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HumaLyzer 3500 | User Manual

| Cat.No. 16801/1

Revision List of the Manual No. 1 2 3

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Rev. / Date 01/2006-12 02/2007-03 03/2008-07

REVISION DESCRIPTION First edititon Correction of typing errors Flow Cell Cleaner for Maintenance

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1 INTRODUCTION This manual is considered as a part of the instrument; it has to be at the operator’s hand as well as at the maintenance operator’s availability. For accurate installation, use and maintenance, please read the following instructions carefully. In order to avoid instrument or personal damages, carefully read the ”GENERAL SAFETY WARNINGS”, describing the suitable operating procedures. In case of breakdowns or any troubles with the instrument, apply to the local Technical Service. 2 USER WARRANTY HUMAN warrants that instruments sold by one of its authorised representatives shall be free of any defect in material or workmanship, provided that this warranty shall apply only to defects which become apparent within one year from the date of delivery of the new instrument to the purchaser. The HUMAN representative shall replace or repair any defective item at no charge, except for transportation expenses to the point of repair. This warranty excludes the HUMAN representative from liability to replace any item considered as expendable in the course of normal usage, e.g.: lamps, valves, syringes, glassware, fuses, diskettes, tubing etc. The HUMAN representative shall be relieved of any liability under this warranty if the product is not used in accordance with the manufacturer's instructions, altered in any way not specified by HUMAN, not regularly maintained, used with equipment not approved by HUMAN or used for purposes for which it was not designed. HUMAN shall be relieved of any obligation under this warranty, unless a completed installation / warranty registration form is received by HUMAN within 15 days of installation of this product. This warranty does not apply to damages incurred in shipment of goods. Any damage so incurred shall be re-ported to the freight carrier for settlement or claim. 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.

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5 DISPOSAL MANAGEMENT CONCEPT The currently valid local regulations governing disposal must be observed. It is in the responsibility of the user to arrange proper disposal of the individual components. All parts which may comprise potentially infectious materials have to be disinfected by suitable validated procedures (autoclaving, chemical treatment) prior to disposal. Applicable local regulations for disposal have to be carefully observed. The Instruments and electronic accessories (without batteries, power packs etc.) must be disposed of according to the regulations for the disposal of electronic components. Batteries, power packs and similar power source have to be dismounted from electric/electronic parts and disposed off in accordance with applicable local regulations. 6 INSTRUMENT DISINFECTION Analytical instruments for in vitro diagnostic involve the handling of human samples and controls which should be considered at least potentially infectious. Therefore every part and accessory of the respective instrument which may have come into contact with such samples must equally be considered as potentially infectious. Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be decontaminated/disinfected. Decontamination/disinfection should be performed by a authorised well-trained personnel, observing all necessary safety precautions. Instruments to be returned have to be accompanied by a disinfection certificate completed by the responsible laboratory manager. If a disinfection certificate is not supplied, the returning laboratory will be responsible for charges resulting from non-acceptance of the instrument by the servicing centre, or from authority’s interventions. 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.

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

BIOHAZARD The „BIOHAZARD“ warning label must be affixed to instrument prior to first use with biological material !

Servicing Note:

Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be decontaminated. Decontamination should be performed by authorised well-trained personnel only, observing all necessary safety precautions. Instruments to be returned have to be accompanied by a decontamination certificate completed by the responsible laboratory manager. If a decontamination certificate is not supplied, the returning laboratory will be responsible for charges resulting from non-acceptance of the instrument by the servicing centre, or from authority’s interventions.

HUMAN Gesellschaft für Biochemica und Diagnostica mbH | Max-Planck-Ring 21 · 65205 Wiesbaden · Germany | Tel.: +49 61 22/99 88-0 · Fax: +49 61 22/99 88-100 | e-Mail: [email protected] · www.human.de

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Contents

1

INTRODUCTION

3

2

DESCRIPTION OF THE ANALYZER

3

2.1 Technical specifications

4

INSTALLATION

5

3.1 Packaging

5

3.2 Rear panel setting

5

3.3 Location of the instrument

6

3.4 Power supply connection

6

3.5 Caution

6

3.6 Measurement block

7

3.7 Tube setting

7

3.8 Incubator

8

3.9 Printer settings

8

4

MAIN MENU

9

5

SETUP MENU

11

6

ARCHIVES MANAGEMENT

14

6.1 Database dimensions

14

6.2 Edit Method 6.2.1 Select one method and the relevant parameters will appear as follow: 6.2.2 List of the method parameter requirements for each test: 6.2.3 Create New method: 6.2.4 Edit method: 6.2.5 Erase method:

17 18 22 23 23 23

6.3 Edit Control

23

6.4 Graphic QC

24

6.5 Delete Archives

27

6.6 Delete Archiv. Method

27

OPERATING TIPS

28

7.1 How to aspirate the liquids into the flowcell 7.1.1 Instruction for a correct aspiration:

28 28

7.2 Manual reading mode

28

7.3 Washing

28

7.4 Reset and switching off

29

7.5 Using Manual Cuvette

29

RUN METHOD

30

8.1 Recall method

30

8.2 Blank (Zero-setting)

33

8.3 Production of Standards

33

8.4 Standard confirming procedure

33

3

7

8

8.4.1

Procedure:

34

8.5 Sample measuring 8.5.1 Name assignment criterion 8.5.2 ID assignment criterion: 8.5.3 Test repetition 8.5.4 Processing QC controls

35 36 36 36 36

8.6 External keyboard functions

38

9

ABS MENU

39

10

WASHING MENU

39

11

MAINTENANCE

40

11.1 Cleaning procedures:

40

11.2 First installation

40

11.3 Daily cleaning

40

11.4 Empty the waste tank

40

11.5 Special cleaning

40

11.6 Further advice

41

11.7 Lamp changing procedure

41

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1 INTRODUCTION The HumaLyzer 3500 is a semi-automated, programmable photometer intended for In Vitro Diagnostic (IVD) use by qualified laboratory staff only. For best results become familiar with the instrument and its capabilities before attempting any clinical diagnostic tests. Refer any questions to your HUMAN distributor. 2 DESCRIPTION OF THE ANALYZER Technical features: -

Touch screen with virtual alphanumeric keyboard. Multilingual capability, up to 6 different languages (including Chinese characters). 200 programmable tests. 1000 results storing capability ordered by date. Intelligent patient methods management inbuilt QC (quality control) Built-in eight position incubation block. Integrated pump and flow cell. Programmable aspiration features (with re-run capability) Internal pre-adjusted Peltier element at 25°C, 30°C, 37°C. 16 different QC values storage capability. 25 QC archives with 100 results capability.

It performs: -

End Point Kinetic Fixed Time Multistandard methods

Results are shown on graphic display and printed on paper by built-in printer.

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2.1

Technical specifications

Graphic Display

320x240 (1/4 of VGA)

Patient name length

16 characters

Max test storage

1000 tests

External interface

-

PS2 external keyboard (connection on rear side of instrument)

-

RS232

Light source

Halogen lamp 12V, 20W

Photo detector

Silicon based (range 300-1000nm)

Wavelengths

340nm-700nm.

Wavelength selection

Automatic via 8-position filter wheel; 6 standard interference filters: 340nm, 405nm, 505nm, 546nm, 578nm, 630nm. Two free positions for optional filters.

Photometric Range:

0-2.5 O.D.

Flow cell system

32µL flow cell with 10mm light path, interchangeable with disposable macro, semi-micro, or special optical glass cuvettes.

Reading time

1-999 seconds

Incubation time

5-999 seconds.

Temperature control

Peltier elements, 25°C, 30°C and 37°C.

Reaction volume

500 µL per test.

Printer

Graphic, 24 characters per line.

Printing sort

Batch, profile, reaction dynamics, QC print, Levey Jennings graph curves

Dimensions

Length 33cm x width 34cm x height 18cm.

Weight

8.5kg

Power supply

110-230 AC 50-60 Hz.

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3 INSTALLATION 3.1

Packaging

Inside the package there is a starting kit composed of the items listed below including a User Manual which explains how to correctly install the instrument. If any of the following items are missing or damaged, please contact HUMAN for help. 3.2

Touch Stylus Fuse 2A Main Cable Waste Kit 1 Roll of thermal paper User Manual

Rear panel setting

Located in the rear panel (from left to right as shown in the picture) you will see: 1 2 3 4 5

Fan for internal cooling. Power supply switch. Waste outlet. RS232 connection PS2 External keyboard connection

5) PS2

4) RS232, IBM printer compatible

1) FAN

2) POLYSNAP and POWER SWITCH

3) OUTLET

WASTE OUTLET: Before switching on the instrument, remember to connect the plastic outlet connector (red) to a waste tank by means of a silicone tube.

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3.3

Location of the instrument

The instrument should be located in a clean environment, placed on a stable surface, and away from direct sunlight, which could affect the operating temperature and the quantity of light measured by the instrument. The following points should be taken into consideration. -

-

3.4

Ensure that it is on a level surface. Avoid positions subject to jerks or vibrations. Make sure that the instrument is not placed close to air conditioning or heat sources. For the long life of the instrument these temperature conditions should be followed: 5°C - 50°C for instrument storage. 15°C - 30°C for instrument use. Avoid excessive dust

Power supply connection -

-

Please check the setting of the power supply switch according to your country’s electrical network. Connect the power plug to a good grounded AC wall outlet, preferably one that is not shared with other electric appliances and with low fluctuation of line voltage compared to the standard voltage specified (10-15%). Keep the instrument away from other appliances that generate high frequency electrical noises (e.g. radiological instruments). Before connecting the power cord, check that the AC power supply corresponds to the value that is stated on the instrument’s label.

Label:

‡

HumaLyzer 3500

Human GmbH Max Planck Ring 21 65205 Wiesbaden Germany

100/230V AC 50-60 Hz 75W 2A T

[REF] 16800

[IVD]

[SN] 3.5

|

1001

Caution

Do not connect the instrument to a power supply different from the value indicated on the label. -

Before connecting the power, make sure that the instrument is turned off (main switch on the back of the instrument). Make sure that your AC main line has an efficient ground line. A bad ground line connection may compromise analysis results and damage the instrument. Do not spill liquids or micro solid substances on or around the instrument.

If the above procedures are carefully followed, it will be possible to TURN ON the instrument by using the main switch.

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3.6

Measurement block

Open the measurement block cover lid, positioned on the top left part of the instrument. Inside you will see:

3.7

-

Peristaltic pump that allows the solution to enter the instrument for measurement.

-

Incubator well which keeps the flow-cell or manual cuvette at the temperature of approximately 37° C.

-

Inlet tube. Tube setting

Make sure that the transparent tube (the one that connects the flow-cell with the internal hydraulic circuit) is not twisted or squashed. Place the red tube around the peristaltic pump and make sure that the white plastic connections are set as shown in the figure below:

PUMP

RED TUBE

INLET TUBE

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CUVETTE POSITION

Under the measurement block there is a lever (the PUSH button). Do not keep the lever pressed for more than half a second .

3.8

Incubator

The incubator temperature is brought up to 37 °C by the software and it will remain constant until the instrument is turned off. NOTE: It is very important to heat the macro cuvettes to the proper temperature for obtaining the most accurate analysis results.

Built-in incubation block.

3.9

Printer settings

To insert the paper roll, proceed as follows: -

Switch on the instrument. Remove the printer cover by lifting the lever (see picture). Raise the printer cover. Take a new paper roll and pass the edge of the paper under the black rubber cylinder. Close cover.

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Lift Lever to open cover and access paper roll (use thermal type)

4 MAIN MENU 1. Switch on:

Start up the instrument from the main power switch located on the rear side of the instrument. 2. First screen: User name screen, enter the operator code by the internal or external keyboard than press SAVE button. Now the software will proceed to main menu. The operator code will be displayed at the beginning of each method analysis. 3. To skip this option and proceed to main menu just press EXIT Main menu: The main menu is composed of 6 options, which can be selected by scrolling over the messages. Every option is linked to a function of the instrument:

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The main screen will show all the instrument options as following: MESSAGE

DESCRIPTION

Run method

Press on this message and the list of methods available for test will be displayed. To return to main menu press EXIT button.

Archives management

Press on this message to enter in the memory management of the instrument. To return to main menu press EXIT button

Set up

Press on this message to enter in the hardware and software settings of the instrument. To return to main menu press EXIT button

Utility

Printing

-

Absorbance reading: Press on this message to enter in ABS test on sample with programmable volume and filter with zero option.

-

Host: Command to connect to dedicated host PC software.

-

Exit: To return to main menu

Press on this message to enter in the printing options. It will be possible to print: -

patient test results

-

patient profile report

-

QC values

-

List of tests

-

Test Parameters

To return to main menu press EXIT message Washing

Press on this message to activate the peristaltic pump for several seconds where it will be possible to rinse the flow-cell with cleaning solution or distilled water.

Time and Date:

This window shows the time and date memorised in the instrument. The instrument is equipped with a back-up battery so the memory is active also with instrument switched off. In case set new time and date from Setup menu.

Feed button:

Press this button to feed paper out from the printer.

Temperature

This window shows the current temperature in the flow-cell reading well. When this number is flashing, it means that the temperature has not reached the target; in these cases wait until the indicator stops flashing.

Software release:

This message shows the software release loaded in the instrument. In case of software update, this date will change.

Up and Down Arrows:

Use the up and down arrows to move to different options over the screen. The different option will be highlighted once selected.

Enter arrow:

Enter button, once one option is selected on the screen, in order to confirm the choice press this button.

Exit Button:

Press this button to exit from all menus and return to main menu.

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5 SETUP MENU From main menu press setup message, the following screen will appear:

From set up menu it is possible to customise the instrument features for the best fit the operator needs. Scroll the menu by using the up and down arrows. MESSAGE

DESCRIPTION

Temperature cuvette

Select the flow cell working temperature using the left and right arrows. Available temperatures: 37° C, 30° C and 25° C NOTE: Give adequate time for the incubator to reach the set temperature. Specially when changing the temperature from a higher to a lower value during one session.

Language

Select the language using the left and right arrows. Available languages: English French Italian

Print enable

Enable or disable the printer using the left and right arrows. - YES: Print enable - NO: Print disable

Print method

To decide whether or not to print the method (please refer to PRINT MENU for information about printing format) press: Enable or disable the method print using the left and right arrows. - YES: to print the method. - NO: not to print the method. Press SAVE button to store changes.

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Print result

To decide whether or not to print the patient result when running a test method (the result can be printed at the end of work) press: Enable or disable the result print using the left and right arrows. - YES: to print the result. - NO: not to print the result. Press SAVE button to store changes.

Graphic Print

To decide whether or not to print the graphic when running a test method (for kinetic or fixed time) press: Enable or disable the dynamics print using the left and right arrows. - YES: to print the graphic. - NO: not to print the graphic. SAVE button to store changes.

Temperature incubator

Enable or disable the incubator warm up using the left and right arrows. Press SAVE button to store changes.

Hour

Set the current hour using the number keys

Minutes

Set the current minutes using the number keys

Day

Set the current day using the number keys

Month

Set the current month using the number keys

Year

Set the current year using the number keys

Gap Delay

NOTE:

The HumaLyzer 3500 aspiration is divided in two actions:

Sample Aspiration: The pump aspires the volume amount set in test parameters. Air Gap:

The pump aspires a fixed air amount after the sample has been aspired.

GAP DELAY:

This command inserts a delay time between the sample aspiration and the air gap aspiration.

Delay time is defined in milliseconds; default value 1 milliseconds. This feature allows the operator to prepare a sample test for a double check in the same disposable reaction cuvette: Example: 1.

Glucose 500µl minimum volume for sample test.

2.

Prepare a double test solution to be tested ex: 1 ml in cuvette.

3.

Program delay time 3000 milliseconds (equivalent to 3 seconds)

Set cuvette under inlet pipe and aspire 1st test (500µl) by pressing Push Button, now you will have 3 seconds time to extract the cuvette from the inlet pipe. After measurement, set again cuvette under inlet pipe and aspire 2nd test (500µl left in cuvette) by pressing Push Button.

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Automatic Empty

To decide whether or not to activate the peristaltic pump after sample measurement. Enable or disable the peristaltic pump using the left and right arrow keys. -

YES: After sample measurement the pump will be activated and sample emptied in waste bottle.

-

NO: After sample measurement, the pump will be not be activated and sample will remain in the flow cell. In this way it is possible to repeat the reading by pressing the Rep. Button. In order to empty the flow cell, aspire new sample or press Wash button.

Press SAVE button to store changes. Save button:

Press this button to SAVE changes.

Exit Button:

Press this button to exit from all menus and return to main menu.

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6 ARCHIVES MANAGEMENT 6.1

Database dimensions

The HumaLyzer 3500 keeps in memory the database in two different hardware parts, one is the EEPROM and the other is the Flash memory. The HumaLyzer 3500 archives are the following:

Languages:

Up to 6 different languages management.

Methods:

200 programmable methods

QC for each method:

Up to 3 different QC levels for each method.

Results:

1000 results storage capability ordered by date. This is a circular buffer and so the result number 1001 will be automatically superimposed to result number 1.

QC

Up to 16 different controls can be memorised, each one holds up to 200 results.

QC results

25 QC archives holding 100 results each.

NOTE: The HumaLyzer 3500 has 1000 test results memory capability. If the test number exceeds this capacity, the new values will be superimposed over the old ones.

From main menu press Archives Management message. To return to main menu, press EXIT message

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MESSAGE

DESCRIPTION

Edit Method

Press on this message to enter the method parameter. A list of the entire methods present in the memory will be visualised. Press the relevant method to be edited or viewed. To return to main menu press EXIT button.

Edit Control

Press on this message to enter in the Quality Control name list. In this menu, it is possible to name the control serums used in the QC menu. Note:

When the instrument is new, no control names will be memorised, the available positions are visualised with the message: New QC. Note: It is possible to insert up to 16 controls.

Note:

Up to 15 characters are allowed.

How to edit a control: -

Press on the first free position, a virtual keyboard will be visualised.

-

As operator requires, digit the control name or Lot or the control concentration (low, normal or high), then press SAVE button.

-

Now a new control name will be visualised in the list.

Note: the values of all the controls will be memorised in the method parameters. How to delete a control: -

Press on the control name to be deleted, a virtual keyboard will be visualised.

-

Press Del button

-

Press Save button

Delete Archives

In order to delete all the results and names resident in memory for all tests, press this button.

Del Arch. Method

Delete Archive Method: In order to delete all the results resident in memory for a specific test, press this button. The list of available methods will be displayed. Select with the up and down arrows the test results to be deleted for a specific method. Press the dust-bin button to delete.

Graphic QC

In this menu, all the Control Quality values for all the control serums previously memorised are visualised. Press on this message to show the Quality Control list. To view a method QC database, select the relevant method, a QC screen will open showing the following: -

Levey Jennings graph

-

Westgard Rules

-

Centred value

-

Mean

-

SD: Standard Deviation

-

CV: Coefficient of Variation

Note: A Print button is available to print all the QC values and their date of performance. Note: A graph button is available to print all the Levey Jennings chart

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Exit

Press this button to exit from all menus and return to main menu.

Edit Button:

This button is present in every method of the Graphic QC menu. Press Edit button to view and edit a specific value of the QC database. This button is present in every method of the Graphic QC menu. Press this button to print the list of QC values for each method. QC Print Format:

11/01/2005 015- GLUCOSE Date

ABS

Result

09/02

0.345

101.4

mg/dl

10/02

0.341

100.2

mg/dl

12/02

0.347

101.9

mg/dl

N. Samples 3 Average: 101.1 Use this button to print Levey-Jennings graph Bin Button

Press this button to delete the selected item. -

Delete method

-

Delete Arch. Method

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6.2

Edit Method

NOTE: HumaLyzer 3500 applications are loaded into the memory during System installation and are ready to use with HUMAN reagents. NOTE: Editing the method parameter files incorrectly may affect the calculation of the results and may produce erroneous results. Press Archive Management menu and the following screen will appear:

Choose Edit method, the list of methods present in memory will appear. -

Use the up and down arrows to move to different options over the screen. The different option will be highlighted once selected. Use the Page up and down buttons to move between the list pages. Use the Home and End buttons to move to the limits of the list.

In the Edit method menu there are three options: -

Create a new method Edit a method present in memory Delete a method

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6.2.1

Select one method and the relevant parameters will appear as follow:

MESSAGE

DESCRIPTION

N. Method

Select this option and press virtual keyboard, insert the Assay name than press SAVE. The name will be saved in the memory and shown in the list.

Method Type

Method Reading Type: -

EP:

END POINT

-

KIN:

KINETIC

-

FXT:

FIXED TIME

-

EIA:

ELISA

Select the different options by using the left and right arrow keys. Zero

Setting the instrument to Zero: -

WATER

-

BLANK

-

SAMPLE BLANK

Select the different options by using the left and right arrows. Units

Measurement units g/dl, mg/dl, g/dl, g/l, mg/l, g/l, g/ml mg/ml UI/l, UI/dl UI/ml, mUI/ml mEq/l, mol/l, nmol/l, mmol/l, %, ABS select the different options by using the left and right arrows.

Temperature

Flow cell temperature: -

OFF (room temperature)

-

25° C

-

30° C

-

37° C

Select the different options by using the left and right arrows keys. Calibration

Calibration mode: Different screens will appear according to the calibration mode: Select the different options by using the left and right arrows. FACTOR CALIBRATION: 1. Select: Calibration NO 2. Then press down arrow 3. The Factor box will be displayed. 4. Insert the numeric value for the factor. Use the number keys to enter the numeric value, press C to delete. STANDARD CALIBRATION: 1. Select: Calibration YES 2. Then press down arrow 3. The Factor box will be displayed. 4. Insert the number of standards by using the left and right arrows (From 1 to 9). 5. Then press down arrow 6. Insert the Standard concentration values. (The standard values required are equal to the standard number inserted).

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NOTE: In order to display all the concentrations, use the up & down arrow keys to choose the amount of times needed (for example: if 5 has been chosen as the number of the standards and all the standard concentrations have been inserted, use the keys to scroll and check all the standard concentrations). The standards have to be inserted from the lowest to the highest value Sample (µl)

Insert the sample volume used in the method.

Reagent 1 (µl)

Insert the reagent 1 volume in microliters NOTE: Sample volume + Reagent 1 volume + Reagent 2 volume > =500 µl

Reagent 2 (µl)

Insert the reagent 2 volume in microliters.

Filter

Select the method wavelength required; the different filters can be selected by using the left and right arrow keys.

Normal Max.

Insert Maximum normal value for the method parameter. NOTE: If this option is not programmed (i.e. all values are left at zero), the software will not take these values into consideration when checking the results.

Normal Min.

Insert Minimum normal value for the method parameter NOTE: If this option is not programmed (i.e. all values are left at zero), the software will not take these values into consideration when checking the results.

Max. ABS

Insert the maximum ABS value for samples that method reaction supports (this value depends on reagent specifications and method parameters inserted). This value is important to evaluate reactions with positive gradient. NOTE: If this option is not programmed (i.e. all values are left at zero), the software will not take these values into consideration when checking the results.

Min. ABS

Insert the minimum ABS value for samples that method reaction supports. (This value is useful to detect problems of not active or too much active reaction). This value is important to evaluate reaction with negative gradient. NOTE: If this option is not programmed (i.e. all values are left at zero), the software will not take these values into consideration when checking the results.

Delta ABS

Insert the maximum Delta ABS (ΔABS) value for samples that method reaction supports (this value depends on reagent specifications and method parameters inserted). NOTE: If this option is not programmed (i.e. all values are left at zero), the software will not take these values into consideration when checking the results.

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Inc. Time

The delay time is the length of time between the moment at which the sample is placed into the flow cell (or cuvette) and the point when temperature and motion within the sample stabilises. In this software it is not programmable and it amounts to 2 seconds. The Incubation time is the period of time that the reaction needs to develop its real ABS gradient. This time is always greater than delay time so the delay is not considered for kinetic and fixed time. In fact the software provides a minimum incubation time of 10 seconds. ABS

sec

Delay tim e Incubation tim e

Reading Time

Reading tim e

Digit the Reading time (in seconds) for the reaction by using the side number keyboard. The Reading time is the period of time the reaction takes to reach its real speed and during this time the instrument achieves one measure per second. NOTE: The reading time for EP method is fixed. NOTE: Reading time option will be available only if Kinetic and Fixed time reading type have been selected.

Name QC 1

Select one of the QC control names, previously programmed in Edit controls menu. View the different Controls by using the left and right arrows.

Value QC 1

Digit the control serum centred value for this specific method by using the side number keyboard.

Standard Dev. QC 1

Digit the control serum 2 SD value for this specific method by using the side number keyboard.

Name QC 2

In order to use a second control serum programmed in Edit controls menu, select one of the QC control names, previously programmed in Edit controls menu. View the different Controls by using the left and right arrows. NOTE: The QC 2 must be different from the QC 1.

Value QC 2

Digit the control serum centred value for this specific method by using the side number keyboard.

Standard Dev. QC 2

Digit the control serum 1 SD value for this specific method by using the side number keyboard.

Name QC 3

In order to use a Third control serum programmed in Edit controls menu, select one of the QC control names, previously programmed in Edit controls menu. View the different Controls by using the left and right arrows.

Value QC 3

Digit the control serum centred value for this specific method by using the side number keyboard.

Standard Dev. QC 3

Digit the control serum 3 SD value for this specific method by using the side number keyboard.

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Keyboard:

Press this button to recall the virtual keyboard for the following: -

Name an Assay Method

Save button:

Press this button to SAVE changes.

Up and Down Arrows:

Use the up and down arrows to move to different options over the screen. The different options will be highlighted once selected.

Exit Button:

Press this button to exit from all menus and return to main menu.

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6.2.2

List of the method parameter requirements for each test:

x

Field

EP

KIN Elisa

FXT

Note

1

Name

*

*

*

*

Max characters allowed 16, max characters displayed 11

2

Type

*

*

*

*

Type of reading: Kinetic, Endpoint, Fixed Time, Elisa

3

Zero

*

*

*

*

0 = H2O, 1 = Blank, 2 = Sample Blank

4

Units

*

*

*

*

unit of measurement

5

Temperature

*

*

*

*

0 = Off 1 = 25°C 2 = 30°C 3 = 37°C

6

Calibration

*

*

*

*

Type of Calibration

7

STD Number

*

*

*

*

Number of Standards (1 – 9)

8

STD concentration * [max 9]

*

*

*

Standard Concentration Value.

9

K Factor

*

*

*

*

K Factor (Range 0.01-99999)

10

Sample (μl)

*

*

*

*

Sample Volume (Min 1 μl)

11

Reagent 1

*

*

*

*

Reagent Volume (Min>= 100 μl max 3000 μl)

12

Reagent 2

*

*

*

*

Reagent Volume (Range 1- 1000µL) R1+R2+S Max. Conc. value defined for the test in Control menu.

Pathological evidence. Corrective Action Review the result and report as over than the normal high range value. Dilute the sample and rerun. Pathological evidence. Corrective Action Review the result and report as under than the normal low range value. Concentrate sample and rerun.

Probable Cause Sample concentration is greater than the linearity defined on the parameter page of the Method. Corrective Actions Dilute the sample and rerun. M

Linearity high ABS value > Max. ABS. value defined in Control menu. (For Kin and FXT) (Expressed in Probable Cause ABS value) Sample ABS value is greater than the Reaction Linearity Range defined on the parameter page of the Method. Corrective Actions Dilute the sample and rerun.

m

Linearity low ABS value < Max. ABS. value defined in Control menu. (For Kin and FXT) (Expressed in Probable Cause ABS value) Sample ABS value is lower than the linearity defined on the parameter page of the Method.

D

Reaction Check for Delta Value (Expressed in Δ ABS) is outside the range

T

Target Reached

Δ ABS reaction test value>ABS Max.Delta Probable Cause Sample concentration is greater than the Reaction Linearity Range defined on the parameters page of the Method. Corrective Actions Dilute the sample and rerun.

Not The target temperature for the reading well (37, 30 or 25° C) has not been reached. Probable Cause The instrument has just been switched on. Corrective Action Wait some minutes for increasing of temperature. Wait for temperature target.

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8.6

External keyboard functions

HumaLyzer 3500 is capable to operate with a standard PC keyboard (American type). Connect the keyboard jack PS2 with the relevant socket placed on the rear side of the instrument. The flowing keys simulate the touch screen functions: Key

Function

F1

Simulates the Push Button

F2

“No” command

F3

Edit Kf / Edit method

F4

Edit ID

F5

Edit Patient Name

F6

Delete (Method, QC, etc.)

F7

Edit standard

F8

Activate video keyboard/enter in test TS

F9

Enter in touch screen test menu/calibration touch screen

F10

Save / Yes /save calibration TS

X

Enter in Calibration touch screen

C/c

Deletes current and indicates the next free ID.

G/g

Print Graph under request/print Levey-Jennings graph

L/l

Washing

N/n

No

P

Paper Feed/ Print Absorbance Value/ Print QC list

R/r

Repeat reading

S/s

Yes

Esc

Exit

Ctrl ←

Reading by touch screen command

Ctrl ↑

Select QC1

Ctrl →

Select QC2

Ctrl ↓

Select QC3

“SRV”

Select service menu

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9 ABS MENU ABS mode is a service function, useful to test the ABS of sample with a programmable wavelength. To use this function, first you have to set the instrument to zero with blank material. The instrument will set up the optical filter (showing the current wavelength). Set the test tube of water (or other substances) in the inlet pipe and press the PUSH button. After a few seconds, continuous evolution of the ABS value will appear on the display. During the screening the following options must be chosen: -

Press 0 key to have zero on the current ABS value (blank material). Prepare a new sample (reagents, potassium-dichromate or others) and press the PUSH button to start a new ABS measurement session.

At the screen exit, the instrument expels the volume from flow cell via the waste outlet. SELECTION KEYS: -

Press the PUSH button to fill the flow cell with the sample. Press 0 key to choose the zero value. Press exit button to return to main menu.

10 WASHING MENU After each session of measurements, it is recommended that to wash the flow cell with distilled water. Washing is possible every time: -

Within the MAIN menu Within the RUN Mode Within the ABS Mode.

For washing the flow cell press the Wash button, so the pump will drain away the water at high speed into the flow cell. After the washing, it is necessary to repeat the operation without water so that the water remaining inside the instrument can be expelled completely. This is very important for not altering the following measurement.

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11 MAINTENANCE There are no user serviceable parts inside the instrument. Refer servicing to qualified service personal. Use only parts authorised by Human GmbH. Failure to do so may void the warranty. Materials required [REF]

18222

FLOW CELL CLEANER Detergent NaOH Sodium azid

0.1% < 0.5% 0.1%

100 ml

HCl

0.1 N

Disinfectant: Propane-2-ol (isopropyl alcohol) Sodium hypochlorite (bleach)

70% or 1.5%

Chemicals

Warning The above chemicals present the following hazards and should be handled with due care: HCl and sodium hypochlorite are corrosive and toxic solutions which cause severe burns. Propane-2-ol (isopropyl alcohol) is highly inflammable and harmful. 11.1

Cleaning procedures:

Press washing command to activate the peristaltic pump for flow-cell washing. The peristaltic pump will aspire for several seconds in order to aspirate distilled water or cleaning solutions. This feature is achievable in each instrument menu (also during sample readings). 11.2

First installation

Perform at least 10 complete washing cycles by using distilled water. Every washing cycle lasts approx. 1 minute and stops automatically.

11.3

Daily cleaning

At the end of each working session, it is necessary to rinse the instrument with FLOW CELL CLEANER([REF] 18222) or propane-2-ol (isopropyl alcohol) via the inlet pipe. Place a cup of detergent solution under the inlet pipe and carry-out the Washing procedure. 11.4

Empty the waste tank

Caution: The waste bottle and all tubing's contain sample and reagent material. This material should be treated as potentially bio hazardous Appropriate waste management should be observed! 11.5

Special cleaning

Every month perform at least 2 complete washing cycles with isopropyl alcohol or sodium hypochlorite (bleach) by using the Washing procedure. NOTE: Do not use corrosive detergents to clean the instrument surface.

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11.6

Further advice

Further advice for correct use and maintenance of the instrument: -

11.7

If the instrument is not being used for a long period of time, empty the hydraulic circuit and disconnect the tubes. When the instrument is in use, keep the two little doors of the instrument (measurement block and printer doors) firmly closed. Clean the external surface of the instrument every month with a non-abrasive detergent. Clean the surface near the two fans every month in order to take off dangerous dust.

Lamp changing procedure Caution: Lamp is hot! Allow the lamp to cool down before handling.

When the lamp is damaged, it is necessary to replace it with a new one by following this procedure: -

Open case of the instrument, remove the four screws under the equipment and the three screws on the back. Remove the two screws at right and left side of flow cell site, and move aside the pump support (with pump rotor). Move aside the little tongue that fixes the lamp by unscrewing the screw. Take out the old lamp and insert the new one carefully, bringing it up to the bottom of the site (pay attention not to touch lamp glass with bare finger). Replace the little tongue and check that the top of the lamp is inside the little hole.

Set up again pump support and equipment case.

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HUMAN Gesellschaft für Biochemica und Diagnostica mbH | Max-Planck-Ring 21 · 65205 Wiesbaden · Germany | Tel.: +49 61 22/99 88-0 · Fax: +49 61 22/99 88-100 | e-Mail: [email protected] · www.human.de