Analyticon combi scan 500 Manual de usuario

User‘s Manual
Analyzer for
CombiScreen®11 SYS
urine test strips

1
Contents

1
Contents
Contents
1. Introduction .......................................................................................... 2
1.1. Methodology of the urine test ............................................................................... 2
1.2. The test strips........................................................................................................ 3
1.3. Intended use.......................................................................................................... 3
2. Description of the reader..................................................................... 4
2.1. Packing list ............................................................................................................ 6
3. Installation ............................................................................................ 7
4. Operation .............................................................................................. 9
4.1. Switching on/off..................................................................................................... 9
4.2. Overview of the menu system ............................................................................... 9
4.3. Worklist ................................................................................................................ 10
4.3.1. Add a worklist .............................................................................................. 10
4.3.2. Edit a worklist .............................................................................................. 10
4.4. Start ..................................................................................................................... 11
4.4.1. Mesurement ................................................................................................. 12
4.4.2. Result printout ............................................................................................. 13
4.5. Menu.................................................................................................................... 13
4.5.1. Setup menu.................................................................................................. 13
4.5.1.1. Output settings .................................................................................... 14
4.5.1.1.1. Printer settings ............................................................................ 14
4.5.1.1.2. Serial port settings ...................................................................... 14
4.5.1.1.3. Language settings....................................................................... 14
4.5.1.2. Strip options ........................................................................................ 15
4.5.1.2.1. Measurement units...................................................................... 15
4.5.1.2.2. Sensitivity adjustment ................................................................. 15
4.5.1.2.3. Pad sequence in printout ............................................................ 16
4.5.1.3. Clock and date settings....................................................................... 16
4.5.2. Service ......................................................................................................... 17
4.5.2.1. Cleaning............................................................................................... 17
4.5.2.2. Calibration settings.............................................................................. 18
4.5.3. Memory........................................................................................................ 18
4.5.3.1. Memory data transfer .......................................................................... 19
4.5.3.2. Clearing data from memory................................................................. 19
4.6. Data download .................................................................................................... 20
5. Care of the instrument....................................................................... 21
5.1. Cleaning of the waste bin .................................................................................... 21
5.2. Cleaning of the conveyor..................................................................................... 21
6. Warnings / Precautions ..................................................................... 22
7. Troubleshooting.................................................................................. 23
8. Technical data..................................................................................... 24
9. Symbols............................................................................................... 25
Appendix ................................................................................................. 26
V4.2.3 revised 3/2009

2
Introduction
3
Introduction
1. Introduction
1.1. Methodology of the urine test
The urinalysis is part of the medical diagnosis methods frequently used by medical doc-
tors in laboratories in order to reveal diseases. The most cost-effective device used to
screen urine is a reagent test strip. This microchemistry system has been available for
many years and allows qualitative or semi-quantitative analysis within one minute by sim-
ple but careful observation. The colour change occurring on each test pad of the strip is
compared to a colour chart to obtain the result. However, misreading or misinterpreting of
results, caused by individual handling habits of the user or different light conditions, may
happen. Urine analyzer (urine strip reader) equipment is designed specifically to improve
the accuracy and security of urine strip evaluation by using light and photometric reader
in order to detect the colour changes on the test strips. The CombiScan®500 supports
test data management and report generation by offering data storage and computerised
data processing features.
The CombiScan®500 is a urine analyzer for professional use. The reader is a semi-auto-
matic benchtop instrument designed to read the CombiScreen®11SYS reagent strips.
The operator needs only to feed the equipment by placing the moisturised strip on the
conveyor – the rest, as forwarding, reading, evaluating and disposal of the strips is done
automatically by the device. The timing (route-length and speed of the conveyor belt) is
adequate to the incubation time of the test strip.
The CombiScan®500 analyses the colour and intensity of the light reflected from the rea-
gent surface and reports the results in clinical meaningful units. No further calculation is
needed by the user. When a strip is moved into the measuring position under the optical
unit, the reflectance of each reagent pad is measured. The light reflected at specific wave-
lenghts from the test pad depends upon the degree of colour change of the pad, which
is related to the concentration of the particular parameter in urine. The intelligent image
analyzer software first detects, locates the strip and the pads, then, based on these colour
light-wave information the CombiScan®500 reads the reagent areas and the values are
calculated automatically. Results are stored, then printed out by the built-in printer and
can optionally be sent to host computer via serial connection.

2
Introduction
3
Introduction
1.2. The test strips
The base of the urine analysis is the good quality of the urine test strip. These strips have
separated pads for each parameter. The test pads contain reagents, which cause colour
changes according to the parameter concentration in the urine. The CombiScan®500 is
calibrated to CombiScreen®11SYS urine test strips and guarantees accurate results all
time. The CombiScreen®11SYS urine test strip contains reagents for testing:
Bilirubin
Urobilinogen
Ketones
Ascorbic Acid
Glucose
Protein
Blood
pH
Nitrite
Leukocytes
Specific Gravity
Besides the CombiScreen®11SYS, the CombiScreen®11SYS PLUS can also be used
with this instrument. To facilitate reading of the manual, the test strip is always named
CombiScreen®11SYS in this manual.
IMPORTANT! Before using the test strip read carefully the CombiScreen®
11 SYS packing insert! The meter can only be used with the CombiScreen®
11 SYS urine test strip!
1.3. Intended use
CombiScan®500 is an instrument for measurement of urine test strips CombiScreen®
11SYS for in-vitro determination of Ascorbic acid, Bilirubin, Blood, Glucose, Ketones,
Leukocytes, Nitrite, pH, Protein, Specific Gravity and Urobilinogen from urine. These
measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases,
urogenital and kidney disorders or metabolic abnormalities. For professional use, not for
self testing.

4
Description of the reader
5
Description of the reader
2. Description of the reader
The equipment is designed specifically for use in clinical laboratories. In its basic instal-
lation the housing is almost fully closed, its physical appearance including colour meets
the requirements raised by medical laboratories. Its throughput is about 500 test strip
evaluations/hour.
The optical system is designed espe-
cially for evaluation of urine test strips.
The test strip is illuminated by white
light and the reflected light from the
reagent strip is detected by a colour
CCD sensor. The signals are digitalized
and this digitalized image is evaluated
by the built-in program.
Due to the CCD-technology, the instru-
ment is able to distinguish between
colour changes caused by reaction of
the test pad chemistry and non-spe-
cific colour development, caused by
the sample.
Operation is very simple, and doesn’t
require any special knowledge or dif-
ficult practice. When measurement
starts, the front door opens and the
conveyor assembled onto a carriage
moves into the measuring position.
The strip needs to be placed on the
conveyor. Both the conveyor and the
carriage are driven by a DC motor.
Fig.1 Front view of the CombiScan®500 urine analyzer
LCD
Controll Keys
Numeric Keys
Function Keys
Front Waste-bin
Fig. 1
Carriage Strip Pumper
Front Shaft
Support
Rear Shaft Cylinder 1 Cylinder 2
Belts
Fig. 2 Description of the parts for installation
Fig. 2

4
Description of the reader
5
Description of the reader
The carriage has three positions:
Closed: The whole carriage is inside of the housing and the Frontdoor is closed. This is
the stand-by or off position.
Measurement: The front of the carriage is ejected of the reader housing in order to let
the operator place the strip onto the three-belt conveyor.
Maintenance: The carriage is fully ejected. In this position you can remove the belts and
cylinders for cleaning.
CAUTION! The carriage movement is controlled by the reader, never try to move
it manually, not even when the reader is in stand-by or turned-off position! If the
power shuts down when the carriage is ejected or an error occures, turn the
reader off and on. The carriage will find its normal position automatically.
The used strips are collected in a waste bin located under the conveyor inside the Com-
biScan®500 (capacity: about 150 strips). If the automatic strip-counter reaches 150 you
will get a warning message which asks you to empty the waste-bin. To remove the waste-
bin just push and release its front panel. It will be automatically ejected. Pull it out totally,
empty it and insert it back. Slip it gently till it is bumping (see section 5.1.).
On the top side of the CombiScan®500 you can find the built in printer. If you open the
printer cover by lifting it’s front side you will get access to the paper roll cave to load
printer paper. For loading the printer paper refer to section 3 (Installation).
The interface connectors are located on the back panel. The external barcode reader and/
or keyboard can be connected to the keyboard interface connector. The host computer
can be connected to the RS232 serial port.
DC connector Keyboard
Interface
RS232
Serial Port
Fig. 3 Rear view of the CombiScan®500 urine analyzer
Fig. 3
Slot
Firmware

6
Description of the reader
2.1. Packing list
CombiScan®500 instrument 1 pc
cylinder 1 1 pc
cylinder 2 (with gearwheel) 1 pc
belt 6 pcs
power adapter 1 pc
power cord 1 pc
serial cable 1 pc
users’ manual 1 pc
printer paper 1 roll
CD 1 pc (optional)

7
Installation
3. Installation
The CombiScan®500 is shipped in a carton box. Prior to unpacking, clear the area where
the instrument is to be operated, a surface of about 30x50 cm will be needed. While
handling the package, please be cautious of the shipping marks on the box. Open the
box. Cut the tape only, leaving the carton material intact. It is recommended to keep the
packing materials for a while as well, in case the instrument needs to be moved to another
location or must be shipped to have it been repaired in the manufacturers’ service. Check
the packing list, if the shipment is complete (see section 2.1.). If it is complete follow the
instruction below otherwise please contact your distributor immediately.
Place the CombiScan®500 to its working position.
Optional: Connect the CombiScan®500 to your computers’ serial port, by using the
serial cable, if necessary.
Optional: Connect your keyboard or barcode reader optional to the interface connec-
tor.
Connect the power adapter first to DC connector then to the mains.
Switch the reader on by pressing ENTER on the built-in keypad.
In a few seconds the actual software version appears for a short moment on the LCD.
„CLEAR MEMORY“ appears on the display.
Press QUIT. Now you reach the MAIN MENU.
Select MENU by pressing the control key below the MENU sign.
Select SERVICE by pressing the control key.
Select CLEAN by pressing the control key. Now the door opens automatically and the
conveyor section moves out until the cleaning position is reached.
Install the cylinder 2 (with the gear-
wheel) onto the rear shaft until the
built in magnet fixes it in the proper
position (see fig. 4).
Install the cylinder 1 onto the front
shaft until the built in magnet fixes
it in the proper position (see fig.4).
Front Shaft Rear Shaft
Strip
Bumper
Fig. 4 Installation of the cylinders
Fig. 4

8
Installation
Install all the three belts onto the
cylinders (see fig. 5).
Press the OK key. Now the convey-
or slips back and the door closes
automatically.
Open the printer cover.
Take the roll of printer paper and insert the roll into its cave. Load the free end of the
paper into the feeding slot in a way, that the outer side of the paper roll is facing down
while inserting it into the feeding slot (if the paper is inserted in the wrong way, there
will be no printout on the paper). The paper will be loaded automatically (see fig. 6). To
remove the paper, just pull out from top side.
Now, the CombiScan®500 is ready to work.
Note: Before the first measurement a calibration process should be done (see
section 4.5.2.2.)!
Fig. 5 Installation of the belts
Fig. 5
Printer Cover
Printer Paper
Printer
Fig. 6 Loading the printer paper
Fig. 6
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