UF-1000i - ALLIANCE OVERSEAS

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UF-1000i - ALLIANCE OVERSEAS
UF-1000i
Launch
Information
UF-1000i
Title
UF-1000i Fully automated Urine Particle Analyser
Status
Announcement
Content
Launch information
Start of sales is scheduled for August 15, 2006
Date
June 2006
Informed by
Product Marketing
Product Management Urinalysis
Susanne Jäkel
SYSMEX EUROPE GMBH 08.06.2006
SYSMEX EUROPE GMBH
Bornbarch 1
D-22848 Norderstedt
Launch Information
UF-1000i
June 2006
Phone
49-40-527 26-0
Fax
49-40-527 26-100
Web
www.sysmex-europe.com
page 1/12
SYSMEX EUROPE GMBH 08.06.2006
Table of Contents
1.
Introduction
3
2.
2.1.
4
4
2.2.
Strategic Intent
Strengthen the market position by further market penetration in
clinical chemistry
Open new markets in the business field of microbiology
3.
3.1.
3.2.
3.3.
3.4.
3.5.
3.6.
3.7.
3.8.
3.9.
3.10
3.11.
3.12.
3.13.
3.13.1.
3.13.2.
3.14.
3.15
3.16
3.17
Product Description
Instrument components
Dimensions and weights
Installation requirements
Principle and technology
Throughput
Sample volume
Analysis profiles
Analysis parameters and graphics
Data storage
Quality control
Output
Interfaces
IPU
Specifications
Multilingual software
Reagents
IVD documentation
SPM
Further information
6
6
6
7
7
7
7
7
8
8
9
9
9
10
10
10
11
11
11
12
4.
4.1.
4.2.
4.3.
Order Information
Release date
Product codes
Prices
12
12
12
12
Launch Information
UF-1000i
June 2006
4
page 2/12
1.
Introduction
It was more than 10 years ago when SYSMEX entered the European market with the first
urine flow cytometers. More than 2,000 systems are installed worldwide to date. The majority
of these systems can be found in Europe, thanks to a top class organisation in sales, the
shown commitment to urinalysis in numerous national and international events and the
proven competence built up within the European SYSMEX distributor team.
Competitive products, both those already brought up in the last years and those to be
expected in the near future, show the attractivity of the business in urinalysis after Sysmex
set the stage for it. Competition is noticeably vitalising this business segment further and the
interest in automation is increasing.
The new UF-1000i will attract more interest by this raised awareness, a factor which was not
existing during the pioneer era for Sysmex around 1995. Numerous UF-series customers
have expected further developments from Sysmex in urine fluorescence flow cytometry in the
last years. They had a long wait, unfortunately a situation the competitor took advantage of
by using partly indefensible arguments against Sysmex urine flow cytometry technology in
particular but also against Sysmex urinalysis in general.
SYSMEX EUROPE GMBH 08.06.2006
It is time now to stop this trend and go into the market with the new UF-1000i which is still a
fluorescence flow cytometer, but now based on the new laser diode technology and featuring
further major developments and improvements in the hardware components and also in a
sophisticated reagent system. A new phase in urinalysis can be started now with UF-1000i.
Launch Information
UF-1000i
June 2006
page 3/12
2. Strategic intent
2.1
Strengthen the market position by further market penetration in clinical chemistry
The first analysers of the UF-series have been mainly installed in clinical chemistry labs.
Replacements of UF-100/50 already started in this market segment a certain time ago due to
the continuous usage of the instruments for years. Now UF-1000i can be offered instead of
UF-100i. The newly developed analyser can not only meet the expectations that known
weaknesses of the current UF-100/50 have been improved but also raise the interest of new
potential customers in this segment looking for a solution to automate their urinalysis work
area. The newly designed analyser offers:
-
-
better classification of the particles than ever before, particularly for erythrocytes, due to
less interferences without losing the high sensitivity required for a device used for
screening
lower review rate because of a minimised interference rate
streamlined design: one main unit with integrated pneumatic unit, completed by a
multilingual IPU.
Although no direct connection of teststrip readers is possible and a rack system for the
Hitachi 5-position rack is not yet available, UF-1000i can be offered to customers in clinical
chemistry labs where teststrip reading is done:
SIS-U (SIS lite, software version 3.2) will consolidate the data and do the technical validation,
and all teststrip readers directly connected to UF-100 shall become connectable to SIS-U
within shortest time.
A sampler system for the Hitachi 5-position rack is already under consideration.
2.2.
Open new markets in the business field of microbiology in further European countries
There is a growing concern in hospitals about the frequency of nosocomial (hospitalacquired) infections which can result in compromised quality of care for the patient, prolonged
hospital stays, increased costs, and even death. The increasing awareness of these costs
has given rise to the search for a solution in the recent past.
UF-1000i with its significant improvement in bacteria detection also in the lower concentration
ranges is the attractive solution to their search. The clinicians can get the results for all
infection indicators – leucocytes, yeast-like cells and bacteria – within minutes to decide
whether a treatment should be started or not. This will result in cost saving for hospitals by
partly eliminating unnecessary drug prescription.
Although commercial labs have also a high workload and a lot of manual working steps, the
short time for reporting a negative result can be the decisive argument in hospitals.
Customers in microbiology can be more intensively approached than before with a solution to
exclude bacteriuria very quickly and get also a fast indication on possible inflammations.
Therefore the analysis features relevant for microbiology are:
−
SYSMEX EUROPE GMBH 08.06.2006
−
Launch Information
UF-1000i
June 2006
A dedicated reagent system provides for a convincing bacteria detection performance
down to clinically relevant concentration ranges between 103/mL to 104/mL (instead
of 105/mL known from UF-100/50)
The flagging combination of the two indicators for inflammation and infection, the
leucocyte count and bacteria count, proved successful in the UF-series and is
continued in UF-1000i. If there is any suspicion for bacteriuria, infection or
inflammation, “UTI?” is displayed. This parameter combination is superior to other
page 4/12
methods like the turbidimetric measurement method offered e.g. with the UROQUICK
system which does not detect leucocytes as indicator for inflammations.
SYSMEX EUROPE GMBH 08.06.2006
The features of UF-1000i will raise the interest of hospital managers for their microbiology
laboratories and will in due course extend the market share of SYSMEX UFC in the European
urinalysis market.
Launch Information
UF-1000i
June 2006
page 5/12
Product description
3.1
The instrument components
The new analyser has an integrated pneumatic unit inside the main unit and is
equipped with an information processing unit (IPU).
The optional, newly designed sampler, delivered together with the
accompanying bar code reader, is suitable for the SYSMEX 10-position racks.
The racks are moved in the sampler line towards a rotation unit before
reaching the bar code reader which smoothly turns the tubes so that bar code
read errors are almost totally eliminated.
SYSMEX EUROPE GMBH 08.06.2006
3.2.
Dimensions and weights
Main unit
UASU-3
IPU
Launch Information
UF-1000i
June 2006
w x h x d (mm)
approx. 572 x 615 x 687
approx. 572 x 93 x 230
approx. 300 x 90 x 350
Weight (kg)
approx 67
approx 8.5
approx 8
page 6/12
3.3.
Installation requirements
Installation conditions: ambient temperature 15 - 30?
relative humidity of 30 – 85 %
atmospheric pressure of 85 kPa – 106 kPa
no exposure to direct sunlight, dust, vibration and acid vapours
3.4.
Principle and technology
−
−
−
Fluorescence Flow Cytometry using semiconductor laser for
§ Bacteria analysis
§ ‘Sediment’ particle analysis
Hydrodynamic focussing
Conductometry
The new analyser uses more optical signals than its forerunners of the UF-series: the
sideward scatter and sideward fluorescence signals contribute to achieve a better
classification performance.
3.5.
Throughput
The throughput depends on the setting for the bacteria detection mode: if a low cut-off (in
some laboratories a bacteria concentration of about 104/mL is considered as the upper
reference limit) has to be taken into account or primary tubes are taken for urinalysis to
UF-1000i and afterwards to the culture plate, the instrument enables to set additional
autorinse cycles performed between analyses in order to minimise the risk of carry-over.
The throughput varies between 60 (if additional autorinse cyles will be performed regularly)
and 100 samples/hour.
3.6.
Sample volume
Minimum volume for
§
sampler analysis mode: 4 mL
§
manual analysis mode: 1 mL
Aspiration volume for
§
sampler analysis mode: 1,200 µL
§
manual analysis mode: 800 µL
3.7.
Analysis profiles
SYSMEX EUROPE GMBH 08.06.2006
Two profiles can be selected:
§
Bacteria analysis only
§
Complete particle analysis (including bacteria)
Launch Information
UF-1000i
June 2006
page 7/12
3.8.
Analysis parameters and graphics
−
12 parameters (analysis parameters and research information)
−
9 additional items (flagging information and information for research purposes)
Analysis parameters
RBC
Red blood cells
WBC
White blood cells
EC
Epithelial cells
CAST
Casts
BACT
Bacteria
Flagging information
X’TAL
Crystals
YLC
Yeast-like cells
SRC
Small round cells
Path. CAST
Pathological casts
MUCUS
Mucus
SPERM
Spermatozoa
Research information (quantitative results completing the flagging information)
X’TAL
YLC
SRC
Path. CAST
MUCUS
SPERM
Cond.
Crystals
Yeast-like cells
Small round cells
Pathological casts
Mucus
Spermatozoa
Conductivity
Information for research purposes
RBC-Info.
RBC morphology information
Cond.-Info.
The concentration of charged ions in the urine, expressed in ranks
UTI-Info.
Information on possible urinary tract infections
8 scattergrams on the main screen and/or research screens
2 histograms on the main screen or research screens
3.9.
Data storage
SYSMEX EUROPE GMBH 08.06.2006
Test results
Patient information
Work list
Doctor list
Ward list
Launch Information
UF-1000i
June 2006
up to 10,000 samples (including scattergrams and histograms)
up to 5,000 patients’ information records
up to 3,000 selective test orders
up to 100 doctors
up to 100 wards
page 8/12
3.10. Quality control
To ensure the instrument’s and reagents’ performance by a daily internal quality control
system, a special control material is available. One package includes two bottles: one low
and one high concentration level each. The target values for all 5 main parameters and
several technical parameters can be entered via bar code if a hand-held bar code reader is
connected to UF-1000i.
QC mode:
Xbar and L-J
QC storage capability: 24 files with 300 data points
each
QC material:
2-level control material “UF II
CONTROL” in lower and
higher pathologic range
QC parameters:
3.11.
Output
DP
LP/GP
Host
SYSMEX EUROPE GMBH 08.06.2006
3.12.
RBC, WBC, EC, CAST,
BACT, conductivity,
sensitivity parameters
Auto printout, stored data
Auto printout, stored data list, QC data, setting data
Stored data, QC data
Interfaces
Main unit:
IPU interface (TCP/IP, Network 10BaseT, 1 port)
IPU:
Main unit interface (TCP/IP)
DP / GP interface (parallel)
GP / LP interface (via USB)
Host computer interface (RS-232C)
LAN interface (TCP/IP)
Launch Information
UF-1000i
June 2006
page 9/12
3.13.
IPU
The IPU is Windows® based. The intuitive IPU software is easy to understand and allows the
analyser’s operation within shortest time.
3.13.1. Specifications
HP Business Desktop dc7600 USDT BTO
CPU: INTEL CELERON D 336 3.3 GHz
RAM: 512MB PC2-4200 (DDR2-533)
Hard drive: 40GB SATA 1.5MB/S
CD-RW: MULTIBAY 24X/24 COMBO - NO S/W
Keyboard: 2004 STANDARD KYBD USB BG1650
Mouse: HP USB OPTICAL MOUSE CBT/SLVR
PCI RISER CARD FOR DC7600 USDT
Monitor: L1706 TFT 17IN TN 1280X1204 60H
Ahead Nero Express 6 OEM Suite
Network: HP Ethernet 10/100/1000TX PCI Card Intel Pro 1000 MT NIC
SB MS Windows XP Pro +SP2 e.
MS USB Stick 2.0 Mini 256 MB inkl. Sysmex Logo
Roline FTP-Patchkabel konf. Kat. 5e, 3m
3.13.2. Multilingual software
SYSMEX EUROPE GMBH 08.06.2006
The IPU software will be available in English, French, German, Japanese, Italian, Portuguese
and Spanish. The IPU in Turkish is under consideration.
Launch Information
UF-1000i
June 2006
page 10/12
3.14. Reagents
Reagent
Expiry date after opening
UF II SHEATH (20L)
2 months
UF II PACK-SED (2 x 2,100 mL)
UF II PACK-BAC (2 x 2,100 mL)
UF II SEARCH-SED (2 x 29 mL)
UF II SEARCH BAC (2 x 25 mL)
UF II CALIBRATOR (2 x 47 mL)
2 months
UF II CONTROL (2x 47mL)
2 months
Reagent
2 months
2 months
2 months
2 months
Consumption/sample
UF II SHEATH (20L)
approx. 39 mL/sample
UF II PACK-SED (2 x 2,100 mL)
UF II PACK-BAC (2 x 2,100 mL)
UF II SEARCH-SED (2 x 29 mL)
UF II SEARCH BAC (2 x 25 mL)
approx. 1.17 mL/sample
approx. 1.46 mL/sample
approx. 15 µL/sample
approx 12.5µL/sample
UF II CALIBRATOR (2 x 47 mL)
approx 800 µL/analysis to check the
sensitivity adjustment during installation
UF II CONTROL (2x 47mL)
approx. 800 µL/control measurement
Please note:
The reagent consumption for operational sequences varies and depends on the instrument’s
setting for the bacteria detection mode.
CELLCLEAN must not be used for the daily shutdown or any other maintenance performed
by the customer!
Detailed calculation tables for reagent consumption can be received from the Product
Management Urinalysis within the Product Marketing of SYSMEX EUROPE GMBH.
3.15
IVD Documentation
The Instructions for Use in English, Italian, Spanish, French, German and Portuguese will be
available by mid to end of July 06.
In case that further languages are needed, please contact Product Marketing as soon as
possible.
3.16.
Sales Promotion Material
SYSMEX EUROPE GMBH 08.06.2006
Catalogue material for UF-1000i is under preparation and will be available from end of July.
Launch Information
UF-1000i
June 2006
page 11/12
3.17.
Further information
For the dates and contents of product trainings and technical trainings please refer to the
SYSMEX non-public pages under “Training Centre” (www.sysmex-europe.com/npublic).
4
Order information
4.1
Release date
The production of UF-100i will be continued for the next few months.
UF-1000i will be available from mid-August 2006.
4.2.
Product codes
Product Name
UF-1000i
UF-1000i Supply Parts
(EU)
UF II SHEATH
UF II PACK-SED
UF II PACK-BAC
UF II SEARCH-SED
UF II SEARCH BAC
Product code
05366719
05372010
06402017
06401615
06401712
06401810
06401917
UF II CONTROL
06404115
Calibrator
UASU-3
06404310
05371635
Cover
Handheld barcode
reader
IPU for UF-1000i
HP TFT Monitor 17’’
for IPU
Keyboard HP standard
(INT)
05372818
Will be informed
later
37000067
37000042
37000043
Description
Main unit
Supply parts
Sheath reagent
Diluent for particle analysis
Diluent for bacteria analysis
Stain for particle analysis
Stain for bacteria analysis
Control material for UF-1000i
Calibrator for service engineers only
Sampler for UF-1000i (Sysmex racks)
including bar code reader
Cover for model if no sampler is used
Handheld barcode reader for comfortably
inserting the QC and reagent information
PC for UF-1000i
Monitor for UF-1000i
Keyboard for UF-1000i
Keyboard standards: INT, DE, GB, I, E, F, B, GR, DK, S
Standard
Option
IPU
For a complete system the minimum order must comprise the main unit, the supply parts, the
PC and monitor.
SYSMEX EUROPE GMBH 08.06.2006
4.3.
Prices
The prices for the UF-1000i and its reagents will be informed separately.
Launch Information
UF-1000i
June 2006
page 12/12