HumaLyzer Primus User Manual

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Humalyzer Primus

| User Manual

Cat No. 18200100


REVISION LIST OF THE MANUAL
Rev. /DATE. REVISION DESCRIPTION
01/2010-01 First edition
02/2010-07 Correction of typing errors
03/2010-11 Removal of software version statement
04/2011-09 Correction dimension
05/2013-08 Correction of specifications, delivery, minor errors

SYSTEM VERSION

COPYRIGHT

Copyright 2011, Human Gesellschaft für Biochemica und Diagnostica mbH, Wiesbaden,
Germany. All rights reserved.

No part of this documentation may be reproduced in any form, nor processed, copied or
distributed by means of electronic systems, without prior permission of HUMAN in wri-
ting. Since all precautionary measures were taken into account in producing these operating
instructions, the manufacturer accepts no responsibility for any errors or omissions. This
includes any liability for damage that could arise from possible incorrect operation based on this
information. Subject to changes without notice as result of technical development.

SERVICE UND SUPPORT


CONTENTS

TABLE OF CONTENTS

1 SAFETY INSTRUCTIONS 5
1.1 INTRODUCTION 5
1.2 USER WARRANTY 5
1.3 INTENDED USE OF THE INSTRUMENT 5
1.4 GENERAL SAFETY WARNINGS 6
1.5 DISPOSAL MANAGEMENT CONCEPT 6
1.6 BIOHAZARD WARNING 7
1.7 INSTRUMENT DISINFECTION 7

2 SYSTEM DESCRIPTION 11
2.1 UNPACKING 11
2.2 PRODUCT FEATURES 11
2.3 PRODUCT STRUCTURE AND COMPOSITION 12
2.4 INSTALLATION 12
2.4.1 Selecting a proper location for the Instrument 12
2.4.2 Power Supply Requirement 12
2.4.3 Connecting the Instrument to Power Supply 12
2.4.4 Installing the Flow Cell 13
2.5 MAIN STRUCTURE 14
2.5.1 Front View 14
2.5.2 Keypad 15
2.5.3 Back View 16
2.5.4 Internal Printer 16
2.5.5 Flow Cell and Cuvette 17
2.5.6 Lamp and Peristaltic Pump 18
2.5.7 Schematic System Diagram (for Reference only) 19

3 OPERATION 21
3.1 POWERING ON 21
3.2 INTRODUCTION TO MAIN MENUS FUNCTIONS 21
3.3 SOFTWARE USAGE 22
3.4 SYSTEM SETTINGS 22
3.5 SAMPLE TEST 26
3.5.1 Test Parameter Settings 26
3.5.2 Item Test 33
4 REPORT 45
4.1 SAMPLE REPORT 45
4.2 ITEM REPORT 47
4.3 QC REPORT 49
4.4 DELETING RECORDS 50

5 POWER OFF 51

6 MAINTENANCE 53
6.1 OVERVIEW 53
6.2 INSTRUMENT CLEANING 53
6.2.1 Cleaning the Surface of the Instrument 53
6.2.2 Cleaning the flow cell 53
6.3 INSTRUMENT MAINTENANCE 54
6.3.1 Changing the Fuse 54
6.3.2 Adjusting the Peristaltic Pump Tube 54
6.3.3 Changing the Aspiration Tube 54
6.4 BASIC TROUBLESHOOTING 55

7 APPENDIX 57
7.1 TECHNICAL SPECIFICATION 57
CONTENTS
SAFETY INSTRUCTIONS 5

1 SAFETY INSTRUCTIONS

1.1 Introduction
This manual is considered part of the instrument and must be available to the
operator and the maintenance personnel. For accurate installation, use and
maintenance, please read the following instructions carefully.
In order to avoid damage to the instrument or personal injury, carefully read
the ”GENERAL SAFETY WARNINGS”, describing the appropriate operating pro-
cedures. Please contact your HUMAN authorised local Technical Service in the
event of instrument failure or other difficulties with the instrument.

1.2 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 within this
warranty period 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, 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.

1.3 Intended Use of the Instrument


The instrument must be used for its intended purpose (see paragraph 2). It must
[IVD]
be operated in perfect technical conditions, by qualified personnel, in such
working conditions and maintained as described in this manual, in the GENERAL
SAFETY WARNINGS. This manual contains instructions for qualified professional
operators.
6

1.4 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 flat, stationary working surface, that is
free of vibrations.
Do not operate in area with excessive dust.
Operate at temperature and at a humidity level in accordance with the
specifications listed in this manual (chapter x)
Do not operate this instrument with covers and panels removed.
Use only 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.
The 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 environments that are potentially explosive or
at risk of fire.
Prior to cleaning and/or performing maintenance on the instrument, switch off
the instrument and remove the power cord.
Only cleaning materials described in this manual may be used, as other mate-
rials may damage parts. It is recommended to always wear protective clothing
and eye protection while using this instrument.
All warning symbols that appear in this manual must be carefully observed.

1.5 Disposal Management Concept


The applicable local regulations governing disposal must be observed. It
is the user‘s responsibility to arrange for proper disposal of the individual
components.
All parts which may contain potentially infectious materials must be
disinfected by suitable, validated procedures (autoclaving, chemical treatment)
prior to disposal. Applicable local regulations for disposal must be carefully
observed. The instruments and electronic accessories (without batteries, power
packs etc.) must be disposed of according to the applicable local regulations
for the disposal of electronic components.

HumaLyzer Primus | User manual


SAFETY INSTRUCTIONS 7

Batteries, power packs and similar power sources must be removed from
electric/electronic parts and disposed of in accordance with applicable local
regulations.

1.6 Biohazard Warning


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 instru-
ment which may have come into contact with such samples must equally
be considered as potentially infectious.
The „BIOHAZARD“ warning label must be affixed to the instrument prior to first
use with biological material!

FIGURE 1
Biological Hazard
Symbol

1.7 Instrument Disinfection


Before performing 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 must be performed by authorised well-
trained personnel, and in observance of all necessary safety precautions.
8

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SAFETY INSTRUCTIONS 9

Notes:
10

HumaLyzer Primus | User manual


SYSTEM DESCRIPTION 11

2 SYSTEM DESCRIPTION
The product is intended for the in vitro diagnostic [IVD] clinical testing of serum,
plasma, urine and CSF samples.
The HumaLyzer Primus is a semi-automated Chemistry Analyzer.

2.1 Unpacking
Remove all the parts from their package.
When unpacking the instrument, please make sure that the following items are
contained in the packing. In case of damage or missing item, please contact the
supplier immediately.

HumaLyzer Primus 1 [REF]:18200


Flow Cell 1 [REF]:18200/15
User Manual 1 [REF]:18200/100
Power Cord 1 [REF]:18200/75
Spare Fuse 2 [REF]:18200/41
Aspiration Tube 1 [REF]:18200/18
Pump Tube 1 [REF]:18200/19
Lamp assembly 1 [REF]:18200/13
Dust Cover 1 ---
Waste Bottle 1 ---
Cable Tie 4 ---
Printer Paper 2 rolls [REF]:18144/5
RS-232 Cable 1 [REF]:18200/44

2.2 Product Features


- Monochrome LCD, English menu (Spanish, and Russian and French software
available on request).
- Two test modes for single wavelength and double wavelength.
- The following test methods are available:
End-point
Fixed-time
Kinetic
Bichromatic
Absorbance
Multi-point calibration
12

- It can perform sample analysis of serum, plasma, whole blood and urine.
- Compatible with reagents without any specific restrictions.
- Internal printer can print reports and programming parameters, etc.

2.3 Product Structure and Composition


The product is composed of an optical system, a sipper system, a computer con-
trol system and software.

2.4 Installation

2.4.1 SELECTING A PROPER LOCATION FOR THE INSTRUMENT


Find a place that is not exposed to direct sunshine. The surface of the selected
installation location should be flat and provide sufficient space to accommo-
date the HumaLyzer Primus. The front edge of the instrument should be near
the edge of the working table. Avoid significant vibrations on the working table
(for example, do not place a centrifuge on the working table).
The temperature of the
instrument’s operating envi- In order to ensure proper functioning of the instrument, it may not be placed in
ronment must be between the following areas:
10…30°C with a relative humidity - Areas subject to extreme temperature changes
below 70%. - Very hot or cold areas
- Very dusty areas
- Areas near electromagnetic devices that produce a magnetic field
- Areas exposed to direct sunshine

2.4.2 POWER SUPPLY REQUIREMENT


- 110/220Vac ±10%
- 50/60±1 Hz
- 80VA

2.4.3 CONNECTING THE INSTRUMENT TO POWER SUPPLY


1. Insert one end of the power cable into the instrument’s power plug.
2. Insert the other end of the power cable into the power supply’s outlet.

HumaLyzer Primus | User manual


SYSTEM DESCRIPTION 13

Warning:
AC power must be well earthed (near-ground voltage <5V).
The AC power supply must be stable. High-power equipment may not be used
on the same power supply. A voltage-regulated power supply is preferable. In
areas with unstable voltage, please use a UPS power supply to ensure proper
functioning of the instrument.
When removing the power cable, pull on the plug instead of on the power cable.
In the event that smoke, abnormal smell or unusual sound emanate from the
instrument, immediately switch off the power and contact the distributor.

2.4.4 INSTALLING THE FLOW CELL


Open the cover of the light source as shown in the following figure 2.4.4-1.

FIGURE 2
Opening the lamp cover

1. Remove the adhesive tape used to secure the flow cell.


2. Remove the wrapping materials.
3. Place the flow cell into thermostatic bath.
4. Carefully insert the flow cell. Run the aspiration tube through the fixing hole
on the machine; allow it to extend a few centimetres.
5. Close the lamp cover.
14

Warning:
Do not touch the surface of the light inlet window on the flow cell by hand to
avoid transferring grease from your hands onto the window, which will affect
transmittance.
Ensure that the aspiration tube is in the socket. Otherwise, it will cause pressure
build-up and bend the tube, which will affect the test results. This can easily
cause significant bubble formation and increase the water blank.

2.5 Main Structure


This part presents the structure of all major components of the
HumaLyzer Primus.

2.5.1 FRONT VIEW

FIGURE 3
Front view

1. Printer cover
2. Lamp cover
3. Aspiration tube
4. Aspiration key
5. Keypad
6. Power supply indicator light
7. LCD

HumaLyzer Primus | User manual


SYSTEM DESCRIPTION 15

2.5.2 KEYPAD

FIGURE 4
Keypad

Direction keys: Move the cursor in four directions on the screen:


up, down, left and right.
Paper feed key: Manually feed paper; is also the shortcut key
for parameter printing.
Rinse key: Clean the pipeline.

Exit key: Exit the menu and cancel the operation.

Enter key: Confirm the input and save.


16

2.5.3 BACK VIEW

FIGURE 5
Back view

1. Parallel port (not used)


2. RS-232 serial port
3. RS-232 serial port
4. Drain port
5. Power switch
6. Fuse
7. AC input
8. Fan
9. Backplate label
10. Peristaltic pump

2.5.4 INTERNAL PRINTER


HumaLyzer Primus has a built-in thermal printer.

HumaLyzer Primus | User manual


SYSTEM DESCRIPTION 17

2.5.5 FLOW CELL AND CUVETTE


1. Open the lamp cover as shown in the following figure 2.5.5-1.

FIGURE 6
Opening the lamp cover

To open the light source co-


ver, first press the knobs on
both sides of the cover firmly in-
ward and ensure that they recess,
then open the cover in the direc-
tion shown in the figure above.

2. Internal components of the colorimetric system

FIGURE 7
Internal components of the
colorimetric system

- Thermostatic bath
- Flow cell

3. Using the cuvette system

- Remove flow cell from thermostatic bath.


- Place the cuvette with samples into the thermostatic bath.
- All test methods are the same as those in a test using the flow cell system.
18

2.5.6 LAMP AND PERISTALTIC PUMP


1. Open the lamp cover.
2. When changing the lamp, remove the connecting line for the lamp bracket
and power supply, unscrew the fixing screws on the lamp bracket, remo-
ve the lamp bracket, replace the old lamp with a new one and place it in
the same position, then tightly screw in the tightening screws on the lamp
bracket. Reconnect the connecting line for the light bracket and the power
supply firmly.
3. Lamp and peristaltic pump as shown in the following figure:

FIGURE 8
Light source system

HumaLyzer Primus | User manual


SYSTEM DESCRIPTION 19

FIGURE 9
Peristaltic pump system

2.5.7 SCHEMATIC SYSTEM DIAGRAM (FOR REFERENCE ONLY)

FIGURE 10
Schematic system diagram
20

HumaLyzer Primus | User manual


OPERATION 21

3 OPERATION

3.1 Powering On
Flip the power switch on the back of the instrument. After several seconds, a
menu will appear in the screen as shown in figure 3.1-1:
FIGURE 11
Temperature control

After the temperature control process runs for approximately three minutes (if
the ESC key is pressed on the keypad, the system will stop temperature control
and directly enter the software main menu), as shown in figure 3.1-2.

FIGURE 12
Main Menu

3.2 Introduction to main menus functions


1. Test: Edit parameter settings, calibration settings and quality control set-
tings for the test item selected. It will save the parameters automatically af-
ter confirmation and start the test process to perform the test on that item.
2. Report: Perform data administration for the test system. The functions inclu-
de printing by test and patient number, deleting the test results, and sear-
ching the quality control information for the current month.
22

3. Sys. Setup: Set up the basic system functions. It includes printer settings,
power on and off, time settings, and an external administration system to
transmit all test data from the current day.
4. Power off: This will request to wash the tubes before power is switched OFF.
Users can turn off the power supply directly to prevent tubes from being
washed (it is recommended that tubes be washed before shutdown).

3.3 Software Usage


The number in front of the item name corresponds to the number key on the
keypad, for example, if you press number key 1 on the keypad in the main menu,
the system will enter the test menu); ◄► to the right of the name indicates
that the left and right keys on the keypad can be used to change parameter
settings.
in the menu indicates that the up and down keys on the keypad can be used
to select the desired menu item.
Also date and time as well as the current software version is displayed in the
lower part of the display.

3.4 System Settings


System parameters are used to set the fundamental parameters of the instru-
ment such as date and time, etc. Press key 3 and enter the system settings menu
as shown in figure 3.4-1.
The ID: indicates the instrument serial number.

FIGURE 13
System settings menu

HumaLyzer Primus | User manual


OPERATION 23

1. Printer Settings
Press key 1 in the system settings menu. The instrument will enter the following
menu as shown in figure 3.4-2.

FIGURE 14
Printer settings

The instrument is equipped with an internal thermal printer. It can be activated


or deactivated using the ◄► key on the keypad. Instant printing can be reacti-
vated during the test procedure. (Please refer to the printer settings for detailed
settings during the test procedure).

2. Time Settings
In the system settings menu, press key 2. The instrument will enter the follow-
ing menu as shown in figure 3.4-3.

FIGURE 15
Time Settings

Use the ◄► key on the keypad to select the item you wish to change, press the
appropriate number keys to change the current date or time, press the ENTER
key to save and press the ESC key to return to the system settings menu.

3. Data Transfer
In the system settings menu, press key 3 (before this operation, ensure that the
communication cable is connected between the instrument and the external
PC and that the serial interface on the external PC is ready to receive data. The
instrument will enter the following menu as shown in figure 3.4-4. When the
menu shown in figure 3.4-5 appears, it indicates that data transfer is complete.
A special software for receiving data is required.
24

FIGURE 16
Data Transferring

FIGURE 17
Data Transfer finished

4. Optics Settings
In the system settings menu, press key 4 to enter the optics settings menu as
shown in figure 3.4-6. Wavelength X corresponds to the installation position of
the corresponding filters as shown in figure 3.4-7.

FIGURE 18
AD (analog to digital)
display menu

HumaLyzer Primus | User manual


OPERATION 25

FIGURE 19
Layout of filter wheel (facing
the installation side)

1. Checking the AD (analog to digital) Value


Press the RINSE key to aspirate a certain volume of distilled water (the sipper
system must be filled). Press the left or right key ◄► to switch between
wavelengths and check the AD value of the current wavelength.
2. Saving the AD Value
Because the AD value will be taken as a fiducial value for calculation, it
cannot be saved arbitrarily. You only need to save the AD again after filter
replacement or if the system displays a constant “Retest” prompt during a
water blank test.

First, press the RINSE key to aspirate distilled water (the pipeline must be filled)
then press the left or right key ( ◄► ) to switch the wavelength.
After the stable AD value has been determined, press the ENTER key to save the
AD value for the current wavelength. The “Save?” prompt will disappear

Note:
This operation will affect test performance; it is only used to determine whether
to replace the lamp or if “redo” is shown repeatedly during water blanking.
Ensure sufficient water is present in the flow cell during this operation; aspirate
using the “RINSE” key as appropriate.
Pressing the “ENTER” key will only store the AD value for the current filter; other
filters will remain unchanged.
26

3.5 Sample Test


The sample test includes parameter settings and the selected test. Parameter
settings include the test method, test name, unit, temperature, wavelength,
blank, delay time, test time, and aspirate volume, range of the normal reference
value, factor, standard and quality control, etc. The test includes a blank test,
standard test, quality control test and sample test, etc.

3.5.1 TEST PARAMETER SETTINGS

3.5.1.1 Selecting Test Item


Figure 3.5.1.1-1 shows the main menu for test selection. The first line is the sta-
tus column, and the following three lines indicate the test name and its corre-
sponding serial number in sequence. You can use the direction keys, number
keys or name search to select tests. The details are as follows:

FIGURE 20
Test selection menu

1. Select using direction keys: Select tests using the up, down, left or right keys.
The selected test will be highlighted and its number will be shown at the
top-left of the screen.
2. Select by name search: The input methods are displayed at the top-right of
screen as “123” and “ABC”. Use the . key to switch between the two. “123”
indicates numerical input, which allows numbers to be entered directly; the
test will be automatically selected according to its serial number and it will
be highlighted on the display. “ABC” indicates character input, which allows
characters to be entered as indicated on the keypad; the characters will
be displayed at the middle-top of the screen. After you finish entering the
search term, press the ENTER key to automatically select the corresponding
test (there is no response if the search fails to find a corresponding test).

HumaLyzer Primus | User manual


OPERATION 27

3.5.1.2 Confirming Test Parameters


Select a test and press the Enter key to enter the parameters confirmation menu
test as shown in figure 3.5.1.2-1, Press the ◄► key to switch between “QC”,
“STD”, “Edit” and “Ok”, then press the Enter key to enter the corresponding pro-
grammes.

FIGURE 21
Parameters confirmation menu

The meaning of each parameter is as follows:


1st row: Test name, Test method, Unit, Temperature
2nd row: First /Second wavelength, Blank type, Factor, Aspirate vol., Decimal
digits
3rd row: Delay Time, Test Time, Norms high, Norms Low
4th row: QC settings, Standard settings, Parameter settings, Enter test menu
Press the ◄► key to switch between “QC”, “STD”, “Edit” and “OK”, then press
the Enter key to enter the corresponding programmes.

3.5.1.3 Editing Test Parameters


In the parameters confirmation menu, select “Edit”, press the ENTER key, and
the parameter setting for the corresponding test will be opened for editing as
shown in figure 3.5.1.3-1.
28

FIGURE 22
Parameter
editing menus

Basic procedure:
1. Select the test which you wish to edit; move the cursor by pressing on the keypad; the
selected test will be highlighted on the display.
2. To edit the settings: If the right side of the selected test displays test ◄► , it can be edited
using the ◄► key. If the right side displays ► , it indicates that the next editing menu
can be entered using the ► key. If the selected test has a decimal point, it indicates that
decimal points may be entered; otherwise, only integers can be entered.
3. Quick page turning: If the current page does not need to be edited, press the ENTER key to
move to the next page or test process.
4. Test parameter print: In the test parameter settings menu press PAPER to print this test
parameter once the parameter has been set.
5. Press the ENTER key on the last page of the test settings to automatically save the para-
meter settings and enter the test process.

Set all parameters:


1. Test name: The system allows 60 tests to be set, including approximately 39 fixed tests.
Users can define the remaining tests.
2. Select test method: end-point method, two-points method or kinetics method. Choose
the method using the ◄► key.

HumaLyzer Primus | User manual


OPERATION 29

a) End-point method: In the end-point method, the reaction reaches the end
point after a period of time by mixing reagents and sample. The end point
is indicated when, for example, the reaction fluid no longer changes colour
or absorbance. At that time, the absorbance value of the reaction fluid and
concentration of the reaction solution can be obtained on the basis of the
Lambert-Beer Law. The kits for some tests require that tests use dual wave-
length, which allows some interference factors to be eliminated. The instru-
ment supports the dual wavelength test method.
b) Kinetics method: In the kinetics method, a photometer is used to continu-
ously test the absorbance value of the reaction fluid after mixing reagents
and sample. The change of absorbance is tested once the absorbance value
begins to change linearly. The concentration of reaction solution can be ob-
tained on the basis of the Lambert-Beer Law.
c) Two-points method: The two-points method test is a special type of the ki-
netics method test. In this method, the difference in the absorbance value
at two points in the linear section is measured once the absorbance value
begins to change linearly. This allows the concentration of the reaction solu-
tion to be obtained.
3. Unit: Select the unit for the test result. The following 9 units are available:
mg/dl, mg/l, g/L, μmol/l, mmol/l, mol/l, U/l, IU/l and blank. Select the unit
using the ◄► key.
4. Temperature: Select test temperature, 4 settings are available: ambient tem-
perature, 25°C, 30°C and 37°C. Choose the temperature using the ◄► key.
5. First wavelength: Choose the required wavelength in the test according to
the kit requirements. 5 wavelengths are available: 340 nm, 405 nm, 500 nm,
546 nm and 620 nm. Choose the required wavelength using the ◄► key.
6. Second wavelength: Select the secondary wavelength in the test according
to the kit requirements, and the system will flexibly implement the dual
wavelength method by setting the secondary wavelength. It includes 6 se-
lectable secondary wavelengths: 340 nm, 405 nm, 500 nm, 546 nm, 620
nm and none. When a single wavelength is used for the test, the secondary
wavelength must be set as none. Choose the secondary wavelength using
the ◄► key.
7. Blank: Select the blank testing, including none, reagent blank and sample
blank. Choose the blank type using the ◄► key. In the end-point method
test, reagent blank and sample blank can be selected according to user requi-
rements. Reagent blank can be selected for the two-points method test, and
no blank settings can be selected for the kinetics method.
30

8. Factor: Enter the calculation factor; negative and positive values can be
switched using the ◄► key. The system supports the direct input of factors
and the determination of calculation factors by system calibration (standard
test).
9. Norms high: The entered result is the value of norms high based on empiri-
cal evidence.
10. Norms low: The entered result is the value of norms low based on empirical
evidence.
11. Delay time: Enter the delay time for the test process. The delay time is the
time between aspirating the sample to the flow cell and the actual test start.

Note:
A certain time delay is necessary in order to ensure that the test samples are at
a stable temperature and to eliminate bubbles in the flow cell.
The time delay is 5 seconds for most end-point method tests.
The time delay should not be less than 10 seconds on kinetics method tests be-
low 25°C.
The time delay should not be less than 12 seconds on kinetics method tests be-
low 30°C.
The time delay should not be less than 15 seconds on kinetics method tests be-
low 37°C.

12. Test time: Enter the reaction time for the test procedure (the end-point me-
thod does not require this parameter).
13. Decimal Digits: The reserved digits after the decimal point in the result; the
maximum is 4.
14. Aspirate volume: The amount of solution aspirated by the peristaltic pump.
This parameter indicates the amount of imbibed fluid which will be tested
each time. In order to ensure test accuracy, the aspirate volume is generally
greater than 400 μl. (General it should be set at 500 μl; the aspirate volume
of reagents with significant contamination can be increased to 700 μl).
Generally, an aspirate volume
of 500 μl is sufficient to ensu- After setting all the parameters, press the ENTER key to automatically save the
re a cross-contamination ratio be- parameters and return to the test parameters confirmation menu. Press the ESC
low 1%. The aspirate volume can key if you wish to return without saving. Therefore, correct standard parameters
be increased or reduced by must be entered.
number entry on the keypad.

HumaLyzer Primus | User manual


OPERATION 31

3.5.1.4 Standard Settings


In the parameters confirmation menu, select “STD” and press the ENTER key to
enter the settings menu for standard parameters according to the indications
as shown in figure 3.5.1.4-1.
Method: The calculation method for standard tests is linear regression or non-
linear regression. Select using the ◄► key.
No. of Std: The number of standard preparations used in the standard test pro-
cess. The maximum is 8 for calibration.
Repeat Times: The number of times the test is repeated for each standard pre-
paration.
Concentration: Standard preparation concentration used in the standard test
process.

FIGURE 23
Standard parameter setup menu

Note:
When non-linear regression is selected, the number of standards should be
more than 3; otherwise, calibrate according to the linear regression method.
When more than two standards are selected, the number of repetitions is chan-
ged to a single measurement for all standards time.
When more than three standard concentrations are entered, they must be
entered using the progressive or degressive method; otherwise, the calibrati-
on will fail. When it processes standard parameters, the system will indicate
the third started standard concentration range as shown in figure 3.5.1.4-2. The
system will evaluate the progressive or degressive tendency automatically in se-
quence, and the third started concentration range will be indicated at the right
side.
32

FIGURE 24
Standard concentration menu

After setting all the parameters, press the ENTER key to automatically save the
parameters and return to the item parameters confirmation menu. Press the
ESC key if you wish to return without saving. Therefore, correct standard para-
meters must be entered.

3.5.1.5 QC Settings
In the parameters confirmation menu, select “QC” and press the ENTER key to
enter the settings menu for quality control parameters according to the indica-
tions as shown in figure 3.5.1.5-1.
Control: The system can set two quality control preparations. Select using the
◄► key (in the settings menu for quality control parameters, press the ◄► key
to select the quality control preparations in cycle).
Average Value: Standard concentration of the quality control preparation.
SD: Standard deviation of the quality control preparation.
Batch number: Corresponding batch number for quality control.

FIGURE 25
Quality control parameters menu

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OPERATION 33

After setting all the parameters, press the ENTER key to automatically save the
parameters and return to the menu for item parameters confirmation. Press the
ESC key if you wish to return without saving. Therefore, correct quality control
parameters must be entered.

3.5.1.6 Parameter Print


Under the menu for parameters confirmation or the menu for parameter set-
tings as shown in figure 3.5.1.2-1 or figure 3.5.1.3-1, press the PAPER key to print
the parameters of the current item.
After you finish setting and checking all the parameters, select “Ok” in the menu
for parameters confirmation and press the ENTER key to enter the item test pro-
cess. It must therefore be ensured that the correct parameters are entered. Pres-
sing the ESC key will return to the item selection menu.

3.5.1.7 Item User-Definition


The instrument can save 60 test items, including approximately 39 fixed items
and 21 user-defined items; user-defined items can also be implemented direct-
ly on the basis of the 47 fixed items. The specific user-defined methods are as
follows:
1. Move the cursor to the “Name” column for parameter settings. The item
name is highlighted or displayed as a cursor symbol (no item name);
2. Directly enter the item name according to the character index on the keypad;
the name is limited to a maximum of 5 characters. As you enter the name,
the system will automatically determine characters at a 3-second interval
each, and will indicate when to enter the next character.
3. If necessary, press the DEL key to delete the characters you have entered.
4. Set item parameters, then press ENTER to automatically save the user-de-
fined item name and parameters and enter the test process.

3.5.2 ITEM TEST


After setting test parameters, press the ENTER key to automatically save the
parameter settings and enter the test process. First, the system will switch the
light filter according to the set wavelength and will load the required informa-
tion. The information output is as shown in figure 3.5.2-1. The switching time
is very short (typically few seconds). Temperature control is then started auto-
matically.
34

FIGURE 26
Test switch indication

After finishing the test switch and information loading, the system will enter
temperature control as shown in figure 3.5.2 2. The temperature control time is
set on the basis of the temperature difference before and after the item switch
and typically lasts from several seconds to three minutes. Press the ESC key if
you wish to cancel temperature control and enter the blank test.

FIGURE 27
Temperature control state

3.5.2.1 Blank Test


After finishing the test switch and temperature control, the system automati-
cally enters the blank test process. Based on the parameters’ settings, the sy-
stem will select whether to perform a reagent blank. When the blank settings in
the parameter settings are set to perform no blank or a sample blank, the blank
test will simply be performed as a water blank. When a reagent blank is selected,
the blank test will be performed as a water blank and a reagent blank.

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OPERATION 35

FIGURE 28
Blank Test

As shown in figure 3.5.2.1-1, a water blank is performed first and “Aspirate


Please” is shown in the water blank column. Prepare distilled water and press
the aspiration key. The system will automatically perform the test and output
the results of the water blank. When the value of the water blank is too high, the
display will show “Aspirate Please Retest” and the real-time absorbance value
will be shown below as shown in figure 3.5.2.1-2. In this case, the water blank
must be repeated. If “Aspirate Please” “Retest” is still shown after several repe-
titions, please check whether the light path is blocked.
FIGURE 29
Water blank abnormality

After testing the water blank, the system will automatically enter the reagent
blank, aspirate the reagent according to the indications, test the system, and
output the results.
After testing the reagent blank, no key needs to be pressed, as the system will
automatically enter the test selection menu and wait for several seconds, as
shown in figure 3.5.2.1-3. The cursor points to “Test sample” with no selection;
select the test sample using the key. Press the ENTER key to enter the cor-
responding test process, and press the ESC key to return to this test selection
menu for the other tests.
36

FIGURE 30
Test selection menu

3.5.2.2 Standard Test


The system can obtain the standard factors through two methods. One method
is the entry of factors when setting parameters. “K=xxx” will then be displayed
in the test selection menu as shown in figure 3.5.2.1-3. The other method is ob-
taining the standard factors from a standard test. This section will explain the
basic process of the standard test in detail.

1. Test Selection
In the test selection menu, move the cursor to “Test Standard”; the text will
then be highlighted. The system determines whether the settings for the stan-
dard parameters are correct. If the settings are wrong, the system will display
“None!”, which indicates that the standard test is either unnecessary or incorrect
as shown in figure 3.5.2.2-1(a). If the settings are correct, it displays “Ok?” as
shown in figure 3.5.2.2-1(b). Confirm whether the standard test is to be per-
formed. If it should be performed, please press the ENTER key to enter the test
procedure. Otherwise, move the cursor to select other tests or press the ESC key
to return to the main menu.

FIGURE 31
Standard test selection

a) Standard parameter has errors

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OPERATION 37

b) Standard parameter is correct

2. Test Operation
After entering the standard test procedure, the standard test menu will appear
as shown in figure 3.5.2.2-2. “Test” displays the item name for the current test.
“STD” displays the serial number of the current standard fluid. The corresponding
concentration value is shown on the right side. For example, with “Con.: 133.00”
as shown, please ensure that solution of that concentration is introduced before
aspirating the standard fluid. “Status” shows the test process schedule and test
results. “Aspirate Please”, “Testing…” and “Save?” are displayed in sequence in
the lower-middle area of the menu. The specific test procedure is the same as
the item test process; please refer to the specific operation of the item test.

FIGURE 32
Standard test menu

3. Test Saving
After aspirating the corresponding standard fluid according to the procedure,
the system will calculate the standard factors in real time. The K and b calibra-
tion values will be displayed in the “Result” column, and “Save?” will be shown
in the system’s status column. Press the ENTER key to save the calibration result.
38

All subsequent item tests will be calculated on the basis of this calibration result
until the standard factors are reset or recalibrated and saved as shown in figure
3.5.2.2-3. Press the ESC key to cancel saving and directly enter the item test pro-
cess. In this case, all the subsequent item tests will be calculated according to
the previous calibration settings. If recalibration is required, please select “Stan-
dard Test” in the test selection menu to perform calibration again as shown in
figure 3.5.2.1-3.

FIGURE 33
Standard test saving

3.5.2.3 Quality Control

1. Test selection
In the test selection menu, move the cursor to “Test QC”. The text will then be
highlighted. On the right side, the system displays that the quality control pre-
paration can be selected. Select the preparation using the ◄► key on the ex-
treme right side.
The system supports single quality control and double quality control. This is
selected using the ◄► key, which highlights the selected quality control prepa-
ration as shown in figure 3.5.2.3-1(a). To select double quality control, press and
hold the ◄► key until two of the quality control preparations are highlighted
together as shown in figure 3.5.2.3-1(b).
Confirm that the selected quality control preparation is correct and press the
ENTER key to enter the menu for the quality control test as shown in figure
3.5.2.3-2.

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OPERATION 39

FIGURE 34
Quality control test selection

a) Select single quality control

b) Select double quality control

2. Test Operation
After entering the process for the quality control test, the menu for the quality
control test will appear as shown in figure 3.5.2.3-2. “Test” displays the item
name of the current test. “QC” shows the serial number of the current quality
control solution. The corresponding quality control batch number is shown on
the right side. For example, with “Batch: 070691”, please ensure that quality
control preparations with the same batch number are introduced before aspira-
ting the quality control solution. “Status” displays the progress of the test pro-
cess and the test results. “Aspirate Please”, “Testing…” and “Save?” are displayed
in sequence in the lower-middle of the menu. The specific test procedure is the
same as the item test process; please refer to the specific operation of the item
test.
FIGURE 35
Quality control test menu
40

3. Test Saving
After aspirating the corresponding quality control solution according to the pro-
cedure, the system will calculate the results in real time. Quality control results
are displayed, and quality control conditions are evaluated in the “Result” co-
lumn (“C>2SD” indicates that the quality control result is larger than the va-
lue of two SD; otherwise, this information is not displayed), and “Save?” will
be shown in the system’s status column. After confirming that quality control
was successful, press the ENTER key to save the quality control results. When
double quality control is selected, test the two quality control preparations in
sequence. Aspirate the corresponding quality control solution according to the
indications and save the valid quality control results (only one quality control
result for the same item and same batch number is saved each day) as shown
in figure 3.5.2.3 3. Press the ESC key to repeat quality control. After the quality
control test is complete, the system will automatically skip to the test selection
menu and point to the item test as shown in figure 3.5.2.1-3.

FIGURE 36
Saving quality control test

3.5.2.4 Sample Test


In the test selection menu, the cursor points to “Sample Test” with no selection
and “Sample Test” is highlighted. Press the ENTER key to enter the sample test
procedure.

1. Test Operation
When sample blank is selected in the parameter settings, a sample blank is per-
formed first before the sample test as shown in figure 3.5.2.4-1(a). When no
blank or reagent blank is selected, this means it was already finished during the
previous blank test, and the system will directly enter test menu as shown in
figure 3.5.2.4-1(b).
“Blank” and “Test” will display the item name for the current test.
“>Print On” or “>Print Off” on the upper-right corner of the window allow the
online print function to be switched on or off, respectively, using the ► key. If
this function is switched on, the results are printed immediately after the test

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OPERATION 41

is complete. It can only be changed while the system is waiting for sample as-
piration.
“Sample” displays the next sample number to be tested and can be changed be-
fore the test. A change will be indicated by highlighting “Change No.” on the
right side of the corresponding column. It is advisable to check whether the
number is correct before starting the test, as the previous test result would
otherwise be automatically overlapped by the new test result with the same
item and same number.
“Status” displays the progress of the test process, and “Result” indicates the test
absorbance and concentration.
“Aspirate Please”, “Testing…” and “Printing…” are displayed in sequence in the lo-
wer-middle part of the status column. Please aspirate the sample or wait for the
test according to the indications. When “Overlapped?” appears after testing, it
indicates that this item already has a test result with the same sample number
on the same day. Press the ENTER key if you want to overlap the existing result.
If you want to save the result as a new sample, enter a new sample number then
press the ENTER key.
FIGURE 37
Sample test menu

a) Sample blank

b) Sample test
42

2. Test Process
The procedure and related operations for this test process are the same as for
no sample blank (no blank or reagent blank setting) and detailed in that section.
If sample blank is selected, a sample blank will be performed before each item
test and a sample test will be automatically entered to wait for the sample to be
aspirated. Its operation is completely the same as that of the sample test.
a) Confirm the sample number (the sample number displayed is the number
of the sample to be tested) and activate or deactivate the online print func-
tion using the ► key as shown in figure 3.5.2.4-1.
b) When the system displays “Aspirate Please”, prepare the test sample and
press the aspiration key to imbibe the sample preparation. The system will
imbibe the fluid according to the set aspirate volume and will automa-
tically enter the test process. “Testing……” will be displayed in the status
column, and the test progress will be indicated in seconds in the “Status”
column as shown in figure 3.5.2.4-2.

FIGURE 38

c) After the test is complete, the test results are automatically saved (if
this item already has a test result with the same sample number on
the same day, “Overlapped?” will appear and the system will wait for
a response. Press the ENTER key if you want to overlap the existing re-
sult. If you want to save the result as a new sample, enter a new sample
number then press the ENTER key). The sample number will be increased
by one for the next test sample and can be modified by the user.
d) Print the results: If the online print function is available, activate or deac-
tivate it using the ► key while the system is waiting for fluid aspiration.
e) When the current sample test and print are complete, the sample
number will be increased by one and the system will wait for fluid aspi-
ration for the next sample test.

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OPERATION 43

f) If operated according to instructions, the system can continuously test


samples. If quality control, calibration or cancellation are required during
the test procedure, press the ESC key to return to the test selection menu
and select the relevant operations.
44

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REPORT 45

4 REPORT
The report functions deal mainly with data from test results and quality control
tests for the current month. They also provide basic functions for data search,
print and delete, etc.
In the system’s main menu, press the 2 key to enter the administration menu as
shown in figure 4-1. The available functions are sample report, item report and
control report. The corresponding function modules are accessed using number
keys 1, 2 and 3, respectively.
Sample report: Search the test results according to the date and sample number.
Item report: Search the test results according to the date and item number.
QC report: Search the quality control results according to the month, item
number and batch number from quality control.

FIGURE 39
Administration function selection

Note:
The HumaLyzer Primus has storage capacity for 2200 test results. The system
can automatically manage its storage. When the quantity of test data exceeds
the system’s storage capacity, the system will automatically delete parts of old
data. The system will also issue corresponding notifications during this process.
Please wait a moment while the system clears old data, after which it will auto-
matically return to normal operation and can continue to perform tests.

4.1 Sample Report


Enter the time range and sample number to be searched for in the test results.
Enter the start date and end date, respectively. The end date must be on or later
than the original day. Enter the sample number you wish to search for in “Sam-
ple No”. “-” stands for number A to number B; B must not be less than A. When
A is equal to B, a single sample will be searched. As shown in figure 4.1-1, the
system will search the test results of samples 1, 2 and 3 tested on November 9,
2009.
46

FIGURE 40
Sample report search

After entering the time range and sample number, press the ENTER key to
search for records which meet the search criteria. If no matching record is found,
“None” will be displayed at the lower-right of the window as shown in figure
4.1-2(a). If matching records are found, all records which satisfy the criteria will
be displayed as shown in figure 4.1-2(b).

FIGURE 41
Sample search criteria

a) No record

b) Condition satisfied records

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REPORT 47

Several shortcut keys are defined in the display window for search results as
shown in figure 4.1-2(b):
- Page up/down: Only 3 records can be displayed per page; press the key to
display more records. The „remark“ in the display
- Print: Press the ENTER key to print all search results. and printed report is not dis-
- Delete: Press the DEL key to delete all search results. played if status is normal; „H“ in-
- Return: Press the ESC key to return to the search window. dicates the test result is above the
maximum reference value; „L“ in-
dicates that the test result is be-
4.2 Item Report low the minimum reference va-
Enter the time range and item number to be searched for in the test results. lue.
Enter the start date and end date, respectively. The end date must be later than
the original date or on the same day as the start date. Enter the item number
you wish to search for in “Item No”. The item name corresponding to the number
will be displayed on the right side of the screen in real time. Alternately, you may
enter characters in character mode when “ABC” appears on the upper-right side
of the screen. The “ . “ key is used to switch between number and character input
mode. As shown in figure 4.2-1, the system will search for all results for the ALT
item tested on November 9, 2009.

FIGURE 42

After entering the time range and item number, press the ENTER key to search
for records which meet the search criteria. If no matching record is found, “None”
will be displayed at the lower-right of the window as shown in figure 4.2-2(a). If
matching records are found, all records which satisfy the criteria will be displa-
yed as shown in figure 4.2-2(b).
48

FIGURE 43
Item search condition

a) No record

b) Records matching criteria

Several shortcut keys are defined in the display window for search results as
The „remark“ in the display shown in figure 4.2-2(b):
and printed report is not dis- - Page up/down: Only 3 records can be displayed per page; press the key to
played if status is normal; „H“ in- display more records.
dicates the test result is above the - Print: Press the ENTER key to print all search results.
maximum reference value; „L“ in- - Delete: Press the DEL key to delete all search results.
dicates that the test result is be- - Return: Press the ESC key to return to the search window.
low the minimum reference va-
lue.

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REPORT 49

4.3 QC Report
Enter the month, item number and quality control batch number to search for in
quality control results. Enter the test date, and enter the item number you wish
to search for in “Item No”. The item name corresponding to the number will be
displayed on the right side in real time (if necessary, switch the character input
mode using the “ . ” key). Enter the quality control batch number in “Batch No”
as shown in figure 4.3-1. The system will search It will search for quality control
results for the ALT item with batch number 070691 in November 2009.

FIGURE 44
Control report search

After entering the month, item number and quality control batch number, press
the ENTER key to search for records which meet the criteria. If no matching
record is found, “None” will be displayed at the lower-right of the window as
shown in figure 4.3-2(a). If matching records are found, all records which satisfy
the criteria will be displayed as shown in figure 4.3-2(b).

FIGURE 45
Quality control search condition

a) No record
50

b) Records meet conditions

Several shortcut key are defined in the display window for search results as
shown in figure 4.3-2(b):
The „remark“ in display and - Page up/down: Only 3 records can be displayed per page; press the key to
print report: Normal conditi- display more records.
on is no display. „H“---Test result - Print: Press the ENTER key to print all search results.
higher than 2SD, „L“ ---Test result - Delete: Press the DEL key to delete all search results.
lower than 2SD. - Return: Press the ESC key to return to the search window.

4.4 Deleting Records


The delete command can be used to clear all test results and/or quality control
results stored on the device as shown in figure 4.4-1.

FIGURE 46
Quality control search

This will delete all test results or quality control results. Individual records can be
deleted as described in sections 4.2 and 4.3.

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POWER OFF 51

5 POWER OFF
After completing all tests, return to the main menu. Press key 4 to execute the
power-off program. When the screen displays as in figure 5-1, press the ENTER
key (if you press the ESC key, the system will not power off and you will return
to the main menu).

FIGURE 47
Confirmation of power off

When the system displays as in figure 5-2, it indicates that the system needs to
aspirate distilled water to clean the flow cell.

FIGURE 48
Cleaning the flow cell

Prepare a sufficient amount of distilled water and press the Aspiration key or
the RINSE key to clean the flow cell as shown in figure 5-3.

FIGURE 49
Indication of cleaning procedure
52

After the flow cell has been cleaned, the system displays “Power off please!” as
shown in figure 5-4.

FIGURE 50
Power off

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MAINTENANCE 53

6 MAINTENANCE

6.1 Overview
HumaLyzer Primus is a clinical precision analyzer. Daily maintenance work must
be performed properly to keep the instrument in good working condition. Main-
tenance work on the HumaLyzer Primus is very easy to perform, but it must be
done thoroughly and carefully.

6.2 Instrument Cleaning

6.2.1 CLEANING THE SURFACE OF THE INSTRUMENT


- Keep the instrument’s working environment clean.
- The surface of the instrument may be cleaned using a neutral cleaner and a
wet cloth.
- Use only a soft cloth to clean the liquid crystal display.
Do not let solvent, liquids or
corrosive materials contact
6.2.2 CLEANING THE FLOW CELL the instrument.
The flow cell must be kept clean in order to ensure the accuracy and reliability
of test results.
1. Cleaning the exterior of the flow cell
a) The flow cell must be installed according to instructions (see section
2.4.4).
b) If the exterior of the flow cell is dirty, wipe clean using a soft cloth moi-
stened with dehydrated alcohol.

2. Cleaning the interior of the flow cell


c) Place the container with distilled water under the aspiration tube,
press the RINSE key, and start the continuous washing function. Press
the RINSE key again to finish the washing procedure. 30 seconds of con-
tinuous washing are typically sufficient.
d) Flow Cell Cleaner 18222 is used to clean the flow cell. Press the RIN-
SE key to aspirate the cleaner then press the RINSE key again to stop
the rotation of peristaltic pump. Leave the cleaner in the flow cell for
5 minutes, then wash continuously with distilled water for 1 minute.
Cleaner can be used to wash again if the flow cell is still not clean.
54

The flow cell must be cleaned in the following cases:


- The value of the water blank is too high.
Do not leave reaction fluid or - Test items have been changed (use water only).
other contaminants in the - Before power off (see above).
flow cell for an extended period
of time.
6.3 Instrument Maintenance

6.3.1 CHANGING THE FUSE


A fuse of the type indicated The fuse is installed in the fuse box beside the power switch on the rear of the
above must be used. The user instrument. Open the box cap to conveniently access and change the fuse.
must ensure that the power cable Fuse specification: 3.15AL250V.
is disconnected while changing Users are recommended to use a voltage-regulated power supply.
the fuse.

6.3.2 ADJUSTING THE PERISTALTIC PUMP TUBE


After the instrument has been in use for six months, the position of peristaltic
pump may have to be adjusted.
Procedure:
- Rotate the lock catch on the peristaltic pump tube clockwise, and open the
back plate on the pump tube.
- Remove the peristaltic pump tube.
The instrument will not aspi- - Loosen the fixing steel wire on the pump tube connecter, rotate the pump
rate if the pump tube is not tube 180°, and then retighten the steel wires.
installed properly. - Install the pump tube properly and lock it (rotate the lock catch on the peri-
staltic pump counter-clockwise).

6.3.3 CHANGING THE ASPIRATION TUBE


If the aspiration tube for the flow cell becomes blocked by objects, it can be
cleaned and purged using a syringe. The aspiration tube can be replaced if it
becomes seriously damaged or blocked.
- Remove the flow cell.
- Remove the aspiration tube at the inlet, and replace with a new aspiration
tube. Sheath the compass tube (middle section) at one end of the new aspi-
ration tube, then sheath the fixing tube (thick section). Be sure to leave 1 cm
outside the compass tube (as shown in figure 6.3.3-1).
- Insert the tube into the flow cell inlet.

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MAINTENANCE 55

FIGURE 51
Aspiration tube connector
at the flow cell inlet

6.4 Basic Troubleshooting

Problem Resolution
- Check whether the instrument is
switched on.
1. Analyser cannot be started. - Check whether the power plug is
loose.
- Check the fuse.
- Check the voltage.
2. The photometer lamp does not - Check the power supply before
shine. changing lamps.
- If the lamp is damaged, replace.
3. Internal printer does not print. - Check whether the plug is properly
connected.
- Check whether the peristaltic pump
is functioning properly.
- Check the connection of the inter-
faces for the aspiration tube and
4. There is no fluid in the flow cell. flow cell, etc.
- Aspiration tube is too long or too
short.
- Aspiration tube may be blocked, and
should be cleared and purged.
- Flow cell is very dirty.
- Check whether the photometer bulb
5. There is no reading on the photo- works properly.
meter. - Try another reading wavelength.
- Flow cell is not inserted in the bot-
tom.
56

6. The difference value in water blank - Clean flow cell.


is too high. - Replace distilled water.
- Check the photometer bulb.

- There are bubbles inside the flow


cell, and it needs to be washed.
- Check the aspiration status of the
flow cell.
- Too little reagent is being used; the
7. The result reproducibility is low. dosage needs to be increased.
- Change the bulb of photometer.
- The reaction fluid is contaminated.
- The aspiration tube is inserted rela-
tively deep in the flow cell and pulls
it out slightly.
- Check whether the aspiration tube
8. The aspirate flow volume of the is blocked.
flow cell is not constant. - The peristaltic pump tube may need
to be replaced.
- Check the expiration date of the re-
agent.
- Check whether the settings are cor-
Different versions of the in- rect and whether they need to be
strument may have slightly edited.
different procedures. None of 9. Quality control results are not - Ensure the quality control system is
these operations should nega- within the target value range. not contaminated.
tively affect the functions and - Repeat the measurement using
operation of the instrument; they other methods.
can be performed easily by the - Check the flow in the flow cell, and
user. use another reagent and quality
control system to repeat the mea-
surement.

HumaLyzer Primus | User manual


APPENDIX 57

7 APPENDIX

7.1 Technical Specification


Resolution 0.001 Abs (display) , 0.0001 Abs (internal calcu-
lation)
Light source: Halogen tungsten lamp
Wavelength: There are 5 filters inside: 340, 405, 500, 546,
620nm;
Two more wavelengths can be added optionally.
Temperature control: Ambient temperature, 25°C, 30°C, 37°C
Flow cell : Micro flow cell (32 μl)
Interface: RS-232 communication
Display: Liquid crystal display
Printer: Internal printer
Operating environment: 10…30°C; relative humidity ≤70%
Storage environment: 10...30°C; relative humidity ≤80%
Dimensions ( W x D x H): Instrument without any components:
36 x 35 x 16 cm
Space required for routine use: 53 x 55 x 29 cm
Packaging: 56 x 43 x 32 cm
Weight: Gross 6.8 kg, Net 5.9 kg
Power supply: 110/220 V AC ± 10%, 50/60 Hz ± 1Hz
Input power: 80 VA
Fuse type: 5×20
Fuse specification: 3.15AL250V
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
Max-Planck-Ring 21 • 65205 Wiesbaden • Germany
Tel.: +49 6122/9988 0 • Fax: +49 6122/9988 100
eMail: human@human.de • www.human.de

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