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Section 1 Specifications: XT Series S/M
Section 1 Specifications: XT Series S/M
Section 1 Specifications: XT Series S/M
28
1.5.2 Calibration function .............................................................. 29
1.1 Outline.................................................................................. 1 1.5.3 Quality Control Function....................................................... 29
1.2 Name.................................................................................... 1 1.5.4 Online QC Function (option of SNCS installation) ................ 29
1.2.1 Name ..................................................................................... 1 1.5.5 Timer Function..................................................................... 30
1.2.2 Model ..................................................................................... 1 1.5.6 Analysis Order Registration Function (Work Load List
Function) ......................................................................................... 30
1.3 Shape, Structure and Dimensions........................................ 1
1.5.7 Sampler Unit Function ......................................................... 30
1.3.1 Configuration and Expansion to the system ........................... 1
1.5.8 Manual Mode Measurement Function .................................. 33
1.3.2 Electrical Rating ..................................................................... 3
1.5.9 Abnormal Numerical Value Monitor Function ....................... 33
1.3.3 Appearance, Dimensions and Weight .................................... 3
1.5.10 Analysis Result Storage Function ......................................... 33
1.4 Performance Characteristics ................................................ 7
1.5.11 Stored Data (Analysis Result) Processing Function.............. 33
1.4.1 Intended Use.......................................................................... 7
1.5.12 Stored Data Operation Function by Patient ID (Option) ........ 35
1.4.2 Analysis Mode and Throughput.............................................. 7
1.5.13 Patient Information Control Function (Option)....................... 35
1.4.3 Measurement, Analysis Parameters....................................... 9
1.5.14 Shut Down Function ............................................................. 36
1.4.4 Analysis and Display Range................................................. 12
1.5.15 Status of Main Unit Display Function .................................... 36
1.4.5 Reproducibility ..................................................................... 13
1.5.16 Error Monitor Function.......................................................... 36
1.4.6 Accuracy .............................................................................. 16
1.5.17 Error Alerting Function.......................................................... 37
1.4.7 Linearity ............................................................................... 17
1.5.18 Maintenance Function (User can operate) ............................ 37
1.4.8 Carryover ............................................................................. 19
1.5.19 Service Function................................................................... 38
1.4.9 Difference between Manual Mode and Sampler Mode ......... 20
1.5.20 On-Line Support Function (Option at joining SNCS) ............. 38
1.4.10 Stability .............................................................................. 21
1.5.21 Protection Function............................................................... 38
1.4.11 Within-a-Day Stability after Collection of Blood ..................... 23
1.5.22 Waste Tank Fluid Level Monitor Function (Option) ............... 38
1.4.12 Detection Sensitivity of Immature Cell................................... 25
1.6 Intended Use ...................................................................... 39
1.4.13 Required Reagent Volume ................................................. 26
1.6.1 Environmental Requirements ............................................... 39
1.5 Function ............................................................................. 28
1.6.2 Rated Voltage ...................................................................... 39
XT Series S/M
1.6.3 Grounding ............................................................................ 39
1.6.4 Reagents ............................................................................. 39
1.7 Storage and Transportation................................................ 40
1.7.1 Storage Condition ................................................................ 40
1.8 ACOUSTIC NOISE............................................................. 40
1.9 XT-2000iV/XT-1800iV Specifications ................................. 41
1.9.1 Outline ................................................................................. 41
1.9.2 PRODUCT NAME ................................................................ 41
1.9.3 System Configuration........................................................... 41
1.9.4 Functions ............................................................................. 41
1.9.5 Remarks .............................................................................. 42
XT Series S/M
January 7, 2009
SECTION 1 SPECIFICATIONS
1.3 SHAPE, STRUCTURE AND DIMENSIONS
1.2 NAME
(2) Option
1.2.1 Name
1) Sampler (50 samples)
AUTOMATED HEMATOLOGY ANALYZER 2) Built-in Bar Code Reader
3) Handy Bar Code Reader (local procurement)
4) Data Printer (Ticket Printer: DP-510 Compatible)
(Z-folder Printer: DP-490 Compatible)
1.2.2 Model 5) Color Graphic Printer
6) Laser Printer
XT-4000i 7) Patient Information Program (standard equipment on XT-4000i)
XT-2000i 8) Twin Program (Two Main Unit Connection) (standard equipment on
XT-1800i XT-4000i)
9) Color LCD Monitor
10) Rear Decorated Cover
*Specifications for Personal Computer is as follows:
・ CPU: Intel Pentium3, Pentium4, or Celeron
Clock frequency 733MHz or greater
(For Twin System: Pentium 4 and clock frequency 1.5GHz
or greater)
・ Memory: 128MB or greater
・ HDD: Size: 10GB or greater, I/F: ATA100 or greater
・ Auxiliary storage: CD-ROM Drive: 1 unit
XT Series S/M 1-1
January 7, 2009
Figure 1 Interface
50Hz or 60Hz
It is shown below.
1.4 PERFORMANCE CHARACTERISTICS Table 3 Sample Aspiration Mode, Discrete Mode, and Throughput
Reportable
Screen
Research
Whole Blood Capillary
for North
America
RET*
Parameter Remarks
CBC
DIFF
CBC
RET*
White Blood Cell Count (WBC) X - - X - X X
CBC Red Blood Cell Count (RBC) X - - X - X X
Parame Hemoglobin (HGB) X - - X - X X
ters Hematocrit (HCT) X - - X - X X
Mean Corpuscular Volume (MCV) X - - X - X X
Mean Corpuscular Hemoglobin (MCH) X - - X - X X
Mean Corpuscular Hemoglobin X - - X - X X
Concentration (MCHC)
Platelet Count (PLT) X - - X - X X *When RET is ordered, PLT-O at RET
channel or PLT is selected and displayed.
RBC Distribution Width (RDW-SD, X - - - - X X
RDW-CV)
Platelet Distribution Width (PDW) X - - - - - X
Mean Platelet Volume (MPV) X - - - - X X
Platelet -Large Cell Ratio (P-LCR) X - - - - - X
Plateletcrit (PCT) X - - - - - X
DIFF Neutrophil Percent (NEUT%) - X - - - X X
Parame Lymphocyte Percent (LYMPH%) - X - - - X X
ters Monocyte Percent (MONO%) - X - - - X X
Eosinophil Percent (EO%) - X - - - X X
Basophil Percent (BASO%) - X - - - X X
Neutrophil Count (NEUT#) - X - - - X X
Lymphocyte Countt (LYMPH#) - X - - - X X
Reportable Research
NO. Parameter Remarks
CBC DIFF RET screen
Basophil Count (BASO#) - - Residual or Residual ratio at specific concentration should be within the
following range.
Reticulocyte Ratio* (RET%) 1) r=0.90 or more +/- 30% or within
2)+/- 20% or +/- 0.5RET% Table 10 Linearity
0.3RET% Parameters Linearity
Reticlulocyte (RET#) 1) r=0.90 or more +/-30% or within Whole Blood Capillary Condition
Count* +/-20% or within +/-2.5X104/µL Mode mode
+/-1.5X104/µL White Blood (WBC) +/-3% or within +/-5% or 0-1000X102/µL
Red Blood Cell (RBC-O) (Unreportable (Unreportable Cell +/-3.0X102/µL within
Optical* parameter for parameter for +/-5.0X102/µL
research purpose) research purpose) Red Blood (RBC) +/-3% or within +/-6% or 0-800X104/µL
4
Low Fluorescence (LFR) +/- 30% or within Not Measured Cell +/-3.0X10 /µL within
Ratio* +/- 10LFR% +/-6.0X104/µL
Middle (MFR) +/- 30% or within Not Measured Hemoglobin (HGB) +/- 2% or within +/- 7% or 0.0-25.0 g/dL
Fluorescence +/- 10MFR% Concentration +/- 0.2g/dL within +/-
Ratio* 0.7g/dL
High Fluorescence (HFR) +/- 30% or within Not Measured Hematocrit (HCT) +/- 30% or +/- 6% or 0.0-60.0
Ratio* +/- 5HFR% within +/- within +/- HCT%
Immature (IRF) +/- 30% or within Not Measured 1HCT% 2.0HCT%
Reticulocyte 0.5IRF% Mean (MCV) Variation of - RBC approx.
Fraction* January 7, 2009 Corpuscular RBC 450X104/µL or
Platelet Optical* (PLT-O) 1) r=0.90 or more Within +/- 15% (erythrocyte) concentration 200<RBC<700
2) Within +/- 7% volume should be within ×104/µL
WBC-BF** +/- 2fL
RBC-BF** Mean (MCH) - - -
Corpuscular
*XT-2000i only
Hemoglobin
**XT-4000i only
Mean (MCHC) - - -
Corpuscular
Hemoglobin
Concentration
(3) RET channel parameters (RET#, RET%, RBC-O, PLT-O, LFR, MFR,
HFR, IRF)(XT-2000i only)
Difference values of healthy person's RET channel parameters
obtained from immediately after collection of blood to 24 hours
compared with standard instrument at Scientific Division (R-3500)
should be within following range. About analysis parameters,
difference from average becomes estimated value.
XT-2000i
Abnormal Normal
Abnormal TP FN
eye count
method Normal : FP TN
(Condition)
Accorded flag (e.g Blast flag for Blast sample) is not estimated. CBC+RET 34.0 2.0 0.0 0.0 0.02 2.0 0.5 0.0 38.5
Single measurement (sampler)
CBC 42.0 2.0 0.0 0.0 0.000 0.0 0.5 0.0 33.5
CBC+DIFF 44.0 2.0 2.0 0.04 0.0 0.0 0.5 0.0 37.5
CBC+DIFF+RET 46.0 2.0 2.0 0.04 0.02 2.0 0.5 0.0 41.6
CBC+RET 45.0 2.0 0.0 0.0 0.02 2.0 0.5 0.0 38.5
Single measurement (Manual)
CBC 41.0 2.0 0.0 0.0 0.000 0.0 0.5 0.0 33.5
CBC+DIFF 43.0 2.0 2.0 0.04 0.0 0.0 0.5 0.0 37.5
CBC+DIFF+RET 45.0 2.0 2.0 0.04 0.02 2.0 0.5 0.0 41.6
CBC+RET 44.0 2.0 0.0 0.0 0.02 2.0 0.5 0.0 38.5
Start up 114.0 6.0 6.0 0.06 0.06 6.0 1.5 0.0 134.0
Auto rinse 114.0 6.0 6.0 0.06 0.06 6.0 1.5 0.0 134.0
(background check
once)
Auto rinse 149.0 8.0 8.0 0.08 0.08 8.0 2.0 0.0 176.0
(background check
twice)
Resume from sleep 0 0 0 0 0 0 0 0 0
(less than 15 min.)
Resume from sleep 1.0 0 0 0 0 0 0 0 1.0
(more than 15 min.)
Resume from sleep 114.0 6.0 6.0 0.06 0.06 6.0 1.5 0.0 134.0
(more than 3 hours)
Shutdown 95.0 0 0 0 0 0 0 3.0 98.0
Remove Flow Cell Air 10.0 0 0 0 0 0 0 0 10.0
Bubble
Clean Flow Cell 50.0 0 0 0 0 0 0 1.5 51.5
*XT-2000i only
User can calibrate instrument. (1) Quality Control Method and Quality Control File
Table 19 Quality Control Method and Quality Control File
(1) Calibration Method and Parameters
Table 18 Calibration Method and Parameters Analysis Measurement
Point
File
Name level Lot Numb
Mode Mode Number
er
WBC RBC HGB HCT PLT PLT-O 1, 2, OPEN Current 300
Auto Calibration - - X X - - e-CHECK e-CHECK 12
X Control 3 CLOSE New /Lot
Manual Calibration - - X X - - or OTHER1
Human
-
OPEN Current 300
4
Calibration by X X X X X X L-J Blood CLOSE New /Lot
Calibrator Control Human OPEN Current 300
OTHER2 - 4
Blood CLOSE New /Lot
XM (Human
(2) Auto Calibration Xbar-M
Blood)
- - - 300 1
Control
Instrument is calibrated by automatically calculated compensation
ratio obtained from analysis results on instrument.
(2) Input/Output of Quality Control Data
(3) Manual Calibration It's possible to store/read all Quality Control Data to FD.
Instrument is calibrated by manually entered compensation ratio.
(3) Input/Output of Quality Control File
(4) Calibration by Calibrator (North America only) It's possible to install Quality Control File Storage program (Sysmex
Instrument is calibrated by automatically calculated compensation Insight).
ratio obtained from analysis results of SCS-1000.
(4) Output of Quality Control Data
(5) Precision Check (North America only) It's possible to output Quality Control Data to following equipment.
Reproducibility of instrument is checked to confirm if calibration by ・ Data Printer (DP) (as for stored data function)
calibrator is possible. ・ Color Graphic Printer (GP)
・ Laser Printer (LP)
(6) Calibration History Storage Function ・ Host Computer
10 Calibration Histories are stored.
Presence
ON Error history is remained,
15mm Approx. 1.0 to 7mL left at room temperature with NG and it conforms to Sampler
in 4 hours Stop Setting.
12mm Approx. 1.0 to 5mL left at room temperature with O OFF Analysis is performed.
in 4 hours N
Blood is not aspirated and
None.
(4) Monitor Function Presence error history is remained, and
-
1) Blood Volume Monitor it conforms to Sampler Stop
Above appropriate blood volume is monitored, and if blood volume Setting.
is less than appropriate volume, it's judged as No Blood. G Analysis is performed.
2) Blood Collection Tube Monitor Error history is remained,
ON
It's monitored if blood collection tube is set at sample rack. OFF NG and it conforms to Sampler
3) Blood aspiration Monitor Stop Setting.
It has a function that monitors if blood was aspirated (Blood OFF Analysis is performed.
Aspiration Sensor Function). None. - - It skips analysis.
4) Relation of Monitor with Operation
The relation of monitoring result with operation is shown below.
(5) Abnormally Low Value Monitor Function
Counting result is monitored if it is abnormally low value, and if it is
abnormal, error history is remained and sampler operation conforms
to sampler stop setting.
(1) Blood Collection Tube and Sample (1) Abnormal Value (Patient Limit)
1) Blood Collection tube Normal range (Upper and Lower limits) of each parameter can be
Overall length of the blood collection tube is less than 80mm. set and monitored.
2) Sample If patient information program (option) is installed, normal range for
Whole blood mixed enough each condition of age and sexuality can be set.
(1) Patient ID Ragistration Function When patient ID function is added, additional function that can store and
1) Contents of Registration control Patient Information associated with Patient ID.
Patient ID: 16 characters
*Character Number counts half size character(1 byte character). (1) Registration Number
2) Input, Edit 5,000 peoples
Input or edit operation is possible at IPU during input of Work Load
List or edit stored sample(before validation). (2) Contents of Registration
3) Output 1) Patient Name 40 Characters
It's outputted when stored sample is displayed and external output 2) sexuality 1 Character
is performed. 3) Birthday 8 Characters
4) Doctor Name 20 Characters
(2) Previous Data Check Function 5) Ward 20 Characters
Previous analysis data can be checked based on Patient ID. 6) Comment 100 Characters
*Character Number counts half size character(1 byte character).
(3) Cumulative Screen Display Function
Cumulative screen can be displayed based on Patient ID. (3) Input, Edit
Input or edit operation is possible at IPU. And, It's possible to input
with Patient ID transfered from Host Computer.
(4) Display
It's possible to display on IPU screen.
Rinsing of instrument is performed, and power of Main Unit can be Status of instrument is monitored, and alarm sounds when error occurs.
turned OFF.
(1) Monitored Parameter
(1) Start Up of Shut Down 1) Pressure
1) Selection of Shut Down Mode 2) Reagent Level
After shut down mode is selected, it proceeds next step. (It's 3) Fluid Level in the Waste Chamber
possible to cancel.) 4) Sample Aspiration Syringe Operation
2) Starting Shut Down 5) Sheath Syringe Operation
User aspirates CELLCLEAN by same operation as starting Manual 6) Manual Rinse Cup Operation
Mode Analysis. 7) Temperature
(a) Reagent Heater Temperature
(2) Shut Down Operation (b) Reaction Unit Temperature
Rinsing of manual whole blood line, CP whole blood line, and (c) FCM Detector Temperature
measurement line are performed. 8) FCM Detector Laser Power
9) DC Sheath Flow Detector Clog
(3) Output 10) DC Sheath Flow Detector Air Bubbles
Message that shows power of Main Unit can be turned OFF is 11) HGB Measurement Status
displayed on the IPU screen. 12) Main Unit System (Control Unit) check (at Start Up)
And, re-start up operation of Main Unit is possible. 13) Host Connection Status
14) Main Unit Connection Status
15) Sampler Unit Operation
1.5.15 Status of Main Unit Display Function 16) Sampler Unit Left Rack Pool Status
17) CP Unit Operation
Status of Main Unit (Standby, Analysis Mode, Error, and so on)is 18) Built -in Barcode Reader
displayed with instrument name on the IPU screen. (a) Read Error
(b) Communication
And so on.
1.5.17 Error Alerting Function 1.5.18 Maintenance Function (User can operate)
Alerting is performed when error occurs. User can perform following maitenance function.
Parameter Range
WBC 1.0X102/uL or less
DIFF WBC 2.0X102/uL or less
RBC 2X104/uL or less
HGB 0.1g/dL or less
PLT 0.5X104/uL or less
RBC-O* 3.0X104/uL or less
PLT-O* 1.0X104/uL or less
WBC-BF** 0.01X102/uL or less
RBC-BF** 0.3X104/uL or less
*XT-2000i only
**XT-4000i only
2) Reagent Exchange Sequence
3) Flow Cell Rinse Seuence
4) Flow Cell Bubble Removal Sequence
5) RBC Detector Clog Removal Sequence
And so on.
(1) Ambient Temperature:15 to 30°C (The reagent temperature should (2) STROMATOLYSER-4DL
also be within this range.)
(3) STROMATOLYSER-4DS
(2) Relative Humidity: 30 to 85%
(4) SULFOLYSER (500mL)
(3) Atmospheric Pressure: Normal Pressure
(5) STROMATOLYSER-FB(II)
(4) Installation Condition: Avoid installation in a place where the
instrument may be exposed to direct sunlight, dust, vibration, or acid. (6) RET SEARCH(II) (Diluent, Stain) (XT-4000i/XT-2000i only)
1.6.3 Grounding
1.7.1 Storage Condition 55 dB or less during ready status and operation excepting the following
noises:
・ Ambient Temperature: -10 to 60℃ (1) Draining noise of Rinse Cup
・ Relative Humidity: 30 to 95% (no condensation)
・ Atmospheric Pressure: 70 to 106kPa (2) Sample rack moving noise
Instrument is designed to withstand the above conditions. However,
store it at amormaltemperature and normal humidity, in a place (3) Noise of releasing and clamping sample tubes
where it is not exposed to direct sunlight, if possible.
(4) Alarm sound