product fact sheet added values xn cbc and xn diff · sysmex europe gmbh bornbarch 1, 22848...
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Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 10/08/2015 by Melanie Steffens - Page 1 / 3
Product Fact Sheet Added values XN-CBC and XN-DIFF
Product name
Added value XN-CBC
Added value XN-DIFF
Manufacturer information
Sysmex Corporation
www.sysmex-europe.com
Summary
XN-Series offers a high analytical level of screening by fluorescence flow cytometry for the counting/differentiation of white blood cells in CBC and DIFF mode. The advanced XN-CBC profile includes the counting of rare event cells as basophils and nucleated red blood cells in every measurement. It reports NRBC as low as 0.1/100 WBC. Furthermore, interferences from non-cellular particles such as lyse-resistant RBC or lipids are avoided.The XN instrument always reports automatically corrected WBC values if NRBC are present. The differential of the XN-Series includes the counting of immature granulocytes (IG) and provides high sensitivity detection of WBC abnormalities. Samples showing a low white blood cell concentration can be re-measured automatically in the special “low WBC mode”. This ensures obtaining reliable results of all parameters inclu- ding the differential by an extended count sequence. An additional dedicated pre-diluted mode is designed for the analysis of capillary samples as only 20 μL of blood is required.
Productivity values
Decreased turn-around time (TAT) as no reflex testing for NRBC is needed in all profiles
Reducing smears and potential manual errors by eliminating manual NRBC counts and by an improved flagging efficiency for WBC
Always correct WBC values in neonate samples by auto-correction for NRBC
Clinical values
Reliable NRBC counts for all neonate and adult samples of low and high counting ranges enable immediate therapeutic action, e.g. for patients in ICU
Highly sensitive detection of WBC abnormalities with improved flagging nomenclature guide to quick patient diagnosis
Support of detection of inflammations or infections and in therapy monitoring of infections
Specifications
Feature Description
Discrete mode CBC and CBC+DIFF
Sampling mode Whole blood mode
Low-WBC mode
Pre-dilution mode
Whole blood mode
Analysis time
36 s
Low-WBC mode
Analysis time
41 s
Pre-dilution mode
Analysis time
Dilution ratio
40 s
1:7
Technologies Fluorescence flow cytometry
Hydrodynamic focussed impedance measurement
Light emitting diode (LED) photometry
Adaptive cluster analysis system (ACAS) and special shape recognition analysis of each WBC subpopulation
Reflex testing optional available for
Myeloid and lymphatic information
Critical PLT information
Low-WBC mode
Diagnostic parameters
XN-CBC (16, incl. NRBC)
WBC – White blood cell count
NRBC%, NRBC# – Nucleated red blood cells
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 (PLT-I)
Product Fact Sheet Product Name or Title
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 10/08/2015 by Melanie Steffens- Page 2 / 3
XN-DIFF (12)
RDW-SD – Red cell distribution width (standard deviation)
RDW-CV – Red cell distribution width (coefficient of variation)
PDW – Platelet distribution width
MPV – Mean platelet volume
P-LCR – Platelet large cell ratio
PCT – Plateletcrit
NEUT%, NEUT# – Neutrophils
LYMPH%, LYMPH# – Lymphocytes
MONO%, MONO# – Monocytes
EO%, EO# – Eosinophils
BASO%, BASO# – Basophils
IG%, IG# – Immature granulocytes
Research parameters
XN-CBC (6)
XN-DIFF (28)
Microcytic red blood cell ratio (MicroR)
Macrocytic red blood cell ratio (MacroR)
WBC-N
BA-N#, BA-N%
Total nucleated cell count WNR channel (TNC-N)
Total nucleated cell count DIFF channel (TNC-D)
WBC-D (TNC-D - NRBC#)
High fluorescence lymphocyte count (HFLC#, HFLC%)
NEUT#& (NEUT# - IG#)
NEUT%& (NEUT% - IG%)
LYMP#& (LYMPH# - HFLC#)
LYMP%& (LYMPH% - HFLC%)
Basophils analysed in the DIFF channel (BA-D#, BA-D%)
Neutrophil granulation (NE-SSC)
Neutrophil fluorescence (NE-SFL)
Neutrophil FW scatter (NE-FSC)
Lymphocyte SW scatter (LY-X)
Lymphocyte fluorescence (LY-Y)
Lymphocyte forward scatter (LY-Z)
Monocyte side scatter (MO-X)
Monocyte fluorescence (MO-Y)
Monocyte forward scatter (MO-Z)
Neutrophil side scatter width (NE-WX)
Neutrophil fluorescence width (NE-WY)
Neutrophil FW scatter width (NE-WZ)
Lymphocyte side scatter width (LY-WX)
Lymphocyte fluorescence width (LY-WY)
Lymphocyte FW scatter width (LY-WZ)
Monocyte side scatter width (MO-WX)
Monocyte fluorescence width (MO-WY)
Monocyte FW scatter width (MO-WZ)
Service parameters 29 (XN-CBC) and 16 (XN-DIFF)
Linearity (whole blood mode)
WBC
RBC
HGB
HCT
MCV
NRBC#
NRBC%
NEUT%
LYMPH%
MONO%
EO%
BASO%
IG%
Within ±3.0 % or ±0.20 x 103/μL (0.00 to
100.00 x 103/μL)
Within ±6.0 % (100.01 to 310.00 x 10
3/μL)
Within ±11.0 % (310.01 to 440.00 x 10
3/μL)
Within ±2.0 % or ±0.03 x 106/μL (0.00 to
8.00 x 106/μL)
Within ±4.0 % or ±0.06 x 106/μL (8.01 to
8.60 x 106/μL)
Within ±2.0 % or ±0.2 g/dL (0.0 to 25.0 g/dL, 0.00 to 15.52 mmol/L)
Within ±5.0 % or ±0.5 g/dL (25.1 to 26.0 g/dL, 15.53 to 16.14 mmol/L)
Within ±3.0 % or ±1.0 HCT (0.0 to 75.0 %)
Within ±3 % or ±2.0 fL
Within ±10.0 % or ±0.20 x 103/μL (0.00 to
20.00 x 103/μL)
Within ±20.0 % or ±2.0 NRBC % (0.0 to 600.0/100 WBC)
Within ±3.0 NEUT%
Within ±3.0 LYMPH%
Within ±2.0 MONO%
Within ±1.0 EO%
Within ±1.0 BASO%
Within ±1.5 IG%
Precision (whole blood mode)
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
RDW-SD
RDW-CV
PDW
MPV
P-LCR
PCT
PLT
NRBC#
NRBC%
NEUT#
NEUT%
LYMPH#
LYMPH%
MONO#
MONO%
EO#
3.0 % or less (4.00 x 109/L or more)
1.5 % or less (4.00 x 1012
/L or more)
1.0 % or less
1.5 % or less
1.0 % or less
2.0 % or less
2.0 % or less
2.0 % or less
2.0 % or less
10.0 % or less
4.0 % or less
15.0 % or less
6.0 % or less
4.0 % or less (100 x 103/μL or more)
25.0 % or less, or within ±0.12 x 103/μL
25.0 % or less, or within ±1.5 NRBC% (WBC 4.00 x 10
3/μL or more)
8.0 % or less (1.20 x 103/μL or more)
8.0 % or less (30.0 NEUT% or more, WBC 4.00 x 10
3/μL or more)
8.0 % or less (0.60 x 103/μL or more)
8.0 % or less (15.0 LYMPH% or more, WBC 4.00 x 10
3/μL or more)
20.0 % or less (0.20 x 103/μL or more)
20.0 % or less (5.0 MONO% or more, WBC 4.00 x 10
3/μL or more)
25.0 % or less, or within ±0.12 x 103/μL
Product Fact Sheet Product Name or Title
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 10/08/2015 by Melanie Steffens- Page 3 / 3
EO%
BASO#
BASO%
IG#
IG%
25.0 % or less, or within ±1.5 EO% (WBC 4.00 x 10
3/μL or more)
40.0% or less, or within ±0.06 x 103/μL
40.0% or less, or within ±1.0 BASO% (WBC 4.00 x 10
3/μL or more)
25.0% or less or within ±0.12 x 103/μL
(IG# 0.10 x 103/μL or more)
25.0% or less or within ±1.5 IG% (IG% 2.0% or more, WBC 4.00 x 10
3/μL or
more)
Carry over (pre-dilution mode)
WBC
RBC
HGB
HCT
PLT
NRBC#
NEUT#
LYMPH#
MONO#
EO#
BASO#
1.0 % or less
1.0 % or less
1.0 % or less
1.0 % or less
1.0 % or less
2.0 % or 0.02 x 103/μL or less
2.0 % or 0.05 x 103/μL or less
2.0 % or 0.05 x 103/μL or less
2.0 % or 0.03 x 103/μL or less
2.0 % or 0.03 x 103/μL or less
2.0 % or 0.03 x 103/μL or less
Sample stability
8 hours
24 hours
36 hours
48 hours
72 hours
HCT within +5.0 %
MCV within +5.0 %
HCT within +8.0 % (in a refrigerator), within +15.0 % (stored at 18 to 26 °C)
MCV within +8.0 % (in a refrigerator), within +15.0 % (stored at 18 to 26 °C)
NRBC% within +10.0 % or ± 3.0/100 WBC
IG% within ±2.0 % IG%
NEUT% within ±8.0 NEUT%
LYMPH% within ±7.0 LYMPH%
MONO% within ±3.0 MONO%
EO% within ±3.0 EO%
BASO% within ±1.0 BASO%
PLT within +10% or ± 30 x 103/μL
NEUT% within ±8.0 NEUT%
LYMPH% within ±7.0 LYMPH%
MONO% within ±4.0 MONO%
EO% within ±3.0 EO%
BASO% within ±1.0 BASO%
WBC within ±10.0%
RBC within ±5.0%
HGB within ±5.0%
References: XN-Series IFU version February 2014
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 20/04/2017 by Michael Preukschas - Page 1 / 2
Product Fact Sheet Added value RET
Product name
Added value RET
Manufacturer information
Sysmex Corporation
www.sysmex-europe.com
Summary
Since anaemia is one of the most common symptoms of many diseases and one of the most underestimated RBC disorders, knowing the erythropoietic status is of prime importance for many patients. Next to the pure count of reticulocytes, the XN-Series ‘added value RET’ application provides the reticulocyte fractions (IRF, LFR, MFR, HFR) and additional information on the quality of the newly formed RBC by reporting the degree of the haemoglobinisation of the reticulocytes (RET-He) and red blood cells (RBC-He). The parameter Delta-He is derived from the difference between these two parameters. Delta-He values above the normal range may indicate an improvement in erythropoiesis, for example after EPO and/or iron therapy. In contrast, when Delta-He values are below the normal range for longer periods, this may indicate the onset of anaemia. In addition, the ‘added value RET’ application allows obtaining information about hypochromic and hyperchromic RBC, about microcytes and macrocytes as well as fragmentocytes and the automatic calculation of the reticulocyte production index (RPI).
Productivity values
• Quick screening of the erythropoietic status
Clinical values
• Reliable diagnosis of anaemic patients based on the complete picture of the erythropoiesis by qualitative and quantitative information
• Early prognosis of therapy monitoring by advanced cli- nical parameters and their combinations (e.g. RET-He, Delta-He, IRF)
Article number
Article no. Item Description Qty
ZE000322 Media Kit RET RET application kit 1
Specifications
Feature Description
Discrete mode (Depending on XN configuration)
CBC+RET
CBC+DIFF+RET
CBC+DIFF+WPC+RET
CBC+DIFF+RET+PLT-F
CBC+RET+PLT-F
CBC+DIFF+WPC+RET+PLT-F
Sampling mode Whole blood mode
Low-WBC mode
Pre-dilution mode
Technologies Fluorescence flow cytometry
Diagnostic parameters 11*
RET% – Reticulocyte percent
RET# – Reticulocyte count
HFR – High fluorescence ratio
MFR – Medium fluorescence ratio
LFR – Low fluorescence ratio
IRF – Immature reticulocyte fraction
RET-He – Reticulocyte haemoglobin equivalent
RBC-He – Red blood cell haemoglobin equivalent
Delta-He – Difference between RET-He and RBC-He
HYPO-He – Percent hypochromic red blood cells
HYPER-He – Percent hyperchromic red blood cells
Research parameters (whole blood mode)
11*
RBC-O – Red blood cell count (optical)
RET-Y
RBC-X, RBC-Y
IRF-Y
FRC% – Fragmented red blood cell percent
FRC# – Fragmented red blood cell count
Product Fact Sheet Product Name or Title
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 20/04/2017 by Michael Preukschas - Page 2 / 2
RPI – Reticulocyte production index
RET-UPP
RET-TNC
PLT-O
Service parameters 8
Linearity (whole blood mode)
RET%
RET#
IRF
LRF
MFR
HFR
PLT-O
Within ±20% or ±0.30 RET% (0.00 to 30.00%)
Within ±20% or ±0.0150 x 106/µL (0.0000 to 0.7200 x 106/µL)
Within ±30% or ±10.0 IRF%
Within ±30% or ±10.0 LFR%
Within ±30% or ±10.0 MFR%
Within ±30% or ±5.0 HFR%
Within ±7% or ±10 x 103/µL (0 to 5,000 x 103/µL)
Precision (whole blood mode)
RET%
RET#
IRF
LFR
MFR
HFR
RET-He
RBC-He
PLT-O
15.0 % or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00%)
15.0% or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00%)
30.0% or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00%, IRF 20.0% or more)
30.0% or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00%, LFR 20.0% or more)
50.0% or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00%, LFR 20.0% or more)
100.0% or less or within ±2.0 HFR% (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %)
5.0% or less (RET# 0.02 x 106/µL or more)
5.0% or less
6.0% or less (100 x 103/µL or more)
Precision (pre-diluted mode)
RET%
RET#
PLT-O
35.0% or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %)
35.0% or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %)
13.0 % or less (100 x 103/µL or more)
Sample stability (whole blood mode)
24 hours at RT and 4 °C
RET%
RET#
IRF
LFR
MFR
HFR
RET-He
RBC-He
± 20.0% or within ±0.3 RET%
± 20.0% or within ±0.015 x 106/µL
± 30.0 % or within ±10.0 IRF
± 30.0% or within ±10.0 LFR
± 30.0% or within ±10.0 MFR
± 30.0% or within ±5.0 HFR
Within ± 8.0% (RET# 0.0100 x 106/µL or more)
Within ± 8.0%
48 hours at RT and 4 °C
PLT-O
Within +15.0%
*Availability of certain diagnostic parameters depends on the IPU software version. Please refer to the release notes of IPU software 21.12 for further information.
References: XN-Series IFU version 1611 November 2016
RIAm: Regional IFU Amendment –Sysmex XN series October 2016
Product Fact Sheet Added value for the leucopoiesis
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 28/11/2016 by Telmo Costa - Page 1 / 2
Product Fact Sheet Added value for the leucopoiesis
Product name
Added value WPC
Manufacturer information
Sysmex Corporation www.sysmex-europe.com
Summary
High specificity in white precursor and pathological cells (WPC) analysis is provided with a dedicated measurement channel. It is dedicated for detecting malignant white blood cells with high specificity since they feature altered membrane characteristics. If the flags for ‘Blasts/Abn Lympho?’ or both ‘Atypical Lympho?’ and ‘Blasts/Abn Lympho?’ are triggered by the WDF channel, the automated WPC analysis can turn these into one of four more specific flagging messages: •‘Blasts?’ flag: indicates a suspected acute malignant disorder (e.g. acute leukaemias). •‘Abn Lympho?’ flag: points to a suspected malignant disorder of lymphocytes (e.g. chronic leukaemias and lymphomas). •‘Atypical Lympho?’ flag: points to a reactive disorder (e.g. infections or inflammations, allowing the characterisation of the state of the immune system. •‘Negative’: The high specificity of WPC analysis further filters out false-positive suspected malignant samples. The WPC analysis is triggered by a reflex testing after a positive detection in the CBC+DIFF mode. But for known special samples, e.g. from oncology wards, the profile may also be ordered initially. The WPC channel’s high specificity is contributing further to improve the laboratory workflow after the sensitive screening for WBC abnormalities in the CBC+DIFF profile. Especially laboratories handling a large number of samples with such abnormalities, e.g. from oncology or
haematology wards, will benefit from a significant smear reduction. False-positive and false-negative rates are both optimised and flagging algorithms effectively support the identification of myeloid and lymphatic malignancies.
The WPC channel further enables to use the optional XN Stem Cell mode. * * Only available after activation of ‘XN Stem Cells license’
Productivity values
Minimisation of the number of false-positive suspected malignant samples from the XN-DIFF, thus stream-lining the diagnostic pathway by reduction of follow-up tests
Confidence that the right smears are performed Decreased TAT time thanks to automatic reflex testing
Clinical values
Optimal differentiation between malignant and reactive samples and deeper insight into the immune response status once malignant conditions have been excluded
Assuring that the right smears are done and no time is invested in false positive samples
Faster follow-up of true pathological samples can become beneficial during the treatment process
Article number
Article no. Item Description Qty
ZE000324 Media Kit WPC WPC precursor kit 1
Specifications
Feature Description Discrete mode (depending on XN configuration)
CBC+DIFF+WPC CBC+DIFF+WPC+RET* CBC+DIFF+WPC+RET*+PLT-F* CBC+DIFF+WPC+PLT-F* *optional
Product Fact Sheet Added value for the leucopoiesis
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 28/11/2016 by Telmo Costa - Page 2 / 2
Sampling mode Whole blood mode ‘Low WBC’ mode Capillary/pre-diluted mode
Technologies Fluorescence flow cytometry
Diagnostic parameters HPC% and HPC# Haematopoietic progenitor cell count only available after license activation (for more information refer to XN Stem Cells PFS)
Reflex testing Automatically triggered by the XN-DIFF flag ‘Blasts/Abn Lympho?’
Flagging information ‘Blasts?’ flag ‘Abn Lympho?’ flag ‘Atypical Lympho?’ flag Negative
Sample stability whole blood mode
24 hours at RT and at 4°C
References: XN-Series Instructions for Use Revised January 2016
Product Fact Sheet XN CHECK
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 05/01/2017 by Sandra Valdmanis - Page 1 / 2
Product Fact Sheet XN CHECK
Product name
XN CHECK
Manufacture information
Sysmex Corporation, Japan
"Producer" on OEM-Basis: STRECK, U.S.A.
Summary
The XN CHECK is a control blood designed to fit specifically to the XN-Series and XN-L Series instrumentation thus allowing to thoroughly checking the analysers’ technical functions and reagent system. The material enables an effective and reliable internal and external quality control of the XN-Series and XN-L Series haematology system.
Article number
Article no. Item Quantity
213487
213488
213489
213484
213485
213486
ZE000528
XN CHECK L1
XN CHECK L2
XN CHECK L3
XN CHECK L1
XN CHECK L2
XN CHECK L3
XN CHECK / XN CHECK BF USB stick (for XN-L Series)
1 x 3.0 mL
1 x 3.0 mL
1 x 3.0 mL
8 x 3.0 mL
8 x 3.0 mL
8 x 3.0 mL
1
Specifications
Feature Description
Concentration Available in three concentration levels named L1, L2 and L3 to cover the abnormal low, normal and abnormal high concentration range.
Parameter RBC, HGB, HCT, MCV, MCH, MCHC, RDW-SD, RDW-CV, MicroR, MacroR
PLT(-I), PLT-F*, PDW, PCT, MPV, P-LCR, IPF (%,#)*
WBC, WBC-D, WBC-P*, NEUT (%,#), LYMPH (%/#), MONO (%/#), EO (%,#), BASO (%,#), NRBC* (%/#), IG (%/#), HPC (%,#)*, AS-LYMP (%,#)*
RET(%,#), HFR, MFR, LFR, IRF, RET-He, RBC-He, Hypo-He, Hyper-He, RBC-O, PLT-O
* not on XN-L Series
Composition Stabilised human red blood cells, human white blood cells, a platelet and nucleated red blood cell component in a preservative medium.
Application on XN-Series and XN-L Series
Measurement mode
Control mode
Temperature of use
Room temperature
Storage 2-8°C before and after opening
Period of use 8 weeks per lot
Open vial stability 7 days if stored at 2 - 8 °C.
Volume 3.0 mL per vial
Dead volume 1.0 mL per vial
IFU
(package insert)
The package inserts for XN CHECK are enclosed to the product as paper sheets in four languages only (English, French, Spanish, Portuguese).
They are available in 23 languages for download on www.sysmex-europe.com/ifu. The clam shell labels of both products reflect that situation by displaying this website for download of package inserts.
Assay data Provided as assay mean and assay
Product Fact Sheet XN CHECK
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 05/01/2017 by Sandra Valdmanis - Page 2 / 2
range.
Assay files Assay data is provided in electronic format for each lot and level of XN CHECK on
CD-ROMs (for XN-Series)
USB sticks (for XN-L Series & XN-Series).
Assay data input Upload of assay data from assay CD-ROM (XN-Series) and assay USB stick (XN-L Series & XN-Series).
Manual data input by manual typing.
Manual bar code data input (for XN-L Series): read in assay data via the barcode reader
External QC:
SNCS IQAS Online
Sysmex is offering the Sysmex Network Communication System (SNCS), which is an Internet based platform for online services. Part of SNCS is IQAS Online, which is based on the use of XN CHECK and XN CHECK BF and provides external quality control to continuously monitor the XN and XN-L Series performance range. That includes all diagnostic parameters as well as purely technical parameters (sensitivity parameters).
Product Fact Sheet XN-10
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 30/11/2015 by Melanie Steffens - Page 1 / 2
Product Fact Sheet XN-10
Product name
XN-10 with the standard Clinical Value applications
Manufacturer information
Sysmex Corporation
www.sysmex-europe.com
Summary
As the analysis module of the XN-solution portfolio, the XN-10 delivers an efficient processing of the sample analysis. Its technical performance provides reliable and accurate test results by applying a maximum of six measurement channels. The XN-10 can process primary sample tubes in sampler and manual mode via the same aspiration line. Further, micro tube samples and body fluid samples (with the optional XN-BF application) can be measured in the manual mode immediately.
Article numbers
Instruments
Article no. Item Description Qty
AP795756 XN-10 complete Analysis module 1
Reagents for dilution*
Article no. Item Description Qty
AJ370801 CELLPACK DST
Concentrated diluent (politainer) for preparation by RPU
20 L
BQ505775 CELLPACK DST
Concentrated diluent (politainer) for preparation by RPU
10 L
CT661628 CELLPACK DCL Diluent (politainer) 20 L
CU228496 CELLPACK DCL Diluent (politainer) 10 L
* Either CELLPACK DCL or CELLPACK DST is connected
Reagents for XN-CBC
Article no. Item Description Qty
90411414 SULFOLYSER Lysing reagent (politainer) to detect HGB
5 L
AN577063
Lysercell WNR
Surfactant (paper pack) to detect WBC and NRBC
2x4 L
BL121531 Surfactant (politainer) to detect WBC and NRBC
5 L
CP066715 Fluorocell WNR Labelling reagent (cartridge) to detect WBC and NRBC
2x 82 mL
Reagents for XN-DIFF
Article no. Item Description Qty
AW993605
Lysercell WDF
Surfactant (paper pack) to obtain the WBC differential
2x4 L
AL337564 Surfactant (politainer) to obtain the WBC differential
5L
CV377552 Fluorocell WDF Labelling reagent (cartridge) to obtain the WBC differential
2x
42 mL
Reagents for XN-RET
Article no. Item Description Qty
BT965910 CELLPACK DFL Surfactant (paper pack) to detect RET and PLT
2x 1.5 L
BN337547 Fluorocell RET Labelling reagent (cartridge) to detect RET and PLT-O
2x
12mL
Reagents for XN-PLT-F
Article no. Item Description Qty
BT965910 CELLPACK DFL Surfactant (paper pack) to detect RET and PLT
2x 1.5 L
CD994563 Fluorocell PLT Labelling reagent (cartridge) to detect PLT-F
2x 12 mL
Product Fact Sheet XN-10
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 30/11/2015 by Melanie Steffens - Page 2 / 2
Quality control
Article no. Item Description Qty
213484 XN CHECK L1 Whole blood QC level 1 for XN
8 x 3 mL
213485 XN CHECK L2 Whole blood QC level 2 for XN
8 x 3 mL
213486 XN CHECK L3 Whole blood QC level 3 for XN
8 x 3 mL
213510 XN CHECK BF L1 and L2
Body fluid QC level 1 and 2 for XN
3 x 3 mL
213523 XN CAL Calibrator material
3 x 3 mL
Specifications
Feature Description
Number of diagnostic parameters*
Standard:
CBC+DIFF: 28
Optional:
RET: 7
PLT-F: 2
BF: 7
Number of research parameters*
Standard:
CBC+DIFF: 34
Optional:
RET: 15
PLT-F: 2
BF: 11
* For further details please refer to the Product Fact Sheets (PFS) on Added Values available on the Sysmex Extranet
Feature Description
Discrete mode profiles
Standard:
CBC (NRBC)
CBC (NRBC) + DIFF
Optionals (depending on the configuration):
CBC+RET
CBC+DIFF+RET
CBC+DIFF+RET+PLT-F
CBC+RET+PLT-F
CBC+PLT-F
CBC+DIFF+PLT-F
Body fluid
Sampling mode Standard:
Whole blood mode
Low WBC mode
Pre-dilution mode
Optional:
Body fluid mode
Aspiration volume
Sampler mode
Manual open mode
Manual closed mode
Pre-dilution mode
Micro analysis
Body fluid mode
88 µL
88 µL
88 µL
70 µL
88 µL (micro tube)
88 µL
Required sample volume
Whole blood mode:
Sampler mode
Manual closed
Manual open
Pre-dilution mode:
Manual open
Body fluid mode:
Manual closed
Manual open
1 mL
1 mL
300 µl (regular tube)
160 µl (micro tube)
300 µl (regular tube)
140 µl (micro tube)
1 mL
300 µl (regular tube)
160 µl (micro tube)
Operative temperature
15 °C to 30 °C
Operative humidity 30 % to 85 %
Power requirement AC 100 to 240 V (50/60 Hz)
Power consumption 270 VA or less
Reference: XN IFU EU 1105
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations. Last updated: 26/11/2015 - Page 1 / 2
Product Fact Sheet XN-20
Product name
XN-20 with the standard applications
Manufacture information
Sysmex Corporation
www.sysmex-europe.com
Summary
As the analysis module of the XN–solution portfolio, the XN-20 provides reliable and accurate test results by applying a maximum of seven measurement channels, including one dedicated to white precursor cells (WPC). The XN-20 can process primary sample tubes in sampler and manual mode via the same aspiration line. Micro tube samples and body fluid samples (with the optional XN-BF application) can be measured in the manual mode immediately.
Article numbers
Article no. Item Description Qty
AE97961 XN-20 complete Analysis module 1
Reagents for dilution*
Article no. Item Description Qty
AJ370801 CELLPACK DST
Concentrated diluent (politainer) for preparation by RPU
20 L
BQ505775 CELLPACK DST
Concentrated diluent (politainer) for preparation by RPU
10 L
CT661628 CELLPACK DCL Diluent (politainer) 20 L
CU228496 CELLPACK DCL Diluent (politainer) 10 L
* Either CELLPACK DCL or CELLPACK DST is connected
Reagents for XN-CBC
Article no. Item Description Qty
90411414 SULFOLYSER Lysing reagent (politainer) to detect HGB
5 L
AN577063
Lysercell WNR
Surfactant (paper pack) to detect WBC and NRBC
2x 4 L
BL121531 Surfactant (politainer) to detect WBC and NRBC
5 L
CP066715 Fluorocell WNR Labelling reagent (cartridge) to detect WBC and NRBC
2x 82 mL
Reagents for XN-DIFF
Article no. Item Description Qty
AW993605
Lysercell WDF
Surfactant (paper pack) to obtain the WBC differential
2x 4 L
AL337564 Surfactant (politainer) to obtain the WBC differential
5 L
CV377552 Fluorocell WDF Labelling reagent (cartridge) to obtain the WBC differential
2x 42 mL
Reagents for XN-RET
Article no. Item Description Qty
BT965910 CELLPACK DFL Surfactant (paper pack) to detect RET and PLT
2x 1.5 L
BN337547 Fluorocell RET Labelling reagent (cartridge) to detect RET and PLT-O
2x 12 mL
Reagents for XN-PLT-F
Article no. Item Description Qty
BT965910 CELLPACK DFL Surfactant (paper pack) to detect RET and PLT
2x 1.5 L
CD994563 Fluorocell PLT Labelling reagent (cartridge) to detect PLT-F
2x 12 mL
Product Fact Sheet XN-20
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 26/11/2015 by Melanie Steffens- Page 2 / 2
Reagents for XN-WPC
Article no. Item Description Qty
CS412800 Lysercell WPC Surfactant (paper pack) to be used in the WPC channel
2x 1.5 L
BU306227 Fluorocell WPC
Labelling reagent (cartridge) to be used in the WPC channel
2x 12 mL
Quality control
Article no. Item Description Qty
213484 XN CHECK L1 Whole blood QC level 1 for XN
8 x 3 mL
213485 XN CHECK L2 Whole blood QC level 2 for XN
8 x 3 mL
213486 XN CHECK L3 Whole blood QC level 3 for XN
8 x 3 mL
213510 XN CHECK BF L1 and L2
Body fluid QC level 1 and 2 for XN
3 x 3 mL
213523 XN CAL Calibrator material
3 x 3 mL
Specifications
Feature Description
Number of diagnostic parameters*
Standard:
CBC+DIFF: 28
Optional:
RET: 7
PLT-F: 2
BF: 7
Research parameters
Standard:
CBC+DIFF: 34
Optional:
RET: 15
PLT-F: 2
BF: 11
* For further details please refer to the Product Fact Sheets (PFS) on Added Values available on the Sysmex Extranet
Feature Description
Discrete mode profiles
Standard:
CBC (NRBC)
CBC (NRBC)+DIFF
CBC+RET
CBC+DIFF+RET
CBC+DIFF+RET+WPC
Optionals (depending on the configuration):
CBC+RET+PLT-F
CBC+DIFF+RET+PLT-F
CBC+DIFF+RET+PLT-F+WPC
CBC+PLT-F
CBC+DIFF+PLT-F
Body fluid
Sampling mode Standard:
Whole blood mode
Low WBC mode
Pre-dilution (PD) mode
Optional:
Body fluid mode
Aspiration volume
Sampler mode
Manual closed
Manual open
Pre-dilution mode
Micro analysis
Body fluid mode
88 µL
88 µL
88 µL
70 µL
88 µL (micro tube)
88 µL
Required sample volume
Whole blood mode:
Sampler mode
Manual closed
Manual open
Pre-dilution mode:
Manual open
Body fluid mode:
Manual closed
Manual open
1 mL
1 mL
300 µl (regular tube)
160 µl (micro tube)
300 µl (regular tube)
140 µl (micro tube)
1 mL
300 µl (regular tube)
160 µl (micro tube)
Operative temperature
15 °C to 30 °C
Operative humidity 30 % to 85 %
Power requirement AC 100 to 240 V (50/60 Hz)
Power consumption 270 VA or less
Reference: XN IFU EU 1105
Product Fact Sheet XN-1000
Sysmex Europe GmbH Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations. Last updated on 07/01/2015 by Claudia Dahmen - Page 1 / 3
Product Fact Sheet XN-1000 Pure
Product name
XN-1000 Pure
Manufacture information
Sysmex Corporation
www.sysmex-europe.com
Summary
The XN-1000 Pure provides the full flexibility of profiles in haematology testing. It targets at laboratories with small to medium workloads where 100 samples/h are suitable. The measurement of routine haematology profiles includes already advanced clinical parameters like nucleated red blood cells (NRBC) and immature granulocytes (IG). Equipped with an additional application for reticulocyte measurement, the XN RET APP, reticulocyte haemoglobin equivalent gives a complete picture and early prognosis of the patient’s erythropoesis by quality and quantity information.
The new XN-IPU (Information Processing Unit) eases operations, fully monitors the analyser performance 24/7 through continuous remote service and supports the accreditation of labs by ensuring i.e. full reagent traceability.
Productivity values
The first step into full automation: excellent productivity per square metre
Decreased TAT through potential reduction of smears by diagnostic applications
Clinical values
Standard routine testing supports detection of inflammations or infections and therapy monitoring of infections by reliably counted nucleated red blood cells (NRBC) and immature granulocytes (IG)
Using the optional RET application reliable diagnosis of anaemic patients based on the complete picture of the erythropoiesis by qualitative and quantitative information becomes standard and early prognosis of therapy monitoring can be realised by advanced clinical parameters and their combinations (e.g. RET-He, IRF)
Availabilty of results of high precision in clinically relevant concentration ranges and support in detection of inflammatory processes (e.g.by WBC-BF count
completed by PMN, MN) by using the optional BF mode
Configurations
No.
Name Application Description
1
XN-1000 [DIFF]
1 XN-10 unit with a non-reflex sampler for CBC+DIFF screening
Optional BF mode
2
XN-1000 [RET]
XN-10 unit with a non-reflex sampler for CBC+DIFF screening + RET
Product Fact Sheet XN-1000
Sysmex Europe GmbH Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations. Last updated on 07/01/2015 by Claudia Dahmen - Page 2 / 3
Optional BF mode
Main components
Article no. Item Description Qty
AP795756 XN-10 haematology unit
Unit for haematology screening testing for the configuration 1,2
1
CM660381 Non-reflex sampler for XN-1000
Sampler main unit to be connected with XN-10
1
AL898214 XN-1000 supply parts (SA-01)
IFU, cables, tubes etc. 1
01330061 Pneumatic unit
External pneumatic unit for XN instruments
1
3700037 Monitor arm Monitor arm to connect the IPU touch screen
1
37000088 XN IPU Instrument processing unit to operate the analyser
1
37000033 XN touch panel
Touch screen for XN IPU
1
Specifications
Feature Description
Diagnostics parameters (whole blood)
Up to 36 depending on the configuration (refer to “PFS_XN-10”)
Research parameters (whole blood)
Up to 42 depending on the configuration (refer to “PFS_XN-10”)
Diagnostics parameters (BF)
Up to 7 depending on the configuration (refer to “PFS_XN added value BF”)
Research parameters (BF)
Up to 11 depending on the configuration (refer to “PFS_XN added value BF”)
Scattergram & histogram
Up to 15 scattergrams
Up to 4 histograms
Discrete mode profiles
(refer to “PFS_XN-10”)
Technologies Fluorescence flow cytometry
Hydrodynamic focussed impedance measurement
Light emitting diode (LED) photometry
Adaptive cluster analysis system (ACAS) and special shape
recognition analysis of each WBC subpopulation
Throughput
CBC
CBC+DIFF
CBC+DIFF+RET
CBC+RET
Body Fluid analysis
Up to 100 samples/hour
Up to 100 samples/hour
Up to 83 samples/hour
Up to 83 samples/hour
Up to 40 samples/hour (BF modus only)
Sampler unit loading capacity
5 racks (50 samples)
STAT function Approx. 1 min by using the manual mode
Reagent management
Always available
Data storage
Analysis registration function
Samples (incl. graphics)
Patient information
Wards registered
Doctors names registered
Selective test orders
Quality control files
Reagent replacement history
Maintenance history
2,000 records
100,000 results (including histograms and scattergrams)
10,000 records
200 wards
2,000 records
12 discrete profiles (depending on the configuration)
99 files 300 plots x 94 files (L-J control)
300 plots x 5 files (XbarM control)
5,000 records
5,000 records
Product Fact Sheet XN-1000
Sysmex Europe GmbH Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations. Last updated on 07/01/2015 by Claudia Dahmen - Page 3 / 3
Dimension
Main unit (incl. sampler unit)
Pneumatic unit
520x 840x 680 mm (WxHxD)
280x400x355 mm (WxHxD)
Weight
Main unit (incl. sampler unit)
Pneumatic unit
Approx. 70 kg
Approx. 17 kg
QC functions
Xbar and or L-J
Xbar M
300 plots x 94 files (L-J control)
300 plots x 5 files (XbarM control)
Interface LP, DP, GP, host computer via LAN
Operative temperature
15 to 30 °C
Operative humidity
30 to 85 %
Power requirement
Main unit
Sampler
Pneumatic unit
AC 100 to 240 V (50/60 Hz)
AC 100 to 240 V +/-10 %
AC 220 to 240 V (50/60 Hz)
Power consumption
Main unit
Sampler
Pneumatic unit
270 VA or less
110 VA or less
50 Hz: 230 VA or less (100-117 V), 220 VA or less (220-240 V) 60 Hz: 280 VA or less (100-117 V), 250 VA or less (220-240 V)
Reference: XN-1000 IFU 1302
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 02/12/2016 by SVCMOSS - Page 1 / 3
Product Fact Sheet XN-350
Product name
XN-350
Manufacturer information
Sysmex Corporation
www.sysmex-europe.com
Summary
The XN-350 is a member of the XN-L Series and part of the XN-Class. Encompassing Sysmex Silent Design®, high levels of performance and operability and proven Sysmex technology, the XN-350 provides full flexibility of profiles in haematology testing.
Optional productivity values
Reliable analysis and accurate WBC counts including differentials for leucocytopenic samples in L-WBC measurement mode.
Decreased TAT by using the Speed-up application
due to increased throughput from 60 to 70 samples/hour.
Standard clinical values
Standard routine CBC and DIFF testing delivers a great range of clinically relevant parameters. The DIFF testing supports the detection of infections and provides guidance for diagnosis and therapy monitoring of infections by reliably counting immature granulocytes (IG).
Optional clinical values
Using the optional RET application, reliable diagnosis of anaemic patients, based on the complete picture of the erythropoiesis by qualitative and quantitative information becomes standard. Early prognosis for therapy monitoring can be realised by advanced clinical parameters and their combinations (e.g. RET-He, IRF). In addition, the RET application provides improved PLT count reliability due to an automated switching algorithm in the case of interferences such as RBC fragments, microcytic RBC or giant PLT etc.
Using the optional BF application, availability of results
with high precision in clinically relevant concentration ranges and support in detection of inflammatory processes (e.g.by WBC-BF count completed by PMN, MN) by using the optional BF mode becomes standard.
Main components
BOM Item Description Qty
SE000620 XN-350 XN-350 main unit including items listed in the table below
1
The following items are included in the BOM:
Article No. Item Description Qty
AW618382 XN-350 XN-350 main unit (excl.supply parts)
1
38000340 Handheld BR Gryphon
Handheld barcode reader (excl. cable for
1
Product Fact Sheet XN-350
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 02/12/2016 by SVCMOSS - Page 2 / 3
connection to instrument)
38000313 CAB-426 CABLE XN/XT/XS/UF-1000I
Cable for connection of handheld barcode reader to instrument
1
CE537607 XN-350/450 SUPPLY PARTS (EU)
Supply parts (for detailed content see IFU)
1
ZE000539 Perixx Keyboard PERIBOARD-505H PLUS [US]
Additional keyboard for service (international keyboard)
1
ZE000671
XN-L PRBC FLAG LICENCE
XN-L licence to activate the iRBC? Flag, which is mandatory on each XN-L analyser
1
ZE000544 XN-L INSTALLATION KIT
Installation kit (incl. ZE000537 XN-L EMBEDDED SOFTWARE-IPU MEDIAKIT, ZE000538 XN-L Labelling KIT)
1
Optional components
Article no. Item Description Qty
ZE000540 XN-L BF licence XN-L licence for the BF mode
1
ZE000541 XN-L RET licence
XN-L licence for the RET channel
1
ZE000542 XN-L L-WBC licence
XN-L licence for the low WBC mode
1
ZE000543 XN-L Speed-up licence
XN-L licence for higher throughput
1
ZE000583 AGED SAMPLE IDENTIFIER
XN-L software ASI Package, includes: ASI certificate, 3 APP stickers and a fixing template to place the stickers properly on the analyser
1
01330061 PU-17 COMPLETE 200V(white)
Additional pneumatic unit for use at high altitude
1
ZE000321 Extended IPU Media kit
SW to interlink all Sysmex workplaces to improve sample and data workflow
1
VS933AV Extended IPU server hardware Standard
Computer hardware for the Extended IPU server
1
XL510AV Extended IPU Computer hardware 1
client hardware for an Extended IPU client
XN375ATABB
Extended IPU TFT monitor
TFT monitor for Extended IPU server and client hardware
1
SE000893 Ext. IPU SQLSV
2012 STD RT 1 LIC 5 CAL
SQL Server Licence for Extended IPU; CAL licence package including licences for 5 CALs
1
ZE000902 Handheld BR GRYPHON Cordless complete
Handheld cordless barcode reader as alternative for 38000340
1
38000305 Gryphon Desk-/Wall Holder
Wall holder for handheld barcode reader 38000340
1
AK369883 Intake Tube ASSY NO. 12
For connecting 20 L CELLPACK DCL (politainer)
1
ZE000550 Spout Kit FOR 5L POLITAINER
For connecting 5 L Sulfolyser (politainer) and 5L Lysercell WDF (politainer)
1
CM915147 Intake Tube ASSY NO. 70
For connecting 4 L Lysercell WDF (paper pack) and 1.5 L CELLPACK DFL (paper pack)
1
Reagents
Article no. Item Qty
CU228496 CELLPACK DCL 10 L
05433514 SULFOLYSER 1 x 500 mL
90411317 SULFOLYSER 3 x 500 mL
BG689680 LYSERCELL WDF 1 x 2 L
AA325279 FLUOROCELL WDF 2 x 22 mL
83401621 CELLCLEAN 1 x 50 mL
CF579595 CELLCLEAN AUTO 20 x 4 mL
AR829995 CELLPACK DFL 1 x 1 L
CU920210 FLUOROCELL RET 2 x 12 mL
Quality control and calibration
Article no. Item Qty
213570 XN-L CHECK L1 6 x 3 mL
213571 XN-L CHECK L2 6 x 3 mL
213572 XN-L CHECK L3 6 x 3 mL
Product Fact Sheet XN-350
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 02/12/2016 by SVCMOSS - Page 3 / 3
213484 XN Check L1 8 x 3 mL
213485 XN Check L2 8 x 3 mL
213486 XN Check L3 8 x 3 mL
213510 XN Check BF 2 levels
3 x 3 mL
213523 XN CAL 3 x 3 mL
ZE000600 USB STICK XN-L CHECK 1
ZE000528
USB STICK
XN Check/XN Check BF
1
ZE000548 USB STICK XN CAL 1
Specifications
Feature Description
Standard parameters 28 Standard diagnostic parameters
WBC, RBC, HGB, HCT, MCHC, MCH, MCV, PLT, RDW-SD, RDW-CV, MPV, PDW, P-LCR, PCT, MicroR, MacroR
NEUT%, MONO%, EO%, BASO%, LYMPH%, IG%, NEUT#, MONO#, EO#, BASO#, LYMPH#, IG#
Optional parameters
18 Optional diagnostic parameters
RET%, RET#, IRF, LFR, MFR, HFR, RET-He, Delta-He, RBC-He, HYPO-He, and HYPER-He
WBC-BF, RBC-BF, PMN%, PMN#, MN%, MN#, TC-BF#
Research parameters 31 Research parameters
TNC, TNC-C, TNC-D, WBC-C, WBC-D, NE-SSC, NE-SFL, NE-FSC, NRBC #, NRBC %, HFLC#, HFLC%
FRC#, FRC%, RPI, RBC-O, HGB-O, MCHC-O, Delta-HGB,
PLT-O
HF-BF#, HF-BF%, NE-BF#, NE-BF%, LY-BF#, LY-BF%, MO-BF#, MO-BF%, EO-BF#, EO-BF%, RBC-BF-2
Technologies Fluorescence flow cytometry
Hydrodynamic focused
impedance measurement
SLS Haemoglobin method
Throughput
CBC
CBC+DIFF
CBC+RET
CBC+DIFF+RET
Body Fluid (BF) analysis
Up to 60 (70*1) samples/hour
Up to 60 (70*1) samples/hour
Up to 35 samples/hour
Up to 35 samples/hour
Up to 30 samples/hour (BF mode only) 1 – With optional Speed-up Licence
Aspiration volume
Manual mode
Low WBC mode
Pre-dilution mode
Body fluid mode
25 µL
25 µL
70 µL
70 µL
Data storage
Samples (incl. graphics)
Patient information
Wards registered
Doctors names registered
Calibration log
Quality control files
Analysis registration function
Reagent replacement history
Maintenance history
100,000 (including histograms and scattergrams)
10,000
200 wards
200 names
20 records
99 files (300 plots per file)
2,000 records
5,000 records
5,000 records
QC functions
Xbar and or L-J
XbarM
300 plots x 96 files (L-J control)
300 plots x 3 files (XbarM control)
Weight Approx. 35 kg
Dimensions Approx. 450 (W) x Approx. 460 (D) x Approx. 510 (H) mm
Interface RS-232C, 2x Ethernet (RJ45), 4x USB
Operating system Embedded Microsoft ® Windows 7 with McAfee Security
Operative temperature 15 to 35 °C
Operative humidity 20 to 85 %
Noise level 60dB or less
Power requirement AC 100 to 240 V (50/60 Hz)
Power consumption 235 VA
Reference: XN-L BO, GI & TS IFU 1606
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 02/12/2016 by SVCMOSS - Page 1 / 3
Product Fact Sheet XN-450
Product name
XN-450
Manufacturer information
Sysmex Corporation
www.sysmex-europe.com
Summary
The XN-450 is a member of the XN-L Series and part of the XN-Class. Encompassing Sysmex Silent Design®, high levels of performance and operability and proven Sysmex technology, the XN-450 provides full flexibility of profiles in haematology testing.
Optional productivity values
Reliable analysis and accurate WBC counts including differentials for leucocytopenic samples in L-WBC measurement mode.
Decreased TAT by using the Speed-up application
due to increased throughput from 60 to 70 samples/hour.
Standard clinical values
Standard routine CBC and DIFF testing delivers a great range of clinically relevant parameters. The DIFF testing supports the detection of infections and provides guidance for diagnosis and therapy monitoring of infections by reliably counting immature granulocytes (IG).
Optional clinical values
Using the optional RET application, reliable diagnosis of anaemic patients, based on the complete picture of the erythropoiesis by qualitative and quantitative information becomes standard. Early prognosis for therapy monitoring can be realised by advanced clinical parameters and their combinations (e.g. RET-He, IRF). In addition, the RET application provides improved PLT count reliability due to an automated switching algorithm in the case of interferences such as RBC fragments, microcytic RBC or giant PLT etc.
Using the optional BF application, availability of results
with high precision in clinically relevant concentration ranges and support in detection of inflammatory processes (e.g.by WBC-BF count completed by PMN, MN) by using the optional BF mode becomes standard.
Main components
BOM No. Item Description Qty
SE000621 XN-450 XN-450 main unit including items listed in the table below
1
The following items are included in the BOM:
Article No. Item Description Qty
BM392756
XN-450 XN-450 main unit (excl. supply parts)
1
38000340 Handheld BR Gryphon
Handheld barcode reader (excl. cable for
1
Product Fact Sheet XN-450
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 02/12/2016 by SVCMOSS - Page 2 / 3
connection to instrument)
38000313 CAB-426 CABLE XN/XT/XS/UF-1000I
Cable for connection of handheld barcode reader to instrument
1
CE537607 XN-350/450 SUPPLY PARTS (EU)
Supply parts (for detailed content see IFU)
1
ZE000539 Perixx Keyboard PERIBOARD-505H PLUS [US]
Additional keyboard for service (international keyboard)
1
ZE000671
XN-L PRBC FLAG LICENCE
XN-L licence to activate the iRBC? Flag, which is mandatory on each XN-L analyser
1
ZE000544 XN-L INSTALLATION KIT
Installation kit (incl. ZE000537 XN-L EMBEDDED SOFTWARE-IPU MEDIAKIT, ZE000538 XN-L Labelling KIT)
1
Optional Components
Article no. Item Description Qty
ZE000540 XN-L BF licence XN-L licence for the BF mode
1
ZE000541 XN-L RET licence
XN-L licence for the RET channel
1
ZE000542 XN-L L-WBC licence
XN-L licence for the low WBC mode
1
ZE000543 XN-L Speed-up licence
XN-L licence for higher throughput
1
ZE000583 AGED SAMPLE IDENTIFIER
XN-L software ASI Package, includes: ASI certificate, 3 APP stickers and a fixing template to place the stickers properly on the analyser
1
01330061 PU-17 COMPLETE 200V(white)
Additional pneumatic unit for use at high altitude
1
ZE000321 Extended IPU Media kit
SW to interlink all Sysmex workplaces to improve sample and data workflow
1
VS933AV Extended IPU server hardware Standard
Computer hardware for the Extended IPU server
1
XL510AV Extended IPU Computer hardware 1
client hardware for an Extended IPU client
XN375ATABB
Extended IPU TFT monitor
TFT monitor for Extended IPU server and client hardware
1
SE000893 Ext. IPU SQLSV
2012 STD RT 1 LIC 5 CAL
SQL Server Licence for Extended IPU; CAL licence package including licences for 5 CALs
1
ZE000902 Handheld BR GRYPHON Cordless complete
Handheld cordless barcode reader as alternative for 38000340
1
38000305 Gryphon Desk-/Wall Holder
Wall holder for handheld barcode reader 38000340
1
AK369883 Intake Tube ASSY NO. 12
For connecting 20 L CELLPACK DCL (politainer)
1
ZE000550 Spout Kit FOR 5L POLITAINER
For connecting 5 L Sulfolyser (politainer) and 5 L Lysercell WDF (politainer)
1
CM915147 Intake Tube ASSY NO. 70
For connecting 4 L Lysercell WDF (paper pack) and 1.5 L CELLPACK DFL (paper pack)
1
Reagents
Article no. Item Qty
CU228496 CELLPACK DCL 10 L
05433514 SULFOLYSER 1 x 500 mL
90411317 SULFOLYSER 3 x 500 mL
BG689680 LYSERCELL WDF 1 x 2 L
AA325279 FLUOROCELL WDF 2 x 2 mL
83401621 CELLCLEAN 1 x 50 mL
CF579595 CELLCLEAN AUTO 20 x 4 mL
AR829995 CELLPACK DFL 1 x 1 L
CU920210 FLUOROCELL RET 2 x 12 mL
Quality control and calibration
Article no. Item Qty
213570 XN-L CHECK L1 6 x 3 mL
213571 XN-L CHECK L2 6 x 3 mL
213572 XN-L CHECK L3 6 x 3 mL
Product Fact Sheet XN-450
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 02/12/2016 by SVCMOSS - Page 3 / 3
213484 XN Check L1 8 x 3 mL
213485 XN Check L2 8 x 3 mL
213486 XN Check L3 8 x 3 mL
213510 XN Check BF 2 levels
3 x 3 mL
213523 XN CAL 3 x 3 mL
ZE000600 USB STICK XN-L CHECK 1
ZE000528
USB STICK
XN Check/XN Check BF
1
ZE000548 USB STICK XN CAL 1
Specifications
Feature Description
Standard parameters (whole blood)
28 Standard diagnostic parameters
WBC, RBC, HGB, HCT, MCHC, MCH, MCV, PLT, RDW-SD, RDW-CV, MPV, PDW, P-LCR, PCT, MicroR, MacroR
NEUT%, MONO%, EO%, BASO%, LYMPH%, IG%, NEUT#, MONO#, EO#, BASO#, LYMPH#, IG#
Optional parameters
18 Optional diagnostic parameters
RET%, RET#, IRF, LFR, MFR, HFR, RET-He, Delta-He, RBC-He, HYPO-He, and HYPER-He
WBC-BF, RBC-BF, PMN%, PMN#, MN%, MN#, TC-BF#
Research parameters 31 Research parameters
TNC, TNC-C, TNC-D, WBC-C, WBC-D, NE-SSC, NE-SFL, NE-FSC, NRBC #, NRBC %, HFLC#, HFLC%
FRC#, FRC%, RPI, RBC-O, HGB-O, MCHC-O, Delta-HGB,
PLT-O
HF-BF#, HF-BF%, NE-BF#, NE-BF%, LY-BF#, LY-BF%, MO-BF#, MO-BF%, EO-BF#, EO-BF%, RBC-BF-2
Technologies Fluorescence flow cytometry
Hydrodynamic focused
impedance measurement
SLS Haemoglobin method
Throughput
CBC
CBC+DIFF
CBC+RET
CBC+DIFF+RET
Body Fluid (BF) analysis
Up to 60 (70*1) samples/hour
Up to 60 (70*1) samples/hour
Up to 35 samples/hour
Up to 35 samples/hour
Up to 30 samples/hour (BF mode only) 1 – With optional Speed-up Licence
Aspiration volume
Manual mode
Low WBC mode
Pre-dilution mode
Body fluid mode
25 µL
25 µL
70 µL
70 µL
Data storage
Samples (incl. graphics)
Patient information
Wards registered
Doctors names registered
Calibration log
Quality control files
Analysis registration function
Reagent replacement history
Maintenance history
100,000 (including histograms and scattergrams)
10,000
200 wards
200 names
20 records
99 files (300 plots per file)
2,000 records
5,000 records
5,000 records
QC functions
Xbar and or L-J
XbarM
300 plots x 96 files (L-J control)
300 plots x 3 files (XbarM control)
Weight Approx. 35 kg
Dimensions Approx. 450 (W) x Approx. 460 (D) x Approx. 440 (H) mm
Interface RS-232C, 2x Ethernet (RJ45), 4x USB
Operating system Embedded Microsoft ® Windows 7 with McAfee Security
Operative temperature 15 to 35 °C
Operative humidity 20 to 85 %
Noise level 60dB or less
Power requirement AC 100 to 240 V (50/60 Hz)
Power consumption 235 VA
Reference: XN-L BO, GI & TS IFU 1606
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 02/12/2016 by SVCMOSS - Page 1 / 4
Product Fact Sheet XN-550
Product name
XN-550
Manufacturer information
Sysmex Corporation
www.sysmex-europe.com
Summary
The XN-550 is a member of the XN-L Series and part of the XN-Class. Encompassing Sysmex Silent Design®, high levels of performance and operability and proven Sysmex technology, the XN-550 provides full flexibility of profiles in haematology testing. Additionally, the built-in Rerun & Reflex and Intelligent Rack Sampling functionalities provide a more streamlined workflow and a decrease in the sample turnaround time.
Standard productivity values
Superb performance and decreased TAT through an integrated IPU rule set for automated Rerun and Reflex testing
Decreased TAT through automatic measurement of
raised bottom tubes (RBT) by Intelligent Rack Sampling.
Optional productivity values
Reliable analysis and accurate WBC counts including differentials for leucocytopenic samples in L-WBC measurement mode.
Decreased TAT by using the Speed-up application
due to increased throughput from 60 to 70 samples/hour.
Standard clinical values
Standard routine CBC and DIFF testing delivers a great range of clinically relevant parameters. The DIFF testing supports the detection of infections and provides guidance for diagnosis and therapy monitoring of infections by reliably counting immature granulocytes (IG).
Optional clinical values
Using the optional RET application, reliable diagnosis of anaemic patients, based on the complete picture of the erythropoiesis by qualitative and quantitative information becomes standard. Early prognosis for therapy monitoring can be realised by advanced clinical parameters and their combinations (e.g. RET-He, IRF). In addition, the RET application provides improved PLT count reliability due to an automated switching algorithm in the case of interferences such as RBC fragments, microcytic RBC or giant PLT etc.
Using the optional BF application, availability of results
with high precision in clinically relevant concentration ranges and support in detection of inflammatory processes (e.g.by WBC-BF count completed by PMN, MN) by using the optional BF mode becomes standard.
Product Fact Sheet XN-550
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 02/12/2016 by SVCMOSS - Page 2 / 4
Main components
BOM No. Item Description Qty
SE000622 XN-550 XN-550 main unit including items listed in the table below
1
The following items are included in the BOM:
Article no. Item Description Qty
BD634545
XN-550 XN-550 main unit with 2 sampler adapter with the capacity of 10 samples each. (excl. supply parts)
1
38000340 Handheld BR Gryphon
Handheld barcode reader (excl. cable for connection to instrument)
1
38000313 CAB-426 CABLE XN/XT/XS/UF-1000I
Cable for connection of handheld barcode reader to instrument
1
AH172969
XN-550 SUPPLY PARTS (EU)
Supply parts (for detailed content see IFU)
1
ZE000539 Perixx Keyboard PERIBOARD-505H PLUS [US]
Additional keyboard for service (international keyboard)
1
ZE000671
XN-L PRBC FLAG LICENCE
XN-L licence to activate the iRBC? Flag, which is mandatory on each XN-L analyser
1
ZE000544 XN-L INSTALLATION KIT
Installation kit (incl. ZE000537 XN-L EMBEDDED SOFTWARE-IPU MEDIAKIT, ZE000538 XN-L Labelling KIT)
1
Optional Components
Article no. Item Description Qty
ZE000540 XN-L BF licence
XN-L licence for the BF mode
1
ZE000541 XN-L RET licence
XN-L licence for the RET channel
1
ZE000542 XN-L L-WBC licence
XN-L licence for the low WBC mode
1
ZE000543 XN-L Speed-up XN-L licence for 1
licence higher throughput
ZE000583 AGED SAMPLE IDENTIFIER
XN-L software ASI Package, includes: ASI certificate, 3 APP stickers and a fixing template to place the stickers properly on the analyser
1
01330061
PU-17 COMPLETE 200V(white)
Additional pneumatic unit for use at high altitude
1
ZE000321 Media kit Extended IPU
SW to interlink all Sysmex workplaces to improve sample and data workflow
1
VS933AV Extended IPU server hardware
Computer hardware for the Extended IPU server
1
XL510AV Extended IPU
client hardware
Computer hardware for an Extended IPU client
1
XN375ATABB Extended IPU
TFT monitor
TFT monitor for Extended IPU server
and client hardware
1
SE000893
Ext. IPU SQLSV 2012 STD RT 1 LIC 5 CAL
SQL Server Licence for Extended IPU;
CAL licence package including licences for 5 CALs
1
ZE000902
Handheld BR GRYPHON Cordless complete
Handheld cordless barcode reader as alternative for 38000340
1
38000305 Gryphon Desk-/Wall Holder
Wall holder for handheld barcode reader 38000340
1
AK369883 Intake Tube ASSY NO. 12
For connecting 20 L CELLPACK DCL (politainer)
1
ZE000550 Spout Kit FOR 5L POLITAINER
For connecting 5 L Sulfolyser (politainer) and 5 L Lysercell WDF (politainer)
1
CM915147 Intake Tube ASSY NO. 70
For connecting 4 L Lysercell WDF (paper pack) and 1.5 L CELLPACK DFL (paper pack)
1
Reagents
Article no. Item Qty
CU228496 CELLPACK DCL 10 L
Product Fact Sheet XN-550
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 02/12/2016 by SVCMOSS - Page 3 / 4
05433514 SULFOLYSER 1 x 500 mL
90411317 SULFOLYSER 3 x 500 mL
BG689680 LYSERCELL WDF 1 x 2 L
AA325279 FLUOROCELL WDF 2 x 22 mL
83401621 CELLCLEAN 1 x 50 mL
CF579595 CELLCLEAN AUTO 20 x 4 mL
AR829995 CELLPACK DFL 1 x 1 L
CU920210 FLUOROCELL RET 2 x 12 mL
Quality control and calibration
Article no. Item Qty
213570 XN-L CHECK L1 6 x 3 mL
213571 XN-L CHECK L2 6 x 3 mL
213572 XN-L CHECK L3 6 x 3 mL
213484 XN Check L1 8 x 3 mL
213485 XN Check L2 8 x 3 mL
213486 XN Check L3 8 x 3 mL
213510 XN Check BF 2 levels
3 x 3 mL
213523 XN CAL 3 x 3 mL
ZE000600 USB STICK XN-L CHECK 1
ZE000528
USB STICK
XN Check/XN Check BF
1
ZE000548 USB STICK XN CAL 1
Specifications
Feature Description
Standard parameters (whole blood)
28 Standard diagnostic parameters
WBC, RBC, HGB, HCT, MCHC, MCH, MCV, PLT, RDW-SD, RDW-CV, MPV, PDW, P-LCR, PCT, MicroR, MacroR
NEUT%, MONO%, EO%, BASO%, LYMPH%, IG%, NEUT#, MONO#, EO#, BASO#, LYMPH#, IG#
Optional parameters
18 Optional diagnostic parameters
RET%, RET#, IRF, LFR, MFR, HFR, RET-He, Delta-He, RBC-He, HYPO-He, and HYPER-He
WBC-BF, RBC-BF, PMN%, PMN#, MN%, MN#, TC-BF#
Research parameters 31 Research parameters
TNC, TNC-C, TNC-D, WBC-C, WBC-D, NE-SSC, NE-SFL, NE-FSC, NRBC #, NRBC %, HFLC#, HFLC%
FRC#, FRC%, RPI, RBC-O, HGB-O, MCHC-O, Delta-HGB,
PLT-O
HF-BF#, HF-BF%, NE-BF#, NE-BF%, LY-BF#, LY-BF%, MO-BF#, MO-BF%, EO-BF#, EO-BF%, RBC-BF-2
Technologies Fluorescence flow cytometry
Hydrodynamic focused impedance measurement
SLS Haemoglobin method
Throughput
CBC
CBC+DIFF
CBC+RET
CBC+DIFF+RET
Body Fluid (BF) analysis
Up to 60 (70*1) samples/hour
Up to 60 (70*1) samples/hour
Up to 35 samples/hour
Up to 35 samples/hour
Up to 30 samples/hour (BF mode only) 1 – With optional Speed-up Licence
Aspiration volume
Manual mode
Sampler mode
Low WBC mode
Pre-dilution mode
Body fluid mode
25 µL
25 µL
25 µL
70 µL
70 µL
Data storage
Samples (incl. graphics)
Patient information
Wards registered
Doctors names registered
Calibration log
Quality control files
Analysis registration function
Reagent replacement history
Maintenance history
100,000 (including histograms and scattergrams)
10,000
200 wards
200 names
20 records
99 files (300 plots per file)
2,000 records
5,000 records
5,000 records
QC functions
Xbar and or L-J
300 plots x 96 files (L-J control)
Product Fact Sheet XN-550
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.
Last updated on 02/12/2016 by SVCMOSS - Page 4 / 4
XbarM 300 plots x 3 files (XbarM control)
Weight
Main unit (incl. SU*)
Monitor
Approx. 53 kg
Approx. 3 kg
Dimensions
Main unit
Monitor
Approx. 450 (W) x Approx. 660 (D) x Approx. 450 (H) mm
Approx. 267 (W) x Approx. 205 (D) x Approx. 240 (H) mm
Interface RS-232C, 2x Ethernet (RJ45), 4x USB
Operating system Embedded Microsoft ® Windows 7 with McAfee Security
Operative temperature 15 to 35 °C
Operative humidity 20 to 85 %
Noise level 60dB or less
Power requirement
Main unit
AC 100 to 240 V (50/60 Hz)
Power consumption
250 VA
Reference: XN-L BO, GI & TS IFU 1606
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations. Last updated: 14/07/2011 - Page 1 / 2
Product Fact Sheet Added value for the body fluid analysis
Product name
Added value XN-BF
Manufacture information
Sysmex Corporation
www.sysmex-europe.com
Summary
The automated body fluid mode is dedicated to the analysis of CSF (cerebrospinal fluid), synovial, pleural, CAPD or ascites fluids.
A special prolonged counting sequence provides a precise count of nucleated cells also in lowest counting ranges such as applicable for CSF.
Productivity values
• Standardisation and reproducibility
• Reduction of manual chamber counts
• Reduction of cytospin smear preparation and analysis
• Convenient automatic measurement of a variety of body fluids without sample pre-treatment
• Fast analysis 24 hours per day, 7 days a week
Clinical values
• Results of high precision in clinically relevant concentration ranges
• Support in detection of inflammatory processes (e.g. by WBC-BF count completed by PMN, MN)
Article number
Article no. Item Description Qty
ZE000325 Media Kit BF Body fluid application kit 1
Specifications
Feature Description
Discrete mode Body fluid mode
Sampling mode Manual mode (open or closed)
Technologies Fluorescence flow cytometry
Diagnostic parameters 7
WBC-BF = White blood cell count (BF)
RBC-BF = Red blood cell count (BF)
TC-BF = Total cell count (BF)
MN# = Mononuclear cell count
PMN# = Polymorphonuclear cell count
MN% = Mononuclear cell percent
PMN% = Polymorphonuclear cell percent
Research parameters 11
HF-BF# = High fluorescence cell count (BF)
HF-BF% = High fluorescence cell percent (BF)
LY-BF# = Lymphocyte count (BF)
LY-BF% = Lymphocyte percent (BF)
MO-BF# = Monocyte count (BF)
MO-BF% = Monocyte percent (BF)
NEUT-BF# = Neutrophil count (BF)
NEUT-BF% = Neutrophil percent (BF)
EO-BF# = Eosinophil count (BF)
EO-BF% = Eosinophil percent (BF)
RBC-BF2 = Red blood cell count (BF) 2
Service parameters 4
Linearity (body fluid mode)
WBC-BF
RBC-BF
TC-BF#
Within ±0.010 x 103/µL (0.000 to 0.050 x
103/µL)
Within ±20.0% (0.051 to 10.000 x 103/µL,
RBC < 1.00 x 106/µL)
Within ±3.0% or within ±0.030 x 106/µL
(0.000 to 5.000 x 106/µL)
Within ±0.010 x 103/µL (0.000 to 0.050 x
103/µL)
Product Fact Sheet Added value for the body fluid analysis
Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations. Last updated: 14/07/2011 - Page 2 / 2
WBC-BF
RBC-BF
TC-BF#
MN#
PMN#
MN%
PMN%
Within ±20.0% (0.050 to 10.000 x 103/µL,
RBC < 1.00 x 106/µL)
r=0.9 or more, and within slope=1 ±0.3
r=0.8 or more, and within slope=1 ±0.3
r=0.9 or more, and within slope=1 ±0.3
r = 0.9 or more, and within slope=1 ±0.5
r = 0.9 or more, and within slope=1 ±0.5
r = 0.7 or more, and within slope=1 ±0.5
r = 0.7 or more, and within slope=1 ±0.5
Precision (body fluid mode)
WBC-BF
RBC-BF
TC-BF#
30.0% or less (0.005 to 0.015 x 103/µL)
15.0% or less (0.016 to 0.030 x 103/µL)
10.0% or less (0.031 to 0.050 x 103/µL)
40% or Max - Min ≤ 0.007 x 106/µL
(0.003 to 0.050 x 106/µL)
30.0% or less (0.005 to 0.015 x 103/µL)
15.0% or less (0.016 to 0.030 x 103/µL)
10.0% or less (0.031 to 0.050 x 103/µL)
Carry over (body fluid mode)
WBC-BF
RBC-BF
TC-BF#
0.3 % or 0.001 x 103/µL or less
0.3 % or 0.003 x 103/µL or less
0.3 % or 0.001 x 103/µL or less
Aspirated sample volume
88 µL
Required sample volume (micro tube)
160 µL
References: XN-series IFU version May 2011