XS-1000i XS-800iLaunch Information

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XS-SERIES

Title XS-1000i & XS-800i Fully automated fluorescence flow cytometry

5-part diff analysers also for the smallest workload Status Announcement – Start of sales is scheduled for April 1st, 2006 Content Launch information Date March 2006 Informed by Product Management Haematology

Tanja Tornow

SYSMEX EUROPE GMBH Bornbarch 1 D-22848 Norderstedt Phone 49-40-527 26-0

Fax 49-40-527 26-100

Web www.sysmex-europe.com

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XS-Series Fully automated fluorescence flow cytometry 5-part diff analysers also for the smallest workload

1. Summary: features and benefits of the XS-series 3 2. Introduction 4 3. Strategic intent 53.1. Respond to the market trend of shifting towards 5-part differential analysis 53.2. Transfer first class technology also to small workload laboratories 53.3. Complete the X-family portfolio 53.4. Provide a unique instrument for paediatric samples 63.5. Create the platform for a service-based business model 63.6. Target market for XS-series 6 4. Product description 74.1. Instruments 74.2. Principles and Technologies 84.3. Blood Volume 84.4. Measurement modes (discrete mode) 84.5. Throughput 84.6. Parameters and graphical images 94.7. Quality Control and SNCS 104.8. QC Functions 104.9. Data storage 104.10. Output 114.11. Technical data 114.12. Languages 114.13. Interfaces 114.14. Sysmex Universal Standard Interface “SUIT” on XS-1000i/XS-800i 114.15. Current IPU Specifications 124.16. Dimensions 124.17. Reagents 134.18. Additional features known as “PRO” functions from XE- and XT-series 144.19. Further information 15 5. Order information 5.1. Release date 165.2. Product codes 165.3. Prices 17

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1. Summary: features and benefits of the XS-series

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2. Introduction Despite the diversity of the markets in the region Sysmex Europe is responsible for with 119 countries including central Europe, the Middle East and Africa, some market trends are still quite comparable in the whole area. This mainly applies to the cost pressure in health care sectors and laboratory diagnostics, although reasons for this might differ from country to country. Secondly, in the whole SEG region we can observe a shift from 3-part differential haematology analysers towards 5-part differential analysers. This trend is quite advanced in some countries while in others it just has started. A severe price fight with competitors accelerates this tendency further since today 5-part differential analysers are sold for prices that only recently 3-part differential analysers were sold for. In 2005 both market trends led to the situation that Sysmex observed a gap in our blood cell counter (MCC) product portfolio between the smallest and cheapest 5-part differential analyser, the XT-1800i, and the 3-part differential analysers of the K-series, mainly K-4500 and KX-21N.

Being very successful in the top-range of the haematology market with XE-series, its various additional Master software and automation capabilities as well as in the middle range with more than 3,000 XT-instruments sold worldwide only in the first 2.5 years after launch, Sysmex was just about to start losing business in the lower haematology market segment. This unfavourable trend we will now stop by the introduction of the new XS-series. Comprising of two different instruments, XS-1000i and XS-800i with an optional sampler in place, the XS-series is especially designed to perfectly fit in the described gap of our current product portfolio. As such, XS-series will serve as the missing link between XT-1800i and K-series not to replace either. As new Sysmex’ 5-part differential haematology analysers, also the XS-series follows the well-proven and established key technology of Fluorescence Flow Cytometry. The success with this still unique technology platform since the introduction of XE-2100 in 1999 makes us very confident to trust in our X-family concept and also its new member. Thus, we still follow our famous slogan:

Haematology is Fluorescence Flow Cytometry - ANYWHERE We are very much looking forward to the coming years working together with you as our distributors on this new chapter in Sysmex haematology business.

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3. Strategic intent

3.1. Respond to the market trend of shifting towards 5-part differential analysis In the past decade a gradual shift away from the 3-part differential haematology analysis towards a true 5-part differential we all observed. Nowadays, in some countries this trend is quite far developed and became state-of-the-art in mid-sized laboratories. In continuation of this market trend, now also small laboratories demand 5-part differential haematology analysers. At the same time, the average workload of roughly 40 samples per day of laboratories that in the past used to have 3-part differential analysers, either as backup or as a standalone instrument, has not changed much. Today, we are challenged to provide a true 5-part differential analyser for laboratories that in the past have not seen the need for such. But still the cost per test and size of the analyser shall not exceed the equipment of the past by too far. For these very reasons the XS-series was designed to be:

- much smaller than the XT-series, - operating with less reagents than the XT-series, - suitable for a smaller workload than the XT-series and - of lower purchasing prices than XT-series.

3.2. Transfer first class technology also to small workload laboratories

Laboratories of small workloads have long been the classical target market for instrumentation that mainly provides a cell count for the CBC, partially a pre-differential and no to little evidence of pathological cells if present in the peripheral blood. Meanwhile, the newest and most innovative technology has always been available to top-end analysers only, not only in Sysmex instruments. Of today, with the new XS-series these customers now have access to an advanced and sophisticated technology that still is the most innovative and unique technology of all in the haematology field: The Sysmex Fluorescence Flow Cytometry for the WBC 5-part differential. Moreover, reference or research laboratories that are using this technology in XE- or XT-instruments already now are given the chance of a backup system that provides the same technology platform to them at sites of a smaller workload.

3.3. Complete the X-family portfolio

By transferring this unparalleled technology also to laboratories of small workloads Sysmex now becomes the only company to provide a true 5-part differential instrument family of identical technology and operational platform from the top-range all the way to the smallest system. Thus, compared to other big haematology companies such as Abbott, ABX Horiba, Bayer and Beckman Coulter, Sysmex is now the only company having invested in the development of a small 5-part differential analyser instead of buying in OEM products of different technology and questionable quality than the top-end analysers, which is the trend our competitors follow nowadays. This easily proves that Sysmex is developing instruments according to the market requirements and made for all customers and all needs, not only for the top-range.

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3.4. Provide a unique instrument for paediatric samples Crucial in all paediatric haematology analysis is the withdrawal of a sufficient amount of blood from patients. And the younger the patient especially in cases of premature birth the more difficult blood collection gets. A haematology analyser capable to provide reliable complete blood count including the differential from a minimum of aspirated blood is the key requirement for such patients. In addition to this, also the required total sample volume is a critical point. Both, the needed sample volume as well as the aspirated volume of blood has been reduced to an absolute minimum in the XS-series in order to suit the needs of laboratories when measuring paediatric samples. With the XS-800i manual open analysis it is possible for the operator to control the aspiration even of the smallest blood volume out of any tube used in the laboratory.

3.5. Create the platform for a service-based business model Comparable to XE- and XT-series also the XS-series is designed to fit to the Sysmex

Network Communication Service (SNCS). Online QC, error message survey and remote services will yield unique selling points in a highly competitive environment against our competition. And it will be of prime importance to guarantee long-term reliability of the hardware and customer support, which is the basis for a strong service oriented business that will increasingly contribute to the overall turnover in the future.

3.6. Target markets for XS-series

Target for XS-series are sites of a workload below 50 samples/d while XT-1800i is targeting to labs with a workload of above 50 samples/day. A grey zone we can expect in the range between 50 and 70 samples/day though.

Stand-alone instrumentation: Probably the largest portion of XS-instruments will be placed in laboratories, either private or public, with a small workload and the need for a 5-part differential analysis where XT-1800i is oversized and too extensive.

As backup instrumentation for XE- and/or XT-series: Being a true 5-part differential analyser by using their same technology, the XS-series will be most suitable to serve as the ideal backup system for XE- and/or XT-series.

Specialized and decentralized testing: Here the aim is to introduce XS-series at ICU, satellite labs, oncology or pediatric wards, POC environment and others, where the specifications of the XS-series meet the specific requirements of these sites. With full feature of the AOKI principle and SNCS, the XS-series can easily be implemented into existing communication platforms, information systems and networks even when used in remote sites.

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4. Product description

4.1. Instruments

XS-800i: open tube mode Capable to measure only open tubes manually

XS-1000i: cap-piercing model Capable to measure open and closed tubes

Sampler: optional for XS-1000i only Capable to measure closed tubes with automatic mixing and piercing function as well as STAT samples as open or closed tubes

Note: The design might be subject to changes.

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4.2. Principles and Technologies

• Fluorescence Flow Cytometry using semiconductor laser - WBC differential - IG (research parameter) - OTHER (research parameter)

• Impedance including Hydrodynamic Focusing - RBC - Haematocrit - Platelets

• SLS-Colorimetric Method - Haemoglobin

4.3. Blood Volume

20 µL for all modes:

- Aspiration volume for open/closed, sampler mode: 20 µL Note: The dead volume may vary depending on the type of tube used. For the

manual open mode in XS-800i no official number is provided on required dead volume as this is the responsibility of the operator during measurement.

- Needed sample volume for capillary mode: 20 µL

Note: In the capillary mode 67 µL are aspirated after a 1:7 dilution of the sample.

4.4. Measurement modes (discrete mode)

2 discrete modes for both whole blood and prediluted mode: - CBC, CBC+DIFF

4.5. Throughput

Sample aspiration mode throughput XS-1000i Manual 60 samples/hr. Capillary 49 samples/hr. Sampler 20 samples/23min. Sample aspiration mode throughput XS-800i Manual 60 samples/hr. Capillary 55 samples/hr. Note: The throughput for CBC and CBC+DIFF is identical.

Analysis time is 100 sec per sample.

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4.6. Parameters and graphical images

• 24 reportable parameters • 4 additional research parameters • 1 scattergram (DIFF) • 3 histograms (PLT, RBC and WBC)

Reportable parameters WBC White Blood Cell Count RBC Red Blood Cell Count HGB Haemoglobin HCT Haematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Haemoglobin MCHC Mean Corpuscular Haemoglobin Concentration PLT Platelet Count RDW-SD RBC Distribution Width SD RDW-CV RBC Distribution Width CV PDW Platelet Distribution Width MPV Mean Platelet Volume P-LCR Platelet Large Cell Ratio PCT Plateletcrit NEUT % Neutrophil Ratio LYMPH % Lymphocyte Ratio MONO % Monocyte Ratio EO % Eosinophil Ratio BASO % Basophil Ratio NEUT # Neutrophil Count LYMPH # Lymphocyte Count MONO # Monocyte Count EO # Eosinophil Count BASO # Basophil Count

Non reportable parameters (available in research screen only) IG % Immature Granulocytes % IG # Immature Granulocytes Count OTHERS % High-Fluorescence Lymphocytes % OTHERS # High-Fluorescence Lymphocytes Count WBC-C White Blood Cell Count in CBC mode using forward scatter light WBC-D White Blood Cell Count in CBC+DIFF mode using fluorescence

scatter light and side scatter light

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4.7. Quality Control and SNCS

In order to continuously monitor the performance of the XS-analyser we will offer multilevel control blood covering both the internal and external quality control for the whole parameter range. Internal quality control is performed with e-CHECK (XS). Assay sheets and assay-CD-ROMs will be available with the assay values for XS-series. A separate product announcement will inform about the details for this new product. For the external quality control the Online QC service will soon be offered as part of the SYSMEX NETWORK COMMUNICATION SERVICE (SNCS). The external QC will be of special importance since on-site service will be reduced comparable to other instruments of the X-family (XE- and XT-series). The Sysmex Network Communication System (SNCS) is an Internet based platform for a row of online customer services for all X-family analysers. SNCS enables us to pro-actively control the total quality within the haematology work area of the laboratory. As SNCS is of strategic importance for the whole of Sysmex in terms of utilizing the synergy effects between our IVD and IT competences and business, it will be soon available for XS-Series analysers. As a web based system, SNCS provides the technical platform to maintain the quality in haematology on three relevant levels: The SNCS module • Online QC is based on the use of e-CHECK (XS) thus providing external quality control

to continuously monitor the XS-Series’ performance for the whole parameter range. • Remote Monitoring enables us to proactively control and maintain the quality and

performance of the analytic devices. • Scientific Web Info provides a platform to educate the staff working in haematology and

supports the quality of the diagnostics and result interpretation.

4.8. QC Functions

• Xbar and/or L-J 20 files, 300 data points each 28 parameters

• XbarM 1 file, 300 data points

26 parameters

4.9. Data Storage

Test results Up to 10.000 test results including scattergrams and histograms Patient information Up to 5.000 patient information records Work List Up to 1.000 orders QC Files Up to 21 files, each with 300 data points

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4.10. Output

DP Auto printout, Stored data LP/GP Auto printout, Stored data list, QC data,

Setting data, Screen shot HOST Stored data, QC data

4.11. Technical data

Noise level: less than 60 dB during operation less than 45 dB in stand-by Installation conditions: ambient temperature of 15°C to 30°C relative humidity of up to 85% atmospheric pressure until 106 kha Heat production: 210 VA or less (equivalent to 181kcal/h)

4.12. Languages

Chinese, English, French, German, Greek, Italian, Japanese, Portuguese, Russian, Spanish 4.13. Interfaces

• Main Unit - IPU interface (TCP/IP, Network 10BaseT, 1 port)

• IPU

- main unit interface (TCP/IP) - Host computer interface (RS 232C) - 8 USB ports, 2 in the front and 6 at the rear - GP/LP interface (via USB) - LAN interface (TCP/IP) - Mouse interface (PS2) - Keyboard interface (PS2) - Hand-held bar code reader connection via keyboard (PS2 – wedge)

4.14. Sysmex Universal Standard Interface “SUIT” on XS-1000i/XS-800i

The LIS Interface protocol for the XS-1000i and XS-800i is optimized by the Sysmex Universal Standard Interface “SUIT” providing high flexibility and transparency in the communication with the LIS and thus offering numerous advantages for both the laboratory and Sysmex with their distributors. “SUIT on IPU” enables the smooth standard LIS connection for all current and future Sysmex IPU based analysers. Future replacements of analysers will only require minor changes in the interface setting done in the SUIT software. Changes at the LIS will no longer be required, except the mapping of new parameters by the customer if necessary.

SUIT will be available for all XS-instruments as it is preinstalled on the IPU. SUIT is capable to work either in query mode or via download by using a specific ASTM protocol.

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4.15. Current IPU 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

These specifications will be updated on a regular basis according to technological developments.

4.16. Dimensions

W x H x D (mm) Weight (kg) Main Unit (XS-1000i) 320 x 403 x 385 24 Main Unit (XS-800i) 320 x 503 x 385 24 Sampler 280 x 400 x 355 10 Note: Unlike other instruments, no additional space for ventilation is needed at the back of

the system.

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4.17. Reagents

*Note: Number of samples calculated for CBC+DIFF, which varies depending upon analysis

modes and maintenance performed.

Reagent consumption

Detailed calculation tables for reagent consumption for all operational sequences are available in electronic format and are handed out during the SYSMEX EUROPE GMBH product training.

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4.18. Additional features known as “PRO” functions from XE- and XT-series

4.18.1. Reagent management As essential requirements especially for accreditation purposes all quality related steps in reagent handling are documented by the reagent management of XS-series. A reagent replacement history will provide the long-term archiving of reagent handling. The reagent information is encoded by bar codes which are applied to each of the reagent containers. A hand-held bar code scanner can then read the information that encodes the following characteristics: reagent name, lot-no., expiry date, amount and log on user. The expiration date of each reagent is checked upon start up of the system and upon sample aspiration.

4.18.2. Reagent meter Reagent consumption is calculated from the pump cycles of the analyser. The approximate remaining volume is displayed in a graphical format. A warning message is displayed if the amount of reagent falls beneath a pre-set value.

4.18.3. Counters Counters in XS-series are used to monitor reagent consumption as well as analysis cycles. For reagent rental charging two types of counters exist in XS-series: - The counters “Total”, “CBC” and “DIFF” continuously count each analysis cycle, but they

do not include any of the reagent consuming maintenance or start-up sequences. Furthermore, they may be reset by any service technician or persons logged on with the Sysmex service password. Separate reagent counters in the same menu are reset at reagent exchange and consequently are only useful to monitor consumption of each reagent package. These counters are identical to counters used in XT-series .

- New “permanent counters” are designed to improve reagent consumption calculations. As they are hidden in the service menu the operator has no access to these counters. They monitor reagent consumption, which includes start-up, maintenance cycles and analyses. Also, they can not be reset.

Note: The permanent counter for Cellpack may not be 100% accurate. Hence, a discrepancy between the counter and the actual consumption can be observed with the latter to be higher.

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4.18.4. Customisable GP layout printout This function allows to create individual printouts to meet local requirements for hard copy documentation. It is a very useful function for most XS users that merely rely on the XS printout function when no LIS is connected and also during instrument demonstrations. The user-definable heading for example can display name and logo of the laboratory/institution. Two printout formats are available: one general report and one for laboratory-use-only. The latter will also display research parameters and non-validated results and is identifiable by the laboratory-use-only watermark. The customisable printout offers the following features: • specific characters and specific images can be printed to a specified area • sample information, parameters, scattergrams, histograms, patient information and action

messages can be printed • normal range of the histogram can be printed (user selectable) • non-validated results can be printed in a specific format “for-laboratory-use-only” • research parameters can be printed in a specific format “for-laboratory-use-only” • information such as log on user name, software version, date and time of print-out can be

printed As a special and very new function the printout may also contain the respective reference ranges according the patient’s categories. Thus, a sample of a neonate will print the normal ranges of this age. This function may be added by including “Reference Interval” to the printout for each parameter separately.

4.18.5. QC chart selection

A QC range can be selected and the following actions can be performed: • display mean SD, CV • set auto target/limit • delete selected data • output selected data to GP/LP/Host

4.19. Further information

Comprehensive product information is kept ready within the Product Marketing department of SYSMEX EUROPE GMBH and will be handed out during the product trainings. For the dates and content of product trainings and technical trainings please refer to the SYSMEX non-public pages under “Training Centre” (www.sysmex-europe.com/npublic/).

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5. Order information

5.1. Release date

The XS-1000i and XS-800i are released for sales April 1st 2006. A pre-launch exhibition took place at Medica in Düsseldorf, Germany, November 2005.

5.2. Product codes

Main unit Options IPU

For a complete system the minimum order must comprise the main unit, the supply parts, the PC and monitor.

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Reagent name PS code Description Cellpack 83400116 Cubitainer 20 L Cellpack 834001110 Cubitainer 10 L Stromatolyser 4DS 98417216 Packung 3 x 42 ML Stromatolyser 4DS 05433310 Packung 1 x 42 ML Stromatolyser 4DL 98417615 Cubitainer 5 L Stromatolyser 4DL 05433212 Cubitainer 2 L Sulfolyser 90411414 Cubitainer 5 L Sulfolyser 05433514 Packung 3 x 500 ML Sysmex Cleaning Solution Cellclean 83401621 1 x 50 ML Sysmex Control Material E-Check (XS) Low 211154 Packung 4 x 1,5 ML E-Check (XS) Normal 211155 Packung 4 x 1,5 ML E-Check (XS) High 211156 Packung 4 x 1,5 ML

5.3. Prices Prices will be informed about separately.