1. Manuals
  2. Brands
  3. Human Manuals
  4. Laboratory Equipment
  5. HumaStar 600
  6. User manual

Human HumaStar 600 User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

HumaStar 600
| User Manual
Cat No. 16660/001

Advertisement

Table of Contents
loading

Related Manuals for Human HumaStar 600

Summary of Contents for Human HumaStar 600

  • Page 1 HumaStar 600 | User Manual Cat No. 16660/001...
  • Page 3 No part of this documentation may be reproduced in any form, nor processed, copied or distrib- uted by means of electronic systems, without prior permission of Human GmbH in writing. Since all precautionary measures were taken into account in producing these operating instructions, the manufacturer accepts no responsibility for any errors or omissions.

  • Page 5: Table Of Contents

    CONTENTS TABLE OF CONTENTS 1 SAFETY INSTRUCTIONS 1.1 INTRODUCTION 1.2 USER WARRANTY 1.3 INTENDED USE OF THE INSTRUMENT [IVD] 1.4 GENERAL SAFETY WARNINGS 1.5 DISPOSAL MANAGEMENT CONCEPT 1.6 INSTRUMENT DISINFECTION 1.7 BIOHAZARD WARNING 1.8 ADDITIONAL LABELS 2 INTRODUCTION 3 SYSTEM DESCRIPTION 3.1 UNPACKING 3.2 INSTALLATION 3.2.1 Installation Requirements...
  • Page 6 4 GET READY FOR OPERATION 4.1 AUTOMATIC OPERATION 4.1.1 Clot detector 5 ROUTINE TASKS 5.1 REAGENTS 5.1.1 Reagent tray 5.1.2 Loading barcoded reagents, Diluent and Cleaning Solutions 5.1.3 Loading non barcoded reagents and solutions 5.1.4 Removing reagents and solutions 5.1.5 Refilling reagent bottles (only for open channels) 5.1.6 Method assignment to trays 5.2 SAMPLES 5.2.1 Working with patients...
  • Page 7 CONTENTS 5.6.4 Processed controls 5.7 TWIN QC 5.7.1 QC scheduler 5.8 WORKING WITH LIS 5.9 DEFINITION AND USE OF SAMPLE PROFILES 5.9.1 Defining a sample profile 6 DEFINITION OF METHODS 6.1 METHOD TYPES AND CALCULATIONS 6.1.1 Endpoint 6.1.2 Fixed Point 6.1.3 Kinetics 6.2 METHOD PARAMETERS 6.2.1 Common parameters...
  • Page 8 8.3 WEEKLY MAINTENANCE 8.3.1 Intensive Cuvette Cleaning 8.3.2 Cuvette Water Blank 8.3.3 Service Backup 8.4 MONTHLY MAINTENANCE 8.4.1 Photometer Calibration 8.4.2 Washer Volume Calibration 8.4.3 Clean System Bottles 8.4.4 Intensive Washer Cleaning 8.5 MAINTENANCE ON DEMAND 8.5.1 Cuvette Change 8.5.2 Lamp Replacement 8.5.3 Pump tube replacement 8.6 COUNTERS 9 TROUBLESHOOTING...

  • Page 9: Safety Instructions

    HUMAN, not regularly maintained, used with equipment not approved by HUMAN or used for purposes for which it was not designed.

  • Page 10: Intended Use Of The Instrument [Ivd]

    1.4 General Safety Warnings Use only chemical reagents and accessories specified and supplied by HUMAN and/or mentioned in this manual. Place the product so that it has proper ven- tilation.

  • Page 11: Disposal Management Concept

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

  • Page 12: Biohazard Warning

    FIGURE 1 Biological Hazard Symbol 1.8 Additional Labels The labels used on Human products are among those specified by the interna- tional Organisation for Standardization (ISO). They are placed at critical points on each instrument as a warning of the risks involved.

  • Page 13: Introduction

    IntroductIon 2 INTRODUCTION The HumaStar 600 is a reliable in vitro diagnostic chemistry analyzer for auto- matic testing of routine clinical chemistry tests and electrolytes. Being real random access, this HumaStar 600 is the ideal solution for medium to large size labs, with a throughput of more than 600 photometric tests/hour (720 tests/hour with ISE).
  • Page 14 HumaStar 600 | User manual...

  • Page 15: System Description

    SyStem deScrIptIon 3 SYSTEM DESCRIPTION 3.1 Unpacking Remove all the parts from their package. When unpacking the instrument, please make sure that the following items are contained in the packing. In case of damage or missing item, please contact the supplier immediately.

  • Page 16: Electrical Connections

    3.2.2 ELECTRICAL CONNECTIONS Plug in the mains cord to a socket with ground connection. The power require- Instrument is Installation Cat- ments for the HumaStar 600 are as follows: 100~240 VAC, 50/60 Hz, 1400 VA egory II. Instrument requires maximum.

  • Page 17: Handling Of Biological Fluids

    SyStem deScrIptIon FIGURE 2 3.2.4 HANDLING OF BIOLOGICAL FLUIDS Before connecting wash and drain lines, be sure to remember and understand regulations and cautions about potentially dangerous biological fluids. Keep in mind the following considerations: 1. Due to the presence of biological fluids, some instrument areas are poten- Never dispose potentially tially dangerous.

  • Page 18: Computer Setup

    /or breakdown. The visual effects to best performance. Change the setting of the operating system. Under properties  Advanced options  visual effects select “Adjust for best performance”. HumaStar 600 | User manual...

  • Page 19: Parameters

    Setting of the Anti Virus Software We recommend the use of Anti Virus Software on the Personal Computer of the HumaStar 600. The HumaStar 600 “Rayo” directory has to be excluded from the scanning process. Please refer to the documentation of the Anti Virus Software Don‘t use the predefined MS Windows folders.
  • Page 20 FIGURE 4 1. Communications: Select serial port according to your computer setting and specification. If setting is wrong, the HumaStar 600 temporarily checks for other port; but if no ports are free, program might not work properly. 2. Language: Select among languages already set in the translator. Changes will come into effect when program is closed and re-opened.
  • Page 21 SyStem deScrIptIon 11. Reagent integrity check: run the reagent integrity check at each start of sam- ples or only once a day. 12. Clot behavior: Enables the use of clot detection and offers additional options in analyzer behavior in case that a clot is detected. Options: only flag - a flag is added to the result, invalidate - the result will be deleted.
  • Page 22 5. Lot Number: To use multiple lots for the same reagent select the box “Mix lots”. Press Apply Changes in order to save the changes. HumaStar 600 | User manual...
  • Page 23 SyStem deScrIptIon LIMS FIGURE 7 1. Enabled: Select to activated and set informations for the communication with host computer. 2. Options: Select parameters according to specifications of your LIMS provider. 3.2.6.2 Use FIGURE 8 Use parameters are split in several sections: Cuvette absorbance limits, ISE and definitions of sample vials.
  • Page 24 Volume calculations require careful section measurement for each defined vial. 3. ISE: Sample prewash can be enabled or disabled. For details, refer to ISE User Manual REF 16663/1. 3.2.6.3 Report FIGURE 10 HumaStar 600 | User manual...
  • Page 25 SyStem deScrIptIon This section allows sorting how methods are ordered in report and printout. Keys Up and Down allow moving methods to different positions in the final printout. If not enabled, sorting will take place alphabetically. Press Apply Changes in order to save the changes. FIGURE 11 3.2.6.4 Sector definition In this section user defines the number of sectors that are available on the...
  • Page 26 On the right side of the screen all programed sectors are displayed. Press to add an other sector. To define it as a STAT, tick the box “STAT sector” and press Ok . All samples placed on a STAT sector will be processed with priority. 3.2.6.5 Debug HumaStar 600 | User manual...

  • Page 27: Tools

    SyStem deScrIptIon In this section hardware and and hardware check functions can be activated or deactivated. FIGURE 14 To minimize down time following parts can be temporary deactiated: front- or back arm and washer. In case the system is conneted to a water supply and drain system the sensors for DI water and waste should be deactivated.
  • Page 28 “Global” will effect all entries in the software. Modifications take effect only when program is restarted. When a given trans- lation is empty, system will use Internal language, no matter which language is selected. Translation with Dictionary: FIGURE 16 HumaStar 600 | User manual...
  • Page 29 SyStem deScrIptIon Translation can be done using the dictonary tool. FIGURE 17 When any entry is selected, upper window shows internal text and lower win- dow, the translation, if present. Sorting can be performed by internal or by translation. There is also a built-in search tool. Entries can be deleted by press- ing the corresponding button.
  • Page 30 There are two types of fields: DataText are the Results written by instrument once a value is printed. They can be moved, eliminated, changed font, etc. but its text is out of operator‘s control. There also Report variables that can be added HumaStar 600 | User manual...
  • Page 31 SyStem deScrIptIon at this time. They include page numbering date and time in different possible formats. In the New/Edit Data Text, the Change button allows selecting the desired field to be shown. The Texts are the true headers corresponding to the Data texts and can be fully modified by pressing Change button: FIGURE 21 As an example, the following report format is included in software.

  • Page 32: Parts Of The Instrument

    4 Washing pumps 5 Front/Back dilutor 6 System Wash Container 3.3.2 TOP VIEW FIGURE 24 Top view 1 Back reaction tray 2 Front reaction tray 3 Reagent tray 4 Sample sectors 5 Front/back pipettors 6 ISE unit HumaStar 600 | User manual...

  • Page 33: Left Side

    SyStem deScrIptIon 3.3.3 LEFT SIDE FIGURE 25 1 Service door for lamp 2 Electronics 3.3.4 SAMPLES AND SAMPLE SECTORS Samples are loaded in a 19 positions sample sector. Continuous processing is possible by the use of different bar-coded sample sectors, which the user can insert or remove from sample tray during analysis.

  • Page 34: Reagents

    3.3.5 REAGENTS This HumaStar 600 has a cooled reagent tray where 25ml and 70ml containers can be placed. The reagent tray includes integrated barcode reader for 24 inner and 24 outer positions. Sample Diluent as well as cleaning solutions are also placed in the reagent tray.

  • Page 35: Software Functions Overview

    SyStem deScrIptIon 3.4 Software functions overview The software offers complete functionality to control the instrument and mon- itor the overall operation which includes: samples and patients management, control reagents, program tests, calibration of methods, perform QC tasks, reac- tions follow up, statistic on results, among others. 3.4.1 LEVELS OF ACCESS System has different levels of access depending of the type of user: Normal user...

  • Page 36: Data Menu

    3.4.2 DATA MENU FIGURE 30 Import: Methods, QC Sets, Calibration Sets, Units Conversions and Translator information can be imported. FIGURE 31 Service Backup: creates a instrument image for service puposes. Reconnect: restarts the instrument hardware operation. HumaStar 600 | User manual...

  • Page 37: Main Screen

    SyStem deScrIptIon 3.4.3 MAIN SCREEN FIGURE 32 Main Screen 1 Menu & Quick keys 2 Control bar 3 Running options 4 Operator request 5 System information 6 System messages 7 Transmission and operating status 8 Calibration and reagent status 9 Tests in progress 10 Current activities 11 Eventlog 12 ISE eventlog...
  • Page 38 ISE module is not enabled. Process Coagulation assays: disable if coagulation samples are not expect- ed for the day. This option will not be shown, if coagulation assays are not enabled. HumaStar 600 | User manual...
  • Page 39 SyStem deScrIptIon 4. Operation request bar provides actions requested from instrument to com- plete some operation such as confirmation of calibrations, confirmation on sample results outside reference class limits, etc. 5. System information indicates the status of the system such as maintenance tasks, system alerts and system logs.

  • Page 40: Quick Key Menus

    In this menu flagged and calculated results can be validated and/or re- FIGURE 35 peated. Test results can be printed or exported. Data storage of sample is unlimited. External results can be imported, to complete reports calculated methods. HumaStar 600 | User manual...
  • Page 41 SyStem deScrIptIon Reagent Tray Menu: FIGURE 36 From main menu it is possible to access the reagent tray programming to place or remove reagent or solutions. The second reagent of a given double re- agent method will be marked with a dot. Slide mouse over a reagent on the tray to obtain details on the right panel regard- ing reagent usage, available volume and...
  • Page 42 Levy-Jennings plot and Westgard mul- ti-rules are integrated to facilitate QC analysis. Twin QC is designed to relate high and low controls and get an accurate sta- tistical picture. Scheduler is designed to program con- trols at pre-set dates. HumaStar 600 | User manual...
  • Page 43 SyStem deScrIptIon Method Definition Menu: FIGURE 42 New methods for the open channels can be set up by the supervisor. For the closed channels the limits and reference classes can be set.
  • Page 44 HumaStar 600 | User manual...

  • Page 45: Get Ready For Operation

    Turn reagent cooling system on by pressing green button lateral on the front panel. Once operating system is ready, activate the desktop‘s program icon to open the HumaStar 600 program. Do not change the computer Accept the startup offered by the program, wait until operation finishes and date or time during opera- checks there are no visible warning messages on the screen.

  • Page 46: Clot Detector

    The clot condition will be posted in the details of the sample result. If sample is discarded, it will continue as in process and a message will be shown in the window of messages in main menu. Clot detector version is posted in the ErrorsLog.txt file. HumaStar 600 | User manual...

  • Page 47: Routine Tasks

    routIne taSKS 5 ROUTINE TASKS 5.1 Reagents 5.1.1 REAGENT TRAY To inspect the onboard reagents press the Reagent Tray Menu button. The reagents tray window is displayed showing a graphical representation of the actual distribution of reagents in the tray. FIGURE 43 After the placing or removing reagents as described below,...

  • Page 48: Loading Barcoded Reagents, Diluent And Cleaning Solutions

    If a reagent barcode label cannot be read a window will open and the barcode can be insert manually. HumaStar 600 | User manual...

  • Page 49: Loading Non Barcoded Reagents And Solutions

    routIne taSKS 5.1.3 LOADING NON BARCODED REAGENTS AND SOLUTIONS After the placing or removing  To define a reagent into the tray, press Place Reagent , then from the win- reagents as described below, dow select the reagent and desired position and press Ok or press Cancel or press Apply Changes to start the key to abort.
  • Page 50 Following window appears: FIGURE 46  Open the cover, take out the reagent or solution bottles and close the cover. Press Ok button to confirm the operation. Same procedure must be followed for removing diluents and solutions. HumaStar 600 | User manual...

  • Page 51: Refilling Reagent Bottles (Only For Open Channels)

    routIne taSKS 5.1.5 REFILLING REAGENT BOTTLES (ONLY FOR OPEN CHANNELS) When pressing right button over a given reagent, menu will include a Refill option. Once the Apply Changes button is pressed, tray will move in the desired reagent position. Several reagent vials can be refilled with this procedure: when Apply Changes is pressed tray will sequentially position in all the defined refilling reagents.

  • Page 52: Working With Patients

    2. Display of all defined patients. 3. Display of all samples defined for the patient Id shown above. 4. Display of all tests defined for the patient Id shown above. HumaStar 600 | User manual...

  • Page 53: Defining Sample Data And Tests

    routIne taSKS 5.2.2 DEFINING SAMPLE DATA AND TESTS To define new samples or request tests for a given sample, press the Samples Menu button. FIGURE 49 In this menu it is possible to add, edit, delete and copy samples and correspond- ing tests.

  • Page 54: Removing A Sample

    Place . A new window opens, select the sector and position number and press Ok to save or Cancel to abort. 5.2.3 REMOVING A SAMPLE  To remove a sample from the list press Delete FIGURE 51 HumaStar 600 | User manual...

  • Page 55: Removing Tests

    routIne taSKS Then press Yes to confirm or No to abort. Delete All button will remove all samples from the window on the right side. 5.2.4 REMOVING TESTS  To remove tests from a sample, first select the sample from the list on the right window and then press Delete Test .

  • Page 56: Loading Samples

    Data are also available for printout in Reports > Input Tray 5.2.6.1 Loading barcoded samples Be sure that barcode reading is enabled. Access for enabling is in Maintenance > Parameters > Software (Supervisor only) HumaStar 600 | User manual...

  • Page 57: Removing A Sample

    routIne taSKS Once a sector is loaded, codes are read for all samples, if samples are not present, reader will reach code located on the rear of sector. Its reading is equivalent to “sample is not present”. When Sample ID is recognized, vial position will match defined sample. If sam- ple ID was not defined in advance, new sample entry is created with recognized Note that non barcoded sam- ID but user will have to complete data.

  • Page 58: Removing A Sector

    If so, first delete defi- nition and then re-enter new definition, including STAT condition. To give a sample a STAT priority on a routine sector, select the Stat Sample option in the Sample menu. HumaStar 600 | User manual...

  • Page 59: Reports

    routIne taSKS 5.2.11 REPORTS From the menu bar, select Reports. FIGURE 54 Following reports can be generated: Input Tray Data of samples introduced by operator or through LIS. TABLE 6 Reagents Reagents and solutions already present in tray. Only those used by the programmed samples are shown.

  • Page 60: Test Results

    To see the detail infor- mation of a result (raw data) select a result and press Detail. Cumulative Historic Results can be stored permanently in folders named with year and month. The button Cuvettes is for Service use only. HumaStar 600 | User manual...

  • Page 61: Acceptance Of Results

    routIne taSKS 5.3.1 ACCEPTANCE OF RESULTS  To confirm the result for a given test open the Pending Acceptance Menu , then select the desired sample test from the list and then press Accept . Press Reject to reject the test result. To reprocess the reaction just press Rerun or Diluted Replicate if additional dilution could be useful for confirmation of result.

  • Page 62: Calibration

    Actual and historic ISE calibrations can be reviewed. Automatic Calibrator Lot numbers can be defined for the use in the next calibration automatic calibration, this can be in advance. Calibrator Set Single and Multipoint calibrators can be set up, modified or deleted. HumaStar 600 | User manual...

  • Page 63: Calibrator Sets

    routIne taSKS 5.4.1 CALIBRATOR SETS Calibrators for single or mutipoint calibrations are defined for methods. This calibrators can contain a single- or multiple methods. Following information are included in the sets: calibrator set Id, Lot number, number of vials, tests, mean values and automatic dilution if necessary.
  • Page 64 Delete. Press Yes to confirm or No to abort. 5.4.1.3 Automatic Dilutions It is possible to dilute a single calibrator for a multi point calibration. When Add Test is pressed, the following screen will show up: HumaStar 600 | User manual...

  • Page 65: Requesting A Calibration

    routIne taSKS FIGURE 60 The window for automatic Dilutions will show the number of points that inte- grate the curve. The Serial factor indicates the dilution factor: a factor of 2 will The instrument will automat- define the concentration as 1/2, 1/4, 1/8, etc.; a factor of 3 will define concen- ically adjust the number of trations as 1/3;...
  • Page 66 Add Test . Check one or more tests you want to add. Define the number of replicates. They can be equal or different for different tests. Press Ok when done or Cancel to abort. HumaStar 600 | User manual...

  • Page 67: Ordering A Calibration

    routIne taSKS 5.4.3 ORDERING A CALIBRATION To load the calibrator‘s cups on the instrument sample tray refer to section 5.2.6. 5.4.4 CALIBRATION ACCEPTANCE  Open the Calibration Menu and select on the left side the Pending Accept- ance Submenu. Following window will be displayed: FIGURE 63 To confirm a calibration test result, select the desired method and the calibra- tion curve including replicates will be displayed.

  • Page 68: Automatic Calibration

    This set can also be “Run in advance” and be ready several hours be- fore the present calibration expires. Open the Calibration Menu and select on the left side the Automatic Calibration Submenu. HumaStar 600 | User manual...

  • Page 69: Reagent Blank

    routIne taSKS FIGURE 64 Select from the right window the desired Method-Calibration Set combination and press the button. With the corresponding button the Run in ad- vance interval is also fixed. This interval is checked every 15 minutes when the system is running, it is in the “don’t stop”...
  • Page 70 The final result is the average of all accepted values. Use the reject function to rerun the reagent blank. In Use Actual reagent blanks can be reviewed, deleted or printed. Historic Former reagent blanks can be reviewed or printed. HumaStar 600 | User manual...

  • Page 71: Quality Control

    routIne taSKS To request a reagent blank press the New button in the Blanks Submenu. FIGURE 66 Table shows last measured absorbance and its date. By checking and adding the number of replicates, blanks can be measured. 5.6 Quality control Quality control system is based on the use of Control Sets.
  • Page 72 Quality control results will be displayed in a Youden Plot. Scheduler QC actions can be programmed in advance for the com- plete week. Control Set Single and Multi controls can be set up, modified or deleted. HumaStar 600 | User manual...

  • Page 73: Creating A Control Set

    routIne taSKS 5.6.1 CREATING A CONTROL SET Open the Quality Control Menu and select on the left side the Control Set Submenu. FIGURE 68  To define a new control set, press New . FIGURE 69...
  • Page 74 To remove a control set from the list, first select the control profile from the list on the right and then press Delete . Press Yes to confirm or No to abort. Delete All button will remove all control sets. HumaStar 600 | User manual...

  • Page 75: Requesting A Control

    routIne taSKS 5.6.2 REQUESTING A CONTROL Open the Quality Control Menu and select on the left side the Submenu Controls. FIGURE 70 To request a control based on a control set press New . FIGURE 71 Select the desired control set in the list on the left side. Tick at least one box in front of a test name to select them and enter the number of replicates.

  • Page 76: Processing A Control

    They will be organized in directories, where results of each month are au- tomatically stored. 5.6.4 PROCESSED CONTROLS To display processed Controls, open the Quality Control Menu and select on the left side the Submenu Done. HumaStar 600 | User manual...
  • Page 77 routIne taSKS FIGURE 72 In the upper section following filter options are available to display the desired data: Date (From - To) Index (From - To) Test Id Lot Number Control Id Last (number of displayed results) Date selectors show calendar for simple selection. All results are indexed and in- dex is shown at the beginning of each column.
  • Page 78 To exclude results from the statistics press the Results button. Press Close to get back to the main window. To view additional statistic press the Statistics Submenu button on the left side. FIGURE 74 HumaStar 600 | User manual...

  • Page 79: Twin Qc

    routIne taSKS The results of the day will be displayed including the Westgard rules violation, the assigned- and cumulative values. CV and SD are calculated if multiple meas- urements are available. Press Detail to display the single measurements. To exclude a results form the statistics, select a result in the table on the left side, press Exclude and insert a reason.
  • Page 80 Coupled quality control is a useful tool if both controls of each pair are taken in similar conditions. Observe index num- ber, date, time and lot number and verify that data were taken in close conditions. HumaStar 600 | User manual...
  • Page 81 routIne taSKS 3. To display the linked Twin QC press Statistics tab. FIGURE 78 Linked entries will appear in the upper (Linked) window. For identification purposes entries will be shown in alternate colors yellow and white. Every entry can be unlinked by selecting one of both components and pressing the Unlink button.

  • Page 82: Qc Scheduler

    Press the Levey-Jennings Plot button and follwing graph will be displa- yed: FIGURE 80 5.7.1 QC SCHEDULER To display and program the QC Scheduler, open the Quality Control Menu and select on the left side the Submenu Scheduler. HumaStar 600 | User manual...
  • Page 83 routIne taSKS FIGURE 81 QC scheduler allows programming in advance all the QC actions on a weekly basis. The defined controls are shown in the lower part of the screen. They must be dragged and dropped in the desired hour and day and then saved by pressing the Save button.

  • Page 84: Working With Lis

    5.9.1.1 Removing a sample profile To remove a sample profile from the list, first select the sample profile from the list on the right and then press Delete . Press to confirm or No to abort. HumaStar 600 | User manual...

  • Page 85: Definition Of Methods

    defInItIon of metHodS 6 DEFINITION OF METHODS For open channels only! There are four mayor types of methods or procedures in clinical chemistry analy- sis results. Photometric methods control the way the reactions take place. Their definitions include the volumes of reagent and sample, the times when the ab- sorbance measurements shall be taken by the photometer and the calculations to obtain the final result.

  • Page 86: Endpoint

    ) – B Where F is a Volume Factor Correction given by F= (V1 + Vs ) / (V1 + V2 + Vs) With V : first reagent volume : second reagent volume : sample volume HumaStar 600 | User manual...

  • Page 87: Fixed Point

    defInItIon of metHodS If no correction is applied, formula becomes M = (A ) - B. where B is the measurement of the reagent blank if required, otherwise set to 0. The reagent blank determination is analogous to sample reaction. If extra precision is required, readings are computed as the average of the first and extra precision readings as M = ((A...

  • Page 88: Kinetics

    6.2 Method parameters Several sections can be accessed in the method definition window. 6.2.1 COMMON PARAMETERS The common parameters are available for following methods: Endpoint, Fixed Point, Kinetics, Calculated and External. FIGURE 85 HumaStar 600 | User manual...

  • Page 89: Main Page

    defInItIon of metHodS Item Input Comments Method Id Letters (A to Z , a to z), numbers It is unique; first 4 characters are used TABLE 10 (0 to 9) and hyphen signs (- and _) for the identification in the reagent tray screen Name Letters (A to Z , a to z), numbers...
  • Page 90 (defined in Solutions menu) and the reagents of this test are availble Use extra volume Check / No Check Check and the defined extra volume of the sample diluent will be used and after dis- pensing discarded HumaStar 600 | User manual...
  • Page 91 defInItIon of metHodS Predilution Check / No Check Check to enable the sample predilution function Factor 1 to 100 Dilution will be done in an extra cuvette; di- lution volume 300 µl (factor 10 -> 30 µl sam- ple + 270 µl sample diluent) Check / No Check Check and QC samples will be pre diluted Calibration...

  • Page 92: Quantitative

    Check / No Check; 1 to 20 Check and insert the number of points used in the calibration; If this option is not select- ed, the user can define a calibrator set with any number of points. HumaStar 600 | User manual...

  • Page 93: Limits

    defInItIon of metHodS Mandatory None, Linear, MultLinear, Select from dop down menu if a special for- formula Sigmoidea, Logit4, Logit5 or mula should be used; if none is used the for- Spline. mula can be manually modified in the Cali- bration>Pending Acceptance window Factor -999999 to 999999...
  • Page 94 Insert a high factor limit Change in % Check / No Check; Check if the deviation from the previous valid -999999 to 999999 (in use) calibration should be checked and in- sert the allowable percentage HumaStar 600 | User manual...

  • Page 95: Reference Classes

    defInItIon of metHodS Correlation Only for Kinetics; Lineartiy Check coefficient limit Low limit -999999 to 999999; drop Insert a limit and select if a rerun should be down menu triggered or not 6.2.5 REFERENCE CLASSES Reference classes define the normal limits or reference values for the various types of samples: men, women, children, etc.

  • Page 96: Advanced Features

    Water Check / No Check Check to use water for the extra wash Solution Check / No Check, Check and select the solution which should drop down menu used for the extra post wash HumaStar 600 | User manual...
  • Page 97 defInItIon of metHodS Tip pre wash Check / No Check Check to enable an extra probe wash before aspirating the reagent Water Check / No Check Check to use water for the extra wash Solution Check / No Check, Check and select the solution which should drop down menu used for the extra wash Reagent...

  • Page 98: Consumption

    -999999 to 999999 Insert the OD limit; if absorbance is below limit in a de- limit creasing reaction or above limit in increasing reaction the sample will be prediluted Dilution factor 1 to 120 Insert a dilution factor HumaStar 600 | User manual...

  • Page 99: Reagent Substitution

    defInItIon of metHodS 6.2.8 REAGENT SUBSTITUTION Two or more methods can share the same reagent. Or a defined diluent can be used as a reagent. FIGURE 93 Item Input Comments TABLE 16 Reagent Check / No Check Check to apply a reagent or diluent for reagent 1 drop down menu Choose “Use Method”...

  • Page 100: Kits

    The information of the first kit are automatically insert from the Main and Ad- vanced tab. If a second Kit size should be used insert the BCR code, the on board stability and the Kit Volume in µl. HumaStar 600 | User manual...

  • Page 101: Solutions

    defInItIon of metHodS 6.3 Solutions To set up Solutions press the Method Definition Menu button and select the Submenu Solution. FIGURE 95 Two categories of solutions are available: Fixed in the system Solutions which are fixed in the system and can not be modified TABLE 17 Solution BCR Code Usage...

  • Page 102: Options

    To delete a solution, select the solution in the table and press Delete . 6.4 Options To add or delete Reference Classes or Measurement Units press the Method Definition Menu button and select Submenu Options. FIGURE 97 HumaStar 600 | User manual...

  • Page 103: Calculated Methods

    defInItIon of metHodS Following options are available: Reference classes Defined reference classes are displayed; to add a new press Add and type in the name and press Ok to confirm or Cancel to abort; to delete select the line and press Delete .

  • Page 104: External Methods

    Method ID, name, units, decimals, external names are introduced as usual. To add a reference class to the external method, press Add and select the class and insert the low and high limit. Press Ok to confirm or Cancel to abort. HumaStar 600 | User manual...

  • Page 105: Units And Limits

    defInItIon of metHodS 6.7 Units and Limits Units and limits can be modified from the menu of methods without direct ac- cess to a given method in particular. This feature is used to set lab specific limits or checks to closed methods. FIGURE 100 In brief, the method ID and measuring units can be modified.
  • Page 106 In Results, measurements can be viewed graphically and Time 1 and Time 2 can be adjusted in order to focus on required time interval. This funtion is mostly used for research and development projects as well as method optimization. HumaStar 600 | User manual...

  • Page 107: Ise Module Cat.-No. 16663-03

    ISe module cat.-no. 16663-03 7 ISE MODULE CAT.-NO. 16663-03 See HumaStar 600 ISE MODULE User Manual, 16663/1.
  • Page 108 HumaStar 600 | User manual...

  • Page 109: Maintenance

    maIntenance 8 MAINTENANCE A regular maintenance is necessary, to keep the system in good operating con- dition. The scheduler will help to manage the daily, weekly and monthly main- tenance. From time to time it’s also necessary to do some maintenance on de- mand i.e.

  • Page 110: Schedule

    0 to 24 o’clock Set the time when the weekly maintenance should take place Monthly Monday to Select the day the monthly maintenance should Maintenance Sunday take place 0 to 24 o’clock Set the time when the alert should take place HumaStar 600 | User manual...

  • Page 111: Status

    maIntenance Service Bakup Daily Check / No Check Check for a daily backup Weekly Check / No Check Check for a weekly backup Cuvette Water Blank Daily Check / No Check Check for a daily cuvette water blank Weekly Check / No Check Check for a weekly cuvette water blank Start of the day...

  • Page 112: Daily Maintenance

    The washing solution is pumped up from its res- ervoir and is disposed into the waste reservoir, both reservoirs have electronic level sensors. If volume is not sufficient, a message will warn after initialization. HumaStar 600 | User manual...

  • Page 113: Empty Waste Bottle

    maIntenance The Tip clean and Tip rinse solutions are needed to clean and rinse the probes after measurement, before the system stops and should be replaced (if not used up) all three months. The Cuvette Clean is used during run for tip pre/post wash- and cuvette post wash and should be replaced (if not used up) all three months.

  • Page 114: Weekly Maintenance

    6. Check if enough C-Clean is placed on the reagent tray (160 x the volume set above). 7. Press to start the cleaning. 8. After the cuvette cleaning finished the scheduler will be updated automat- ically. It is mandatory to perform a Cuvette Water Blank after the cleaning. HumaStar 600 | User manual...

  • Page 115: Cuvette Water Blank

    maIntenance 8.3.2 CUVETTE WATER BLANK Cuvette water blank should be done weekly and after each intensive cuvette cleaning. Washers are dispensing system wash in all cuvettes and photometer records the background measurement of each cuvette at all 12 filters. The process takes places into two parts;...

  • Page 116: Monthly Maintenance

    Photometer Calibration function and a pop up window will appear. If the cuvette is clean, a new placement is not necessary. 2. Press Ok and the calibration will start automatically. 3. When finished refer to the summarize tab and following window will be dis- played: HumaStar 600 | User manual...

  • Page 117: Washer Volume Calibration

    maIntenance FIGURE 109 Check following values: Front and Back Gain ≤ 8 Ref Gain ≤ 16 4. If the gains are over the limit, refer to chapter 9 “Troubleshooting”. 8.4.2 WASHER VOLUME CALIBRATION The washer volume should be between 500 and 700 µl. The calibration will take approximately 3 minutes.

  • Page 118: Clean System Bottles

    Ref 18971). 5. Take out and empty the waste bottle. 6. Clean with dilute hypochlorite (1 %) and rinse once with water. 7. Press Ok when finished, the scheduler will be updated. 8. Flush the System. HumaStar 600 | User manual...

  • Page 119: Intensive Washer Cleaning

    maIntenance 8.4.4 INTENSIVE WASHER CLEANING To provide a good cuvette cleaning the wash station should be cleaned at least monthly using the instructions below. The procedure will take approximately 5 min. To open the Operation menu select: FIGURE 111 FIGURE 112 1.

  • Page 120: Maintenance On Demand

    5. When finished press Ok . 6. The cuvette water blank will be automatically started, when the tempera- ture in the reaction try is reached. The number in the counter table (Wear) will be reset to Zero. HumaStar 600 | User manual...

  • Page 121: Lamp Replacement

    maIntenance 8.5.2 LAMP REPLACEMENT When required, lamp replacement can be easily performed by user following these instructions: Do not touch lamp bulb with bare hands, only with gloves. 1. Turn off and unplug instrument from Main Plug and wait 10 min in order to If touched accidentally, clean let the lamp cool down.
  • Page 122 When a replacement is done, the reset button should be pressed to reset the actual number to zero. Check regularly this table and be sure to have spares for all elements. HumaStar 600 | User manual...

  • Page 123: Troubleshooting

    troubleSHootInG 9 TROUBLESHOOTING Instrument related problems can be classified into three groups: 1. Operation malfunctions with visual, acoustic or printed warnings. 2. Visible faults or problems. 3. Measurement inconsistencies (for example: GOT method with high disper- sion). 9.1 Messages and Warnings Self-explanatory messages are not included in the present listing.

  • Page 124: Measurement Inconsistencies

    If problem persists, replace standard and/or reagent. 2. Clean probe and check for cross contamination by changing the order of dis- pensing (“Time priority for reagents” parameter). Check proper probe wash- ing/clean probe. HumaStar 600 | User manual...
  • Page 125 troubleSHootInG 3. Check for exceeded method linear range; compare method definition with reagent specification. 4. Verify sample volume is not excessive. 5. Perform stray light verification, high range and low range linearity test, and dilution test. Kinetics with high dispersion or low linearity 1.
  • Page 126 3. Decrease parameter “minimal standard absorbance”. “Doubtful” flagged reaction This message appears when concentration after dilution is lower than meas- ured before dilution; it could be due a bubble, dirty probe or problem in reagent. HumaStar 600 | User manual...

  • Page 127: Appendix

    appendIx 10 APPENDIX 10.1 Technical Specification Up to 600 test/hr with 1 shot assays; Typical 450 tests/ TABLE 22 Throughput hr with 2 shot assays; plus 120 test/hr ISE (optional). Analysis Modes End point with sample or reagent blank. Factor or standard. Priority selection by sample (profile) or by reagent (batch).
  • Page 128 Instrument without 100 x 74 x 113 cm any components: Space required for 162 x 128 x 160 cm routine use: Packaging: 135 x 86 x 135 cm Weight: Gross: 250 kg, Net: 180 kg. HumaStar 600 | User manual...
  • Page 130 HumaStar 600 | User manual...
  • Page 132 HUMAN Gesellschaft für Biochemica und Diagnostica mbH Max-Planck-Ring 21 • 65205 Wiesbaden • Germany Tel.: +49 6122/9988 0 • Fax: +49 6122/9988 100 eMail: human@human.de • www.human.de...

Table of Contents