Human COMBILYZER Plus Manuale utente
02/2005-05 Cat.-No.: 17601P
Human
Gesellschaft für Biochemica
und Diagnostica mbH
Max-Planck-Ring 21 !D-65205 Wiesbaden
Germany
Telefon: +49 6122 9988 0
Telefax: +49 6122 9988 100
eMail: human@human.de
Internet: http://www.human.de
User Manual
!"#$%&'()*+,-./
!
CONTENTS
1INTRODUCTION 3
1.1 Methodology of Urine Testing 3
1.2 Test Strips 3
2DESCRIPTION OF COMBILYZER PLUS 4
3INSTALLATION 6
4OPERATION GUIDE 8
4.1 Control Menu System 8
4.2 Setup Procedure (Menu/Setup) 8
4.2.1 Setting the Clock 8
4.2.2 Setting Serial Output Port 9
4.2.3 Setting the Language 9
4.3 Strip Setup Options (Menu/Strip) 10
4.3.1 Setting Measurement Unit 10
4.3.2 Setting the Sensitivity Attribute of the Image Processing
Program 10
4.3.3 Setting Pad Sequence in the Printout 11
4.4 Service Menu Options (Menu/Service) 12
4.4.1 Code Card 12
4.4.2 Selecting Measuring Mode 13
4.5 Measurement 13
4.5.1 Setting Patient ID for Measurement 13
4.5.2 Performing Measurement 13
4.6 Memory/Data Management 15
4.6.1 Result Printout 15
4.6.2 Sending data to Host Computer 16
4.6.3 Enter Patient ID for Memory Record 16
4.6.4 Clearing Test Data from Memory 16
4.7 Printer Station 17
4.8 Serial Port17
5MAINTENANCE 18
6ERROR MESSAGES AND TROUBLESHOOTING 19
7TECHNICAL FEATURES 20
8PACKING LIST 20
9SYMBOLS 21
10 APPENDIX 22
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1INTRODUCTION
1.1 Methodology of Urine Testing
Urinalysis is one of the medical diagnosis methods frequently used by medical
doctors in laboratories in order to reveal diseases.
This micro-chemistry system has been available for many years and allows
qualitative and semi-quantitative analysis within one minute by simple but careful
observation. The colour change occurring on each segment of the strip is
compared to a colour chart to obtain the result. However, misreading or
misinterpreting of results may happen, caused by individual handling habits of
different users or different light conditions.
1.2 Test Strips
The COMBILYZER Plus works with COMBINA 11S urine test strips:
Tested parameters are as follows:
Bilirubin
Urobilinogen
Ketones
Ascorbic Acid
Glucose
Protein
Blood
pH
Nitrite
Leucocytes
Specific Gravity
4/22 User Manual COMBILYZER Plus
2DESCRIPTION OF COMBILYZER Plus
The COMBILYZER Plus is
designed for urine test strip reading.
The instrument includes two main
functional units:
-portable, battery-operated
Reader Unit for urine analysis
-bench-top, AC-powered Printer
Station,which docks with the
portable Reader Unit and
produces printed reports.
Figure 2. The Reader Unit
The Reader is menu-driven, so
the operator needs to set up the
Reader Unit first according to the
operational conditions with the
help of the function menus. After
placing the moistened urine strip
on the strip holder the instrument
reads and evaluates the strips
automatically.
The urine test strip containing chemical reagents is positioned under the reader's
sensor. After the pads' colours have been evaluated, the strip should be
discarded by the operator. The testing corresponds with the reaction time of the
chemical reagents - about 60 seconds.
The COMBILYZER Plus works using the reflectance photometry method: inside
the reader, the strip is illuminated by white light, and the light reflected from the
strip is detected by a colour CCD sensor. The RGB signals are digitised using
analogue-digital conversion. The digitised image is processed by a built-in
program: it locates the pads and, based on the reflected light, calculates the
results. The results, together with the current date, time and patient ID, are
Figure
1
. Parts of COMBILYZER Plus
User Manual COMBILYZER Plus 5/22
stored and can be printed out by connecting the reader to the Printer Station.
The instrument is designed specifically for in vitro diagnostic professional use
and to meet the requirements of medical professionals. The measurement
capacity is up to 80 test strip evaluations per hour.
6/22 User Manual COMBILYZER Plus
3INSTALLATION
The COMBILYZER Plus is shipped in a cardboard box. Prior to
unpacking, clear the area where the instrument is to be operated: a 30 x
50 cm size space will be needed. Please note the shipping marks on the
box while handling. Open the box. Cut the tape only, leave the carton
material intact. (It is recommended to keep the packaging materials)
Prepare the accessories: power adapter, rechargeable batteries and
printer paper.
-
Place
COMBILYZER Plus
in its
operating position.
-
Remove the Reader Unit from its
docked position, locate its battery
holder on the bottom, remove the
cover-plate and load the batteries
(included) as shown in figure 3.
Reconnect the Reader Unit in its
docked position.
-
Using the standard RS232 serial
cable (included) to connect the
Reader Unit's serial port (see figure
2) to the computer's serial port if
you intend to upload data to an
external device i.e. Computer
-
Connect the power adapter first to
the DC socket on the reader, then
to the mains.
-
Switch the COMBILYZER Plus on
by pressing the Power-On button.
In a few seconds the HUMAN logo
will appear on the LCD, followed by
the main menu, which offers the
Memory/Meas/Menu options.
Figure 3. Installation of the batteries
User Manual COMBILYZER Plus 7/22
Note: If during power on process the user keeps any part of the LCD pressed
(touched), the boot up process will be interrupted and the system information can
be viewed (serial number, software version, etc.). After releasing the screen the
boot up process will continue.
-Take a roll of printer paper and load it
into the printer paper holder (see fig.
4) Insert the paper into the paper
feeder slot and close the cover plate.
The printer paper will be feed
automatically to its start position.
Now, the COMBILYZER Plus is
ready to operate using the Main Menu
options (see chapter 9).
Note: After installation check whether the instrument is operating accurately.
Figure 4. Loading the printer
paper
8/22 User Manual COMBILYZER Plus
4OPERATION GUIDE
4.1 Control Menu System
The operation and functions of the COMBILYZER Plus can be viewed in the
menu system chart (see Appendix). Each selected menu allows the user to
control one of the operational or setup functions. For a detailed explanation of
the submenus, please see the detailed descriptions in following chapters.
Pressing the QUIT button will return to main-menu. The OK button is used to
enter the edited data and quit the function.
4.2 Setup Procedure (Menu/Setup)
4.2.1 Setting the Clock
Select Menu/Setup/Clock in the
menu to set date and time (see
figure 5). By pressing the UP and
DOWN function keys, the
parameters inside the frame can be
set. To go on to the next parameter
press the NEXT button. By
changing the SEQ. parameter the
date display mode can be set from
Month/Day/Year to
Year/Month/Day or
Day/Month/Year. When all the
parameters are set, save the
changes and return to the main
menu by pressing OK.
Figure 5. Clock setting
User Manual COMBILYZER Plus 9/22
4.2.2 Setting Serial Output Port
The serial output port can be set
in the Menu/Setup/Serial menu
(see figure 6). If enabled, the
instrument is programmed to
communicate with a host
computer in two ways: either PC
unidirectional or network mode.
Choose between the two
protocols with the UP and DOWN
buttons or by directly selecting the
circle next to the desired protocol.
In network mode, information is
sent in blocks. The blocks are
arranged either by sequence
number (Seq. Nr.) or by patient ID.
(set by the user in advance by selecting or unselecting the B1. ID.) identifies the
result reports. The standard mode setting is 9600 Baud, 8 bits with 1 Stop bit and
no parity. Other options can not be programmed. For more information on the
serial port refer to section 4.8.
Note: By disabling the serial port, the printer will be disabled, too. In this case,
the test results will appear only on the display.
4.2.3 Setting the Language
Select the Menu/Setup/Language menu to set the language. The instrument is
programmed to communicate with the user in the following languages: English,
German or Hungarian. The language can be selected with the UP and DOWN
buttons or by directly marking the field next to the desired language. Store the
changes and return to main menu by pressing OK.
Figure 6. The serial setup menu
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