Hycount 3N VET Operation Manual
Hycount 3N VET Operation Manual
USER'S MANUAL
About this Manual
Release Date: June 2017
Item No.: L00.2017032506
Statement
This manual will help you understand the operation and maintenance
of the product better. It is reminded that the product shall be used strictly
complying with this manual. User’s operation failing to comply with this
manual may result in malfunction or accident for which the
manufacturer cannot be held liable.
The manufacturer owns the copyrights of this manual. Without prior
written consent of the manufacturer, any materials contained in this
manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to
confidential information such as technical information and patent
information are contained in this manual, the user shall not disclose
such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him,
expressly or implicitly, any right or license to use any of the intellectual
properties of the manufacturer.
The manufacturer reserves the right to modify and update this manual
without prior notice.
The manufacturer reserves the final explanation right to this manual.
Warning
This system can only be operated by test professionals, doctors, lab
workers or personnel for system maintenance and troubleshooting, who
have been trained by the manufacturer.
It is important for the hospital or organization that employs this
equipment to carry out a reasonable maintenance schedule. Neglect of
this may result in machine breakdown or injury of human health.
I
Make sure to use the instrument under the provisions of this Operation
Manual. Otherwise, the instrument may not work normally, the test
result is unreliable and it may damage the instrument parts and
endanger people’s safety.
II
Safety notice
To operate the instrument safely and effectively, be sure to read the
following notices first. Operating the instrument, without following the
appointed methods of the manufacturer, may break down the defensive
function of the system, and cause bodily injury or damage the
instrument.
• Avoid electric shock
1) When the power is on, the unauthorized maintenance personnel
should not open the instrument.
2) If liquid enters into the instrument or the instrument has leakage,
please shutoff the power immediately, and contact the Customer
Service Department of the manufacturer or your local distributor in due
course. Improper use of the liquid may cause electric shock and result
in damaging the instrument.
• Defense for biohazard and chemical hazards
Improper use of the sample may result in being infected.
Avoid hand touch the sample, reagent and waste directly. When
operate the instrument, be sure to wear gloves to avoid being infected.
If the skin touched the sample, manage it according to operator working
standard or inquiring a doctor to take remedial measures immediately.
Use the reagent carefully to avoid hand and clothes touch directly.
Once hand or clothes touch, flush the touched area with soap and
plenty of water immediately.
If the reagent enters into the eyes incautiously, flush with plenty of water
at once, and inquire a doctor for further treatment.
Be sure not to use flammable dangerous materials around the
instrument.
Reagents, quality control serum, some materials in the sample are
controlled by Pollution Regulations and Standard for Discharge of
Pollutants. Please abide by the local discharge regulation and inquire
III
related reagent manufacturer.
• Prevention of fire and explosion
Operation notice
To operate the instrument safely and reliably, be sure to obey the
following notices.
• Purpose
Pay attention to the application range of the instrument. Make sure your
use does not exceed the application range.
• Limitation of operating environment
The instrument should be installed according to the required installation
environment of the manual. Installation and use out of the appointed
range may cause unreliable results, and make the instrument damaged.
Contact the Customer Service Department of the manufacturer or your
local distributor if you need to change the state of the instrument.
• Limit of operator
Only personnel trained and authorized by the manufacturer can operate
the instrument.
• Maintenance and service
Be sure to service and maintain the instrument according to this manual
strictly.
IV
Table of Contents
Chapter 1 Instrument Introduction ................................................... 1
1.1 Composition ................................................................................ 1
1.1.1 Host ...................................................................................... 1
1.1.2 Accessory ............................................................................. 1
1.2 Purpose ....................................................................................... 2
1.3 Specifications .............................................................................. 3
1.4 Structure .................................................................................... 10
1.4.1 Front Panel ......................................................................... 10
1.4.2 Rear Panel.......................................................................... 11
1.5 Operation .................................................................................. 11
1.5.1 Display Screen ................................................................... 12
1.5.2 Menu................................................................................... 12
1.6 Detection Principle .................................................................... 15
1.6.1 Detection Principles of WBC, RBC and PLT ...................... 15
1.6.2 Detection Principle of HGB................................................. 16
1.6.3 Volume Distribution of Blood Cell ....................................... 16
1.6.4 Results and Calculation of Parameter Measurement ........ 17
Chapter 2 Installation ....................................................................... 19
2.1 Package .................................................................................... 19
2.2 Unpack ...................................................................................... 19
2.3 Installation Requirements ......................................................... 19
2.4 Reagent Tubing Connection ..................................................... 21
2.4.1 Lyse Connection ................................................................. 21
2.4.2 Diluent Connection ............................................................. 21
2.4.3 Waste Connection .............................................................. 21
2.5 Recorder Paper Installation ...................................................... 23
2.6 Keyboard and Mouse Installation.............................................. 23
2.7 Printer Installation (Optional) .................................................... 23
2.8 Power Cable Connection .......................................................... 24
V
Chapter 3 Sample Analysis ............................................................. 25
3.1 Preparation before Startup ........................................................ 25
3.2 Startup ....................................................................................... 25
3.2.1 Function .............................................................................. 26
3.3 Background Test ....................................................................... 30
3.4 Quality Control .......................................................................... 32
3.5 Preparation for Sample Collection ............................................ 32
3.5.1 Venous Blood Collection .................................................... 32
3.5.2 Capillary Blood Collection .................................................. 32
3.5.3 Prepare Samples in Prediluted Mode ................................ 33
3.5.4 Prepare Samples in Capillary Mode ................................... 33
3.5.5 Sample Homogenization .................................................... 33
3.6 Sample Count and Analysis ...................................................... 34
3.6.1 Sample Information Input ................................................... 34
3.6.2 Procedures of Sample Count and Analysis........................ 36
3.6.3 Parameter Alarm ................................................................ 36
3.6.4 Histogram Alarm ................................................................. 36
3.7 Analytical Results Modification ................................................. 37
3.8 Shutdown .................................................................................. 39
Chapter 4 Quality Control ................................................................ 41
4.1 Edit Quality Control Files .......................................................... 41
4.2 Quality Control Run ................................................................... 43
4.3 Quality Control Graph ............................................................... 44
4.4 Quality Control List .................................................................... 46
Chapter 5 Calibration ....................................................................... 48
5.1 Operator Calibration .................................................................. 49
5.1.1 Background Test ................................................................ 49
5.1.2 Assurance of Repeatability................................................. 49
5.1.3 Calculate Calibration Factors ............................................. 50
5.1.4 Modify Calibration Factors.................................................. 50
VI
5.2 Auto Calibration......................................................................... 51
Chapter 6 Setting .............................................................................. 54
6.1 Date & Time .............................................................................. 54
6.2 Printout ...................................................................................... 55
6.3 Control ....................................................................................... 56
6.4 Limits ......................................................................................... 59
6.5 Department Information ............................................................ 60
6.5.1 Add record information ....................................................... 61
6.5.2 Print department information .............................................. 62
6.6 Operator Information ................................................................. 62
6.6.1 Add operator information .................................................... 63
6.6.2 Print operator information ................................................... 64
Chapter 7 Review .............................................................................. 65
7.1 Sample Review ......................................................................... 65
7.2 Detail Review ............................................................................ 68
Chapter 8 Service ............................................................................. 71
8.1 Flush ......................................................................................... 71
8.2 Enhanced Flush ........................................................................ 71
8.3 Cleaning .................................................................................... 72
8.4 Prime Chamber Outside ........................................................... 72
8.5 Drain Chambers ........................................................................ 72
8.6 Drain All ..................................................................................... 72
8.7 Prime Diluent ............................................................................. 72
8.8 Prime Lyse ................................................................................ 72
8.9 Prime ......................................................................................... 72
8.10 Maintenance............................................................................ 72
8.11 Mechanic ................................................................................. 72
VII
8.12 Special .................................................................................... 74
Chapter 9 Maintenance .................................................................... 75
9.1 Routine Maintenance ................................................................ 75
9.1.1 Clean the appearance ........................................................ 75
9.1.2 Replace fuse ...................................................................... 75
9.2 Daily Maintenance..................................................................... 76
9.3 Weekly Maintenance ................................................................. 76
9.4 Monthly Maintenance ................................................................ 77
9.5 Yearly Maintenance .................................................................. 77
9.6 Maintenance before Transport or for the Instrument that will not
be used for a long time.................................................................... 77
Chapter 10 Troubleshooting ............................................................ 79
10.1 Abnormal Startup .................................................................... 79
10.2 Waste Full ............................................................................... 79
10.3 Diluent Empty .......................................................................... 79
10.4 Lyse Empty ............................................................................. 79
10.5 WBC Clog or RBC Clog .......................................................... 80
10.6 HGB Error ............................................................................... 80
10.7 HGB Bubbles .......................................................................... 80
10.8 Recorder out of Paper ............................................................. 80
10.9 Recorder too Hot ..................................................................... 81
10.10 The Result of Background Test too high .............................. 81
Chapter 11 Help ................................................................................ 82
Appendix 1 Symbol .......................................................................... 83
Appendix 2 Specification ................................................................. 85
A 2.1 Reagent ................................................................................. 85
A 2.2 Parameter Information ........................................................... 85
VIII
A 2.3 Sampling Characteristics ....................................................... 87
A 2.4 Performance Index ................................................................ 87
A 2.5 Background Range ................................................................ 88
A 2.6 Linear Range ......................................................................... 88
A 2.7 Repeatability Index ................................................................ 89
A 2.8 Pollution Rate ........................................................................ 90
A 2.9 Input / Output ......................................................................... 90
IX
Chapter 1 Instrument Introduction
1
Chapter 1 Instrument Introduction
1.2 Purpose
This analyzer is used for detecting the parameters of RBC, WBC, HGB
and differential counting. The following 20 parameters and 3 histograms
of blood can be obtained from the analysis.
Hematocrit HCT %
2
Chapter 1 Instrument Introduction
Concentration
Plateletcrit PCT %
WBC
White Blood Cell Histogram
Histogram
RBC
Red Blood Cell Histogram
Histogram
Table 1-1
1.3 Specifications
• Standard Classification of the Instrument
According to anti-electrical shock hazard: Grade II, Pollution 2
According to the defence for deleterious liquid: General Device (Closing
device of non-defensive liquid)
3
Chapter 1 Instrument Introduction
Table 1-2
Derived from Histograms:
4
Chapter 1 Instrument Introduction
Mean Corpuscular
MCV fL
(erythrocyte) Volume
Table 1-3
Calculated Parameters:
Hematocrit HCT %
5
Chapter 1 Instrument Introduction
Plateletcrit PCT %
Table 1-4
Sampling Features:
Sample Volume:
Venous Blood Mode: 10μL Venous Blood
Capillary Blood Mode: 10μL Capillary Blood
Prediluted Mode: 20μL Capillary Blood
Reagent Volumes Required for Single Sample:
Diluent: 26mL
Lyse: 0.35mL
Venous and Capillary Blood Mode:
WBC/HGB 1:285
RBC/PLT 1:21667
WBC/HGB 1:500
RBC/PLT 1:43333
Cell Counting Aperture Size:
WBC: 100μm
RBC/PLT: 70μm
Throughput: Up to 35 samples per hour
Up to 60 samples per hour
6
Chapter 1 Instrument Introduction
Working mode:
Double counting pathway + independent HGB detection system
Display:
Liquid Crystal Display (LCD), touch screen resolution: 800*600
Language: English, Chinese, Spanish, etc. (Customizable)
Indicator: Power indicator light
Interface:
One power input socket
One printer port
One RS232/C serial port
One VGA interface
Four USB interfaces
Recorder:
Rapid Thermal Recorder: Recording width: 35mm, Paper width: 80mm
Precision Specifications of the Instrument
Repeatability:
Parameter Repeatability
WBC ≤ 2.0%
RBC ≤ 1.5%
HGB ≤ 1.5%
MCV ≤ 0.4%
PLT ≤ 4.0%
7
Chapter 1 Instrument Introduction
Table 1-5
Linear Range:
0~5.9×109/L (±0.3×109)/L
WBC
6.0~99.9×109/L ±5%
0~0.99×1012/L (±0.05×1012)/L
RBC
1.0~9.99×1012/L ±5%
0~99g/L ±2.0g/L
HGB
100~300g/L ±2%
0~99×109/L (±8.0×109)/L
PLT
100~999×109/L ±10%
Table 1-6
Screen display and the parameter ranges for report output
Parameter
Parameter Parameter Parameter Range
Range
8
Chapter 1 Instrument Introduction
Table 1-7
Operation Condition
Temperature: 18℃-35℃
Humidity: 10%RH~90%RH
Atmospheric Pressure: 86.0kPa~106.0kPa
Storage Condition
Temperature: -10℃-40℃
Humidity: 10%RH~90%RH
Atmospheric Pressure: 50.0kPa~106.0kPa
This instrument should be placed at a good ventilation area.
Electric Specifications
Power Supply:
AC 100~240V, 50/60Hz, auto adapt according to the input voltage
Fuse: F3AL250V
9
Chapter 1 Instrument Introduction
1.4 Structure
1.4.1 Front Panel
10
Chapter 1 Instrument Introduction
1.5 Operation
Designed according to human engineering and transferring information
to users by software windows and mouse, both are convenient for your
operating.
11
Chapter 1 Instrument Introduction
12
Chapter 1 Instrument Introduction
Figure 1-3
The button functions are as follows:
Measure: Used to test sample.
Calibration: Used to calibrate the instrument for correct test results.
1) Operator: Enter the operator calibration window to calibrate the
instrument manually.
2) Auto: Enter the auto calibration window to calibrate the instrument
automatically.
QC: Enter the quality control window to carry out quality control
operation.
1) QCE: Enter the QC edit window to edit the QC parameters.
2) QCR: Enter the QC run window to carry out the selected QC files.
3) QCG: Enter the QC graphs window to browse the selected QC
graphs.
13
Chapter 1 Instrument Introduction
14
Chapter 1 Instrument Introduction
15
Chapter 1 Instrument Introduction
Voltage Analytical
circuit
Electrode
Constant
current source
Time
Pulse
Figure 1-4
1.6.2 Detection Principle of HGB
Adding lyse in the blood, the red blood cell will rapidly be broken down
and release hemoglobin. Hemoglobin and lyse form a new mixture,
which can absorb the wavelength of 540nm. Measure the absorbency.
Through comparison of the absorbency between the pure diluent and
the sample, the concentration of the sample hemoglobin is calculated.
1.6.3 Volume Distribution of Blood Cell
When different types of cells pass through the aperture sensor, there
will be different electrical pulse height. Because of the evident
16
Chapter 1 Instrument Introduction
17
Chapter 1 Instrument Introduction
MPV is the average volume of individual platelets, derived from the PLT
histogram. It represents the mean volume of the PLT populations and
can be expressed in fL.
PDW derives from the PLT histogram. It represents the geometry
standard deviation (GSD) of the volume of the PLT populations.
P-LCR derives from the PLT histogram. It represents the ratio of the
larger PLT, and the unit is %.
• HCT (%) = RBC × MCV/10
• MCH (pg) = 10 × HGB/RBC
• MCHC (g/L) = 100 × HGB/HCT
• PCT (%) = PLT × MPV/10
• LYM% = 100 × AL / (AL+AM+AG)
• MID% = 100 × AM / (AL+AM+AG)
• NEUT% = 100 × AG / (AL+AM+AG)
• LYM# = LYM% × WBC/100
• MID# = MID% × WBC/100
• NEUT# = NEUT% × WBC/100
AL: Number of cells in LYM area;
AM: Number of cells between lymphocyte and neutrophil area;
AG: Number of cells in NEUT area.
18
Chapter 2 Installation
Chapter 2 Installation
2.1 Package
If packing damage is discovered after receiving the instrument, or the
instrument is badly damaged, contact with the freight agent immediately
to file a claim according to the damage level. At the same time contact
with your supplier to make sure the packing is complete. Then unpack
and install the instrument according to the following steps.
2.2 Unpack
Take out the instrument and accessories from the packing box carefully.
Preserve the packing material for future transportation or storage.
1) Check the accessories according to the packing list.
2) Check whether there are mechanical damages on the instrument and
accessories.
If there is any problem, please recover the package and contact with
your supplier immediately.
19
Chapter 2 Installation
Caution:
Do not use equipment that may create strong radiation field such as
mobile phone and cordless telephone. Strong radiation field will disturb
some functions of the instrument.
Space Requirement
At least 20cm on each side is the preferred access to ensure good
airiness.
Notice:
Reagents must be placed at the same working height as the instrument.
Power Requirement
The power requirement is as follows:
• AC 100~240V, 50/60Hz
• The maximum power consumption is 150VA
Warning:
The instrument requires a single well-grounded power socket. Its
grounding voltage is no more than 0.5V.
Warning:
A grounded outlet is required to connect with the grounding pole on the
rear panel. Make sure of the reliability of the power grounding at
working site.
Caution:
Fluctuating electric will badly decrease the performance and reliability
of the instrument.
Proper action such as the installation of UPS (self-preparation) should
be taken before use.
First Installation Notice
1) Open the right door, cut the ties binding to the sampling module and
20
Chapter 2 Installation
21
Chapter 2 Installation
Caution:
After completing all the tubing installation, keep the tubing natural state,
without distortion, folding, and twist.
Caution:
All the tubing connectors must be installed manually. Forbid using any
tool.
Caution:
The reagent must be supplied with the instrument. Otherwise it may
easily cause inaccurate measurement results and incorrect
classification of the blood cell, or make the tubing system badly
damaged.
Caution:
Keep the reagent from direct sunlight.
Caution:
After replacing the reagent container, discard the rest of the reagent in
the former container. Forbid putting the rest of the reagent into the
replacing container. Avoid polluting the new replacing reagent.
Caution:
When replacing the reagent, avoid making the plastic tube inserted into
the reagent container or contacted with other things. Avoid polluting the
new replacing reagent.
Caution:
Avoid using frozen reagent.
Caution:
Avoid using the reagent out of its expiration date.
Warning:
22
Chapter 2 Installation
Plug keyboard cable into the interface marked with . Plug mouse
cable into the interface marked with on the rear panel of the
instrument.
The keyboard and mouse can be placed where it is convenient for your
operating. We suggest that the keyboard placed under the display
screen of the instrument, the mouse cushion at the right side of the
keyboard, and the mouse on the mouse cushion.
23
Chapter 2 Installation
24
Chapter 3 Sample Analysis
3.2 Startup
If external printer is equipped, turn on the printer power and ensure they
are in ready status.
Press the power button on the rear panel of the instrument, then the
power lamp on the front panel of the instrument lights on. The
instrument automatically performs initialization program.
After completing initialization, the instrument will enter into the self-test
window. It tests the working conditions of each part and if there are
enough diluent and lyse. Simultaneously prime and clean the tubing.
After self-test, the instrument will enter into the hematology analyzer
window, as shown in Figure 3-1.
If the system detects malfunction, the failure information will be
displayed on Information Section.
25
Chapter 3 Sample Analysis
Figure 3-1
The button functions are as follows:
Info: Used to set patient information.
Print: Used to print report.
Flush: To get rid of the aperture clog.
Func: Used to change sample type, adjust classification line for current
result and dispense diluents for prediluted test mode.
Menu: Used to get into the main menu.
3.2.1 Function
In the hematology analyzer window, press “Func” button to enter into
the “Function” window, as shown in Figure 3-2.
26
Chapter 3 Sample Analysis
Figure 3-2
The button functions are as follows:
Sample Type: Select the sample type among Venous, Capillary and
Prediluted, as shown in Figure 3-3.
27
Chapter 3 Sample Analysis
Figure 3-3
If select “Prediluted”, the “Function” window changes, as shown in
Figure 3-4.
28
Chapter 3 Sample Analysis
Figure 3-4
Diluent: Inject the diluent quantitatively by sample needle. This menu is
used only in Prediluted mode, and “Diluent” button will not display in
other modes.
Vet Type: Select the pet’s type, as shown in Figure 3-5.
29
Chapter 3 Sample Analysis
Figure 3-5
Histogram: Enter the histogram adjustment window of the current
sample. You can manually adjust the histograms of the current sample.
30
Chapter 3 Sample Analysis
Parameter Data
WBC ≤ 0.2×109/L
RBC ≤ 0.02×1012/L
HGB ≤ 1g/L
HCT ≤ 0.5%
PLT ≤ 5×109/L
Table 3-1
If the value of the background test exceeds the permissive range,
repeat the above testing procedures until the testing result is acceptable.
If the test has been carried on for more than five times, but the testing
result still cannot reach the standard required, please refer to Chapter
10 “Troubleshooting” in this manual.
Notice:
31
Chapter 3 Sample Analysis
Only five parameters WBC, RBC, HGB, HCT and PLT can be tested
and displayed in background test.
Notice:
The serial number 999 is a special number for background test.
32
Chapter 3 Sample Analysis
33
Chapter 3 Sample Analysis
34
Chapter 3 Sample Analysis
35
Chapter 3 Sample Analysis
36
Chapter 3 Sample Analysis
37
Chapter 3 Sample Analysis
Figure 3-6
2) After selecting the histogram, press “Line” button, and select the
sorting line you want to adjust.
3) Press “Left” or “Right” button, you can move the sorting line to the
left or right, the data of the line will be displayed at the top right corner
of the screen.
4) Press “Back” button when the adjustment finished. If this operation
did not change any data, the system would return to the hematology
analyzer window directly, or else pops up the “Ok/Cancel” window.
Press “Ok” to save the adjustment result, while select “Cancel” to cancel
the adjustment result.
Caution:
Unnecessary and incorrect manual adjustment will cause unreliable
analytical result. Make sure the necessity of the operation.
38
Chapter 3 Sample Analysis
Notice:
If the result of WBC is less than 0.5x109/L, the system will not perform
leukocyte differential automatically.
3.8 Shutdown
Shutdown routine must be performed before turning off the power every
day.
During shutdown procedure, the instrument will perform daily
maintenance and clean the tubing automatically.
The procedures are as follows:
1) In the hematology analyzer window, press “Menu” button, then select
"Shutdown" button, the shutdown window pops up.
Figure 3-7
2) If you do not want to shutdown the instrument for the moment, click
“Cancel” to return to the main menu window.
3) Press “Ok”, the instrument will perform daily maintenance and clean
the measuring tubing. When the shutdown procedure finished, the
screen displays “PLEASE TURN OFF THE POWER!”, turn off the
power on the rear panel of the instrument.
39
Chapter 3 Sample Analysis
Figure 3-8
4) Turn off the printer power (if equipped), clean the workbench and
dispose the waste.
Notice:
Do not turn off the power of the instrument directly while performing the
shutdown procedures.
40
Chapter 4 Quality Control
41
Chapter 4 Quality Control
Figure 4-1
2) In quality control edit window, select the QC file you want.
3) Input lot number and expiration date of the control, the assay and
limit of the quality control parameters.
4) Press “Save” button to save the data of the current QC file.
5) Press “Delete” button to delete the data of the current QC file.
6) Press “Back” button to save the data of the current QC file and return
to the main menu window.
Notice:
If the parameter is an invalid data, the system will take the assay and
limit as no assignment. It needs to re-input. Or else the quality control
will only act on other parameters.
42
Chapter 4 Quality Control
Notice:
If the lot number or expiration date is invalid, the system will take them
as no assignment. It needs to re-input. Or else the QC file cannot run
quality control program.
Figure 4-2
3) Place the controls under the sampling needle. Press “START” key,
43
Chapter 4 Quality Control
the indicator lamp starts to glitter, the instrument aspirates the controls,
move the controls away until the indicator lamp stops glittering.
4) When the test finished, the result will be displayed on the column of
the current window. If alarm occurs during the test, the current result
may be incorrect.
5) Press “Del” button to delete the result and test again after the
problem is solved.
6) Press “Back” button, the instrument will return to the hematology
analyzer window.
Notice:
Each QC file can store up to 31 QC data.
44
Chapter 4 Quality Control
Figure 4-3
The screen can display QC graph of one parameter. The graph shows
the lot number, date, serial number, QC mode and distribution of the
QC data. Click the scroll bar on the right side of the screen, and
continuously select the QC graph of different parameters.
The seven parameters at the left side of the QC graph from top to
bottom:
Assay + 3limit
Assay + 2limit
Assay + limit
Assay
Assay - limit
Assay - 2limit
45
Chapter 4 Quality Control
Assay - 3limit
The three parameters at the right side of the QC graph from top to
bottom:
Mean: average value
Diff: standard deviation
CV: coefficient of variation
The vertical line in the middle of the QC graph indicates the current
chosen number. Click the scroll bar on the left side of the screen to
continuously select the different number.
The chosen number is displayed in the data box below the
corresponding parameter. The test time for the chosen number is
displayed in the time box on the screen.
In the QC graph window, the following marks represent:
The mark “*” between the broken line represents that the point is within
control range. Otherwise it is out of control range.
The mark “.” represents that the parameter value is outside the
operating range, or error has occurred during the run. Blank represents
that there is no quality control on running.
Press “Print” button, it will print the data of the parameters which you
select.
Press “Back” button to return to the hematology analyzer window.
46
Chapter 4 Quality Control
Figure 4-4
The screen can display 12 QC parameters of 7 groups at the same time.
Click the scroll bar to select different serial number.
Press “Print” button, it will print the data of the parameters on the screen.
Press “Back” button to return to the main menu window.
47
Chapter 5 Calibration
Chapter 5 Calibration
The instrument has been calibrated strictly at the factory. You may need
to perform calibration procedures when you replace any component
that involves the primary measurement characteristics, or when the
shift occurs during controls. Calibration of the instrument is to provide
the assurance that the instrument is providing results with accuracy as
design. The purpose of calibration is to ensure the accuracy of the
measurement result to meet the requirement of the design all the time.
To ensure the accuracy of the instrument and obtain reliable
measurement results, it is necessary to calibrate the instrument in the
following situations:
1) Installation for the first time or re-setup in a new place.
2) The instrument is maintained.
3) The result of quality control is abnormal.
4) Replace reagent.
To ensure the instrument's precision and obtain reliable measurement
results, the instrument should be calibrated in these situations:
Warning:
Calibrators should be stored and used properly according to the
calibrator manual.
Warning:
Make sure the instrument is in a normal state before calibration.
Warning:
Avoid using the measurement result on medical test or clinical before
the calibration is finished accurately.
Check the instrument and reagents carefully before calibration. Make
sure the instrument is in normal status, and the required sample mode
of the measurement is selected.
48
Chapter 5 Calibration
∑ (X − X )
i=1
i
2
CV = n −1 × 100%
X
x -- Average value of the test results
x i -- Test result of the ith test
n – Test times of the sample
49
Chapter 5 Calibration
Parameters CV (%)
WBC ≤ 2.0
RBC ≤ 1.5
HGB ≤ 1.5
MCV ≤ 0.4
PLT ≤4
Table 5-1
5.1.3 Calculate Calibration Factors
Calculate the new factors according to the following formula:
50
Chapter 5 Calibration
Figure 5-1
2) Select the needed calibration data from the calibration data menu
box.
3) Press “Print” button. The instrument will print the current calibration
result.
4) Press “Ok” button to save the current calibration result and return to
the main menu window.
5) Press “Cancel” button. The instrument will cancel the current
calibration result and return to hematology analyzer window.
51
Chapter 5 Calibration
Figure 5-2
2) Input the reference value of each calibration parameter.
3) Prepare the calibrators and shake up the container until it is well-
mixed.
4) Place the calibrators under the sample needle. Press “START” key,
the instrument aspirates the calibrators. Move the calibrators away until
it stops.
5) When the measurement finished, the result will be displayed on the
column of the current window. If alarm occurs in measurement, the
current result may be incorrect.
6) Press “Del” button to delete the result and test again after the
problem is solved.
7) Press “Back” button, the instrument will return to the hematology
analyzer window.
52
Chapter 5 Calibration
Notice:
Calibration can be performed 5 times at the most.
Notice:
The calibration result will be displayed after testing 3 times.
Notice:
If the parameter is an invalid data, the system will not perform
calibration. It needs to re-input valid data.
53
Chapter 6 Setting
Chapter 6 Setting
The instrument has accomplished all the settings at the factory. For
customer's convenience, most of the system parameters can be set by
operators so as to meet various requirements.
Notice:
Operations in this chapter will change the running state of the
instrument. Make sure of the necessity of changing before operating.
Figure 6-1
54
Chapter 6 Setting
6.2 Printout
In the hematology analyzer window, press “Menu” button, select
“Setting” in the menu, then select “Print". The instrument will enter into
the print window, as shown in Figure 6-2.
Figure 6-2
Click the menu box you want to adjust, the option window pops up. Click
the item you want to set.
Press “Ok”, the system will save the current parameters and return to
the setting window. Press “Cancel” button, the system will not save the
current parameters and return to the main menu window.
Print select
Select recorder, the data will only be transported to the recorder.
Select serial port, the data will only be transported to the net.
Select recorder and serial port, the data will be transported to the
55
Chapter 6 Setting
6.3 Control
In the hematology analyzer window, press “Menu” button, select
“Setting” in the menu, then select “Control”, the instrument will enter
into the control setting window, as shown in Figure 6-3.
56
Chapter 6 Setting
Figure 6-3
Click the menu box you want to adjust, the option window pops up. Click
the item you want to set.
Press “Save”, the system will save the current parameters and return
to the hematology window.
Press “Cancel” button, the system will not save the current parameters
and return to the main menu window.
Auto
Set “Print” as “OFF”, the system will not print the test report
automatically after the sample test finished.
Set “Standby” as “OFF”, the instrument will keep working status all
along. Set “Standby” as data. When the time, which the user does not
perform any operation, exceeds the setting time, the instrument will
access sleep state. During sleep time, the instrument will turn off part
of the circuit power, and take the sample needle back. Sleep function
57
Chapter 6 Setting
can greatly save electrical energy and extend the life of the instrument.
Press the left key of the mouse or any key on the keyboard, sleep will
be canceled.
Set “Clean” as “OFF”, the instrument will not perform auto-cleaning. Set
“Clean” as data. When the running time of the instrument exceeds the
setting time, the instrument will perform “Clean” procedure once. It can
ensure the measured tubing of the instrument clean and prevent the
possible measurement malfunctions and maintain the instrument.
Sound
Set “Alarm” as “OFF”. When the instrument appears alarm, it will not
make alarm sound, but display the alarm information in the Information
Section.
Set “Alarm” as “ON”. When the instrument appears alarm, it will make
alarm sound and display the alarm information in the Information
Section.
Set “Prompt” as “OFF”. When the sample test finished, the instrument
makes no sound.
Set “Prompt” as “ON”. When the sample test finished, the instrument
will make a prompt sound like “di”.
Display
Set “Para” as “English”. In parameter area of the hematology analyzer,
the parameters will be displayed in abbreviations.
Set “Limits” as “No Display”. In parameter area of the hematology
analyzer, the parameters will not display reference value of the current
sample.
Set “Limits” as “Low-High”. In parameter area of the hematology
analyzer, the reference values will be displayed from low to high.
Set “Limits” as “High-Low”. In parameter area of the hematology
analyzer, the reference values will be displayed from high to low.
58
Chapter 6 Setting
6.4 Limits
In the hematology analyzer window, press “Menu” button, select
“Setting” in the menu, then select “Limits” to enter into the limits setting
window, as shown in Figure 6-4.
The 12 Group reference values are displayed at the left side of the
screen. They are Canine, Feline, Equine, Porcine, Bovine, Ovine,
Simian, Murine, Goat, Rabbit, VP Pig and Define1. The dot in front of
the reference value represents that this is the current selected
reference group. The limits of the reference value are displayed in the
limits boxes on the screen.
Click the dot in front of the group to select the group required for setting.
Figure 6-4
Click “Default” button, the instrument will select the default reference
values to replace the current reference values.
59
Chapter 6 Setting
Click the adjustable bar of the limits box to adjust the upper and lower
limit of the reference value.
Function of menu buttons:
Save: Save the reference values of the current group.
Print: Print the reference values of the current group.
Back: Exit from current window and return to main menu window.
Notice:
The default reference value may not suitable for the local conditions.
Users can modify it according to the local specific circumstances.
Caution:
The changing of the reference value will cause variation of abnormal
prompt on hematology target. Please make sure the necessity of the
variation.
60
Chapter 6 Setting
Figure 6-5
Click the scroll bar at the right side of the window, the instrument can
record the serial number continuously.
Click “Back” button, the system exits from the current window and
returns to the hematology analyzer window.
6.5.1 Add record information
Click “Add” button to enter into the record adding window, as shown in
Figure 6-6.
Input the information of department and abbreviation.
Notice:
The coding method of the abbreviation should be easy to memory. In
most circumstances, the abbreviation of the department name is
recommended.
61
Chapter 6 Setting
Click “Ok” button to save the current input information. The system
returns to department setting window.
Click “Cancel” button, the current input information will be canceled, and
the system returns to department setting window.
Figure 6-6
6.5.2 Print department information
Click “Print” button to print all the department information saved.
62
Chapter 6 Setting
Figure 6-7
Click the scroll bar at the right side of the window to display continuously
the records of different numbers.
Click “Back” button, the system will exit the current window and return
to the main menu window.
6.6.1 Add operator information
Click “Add” button, the instrument enters into the record adding window,
as shown in Figure 6-8.
63
Chapter 6 Setting
Figure 6-8
Input the information of name and abbreviation.
Input abbreviation information at the left input box of department, the
system will select department automatically. You can also select the
department directly from the right input box of the department.
“Status” represents the status of the doctor, including: doctor, operator
and checker. Click the box in the left directly, blank means no choice,
black fork means selected. Selecting more than one item is allowed.
Notice:
The coding method of the abbreviation should be easy to remember. In
most cases, abbreviation of the department name is recommended.
6.6.2 Print operator information
Click “Print” button, the instrument will print all the operators information
saved.
64
Chapter 7 Review
Chapter 7 Review
The instrument can automatically store the results after each sample
analysis. The operator can review, search, modify, print, and delete the
data.
Figure 7-1
The data can be reviewed and printed in table.
8 sample parameters are displayed in each review screen in the order
of time sequence.
The button of scroll bars at the bottom of the screen shows the current
position.
65
Chapter 7 Review
66
Chapter 7 Review
2) Click “Delete” button, a dialog box pops up, and choose to delete the
data or not. Press “Ok” button, the data will be deleted. Press “Cancel”
button, the operation will be cancelled.
Print the current sample data in table
The procedures are as follows:
1) Click “All” button at the top of the screen, the data will be selected.
Click again, the selection will be canceled.
2) Click “Print” button, the selected data would be printed in table.
Search sample data
Print the selected data as the following procedures:
1) Click “Query” in the menu, the search window pops up, as shown in
Figure 7-2.
2) Click the button on the left of the item to be searched, input the
keyword you want to search.
3) Repeat the b) procedure until the current inputting item finished. Click
“Cancel” button to cancel the searching. Click “Ok” button, start to
search the data. When the searching finished, the proper sample data
will be displayed on the screen.
67
Chapter 7 Review
Figure 7-2
The functions of the menu buttons are as follows:
All: select or recover all the sample data.
Detail: Enter the detail review window.
Delete: Delete the selected data.
Print: Print the current data in table.
Query: Search the required sample data in any condition.
Menu: Exit from the current window.
68
Chapter 7 Review
Review
Click “Next” button to review the next data.
Click “Prev” button to review the previous data.
Modify Sample Information
Click “Info” button, “Information” window pops up. Refer to section 3.6.1
in Chapter 3 “Sample Analysis” for the operation of this window.
Modify Sample Data
Click “Histogram” button in the menu.
The operation procedures are as follows:
a) Click “Para” button to select WBC, RBC, and PLT in turn.
b) Click “Line” button to select the sorting lines in the histogram.
c) Click “Right” or “Left” button to move the line to the right or left.
Data calculated according to the new sorting line would be displayed in
the data area at the left side of the screen.
d) Click “Back” button. If the sample data has been modified, a dialog
box pops up. Users can select to save the modification result or not.
Click “Ok” button to save the result. Click “Cancel” button not to save it
and exit from the histogram modification status.
69
Chapter 7 Review
Figure 7-3
The functions of the menu buttons are as follows:
Histogram: Review the histograms.
Info: Input and modify the sample data.
Print: Print the current sample data.
Next: Review the next data.
Prev: Review the previous data.
Back: Exit from the current window and return to the main menu window.
70
Chapter 8 Service
Chapter 8 Service
This chapter gives the description of various service functions provided
by the instrument. These functions will bring user convenience and
pleasure.
In the hematology analyzer window, press “Menu” button, then select
“Service” in the menu.
Figure 8-1
8.1 Flush
This function is used to solve general probe clogs. The instrument
makes a fixed pressure and voltage act on the probe to get rid of clogs.
71
Chapter 8 Service
8.3 Cleaning
This function is used to clean the sampling needle and tubes.
8.9 Prime
Prime diluents and lyse to the related tube.
8.10 Maintenance
Perform the weekly maintenance according to the prompt information
on the screen. Prepare probe cleanser before maintenance.
8.11 Mechanic
Users can detect the valve, motor, circuit and interface in the “Mechanic”
menu. It is helpful to the detection of malfunctions.
72
Chapter 8 Service
Figure 8-2
Valve:
“ON” represents the valve is on. “OFF” represents the valve is off.
Motor:
"OK" represents that the motor is in normal status.
"FAIL" represents the motor has failure.
Recorder:
Click this button, the recorder will print a test paper.
Printer:
Click this button, the external print will print a test paper.
Back:
73
Chapter 8 Service
Figure 8-3
8.12 Special
The instrument enters special maintenance window. User can adjust
the running control data. This function should be performed in guidance
of the engineers authorized by the manufacturer.
74
Chapter 9 Maintenance
Chapter 9 Maintenance
As a precise instrument, only careful daily service and periodic
maintenance can the instrument has a good working status, and can
we get the reliable measurement results and have few malfunctions.
This chapter introduces some preventive methods for service and
maintenance.
If you want to know more related information, please contact the
Customer Service Department of the manufacturer.
According to the requirements for maintenance of the instrument during
the using procedures, the manufacturer divides the preventive service
and maintenance into the following types: daily, weekly, monthly, yearly
and maintenance according to the actual need.
Warning:
It is important for the hospital or organization that employs this
instrument to carry out a reasonable maintenance schedule. Neglect of
this may result in machine breakdown.
75
Chapter 9 Maintenance
76
Chapter 9 Maintenance
77
Chapter 9 Maintenance
78
Chapter 10 Troubleshooting
Chapter 10 Troubleshooting
This chapter contains information that is helpful in identifying and
resolving instrument problems that may occur in the operation of the
analyzer. If the problems cannot be corrected with the aid of this chapter,
the user should contact the Customer Service Department of the
manufacturer.
79
Chapter 10 Troubleshooting
80
Chapter 10 Troubleshooting
81
Chapter 11 Help
Chapter 11 Help
The instrument provides on-line help during operation. It is helpful for
user to solve common problems and indicate the next operation.
Besides, the instrument provides help for user to read and search the
information in window. In the hematology analyzer window, select
“Menu/Help”, the help window will pop up, as shown in Figure 11-1.
Figure 11-1
This window shows in chapter mode. User can search help information
conveniently. Click the scroll bar up and down to read the previous or
next information.
82
Operation Manual Appendix 1 Symbol
Appendix 1 Symbol
Symbol Meaning Symbol Meaning
Equipotential
COM 2 Interface
Terminal
83
Operation Manual Appendix 1 Symbol
84
Appendix 2 Specification
Appendix 2 Specification
A 2.1 Reagent
Diluent, lyse and probe cleanser
WBC 109/L
Neu# 109/L
Lym# 109/L
Mid# 109/L
Neu% %
Lym% %
Mid% %
RBC 1012/L
HGB g/L
HCT %
MCV fL
MCH pg
85
Appendix 2 Specification
MCHC g/L
RDW-SD fL
RDW-CV %
PLT 109/L
MPV fL
PDW None
PCT %
p-LCR %
86
Appendix 2 Specification
Venous 10μL
Capillary 10μL
Prediluted 20μL
WBC 0~200.0×109/L
RBC 0~20.00×1012/L
HGB 0~300g/L
PLT 0~2000×109/L
HCT 0%~80%
87
Appendix 2 Specification
WBC ≤ 0.2×109/L
RBC ≤ 0.02×1012/L
HGB ≤ 1.0g/L
HCT ≤ 0.5%
PLT ≤ 5.0×109/L
0~5.9×109/L (±0.3×109)/L
WBC
6.0~99.9×109/L ±5%
0~0.99×1012/L (±0.05×1012)/L
RBC
1.0~9.99×1012/L ±5%
0~99g/L ±2.0g/L
HGB
100~300g/L ±2%
0~99×109/L (±8.0×109)/L
PLT
100~999×109/L ±10%
88
Appendix 2 Specification
Item CV Range
LYM%≥15.0%,
LYM% ≤8.0%
WBC≥4.0×109/L
MID%≥5.0%,
MID% ≤10.0%
WBC≥4.0×109/L
NEUT%≥30.0%,
NEUT% ≤8.0%
WBC≥4.0×109/L
89
Appendix 2 Specification
WBC ≤1%
RBC ≤1%
HGB ≤1%
PLT ≤1.5%
Voltage Frequency
90
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