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User Manual

!"#$%&$'()*

Cat.-No.: 16880/1
!
,-./%/01(2/%3(04(3!-(561762

No. DATE / Rev. REVISION DESCRIPTION


01 February 2005 Correction of text errors
02 September 2005 Adaptation to software release 1.07

+
++
/13,08793/01
This manual is considered as a part of the instrument; it has to be at the operator’s hand as well as at the main-
tenance 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.

7%-,(:6,,613;
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 ac-
cordance 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 regis-
tration 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.

!"#$%
/13-18-8(7%-(04(3!-(/1%3,75-13(!"#$%
The instrument has to be used for the expected purposes and in perfect technical conditions, by qualified per-
sonnel, in working conditions and maintenance operations as described in this manual, according to the
GENERAL SAFETY WARNINGS. This manual contains instructions for professional qualified operators.

+++
=-1-,62(%64-3;(:6,1/1=%
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 ventilation.
The instrument should be installed on a stationary flat working surface, free from vibrations.
Do not operate in area with excessive dust.
Work at room temperature and humidity, according to the specifications listed in this manual.
Do not operate this instrument with covers and panels removed.
Only use the power cord specified for this product, with the grounding conductor of the power cord connected to
earth ground.
Use only the fuse type and rating specified by the manufacturer for this instrument, use of fuses with improper
ratings may pose electrical and fire hazards.
To avoid fire or shock hazard, observe all ratings and markings on the instrument.
Do not power the instrument in potentially explosive environment or at risk of fire.
Prior to cleaning and/or maintaining the instrument, switch off the instrument and remove the power cord.
For cleaning use only materials specified in this manual, otherwise parts may become damaged.
It is recommended always to wear protective apparel and eye protection while using this instrument.
Respective warning symbols, if appearing in this manual, should be carefully considered.

8/%>0%62(5616=-5-13(9019->3
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.

/1%3,75-13(8/%/14-93/01
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 authorized 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.

103/9-
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.

+<
9013-13%

? 40,-:0,8 @
A 71>69B/1=(618(/1%362263/01 C
2.1 List of Contents 4
2.2 Main Component Identification 5
2.3 Installation and Location 8
2.4 Connection to Power Supply 9
2.5 How to Start 10
2.6 Re-shipment 12
@ 8-%9,/>3/01(04(3!-(/1%3,75-13 ?@
3.1 Technical Specifications 14
C 5-3!08(04(0>-,63/01 ?D
4.1 The Main Menu 17
4.2 Report 19
4.3 Utility 26
E -8/3/1=(>,0=,65% A)
5.1 How to Edit Test Methods 28
5.2 How to Edit Calibrators 34
5.3 How to Edit Controls 36
5.4 How to Edit Profiles 38
F :0,B>261 @G
6.1 Create Method List Window 41
6.2 Summary Table Window 42
6.3 Tray Setup 43
D %363(508- CC
) %3637%(501/30, CD
G ,->,09-%%(%65>2- CG
?* 5-6%7,-5-13(>,09-87,-%(618(96297263/01 E*
10.1 End Point 50
10.2 Differential 55
10.3 Fixed Time 56
10.4 Kinetic 57
?? 3,07H2-%!003/1= EG
?A 699-%%0,/-%(618(,->269-5-13(905>01-13% FA
WE RECOMMEND THAT YOU READ THIS MANUAL CAREFULLY BEFORE YOU BEGIN TO
USE THE INSTRUMENT. IN THIS 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.

!"#$%

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: human@human.de

PLEASE ALSO VISIT OUR WEB PAGE: www.human.de

All rights reserved

2/64 User Manual HumaStar 80


?( 40,-:0,8
First, we would like to thank you for purchasing the HumaStar 80. Our analyzer is very easy to use and we are
sure that it will be a useful addition to your laboratory.
This instrument has been designed to perform spectroscopic measurements at predetermined wavelengths of
analyte concentration and enzyme activity using various reagents. You can perform any combination of tests up
to 54 samples per work plan. The analyzer automatically performs all reagent and sample pipetting, incubation,
photometric measurements and calculations. Programming and operating the analyzer is simple and made
easier by Windows™. The software supplied with the analyzer should be installed on a PC connected to the
instrument.
This sophisticated software allows you to program and permanently store in the memory of your PC an almost
unlimited number of tests, up to 9 test profiles, calibrators and controls. You can create a routine work plan by
assigning patients data and tests and/or profiles to sample. Once the results have been obtained, you can
request reports organised per patient or per test or examine the quality-control data.
The analyzer can perform end-point (one or two reagents, monochromatic or dichromatic), differential mode,
fixed time and kinetic mode measurements. Calibration can be done using a factor or using calibrators. Up to
nine standards/calibrators can be programmed. If several calibrators are used, you can select your preferred
calculation function (polygonal, spline, regression line, regression parabola), scale (linear or logarithmic), and
study the calibration curve.
Samples can be distributed in up to three racks containing 24, 18 or 12 positions each. Up to 20 reagents (plus 1
container for dilution) can be distributed in one row (changing of a single reagent container or of the entire plate
in the analyzer should be performed manually). The program automatically distributes in racks the reagents
required for a work plan and indicates the minimum required volume of each one. There is also the possibility to
program the reagents in fixed rack positions.
The program includes a complete range of analytical controls allowing you to flag abnormal results: linearity limit,
blank absorption limit, kinetic blank limit, factor (obtained from calibration) limits and reference interval. Up to
three different control materials (per test) can be included in the work plan. Quality control results can be
permanently stored and can be examined as a list, in Levey-Jennings chart format, or in a Shewart chart.

User Manual HumaStar 80 3/64


A( 71>69B/1=(618(/1%362263/01
Please read this chapter carefully before installing the instrument. First, check that the packaging is undamaged
and that the seals are intact. Do not throw the packing material away because you could need it in case of re-
shipment.

AI?( 2+J&(KL(9KM&NM&J
This is the list of items that you should find upon unpacking the instrument:

The HumaStar 80 analyzer


A box containing accessories
A sheet with instructions for unpacking
Contents of box:
2 Reagent racks
1 Sample tray
40 Reagent bottles of 45 ml
40 Caps for reagent bottles
50 Reaction wells segment
500 Sample cup of 1.2 ml
20 Kodak cups for the R2- of 2,5ml
2 pages of reagent labels
1m tube for external tank
1 Halogen lamp 12V 20W
2 fuses of 5 A
A standard power cable
2 cleaning needles
Tube kit
Wash station
1 software CD
1 layout diskette
User manual
A section of the case (to be placed under the arm)

4/64 User Manual HumaStar 80


AIA( 5$+M(9K#OKMNM&(/PNM&+L+Q$&+KM

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

User Manual HumaStar 80 5/64


REAR VIEW
1) Power socket
2) Fuses
3) Identification label
4) Waste outlet

6/64 User Manual HumaStar 80


RIGHT VIEW
1) Serial port

LEFT VIEW

1) Power switch

User Manual HumaStar 80 7/64


AI@( /MJ&$RR$&+KM($MP(2KQ$&+KM
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.

AI@I?( /MJ&$RR+MS(&TN(%+OON'(%UJ&N#($MP(9"<N&&N
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 wash fluid.
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 less then 0.5l of water. For each litre of water, add 300µl wash additive (cat. no. 18971).
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.
After use, do not remove the tubing from the pump. The analyzer keeps it filled with water to prevent it from
drying.

8/64 User Manual HumaStar 80


AI@IA( /MJ&$RR+MS(&TN(:$JT(%&$&+KM
The wash station should simply be placed into its lodging, located in the upper part of the case. Before using the
station, ensure that it is clean and that it does not contain any dust particles or other materials that could obstruct
the needles.

AI@I@( /MJ&$RR+MS(&TN(%$#ORN(3'$U
To install the sample tray proceed as follows:
Mount the tray on its axle, taking care that the two stems in the axle fit into the holes located in the central part of
the tray.
Fix the tray to the axle with the screw provided with the analyzer.

AI@IC( /MJ&$RR+MS(&TN(,N$Q&+KM(:NRRJ
The reaction wells should be placed around the outside ring of the sample tray, taking care to insert the stems
into the corresponding slots.

AI@IE( /MJ&$RR+MS(&TN(,N$SNM&(,$QVJ
The reagent rack can be loaded with up to 21 reagent bottles. Take care that the rack is properly fixed in the
correct position.

AIC( 9KMMNQ&+KM(&K(>KWN'(%"OORU
It is very important to connect the analyzer to a good electrical system. If possible, it should be on its own circuit
and the outlet must definitely be grounded.
If a malfunction occurs (program crashes, sporadic re-starts, etc.), check that the unit is not near machinery
containing motors or electromagnets, which can generate strong electrical noise. In such a case, move the
analyzer as far away as possible from such equipment.

Installation category (over-voltage category): II.


The analyzer is able to work at the voltages:
- 110-230 V +/- 15%
- 50/60 Hz

NOTE: Working beyond the tolerance limits will cause the instrument to function incorrectly and the analyzer
may be damaged.

Change the fuses according to the following table:

NOMINAL FUSE VELOCITY


230V 5A F
115V 5A F

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).

User Manual HumaStar 80 9/64


AIE( !KW(&K(%&$'&
Verify that the PC is connected to the analyzer; then turn on the PC and start the software by double-clicking the
icon “HumaStar 80”, which can be found on the desktop.
When the window (!"#$% opens, click on the &'#(#') button and the instrument will initialise itself.

In the utility window, click on *+#,-./#(0'-+ button.

The instrument begins to prepare the hydraulic circuit.


After the prime diluter operation, the service window and the utility
window must be closed.

10/64 User Manual HumaStar 80


In the Main window, click on the 10'23#"4$25#5 button.

When the window opens, click 6-5 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.

User Manual HumaStar 80 11/64


AIF( ,NXJT+O#NM&

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..

12/64 User Manual HumaStar 80


@( 8-%9,/>3/01(04(3!-(/1%3,75-13
The instrument is composed of the following parts:

7",8(-.'+")
The sample tray has 54 numbered holes, each one able to hold a sample well. The sample well can contain a
sample, calibrator or control.

9-":'#2$.;-((5
The reaction wells surround the sample tray. There are 12 rows of 12 wells each, resulting in 144 available
reaction wells. The use of new disposable reaction wells is recommended.
The reaction wells have a maximum useful capacity of 1 ml and have been designed to make the mixture of the
sample with the reagent during the pipetting as easy as possible.
The reaction well holder is thermostated.

<+"$5=-+."+,
The transfer arm is fixed to the analyzer by means of an axle. The arm moves up, down and horizontally on its
axis during operation.
The transfer arm has two needles: the needle on the right aspirates reagent and sample and dispenses
them into the reaction well; the needle on the left will later aspirate the liquid from the reaction well and
transport it to the flow cuvette. The reagent aspirated by the right needle is thermostated while it is inside
the tubing inside the arm.
The needle unit is retractable to avoid damage in case the unit is bumped. The arm will return to the
standby position.

9-"4-$'.>2''(-5."$3.+":?5
The capacity of the reagent bottles is approx. 45 ml. The bottles fit into the supplied reagent racks. Each rack
accepts up to 20 reagent bottles + 1 diluent bottle.
Two racks are supplied with the instrument, although only one of them can be mounted in the instrument
at one time.
The program will automatically distribute the reagents needed for a work plan in the minimum number of
racks. Each reagent must be placed in the position in the rack indicated by the software.

/#58-$5#$4
The dispensing circuit consists of the dispensing needle (on the right), the thermostating block, the syringe with
the needle and the wash station. The syringe has a maximum capacity of 1000 µl, in 1 µl steps.

The dispensing circuit is filled with water. When dispensing, the transfer arm moves to the reagent and the
plunger of the syringe retracts to aspirate. The arm then moves to the sample and again aspirates. Finally,
the arm moves to the reaction well and the plunger of the syringe moves downward, dispensing the
aspirated liquids. During this process, the needle is washed in the wash station after each aspiration of
liquid.

User Manual HumaStar 80 13/64


@"5A.5'"'#2$
It consists of a removable plastic cuvette located in the upper part of the case. The wash station is filled
with water when the instrument is started and is used to wash the external surface of the needles as well
as to wash the sipper circuit and cuvette.

7#88-+.5)5'-,
The system consists of the thicker needle, the tubing connecting the needle to flow cuvette and the tubing
connecting the cuvette to the waste bottle through the peristaltic pump tubing. The peristaltic pump
performs the job of sipping and transporting the liquids to be measured.

B8'#:"(.5)5'-,
The instrument is equipped with a filter photometer. The filter wheel holds up to seven filters with one free
position. A stepping motor executes the selection and positioning of the filter.
The light beam passes through the input optics where it is focussed, and after passing through the cuvette
through the selected interference filter . The light beam finally reaches the photodiode, where it is converted to
an electrical signal, and so read by the electronics.
The optical system is slightly inclined to facilitate the elimination of bubbles that may appear in the flow cuvette.

@I?( 3NQTM+Q$R(%ONQ+L+Q$&+KMJ
C-$-+"(.:A"+":'-+#5'#:5
Processing capacity: up to 54 positions (including samples, calibrators and controls) per tray in a work plan.
Incubation 1: 21 to 9999 s
Incubation 2: 0 to 180 s
Unlimited duplicates for blanks, calibrators and samples
Calibration storing
Patient data (name, age, sex, etc. ) files – demography data base
QC

7",8(-.'+")
Sample cup capacity: 1.2 ml maximum
Tray capacity: 54 cups for samples, calibrators and controls

9-"4-$'.'+")
Tray capacity: 20 reagent bottles of about 45 ml

9-":'#2$.;-((5
12 rows with 12 wells each
Reaction well capacity: 1 ml maximum

9-5-+D2#+5
Wash bottle: 0.5 l
Waste bottle: 0.5 l
There is also the possibility to connect to an external waste tank. It is necessary to disconnect the Tygon tube
from the Waste Bottle and to attach it to the white connector to the left of the bottles. It is then necessary to
connect the tube found in the accessory box to the blue connector on the base of the instrument.

*+24+",,#$4
Tests: unlimited
Profiles: Up to 9 with an unlimited number of tests
Calibrators
Controls
Filters
Reagents

14/64 User Manual HumaStar 80


1$"()5#5.,23-5
End point: 1 or 2 reagents
Differential
Fixed time
Kinetic
Multi-standard

E#$-'#:."$"()5#5
Absorbance measurements during the programmed interval
Linearity evaluation
Use of factor or calibrator

F"(#>+"'#2$.')8-5
Factor
Single calibrator: for one test (specific) or for several tests (multiple)
Calibration curve

F"(#>+"'#2$.:0+D-
Up to 8 standards
Axes: linear and logarithmic
Calculation functions: spline, linear regression, square regression, polygonal

G0"(#').F2$'+2(
Analytical limits control: blank, linearity, factor
Up to 3 control materials per test
Levey-Jennings / Shewart charts

7",8(-."$3.+-"4-$'.3#58-$5#$4
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

<-,8-+"'0+-.:2$'+2(
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

B8'#:"(.5)5'-,
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

<+"$5=-+.5)5'-,
Continuous flow system with peristaltic pump
Capacity of the cuvette flow: 18 µl
Automatic calibration

User Manual HumaStar 80 15/64


*F.,#$#,0,.+-H0#+-,-$'5
The instrument should be connected to a personal computer which fulfils the following minimum requirements:
- Processor 2GHz
- RAM 256 Mbytes
- Hard Disk capacity 20 Gbytes
- Operating system: Windows™ 98, 2000 or XP
- Floppy Disk Drive for 3.5” 1.44 Mbytes disks
- CD-ROM drive

Output: serial port


External printer

*A)5#:"(.3#,-$5#2$5
- 450 (width) x 720 (length) x 750 (height) mm
Weight: 45 kg

I(-:'+#:"(.+-H0#+-,-$'5
115/230 VAC (! 15%) (autodetect)
50/60 Hz
350 VA

155#5'"$:-.'2.05-+5
Automatic selection of the calibrators and controls required for a work plan
Automatic selection of the reagents required for a work plan
Dialogue screens (Windows) for programming, preparing work plans, presenting reports, etc.
Automatic on-screen alert messages

C+"8A5
Calibration and kinetic curves
Quality control (Levey-Jennings)

16/64 User Manual HumaStar 80


C( 5-3!08(04(0>-,63/01
CI?( 3TN(5$+M(5NM"

Click on the HumaStar 80 icon to open the main menu:

The following icons are available:

Under 7-55#2$:

@2+?.8("$J.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.
70,,"+)J.Displays a summary table of the work session plan.
<+"). 5-'08: 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.
7'"+': Allows you to start the measurement session.

For information on the creation of a work plan, please see also Chapter 6 “Work plan”.

Under 9-82+':

*"'#-$'.3"'": Allows you to associate the ID sample with the patient’s name and consult the patient database.
G0"(#').F2$'+2(: Displays the results of quality controls.
9-50('J 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”.

User Manual HumaStar 80 17/64


Under I3#':

!-'A23: Allows you to archive, view, edit and print the test methods.
*+2=#(-: Allows you to edit, view and print a group of analyses (e.g. liver, kidney, etc)
F"(#>+"'2+: Allows you to do a calibration and enter the necessary data.
F2$'+2(: Allows you to do quality controls on the instrument.

For information on how to edit a method or a profile, please see also Chapter 5 “Editing”.

Under &'#(#'):

7-'08: Allows you to enter the user’s customised settings, such as language and printer.
&'#(#'): Allows you to perform service on the instrument, such as maintenance, etc. It may be used only by an
expert technician.
7:A-30(#$4J.Allows you to schedule maintenance on the instrument (what parts and how often). Once you have
set this data, a window will open when you turn on the instrument to remind you of the maintenance that must be
performed. In this section, you can also enter all of the maintenance operations you or a technician has
performed, with comments.
10'23#"4$25#5J Allows you to perform an automatic diagnosis of the entire system (both electronic and
mechanical components).

Regarding this part, please see also Chapter 4.3 “Utility”.

The 7'"'05 icon: Allows you to see which session the instrument is performing and gives you information about
the wells, including current temperature.
Above, two indicators can be found: the first one shows the STAT status (off if no STAT sample has been
requested, green if a STAT sample has been requested but the instrument is still performing routine tests, red if
the instrument is performing STAT tests), the second one shows the PAUSE mode (off if no pause has been
requested, green if a pause has been requested but the instrument is still working, red if the instrument is
paused).
The 7<1< icon: Allows you to analyse urgent samples during a routine session. The steps to be followed are the
same as for a routine workplan (see chapter 7 for more details).
The 7A0'32;$ icon: Shuts down the program.
The K-+5#2$.box displays the current software version installed on the instrument (or on the PC).

18/64 User Manual HumaStar 80


CIA( ,NOK'&

CIAI?( >$&+NM&(P$&$

Clicking the *"'#-$'./"'" button in the Main Menu will open the following window:

User Manual HumaStar 80 19/64


In the 7",8(-. L/. 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 70+$",- in the upper left of the screen and
click 188().
If the patient’s name is found in the list on the left, a click on the patient record will provide all of the relevant
data, which will appear automatically on the right. Click on the M#$? button and all the data will appear in the
upper table.
If the patient is not present in the database or if you want to modify data on a patient already entered, click the
/"'">"5- button.

Click N-;.if you want to enter a new patient; !23#=).(after you have clicked on the patient record in question) if
you want to make a modification; /-(-'- if you want to delete a patient file.
The information that can be entered is: Surname, Name, Sex, Age, Address, Location, Physician and Notes.

20/64 User Manual HumaStar 80


CIAIA( Y"$R+&U(9KM&'KR

Click on G0"(#').F2$'+2(.to open the G0"(#').F2$'+2(.!"$"4-+. 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 K#-;: 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 F0,0("'#D- graph in order to see the precision of the tests you are performing or the
7A-;"+' 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 7-'08 will open a new window. Click on the 7-' button in order to enter the data (Average and SD) from
the control leaflet. Otherwise, you can click on C"(:0("'- and enter the period you are interested in if you want
the instrument to calculate the average and the SD.

User Manual HumaStar 80 21/64


CIAI@( ,NJ"R&

Clicking on the 9-50('5 button in the Main Menu will open the 9-50(' window:

In the 7-55#2$ 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 9-82+' choose either *"'#-$', to view the patient samples
that have been analysed during the session, or <-5', to see the tests performed during the session. Next, click
on a test or patient in the test/patient section and click K#-;O.A new window will open displaying the information
on the test or patient you have chosen.
Please note that if in the selected session samples are present that are out of linearity, the 7",8(-. 20'. 2=
(#$-"+#').window will appear immediately. See chapter 10 for more details.

22/64 User Manual HumaStar 80


If <-5' 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:

*"'#-$'. (#5': gives you the possibility to see the list of the patients of that session. If you click one L/ and then
K#-;, you can see the tests performed on that ID. There is also the possibility to print test results.

7"D-.F'+(J clicking here will save controls if the instrument is not configured to save them automatically.

!23#=).5'"$3"+3: clicking here will cause a window to open with information about the blank and the standards.
To modify a value, click on it to select it, then click on the digit to be modified. Make the desired changes and
click 188(). You can also modify the ?=":'2+ by clicking on the k-factor section and then clicking 188(). You can
also exclude a value by clicking on it and then on the IP:-8' button. If you want to include it again, click the
L$:(03- button.

User Manual HumaStar 80 23/64


E#$-'#:.:0+D-:.displays the kinetic curve graph (see the following figure)

*+#$' prints the results.

IP:-8': 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 Q"':A.5'"'#5'#:O

If you choose to list by patient, the following window appears:

24/64 User Manual HumaStar 80


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).
*+#$': Prints all of the displayed results.
9-8+2:-55J.allows the sample to be reprocessed
B==(#$-J allows an offline test to be entered into the list
!23#=)J allows a selected result to be modified
9-5'2+-.K"(0-5J restore all the modified results

The R#$3.button in the result window opens the results search engine window:

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.

User Manual HumaStar 80 25/64


CI@( 7&+R+&U

CI@I?( %N&"O
Click the 7-'08 button in the Main Menu to set up the printer.

CI@IA( 7&+R+&U
Click this button to open the 0'#(#') window below:

L$#'#"(#5-: The arm and the rotor will be moved to the correct start position.
*+#,-. 3#(0'-+: 1 diluter priming cycle will be performed. This is useful for filling the hydraulics, checking
hydraulics, or removing air bubbles from syringe.
@"5A. :0D-''-: Will perform an aspiration with the peristaltic pump through the cuvette. Can be used if the
peristaltic pump needle is dirty or blocked and the instrument does not have good aspiration from the peristaltic
pump. Sodium hypochlorite (10% solution in water) is a good washing solution.
K2(0,-. :"(#>+"'#2$: Only perform this kind of calibration if you are experiencing too-high dead volume in the
reagent bottles or if a washing cycle is not efficient (because of too-high residual volume left in the washing well).

26/64 User Manual HumaStar 80


*A2'2,-'-+.:A-:?: Checks the manual functioning of the photometer.
*0,8.:"(#>+"'#2$: 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: 0.8 – 3.5
7-+D#:-: Click this button to access the service menu (special maintenance). This operation requires a password
and is for authorised persons only.

CI@I@( %QTNP"R+MS
This is a reminder for ordinary maintenance and operation.

CI@IC( 6"&KP+$SMKJ+J
If you click on this button, all components and conditions inside the instrument are checked, such as
temperature, filter energy level, filter position, etc.

User Manual HumaStar 80 27/64


E( -8/3/1=(>,0=,65%
EI?( !KW(&K(-P+&(3NJ&(5N&TKPJ
Click !-'A23 in the I3#' section of the 5$+M(5NM" to open the !-'A23.-3#'2+.window :

The already-edited tests will be listed (the HUMAN tests pre-edited). The following buttons are available:

!#$05.5#4$: Removes a separator line.


*(05.5#4$: Inserts a separator line.
K#-;: Allows you to view the current parameters for the selected method.
E-): Allows the password to edit the tests to be entered.

Click the View button to open the I3#'#$4. <-5' window. All of the parameters set for the selected test can be
viewed, but not modified. Click the B8'#2$5 button to open the *"+",-'-+5. 28'#2$5 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.

28/64 User Manual HumaStar 80


The !-'A23.-3#'2+ window will appear thus:

Three new buttons are available:


N-;: Allows new tests to be edited. A new screen will appear in which the parameters associated with the test
can be entered.
!23#=)J. Changes the parameters of an already edited test. Select a file name from the list of edited tests and
then click this button.
/-(-'-: Deletes an edited test to be deleted. Select a file name from the list of edited tests and then click this
button.

Clicking N-; will open the window 5N&TKP(R+J&JI(Here the method for the test can be chosen.

User Manual HumaStar 80 29/64


Once it has been chosen, the -P+&+MS(&NJ& window will appear (the same window will appear when the Modify
button is clicked):

In the <-5'.box, the following dialogue boxes are present:


/-5:+#8'#2$: Enter the name of the test in this field.
!"$0=":'0+-+: Enter the name of the test kit manufacturer here.
<-5'.L/: Enter the test ID.
*25#'#2$: The position of the test in the Test List will appear automatically in this field.
IP8#+-: Enter the expiry date of the test kit you are using.
!23-: The test method will appear automatically..
N2'-: Enter notes about the test.

In the @"D-(-$4'A.section the following information may be entered:


R#('-+S: The first wavelength needed for the test.
R#('-+T: The possible second wavelength needed for the test.

In the K2(0,-5.U"(%.section, the following information may be entered:


7",8(-: Enter the required sample volume.
9-"4-$'.S: Enter the required volume of reagent 1.
9-"4-$'.T: Enter the required volume of reagent 2.

In the 9-"3#$4.*"+",-'-+5.section the following information can be entered:


5'
S .L$:0>"'#2$: Enter the sample incubation time for the rack.
$3
T .L$:0>"'#2$: Enter the sample incubation time for the photometric cell.
7'">#(#'): Enter the period of time during which the absorbance resulting from the reaction remains unchanged.
7",8(-.9-8(#:"'-: Enter the number of repeat measurements you want for each sample.

In the 9-50('5.section, the following printing options are available:


!-"50+-.0$#'5: Choose the measurement units for the results.
NO.3-:#,"(: Enter the number of decimals for the results.
!#$O.F2$:.: Enter the minimum concentration. Every result below the minimum concentration displayed as equal
to this figure (e.g. if you enter 10 and the result obtained by the instrument is 8, the shown result will shown as
10).
9-8(#:"'-.Q("$?: If checked, the blank reading will be repeated.

30/64 User Manual HumaStar 80


In the F"(#>+"'#2$.section, the following settings and options are available:
?=":'2+: If desired, the k-factor value for the measurements can be entered here.
!0('#8(-: Choose this option to use the same calibrator for more than one test.
78-:#=#:: 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.
NO.5'"$3"+3: Enter the number of standards to be used.
9-8(#:"'-: Enter the number of times the standard should be repeated.
B==5-': If desired, enter a number you want to be added to all the results.
F2$:-$'+"'#2$5: Enter the concentration(s) of the standard(s) you are going to use for the calibration.
/-:+. VL$:+J. 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).

F"(:0("'#2$.R0$:'#2$:.Choose the desired function for the results (i.e. spline, polygonal, etc).
WX1P#5..and.6X1P#5.J..Choose the scale to be used for the calculations and graphics: linear or logarithmic.
F"$:-(: Exit the window without saving the entered data.
B8'#2$: Opens the >$'$#N&N'J(0O&+KMJ window.
F2$'+2(.7-+0,: Set up a quality control using control serum. The 9KM&'KR(%N'"# window will open.
*+#$': Print out the current settings.
BE: Save changes when all the parameters required for the test have been set.

EI?I?( >$'$#N&N'J(0O&+KMJ(W+MPKW

Click B8'#2$ in the -P+&(&NJ& window to open the following window:

In the N2+,"(.+"$4- section: low, A#4A 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 *+-3#(0'#2$ and *25'3#(0'#2$ sections, the predilution or postdilution ratios are chosen. In the postdilution
section, the linearity and absorbance limits are chosen.
M#$-"+#').(#,#': 1.,-55"4-.#5.4-$-+"'-3.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.

User Manual HumaStar 80 31/64


1>52+>"$:-. (#,#': when the blank value exceeds a limit, an information message will be issued. Type the limit
value of absorbance (0.000 to 2.300) for the blank. It should be a minimum value for 3-:+-"5#$4 reactions and a
maximum value for #$:+-"5#$4 reactions. If this limit is not selected, the program does not perform any check.

DILUTION
The analyzer is able to perform pre-dilution and post-dilution on samples according to the programming of the
method.

PREDILUTION:
If pre-dilution is programmed for a specific test, every time a sample is required for that specific test it will be
diluted according to the dilution ratio programmed.
Note that the pre-dilution does not affect the result. This means that the absorbance of the result will not be
corrected by the dilution factor.

POST-DILUTION:
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
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).

1K&N(?Z The dilution ratio is in percent, so for example, 1:3 means dilution at 33%
1K&N(AZ Whenever a dilution needs to be performed, the diluent is taken from the diluent bottle container (D
position) in the reagent rack.

In the FA-:?.K"(0- section, the following parameters should be set:


!#$#,0,. "$3. ,"P#,0,. ?X=":'2+: This applies only to tests using one or several calibrators and where
concentration is linearly related to the absorbance measurement. After performing a test the instrument
calculates a factor to transform the measured signal into concentration values. If selected, a message will be
displayed when the factor value is outside of the limits. Enter the maximum and the minimum values for this
factor (0 to 99999). If it is not selected, the program does not perform any check.
@"5A#$4: In this field, enter the number of required washings.
IP'+".;"5A#$4J.this check box allows an extra washing for needles between dispensing into the reaction well and
the next preparation cycle.
F"$:-(: Exits without saving the setup data.
9-5'2+-: Restores the initial settings.
BE: Saves the current parameters.

32/64 User Manual HumaStar 80


EI?IA( 9KM&'KR(%N'"#(:+MPKW

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 F2$'+2(5.window, which can also be opened from the main menu (see section 5.3 for more
details).

User Manual HumaStar 80 33/64


EIA( !KW(&K(-P+&(9$R+['$&K'J
Clicking on F"(#>+"'2+ in the 5$+M(5NM" will open the :"(#>+"'2+5 window:

The calibrators that have been entered will be displayed. The following buttons appear in the window:
N-;: Allows a new calibrator to be entered. Enter the name and the lot of the new calibrator.
!23#=): Allows the name and/or lot of an already edited calibrator to be modified. Select the calibrator to be
modified and click !23#=).
FA"$4-.D"(0-5: Opens the 9$R+['$&K'(<$R"NJ window. Click the name of the calibrator to which values should
be added and click FA"$4-.D"(0-5.
/-(-'-: Deletes an edited calibrator.
F"$:-(: Discards changes to a calibrator.
BE: Saves data entered for the calibrator. IP#': Closes the window after the calibrator values have been
modified.

34/64 User Manual HumaStar 80


9$R+['$&K'(.$R"NJ
Clicking FA"$4-.D"(0-5 in the 9$R+['$&K'J(window will display the F"(#>+"'2+5.D"(0-5 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 Test Edit window) with the corresponding current name and
lot of the calibrator you are using.
If you wish to use the calibrator selected in the 9$R+['$&K'J( window, click on the test, enter the concentration
value and click the BE button.
F"$:-(: Click this button to discard changes to the calibrator.
IP#': Closes window.

User Manual HumaStar 80 35/64


EI@( !KW(&K(-P+&(9KM&'KRJ

Clicking F2$'+2( in the Main Menu will open the :2$'+2(5 window:

You will see the list of controls already set up. The following buttons appear in the window:
N-;: Allows a new control to be entered. After you have clicked this button enter the name and the lot of the
new control.
!23#=): 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.!23#=).
FA"$4-.D"(0-5: Opens the Control values window. Click the name of the control for which for which values are
to be added and then click.FA"$4-.D"(0-5.
/-(-'-: Allows an edited control to be deleted.
F"$:-(: Click this button to abandon changes made to the control data.
188(): Click this button to save the data on the particular control.
BE: Click this button to save all changes made to the controls.

36/64 User Manual HumaStar 80


9KM&'KRJ(<$R"NJ

Clicking FA"$4-.D"(0-5 in the Controls window will open the F2$'+2(5.D"(0-5 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 :2$:-$'+"'#2$.(#,#' values
((2;-+ and 088-+ limit) and click the 188() button. If there are three levels of Control (M2;, !-3#0, and Y#4A),
select one of these three before entering the concentration limit values.

F"$:-(: Click this button to abandon changes made to the control.


BE: Click this button to save changes made to the control values.

User Manual HumaStar 80 37/64


EIC( !KW(&K(-P+&(>'KL+RNJ

Click on *+2=#(- in the Main Menu to open the *+2=#(-.I3#'2+:

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
133. It is also possible to remove or move one or more tests; select the test(s) and click 9-,2D-, !2D-. 08 or
!2D-.32;$.

38/64 User Manual HumaStar 80


F( :0,B>261
Click the @2+?.8("$ button in the 7-55#2$ section of the 5$+M(5NM" window to open the @2+?8("$.,"$"4-+:

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 $M$RUJ+J(O'KL+RNJ (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 !-'A23.(#5', the following buttons are present:


N-;: Allows a new workplan.to be created; clicking new will open the F+-"'-.!-'A23.M#5'(window.
B8-$: Allows already edited files for set up.
I3#'J.Allows the test displayed in the current workplan to be edited in the F+-"'-. !-'A23. M#5' window. You can
also open this window by clicking on the background with right mouse button and clicking the box labelled “Edit
method list”.
*+2:-55: Clicking this button causes the program to generate a work list for the work plan you have created
using a particular algorithm to optimise the instrument work. This operation is necessary to create the session
work list.
IP#': Close the W2+?8("$.,"$"4-+ without creating the worklist.

Other buttons present in this window are:


N-;.'">(-: Click this button to create a new table.

User Manual HumaStar 80 39/64


L/.#$5-+'J.This button opens the *"'#-$'.3"'".window, which allows you to enter an ID for the samples you have
scheduled.

L,82+'. ;2+?(#5'J This function allows a worklist to be imported from an external PC. See appendix 1 for more
details.
F28)V*"5'-V/-(-'-J Copies/pastes/deletes rows.
F"(#>+"'2+5J Opens the F"(#>+"'2+5 window (see section 5.2 for more details).
F2$'+2(5J Opens the F2$'+2(5 window (see section 5.3 for more details).

40/64 User Manual HumaStar 80


FI?( 9'N$&N(5N&TKP(2+J&(:+MPKW
Clicking N-; in the @2+?8("$.,"$"4-+ window will open the F+-"'-.,-'A23.(#5' window:

To select a method, you can drag and drop the method you are interested in from !-'A235."D"#(">(- to 7-(-:'-3
,-'A235 with the mouse.

The following buttons are available:


!2D-.08.and.!2D-.32;$J.Moves the selected method one space up or one space down.
9-5-': Clears the 7-(-:'-3.,-'A235 box.
/2$-: Click this button to save the methods under 7-(-:'-3.,-'A235 in the method list.
F"$:-(: Exits without saving.

User Manual HumaStar 80 41/64


FIA( %"##$'U(3$[RN(:+MPKW
Click 70,,"+) in the main menu to display the results obtained by processing the data in the @2+?8("$
,"$"4-+O

The IP-:0'#2$ S-H0-$:- 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 F"(#>+"'2+5 the names of the calibrators and the volume required for each test are displayed.
Under F2$'+2(5 the names of the controls and the volume required for each test are displayed.
Under 7",8(-.K2(0,- the sample ID is shown in addition to the volume necessary for the test.
Under 9-"4-$'.K2(0,-.the names of the reagents and the volume required for each test are shown.

!23#=): Modifies a selected sample, calibrator, control or reagent.


F"$:-(: Click this button to return to the main window without enabling the <+").7-'08 button.
BE: Click this button to save your changes.
*+#$': Prints out the test sequence.
9-5-': Starts the allocation of tests from the first reaction well.
Before clicking reset, remember to replace the used reaction well strips .
R+2,.M"5': Click to start the allocation of tests from the last used reaction well.
R#P.7",8(-.*25#'#2$.check box: If checked, every sample will maintain the same position according to workplan
line number. If not the instrument will reassign the samples to save space .
B8'#,#5"'#2$ 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.

42/64 User Manual HumaStar 80


FI@( 3'$U(%N&"O
Click the <+").5-'08 button in the Main Menu to open the *("'-5 window:

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 1((.
Click F(-"+.to remove all the reagents from the rack and restart the allocation from the beginning.
Click M2"3 to restart from the last reagent rack layout
F"$:-(J.Exit.without saving.
*+#$': Prints the window.
BEJ.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
7<19< button in the Main window.
Pressing Z22, will display the enlarged image with a description of the samples (type, minimum volume and
sample ID).
Click Y-(8.to display the key explaining the colour coding used in the sample tray image.

User Manual HumaStar 80 43/64


D( %363(508-
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.

44/64 User Manual HumaStar 80


Add the desired STAT samples by selecting free positions on the sample tray and schedule the tests. Every
STAT ID is preceded by the letter E (for emergency). If a test is not already present in the workplan, right-click
on the background and select the box labelled “Edit method list”. Use the Method List window to modify the test
for the worklist (refer to section 6 for more details). If the test is not the first STAT called during the current
routine session, the previously allocated rows will still be present, but disabled. This serves as a reminder how
many STAT samples have been performed previously and prevents any ID overlapping.
When you are finished entering information, click BE; the 70,,"+) window will appear on the screen. Most
buttons are disabled, but the *+#$'.and !23#=).buttons are enabled in case it is necessary to make changes to
calibrators or controls. Click BE to open the *("'-5. window: make sure that all of the reagents are correctly
allocated and click BE to process the worklist. A message will indicate that the STAT sample (s) will be analyzed
as soon as possible. STAT samples are labelled with a yellow triangle with a red exclamation point inside.
Returning to the main window, the indicator next to the STAT box will be green: this means that the instrument is
still processing pending tests before executing the STAT reading. Remember that if in the 70,,"+) window you
chose to optimise end-point test execution, STAT samples will be processed later than without optimisation,
because optimisation rearranges the test execution in order to minimise time and instrument cannot interrupt
routine execution as quickly.
When the instrument is ready, a message box will ask you to load the samples and reagents.
When ready, click the START button: the instrument will perform the STAT sample reading and the STAT
indicator will now be red. Before and after the execution of STAT mode the instrument washes the needles and
tubing to prevent any contamination.
When the instrument has processed all of the STAT samples, it automatically resumes the routine session from
the point where it left off. It is possible to enter as many STAT tests as necessary; the only limitation is the
number of free positions available on the sample tray.

PAUSE and ERROR Handling

If you need to stop the instrument temporarily (for example because sample cups were forgotten), click the
7<B* icon in the main window (the same button as the 7<19<. icon, which changes depending on the
instrument’s status).
When the button is clicked the following window appears:

User Manual HumaStar 80 45/64


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 9I7&!I 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.

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 9I<96..will cause the instrument to continue the execution of tests.

46/64 User Manual HumaStar 80


)( %3637%(501/30,
<A-.7'"'05.!2$#'2+.window displays information on reagents, samples and reaction wells:

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 L$=2 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:

User Manual HumaStar 80 47/64


Using the same button (L$=2% information can be displayed for any reagent bottle: select a reagent from the
corresponding column (blue rectangles) and then click L$=2. A window will display the current level of reagent in
the bottle.
The Y-(8 button displays the key which explains the meaning of each colour used in the figure.
The 7-H0-$:-. button opens a window that lists all the operations performed by the instrument during the test
session: the coloured row indicates the operation currently being executed.
<A-.7'"'05.,2$#'2+.window also provides information on the current temperature of the pre-heater, flow cell and
reaction wells (box to the upper right of the sample tray). The box to the lower right of the sample tray indicates
the time remaining time before the session is concluded and the percentage already executed.

48/64 User Manual HumaStar 80


G( (,->,09-%%(%65>2-
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:

The following options are available:


/-(-'-.=+2,.(#5': The selected test will be deleted from the reprocess list and will not be reprocessed.
L4$2+-.=2+-D-+: The selected test will be deleted from the reprocess list and the reprocess window will not appear
in future for this test type.
9-8+2:-55. "((. (#5': All of the samples in the list will be entered into the reprocess list and will be reprocessed
during the next session.

User Manual HumaStar 80 49/64


?*(5-6%7,-5-13(>,09-87,-%(618(96297263/01
This instrument allows you to perform measurements using the following methods: end point, differential, fixed-
time and kinetic. In this chapter, we will use the following abbreviations:

As Absorbance of the sample


A> Absorbance of the blank
A:"(#> Absorbance of the calibrator
Cs Concentration of the sample
F Programmed calculation factor
RT Fixed factor depending on the programmed reaction type; its value is +1 for increasing
reactions and –1 for decreasing reactions
Ccalib Programmed concentration of the calibrator
N Number of duplicates
AR1 Absorbance of the sample, blank or calibrator with Reagent 1 (sample blank reaction)
AR2 Absorbance of the sample, blank or calibrator with Reagent 2 (overall reaction)
AT1 Absorbance of the sample, blank or calibrator after incubation 1
AT2 Absorbance of the sample, blank or calibrator after incubation 2
#A/min Absorbance rate change per minute of the sample, blank or calibrator

?*I?( -MP(>K+M&
With this method, the absorbance of the reaction mixture is measured at one point in time. Either one or two
reagents can be used and the absorbance can be measured at one wavelength (monochromatic) or at two. The
calibration can be based on the use of calibrators (one or more) or on a programmed factor.

?*I?I?( >'KQNP"'NJ(+M(-MP(>K+M&(5KPN
The procedure is different depending on whether the test uses one or two reagents (Figure 11.1). If two reagents
are used, a second incubation period is required after pipetting the second reagent and before taking
absorbance measurement. In dichromatic readings, two measurements of each reaction mixture are done at
each of the programmed wavelengths. A blank is always prepared for each test using distilled water instead of
the sample and reading is done against a baseline of water.

?*I?IA( >'KQNP"'NJ(+M(&NJ&J("J+MS(KMN('N$SNM&
The sample or calibrator is pipetted together with the reagent into the reaction wells. The reaction mixture is
incubated for the programmed period of time. The mixture is then moved to the cuvette and, after the
stabilisation time has elapsed, the absorbance is measured. Note that the time required to move the reaction
mixture to the cuvette as well as the stabilisation time are included in the incubation time.

?*I?I@( >'KQNP"'NJ(LK'(&NJ&J("J+MS(&WK('N$SNM&J
The sample or calibrator is pipetted together with the first reagent into the reaction wells. The reaction mixture is
incubated at 37 °C for a programmed period of time (incubation 1). The second reagent is then pipetted into the
well and the reaction mixture is incubated again. Next, the mixture is moved into the cuvette and the
measurement of the absorbance is taken. Note that the time required to move the reaction mixture to the
nd
cuvette as well as the stabilisation time are subtracted from the incubation time. If a 2 incubation time is
nd st
programmed and the method requires 2 reagents, the 2 reagent is added after the 1 incubation time and
nd
incubated for the duration of the programmed 2 incubation time. See figure below:

Note also that the stability time is used to postpone the readings in end point and differential modes in order to
increase the performance of the instrument, and indicates the time in which the reaction is stable (expressed in
seconds). This parameter is not considered in fixed time and kinetic tests because these methods do not have
stability and must be read immediately after the INC 1 time has elapsed.

50/64 User Manual HumaStar 80


4+SI(?*I?((X((-18(>0/13(508-

According to the programming of the method editor, several operations are possible for end point tests.

Read interval Read interval


%\,? %\(,?\(,A

5 T %&$[+R+& 4 T %&$[+R+&U

INC 1 08 INC 1 08

Reaction well Flow Reaction well Flow cell

01-( ,-6=-13 3:0( ( ,-6=-13%


st st
1 incubation = INC 1 1 incubation = INC 1
nd nd
2 incubation = (Empty.) 2 incubation = Empty

Read interval
%\,? ,A 3 T

%&$[+R+&U

INC 1 INC 2
08

Flow cell

3:0( ,-6=-13%
st
1 incubation = INC 1
nd
2 incubation = INC2

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

User Manual HumaStar 80 51/64


4+SI(?*IA((X((B/1-3/9(508-

Reaction curve
%\(,?(^(\(,A(_

2 T /19A

INC 1
08? 08M
Reaction well Flow cell

nd
Reading are taken each second, for all the duration of the reaction time kinetic interval (2 incubation time).
st
During the 1 incubation time no reading is taken.

4+SI(?*I@((X(4/]-8(3/5-(508-

Reaction curve
%\(,?(^(\(,A(_

1 T /19A

INC 1
08? 08A
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.

52/64 User Manual HumaStar 80


4+SI(?*IC((X((8/44-,-13/62(508-

For differential mode, several combinations are possible. See figure below:

Read interval Read interval


%\,? %\(,?\(,A

6 T %&$[+R+&U 7 T %&$[+R+&U

INC 1 INC 1
08 08

Reaction well Flow cell Reaction well Flow cell

BLANK SAMPLE

st
1 incubation = INC 1
nd
2 incubation = Empty

%\,? Read interval Read interval


%\,? ,A
9 T 8 T
%&$[+R+&U %&$[+R+&U

INC 1 INC 2 INC 1 INC 2


08 08

Reaction well Flow cell Reaction well Flow cell

H261B %65>2-

st
1 incubation = INC 1
nd
2 incubation = INC 2

User Manual HumaStar 80 53/64


?*I?IC( 9$RQ"R$&+KMJ(+M(NMP(OK+M&(#KPN

In the case of P+QT'K#$&+Q( 'N$P+MSJ, 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.

As , Ab , Acalib = Amain wavelength –ARef wavelength

If a(L$Q&K'(is used, the concentration of each sample is calculated using the following formula:

Cs= (As-Ab) x Kfact x RT

If($(J+MSRN(Q$R+['$&K'(is used, the concentration of each sample is calculated using the formula used above for
calculations using a factor, but R is obtained in the following way:

' "#$%!
!"#$% %
&"#$%! $ &!

If( JN<N'$R( Q$R+['$&K'J( are used, the concentration of each sample is calculated using a calibration curve
obtained using the selected :"(:0("'#2$. =0$:'#2$ and "P-5. A calibration curve is generated using the
programmed concentration values for the calibrators and the absorbances measured for each one:

(Acalib- Ab) x RT

The concentration of the samples is then calculated by interpolation of their absorbances in a curve:

(As- Ab) x RT

With 'NOR+Q$&NJ, 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:

& (
)*#(&! % & &%
( % %&

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:

As or calib- ,-"$.1>

If calibrators are used, the mean absorbance value for each calibration is obtained as follows:
& (
)*#(&"#$%! % & ' &"#$%! $ )*#(&! (%
( % %&
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:

& (
'+ % & '%
( % %&

54/64 User Manual HumaStar 80


?*IA( 8+LLN'NM&+$R
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.

?*IAI?( >'KQNP"'N(+M(8+LLN'NM&+$R(5KPN
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 move the
nd
reaction mixture to the cuvette as well as the stabilisation time is included in the incubation time. If the 2
st
incubation time is programmed, the reagent 2 is added after the 1 incubation time and an extra incubation is
nd
performed by the analyzer for the duration of the 2 incubation time.

?*IAIA( 9$RQ"R$&+KMJ(+M(8+LLN'NM&+$R(5KPN
If a(L$Q&K'(is used, the concentration of each sample is calculated using the following formula:

Cs= [(AR2s- AR1s)-(AR2b - AR1b)] x Kfact x RT

If a(J+MSRN(Q$R+['$&K'(is used, the concentration of each sample is calculated using the formula used above for
calculations using a factor, but R is obtained in the following way:

' "#$%!
!"#$% %
) &, '"#$%! $ &,&"#$%! ( $ ' &, '! $ &,&! (

If JN<N'$R(Q$R+['$&K'J(are used, the concentration of each sample is calculated using a calibration curve, which
is obtained using the selected :"(:0("'#2$. =0$:'#2$ and "P-5. A calibration curve is prepared using the
programmed concentration values for the calibrators and the absorbances measured for each one:

[(AR2calib- AR1calib)-(AR2b – AR1b)] x RT

The concentrations of the samples are then calculated by interpolation of their absorbances in the curve:

[(AR2s- AR1s)-(AR2b – AR1b)] x RT

In the case of the 'NOR+Q$&NJ, 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:

& (
)*#(' &, ' ! $ &,&! ( % & '&, '! $ &,&! (%
( % %&

The absorbance difference of each sample or calibrator (when used) replicate is calculated in this way:
A R2s or calib- 19S5.2+.:"(#>

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- 19S5.2+.:"(#>) – mean (AR2b –AR1b)


'&, '! $ &,&! (

User Manual HumaStar 80 55/64


If calibrators are used, the mean absorbance value for each calibrator is obtained as follows:

& (
)*#(&"#$%! % & )'&, '"#$%! $ &,&"#$%! ( $ )*#() &, '! $ &,&! (*%
( % %&

The mean absorbance values of the calibrators are then used in the calculations (See descriptionusing factor
,single calibrator or several calibrators) to obtain the sample concentrations.
Finally, the mean concentration value of each sample is calculated:

& (
'+ % & '%
( % %&

?*I@( 4+`NP(3+#N
For this method, the absorbance of the reaction mixture is measured at two fixed times. Only one reagent can be
used. The calibration can be based on the use of calibrators (one or more) or on a programmed factor.

?*I@I?( >'KQNP"'N(+M(4+`NP(3+#N(5KPN
The sample or calibrator is pipetted together with the reagent into a reaction well. The reaction mixture is
incubated for the programmed period of time (incubation 1). The mixture is then transported to the cuvette and,
after the stabilisation time has elapsed, a first measurement of the absorbance is taken (AT1). Note that the time
required to move the reaction mixture to the cuvette as well as the stabilisation time are included in the
incubation 1 time. The reaction mixture is further incubated for a second period in the cuvette (incubation 2), and
a new measurement of the absorbance is taken (AT2). A blank is always prepared for each test using distilled
water instead of the sample and reading against a baseline of water at the same fixed times.

?*I@IA( 9$RQ"R$&+KMJ(+M(4+`NP(3+#N(5KPN
If a L$Q&K'(is used, the concentration of each sample is calculated using the following formula:

Cs= [(AT2s- AT1s)-(AT2b – AT1b)] x Kfact x RT

If a(J+MSRN(Q$R+['$&K'(is used, the concentration of each sample is calculated using the formula used above for
calculations using a factor, but R is obtained in the following way:

' "#$%!
!"#$% %
) &- ' "#$%! $ &- &"#$%! ( $ ' &- '! $ &- &! (

If several(Q$R+['$&K'J are used, the concentration of each sample is calculated using a calibration curve obtained
using the selected :"(:0("'#2$. =0$:'#2$ and "P-5. A calibration curve is prepared using the programmed
concentration values for the calibrators and the differences between the absorbances obtained for each one:

[(AT2calib – AT1calib)-(AT2b – AT1b)] x RT

The concentrations of the samples are then calculated by interpolation of their absorbances in the curve:

[(AT2s- AT1s)-(AT2b – AT1b)] x RT

In the case of 'NOR+Q$&NJ, 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:

56/64 User Manual HumaStar 80


First of all, the mean value of the blank is calculated:
& (
)*#(' &- '! $ &- &! ( % & ' &- '! $ &- &! (%
( % %&
The absorbance difference of each sample or calibrator (when used) replicate is calculated in this way:

A<Ts or calib- 1<S5.2+.:"(#>

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:

(A<T5.2+.:"(#>- 1<S5.2+.:"(#>) – mean (AT2b –AT1b)


'&, '! $ &,&! (
If calibrators are used, the mean absorbance value for each calibrator is obtained as follows:
& (
)*#(&"#$%! % & )' &- ' "#$%! $ &- &"#$%! ( $ )*#() &- ' ! $ &- &! (*%
( % %&
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:

& (
'+ % & '%
( % %&

?*IC( B+MN&+Q
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.

?*ICI?( >'KQNP"'N(+M(B+MN&+Q(5KPN
The sample or calibrator is pipetted together with the reagent into a reaction well. The reaction mixture is
incubated during the programmed period of time (incubation time 1). The mixture is then transported to the
cuvette and, after the stabilisation time has elapsed, a first measurement of the absorbance is taken (A0). Note
that the time required to move the reaction mixture to the cuvette as well as the stabilisation time are included in
incubation time 1.

?*ICIA( 9$RQ"R$&+KMJ(+M(B+MN&+Q(5KPN
Catalytic activity is measured by the catalysed rate of conversion (reaction rate). The rate of conversion is the
slope of the absorbance curve over time and it is calculated using the linear regression method. The slope
dimension is #A/min.
During the measurement period, absorbance values are taken once each second. A linear search is performed
on each individual set of data to find the linear portion of the data. The absorbance values are divided into three
segments. The slope of each segment as well as of the total data are calculated with the linear regression
method. The slopes obtained for the segments are compared with those obtained for the total data. Those
segments with slopes 20% higher or lower than the slope of the total data are eliminated from the final
calculation. Finally, the slope is calculated with the linear regression of all of the values included in the selected
segments. If all three segments are eliminated, the slope of the total data will be retained for calculations.
If a L$Q&K'(is used, the concentration of each sample is calculated using the following formula:

1 1 #& . 1 #& . .
' + % // / , $/ , ,, + !"#$% + ,-
0 0 *+, - + 0 *+, - ! -

User Manual HumaStar 80 57/64


If a(Q$R+['$&K'(is used, the concentration is calculated using the same formula as above, but Kfact is obtained in
the following way:

' "#$%!
!"#$% %
1 1 #& . 1 #& . .,
// / , $/ , ,
0 0 *+, - "#$%! 0 *+, - ! -

In the case of 'NOR+Q$&NJ, 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:

1 #& . & ( 1 1 #& . .


)*#(/ , % &// , ,
0 *+, - ! ( % %& /0 0 *+, - ! ,- %

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:

1 #& . 1 #& .
/ , $ )*#(/ ,
0 *+, - +./"#$%! 0 *+, - !

3. Finally the mean concentration value of each sample is calculated:

& (
'+ % & '%
( % %&

58/64 User Manual HumaStar 80


??(3,07H2-%!003/1=
6JO+'$&+KM(MNNPRNZ facing the instrument, the aspiration needle is on the left. It has the wider aperture and is cut
at an angle.

8+JONMJ+MS(MNNPRNZ facing the instrument, the dispensing needle is on the right. It has a smaller aperture and a
pointed tip.

TUBING DIAGRAM

User Manual HumaStar 80 59/64


-,,0,(5%= 967%-(a(%0273/01

Pump calibration value > 1.6 - Aspiration needle is obstructed (cleaning necessary)
- Tube disconnected (check)
Too long time depleting washing cup > 20 sec. - Aspiration needle obstructed
- Volume calibration required
Air bubbles in the cuvette - Flow cell is dirty (wash with deproteinizing agent)
- Check tube size (110 to 125) and air gap value
- Peristaltic pump calibration needed
- Aspiration needle obstructed
Volume calibration - R1 not present (place R1 in the carousel)
Error: R1 not present or air present in the dispensing - Air inside dispensing circuit (perform diluter prime)
circuit - Dispensing needle obstructed (cleaning necessary)
Prime diluter - Perform volume calibration
Needles touch bottom in the washing well - Perform diluter prime without the washing cup, then
replace the washing cup and perform a volume
calibration
High CV (low precision / repeatability) - Dispensing needle obstructed (cleaning necessary)
Diluter drift observed for same sample - Use washing solution (perchloric acid 50% diluted) or
pepsine-based solution to clean the dispensing
needle (use special “clean dispensing needle”
program, in MAIN->utility)
Linearity test exceeds 3% max error - Adjust offset of preamplifier board through “Dark
current setting procedure”
- Check for obstruction of the needles
Too much residual solution in ALL reaction wells - Volume calibration is needed to adjust minimum
volume
Too much residual solution in SOME reaction wells - Aspiration needle is obstructed. Cleaning necessary.
First sample result low in kinetic test (GOT, GPT) - Reagent is too cold (wait longer before performing
test)
- The cuvette is cold due to the previous washing:
st
increase the 1 incubation time
- Washing solution is too cold? Check!!
Leakage from ASPIRATION needle. - Check the connection of tube (B) tube to the flow cell
and aspiration needle
- Check the grey rubber peristaltic pump tube
- Check the connections of tube (A)
- Check integrity of tubes (A) and (B)
Leakage from DISPENSING needle. - Check the connection of tube (C) tube to tube (D).
Screw it down tight to seal it.
- Check the tube (D) connection to the electro valve.
Replace the O-ring if necessary.
- Do not tighten excessively! O-Ring is present.
Excessive tightening may permanently damage the
electro valve.
- Check the integrity of tubes (C) and (D)
No aspiration from WASH BOTTLE - Check for presence and integrity of the O-Ring on
the left side of the electro valve (E-tube)
- Check the E tube connections.
The probe does not aspirate sample and/or reagent - The probe is not connected properly
- If the module works correctly, check if there are
problems with the tubing and if there is enough
washing solution in the container.
The probe does not dispense the solution into the - Check the diluter valve
sampling well - Check if there is enough wash solution in the
container

60/64 User Manual HumaStar 80


- Check all the tubing
The test using a 3 "l sample size is not reproducible - Check the sampling probe. If it is dirty, clean it. If
there 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 washing - Check the tubing between the well and the valve.
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
voltages are obtained after resetting. with 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 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 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
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.

User Manual HumaStar 80 61/64


?A( 699-%%0,/-%(618(,->269-5-13(905>01-13%
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. Below is a list of all the components or accessories you may need:

[REF] DESCRIPTION
16880/1 User manual
16885/51 Sample tray
16885/52 Reagent rack
16885/53 Set of reagent bottles 40 ml
16885/54 Reaction wells segment (50 units)
16885/55 Sample wells (1000 units)
16885/57 Waste bottle
16885/56 Washing bottle
16885/35 Syringe
16885/59 Wash station
16885/48 Halogen lamp 12V 20W
16885/23 Filter set 340 nm
16885/24 Filter set 405 nm
16885/25 Filter set 492 nm
16885/26 Filter set 505 nm
16885/27 Filter set 546 nm
16885/29 Filter set 578 nm
16885/28 Filter set 630 nm

62/64 User Manual HumaStar 80


6>>-18/](? 2/%(/13-,469-

The analyzer was designed to be used as a stand-alone instrument or to be interfaced with a Laboratory
Information System (LIS). In the latter case the analyzer can perform the following operations:

- Import a worklist from a remote system (by serial port)


- Export results to a remote system (by serial port)

The LIS interface can be archived through serial port. For this reason at least 2 serial ports are required in order
to provide LIS support to analyzer, since one serial port is needed by the application software to communicate
with the analyzer, the other serial port is needed to connect the analyzer to an LIS host.

The figure below shows how to connect a HumaStar 80 to a LIS. Note that in this case a PC is needed that has
at least 2 serial ports.
A standard USB-to-serial adapter can also be used.

RS-232

Analyzer

PC with instrument
application software

RS-232

LIS server (HOST)

User Manual HumaStar 80 63/64


6>>-18/](A 8+J+MLNQ&+MS(&TN(/MJ&'"#NM&

To disinfect the instrument cover of the instrument we recommend the use of ammonia (6% solution) or sodium
hypochlorite (bleach). Do not use alcohol because it may damage the glass cover.
After disinfection it is possible to use standard glass-cleaning products to polish the cover.

You can use alcohol to disinfect all other parts of the instruments

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Human
Gesellschaft für Biochemica
und Diagnostica mbH
Max-Planck-Ring 21 2 D-65205 Wiesbaden
Germany
Telefon: +49 6122 9988 0
Telefax: +49 6122 9988 100

eMail: human@human.de
Internet: http://www.human.de

03/2005-09

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