Professional Documents
Culture Documents
Operation Manual
3) Turn off the power and disconnect the power cord if the analyzer is idle
for a long time.
Guidance..................................................................................................................................III
I
Contents
II
Contents
4.2.6 X QC Edit.......................................................................................................51
4.2.7 Manual Calibration....................................................................................... 52
4.2.8 Automatic Calibration...................................................................................53
4.2.9 System Setting..............................................................................................54
4.2.10 Service......................................................................................................... 55
Chapter 5 System Setting.....................................................................................................57
5.1 System Maintenance.............................................................................................. 57
5.2 Transfer Setting........................................................................................................58
5.3 Print Setting.............................................................................................................. 59
5.4 Parameter Setting....................................................................................................60
5.5 Date/Time Setting.................................................................................................... 61
5.6 System Version........................................................................................................ 62
Chapter 6 Quality Control..................................................................................................... 63
6.1 Quality Control Options.......................................................................................... 63
6.2 QC Operation........................................................................................................... 64
6.2.1 QC Mode Select........................................................................................... 64
6.2.2 L-J QC............................................................................................................65
6.2.3 X QC...........................................................................................................70
6.2.4 X -R QC.......................................................................................................74
III
Contents
Appendix C: Communication..............................................................................................123
IV
Copyright and Declaration
Declaration:
All contents in this manual were strictly compiled according to related laws and
regulations in local, as well as the specific condition of Spincell3 Automated
Hematology Analyzer, covering all the updated information before printing.
URIT Medical Electronic Co.,Ltd. is fully responsible for the revision and
explanation of the manual, and reserves the right to renovate the relevant
contents without separate notification. Some of the demonstration pictures are
for reference and subject to real object if any differences.
URIT warrants the Spincell3 sold by the URIT and its authorized agents to be
free from defects in workmanship and materials during normal use by the
original purchaser. This warranty shall continue for a period of one year since
the date of installation. The instrument service life is 10 years.
I
Copyright and Declaration
URIT assumes no liability in the following situations even during the period
warranty:
1) Failure due to abuse the instrument or neglect the maintenance.
2) Use reagents and accessories other than manufactured or recommended
by URIT.
3) Failure due to the operation which is not under the instructions described
in the manual.
4) Replace accessories which are not specified by URIT. Maintain or repair
the analyzer by a service agent who is not approved or authorized by
URIT.
5) Components have been dismounted, stretched or readjusted.
CAUTION:
THE ANALYZER IS FOR PROFESSIONAL AND PRESCRIPTION USE ONLY.
Version : 07/2015
II
Guidance
III
Chapter 1 System Description
1.1 Overview
1.1.1 Function
1
System Description
1 5
7
6
3
4 2
1. Status Indicator
Run Indicator: Indicates that the analyzer is running a sample.
Standby Indicator: Indicates that the analyzer is ready to run a sample.
2. Aspiration Probe
Aspirate samples.
3. RUN Key
Press the RUN key to startup the aspiration probe and then analyze specimen
only in the screens of main menu or Quality Control. At other screens, the RUN
key is invalid.
4. Recorder
Print the test result.
5. Work Mode Indicator
The light indicator means whole blood mode, and dark indicator means
pre-diluent mode.
6. Touch Screen
10.4 inch LCD . The screen is divided into 5 areas as shown in Figure 1-2.
2
System Description
Test Result
Menu
3
System Description
4
System Description
cautery, etc.
Limit: Direct to limit-setting screen to modify the limits of parameters.
Stast.: Calculate the workload during a certain time.
QC: Direct to quality-control window to process QC.
Cal.: Direct to calibration window to calibrate the analyzer.
Setup: Direct to setup window to reset parameters
Sev.: Direct to service window to process self-check and maintenance.
Help: Direct to system help window.
7. Shortcut Key
5
System Description
5
13
9 6
12
11
7
10 8
6
System Description
10. DETERGENT
Detergent port connects to the detergent inlet tube.
11. WASTE
Waste port connects to the waste outlet tube.
12. LYSE
Lyse port connects to the lyse inlet tube.
13. DILUENT
Diluent port connects to the diluent inlet tube.
1.2 Parameters
Analyzer can automatically analyze the sample data, differentiates WBCs into
3 differentials and displays 21 parameters and 3 histograms of WBC, RBC and
PLT. Refer to Table 1-1 for details of 21 parameters.
Table 1-1 21 Parameters
Abbreviation Full Name Unit
WBC White Blood Cell Count 109cells/L
LYM% Lymphocyte Percent %
MID% Monocyte Percent %
GRAN% Granulocyte Percent %
LYM# Lymphocyte Count 109cells/L
MID# Monocyte Count 109cells/L
GRAN# Granulocyte Count 109cells/L
RBC Red Blood Cell Count 1012cells/L
HGB Hemoglobin Concentration g/L
HCT Hematocrit (relative volume of erythrocytes) %
MCV Mean Corpuscular Volume fL
MCH Mean Corpuscular Hemoglobin pg
MCHC Mean Corpuscular Hemoglobin Concentration g/L
Red Blood Cell Distribution Width Repeat
RDW_CV %
Precision
RDW_SD Red Blood Cell Distribution Width STDEV fL
PLT Platelet Count 109cells/L
MPV Mean Platelet Volume fL
PDW Platelet Distribution Width fL
7
System Description
PCT Plateletcrit %
P_LCR Large Platelet Ratio %
P_LCC Large Platelet 109cells/L
1.3 Structure
FPGA board is the control center of the analyzer; it controls the following
8
System Description
Figure1-7
9
System Description
It mainly provides DC12V, DC5V voltage to the ARM board, FPGA driver board,
and operating voltage to motor, pump, valve, and recorder.
To provide the analog voltage and DC high voltage to front-end signal panel.
Transform the signals from FPGA board, then drive the valve, motor and pump
to work.
10
System Description
Flow System --- The flow system uses negative pressure to aspirate
diluent, detergent and sample from each container into metering tube, and
discharge waste at the end of the processing.
1.3.3 Display
1.4 Accessory
The accessories of the analyzer include power cord, grounding cord, external
printer (optional), etc.. And the printer should be supplied or authorized by
manufacturer.
11
System Description
Diluent: 31mL
Detergent: 8mL
Lyse: 0.7mL
NOTE: Reagent consumption is various according to the software version.
1.8 Storage
WBC≤0.2×109/L;RBC≤0.02×1012/L;HGB≤1g/L;PLT≤10×109/L
1.10 Carryover
WBC≤0.5%;RBC≤0.5%;HGB≤0.5%;HCT≤0.5%;PLT≤0.5%
1.11 Accuracy
12
System Description
1.12 Precision
1.13 Linearity
1) Temperature: -10℃~55℃
2) Relative Humidity: ≤95%RH
3) Barometric Presssure: 50kPa~106kPa
13
System Description
1) Temperature: 15℃~35℃
2) Relative Humidity: ≤90%RH
3) Barometric Pressure: 60kPa~106kPa
1.17 Reagent
Reagent inlet tubes have a cap attached which can minimizes evaporation and
contamination during use. However, reagent quality may deteriorate with time.
Therefore, use all reagents within the dating period.
1.17.1 Diluent
Diluent is a kind of reliable isotonic diluents which can meet the requirements
as follows:
1) Dilute WBC, RBC, PLT, HGB.
14
System Description
1.17.2 Lyse
Lyse is a new-type reagent without NaN3 complex and cyanide which can
meets the requirements as follows:
1) Dissolve RBC instantly with minimum ground substance complex.
2) Transform the membrane of WBC to diffuse cytoplasm, and then WBC
shrinks to form membrane-bound nuclei. As a result, WBC present in
granular shape.
3) Transform the hemoglobin to form hemo-compound which is suitable for
the measurement in the condition of 540nm wavelength.
4) Avoid the pollution caused by cyanide.
1.17.3 Detergent
Detergent contains the active enzyme which can dissolve the agglomerated
protein in the WBC, RBC cups and measurement circuit.
15
System Description
conductivity.
Cell pulse size is related to valve voltage, mesh current and pulse gain.
2) Please operate under professional ‘s instruction.
3) Avoid contacting with skin and eyes. If does, rinse with water and seek
medical advice immediately.
4) Avoid inhaling reagent gas.
16
Chapter 2 Principles of Operation
The measurement is mainly on the quantity, volume of blood cells and HGB.
The cells are counted and sized by the electrical impedance method. As Figure
2-1 shows, this method is based on the measurement of changes in electrical
current which are produced by a particle, suspended in a conductive liquid, as
it passes through an aperture of known dimensions. An electrode is
submerged in the liquid on either side of the aperture in order to create an
electrical pathway through it.
17
Principles of Operation
Lyse added into the blood sample will crack the membrane of red blood cells
promptly and transfer into a kind of compound which can absorb the
wavelength of 540 nm. Through the comparison of the absorbance between
the pure diluent and the sample, the concentration of sample hemoglobin is
calculated.
18
Principles of Operation
In Spincell3, counting system has a high sensitivity of the cell volume. Cells
which are suspended in conducting liquid should be protected from physical
condense and adhesion. Control the osmotic pressure of conducting liquid
(mainly diluent) and keep the structure of cells so as to minimize the volume
change. Lyse can dissolve the RBC membrane fleetly and keep the structure
of WBC so that the instrument can count and classify cells.
19
Principles of Operation
20
Principles of Operation
P-LCR
LD ( 12fL ) UD
Figure 2-3 P-LCR
P-LCR indicates the ratio of large platelet (≥12 fL). It is derived from
PLT histogram. See Figure 2-3. LD,UD is the differentiating line of 2~6
fL and 12~30 fL. These two lines are decided by analyzer
automatically. P-LCR is the ratio of particles between 12 fL line and UD
to particles between LD and UD.
P_LCC: Large platelet,it is the particles between 12 fL line and UD.
21
Chapter 3 Installation and Specimen Analysis
Carefully remove the analyzer and accessories from shipping carton, keep the
kit stored for further transport or storage. Check the following:
1) Quantity of accessories according to the packing list.
2) Leakage or soakage.
3) Mechanical damage.
4) Bare lead, inserts and accessories.
22
Installation and Specimen Analysis
Be sure that the system is located at the desired site before attempting any
connections. See Table 3-1 for details.
Remove the lyse tube with red faucet from reagent kit and attach it to LYSE
connector on the rear panel, place the other end into the lyse container. Twist
the cap until secure. Place the container on the same level as the analyzer.
23
Installation and Specimen Analysis
Remove diluent tube with blue faucet from reagent kit and attach it to DILUENT
connector on rear panel. Place the other end into diluent container. Twist cap
until secure. Place the container on the same level as the analyzer.
Remove the waste tube with black faucet from reagent kit and attach it to
WASTE connector on the rear panel, connect BNC plug with the socket
marked “SENSOR” on the rear panel. Twist the tube’s cap clockwise onto the
waste container until secure. Place the container on the level at least 50cm
lower than the analyzer.
Remove the detergent tube with yellow faucet from reagent kit and attach it to
DETERGENT connector on the rear panel. Place the other end into the
detergent container. Twist the cap until secure. Place the container on the
same level as the analyzer.
CAUTION: keep the tube in loose condition after installation, no distortion or
folding.
CAUTION: All the tubes should be installed manually. Do NOT utilize any tool.
CAUTION: If any damage or leakage occurs in the reagent container, or the
reagents have exceeded expiry date, contacts manufacturer Customer Support
Centre for replacement.
24
Installation and Specimen Analysis
Take out the printer from the shipping carton. Inspect the printer carefully
according to its manual and Section 3.1 and perform the following procedures:
1) Find a suitable location adjacent to the analyzer. Location of at least 30cm
away from analyzer on its right side is recommended.
2) Assemble the printer as directed in the printer manual.
3) Connect the printer and analyzer with printer cable which plug into
PRINTER or USB on rear panel of the analyzer according to the type of
printer.
4) Be sure that the printer power switch is OFF; plug the end of power cord to
power socket.
5) Install printing paper as directed in the manual.
Remove keyboard, mouse and mouse pad from the shipping carton, and insert
the plugs of keyboard and mouse into the two connector of the line, then
connect to the rear panel with “PS/2” port. It is recommended to place the
keyboard beneath the display.
Make sure the power switch is OFF (O) and the grounding terminal on the rear
panel is well grounded firstly, then connect the analyzer to the main power with
the power cable.
3.8 Startup
Turn on the power switch on the rear panel, then the status indicator on the
front panel will be orange. The analyzer will start self-checking after loading,
and automatically aspirate the diluent , detergent and lyse, then rinse the
tubing.
The main menu screen is displayed after self-checking (See Figure 3-1).
25
Installation and Specimen Analysis
Background test should be performed after startup and before blood sample
test, operate as follows:
1) Put the clean empty tube under the aspiration probe. At main menu screen,
click the mode switch button on the top of the screen, current mode will be
switched to “Pre-diluent” mode, then click “Drain” to discharge the
diluent into the tube.
2) At main menu screen, click “Info”, and then modify ID to 0, click “OK” back
to save it.
3) Click "Pre-diluent" to switch to “Whole Blood” mode, put the
tube containing diluent beneath aspiration probe and ensure the probe
touch the bottom of tube.
4) Press RUN key on the front panel, move away the tube after the beep
sounds. Then the analyzer starts to count and measure automatically.
5) Counting time of RBC, WBC will be displayed at the lower right corner of
screen during counting. Analyzer will alarm and display the error at top left
corner if the counting time is too long or too short. Refer to Chapter 11 for
26
Installation and Specimen Analysis
problem correction.
6) The acceptable range of background is listed in Table 3-2.
3.11 Calibration
CAUTION: Consider all the clinical specimens, controls and calibrators etc
that contain human blood or serum as being potentially infectious, wear lab
coats, gloves and safety glasses and follow required laboratory or clinical
procedures when handling these materials.
CAUTION: Blood collection and disposal should be performed according to
the local and national environmental regulations or laboratory’s requirements.
CAUTION: Be sure the blood collection clean and contamination-free. All
27
Installation and Specimen Analysis
Capillary blood is usually collected from finger tip. The volume of sample tube
is set to be 20μl.
CAUTION: Never over-press the finger avoiding collecting tissue liquid into
sample tube, tissue liquid will cause error in results.
In the screen as Figure 3-1 shows, click the mode switch button on the top to
switch among Whole Blood Mode for Venous Blood, Pre-diluent
Mode for Peripheral Blood and Whole Blood Mode for Peripheral Blood.
Corresponding sign on screen will indicate current operating mode. Press the
shortcut key “Mode” in front of the analyzer can also switch between whole
blood mode and pre-diluent mode.
28
Installation and Specimen Analysis
29
Installation and Specimen Analysis
NOTE: The ID number is set to 0 only under background test. The blood
sample ID CAN NOT be 0.
Counting and analysis should be performed within 3~5 minutes after blood
collection.
Pre-diluent Mode for Peripheral Blood
1) Present the empty sample tube under the aspiration probe. At main menu
screen, click “Drain”; the diluent will be dispensed into the tube.
2) Remove the tube, add 20μl of the blood sample to the tube, and gently
shake the tube to make them well mixed.
3) Present the well-mixed sample under the aspiration probe; make sure the
probe touches the tube bottom slightly.
4) Press RUN key on the front panel and remove the sample after hearing
beep sound.
5) Process of analysis will take some time, please wait a moment.
30
Installation and Specimen Analysis
Test results and histograms of WBC, RBC and PLT will be displayed at main
menu screen after counting and analysis (see Figure 3-1).
If Auto Rec or Auto Print is ON (set in “system setting” screen), the test results
will be printed out automatically.
If problems like clog or bubbles occur during the counting and analysis
procedures, the analyzer will alarm and give indication at the top left corner of
the screen. The test results are invalid. Refer to Chapter 10 for solution.
If Auto Rec or Auto Print is ON (set in “system setting” screen), the test results
will be printed out automatically.
If problems like clog or bubbles occur during the counting and analysis
procedures, the analyzer will alarm and give indication at the top left corner of
the screen. The test results are invalid. Refer to Chapter 11 for solution.
”H” or “L” present on the right side of the parameter means the result is out of
the range of reference value.
“***” means the result is invalid or out of display range.
If the WBC Histogram is abnormal, R1, R2, R3, R4, RM will be displayed on
the right side of the histogram.
R1 indicates there is abnormality in the left side of LYM wave peak, which
probably caused by incomplete hemolysis of RBC, platelet clump, giant
31
Installation and Specimen Analysis
R2 indicates there is abnormality in the area between LYM wave peak and MID
wave, which probably caused by pathologic lymphocyte, plasmocyte, atypia
lymphocyte, original cell or an increase in eosinophil and basophilia,
R3 indicates there is abnormality in the area between MID wave and GRAN
wave peak, which probably caused by immature granulocyte, abnormal cell
subpopulation, eosinophilia.
R4 indicates there is abnormality in the right side of GRAN wave peak, which
probably caused by an absolute increase in granulocyte.
When the histogram of PLT has abnormalities, PM alarm will be shown in the
right side.
If counting time lower than system setting time, the system will alarm
“WBC bubble” or “RBC bubble”, at the same time display “B” before test
result.
If counting time higher than system setting time, the system will alarm
“WBC clog” or “RBC clog”, at the same time display “C” before test result.
Because of large display of limit sequence, it should be set “None” in
System Setting for limit sequence firstly, then “L”, “H”, “B”, “C” will appear.
NOTE: If Parameter value is ***, it indicates invalid data.
NOTE: WBC differential may be incorrect if WBC is lower than 0.5 x109 /L.
Microscope examination is recommended.
Spincell3 offers recorder and printer which are optional according to customer
needs. After blood sample analysis completed, if Auto Print is ON, test report
will be printed automatically by recorder or printer; if the Auto Trans is ON, test
results will be transmitted to network automatically.
The recorder, printer and transmit are set up at Settings window. Refer to
Chapter 5 for details.
If the auto-classification of floating limit for WBC, RBC and PLT do not reach
clinical or laboratory requirements on special samples, manual classification is
feasible.
33
Installation and Specimen Analysis
34
Installation and Specimen Analysis
3.18 Shutdown
Shutdown procedure is performed after daily operation and before turning the
analyzer off. Daily maintenance and tubing-clean avoid protein aggregation
during non-working and keep system clean. Shutdown procedure is as follows:
1) At main menu screen, click “Exit”, shutdown information will appear (see
Figure 3-5).
Figure 3-5
If turn off the instrument, click “Yes”. After finishing maintenance, cleaning
and shutdown procedures, “Thank you, and now turn off power” will
appear to instruct operator to turn off the power switch on rear panel.
2) Tidy the work platform and dispose waste.
3) Click “No” if operator does not want to shutdown analyzer temporarily.
35
Installation and Specimen Analysis
36
Installation and Specimen Analysis
At main menu screen, click “Func”,and then click “Rev” to enter query screen.
Data of today will be displayed in the list box as Figure 3-6.
Select data in the list, and then click “Detail”, that the analyzer enters into detail
inquiry window.
Condi: Query data that are compliant with specific criteria in certain period.
Detail: Select a data in the list, click “Detail”, the parameters result and
histograms of selected data will be displayed.
Pgprv/Pgnex: If the data is too much to display in one page, the system will
display the data in more pages. Click “Pgpre” or “Pgnex” to view more
information.
Print: Click “Print” to print the selected data.
P_All: Click “P_ All” to print all the data in current list by printer.
Count: Click “Count” to print all the data saved in list by printer according to
counterfoil format.
Back: Click “Back” to go back to main menu screen.
37
Installation and Specimen Analysis
If the sample quantity reaches a certain amount and takes up a large save
space, operator can delete the data termly if necessary. Data deletion is
divided into “Delete” and “Delete All”.
(1) Delete All
Click “DelAll”, a dialog box as Figure 3-9 will present, input password 9999,
then the system will prompt to ask whether you want to delete all, see Figure
3-10, if click “Yes”, then the system will perform all delete operations.
NOTE: Be aware that the data once being deleted, it can NOT be recovered,
please operate with caution.
38
Installation and Specimen Analysis
39
Installation and Specimen Analysis
After data review from condition query, click one result, then press space bar
(click “Select” if using touch screen), the result will be selected and in red
letters as Figure 3-13.
After selecting one sample result as preceding method, press F9 (click “CV” if
using touch screen) to enter the CV data screen like as Figure 3-14.
“Mean” indicates the parameter average value of selected samples. “CV”
indicates the Coefficient of Variance of corresponding parameter.
NOTE: The system can only calculate CV automatically when more than one
sample results are selected.
NOTE: If only one sample result is selected, the “Mean” indicates the sample
result itself.
40
Installation and Specimen Analysis
41
Installation and Specimen Analysis
42
Installation and Specimen Analysis
43
Installation and Specimen Analysis
44
Chapter 4 Soft Keyboard
1. Layout
There are 43 keys in soft keyboard: 10 number keys, 26 alphabet keys,
backspace key, slash key, space key, CAP key, CH key and EN key.
“<--”: Backspace key, delete the character before cursor;
“/”: Slash key, enter a slash;
“Spc”: Space key,enter a space;
“CAP”: Switch between lowercase and uppercase;
“CH”: Chinese input method.
“EN”: English input method.
45
Soft Keyboard
3. Delete Character
First move the cursor behind the character that needs to be deleted, click "<--"
to delete the character before the cursor.
4.2 Function
The soft keyboard is displayed in the following screens: data edit, condition
query, parameters limit setting, control edit, system calibration, system setting
and service.
46
Soft Keyboard
Click “Condi” at query screen, condition query and soft keyboard will pop up at
the same time, and soft keyboard is warded off by condition query screen.
The procedure of inputting information in edit box is as follows:
1) Click target edit box, move the cursor on the edit box;
2) Click the soft keyboard, this moment soft keyboard is warded off by
condition query screen, click soft keyboard to input data;
3) After data input, click condition query screen to move the cursor on this
screen, click “OK” to query according to input conditions, click “No” to
cancel and exit query. See Figure 4-4.
47
Soft Keyboard
Enter the parameter setting screen, click "Keyboard", soft keyboard will pop up,
if click "Keyboard" again, soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:
1) Click target edit box, move the cursor on edit box;
2) Click soft keyboard, user can input data through soft keyboard;
3) After data input, click parameter limit setting screen to move the cursor on
this screen. This moment soft keyboard will be hidden. If click "Keyboard"
again, the soft keyboard will pop up;
4) When the focus is on parameter limit setting screen, click “OK” to save,
click “Back” to cancel and exit. See Figure 4-5.
48
Soft Keyboard
Enter L-J QC Edit screen, click "Keyboard", then soft keyboard will pop up, if
click "Keyboard" again, soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:
1) Click target edit box first, move the cursor on the edit box;
2) Click soft keyboard, user can input data through soft keyboard;
3) After data input, click L-J QC edit screen to move the cursor on this screen.
This moment soft keyboard will be hidden. If click "Keyboard" again, the
soft keyboard will pop up;
4) When the focus is on L-J QC edit screen, click “OK” to save, click “Back” to
cancel and exit. See Figure 4-6.
49
Soft Keyboard
Enter X-B QC Edit screen, click "Keyboard", then soft keyboard will pop up, if
click "Keyboard" again, soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:
1) Click target edit box first, move the cursor on edit box;
2) Click soft keyboard, then user can input data through soft keyboard;
3) After data input, click X-B QC edit screen to move the cursor on this screen,
this moment the soft keyboard will be hidden. If click "Keyboard" again, the
soft keyboard will pop up;
4) When the focus is on X-B QC edit screen, click “OK” to save, click “Back”
to cancel and exit. See Figure 4-7.
50
Soft Keyboard
4.2.6 X QC Edit
Enter X QC Edit screen, click "Keyboard", then the soft keyboard will pop up, if
click "Keyboard" again, soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:
1) Click target edit box first, move the cursor on the edit box;
2) Click soft keyboard, then user can input data through soft keyboard;
3) After data input, click X QC edit screen to move the cursor on this screen,
this moment soft keyboard will be hidden. If click "Keyboard" again, the
soft keyboard will pop up;
4) When the focus is on X QC edit screen, click “OK” to save, click “Back” to
cancel and exit. See Figure 4-8.
51
Soft Keyboard
Enter manual calibration screen, click "Keyboard", then soft keyboard will pop
up, if click "Keyboard" again, soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:
1) Click target edit box, move the cursor on the edit box;
2) Click soft keyboard, then user can input data through soft keyboard;
3) After data input, click manual calibration screen to move the cursor on this
screen, this moment soft keyboard will be hidden. If click "Keyboard" again,
soft keyboard will pop up;
4) When the focus is on manual calibration screen, click “OK” to save, click
“Back” to cancel and exit. See Figure 4-9.
52
Soft Keyboard
Enter automatic calibration screen, click "Keyboard", soft keyboard will pop up.
If click "Keyboard" again, soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:
1) Click target edit box, move the cursor on the edit box;
2) Click soft keyboard, then user can input data through soft keyboard;
3) After data input, click automatic calibration screen to move the cursor on
this screen, this moment soft keyboard will be hidden. If click "Keyboard"
again, soft keyboard will pop up;
4) When the focus is on automatic calibration screen, click “OK” to save, click
“Back” to cancel and exit. See Figure 4-10.
53
Soft Keyboard
Enter system setting screen, click "Keyboard", soft keyboard will pop up. If
click "Keyboard" again, the soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:
1) Click target edit box, move the cursor on the edit box;
2) Click soft keyboard, then user can input data through soft keyboard;
3) After data input, click system setting screen to move the cursor on this
screen, this moment soft keyboard will be hidden. If click "Keyboard" again,
the soft keyboard will pop up;
4) When the focus is on system setting screen, click “OK” to save, click “Back”
to cancel and exit. See Figure 4-11.
54
Soft Keyboard
4.2.10 Service
Enter service screen, click "Keyboard", then soft keyboard will pop up, if click
"Keyboard" again, soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:
1) Click target edit box, move the cursor on edit box;
2) Click soft keyboard, then user can input data through soft keyboard.
3) After data input, click service screen to move the cursor on this screen, this
moment the soft keyboard will be hidden. If click "Keyboard" again, the soft
keyboard will pop up.
4) When the focus is on service screen, click “OK” to save, click “Back” to
cancel and exit. See Figure 4-12.
55
Soft Keyboard
56
Chapter 5 System Setting
57
System Setting
Pre-diluent notice: If the Pre-diluent is ON, each time when operator runs a
sample, the system will prompt that whether or not to run the sample under
pre-diluent mode.
In transfer setting as Figure 5-2, operator can setup the port number, baud rate,
data bit, stop bit and parity bit of the communication port. The communication
parameters are set before delivery. User should not modify them; otherwise
the data can not be transmitted.
Auto trans: the test results will be transmitted from the communication port
automatically.
Encoded: hexadecimal and ASCII.
NOTE: Transfer setting should be under the guidance of manufacturer
engineer.
58
System Setting
In Print Setting as Figure 5-3, operator can select printer type, print format,
auto print, and input hospital name in “print title”.
59
System Setting
In Parameter Setting as Figure 5-4, operator can setup the unit of WBC, RBC,
PLT, HGB and MCHC, as well as the language and order of parameters.
60
System Setting
61
System Setting
User can check the software version, printer software version, printer template
version, FPGA version, kernel version and library version. If there are
problems, the user can provide this information to manufacturer service
engineers as Figure 5-6.
NOTE: Above system settings have been set up before delivery. User does not
need to reset them generally. If needed, all the operations should under the
guidance of manufacturer engineer.
62
Chapter 6 Quality Control
Quality control is needed for maintaining the analyzer precision and eliminating
system errors. Spincell3 offers four quality control options: L-J QC, X QC,
X -R QC and X-B QC. In following conditions, perform quality control with
control materials recommended by manufacturer.
After daily start-up procedures completed
The reagent lot number changed
After calibration
After maintenance, or component replacement
In accordance with the laboratory or clinical QC protocol
In suspicion of parameter value
CAUTION: Consider all clinical specimens, controls and calibrators etc. that
contain human blood or serum as potentially infectious. Wear lab coats, gloves
and safety glasses and follow required laboratorial or clinical procedures when
handling these materials.
(1) L-J QC
L-J QC (Levey-Jennings graph) is a simple and visual QC method. Operator
can draw QC value directly on graph after getting the Mean, SD and CV which
derived from following formulas:
63
Quality Control
X i
Mean i 1
SD
(X i Mean) 2
n 1
SD
CV % 100
Mean
(2) X -R QC
In X -R QC method, X indicates mean value, R indicates range of value. X
graph is mainly used to judge that if the mean value falls in required level. R
graph is mainly used to judge that if the range of value falls in required level.
(3) X QC
X QC is the variation of X -R QC; they have the same basic principle. The
difference is that the control dot in X graph indicates the mean value of two
values other than a single value. On this foundation, analyzer calculates the
Mean, SD and CV.
(4) X-B QC
X-B QC is a moving average method promoted in 1970s. It’s based on the
principle that RBC count is varied due to the concentration of dilution, human
blood pathology and technical factor, but the hemoglobin content in specific
unit is hardly interfered by those preceding factors. According to this
characteristic, X-B QC is done by detecting the value of MCV, MCH, and
MCHC.
6.2 QC Operation
In main menu screen, click “Func” and then select ”QC”, dialog box as Figure
6-1 will pop up.
64
Quality Control
6.2.2 L-J QC
Select L-J QC mode and click “OK” to enter corresponding screen as Figure
6-2.
65
Quality Control
In L-J QC screen click “Edit”, enter QC Edit screen as Figure 6-3. There are 3
different groups and each group has 3 (low, normal and high) levels. Input
control lot No., expiry date, assay and limit according to the control description.
NOTE: Assay is a standard value which is the reference of quality control. Limit
indicates the allowable biased range. but the limit should not be more than
40% of assay, or it cannot be saved in database.
NOTE: The expiry date format should be MM-DD-YYYY.
66
Quality Control
67
Quality Control
In L-J QC screen, there are low, normal and high graphs. If select group 1 and
low level to run QC, the control dot will present in low 1 graph. It is also true for
other types of QC.
There are function buttons at the bottom of L-J QC screen. Click “Group” to
change the group. Click “Paramr” to change current displayed parameter, for
instance, change from WBC to RBC. Click “Level” to shift the classification line
in the same group. Click “Left” or “Right” to shift the classification line in same
QC graph. Click “Print” to print the current data.
68
Quality Control
69
Quality Control
In this screen, click “Group” to change group, click “Left” or “Right” to switch
page. Operator could review 31 items at most. Click “Del All” to delete all data.
The assay and limit can be input and changed in QC Edit screen.
The QC data would be updated after running a new control.
6.2.3 X QC
6.2.3.1 X QC Edit
Select X QC mode in the dialog box as Figure 6-1 shows and then click “OK”
to enter corresponding screen. Click “Edit”, enter X QC Edit screen as Figure
6-7.
NOTE: The same as L-J QC, the limit should not be more than 40% of assay,
or it cannot be saved in database.
70
Quality Control
6.2.3.2 X QC Run
In X QC Run screen, place the control tube under aspiration probe, press
RUN key, the analyzer will start to process control sample. If the current group
assay is empty, the system will display “No QC reference data, cannot perform
QC running”. At this time, operator should back to the Edit screen to input
assay and limit.
X QC needs control material. If run a background QC, the system will alarm
QC result is invalid.
71
Quality Control
6.2.3.3 X QC Review
(1) X QC Graph
Click “Back” in QC Run screen or select corresponding QC mode in QC Mode
dialog box, enter the X QC screen as Figure 6-9 shows. Operator can review
12 parameters of QC results. As a difference to L-J QC Graph, the dot on X
72
Quality Control
(2) X QC Data
In L-J QC graph screen (see Figure 6-9), click “Data”, operator can review QC
data with 12 parameters as Figure 6-10 shows.
In this screen, click “Group” to change group, click “Left” or “Right” to switch
page. Operator could review 31 items data at most. Click “DelAll” to delete all
the data.
The assay and limit can be input and changed in QC Edit screen.
The QC data will be updated after running QC twice. At the same time, the
mean value will be displayed.
73
Quality Control
Figure 6- 10 X QC Data
6.2.4 X -R QC
6.2.4.1 X -R QC Run
74
Quality Control
6.2.4.2 X -R QC Review
75
Quality Control
X graph instruction:
1. Graph abscissa indicates QC run times, ordinate indicates QC results.
2. QC graph can display 31 dots for each parameter.
3. Every parameter graph’s middle transverse line indicates X —the
mean value of QC results.
4. Every parameter graph’s upper transverse line means X upper limit
= X +A×R.
5. Every parameter graph’s lower transverse line means X lower limit=
X -A×R.
6. The 3 values on the left side of parameter graph mean:
upper limit —— X upper limit= X +A×R
middle line —— X
76
Quality Control
R graph instruction:
1. Graph abscissa indicates QC run times, ordinate indicates QC result.
2. QC graph can display 31 dots for each parameter.
3. Every parameter graph’s middle transverse line indicates R—the mean
value of QC result range.
4. Every parameter graph’s upper transverse line means R upper limit=
B×R.
5. Every parameter graph’s lower transverse line means R lower limit=
C×R.
6. The 3 values on the left side of parameter graph mean:
upper limit —— R upper limit=B×R
middle line —— R
lower limit —— R lower limit=C×R
If the control dot falls in the area between upper and lower lines of the
corresponding graph, it means the dot is in the control range; if not, the dot is
not in the control range.
(2) X -R QC Data
In X -R QC Graph screen (See Figure 6-12), click “Data”, operator can review
QC data with 12 parameters as Figure 6-13 shows.
On this screen, click “Group” to change group, click “Left” or “Right” to switch
page. Operator could review 31 items at most. Click “DelAll” to delete all the
data.
X -R QC data screen can only display three control results, and each one
contains mean and range. The first two lists on this screen are total mean and
average range. See Figure 6-13.
The QC data would be updated after running new controls twice.
77
Quality Control
6.2.5 X-B QC
X-B QC Edit is different to others, with which the system only edits three
parameters: MCV, MCH, and MCHC.
Select X-B QC mode in the dialog box as Figure 6-1 shows. click “OK” to enter
the X-B QC screen, then click “Edit” to enter X-B QC Edit screen. See Figure
6-14.
At Edit screen, click “Del” to delete current assay and limit; click “OK” to save
them; click “Back” to exit.
NOTE: Assay is a standard value which is the reference of quality control. Limit
indicates the allowable biased range. but the limit should not be more than
40% of assay, or it cannot be saved in database.
NOTE: The expiry date format should be MM-DD-YYYY.
78
Quality Control
79
Quality Control
80
Quality Control
81
Quality Control
82
Chapter 7 Calibration
To ensure analyzer’s precision and obtain reliable test results, the parameters
(WBC, RBC, PLT, HGB, and MCV) should be calibrated in the following
situations:
1) Working environment changes greatly.
2) One or multiple parameters’ test results are moving.
3) Any major component that could affect the measurement is replaced.
4) Requirement of clinic or laboratory.
5) The reagent has been replaced.
6) The analyzer presents deviation when running quality control.
MCV, HCT are relative parameters to each other, thus one can be obtained
from given value of the other. Only MCV will be calibrated by the analyzer.
Usually the manufacturer will give the reference value for MCV, HCT at the
same time.
CAUTION: Consider all clinical specimens, controls and calibrators etc. that
contain human blood or serum as potentially infectious. Wear lab coats, gloves
and safety glasses and follow required laboratorial or clinical procedures when
handling these materials.
CAUTION: Only calibrators recommended by manufacturer can be used to
accomplish the calibration.
CAUTION: Follow the recommendations provided by manufacturer to store the
calibrators.
CAUTION: Check if the container is broken or cracked before using the
calibrator.
CAUTION: Make sure the calibrators are brought to room temperature and
well mixed slowly before use.
CAUTION: Make sure the calibrators are within the expiry date.
CAUTION: Make sure the analyzer has no problem before calibration.
CAUTION: Never apply the test data to laboratory or clinic use unless all
parameters are accurately calibrated.
83
Calibration
5) Running with high control in triplicate, then using diluent instead of high
control to test 3 times continuously. Carryover(%) is calculated from the
following formula. Results must conform to Table 7-2.
84
Calibration
NOTE: If whole blood and capillary blood are both used in daily work,
calibration should be done after confirming the sampling mode.
NOTE: After confirming the mode, all test should be done in the same
mode.
NOTE: If any malfunction occurs during measurement, the test results are
invalid. Repeat the measurement after troubleshooting.
At main menu screen, click “Cal” to enter System Calibration screen. Choose
“manual Cal”, click “OK” to enter manual calibration interface.
Input assay and values, then click “New Cal” button, the system will calculate
the new calibrated value automatically and the date will be updated
simultaneously. See Figure 7-1:
85
Calibration
At main menu screen, click “Cal” to enter System Calibration screen, Choose
“Auto Cal”, click “OK” to enter auto calibration interface. See Figure 7-2.
86
Calibration
At Auto Calibration Mode, input assay then place the calibrator tube under the
aspiration probe, press RUN key, the analyzer starts to count and then
displays the results in Value 1 to Value 4 according to the sequence of 4
counts.
Analyzer cannot count or display the test value in following conditions:
1) After counting for 5 times, press RUN key, analyzer will prompt that there is
no space to process calibration count.
2) If the precision of test result is abnormal, analyzer will prompt “data is
abnormal, please re-counting”.
3) After each counting, analyzer will calculate a new calibration value
according to reference value and test result and update the calibration
date.
Click “Print” to print the new calibration values.
X i
Mean of the new calibration value: Mean= i=1
n
New calibration value=(assay/mean value) ×former calibration value
If the new calibration value<70%, consider it equals to 70%; if the new
calibration value>130%, consider it equals to 130%.
NOTE: Click “OK” after counting and then system will save the values. Click
“Back” without clicking “OK”, the value will not be saved.
87
Chapter 8 Parameter Limit
At Limit Setting screen, operator can input proper parameter limits or use
default limits. Default limits are different depending on patient group. Figure
8-1 depicts General group limits. Figure 8-2 depicts User 1 group limits
88
Parameter Limit
Click “Def”, the system prompts the operator to decide whether to recover all
the default limits. Select “Yes” to recover parameters of all groups to default
limits; select “No” to exit. See Figure 8-3.
Click “OK” to save current default limits which will be displayed when operator
enter Limit Setting screen again.
89
Parameter Limit
8.3 Print
Click “Print”, then system will print out limits of all groups in list form
automatically.
90
Chapter 9 Maintenance
91
Maintenance
Weekly Maintenance
Clean the smudge on the surface of analyzer, especially the spilled blood on
the aspiration probe and surrounding, to remove the protein buildup or debris
and reduce the possibility of a blockage. Wipe the outside of the probe and
surrounding with gauze soaked by litmusless detergent before cleaning other
parts.
92
Maintenance
CAUTION: Never use corrosive acids, alkali or volatile organic solvent (such
as acetone, aether and chloroforms etc.) to clean the outside of the analyzer.
Only litmusless detergent is allowed.
At main menu screen select “Func”, then select “Maint” to enter the screen as
Figure 9-2.
93
Maintenance
Flush Aperture helps to prevent and remove aperture clog associating with
Cauterize Aperture. The procedure is as follows:
1. Select “Flush Aperture” in Maintain screen.
2. The analyzer starts to perform the function and display the progress
bar at the bottom of the screen.
3. After completing, system will back to the Maintain screen.
Perform this operation to drain diluent out of WBC and RBC cups.
94
Maintenance
Perform this operation to rinse the aperture to prevent blockage when counting
time is too long. The procedure is as follows:
1. Select “Rinse Cups” in Maintain screen.
2. The analyzer starts to perform the function and display the progress
bar at the bottom of the screen.
3. After completing, system will back to the Maintain screen.
CAUTION: Consider all clinical specimens, controls and calibrators etc. that
contain human blood or serum as potentially infectious. Wear lab coats, gloves
and safety glasses and follow required laboratorial or clinical procedures when
handling these materials.
CAUTION: As probe detergent is corrosive, operator should wear lab coats,
gloves and follow required laboratory operation procedures.
95
Maintenance
3) After several seconds, the dialogue box as Figure 9-4 will pop up, put the
probe detergent container under the aspiration probe again then click
“OK”.
CAUTION: Consider all clinical specimens, controls and calibrators etc. that
contain human blood or serum as potentially infectious. Wear lab coats, gloves
and safety glasses and follow required laboratorial or clinical procedures when
handling these materials.
NOTE: Keep the lyse still for a certain time to ensure it stable.
NOTE: After replacing diluent, detergent or lyse, perform background test to
make sure the background values are in a acceptable range.
96
Maintenance
CAUTION: Consider all clinical specimens, controls and calibrators etc. that
contain human blood or serum as potentially infectious. Wear lab coats, gloves
and safety glasses and follow required laboratorial or clinical procedures when
handling these materials.
NOTE: Keep the diluent still for a certain time to ensure it stable.
NOTE: After replacing diluent, detergent or lyse, perform background test to
make sure the background values are in a acceptable range.
CAUTION: Consider all specimens, controls and calibrators etc. that contain
human blood or serum as potentially infectious. Wear lab coats, gloves and
safety glasses and follow required laboratorial or clinical procedures when
handling these materials.
NOTE: Keep the detergent still for a certain time to ensure it stable.
NOTE: After replacing diluent, detergent or lyse, perform background test to
make sure the background values are in acceptable range.
97
Maintenance
If background test results are abnormal or clog, bubbles faults are prompted,
perform this operation to rinse the apertures and cups. The procedure is as
follows:
1) Select “Rinse Fluidics” in Maintain screen.
2) The analyzer starts to perform the function and display the progress bar at
the bottom of the screen.
3) After completing, system will back to the Maintain screen.
Perform this function before shipping or leave the analyzer unused for a long
time. Please refer to section 9.5 for details. The procedure is as follows:
1) Select “Prepare Shipping” in Maintain screen, then the dialogue box as
Figure 9-5 will pop up, select “Yes” to perform this operation, select “No” to
back to Maintain screen.
98
Maintenance
If the analyzer is left unused for more than 3 months or being shipped, please
perform following operations for maintenance:
1) Take out the diluent inlet tube which is connecting with diluent port on the
rear panel from waste container, discharge the remaining diluient in tube.
2) Take out the lyse inlet tube which is connecting with lyse port on the rear
panel from waste container, discharge the remaining lyse in tube.
3) Take out the detergent inlet tube which is connecting with detergent port on
the rear panel from waste container, discharge the remaining detergent in
tube.
4) Store the remaining reagents according to instructions and avoid
supercooling and overheating. Operator should establish and conform to
effective storage measures to prevent reagent from degeneration,
misusage or misdrinking.
5) Keep the diluent, lyse and detergent inlet tubes hanging in the air.
6) At main menu screen, click “Prime” several times until the top left corner of
the screen present “No Diluent”, “No Lyse”, “No Detergent”, then Click
“Prime” once again.
7) Insert diluent, lyse and detergent tubes into distilled water.
8) At main menu screen, click “Func”→“Maint”→”Prepare Shipping” to inter
the screen as Figure 9-6 shows.
99
Maintenance
1) After completed, take out the diluent, lyse and detergent tubes from
distilled water and click “Prepare Shipping” again to drain the reagent in
tubes.
2) At main menu screen, click “Exit”, “Thank you, now turn off power” will
appear to instruct the operator to turn off the power switch on the rear
panel.
3) Pull out outlet tube from the rear panel, clean it with distilled water and
save it with plastic bag after dry by airing.
4) Cover the connectors of DILUENT, LYSE, DETERGENT and WASTE on
the rear panel with caps which are taken out at initial installation.
5) Disconnect the power cord of analyzer and save it in plastic bag. Place the
analyzer and components in plastic bags into the shipping box.
100
Chapter 10 Service
Click “Func” at main menu screen, select “Sev”, input “2006” in the pop-up
dialog box to enter the System Check screen.
The System Status Check screen presents the current status information for
example temperature, constant-current source voltage, 5V voltage, HGB zero
voltage, HGB background voltage, WBC stenopaic voltage, RBC stenopaic
etc.. See Figure 10-1.
101
Service
At Valve Check screen (see Figure 10-2), operator can check if the valves are
in normal condition.
102
Service
103
Service
At Motor Check screen, operator can check if the motors are in normal
condition. At the screen, click motor buttons, the corresponding result will be
displayed in result list. See Figure 10-4.
104
Service
Click “Func” at main menu screen, select “Sev”, input “6666” in the pop-up
dialog box to enter the System Log screen as Figure 10-5 shows:
105
Service
Data Query
Choose the begin date and end date on System Log screen, then click “Rev”,
the query results will be displayed in the list box. As shown in Figure 10-6.
106
Service
107
Service
108
Service
After getting the query results, operator can perform following operations:
1) The number of total pages and current page number will be automatically
displayed on the list box.
2) If query logs are in a large quantity and cannot be displayed in one page,
press Pgprv and Pgnex buttons to view the results in previous or next
page.
3) Select a record, click "Del.", then it will be deleted.
4) Press "DelAll", all the records will be deleted.
5) Click "Back" to return to the main screen.
109
Chapter 11 Troubleshooting
110
Troubleshooting
11.3 Troubleshooting
Familiar faults and corrective actions are listed as follows. If faults still cannot
be corrected according to this chapter, or more technical assistance is needed,
please contact with manufacturer Customer Support Centre.
111
Troubleshooting
Lyse has been 1. Check that if the lyse has been used up;
used up or lyse 2. Perform “Func” → “Maintain” →”Prime Lyse”;
Lyse Empty
inlet tube is 3. If fault still occurs, please contact with
blocked. manufacturer.
112
Troubleshooting
113
Troubleshooting
114
Troubleshooting
115
Chapter 12 Precautions, Limitations and Hazards
12.1 Limitations
116
Precautions, Limitations and Hazards
ultrasonic cleaner.
3) Place the reagent containers at the same level of the analyzer.
4) The installation area of analyzer and reagents is 2m2. Please keeping at
least 40cm distance from surrounding objects to ensure ventilation.
Adequate space should be left for maintenance and service.
5) Please perform following operations prior to initial use:
Ensure liquid connection is proper and stable.
Ensure tubes are not bending.
Ensure reagents are flowing fluently.
Ensure wastes are being drained into a suitable waste container.
6) Do not disconnect any electrical connection while power is ON. Ensure the
analyzer is grounded well to prevent electrical interference and ensure
safety.
117
Precautions, Limitations and Hazards
CAUTION: Reagent will freeze if being stored below 0℃. Disuse the reagent if
is frozen.
CAUTION: Keep away from direct sunlight. Seal the cap of the container and
minimize the pore size to avoid evaporation and contamination.
118
Appendix A: Instrument Specifications
Scope of Application
Venous blood, peripheral blood of human being
Appearance Specifications
Display: 10.4-inch LCD
Language: English/Simplified Chinese
Parameter: 21 parameters and 3 histograms
Indicator: Status Indicators/Work Mode Indicators
System Alert: Alert message/Alert beep
Ports: Power Receptacle
Printer Ports
RS-232 Port
PS/2 Port
USB Ports
Recorder Specifications
Recorder Width: 48mm
Paper width: 57.5mm
Paper Roll Diameter: 53mm
Print Speed: 25mm/s
119
Appendix A
Sample Volume
Whole Blood Mode for Venous Blood: Venous Blood 10 μL
Pre-diluent Mode for Peripheral Blood: Capillary Blood 20 μL
Whole Blood Mode for Peripheral Blood: Capillary Blood 10 μL
NOTICE: Sample dosages can be different according to analyzer version.
Background Results
WBC≤0.2×109/L;RBC≤0.02×1012/L;HGB≤1g/L;PLT≤10×109/L
Carryover
WBC≤0.5%;RBC≤0.5%;HGB≤0.5%;HCT≤0.5%;PLT≤0.5%
Accuracy
Table A-1 Accuracy Specifications
Parameter Acceptable Limits(%)
WBC ≤±2.0%
RBC ≤±1.5%
HGB ≤±1.5%
MCV ≤±0.5%
HCT ≤±1.0%
PLT ≤±4.0%
Precision
Table A-2 Precision Specifications
Parameter Acceptable Limits(CV/%) Precision Range
WBC ≤2.0% 4.0×109/L ~ 15.0×109/L
RBC ≤1.5% 3.00×1012/L ~6.00×1012/L
HGB ≤1.5% 100 g/L ~180g/L
HCT/ ≤1.0% 35%~50%
MCV ≤0.5% 76fL ~110fL
PLT ≤4.0% 100×109/L ~500×109/L
120
Appendix A
Linearity
Table A-3 Linearity Specifications
Parameter Linearity Range Acceptable Limits
0×109/L~10.0×109/L ≤±0.3×109/L
WBC
10.1×109/L ~99.9×109/L ≤±5%
0×1012/L ~1.00×1012/L ≤±0.05×1012/ L
RBC
1.01×1012/L ~9.99×1012/L ≤±5%
0 g/L ~70 g/L ≤±2g/L
HGB
71 g/L ~300 g/L ≤±2%
0×109/L ~100×109/L ≤±10×109/L
PLT
101×109/L ~999×109/L ≤±10%
121
Appendix B: Instrument Icons and Symbols
Caution
Biohazard
Equipotentiality
Protective Grounding
Serial Number
Manufacturer
122
Appendix C: Communication
The system transfers sample data and analyzer information to outer computer
through RS-232 COM. Communication can be done automatically after
analysis or manually when the analyzer is in idle mode. This appendix explains
the settings of communication parameters and data communication formatter
for easy operation.
Before communication, please ensure the analyzer has connected with outer
computer through appropriate COM.
Communication can be done in hexadecimal format or ASCII format.
123
Appendix C
1.2.3 Convention
TYPE DATA
Field Definition:
Field Length
1 TYPE 1
2 DATA xx
TYPE Value:
Type Value
TRANS_CONDITION 0x42
If TYPE value of DATA field is TRANS_CON and the opposite party can
receive 0x01 message which sent by us, it means online is normal.
124
Appendix C
| Field mark
^ Component mark
& Child component mark
~ Repeat mark
\ Escape character
125
Appendix C
126
Appendix C
1 Field mark ST 1
2 Encoding chars ST 4
3 Sending Application EI 180
4 Sending Facility EI 180
5 Receiving Application EI 180
6 Receiving Facility EI 180
7 DateTime Message TS 26
8 Security ST 40
9 MessageType CM 7
10 Message Control ID ST 20
11 Processing ID PT 3
12 VersinID VID 60
13 Keep
14 Keep
15 Keep
16 Keep
17 Keep
18 Encoder ST Encoding (with UNICODE)
Example:
MSH|^~\&|manufacturer|UT-3020|LIS|PC|20100930100436||ORU^R01|m
anufacturer-BLD|P|2.3.1||||||UNICODE
127
Appendix C
4 Alternate Patient ID CX 20
5 PatientName XPN 48
6 Mother Maiden Name XPN 48 Set null
7 Date/Time of Birth TS 26
8 Sex IS 1 M or F
9 Patient Alias XPN 48 Keep
10 Race CE 80 Keep
11 Patient Address XAD 106 Keep
12 County Code IS 4 Keep
13 Phone Number XTN 40 Keep
13 Phone Number Bus XTN 40 Keep
14 Primary Language CE 60 Keep
15 Marital Status CE 80 Keep
16 Religion CE 80 Keep
Basically, the Latter
…
parts do not need to fill
Example: PID|1|1010051|A1123145|15|Jame||19811011|M
128
Appendix C
OBR Field:
Number Field Type Length Remark
Confirm different fields,
1 Set ID OBR SI 4
generally set 1 or null
2 Placer Order Number EI 22
3 Assigned Patient Location EI 22
4 Universal Service ID CE 200
5 Priority ID 2 Set null
6 Requested DateTime TS 26
7 ObservationDatetime TS 26
8 Observation DateTime end TS 26 Set null
9 Collection Volume CQ 20 Set null
10 Collector Identifier XCN 60 Set null
11 SPE ActionCode ID 1 Set null
12 Danger Code CE 60
Clinical information,
13 Relevant Clinical Info ST 300
diagnosis or remark etc.
14 SPE Received DateTime TS 26
15 SPE Source CM 300 Blood, urine or others
16 Ordering Provider XCN 120
OrderCallback Phone Set null
17 XTN 40
Number
18 Placer Field1 ST 60 Inspection applicant
19 Placer Field2 ST 60 Set null
20 Filler Field1 ST 60 Set null
… Do not need to fill basically Set null
Example:
OBR|1|1010051|000001|manufacturer^UT-3020||20101010093020|20101
010093500|||||| Jaundice||BLD|Tom||011
129
Appendix C
OBX Field:
Number Field Type Length Remark
1 Set ID OBX SI Confirm different fields,
4
generally use 1 or null
2 Value Type ID NM indicates number type,
3
ST indicates value type
3 Observation CE Observation
590
Identifier Identifier or item ID
4 Observation SubID ST 20
5 Observation value ST 65535 Test result
6 Units CE 90
7 References Range ST 90
8 Abnormal Flags ID 5 Value mark: L H N
9 Probability ID 5 Set null
10 Nature of Abnormal ID Set null
2
Test
11 Observe Status ID Observe results and take F
1
as final result
12 Date Last Observe TS 26 Set null
13 User Defined ST Original result, such as
20
Access Checks absorbance
14 DateTime TS 28 Use for biochemical result
15 Producer ID
16 Responsible
Observer
17 Observation CE Use for biochemical
60
Method analyzer
130
Appendix C
ampleTime]|[StartTime]||||||[Symptom]||[SanpleType]|[SendDOCName]||[Send
DP]<CR>
OBX|[ResultType]|[ValueType]|[ItemID]|[ItemName]|[TestResult]|[Unit]|[Co
nsultValue]|[Flag]|||F||||[DocDP]|[DOCName]|<CR>
OBX|1|NM|[ItemID]^LeftLine||[TestResult]||||||F||||[DocDP]|[DOCName]|<C
R>
OBX|1|NM|[ItemID]^RightLine||[TestResult]||||||F||||[DOCDP]|[DOCName]|
<CR>
OBX|1|ED|[ ItemID]||[InstrID]^Histogram^32Byte^HEX^[TestResult]||||||F|||
|[DOCDP]|[DOCName]|<CR>
<EB>
<CR>
3 Communication Operations
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