Urilyzer Cell

User Manual

agile - affordable - accurate

 Made in Hungary, EU
77 Elektronika Kft.
H-1116 Budapest, Fehérvári út 98., Hungary
www.e77.hu
sales@e77.hu

Analyticon Biotechnologies GmbH

Am Muehlenberg 10 35104 Lichtenfels - Germany
info@analyticon-diagnostics.com
www.analyticon-diagnostics.com

ULC060 IUCell_en_26_001_03.01_20230905

2
 

Table of Contents
1 Introduction 4 7 Managing results 66
1.1 About Urilyzer Cell 4 7.1 Test results 66
1.2 Intended Use 4 7.2 Microscopy images 70
1.3 Limitations of Use 5
1.4 Limitation of Liability 5 8 Quality Control 75
1.5 Use of Third-Party Computer 8.1 QC settings 76
Products 5 8.2 QC measurement 76
1.6 How to Use This Manual 6 8.3 QC records management 77

2 Quick Start 7 9 Cleaning & Maintenance 78

9.1 Cleaning and disinfection 78
3 System Description 8
3.1 Theory of Operation 8 10 Troubleshooting 80
3.2 Overview of Operating 10.1 Information messages 80
Elements 8 10.2 Warning messages  81
3.3 Technical Specifications 10 10.3 Error messages 86
3.4 Analytical performance 11
11 Appendices 90
3.5 Instrument and Labeling
11.1 Disposal of the analyzer 90
Symbols 15
11.2 Recycling 90
3.6 Safety information 16
11.3 Modification history 90
4 Installation  20
4.1 Preparing the installation site 20
4.2 Unpacking  20
4.3 Installing the analyzer 21
4.4 Installing barcode reader 21
4.5 Taking Urilyzer Cell out of
operation 22

5 Menu system 23
5.1 System info 23
5.2 User rights 23
5.3 Database menu 26
5.4 The Settings menu 33

6 Operation 55
6.1 Cuvette handling 55
6.2 Worklist 56
6.3 Measurement 57
6.4 Operating with chemical
analyzer 64

3
Introduction

1 Introduction
The goal of this manual is to help qualified operators of the Urilyzer Cell analyzer
use the instrument effectively, with accurate results, and up to its full potential.
It provides information about every relevant aspect of the installation, use, and
database management of the analyzer, as well as basic maintenance and trou-
bleshooting information. Please read the User Manual carefully, as it contains the
directions you need to use the device correctly and safely and keep it in good
working condition.
Keep the User Manual in a safe place to ensure that it is not damaged and re-
mains available for use. It must be easily accessible at all times.

1.1 About Urilyzer Cell

The Urilyzer Cell instrument is a semi-automated microscopy urine sediment
analyzer. The Urilyzer Cell installation kit includes the analyzer and the device
software that lets the operator interact with the automated processes and the
image and measurement results database.
The Urilyzer Cell analyzer takes special cuvettes that hold the urine samples,
centrifuges the cuvettes to form a monolayer of urine sediment inside them, then
takes high power field–like images of the particles with a camera under a bright-
field microscope.
ÂÂYou do not need any special reagents to make measurements with the Urilyzer
Cell analyzer. The cuvettes and the pipette tips are the only consumables of
the instrument.
Urilyzer Cell images are evaluated by a neural network-based software called
AIEM (Artificial Intelligence-based Evaluation Module). This software detects and
categorizes sediment-forming particles in the images.
The operator only needs to load the analyzer with cuvettes, inject urine samples
in them with manual pipette — cuvette forwarding, centrifugation, microscopy
focusing, image capture, image evaluation and storage, and the disposal of used
cuvettes are automated.

1.2 Intended Use

Urilyzer Cell is an in vitro diagnostic use device (IVDD) to increase, through semi-
automation, the reliability, speed and accuracy of detecting renal and urinary
tract abnormalities. Urilyzer Cell provides reproducable detection, quantitative
and semi-quantitative analysis of the following fifteen (15) sediment-forming par-
ticles in native urine samples:

particle sensitivity
red blood cells quantitative
white blood cells and white blood cell quantitative
clumps
hyaline casts semi-quantitative

4
 Introduction

squamous epithelial cells semi-quantitative

non-squamous epithelial cells semi-quantitative
pathological casts semi-quantitative
bacteria semi-quantitative
yeast semi-quantitative
crystals: semi-quantitative
Calcium-oxalate monohydrate semi-quantitative
Calcium-oxalate dihydrate semi-quantitative
Uric acid semi-quantitative
Triple phosphate semi-quantitative
mucus semi-quantitative
sperm semi-quantitative

1.3 Limitations of Use

Do not use the results that the analyzer provides automatically to make diag-
nostic or therapeutic decisions without manual review (validation) of the relevant
microscopy images by a trained medical technician.
If the equipment is used in a manner, that is not specified in this manual, the
protection impairment could be reduced.

1.4 Limitation of Liability

To the maximum extent permitted by applicable laws, under no circumstances
shall Analyticon Biotechnologies be liable for any loss of data or income or any
special, incidental, consequential, or indirect damages howsoever caused.

1.5 Use of Third-Party Computer Products

All connected devices must comply with the EN 60950 standard and all
its extensions relevant to the type of connected device.
Analyticon Biotechnologies does not provide a warranty or take any responsi-
bility for the functionality, content, or end-user support of third-party computer
products used in conjunction with the Urilyzer Cell analyzer.

5
Introduction

1.6 How to Use This Manual

1.6.1 Symbols and Formatting Conventions
This manual uses the following symbols to help you navigate the text:

WARNING This symbol indicates maintenance procedures, opera-

tions, and other processes that can cause personal injury or harm if the
instructions are not followed carefully.
This is an example of warning text.

CAUTION This symbol indicates maintenance procedures, operations,

and other processes that can cause equipment malfunction, equipment
failure, or damage to the equipment if the instructions are not followed
carefully.
This is an example of caution text.

NOTE This symbol indicates important information or useful tips for

operating and handling the device.

This is an example of note text.

The manual uses the following formatting conventions to highlight important in-
formation and help you navigate the text:
• Bold italic blue text indicates a cross-reference that points to a related sub-
section of the manual or to an external hyper link.
• Bold monospace type indicates text that appears on a connected display.
• [Text in square brackets] indicates article numbers for parts and accessories
that you can order for the device.
• numbering within procedures indicates steps that you need to perform in se-
quence.
• Bullet points (•) indicate items on a list or steps that you do not need to per-
form in sequence.

6
 Quick Start

2 Quick Start
After you installed the analyzer and connected it to a monitor, keyboard and
mouse, you are ready to start analyzing urine samples. Complete the following
steps to start a measurement:
1. Turn on the analyzer.
2. Open the analyzer door and load it with cuvettes. Close the door.
3. Push START button and the analyzer loads a cuvette into pipetting position.
4. Manually pipette 0.175 ml previously homogenized sample into the cuvette.
ÂÂIt is important to homogenize the sample before measurement to make sure of
the particle’s equal distribution.
5. Press START button to continue the measurement. The analyzer transfers the
cuvette to the centrifuge. After the short spin, the cuvette is taken to the mi-
croscope and the camera takes predefined numbers of images and evaluates
them.
6. At the end of the measurement cycle the analyzer discards the cuvette into
the waste bin.
7. The result gets stored in the Database.

7
System Description

3 System Description
3.1 Theory of Operation
The Urilyzer Cell device aims to emulate manual microscopy urine sediment
analysis as closely as possible while partially automating sample processing and
result evaluation for increased throughput and analysis accuracy. The following
steps demonstrate a typical analysis work flow:
1. The operator loads a cuvette into the filling position by pressing the START
button.
2. The operator homogenizes and pipettes a native urine sample into a cuvette.
3. After pressing the START button again the analyzer centrifuges the cuvette to
produce a monolayer of urine sediment particles at the bottom of the cuvette.
4. The system takes 15 whole field of view HPF-like images through a bright-field
microscope after automatic focussing.
5. An image processing software that runs on the built-in computer evaluates
the images. The Evaluation Module of the software identifies particles in the
image, to arrive at a semi-quantitative analysis result. If the recognition of a
sample is not reliable (for example due to overcrowded images), it is flagged
for the operator’s review.

3.2 Overview of Operating Elements

The following table summarizes the functional and interactive components of the
Urilyzer Cell analyzer.

Fig. 1: Front view of the Urilyzer Cell analyzer

8
 System Description

Error control light

Ready control light

START button

Connector panel

Air filter

PC fan

Factory label

LIS connector
Barcode reader connector
Mains connector

Chemical analyzer connector

Fig. 2: Rear view of the Urilyzer Cell analyzer

Centrifuge arm

Cuvette cartridge Cuvette hold down

Door pillar Power ON/OFF button

Microscope lamp
Drop tray

Cuvette holder seat

Door lock

HDD control LED

Cuvette mover arm

Microscope unit
Cuvette mover tongue

Fig. 3: Front view of the analyzer without the door, the waste bin and the centrifuge cover

9
System Description

3.3 Technical Specifications

ÂÂTechnical specifications may change without notice. Every effort has been
made to ensure that all the information is correct at the time of publication.
However, Analyticon Biotechnologies reserves the right to make any necessary
changes without notice as part of ongoing product development.

Technology Automated microscopy and image processing

Throughput Up to 60 samples per hour

Sample volume 175±5 microliters
Dispenser pipette tip outer 1.2 - 2.8 mm
diameter
Operating conditions
Not suitable for wet location application.
Ambient room temperature +15 - +40°C (59 °F to 104 °F)
Relative humidity 20% - 80% at 30 °C (86 °F), non-condensing
Altitude and pressure Max. 2000 meters (6561 feet) above sea level
Pollution Degree 2 (EN 61010-1)

Storage conditions

Ambient room temperature +5 - +40°C (41 °F to 104 °F)

Relative humidity 20% - 80% at 30 °C (86 °F), non-condensing
Transportation conditions
Temperature -25 - +60°C (59 °F to 104 °F)
Power requirements
Line voltage 100 - 240 VAC +-10% / max 6A
Line frequency 50 - 60 Hz
Fuse 2 x T8AL250V
Overvoltage category II
Dimensions (w × d × h) 305mm × 315mm × 325mm
Weight 10 kilograms
Database capacity 10000 measurement results (of 15 microscopy
images each)
Waste drawer capacity 50 used cuvettes
Interfaces 2 x PS/2, 1 x DVI-D, 1 x RS232, 2 x DisplayPort, 2 x
Ethernet (RJ45) port, 2 x USB 3.0, 2 x USB 3.1, 4 x
USB 2.0, 2 x Audio jack

10
 System Description

3.4 Analytical performance

Performance characteristics of this analyzer are evaluated by determining analyti-
cal sensitivity (limit of detection), accuracy and precision to measure the reported
analytes:
• Quantitative: Red Blood Cell (RBC); White Blood Cell (WBC)
• Semi-quantitative: Hyaline Cast (HYA); Squamous Epithelial Cell (EPI); Non-
Squamous Epithelial Cell (NEC); Bacteria (BAC); Rod Bacteria (BACr); Coccus
Bacteria (BACc); Crystal (CRY)
• Qualitative: WBC Clump (WBCc); Pathological Cast (PAT); Yeast (YEA); Mucus
(MUC); Sperm (SPRM)

3.4.1 Reference range study

ÂÂThis Information is provided as a guideline only. Analyticon Biotechnologies
GmbH recommends that each laboratory conduct a study to determine the
reference range specific to its location and patient population.

ÂÂCommon findings in a urine sample from a healthy individual may include low
levels or few red blood cells (RBCs), white blood cells (WBCs), and epithelial
cells. An abundance of RBCs or WBCs may suggest pathology; therefore, ref-
erence ranges are determined. The presence of epithelial cells in urine gener-
ally reflects contamination of the sample with skin flora. The reference range is
dependent on the specific study, its location, and sample population.

ÂÂThe normal reference range was determined following the Clinical & Laborato-
ry Standards Institute (CLSI) guidelines described in Defining, Establishing,and
Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline–
Third Edition (EP28-A3c).
For reference range study 226 normally voided urine specimens from a popula-
tion of 148 male and 78 females in apparent good health were investigated on
the analyzer. The measured samples with normal urine chemistry showed the
following distribution of particles:

Parameter RBC WBC

Expected N 95th N 95th
values percentile percentile
Female 78 5.28 p/µl Female 78 7.0 p/µl
Male 148 2.2 p/µl Male 148 3.1 p/µl

3.4.2 Method comparison

ÂÂMethod comparison acc. to CLSI EP9-A
Method comparison against manual microscopy with KOVA chamber couting
with human.
Number of samples measured: 311

11
System Description

The diagnostic performance results of the analyzer compared to manual micros-

copy by KOVA counting chamber are summarized below.

Quantitative diagnostic performance: linear regression

RBC WBC
Pearson R2 0.94 0.91

Semi quantitative diagnostic performance:

RBC WBC EPI NEC HYA PAT CRY YEA BAC MUC

Sensitivity (%) 82 90 82 62 68 77 88 78 95 72
Specificity (%) 87 91 90 82 82 69 90 84 87 74
Exact category 71 74 84 71 75 65 87 82 81 70
agreement (%)
+/- 1 category 95 99 99 93 92 91 98 97 98 96
agreement (%)
Accuracy (%) 84 90 88 77 80 70 89 83 88 73
Prevalance (%) 60 59 22 27 17 10 8 6 14 18

3.4.3 Precision
For precision measurements the following control was used:
Quantimetrix Dip&Spin Normal and Abnormal Level
The below tables are the summary of the investigations.

Between run precision

ÂÂPrecision acc. to CLSI EP5-A2
20 days measurement series with 2 sets of measurements per day, both per-
formed in duplicate on one instrument.
For low concentration SD is calculated as a precision value. For high concentra-
tion the CV is calculated instead.

Between-run RBC WBC

precision Average CV SD Average CV SD
(p/µl) (p/µl)
QC normal 10.1 - 2.5 5.8 - 2
QC abnormal 43.8 16% - 28.2 12% -

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 System Description

Inter-system precision
ÂÂPrecision acc. to CLSI EP5-A
5 days measurement series with 2 sets of measurements per day, both per-
formed in duplicate on 4 instruments.
For low concentration SD is calculated as a precision value. For high concentra-
tion the CV is calculated instead.

Between-run RBC WBC

precision Average CV SD Average CV SD
(p/µl) (p/µl)
QC normal 19.8 - 5 12.2 - 3
QC abnormal 136.3 14% - 66.1 10% -

Within-run precision
ÂÂPrecision acc. to CLSI EP5-A
20 repetitions on one instrument in one run.
For low concentrations SD is calculated as a precision value. For high concentra-
tion the CV is calculated instead.

Between-run RBC WBC

precision Average CV SD Average CV SD
(p/µl) (p/µl)
QC normal 9.4 - 1.5 4.6 - 1.6
QC abnormal 43.9 12% - 26.1 12% -

Limitations: Limitations given include specific substances and conditions that

may affect the test results. As with all laboratory tests, definitive diagnostic or
therapeutic decisions should not be based on any single result or method.

3.4.4 Lower limit of measurement

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined
in accordance with the CLSI EP17-A2 requirements.
The Limit of Blank is 95th percentile value from n ≥ 60 measurements of analyte-
free samples over several independent series. The Limit of Blank corresponds to
the concentration below which analyte-free samples are found with a probability
of 95%.
The Limit of Detection is determined based on the Limit of Blank and the stand-
ard deviation of low concentration samples. The Limit of Detection corresponds
to the lowest analyte concentration which can be detected (value above the Limit
of Blank with probability of 95%).
The Limit of Quantitation is the lowest analyte concentration that can be repro-
ducibly measured with a coefficient of variation (CV) of 60%.

13
System Description

LoB [p/µl] result

RBC WBC NEC EPI HYA PAT BAC BACc BACr CRY YEA MUC SPRM

0.5 0.32 0.05 0.07 0.18 0 12.32 12.3 0.11 0.71 0.05 13.01 0.05

LoD [p/µl] result

RBC WBC EPI
2.8 2.18 1.71

LoQ [p/µl] result

RBC WBC
3.7 3.2

3.4.5 Preservative tubes

The interference measurements were performed based on CLSI EP7-A2 guide-
line, applied to urine sediment microscopy analysis.
The goal of the evaluation of preservatives test was to evaluate if the two sup-
ported tube types (Boritex urine tube, BD vacutainer urinalysis preservative tube)
cause any interference on the analyzer measurements.
The evaluation does not target the preserving capabilities of the tubes them-
selves, as this is the tube manufacturer’s responsibility.
The LoB measurements with the supported preservative tubes were performed-
together with the LoB measurements with normal tube, therefore the same sam-
ples constitute the data pool. In case any deviations are visible, this can most
likely be accounted to the preservative tube. The same measurements were per-
formed as in case of the LoB measurement described in „3.4.4 Lower limit of
measurement“.
SPRM
BACc

BACr
WBC

MUC
RBC

NEC

BAC

CRY
HYA

YEA
PAT
EPI

Non-
12.3

12.3

13.0
0.5

0.3

0.1

0.1

0.2

0.0

0.1

0.7

0.1

0.1

preservative
tube
BD vacutainer
123.3

119.4
0.0

0.7

0.0

0.0

0.0

0.1

6.0

3.3

0.0

4.5

0.0

preservative
tube
Boritex
67.4

66.1

15.4
0.0

0.0

0.0

0.5

0.0

1.8

9.8

0.4

0.0

0.0

preservative
tube

14
 System Description

3.5 Instrument and Labeling Symbols

Symbols on the package

Symbol Meaning Symbol Meaning

Temperature limitation indicating

This way up
upper and lower limits

Keep package out of rain and

Fragile
away from damp conditions

Do not stack

Symbols on the analyzer

Symbol Meaning Symbol Meaning

Biological hazard Warning

Electrostatic discharge
Protective ground
sensitive

The CE mark identifies that

the product complies with the
Moving parts
applicable directives of the
European Union

Manufacturer Date of manufacture

Alternating voltage Consult instructions for use

Reference number Serial number

15
System Description

Symbol Meaning Symbol Meaning

This product has been tested
to the requirements of CAN/
CSA-C22.2 No. 61010-1, second
In vitro diagnostic edition, including Amendment
medical device 1, or a later version of the same
standard incorporating the same
level of testing
requirements

Distributed by Global Trade Item Number

3.6 Safety information

Particular attention must be paid to the following safety information. If
they are ignored, the operator may suffer serious or fatal injury or pa-
tients may be put at risk through faulty sample evaluation.
This safety summary contains the most important and general requirements and
precautionary instructions about the safe operation of the analyzer. Additionally,
you will find specific safety information in the form of warning or caution mes-
sages at the beginning of chapters and with the description of procedures.

3.6.1 Operator qualification

Operators are required to have a sound knowledge of relevant guidelines and
standards as well as the information and procedures contained in the User Man-
ual.
Do not carry out operation and maintenance unless you have been trained. Care-
fully follow the procedures specified in the User Manual for the operation and
maintenance of the analyzer.
Leave maintenance, installation or service that is not described in the User Man-
ual to trained service representatives.
Follow Good Laboratory Practices especially when working with biohazardous
material.

3.6.2 Electrical safety

Removing the covers of electronic equipment can cause electric shock, as there
are high voltage parts inside.
Do not attempt to work in any electronic compartment.
Do not remove any cover of the analyzer other than those specified in this User
Manual.
To prevent fire or shock hazard, do not expose the analyzer to rain or moisture
of any kinds.

16
 System Description

To prevent electric shock, never use an extension cord. Ensure all plugs and
sockets are fully inserted so that no parts of the plug prongs or blades are visible.
Installation, service, and repair must only be performed by personnel authorized
and trained by Analyticon Biotechnologies only.

3.6.3 Protection from biohazardous materials

All components of the analyzer may come into contact with human urine and are
therefore possible sources of infection. Urine specimens should be handled at
Biosafety Level 2.
Be sure to wear appropriate protective equipment, including, but not limited
to, eye protection with side shields, fluid resistant lab coat, and approved lab
gloves. Wear a face shield if there is a chance of splash or splatter.
Change gloves when contaminated, glove integrity is compromised, or when
otherwise necessary. Do not wash or reuse disposable gloves.
Do not eat, drink, smoke, handle contact lenses, apply cosmetics or store food
while in the laboratory.
Do not pipette any liquid by mouth; use only mechanical pipetting analyzers.
During service work, keep your hands and fingers away from your mouth, nose
and eyes.
Remove your protective clothing and wash your hands before leaving for non-
laboratory areas.
If you take the analyzer out of operation and/or want to transport it, first you have
to clean and disinfect the analyzer, empty and disinfect the waste bin (cuvettes).
The analyzer still can be potentially infectous after removal from use and during
transportation. Therefore, it should be treated as biological hazard.

3.6.4 Possible accidents

Sample or liquid waste spill

If any biohazardous material is spilled, wipe it up immediately and apply disin-
fectant. If it happens in the analyzer, stop the measurement process and start a
cleaning procedure.
If sample or liquid waste comes into contact with your skin, wash it off immedi-
ately with soap and water and apply disinfectant. Consult a physician.

Solid waste dropping

When contaminated solid material drops on floor or analyzer (i.e. waste bin falls
out and the used cuvettes scatter) collect and discard all of them into a waste
container for biohazardous waste and clean the area with water and disinfectant.

17
System Description

3.6.5 Waste management

The waste of the analyzer is potentially biohazardous and must be treated in ac-
cordance with the relevant laws and regulations.
When disposing of any waste, do so in accordance with the appropriate local
regulations.
Any substances contained in QC materials and other working materials, which
are legally regulated for environmental protection, must be disposed of in ac-
cordance with the relevant water discharge facility regulations. For the legal reg-
ulations on water discharge, please contact the suppliers of the materials.

3.6.6 Safe and proper use of the analyzer

Accuracy and precision of measured results

An incorrect measuring result may lead to an error in diagnosis and therefore
poses danger to the patient.
For proper use of the instrument, measure QC samples and monitor the instru-
ment during operation.
Do not use consumables that have exceeded their expiry date, otherwise inac-
curate data may be obtained.
For diagnostic purposes always assess the results in conjunction with the pa-
tient’s medical history, clinical examination, and other findings.

Installation and service

The installation and servicing of the analyzer must be performed by personnel
authorized and trained by Analyticon Biotechnologies only.
Connect the analyzer to the mains with its own power cable the analyzer is sup-
plied with and always use grounded socket.
Do not try to replace electric or mechanical parts which are not described in the
User Manual.
Do not use any cable that is longer than 3 m.
There is a safety interlock, which cuts the power and stops the sample pro-
cessing when the analyzer door opens. Do not attempt to disable the interlock.
Disabled interlock would not stop the analyzer operating and moving inside parts
could cause accidents if you reach in the inside of the analyzer.
Removing the covers of electronic equipment can cause electric shock, as there
are high voltage parts inside. Do not remove any cover of the analyzer other than
those specified in this User Manual.
Do not attempt to work in the electric compartment.
The safety level of the analyzer does not change after servicing if it is done by
personnel authorized and trained by Analyticon Biotechnologies only.

Operational conditions
Operation outside the specified operating conditions may lead to incorrect re-
sults or malfunction of the instrument. (See 3.3)
Use the instrument indoors only and avoid heat and humidity.

18
 System Description

Always comply with your local laboratory regulations.

Perform maintenance according to the specified intervals and when instructed to
do so by the system software to maintain the required operating conditions for
the analyzer. Ensure that the analyzer’s ventilation openings remain unobstructed
at all times.
Ensure that no vibrations influence the surface the analyzer stands on and take
care not to knock or tilt the analyzer while processing tests.
Strong vibrations, knocking or tilting the instrument may influence the position-
ing of the measuring device and may lead to incorrect sample identification or
incorrect results.
There is no further user action required in case of residual risk.

Approved parts
Use of non-approved parts or devices may result in malfunction and may render
the warranty null and void.
Only use parts and devices approved by Analyticon Biotechnologies.

Third-party Software
It is forbidden to install any software on the instrument.

Instrument approvals
The Urilyzer Cell urine analyzer meets the protection requirements laid down in
IVD Directive 98/79/EC. Furthermore, our instruments are manufactured and
tested according to the following international standards:
IEC 61010-1:2010
IEC 61010-2-020:2016
IEC 61010-2-081:2015
IEC 61010-2:101:2015

19
Installation

4 Installation
Read the Urilyzer Cell User Manual carefully before installation and follow the in-
structions carefully to ensure proper operation, correct results and avoid making
any damage to the analyzer.

4.1 Preparing the installation site

Before start unpacking find a suitable space for the analyzer. Check the
dimensions of the analyzer, monitor and keyboard and combine it with
the needed workspace for sample handling to meet the requirements.

The analyzer should only be used indoors.

Keep out of direct sunlight. Intense light can interfere with the optical
sensors.

Make sure that there is enough room at the back of the analyzer for easy
connection and disconnection of power supply, the peripherals and also
for the proper ventillation of the analyzer. The recommended safety
clearance is 10 centimeters (3.94 inches).

Make sure that you set up and operate the analyzer on a solid level sur-
face in an environment with fairly constant temperature and humidity.
Do not operate the analyzer in temperatures below 15°C (59°F) or above
40°C (104°F) and outside of the 20-80 % relative humidity range. Do not
expose the analyzer to strong light.

Do not operate the analyzer in close proximity to sources of intense

electromagnetic radiation (such as unshielded intentional RF sources).
The analyzer is certified to meet the EMC requirements of EN 61326-
1:2007 and EN 61236-2-6:2007.

The device can be used only in normal electromagnetic environment for

IVD medical equipment.

Do not set up and operate the analyzer in an environment with vibration

sources as it may influence the results and also could cause failures to
the instrument.

Make sure the instrument is allowed to acclimatize to room temperature

prior to use.

4.2 Unpacking
Check that the items in the shipping list are inside the delivered package, and
that they are intact and in working condition. If there is any visible sign of dam-
age, contact the distributor immediately.
ÂÂ It is recommended to keep the packaging and the package cushioning wrap-
pers in case you would like to relocate the complete system in the future.

20
 Installation

4.2.1 Shipping list

1. Urilyzer Cell device
2. PC keyboard
3. PC mouse
4. LCD monitor (with accessories)
5. Power cord
6. Quick reference guide (with QR code to the User Manual)

4.3 Installing the analyzer

Urilyzer Cell operates with 100 to 240 VAC mains voltage. In this range
the equipment manages voltage levels automatically. Do not use the
equipment with different mains voltages.
1. Place the analyzer on a solid, level surface that can reliably bear the weight of
the analyzer and its accessories.
2. Connect the power cable to the analyzer and plug it into a wall outlet. Connect
the monitor, a keyboard and a mouse to the analyzer. Switch on the con-
nected monitor.
3. Press the On/Off button on the right-hand side of the analyzer.
4. The user software of the instrument will start automatically after switching on.

4.4 Installing barcode reader

Urilyzer Cell can be used with a barcode reader to identify samples.
Urilyzer Cell is able to be connected to a barcode reader through its RS-232 or
USB-A interface.
ÂÂDuring barcode scanning via USB-A connection, the Urilyzer Cell user software
should be the active window.
Contact your IT department to install it and refer to the user manual of the bar-
code reader and the analyzer service manual for help.

21
Installation

4.5 Taking Urilyzer Cell out of operation

Since urine is a fluid of human origin, the device may be infectious and
may carry biological risks.

Handle used cuvettes and urine contaminants with care!

Always wear rubber gloves or other protecting clothing when operating

and cleaning the Urilyzer Cell.
To take Urilyzer Cell out of operation, perform the steps listed below to preserve
good condition of the device while it is not being used:
1. Switch off Urilyzer Cell and disconnect from the mains.
2. Discard all used cuvettes from the waste bin.
3. Clean Urilyzer Cell thoroughly, including all of its removable parts.
4. Let them dry and pack up Urilyzer Cell as it was packaged when it arrived to
you.
If you would like to put the Urilyzer Cell back into operation, follow the steps
described in the previous section to properly install the device.

22
 Menu system

5 Menu system
Urilyzer Cell has a menu structure which is very straight-forward and easy to use.
The menu buttons are lined up on the right side of the screen. The buttons within
each menu are lined up across the bottom of the screen and in bounding boxes
across the screen. Some buttons have more than one state: When you click such
a multi-state button, its displayed icon and text changes to indicate whether the
process is in progress or has ended.
System status information is displayed in the status bar running along the bot-
tom of the screen. The following table lists the information fields of the status bar.
Driver connection status Online
Offline
Initializing...
Not ready (by HW error)
Upgrading..
LIS connection status LIS Online
LIS Offline
LIS Initializing...
User rights according to login Operator
level or User name Administrator
Service
User name

Number of particles which Classes: X

are evaluated (It can be set in
Settings/Evaluation menu up to a
maximum of 49).
Measurement status Ready to measure
Measurement in progress. X/Y images arrived.
Current date and time Date & time

5.1 System info

Click the Info button to toggle a splash window that lists the version of
the currently installed device software, the module firmware versions, and
driver version data. You can find the Info button among the menu buttons in
each of the screens except for the Quality Control screen.

5.2 User rights

Depending on the user login scheme selected by your service personnel, Uri-
lyzer Cell user accounts can be ranked and identified either only by pre-pro-
grammed access levels or by individual user names assigned to one of the pre-
programmed access levels. Regardless of the user login scheme, there are three
pre-programmed access levels in Urilyzer Cell: Operator, Administrator and Ser-
vice.

23
Menu system

• In the ‘‘By level’’ user login scheme, the user names and the access level as-
signed to a particular user account are identical (for example, an Administra-
tor-level user is always called Administrator).
• In the ‘‘By user name’’ user login scheme, the user name, password, and the
pre-programmed access level associated with user accounts can be custom-
ized. In the ‘‘By user name’’ user login scheme, whenever a user logs off the
system, another user must be logged on. In this login scheme, the user soft-
ware is non-operational unless someone is logged in.
ÂÂFor more information and to change the active login scheme, ask your service
personnel.

5.2.1 Logging in
In the ‘‘By level’’ user login scheme, it is recommended to use Administrator– and
Service-level user accounts only when necessary, in order to avoid accidentally
modifying system settings.
ÂÂFor more information and to change the active login scheme, ask your service
personnel.
• In the ‘‘By level’’ user login scheme, each time you run the software, you are
logged in as an Operator-level user by default. This access level allows you to
perform measurements and manage sample data in the Database. To access
system settings, you need to log in as Administrator.
• In the ‘‘By user name’’ user login scheme, ideally, each person using the de-
vice should have their own individual user account with a unique, custom user
name and password, and be assigned one of the three pre-programmed ac-
cess levels.
1. Right-click into the User rights field of the bottom status line to display the
Login pop-up box.
2. Click the pop-up box to display the login window (see Figure 4).
3. In the ‘‘By user name’’ user login scheme, type your unique user name and
password, then click OK. The User rights field of the status bar wild display
your user name, and, if your pre-programmed access level is Administrator or
higher, the Settings menu button will appear on the right side of the screen.
4. Type ‘‘administrator’’ as user name and ‘‘settings’’ as password (both words
without the inverted commas), and click OK. The User rights field will display
Administrator to indicate the successful login, and the Settings menu button
will appear on the right side of the screen.

24
 Menu system

Fig. 4: The Login window

5.2.2 Changing your password

When you are logged in with a password-protected user account, the Login pop-
up box (accessed by right-clicking the User rights status bar field) will include an
option to change your password. Click this option if you wish to modify the exist-
ing password. The system will prompt you to enter the existing password, then
the new password, two times, for confirmation.

Fig. 5: The Login pop-up box for

password-protected user accounts

5.2.3 Logging out from the system

1. Right-click into the User rights field of the bottom status line to display the
Login pop-up box.
2. Click Log out in the pop-up box (see Figure 5). In the ‘‘By level’’ user login
scheme, your access level will automatically revert to Operator.
ÂÂIn the ‘‘By user name’’ user login scheme, Administrator– and Service- level
users can set up new user accounts.

ÂÂIn the ‘‘By user name’’ user login scheme, whenever a user logs off the system,
another user must be logged on. In this login scheme, the user software is non-
operational unless someone is logged in.

25
Menu system

5.3 Database menu

The Database menu lets you manage analysis results. Using the functions on this
screen, you can review, edit, or send to output the sediment analysis results and
the microscopy images.

Fig. 6: The database menu with windows and boxes numbered

26
 Menu system

1. A scrollable list of the records for all the urine samples that the instrument has
processed. In the default view, only a limited number of columns is displayed
in the Sample List. To expand the Sample List to review the complete record
for the processed samples, click the LIST button.
ÂÂFor information on how to set up the default columns of the Sample List, see
the Display tab.

Key to all available columns of the Sample List

Mark Indicates (with a yellow star) whether you or another operator has
marked the sample as special for any reason.
ÂÂ Click on the mark field to mark and unmark samples.
Instrument The column shows the instrument serial number
Date&Time Displays the date and time when the instrument processed the
sample.
ÂÂ You can customize the format for the date and time on Display tab.
ID Displays the unique identifier of the urine sample: either the barcode
on the test tube of the sample, or an identifier that the system
generated based on the sequence of the sample.
Name Displays the name of the patient who supplied the sample.
+/- Sed Indicates (with pictograms) whether the sediment analysis result
is positive, negative, or recommended for review by a laboratory
professional.
Eval Indicates the number of images that the system accepts as valid out
of the fifteen that the system makes for each analyzed sample.
LIS Indicates whether the sample was transferred over the connected
LIS.
Measured by
Validated by
These columns display the name of the operator who performed the
Sent to LIS by
given operation for the sample.
Exported by
Printed by
Microscopy Automatic, when the analyzer evaluates the automatically taken
mode images.
Manual, when the Live View is on and the operator positions the
camera to take the viewfield images

27
Menu system

2. Database menu function buttons bar. You can edit, filter, or modify one or more
selected samples using the function buttons in this screen area.

Key to the function buttons of the Database menu

Select All/ Click this button to select or deselect every record in the sample list.
Deselect All
ÂÂ The button becomes inactive if there is only one sample record in
the list.
Delete Click this button to delete the selected sample record or records from
the sample list.
ÂÂ If you delete sample records from the list, you will not be able to get
them back.
Modify Click this button to edit some of the details of the selected sample.
ÂÂ The button becomes inactive if you select a QC result or more than
one sample record.
Filter Off/Filter Click this button to toggle on or off the sample filter dialog box.
On (see 5.3.2)
Gallery Click this button (or double-click the row of a sample record) to
display every microscopy image that the instrument has taken of the
selected urine sample.
Double-click any image in the gallery, or any record in the database
to open it in Sample View Editor (SVE).
Use Quick particle (page 46) feature to modify results in full-
screen viewing.
ÂÂ The images will appear as a grid of numbered thumbnails, without
any particle tags. Press letter c for particle tags to appear.
Full Eval Click this button to make the evaluation module evaluate every single
microscopy image that is available for the selected urine sample or
samples.
ÂÂ This function requires confirmation.

ÂÂ This function is only available for users with administrator rights or

above.
Comment Click this button to add a comment to the record of the sample, and
to review the system comments for the sample.
ÂÂ This button becomes inactive if you select more than one sample
record.
Worklist Click to launch the Worklist editor

Outputs Click this button to set up the export, transfer, or printing of the
selected sample or samples.

28
 Menu system

Key to the function buttons of the Database menu

List Click this button to toggle between the expanded, full-screen view of
the Sample List, and the limited default view of the list.
Validate If manual validation is active, click this button to validate the selected
sample or samples.

3. Selected sample header. This box displays the basic identifiers of the sample
that you selected in the Sample List.
4. Microscopy image list box for the selected sample. You can review the basic
details of all the view field images that the microscope took of the sample that
you selected in the Sample List. Click any of the rows to preview the associ-
ated image in the image list thumbnail. The selected row will be highlighted
in blue. Double-click any of the rows to view the associated image in the SVE
(Sample View Editor).
5. Sediment analysis result box for the selected sample. This box lists the de-
tailed sediment analysis result for the selected sample record for each particle
type. You can modify the particle sediment results of a sample by double-
clicking any of the particle class rows in the sediment analysis result box. In
case of a connected chemical analyzer and checked Show chemical data
checkbox on Settings/Display menu, the Selected Sample window is di-
vided into a sediment and a chemical result window.

Key to the Image List header

Image The sequence number of the image. The numbering corresponds to
the numbers used in the Gallery.
For review This column indicates whether the image is recommended for review
by a laboratory professional.
There are two main reasons why a microscopy image is
recommended for further review:
• the image is so crowded with particles that sediment particle detec-
tion is unreliable
• the detected number of mucus particles in the image exceeds the
allowed level of mucus (you can disable this function)
Checked This column indicates whether an operator has opened the image in
the SVE (Sample View Editor).
Modified This column indicates whether an operator has modified the
automatic evaluation results in the SVE.
Valid Select or deselect the checkbox in this column to accept or reject the
image as the basis for automatic image evaluation.
ÂÂ By default, every view field image is accepted as valid. However, if
the amount of a sample in the test tube is below the minimum ac-
cepted sample level, all of the images for that sample will be invalid
by default.

29
Menu system

6. Thumbnail of the view field image that is selected in the image list. Double-click
the thumbnail image to view the view field image in the SVE (Sample View Editor).
For more information about SVE see 7.2.1.

5.3.1 Result indicator meanings

N/A
No sediment results available. The sample was analyzed only with the interfaced
chemical urinalysis device but not using the microscopy method, or the sediment
and chemical results could not be matched to a single sample because the sam-
ple was not barcoded, or because there was a barcode reading error.
+
Positive (abnormal) sample. The concentration of one or more particle classes
exceeds the negative reference range in the sample. Detection of MUC, SPRM,
and ART particles has no effect on this attribute.
-
Negative (normal) sample. All values of the enabled particles are within the nega-
tive reference range, except for MUC, SPRM and ART particles.

Hard review. Some images are so crowded that it can be difficult to distinguish all
the particles present in them. The majority of the images of this sample have Yes
in their For review column in Image List indicating that they are not accepted
by the system. The comment Review of images is necessary! is displayed in the
Sample list and Image excluded from the automatic evaluation in the Sample
View Editor for these records, as they require manual re-evaluation (See 7.2.1
The Sample View Editor (SVE)). The records will display N/A for every particle
class as long as the results are not modified manually (See 7.2.2.1 Modifying
microscopy results in the Database). The automatic validation is disabled in
case of hard review, therefore the operator has to validate the measurement
records manually.

or
Soft review. Only a few images of this sample have Yes in their For review col-
umn in Image List indicating that they are not accepted by the system. The com-
ment Review of images is necessary! is displayed with the quantitative results
and Image excluded from the automatic evaluation in the Sample View Editor
for these records, as they require manual re-evaluation (See 7.2.1 The Sample
View Editor (SVE)). An automatic result is available for the sample. The auto-
matic validation is disabled in case of soft review, therefore the operator has to
validate the measurement records manually.

30
 Menu system

or
MUC review. The mucus level in the sample is higher than the user-enabled limit
in Settings/Evaluation tab. The measurement record has result, but has to be
validated manually. The MUC review state and marking is only an indication for
the operator, it is not exported, transferred or printed. The MUC review marking
can be taken off, if the feature is disabled in Settings/Evaluation tab, its limit is
raised or the Valid checkmark is taken off of some of the images.
ÂÂThis feature is enabled by default.

Invalid sample.
Samples are indicated as invalid
a, if the Valid checkbox for all their view field images are manually unchecked;
b, if the status of the sample is manually set to invalid;

When records of invalid samples are exported or printed

a, the Sample status field indicates that the sample is invalid;
b, the message General sediment result: invalid is displayed in the header;
c, the message Invalid measurement is displayed in the Sediment result field;
d, zeros (0) are displayed in all of the value fields and N/A is displayed in all of the
Category fields unless you modify these fields manually.

or
Cross-check rule is triggered.
Any of the selected cross-check rule is true for the given sample result of the
sediment and chemistry analyzer. The operator with Administrator access can
select the rules on the Settings/Evaluation tab.
ÂÂThis feature is not enabled by default.

QC measurement passed

QC measurement failed

31
Menu system

5.3.2 Data filtering

The data filtering function is not working during measurement with more than
5000 results in the database.
Click FILTER ON to bring up the Sample filter dialog box. Records can be fil-
tered by date of measurement, patient name, ID, status, positive or negative
result, standard or QC measurement, marked or non-marked and many param-
eters in sediment method.
Fig. 7:
The sample filter
dialog box

Filtering by dates: Starting and/or finishing dates can be set by typing in or with
the drop-down lists. You have to click in the checkbox to make the selections
active.
Filtering by ID and Name: Click in the checkbox first to be able to type in the
text box. The text box becomes red when an unusable character typed in.
Filtering by measure type or marking: Click in the checkbox for selecting be-
tween results of standard or QC measurements, and marked or non-marked re-
sults.
ÂÂSelecting none of the two choices is the same as both were selected.
Filtering by the status of validation.
Filtering by microscopy mode: Click in the checkbox for selecting between
results of manual microscopy or automatic measurements.

32
 Menu system

Filtering by the characteristics of sediment results: Click in a checkbox that

is for a parameter you want in your selection. If you do not select any checkbox
the filtered sample list will show all results.
Filtering by the characteristics of chemical results: You can filter here for
records of a sample with chemical results. Click in a checkbox that is for a pa-
rameter you want in your selection. If you do not select any checkbox the filtered
sample list will show all results.
Filtering by the cross-check rule: You can filter for records of any cross-check
rule compliance.
After making a selection of filter options tap the radio button On to make it ap-
plicable. Click Apply to display in the Sample List only the records that fit your
conditions. Revert to the full Sample List by checking the radio button Off in the
Filter switch bounding box and clicking Apply. When you check On again your
previous selection becomes active again. Click Reset to clear selection.

5.4 The Settings menu

Click the Settings button to enter the Settings menu, where you can configure
various aspects of the analyzer’s functionality, categorized into tab groups that
run along the top of the Settings menu.
ÂÂThe Settings button is disabled while a measurement is in progress.

5.4.1 The Category tab

Fig. 8: The Category tab in the Setting menu

33
Menu system

The analyzer device provides quantitative results for RBC and WBC and semi-
quantitative category to all other sediment parameters. The relative ranges and
the names of these semi-quantitative categories can be fully customized to fit
the conventions of the testing site.
ÂÂBy default, the Category tab displays only the default set of particle classes
and subclasses. The Category tab will only display the additional particle class-
es and subclasses that are specified on the Evaluation tab (See Figure 18).

Modifying semi-quantitative relative categories

1. Double-click on the particle class row that you wish to modify to display the
Category modification dialog box (see Figure 9).
2. Enter the upper cutoff for the quantitative ranges of the semi-quantitative rela-
tive categories. The upper cutoff for a category will automatically be entered
as the lower cutoff for the next category so that overlapping is prevented.
Semiquantitative relative category number 1, topmost in the dialog box,
is displayed as reference for each of the particle classes in the particle
result window on the Database menu. You can disable the display of this
reference range on the Display tab of the Settings menu.

Fig. 9: The Category modification dialog box

ÂÂThe < symbol indicates the upper cutoff of the highest relative category range
for the given particle class or subclass—modifying it will create a new relative
category higher, up to a maximum of eight (8) relative categories.
3. Enter the name that you would like the device to display for the semi-quanti-
tative relative category.
ÂÂThe maximum length of twenty (20) characters is allowed for the category
names. Empty and duplicate category names are not allowed.

34
 Menu system

4. Click OK to store your changes or CANCEL to discard the changes. Click

SET on the Category tab screen to save your modifications. The system will
recalculate the results and use the new categories to display results in the
Database menu, the Sample View Editor, and on transferred, exported and
printed analysis reports.
ÂÂYou can revert to the default relative category names and ranges by clicking
RESTORE DEFAULTS.

The relative categories of particle classes and their subclasses are iden-
tical by default. However, you can modify any of the particle subclasses
independent of their parent particle class.

Exporting and importing relative categories

• You can export the customized relative category ranges that you have set up
to other analyzers, in a .csv file. To export the current ranges, click the Export
button in the top right-hand corner of the Category tab, set the path for the
export in the pop-up dialog box, and then exit the dialog box.
• To import a previously exported set of relative category ranges, click the
Import button on the Category tab, select a .csv file in the pop-up dialog box,
click the SET button, and then close the dialog box.
ÂÂIf you are creating a category range .csv file from scratch, create a table (using
Microsoft Excel, for example) that matches the following formatting protocol:

Header
Particle Maximum Display ...
[abbreviated name of
particle class]
...

35
Menu system

5.4.2 The Display tab

Grid, ruler and particle font properties

Fig. 10: The Grid, ruler, and particle font properties window

This screen area displays a preview of a random microscopy image as displayed

in the Database menu. The settings that you make here take effect in the Sam-
ple View Editor.
• Toggle the grid and the ruler overlay in the SVE screen with the Grid visible
and Ruler visible checkboxes, respectively (SVE keyboard shortcuts)
• You can specify the opacity of the grid lines (how clearly visible the lines are)
with the Alpha blending slider: Increase the width of the lines by moving the
slider to the right.
• In the 1 grid: text box, you can set the length (µm) of the sides of the unit
square of the grid for easier determination of the size of particles in the im-
ages.
ÂÂIf the ruler is enabled, the unit grid size is displayed in the top left corner of the
microscope images in the SVE.
• Click CHANGE FONT to display a pop-up window with options for how you
would like the tags in the microscopy images to appear: font, font style, font
size, effects, color, and script can be set.
ÂÂThe language used in the Fonts dialog box is the language specified for the
operating system of the connected PC as the display language.
• Click SET DEFAULT to revert to the default font settings: 14-point yellow Cou-
rier New Bold characters using the Central European script.
• Click the radio buttons next to the flags and country demonyms to modify the
display language of the system.

36
 Menu system

The Visible settings screen area

Fig. 11: The Visible settings window

• Click the radio buttons in the Unit dialog box to set the default measurement
units to either particles per High Power Field or particles per sample microliter.
ÂÂIf you change the default unit, the system will retroactively recalculate all the
measurement results for every sample in the database.
• Click the radio buttons in the Visible particle result columns dialog box to
enable or disable the Ref. column in the results summary.
• In the Show particles on images dialog box, click the radio buttons to enable
or disable the automatic tagging of particles in the view field images.
• Check the checkboxes in the Sample status modification dialog box to en-
able or disable manual modification of the status of samples.
• Use the Date- and time format text boxes to select how the date and time
should appear in the displayed, exported, printed, and transferred measure-
ment results.

37
Menu system

• In the Columns of Sample List dialog box, you can:

Fig. 12: The Sample List will display 8 columns in compact view; chemical urinalysis
results will be omitted; the samples in the list will be sorted by date in descending order
–– enable or disable any of the available columns in the sample list by checking
or unchecking their checkboxes;
–– modify the order in which they appear by selecting a row and moving it to-
wards the beginning or end of the list using the and buttons;
–– sort the samples based on any of the column parameter by clicking the box
of the column: clicking once will sort the samples based on the selected
parameter in ascending order; clicking twice will sort the samples based on
the selected parameter in descending order;
–– specify how many columns are displayed in the compact view of the Sam-
ple List by increasing or decreasing the number in the Extended columns
from: text box (for example, if the number in the box is 9, columns up to 9
(that is, 1–8) will be displayed in compact view;
–– and revert to the default Sample List setup by clicking DEF.

38
 Menu system

• If a chemical urinalysis device is interfaced to your device, use the checkboxes

in the Visible chemical result columns to enable the display of the chemical
measurement results.
• Set the default percentage of magnification of the selected image on the Zoom
mode/Default scale.
• Set the default degree of enlightenment to images for better visibility on the
Brightness scale. The scale appears in SVE.
ÂÂUsing the scale in SVE does not change the setting.

5.4.3 The Measure tab

Database sample limit

Fig. 13: The Database sample limit window

• Use the Database sample limit text box to specify the size of the results da-
tabase between 1000 and 10000 records.

Validation
Only validated results can be exported, printed, or transferred.

Fig. 14: The Validation window

Use the radio buttons to specify whether all, none or only the negative measure-
ment results are required to be validated automatically.

39
Menu system

Use the checkboxes to cancel possibilities of auto validation in case of a gener-

ated ID.
A measurement result cannot be validated automatically if its status is:
Empty, Soft review, Hard review, MUC review or Low level.

Worklist settings

Fig. 15: The worklist window

Worklist usage
• Check the Enable worklist function check box to make the device automati-
cally assign the patient names and comments in a predefined worklist to
measurement results.
• In case you are using a worklist uploaded as a text file from an external loca-
tion, check the Enable worklist file auto delete check box to make the de-
vice delete a worklist file as soon as it has processed all the entries on the list.
Entry ID principle
• When performing a measurement cycle based on a worklist, you have the
option to assign the patient names and comments defined in the worklist to
sample measurement results either based on the sequence in which the de-
vice measures them, or based on the bar codes attached to the sample test
tubes. Click the relevant radio buttons to select your preferred setting.
If you wish to assign worklist data to measurement results based on
barcodes, make sure that you include not only patient names but bar
codes as well in the worklist entries.
Worklist file check

40
 Menu system

• If you wish to import a worklist click IMPORT to display a dialog box to define
the path for the worklist file. If you would like to continually update the worklist
based on the imported worklist file, Check file in every X minutes text box to
specify how often the system should refresh the worklist based on potential
changes in the external worklist file.
If you enable refreshing the worklist (the number of minutes in the check
box is >0, the Enable worklist file auto delete check box becomes
checked and disabled by default.

Live view

Fig. 16: Live view checkbox

The Live view mode is a unique feature of Urilyzer Cell, which gives the opportu-
nity to the user to examine the sample in the cuvette via live image of the camera.
After the cuvette arrives to the microscope the user has the option to move the
cuvette via on-screen buttons, to change the focusing height and to take images
of any area of the cuvette. The user has live view of the cuvette during the pro-
cess, which could be useful if the user wants to study any possible movements in
the sample. The taken images are evaluated by evaluation module of the device.
Set up the possibility of manual microscopy on the Settings/Measure screen by
checking Enable Live view checkbox.
For more information about the Live view go to “Operation”.

Repeated Barcode checking

Fig. 17: Repeated barcode checkbox

If the checkbox Check for repeated barcodes is activated, the device recog-
nizes repeated barcodes in a defined time period. The time period can be set by
the drop down menu.

41
Menu system

5.4.4 The Evaluation tab

On this tab, you can specify which sediment particles you would like the device
to identify in the view field images by checking the checkboxes that correspond
to the particle classes and subclasses that you wish to include, and unchecking
the ones to leave out.
You will need to check the enable extended particle categories check-
box to activate the particle classes and subclasses that are not auto-
matically identified by the device. These ‘added particles’ are displayed
in red after you activate them, and their checkboxes become active.

Only the particle classes and subclasses that you have checked on this
tab are available as tags in the Sample View Editor. However, if you en-
able the ‘Extended particle categories’ and check any of them, the sys-
tem will reevaluate all the previous view field images and retroactively
assign the newly enabled parameters where necessary.

Fig. 18: The Particle settings window on the Evaluation tab

42
 Menu system

Using the Evaluation tab

• Subclasses may be enabled only if their parent classes are enabled.
• All subclasses of a disabled parent particle class become disabled too.
• Whenever you enable a parent particle class, its subclasses’ status will revert
to the default setting. The default setting for subclasses is disabled except for
CaOxm and CaOxd crystals.
• Click the SET button to save your changes. The system will reevaluate all
previous samples using the new settings, and measurement results will be
displayed, exported, printed, and transferred with the particle tags you ena-
bled on this tab.
• Click the SET ALL button to enable all of the particle classes and subclasses.
An alert dialog box will pop up prompting you to confirm the action.
• When BAC is enabled, BACr and BACc subclasses are automatically recog-
nized and separated during evaluation, but either or both subclasses can be
deselected.

Particle setting defaults

Click DEFAULT to revert to the following default settings.

✔: Enabled ✘: Disabled
RBC ✔ URI ✘
WBC ✔ TRI ✘
NEC ✔ YEA ✔
EPI ✔ BAC ✔

PAT ✔ BACr ✔
HYA ✔ BACc ✔
CRY ✔ MUC ✔
CaOxm ✔ SPRM ✘
CaOxd ✔

Full list of evaluated particles

Class Subclass auto added

RBC
Isomorphic RBC RBCi
Red Blood Cells Dismorph RBC RBCd
RBC-Aca (Acanthocyte) RBC-Aca
RBC others RBC-oth
WBC
White Blood Cells
White Blood Cells Clumps WBCc

43
Menu system

Class Subclass auto added

Squamous Epithelial
EPI
Cells

NEC
Non Squamous Superficial Trans. Epithelial Cells s-TRA
Epithelial Cells
Deep Transitional Epithelial Cells d-TRA
Renal Epithelial Cells REN
LIP
Lipids - Oval Fat Bodies REN-L
Lipids
Lipids - Free Droplets LDR
Lipids - Cholesterol Crystal CHOL
Casts - Hyalin HYA
PAT
Casts - Hyalin-granular C-HGR
Casts - Granular C-GRA
Casts - with Renal Tubular Cells C-NEC
Casts - RBC C-RBC
Casts - WBC C-WBC
Casts - Crystal C-CRY
Casts - Microorganism C-MIC
Casts - Pathological Casts - Fatty C-FAT
Casts - Waxy C-WAX

Casts - Mixed C-MIX

44
 Menu system

Class Subclass auto added

CRY
CRY - Calcium-oxalat CaOx
CRY – Calcium-oxalate
CaOxm
monohydrate
CRY – Calcium-oxalate dihydrate CaOxd
CRY – Triple-phosphate TRI
Crystals CRY - Uric acid URI
CRY - Calcium-phosphate CaPh
CRY - Amorphous AMO
CRY – Cystine CYS
CRY – Leucine LEU
CRY – Tyrosine TYR
CRY – Atypical ATY
Yeast YEA
BAC
Bacteria Bacteria Rods BACr
Bacteria Cocci BACc
Mucus MUC
Spermatozoa SPRM
Unclassified particles UNC
Trichomonas TRV
Parassites –
Schistosoma SCH
Haematobium

Artifacts ART

MUC review settings

Fig. 19: MUC review settings

Set a p/μl or p/ HPF value in the text box and check Enable MUC review in the
dialog box to enable the automatic highlighting (with a red circle) of samples with
a Mucus particle level that exceeds the set p/μl or p/ HPF value.

45
Menu system

ÂÂThis setting is enabled by default. Users with administrator rights or above can
alter the threshold limit. Altering the limit has no retroactive effect.

Cross-Check rules

Fig. 20: Cross-check rules

In case a cross-check rule is selected, it provides a status mark (black square)
and a specific comment, when the rule is true for the sample results of the sedi-
ment and chemistry analyzer. Cross-check rules exist for RBC & ERY discrep-
ancy, and WBC & LEU discrepancy to support operator decision for result modi-
fication/validation.
ÂÂThis setting is not enabled by default. Users with administrator rights or above
can enable them.

46
 Menu system

5.4.5 The Transfer tab

The Transfer tab lets you adjust the data management settings.

The Transfer screen area

Fig. 21: The Transfer screen area on the Transfer tab

The settings in the two dialog boxes apply to data transferred through the serial
ports.
• Select unidirectional, bidirectional, LIS2 A2 or HL7 transfer option from the
drop down list.
ÂÂHL7 only works with TCP connection.
• Click the radio buttons to select the connector for transmission. HL7 is only
available via TCP connection.
• Set IP address and port or baud rate in drop-down list.
Contact your distributor to determine which transfer type and transfer
speed you require.
• Check the Send report after measurement checkbox to enable the automatic
transfer of the results table of each processed sample through the serial port.
• Check the Send all (even not validated sample) checkbox to be able to send
all results to LIS.

47
Menu system

• Check or uncheck the Send only... checkboxes in the Data sending screen
area to enable or disable the editing of the measurement results when trans-
ferring them: you can decide to leave out particle classes and subclasses
or test strip pads (if chemical urinalysis results are available) with negative
results to reduce the size of transferred data.
ÂÂIf you enable one or both of these features, the message Only positive items
is displayed as the first line of the transferred results table.
• Check the Send N/A instead of extended 0 result checkbox to send N/A
to LIS in every extended particle result column if their automated evaluation
found no particles.
• Check the Send N/A with all units checkbox to send N/A to LIS in all unit (p/
μL, p/HPF, number and category) when the sample is invalid or the result is
N/A.
• Check the Quick transfer checkbox to enable the one-click transfer to LIS of
selected records. If Quick transfer is enabled, and the Sample List screen is
active, you can press the F3 key to automatically transfer any selected record.
ÂÂThe records that you would like to transfer this way need to be validated oth-
erwise they won’t be transferred without notice.
• Choose the preferred sending order of the chemical and sediment results to
LIS.
• Check the Enable modify checkbox in the After sent window panel to be
able to modify results after they were sent to LIS.

48
 Menu system

The Export screen area

Fig. 22: The export screen area on the Transfer tab

49
Menu system

• Check the Export with images checkbox to include view field images with the
results tables when exporting results manually.
• Check the Quick export checkbox to enable the one-click exporting of se-
lected records. If Quick export is enabled, and the Sample List screen is
active, you can press the F2 key to automatically export any selected record
in the same folder where you last exported sample records.
ÂÂ The records that you would like to export this way need to be validated, oth-
erwise they won’t be exported without notice.
• Check Export with extended information when you want to add more de-
tails to the result lists. These information include the dilution factor, any pos-
sible sediment and system comments connected to the selected result.
ÂÂIf you previously set up a default export directory, Quick export will use this
default path.
• Click the SELECT DIRECTORY button to set up a default export path for future
sample record exporting.
• Select one of the radio buttons to determine whether the export path dialog
box displays the default directory (if you have set one up), or the directory of
the last sample export as the suggested export path.
ÂÂThe export path dialog box is displayed only if Quick export is disabled.
• In the Export report after measurement dialog box, check the checkboxes
to enable the automatic export of each processed sample, with or without
view field images, to a folder on the PC you can specify by clicking the SE-
LECT DIRECTORY button. Results are exported as html tables and separate
folders for each of the samples is generated inside the folder you specify.
If you enable automatic export, the Export button in the Outputs dialog
box on the Database menu becomes active when no measurement is in
progress.
• Click the radio buttons in the First part of export folder name dialog box to
specify whether you would like names of the folders generated for the sam-
ple results to start with the sample ID, the patient’s name, or the date of the
measurement.
ÂÂAll three details will be included in the name of the generated folders, regard-
less of which radio button you select.
• Check or uncheck the Export positive particles only checkbox to enable or
disable the editing of the measurement results when exporting them: you can
decide to leave out particle classes and subclasses with negative results to
reduce the size of transferred data.
• Export positive pads only checkboxes to enable or disable the editing of the
measurement results when exporting them: you can decide to leave out test
strip pads (if chemical urinalysis results are available) with negative results to
reduce the size of transferred data.
• Check the Export all (even not validated sample) checkbox to be able to
send all results to the preferred destination.

50
 Menu system

• In the Chemical pads in list dialog box, use the text box to specify the default
units for the exported chemical urinalysis results, and use the checkboxes
to control which test pad analyte results and which physical measurement
results are exported with the routine urinalysis results.

5.4.6 The Print tab

On this tab you can specify the settings for the printout on the connected printer.
• Check the Print report after measurement checkbox to enable the auto-
matic printing of each processed sample.

Fig. 23: The Report configuration dialog box on the Print tab

The filters are available only if automatic printing is enabled.

• Check or uncheck the Print only positive particles or the Print only posi-
tive pads checkboxes to enable or disable the editing of the measurement
results when exporting them: you can decide to leave out particle classes and
subclasses or test strip pads (if chemical urinalysis results are available) with
negative results to reduce the size of printed data.
ÂÂIf you enable one or both of these features, the message Only positive items is
displayed as the first line of the printed results table.
• Check Print only non-zero added particle checkbox to make sure none of
the enabled added particles with no actual findings are printed.
• Check the Print report with images checkbox to print view field images
when printing results. If you enabled image printing, use the up and down
arrows next to the Number of images... spin box to determine the number of
view field images that are printed for each record.
ÂÂBy default, view field images are not printed.

51
Menu system

• Check the Mark modified records checkbox to enable the highlighting of

manual modifications of the automatic sample evaluations on the printout. If
you enable this feature, the Mod. tag will appear on the printout next to the
results that have been manually modified.
• Check the Quick print checkbox to enable the one-click printing of selected
records. If you enable this feature and the Sample List screen is active, press
the F4 key to automatically print off any selected record.
ÂÂThe records that you would like to print this way need to be validated, other-
wise they won’t be printed without further notice.

5.4.7 The Maintenance tab

Laboratory name
Enter the name or code of your laboratory in the text box to display it as a header
on printed reports, and on exported sample results.

Diagnostic report

Click the DIAGNOSTIC button in the dialog box to generate a status report of
the software and driver versions, and the current settings of the analyzer, saved
in the folder you specify in the file path popup window.
ÂÂReport generation may take up to several minutes, during which the system
will not respond.

It is highly recommended that you generate a diagnostic report every

time you encounter a problem or upgrade the software, and send it to
your distributor for evaluation.

Raw data export

In case of noticed evaluation irregularities click this button to save measurement

process-related information in a password-protected zip file to a selected folder.
Send it to your distributor for investigation.

52
 Menu system

Users

Fig. 24: The Users dialog box

Administrator– and Service-level users can manage (create, modify, or delete)

user accounts in this dialog box by selecting the accounts and clicking the rel-
evant buttons.
The default password for newly created user accounts is the same as
the user name, which needs to be changed at the first login.

ÂÂAdministrator-level users may only manage Operator– and Administrator-level

user accounts.

You cannot delete your own user account.

The Users dialog box is available only if the ‘‘By user name’’ user login
scheme is in use.

53
Menu system

Enable QC result deleting

Check Enable QC result deleting to override the protection of QC data and dis-
able the warning message Delete is not available, because QC result deleting is
not enabled! whenever you attempt to delete QC results.

Fig. 25: Enable QC result deleting checkbox

Keep log size within

The operator can maximize the size of log files.

54
 Operation

6 Operation
Depending on the needs of your laboratory, there are two workflows you can
choose from:
• Quick analysis using automatically generated sample IDs, where either you
leave the sample ID as it was generated, or change it after the measurement
(see 7.1.1 Editing test results).
• Analyzing barcoded samples, where the data related to the patient of the given
samples are attached to a barcode and are stored in the LIS.
You can further customize some aspects of the analysis process itself (see 5.4
The Settings menu), and what happens to the analysis results after the analysis
process is finished (see 7.1 Test results).

6.1 Cuvette handling

Urilyzer Cell operates with single use disposable cuvettes. Cuvettes are sup-
plied in containers, each holding 50 cuvettes. Before starting the measurement
cuvettes should be loaded into the instrument.
Take a cuvette container supplied by the manufacturer and insert it into the cu-
vette holder seat. The asymmetric shape of the container assures the proper
alignment. After placing the container into the cuvette holder seat, remove the
sticker from the bottom of the container by simply pulling it. Hold firmly the top
of the container while pulling the sticker, to prevent the container from falling out.
Empty cuvette containers should be removed from the instrument and disposed
separately.
Important!
Urilyzer Cell can be operated only with its own cuvettes supplied by the manu-
facturer or distributor of the instrument.
Cuvettes are for single use only. Never use cuvettes for more than one
time.

Never touch unused cuvettes, as any contamination might frustrate the

microscopic evaluation.

Remove the sticker from the cuvette cartridge only after it has been in-
serted into the cuvette holder seat. Otherwise, cuvettes can fall out eas-
ily from the container during insertion.

Never refill the cuvette cartridges with any fallen out cuvettes.

Never use damaged or contaminated cuvette cartridges.

Cuvette cartridge can be removed from the instrument only with the cu-
vette holder seat. The cuvette holder seat with the cuvette cartridge
must be handled carefully when taken out and is forbidden to be tilted or
turned round as cuvettes could fall out or their directions could change.

Always empty the waste bin before placing a new cuvette cartridge in
the analyzer.

55
Operation

6.2 Worklist
Click to launch the Worklist editor. You can populate the worklist with the
names of the patients whose samples you want to analyze. The system
software will automatically assign the names entered to test results during meas-
urement based either on their sequence or on their identifying barcodes, accord-
ing to your preferred setting. For further details see “Worklist settings”.

Fig. 26: The worklist editor window (new worklist element dialog box)

Key to the Worklist Editor

Click to add a new Patient Name to the worklist. You can add
a corresponding barcode if applicable, as well as a comment.
(Comments are displayed in the results summary window of the
Selected Sample screen area and appear on the printout.) No
duplicate barcodes are allowed.
Click to edit the details of the selected worklist element.

Click to delete the selected worklist element or elements.

Click to toggle selection of all the records on the Worklist. The button
is inactive if there is only one record on the Worklist.

Click to import a Worklist created on an external computer.

56
 Operation

Key to the Worklist Editor

Click to close the Worklist editor.

6.3 Measurement
6.3.1 Regular measurement
ÂÂBefore you begin, prepare your native urine samples for manual pipetting ac-
cording to the standards in your laboratory. Homogenize the samples.

1. Switch on the analyzer, and the connected computer monitor. The user soft-
ware of the instrument will start automatically.

Fig. 27: Press the On/Off button to

switch on the analyzer

57
Operation

Fig. 28: Open the analyzer door to

access the cuvette holder slot

2. Open the door of the analyzer and place the cuvette holder into the holder slot.
Carefully remove the piece of tape from the bottom of the cuvette holder after
placing it into the instrument.

Fig. 29: Slide a cuvette holder into

the holder slot, then remove the tape
from the bottom before you start a
measurement

3. Feed a cuvette from the holder into pipetting position, by pushing the Start
button on the top of the analyzer.

58
 Operation

Fig. 30: The Start button on the top

of the analyzer is the only interface
element you need: press it once and
the system feeds a cuvette into pipet-
ting position.

4. The system feeds a cuvette from the cuvette holder into the pipetting position,
and prompts you to pipette the sample into the cuvette (see Figure 31). If you
are using barcoded samples you have to scan the barcode now to assign pa-
tient ID to the particular measurement.
The system stores only one patient ID at a time. At any multiple barcode
scanning the system always uses the last scanned barcode.
5. When a cuvette is in the pipetting position, manually pipette 175 µl of native
urine sample into the cuvette’s fillup inlet (see Figure 32). Make sure to hold
the pipette perpendicular to the cuvette. For pipetting the cuvette place the
pipette tip onto the cuvette inlet and fill the cuvette by pressing the button of
the pipette. Lift the pipette tip from the cuvette inlet and release the pipette
button.
Do not touch or put your finger through the pipetting window when the
analyzer is in use to avoid accidents.

Fig. 31: When the cuvette is in the

pipetting position, a message prompt
appears. Scan the barcode or type in
ID. Click OK and push the start button
again to start cuvette processing.

59
Operation

Fig. 32: The backlighting under the

see-through plastic cuvette helps you
guide the tip of the pipette for fast and
efficient work

Pay particular attention not to spill any sample inside the instrument. To
avoid mechanical jam of the cuvette transporting system, clean the in-
side of the instrument after every unsuccessful pipetting.

ÂÂThe pipette you can use with the instrument should be capable of aspiring
175±5 uL liquid. The dispenser hole of the pipette tip should be at an outer
diameter of 1.2-2.8 mm). Do not use pipette tips with an outer diameter less
than 1 mm.

If the diameter of the pipette tip is less than 1 mm, it may get stuck in the
cuvette inlet.

ÂÂIf there is a problem with the pipetting, and you would like to start over with a
new cuvette, do not try to remove the cuvette by hand. Press the Start button
and hold it until initialization is started. The system will push the cuvette directly
into the waste drawer, then you can start the measurement again.

Pay particular attention to correct pipetting to avoid receiving false re-

sults.

60
 Operation

Fig. 33: The proprietary Urilyzer

Cell disposable cuvette. Key:
1: Fill up inlet
2: Fill up channel
3 3: Imaging chamber
4: Bubble capillary
5: Overflow
2 1

4
5

6. To start the centrifugation and the microscopy sediment analysis, press the
Start button once again. At the end of evaluation the system disposes the
used cuvette into the waste drawer.
Do not try to tilt or move the analyzer during measurement as it could
move the cuvette out of its place and cause the cuvette transporting
system to jam and also could compromise the measurement result due
to disrupting of the focusing process.
7. Repeat steps 3–5 for each new sample that you want to analyze. If the cuvette
holder runs out, you need to load another cuvette holder into the analyzer.
Always change the tip of the pipette between the samples to avoid sam-
ple carryover.

8. At the end of the day, remove and empty the waste drawer (see Figure 34),
and dispose of the used cuvettes according to the laboratory guidelines for
biohazardous waste.

61
Operation

Fig. 34: Do not leave any used cu-

vettes in the waste drawer at the end
of the day. Use the overhanging flap of
the waste drawer to grip it and take it
off the analyzer.

6.3.2 Live view

You can customize the positions where the microscope takes the view field im-
ages, and the microscope focus height during the imaging process for a single
urine sample. All other elements of the measurement cycle remain the same – the
analyzer feeds the cuvette to the pipetting position, waits for pipetting, centri-
fuges the sample and discards the cuvette after the images were taken, as usual.
The automated image evaluation module also analyzes the resulting images the
usual way. To set up and perform a manual microscopy process, complete the
following steps:
1. Set up the manual microscope function by checking Enable Live view check-
box on Settings/Measure screen.

Fig. 35: Enable manual microscope checkbox on Settings/Measure screen

2. Press START button to begin the measurement cycle. When the cuvette ar-
rives into pipetting position a pop-up window appears with a manual micro-
scope checkbox to check. If you leave it unchecked, the cycle goes on as
regular measurement. Pipette the sample in the cuvette and press the START
button.

62
 Operation

Fig. 36: The Live view checkbox appears with the

Please fill sample into cuvette message, if you enabled
the function in the Measure tab

3. The cuvette with the sample inside it gets centrifuged and reaches the micro-
scope.
4. The live image screen will appear in place of the previous screen.

Fig. 37: The live image screen

63
Operation

5. Use the up and down (Y), left and right (X) arrows to move the microscope into
your preferred image position, and the Z arrows to shift the focus height up or
down. When you are satisfied with the image position, click the Take image
button to take a view field image in the specified position. You can reset both
the focus height and the image position to their defaults by clicking the Auto-
focus and the Start position buttons, respectively.
6. The Counter marker keeps track of the number of view field images that you
have taken. When the Counter reaches the number of images that is speci-
fied, or you stop the process by tapping the Close button, the arm discards
the cuvette.

6.4 Operating with chemical analyzer

To maintain complete urine analysis, the Urilyzer Cell can be connected to an
Urilyzer® 100 Pro or Urilyzer® 500 Pro urine chemistry analyzers. The two devices
together provide a complex solution in urinalysis, offering both chemistry and
microscopy urinalysis results.
The sample is analyzed first with the Urilyzer® 100 Pro or Urilyzer® 500 Pro and
then with the connected Urilyzer Cell microscopy analyzer.

Fig. 38: Chem analyzer connection box

Establishing connection
Please contact your service representative to connect your analyzers.

Joint operation
The two analyzers can work together after they were connected correctly and the
online status of the urine chemistry analyzer is displayed in the status bar. The
measurement of urine sample is done in the urine chemistry analyzer first. The
data is exported to the sediment analyzer where the analysis is finished.

64
 Operation

Identification of a sample
The sample ID can be entered by typing in a unique string of numbers or using
a barcode reader. At the end of each measurement the urine chemistry analyzer
sends its report to Urilyzer Cell with the ID in it. Each report can be found in the
database with a comment: No sediment results. To assign microscopy measure-
ment to a chemical result you either have to read the barcode of the sample or
type in the same ID number.

Measurement
1. Prepare the samples.
2. Turn on both analyzers.
3. Establish and/or check the connection between the two instruments.
4. On the urine chemistry analyzer, enter patient ID by typing or using a barcode
reader and start measurement.
5. Wait until the result is sent and perform the measurement on the sediment
analyzer, too.
ÂÂType in the same ID or use the barcode reader to assign the measurement to
the chemical result.

65
Managing results

7 Managing results
7.1 Test results
To review the analysis results for the samples in the database, click the Data-
base button.
The database menu will be displayed:

1
3

4 5
Fig. 39: Database menu: 1) Sample List, 2) Selected Sample header, 3) Particle
results,4) Image List, 5) Thumbnail image

ÂÂThe Database menu is available even while a measurement cycle is going on.
Each processed urine sample appears in the Sample List (see 1 in Figure 39)
in real time, as soon as the analyzer successfully processes it.
1. To review the detailed analysis results of a single urine sample, select the
sample: click the row of the sample in the Sample List. The row will turn dark
blue to indicate that you selected it, and the details of the selected sample will
populate the Selected Sample window.
ÂÂTo select multiple sample records, hold down the Shift key or the Ctrl key
while you click further samples for contiguous or non-contiguous selection,
respectively.
2. The results of the automatic image evaluation for the selected sample will ap-
pear in the particle results window (see 3 in Figure 39), broken down by the
particle types that are active. For more information on how to activate and
disable particle types, see 5.4.4 The Evaluation tab.

66
 Managing results

7.1.1 Editing test results

Selecting one or more test result records

• To select a sample result record in the database, go to the Database menu,
and in the Sample List click the row of the record. Dark blue highlighting indi-
cates that the record is selected.
ÂÂTo deselect a record that you accidentally selected, click to select another
record.
• To select more than one record, press and hold the Ctrl key on the connected
keyboard while you click each record that you want to select. Dark blue high-
lighting indicates that the records are selected.
ÂÂTo deselect one of the selected records, click it again while still holding the
Ctrl key.
• To select a group of records, press and hold the Shift key on the connected
keyboard while you click the first and last row of the group of records that you
want to select. Dark blue highlighting indicates that the group of records is
selected.
ÂÂTo deselect one of the selected records in the group, click it again while still
holding the Ctrl key.
• To select all the sample result records that are currently in the database, go to
the database menu, and click the Select all button.
• To de-select every record, click the Deselect all button that the Select all
button changed to when you clicked it.
• To mark a sample result record as special, click the row of its record inside the
Mark column of the Sample List. A golden star will appear in the Mark col-
umn of the record. When you are filtering for specific records, you can choose
to only look at starred records.
• To delete one or more sample result records, go to the Database menu, select
the record or records in the Sample List, and click the Delete button. In the
confirmation dialog that pops up, click the OK or the Cancel button to confirm
or cancel the action.
ÂÂYou cannot restore result records after you deleted them from the database.

Modifying test result records

To modify the ID, Patient name, Dilution factor, and Status of a sample, select
the record in the Sample List, and click the Modify button. In the Modify dialog
box that pops up, you can modify the ID, the Name, dilution factor, and the (+/-)
status of the sample result record.

67
Managing results

Fig. 40: Modify sample pop-up window

ÂÂIf the Status modification list is not available, you need to enable it: Go to the
Settings menu, and on the Display tab, in the Manual sample status edit box,
select Enable.

ÂÂIf a sample is very crowded, you may need to dilute it with saline solution, and
re-analyze it to get correct evaluation results. To calculate the dilution factor,
use the formula:
DF = final volume/original sample volume
ÂÂThe Modify button is inactive if you select more than one record in the Sample
List.

ÂÂClick the Automatic button to reset the status of the sample record to the au-
tomated evaluation result.
To modify the quantitative and semi-quantitative particle sediment results of a
processed sample:
1. Go to the Database menu and select the record of the sample result in the
Sample List.
2. In the particle results box, double-click the first particle class or particle sub-
class row that you would like to modify. The Sediment Result Modification
dialog box will pop up (see Figure 40).
3. In the Sediment Result Modification dialog, enter a new value in the Particle
Number text box, or select a new semi-quantitative category in the Category
drop-down list for the given particle class or subclass. The Category drop-
down list that indicates the semi-quantitative category results will change to
conform to the modified particle/view field value.

68
 Managing results

ÂÂIf you select a new semi-quantitative category result in the Category drop-
down list, the Particle Number value will change to conform to the new cat-
egory.
4. Click OK to save your changes or Cancel to discard them. To undo the chang-
es without closing the dialog box, click the Automatic button.
ÂÂThe row of the class or subclass that you modified will be highlighted in blue
in the Particle results box.

If you modify the results of a particle class that has active subclasses,
the system will disable both the semi-quantitative and the particle num-
ber results for the active subclasses. You will only be able to modify
subclass results if you undo the changes you made to the particle class
(by clicking the Automatic button in its Result Modification dialog box).

7.1.2 Validating analysis results

A laboratory professional needs to validate, that is, check that the automated
image evaluation module has correctly detected and identified the sediment par-
ticles in the urine sample.
ÂÂThe system will not accept sample results as valid unless they are confirmed
as correct. However, you can enable automatic validation to make the system
accept every analysis result automatically.

ÂÂYou cannot export, transfer to the LIS, or print sample results whose Validated
by status in the Sample List is Not yet validated. If automatic validation is ac-
tive, the Validate button on the Database menu is inactive, and the Validated by
status of samples is automatically validated.
• To validate a sample result (when automatic validation is inactive), select its
record in the Database menu, and click the Validate button.
ÂÂIf an operator validates a sample result, the operator’s name becomes part of
the sample result record. Because of this, manual validation is only available in
the “By user name” login scheme.
• To activate or disable automatic sample result validation, go to the Settings
menu, and on the Measure tab, select the Automatic or the Manual option in
the Validation box.
ÂÂIf automatic sample validation is active, the Validate button on the Database
menu becomes inactive.

69
Managing results

7.2 Microscopy images

7.2.1 The Sample View Editor (SVE)
By default, the device processes all of the view field images and attempts to
identify each of the detected particles in the images, then tags the identified par-
ticles. You can review and modify the automatically assigned tags using the SVE.
To access the SVE, and view a microscopy image and its particle tags in full
screen, double-click any of the view field image thumbnails in the Image List
in the bottom right corner of the Database menu screen, or the measurement
record associated with the view field image. There are essentially two types of
view field images:
• View field images that are not crowded with particles are, regardless of wheth-
er they are negative or pathological, considered Normal: they have No in their
For review column in the Image List. The majority of view field images is of
this type.
• View field images that are so crowded with particles that it is difficult to dis-
tinguish between various elements are considered Images for review: View
field images that are so crowded with particles that it is difficult to distinguish
between various elements are considered Images for review

Breakdown of the SVE interface elements

• The sample to which the enlarged view field image belongs is identified in the
header of the SVE by its results summary.
• The number of the current view field image out of all the view field images
available for the given sample is displayed in the top right corner.
• Use the buttons to scroll through the view field images of a single
sample; use the and to scroll through all the sample records in
the database.
• A table summarizing the particle classes and their number found in the cur-
rently displayed view field image is displayed on the right. Each of the particle
classes that were identified in the image have a checkbox inside the table. Use
the checkboxes to toggle the tagging of the particle in question. The tagging
preference you set in one of the view field images applies to every other view
field image in the series for the current sample, but not to the view field images
of other samples. For example, if you hide WBC (White Blood Cell) tags for one
of the images, no WBC tags will be displayed in any of the view field images
for the selected sample.

Click to cancel all manual modifications and revert to the

automated evaluation results for the currently displayed view field
image.

70
 Managing results

Click to toggle all the tag text over the raw view field image
currently displayed. (Works just like the C keyboard shortcut.)

Click to print a urinalysis report of the current sample with the

default printer settings.

Click to toggle a slideshow of the view field images. A new image

is displayed every three (3) seconds.

To quickly apply multiple instances of a particle type: choose a

particle type from the drop-down list to “load” the particle type
into your cursor, then click anywhere in the image to apply the
particle tag.
Click the arrows to adjust the gradation of the grid that the G
keyboard shortcut displays over the view field image.

Click to save the current view field image as displayed (without

particle tags) as a bitmap image. You can specify where you want
to save the image in a dialog box.

Click to close the Sample View Editor and return to the Database
menu. You can also leave the SVE by pressing the Esc key on the
keyboard.

Slide the ZOOM scale bar for changing the enlargement ratio of
the selected image.
ÂÂ It does not change the Zoom mode settings in the Display tab.
Slide the Brightness scale bar for changing the degree of
enlightenment of the image. Its keyboard shortcuts are Page up
and Page down.
ÂÂ It does not change the Brightness settings in the Display tab

71
Managing results

7.2.2 Modifying automated evaluation results

Parent particle classes inherit the highest relative value present among
their enabled subclasses. If any of the subclasses are manually assigned
a relative value higher than that of their parent particle class, the parent
class result will be overridden.
Urilyzer Cell was developed to help the work of the doctors and not to replace
them: all automated evaluation results can be modified manually. There are two
ways to edit the results that the device generates: in the Database menu, and in
the Sample View Editor.

Modifying microscopy results in the Database

ÂÂModifying results in the Database menu will not affect particle numbers dis-
played in the Sample View Editor.
1. In the summarized microscopy urinalysis report, double-click on the row of the
particle you wish to modify.
2. Enter the desired value in the dialog box that pops up. The system will au-
tomatically apply the change you made in one of the text boxes to both text
boxes.

Fig. 41: The Sediment result modification dialog box

If you change the semi-quantitative result category, the average particle

per image and the quantitative result will be reset to the middle of the
range of the new category.

ÂÂThe maximum value you can enter into the particle number text box is 99999.9
3. Click OK to save the changes, or Cancel to discard the changes. Click Auto-
matic to undo the changes and revert to the automated evaluation.
ÂÂModified records will be displayed in blue in the report.

72
 Managing results

If the result of a particle class is modified, the Category columns of cor-

responding subclasses change to N/A and their values to 0. Further
modification of subclasses is possible only in the Sample View Editor.
However, if you revert to the automated evaluation results, you can re-
start the editing process.

Adding particle tags in the Sample View Editor

Any particle class– or particle number modifications in the Sample View
Editor will affect the results summary in the Database menu.
To tag any area of the view field image, do one of the followings:
1. Choose a particle type in the Quick particle drop-down list in the right sidebar
of the Sample View Editor.
2. Left-click anywhere in the view field image to apply the particle tag. You can
apply the selected tag as many times as necessary.
ÂÂThe cursor will stay ‘loaded’ with the particle type that you selected until you
select another one, or you click another button in the Sample View Editor.

There are several particle classes and subclasses (‘‘extended particle

categories’’) that are not available for automated evaluation, but that you
can add to the view field image manually. You need to enable their use
before they become available choices (see 5.4.4).

ÂÂThe software takes all the new particles that you added into consideration
when generating the microscopy report.

ÂÂNew particle tags are displayed in blue to indicate that they have been modi-
fied.

Modifying particle tags in the Sample View Editor

Any particle class or particle number modifications in the Sample View
Editor will affect the results summary in the Database menu.
1. To modify a particle tag in the SVE image, complete the following steps:
Choose a particle type in the Quick particle drop-down list in the right sidebar
of the Sample View Editor.
2. Move the cursor above the tag you wish to modify.
3. Right-click the tag. You can apply the selected tag as many times as neces-
sary.
There are several particle classes and subclasses (‘‘extended particle
categories’’) that are not available for automated evaluation, but can be
added manually. You need to enable their use before they become avail-
able choices (see 5.4.4).

ÂÂThe software takes all the new particles that you added into consideration
when generating the microscopy report.

73
Managing results

ÂÂNew particle tags are displayed in blue to indicate that they have been modi-
fied.

Deleting particle tags in the Sample View Editor

1. Choose DEL in the Quick particle drop-down list in the right sidebar of the
Sample View Editor.
2. Move the cursor above the tag you wish to delete.
3. Right-click the tag. You can delete as many tags as necessary.
ÂÂThe software takes all the new particles that you added into consideration
when generating the microscopy report.

You can discard every manual modification by clicking the Default but-
ton. This will restore the particle results of the automated evaluation.

74
 Quality Control

8 Quality Control
You can test the performance of Urilyzer Cell by using the integrated quality con-
trol procedure. Click the Quality Control button on the right of the software in-
terface to access all information and parameters concerning quality control
measurements.

Fig. 42: The Quality Control menu

Check the measurement ability of the Urilyzer Cell regularly according to

local regulations.
Generally, there are two types of control solutions: normal (Low level) and ab-
normal (High level). The normal control solution, like non-pathological urine,
contains only a few sediment particles, while the abnormal control solution, like
pathological urine, contains more formed elements in a given concentration. Dur-
ing quality control the device analyses first the normal, then the abnormal control
solution and checks whether diluted elements (RBC-and WBC-like particles) can
be found at the concentration that was set for that particular control solution lot.
Low level and High level control solutions pass Quality control analysis if both
analyzed particles (WBCs and RBCs) are within the values you specified previ-
ously.
The user can easily collect and manage quality control solution lots on the QC
Settings screen.
ÂÂThere are only RBC- and WBC-like particles in the control solution.

75
Quality Control

8.1 QC settings
1. On the left side of the screen both the Low and High level controls will be listed
if you have populated their database. The acceptance ranges of checked ele-
ments (RBC-and WBC-like particles) can be adjusted separately for the Low
level and High level control solutions.
ÂÂBefore a new control solution lot can be used, you have to enter all its informa-
tion.
2. Click the New button below the Low or High level solutions list, and enter the
control solution’s unique lot number in the Lot number text field.
3. Choose the type of control solution you are using from the drop-down list in
the Liquid type text box.
The device is compatible with the following quality control solutions:
–– Quantimetrix QuanTscopics
–– Quantimetrix Dip and Spin
–– Hycor KOVA Liqua-Trol
–– Biorad Liquichek
ÂÂContact your distributor for details of the quality control solutions.
4. Refer to the control solution package insert and enter the expiration date it
indicates in the Expiration date field.
5. Modify the values of acceptance ranges in the Quality Control menu by en-
tering the expected limits in the relevant boxes according to the lot-specific
ranges given in the control solution package inserts. Click the SAVE button to
save your changes.
6. Click the Modify, Select, and Delete buttons to manage the list of control
solutions. If you delete a quality control solution lot, all of its related QC data
will also be erased.

8.2 QC measurement
1. Go to QC menu and click a solution on the list. Enable it with the Select button
(a star icon indicates selection), and then click Start QC.
2. Push the START button.
3. Pipette normal (low level) control solutions in the forwarded cuvette.
4. Push START button again to start centrifugation and evaluation. will switch
to the Database menu to perform the measurements, the same as during
normal sample measurement. After finishing the analysis, displays a message
whether the test was successful, and label failed and passed quality control
tests in the Sample List accordingly. The record of the control measurement
will be named QC_LOW.
5. The system will prompt you to perform the high level measurement.
6. Press START button and pipette the high level control solution in the forward-
ed cuvette.

76
 Quality Control

7. Push START button again to start centrifugation and evaluation. After finishing
the analysis, Urilyzer Cell displays a message whether the test was successful,
and labels failed or passed quality control tests in the Sample List accordingly.
The record of the control measurement will be named QC_HIGH.
8. Quality control analysis results are stored in the Database. In the Database
the Comment fields for quality control analysis results include the failure or
success of each test.

Fig. 43: An example of a Quality Control diagram. The x-axis represents the time period;
the y-axis represents the measurement result values.

9. Click the Low diagrams and the High diagrams tabs on the Quality control
menu to use the quality control visualization feature. Select the time period
you want to review using the radio buttons and the text boxes at the top of the
screen, and click Show to display the results of all the quality control measure-
ments during the given period on a chart (see Figure 43). Click the Labels on/
off button to toggle the display of the exact result value captions. Check or
uncheck the checkboxes in the tabular summary in the top left corner to show
or hide any given control solution lot.
ÂÂEvery control solution lot is represented by a different line color. Upper and
lower range cutoffs are represented by darker lines of the same color as the
results they refer to.

ÂÂIf there is only a single QC result to display, the top and bottom cutoffs are
represented by squares instead of lines.

ÂÂThe QC lot data above the diagrams is listed for identification and statistical
information purposes (CV%, SD) and also indicate specific color and measure-
ment count for the lot.

8.3 QC records management

QC records are stored in the database amongst other measurement records
marked with the name of the used control solution in the Name column of the
Sample list. Using database filter you can select only QC records to be dis-
played and the list can be narrowed down by applying the filter criteria.

77
Cleaning & Maintenance

9 Cleaning & Maintenance

9.1 Cleaning and disinfection
ÂÂDo not use any solvent, oil, grease, silicone spray, or lubricating liquid to clean
any part of the device.

ÂÂUse commercially available isopropyl alcohol or aldehyde-free and NaOH-free

disinfectant (for example Isorapid, Microzid, etc.).

9.1.1 Cleaning the analyzer every day

Complete the following steps every 24 hours, before you finish working with the
analyzer at the end of the day or according to the regulations of your laboratory.
1. Switch off the analyzer and wipe the outside covers with a lint free cloth dipped
in detergent solution.
ÂÂDo not remove the partially used cuvette container alone. Remove the cuvette
container along with the cuvette holder seat.
2. Open the device door and remove the cuvette holder along with the cuvette
holder seat. Remove the waste bin, empty it, and rinse it thoroughly with a de-
tergent solution. Wipe it dry with a lint free cloth or let it dry completely before
you replace it.
3. Using a detergent solution, wipe both surfaces of the see-through plastic pi-
petting guard that helps you direct the manual pipette into the fill up inlet of
the cuvette.
4. Remove and rinse the following elements of the analyzer:
–– the metal cuvette holder seat
–– the plastic cuvette feeder arm
–– the cuvette hold down assembly
–– the drop tray
–– the centrifuge cover
–– the centrifuge arm
ÂÂTurn the centrifuge arm until it is horizontal, snap it off its hub.

Make sure that you do not damage the microscope lamp when you re-
move the centrifuge arm.
5. Wipe each of the elements with a lint free cloth.
6. Wipe the cuvette mover arm and the cuvette way underneath with a lint free
cloth dipped in detergent solution.
Do not replace any element before it has dried completely, and make
sure that the outside covers are dry before you switch on the analyzer.

Do not forget to replace the centrifuge arm in the instrument after clean-
ing.

78
 Cleaning & Maintenance

7. When you switch on the analyzer again, initialize the system before you re-
sume normal operation.

9.1.2 Cleaning the microscope lens

When you see scratches or blotches that repeat on every view field image, some
dust or dirt has probably collected on the surface of the objective. To keep micro-
scope image quality at the optimum level and prevent mistakes in the automated
image evaluation, complete the following steps to clean the lens.
1. To access the microscope objective, remove the cuvette hold down.
ÂÂTake care not to damage the microscope lamp as you remove the cuvette hold
down.

Do not blow air on the microscope objective with your mouth.

2. Push the cuvette mover arm assembly towards the back of the analyzer.
3. Use compressed air or an air bulb blower to blow the dust off the microscope
objective.
 When cleaning the microscope objective, take special care not to
scratch its surface or damage its reflective coating.
4. If the surface is still not clean, use a special lens cleaning tissue, and lightly
wipe the objective free of dust.
5. If the lens is still not clean, fold the objective cleaner cloth to produce a point-
ed triangular end or use a cotton swab and dip it into 96% ethanol. Wipe
across the objective.
6. Re-insert the cuvette hold down before you resume normal operation.

9.1.3 Servicing contact information

Analyticon Biotechnologies offers full service support for its products. feel free to
contact us if you encounter any problem with your Urilyzer Cell analyzer. There
are several ways to contact us:
Phone: +49 6454 7991 - 0
Fax: +49 6454 7991 - 71
E-mail: support@analyticon-diagnostics.com

79
Troubleshooting

10 Troubleshooting
10.1 Information messages
Message Message Information description
code text
44 Password successfully changed! The new password is now valid.
N/A N/A
47 No particles detected - please Validate the sample manually.
validate X.
48 Diagnostic report created The diagnostic file has been properly
successfully. created in the designated location.
50 Quality control test (Low level) The QC measurement has shown
passed! proper instrument functioning.
51 Quality control test (High level) The QC measurement has shown
passed! proper instrument functioning.
54 Please fill the sample into the Pipette 175 microliter sample into
cuvette. the cuvette manually.
55 Please start to measure Low level Press START button to laod
QC. the cuvette for Low level QC
measurement.
56 Please start to measure High level Press START button to laod
QC. the cuvette for High level QC
measurement.
57 Please fill Low level QC into the Pipette 175 microliter Low level QC
cuvette. solution into the cuvette manually.
58 Please fill High level QC into the Pipette 175 microliter High level QC
cuvette. solution into the cuvette manually.
303 Raw data export created The raw data export has been
successfully. properly done.

80
 Troubleshooting

10.2 Warning messages

Message Message Recommended
code text action
62 Empty the trash because it is full. Remove the waste bin, empty it
Please press OK when emptied. and place it back. Press OK.
63 Temperature exceeds warning limit. Stop measuring samples and
turn off the instrument. Check
room temperature and never
use the analyzer outside the
operational condition ranges. If
error persist, call your service
representative.
66 Please close centrifuge door. Re-install the centrifuge cover
232 back.

67 Please replace the plate. Re-install the centrifuge drop

tray.
68 Please shut the door. Close the analyzer door.
69 Cuvette holder is empty. Please Replace the empty cuvette
change it. Please press OK when cartridge with a new one.
changed.
70 Database sample count limit is Delete the unused data to
approaching. have enough storage in the
database.
72 The new limit is not correct. Please Delete results from database in
delete some samples, before you set order to decrease the number
this limit! of elements in database below
the set limit.
74 Shut the waste please. Re-attach the cuvette waste
bin to the instrument.
75 ID contains an illegal character. The ID doesn't contain '
character at filter.
76 Name contains an illegal character. The Name doesn't contain '
character at filter.
78 Quality control test (Low level) failed! The result of the first quality
control is outside the limits.
Check the limits, the control
type and the control. Repeat
the measurement.

81
Troubleshooting

Message Message Recommended

code text action
79 Quality control test (High level) failed! The result of the second quality
control is outside the limits.
Check the limits, the control
type and the control. Repeat
the measurement. Open a new
control solution.
81 Please enter a Lot number. Please fill in the Lot number.
82 Pick a QC liquid type from the list. None of liquid types was
selected. Choose a liquid type.
83 This Low level lot does not exist in the Select a Low level Lot from
database. Please select another Lot. the list.
84 This High level lot does not exist in Select a High level Lot from
database. Please select another Lot. the list.
85 Login failed. Invalid user name or Enter the correct password for
password. log in.
86 Original password incorrect. At password change the
original password was given
incorrectly. Enter the original
password correctly.
87 You cannot delete the currently active It is not possible to delete your
user account. user name by yourself. It can
only be deleted by another user
from same or higher level.
88 The user name must be at least 2 Change the user name to
characters long! contain at least 2 characters.
89 The user is not Service user, login Exit service menu.
failed!
90 This user name is already in use. The user name you tried is
already in use by another
person. Please choose another
user name!
96 Instrument is not ready! Initialize system. Restart PC. If
error persists call service.
103 No more samples. There is no more sample to
check in the SVE.
104 Repeated barcode: A measurement record
associated with the indicated
barcode already exists in the
database.
106 Please enter the correct serial number. Call service.

82
 Troubleshooting

Message Message Recommended

code text action
107 QC deletion not enabled. See 5.4.7 The Maintenance
tab
108 Name contains an illegal character. The Name cannot contain ' & /
\ : * ? " < > | ^ ~ characters at
Sample Data Modifying.
109 ID contains an illegal character. The ID cannot contain ' & / \
: * ? " < > | ^ ~ characters at
Sample Data Modifying.
110 Comment contains an illegal character. The Comment cannot contain '
& | ^ ~ characters at Comment
changing.
114 Category display contains one or more The Category display cannot
illegal characters. contain ' & | ^ ~ characters at
Category definition settings.
115 Lot number contains an illegal The Lot number cannot contain
character. ' & | ^ ~ characters at QC
settings.
116 Serial number is missing. Call your service
representative.
117 Instrument is not ready. Initialize system. Restart PC. If
error persists call service.
118 X sample(s) were not exported. Validate the sample and try
again to export!
119 Sample(s) were not sent. Validate the sample and try
again to send!
120 Sample(s) were not printed. Validate the sample and try
again to print!
123 Incorrect dilution factor. Set the correct dilution factor
(1-100) with correct decimal
separator.
124 The ID must be at least 1 character Insert at least one character in
long. the ID textbox to make it valid:
125 Low disk space, less than X MB! Free up disk space.
131 Not enough free disk space. Delete the unused data to
Measurement has stopped. have enough storage in the
database.
132 The LIS is busy. Try again later." Try to change transfer type
later!
133 LIS port is busy. Initialize system. Restart PC. If
error persist call service.

83
Troubleshooting

Message Message Recommended

code text action
134 Must be member of service. The instrument is in service
mode. Contact your service
representative.
135 No diagram available for these filter Perform different selection by
conditions. the filter to get a diagram.
136 There is no Low level Lot. Please No Low level Lot has been
register one. saved. Add the data of a new
Low level Lot.
137 There is no High level Lot. Please No High level Lot has been
register one. saved. Add the data of a new
High level Lot.
138 Please select a Low level Lot. Select a Low level Lot from
the list.
139 Please select a High level Lot. Select a High level Lot from
the list.
140 Lot already on list. The Lot number already exists.
Please fill in another Lot
number.
141 N/A N/A
216 Log folder changing in progress. Wait until the change is
Please, try it later. finished.
228 Front cover open. Close door(s) of the device.
292 The LOT has been expired! Register new QC LOT.

293 The selected Low level lot has been Register new QC LOT.
expired, measurement cannot start.
294 The selected High level lot has been Register new QC LOT.
expired, measurement cannot start.
297 The result has been sent to LIS. The results, that had been sent,
cannot be modified.
298 Raw data export is in progress Wait until the export is finished.
301 Error creating raw data zip file. Repeat creating raw data.
302 Export list is in progress Wait until the export is finished.
304 The image of sample is in evaluation Wait until the evaluation is
queue. finished.
305 The sample is in output queue. Wait until the export/transfer is
finished.
362 Full Eval is not enabled at the moment Follow on-screen instructions.
for the sample, please try it later.

84
 Troubleshooting

Message Message Recommended

code text action
363 Full Eval is not enabled at the moment Follow on-screen instructions.
for some samples, please try it later.
373 A sample was not deleted. This record is in use. Wait until
the procedure is finished, and
try gain.
374 samples were not deleted. These records are in use. Wait
until the procedure is finished,
and try again.
375 The image of sample of this QC LOT is Wait until the evaluation is
in evaluation queue. finished.

381 No chemical setup Call your service

representative.
382 Chemical class creation error Call your service
representative.
383 TCP configuration is not permitted in Call your service
chemical connection. representative.
384 Port open error in chemical Call your service
connection. representative.
385 Cannot connect to chemical analyzer. Call your service
representative.
386 Chemical result was not saved, Follow the on-screen
because invalid date arrived from instructions.
chemical analyzer. Please set the date
and time on chemical analyzer.

85
Troubleshooting

10.3 Error messages

Error Message Error elimination
code text

146 Sample editing error Database connection error, exit the

program and restart.
147 Sample comment editing error Database connection error, exit the
program and restart.
148 Database error. The modification An error occurred during the save of
cannot be saved. chemical result modification into the
database. Database connection error,
exit the program and restart.
149 Database error. The modification An error occurred during the save of
cannot be saved. sediment result modification into the
database. Database connection error,
exit the program and restart.
150 Number of particles is over. At sediment result modification the given
particle number cannot be more than
99999.9. Give a smaller number.
151 Cannot save modification. The min In QC menu at range setting: Give
range is higher than max! correct values.
152 Not a proper number format. Use Change the decimal character in the
decimal character. typed number. (Sample mod.)
162 Sample count exceeds sample It appears at measurement start. There is
limit. Please delete unused data. not enough storage in the database for
measurement results. Delete the unused
data.
172 Re-entered password does not At password change the new password
match new password. must be entered twice: Enter the new
password twice correctly.
173 Password doesn’t change! Try to modify the passwords once
more. If it was unsuccessful, there is a
database error. Exit the program and
restart.
174 New password must not match Change the password to a different one
default password. from default password.
175 The password must be at least 5 Change the password to contain at least
characters long! 5 characters.
176 Cannot connect to device. Restart PC. If error persists call service.
177 Device is not connected. Restart PC. If error persists call service.

86
 Troubleshooting

Error Message Error elimination

code text

178 Temperature exceeds critical limit. Stop measuring samples and turn off
the instrument. Check room temperature
and never use the analyzer outside the
operational condition ranges. If error
persist, call your service representative.
179 Category definition incorrect! At category modification: Maximum
value is less than minimum value. Enter
correct values.
180 Empty category display strings. At category modification: Enter the
category name.
181 Category display strings are the At category modification: Existing
same. category name. Enter another name.
182 Minimum and maximum limits are Please increase X. category definition,
the same in category definition. because it is the same as the previous
one.
183 Not a proper number format in Change the decimal character in the
category. Use decimal character. typed number. (Cat def.)
184 Empty maximum range. Please fill in the maximum range.
185 The directory does not exist. Select an existing directory.
186 Directory creation error Do not use the following characters in
folder names: ' & / \ : * ? " < > | ^ ~
187 Cannot save/overwrite the html Check the LIS cable, close the HTML
file. Access denied! file, if opened.
191 There is no connection with the Restart PC. If error persist call service.
Printer!
192 Error detected in CSV file in line: Load the worklist file again. If error
persists call your IT department or
service.
194 Selected input file is missing. Load the worklist file again, If error
persist call your IT department or
service.
196 N/A N/A
197 N/A N/A
198 LIS communication error! Check the Host settings and the Host
program. Check the soundness and
connections of the communication cable.
199 LIS connection offline. Check the Host settings and the Host
204 program. Check the soundness and
connections of the communication cable.

87
Troubleshooting

Error Message Error elimination

code text

200 LIS winsock open error. Call your IT department. If error persists
call service.
201 LIS socket open error. Call your IT department. If error persists
call service.
202 LIS TCP connection error Call your IT department. If error persists
call service.
203 N/A N/A
205 Not a proper number format in Change the decimal character in the
limit. Use decimal character. typed number. (QC)
206 Diagnostic report created NOT Reconnect the USB flash drive, reinstall.
successfully. If error persists call service.
207 Error during PCB upgrade. Call service.
251 Delete the oldest sample failed. Enable QC deleting option in the
(May be all of them are QC.) maintenance tab of settings menu.
296 Error in AMAX header Initialize system. Restart PC. If error
persists call service.
300 At least one cell has to be Select at least one particle type.
selected.

10.3.1 Hardware related error messages

If you encounter an error that indicates a moving part might be stuck in the
analyzer during patient testing, first you need to clean those moving parts that
are exposed to a possible urine spill. Follow the procedure described in “9.1.1
Cleaning the analyzer every day”.
Error Message Recommended
code text action
235 Forwarding bar base position error. Initialize system. Restart PC. If error
persists call service.
236 Forwarding bar pipetting position Initialize system. Restart PC. If error
error. persists call service.
237 Forwarding bar centrifuge position Initialize system. Restart PC. If error
error. persists call service.
264 Microscope table position error. Initialize system. Restart PC. If error
persists call service.
267 Focus motor base position error. Initialize system. Restart PC. If error
persists call service.
272 Centrifuge arm blocked. Initialize system. Restart PC. If error
persists call service.

88
 Troubleshooting

Error Message Recommended

code text action
288 Error during camera init. Initialize system. Restart PC. If error
persists call service.
289 Error during focus init. Initialize system. Restart PC. If error
persists call service.
290 Error during focus init. Initialize system. Restart PC. If error
persists call service.
315 Not enough serial ports present. Restart PC. If error persists call service.
316 Too many serial ports Restart PC. If error persists call service.
317 Protocol usage is not defined Restart PC. If error persists call service.
318 Instrument port open error Restart PC. If error persists call service.
319 Please, restart the instrument. Restart PC. If error persists call service.
320 Arm home position error Initialize system. Restart PC. If error
persists call service.
321 Arm microscope position error Initialize system. Restart PC. If error
persists call service.
322 Arm load position error Initialize system. Restart PC. If error
persists call service.
323 Focus home position error Initialize system. Restart PC. If error
persists call service.
324 Centrifuge rotation error Initialize system. Restart PC. If error
persists call service.
325 Camera error Initialize system. Restart PC. If error
persists call service.
326 Feeder cuvette position error Initialize system. Restart PC. If error
persists call service.
327 Feeder arm position error Initialize system. Restart PC. If error
persists call service.
328 Feeder arm moving error. Initialize system. Restart PC. If error
persists call service.
329 Arm moving error. Initialize system. Restart PC. If error
persists call service.
330 Microscope CTS timeout Initialize system. Restart PC. If error
persists call service.

89
Appendices

11 Appendices
11.1 Disposal of the analyzer
The instrument must be treated as biological contaminated-hazardous waste.
Proper disposal of old appliances ( including its plastic parts, electrical compo-
nents) prevents potential negative consequences for the environment and hu-
man health. All electrical and electronic products and other components of the
analyzer should be disposed separately from the municipal waste system. Final
disposal must be organized in a way that does not endanger waste handlers. As
a rule, such equipment must be sterile before it is passed for final disposal. For
more information about disposal of such product, please contact your city office,
waste disposal service or your Local Safety Officer.

11.2 Recycling
Make sure that unwanted, old instruments do not pollute the environment more
than is unavoidable is very important.
Parts and components of the analyzer could be sent to recycling after proper
disinfection:
• the power cable: contact the manufacturer for disposal information or find a
recycling center online
• the electrical wires: find a recycling center online
• the casing panels: follow the local guidelines and regulations for Acrylonitrile
butadiene styrene (ABS) disposal
• the printed circuit boards (PCBs): find a specialized recycling firm
• the CR2032 real-time clock battery on the Mainboard: follow local regulations
and guidelines for lithium battery disposal
• metallic elements: follow local guidelines and regulations for metal disposal
• silicone supports: dispose of these as municipal waste

11.3 Modification history

Version Software Modification

IUCell_en_26_001_01.01_20220324 4.3 not released
IUCell_en_26_001_02.01_20220701 4.3 First release
IUCell_en_26_001_03.01_20230905 4.5 Implementation of new
functions and update to SW 4.5

ÂÂDue to software changes, some screens on the instrument may appear slightly
different from those in this manual.

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