Professional Documents
Culture Documents
Service Manual
Analyzer for CombiScreen® 11SYS Plus and CombiScreen® 11SYS urine test strips
Analyticon
Biotechnologies AG
Am Muehlenberg 10
35104 Lichtenfels - Germany
info@analyticon-diagnostics.com
www.analyticon-diagnostics.com
info@analyticon-diagnostics.com
www.analyticon-diagnostics.com
2
UL500_V1.1_11-2017 Contents
Contents
1. Introduction................................................................................................................... 5
1.1 How to use this manual......................................................................................... 5
1.2 Symbols and formatting conventions.................................................................... 5
1.3 Safety precautions................................................................................................. 8
1.4 Intended use........................................................................................................ 10
1.5 Indications for use............................................................................................... 10
1.6 Limitation of use.................................................................................................. 10
3
Contents
6. Troubleshooting.......................................................................................................... 57
6.1 Abnormal analysis results.................................................................................... 57
6.2 Troubleshooting chart.......................................................................................... 59
8. Appendices................................................................................................................. 63
8.1 Technical specifications...................................................................................... 63
8.2 Printed circuit board diagrams............................................................................ 64
4
Introduction
1. Introduction
1.1 How to use this manual
The Urilyzer® 500 Pro Service Manual is intended as a guide and reference for service
personnel. Urilyzer® 500 Pro may only be serviced by sufficiently trained service personnel
employed or commissioned by distributors certified by Analyticon Biotechnologies AG.
This Service Manual provides information on how the qualified service person can veri-
fy the performance of the device, perform troubleshooting, repair serviceable parts, and
calibrate the device.
Other applicable documents are:
– the Urilyzer® 500 Pro Operator’s Manual
– the CombiScreen® 11SYS Plus Instructions for Use
– the CombiScreen® 11SYS Instructions for Use.
For further assistance and feedback, visit
The Operator’s Manual contains the directions you need to unpack the analyzer, safely use
it for your daily urinalysis and keep it in good working condition.
Before reading this Service Manual, please read the related chapter of Urilyzer®
500 Pro Operator’s Manual, as descriptions and instructions in this Service Manual
assume the knowledge included in the Operator’s Manual.
The Operator’s Manual of Urilyzer® 500 Pro contains the following chapters:
– Quickstart
– System Description
– Unpacking & Setup
– Interacting with the analyzer
– Start-Up Wizard
– Analyzing samples
– Working with results
– Quality Control (QC) Testing
– Main menu options
– Instrument Settings
– Cleaning & Maintenance
– Troubleshooting
– Appendices (incl. technical specification, safety information, and intended use)
5
Introduction
Symbol Explanation
CAUTION: Indicates a potentially hazardous situation that if not avoided
could result in personal injury or damage to the instrument. This symbol is
also used to highlight situations that can compromise results. Caution text
appears in bold type.
BIOHAZARD: Indicates a potentially dangerous situation involving the
presence of biohazardous material. All safety precautions must be taken to
prevent personal injury or damage to the equipment.
NOTE: Contains important information or useful tips on using the analyzer.
Notes appear in italicized type.
The symbol indicates a cross-reference within the text. In the manual, you will notice
some text is in bold/italic or bold. The bold/italic text identifies screen names, while sim-
ple bold text identifies a button (touch sensitive area) on the analyzer display.
6
Introduction
7
Introduction
1.2.2 Abbreviations
The following abbreviations are used:
Abbreviation Definition
AC Alternating Current
arb arbitrary
ASTM American Society for Testing Material
conv conventional
csv comma separated values
DC Direct Current
EN European Standard
ID identification number
LED Light Emitting Diode
neg negative
norm normal
SI Standard International
8
Introduction
1.3.5 IT security
The built-in PC of the analyzer does not contain any anti-virus program therefore it is very
important to follow the below listed precautions.
Always check all external storage devices with an anti-virus program before connect them
to the analyzer.
Never connect external devices to the analyzer, which are used in any public computer
systems or at home.
Do not add, move or delete any files or software unless specified in the User or Service
Manuals.
9
Introduction
See the MedlinePlus Medical Encyclopedia article on urinalysis for further details.
10
Analyzer overview
Middle
housing
Bottom housing
11
Analyzer overview
PS/2
12
Analyzer overview
Printer
Mainboard
Puller home sensor
Sensor flag
Ferrit
bound
Lift home
sensor
ON button board
Measuring head
Detector board
Micro switch
Drop tray
Bottom housing
Figure 3: Analyzer front view without top housing, touch screen, test strip tray and strip
loading sensor board cable
13
Analyzer overview
Lift motor
power connector
Head home sensor
Puller motor
power connector
Head motor
Head motor power
connector
Power to motor
controller card
Interlock board
Figure 4: Analyzer back view without top housing, touch screen, test strip tray and strip
loading sensor board cable
14
Analyzer overview
15
The service software
The device will not be able to access the update files unless they are located in the
root folder of the USB flash drive in a folder named ‘update’.
3. Complete the steps in 3.1.1.
16
The service software
The file contains the language settings, the operator name and the password: -L=en_
GB.UTF8 -n=service -p=oOrMIy47uxE23w
The language can be changed if needed using the ISO 639-1 Code for the required lan-
guage. For example, the string should be change to -L=pl_GB.UTF8 if you want polish
language setting.
3. Insert the service USB flash drive into the top USB A connector at the back of the
Urilyzer® 500 Pro device.
4. Log out and tap in the “Enter name” textbox and when the system asks for the name,
tap enter. The system logs you in as service. Once you have logged in as a Service
level user, a Service button to access the Service menu will become available on the
Settings screen. The system, however, does not store the service password that is on
the USB flash drive. You will have to insert the service flash drive to log in as a service
level user after logging off the device or before you turn on the device.
17
The service software
Users with service-level operator profiles have exclusive access to a number of functions
that help them test and set up basic hardware-related functions of the device. These fea-
tures are collected on the Service menu. In this section, you can find all the details that
you need to use these functions.
The Service menu is a single screen, offering all the functionality that is hidden from
normal users and administrators but is available above Service security level.
18
The service software
that checks every part of the device hardware and functionality. The test sequence runs
automatically but you can skip any step or stop the test at any time.
The Fast Test function aims to run a short but thorough testing of various funcionality and
components of the instrument. The service personnel only need to follow the instructions
appearing on-screen, while results of the tests are printed as a Fast Test printout form.
Passed tests are indicated with OK, skipped test are indicated with SKIP, and failed tests
are indicated with FAIL on the printout.
During the Fast Test function the following HW and SW parts are tested: printer detection
& printing, display, touch screen function, strip sensing, sensors of the strip transmitter &
measurement system, measurement capability, input and output connectors.
Test parts can be skipped by using the right arrow button. The whole test can be cancelled
and quit by using the left arrow button.
Read the description and collect the needed accessories before you start Fast Test.
You will need the following accessories and external devices to complete the test:
– at least about 50 centimeters (20 inches) of thermal printer paper
– the serial number (S/N) of the device at hand
You can find the serial number printed below a barcode on a label on the back of the
device.
– a USB Type A-to-USB Type B converter cable
– a connected external keyboard
– a DHCP router connected via the Ethernet connector that can assign an IP address to
the DocUReader device
– a grey check strip
– unused test strips
– a USB flash drive with some content
– Laptop or PC with a serial port checking software - e.g. Terminal - on it and a serial
cable to connect it to the analyzer. Set baud rate to 115200, parity to none and bit rate
to 8.
This can be omitted from the test and skip the step where these accessories needed.
3.3.1.1 The test sequence includes the following steps and screen prompts
19
The service software
20
The service software
If you skip a subsystem test, it gets a FAILED mark. The following table summarizes
the symbols that appear next to values on the Fast Test results printout.
On the Set Mechanic screen, service personnel can run mechanic tests to find out wheth-
er any change, repair or fine-tuning in the mechanical system is necessary.
The left and right arrows let the service personnel browse amongst the seven screens
each applied to specific movements, the setting of home positions or flow tests of the
three motors. Three screens are for running test and jitter checks of the three motors.
Three screens for setting home positions of the three motors. The seventh screen is for
flow tests.
21
The service software
Mode: It shows the name of the motor, which the screen is applied to.
–
Right-left arrows: It changes the mode and therefore the screens.
–
Home: It moves the particular motor to Home position.
–
OFF: It cuts off the power of the motor.
–
<<Backward: It moves the motor backward (The flag moves toward the sensor).
–
Forward >>: It moves the motor forward (the flag moves out of the sensor).
–
Jitter (short): It checks (with a short movement) the lost motion of the particular motor,
–
which caused mainly by the looseness of the gear belt.
Jitter (long): It checks (with a long movement) the lost motion of the particular motor,
–
caused mainly by the looseness of the gear belt.
Run: It makes the motor do continious, full movements.
–
Stop: It stops the motor.
–
Speed: It sets the speed of the movements. All movements can be run at three different
–
levels of speed. Slow represents the normal operational level of speed. Fast is a medi-
um level and the Service level is the fastest.
Sensor (home): The blue circle works as a control lamp. When the flag is in the sensor
–
the blue circle “lights up”.
The sensor is not activated when the motor is in home position as the motor takes just
as many steps as needed to move the flag out of the sensor.
Back: It takes back to the previous level of the menu system.
–
22
The service software
The head motor home position setting is a little different from the other two. It comes from
the main requirement of a measuring head: most accurate reading of the pads. Therefore
the head home position must be where the reading of the check pad is the most effective.
There are five different reading positions represented in five rows. The middle row shows
the values of the position of a normal measurement check pad check. The other rows
show the values that are read when the head moves forward or backward 0.3 mm or 0.6
mm. Each position has four columns, showing the reflectance values of the four different
wavelenght (colour). The number in the brackets are the measured value, the negative
number above it is the difference from the expected value. If the difference is more than
150, the numbers turn blue, showing the irregularity. The positions can be measured one-
by-one with the Up and Down buttons. The checking starts straight away when the row
is selected. The Run button changes to Stop with an orange background colour. The All
Check measures all the positions.
23
The service software
The lift motor home position setting is based on the movement of strip lifting. Five motor
position can be checked in a predefined sequence to make sure of the correct position.
The position check is selected by the Up and Down arrows. The motor makes the move-
ment as soon as it is selected and can be checked again by tapping Run. The actually
selected position check is highlighted with a blue rectangular frame.
– Set: Lift “LIFT strip” position
The gap after the first, longer “puller” pair of the rake is about 1.5 mm above the “pull” pins
of the test strip tray (see Figure 37).
– Check: Lift “PULL end” position
The top of the longer “puller” pair of rake tooth are about 2.5 mm above the test strip tray
(see Figure 38).
– Check: Lift “PULL start” position
The first, longer “puller” pair of rake tooth are in the slot just under the end of the test strip
tray (see Figure 39).
– Check: Lift “BASE” position
The rake is in BASE position, under the level of the test strip tray.
– Check: Lift “MOVE end” position
The rake is in the end of its strip loading cycle, under the level of the test strip tray. The
rake shouldn’t touch the test strip tray.
24
The service software
The puller motor Home position setting is based on how close the strip is pulled to the pins
of the test strip tray at the end of the strip pull phase of the strip loading process.
– Set: Pull “PULL end” position
The strip is pulled just next to the pins (app. 0.5 mm) and does not touch them (see Figure
40).
– Check: Pull “MEASURE” position
The rake just passed (app. 0.2 mm) the pins of the test strip tray and the front mover teeth
are just a test strip away from the “measure” pins.
Flow test
25
The service software
Flow test screen contains combined movements of the measurement process. The test
needs to be done with unused test strips.
– Pull Strip
The first phase of the measurement process. The rake goes to “PULL start” position,
moves towards the pins until “PULL end” position and goes under the Test strip tray.
– Move Strip
The second phase of the measurement process. The rake moves upwards from under the
test strip tray until “LIFT strip” position, moves towards the measuring head until “MOVE”
position. Then it goes under the test strip tray and back to lift motor “BASE” position
– Load Strip
The combined movement of the previous two. There is one “Pull Strip” and nine “Move
Strip” movement, emulating the whole strip loading process from the moment the strip is
placed at the strip delivery area until it arrives under the measuring head.
– Measure Strip
The measuring head reads the check pad then all the pads of the test strip tray.
– Run
Combined movement of one “Pull Strip” and one “Move Strip” motion repeatedly emulat-
ed until tapping Stop.
3.3.3 Sensors
The Sensors screen shows values of different sensors of the strip transporting system.
The “OnTray” sensor detects whether a strip is placed on the test strip tray for measure-
ment, the “Pull check” sensor detects whether the strip was successfully moved from the
strip placing area, and the “Detect” sensor detects whether the strip got to the area where
it cannot be reached by the operator anymore (inside the housing, before the measuring
head). The service personnel can give commands to the instruments with the Pull Strip
and the Move Strip buttons. Limits of the three sensors can be set with the left arrow and
the right arrow buttons and can be updated with the Update button. Negative limit values
26
The service software
(–X) activate an automatic mode which sets the given sensor value according the following
formula:
Limit of … sensor: -X
Automatically set limit: <VALUE MEASURED WITHOUT STRIP> - X
27
The service software
28
Instructions for replacing parts
Always pay attention to the cables and connectors when re-assembling the analyzer.
Unplugged connectors would make the analyzer working with errors or not working en-
tirely.
29
Instructions for replacing parts
30
Instructions for replacing parts
31
Instructions for replacing parts
Figure 18: The middle housing has been removed from the analyzer
32
Instructions for replacing parts
Figure 19: The measuring head cable has to be disconnected before remove the main-
board
33
Instructions for replacing parts
3. Unscrew the head board securing screws (circled in blue in Figure 20) and carefully lift
the measure head panel.
4. Replace with a new one and complete the previous steps in reverse order.
5. Turn the analyzer on and log in as service.
6. Go to Service/Set Mechanic/Head (home set) menu.
7. Check and – if necessary – adjust the head motor home position sensor (see “5.3 Head
motor home position”).
34
Instructions for replacing parts
4. Unscrew and remove the hex sockcet screw and the countersunk screw, which secure
the motor controller card to the analizer.
5. Remove the motor controller card and replace it with a new one.
6. Complete the previous steps in reverse order.
It is necessary to start with the countersunk screw, next to the sensor, when
attaching the new motor controller card.
7. Turn the analyzer on and go to the Service/Set Mechanic/Puller (home set) menu.
8. Check the puller motor home position sensor – and if necessary – adjust the sensor flag
positioning (see “5.2 Puller motor home position”).
35
Instructions for replacing parts
36
Instructions for replacing parts
37
Instructions for replacing parts
38
Instructions for replacing parts
Start to pull the timing bell off of the top idler pulley.
5. Replace the belt with a new one, re-attach the retainer plates, the mainboard and the
LCD screen.
6. Turn the analyzer on and check the head motor jitter value in the Service menu and – if
necessary – adjust the tightness of the gear belt (see “5.4 Head motor gear belt tight-
ness”).
39
Instructions for replacing parts
40
Instructions for replacing parts
41
Instructions for replacing parts
42
Instructions for replacing parts
43
Instructions for replacing parts
Figure 30: Drop tray detector board securing screws circled in red
44
Instructions for replacing parts
Figure 31: Strip loading sensor board securing screws circled in red
45
Instructions for replacing parts
46
Instructions for replacing parts
47
Instructions for replacing parts
48
Instructions for replacing parts
49
Instructions for replacing parts
50
Checking and adjustments
To adjust the lift motor home position sensor complete the following steps:
1. Remove the top housing as described in “4.2 Disassembling the top housing”.
2. Turn the analyzer on and go to Service/Set Mechanic/Lift (home set) screen.
If the driven pulley is being replaced, the flag may be positioned far away from
its correct place, which may prevent running the checking procedure with the ser-
vice software. In this case move the rake mover to its downmost position manually
and check that the top of the sensor flag is in the sensor and overlapping for about
two millimeters. If not, move the flag to the previously described state.
3. Go to “LIFT strip” position and check that the rake would lift the strip above the level of
the two “pull” pins on the test strip tray.
Figure 37: (LIFT srtrip) The gaps between the first two pairs of teeth that lift the strip should
be about one mm above the pins of the test strip tray
4. Go to “PULL end” position and check that rake move to a position where its shorter
“mover” teeth are just below the top of the test strip tray and the 2 longer “puller” teeth
are about 2.5 millimeter above the top of the test strip tray.
51
Checking and adjustments
Figure 38: (PULL end) The first, longer teeth are about 2.5 mm above the level of the test
strip tray
5. Go to “PULL start” position and check that the rake stays on level off “Pull Strip” po-
sition and moves to its leftmost position. The longer “puller” teeth of the rake are flush
with the strip timer rake and are under the end of the rake.
Figure 39: (PULL start)The first, longer teeth are under the end of the test strip tray
6. Go to “BASE” position where all the teeth are under the test strip tray.
7. Go to “MOVE end” position and check that the rake does not touch the bottom of the
test strip tray. You checking it by listening the sounds that the rake makes.
8. If the checking positions are correct, re-assemble the components. If the positions are
not correct, follow the instructions written below.
9.Remove the LCD as described in “4.3 Replacing the LCD touch screen” . Remove the
middle housing as described in “4.4 Disassembling the middle housing”.
10. Replace the test strip tray and the LCD.
Use a piece of cardboard or towel to place the LCD touch screen on. Do not
place it on the mainboard directly as it could scratch it.
11. Turn lift motor off.
12. Loosen the 2 hex socket set screws, which secure the driven pulley on the square axle
until the pulley can be moved around manually on the axle, but holds strong enough
to it to be able to drive the axle when checking lift motor movements.
13. Reposition the driven pulley on the axle according to the experienced misalignement
and check the position again. Repeat this procedure until the position is correct.
14. Re-assemble components.
52
Checking and adjustments
Figure 40: (PULL end) The first, longer teeth are just a test strip away from the pins
4. Go to “MEASURE” position, lift up the LCD touch screen without disconnecting its ca-
ble and place a test strip between the last pair of “puller” teeth and the “measure” pins.
Check that the strip has enough place.
Figure 41: (MEASURE) The test strip has enough place between the pins and the teeth
5. If necessary, loosen the 2 hex socket screws, which secure the sensor flag on the axle
holder block until the flag can be shifted manually, but holds strong enough to it when
checking puller motor movements.
6. Adjust the sensor flag manually according to the position checking and redo the posi-
tion checks.
7. When the sensor flag is in the correct position tighten the sensor flag securing screws.
53
Checking and adjustments
If the positions,that are back of the check pad checking position (-0.3mm and -0.6mm)
are out of range, you need to move the sensor forwardly. It follows from this, that if the
positions,that are front of the check pad checking position (+ 0.3 mm and +0.6 mm) are out
of range, you need to move the sensor towards the back of the analyzer.
Figure 42: An example of wrong positioning. As the results are out of range in the forward
positions, the sensor has to be moved towards the back of the analyzer
54
Checking and adjustments
Use a piece of cardboard or towel to place the LCD touch screen on.Do not
place it on the mainboard directly as it could scratch it.
3. Loosen the four screws (circled in red in Figure 43) that secure the head motor to the
chassis. Adjust tightness and tighten the screws.
4. Check jitter values on Service/Set Mechanic/Head (motor) screen and adjust again if
necessary.
5. Repeat steps 3–4 until the values are in the tolerable range.
6. Re-assemble the analyzer.
55
Checking and adjustments
Use a piece of cardboard or towel to place the LCD touch screen on. Do not
place it on the mainboard directly as it could scratch it.
3. Loosen the four screws (circled in red in Figure 44) that secure the head motor to the
chassis. Adjust tightness and tighten the screws.
4. Check jitter values on Service/Set Mechanic/Lift (motor) screen at all three speeds
and adjust again if necessary.
5. Repeat steps 3–4 until the values are in the tolerable range.
6. Re-assemble the analyzer.
56
Error messages and recommended action
6. Troubleshooting
Your Urilyzer® 500 Pro analyzer will operate properly if you follow the directions for using
and cleaning the instrument. In case of an error, try to solve it according to the below
trouble-shoot guide first. If the failure remains, please contact your service representative.
If the pads of the test strip are not right under the measuring head, the light of the
LED is not in the pads’ center which can affect the results. You need to adjust the puller
motor home postion.
2. Open a new lot of test strips. Use the fresh strips to test one or more urine samples that
are either definitely positive or definitely negative regarding one or more of the analyte
properties the device measures. Print or otherwise record the measurement results.
If the results you get match the definite results of the previous analysis of the sample,
the test strips you used at abnormal results earlier were probably defective. If not, it is the
measuring head that is probably defective.
3. Run three or four (3–4) quality checks with as many grey checks strip as you have avail-
able.
If the device passes the check strip quality check, the measuring head is probably
working correctly.
If the device repeatedly does not pass the check strip quality check, the measuring
head is almost certainly defective
4. Run a quality check with the recommended Quantimetrix Dipstick Control solutions,
using the fresh test strips you opened in step 1.
If you get the expected values indicated in the package insert of the control solutions,
the test strips you used earlier were probably defective. If not, it is the measuring head that
is probably defective.
5. Use the urine samples you used in the previous steps and test them using the lot of
fresh test strips you opened in step 1. Read the test strips visually by comparing the
57
Error messages and recommended action
pads to the color chart on the test strip tube. Consult the CombiScreen® 11SYS Plus or
CombiScreen® 11SYS user’s manual for further details. Record the results.
If the results you read match the results you got in step 1, the test strips you used
earlier were probably defective. If not, it is the measuring head that is probably defective.
6. Optional: Use the grey check strips, the lot of fresh test strips, and the urine samples
you used in the previous steps, and test them again with a second Urilyzer® 500 Pro
device. Print or otherwise record the measurement results.
If the results you get do not match those you got with the first device, the measuring
head of the device you are servicing is probably defective.
58
Error messages and recommended action
59
Error messages and recommended action
60
Error messages and recommended action
61
Error messages and recommended action
Mes-
sage C. T. Status line text Full text Recommended action
ID
E196 E P DB failure: configura- Do a “Full database and config
tion is corrupted. clear” (see Operator’s Manual) or
Please check the con- call the manufacturer.
figuration settings.
E195 E P Worklist DB failure: Do a “Full database and config
cannot write new clear” (see Operator’s Manual) or
item. call the manufacturer.
E194 E P Worklist DB failure: Do a “Full database and config
cannot insert or modi- clear” (see Operator’s Manual) or
fy item. call the manufacturer.
E193 E P Worklist DB failure: Do a “Full database and config
cannot delete item. clear” (see Operator’s Manual) or
call the manufacturer.
E99 E S Head HW Head hardware error. Check all cables for visible dam-
Please call Service. age and unproper plugging in. If
error remains, replace measuring
head or contact manufacturers.
E98 E S Printer HW Printer hardware error. Check all printer cable connec-
Please call Service. tions. Check any possible me-
chanical cause of printer malfunc-
tion. If problem remains or printer
unrepairable, replace the printer.
E97 E S Head voltage Head voltage value is Check the cable between the
out of range. Please mainboard and the measuring
call Service. head and replace if needed. If
error remains, replace the main-
board.
E96 E S Power voltage Power voltage value is Check the adapter functioning. If
out of range. Please its not working properly, replace
call Service. the mainboard.
E95 E S Mechanic HW Mechanical hardware Run “Mechanic set” checks and
error. Please call Ser- apply corrective action regarding
vice. the result.
E90 E S Reference pad Failure of reference The check pad is contaminated or
pad check. Reference damaged. Replace the check pad
pad value of the tray and do a head home position set-
is out of range. See ting.
Operator’s Manual for
further instructions.
62
Appendices
8. Appendices
8.1 Technical specifications
Type: Reflectance photometer with 4 discrete
wavelengths: 505, 530, 620, 660nm
63
Appendices
64
Appendices
65
Appendices
66
Appendices
67
Appendices
68
Appendices
69
Appendices
70