Analyticon Urilyzer 100 Pro User manual

agile - affordable - accurate
Urilyzer®100 (Pro)
User Manual
Analyticon
Biotechnologies AG
Am Muehlenberg 10
35104 Lichtenfels - Germany
[email protected]
www.analyticon-diagnostics.com

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Analyticon Biotechnologies AG
Am Muehlenberg 10
35104 Lichtenfels - Germany
[email protected]
www.analyticon-diagnostics.com
The information in this manual was correct at the time of printing.
However, Analyticon Biotechnologies AG continues to improve its products and
reserves the right to change specifications, equipment, and maintenance proce-
dures at any time without notice.
Companies, names and data used in examples are fictitious unless otherwise
noted. No part of this document may be reproduced or transmitted in any form or
by any means, electronic, mechanical or otherwise, for any purpose, without the
express written permission of Analyticon. Analyticon may have patents or pend-
ing patent applications, trademarks, copyrights or other intellectual or industrial
property rights covering this document or subject matter in this document. The
furnishing of this document does not give a license to these property rights ex-
cept as expressly provided in any written license agreement from Analyticon.
If this instrument is used in a manner differently than specified in this manual, the
protection provided by the equipment may be impaired.
V1.03 (GB) (2012-11)

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Table of Content
Table of Contents
1. Introduction 5
1.1 How to use this manual 5
2. Quickstart 8
3. System description 10
3.1 Measuring principle 10
3.2 Components and Functions 11
3.3 Instrument and Labeling Symbols 12
4. Unpacking & Set Up 14
4.1 Unpacking 14
4.2 Setting up 14
4.3 Analyzer software updates 18
5. Use of the instrument 20
5.1 Screens 20
5.2 Interacting with the touch screen 20
5.3 Data input: Barcode reader, keyboard 23
5.4 Flow-chart of the menu structure 25
6. Start-Up Wizard 27
7. Testing 28
7.1 Quick Test 28
7.2 Test features and customization 31
7.3 Full Test 34
7.4 Latest result 36
7.5 Worklist management 36
8. Recall Results 39
8.1 List view 39
8.2 Result view 40
8.3 Filtering: How to find specific results 40
8.4 Modifying the active selection of results 41
8.5 Action with selected items 42
9. Quality Control Testing 43
9.1 QC Options 44
9.2 QC Testing 46
9.3 Recall QC Results 47

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Table of Content
10. Options menu 48
10.1 Strip LOT 48
10.2 View Settings 48
10.3 User Options 48
11. Instrument Settings 50
11.1 Language 51
11.2 Date, time 51
11.3 Printout 51
11.4 Output (Connectivity: Transfer/Export) 52
11.5 Measurement 54
11.6 Strip options 54
11.7 Database management 55
11.8 QC options (Pro only) 55
11.9 Power management 56
11.10 Log export 56
11.11 Editing color and clarity list (Pro only) 56
11.12 Ethernet interface configuration (Pro only) 57
11.13 Update 57
11.14 Operators (Pro only) 58
12. Cleaning & Maintenance 64
12.1 Cleaning the analyzer 64
12.2 Cleaning the test strip tray 64
13. Troubleshooting 66
13.1 List of Errors and Information Messages 67
13.2 Problem Checklist 78
14. Appendices 79
14.1 Appendix A: Results table 79
14.2 Appendix B: Specifications 81
14.3 Appendix C: Analyzer Default settings 82
14.4 Appendix D: Safety information 83
14.5 Urilyzer 100 Intended Use and Indications for Use 85

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Introduction
1 Introduction
Due to software changes, some screens on the instrument may appear slightly
different from those in this manual.
What does the analyzer do?
The Urilyzer 100 analyzer is a lightweight instrument for reading CombiSceen
Plus urinalysis strips (CombiScreen 11SYS Plus, CombiScreen 7SYS Plus and
CombiScreen 5SYS Plus). It is a reflectance photometer that analyzes the inten-
sity and color of light reflected from the reagent areas of the strip. It is designed
for In Vitro Diagnostic (IVD) use by qualified physicians and laboratory staff; how-
ever no special training is required to operate the instrument.
The analyzer can be set up to be as simple or sophisticated as you prefer. You
may simply insert a dipped urinalysis strip into the analyzer and the result will be
reported. By modifying the user options the measurements can be automatically
started, printed and transferred.
Alternatively, you have the option to enter the Sample ID, Patient ID, and color,
clarity of the specimen manually. This added information will be reported along
with the test results. The system also allows full customization to determine
which fields appear on the printouts. You can also enable the user manage-
ment features, thus the Operator ID is also recorded with the test results. The
advanced security functions may also prevent unauthorized use through config-
urable settings. Remember, these features can be set independently.
The touch screen displays instructions and prompts you through the operation
of the analyzer. In addition, you enter information through the touch screen. The
optional barcode reader and external keyboard are also available for accurate
data entry to reduce transcription errors.
Do I have to calibrate?
You do not have to do anything to calibrate. The instrument performs a system
test each time it is turned on. Then, each time a test is run, the instrument auto-
matically checks and corrects its performance through the independent internal
sensor.
1.1 How to use this manual
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.
Symbols
Symbols are used to help quickly locate and interpret information in this manual.
This section explains the formatting conventions used in this manual.
The following symbols are used throughout this document:

6
Introduction
7
Symbol/Sign Explanation
CAUTION: Indicates a potentially hazardous situation that if not
avoided could result in personal injury or damage to the instru-
ment. This symbol is also used to highlight situations that can
compromise results. Cautions appear in bold type.
BIOHAZARD: Indicates a potentially dangerous situation involv-
ing the presence of biohazardous material. All safety precau-
tions 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 sign labels a cross-reference inline the text. In the manual, you will notice
some text is in bold/italic or bold. The bold/italic text identifies screen names,
while simple bold text identifies a button (touch sensitive area) on the screen.
Safety precautions
Before operating the Urilyzer 100 analyzer, it is essential that the warnings, cau-
tions, and safety requirements contained in this manual are read and understood
by the user.
Detailed safety information can be found in 14.4 Appendix D: Safety
information section.
User qualification: Only appropriately trained operators are qualified to
operate the analyzer.
Correct use: Any disregard of the instructions in the Operator’s Manual
may result in a safety risk. Use the Urilyzer 100 analyzer to analyze urine
samples only. It is not intended for any other application.
Environmental conditions: The Urilyzer 100 analyzer is approved for in-
door use only.
Strip waste is potentially biologically hazardous. Always wear personal
protective equipment when handling and disposing of samples of hu-
man origin. Use universal precautions. Consult your facility’s infection
control policy. See 14.4.1 Protecting yourself from biohazards sec-
tion for more information.

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7
Introduction
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
pos positive
SI Standard International

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Quickstart
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2. Quickstart
Unpack the instrument and place it on an even, hard surface (for detailed instal-
lation instructions see 4. Unpacking & Set Up). Load the strip tray and the
printer paper.
Connect the power supply and turn the reader on with the On/Off-switch (See
4.2.5: Powering up).
After the boot-up procedure and self-test the Mea-
surement screen will appear on the display.
Strip waste is potentially biologically hazard-
ous. Always wear personal protective equip-
ment when handling and disposing of sam-
ples of human origin. Use universal precau-
tions. Consult your facility’s infection control
policy. See 14.4.1 Protecting yourself from
biohazards section for more information.
• Dipateststick(CombiScreen11SYSPlus)intotheurinesampleforapprox.
one second.
• Blot by touching the edge of the strip to a paper towel to remove excess
urine.
• Placethestriponthestripholder
• Slideor pushthe stripto theend ofthe channel.Do nottouch thereagent
pads on the test strip.
The instrument will automatically detect an applied strip. The measurement cycle
will be started. A progress bar on the display shows the remaining incubation
time.
If „Autostart“ (see 7.2.1 Features: Autostart-, print-, transfer- and fast
mode) is deactivated, the measurement must be started by pressing the Start
button.
Measurement

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9
Quickstart
After approx. 60 seconds the pad results will be dis-
played on the screen.
If Autostart is ON: The result screen will be dis-
played until you remove the test strip from the tray.
Once the strip is removed, the display automatically
returns to the Measurement screen.
If Autostart is OFF: The result screen will be dis-
played for approximately 5 seconds –while display-
ing a circle animation – then the display will return
to the Measurement screen (if no error occurred
during the readout). If you touch the display while
the circle animation is running, the system will not
automatically return back.
On the Result screen:
• Bypressingthe Delete button the result can be deleted
• Bypressingthe Printer symbol the result can be printed
• Bypressingthe Transfer button the result can be transferred
• Bypressingthe Meas. button the system goes back to the measurement
• Bypressingtheright arrow the additional fields
of the result are showed
– Color, clarity, Patient ID, Strip LOT and com-
ment
– On the second result screen the result can
be edited by pressing the Edit button (if it
wasn’t printed or sent already)
At the Measurement screen another analysis may be started by applying the
next test strip.
The latest result can be reviewed by selecting the Latest button on the
Measurement screen.
Result (1)
Result (2)

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System description
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3. System description
3.1 Measuring principle
The test strip is moved below a fixed measurement unit on a slide called test strip
tray with an embedded reference pad. The analyzer reads the reference pad, fol-
lowed by each of the test pads on the strip.
The optical unit contains four LEDs that emit light at various wavelengths. Read-
ing is done electro-optically, as follows:
The LEDs (1) subsequently emit light of a defined wavelength onto the surface of
the test pad (2) from directly above the test zone. The light hitting the test zone is
reflected more or less intensely depending on the degree of color change of the
test pad (directly related to the concentration of the particular constituent in the
urine), and is picked up by the detectors, photodiodes (3) positioned at optimum
angles. The phototransistors send analogue electrical signal to an A/D converter
(4), which changes it to digital form. The microprocessor (5) then converts this
digital reading to a relative reflectance value by referring it to a calibration stand-
ard.
Finally, the system compares the reflectance value with the defined range limits
(reflectance values that are programmed into the analyzer for each parameter)
and outputs a semi-quantitative result (6).
Each test pad is read photometrically after a lead (incubation) time of about 55–
65 seconds.
Principle of measurement