrument. Programmed Washing ...

  • Page 185: General Cleaning Of The Instrument

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 9. Calibrate the photometer and all the cuvettes Maintenance  Instrument  Calibration  select Calibrate photometer  select Calibrate cuvettes  Range 1 to 100  select the position of the solution to use ex: Use container  OK General cleaning of the instrument 1.

  • Page 186: Ise Module Maintenance Program (Optional)

    Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 15-1 ISE Module Maintenance Program (Optional) Recommended Component Replacement Schedule (low volume user) Li+ Electrode Pump Tubing Na+ Electrode...

  • Page 187: Maintenance According To Programmed Alarms

    Warning: The maintenance must be done by HTI trained personnel. Contact authorized technical support for this purpose. There are two maintenance levels: 1 and 2. Next we detail the procedures carried out during these maintenances.

  • Page 188: Disinfecting The Tubing And Cleaning Of The Containers

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Note: If necessary, repeat step 5. 15.5.2.2 Disinfecting the tubing and cleaning of the containers 1. Remove the tubing from the probe and cuvettes containers (NOTE: do not disconnect the tubing from the plastic connector, remove the filters) 2.

  • Page 189: Cleaning Of The Washer Circuit Filter

    J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 15.5.2.5 Cleaning of the washer circuit filter Contact Technical Support 15.5.2.6 Replacement of the Teflon seals in the piston pump Contact Technical Support 15.5.2.7...

  • Page 190: Diluter Liquid Diaphragm Pump Membrane Replacement

    Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 15.5.3.8 Diluter Liquid Diaphragm Pump Membrane Replacement Contact Technical Support 15.5.3.9 Cuvettes replacement 1. Turn off the analyzer. 2. Remove the metal nuts that hold the cuvette strips. Remove all cuvette strips.

  • Page 191: Lamp Replacement

    Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 2. Select Maintenance Menu  Settings  Enter password  Database Export results  select the folder where the data will be saved. Name the file as results yymmdd.csv, where yy is the year, mm is the month and dd is the day for the date of the back-up.
  • Page 192 Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 cuvette in the optical path and place a white piece of paper against the lens of the photometer. Adjust the position of the lamp such that the filament can be seen sharply against the paper. In case...

  • Page 193: Cuvettes Replacement (See Item 15.5.3.8)

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Cuvettes Replacement (see item 15.5.3.8) 15.6.3.1 Interferential filters replacement a. Turn off the analyzer, remove the lids and the main cover of the autoanalyzer to have access to the photometer, located on the right back side.
  • Page 194 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 15-7 c. Disconnect the connector from PCB and remove the fixing screws on the PCB. To remove the Sample / Reagent probe remove the PCB Figure 15-8 d.
  • Page 195 Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 15-9 e. Assembly the PCB and connect the Teflon tubing. Perform several purge cycles and check that there is no leak. Caution: when assembling check the following items for proper replaces Check distance I is the...
  • Page 196 109 Production Road, Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 15-11 Correct position Figure 15-12 Incorrect position Page 188 of 217 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL...

  • Page 197: Replacing The Fuses

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Figure 15-13 Replacing the fuses 1. Turn off the instrument 2. Remove the feed cable from the line filter 3. Remove the lid of the fuse-box located in the upper part of the line filter 4.

  • Page 198: Electrode Replacement (For Analyzers With Ise Module Installed)

    S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Electrode replacement (For analyzers with ISE Module installed) This cycle is used to clear fluid from the flow path of the ISE Module and to pause the Sip Cycle. Warning: This cycle is required before any electrode(s) is removed from the ISE Module. Failing to run this cycle will cause the fluid in the flow path to leak when electrodes are removed.

  • Page 199: Replacing Ise Peristaltic Pumps Tubing (For Analyzers With Ise Module Installed)

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 15.6.9.1 Replacing ISE peristaltic pumps tubing (For analyzers with ISE Module installed) Figure 15-15 1. Remove the reaction Tray cover. 2. Locate the front black plate supporting the three peristaltic pumps and remove the tubing connection from the yellow connectors.

  • Page 200: Washing Solution For Probe And Cuvettes When Running Turbidimetric Methods

    Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Washing solution for probe and cuvettes when running turbidimetric methods In those cases where latex reagents are used, is highly recommended to use the following washing solutions: Washing solution for probe: use distilled water alone Washing solution for cuvettes: dilute 3 ml of wash concentrate in 1 liter of distilled water.
  • Page 201 Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Basic operation of the instrument General operation of the software General maintenance and replacement of basic components Problems can be divided into two major groups:...

  • Page 202: Chemical Problems

    Operator’s Manual: HTI BioChem FC-360 Figure 17-1 Once located the path, minimize BioChem FC-360 software. Search for the folder indicated in the path. Once located the folder, look for the type of files log.html. They are identified by year, month and day (for example, the file from day 21 of August 2007 will have the name: 2007-08-21.log.html).

  • Page 203: High Results

    S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 From the results obtained from the method calibration, quality controls, and patient samples tested, decide which of the following conditions best describe the problem encountered and run the checks and actions...

  • Page 204: Low Results

    109 Production Road, Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Low Results Observation Probable cause Action Low cuvette tray temperature Contact Technical Support Incubation temperature < 37ºC Low ambient temperature Increase the ambient temp to >...

  • Page 205: Only One Affected Sample For All Of The Methods

    J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Presence of bubbles or fibrin in the Use samples free of bubbles and/or sample tubes fibrin Absence of the sample in the assigned...

  • Page 206: Only One Affected Method For All Of The Samples

    Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Sample reconstituted with an Incorrect preparation of the Reconstitute a new vial correctly inadequate volume or poorly sample homogenized Sample diluted incorrectly...

  • Page 207: Instrumental Problems

    J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Configure the linearity correctly: a Message of a re-diluted result Linearity configured incorrectly value between 0.80 y 0.95 or re-dilute manually with Configure the method’s initial...

  • Page 208: Diluter

    Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Observation Probable cause Action Adjust the connections Purge the Connections adjusted inadequately diluter Purge the diluter Run a TIP cleaning...

  • Page 209: Reaction Cuvettes Tray

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Clean the exterior of the probe with Adhesion of remains of samples and/or Probe and its capillary dirty paper towel dipped in ethyl alcohol.

  • Page 210: Hardware Messages

    Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Recalibrate with the method setting Calibration made with the method Failure to update a calibration screen closed or edit the value setting screen open...

  • Page 211: Operator's Manual: Hti Biochem Fc

    Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 There are two types of messages:  Error messages, this error stops the running (Figure 17-1)  Warning messages, this is just a warning, it will not stop the running (Figure 17-2) This kind of flags report the Message ID number (the number between (xxxx)) and a brief description of the problem.
  • Page 212 Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 (0037) EEPROM reading error Wrong Direction Contact Technical Support. (variable does not exist) VERTICAL Message ID Number and Probable cause...
  • Page 213 109 Production Road, Prepared by J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Message ID Number and Probable cause Possible Solution Description (0151) Probe impact Physical impact Verify possible obstacles in the...
  • Page 214 Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Home sensing error. Contact Technical Support. (0205) Reaction Tray error Mechanical failure. Contact Technical Support. (slotted tray counting error) Sensor P out of counting position.
  • Page 215 109 Production Road, Prepared by J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 (0256) Samples and Sensing failure. Contact Technical Support. Reagents Tray error (Home active) Mechanical failure Contact Technical Support.
  • Page 216 Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 (0321) The time is not enough A reading was performed before for thermal stabilization. Please Wait .(it is recommended at least 10 reaching the time of thermal...
  • Page 217 J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Reference amplifier failure. Contact Technical Support. Filter missing Contact Technical Support. Incorrect positioning of a Beam Filter. Contact Technical Support. Reaction tray lid not placed.
  • Page 218 J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Contact Technical Support. Exit lens of the reference channel. Contact Technical Support. Amplifier sample Failure. Contact Technical Support. Exit lens of the reference channel.
  • Page 219 J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 (0364) Photometer Calibration Defective EEPROM Contact Technical Support. error (EEPROM writing error) Replace the cuvette or try to calibrate another cuvette. (Anyway, it is recommended to replace defective Scratched cuvette or not aligned.
  • Page 220 J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 (0386) Cuvettes Calibration Exit lens of the reference channel. Contact Technical Support. error (low energy in Reference Beam) Replace the cuvette.(it is recommended...
  • Page 221 109 Production Road, Prepared by J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Message ID Number and Probable cause Possible Solution Description (0501) Diluter Initialization Wiring failure Contact Technical Support.
  • Page 222 109 Production Road, Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Pump initialization error Electrical failure Contact Technical Support. (Home active) Mechanical failure Contact Technical Support. 0572) Washer Flushing Pump HOME sensing failure Contact Technical Support.
  • Page 223 Prepared by J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Message ID Number and Probable cause Possible Solution Description Remove electrodes and clean or Salt is plugging the electrode flow replace electrode with plugged flow path.
  • Page 224 Prepared By J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Electrical noise spike from Contact Technical Support. environmental source. Component failure on ISE Module Contact Technical Support board. Purge the Calibrant A and recalibrate If single electrode is flagged: May the ISE module.
  • Page 225 Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 If single electrode is flagged Replace the electrode and recalibrate. If multiple electrodes are flagged Purge the Calibrant A and recalibrate May occur when new electrode or the ISE module.
  • Page 226 J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 10 – 500 mmol/L 5 – 200 mmol/L Run Calibration procedure, run control samples and retest. 15 – 400 mmol/L Purge Calibrant B and recalibrate the If single electrode is flagged: May ISE module.
  • Page 227 J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Component failure on ISE Module Contact Technical Support board. Remove electrodes and clean or Salt is plugging the electrode flow replace electrode with plugged flow path.
  • Page 228 J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Remove electrodes and clean or Fibrin or salt is plugging the replace electrode with plugged flow electrode flow path. path. Reinstall electrodes and recalibrate.
  • Page 229 Prepared by J.S. Bolio Walpole MA 02081 USA Approved by S. Titov Effective Date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 Insufficient cleaning solution Check cleaning solution tube pipette into ISE module sample Contact Technical Support. entry port. Waste peristaltic pump failure.
  • Page 230 J.S. Bolio Walpole MA USA 02081 Approved By S. Titov Effective date 8/15/2016 Operator’s Manual: HTI BioChem FC-360 (0764) ISE Module Calibration time expired (more Run a calibration procedure. calibration out of time. than 8 hours from last) Please Calibrate it Module has been turned off.

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