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humastar 80 user manual
humastar 80 user manual
| User Manual
Cat.No. 16880/1
Revision List of the Manual
No. DATE / Rev. REVISION DESCRIPTION
1 02-2005/01 Correction of text errors
2 09-2005/02 Adaptation to software release 1.07
3 03-2006/03 Adaptation to software release 1.08
4 05-2006/04 Revision of spare part list
5 07-2008/05 Adaptation to software release 1.09, new corporate design
6 10-2008/06 Adding description about Washsolution preparation
7 02-2009/07 Adaption of installation and maintenance procedure
8 04-2009/08 Adaption to software release 1.12c
9 09-2011/09 Correction dimension
10 05-2012/10 Washing, delivery, methods, troubleshooting
11 02-2013/11 Maintenance, software release 1.13a, flags,pump calibration
12 11-2014/12 Adding of System Wash Solution
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1 INTRODUCTION
This manual is considered as a part of the instrument; it has to be at the operator’s hand as well as at the
maintenance operator’s availability. For accurate installation, use and maintenance, please read the following
instructions carefully. In order to avoid instrument or personal damages, carefully read the ”GENERAL SAFETY
WARNINGS”, describing the suitable operating procedures. In case of breakdowns or any troubles with the
instrument, apply to the local Technical Service.
2 USER WARRANTY
HUMAN warrants that instruments sold by one of its authorised representatives shall be free of any defect in
material or workmanship, provided that this warranty shall apply only to defects which become apparent within
one year from the date of delivery of the new instrument to the purchaser.
The HUMAN representative shall replace or repair any defective item at no charge, except for transportation
expenses to the point of repair.
This warranty excludes the HUMAN representative from liability to replace any item considered as expendable in
the course of normal usage, e.g.: lamps, valves, syringes, glassware, fuses, diskettes, tubing etc.
The HUMAN representative shall be relieved of any liability under this warranty if the product is not used in
accordance with the manufacturer's instructions, altered in any way not specified by HUMAN, not regularly
maintained, used with equipment not approved by HUMAN or used for purposes for which it was not designed.
HUMAN shall be relieved of any obligation under this warranty, unless a completed installation / warranty
registration form is received by HUMAN within 15 days of installation of this product.
This warranty does not apply to damages incurred in shipment of goods. Any damage so incurred shall be re-ported
to the freight carrier for settlement or claim.
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5 DISPOSAL MANAGEMENT CONCEPT
The currently valid local regulations governing disposal must be observed. It is in the responsibility of the user to
arrange proper disposal of the individual components.
All parts which may comprise potentially infectious materials have to be disinfected by suitable validated
procedures (autoclaving, chemical treatment) prior to disposal. Applicable local regulations for disposal have to be
carefully observed.
The Instruments and electronic accessories (without batteries, power packs etc.) must be disposed of according to
the regulations for the disposal of electronic components.
Batteries, power packs and similar power source have to be dismounted from electric/electronic parts and disposed
off in accordance with applicable local regulations.
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.
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be
decontaminated/disinfected. Decontamination/disinfection should be performed by a authorised well-trained
personnel, observing all necessary safety precautions. Instruments to be returned have to be accompanied by a
disinfection certificate completed by the responsible laboratory manager. If a disinfection certificate is not
supplied, the returning laboratory will be responsible for charges resulting from non-acceptance of the instrument
by the servicing centre, or from authority’s interventions.
8 NOTICE
Every effort has been made to avoid errors in text and diagrams, however, HUMAN GmbH assumes no
responsibility for any errors which may appear in this publication. It is the policy of HUMAN GmbH to improve
products as new techniques and components become available. HUMAN GmbH therefore has to reserve the right
to change specifications if necessary in the course of such improvements.
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NOTICE
Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls
which should be considered at least potentially infectious. Therefore every part and accessory of the respective
instrument which may have come into contact with such samples must equally be considered as potentially
infectious.
BIOHAZARD
The „BIOHAZARD“ warning label must be affixed to instrument prior to first use with biological material !
Servicing Note:
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be decontaminated.
Decontamination should be performed by authorised well-trained personnel only, observing all necessary safety
precautions. Instruments to be returned have to be accompanied by a decontamination certificate completed by
the responsible laboratory manager. If a decontamination certificate is not supplied, the returning laboratory will
be responsible for charges resulting from non-acceptance of the instrument by the servicing centre, or from
authority’s interventions.
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 · 65205 Wiesbaden · Germany
| Tel.: +49 61 22/99 88-0 · Fax: +49 61 22/99 88-100
| e-Mail: tech-support@human.de · www.human.de
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Contents
1 Foreword 5
2 Unpacking and Installation 7
2.1 List of Contents 7
2.2 Main Component Identification 8
2.3 Installation and Location 11
2.4 Connection to Power Supply 12
2.5 How to Start 13
2.6 Re-Shipment 15
3 Description of the Instrument 17
3.1 Technical Specifications 18
4 Method of Operation 21
4.1 The Main Menu 21
4.2 Report 23
4.3 Utility 31
5 Editing Programs 34
5.1 How to Edit Test Methods 34
5.2 How to Edit Calibrators 40
5.3 How to Edit Controls 42
5.4 How to Edit Profiles 44
6 Workplan 45
6.1 Create Method List Window 47
6.2 Summary Table Window 48
6.3 Tray Setup 50
7 Stat Mode 51
8 Status Monitor 55
9 Reprocess Sample 57
10 Measurement Procedure and Calculation 58
10.1 End Point 58
10.2 Differential 63
10.3 Fixed Time and Multi-Fixed Time 66
10.4 Kinetic 67
11 Maintenance 69
12 Troubleshooting 74
13 Accessories and Replacement Components 79
14 APPENDIX 1 LIS INTERFACE 81
15 APPENDIX 2 CLEANING GUIDE 83
16 APPENDIX 3 Disinfecting the Instrument 85
17 APPENDIX 4 Massages about Results 87
18 APPENDIX 5 WEEE and RoHS Directives 88
19 Huma Star 80 SETUP MENU 90
WE RECOMMEND THAT YOU READ THIS MANUAL CAREFULLY BEFORE YOU BEGIN TO USE THE
INSTRUMENT. THAT WAY YOU WILL BE ABLE TO INSTALL AND MAINTAIN THE INSTRUMENT AND
PROGRAM THE OPERATIONS MUCH MORE EASILY AND YOU WILL GET THE MAXIMUM BENEFIT FROM
IT. BEFORE USING THE HUMASTAR 80 FOR TESTING SAMPLES, THE ENTIRE SYSTEM MUST BE
CALIBRATED FIRST BEFORE DEFINING, CALIBRATING AND VALIDATING METHODS.
[IVD]
IF YOU NEED FURTHER ASSISTANCE, PLEASE CONTACT YOUR LOCAL HUMAN DISTRIBUTOR OR HUMAN’S
TECHNICAL SUPPORT:
HUMAN Gesellschaft für Biochemica und Diagnostica mbH
Max-Planck-Ring 21
D-65205 Wiesbaden
Germany
e-Mail: tech-support@human.de
PLEASE ALSO VISIT OUR WEB PAGE: www.human.de
All rights reserved
FRONT VIEW
1) Model plate
2) Sample tray
3) Reaction wells
4) Wash station
5) Horizontal arm
6) Reagent rack
7) Reagent bottles (45 ml)
8) Waste and wash bottles
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REAR VIEW
1) Power socket
2) Fuses
3) Identification label
4) Waste outlet
LEFT VIEW
1) Power switch
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2.3 Installation and Location
Please take special care when installing and positioning this precision instrument.
Some of the components mentioned in the following sections are already assembled in the factory and are
mentioned here only for repair or maintenance. Please follow the instructions below.
The analyzer must be located in a dry place, free of corrosives. Ambient room temperature should not exceed 34°C.
The analyzer should not be placed near a source of electromagnetic radiation (e.g. motors, centrifuges, etc.) near a
source of heat, or in direct sunlight.
It must be located on a stable, flat surface of sufficient size; care should be taken that no objects obstruct the fan
exhaust. Leave at least 10 cm between the back of the analyzer and the nearest wall or object.
2.3.1 Installing the Sipper System and Cuvette
The sipper system consists of the flow cuvette, the peristaltic pump and the corresponding tubing. To install it
proceed as follows:
Insert the short end of the peristaltic pump tubing into the cuvette outlet adapter (A).
Screw the longer tube adapter (extending from the transfer arm) into the cuvette inlet adapter marked with an
arrow (B).
Connect the shorter tube extending from the arm to the right tube coming from the diluter (C).
Attach the peristaltic pump tubing by inserting the collars into the slots and winding the tube around the pump
rotor. Connect the tube to the waste bottle (D).
Connect the left tube coming from the diluter to the wash
bottle (E).
Connect the two connectors for the waste and wash bottles
to the red connectors on the rear panel; the red connector on
the left is for waste fluid; the black connector on the left is for
System Wash Solution.
Fix the two tank tubes into the black holder that are above
the red and black connectors as shown in the picture.
Place the cuvette into its lodging with the face marked with
an arrow towards the front of the analyzer. Tighten the screw
holding the cuvette.
Fill the wash bottle with little less than 0.5l of System Wash Solution, preperation see page II, 8 System Wash
Solution).
If the needles are protected by silicone tubes, remove them.
NOTE: When you fit the tubing into the peristaltic pump, do not twist it in order to avoid incorrect positioning
and do not stretch it excessively in order to avoid irreversible distortion.
Using the line voltage selector, select the voltage of your electrical supply.
Once the voltage has been set correctly, proceed as follows:
Check that the switch is in the OFF position (O).
Connect the power cable, first to the analyzer, then to the electrical supply.
Move the switch into the ON position (I).
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2.5 How to Start
Verify that the PC is connected to the analyzer; then turn on the PC and start the software by double-clicking the
icon “HumaStar 80”, which can be found on the desktop.
When the window (Main) opens, click on the Utility button and the instrument will initialise itself.
Prime Diluter:
In the utility window, click on Prime Diluter button.
The instrument begins to prepare the hydraulic circuit.
After the prime diluter operation, the service window and the utility window must be closed.
Wash circuit:
Cleaning the flow-thru cuvette
Perform the Wash Cuvette program. Wash with alcohol and deproteinizing agent to remove grease and
protein. Follow this washing sequence:
ALCOHOL 15 cycles
DEPROTEINIZER [perchloric acid (50%) or Wash Solution Concentrate (10% concentrated)] 15 cycles
DISTILLED WATER 20 cycles
When the window opens, click Yes and the self test will run.
After finishing, verify that there are no warnings or error messages in the window.
If there are any problems, please contact your HUMAN distributor.
If there are no problems, your instrument is ready to use.
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2.6 Re-Shipment
If the analyzer has to be re-shipped for any reason, or has to be moved involving the use of a transport vehicle, it is
important to use the original packaging to ensure that the instrument does not suffer any damage. The figure
shows how the analyzer and its accessories must be packed.
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Analysis modes
End point: 1 or 2 reagents
Differential
Fixed time
Kinetic
Multi-standard
Kinetic analysis
Absorbance measurements during the programmed interval
Linearity evaluation
Use of factor or calibrator
Calibration types
Factor
Single calibrator: for one test (specific) or for several tests (multiple)
Calibration curve
Calibration curve
Up to 8 standards
Axes: linear and logarithmic
Calculation functions: spline, linear regression, square regression, polygonal
Quality Control
Analytical limits control: blank, linearity, factor
Up to 3 control materials per test
Levey-Jennings / Shewart charts
Sample and reagent dispensing
Single-syringe pipetting up to 1000 µl (positive displacement), 1/16 µl steps
Sample volume range: 2 to 200 µl in 1/16 µl steps
Reagent 1 volume range: 30 to 1000 µl in 1/16 µl steps
Reagent 2 volume range: 0 to 1000 µl in 1/16 µl steps
Liquid detection: ohm resistive sensor
Temperature control
3 thermostated areas
Reagent pre-warmed in the transfer arm (+/-1°C)
Reaction mixture thermostated in the reaction wells to 37°C ± 2°C
Reaction mixture thermostated in the flow cuvette to 37°C ± 0.2°C
Optical system
Principle: interference filter
Readings: monochromatic or dichromatic
Filters wheel with up to 8 filters and automatic filter selection
Light source: halogen lamp (12 V, 20 W)
Detector: silicon photodiode
Absorbance range: -0.200 to 2.500 O. D.
Spectral range: 320 to 690 nm
Wavelength error: ± 2 nm
Bandwidth: 8 ± 2 nm
Resolution: 0.0001 O. D.
Precision: CV<1% @ 2.0 OD
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4 Method of Operation
Lamp Status area: in this area you can see the status of the lamp. Lamp could be off (stand by), warming up or
ready. When the lamp is warming up, it is shown the time needed to have the lamp ready. Lamp will be switched
off automatically if the instrument is in idle status according to lamp save option (available under setup). Press the
button with the lamp icon to turn on or off the lamp. When lamp is off, it will switched on automatically when
preparing a new workplan.
Under Session:
Work plan: Allows you to prepare the work list by entering the sample IDs and test you
want to perform on each sample. See also chapter 6.
Summary: Displays a summary table of the work session plan.
Tray setup: Displays a figure showing the samples and reagent trays and allows you to
enter the list and the position of reagents you want to use.
Start: Allows you to start the measurement session.
For information on the creation of a work plan, please see also Chapter 6 “Work plan”.
Under Report:
Patient data: Allows you to associate the ID sample with the patient’s name and consult the
patient database.
Quality Control: Displays the results of quality controls.
Result: Allows you to see the results of the analyses you are performing and those of
the previous sessions.
Regarding this section, please see also Chapter 4.2 “Report”.
Under Edit:
Method: Allows you to archive, view, edit and print the test methods.
Profile: Allows you to edit, view and print a group of analyses (e.g. liver, kidney, etc)
Calibrator: Allows you to do a calibration and enter the necessary data.
Control: Allows you to do quality controls on the instrument.
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4.2 Report
In the Sample ID column, the list of patient samples you have entered into the workplan will be displayed. To create
a link to a patient’s information, first check if the patient is already present in the database. This list is at the
bottom left. Enter the first letter of the surname into the space Surname in the upper left of the screen and click
Apply.
Click New if you want to enter a new patient; Modify (after you have clicked on the patient record in question) if
you want to make a modification; Delete if you want to delete a patient file.
The information that can be entered is: Surname, Name, Sex, Age, Address, Location, Physician and Notes.
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4.2.2 Quality Control
Click on Quality Control to open the Quality Control Manager. A window will open that is divided into two parts: in
the section on the left you can see the name of the test and the manufacturer; in the section on the right you can
see the number of controls and the lot number.
If you click on one test, the controls done since the test was entered will appear on the right-hand side. Click on one
of them and then click on View: A new window will open with the name of the test, the control number, the lot
number, the number of samples and the date (start and end) relative to the controls. A graph appears under these
data: choose the Cumulative graph in order to see the precision of the tests you are performing or the Shewart
chart in order to see the accuracy of the tests. In a small window to the right of the graph the data relevant to the
test will appear. If you click on one set of data, a square will appear around the icon. Under the graph, statistical
data will appear: average, SD, CV, minimum and maximum values.
Clicking Setup will open a new window. Click on the Set button in order to enter the data (Average and SD) from the
control leaflet. Otherwise, you can click on Calculate and enter the period you are interested in if you want the
instrument to calculate the average and the SD.
In the Session section choose whether to visualise all of the sessions performed by the instrument or just that day’s
sessions.
Double click the session you are interested in. Under Report choose either By patient, to view the patient samples
that have been analysed during the session, or By test, to see the tests performed during the session. Next, click on
a test or patient in the test/patient section and click View. A new window will open displaying the information on
the test or patient you have chosen.
Please note that if in the selected session samples are present that are out of linearity, the Sample out of linearity
window will appear immediately. See chapter 10 for more details.
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If Test is selected, the following test results will appear:
The available information is: number of wells, Patient ID, OD value, Well Result, Average OD (in the case of
replicates), the result. In the bottom part, the following buttons are present:
Calibration: clicking here will cause a window to open with information about the blank
and the standards. To modify a value, click on it to select it, then click on the
digit to be modified. Make the desired changes and click Apply. You can also
modify the kfactor by clicking on the k-factor section and then clicking Apply.
You can also exclude a value by clicking on it and then on the Except button. If
you want to include it again, click the Include button.
The available information is: number of wells, Patient ID, OD value, Well
Result, Average OD (in the case of replicates), the result. In the bottom part,
the following buttons are present:
Kinetic curve: displays the kinetic curve graph (see the following figure).
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Except: allows a selected result to be excluded from the calculation (for example, if
you think that a value is incorrect because there was a bubble was in the
cuvette). Clicking the button again will include the result again. To calculate
statistical parameters, choosing the start and end well under Batch statistic.
Save Ctrl: clicking here will save controls if the instrument is not configured to save
them automatically.
The available information includes: the test performed on the sample, the results, the unit, reference values and
the notes on the results (e.g. if the value is pathological).
Print: Prints all of the displayed results.
Reprocess: allows the sample to be reprocessed
Offline: allows an offline test to be entered into the list
To find the desired results, search criteria can be entered, such as a particular date to be searched for, the results, a
range of dates, a particular test or a patient’s name and/or surname. At least one of these parameters should be
entered to start the search.
If you remember only part of a patient’s surname, you can enter the part you remember followed by an asterisk ‘∗’:
the search engine will display all the results compatible with letters entered. For example, if you enter “Frank∗” in
the surname field, the search engine will display all related results including Franklin and Frankenheimer.
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4.3 Utility
4.3.1 Setup
Click the Setup button in the Main Menu to set up the printer.
4.3.2 Utility
Click this button to open the utility window below:
Initialise: The arm and the rotor will be moved to the correct start position.
Prime diluter: Diluter priming cycle will be performed. This is useful for filling the hydraulics, checking
hydraulics, or removing air bubbles from syringe.
Pump calibration: Compensates for wear of the peristaltic pump rubber; an autocalibration of the peristaltic
pump is recommended as an occasional service operation. Good values should be between:
1.2 – 1.5
Advanced: Opens a new window with additional utilities
4.3.3 Scheduling
This is a reminder for ordinary maintenance and operation.
4.3.4 Autodiagnosis
If you click on this button, all components and conditions inside the instrument are checked, such as temperature,
filter energy level, filter position, etc.
4.3.5 Setup
If you click on this button, you will open a windows which allows you to edit general settings for the instrument.
(to enter setup menu you need supervisor password).
In the Printer section, you can edit font size, line feed and welcome message for the printer.
In the Others section you find some service flag and some edit boxes to customise your instrument (installation
data). “Self initialize on power on” allows the instrument to initialise all the stepping motors when software is
turned on. “Enable lamp saving” allows the instrument to turn off the lamp when the instrument is not performing
any work session to increase its life. “Shutdown on exit” allows the instrument to turn off (or to turn off the
external PC) when software of the HumaStar 80 is closed.
The Edit boxes allow you to customise report printed by the instrument.
In the Photometer section there are some flags which concern instrument functioning during work session. “Print
initial O.D. reference values” enable automatic printing of reference values calculated at the beginning of each
session. “Auto save QC data” allows to save automatically results of control serums in the CQ archive. “Use primary
tubes” allows you to use primary tubes for samples instead of standard sample cup of HumaStar 80. “Automatic
optimisation of worklist” allows you to open summary module with optimisation flag enabled (see section 6 for
details about optimisation flag). “Load samples without stopping” avoid that instrument stop itself to ask for STAT
samples and reagents before performing STAT readings (see section 7 for more details about STAT).
In the Language section you can select language for the software.
In the Hardware section you can edit some parameters which concern communication with external pc and with
host computer (do not modify these parameters without calling service before).
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5 Editing Programs
The already-edited tests will be listed (the HUMAN tests pre-edited). The following buttons are available:
Minus sign: Removes a separator line.
Plus sign: Inserts a separator line.
View: Allows you to view the current parameters for the selected method.
Key: Allows the password to edit the tests to be entered.
Click the View button to open the Editing Test window. All of the parameters set for the selected test can be
viewed, but not modified. Click the Options button to open the Parameters options window. For a detailed
description of both windows, see below.
If you wish to edit a new test, modify an existing test or delete a test, you must be logged in as supervisor:
click the key icon and enter the password.
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The Method editor window will appear thus:
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Min. Conc.: Enter the minimum concentration. Every result below the minimum concentration displayed
as equal to this figure (e.g. if you enter 10 and the result obtained by the instrument is 8, the
shown result will shown as 10).
Replicate Blank: If checked, the blank reading will be repeated.
Water Blank (available only for End Point, Differential and Multistandard):
if checked allows you to execute blank reading aspirating a volume of distilled
water from Dilution bottle (position D). The volumes aspirated for blank
preparation depend on the test to be executed as explained in following table:
EP, MSD with 1 Takes a volume of R1 equal to the sum of Takes a volume of R1 equal to reagent
reagent. reagent volume and sample volume set for volume plus a volume of distilled water equal
the test to sample volume
EP, MSD with 2 Takes a volume of R1 equal to the sum of Takes a volume of R1 equal to reagent
reagent. Single reagent volume and sample volume set for volume plus a volume of distilled water equal
step preparation the test plus set volume of reagent R2 to sample volume plus set volume of R2
EP, MSD with 2 Takes a volume of R1 equal to the sum of Takes a volume of R1 equal to reagent
reagent. Two reagent volume and sample volume set. Add volume plus a volume of distilled water equal
steps preparation R2 volume after first incubation time to sample volume. Add R2 volume after first
incubation time.
DIFFERENTIAL, Takes a volume of R1 equal to the sum of Takes volume of R1 plus volume of distilled
MULTI-POINT reagent one and reagent two and a volume water equal to volume of R2 plus volume of
DIFFERENTIAL of sample equal to set sample volume for the sample
Single or two test
steps preparation
Preparation of sample remains the same with or without Water Blank (see section 10 for more details)
In the Calibration section, the following settings and options are available:
kfactor: If desired, the k-factor value for the measurements can be entered here.
Multiple: Choose this option to use the same calibrator for more than one test.
Specific: Choose this option to use a calibrator specific to one reaction.
In the edit box below, you can choose how often the calibration should be repeated.
N. standard: Enter the number of standards to be used.
Replicate: Enter the number of times the standard should be repeated.
Offset: If desired, enter a number you want to be added to all the results.
Concentrations: Enter the concentration(s) of the standard(s) you are going to use for the
calibration.
Decr. /Incr: Select “Decr” if the absorbance decreases with concentration (end point,
differential) or decreases over time (fixed time, kinetic). Select “Incr” if the
absorbance increases with concentration (end point, differential) or increases
over time (fixed time, kinetic).
Calculation Function: Choose the desired function for the results (i.e. spline, polygonal, etc).
X-Axis and Y-Axis: Choose the scale to be used for the calculations and graphics: linear or
logarithmic.
Cancel: Exit the window without saving the entered data.
Option: Opens the Parameters Options window.
Control Serum: Set up a quality control using control serum. The Control Serum window will
open.
Print: Print out the current settings.
OK: Save changes when all the parameters required for the test have been set.
In the Normal range section: low, high limits can be entered for male, female and child. In the window a
message can be entered for cases where the results are above or below the
limits.
In the Predilution and Postdilution sections, the predilution or postdilution ratios are chosen. In the postdilution
section, the linearity and absorbance limits are chosen.
Linearity limit: A message is generated when a concentration exceeds this limit. Type the value
of the linearity limit of the programmed test, expressed in concentration units
(0 to 99999). If this limit is not entered, the program will not perform the
check.
Absorbance limit: In kinetic and fixed time methods, when the first value read for the sample
exceeds a limit, an information message will be issued. Type the limit value of
absorbance (0.000 to 2.300) to detect hyperactive samples (substrate
depletion). It should be a minimum value for decreasing reactions and a
maximum value for increasing reactions. If this limit is not selected, the
program does not perform any check.
DILUTION
The analyzer is able to perform predilution and postdilution on samples, according to parameters set in the method
and to your setting in workplan module (see chapter 6 for more details).
PREDILUTION
Here you can set a predilution ratio for this method. Performing of predilution is however related to the sample,
not to the test. This means that just setting a predilution ratio for the method is not enough to perform it.
Predilution must be activated in workplan module (see chapter 6 for more details) for each sample which needs to
be prediluted: sample will be diluted according to the ratio specified for each test performed for this sample.
If sample is prediluted, results are calculated correcting concentration’s values according to predilution’s ratios of
each test performed on it.
POSTDILUTION
The post-dilution, if programmed for a specific test, is performed whenever a sample is outside of the reagent
linearity limit. In this case the instrument will enter the sample in a reprocess list. This list will be automatically
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post-diluted according to the post-dilution ratio of the method, and represented in the next workplan session as a
test to be reprocessed.
See the Reprocess Test section below (chapter 10).
Note 1 : The dilution ratio is in percent, so for example, 1:3 means dilution at 33%
Note 2 : Whenever a dilution needs to be performed, the diluent is taken from the diluent bottle container (D
position) in the reagent rack.
In this window reading parameters for control serums (frequency of reading, read control serum before the first
sample, read the control serum after the last sample) can be changed for the selected test. Clicking on an edit
button will open the Controls window, which can also be opened from the main menu (see section 5.3 for more
details).
Clicking on Calibrator in the Main Menu will open the calibrators window:
The calibrators that have been entered will be displayed. The following buttons appear in the window:
New: Allows a new calibrator to be entered. Enter the name and the lot of the new
calibrator.
Modify: Allows the name and/or lot of an already edited calibrator to be modified.
Select the calibrator to be modified and click Modify.
Change values: Opens the Calibrator values window. Click the name of the calibrator to which
values should be added and click Change values.
Delete: Deletes an edited calibrator
Cancel: Cancels the calibrator modifications
OK: Saves data entered for the calibrator
Exit: Closes the window after the calibrator values have been modified.
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Calibrator Values
Clicking Change values in the Calibrators window will display the Calibrators values window:
The name and lot of the calibrator you have chosen will be displayed. It will also appear in the list of tests that
require calibration (these have been chosen in the Editing test window) with the corresponding current name and
lot of the calibrator you are using.
If you wish to use the calibrator selected in the Calibrators window, click on the test, enter the concentration value
and click the OK button.
Exit: Closes window.
5.3
You will see the list of controls already set up. The following buttons appear in the window:
New: Allows a new control to be entered. After you have clicked this button enter the name and the lot
of the new control.
Modify: Allows the name and/or lot of an already edited control to be modified. Click the name of the
control to be modified and then click Modify.
Change values: Opens the Control values window. Click the name of the control for which for which values are to
be added and then click Change values.
Delete: Allows an edited control to be deleted.
Cancel: Click this button to abandon changes made to the control data.
Apply: Click this button to save the data on the particular control.
OK: Click this button to save all changes made to the controls.
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Controls Values
Clicking Change values in the Controls window will open the Controls values window:
The name and lot of the selected control will appear. The list of tests that require calibration (chosen in the Test
Edit window) with the corresponding current name and lot of the control you are using are also shown.
To use the control selected in the Controls window, click on the test, enter the concentration limit values (lower and
upper limit) and click the Apply button. If there are three levels of Control (Low, Medium and High), select one of
these three before entering the concentration limit values.
OK: Click this button to save changes made to the control values.
First, select one of the nine profiles. You can change the name of the profile in the box “Name” (e.g. liver, Profile 9).
It is possible to add one or more tests by selecting from the available tests. Click on the test(s) and then click Add. It
is also possible to remove or move one or more tests; select the test(s) and click Remove, Move up or Move down.
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45/93 Human HumaStar 80 User Manual
6 Workplan
Click the Work plan button in the Session section of the Main Menu window to open the Workplan manager:
In the table above, samples are listed in the rows and the type of test in the columns. Click on a sample to make
changes to the workplan. Choose the tests to perform on each sample by clicking them with the mouse or pressing
the space bar or enter on the keyboard.
The analysis profiles (e.g. liver) are also listed. There are nine configurable profiles. Select a sample and then click
on a profile: all of the tests currently associated with that profile will be run for that sample.
Under Method list, the following buttons are present:
New: Allows a new workplan to be created; clicking new will open the Create
Method List window.
Open: Allows already edited files for set up.
Edit: Allows the test displayed in the current workplan to be edited in the Create
Method List window. You can also open this window by clicking on the
background with right mouse button and clicking the box labelled “Edit
method list”.
Process: Clicking this button causes the program to generate a work list for the
work plan you have created using a particular algorithm to optimise the
instrument work. This operation is necessary to create the session work
list.
Exit: Close the Workplan manager without creating the worklist.
Import worklist: This function allows a worklist to be imported from an external PC. See
appendix 1 for more details.
Copy/Paste/Delete: Copies/pastes/deletes rows.
Calibrators: Opens the Calibrators window (see section 5.2 for more details).
Controls: Opens the Controls window (see section 5.3 for more details).
To allow Predilution for a sample, click with right mouse button on the label of the sample and select
Enable/Disable predilution. Sample will appear labelled with a blue P (see next picture). Perform same operation to
disable predilution on a sample.
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6.1 Create Method List Window
Clicking New in the Workplan manager window will open the Create method list window:
To select a method, you can drag and drop the method you are interested in from Methods available to Selected
methods with the mouse.
The following buttons are available:
Move up et Move down: Moves the selected method one space up or one space down.
Reset: Clears the Selected methods box.
Done: Click this button to save the methods under Selected methods in the method list.
Cancel: Exit without saving.
6.2
The Execution Sequence appears in the first column on the left and displays the type of test and whether the
analysis will be done on a sample, blank or standard, as well as the sample ID.
Under Calibrators the names of the calibrators and the volume required for each test are displayed.
Under Controls the names of the controls and the volume required for each test are displayed.
Under Sample Volume the sample ID is shown in addition to the volume necessary for the test.
Under Reagent Volume the names of the reagents and the volume required for each test are shown.
Modify button: Press this button to modify settings for one calibrator or one control. After you
have clicked the one of these you want to modify, press this button. If you
selected a calibrator, following window will appear:
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Click on calibration flag to select if you want to perform or to skip calibration for this test in current session. Your
choice won’t change general setting of the method. You can also choose how many replicates of calibrator you
want to perform in this section.
In this window you can modify, for this session only, settings of control’s reading for each test which have a control
to be read.
Cancel: Click this button to return to the main window without enabling the Tray Setup
button.
OK: Click this button to save your changes.
Print: Prints out the test sequence.
Reset: Starts the allocation of tests from the first reaction well.
Before clicking reset, remember to replace the used reaction well strips.
From Last: Click to start the allocation of tests from the last used reaction well.
Fix Sample Position check box: If checked, every sample will maintain the same position according to workplan line
number. If not the instrument will reassign the samples to save space.
Optimisation check box: If checked, the software will rearrange the scheduled execution sequence to
minimise execution time. A statistical approach is used to optimise the execution of
the end-point and differential tests: the order of execution will be changed to
minimise instrument dead time. Optimisation will delay the execution of any STAT
samples, because in this case the instrument will postpone STAT execution in
favour of scheduled tests in order to optimise execution time.
In the lower left corner of the window, the number of reaction strips needed to perform the scheduled tests is
displayed.
To select the position of the reagents in the reagent rack, click on a reagent and drag it into the desired position. To
assign the reagents in the right-hand column in the same order as displayed, click All.
Click Clear to remove all the reagents from the rack and restart the allocation from the beginning.
Click Load to restart from the last reagent rack layout.
Cancel: Exit without saving.
Print: Prints the window.
OK: When setup is complete, click OK and the software will process the worklist. When both
progress bars reach 100%, a message will indicate that the that the instrument is ready to
start the session. You can now click the START button in the Main window.
Pressing Zoom will display the enlarged image with a description of the samples (type, minimum volume and
sample ID).
Click Help to display the key explaining the colour coding used in the sample tray image
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7 Stat Mode
This section explains how the HumaStar 80 can be used perform emergency tests during the execution of a routine
session.
At any time while the instrument is working, click the STAT button in the main menu:
A workplan manager specifically for STAT sample programming will appear on the display.
Clicking Pause will cause the indicator next to the PAUSE box in the main window to change to green (indicates the
instrument is preparing to enter pause mode. When the instrument enters pause mode, the indicator will change
to red.
When the instrument has performed the necessary operations to enter pause mode, the arm returns to the home
position and a message announces that the instrument is in pause mode:
click RESUME when you are ready to continue the session.
Just remember that too long a pause could cause the instrument to read a test outside of its stability time.
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The instrument behaves similarly when during the execution of a test it encounters an error, such as the following:
- A sample cup is empty or not present.
- A reagent bottle is empty or not present.
- A reaction strip has not been loaded so the instrument cannot find the solution to be read (and probably
has dispensed the solution under the sample tray through the hole).
- The wash tank is empty.
- The waste tank is full.
If one of these events occurs, the instrument will stop and a message will indicate the reason for the problem so
that it can easily be resolved. Clicking RETRY will cause the instrument to continue the execution of tests.
In the upper left corner of the window, information on the current status of the instrument and STAT mode is
displayed. In this case “No sample” is displayed because no STAT samples have been requested.)
The image in the middle of the window represents the sample tray. For information on a particular sample, click on
the corresponding numbered circle in the image to select it and then click the Info button on the right: a message
window will display all of the information on the sample. In the same way, information on a reaction well can be
viewed: if the test is kinetic, the reading of the test can be followed in real time by observing the image, which is
continuously updated. The next picture shows an example:
Using the same button (Info) information can be displayed for any reagent bottle: select a reagent from the
corresponding column (blue rectangles) and then click Info. A window will display the current level of reagent in
the bottle.
The Help button displays the key which explains the meaning of each colour used in the figure.
The Sequence button opens a window that lists all the operations performed by the instrument during the test
session: the coloured row indicates the operation currently being executed.
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9 Reprocess Sample
A reprocess test is a test that needs to be rerun (reprocessed) either because it is outside of the reagent linearity
limit or because the user has activated the function. In this case the test will be marked with an -RR- flag. This
indicates that the test it has been entered into the reprocess list and is scheduled to be rerun in the next workplan
session.
The reprocessed test will be automatically postdiluted and corrected by the postdilution ratio. The result will
automatically replace the old result that was, for example, out of linearity in the original session.
If a sample result is outside of the linearity limit, the instrument will display a window similar to this one:
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S: Sample
R1: Reagent 1
R2: Reagent 2
INC 1: First incubation time
INC 2: Second incubation time
Tasp: Aspiration time
ST: Stability time
OD: Absorbance measurement
ODn: Absorbance measurement at n seconds
INC 1 OD INC 1
OD
Read interval
S+R1 R2 Tasp
Stability
INC 1 INC 2
OD
Flow cell
TWO REAGENTS
st
1 incubation = INC 1
nd
2 incubation = INC 2
Reaction curve
S+ R1 ( + R2 )
Tasp INC2
INC 1
OD1 ODn
Reaction well Flow cell
st
During the 1 incubation time no reading is taken.
Reaction curve
S+ R1 ( + R2 )
Tasp INC2
INC 1
OD1 OD2
Reaction well Flow cell
nd
The reaction is followed for the entire duration of the 2 incubation time, with sampling done once per second. For
result calculation, only the initial and end point value are used.
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For differential mode, several combinations are possible. See figure below
Fig. 10.4 - DIFFERENTIAL AND MULTI-POINT DIFFERENTIAL MODE
INC 1 INC 1
OD OD
BLANK SAMPLE
st
1 incubation = INC 1
nd
2 incubation = Empty
BLANK SAMPLE
st
1 incubation = INC 1
nd
2 incubation = INC 2
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10.1.4 Calculations in end point mode
In the case of bichromatic readings, the absorbance value used in the calculation for blank, calibrators and samples
is the difference between the absorbance measured at the main wavelength and the absorbance measured at the
reference wavelength.
A s , A b , A calib = A main wavelength –A Ref wavelength
If a factor is used, the concentration of each sample is calculated using the following formula:
C s = (A s -A b ) x K fact x RT
If a single calibrator is used, the concentration of each sample is calculated using the formula used above for
calculations using a factor, but F is obtained in the following way:
C calib
Kfact =
Acalib − Ab
If several calibrators are used, the concentration of each sample is calculated using a calibration curve obtained
using the selected calculation function and axes. A calibration curve is generated using the programmed
concentration values for the calibrators and the absorbances measured for each one:
(A calib - A b ) x RT
The concentration of the samples is then calculated by interpolation of their absorbances in a curve:
(A s - A b ) x RT
With replicates, the use up to three replicates can be selected for each sample, calibrator or control. The blank is
always run for as many times as replicates have been programmed for the calibrators. In the calculations, replicates
are treated thus:
First of all the mean value of the blank is calculated:
1 n
meanAb = ∑ Ai
n i =1
The mean absorbance of the blank is then subtracted from each individual absorbance measured for calibrators
(if used) and samples. The values obtained are used in the calculation of the sample concentration:
A s ou calib - mean A b
If calibrators are used, the mean absorbance value for each calibration is obtained as follows:
1 n
meanAcalib = ∑ ( Acalib − meanAb )i
n i =1
The mean absorbance values of the calibrators are then used in the calculations (see description of single calibrator
or several calibrators) to obtain the sample concentrations.
Finally, the mean concentration value of each sample is calculated:
1 n
Cs = ∑ Ci
n i =1
10.2 Differential
For this analysis method, 2 reagents are used, reagent 1 for the sample blank and reagent 2 for the overall reaction.
Each reaction mixture is incubated in a separate well and the absorbance of each one is measured at one specific
time. The calibration can be based on the use of calibrators (one or more) or on a programmed factor.
10.2.1 Procedure in Differential and Multi-Point Differential Mode
The sample or calibrator is pipetted together with the first reagent into a reaction well (see Fig. 11.4). The same
sample or calibrator is pipetted together with the second reagent into a separate reaction well. The reaction
mixtures are incubated for the programmed period of time. Each mixture is then transported to the cuvette and,
after the stabilisation time has elapsed, the absorption is measured. Note that the time required to transfer the
C calib
Kfact =
( AR 2 calib − AR1calib ) − ( AR 2b − AR1b )
If several calibrators are used (only for Multi-Point Differential mode), the concentration of each sample is
calculated using a calibration curve, which is obtained using the selected calculation function and axes. A
calibration curve is prepared using the programmed concentration values for the calibrators and the absorbances
measured for each one:
[(A R2calib - A R1calib )-(A R2b – A R1b )] x RT
The concentrations of the samples are then calculated by interpolation of their absorbances in the curve:
[(A R2s - A R1s )-(A R2b – A R1b )] x RT
In the case of the replicates, up to three replicates can be programmed for each sample, calibrator or control. The
blank is always run for as many times as replicates have been programmed for the calibrators. Replicates are
treated in the calculations in the following way:
First of all the mean value of the blank is calculated:
1 n
mean( AR 2b − AR1b ) = ∑ ( AR 2b − AR1b )i
n i =1
The absorbance difference of each sample or calibrator (when used) replicate is calculated in this way:
A R2s or calib - A R1s or calib
The mean value of the blank difference of absorbance is then subtracted from each individual absorbance
difference calculated for samples and calibrators (when used). The values obtained are used to calculate the
sample concentration:
(A R2s or calib - A R1s or calib ) – mean (A R2b –A R1b )
( AR 2b − AR1b )
If calibrators are used, the mean absorbance value for each calibrator is obtained as follows:
1 n
meanAcalib = ∑ [( AR 2calib − AR1calib ) − mean( AR 2b − AR1b )]i
n i =1
The mean absorbance values of the calibrators are then used in the calculations (See description using factor ,
single calibrator or several calibrators) to obtain the sample concentrations.
Finally, the mean concentration value of each sample is calculated:
1 n
Cs = ∑ Ci
n i =1
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10.2.3 Procedure for subtractive differential mode
The subtractive differential test is a modality for which it is zeroed the effect added by adding R2.
Theorically, every time the R2 is added you have a dilution effect and a photometric offset added by
it, that should not be consider as part of the reaction. Practically, in most of the case this effect is
near to zero, and is effect on the final result is null, so the standard differential test it is enough. But
in some case it may be needed to use the differential subtractive method to overcome this problem.
For this test, you need to have 2 reagent bottls, one containing the reagent 1 (called R1), the second
containing a mixing of reagent 1 and reagent 2 (according to the kit), called R2.
Number 2 blank wells are prepared before start sampling. Reagent 1 blank (BLK1) , and Reagent 2
blank (BLK2).
BLANK1 = VolR1(R1) + VolSmp(H2O)
BLANK2 = VolR2(R2) + VolSmp(H2O)
That is the designed quantity for R1 is taken by R1 bottle, plus the designed quantity of sample
volume is taken by the dilution bottle. In this case the dilution bottle should contain distilled water
or fisiologic solution.
The sample, control and calibrators are prepared in this way:
SAMPLE BLK = VolR1(R1) + VolSmp(Smp)
SAMPLE = VolR2(R2) + VolSmp(Smp)
The reading is taken after the 1st incubation time is elapsed.
Either if you are working against factor os standard (in this case the factor is calculated using the
input standard concentration), calculation are as follows:
[A]= O.D. value of BLANK1 = VolR1(R1) + VolSmp(H2O)
[B]= O.D. value of BLANK2 = VolR2(R2) + VolSmp(H2O)
[C]= O.D. value of SAMPLE BLK = VolR1(R1) + VolSmp(Smp)
[D]= O.D. value of SAMPLE = VolR2(R2) + VolSmp(Smp)
In the case of using a single calibrator, the concentration of each sample is calculated using the
formula used above for calculations using factor, but F is obtained in the following way:
C calib
Kfact =
( AT 2 calib − AT 1calib ) − ( AT 2b − AT 1b )
If several calibrators are used (only for Multi-Fixed Time), the concentration of each sample is calculated using a
calibration curve obtained using the selected calculation function and axes. A calibration curve is prepared using
the programmed concentration values for the calibrators and the differences between the absorbances obtained
for each one:
[(A T2calib – A T1calib )-(A T2b – A T1b )] x RT
The concentrations of the samples are then calculated by interpolation of their absorbances in the curve:
[(A T2s - A T1s )-(A T2b – A T1b )] x RT
In the case of replicates, up to three replicates can be used for each sample, calibrator or control. The blank is
always run for as many times as replicates have been programmed for the calibrators. Replicates are treated in the
calculations in the following way:
First of all, the mean value of the blank is calculated:
1 n
mean( AT 2b − AT 1b ) = ∑ ( AT 2b − AT 1b )i
n i =1
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The absorbance difference of each sample or calibrator (when used) replicate is calculated in this way:
A T2s or calib - A T1s or calib
The mean value of the blank difference of absorbance is then subtracted from each individual absorbance
difference calculated for samples and calibrators (when used). The obtained values are used to calculate the
sample concentration:
( AR 2b − AR1b )
(A T2s or calib - A T1s or calib ) – mean (A T2b –A T1b )
If calibrators are used, the mean absorbance value for each calibrator is obtained as follows:
1 n
meanAcalib = ∑ [( AT 2calib − AT 1calib ) − mean( AT 2b − AT 1b )]i
n i =1
The mean absorbance values of the calibrators are then used in the calculations described in cases where a factor is
used, using a single calibrator or several calibrators, to obtain the sample concentrations.
Finally, the mean concentration value of each sample is calculated:
1 n
Cs = ∑ Ci
n i =1
10.4 Kinetic
The kinetic mode is used to measure catalytic activity concentration. The absorbance of the reaction mixture is
measured 3 times during the programmed total period of incubation. A single reagent must be used for this
procedure. You can base calibration on the use of calibrators (one or more) or on a programmed factor.
If a factor is used, the concentration of each sample is calculated using the following formula:
∆A ∆A
C s = − × Kfact × RT
min s min b
C calib
Kfact =
∆A ∆A
−
min calib min b
In the case of replicates, up to three replicates can be used for each sample, calibrator or control. The blank is
always run for as many times as replicates have been programmed for calibrators. Replicates are treated in the
calculations in the following way:
1. First, the mean value of the blank is calculated:
∆A 1 n ∆A
mean = ∑
min b n i =1 min b i
2. The mean value of the blank rate is then subtracted from each individual rate calculated for the samples and for
the calibrators (if used). The obtained values are used in the calculations (See description of the factor, single
calibrator ) to obtain the samples concentrations:
∆A ∆A
− mean
min sorcalib min b
1 n
Cs = ∑ Ci
n i =1
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11 Maintenance
In order to ensure optimal operation of this instrument, it is necessary to follow some minimal maintenance rules.
1. Never use detergents or abrasive products for cleaning the outside of the instrument. Use only a cloth
with water and neutral soap.
2. Avoid the penetration of liquid into the inner part of the instrument. If liquid is spilled into the
instrument, clean it with damp paper or cloth.
4. Close the plexiglass cover when not in use in order to avoid dust infiltration.
DAILY:
Work with the plexiglass cover closed. This ensures better temperature stability and avoids dust
infiltration.
Use tensioactive in your distilled water as System Wash Solution. This will avoid needle obstruction and
increase washing efficency. System Wash Solution, preperation see page II, “8 System Wash Solution”.
Cleaning the flow-thru cuvette
Cleanliness of the flow-thru cuvette is a must. You have to clean externally and internally. Internal
cleaning is needed when you are experiencing air bubbles inside the cuvette.
For a proper maintenance proceed as follows:
to clean the inner part, use UTILITY -> WASH CUVETTE program.
Wash with alcohol and deproteinizing agent to remove grease and protein. Follow this washing sequence.
ALCOHOL 5 cycles
DEPROTEINIZER (Wash additive, 1:2000) 5 cycles
DISTILLED WATER 10 cycles
Empty the washing well at the end of each working day.
Close the plexiglass cover at the end of each working day.
WEEKLY:
Cleaning the flow-thru cuvette
Cleanliness of the flow-thru cuvette is a must. You have to clean externally and internally. Internal
cleaning is needed when you are experiencing air bubbles into the cuvette.
For a proper maintenance proceed as follows:
to clean the inner part, use UTILITY -> WASH CUVETTE program.
Wash with alcohol and deproteinizing agent to remove grease and protein. Follow this washing sequence.
Place a bottle filled with alcohol in the position 2 of the reagent rack.
Place a bottle filled with sodium hypochlorite (concentration 6-10 %), deproteinizer (perchloric acid (50%))
or Wash additive (1:2000) in the position 1 of the reagent rack.
Place a bottle filled with distilled water in the position D of the reagent rack. (See Appendix 2 for an
illustration of the bottle setup.)
Turn on the instrument and press “Utility” button. Press “Wash circuit” button.
Set 5 cycles for position 2, 1 and 10 cycles for position D. Press Ok and wait for the execution.
Depending on the samples and reagents used, the three solutions suggested for position 1 can be more or
less effective. Please choose the solution which works best for the conditions in your laboratory.
If necessary you can also increase the number of cycles to 15 cycles for alcohol and the solution in position
1. In that case set 20 cycles for distilled water.
Press “Prime Diluter” button and wait for the execution. Empty manually the washing well and execute
again “Prime diluter”.
Perform autodiagnosys.
Perform peristaltic pump auto calibration.
MONTHLY:
Perform volume auto-calibration
Perform cuvette internal washing with perchloric acid followed by distilled water.
AS REQUIRED (suggested for Service Engineers):
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CLEANING NEEDLES
Remove the 3 screws fixing the arm case (A) (Fig.1).
Detach the connector that links the two led with the main board (Fig.2).
Detach the connector that comes from the axle from the main board (Fig3).
Fig.1
Fig 2 Fig.3
Unscrew the connectors and detach the teflon tubing from the needles (Fig.3).
In order to clean the Dispensing Needle, put the cleaning needle tool with RED cover inside of the straight needle,
starting from the bottom part (Fig. 4).
Pass inside and outside the cleaning needle tool and take off the dust.
Attach the connector on the main board.
Attach the teflon tubing to the needles, fully introducing them, and screw the connectors again.
Re-assembling the arm casing.
Fig.4
1. Verify the belt tension. By rotating the driving pulley, its movement be fully transmitted to the
pulley axle.
PRE-HEATER
1. Its maintenance consists only on checking the proper status of the pre-warming channel and the tray.
ARM MECHANISM
1. Verify the tension of the belt in charge of the horizontal and vertical movements.
DILUTER MECHANISM
2. Clean and lubricate the revolving screw (use oil S.A.E.:30 or similar, W-40)
OPTICAL SYSTEM
PIPETTING SYSTEM
4. Check the needles. Verify that they are properly aligned. Change if they are damaged.
Check the priming tube. Check for obstructions or change in its diameter.
Change in that case.
SIPPING SYSTEM
12
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73/94 Human HumaStar 80 User Manual
Troubleshooting
Aspiration needle: facing the instrument, the aspiration needle is on the left. It has the wider aperture and is cut
at an angle.
Dispensing needle: facing the instrument, the dispensing needle is on the right. It has a smaller aperture and
a pointed tip.
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TUBING DIAGRAM
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reagent - If the module works correctly, check if there are
problems with the tubing and if there is enough
System Wash Solution in the container.
The probe does not dispense the solution into the - Check the diluter valve, syringe
reaction well - Use washing program to purge the syringe.
- Check if there is enough System Wash Solution in the
container
- Check all the tubing
The test using a 3 µl sample size is not re- - Check the sampling probe. If it is dirty, clean it. If there
producible are scratches on it, replace it.
- Check the flow cell; clean it if necessary.
Poor aspiration into the flow cell. - Check whether the aspiration probe may be dirty or
blocked.
- Check the tubing.
- Check the movement of the aspiration arm.
- Check if the probe is positioned correctly
The peristaltic pump works correctly but the - Check the tubing between the well and the valve.
washing well is not emptied. - Check the valve.
- The silicon tube inside the peristaltic pump may be
damaged or badly adjusted.
- Check the peristaltic pump tubing
The analyzer cannot perform auto-zero. Too-low - Check if the micro-flow cell is empty, in case fill it with
voltages are obtained after resetting. water.
- Check the peristaltic pump tubing and change them if
necessary.
- Check the aspiration probe and its connection with cell.
- There may be some leakage or air bubbles in the cell or
the probe could be dirty.
- The sampling of distilled water could not be correctly
executed during the resetting.
- Check if the System Wash Solution container is empty.
- Check the peristaltic pump valve.
- Check if the photometer lamp is burnt out.
- Adjust the aspiration volume; it could be too high or
low.
The results of the controls are out of range. - Check whether the controls are being analyzed
according to the manufacturer’s instructions.
- Check if the parameters settings (wavelengths,
temperature, sample volume, reagent volume, factor)
are correct.
- Check if the water used for the controls is bidistilled or
deionised.
- Check if the reagents, controls and standards have
been prepared according to the manufacturer’s
instructions.
- Check whether the recommended System Wash
Solution has been used.
Kinetics test results are to low - The cell or the reagent is contaminated and bacteria
may be inhibiting the reaction. Clean the cell or change
the reagent container.
- Check whether the correct factor has been used. Check
the temperature and the volume that have been set.
- Check which water, reagents, control serum and
System Wash Solution have been used.
- Check the filter.
- Check whether the reagent has expired, has been open
too long, or has not been correctly stored.
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13 Accessories and Replacement Components
Please contact HUMAN or your local HUMAN distributor if any component of the analyzer is not functioning
properly or if you need consumables, such as sample and reaction wells or reagent bottles. Always use original
materials and order any part by its cat. no. For details please consult you local Human Distributor.
RS-232
Analyzer
PC with instrument
application software
RS-232
Weekly maintenance
Weekly washing
Please see chapter 11 (Maintenance) for details of the weekly
washing procedure.
Extraordinary maintenance
Extraordinary washing
Place a bottle filled with chloridric acid (concentration
10%) in the position 1 of the reagent rack. Place a bottle
filled with distilled water in the position D of the reagent
rack. Turn on the instrument and press “Utility” button.
Press “Wash circuit” button and set 5 cycles for position 1
and D. Press Ok and wait for the execution.
Needle cleaning
Errors
ERROR MEANING
“NV” Result is not valid because OD is negative or not available, or blank OD value is
negative or not available or sample blank OD is negative or not available or average
OD is outside curve for multistandard, multifixedtime and multidifferential methods
“STD Error” OD value of the standard is negative or curve for multistandard, multifixedtime,
multidifferential is not monotone
“Blank Error” No valid OD value for blank
“Conc. Error” OD value of the well is not available or it is outside the curve for Multistandard,
MultiFixedTime, Multipoint Differential. (The curve of multi-standard calibration is
extrapolated slightly beyond the highest/lowest standard concentration.)
“Excepted” Well has been excepted from calculation by the user
“No volume” No solution inside well when aspiration. Well invalid
FLAG MEANING
* Result is under lower limit or over higher limit (normal range) for the test
H Result is over highest point of multistandard calibration curve
L Result is under lowest point of multistandard calibration curve
R Sample reprocessed
-RR- Sample will be reprocessed
M Result has been modified
C Result has been corrected with correlation algorithm
Our company also assures that no one of the materials listed by RoHS Directive (2002/95/05) is used to build and
assemble our instruments.
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19 Huma Star 80 SETUP MENU
User can access “Setup” menu of HumaStar 80 pressing button “Setup” in main window and inserting correct
password. Through this menu user can modify general settings for the instrument.
“Setup” window is composed by a series of menu: each one allows to change some settings
After modifications have been performed, the user can validate them pressing the button “OK” or annul them
pressing the button “Cancel”
PRINTER MENU
Printer Menu allows to change settings
of the external printer.
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For each software module use can set Font Size, Line Space (distance between each row), Margin (distance from left
border of the sheet), Font Type. “Restore default” button restore factory settings.
OTHERS MENU
“Self initialize on power on”: if this box is flagged
instrument will automatically perform
initialization when software is opened (of course
instrument should be on)
“Enable lamp saving”: if this box is flagged,
software will automatically turn off the lamp if
the instrument is left in idle for more than the
time chosen in the list below. Possible settings
are: 5 minutes, 15 minutes, 30 minutes, 1 hour, 2
hours.
“Automatic Pump Calibration Check”: with this
list user can set frequency for automatic check of
the pump calibration performed at the beginning
of the session. Possible settings are: No
(instrument does not perform the check), Daily
(instrument perform one check each day), Each
session (instrument performs the check at the
beginning of each session). At the end of this
check, if the pump calibration value is different
from the current one the instrument will get new
value as valid, if it is inside correct range, or stop
the session if the check value is outside the
range. This last case means that instrument has
problem in aspiration function.
“LIS: do not send Demography to host”: if this
box is flagged, software does not send patient
data when results export is performed
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LANGUAGE MENU
With this menu user can select language
for software messages and button labels.
User should select the language in the list
and press “Apply” button.
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HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 · 65205 Wiesbaden · Germany
| Tel.: +49 61 22/99 88-0 · Fax: +49 61 22/99 88-100
| e-Mail: human@human.de · www.human.de