scil Element HT5+ Manual de usuario
Vers.: 20230710ENG
Page 1
Element HT5+
User Manual
Vers.: 20230710ENG
Page 2
Table of content
1 Safety information....................................................................................................... 6
1.1 Labels and symbols on the system.......................................................................... 6
1.2 General safety messages.......................................................................................10
2 Understanding the analyzer...........................................................................................12
2.1 Intended use ..........................................................................................................12
2.2 Blood sample parameters, histograms and scattergrams.......................................12
2.2.1 Parameters...........................................................................................................12
2.2.2 Histograms......................................................................................................13
2.2.3 Scattergrams...................................................................................................13
2.3 Product description.................................................................................................13
2.4 Overview of the software interface .........................................................................17
2.5 Reagents, controls and calibrators.........................................................................18
2.5.1 Reagents.........................................................................................................19
2.5.2 Controls and calibrators ..................................................................................19
3 Understanding the system principles.............................................................................20
3.1 Introduction............................................................................................................20
3.2 WBC measurement by the SF Cube Cell Analysis technology...............................20
3.3 HGB measurement.................................................................................................21
3.3.1 Colorimetric method........................................................................................21
3.3.2 HGB................................................................................................................21
3.4 RBC, PLT and RET measurement .........................................................................21
3.4.1 RBC and PLT: Sheath flow impedance method...............................................21
3.4.2 PLT and RET: SF Cube Cell Analysis technology...........................................22
3.4.3 Derivation of RBC - related parameters...........................................................22
3.4.4 Derivation of PLT - related parameters............................................................23
3.4.5 Derivation of RET –related parameters ..........................................................24
4 Installing the analyzer....................................................................................................24
4.1 Introduction............................................................................................................24
4.2 Installation requirements ........................................................................................24
4.2.1 Space requirements........................................................................................24
4.2.2 Power requirements........................................................................................25
4.2.3 General environment.......................................................................................25
4.2.4 Moving and installing the analyzer...................................................................26
4.3 Connecting the analyzer system.............................................................................26
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4.3.1 Connection of the reagents.................................................................................26
4.3.2 Connection of the peripherals.............................................................................28
5 Operating the analyzer..................................................................................................29
5.1 Introduction............................................................................................................29
5.2 Initial checks...........................................................................................................30
5.3 Startup and login....................................................................................................30
5.4 Enter/exit from standby ..........................................................................................31
5.5 Sample collection and handling..............................................................................31
5.5.1 Sample preparation.........................................................................................32
5.5.2 Sample analysis..............................................................................................33
5.5.3 Processing analysis results.............................................................................34
5.6 Shutdown...............................................................................................................35
6 Reviewing sample results..............................................................................................36
6.1 Introduction............................................................................................................36
6.2 Browsing in the table review mode.........................................................................36
6.2.1 Table review....................................................................................................36
6.2.2 Graph review...................................................................................................37
6.2.3 Deleting a result..............................................................................................37
6.2.4 Editing information ..........................................................................................37
6.2.5 Searching a result...........................................................................................38
6.2.6 Calculating CV values.....................................................................................39
6.2.7 Printing results ................................................................................................39
6.2.8 Transmitting results (requires connection to LIS).............................................39
6.2.9 Exporting results (for administrators only) .......................................................39
6.2.10 Flags of analysis results..................................................................................40
7 Using the QC program...................................................................................................41
7.1 Introduction............................................................................................................41
7.2 QC program ...........................................................................................................42
7.2.1 Editing settings (for administrators only)..........................................................42
7.2.2 QC run ............................................................................................................42
7.2.3 Reviewing the results......................................................................................43
8 Calibrating the analyzer.................................................................................................44
8.1 Introduction............................................................................................................44
8.2 When to calibrate...................................................................................................44
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8.3 How to calibrate .....................................................................................................45
8.3.1 Preparing the analyzer....................................................................................45
8.3.2 Calibration with calibrator................................................................................45
8.3.3 Verifying calibration factors .............................................................................45
8.3.4 Calibration history (for administrator only).......................................................45
9 Customizing the analyzer software................................................................................46
9.1 Introduction ...................................................................................................................46
9.2 Setting up the analyzer..................................................................................................46
9.2.1 System setup ..................................................................................................46
9.2.2 User management...........................................................................................47
9.2.3 Manage animal type........................................................................................47
9.2.4 Auxiliary setup.................................................................................................47
9.2.5 Parameter setting (for administrators only)......................................................47
9.2.6 Maintenance setup (for administrators only)....................................................48
9.2.7 Reagent setup.................................................................................................48
9.2.8 Gain setup (for administrators only).................................................................48
9.2.9 Auto startup/shutdown time (for administrators only) ..........................................48
10 Servicing the analyzer...................................................................................................50
10.1 Introduction............................................................................................................50
10.2 Reagent management............................................................................................50
10.3 Maintaining the analyzer ........................................................................................54
10.4 Touchscreen calibration.........................................................................................56
10.5 Viewing and exporting logs.....................................................................................56
11 Troubleshooting the analyzer ........................................................................................57
11.1 Introduction............................................................................................................57
11.2 Error information and handling ...............................................................................57
12 Appendices ...................................................................................................................63
A. Specifications...............................................................................................................63
A.1 Classification..............................................................................................................63
A.2 Reagents....................................................................................................................63
A.3 Application tubes........................................................................................................63
B. Sampling features.........................................................................................................63
B.1 Sample volumes required for each analysis................................................................63
B.2 Throughput.................................................................................................................63
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C. Performance specifications ..........................................................................................64
C.1 Display range.............................................................................................................64
C.2 Background/blank count.............................................................................................64
C.3 Linearity Range..........................................................................................................64
C.4 Reproducibility............................................................................................................65
C.5 Carryover ...................................................................................................................66
D. Keyboard (optional)......................................................................................................66
E. External Barcode Scanner (optional)............................................................................66
F. Printer (optional)...........................................................................................................66
G. Interfaces.....................................................................................................................66
H. Power Supply...............................................................................................................66
I. Fuse...............................................................................................................................66
J. EMC description............................................................................................................67
K. Noise level....................................................................................................................67
L. Operating environment..................................................................................................67
M. Storage environment....................................................................................................67
N. Running environment...................................................................................................67
O. Dimensions and weight................................................................................................68
P. Contra-indications.........................................................................................................68
Q. Safety classification......................................................................................................68
Intellectual Property Statement.............................................................................................69
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1 Safety information
1.1 Labels and symbols on the system
The following symbols are used to indicate danger and alert information.
Symbols
Description
Biological hazard
General warning/caution sign
The statement is alerting you to an operating hazard that can
cause personnel injury (warning) or to a possibility of analyzer
damage or unreliable analysis results (caution).
Laser beam
Warning
The sample probe is sharp and potentially biohazardous. Exercise
caution when working around it.
Protective ground
On (power)
Off (power)
USB connection
Computer network
Alternate current
Serial number
Date of manufacture
Temperature limit
Humidity limitation
Atmospheric pressure limitation
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Symbols
Description
Fragile, handle with care
This way up
Keep dry
Do not roll
Stacking limit by number
The use of this symbol indicates that waste electrical and electronic
equipment must not be disposed of as unsorted municipal waste
and must be collected separately.
CE mark
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No
Description
1
Biological risk
2
The sample prob is sharp and potentially
biohazardous. Exercise caution when
working around it.
No
Description
1
Warning
Connect only to a properly earth grounded
outlet.
To avoid electrical shock, disconnect power
prior to maintenance.
2
Biological risk
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No
Description
1
Warning
To avoid personal injury do not put your hand
under the syringe or inside the slot.
2
Warning
To avoid personal injury do not put your hand
under the pipette or inside the slot.
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No
Description
1
Class 3b laser radiation when open and
internal locks defeated.
Avoid exposure to the beam.
2
Laser radiation
Avoid exposure to the beam.
Class 3B laser product
Peak power: 10mW
Wavelength: 635 nm
1.2 General safety messages
BIOHAZARD
•All the samples, controls, calibrators, reagents, waste and areas contacted by them are
potentially biohazardous. Wear proper personal protective equipment (e.g., gloves, lab
coat, etc.) and follow safe laboratory procedures when handling them and the contacted
areas in the laboratory.
•If the analyzer leaks, the leak liquid is potentially biohazardous.
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