XT 2000iautosaved 140501032018 Phpapp02 1

SYSMEX SINGAPORE PTE LTD
XT-2000i
Actual Trends in Healthcare
.. Increase in elderly population

Total reform of medical/hospital system
.. Overall reduction of public spending

Reduction of public healthcare costs
.. Outcome related medicine

Information instead of data required
. Software solutions demanded
SYSMEX SINGAPORE PTE LTD XT-2000i Launch

Hospital structure Japan
University
Hospital
Basic care Long-term care

Hospital Hospital

Common Structure in Asia
G e n e ra l
H o s p it a l
D is t r ic t D is t r ic t D is t r ic t
H o s p it a l H o s p it a l H o s p it a l
H e a lt h H e a lt h H e a lt h H e a lt h H e a lt h H e a lt h H e a lt h H e a lt h H e a lt h
C lin i c C lin i c C lin i c C lin i c C lin i c C lin i c C lin i c C lin i c C lin i c

Hospital/Commercial Lab structure
Core-Lab
Satellite Satellite
Lab. Lab.
Satellite
Lab.
Sender/
Ward Sender/
Sender/ Sender/ Ward
Ward Ward
Sender/
Ward

XT-2000i Development Philosophy
.. Reduction of healthcare expenses

Improve lab productivity and hospital cost
efficiency
. Support Disease management (outcome

related medicine)
. Adapt to new hospital/commercial lab

structures

XT-2000i
Concept
Main Characteristics
..Taking over the technology established by XE-2100.

unifying the results, reagents, and operation with XE.
.. User friendly, easy to use data management

Additional parameters (clinical information)
.. Discrete analysis
48 hr sample stability
..Provides additional features:

Network function
.. Windows 2000
SNCS (on line QC and remote maintenance: under
development)
SYSMEX SINGAPORE PTE LTD . Full-auto Ret analysis

XT-2000i Launch
Main Characteristics
.. Suggests a solution of:

XE-2100 for core lab
. XT-2000i for satellite lab
. To maintain high reputation and market price for XE and

XT-2000i
. Introduction of XT-1800i

XE family concept
.. Breeding the analyzer.

XE developments are continued.
.. new algorithm
new functions
. When new feature or technology is adopted to XE-

2100, also XT will get this
.. vice versa
except the technical limitation.
. i.e. NRBC for XT.

Progress of XE Family
XE-2100
XE-2100
XE-2100L
Value
XE-2100L
XT-2000i
XE-2100
XT-1800i
XT-2000i
XE-2100L XT-1800i
Ver. UP
XT-2000i
Ver. UP
XT-1800i
Year
Core and Satellite Lab.
Sysmex Sysmex
Core Lab
XE-2100 XE-2100
HST
Alpha
Same Reagents
Same Results
Sysmex Same Operation Sysmex
XT-2000i XT-2000i
Satellite Lab A Sysmex

XT-2000i
Satellite Lab C
Satellite Lab B

Inherit XE technologies
..Analysis principle
FCM (Semiconductor Laser)
..Reagent System
Network function
.. .TCP/IP connection
Research Parameter
IG
..
Research Screen
Q-Flag system
..
SNCS:
online QC/remote maintenance

Philosophy
. Provide clinically relevant information of high

accuracy to doctors
. Resting cost reduction in compliance with

governmental regulations
.. Top-level network system: internal and external

Shorten TAT

XT-Series
Two types of XT series
Model Parameter
XT-2000i CBC+DIFF+RET
XT-1800i CBC+DIFF

Schedule
XT-2000i XT-1800i
Release EU and AP: EU and AP:

Date February, 2002 May, 2002
US: US:
June, 2002 July, 2002
*after FDA approval *after FDA approval
Japan: Japan:
April, 2002 May, 2002

Running cost comparison XT vs. SF
..
Theoretical Calculation
XT > SF-3000
..
Actual simulation
XT < SF-3000
.. Discrete testing: cost effective

Less maintenance: cost effective
. Fully automated RET analysis (XT-2000i)

XT-2000i
Specifications
XT-2000i Parameters
. 33 Parameters
WBC, RBC, HGB, Hct, MCV, MCH, MCHC, PLT
RDW-CV, RDW-SD, MPV, PDW, P-LCR, PCT,
NEUT %, LYMPH %, MONO %, EO %, BASO %, IG %,
NEUT #, LYMPH #, MONO #, EO #, BASO #, IG #‚
RET %, RET #, LFR, MFR, HFR, IRF, PLT-fl
. 2 Histograms
RBC, PLT
. 5 Scattergrams
DIFF, WBC/BASO, RET, PLT-O, RET-EXT

Sample Volume
.. Capillary Blood
Open Mode
40 µl
85 µl
.. Manual Closed
Automode
150 µl
150 µl

Throughput
.. CBC
CBC + Diff
80 samples/h
80 samples/h
.. CBC + Diff + RET

CBC + RET
80 samples/h
80 samples/h

Automation
.. Samples for 50 samples (5 rack 10 tubes)

Barcode reader for positive patient
identification
.. Continuous sample loading

Comprehensive Information Processing
System
.. Minimised maintenance
Selectivity
. Closed mode sampling

Information Processing System (IPU)
. Storage 10.000 patient results inclusive all

scattergrams and histograms
.. Work list 1000 samples

Auto validation
.. Interpretive messages
Quality Control

Reagent System
Name Abbreviation
Cellpack EBK
Sulfolyser SLS
Stromatolyser 4DS FFS
Stromatolyser FB FBA
Stromatolyser 4DL FFD
Ret Search 2 Dye RED
Ret Search 2 Lyse RED

Selectivity of XT-2000i
Central-PC
Work list
Barcode
Barcode reading
of each sample
Order information
• CBC
• CBC + DIFF
• CBC + DIFF + RET
Selective Analyse • CBC + RET
after ordering
Results

Configurations XT-2000i
Options
.. PIM software
TCM software: two unit connection with 1 x IPU*
• * only for the same model type available.
. Twin of “XT-2000i and XT-1800i” or “XE-2100 and
..
XT-2000” is not possible.
Sampler (50samples)
Bar coder reader (sampler)
.. Handheld barcode reader

Printer (GP/LP)
local supply
local supply
. Ticket printer (DP-510)
XT Twin
XT-2000i Twin Configuration
Two XT-2000i systems, one Information Processing

System (IPU)
160 Samples per hour

Every 23 seconds a CBC + differential result

Configuration Image
Main Unit
XT IPU
PIM
TCM
BCR
Sampler
TCP/IP O/M Basic soft
connection
accessory
Pneumatic unit

XT-series
Analysis Principle
XT-2000i Multi Channel Analyser
Whole blood sample
Analysis
Block RBC/PLT HGB WBC RET
Hydrodynamic Focusing Colorimetric Flow cytometry Flow cytometry

Principle - DC Detection - Determination
Analysis RBC/PLT HGB DIFF WBC/Ba RET

channel channel channel channel channel channel
PLT RBC DIFF WBC RET

Information histogram histogram scattergram scattergram
Parameter PLT RBC HGB Lymph WBC# RET

Mono Baso
Neut+Ba PLT-O
EO IRF
*IG - research

XT-2000i Multi Channel Analyser
Channel Principle / Dilution Parameters
Flow Cytometry
WBC/BASO Diode laser - 1:50
WBC, Baso #‚ Baso %
Lymph #‚Lymph %,
Flow cytometry Mono #, Mono %,
4 Diff
Diode laser - 1:51 Eo #, Eo %,
Neut #‚ Neut %
Flow cytometry RET #, RET%, PLT-O

RET/PLT-O Diode laser - 1:204 HFR , MFR , LFR, IRF
SLS-Method, Photometry HGB

HGB
1:500
MCH, MCHC, MCV
HDF DC-Detection method RBC, HCT, PLT-I,

RBC/PLT-
Impulse summary RDW-SD, RDW-CV,
Detector 1:500 PDW, MPV, P-LCR

Fluorescence Flow Cytometry
Photo Multiplier
(Fluorescence Light)
Dichroic
Mirror
Photo Multiplier
(Side Scattered Light)
Semiconductor Laser
(λ = 633nm)
Flow Cell
Photo Diode
(Forward Scattered Light)

Side Fluorescence Light:

RNA/DNA Information
Side Scattered Light:
Internal Cell Structure
Forward Scattered Light:

Cell Volume Information
Laser Beam
(λ = 633nm)

4 Diff-Channel
1. Principles and technology
2. DIFF-Scattergram

4 Diff-Channel
Neutrophil Eosinophi Basophil Monocyte Lymphocyt

l e
Band Metamyelocyte Myelocyte Promyelocyte Blast
Lyse & Staining

l e

4 Diff-Channel
DIFF Scattergram Mono
Lymph
Fluorescence
Neut + Baso
Eo
Ghos
t
Side Scatter

4 Diff-Channel (pathological sample)
DIFF Scattergram
Fluorescence
Side Scatter

Diff Scattergram
Atypical
Lymph Promyelo
Myelo
Abn. Lymph/
Blasts
Metamyelo
Band

WBC/Baso Channel
2. DIFF-Scattergram

WBC/Baso Channel

l e
Lyse

l e

WBC/Baso Channel
WBC/BASO Scattergram
Baso
Forward Scatter
WBC
Side Scatter

RET Channel
2. DIFF-Scattergram

Ret Channel
RBC RET PLT NRBC WBC
Lyse & Staining
RBC RET PLT NRBC WBC
Staining:
Polymethine: RNA
Oxazine: DNA
Ret Channel
RET Scattergram
RBC
Forward Scatter
RET
(LFR, MFR, HFR)
IRF
PLT-O
Fluorescence

HDF Technology
2. DIFF-Scattergram

Hydrodynamic Focussing
. DC resistance measurement with hydrodynamic

focussing for measurement of erythrocytes,
thrombocytes and hematocrit
CELLPACK
(Sheath solution)
Sample
Aperture

Hydrodynamic Focussing
C A
B
cells
aperture
Pulse A Pulse B Pulse C

Hemoglobin
1. SLS
2. Reaction Mechanism

SLS-Hemoglobin
. Cyanide free SLS-Method
.. Alternative for KCN

SLS is Sodium lauryl sulphate
.. Equal to the KCN method

Cyanide free, not poisoned, is part of a lot of
soaps
. Sysmex Sulfolyser is used for K-, E-, NE, SF,

SE and and XE-instruments

. The SLS-Method is Standard for Sysmex
instruments
XT-2000i Launch
Reaction Mechanism of Hemoglobin
Hemoglobin-Molecule
SLS (Sodium Lauryl Sulfate)
Hydrophobic
group
Heme
Hydrophilic
group
Globin

Reaction Mechanism of Hemoglobin
1. Hydrophobic groups of
SLS binds to globulin
2. 0xidation of Ferro: Fe2+ --> Fe3+
3. Hydrophilic groups of SLS binds to

Fe3+. and SLS-Hgb is formed

XT
Flagging System
Flag
..
NEGATIVE
No abnormality
..
POSITIVE
One or more of the IP messages is
generated
..
ERROR
Classified as Functional abnormality
XT-2000i Launch
XT Flagging System
NEGATIV Report
E
Result
POSITIVE Review Report
Error Review Report
XT flagging system can provide

valuable information for review
Flagging
POSITIVE
Diff Abnormality in Cell Differential

Morph Abnormality in Cell Morphology
Count Abnormality in Cell Count
ERROR
Func Analysis error other than ID Barcode

Result Low Reliability of Data
Delta Abnormalities with Delta Check

IP Message
Two Types
..Abnormal IP Message:
Indicates that the sample is definitely
abnormal. The IP abnormal message criteria
..
can be set except for some items.
Suspect IP Message:
Indicates that there is a possibility that the
sample is abnormal.

IP message
..
IP messages are detected from:
Cell information
.. Fluorescence
Forward Scatter Light Flowcytometry
. Side Scatter Light
.. Scattergrams
Histograms

WBC Flagging
Abnormal Messages Suspect Messages
. WBC abnormal
Scattergram .. Blasts?
..
Immature Gran?
Neutropenia
Neutrophilia .. Left Shift?
..
Atypical Lympho?
Lymphopenia
Lymphocytosis .. Abn Lympho/L-Blasts?
..
RBC Lyse Resistance?
Monocytosis
Eosinophilia . NRBC?
.. Basophilia
Leukopenia
SYSMEX SINGAPORE PTE LTD . Leukocytosis

XT-2000i Launch
RBC Flagging
.. RBC ABN Distribution

Dimorphic Population
.. RBC Agglutination?
Turbidity / HGB inter
.. Ret ABN Scattergram

Reticulocytosis
.. Iron Def?
HGB Defect?
.. Anisocytosis
Microcytosis
. Fragments?
.. Macrocytosis
Hypochromasia
.. Anaemia
Erythrocytosis

PLT Flagging
. PLT ABN Distribution

.. PLT Clumps ?
..
PLT C(s) ?
PLT ABN Scattergram
Thrombocytopenia
. Thrombocytosis

Product Portfolio
Current and Future

Current MCC Portfolio
Low end Middle High end

Function/Diagnostic Value
Price


Function/Diagnostic Value
XE-2100
XE-2100L
SE/R
SE
SF-
3000
K-4500
KX-21/
KX-21N
F series
Price


Function/Diagnostic Value HmX
CD-3700
Pentra-120
CD-3200
Pentra-60
AcT 5 Diff
ADVIA 70
ADVIA-120
CD-4000
Gen*S/LH750
Micros Pentra-120R
CD-1200
Act DiffⅡ
Price


CD-3700
XE-2100
Pentra-120
XE-2100L
CD-3200
SE/R
SE
Pentra-60
AcT 5 Diff
ADVIA 70
SF-
3000
ADVIA-120
K-4500 CD-4000
Gen*S/LH750
KX-21/
KX-21N Micros Pentra-120R
CD-1200
F series Act DiffⅡ
Price

MCC Portfolio - Future -

CD-3700
XE-2100
Pentra-120 XE-2100L
CD-3200
SE/R
Pentra-60 XT-2000i SE
AcT 5 Diff
ADVIA 70 XT-1800i
ADVIA-120
K-4500 CD-4000
Gen*S/LH750
KX-21/
KX-21N Micros Pentra-120R
CD-1200
F series Act DiffⅡ
Price

Differences
XT-2000i & XE-2100
Sysmex
XE-2100
Specifications
XT-2000 i XE-2100
Parameters 30 32
Throughput CBC 80 samples/hour 150 samples/hour
+ 80 samples/hour 113 samples/hour

RET
Discrete mode 4 7
Sample Manu 85 uL 130 uL

Volume al
Close 150 uL 200 uL
d
Sample No digit 15 15
Sampler 50 samples 100 samples

Parameters
XT-2000 i XE-2100
Reportabl CBC Yes Yes

e
DIFF Yes Yes
RET Yes Yes
PLT- Yes Yes

O
NRBC No Yes
Research HPC No Yes

IG Yes Yes

Reagent
XT-2000 i XE-2100
CELLPACK use use
CELLSHEATH not use use
STROMATOLYSER- use use
FB
4DL
4DS
STROMATOLYSER- not use use
IM
SULFOLYSER use use
STROMATOLYSER- not use use
NR
RETSEARCH II use use

IPU
XT-2000i XT-1800i XE-2100 XE-2100L
OS Windows 2000 Windows NT*

Database SQL-Anywhere 5.5.05 SQL-Anywhere 5.5.04
CPU > Pentium III 733 MHz > Pentium II 450MHz

Memory > 128MB > 64Mb
HDD > 10 GB > 3 GB
ATA > 100 -
result 10,000 10,000

Storage
workload 1,000 1,000

Patient 5,000 5,000
Information
QC files 21 files (300 points/file) 21 files (300 points/file)
* The OS of XE will be changed to Windows 2000 from Ver. 19

Difference: IPU
XE-Series Measure Sample

- analysis result
Sysmex - differential
- flagging Store the results
XE-2100
OS: Windows NT
XT-Series
Measure Sample Analysis the raw data
- differential
Sysmex
XT-2000i
- raw data
- flagging
Store the results
OS: Windows 2000

Coffee break

XT-2000i
Features
Features
1.
2. Flowcytometry
3.
4.
Multi Channel Analyzer
Semi Conductor Laser
5.
6.
Network
Fully Automated RET analysis (XT-2000i)
7.
8.
Random access testing
Common operation & reagent system with XE
9.
10.
Hydrodynamic Focusing System
Effective Hematology Information
11.
12.
SNCS
X-bar-M Control
Q-Flag

Features
Flowcytometry
Principle in Hematology
.. Resistance
Optical Measurement

Optical Principle
. Scatter light
Information
Forward- Cell volume

scatter
Side- Granularity
scatter Internal Cell Structure

Optical Principle
. Fluorescence
DNA/RNA-Content Cell cycles

Cell proliferation
Reticulocytes
Chromosome
..

Optical Principle
..
Light source:
Tungsten lamp
..
He-Ne laser
Argon laser
Semiconductor laser
Forward- Side-
scatter scatter Fluorescence
Tungsten lamp
 
He-Ne-Laser  
Argon laser
  
Semi conductor
laser   

Flowcytometry
Definition:
. Is an optical system which detects scatter

light and fluorescence of sheath flow
focussed single cells

Flowcytometry
Argon laser
. Wavelength λ = 488 nm
Staining (RET)
. Acridine orange, Ethidium bromide, Thiazole orange,

Auramine O
Semiconductor Laser
. Wavelength λ = 633 nm
Staining
.. on basis of Polymethine for fluorescence optical detection

with long stability and high fluorescence gain
. Fluorescence stimulation with semiconductor laser

Formula of Polymethine
X=O, S, Se, N-alkyl or C(Ch3)n

R1,2 = alkyl (1-6C) ;
R3,4 = alkyl, metoxy or no
n = 0-1
Flowcytometry
How does SYSMEX use the new technology?
..Diff
Reticulocytes

Flowcytometry with XT-Series
What is so special on it ?
.There is Forward and Side Scatter, a lot of

information’s about nucleus and granularity!
Why Fluorescence?
. Why is that so new ?

Other are also offering IG count!

Flowcytometry with XT-Series
What is so special?
Polymethine stains DNA/RNA, however important is

staining including RNA, and the use of these reagents
make supra vital staining possible.
Beside the information of

- Cell volume
- Intracellular components ,nucleus and granularity
we get also information about the Cell Activity

- Replication activity of the nucleus
(cause high RNA)
- Cytoplasm activity
(Protein syntheses causes high RNA)

The Cell
1 2
10
7
4
5 6

The Cell
. Cell nucleus (1)

(DNA) . Function: Auto replication and syntheses
Ribonucleinacid (RNA) in the Nucleolus (2)
1 2 Cells with no possibility of replication have less RNA.
These are mature cells (except lymphocytes) and
3
10
NRBC (except pro erythroblast)
.
8
7
4 Cytoplasm (3)
5 6
- Mitochondria (5) energy factory  no RNA/DNA
- Golgi machine (4) pack up enzymes  no RNA/DNA
- Endoplasmatic Reticulum (10) is a membran
structure with Ribosome (RNA) for protein
synthesis (not in RBC)
- Lysosomen (8) Granula  no RNA/DNA, enzymes

4 Diff-Channel

l e
Lyse & Staining

l e

Features
Semiconductor Laser
Optical System
Photo Multiplier
(Fluorescence Light)
Dichroic
Mirror
Photo Multiplier
(Side Scattered Light)
Semiconductor Laser
(λ = 633nm)
Flow Cell
Photo Diode
(Forward Scattered Light)

Semiconductor Laser
.
Feature
Long-life Laser
. . Saves money
Quick start-up
. . Stat samples
Compact
. . Less space – small analyser

Low power consumption
. . Save money
High stability
. Less maintenance cost

Features
Fully automated RET analysis

Fully automated RET analysis
..Just 60 seconds analysis

No pre-treatment
..
Useful information
IRF, LFR, MFR, HFR
SYSMEX SINGAPORE PTE LTD  Fast report XT-2000i Launch

IRF for monitoring of erythropoesis
..Ratio of immature reticulocyte

Useful predictive parameter of
..
bone marrow suppression
recovery in terms of erythropoesis

Features
Efficient Hematology Information
Optical Platelets PLT-fl

IG Count
Atypical Lymph
Feature
Optical Platelets PLT-fl

Fluorescence PLT Count
If there is a problem with the size of RBC and PLT,

than the impedance count often is not enough.
. Pseudo thrombopenia : - Giant PLT

- PLT Aggregation
. Pseudo thrombocytose: - Fragments
A chamber count (lysed RBC) or a flow cytometry

measurement CD 61 (membran antigen) or a check
of the RNA is requested.

“Optical” PLT Count
. Impedance platelet analysis has limitations in the

identification and discrimination of platelets from
interfering particles
. . RBC fragments (similar in size to PLT)

Counted as platelets
. . Small RBC (similar in size to PLT)

Counted as platelets
. . Large platelets (similar in size to RBC)

Excluded from the platelet count

X
Fluorescence PLT

PLT < 100 X 109/L vs. Immunocount
Immunocount versus Immunocount versus

XE impedance count XE “optical” count
RBC ratio v XE (PLT-i) RBC Ratio v XE (PLT-o)

y = 1.0068x + 1.8778
y = 0.9047x + 2.1817
150
150 r = 0.9735
r = 0.8852
XE (PLT-o) x 10 ^9/L
120 120
XE (PLT-i) x 10 ^9/L
90 90
60 60
30 30
0
0
0 30 60 90 120 150 0 30 60 90 120 150
RBC ratio x 10 ^9/L RBC ratio x 10 ^9/L

Results
XE2100 (PLT i) versus CD61
• All counts R²=0.98

• PLT <100 R²=0.78
XE2100 (PLT fl) versus CD61
• All counts R²=0.97

• PLT<100 R²=0.95

Ret Channel
Reliable PLT Count
With the addition of the optical method for PLT counting, the XT-2000i
Can automatically report reliable PLT counts when interferences with
The impedance method are detected

PLT-I and PLT-FL Switching Algorithm
No
PLT-I, unreliable PLT-I Result
Yes
No
PLT-O, unreliable PLT-O Result
Yes
PLT Vote out

Dysplastic Thrombocytes (MDS)
.. Dysplastic Erythrocyte (could be with Fragments)

Dysplastic Thrombocyte (possible with degranulated PLT)
. Problem with Impedance and FSC and SSC (7°).

Dysplasia (MDS)
90% of all measured Fragments are related to MDS
In case of MDS:
dysplastic Erythrocytes (Fragments)
dysplastic Platelets (degranulated)
Problems with Impedance and optical

Measurement (FSC and SSC (no granularity)),
only
fluorescence RNA is possible.

Features
IG Count
IG Count
. Useful information on WBC extended

differential (Not reportable - research parameter)
.. IG:
promyelocyte
.. myelocyte
metamyelocyte
Maturation of neutrophil
myeloblast promyelo myelo metamyelo band segment
IG

Diff Scattergram
Promyelo
Myelo
Metamyelo
Band

Immature Granulocytes

Immature Granulocytes

Inaccuracy of IG proportion
35
No. samples: 134

30
XE-2100 range: 1.0-24%
MICRO range: 0.0-33.0%

25
y = 1.2278x - 0.7245
2
R = 0.8751
MICRO IG% 20
15
10
0
0 5 10 15 20 25 30
XE-2100 IG%

Features
Atypical Lymph
Diff Scattergram
Atypical
Lymph Promyelo
Myelo
Abn. Lymph/
Blasts
Metamyelo
Band

Atyp. Lymph

Atyp. Lymph
Activated
B-Lymphocytes

Atyp. Lymph

Comparison: XT vs. ADVIA
LUC - What is that ?
..
Blast or Blast-like
ALL or AML
NHL (IB or CC-CB)
..
Large Lymphocytes
Activated T-Cells
..
Activated B-Cells
O-Lymphocytes
NHL all kinds.
The result was Other: 11.5%, LUC: 10.8% and manual: 9% respectively,
it showed excellent correlation.

Big differences between Other: 0.1% and LUC: 15.3%, but the result of
manual method was Atyp. Lymph 0.5% and Monocytes: 40%.
It is considered that LUC includes Monocytes

Summary
. XT-2000i gives information about replication

activity of the nucleus (higher RNA content)
. XT-2000i gives information about cytoplasm

activity (Protein syntheses high RNA)
Sub-population for B-lymphocytes.
.. Separates Lymphatic diseases from others

No problem with Giant-PLT or Fragments
(PLT-fl)
. XT-2000i provide a total count of IG´s

(Sepsis)

Features
Network capacity
Network
. The XT can be integrated into computer

network
Sysmex
XE-2100
Room A
NETWORK
PC room
Doctor’s room
Room C
Room B

Network Connection
Clinical Laboratory (1)
Clinical Laboratory (1)
Hospital Information System
Laboratory Information System

Features
Quality Control
.. 24 files for either x bar or L-J
1 file for x bar M
.. 300 points each file

Delta checking is also available for
cumulative review

Primary Goals in Quality Control
.. Error Detection
Error Prevention
. Reliable Test Results

Errors of Laboratory Measurements
. Random errors are the

result of chance or
sampling errors.
. Random errors do not

affect the entire batch of
specimens

Systematic Error
. Systematic errors affect

all specimens in a batch.
. Systematic errors are

attributed to causes other
than chance: e.g.,
deteriorating reagents,
instrument malfunction.

Features
X-bar-M Control
Patient Moving Average
.Quality control tool developed by Dr. Brian

Bull in 1974.
.This algorithm is based on the inherent

stability of the red blood cell indices in a
general hospital populations.
.Utilizes patient data, recording the MCV,

MCH and MCHC of each patient sample.
..
Monitors stability over time of:
Instrumentation
..Reagents
Technique

Feature
..
Use of routine samples
Fresh blood, cells without fixation, optimal
.
to check lyse processes
NO additional costs, because the control runs
in the back ground with routine samples
.
..
no manual handling
Optimal controlling of reagents
especially after reagent change

Feature
. Check of the analyzer every 20, 30, 40

or ... (corresponding batch size)
..Longtime and continuing control

QC is only one shot
.. No optimal check of reagent

Check of dilutions
. Check of lyse processes limited

Advantages of x-bar-m control
.. Inexpensive, simple to use

Utilizes unfixed patient blood
.. Incorporated into current Hematology analyzers

Real time QC

Features
Online QC
On-line QC

Online-QC on the XE-2100
.. Internal & External QC simultaneously

Daily Data Comparison against Reference
and Peer Group Values
. QC-Error Detection in Real-Time by Means

of a QC-Flag System

Categories of Quality Control
.. IQC
Available anytime, but
if any abnormality found...
.. Instrument condition?
Control Blood Problem?
EQC
..Not Available anytime

Long period to get statistics Result

QC flagging Information
Action Limit flag

If data exceeds Group Mean +/- Action
Limit triggers QC-error mail
SDI Limit flag
When data exceeds Group Mean +/- 3SD
Reproducibility flag
When data deference against the

previous QC data in SDI is more than “4”,
Trend flag
1111
When SDI increased or decreased
continuously 6 times

Features
Remote Maintenance
Remote Service
Clinical
Labs
Line for
Remote Support
Line for
Remote Support Sysmex
Support
Center

SNCS Concept

Features
Random Access Testing

Random Access Testing
..
Real-time random access testing
Quick report
. Cost saving
CBC
CBC + DIFF
CBC + DIFF + RET
CBC + RET
Various types of real-time discrete analysis

modes save on reagent

Feature
XE / XT Family Concept
Operation & reagent system with XE
..Solution for
HST (XE) series: Core lab.
. XT series: for satellite lab.
Core Lab
Same Reagents
Same Results
Same Operation

Features
Hydrodynamic Focusing
Hydrodynamic Focusing System
..
New system
Compact
.. Prevent re-circulating and coincidence

No Cellsheath required
CELLPACK
(Sheath solution)
Sample
Aperture

Features
Q-Flag
Unique Q-Flag System
. Q-Flag system visualizes level of each sample

abnormalities and allow to perform the patient monitoring
..
effectively.
Quantitative monitoring of suspect flags:
Blasts?
.. Imm Gran?
Left Shift?
.. Atypical Ly?
Abn Ly/Blasts?
.. RBC Lyse Res?
RBC Agglut?
.. Turb/HGB?
HGB Defect?
..Fragments?
PLT Clumps?

Q-Flag System
IP Message
BLASTS ? BLASTS ?
300 300
200 200
100 100
Red, if
above 100
Green, if 80 250
below 100
Numerical value of the bar height
Sysmex Q-Flag system gives the operator the full picture.

Q-Flag System
Negative Positive
example example
Degree of the
abnormality Trigger
level
Blasts? Imm Gran? Left Shift?

Features
ACAS - Adaptive Cluster Analysis

System
ACAS Adaptive Cluster Analysis System

ACAS ACAS
1. Analysis of the first 500 signals of cells with moving centroids.
2. Determination of clusters of lymphocytes granulocytes, monocytes

and ghost when analysing 1000 signals of cells.
3. Repitition of steps 1 and 2 until the values are stabil (max. 5 times), I.
e. the centroides are in a fixed position.
4. If the differences are not stable after the 5. repetition, there will be no
separation of WBC populations (grey area).
5. A daptive C luster A nalysis S ystem is done for all counted leucocytes

(f.e. 25.670 cells, if the WBC concentration is 25,67 x 10^3/µL).
6. Result: Very exact differentiation, compared to flowcytometrie and the

manual mikroscopic differential.
7. Result: Good differentiation even in pathological and older samples

(24 h).

Position Statement
Purpose Positioning Statement
It’s up to us to choose :
the image or perception
However we intend to generate in the

customer´s mind

Position Statement Elements
.. Images or Perception
Customer Target Groups
.. Competitor Target
Core Strategy

Images or Perception
Image or perception we intend to
generate in customer’s mind:
.. State of the art

we continue to deliver what we promise in
time reliable and innovative products
.. Appealing Software
Unique menu of clinically relevant parameters
.. PLT-fl
.
IG
Fluorescence : ‘brightest’ hematology system

. Is it IT or is it Haematology ? It is the best of

both !
.. The only true WBC count

21st Century laboratory management concept
. perfect combination between research and

routine
.. High class full hematology

a system for eXperTs
. Network connectivity

. Perfect link between technology and

organisation
.. the golden combination

selectivity : cost effective
. compact

.. Fluorescence Activated Differential (F.A.D.) :

a new standard in WBC-differential:
the DIFF is stained, therefore optimum
.
quality
True Selectivity : random access profiling:
CBC, CBC+DIFF, CBC+DIFF+RET,
CBC+RET
. reduce running costs and increase
..
efficiency
New parameters: IG, PLT-fl, RBC-O
a world of new important information

. The top of the range analyzer made by

Sysmex
.. a high quality product of a successful range

High Tech : Windows 2000, Dual, QC, Maint.
.. Up-to-date computer system

Latest Laser Technology : Diode Laser
. Long life, trouble free high stability

Customer Target Groups
Positioning Statement
Customer Target Groups:
.. the Scientist
the Altruist
.. the Money Maker

the Lab-manager

Target Group: the Scientist
The XT-2000i delivers several important new

parameter to be evaluated:
.. IG % and IG #
80 % of all diseases have an increased IG
.. further reduction of manual diff!

Better accuracy for IG detection!
.. PLT-fl
Monitoring of Anemia
New Parameter: RBC-Y
XT-2000i Launch
and RET-Y
Target Group: the Altruist
The XT-2000i delivers several important new

parameter which improve Patient Care:
.. IG count: fast and reliable

PLT-fl: correct PLT count even at fragmented
RBC or PLT-clumps
. RBC-O: correct RBC count also at

agglutination
. IG % at low concentrations : the only clinical

indicator for some diseases

Target Group: the Moneymaker
The XT-2000i delivers several important

new innovations which improve efficiency:
.. full selectivity reduces costs/test

IG count reduces manual differentials further

Target Group: the Lab-Manager
The XT-2000i delivers several important

high tech features which improve lab-service:
.. Windows 2000 software

Online QC support
.. Online Maintenance
Online Application Support
.. Online Service Support

Internet Communications

Competitor Target
Competitor Target Bayer
Position themselves as THE differential counter
.. Where is the IG count ?

How about peroxidase deficiency ?
.. What about maintenance ?

What's about degranulated cells

Competitor Target Abbott
Worked hard to become the new standard
. Did not make it (only a few CD-4000

installations world wide)
.. No real flowcytometry with fluorochrome

9 part diff ? No scientific evidence
. Reliability problems: pinch valves, no SRV

Competitor Target Coulter
.. Used to be Nr. 1
No random access selectivity
.. No IG
No innovations
. Just a Max-M repacked: old technology

Competitor Target ABX
.. A newcomer
No random access selectivity
.. No IG
No Dual System
. Not fast

Core Strategy
Core Strategy MM
Convince the money-maker that …………...

the XT-2000i improves his lab-efficiency
dramatically and in a unique way because :
. the IG count reduces his manual differential

count further
. full selectivity reduces his costs/test

Core Strategy A
Convince the Altruist that ………………….

The XT-2000i produces reliable results on
new parameters which improve the
healthcare of his patients because :
. PLT-fl: correct PLT count even at appearance

of Fragments
. RBC-O: correct RBC count also at

agglutination
. IG count provided within 30 seconds:

inflammation and sepsis (I/T ratio)

Core Strategy S
Convince the Scientist that ……..

The XT-2000i is the superb analyser which
provides a lot of scientific important parameters
to be investigated for clinical
relevance/importance because:
. How powerful is IG% and IG# in detecting

sepsis in an early stage ?
. At what diseases IG appearance at the same

time in the same in the peripheral blood ?

Core Strategy LM
Convince the Lab-manager that ………..

the XT-2000i has a powerful impact onto his
lab-organisation because:
. the Windows 2000 is so easy to operate by all

people
. the Internet-connection allows him to

communicate :
QC-results, application issue’s, maintenance,
service support
.. powerful QC-package
adjust screens to his needs: flexibility

The END!

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SYSMEX SINGAPORE PTE LTD

.. Increase in elderly population

.. Overall reduction of public spending

.. Outcome related medicine

. Software solutions demanded

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

Basic care Long-term care

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

.. Reduction of healthcare expenses

. Support Disease management (outcome

. Adapt to new hospital/commercial lab

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

..Taking over the technology established by XE-2100.

.. User friendly, easy to use data management

..Provides additional features:

SYSMEX SINGAPORE PTE LTD . Full-auto Ret analysis

.. Suggests a solution of:

. XT-2000i for satellite lab

. To maintain high reputation and market price for XE and

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

.. Breeding the analyzer.

. When new feature or technology is adopted to XE-

. i.e. NRBC for XT.

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

Satellite Lab A Sysmex

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

. Provide clinically relevant information of high

. Resting cost reduction in compliance with

.. Top-level network system: internal and external

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

Two types of XT series

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

Release EU and AP: EU and AP:

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

.. Discrete testing: cost effective

. Fully automated RET analysis (XT-2000i)

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

.. CBC + Diff + RET

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

.. Samples for 50 samples (5 rack 10 tubes)

.. Continuous sample loading

. Closed mode sampling

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

. Storage 10.000 patient results inclusive all

.. Work list 1000 samples

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

. Twin of “XT-2000i and XT-1800i” or “XE-2100 and

.. Handheld barcode reader

. Ticket printer (DP-510)

Two XT-2000i systems, one Information Processing

160 Samples per hour

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

Whole blood sample

Hydrodynamic Focusing Colorimetric Flow cytometry Flow cytometry

Analysis RBC/PLT HGB DIFF WBC/Ba RET