humastar 80

HumaStar 80

| User Manual

|

Cat.No. 16880/1

i

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

I

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.

3 INTENDED USE OF THE INSTRUMENT [IVD]

The instrument has to be used for the expected purposes and in perfect technical conditions, by qualified

personnel, 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.

4 GENERAL SAFETY WARNINGS

Use only chemical reagents and accessories specified and supplied by HUMAN and/or mentioned in this manual.

Place the product so that it has proper 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.

II

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.

7 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.

a

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: [email protected] · www.human.de

1/93 Human HumaStar 80 User Manual

Contents

1 Foreword 5

2 Unpacking and Installation 7

2.1 List of Contents 7

2.2 Main Components Identification 8

2.3 Installation and Location 11

2.4 Connection to Power Supply 12

2.5 How to Start 10

2.6 Re-Shipment 13

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 30

5 Editing Programs 33

5.1 How to Edit Test Methods 33

5.2 How to Edit Calibrators 39

5.3 How to Edit Controls 41

5.4 How to Edit Profiles 43

6 Workplan 45

6.1 Create Method List Window 47

6.2 Summary Table Window 47

6.3 Tray Setup 50

7 Stat Mode 51

8 Status Monitor 55

9 Reprocess Sample 57

10 Measurement Procedure and Calculation 59

11 Maintenance 69

12 Troubleshooting 73

13 Accessories and Replacement Components 77

14 APPENDIX 1 LIS INTERFACE 79

15 APPENDIX 2 CLEANING GUIDE 81

16 APPENDIX 3 Disinfecting the Instrument 83

17 APPENDIX 4 Warning Message about Results 85

18 APPENDIX 5 WEEE and RoHS Directives 87

19 Huma Star 80 SETUP MENU 89


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: [email protected]

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

All rights reserved


1 Foreword

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 the Windows™based software.

The software supplied with the analyzer should be installed on a PC connected to the instrument. Please do notinstall any other software to this PC as it may cause the HumaStar 80 software to operate incorrectly.

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 patient´s data and tests and/or profiles to samples. Once the results have been obtained, you canrequest 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 parabole), scale (linear or logarithmic), and study thecalibration 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.


2 Unpacking and Installation

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 might need it in case of re-shipment.

2.1 List of Contents

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/CD

- User manual- A section of the case (to be placed under the arm)

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2.2 Main Component Identification

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


REAR VIEW

1) Power socket

2) Fuses

3) Identification label

4) Waste outlet

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RIGHT VIEW

1) Serial port

LEFT VIEW

1) Power switch


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 asource 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 fanexhaust. 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

wash fluid.

Fix the two tank tubes into the black holder that are abovethe 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 0.5l of water. Add 50 µl Wash Solution Concentrate (cat. no. 16885/100).

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.

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After use, do not remove the tubing from the pump. The analyzer keeps it filled with water to prevent itfrom drying.

2.3.2 Installing the Wash Station

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 obstructthe needles.

2.3.3 Installing the Sample Tray

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.

2.3.4 Installing the Reaction Wells

The reaction wells should be placed around the outside ring of the sample tray, taking care to insert the stems intothe corresponding slots.

2.3.5 Installing the Reagent Racks

The reagent rack can be loaded with up to 21 reagent bottles. Take care that the rack is properly fixed in the correct

position.

2.4 Connection to Power Supply

It is very important to connect the analyzer to a good electrical system. If possible, it should be on its own circuitand 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 analyzermay 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).


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.

In the utility window, click on Prime Diluter button.

The instrument begins to prepare the hydraulic

circuit.

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

Cleaning the flow-thru cuvette

Perform the Wash Cuvette program. Wash with

alcohol and deproteinizing agent to remove greaseand protein. Follow this washing sequence:

ALCOHOL 15 cycles

DEPROTEINIZER (perchloric acid (50%) or Wash

Solution Concentrate (10% concentrated) 15 cycles

DISTILLED WATER 20 cycles

Perform the Pump calib. to adjust the aspiration

pump for the flow-thru cuvette

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In the Main window, click on the Autodiagnosis button.

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.


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.


3 Description of the Instrument

The instrument is composed of the following parts:

Sample tray

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.

Reaction wells

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.

Transfer arm

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.

Reagent bottles and racks

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.

Dispensing

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.

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Wash station

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.

Sipper system

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 pumpperforms the job of sipping and transporting the liquids to be measured.

Optical system

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.

3.1 Technical Specifications

General characteristics

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

Sample tray

Sample cup capacity: 1.2 ml maximum

Tray capacity: 54 cups for samples, calibrators and controls

Reagent tray

Tray capacity: 20 reagent bottles of about 45 ml

Reaction wells

12 rows with 12 wells each

Reaction well capacity: 1 ml maximum

Reservoirs

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.

Programming

Tests: unlimited

Profiles: Up to 9 with an unlimited number of tests

Calibrators

Controls

Filters

Reagents


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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Transfer system

Continuous flow system with peristaltic pump

Capacity of the cuvette flow: 18 µl

Automatic calibration

PC minimum requirements

The instrument should be connected to a personal computer which fulfils the following minimum requirements:

- Processor 2GHz

- RAM 256 Mbyte

- Hard Disk capacity 20 Gbyte

- 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

Physical dimensions

- 450 (width) x 720 (length) x 750 (height) mm

Weight: 45 kg

Electrical requirements

115/230 VAC ( 15%) (autodetect)

50/60 Hz

350 VA

Assistance to users

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

Graphs

Calibration and kinetic curves

Quality control (Levey-Jennings)


4 Method of Operation

4.1 The Main Menu

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

The following icons are available:

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 ofthe 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.

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Control: 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 Utility:

Setup: Allows you to enter the user’s customised settings, such as language and

printer.

Utility: Allows you to perform service on the instrument, such as maintenance, etc. It

may be used only by an expert technician.

Scheduling: 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 have performed, with comments.

Autodiagnosis: 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 Status 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 STAT 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 Shutdown icon: Shuts down the program.

The Version box displays the current software version installed on the instrument (or on the PC).


4.2 Report

4.2.1 Patient data

Clicking the Patient Data button in the Main Menu will open the following window:

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 clickApply.

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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 Link 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

Database button.

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.


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 cansee 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, statisticaldata 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.

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4.2.3 Result

Clicking on the Results button in the Main Menu will open the Result window:

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 Patient, to view the patient samples that

have been analysed during the session, or 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.


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 ofreplicates), the result. In the bottom part, the following buttons are present:

Patient list: gives you the possibility to see the list of the patients of that session. If you

click one ID and then View, you can see the tests performed on that ID. There is

also the possibility to print test results.

Save Ctrl: clicking here will save controls if the instrument is not configured to save

them automatically.

Modify standard: 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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Print: prints the results.

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.

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

The available information includes: the test performed on the sample, the results, the unit, reference values andthe 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

Modify: allows a selected result to be modified

Restore Values: restore all the modified results


The Find 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 beentered 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:

0.8 – 3.5

Advanced: Opens a new window with additional utilities


Initialise: The arm and the rotor will be moved to the correct start position.

Wash circuit: 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. See also more details in the Maintenace section of this manual.

Volume calib.: 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).

Service: Click this button to access the service menu (special maintenance). This operation requires a

password and is for authorised persons only.

Photometer check: Checks the manual functioning of the photometer.

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).


5 Editing Programs

5.1 How to Edit Test Methods

Click Method in the Edit section of the Main Menu to open the Method editor window:

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:

In the menu “Actions” these buttons are available:

New test: Allows new tests to be edited. A new screen will appear in which the parameters associated

with the test can be entered.

Modify test: Changes the parameters of an already edited test. Select a file name from the list of edited

tests and then click this button.

Erase test: Erases a selected test. Select a file name from the list of edited tests and then click this button.

View test: Shows the setting for a selected test.

Insert row: If a position was selected by the mouse a new, empty row will be inserted at this position.

Delete row: A selected position will be completely removed.

Supervisor access: Enables the supervisor to create, edit or delete a test.


Clicking New will open the window Method lists. Here the method for the test can be chosen.

Once it has been chosen, the Editing test window will appear (the same window will appear when the Modifybutton is clicked):

In the Test box, the following dialogue boxes are present:

Description: Enter the name of the test in this field.

Manufacturer: Enter the name of the test kit manufacturer here.

Test ID: Enter the test ID.

Position: The position of the test in the Test List will appear automatically in this field.

Expire: Enter the expiry date of the test kit you are using.

Mode: The test method will appear automatically.

Note: Enter notes about the test.

In the Wavelength section the following information may be entered:

Filter1: The first wavelength needed for the test.

Filter2: The possible second wavelength needed for the test.

In the Volumes (l) section, the following information may be entered:

Sample: Enter the required sample volume.

Reagent 1: Enter the required volume of reagent 1.

Reagent 2: Enter the required volume of reagent 2.

In the Reading Parameters section the following information can be entered:

1st Incubation: Enter the sample incubation time for the rack.

2nd Incubation: Enter the sample incubation time for the photometric cell.

Stability: Enter the period of time during which the absorbance resulting from the reaction remains

unchanged.

Sample Replicate: Enter the number of repeat measurements you want for each sample.

In the Results section, the following printing options are available:

Measure units: Choose the measurement units for the results.

N. decimal: Enter the number of decimals for the results.

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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 blankpreparation depend on the test to be executed as explained in following table:

TEST NO WATER BLANK WATER BLANK

EP, MSD with 1

reagent.

Takes a volume of R1 equal to the sum of

reagent volume and sample volume set for

the test

Takes a volume of R1 equal to reagent

volume plus a volume of distilled water equal

to sample volume

EP, MSD with 2

reagent. Single

step preparation


reagent volume and sample volume set for

the test plus set volume of reagent R2



to sample volume plus set volume of R2

EP, MSD with 2

reagent. Two

steps preparation


reagent volume and sample volume set. Add

R2 volume after first incubation time



to sample volume. Add R2 volume after first

incubation time.

DIFFERENTIAL

Single or two

steps preparation


reagent one and reagent two and a volume

of sample equal to set sample volume for the

test

Takes volume of R1 plus volume of distilled

water equal to volume of R2 plus volume of

sample

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 increasesover 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.


5.1.1 Parameters Options window

Click Option in the Edit test window to open the following window:

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 thelimits.

In the Predilution and Postdilution sections, the predilution or postdilution ratios are chosen. In the postdilutionsection, 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: 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 decreasing reactions and a maximum value for increasingreactions. 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 methodand 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 the Check Value section, the following parameters should be set:

Minimum and maximum k-factor: 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.

Washing: In this field, enter the number of required washings.

this check box allows an extra washing for needles between dispensing into

the reaction well and the next preparation cycle.

Cancel: Exits without saving the setup data.

Restore: Restores the initial settings.

OK: Saves the current parameters.

5.1.2 Control Serum Window

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).


5.2 How to Edit Calibrators

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 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 Calibrators window, click on the test, enter the concentration valueand click the OK button.

Exit: Closes window.


5.3 How to Edit Controls

Clicking Control in the Main Menu will open the controls window:

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 TestEdit 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 ofthese three before entering the concentration limit values.

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


5.4 How to Edit Profiles

Click on Profile in the Main Menu to open the Profile Editor:

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.


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 clickon 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.

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Other buttons present in this window are:

New table: Click this button to create a new table.

ID insert: This button opens the Patient data window, which allows you to enter anID for the samples you have scheduled.

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 todisable predilution on a sample.


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.

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6.2 Summary Table Window

Click Summary in the main menu to display the results obtained by processing the data in the Workplan manager.

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 youselected a calibrator, following window will appear:


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.

If you selected a control, following window will appear:

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 infavour 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.

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6.3 Tray Setup

Click the Tray setup button in the Main Menu to open the Plates 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 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 andsample ID).

Click Help to display the key explaining the colour coding used in the sample tray image


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.

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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 STATsamples have been performed previously and prevents any ID overlapping.

When you are finished entering information, click OK; the Summary window will appear on the screen. Most

buttons are disabled, but the Print and Modify buttons are enabled in case it is necessary to make changes to

calibrators or controls. Click OK to open the Plates window: make sure that all of the reagents are correctly

allocated and click OK to process the worklist. A message will indicate that the STAT sample (s) will be analyzed assoon 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 Summary 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 toprevent 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 STOP

icon in the main window (the same button as the START icon, which changes depending on the instrument’s

status).

When the button is clicked the following window appears:

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 homeposition 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.


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 sothat it can easily be resolved. Clicking RETRY will cause the instrument to continue the execution of tests.


8 Status Monitor

The Status Monitor 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 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 iscontinuously 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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The Status monitor 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.


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:

The following options are available:

Delete from list: The selected test will be deleted from the reprocess list and will not be reprocessed.

Ignore forever: The selected test will be deleted from the reprocess list and the reprocess window will not

appear in future for this test type.

Reprocess all list: All of the samples in the list will be entered into the reprocess list and will be reprocessed

during the next session.


10 Measurement Procedure and Calculation

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

Ab Absorbance of the blank

Acalib 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

10.1 End Point

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. Thecalibration can be based on the use of calibrators (one or more) or on a programmed factor.

10.1.1 Procedures in End Point Mode

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 andreading is done against a baseline of water.

10.1.2 Procedures in tests using one reagent

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 transfer the reaction mixture to thecuvette as well as the stabilisation time are included in the incubation time.

10.1.3 Procedures for tests using two reagents

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 transfer the reaction mixture to the

cuvette as well as the stabilisation time are subtracted from the incubation time. If a 2nd incubation time is

programmed and the method requires 2 reagents, the 2nd reagent is added after the 1st incubation time and

incubated for the duration of the programmed 2nd 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.According to the programming of the method editor, several operations are possible for end point tests.

60/93

Fig. 10.1 - END POINT MODE

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

S+R1

3 T Stability

INC 1

Reaction well Flow

Read interval

1 T Stability

INC 1

Reaction well Flow cell

Read intervalS+ R1+ R2

OD OD

ONE REAGENT1st incubation = INC 12nd incubation = (Empty)

TWO REAGENTS1st incubation = INC 12nd incubation = Empty

S+R1

INC 2

TWO REAGENTS1st incubation = INC 12nd incubation = INC 2

R2 5 T

Read interval

Stability

OD

Flow cell

INC 1


Fig. 10.2 – KINETIC MODE

Readings are taken every second, for the whole duration of the reaction time kinetic interval (2nd incubation time).

During the 1st incubation time no reading is taken.

Fig. 10.3 – FIXED TIME MODE

The reaction is followed for the entire duration of the 2nd incubation time, with sampling done once per second. For

result calculation, only the initial and end point value are used.

S+ R1 ( + R2 )

7 T INC2

INC 1


Reaction curve

OD1 ODn

9 T INC2

INC 1


Reaction curveS+ R1 ( + R2 )

OD1 OD2

62/93

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

Fig. 10.4 - DIFFERENTIAL MODE

INC 1


S+R1 S+ R1+ R2

11 T Stability

INC 1


Read interval

OD

BLANK SAMPLE

1st incubation = INC 12nd incubation = Empty

Stability

Read interval

OD

13 T

INC 1


S+R1

17 T

BLANK

Stability

Read interval

ODINC 2 INC 1


S+R1

15 T

SAMPLE

Stability

Read interval

ODINC 2

R2

1st incubation = INC 12nd incubation = INC 2


10.1.4 Calculations in end point mode

In the case of dichromatic 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 thereference wavelength.

As , Ab , Acalib = Amain wavelength –ARef wavelength

If a factor is used, the concentration of each sample is calculated using the following formula:

Cs= (As-Ab) x Kfact x RT

If a single calibrator is used, the concentration of each sample is calculated using the formula used above forcalculations using a factor, but F is obtained in the following way:

bcalib

calib

AA

C

Kfact

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 programmedconcentration 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 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, replicatesare treated thus:

First of all the mean value of the blank is calculated:

n

iib A

nmeanA

1

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:

As ou calib- mean Ab

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

n

iibcalibcalib meanAA

nmeanA

1

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:

n

iis C

nC

1

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 specifictime. The calibration can be based on the use of calibrators (one or more) or on a programmed factor.

10.2.1 Procedure in 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

64/93

reaction mixture to the cuvette as well as the stabilisation time is included in the incubation time. If the 2nd

incubation time is programmed, the reagent 2 is added after the 1st incubation time and an extra incubation is

performed by the analyzer for the duration of the 2nd incubation time.

10.2.2 Calculations in Differential Mode


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


bRbRcalibRcalibR

calib

AAAA

C

1212 )(Kfact

If several calibrators are used, 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:

[(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 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:

n

iibRbRbRbR AA

nAAmean

11212

1

The absorbance difference of each sample or calibrator (when used) replicate is calculated in this way:

A R2s or calib- AR1s 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- AR1s or calib) – mean (AR2b –AR1b)

bRbR AA 12


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

n

iibRbRcalibRcalibRcalib AAmeanAA

nmeanA

11212 ()

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.


n

iis C

nC

1

1

10.3 Fixed Time

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.

10.3.1 Procedure in Fixed Time Mode

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 transfer 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 waterinstead of the sample and reading against a baseline of water at the same fixed times.

10.3.2 Calculations in Fixed Time


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


bTbTcalibTcalibT

calib

AAAA

C

1212 )(Kfact

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 prepared using the programmedconcentration 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 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 thecalculations in the following way:

First of all, the mean value of the blank is calculated:

n

iibTbTbTbT AA

nAAmean

11212

1

66/93

The absorbance difference of each sample or calibrator (when used) replicate is calculated in this way:

AT2s or calib- AT1s 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:

(AT2s or calib- AT1s or calib) – mean (AT2b –AT1b)

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

n

iibTbTcalibTcalibTcalib AAmeanAA

nmeanA

11212 ()

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.


n

iis C

nC

1

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 thisprocedure. You can base calibration on the use of calibrators (one or more) or on a programmed factor.

10.4.1 Procedure in Kinetic Mode

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 transfer the reaction mixture to the cuvette as well as the stabilisation time are includedin incubation time 1.

10.4.2 Calculation in Kinetic Mode

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 every 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 threesegments are eliminated, the slope of the total data will be retained for calculations.


RTAA

Cbs

s

Kfact

minmin

bRbR AA 12


If a calibrator is used, the concentration is calculated using the same formula as above, but Kfact is obtained in thefollowing way:

bcalib

calib

AA

C

minmin

Kfact

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:

i

n

i bb

A

n

Amean

1 min

1

min

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:

bsorcalib

Amean

A

minmin

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

n

iis C

nC

1

1


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 Washing solution. This will avoid needle obstruction and

increase washing efficency. Recommended is Wash Solution Concentrate, cat.-no. 16885/100. Dilute the

Wash Solution Concentrate 1:100 with distilled water


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 insidethe 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 Solution Concentrate -10% concentrated) 5 cycles


Empty the washing well at the end of each working day.

Close the plexiglass cover at the end of each working day.

WEEKLY:


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.

ALCOHOL 15 cycles

DEPROTEINIZER (perchloric acid (50%) or Wash Solution Concentrate -10% concentrated) 15 cycles


Perform autodiagnosys.

Perform peristaltic pump auto calibration

MONTLY:

Perform volume auto-calibration

Perform cuvette internal washing with perchloric acid followed by distilled water.

AS REQUIRED (suggested for Service Engineers):

Cleaning the needles

If the aspiration needle it is obstructed, you will have HIGH residual volume into the reaction well and AIR BUBBLE

in to the cuvette, causing incorrect results (generally very high results, due to the light deflection of the air bubble

in the optical path). Clean the needle with the cleaning needle procedure:

70/93

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 Preparation 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


General maintenance of the instrument

It is important to keep the instrument free of dust, which to a great extent affects the optical system. Carefully

remove dust from the inside of the instrument particularly from the fan blades, using a dump cloth or a small

vacuum cleaner.

YEARLY: Preventive maintenance (by trained service engineer)

It is recommended to carry out the following yearly or after each 2000 hours of operation.

ROTOR MECHANISM

1. Verify the belt tension. By rotating the driving pulley, its movement be fully transmitted to the

pulley axle.

2. Verify the centering of the reaction wells in the heating channel.

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.

2. Lubricate the displacer guides (use oil S.A.E.:30 or similar, W-40)

DILUTER MECHANISM

1. Verify the tension of the driving belt.

2. Clean and lubricate the revolving screw (use oil S.A.E.:30 or similar, W-40)

OPTICAL SYSTEM

1. Clean the optical components.

2. Clean the filters.

3. Clean the lens.

4. Clean the photodiode.

5. Wash the flow-thru cuvette.

6. Calibrate the photometric system.

PIPETTING SYSTEM

1. Check the water-tightness of the syringe piston.

Verify that there is no leakage or formation of micro bubbles.

Substitute in that case.

2. Change the sipping circuit tubes.

3. Change the silicone tubing of the syringe valve.

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.

6. Clean the washing station.

SIPPING SYSTEM

1. Change the teflon tubing.

2. Change the peristaltic tubing.

Check the waste tubing. Change it in case of cracking or obstruction.


12 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.

74/93

TUBING DIAGRAM


ERROR MSG CAUSE & SOLUTION

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 deproteinising agent)

- Check tube size (110 to 125) and air gap value

- Peristaltic pump calibration needed

- Aspiration needle obstructed

Volume calibration

Error: R1 not present or air present in the

dispensing circuit

- R1 not present (place R1 in the carousel)

- Air inside dispensing circuit (perform diluter prime)

- Dispensing needle obstructed (cleaning necessary)

Prime diluter

Needles touch bottom in the washing well

- Perform volume calibration

- Perform diluter prime without the washing cup, then

replace the washing cup and perform a volume

calibration

High CV (low precision / repeatability)

Diluter drift observed for same sample

- Dispensing needle obstructed (cleaning necessary)

- Use washing solution (perchloric acid 50% diluted) or

pepsin-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:

increase the 1st 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

sampling well

- Check the diluter valve

- Check if there is enough wash solution in the container

- Check all the tubing

The test using a 3 l sample size is not - Check the sampling probe. If it is dirty, clean it. If there

76/93

reproducible 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 well is not emptied.

- Check the tubing between the well and the valve.

- 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

voltages are obtained after resetting.

- Check if the micro-flow cell is empty, in case fill it 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.


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 originalmaterials and order any part by its cat. no. For details please consult you local Human Distributor.


14 APPENDIX 1 LIS INTERFACE

The analyzer was designed to be used as a stand-alone instrument or to be interfaced with a LaboratoryInformation 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 withthe 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.

Analyzer

PC with instrumentapplication software

RS-232

LIS server (HOST)

RS-232


15 APPENDIX 2 CLEANING GUIDE

Weekly maintenance

Weekly washing

Place a bottle filled with alcohol in the position 2 of

the reagent rack. Place a bottle filled with sodium

hypochlorite (concentration 6-10 %) 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 2,1 and D. Press Ok and wait for the execution.

Press “Prime Diluter” button and wait for the execution. Empty

manually the washing well and execute again “Prime diluter”

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.

Press “Prime Diluter” button and wait for the execution.

Empty manually the washing well and execute again

“Prime diluter”

Needle cleaning

Turn off the instrument and remove the arm cover.

Disconnect the tubes from the needles. Insert

completely the cleaning tool given with the starter

kit from the top of the needle and move it forward

and backward for a while. Then extract the cleaning

tool, reconnect the tubes and close the arm cover.

Execute a washing after this.


16 APPENDIX 3 Disinfecting the Instrument

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


17 APPENDIX 4 Warning Massages about Results

Next table shows the meaning of warning messages that could appear in results list (see chapter 4.2).

Reference

number in

printout

Warning Message Kind of test Meaning

(1) TEMP_H ALL Temperature was over 37.5 °C

(2) TEMP_L ALL Temperature was under 36.5 °C

(3) OUT_HIGH ALL Result is over High limit specified for the

test

(4) OUT_LOW ALL Result is under low limit specified for the

test

(5) OUT_STB ALL Sample has been reading when stability

time was over

(6) BEF_INC ALL Sample has been read before first

incubation time

(7) NO_LINEAR Kinetic Kinetic test is not linear (2 intervals are 25%

outside the linear regression of the total

points

(9) BLK_ERR End Point, Differential,

Multistandard

Blank error: Absorbance of blank is less

than 0 or blank has been taken with air

bubble inside the cuvette

(10) IPER_ACTIVE Kinetic, Fixed Time Sample is hyperactive

(11) W_PREDIL ALL Sample has been prediluted

(12) W_POSTDIL ALL Sample has been postdiluted

(13) W_OUTLYER ALL Residual volume sensed in well after

aspiration: possible outlyer on result


18 APPENDIX 5 WEEE and RoHS Directives

The company complies with WEEE EC Directive (2002/96/CE) about recycling of electrical and electronic equipment

waste.

This EC Directive forbids to collect no more used electrical and electronic equipment waste with normal rubbish

and entrusts to the producers the collection and the recycling of such kind of waste.

When you have to discard an instrument, please don’t dispose it with normal rubbish, but contact our company or

the authorised dealer.

Wasting should be performed in the country were the instrument has been sold.

The label present on each instrument certifies that our company complies with WEEE Directive:

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.


19 Huma Star 80 SETUP MENU

User can access “Setup” menu of HumaStar 80 pressing button “Setup” in main window and inserting correctpassword. 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 has been performed, use can validate them pressing button “OK” or annul them pressingbutton “Cancel”

PRINTER MENU

Printer Menu allows to change settings

about external printer.

“Test” button performs a trial printout

useful to understand if the printer works

or not.

“Line Feed” allows the user to set how

many blank rows have to be added at

the end of each print out operation

The big edit box allows the user to edit

the welcome message, which will be

printed together with each patient

report

If the user flag the “Print welcome

message on startup” flag box,

instrument will printout welcome

message every time software is opened.

“Preview” button allows to print out

welcome message

“Settings” button opens a window

where the user can custom print out for

all the printing software modules

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For each software module use can set Font Size, Line Space (distance between each row), Margin (distance from leftborder 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 hasproblem in aspiration function.

“LIS: do not send Demography to host”: if this

box is flagged, software does not send patientdata when results export is performed


“Shutdown on exit”: if this box is flagged when software is closed also the PC will be shut down.

“Show correlation error”: flag this box to activate column of correlation error in the Correlation window (Elabmodule)

“Show residual volume warning”: after each aspiration the instrument senses if some residual volume is still

present in the well. If the box is flagged, each well for which residual liquid has been sensed will have a visiblewarning in the reports

“Installation data”: these fields are printed in each patient report. User can fill these fields with corresponding data

PHOTOMETER MENU

“Print initial O.D. reference values”: if this

box is flagged, instrument will print out

automatically blank reference values read

at the beginning of this section

“Blank accepting feature”: if this box is

flagged, after the blank reference values

have been read, software will show them

to the user, who should choose if session

can be continued or stopped, or blankreference values have to be read again

“Auto save QC data”: if this box is flagged,

software saves automatically in the CQdatabase results read for control sera

“Use primary tube”: user has to flag this

box if he wants to use primary tubes

instead of sample cups. In fact in this case

vertical movement of the arm should be

deeper. Use of primary tubes needs some

adapters to fit the hole on the sampletray.

“Automatic optimization of worklist”: if

this option is enabled, “Summary” window

will automatically apply optimizationalgorithm for the worklist

“Quick test washing”: user can enable this

option to perform quicker washing at the

end of each test. This feature works only if

more than one washing cycle is set for the

test: first washing cycle will be shorter

because instrument will use water alreadyavailable in the washing pot.

“Walk away”: if this option is enabled, instrument will automatically skip after a certain skip time missing reagent,

sample, or solution in the well. Skip time can be set in the edit box below

“STAT: load sample without stopping”: user can enable this option if he does not want that at the beginning of a

STAT instrument stops to ask to insert STAT samples in the sample tray. Of course user should insert STAT samplesimmediately when requested to software

“Change service password” and “Change method password” allow the user to modify password needed to accessservice menu and to modify methods in method editor.

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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.


HARDWARE MENU

In this menu user can set the COM Port

used for the communication between PC

and instrument (“Photometer area”) and

communication

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: [email protected] · www.human.de

humastar 80

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