HumaLyzer 3500 User

HumaLyzer 3500
| User Manual
|
Cat.No. 16801/1
Revision List of the Manual
No. Rev. / Date REVISION DESCRIPTION
1 01/2006-12 First edititon
2 02/2007-03 Correction of typing errors
3 03/2008-07 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 operators hand as well as at the
maintenance operators 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 authoritys 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
authoritys interventions.
HUMAN
Gesellschaft fr Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 65205 Wiesbaden Germany
| Tel.: +49 61 22/99 88-0 Fax: +49 61 22/99 88-100
| e-Mail: tech-support@human.de www.human.de
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Contents
1 INTRODUCTION 3
2 DESCRIPTION OF THE ANALYZER 3
2.1 Technical specifications 4
3 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 17
6.2.1 Select one method and the relevant parameters will appear as follow: 18
6.2.2 List of the method parameter requirements for each test: 22
6.2.3 Create New method: 23
6.2.4 Edit method: 23
6.2.5 Erase method: 23
6.3 Edit Control 23
6.4 Graphic QC 24
6.5 Delete Archives 27
6.6 Delete Archiv. Method 27
7 OPERATING TIPS 28
7.1 How to aspirate the liquids into the flowcell 28
7.1.1 Instruction for a correct aspiration: 28
7.2 Manual reading mode 28
7.3 Washing 28
7.4 Reset and switching off 29
7.5 Using Manual Cuvette 29
8 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
8.4.1 Procedure: 34
8.5 Sample measuring 35
8.5.1 Name assignment criterion 36
8.5.2 ID assignment criterion: 36
8.5.3 Test repetition 36
8.5.4 Processing QC controls 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 25C, 30C, 37C.
- 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.
3/41 HumaLyzer 3500 User Manual

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 32L 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, 25C, 30C and 37C.
Reaction volume 500 L 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.
- Touch Stylus
- Fuse 2A
- Main Cable
- Waste Kit
- 1 Roll of thermal paper
- User Manual
3.2 Rear panel setting

Located in the rear panel (from left to right as shown in the picture) you will see:
1 Fan for internal cooling.

2 Power supply switch.
3 Waste outlet.
4 RS232 connection
5 PS2 External keyboard connection
5) PS2 1) FAN 2) POLYSNAP and POWER SWITCH
3) OUTLET
4) RS232, IBM printer compatible
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.

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.
- 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:
5C - 50C for instrument storage.
15C - 30C for instrument use.
- Avoid excessive dust
3.4 Power supply connection

- Please check the setting of the power supply switch according to your countrys 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 instruments label.
Label:
HumaLyzer 3500
Human GmbH
100/230V AC 50-60 Hz
Max Planck Ring 21
75W
65205 Wiesbaden
2A T
Germany
[REF] 16800 [IVD] |

[SN] 1001
3.5 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:
- 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.
3.7 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
CUVETTE
INLET TUBE 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 accu-
rate 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:

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 - 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
Printing 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.

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.
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.
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 500l 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 (500l) 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 (500l
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.
Save button: Press this button to SAVE changes.

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

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

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

3. The Factor box will be displayed.
4. Insert the number of standards by using the left and right arrows
(From 1 to 9).
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 (l) Insert the sample volume used in the method.
Reagent 1 (l) Insert the reagent 1 volume in microliters
NOTE: Sample volume + Reagent 1 volume + Reagent 2 volume > =500 l
Reagent 2 (l) 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
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.
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.

results.
Delta ABS Insert the maximum Delta ABS (ABS) value for samples that method reaction
supports (this value depends on reagent specifications and method parameters
inserted).
results.

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
Delay tim e sec

Reading
Incubation tim e
tim e
Reading Time 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.
number keyboard.
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.
number keyboard.
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.

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 = 25C 2 = 30C 3 = 37C
6 Calibration * * * * Type of Calibration
7 STD Number * * * * Number of Standards (1 9)
8 STD concentration * * * * Standard Concentration Value.

[max 9]
9 K Factor * * * * K Factor (Range 0.01-99999)
10 Sample (l) * * * * Sample Volume (Min 1 l)
11 Reagent 1 * * * * Reagent Volume (Min>= 100 l max 3000 l)
12 Reagent 2 * * * * Reagent Volume (Range 1- 1000L)

R1+R2+S<=400 l not allowed
13 Filter 1 * * * *
14 Normal Max * * * * Max normal concentration (Range 0.001-99999)
15 Normal Min * * * * Min normal concentration (Range 0.001-99999)
16 Linearity Max * * Max Concentration value (Range 0.001-99999)
17 Max ABS * * * * Maximum Initial ABS 2.5
18 Min ABS * * * * Minimum Initial ABS (0.001)
19 Delta ABS x * x * Maximum Delta ABS (0.001-2.5)
20 Time Inc. * * * * Incubation Time (Range 10-300)
21 Time Read * * x * EP = FixedKIN FXT = measurement period (Range 10-300)
22 Name QC1 * * * * Select QC name from list
23 Value QC1 * * * * Insert control value
24 Stand. Dev. QC1 * * * * Insert SD value
22/41
NOTE: In order to avoid errors in method running (during a set series of experiments), it is important not to
modify the CALIBRATION and the method TYPE once the series of experiments have begun. Any
modification to one specific method parameter will automatically erase the calibration in memory, a
new calibration procedure will be requested before running the method.
6.2.3 Create New method:
1. Look for the first free position stated as NEW METHOD in the method list using the up and down arrow
buttons.
2. Select and enter inside the method parameters
3. Name method and set method parameters following method producer specification
4. Save and Exit
6.2.4 Edit method:
1. Select and enter in the method to be edited

2. Make changes
3. Save and Exit
6.2.5 Erase method:
1. Select and enter in the method to be deleted

2. Select Method line and press virtual keyboard button
3. An edit screen for Name will open, press Del. Button and erase Name.
4. Press save button
5. Exit the method parameter
6. Confirm changes, the method will be erased and reported as NEW METHOD in the list.
6.3 Edit Control

When selecting this button, the software enables you to enter a control serum name list. Insert Control name, all
methods located in memory will be displayed in this list.
There are 16 free positions for the QC control serum name.
In EDIT it will be possible to update all names for that specific control serum name. Control information and
Control values to be assigned to the new Control, will be inserted from method parameters located in memory
(See Edit methods).
- Press NEW QC to insert new name of new control in memory.

- A virtual keyboard will open, digit the name.
- Press SAVE to set the name in memory.
- Press DEL and then SAVE to delete a control from list.

6.4 Graphic QC
In Graphic menu it is possible to view and edit method values for each control serum previously memorised.
The different controls defined on the Edit Control page, will be then visualised into the method parameters in order
to select QC (Quality Control) procedure.
Westgard rules
Levey
Jennings
graph
QC Statistic
values
When QC results are completed, the results are saved in the Graphic QC menu. The QC values and statistics can be
viewed from this menu.
The Quality menu will report quality method status, Levey-Jennings graph, QC Data List and Westgard Rules.
Expected concentration and SD can be defined for the method parameters, and Westgard Rules can be viewed to
evaluate the QC. If a Westgard Rule is violated, the OK message will disappear.
Levey-Jennings graphs will be displayed on left side of screen and QC Summary Table is placed on the right side.
The QC Summary Table displays the Westgard QC Rules and Statistics for all the method and levels of QC.
To view the QC Summary screen, select the EDIT button.
24/41
BUTTON DESCRIPTION
The system holds all the QC value points, in case of some QC values need to be excluded
from the QC statistics, due to a wrong processing of QC, perform as follow: Press this button
to visualise the entire QC values list. Select the QC value that need to be excluded, and press
the dust-bin button. Once the value is null a letter * will appear beside. Restore the
excluded value, select it, then press Enter button.
CODES: N: Normal QC value falls in the 2SD range defined for the test. H: QC result value is
Higher of +2SD range defined for test. L: QC result value is Lower of -2SD range defined for
test.*: Excluded QC value.
In order to print all the QC values list for a control serum, press this button.
In order to print the Levy-Jennings graph, press this button.
Exit from menu.

The following table defines each column of the QC Statistics information:
MESSAGE DESCRIPTION
VALUE The expected concentration defined in the calibrator menu
MEAN The actual mean of the QC data
SD The actual standard deviation of the QC data
CV The actual coefficient of variation of the QC data
The following table defines each column of the Westgard Rules information:
RULE WESTGARD RULES DESCRIPTION
1_2S One control value exceeds 2 standard deviations.
1_3S One control value exceeds 3 standard deviations.
2_2S Two consecutive control values for one level exceed 2 standard deviations.
R_4S The difference between two consecutive controls values exceeds 4 Standard deviations.
4_1S Four consecutive control values for one level exceeds 1 standard deviation.
10X Ten consecutive control values for one level lie on one side of the mean.
Westgard Rules abbreviation messages:
OK= The rule is satisfied
Other sign= The rule is not satisfied
No sign = The rule cannot be applied. (On rule 5 at least 4 readings are needed and on rule 6 at least 10)
Levey-Jennings graphs will be displayed on left side of screen:
DESCRIPTION
Area of the graph The graph area displays the 1SD range, 2 SD range,
3 SD range. Each accepted QC value within the 3 SD
range is displayed as a dot on the graph.
NOTE: If the value is greater than 3 SD, it is displayed

as a point at the top or bottom of graph.
Centred value of the control serum.
, , The left side of the graph displays the SD (Standard

deviation range)
FIRST The lowest right part of the graph displays the date of
the first QC value performed.
LAST The lowest left part of the graph displays the date of
the last QC value performed.
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6.5 Delete Archives
From this menu it is possible to delete all the patient data stored in the memory.
How to delete:
1. Press message Delete Archives

2. A confirmation message will appear
3. Press YES to delete all the patient database results
4. Press No to exit
NOTE: The HumaLyzer 3500 patient database has 1000 test total memory capability. When the reserved
memory space is over, the new test results will be superimposed to the old ones.
Because of this, we suggest to print the patient test results at the end of each working session
(Batch or Profile print), or at the same time as the test is performed.
6.6 Delete Archive. Method

From this menu it is possible to delete all the patient data stored in the memory only for the specific method
selected.
This feature can be useful when wrong ID number has been inserted. The ID number current order is automatically
generated, but the operator can insert an ID as preferred (from 1 to 9999).
If a too high ID has been wrongly inserted, as 9999, it will block the possibility to operate the test, in this case to be
able to continue it is necessary to delete the Archive for this specific method.
How to delete:
1. Press message Del. Arch. Method

2. The list of test will appear
3. Scroll (highlight) with the up and down arrows the method for which the database must be deleted
4. Press the Bin Button
5. A confirmation message will appear
6. Press YES to delete all the patient database results
7. Press No to exit

7 OPERATING TIPS
7.1 How to aspirate the liquids into the flowcell

After pressing the PUSH BUTTON, this device will aspirate the correct amount of liquid volume according to the
method settings (0.5 to 1ml) and it will stop the aspiration after a perfect filling of the flow-cell.
Additionally, in order to reduce interference and carryover, an air gap will be automatically created between one
sample and another.
7.1.1 Instruction for a correct aspiration:
Aspiration tip 1. Prepare disposable cuvettes with correct amount of

reagent and sample volume according to method.
2. Set aspiration tip inside the cuvette,

be sure that aspiration tip is laying in one corner of
Cuvette the cuvette (see figure A)
3. Then press PUSH BUTTON, the sample will be aspired

automatically.
Figure A
Under the measurement block there is a lever (the PUSH button). Press the lever for no more than half a second to
pump samples into the flow cell.
7.2 Manual reading mode

To perform a measurement manually with a disposable cuvette, see the following instruction:
1. Switch off the instrument

2. Extract the flow-cell from the reading well and leave it free inside the measurement block
3. Switch on the instrument
4. Now it is possible to read the cuvette manually, insert the cuvette into reading well.
5. Close measurement block door and touch the help window (see paragraph 8.1) on screen to take
measurement without activating the peristaltic pump
6. Read the sample
7. Repeat the same operation for the following samples
7.3 Washing
After each session of measurements it is recommended to wash the flow cell with distilled water.
Washing is possible every time, within the Run Mode or within the ABS Mode.
For washing the flow cell press Washing command 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.
This is very important for not altering the following measurement.
28/41
7.4 Reset and switching off
In case of software failure it is possible to reset the instrument by switching it off from main power switch.
To reset the instrument:
- Turn off the switch.

- Wait for 10 seconds.
- Turn on the switch.
Remember that the instrument must only be reset if the software does not work.
To power down the instrument:
- Turn off the main switch.
7.5 Using Manual Cuvette

If there are problems in using the flow cell, it is also possible to use the manual cuvette:
Pump
Cuvette position
Take out the flow cell and its adapter
- Insert the disposable manual cuvette into the cuvette position. Make sure that it is pushed firmly inside.
- If using the cuvette, place into the manual cuvette at least 1000 l of sample.
- Then insert the manual cuvette on the cuvette position press the PUSH button.
- Close measurement block door and touch the help window (see paragraph 8.1) on screen to take measure-
ment without activating the peristaltic pump
Make sure to position the manual cuvette correctly:
Cuvette position
Manual cuvette
Screw Screw
Manual cuvette position
Close the measurement block door before pressing the PUSH button.

8 RUN METHOD
From Main screen press Run Method message, the list of all tests present in memory will be visualised.
8.1 Recall method

1. Use the Page Up and page Down buttons to scroll the test list.
2. Use the up and down arrow buttons to select the test to be run, once the test is highlighted press enter
button
3. In case the standard keyboard has been connected, use the number keys to make a selection by entering the
numbers that correspond to the desired method (for example press 024 to review method number 24).
After a method has been chosen, the run screen will be displayed as follow:
The Run screen is divided in 12 windows, some of them are just for data visualisation (the touch screen feature is
not active in such zones), the other windows visualise information and have the touch screen feature active:
30/41
MESSAGE/BUTTON DESCRIPTION
Number and The list number of the method (from 001 to 200) and the name of the test are visualised.
Method name NOTE: The Touch screen is not active in this position.
Patient Name Insert patient name.
Touch the screen, a virtual keyboard will open, digit the patient name, then press Save
button.
The Patient Name will now be visualised on the main screen.
ABS Absorbance of the current reading.
NOTE: The Touch screen is not active in this position.
Res. Concentration result of the current reading.
Id Patient Identification Number (ID).
ID assignment criterion:
The ID number is automatically set to 1 when the first sample of the first method is run for
the first time of the day.
The first free ID for each Assay will be automatically visualised once the test has been
recalled.
In the patient database each ID corresponds univocally to only one patient name; it is not
possible to have the same patient name linked to different ID numbers.
K (Factor value) This box displays the factor of the method.
If factor needs to be carried out (calibration) and no factor value is present in memory, a
sequence of stars (****) will be displayed.
The instrument keeps in memory the last value also when the instrument is switched off.
S (Standard value Standard concentration Value (STD)
Concentration) In case of need, the STD value can be edited directly from this box without entering in edit
method menu.
How to edit:
After blank measurement has been performed, touch the STD box and the STD edit screen
will open, digit the new standard value and save.
Wash Press this button to activate the peristaltic pump for 10 seconds.
This feature allows to clean the flowcell with distilled water or bleach in case of tubing
dirtiness.
Note: Do not use corrosive reagents because they may damage the metal flow cell.
Rep. In order to repeat the reading for the same ID (same patient) press Rep. and read again
sample, the new result will be superimposed to the previous one.
Next In order to visualise next free ID number, press this button.
Feed Press this button for paper feed.
Help Window This help bar has 2 different functions:
1. The bar displays a sequence of messages, touch the message to command one order.
2. The bar is equivalent to the Push Button, so it will start the reading command without
activating the peristaltic pump.
The help window bar is useful to:
1. Perform manual reading using disposable cuvettes.
2. Repeat readings of same sample. In order to do this it is necessary to disable from
setup menu the automatic emptying of the peristaltic pump.

Print Reaction Press this button to print on graph the reaction dynamic.
Dynamic
Flow Cell Tempera- This box will display the actual flowcell temperature, previously selected from setup menu.
ture
Time Indicator This is the time bar. The black bar will advance showing the remaining time before end of
reaction reading.
Reaction Graphical This is the reaction graph, depending on which method it is running, it displays the
Display following:
End Point and Fixed Time methods:
On axis of abscises the concentration value is reported.
On axis of ordinates the absorbance value is reported.
The calibration line is normally displayed.
Kinetics methods:
During the kinetic readings this graph displays the reaction dynamic in real time.
Once the method is loaded, its parameter will be automatically printed. To decide whether or not to print
automatically the method parameters, please refer to setup menu for information about printing format.
Operating Precautions
Be sure to run a sufficient number of controls in each method. If controls are not within their acceptable units
disregard the test results.
32/41
8.2 Blank (Zero-setting)
The Blank is performed each time the absorbance zero is required from method parameters:
- When the water or the reagent blank is chosen, the zero protocol is performed only once, at the beginning
of the running method.
- When the sample blank zero is chosen, the zero protocol is performed at the beginning of each
measurement (standard or sample measurement) of the relevant running session.
Before pressing the PUSH button, after every standard or sample measurement, it is necessary to fill the
flow cell with zero solution again, after this operation it is possible to proceed to a new standard or sample
measurement.
8.3 Production of Standards

The standard measurement is performed any time the standard calibration type does require it:
- When the standard calibration is selected, perform the standard measurement.

- When the multi calibration is selected, perform for each standard a measurement for the number of times
equal to the number of repetitions programmed in the method.
- The standard protocol is not performed with the Factor calibration so, in this case, after the Blank/Water
zero setting, the program goes directly to the sample measurement.
NOTE: Every time that you change the following parameters:

- Method type.
- Zero type.
- Calibration type.
- Filters.
- Volumes (sample or reagent).
- Incubation and reading time.
The stored standard calibration factors are erased.
8.4 Standard confirming procedure

If the current method has been performed at least once, the old standard results will be retained in the memory
and must be reviewed, confirmed, or modified.
If instead the current method has not been previously performed, the standard value will not appear and the
calibration procedure in the help window will automatically be displayed.
The first time that the program runs, the old factor is the current factor.
The first time that the program runs, the old standard session is the current standard session.

8.4.1 Procedure:
Once a method is recalled from the list, it will ask for blank in the help window box as follow:
1)
CALIBRATING METHOD? YES/NO
1.) Press YES to perform blank reading.

2.) Press NO to skip the blank reading.
2)
NEW BLANK? YES/NO
3.) Press YES to perform blank reading.

4.) Press NO to skip to standard reading (point 4).
3)
INSERT BLANK
1.) Set up (according to the zero type) the water or reagent blank
test tube and fill the flow-cell by pressing the PUSH button.
2.) Wait for a delay time (5 sec.) for the environment to stabilise.
3.) ABS blank value will be acquired.
4)
INSERT STANDARD
1.) Set up the standard solution tube and fill the flow-cell
by pressing the PUSH button.
2.) Wait for a delay time (5 sec.) for the environment to stabilise.
3.) Calibration value will be acquired, the K factor will be displayed
on the relevant box, the instrument will wait for
confirmation order as follow:
ACCEPT CALIBRATION? YES/NO
1.) Press YES to accept the value and proceed to patient analyses
2.) Press NO to refuse last calibration procedure, the help
window will ask the following:
REPEAT CALIBRATION? YES/NO
1) Press YES to repeat calibration from point 4

2) Press NO If the new measurement is unsatisfactory, it is possible
to recover the previous standard and proceed to patient analyses.
In case no calibration factor has been stored in the memory, the instrument
will require the calibration as mandatory, starting from point 3
All calibrations, single point or multipoint, will be graphically visualised on the screen.
34/41
8.5 Sample measuring
It is now possible to measure the samples.
For Kinetic and Fixed Time methods the ABS symbol has to be considered as a delta absorbance value.
To run the program, set up the test-tube with the sample and press the PUSH button.
The instrument will fill the flow cell, take a measurement, and then expel the sample.
During the run for End Point methods the screen displays:
For End Point methods, after the delay time, the result of the standard ABS measurement and the concentration
value are displayed. The result of the sample concentration has a supervisor control (see Flag messages)
- The current sample order number.

- The absorbance value.
- The reading time evolution.
- The current working temperature of the flow cell.
- The graphic calibration point.
- The result of the sample concentration at the end of the measurement,
with a supervisor control (see Flag messages).
During the incubation time and reading time for Kinetic and Fixed Time methods the program will display the
following screen:

During the reading time for Kinetic and Fixed Time methods the screen displays:
- The current sample order number.

- The delta absorbance evolution and the initial and final absorbance values.
- The reading time evolution.
- The current working temperature of the flow cell.
- After the first ten seconds of the reading time, a real time graphic dynamics of the measurement is shown
on screen.
- The result of the sample concentration at the end of the measurement,
with a supervisor control (see Flag messages).
8.5.1 Name assignment criterion

Before to perform patient analysis, touch the Nm patient name box, a virtual keyboard will open, enter the patient
name, then save.
The patient name corresponds univocally to only one patient ID for these analyses.
Also if the patient name is not assigned, the analyses measurement can be performed anyhow.
8.5.2 ID assignment criterion:

The ID number is automatically set to 1 when the first sample of the first method is run for the first time of the
day.
The first free ID for each method will be automatically visualised, once the test has been recalled.
In the patient database each ID corresponds univocally to only one patient name; it is not possible to have the
same patient name linked to different ID numbers.
In order to change the patient ID, touch the ID box and a virtual keyboard will open, insert the required ID, exit and
save. Now the next patient will be identified with the programmed ID number.
8.5.3 Test repetition
1. Just after a patient measurement it is possible to repeat it with the same solution in cuvette. In order to do
this press the REP button on the screen and read, the new measurement value will be superimposed to the
old one.
2. In case the sample repetition will be performed , touch the ID box and a virtual keyboard will open, insert
the required ID, exit and save. Now the result of the recalled patient for that analysis will be displayed, press
the REP button on the screen and read again, the new measurement value will be superimposed to the old
one.
Note: To perform repetition of readings using the flowcell, it is necessary to disable the automatic waste
function. In such way the peristaltic pump will not be activated after patient measurement and the
sample will remain in the flowcell for repetition. To disable automatic serum discharge, set NO
automatic Empty in the setup menu, save and exit.
8.5.4 Processing QC controls

In order to insert in the QC database a control serum value for a specific method, proceed as follow:
1.) During the run session, it is possible to insert 3 control types (QC1 QC2 QC3) for each method type.
2.) To process a QC value, touch the ID box and the virtual keyboard will open.
3.) Now it is possible to choose between 3 different QC (QC1 QC2 QC3) stated in the keyboard keys.
4.) Once the selection is done, automatically in the Nm patient name box the selected QC will appear.
5.) Once the QC reading measurement has been processed, the result will be memorised in a dedicated
database.
6.) This QC database allows to memorise 25 archives handling 100 results each; if the number exceeds 100 the
oldest results will be overwritten (circular buffer). Flag Message
36/41
The following Flag Message might be visualised during the sample methods in the RUN menu and printed beside
concentration result:
MESSAGE FLAG DESCRIPTION

H Patient result Probable Cause
value is higher Pathological evidence.
than normal Corrective Action
range defined
Review the result and report as over than the normal high range value.
for test.
Dilute the sample and rerun.
L Patient result Probable Cause
value is lower Pathological evidence.
than normal Corrective Action
range defined
Review the result and report as under than the normal low range value.
for test.
Concentrate sample and rerun.
D Linearity high Result concentration value > Max. Conc. value defined for the test in Control
menu.
Probable Cause
Sample concentration is greater than the linearity defined on the parameter
page of the Method.
Corrective Actions
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
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 ABS reaction test value>ABS Max.Delta

Check for Probable Cause
Delta Value Sample concentration is greater than the Reaction Linearity Range defined on
(Expressed in the parameters page of the Method.
ABS) is
Corrective Actions
outside the
range Dilute the sample and rerun.
T Target Not The target temperature for the reading well (37, 30 or 25 C) has not been
Reached reached.
Probable Cause
The instrument has just been switched on.
Corrective Action
Wait some minutes for increasing of temperature. Wait for temperature
target.

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
38/41
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.

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 100 ml

Detergent 0.1%
NaOH < 0.5%
Sodium azid 0.1%
Chemicals
HCl 0.1 N
Disinfectant:
Propane-2-ol (isopropyl alcohol) 70% or
Sodium hypochlorite (bleach) 1.5%
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.
40/41
11.6 Further advice
Further advice for correct use and maintenance of the instrument:
- 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.
11.7 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.

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

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3 INTENDED USE OF THE INSTRUMENT [IVD]

4 GENERAL SAFETY WARNINGS

2 DESCRIPTION OF THE ANALYZER

- Touch screen with virtual alphanumeric keyboard.

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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)

Light source Halogen lamp 12V, 20W

Photo detector Silicon based (range 300-1000nm)

Wavelength selection Automatic via 8-position filter wheel;

6 standard interference filters: 340nm, 405nm, 505nm, 546nm, 578nm,

Two free positions for optional filters.

Photometric Range: 0-2.5 O.D.

Reading time 1-999 seconds

Incubation time 5-999 seconds.

Temperature control Peltier elements, 25C, 30C and 37C.

Reaction volume 500 L per test.

Printer Graphic, 24 characters per line.

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

Power supply 110-230 AC 50-60 Hz.

3.2 Rear panel setting

1 Fan for internal cooling.

5) PS2 1) FAN 2) POLYSNAP and POWER SWITCH

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The following points should be taken into consideration.

- Ensure that it is on a level surface.

3.4 Power supply connection

[REF] 16800 [IVD] |

3.7 Tube setting

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Built-in incubation block.

3.9 Printer settings

- Switch on the instrument.

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To return to main menu press EXIT button.

- Host: Command to connect to dedicated host PC software.

- Exit: To return to main menu

Printing Press on this message to enter in the printing options.

It will be possible to print:

- patient test results

- patient profile report

To return to main menu press EXIT message

Scroll the menu by using the up and down arrows.

Available temperatures: 37 C, 30 C and 25 C

- YES: Print enable

- NO: Print disable

- YES: to print the method.

- NO: not to print the method.

Press SAVE button to store changes.

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- YES: to print the result.

- NO: not to print the result.

Press SAVE button to store changes.

- YES: to print the graphic.

- NO: not to print the graphic.

SAVE button to store changes.

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