HTI BioChem FC-360 Page 171 Operator'S Manual Download

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High Technology, Inc.

109 Production Road,
Walpole MA 02081 USA

Document Number

OM-E-FC-360-30

Revision Level

Rev. 3

Prepared by

J.S. Bolio

Approved by

S. Titov

Effective Date

8/15/2016

Operator’s Manual: HTI BioChem FC-360

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

Page 163 of 222

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.

The ISE Module contains the ion-selective electrodes and the reference electrode. A bubble detector is
also included at the top of the electrodes.

The three pumps that position the sample and wash/calibrating solutions.

A waste storage is included in the reagent module. Calibrant A and Calibrant B are packaged in foil
pouches within the reagent module.

Summary of Contents for BioChem FC-360

Page 1: ...IETARY AND CONFIDENTIAL 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 ...

Page 2: ......

Page 3: ... Washing solution for probe and cuvettes when running turbidimetric methods 12 INSTALLATION 12 PC configuration 12 2 8 1 1 Install analyzer software 12 Analyzer setup 13 3 ANALYZER TECHNICAL SPECIFICATIONS 14 GENERAL SPECIFICATIONS 15 SAMPLE REAGENT TRAY 15 CUVETTES REACTION TRAY 15 DISPENSING ARM AND HYDRAULIC SYSTEM 16 CUVETTE WASHER 16 PHOTOMETER 16 ISE MODULE OPTIONAL 16 SOFTWARE 17 POWER REQU...

Page 4: ... TAB 47 7 OPERATIONS MENU 48 ADD SAMPLES AND METHODS 48 Add Sample 49 7 1 1 1 Add Patient 50 7 1 1 2 Add Calibrator 52 7 1 1 3 Add Control 52 Add Methods 53 MODIFY SAMPLE 54 DELETE SAMPLES AND METHODS 55 Delete Sample 56 Delete Selected Method 57 PENDING SAVE LOAD AND IMPORT PENDING REQUESTS 58 Save Pending 59 Load Pending 59 Import from CSV 60 SAMPLES TO TRAY 60 SAMPLES TO TRAY BARCODE OPTIONAL 6...

Page 5: ...S 108 LOADING CONTROLS FILES 108 11 STATISTICS MENU 108 LEVY JENNINGS OF PATIENTS 108 LEVY JENNINGS OF CALIBRATORS 110 LEVY JENNINGS OF CONTROLS 111 QUALITY CONTROL 112 12 MAINTENANCE MENU 115 SETTINGS 116 Serial Port Tab 116 Files Tab 116 Database Tab 118 Ages Tab 120 Reports Tab 121 Memory Tab 123 Language Style Tab 124 Access Control Tab 125 CUVETTES STATUS 125 CONTAINERS STATUS 127 PROGRAMMED ...

Page 6: ...PERATIONS 153 CONFIGURATION OF THE PRINTING FORMATS 153 FILE EXCHANGE 156 IMPORTING SAMPLES FROM AN ADMINISTRATION PROGRAM 156 EXPORTING RESULTS TO THE ADMINISTRATION PROGRAM 157 DETERMINATION OF PRECISION OF AN ANALYTIC METHOD 161 DIRECT READING OF THE SOLUTION ABSORBANCE 161 14 ISE MODULE DESCRIPTION AND OPERATION OPTIONAL 163 ELECTRODES 164 FLUID MANAGEMENT 165 SAMPLE TYPE 165 Sample Handling a...

Page 7: ... the instrument 180 15 5 2 4 Axes lubrication 180 15 5 2 5 Cleaning of the washer circuit filter 181 15 5 2 6 Replacement of the Teflon seals in the piston pump 181 15 5 2 7 Flushing Pump Membrane replacement 181 15 5 2 8 Diluter Liquid Diaphragm Pump Membrane replacement 181 Maintenance Level 2 181 15 5 3 1 Disinfecting the reagent tray 181 15 5 3 2 Disinfecting the tubing and cleaning of the con...

Page 8: ...rbidimetric methods 192 TIP CLEANING SOLUTION 192 SPECIAL WASHING SOLUTION FOR MAINTENANCE ACCORDING TO NEED 192 SPECIAL WASHING SOLUTION FOR TURBIDIMETRIC TECHNIQUES WITH LATEX 192 DISINFECTING SOLUTION 192 17 TROUBLESHOOTING 192 INTRODUCTION 192 CHEMICAL PROBLEMS 194 High results 195 Low Results 196 Erratic Results 196 Only one affected sample for all of the methods 197 Only one affected method ...

Page 9: ... laboratory must count on a special residues collection service to handle wastes 12 Do not discard the analyzer neither its accessories along with domestic residues Check the local terms for its correct elimination Is the user s responsibility to deliver the analyzer in the indicated pickup point for recycling of electric and electronic devices otherwise get in contact with HTI or its authorized a...

Page 10: ...k gloves and increase exposure to biological risks Always treat samples and reagents as potentially infectious Waste and waste deposits must be treated as toxic and biologically hazardous Handle them and eliminate them in accordance with routine laboratory protocols Follow in force standards given by local sanitary authority Eye risks Do not look straight at barcode detector light beams Do not loo...

Page 11: ...be damp proof in the course of transport and instrument must be kept in a dry environment The symbol indicates temperature range of the analyzers during storage and transportation 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 ...

Page 12: ...PRIETARY AND CONFIDENTIAL 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 1 TRANSPORTATION STORAGE AND UNPACKING Transportation and storage Do not pile up more than four wooden boxes Keep dry protect from humidity and rain Fragil...

Page 13: ... BioChem FC 360 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Page 5 of 222 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 Figure 1 1 Remove the wooden box lid by unscrewing the eight screws located in the front back and sides Figure ...

Page 14: ...HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL 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 Figure 1 3 Unscrew the four screws located on the sides Figur...

Page 15: ...ed the protective Styrofoam is removed and the instrument can be placed on the working surface 2 INSTALLATION Installation must be carried out by trained personnel Electrical requirements A standard 100 Volts 60 Hz or 220 Volts 50 Hz socket for 400 VA consumption The supply line has a third terminal to ensure proper ground connection If line variations are higher than 10 a ferroresonant voltage re...

Page 16: ...Printer optional The PC must comply with safety regulations IEC 60950 and have a certified source Instrument placement and preparation Warning Avoid hitting the instrument as well as subjecting it to any kind of vibration while moving it The instrument must be placed on a counter in a room free from dust and corrosive vapors to ensure its proper operation The instrument must not be subject to vibr...

Page 17: ...ion tubing must be placed correctly so that it drains by gravity They must not be curved and or collapsed Warning The instrument must be connected to a PC which meets the requirements previously mentioned Warning The instrument has been tested with a tensioactive solution which is added to the distilled water Not using or altering the product or its dilution will affect the operation of the instru...

Page 18: ...e 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 Press the lock stick and move down the ISE module to put in place Warning Do not turn off the analyzer by pressing general button unless maintenance cycle has been done and electrodes removed NOTE ISE module must be power on all time that t...

Page 19: ...he same analyzer level 2 7 1 1 Washing solution for probe and cuvettes First wash concentrate solution has to be prepared from Triton X 100 Solution Then use wash concentrate solution to prepare washing solution for probe and cuvettes Wash Concentrate dilute 1 part v v of Triton X 100 in 9 parts of distilled water Ex 100 ml Triton X 100 in 900 ml of distilled water The Triton X 100 is extremely vi...

Page 20: ...ver Uninstall antivirus Uninstall screensaver 2 8 1 1 Install analyzer software 1 Open Computer 2 Find the device where the software installer is 3 Double Click on the analyzer software installer executable 4 Press Next to continue with the installation or Cancel to exit 5 Choose between Everyone and Just Me option see NOTE 6 Press Next to continue with the installation or Cancel to exit In this s...

Page 21: ... analyzer must be ON Purge cycles are performed by the ISE module automatically every 30 minutes 10 Run several diluter purge cycles visually checking that there are no bubbles present in the diluter s body Maintenance Instrument Diluter Purge 11 Run several wash cycles with the first 10 cuvettes verifying the flow of wash solution into the cuvettes and that there is no overflow Operations Wash cu...

Page 22: ...ement 16 Run Calibrant A and B purge if necessary Maintenance Instrument ISE Calibrant A Purge Calibrant B Purge 17 Run Bubble Sensor Calibration Maintenance Instrument ISE Bubble Sensor Calibration 18 Allow the electrodes to be exposed to fluid for 15 minutes 19 Run Calibration command Maintenance Instrument ISE Calibration 20 Instrument is ready to use Warning Do not turn off the analyzer by pre...

Page 23: ... to be carried out Cuvettes are continuously and automatically washed by the instrument while it is running as required by dispensing Photometric The Analyzer uses 10 optical filters An eleventh filter may be added Sample Reagent Tray Number of positions for reagent bottles 30 positions for single or double reagent bottles allowing 60 reagents Volume of bottles Single reagent bottles 60ml double r...

Page 24: ...rnal washing of the probe through liquid diaphragm pump Volume detection Probe impact sensors Cuvette washer Water consumption 2 4 ml cuvette Uninterrupted washing and drying of cuvettes as required by dispensing or maintenance process Photometer Interferential filters 340 380 405 450 505 546 578 600 650 and 700 nm and an extra filter as optional Krypton halogen lamp 12 volts 20 watts Optical path...

Page 25: ... 50 60Hz 400 VA Description of electronic circuits The Analyzer is a completely micro controlled instrument The fundamental concept regarding its operating way is that it carries out commands it receives through communication port These commands are simple operations sent by the user s software on a PC and the instrument decides when they are to be carried out In order to carry out all the command...

Page 26: ...od Urine Spinal Fluid Puncture Fluid Different biological fluids Chemical solutions Types of Reactions End point reagent blank End point sample blank Kinetics Fixed time kinetics Ion Selective Electrode ISE Optional Types of Methods Colorimetric Kinetics Turbidimetric Ion Selective Electrode ISE Optional 4 GENERAL FUNCTIONS Main parts or modules BioChem FC 360 Auto analyzer can be divided into the...

Page 27: ...thods with two reagents The normal operating temperature of the reagent tray is 15ºC below room temperature i e if room temperature is 25ºC then the reagent temperature is 10ºC The minimum temperature of the reagent tray is 10ºC refrigeration is interrupted below that limit The refrigeration system has a separate power on off button The Sample Reagent tray can hold up to 60 samples in one loading ...

Page 28: ...ports 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 The probe has a conductivity detection system When the probe is 1 mm below the surface of a conductive liquid it stops its movement Due to this characteristic it is important that samples do not have bubbles since the level would be detected and o...

Page 29: ...RY AND CONFIDENTIAL Page 21 of 222 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 The tray is heated by an air bath to 37ºC All reactions are carried out at 37ºC Each cuvette has a minimum reading volume of 220 µl and a maximum reaction v...

Page 30: ...cess Washers Four stainless steel capillaries which aspirate and dispense washing solution The first capillar will aspirate the pure reaction Dryers Two stainless steel capillaries covered with silicone tubing that are placed on the left of the cuvette washer to dry the cuvettes which have already been washed They work with two separate pumps Each cuvette is washed by 2400 µl This circuit operates...

Page 31: ...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 The diluter aspirates the reagent and a sample volume required and dispenses them into the reaction cuvette The liquid diaphragm pump conveys the wash solution from the wash solution container to the end of the probe capillary This allows the wa...

Page 32: ... Wavelengths 340 380 405 450 505 546 578 600 650 and 700 nm and an extra filter as optional Beam splitter Divides the primary beam into two secondary beams one goes towards the sample channel and the other goes to the reference channel Sample channel The sample channel beam passes through the cuvette to the sample photosensor where the signal is read Reference channel The reference channel beam is...

Page 33: ...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 The module requires a minimum sample size of a 70 µl for serum samples and 140 µl for urine samples urine samples must be diluted 1 urine part 9 urine diluent part Description of the Operating Cycle The operating cycle can be divided into four part...

Page 34: ...tte where the reaction is going to be dispensed It dispenses the sample and the reagent together The dispensing arm moves to the washing station and the internal washing of the tubing and the probe is carried out by the liquid diaphragm pump Incubation and Reading Cycle In this cycle incubation and photometric readings of the reaction are carried out at the appropriate wavelengths The incubation a...

Page 35: ...in this manual It is recommended to verify each configured method before reporting the patients results Advanced Operations Daily operation For the daily operation follow the steps below 1 Turn on the instrument by pressing analyzer frontal panel button and let it warm up for 10 minutes 2 Prepare the wash solution and place it in wash solutions containers Maintenance Program 3 Empty the waste cont...

Page 36: ...t Purge cycles are performed by the ISE module automatically every 30 minutes Programmed maintenance In addition to the maintenance processes run during daily operation there are other weekly and monthly maintenance operations performed by the user which are part of the instrument Maintenance Program They are the following 1 Calibration cuvettes once per week 2 Manual washing of the exterior and c...

Page 37: ...enu Figure 6 2 For example to enter the Operations menu press Alt letter p the Operations Menu will be displayed All menus work in the same way The Title bar identifies the software and the software version number Versions are constantly updated and modified so the user must install current software updates The Menu bar allows access to each menu by selecting the menu from this bar When the menu i...

Page 38: ...ded processes patients calibrators and or controls which are part of the working lists are shown in the frame Entered Samples Samples to be processed where pending processes remain such as processes with a method which was not programmed in the reagent tray Samples to be processed are those which are part of the working sequence and are being added to the lower frame by the program Samples in proc...

Page 39: ...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 the following format yy mm dd hh mm ss msmsms 05 10 05 41 34 34 672 This process was carried out Year 2005 Month 10 Date 05 Hour 12 Minutes 41 Seconds 34 Milliseconds 672 Within this column a sign and a sign is shown next to the process number A sign means that this...

Page 40: ...ators are stat by default This symbol represents a control Name First and last names of patients are shown in this column if they have been entered If you click on the sign the names of selected methods will be shown ID This column shows the number previously assigned to the sample Status This column shows the status of the selected method The status shows the percentage of the total process of th...

Page 41: ...on the left of each box correspond to the reagent positions on the tray R1 is for the bottle located in the outer part of the tray and R2 is for the bottle located in the inner part When placing reagents on the tray select on the right if it is a single reagent bottle single mouth or two reagents double mouth by indicating 1 or 2 respectively If you selected 1 single mouth you will only be able to...

Page 42: ...ss Save To load a stored reagent tray configuration select from stored trays displayed in Tray File and then press Load The tray file will be loaded and new reagent positions will appear on screen To delete a reagent tray it must first be loaded by means of the Load key and then deleted by means of the Delete key Figure 6 9 When the volume in a reagent bottle is low an error message lack of reagen...

Page 43: ...d 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 To prevent any human injury be careful with this procedure PAT Results Tab Figure 6 13 Within this tab you have access to all processed patients results It is divided in two parts In the upper part you can find process numbers ID name and other data entered to i...

Page 44: ...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 The following keys have the same functions in the PAT Results tab CAL Results tab and CON Results tab Figure 6 14 Press this key to access the patients list saved in the result...

Page 45: ...ECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Page 37 of 222 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 so that all saved patients are shown 200 patients can be seen in this window To see the next 200 patients press the key To see the previous 2...

Page 46: ...m FC 360 Page 38 of 217 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL 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 Figure 6 17 Third Double click on the result of a method to access Extended information for th...

Page 47: ...TARY AND CONFIDENTIAL Page 39 of 222 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 Main and bichromatic wavelength absorbance will be reported Number of sample re dilutions will also be reported Figure 6 19 corresponds to an End Point Reagent Blank method Figure 6 1...

Page 48: ...em FC 360 Page 40 of 217 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL 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 Figure 6 21 Select from the box Process Date and select a date and time range From To then press the key Search results will be shown on the ...

Page 49: ... 8 15 2016 Operator s Manual HTI BioChem FC 360 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Page 41 of 222 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 Figure 6 23 ...

Page 50: ...hes for patients can be carried out through the following search parameters Process number Name Last Name Age Sex ID Doctor and Bed Each of these parameters can be simplified through a more precise selection such as Same Range Contains Phrase Similar Contains Words Contains Words in Order and Any word Check the box of the search parameter that will be used to search for the patient An example is s...

Page 51: ...earch parameter box If it is not removed and parameters are hidden the advanced search will still operate and all results in the ordinary patients search will not be shown Patient data from the upper window and or results from the lower window can be exported by using this key with no connection between them are two different exported lists The following window will be displayed Figure 6 25 Name t...

Page 52: ...brator name or by method To sort the calibrators click on the name of the appropriate column and the calibrators will be listed in ascending order By clicking again they will be listed in descending order The keys work as previously described Within this screen two types of results will be shown 1 Reagent blank absorbance which corresponds with the calibrator point it was processed with 2 Calibrat...

Page 53: ...calibrator method or by patient report Warning Remove check marks from search parameters before closing advanced searches CON Results tab Figure 6 28 Controls results will be shown in this tab They can be sorted by process number alphabetically by control name or by method To sort the controls click on the name of the appropriate column and the controls will be listed in ascending order By clickin...

Page 54: ...the result is within the programmed control range or Error if the result falls outside the programmed control range The limits are the minimum 2SD and maximum 2SD programmed data Warning Limits has to be programmed in the same units as method and calibrator By double clicking on any result line you can open the extended information box as previously described Press Hide Show search parameters key ...

Page 55: ...the sample tray Positions of tubes can be found here and identified by ID number or name Processing status is shown with different colors Green the position is available for samples or new samples Yellow all processing for the sample has been completed Red sample is in process Figure 6 32 Figure 6 33 shows that patients with ID number 47885 33698 and 21556 are in position 3 4 and 5 respectively Al...

Page 56: ...LOGY INC PROPRIETARY AND CONFIDENTIAL 7 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 Add Samples and Methods The entering of samples to be processed by the instrument as well as the addition of methods to samples already requested can be carried out from the submenu Add ...

Page 57: ...C PROPRIETARY AND CONFIDENTIAL Page 49 of 222 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 Sample or click on the icon Add New Sample The screen Add Process is displayed Figure 7 4 where the kind of sample to be requested is selected Pat...

Page 58: ...ear in the patients report or for them to be saved in the database Warning ID name can be alphanumeric The field Age can be completed with a number representing the age or by selecting the age group of the patient configured according to Chapter 12 section 12 1 4 Figure 7 5 The options Male or Female are configured in the field Sex If no option is selected Male will appear by default Figure 7 5 Us...

Page 59: ...will remain on the screen to be modified upon the next request after pressing Add ID increase box is useful when the requested methods are the same for different samples or when patients data is similar for example consecutive ID numbers This option is alphanumeric You can add several processes at the same time In the box next to Add button you can choose between 1 and 99999 for different groups o...

Page 60: ...calibrator that has been added will appear on the Operations tab with a process number indicating the time when the request was made and a symbol representing a calibrator Figure 7 8 7 1 1 3 Add Control Select Control on the Add Process screen All controls configured according to Chapter 10 section 10 1 will be displayed Select the desired control on the left column The methods for the selected co...

Page 61: ...This option is only available for samples already entered not for those pending or in process Figure 7 10 Select the sample to be modified on the Operations Tab press Operations Add Method or click on the Add New Method to Sample icon A screen with all the available methods and profiles to be added will be displayed Figure 7 11 Select the method s you want to add press Add to add them to the origi...

Page 62: ...uested can be edited in two ways from the Operations Menu Figure 7 12 or from the Edit Sample icon Figure 7 13 Figure 7 12 Figure 7 13 Select the sample to be modified on the Operations Tab press Operations Modify Sample or click on the Edit Sample icon A screen with the patient s data available to be modified or added will be displayed included the Stat status Figure 7 14 Press Add to save the mo...

Page 63: ...PRIETARY AND CONFIDENTIAL Page 55 of 222 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 Figure 7 14 Figure 7 15 Delete Samples and Methods Entered pending or in process samples and or methods can be deleted from the submenu Delete in t...

Page 64: ...eyboard and select all the samples to be deleted Figure 7 18 Before deleting all the requests a screen will appear to confirm the operation Figure 7 19 Press Yes to confirm the deletion or No to cancel it To delete samples which have been sent to tray and which appear as pending on the Operations Tab the instrument must not be working Press Stop to cancel the operation and then delete the selected...

Page 65: ...Operations tab by pressing the symbol next to the request process number Select the method to be deleted and press Operations Delete Delete Selected Method or press the Delete Method icon Figure 7 20 To delete more than one method hold the Control key on the keyboard and select all the methods to be deleted Figure 7 21 Before deleting the method s a screen will appear to confirm the operation Figu...

Page 66: ...016 Operator s Manual HTI BioChem FC 360 Page 58 of 217 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL 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 This operation is unavailable while patients calibrators and or controls are in process Figure 7 23 ...

Page 67: ...e 7 24 Figure 7 24 In the save window select the location where the file will be saved Name it and press Save or Cancel This way all the data of pending requests is saved in a file with extension aop Warning During this process all requests that hasn t been processed will be saved including pending or in process samples with pending results Load Pending Pending sample lists saved in files with ext...

Page 68: ...data from this file select Pending Import from CSV on the Operations Menu Figure 7 23 The exploration window will then be displayed to select the file with extension csv to be loaded Press Open or Cancel All sample requests made by the laboratory information system software are now available on the Operations Tab to be processed by the instrument NOTE The import of a work list in a csv format can ...

Page 69: ... to determine validation of the calibration After reagent blank values calibrator absorbance and controls have been validated continue with the processing of patients Figure 7 27 2 Press the Samples to Tray icon The Samples Position screen will be displayed Figure 7 28 where Type of requested sample patient calibrator control PAT CAL CON Name ID and Position are indicated 3 Check that the actual p...

Page 70: ...oftware establishes the optimal processing order Processing is grouped as New Group by default 5 Press Send to continue or Cancel send if the operation is not carried out 6 Select the methods for reagent verification on the Reagents Verification screen Figure 7 30 After sending samples to be processed the Reagent Verification screen is displayed In this screen all methods where the verification ti...

Page 71: ...e 7 31 Samples to Tray Barcode Optional Processing of samples with barcodes can be initialized from the Samples to Tray Barcode submenu or from the Samples to Tray Barcode icon when the instrument is installed with the optional barcode reader Figure 7 32 Figure 7 32 To begin processing samples follow the next steps 1 Add the daily work list of samples either manually or imported from a pending fil...

Page 72: ...e window for Sample Positions will appear Verify that the positions shown in the list match the ones in the SR tray NOTE Those samples with barcodes that can t be read by the analyzer will remain in the work list Entered Samples not being sent to tray the rest of the samples whose barcodes were read OK will be moved to tray The samples that remain in the work list can be sent to tray manually or p...

Page 73: ...ution 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 Patients Processes samples in the order in which they were requested Reagents All tests of the same method are run before it continues with the tests for the next method The user cannot se...

Page 74: ...ot elapsed can also be verified by selecting them on this screen It is recommended that methods be verified after changes have been made Some examples of changes that require verification are when a new reagent is placed when configuration of certain method parameter is modified etc Figure 7 36 7 Press Verify Selected or Do not verify If the option Do Not Verify is selected the methods that are ch...

Page 75: ...the initial cuvette and in the right box put the number of the final cuvette to be washed Special Wash A special wash solution is placed in a reagent bottle and is assigned a position in the Reagent Pos box During this wash cycle the instrument starts washing cuvettes from 1 to 10 and then dispenses 300 µl special washing solution and 300 µl washing solution in each of the 100 cuvettes This wash s...

Page 76: ... 68 of 217 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL 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 Figure 7 41 Start is used To initialize the instrument To repeat a result when the instrument has already finished the run To restart the processing of samples after having stopped the instrument by...

Page 77: ...le if there is a problem with the probe cuvettes tray cover is out of place washing solution is needed etc When there is an error in the processing For example a reagent has been positioned in the wrong place samples are missing or they have been incorrectly placed reagent deterioration index is out of range etc When there is an error sign on the screen that indicates Retry or Stop the process Whe...

Page 78: ...age 70 of 217 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Figure 7 39 Pause is used to add samples on the samples tray to refill reagents bottles to refill the washing solution container or to empty the waste container After the desired operation has been carried out restart processing of samples by pressing Pause again Pause or not paused is evidenced by the icon Paused Instrument the key is...

Page 79: ... selected results are printed by pressing Print View or from the Operations Menu selecting the submenu corresponding to the type of results Print PAT CAL or CON Results The Print View icon only prints the results selected on the tab in view at the time the print button is pressed A screen will then appear to select the type of printout Patient Report or Technical Report and to filter the results t...

Page 80: ...OLOGY INC PROPRIETARY AND CONFIDENTIAL 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 Figure 7 42 To see all processed methods double click on the ID patient field Uncheck the checkbox next to the methods name and press Filter the preview will...

Page 81: ... Document Number OM E FC 360 30 Revision Level Rev 3 Prepared by J S Bolio Approved by S Titov Effective Date 8 15 2016 Operator s Manual HTI BioChem FC 360 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Page 73 of 222 Figure 7 43 Press Preview Print or Cancel ...

Page 82: ...be repeated are selected from the Operations tab or the Samples in Process window and the Repeat icon is pressed This option is used while the instrument is running To repeat results when the instrument has already finished the complete operation select them and press Repeat Then to initialize the new process press Start see Chapter 7 point 7 8 Warning Results of samples which do not appear on the...

Page 83: ... Figure 7 52 When insufficient sample has been detected the empty sample tube cup must be refilled press Pause button refill sample tube the patient must be selected on the Operations Tab then press the Reload Sample button and press Pause button again Export Results Results obtained in the software can be exported to the laboratory information system software through a standard CSV file comma spa...

Page 84: ...g patients calibrators and or controls Select Settings and enter the access code provided at installation To complete a method configuration enter the information in all the fields of the respective Tabs These tabs are General Factor Reference Values Specials and Advanced IMPORTANT After all the corresponding information for a method has been entered press the Modify button If the Modify button is...

Page 85: ... the name will appear in the field to the left of the Add button For an already existing methods file you have to overwrite the name of any method in the field left of the Add button enter the new name and finally press Add Warning When the first method is programmed it will be displayed with the default values When a new method is created be sure to enter all of the desired parameter values since...

Page 86: ...ing to the reagent sample ratio provided by the reagent manufacturer R2 Volume Enter the volume of reagent 2 according to the reagent 1 reagent 2 sample ratio given by the reagent manufacturer if it corresponds Leave it at 0 for single reagent methods Warning The total volume R1 R2 sample must be less than 500 µl The minimum reading volume should be 220 µl The maximum cuvette capacity is 600 µl Ti...

Page 87: ...lect the Decreasing method option for reagents in which the absorbance decreases upon increasing the analyte concentration If this option is programmed incorrectly a Warning Sign error message along with the calibrator concentration will appear during the method calibration This will also be reflected in negative results Select from the available methods for results calculation Factor or Calibrato...

Page 88: ...n the method settings For that go to the Calibrator Parameters section If only one calibration point is programmed the system will assume the second point of reference is 0 If two or more points are programmed the system stops using 0 as a point of reference and a point of concentration 0 should be programmed Possible Interpolation types are Linear Conc a Abs b Potential Conc 10 a log Abs b Expone...

Page 89: ...Y AND CONFIDENTIAL Page 81 of 222 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 The curve that best fits these points must be selected In this case it would be the Cubic Spline in violet a second ...

Page 90: ...lick in each of the lower fields and enter the corresponding values for Min Age Max Age Sex Minimum Value and Maximum Value Once all the information has been entered press the Enter button and the whole data will appear in the upper field More than one range of reference values can be entered for age and sex These values will be shown in each case related to the age and sex data entered for each p...

Page 91: ... does a reagent blank in a separate cuvette from the test cuvette The blank absorbance is stored and subtracted from each test absorbance The same blank absorbance will be used until the reagent blank is measured again Only one absorbance reading is taken at the end of the incubation period end point This type of measurement is mostly used for colorimetric tests such as Glucose Cholesterol etc Fig...

Page 92: ...nt manufacturer If this value is exceeded the instrument will dilute the sample to obtain a value within the linear range The instrument will run the dilution using half the sample volume programmed in the General tab The software will show that the sample has been re diluted The result will be calculated using a dilution factor for compensation If the new result is still not within the programmed...

Page 93: ...t be more than the time program in General Tab for Time to Dispense Reagent 2 Incubation Time Enter the total time in seconds required for reading the reaction absorbance The sample blank absorbance will be deducted from this value for each sample Repetition Enter a minimum concentration value below which the Autoanalyzer will repeat the test under identical sample and reagent s conditions and wil...

Page 94: ...C Concentration VS Sample Volume VR1 Reagent 1 Volume VR2 Reagent 2 Volume FD Dilution Factor FD VM VR1 VM VR1 VR2 C Am Ab FD F Bichromatic Reading AB Sample Blank Absorbance AB Sample Blank Bichromatic Absorbance Ab Sample Blank Calculated Absorbance As Sample Absorbance As Sample Bichromatic Absorbance As Sample Calculated Absorbance F Factor programmed or obtained by the method calibration C Co...

Page 95: ...substrate consumption calculation but not for the calculation of the end result This absorbance is compared with the Time to start Readings absorbance A T BDT of 20 seconds is suggested Time to start Readings Time from the T BDT at which the absorbance reading should be started according to the instructions given by the reagent manufacturer Time to end Readings Time from the T BDT at which the abs...

Page 96: ...on Another option is the higher laboratory limit for the test However if this value is exceeded the instrument will dilute the sample to obtain a value within the linear limit The instrument will run the dilution using half the sample volume programmed in the General Tab The software will show that the sample has been re diluted The result will be calculated using a volume factor for compensation ...

Page 97: ...rbance calculated by linear regression over n Absorbance readings A1 1 st Bichromatic Absorbance Reading of the Sample A2 2nd Bichromatic Absorbance reading of the Sample AN nth Absorbance reading of the Sample ΔA min change per minute of the sample bichromatic absorbance calculated by linear regression over n Absorbance readings F Factor programmed or obtained by the method calibration C Concentr...

Page 98: ...nt will dilute the sample to obtain a value within the linear range The instrument will run the dilution using half the sample volume programmed in the General tab The software will show that the sample has been diluted The result will be calculated using a dilution factor for compensation If the new result is still not within the programmed values the sample will be diluted again until the minimu...

Page 99: ...hods will not be programmed correctly and the results may be affected Advanced tab Warning Changes should only be made in this tab under supervision or only by trained personnel in advanced options Figure 8 14 The purpose of modifying this part of the Methods Settings is to improve the performance of a certain reagent Within these options are found Initial Air Gap A volume of air drawn in the dilu...

Page 100: ...lue is 2500 1 6 µl second The minimum value is 1600 1 6 µl second Dilution with The dilution of the sample can be performed using half volume of sample or double volume of reagent Only sample option is available at the moment Dilutions with sample will be done when the result exceeds the maximum concentration value or linear limit when the initial substrate consumption is exceeded or when the line...

Page 101: ...agent method the extra wash of the probe will be added between consecutive dispensing of the reagent For example if calcium presents self interferences and two calcium tests are performed in a row the extra washing will be between both tests The washing solution for this extra washing is taken from the 10 liters container by the liquid diaphragm pump If the method that presents self interference i...

Page 102: ...o methods configuration select calcium from the list and go to Advanced tab in the list on the right search for glucose and add the number of extra washings and solution to use This way each time a calcium is made after a glucose and extra wash will be performed before running the calcium If the sequence is Glucose Calcium there will be an extra wash if the sequence is Glucose method x Calcium the...

Page 103: ...and drop down list with the new ISE methods Li Na K Cl appears Figure 8 18 To complete each ion programming process follow this steps In Name field erase the name that you wrote Ex ISE and write the name of the ion shown in the drop down list Li Na K Cl in this case write Lithium Press Modify button Complete the next fields most of them are disabled Unit Enter the units of measurement desired for ...

Page 104: ...ion is selected enter the corresponding value in the field to the right If calibration curve option is selected select Calibrator and complete the fields below In the Point field assign a number for each point starting from 1 Complete calibrator and absorbance field with the value 0 since the concentration is taken from the input value in the concentration field of the calibration parameters and t...

Page 105: ...ple type between Serum Plasma and Urine Serum Plasma 70 µl Urine diluted 140 µl Remember each sample type has different sample volume parameter Must be programmed in the General tab 8 2 3 1 1 Calculations ISE Since the difference in potentials and the concentration of lithium sodium potassium and chloride ions in the calibrant solution are known the computer can calculate the concentration of the ...

Page 106: ...noisy readings will be flagged and the appropriate error message will be shown 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 If this is not done the methods will not be programmed correctly and the results may be affected Advanced tab ISE Warning Changes should only be made in this tab under s...

Page 107: ...gent 1 Aspiration Speed If a viscous reagent is used the aspiration speed can be reduced The default value is 2500 1 6 µl second The minimum value is 1600 1 6 µl second Reagent 2 Aspiration Speed If a viscous reagent is used the aspiration speed can be reduced The default value is 2500 1 6 µl second The minimum value is 1600 1 6 µl second Dilution with The dilution of the sample can be performed u...

Page 108: ...ot appear in the selection options when adding a sample calibrator or control in the reagents tray In use They are seen in the column headed In Use and they will appear in the selection options when adding a sample calibrator or control in the reagents tray To change an Available method to In Use select the chosen method from the Available list and press the key To change an In Use method to Avail...

Page 109: ...aved 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 Open the menu Methods and select Save Figure 8 18 An explorer window will open Select or cre...

Page 110: ...patients calibrators and or controls Open the menu Methods and select Load Figure 8 19 Figure 8 24 An explorer window will open Select the desired amf file Only files with this extension are able to be loaded Press the Open button or press the Close button if opening a file is not the desired operation When loading a new file it is added to the currently loaded file The software saves this informa...

Page 111: ... or controls Open the menu Methods and select Save Profiles Figure 8 20 Figure 8 25 An explorer window will open Select or create the location where the file will be saved Give the file a name and press the Save button or press the Cancel button if saving is not the desired operation Loading Profiles Created profiles can be loaded from a different location than that used by the program Only files ...

Page 112: ...calibrator NOTE Do not enter a name too big Software will cut the name Once the calibrator has been entered concentration values for each analyte have to be programmed In order to do this select the calibrator in the column Calibrator select the method in the column Method and select the concentration fields in the column Conc Type the concentration value assigned to the calibrator for the analyte...

Page 113: ...NFIDENTIAL Page 105 of 222 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 When the calibration of a method is requested the software uses the calibrator in use configured co...

Page 114: ...rough the submenu Load from a different file than the file in use By pressing Calibrators Menu Load an exploration window is displayed Select the folder or location from where the data will be obtained Select the file with extension acf and press Open or Cancel if the operation will not be carried out All the data of the calibrators that appear in the selected file will then be entered Warning By ...

Page 115: ...ect the control in the column Control select the method in the Method column and select the minimum concentration field in the column Min C Add the minimum concentration value assigned to the control and press Enter Then select the maximum concentration field in the column Max C and enter the maximum concentration value and press Enter Finally press OK to save the data previously entered During th...

Page 116: ...on aof and press Open or Cancel if the operation will not be carried out All the data of the controls that appear in the selected file will then be entered Warning By entering configuration data of new controls from the submenu Load all the data of controls in use will be deleted Before this operation it is recommended to back up the controls in use as indicated in Chapter 10 section 10 2 11 STATI...

Page 117: ... all the methods performed to the selected processes Figure 11 2 Select the method to be plotted and press OK or Cancel to cancel the operation Figure 11 2 Figure 11 3 The graph is a Levy Jennings Plot where the results obtained for each point are shown 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 avera...

Page 118: ...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 The following steps must be carried out 1 Select the Process Date from to which the search will be performed 2 Perform an advanced search of a particular calibrator data Figure 11 5 For example Calibrator CAL 1 Method GLUCO DICO The sear...

Page 119: ...ter on the keyboard By pressing Calculate the statistical parameters will be recalculated and a new graph will be obtained Warning Data can be temporarily edited but will not be saved by the program Levy Jennings of Controls Levy Jennings plots can be made to represent values obtained in the same control for a certain analyte To do this data must be previously ordered in the CON Results Tab perfor...

Page 120: ...e 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 The plotted data can be edited place the cursor on the appropriate box enter the new value and press Enter on the keyboard By pressing Calculate the statistical parameters will be calculated and a new graph will be obtained W...

Page 121: ...lected before being drawn Figure 11 8 If more than one method is selected a method selection window will appear Figure 11 9 In the same way if more than one control is selected a control selection window will appear Figure 11 10 Observe between brackets the number of lot that was entered during control programming in Controls Menu and that it s added to the name of the control Thus the controls of...

Page 122: ...ved By S Titov Effective date 8 15 2016 Operator s Manual HTI BioChem FC 360 Page 114 of 217 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL 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 Figure 11 13 ...

Page 123: ... the programmed maximum and minimum control values as 2SD Yellow 2SD this values are obtained from the programmed maximum and minimum control values Red 3SD these values are obtained by considering the programmed maximum and minimum control values as 2SD Selected controls statistics are shown in dotted line Gray Mean value Green 1SD Yellow 2SD Red 3SD Figure 11 14 Lines can be individually hidden ...

Page 124: ...munication 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 The message appears on a green frame Warning Do not make changes in the preset communication port configuration Files Tab The names and addresses of the files the software uses to work on a daily ba...

Page 125: ...ile locations By pressing Browse the explorer window displays the folder where the file in use is located By using this command the files that appear on screen are only those with the same extension as the pertinent file For example if Browse is pressed for Methods File and a folder is selected the files that appear on screen when it is opened are only those with amf extension File modification Th...

Page 126: ... file select it and press Save the new name and address will appear on screen To save modifications press OK or otherwise press Cancel File modification the name of the file in use and or its addresses on the PC may be modified on this screen If such modifications will not be made go back to the original name by pressing Reset To save modifications press OK or otherwise press Cancel Modifications ...

Page 127: ... csv extension will be created and it can be read using Excel This option allows to save separately every type of data or to make statistics searches etc using Excel functions Figure 12 6 Database Copy This button will allow saving adb files that contain results in the database The entire database is saved no range or type can be individually selected It is recommended that a back up copy of the d...

Page 128: ...s box Total represents the Grand Total of all tests in the database in use This counting is refreshed by pressing Refresh Statistics Warning The database must be initialized regularly so that the working speed of the software is not affected This process should be carried out on a monthly basis or when the number of total determinations reaches 10 000 tests Ages Tab Figure 12 8 The age groups are ...

Page 129: ...f 222 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 The report is printed on a separate sheet of paper for each patient The Technical Report has a more compressed format and is used to generate a printed r...

Page 130: ...ppears at the bottom of the screen The configuration is written in the text box in the middle of the page If no modification is made press Reset to go back to the original format To save modifications press OK otherwise press Cancel Figure 12 11 By clicking on Configure Printer a list of the available printers and their properties are shown By clicking on Print Test Page select the number of sampl...

Page 131: ...y 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 By pressing Get from Instrument the software reads all the data saved in the internal memory of the equipment This process takes several minutes and can be seen in the Status Bar Warning...

Page 132: ... 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 Style By displaying the Style menu all the possible screen design style options appear on the screen Select the desired style and press OK For changes of style to be loaded in the system close the software and open it again Warning ...

Page 133: ...enter in Commands Console of Maintenance Menu Select on the left side the option that one to be changed and the right side fill in with the new password repeat new password and finally press Change Password button Figure 12 17 Warning in case of losing or forgetting passwords contact technical support Cuvettes Status By clicking on Maintenance and selecting Cuvettes Status a screen will appear Fig...

Page 134: ...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 Warning Every time the software is unexpectedly closed in unusual way the instrument shows the status of the cuvettes as all dirty this is a preventive action Therefore it is necessary to start ses...

Page 135: ...k again Once new washing solution has been added make five purge cycles of the diluter Maintenance Instrument Diluter Purge Then wash cuvettes from 1 10 five times Operations menu wash cuvettes Range 1 10 Wash Warning The level of liquid is only refreshed when processes that require the aspiration or dispensing of liquid are carried out Programmed washing The Programmed Washing option appears on s...

Page 136: ...NC PROPRIETARY AND CONFIDENTIAL 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 Select Cleaning TIP from the Maintenance Menu and place a tube containing 30 Sodium Hypochlorite in the chosen position On the screen position 60 appears as preset option Click OK This cleaning must be carried ou...

Page 137: ...e 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 The different commands allow for individual movements of the instrument components reading of parameters writing of parameters working sequences etc The desired command can also be straightly written on the Terminal window through the i...

Page 138: ...screen Figure 12 23 This registration only occurs when the screen is open and the command AutoRef is active The following options appear Close It closes the screen Highlight the different operations carried out by the instrument are differentiated with colors for a better view Refresh it updates data AutoRef data is constantly updated Save it allows saving all the data obtained in the PC in HTML f...

Page 139: ...cking 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 Each user can create an internal quality control program of their Autoanalyzer by using these tests Warning A Special Washing cycle with Sodium H...

Page 140: ... 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 Required materials Sodium Nitrite Solution 50 g l Automatic pipette Procedure 1 Dispense manually 300 µl of the solution in cuvette 1 or in any cuvette indicating it on the screen Figure 12 25 2 Wait for 5 minutes to reach thermal ...

Page 141: ...te Required materials Copper Sulfate Solution 30 g l in Sulfuric Acid 0 45 N Automatic Pipette Procedure 1 Dispense manually 300 µl of the solution in cuvette 2 or in any cuvette indicating it on the screen Figure 12 27 2 Wait for 5 minutes to reach thermal stability of the solution in the cuvette 3 Select Maintenance Validations Photometer Precision Cuvette Number OK Filter OK 4 The instrument ma...

Page 142: ... measured using NIST Reference Standards Certificates National Institute of Standards and Technology Example solution A and B Automatic pipette Procedure 1 Dispense manually 300 µl of the solution A in cuvette 3 or in any cuvette indicating it on the screen Figure 12 29 2 Dispense manually 300 µl of the solution B in cuvette 4 or in any cuvette indicating it on the screen Figure 12 30 3 Wait for 5...

Page 143: ...C and D respectively Automatic Pipette Procedure 1 Dispense manually 300 µl of solution A in cuvette 5 or in any cuvette indicating it on screen Figure 12 32 2 Dispense manually 300 µl of solution B in cuvette 6 or in any cuvette indicating it on screen Figure 12 33 3 Dispense manually 300 µl of solution C in cuvette 7 or in any cuvette indicating it on screen Figure 12 34 4 Dispense manually 300 ...

Page 144: ...on Level Rev 3 Prepared By J S Bolio Approved By S Titov Effective date 8 15 2016 Operator s Manual HTI BioChem FC 360 Page 136 of 217 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Figure 12 33 Figure 12 34 Figure 12 35 Figure 12 36 Figure 12 37 Acceptable photometric linearity higher tha 0 9995 ...

Page 145: ...omate solution 0 25 g l in Washing Solution Triton X 100 diluted It is prepared by diluting 5 ml of Sample Solution in one liter of Washing Solution Procedure 1 Set a new method with the parameters shown in Figure 12 38 Methods Settings 2 Place the Sample Solution in a sample tube and the Reagent Solution in a reagent bottle and assign a position in the reagents tray 3 Make the Diluter Precision t...

Page 146: ...etween blanks 72 Main Wavelength 340 Incubation Time 60 Bicrom Wavelength 700 Repetition 0 4 Units Linear Limit 2 0 Decimals 4 Sample Vol 6 ADVANCED R1 Vol 300 Initial Air Gap 2 R2 Vol 0 Initial gap Speed 500 Time to Disp R2 0 Gap Reagent Sample 2 Min Abs 0 Reagent Sample Gap Speed 500 Max Abs 2 R1 Sample Dispensing Speed 2500 Verification time 16 R2 Dispensing Speed 2500 FACTOR R1 Aspiration Spee...

Page 147: ... these precision tests Using the Precision Test Dye solution program the methods referring to section 12 7 6 1 and 12 7 6 2 For the P150 and P250 Precision Tests use DI water as the reagent and the P150 and P250 dyes as the samples P150 solution active ingredients and concentration Potassium Dichoramte 30mM Sulfuric Acid 0 01N P250 solution active ingredients and concentration Potassium Dichoramte...

Page 148: ...C PROPRIETARY AND CONFIDENTIAL 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 P150 P250 1 0 9866 1 1 7018 2 0 9950 2 1 7215 3 0 9906 3 1 7327 4 0 9776 4 1 7220 5 0 9775 5 1 7476 6 0 9741 6 1 7450 7 0 9824 7 1 7105 8 0 9770 8 1 7218 9 0 9798 9 1 7087 10 0 9827 10 1 7184 MEAN 0 9823 MEAN 1 7230 SD 0...

Page 149: ...Revision Level Rev 3 Prepared by J S Bolio Approved by S Titov Effective Date 8 15 2016 Operator s Manual HTI BioChem FC 360 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Page 141 of 222 12 7 6 1 P150 Method Program the P150 Method settings by the following screens Figure 12 40 Figure 12 41 ...

Page 150: ...A 02081 Document Number OM E FC 360 30 Revision Level Rev 3 Prepared By J S Bolio Approved By S Titov Effective date 8 15 2016 Operator s Manual HTI BioChem FC 360 Page 142 of 217 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Figure 12 42 Figure 12 43 ...

Page 151: ...Revision Level Rev 3 Prepared by J S Bolio Approved by S Titov Effective Date 8 15 2016 Operator s Manual HTI BioChem FC 360 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Page 143 of 222 12 7 6 2 P250 Method Program the P250 Method settings by the following screens Figure 12 44 Figure 12 45 ...

Page 152: ...A 02081 Document Number OM E FC 360 30 Revision Level Rev 3 Prepared By J S Bolio Approved By S Titov Effective date 8 15 2016 Operator s Manual HTI BioChem FC 360 Page 144 of 217 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Figure 12 46 Figure 12 47 ...

Page 153: ... Photometer calibration Choose Calibrate Photometer and select the position for the solution to be used for the calibration in Use Solution in reagent pos The photometer can be calibrated with new washing solution placed in a reagent bottle or using the one in the probe washing container in which case select Use container Then press Calibrate Photometric gain for each wavelength on the readings ma...

Page 154: ...ner Then press Calibrate During this process the instrument reads blank absorbance of each cuvette and refreshes the value in the instrument memory to use it later in the calculation of reaction absorbance Warning It is recommended to calibrate all cuvettes tray 1 to 100 and not to make partial calibrations by sectors Warning Do not remove the cuvettes tray lid during this process Figure 12 49 Dil...

Page 155: ...he filling of all tubing of the washer circuit and the elimination of bubbles This cycle is carried out after adding washing solution to the container every time it is necessary to purge tubing Initialize By clicking this command an individual initialization of each and every module will be executed following a certain order photometer probe probe arm SR tray diluter washer and cuvettes tray This ...

Page 156: ...IETARY AND CONFIDENTIAL 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 Finally Start up procedure ends with the Calibration of the module Figure 12 52 This cycle must b...

Page 157: ...ule This procedure eliminates bubbles from the tubing Figure 12 53 12 8 5 3 Calibrant B purge During this cycle a volume of Calibrant B is pumped through the ISE module This procedure eliminates bubbles from the tubing Figure 12 54 12 8 5 4 Calibration This cycle is used to calibrate the electrodes of the ISE Module The ISE Module then cycles Calibrant B and Calibrant A solutions in front of the e...

Page 158: ... QC sample results do not repeatedly fall within the proper ranges 12 8 5 5 Clean Place a tube with cleaning solution in the required position then press ok This cycle is used to remove protein build up from the ISE Module electrodes Figure 12 56 This cycle must be carried out once per 24 hour period after every 50 samples 12 8 5 6 Pumps Calibration Place a tube with saline solution in the require...

Page 159: ...Always dry each electrode when changing electrodes It should be noted that every 30 minutes a Sip Cycle is initiated and 100 μL of Calibrant A is dispensed If the electrodes are removed without initiating this maintenance Cycle Electrode Replacement a Sip Cycle may occur and the 100 μL of Calibrant A will flow into the empty module This can cause significant damage to the ISE Module and or other s...

Page 160: ...2 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 A pop up window will appear replace the reagent kit and press Accept Figure 12 60 The system will start purging to eliminate bubbles from the tubing Place a tube with saline solution in the required positio...

Page 161: ...RATIONS In this chapter are described a series of operations reserved for advanced users These include the configuration of the printing formats the exchange of methods in use files the description of communication files the validation of analytical methods and the solution absorbance readings among others Configuration of the printing formats The printing of results can be done using two differen...

Page 162: ... 217 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL 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 In both cases the following variables can be printed datet...

Page 163: ...o Approved by S Titov Effective Date 8 15 2016 Operator s Manual HTI BioChem FC 360 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Page 155 of 222 dateiso datetext protocol name lastname age sex dr bed methodname methodtecname unit limdown limup limflag pid comment result concentration redilutions id id_date id_dateiso id_datetext ...

Page 164: ... For using a new method file discarding the file in use follow the steps below 1 Create a backup of the method file in use sending it to another location in the computer or to a removable unit 2 Go to Maintenance Settings Files and see the exact location of the method file in use 3 Close the program 4 Go to the location of the method file in use and delete it 5 Open the software and verify that in...

Page 165: ...lore window will appear and select the file with the desired csv extension and press Open or press Cancel if this is not the desired operation Following this all the requested samples generated by the laboratory central administration software are now available in the Operations tab for being processed by the equipment The import of the information can be done automatically Contact Technical Suppo...

Page 166: ...TIAL 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 Patients Process number Order number Method s name PID Patient s name Patient s surname Age Sex ID Doctor Bed Report Blank 1 blank 0 determination Number of r...

Page 167: ...itov Effective Date 8 15 2016 Operator s Manual HTI BioChem FC 360 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Page 159 of 222 Report Blank 1 blank 0 determination Number of re dilutions Calibrators Process Number Order number Method s name Calibrator Name CAL Report Blank 1 blank 0 determination Number of re dilutions Technical Information TEC ...

Page 168: ...IDENTIAL Process Number Order number Method s name Determination Type PAC CAL or CON Method Type EPRB EPSB K or FTK Concentration Main Absorbance Bichromatic Absorbance Number of re dilutions Bichromatic 1 bichromatic 0 monochromatic Blank 1 blank 0 determination Maximum Value Minimum Value Unit Kinetics Points TEC K Process Number Order number Method s name Determination Type PAC CAL or CON Main ...

Page 169: ...bes with a total volume greater than 800 µl for the precision tests Direct reading of the solution absorbance From the Maintenance menu Communications Commands console it is possible to read the solution absorbance without the intervention of the instrument s hydraulic and the dispensing systems In order to do this the number of the cuvette should be recognized Cuvette number 1 is located in cuvet...

Page 170: ...ter in the Parameters field the cuvette number in which the solution was dispensed Press Execute Using this command the selected cuvette will be positioned in front of the photometer 7 Select the command photoRead and press Execute The absorbance value obtained for that cuvette and that filter will be shown in the screen above 8 For consecutive readings press Execute several times The time in whic...

Page 171: ...TION 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 The ISE Module contains the ion selective electrodes and the reference electrode A bubble detector is also included at the top of the electrodes The three pumps that position the sample and wash calibrating solutions A ...

Page 172: ...med each day Perform a two point calibration every 8 hours If the user is running more than 50 serum samples a day both cleaning and two point calibration must be performed after every 50 samples To ensure reliable operation the ISE Module performs calibrant aspiration every 30 minutes beginning after the last sample is run The ISE Module uses a double junction reference electrode The reference el...

Page 173: ...rant B is pumped into the sample entry port by the Calibrant B pump and then positioned in front of the electrodes by the waste pump 3 Cleaning Solution is used once a day to prevent protein buildup on the electrodes and fluid path It must be used more frequently if the ISE Module performs greater than 50 sample measurements per day 100 μL of cleaning solution must be aspirated by the host analyze...

Page 174: ...um specimens are preferable Collect the specimen by venipuncture into a Sodium Heparin evacuated blood collection tube The heparin level should not exceed 15 IU per mL of tube volume Note the time of collection Warning DO NOT USE AMMONIUM HEPARIN LITHIUM HEPARIN EDTA OR NaF TUBES Mix the specimen by inverting the tube Do not shake When using Sodium Heparin collection tubes collect a full tube of s...

Page 175: ...d as no longer acceptable expiration no remaining reagent wrong distributor code Sample Aspirating and Dispensing The sample delivered to the ISE Module must not be contaminated or further diluted The wash solution usually deionized water is the most serious contaminant Sample pickup and delivery to the ISE Module must be highly controlled and consistent Samples and calibrators are positioned in f...

Page 176: ...tant except T one can calculate the ideal slope of the electrodes based on the temperature Some examples of predicted slopes vs temperature are listed below Temp in deg C Slope mV decade 20 58 2 22 58 6 24 59 0 26 59 4 28 59 8 30 60 2 32 60 6 If the module is calibrated at any temperature within its specification and the same temperature is maintained during sample analysis no error in the measure...

Page 177: ...h the tubing from the reagent kit to the ISE Module The ISE Module pumps Calibrant A from the reagent kit through the ISE Module to wash out the flow path Purge B Cycle This cycle is used to purge Calibrant B solution through the tubing from the reagent kit to the ISE Module The ISE Module pumps Calibrant B from the reagent kit through the ISE Module to wash out the flow path Sip Cycle Every 30 mi...

Page 178: ...istaltic pumps of the ISE Module We recommend performing a Pump Calibration Cycle once per day The Pump Calibration values of A and B should be within the range 1500 to 3000 Bubble Cal Cycle The Bubble Cal command is used to allow the module to reestablish a baseline for detecting air liquid interfaces It can also be used as a diagnostic tool to see if the bubble detector is functioning properly M...

Page 179: ...pirate a small volume of Calibrant A from the top port of the reagent kit into a syringe fitted with a blunt needle Inject sufficient volume of Calibrant A into the lumen of the K and Li electrodes until fluid fills the lumen Cover both ends of the lumen both sides of the K and Li electrodes with tape to hold the Calibrant A in place Insert the K and Li electrodes into a sealed bag Remove the reag...

Page 180: ...lume of calibrant and for the solution to be accurately placed in the proper location for analysis Problems can be caused by a partial obstruction from a clot in the tubing from the exit tube to the waste pump a sharp bend in the waste tubing that restricts the flow a misalignment of the electrodes or from too great a length of tubing from the exit tube to the waste pump As the pump tries to pull ...

Page 181: ...lectrodes Inspect O rings Reassemble properly Calibrator solutions Replace Reagent Pack Cl 55 mV decade Electrode low slope Replace electrodes Air bubble on reference Remove electrode tap to electrode membrane Dislodge bubble replace and recalibrate Reference electrode Replace reference electrode and retest ISE Module or fluid temperatures exceed 32 C high slope Decrease the environment temperatur...

Page 182: ...th some blocked Bubbles in Sample Sample must be free of bubbles Fluid leaks Contact Technical Support Sample not positioned Electrodes not seated properly Remove electrodes Inspect O rings and reassemble Replace pump tubing Pump tubing obstructed Replace pump tubing Air in Sample and Calibrant A Sample and Calibrant A are segmented with air Electrodes are not properly seated or compressed Check c...

Page 183: ...act Technical Support Bubble Detector malfunction Contact Technical Support Air in Calibrant A Calibrant A Replace reagent kit with a new one prime and recalibrate Tubing from reagent module is disconnected plugged or crimped Reconnect or replace tubing Calibrant A pump is not working properly Contact Technical Support 15 MAINTENANCE PROGRAM In order to ensure optimal performance and maximum usefu...

Page 184: ... Maintenance TIP Cleaning OK Weekly Maintenance 1 Run one wash cycle of all the cuvettes Operations Wash cuvettes All cuvettes Wash 2 Run two diluter purge cycles Maintenance Instrument Diluter Purge 3 Calibrate all the cuvettes Maintenance Instrument Calibration select Calibrate cuvettes Range 1 to 100 select the position of the solution to use ex Use container OK Monthly Maintenance External was...

Page 185: ...loth 3 Cleaning the cuvette tray clean the black surface of the cuvette tray with a damp cloth 4 Cleaning externally with a damp cloth clean the external covers lids hood of the pipetting arm Caution the instrument needs to be turned off during this procedure Take care not to spill liquids on the instrument 5 Cleaning the tip externally clean the tip from top to bottom with paper towel dipped in i...

Page 186: ...PRIETARY AND CONFIDENTIAL Figure 15 1 ISE Module Maintenance Program Optional Recommended Component Replacement Schedule low volume user Li Electrode Pump Tubing Na Electrode K Electrode Cl Electrode Reference Electrode Fluidic Tubing 12 months Recommended Replacement Schedule high volume user Greater than 100 samples per day Li Electrode 3 000 samples Pump Tubing 6 months Na Electrode 10 000 samp...

Page 187: ...chnical service to perform the necessary maintenance procedures The system involves three independent cycles of use counters one for the hours of work other forcycles of use or tests performed and a third one for lamp hours of use This allows the maintenance program to be according to the volume of work that each user in particular handles Figure 15 2 Warning This message will continue showing unt...

Page 188: ... and cuvettes washing solutions 9 Remove the tubing from the Sodium Hypochlorite solution and rinse the extremes with DI water 10 Remove the filters from the Sodium Hypochlorite solution and rinse with plenty DI water 11 Connect the tubing back to the washing solution containers make sure probe tubing go to probe container and cuvettes tubing go to cuvettes container 12 Purge the diluter thirty ti...

Page 189: ...15 5 2 7 Flushing Pump Membrane replacement Contact Technical Support 15 5 2 8 Diluter Liquid Diaphragm Pump Membrane replacement Contact Technical Support Maintenance Level 2 15 5 3 1 Disinfecting the reagent tray See 15 5 2 1 15 5 3 2 Disinfecting the tubing and cleaning of the containers See 15 5 2 2 15 5 3 3 General cleaning of the instrument See 15 5 2 3 15 5 3 4 Axes lubrication Contact Tech...

Page 190: ...rge the Diluter Maintenance Instrument Diluter Purge 6 Calibrate all cuvettes Maintenance Instrument Calibration select Calibrate Cuvettes Range 1 a 100 select the position of the solution that will be used for calibration Ex Use Container Calibrate As needed maintenance Database Initialization every 10 000 tests 1 Select Maintenance Menu Settings Enter password Database Refresh Statistics In the ...

Page 191: ...ated 4 Select Maintenance Menu Settings Enter password Database Initialize this is where the Patient results Calibrators and Controls results are all erased The last calibration is saved in the methods configuration and the configuration dates of the calibrators controls and methods are not modified 5 Press Yes in this tab close and open software Lamp replacement 1 Turn off the instrument 2 Remove...

Page 192: ...be seen sharply against the paper In case of being necessary to fit the focal length moving the lamp without rotating it to be able to maintain the filament in horizontal position It must look for to focus the beam in the center of the optical path of the cuvette Once obtained the adjustment fix the lamp 12 Place back the main cover and lids 13 Run a calibration of the photometer and all the cuvet...

Page 193: ...ipater c Spot the interferential filter to be replaced and manually turn the filter s wheel clockwise to find and to easily remove the interferential filter holder from the filter wheel d Place the holder with the new filter in the filter wheel Figure 15 6 e Place back the lids and main cover switch on the equipment f Run a calibration of the photometer and all the cuvettes Maintenance Instrument ...

Page 194: ...ve date 8 15 2016 Operator s Manual HTI BioChem FC 360 Page 186 of 217 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL 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 Replace the Sample Reagent probe The new probe has a polarizing pin to make assembly easier ...

Page 195: ...2016 Operator s Manual HTI BioChem FC 360 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Page 187 of 222 Figure 15 9 e Assembly the PCB and connect the Teflon tubing f 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 same as distance II Figure 15 10 Check angle of 90 º ...

Page 196: ...umber OM E FC 360 30 Revision Level Rev 3 Prepared By J S Bolio Approved By S Titov Effective date 8 15 2016 Operator s Manual HTI BioChem FC 360 Page 188 of 217 HIGH TECHNOLOGY INC PROPRIETARY AND CONFIDENTIAL Figure 15 11 Correct position Figure 15 12 Incorrect position ...

Page 197: ...e line filter 4 Remove the burnt fuses and replace them with new ones 5 Replace the lid of the fuse box 6 Reconnect the feed cable to the line filter 7 Turn on the instrument Special Wash 1 Fill a single mouth reagent container with special washing solution see chapter 16 point 16 3 and 16 4 2 Place the container in the reagent tray 3 In the Wash cuvettes screen select Special Wash and enter in Re...

Page 198: ... that every 30 minutes a Sip Cycle is initiated and 100 μL of Calibrant A is dispensed If the electrodes are removed without initiating this maintenance Cycle a Sip Cycle may occur and the 100 μL of Calibrant A will flow into the empty module This can cause significant damage to the ISE Module and or other surrounding components Never leave the Module in this status with the reference electrode in...

Page 199: ...ion Warning Containers must be placed under the level of the analyzer never on the same level Washing solution for probe and cuvettes First Wash Concentrate Solution mother solution has to be prepared from Solution of Triton X 100 this concentrate solution will be used to prepare washing solution for probe and cuvettes Wash Concentrate mother solution dilute 1 part v v of Triton X 100 in 9 parts o...

Page 200: ... to need Use 0 2 Normal sodium hydroxide Weigh out 8 gr of dry sodium hydroxide and dissolve it in 1 liter of distilled water Special washing solution for turbidimetric techniques with latex Use 2 Normal sodium hydroxide Weigh out 80 gr of dry sodium hydroxide and dissolve it in 1 liter of distilled water Disinfecting solution Use a 30 commercial sodium hypochlorite solution 17 TROUBLESHOOTING Int...

Page 201: ...nstrument Methods affected Description of the problem Expiration date for the reagents calibrators and controls in use Absorbance information for the last run calibration Absorbance information for the last run blank Patient results affected Error messages reported by the instrument for the methods affected Instrumental problems Serial number of the instrument Description of the problem Error mess...

Page 202: ... 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 Figure 17 2 Once the file is located send it by mail to technical support or follow the instructions by them given Chemical Problems Chemical problems may appear with an error message along with the results or by unexpected res...

Page 203: ...rin High blank reagent absorbance Verify the blank reagent Insufficient calibrator volume Use a minimum volume of 200 µl Samples concentrated by evaporation Insufficient sample and control volumes Use a minimum volume of 200 µl Inadequate sample and control storage Use fresh samples and controls Deteriorated reagent Inadequate reagent preparation Prepare new reagent Refilled reagent not homogenize...

Page 204: ...nk Avoid foaming Physical and or chemical deterioration of the reagent Prepare new reagent and verify the blank Incorrect information in the configuration of the calibrator Calibrator concentration configured incorrectly Configure the calibrator concentration correctly Insufficient reagent volume or bubbles into the reagent bottle Reagent volume less than 2 ml or more than 55 ml Refill the reagent...

Page 205: ...cle with NaOH 0 2 N See Chapter 7 point 7 7 Failure of the washing and or drying of the cuvettes Contact Technical Support Failure of the optical system Burned lamp Replace the lamp Deteriorated cuvettes Replace the cuvettes Inadequate calibration of the optical system Calibrate the photometer Calibrate the cuvettes Contamination of the circuits Prolonged non use of the instrument Run a decontamin...

Page 206: ...change it without any bubbles Inadequate reagent Incorrect positioning of the reagent in the tray Assign the reagent position correctly Inadequate reagent container Use only the reagent bottles designed for the instrument Dirty reagent bottles Wash the reagent bottles periodically Insufficient reagent volume Refill the reagent bottle Deteriorated reagent Inadequate reagent preparation Prepare new ...

Page 207: ...ing to the affected module or component of the instrument Decide which of the following components is probably affected and run the associated checks and actions in each case Connections and supplies Hydraulic system Washer Diluter Sample Reagent probe Reaction cuvette tray Sample Reagent tray Software If this does not solve the problem contact Technical Support Connections and supplies Observatio...

Page 208: ...un obstruct the drain hose Diluter Observation Probable cause Action Presence of bubbles or air in the diluter Connections adjusted inadequately Adjust the connections Purge the diluter Damaged tubing Contact Technical Support Blocked probe Run a TIP cleaning cycle Purge the diluter Washer Observation Probable cause Action Colored dryer tips Washer failure Contact Technical Support Horizontal move...

Page 209: ...her five times Air entering the tubing Check the connection of the hoses to the washing solution container Purge the washer Damaged opaque cuvettes Prolonged use Change the cuvettes and calibrate them Cuvettes still dirty after washing Washer failure Contact Technical Support Sample Reagent Tray Observation Probable cause Action No refrigeration of the reagents Refrigeration unit turned off Turn o...

Page 210: ...ument turned off and on without initialization procedure Run initialization procedure Burnt out start up fuse Replace the fuses No electricity from the power source Reestablish the electricity Damaged Analyzer on off button Contact Technical Support Instrument disconnected Plug the cable into the power source Invalid communication port Close all open applications that might be using the communicat...

Page 211: ...will be required The analyzer has been powered on with software session active Execute the command to initialize or wait for software automatic initialization sequence 0002 A general power down happened to the Analyzer it could affect the ISE module performance Please purge calibrate and control it The Analyzer general power has been interrupted Long term general power interruptions will affect th...

Page 212: ...tialization error Home inactive Sensing failure home Contact Technical Support Mechanical failure Contact Technical Support Vertical movement not initialized Execute the commands to initialize the movement 0104 Probe Vertical Movement error Home not found Home sensing failure Contact Technical Support Mechanical failure Contact Technical Support 0105 Probe vertical movement error Home active Home ...

Page 213: ...command to initialize 0154 Probe Horizontal Movement error Home active Home sensing failure Contact Technical Support Mechanical failure Contact Technical Support 0155 Probe Horizontal Movement error Home inactive Home sensing failure Contact Technical Support Mechanical failure Contact Technical Support 0156 Upgrade Horizontal Movement Controller Old Controller version Contact Technical Support R...

Page 214: ...hotometer offset Same values for dispensed offset and photometer offset Contact Technical Support SAMPLE REAGENT TRAY Message ID Number and Description Probable cause Possible Solution 0251 Probe Impact Samples and Reagents Physical impact Verify possible obstacles in the movement Tray Impact switches failures preheater board Contact Technical Support Poor contacts Contact Technical Support 0252 S...

Page 215: ... initialized Execute the command to initialize 0303 Filter Wheel not initialized or initialization error Home inactive Home sensing failure Contact Technical Support Mechanical failure Contact Technical Support Filter wheel not initialized Execute the command to initialize 0304 Filter Wheel not initialized Module not initialized Initialize module 0305 Filter Wheel error slotted tray counting error...

Page 216: ...echnical Support 0325 Internal CRC error Amplifier Communication error between amplifier controller and Main controller Contact Technical Support 0326 Low energy in Lack of calibration Run photometer calibration Reference Beam Calibrate Photometer Exit Lens of the reference channel Contact Technical Support Defective Lamp Contact Technical Support Defective Beam Filter Contact Technical Support 03...

Page 217: ...rt Defective filter Contact Technical Support 0332 Saturated Sample Lamp failure Contact Technical Support and Reference Amplifiers Incorrect positioning of a Beam Filter Contact Technical Support Defective filter Contact Technical Support PHOTOMETER CALIBRATION Message ID Number and Description Probable cause Possible Solution 0351 Photometer Calibration error no filters programmed in EEPROM Filt...

Page 218: ... the optical path Contact Technical Support energy in Sample Beam Sample Amplifier Failure Contact Technical Support 0359 Photometer Calibration error high energy in Reference Beam Reference Amplifier Failure Contact Technical Support 0360 Photometer Calibration error high energy in Sample and Reference Beams Incorrect positioning of a Beam Filter Contact Technical Support Lamp failure Contact Tec...

Page 219: ...Amplifiers Defective lamp Contact Technical Support Exit lens Incorrect positioning of a Beam Filter Defective filter CUVETTE CALIBRATION Message ID Number and Description Probable cause Possible Solution 0381 Cuvettes Calibration error no filters programmed in EEPROM Filter ID values set on the EEPROM Contact Technical Support 0382 Cuvettes Calibration error Filter Wheel Controller communication ...

Page 220: ...ace the defective cuvettes Contact Technical Support 0389 Cuvettes Calibration Cuvette absorbance too high replace the cuvettes when possible Striped cuvette or misaligned Check the alignment of the beam with the cuvette Replace the cuvette it is recommended to replace the defective cuvettes Lack of calibration Run photometer calibration 0390 Cuvettes Calibration Cuvette absorbance too low Calibra...

Page 221: ...the movement of the diluter plunger Contact Technical Support 0507 Diluter Valve overload Mechanical failure Contact Technical Support 0508 Diluter Plunger move not allowed Wrong position of the valve Contact Technical Support 0509 Diluter command overflow Contact Technical Support Contact Technical Support WASHER Message ID Number and Description Probable cause Possible Solution 0552 Washer not i...

Page 222: ...al Support Electrical failure Contact Technical Support Mechanical failure Contact Technical Support 0576 Washer Flushing Pump error Home inactive HOME sensing Failure Contact Technical Support Electrical failure Contact Technical Support Mechanical failure Contact Technical Support FILLING PUMP Message ID Number and Description Probable cause Possible Solution 0581 Washer Filling Pump moving erro...

Page 223: ...ed flow path Reinstall electrodes and recalibrate If single electrode is flagged May occur when new electrode or Calibrant A are installed Purge Calibrant A and recalibrate the ISE module If the electrode is new it may initially drift as it rehydrates over the course of 15 minutes If single electrode is flagged Replace the electrode and recalibrate If multiple electrode are flagged May occur when ...

Page 224: ...ged Reference electrode Replace reference electrode and recalibrate Electrical noise spike from environmental source Contact Technical Support Component failure on ISE Module board Contact Technical Support 0706 Out of range in Serum Plasma Samples results are out of range limits Whole blood serum plasma Li 0 20 3 50 mmol L Na 100 0 200 0 mmol L K 1 00 10 00 mmol L Cl 50 0 150 0 mmol L Check quali...

Page 225: ...re on ISE Module board Contact Technical Support 0710 Noise in Calibrant B If single electrodes is flagged Replace problem electrode and recalibrate If multiple electrodes are flagged Replace reference electrode and recalibrate Electrical noise spike from environmental source Contact Technical Support Component failure on ISE Module board Contact Technical Support 0711 Drift in Urine If single ele...

Page 226: ...ath Remove electrodes and clean or replace electrode with plugged flow path Reinstall electrodes and recalibrate If single electrode is flagged May occur when new electrode or Calibrant A are installed Purge Calibrant A and recalibrate the ISE module If the electrode is new it may initially drift as it rehydrates over the course of 15 minutes If single electrode is flagged Replace the electrode an...

Page 227: ...gged May occur when new electrode or Reagent Kit is installed Purge the Calibrant A and recalibrate the ISE module If multiple electrode are flagged Reference electrode Replace reference electrode and recalibrate 0718 Out of Range in Calibration Acceptable slope limits are Slope mV decade Li 47 64 Na 52 64 K 52 64 Cl 40 55 Replace the electrode and recalibrate 0731 ISE Module Air in Sample Urine a...

Page 228: ...ntry port Reagent low or out Fibrin or salt is plugging the electrode flow path Use cleaning procedure Remove electrodes and clean or replace electrode with plugged flow path Reinstall electrodes and recalibrate Waste pump malfunction Contact Technical Support Bubble detector malfunction Contact Technical Support 0734 ISE Module Temperature higher than 32ºC Please decrease the environment temperat...

Page 229: ...eful not to dislodge any particles that may obstruct the flow path Air bubble in sample if the sample probe delivering the sample or any reagent is to fast or forceful air bubbles can be created and drawn into the flow path Contact Technical Support 0758 ISE Module Pump Calibration error Insufficient saline solution pipette into ISE module sample entry port Check saline solution tube Contact Techn...

Page 230: ...e 0770 ISE Pack changed ISE Reagent Kit has been changed Run Reagent Kit replacement 0771 ISE Pack Security Code error Kit electronic key failure Change ISE reagent kit 0772 ISE Pack Wrong Distributor Code Invalid Reagent Kit 5420 0104 ISE reagent kit must be used 0773 ISE Pack Expired ISE Reagent Kit expired Change ISE reagent kit Run Reagent Kit replacement 0774 ISE Pack Not Good Kit electronic ...

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