Automated Urinalysis Solution

UN-Series
The Complete Urinalysis Solution
TM
 This is the art of
Urinalysis
At Sysmex, we believe that creating scalable and modular analyzers — customized for each laboratory’s
needs — is an art form. The Sysmex UN-Series is a fully scalable solution, delivering a comprehensive
assessment of urinalysis results. With fluorescent flow cytometry technology at its core, the Sysmex UN-
Series offers an innovative solution for any laboratory.

Picture perfect: A scalable workflow for your lab

First-pass accuracy and new workflow efficiencies built around the unique needs of your lab
• Modular instrument configurations offer flexibility to manage a wide range of workflow needs for
your changing lab
• Customizable reflex rules ensure seamless urinalysis workflow and reduced manual microscopies
• Minimize risk of procedural errors through standardization and reduction of manual processes

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Craft the perfect solution for your lab

Siemens CLINITEK Novus® Automated Urine
Chemistry Analyzer
The CLINITEK Novus analyzer combines proven dry-pad urine chemistry technology,
easy-to-load, radio frequency identification (RFID) labeled test card cassettes and
a throughput of up to 240 samples/hour to help ensure standardized urinalysis test
results and maximum productivity in busy laboratories. Offering nine chemistry tests
plus specific gravity, color and clarity, as well as new software and system features
like automatic color correction and test card humidity checks, the Novus delivers
consistent, high-quality results.

Sysmex UF-5000™ Fully Automated Urine

Particle Analyzer
Using fluorescent flow cytometry, the UF-5000 delivers accurate, precise and reliable
urine particle counts for rapid screening and auto-validation of samples. The UF-
5000’s powerful blue laser, along with four different optical measurements, provides
greater sensitivity and specificity to aid in particle detection and identification which
provides users a completely automated 5-part microscopic.

Sysmex UD-10™ Fully Automated Urine Particle Digital

Imaging Device
The UD-10 captures particle images from urine samples with fully automated digital
imaging. Using stage scanning technology, the UD-10 can help you confidently
confirm the presence of abnormalities and verify flagging from the UF-5000. The
microscope quality images provide a clear view of urine particles and reduce the need
for manual sediment microscopy.

Sysmex Urinalysis Data Manager (UDM)

The UDM is an intelligent data management program, providing users an intuitive and
streamlined interface for urinalysis test results from the UF-5000, UD-10 and Siemens
CLINITEK Novus devices. The UDM supports auto-validation of results through rule-
based judgments, as well as quality control management and the manual classification
of urine particle images captured with the UD-10.

BeyondCareSM Quality Monitor for Urinalysis (BCQM)

In everyday operation, the BCQM program increases laboratory efficiency with
automated urinalysis quality control management. Quality control (QC) interpretation
is simplified through an intuitive, color-coded dashboard and operator alerts when
QC needs to be performed or has exceeded acceptable limits. Shift activity and QC
statistical reports support and enhance regulatory compliance activities, providing
your laboratory confidence in urinalysis result quality.

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 Siemens CLINITEK
Novus
State-of-the-art automation
Trusted results, ease of use and reliability

The Siemens CLINITEK Novus is an automated urine

chemistry analyzer employing robust automation and
innovative technology that provides extended on-board
stability of reagent cards. The Novus automatically
corrects for abnormal sample color and protects the
accuracy and integrity of test results by performing a
humidity check on the reagent test card prior to each
patient test. The CLINITEK Novus can be configured and
integrated with the Sysmex UN-Series, a customized
and scaleable urinalysis testing solution. Additionally,
CLINITEK Novus uses common dry pad analytes, providing
standardized results throughout your laboratory network
regardless of testing volumes. Chek-Stix®®Urinalysis Liquid
Quality Control*, a liquid-ready urinalysis solution, is
validated for the CLINITEK Novus for QC.

Sysmex UF-5000 —
Enhanced detection
The UF-5000’s advanced technology offers
sensitivity and specificity in particle detection
and identification. The powerful, 488nm blue
laser and Depolarized Side Scatter (DSS)
detector offer enhanced discrimination of
crystals and RBCs. When combined with
additional light scatter patterns from the
flow cell, the resulting scattergrams provide
enhanced flagging and abnormal population
detection. The UF-5000 can provide a
completely automated 5-part microscopic
on all urinalysis samples, or be performed as
a reflex based on the results of the CLINITEK
Novus results.

With increased workflow standardization, labs

can analyze native urine without centrifugation
or pre-treatment, avoiding common sources of
*Not available in Canada errors and extensive hands-on processing.

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Sysmex UD-10 — Images worth a

thousand words
Free your staff from time-consuming manual sediment microscopies by automating the capture of
urine particle digital images. As an integral part of the UN-Series Automated Urinalysis Solution, the
UD-10 employs a high-performance digital camera to capture microscope-quality images from samples
flagged by the UF-5000. The UD-10 images are organized and displayed by class size, which allows the
operator to efficiently identify the particle type without the need to spend additional time correcting and
reclassifying particles. Gentle sedimentation by gravity helps preserve fragile elements and decreases
processing time, while the ability to view individual particles and whole field images instills greater
confidence in result interpretation.

Microscope-quality images with particle grouping by size streamlines review of abnormal elements and
simplifies start-to-finish urine sample processing.

Fungal forms, Class 3

Bacteria
According to the size of "bacteria chain" or "bacteria cluster", the captured items are classified into respective classes.
Class 2 (maximum diameter: 6 – 10 μm)

25μm

Class 3 (maximum diameter: 10 – 16 μm)

25μm

Class 4 (maximum diameter: 16 – 36 μm)

50μm

Class 5 (maximum diameter: 36 – 71 μm)

75μm

Fungi
According to the size of "budding yeast cluster", the captured items are classified into respective classes.
Class 2 (maximum diameter: 6 – 10 μm)

Class 3 (maximum diameter: 10 – 16 μm)

25μm

*1

Class 4 (maximum diameter: 16 – 36 μm)

25μm

*2
50μm

Trichomonas
UD-10 classifies these cells under Class 3 or Class 4
Class 3 (maximum diameter: 10 – 16 μm) Class 4 (maximum diameter: 16 – 36 μm)

*3
25μm

50μm

Casts, Class 7

Crystals, Class 4

Epithelial cells, Class 4

Full field

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 Sysmex UD-10™ Sysmex UF-5000™ Siemens CLINITEK Novus®

Compose the distinctive, scalable

solution for your lab
Create the workflow you want. The UN-Series
offers the freedom of start-to-finish urinalysis
workflow with maximum flexibility. As your
laboratory’s needs change, upsizing or downsizing
is simple. Modular configurations efficiently allow
for increased or decreased throughput.

UN-3000N-111

UN-9000N-121

UN-9000N-221

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Siemens
CLINITEK
Novus

UN-2000N-011

UF-5000

UN-Series | 7
Attention to the details
Siemens CLINITEK Sysmex UF-5000™ Sysmex UD-10™
Novus® Technology
• Fluorescence flow cytometry with 488nm
Technology
• Stage scanning with CCD camera
Technology semiconductor laser and hydrodynamic image capture capability
• LED light source and digital camera increase focusing classifies cells by analyzing Aspiration volumes
optical system longevity and overall uptime forward scatter light (FSC), side scatter
• 0.3 mL in sampler mode
` light (SSC), side fluorescent light (SFL) and
• Digital camera determines sample color for • 0.3 mL in STAT mode
depolarized side scattered light (DSS)
automatic color correction feature Minimum required volumes
Aspiration volumes
• Proven dry-pad technology provides • 1.6 mL in sampler mode
• 0.45 mL in sampler mode
standardization across Siemens urine • 0.6 mL in STAT mode
• 0.45 mL in STAT mode
chemistry analyzers
Throughput
Minimum required volumes
Minimum required volume
• 50 samples/hour (normal mode)
• 2 mL in sampler mode
• 2.0 mL per sample
• 0.6 mL in STAT mode Reagents
Aspiration volume • UF-CELLSHEATHTM
• 0.5 mL in sampler mode Throughput
Controls
• Up to 105 samples/hour
Throughput • UF CONTROLTM (2 levels)
• Up to 240 samples/hour Reagents
Parameters
(one sample every 15 seconds) • UF-CELLSHEATHTM
• Up to 8 particle classes
Test strips • UF-CELLPACK SF TM
• - 40 images per sample
• CLINITEK Novus 10 urinalysis cassette • UF-CELLPACK CR TM
(normal mode)
Calibrator and controls • UF-Fluorocell SF TM

• CLINITEK Novus Calibrators • UF-Fluorocell CRTM

Controls
• Chek-Stix® Urinalysis Liquid Quality Control
(Not available in Canada) • UF CONTROLTM (2 levels)

Parameters Parameters
Test strip parameters: Five reportable parameters:
• Glucose • RBC

• Bilirubin • WBC

• Ketone • Epithelial Cells (EC)

• Blood • Casts (CAST)

• pH • Bacteria (BACT)
Five flagged parameters:
• Protein
• Sperm
• Urobilinogen
• Yeast like cells (YLC)
• Nitrite
• Pathologic casts (Path.CAST)
• Leukocytes
Crystals (X’TAL)
• Color
• Mucus
System parameters:
• Specific Gravity (S.G.) and clarity

Sysmex Corporation
1-5-1-Wakinohama-Kaigandori Chuo-ku, Kobe 651-0073, Japan · Phone +81 78 265-0521 · www.sysmex.co.jp

Sysmex America, Inc.

577 Aptakisic Road, Lincolnshire, IL 60069, U.S.A. · Phone +1 800 379-7639 · www.sysmex.com/us

Sysmex Canada, Inc.

5700 Explorer Drive Suite 200, Mississauga, ON L4W0C6 Canada · Phone +1 905 366-7900 · www.sysmex.ca

Sysmex Latin America and the Caribbean

Rua Joaquim Nabuco 615 - Bairro Cidade Jardim, São José dos Pinhais Paraná – Brasil – CEP 83040-210 · Phone +55 41 2104-1314 · www.sysmex.com.br

© 2023 Sysmex America, Inc.

Program availability varies by location. Programs and specification subject to change without notice. CF-COL-07271, Rev 5, 7/2023