BC-2800 Operation Maunal (2.0) PDF
BC-2800 Operation Maunal (2.0) PDF
BC-2800 Operation Maunal (2.0) PDF
Operators Manual
2005-2009 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operators Manual, the issued date is 2009-06.
other countries. All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.
All information contained in this manual is believed to be correct. Mindray shall not be liable
for errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product,
only if:
all installation operations, expansions, changes, modifications and repairs of this product
are conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national and
local requirements; and
Be sure to operate the analyzer under the situation specified in this manual;
otherwise, the analyzer will not work normally and the analysis results will
be unreliable, which would damage the analyzer components and cause
personal injury.
II
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Definitions
Main unit: Integrated facilities which implement the specified function separately.
Generally speaking, the main unit should include power supply, control system and
some functional modules.
Consumables: Disposable or short-life parts which should be replaced each time after
use or periodically
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from
the improper use or application of the product or the use of parts or accessories not approved
by Mindray or repairs by people other than Mindray authorized personnel.
Malfunction of the instrument or part whose serial number is not legible enough.
Consumables: N/A
III
Return Policy
Return Procedure
In the event that it becomes necessary to return this product or part of this product to Mindray,
the following procedure should be followed:
1.
Return authorization: Contact the international Customer Service Department and obtain
a Return Materials Authorization number. This number must appear on the outside of the
shipping container. Returned shipments will not be accepted if the number is not clearly
visible. Please provide the model number, serial number, and a brief description of the
reason for return.
2.
Freight policy: The customer is responsible for freight charges when this product is
shipped to Mindray for service (this includes customs charges).
3.
Return address: Please send the part(s) or equipment to the address offered by the
international Customer Service Department.
Company Contact
Manufacturer:
E-mail Address:
Tel:
Fax:
EC-Representative:
Address:
Tel:
0049-40-2513175
Fax:
0049-40-255726
IV
Table of Contents
1
Table of Contents
3.4.3 Derivation of WBC-Related Parameters ..................................... 3-6
3.4.4 HGB............................................................................................. 3-7
3.5
3.6
Table of Contents
6.3
Power-on................................................................................................ 6-3
6.4
6.5
6.6
6.7
6.8
6.9
Table of Contents
9.3.4 Manual Calibration Program ..................................................... 9-17
10
11
12
Appendices ..............................................................................................A-1
Index .........................................................................................................A-1
Specifications ..........................................................................................B-1
Table of Contents
1.1 Introduction
This chapter explains how to use your operators manual, which is shipped with your
BC-2800 auto hematology analyzer and contains reference information about the BC-2800
and procedures for operating, troubleshooting and maintaining the analyzer. Read this
manual carefully before operating your analyzer and operate your analyzer strictly as
instructed in this manual.
All illustrations in this manual are provided as examples only. They may not
necessarily reflect your analyzer setup or data displayed and must not be
used for any other purpose.
1-1
1-2
See
Chapter
Understanding
Your Analyzer
learn about the hardware and software of the BC-2800
Chapter
Understanding
Your Analyzer
learn about how the BC-2800 works
Chapter
Installing
Your
Analyzer
learn about how to define/adjust system settings
operating tasks
Analyzer
Chapter
Using
the
QC
Programs
learn about how to calibrate the BC-2800
Chapter
Using
the
Calibration Programs
learn about how to maintain/service the BC-2800
Chapter 11 Troubleshooting
Your Analyzer
Appendix B Specifications
Appendix
manual
Appendix D Communication
1-3
Precautions,
All capital letters enclosed in [ ] indicate a key name (either on the built-in keypad or the
external keyboard), such as [ENTER].
All capital, bold and italic letters indicate a special operation defined in the following
section, such as SELECT.
Bold letters included in indicate text you can find on the screen, such as Prepare to
ship.
Bold letters indicate defined screen areas/fields, such as System Status area, or
chapter titles, such as Chapter 1 Using This Manual.
All illustrations in this manual are provided as examples only. They may not necessarily
reflect your analyzer setup or data displayed.
1-4
It means
to press the arrow keys ([][] [][]) as needed to move the
CLICK
ENTER
Note that besides the numeric keys you may also use the
[PgUp] or [PgDn] keys to enter digits; or to scan the number
using the bar-code scanner.
to press the arrow keys ([][] [][]) as needed to move the
cursor to the character or digit to the left of the one you want to
delete and press [DEL]; or to press the arrow keys
DELETE
MODIFY
and re-enter the desired one using either the built-in keypad or
the external keyboard.
to press the arrow keys ([][] [][]) as needed to move the
SELECT from **
pull-down list
SELECT
This analyzer adopts a fixed decimal point. You can enter the digits without
bothering to look for the [.] on the external keyboard.
1-5
1.6 Symbols
You will find the following symbols in this manual.
When you see
Then
read the statement below the symbol. The statement is
alerting you to an operating hazard that can cause
personnel injury.
read the statement below the symbol. The statement is
alerting you to a possibility of analyzer damage or unreliable
analysis results.
read the statement below the symbol. The statement is
alerting you to information that requires your attention.
read the statement below the symbol. The statement is
alerting you to a potentially biohazardous condition.
You may find the following symbols on the analyzer or the reagents.
When you see
It means
EQUIPOTENTIALITY
CAUTION,
CONSULT
DOCUMENTS.
BIOLOGICAL RISK
HIGH VOLTAGE
ALTERNATING CURRENT
USE BY
1-6
ACCOMPANYING
IN VITRO DIAGNOSTIC
DATE OF MANUFACTURE
TEMPERATURE LIMITATION
THE
CONCERNING
COUNCIL
IN
VITRO
DIRECTIVE
DIAGNOSTIC
BE
WASTE.
TREATED
BY
AS
HOUSEHOLD
ENSURING
THAT
THIS
FOR
INFORMATION
1-7
MORE
WITH
DETAILED
REGARD
TO
AND
RECYCLING
THIS
CONSULT
THE
PLEASE
DISTRIBUTOR
FROM
WHOM
1-8
YOU
3
2
(1)
Equipotentiality.
To avoid electric shock, disconnect power cord prior to removing or replacing fuse;
3
Biological risk.
4
The following definition of the WEEE label applies to EU member states only: The use of this
symbol indicates that this product should not be treated as household waste. By ensuring that
1-9
5
To avoid being injured, do not put hand under the motor when the machine is running.
1-10
6
To avoid electrical shock, disconnect the power supply before maintaining this device.
1-11
7
High Voltage
1-12
2.1 Introduction
The BC-2800 Auto Hematology Analyzer is a quantitative, automated hematology analyzer
and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories.
2-1
The purpose of this analyzer is to identify the normal patient, with all normal
system-generated parameters, and to flag or identify patient results that
require additional studies.
The analyzer is used for the quantitative determination of a maximum of 19 parameters and 3
histograms of blood samples.
White Blood Cell or leukocyte
WBC
Lymphocyte
Lymph#
Mid-sized cell
Mid#
Granulocyte
Gran#
Lymphocyte percentage
Lymph%
Mid%
Granulocyte percentage
Gran%
RBC
Hemoglobin Concentration
HGB
MCV
MCH
MCHC
RDW-CV
Coefficient of Variation
Red Blood Cell (erythrocyte) Distribution Width
RDW-SD
Standard Deviation
Hematocrit
HCT
Platelet
PLT
MPV
PDW
Plateletcrit
PCT
WBC Histogram
RBC Histogram
Platelet Histogram
PLT Histogram
2-2
1 ---- LCD
2 ---- Keypad
3 ---- Recorder
2-3
2 --- Equipotentiality
2-4
2-5
2.3.1 LCD
The LCD is located on the front panel of the analyzer, as Figure 2-4 shows. It displays all
alphanumeric and graphic data.
Aspirate key
The aspirate key is located behind the sample probe, as Figure 2-4 shows. You can press the
key to start the selected run cycle or dispense diluent.
1.Sample probe
2. Aspirate key
2-6
Built-in keypad
The 18-key keypad is located below the LCD, as Figure 2-5 shows.
PS/2 keyboard
The analyzer can also be controlled by an external PS/2 keyboard that should be connected
to the analyzers keyboard interface. See Table 2-1 for the correspondence between the
keypad keys and the keyboard keys and for their functions.
Table 2-1 Key functions
Keypad
PS/2 keyboard
Function
[MENU]
[Esc]
[PRINT]
[P] or [p]
[HELP]
[H] or [h]
[DEL]
[Delete] or [Del]
[ENTER]
[Enter]
[], [],
[], [],
[], []
[], []
[F4], [F5]
[F4], [F5]
[PgUp][PgDn]
[PageUp]
[PageDown]
[MODE]
[Ctrl+A]
[DILUENT]
Other keys
2-7
2.3.3 Recorder
A thermal recorder is located on the front panel. It prints out analysis reports and other related
information.
Printer
An external printer can be connected to the parallel port at the left side of the analyzer. You
can use it to print out a detailed report and other desired information.
Bar-code scanner
A bar-code scanner can be connected to the RS-232 port 1 of the analyzer. You can use it to
scan the bar-coded sample IDs and reagent information into the analyzer.
2-8
Error Message
Area
Help Area
Reagent Status
Area
Title Area
The Title area displays the title of the current screen, which, in case of Figure 2-6, is Count.
The Count Mode area displays in which analysis (count) mode, the next sample is to be
analyzed. In case of Figure 2-6, the next sample is to be analyzed in the Whole Blood-All.
The System Status area displays whether this analyzer is ready for the next analysis. When
it displays Ready, it means this analyzer is ready and you can proceed to analyze the next
sample. When it displays Waiting, it means the analyzer is not ready for the next run yet.
When it displays Running, it means this analyzer is analyzing a sample.
The Sample Information area has two sub-areas, the upper titled Current sample and the
lower Next sample.
The Current sample refers to the sample, whose analysis result is displayed on the
Count screen. Its sample ID, time of analysis, analysis mode and patient information (name,
gender, age), are respectively displayed in the fields of the Current sample area.
The Next Sample refers to the sample to be analyzed next. Its sample ID and analysis
mode are displayed in the Next sample area.
The Analysis Result area displays the analysis result, including histograms, of the current
sample.
The Error Message area displays error messages one by one, alternating every two
seconds.
The Reagents Status area displays how many counts the remaining reagents are enough for.
Note that when it displays 99 counts, it indicates the reagents are enough for over 99
counts and there is also enough space left in the waste container for the counts; when it
displays 0 counts, it indicates either at least one of the reagents is insufficient or the waste
container is full.
Menu Area
When you press [MENU], this area displays the system menu.
Help Area
The Help area reminds you how to proceed to the next step.
2-10
2-11
If you want to
Select
analyze samples
Count
Review
Quality Control
Setup
Service
Calibration
Shutdown
2-12
Store and use the reagents as directed by instructions for use of the
reagents.
When you have changed the diluent, rinse or lyse, run a background to see
if the results meet the requirement.
Pay attention to the expiration dates and open-container stability days of all
the reagents. Never use expired reagents.
After installing new reagents, let the reagents stand for a while before using
them.
2.5.1 Diluent
The diluent is formulated to meet the following requirements:
To provide the blood cells with an environment similar to the blood plasma;
To maintain the cell volume of each red blood cell and platelet during the count and
sizing portion of the measurement cycle;
To provide a conductive medium for impedance counting of white and red blood cells
and platelets.
2.5.2 Lyse
The lyse is formulated to meet the following requirements:
2-13
To rapidly break down red blood cell walls, release the hemoglobin from the cell, and
reduce the size of cellular debris to a level that does not interfere with white blood cell
counting.
2.5.3 Rinse
The rinse is formulated to rinse the bath and metering tubes and to provide proper meniscus
formation in the metering tubes and maintain it during each measurement cycle.
2-14
3.1 Introduction
The two independent measurement methods used in this analyzer are:
the impedance method for determining the WBC, RBC, and PLT data;
During each analysis cycle, the sample is aspirated, diluted and mixed before the
determination for each parameter is performed.
3-1
3.2 Aspiration
This analyzer can process two types of blood samples whole blood samples and prediluted
blood samples.
If you are going to analyze a whole blood sample, you can simply present the sample to the
sample probe and press the aspirate key to aspirate 13L of the sample into the analyzer.
If you are going to analyze a capillary blood sample, you should first manually dilute the
sample (20 L of capillary sample needs to be diluted by 1.6 mL of diluent) and then present
the pre-diluted sample to the sample probe and press the aspirate key to aspirate 0.7 mL of
the sample into the analyzer.
3-2
3.3 Dilution
Usually in blood samples, the cells are too close to each other to be identified or counted. For
this reason, the diluent is used to separate the cells so that they are drawn through the
aperture one at a time as well as to create a conductive environment for cell counting.
Moreover, red blood cells usually outnumber white blood cells by 1,000 times. For this reason,
lyse needs to be added to the sample to eliminate the red cells before the WBC counting.
3-3
3-4
WBC measurement
WBCs are counted and sized by the impedance method, as Figure 3-2 shows. This method is
based on the measurement of changes in electrical resistance produced by a particle, which
in this case is a blood cell, suspended in a conductive diluent as it passes through an
aperture of known dimensions. An electrode is submerged in the liquid on both sides of the
aperture to create an electrical pathway. As each particle passes through the aperture, a
transitory change in the resistance between the electrodes is produced. This change
produces a measurable electrical pulse. The number of pulses generated indicates the
number of particles that passed through the aperture. The amplitude of each pulse is
proportional to the volume of each particle. Each pulse is amplified and compared to the
internal reference voltage channels, which only accepts the pulses of certain amplitude. If the
pulse generated is above the WBC threshold, it is counted as a WBC.
HGB measurement
HGB is determined by the colorimetric method. The WBC/HGB dilution is delivered to the
bath where it is bubble mixed with a certain amount of lyse, which converts hemoglobin to a
hemoglobin complex that is measurable at 525 nm. An LED is mounted on one side of the
bath and emits a beam of monochromatic light, whose central wavelength is 525nm, and then
is measured by a photo-sensor that is mounted on the opposite side. The signal is then
amplified and the voltage is measured and compared to the blank reference reading
(readings taken when there is only diluent in the bath). The HGB is calculated per the
following equation and expressed in g/L.
3-5
WBC
WBC (109/ L) is the number of leukocytes measured directly by counting the white blood cells
passing through the aperture.
WBC = n 109 / L
Note that NRBCs do not react with the lyse and can be mistaken by the analyzer for white
blood cells. If you observe NRBCs in the microscope, correct the system-generated result by
the following formula,
WBC'WBC
100
100NRBC
where WBC represents the system-generated white cell number, NRBC the number of
NRBCs counted in 100 white cells and WBC the corrected white cell number.
WBC differentia
With the help of the diluent and lyse, this analyzer can size the white cells into three
sub-populations - lymphocytes, mid-sized cells (including monocytes, basophils and
eosinophils) and granulocytes. Based on the WBC histogram, this analyzer calculates Lymph
, Mid and Gran as follows and express the results in percents.
Lymph% =
Mid% =
Gran% =
PL
PL + PM + PG
PM
100
100
PL + PM + PG
PG
PL + PM + PG
100
/L)
/L)
/ L ).
Having achieved the three parameters above, this analyzer proceeds to calculate the
Lymph# , Mid# and Gran# per the following equations and express them in
3-6
10 9 / L .
Lymph# =
Lymph% WBC
100
Mid # =
Mid % WBC
100
Gran # =
Gran % WBC
100
WBC histogram
Besides the parameters mentioned above, this analyzer also presents a WBC histogram,
whose x-coordinate represents the cell volumefLand y-coordinate represents the number
of the cells. The histogram is presented in the Analysis Result area of the Count screen
when the analysis is done. You can also review the histograms of the stored patient results
(see Chapter 7 Reviewing Sample Results).
The first three discriminators of the WBC histogram can be adjusted in case you are not
satisfied with the result. Note that you cannot adjust them if the WBC result is less than 0.5 or
out of the operating range.
3.4.4 HGB
Using the colorimetric method, this analyzer calculates hemoglobin concentration (g/L) as
follows.
HGB (g/L)=ConstantLog 10 (Blank Photocurrent/Sample Photocurrent)
3-7
3-8
RBC/PLT measurement
RBCs/PLTs are counted and sized by the impedance method, as Figure 3-4 shows. This
method is based on the measurement of changes in electrical resistance produced by a
particle, which in this case is a blood cell, suspended in a conductive diluent as it passes
through an aperture of known dimensions. An electrode is submerged in the liquid on both
sides of the aperture to create an electrical pathway. As each particle passes through the
aperture, a transitory change in the resistance between the electrodes is produced. This
change produces a measurable electrical pulse. The number of pulses generated indicates
the number of particles that passed through the aperture. The amplitude of each pulse is
proportional to the volume of each particle. Each pulse is amplified and compared to the
internal reference voltage channels, which only accepts the pulses of a certain amplitude. If
the pulse generated is above the RBC/PLT lower threshold, it is counted as an RBC/PLT.
RBC
RBC (1012/L) is the number of erythrocytes measured directly by counting the erythrocytes
passing through the aperture.
MCV
Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and
3-9
HCT =
RBC MCV
10
MCH =
HGB
RBC
MCHC =
HGB
100
HCT
RDW-CV
Based on the RBC histogram, this analyzer calculates the CV (Coefficient of Variation) of the
erythrocyte distribution width.
RDW-SD
RDW-SD (RBC Distribution Width Standard Deviation, fL) is set on the 20% frequency level
with the peak taken as 100%, as Figure 3-5 shows.
RBC Histogram
Besides the parameters mentioned above, this analyzer also presents an RBC histogram,
whose x-coordinate represents the cell volumefLand y-coordinate represents the number
of the cells. The histogram is presented in the Analysis Result area of the Count screen
when the analysis is done. You can also review the histograms of the stored patient results
(see Chapter 7 Reviewing Sample Results).
The two discriminators of the RBC histogram can be adjusted in case you are not satisfied
with the result. Note that you cannot adjust them if the RBC result is less than 0.2 or out of the
operating range.
3-10
PLT
PLT (109/L) is measured directly by counting the platelets passing through the aperture.
MPV
Based on the PLT histogram, this analyzer calculates the mean platelet volume (MPV, fL).
PDW
Platelet distribution width (PDW) is the geometric standard deviation (GSD) of the platelet
size distribution. Each PDW result is derived from the platelet histogram data and is reported
as 10 (GSD).
PCT
PCT =
PLT MPV
10000
PLT Histogram
Besides the parameters mentioned above, this analyzer also presents a PLT histogram,
whose x-coordinate represents the cell volumefLand y-coordinate represents the number
of the cells. The histogram is presented in the Analysis Result area of the Count screen
when the analysis is done. You can also review the histograms of the stored patient results
(see Chapter 7 Reviewing Sample Results).
The two discriminators of the PLT histogram can be adjusted in case you are not satisfied
with the result. Note that you cannot adjust them if the PLT result is less than 10 or out of the
operating range.
3-11
3.6 Wash
After each analysis cycle, each element of the analyzer is washed.
3-12
4.1 Introduction
This chapter introduces how to install the BC-2800. To ensure all system components
function correctly and to verify system performance, Mindray-authorized representatives will
handle the installation and initial software setup.
4-1
enough room on or below the countertop to accommodate the diluent, rinse and waste
containers.
Frequency: 50/601 Hz
Power: 180VA
Before connecting the power cord, make sure the power switch at the back
of the analyzer is placed in the off (O) position.
4-2
Operating temperature: 15 to 30 .
The environment should be as free as possible from dust, mechanical vibrations, loud
noises, and electrical interference.
Do not place the analyzer near brush-type motors, flickering fluorescent lights, and
electrical contacts that regularly open and close.
Do not place the analyzer in direct sunlight or in front of a source of heat or drafts.
4-3
4.3 Unpacking
4.3.1 Unpacking and Inspecting the Analyzer
Your analyzer is tested before it is shipped from the factory. International symbols and special
handling instructions tell the carrier how to treat this electronic instrument. When you receive
your analyzer, carefully inspect the carton. If you see any signs of mishandling or damage,
contact Mindray customer service department or your local distributor immediately. When you
are sure the carton is fine, follow the steps below to unpack the analyzer:
Place the carton on the floor upright with the arrows on the side upwards;
Remove the tape and take out the accessory box. Check the accessories against the
packing list. Notify the Mindray customer service department or your local distributor
immediately if you find anything missing;
Open the main box and check the items inside against the packing list. Notify the
Mindray customer service department or your local distributor immediately if you find
anything missing;
Remove the top protective foam, carefully carry out the analyzer from the box and place
it on the countertop.
Retain the shipping carton and all the packing materials, as they can be
used for packaging if analyzer must be reshipped.
If the carton is intact, you may use a plate and fork-lifter to move the analyzer for a short
distance.
If your analyzer has been used, do the Empty tubing procedure and shut it down
before moving it.
For a short - distance moving on a smooth ground, you may use a trolley to facilitate the
transportation.
During the moving process, protect the LCD and the sample probe from excessive force
and from contact with other objects.
Keep the analyzer upright during the moving process. Do not tilt or incline it.
Do your best to minimize the mechanical shock when moving the analyzer. After a
long-distance moving, check and tune the analyzer before using it.
4-4
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
z
z
z
z
4-6
4-7
4-8
Remove the protective paper between the recorder head and the roller
inside the recorder before installing recorder paper.
Use the latch at the upper right corner of the recorder door to pull the door open.
2.
3.
4.
Check if paper is installed correctly and the paper end is feeding from the top.
Paper roll
Use only specified recorder paper. Otherwise, it may cause damage to the
recorder head, or the recorder may be unable to print, or poor print quality
may result.
Never pull the recorder paper with force when a recording is in process.
Otherwise, it may cause damage to the recorder.
Do not leave the recorder door open unless you install paper or remove
trouble.
Improper installation of recorder paper may jam the paper and/or result in
blank printout.
4-9
4-10
4-11
5.1 Introduction
The BC-2800 is a flexible laboratory instrument that can be tailored to your work environment.
You can use the Setup program to customize the software options as introduced in
Chapters 5.2 to 5.3.
5-1
5.2 Password
The BC-2800 classifies users into two categories: common users (default) and administrators.
You need to enter the administrator password to adjust certain options such as Count,
Gain, etc.
5-2
5-3
This area displays the visible or changeable setting groups. You can press [F1] to select the
desired group. The selected group is preceded by a .
You can change the settings of the items displayed in this area.
5.3.1 Reagent
You can select the Reagent group to change the settings regarding the reagents and the
waste, as Figure 5-7 shows.
You may set the remaining volumes for the diluent, rinse and lyse. When any of the entered
volumes is counted down to zero, the system will remind you to install a new container.
1. SELECT Diluent, Rinse or Lyse in the Remains field as needed;
2. ENTER the desired digits. See Table 5-1 for the valid reagent volumes.
Table 5-1 Valid reagent volumes
Diluent
Allowed range
About 0 to 30.0 L
Rinse
About 0 to 30.0 L
Lyse
About 0 to 999.0 mL
You may enter the usable volume of the waste container. When the system counts down the
entered volume to 0, it will alert you to empty the waste container. Follow the steps given
below to set the volume.
5-5
You can specify the expiration dates for the diluent, rinse and lyse. Once any of these
reagents is expired, the system will alert you to install a new container. Follow the steps given
below to enter the expiration dates.
1. SELECT Exp. Date;
2. ENTER the desired digits. You can use the bar-code scanner (if available) to scan the
bar-code of the reagents into the analyzer;
3. Note that open reagents are stable for 60 days. The entered expiration date should be
the open date + 60 days or the expiration date marked on the packaging of the reagent,
whichever is earlier.
When you have finished changing all the desired reagent settings, you may
1. Press [F1] to select another setting group you want to change; or
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-8 shows. CLICK Yes to save the changes and exit to the system menu; or
CLICK No to exit to the system menu without saving the changes.
5-6
To select a printing device, SELECT Recorder or Printer from the Device drop-down
list, as Figure 5-10 shows.
If you have selected the printer, you can choose either of the following printing formats.
1. Format1 - One page with histogram;
2. Format2 - One page without histogram.
To select a printing format, SELECT desired format from the Format drop-down list,
If you have selected the recorder, you can choose any of the following 4 printing formats.
1. Format1 - parameter values + histograms;
2. Format2 parameter values only;
3. Format3 - parameter values + histograms;
4. Format4 - parameter values only.
To choose the desired format, SELECT the desired format from the Format pull-down list,
as Figure 5-11 shows.
5-7
Auto printing
The auto printing function refers to the analyzers ability to automatically print out the analysis
results once they are done. To activate this function, SELECT ON (or OFF) from the
Auto pull-down list, as Figure 5-12 shows.
To choose one of the four baud rates, 19200, 9600, 4800, 2400 and 1200, SELECT
the desired baud rate from the Baud drop-down list, as Figure 5-13 shows.
5-8
Selecting parity
To choose the Odd, Even or None (default) check, SELECT the desired check from the
Parity drop-down list, as Figure 5-14 shows.
Activating/deactivating handshake
If the Handshake function is activated, to start the transmission this analyzer will send a
handshake signal to an external computer and wait for the response. If the computer does not
respond, this analyzer will abort the transmission and give an alarm for the transmission error.
If the Handshake function is deactivated, this analyzer will transmit data to the external
computer regardless of the response. This function is deactivated by default.
5-9
Auto Communication
The auto communication function refers to the analyzers ability to automatically transmit the
analysis results to an external computer once they are done. To activate or deactivate this
function, SELECT On or Off from the Auto drop-down list in the Transmit field, as
Figure 5-16 shows.
5-10
When you have finished changing all the desired printing and transmission settings, you may
press [F1] to select another setting group you want to change; or press [MENU] and a
message box will pop up to remind you to save the changes, as Figure 5-17 shows. CLICK
Yes to save the changes and exit to the system menu; or CLICK No to exit to the system
menu without saving the changes.
You may choose one of the three formats YYYY-MM-DD, MM-DD-YYYY and
DD-MM-YYYY. To do so, SELECT the desired format from the Format drop-down list,
as Figure 5-19 shows.
When you have finished changing all the desired date and time settings, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-20 shows. CLICK Yes to save the changes and exit to the system menu; or
CLICK No to exit to the system menu without saving the changes.
5-12
5.3.4 Gain
You can select the Gain group to view or change (if you have the administrator password)
the WBC, RBC and HGB gains.
When WBC histograms of most samples are similar to Figure 5-22, it implies too small a
WBC gain and you need to increase the gain appropriately.
5-13
When the difference between the actual MCV result and the expected result exceeds 6%,
you need to change the RBC gain.
5-14
ExpectedMCV
90.0
100%
100% = 109.8%
ActualMCV
82.0
You should adjust the RBC gain to 109.8% as close as possible. Follow the steps given below
to do so.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the Settings screen, press [F1] to select the Gain group;
3. SELECT RBC, as Figure 5-26 shows;
4. ENTER the desired gain so that the adjustment becomes as close to 109.8% as possible.
You may adjust the HGB gain to change the HGB blank voltage, which usually should be set
between 3.4 to 4.8V (4.5V recommended). Follow the steps given below to set the HGB gain.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the Settings screen, press [F1] to select the Gain group;
3. SELECT HGB;
4. ENTER the desired gain so that the HGB blank voltage is between 3.4 to 4.8V, as Figure
5-27 shows.
5-15
When you have finished changing all the desired gain settings, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-28 shows. CLICK Yes to save the changes and exit to the system menu; or
CLICK No to exit to the system menu without saving the changes.
5.3.5 Count
You can select the Count group to view or change (if you have the administrator password)
the parameter units and count time.
5-16
This analyzer provides multiple units for certain parameters. Refer to Table 5-2 for all the
selectable units of all parameters. The 19 parameters are divided into 11 groups based on
their units and you can only select unit for the first parameter of a group. Pay special attention
to the HGB group, which includes HGB, MCHC and MCH. When you select g/L or g/dL as the
unit of HGB, the default unit for MCH is pg; when you select mmol/L as the unit of HGB, the
default unit of MCH is fmol.
Table 5-2 Units of Parameters
Parameter
Display format
Unit
Remarks
***.*
10 /L
Default
***.*
10 /uL
Mid#
****
10 /uL
Gran#
***.*
/nL
Lymph%
**.*
Mid%
.***
***
g/L
Default
**.*
g/dL
**.*
mmol/L
WBC
Lymph#
Default
Gran%
HGB, MCHC
5-17
1012/L
Default
*.**
106/uL
***
104/uL
*.**
/pL
**.*
Default
.***
L/L
***.*
fL
Default
***.*
um3
RDW-CV
**.*
Default
PLT
****
109 /L
Default
****
103 /uL
***.*
104 /uL
****
/nL
***.*
fL
Default
***.*
um3
PDW
**.*
Default
PCT
.***
Default
*.**
mL/L
*.***
pg
Default
**.**
fmol
RBC
HCT
MCV, RDW-SD
MPV
MCH
5-18
If the WBC or RBC count time is inappropriately set, the system may give false alarms for
clogs or bubbles. When this happens, follow the steps given below to change the WBC or
RBC count time. Refer to the actual count time (see Chapter 10.5.1 for details) when editing
the count time. Follow the steps given below to set the count time.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the Settings screen, press [F1] to select the Count group;
3. SELECT WBC or RBC, as Figure 5-31 shows;
4. ENTER the desired digits.
Gender
Age
Not specified.
Not specified.
12 years
Man
Male
12 years
Woman
Female
12 years
Child
Male or Female
Neonate
Male or Female
28 days
The upper and lower limits of the reference ranges are visible to all users but changeable
5-20
Follow the steps given below to select the patient group you want.
1. At the Settings screen, press [F1] to select the Ref. Range group.
2. SELECT the combo box to the right of Group.
5-21
When you have finished changing all the parameter units and count time settings you want to
change, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] to exit to the system menu.
5-24
Muting beeper
This analyzer beeps when an error occurs. You can mute the beeper by pressing any key or
leave it beeping until the errors are removed. If you prefer the former, SELECT Enabled
from the Any key to mute drop-down list ; if you prefer the latter, SELECT Disabled
from the Any key to mute drop-down list. See Figure 5-41 shows.
5-25
Follow the steps given below to set for how long (2s to120s) the error messages listed in
Table 5-4 should be displayed on the screen.
Table 5-4 Error List
No.
1
Error
Communication Error
No.
2
Error
Scanner Error
No.
3
Error
Scanner
Communication Error
Environmental
Background Abnormal
HGB Error
WBC Bubbles
Temperature Abnormal
7
HGB Adjustment
WBC Clog
10
RBC Clog
11
RBC Bubbles
5-26
The PMB color refers to the background color of the screen when your analyzer is in the
prediluted mode. Follow the steps below to select the PMB color.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the Settings screen, press [F1] to select the Other group;
3. SELECT Black (default) or Blue from the PMB color drop-down list, as Figure
5-44 shows.
You can delete the information in the list of Dept., Sender, Tester and Checker stored
5-27
When you have finished changing all the parameter units and count time settings you want to
change, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-46 shows. SELECT Yes to save the changes and exit to the system menu; or
SELECT No to exit to the system menu without saving the changes.
5-28
5-29
6.1 Introduction
This chapter provides step-by-step procedures for operating your analyzer on a daily basis.
Initial Checks
Power on
No
Shutdown
6-1
Check and make sure the diluent, rinse and waste tubes are properly connected and not
bent;
Check and make sure the power cord of the analyzer is properly plugged into an
electrical outlet.
6-2
6.3 Power-on
Place the power switch at the back of the analyzer in the ON position (1) to turn on the
analyzer. The power indicator light will be illuminated and the screen will display
Initializing.
The analyzer will sequentially initialize the file, hardware and fluidic systems and the whole
initializing process lasts 4 to 7 minutes, depending on how the analyzer was previously shut
down.
If any error occurs during the initialization, the analyzer will display the error messages in the
lower left corner of the screen. You should remove all the errors before running any sample.
See Chapter 11 Troubleshooting Your Analyzer for solutions.
Running samples with the abnormal background error present will lead to
unreliable results.
6-3
6-4
6-5
For the whole blood samples to be used for WBC differential or PLT count,
you shall store them at the room temperature and run them within 4 hours
after collection.
If you do not need the PLT, MCV and WBC differential results, you can store
the samples in a refrigerator (2 to 8) for 24 hours. You need to warm the
6-6
Mix any sample that has been prepared for a while before running it.
6-7
When preparing a prediluted sample, only use lint-free tissue to wipe the
external wall of the capillary tube; do not use cotton balls.
After mixing the capillary sample with the diluent, wait 5 minutes before
running the sample.
Mix any sample that has been prepared for a while before running it.
6-8
When you save the next sample information, run sample analysis;
Otherwise, the input sample information cannot be displayed when
restarting the analyzer.
ID only
All Info
ID only mode
To enter the sample ID of the next sample, you may
6-9
6-10
Entering Edit
At the Count screen, press [F1] and an edit window will pop up, as Figure 6-6 shows.
Entering sample ID
ENTER the ID number in the ID box, or if you have the bar-code scanner installed, you can
simply scan the sample ID into the analyzer.
SELECT the desired item from the Gender drop-down list, as Figure 6-7 shows. Note
that you can select blank in case you are not aware of the patient gender.
6-11
This analyzer provides three ways for you to enter the patient age in years, in months and in
days.
To enter the patient age in years: ENTER the desired number, an integer from 0 to 200, into
the Years box.
To enter the patient age in months: ENTER the desired number, an integer from 0 to 12, into
the Months box.
To enter the patient age in days: ENTER the desired number, an integer from 0 to 31, into the
Days box.
ENTER the number of the patients medical chart into the Chart No. box.
ENTER the number of the patients bed into the Bed No. box.
You can either directly ENTER the name of the department, from which the sample came,
into the Department box or SELECT the desired department from the Department
pull-down list (if there are previously saved departments in the list, as Figure 6-8 shows).
6-12
To enter the name of the person who sent the sample for analysis, enter the name into the
Sender box or SELECT the desired name from the Sender pull-down list (if there are
previously saved names in the list); to enter the name of the person who is to run (or has run)
the sample, enter the name into the Tester box or SELECT the desired name from the
Tester pull-down list (if there are previously saved names in the list) ; to enter the name of
the person who is to review the sample results, enter the name into the Reviewer box, or
SELECT the desired name from the Checker pull-down list (if there are previously saved
names in the list). All the three pull-down lists are capable of saving 30 entered names.
Exit edit
When you have finished entering all the desired sample information, CLICK the Yes button
to save the changes and return to the Count screen. If you do not want to save the entered
information, CLICK the No button to return to the Count screen without saving the
changes.
Entering Edit
At the Count screen, press [F4] and an edit window will pop up, as Figure 6-9 shows.
Follow the instructions to enter the information of the first sample.
6-13
Save
Next/Prev
If you want to review the entered information of a specific sample, press the appropriate
arrow keys to CLICK Prev. or Next to review the previous or next sample until the desired
sample is reached.
Delete
If you want to delete the currently displayed sample information, CLICK Delete to complete
the deletion.
Exit
When you are done with the batch, CLICK Exit to exit to the Count screen. After a sample
is analyzed, its corresponding sample information will be automatically displayed in the
Current sample area.
6-14
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
Keep the sample probe tip away from the tube bottom, otherwise the
aspiration volume may be inaccurate.
When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.
1. Present the mixed sample to the sample probe so that the tip is well into the tube, and
press the aspirate key. The System Status area will display Running and the analyzer
will start aspirating sample;
2. When you hear the beep and the sample probe is out of the tube, remove the sample
tube. The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;
3. When the analysis is finished, the result will be displayed on the screen and the sample
ID will automatically increase by 1 and the sample probe will be repositioned. And if the
auto print function is enabled, the analysis result will be automatically printed out;
4. Repeat the above steps on other samples.
6-15
6-16
Parameter flags
If you see *** as opposed to the result, it means the result is either unreliable or out of the
operating range.
If the WBC result is less than 0.5 109/L, this analyzer will not perform the differential
analysis and all the related parameter values will be non-numeric (***).
Histogram flags
The system will flag abnormal histograms.
Abnormal WBC histograms will be flagged by one of the markings: R1, R2, R3, R4 and
Rm.
R1: indicates abnormality on the left side of the lymphocyte hump and possible presence of
6-17
Abnormal PLT histograms will be flagged by one of the markings: Pm, PS and PL.
Pm: indicates blur demarcation between the platelet and red blood cell area and possible
presence of large platelet, platelet coagulation, small red blood cell, cell debris or fibrin.
PS: indicates excessive small PLTs.
PL: indicates excessive large PLTs.
When the PLT value is less than 100 109 / L, a manual count by the
microscope is recommended.
6-18
ID only
All Info
ID only
To enter the sample ID of the next sample, you may
At the Count screen, use the bar-code scanner (if available) to scan the sample ID into the
analyzer; or
At the Count screen, press [F1] to enter the ID window and ENTER the sample ID.
6-19
6-20
Entering Edit
At the Count screen, press [F1] and an edit window will pop up, as Figure 6-15 shows.
Entering sample ID
ENTER the ID number in the ID box, or if you have the bar-code scanner installed, you can
simply scan the sample ID into the analyzer.
SELECT the desired item from the Gender drop-down list, as Figure 6-16 shows. Note
that you can select blank in case you are not aware of the patient gender.
6-21
This analyzer provides three ways for you to enter the patient age in years, in months and in
days.
To enter the patients age in years: ENTER the desired number, an integer from 0 to 200, into
the Years box.
To enter the patient age in months: ENTER the desired number, an integer from 0 to 12, into
the Months box.
To enter the patient age in days: ENTER the desired number, an integer from 0 to 31, into the
Days box.
ENTER the number of the patients medical chart into the Chart No. box.
ENTER the number of the patients bed into the Bed No. box.
You can either directly ENTER the name of the department, from which the sample came,
into the Dept box or SELECT the desired department from the Dept pull-down list (if
there are previously saved departments in the list, as Figure 6-17 shows).
6-22
To enter the name of the person who sent the sample for analysis, enter the name into the
Sender box or SELECT the desired name from the Sender pull-down list (if there are
previously saved names in the list); to enter the name of the person who is to run (or has run)
the sample, enter the name into the Tester box or SELECT the desired name from the
Tester pull-down list (if there are previously saved names in the list) ; to enter the name of
the person who is to review the sample results, enter the name into the Reviewer box, or
SELECT the desired name from the Checker pull-down list (if there are previously saved
names in the list). All the three pull-down lists are capable of saving 30 entered names.
Exit edit
When you have finished entering all the desired sample information, CLICK the Yes button
to save the changes and return to the Count screen. If you do not want to save the entered
information, CLICK the No button to return to the Count screen without saving the
changes.
Entering Edit
At the Count screen, press [F4] and an edit window will pop up, as Figure 6-21 shows.
Follow the instructions to enter the information of the first sample.
6-23
Save
Next/Prev
If you want to review the entered information of a specific sample, press the appropriate
arrow keys to CLICK Prev. or Next to review the previous or next sample until the desired
sample is reached.
Delete
If you want to delete the currently displayed sample information, CLICK Delete to complete
the deletion.
Exit
When you are done with the batch, CLICK Exit to exit to the Count screen. After a sample
is analyzed, its corresponding sample information will be automatically displayed in the
Current sample area.
6-24
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
Keep the sample probe tip away from the tube bottom, otherwise the
aspiration volume may be inaccurate.
When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.
1. Present the mixed sample to the sample probe so that the tip is well into the tube, and
press the aspirate key. The System Status area will display Running and the analyzer
will start aspirating sample;
2. When you hear the beep and the sample probe is out of the tube, remove the sample
tube. The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;
3. When the analysis is finished, the result will be displayed on the screen and the sample
ID will automatically increase by 1 and the sample probe will be repositioned. And if the
auto print function is enabled, the analysis result will be automatically printed out;
4. Repeat the above steps on other samples.
Parameter flags
If you see *** as opposed to the result, it means the result is either unreliable or out of the
operating range.
If the WBC result is less than 0.5 109/L, this analyzer will not perform the differential
analysis and all the related parameter values will be non-numeric (***).
Histogram flags
The system will flag abnormal histograms.
Abnormal WBC histograms will be flagged by one of the markings: R1, R2, R3, R4 and
Rm.
R1: indicates abnormality on the left side of the lymphocyte hump and possible presence of
platelet clumps, giant platelets, nucleated red cell, insolvable red cell, protein and lipoid
debris in sample, or electrical noise.
R2: indicates abnormality between the lymphocyte hump and the mid-sized cell area and
possible presence of abnormal lymphocyte, plasma cell, atypical lymphocyte, original
granulocytes in the sample and eosinophilia or basophilia.
R3: indicates abnormality between the mid-sized cell area and the granulocytes and possible
presence of immature granulocytes, abnormal sub-population in the sample, or eosinophilia.
R4: indicates abnormality on the right side of the granulocytes hump and netrophilia.
Rm: indicates at least two R flags.
Abnormal PLT histograms will be flagged by one of the markings: Pm, PS and PL.
6-26
When the PLT value is less than 100 109 / L, a manual count by the
microscope is recommended.
6-27
6.9 Shutdown
Perform the Shutdown procedure to shut down the analyzer daily.
1. Press [MENU] to enter the system menu and SELECT Shutdown, as Figure 6-20
shows;
6-28
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
4. Present the E-Z cleanser to the sample probe and press the aspirate key. The analyzer
will aspirate the E-Z cleanser and automatically clean the fluidic lines and the bath. The
cleaning progress will be displayed on the screen, as Figure 6-23 shows;
6-29
6-30
7.1 Introduction
The analyzer automatically saves analysis results. Totally 10,000 results can be saved. You
can either browse all the saved sample results in general or search for the results of a
particular sample or samples.
7-1
In this mode, you can review both parameter values and histograms of the saved sample
results, one sample result per screen.
In this mode, the sample results are presented in a columnar fashion without histograms
(namely you can only see the parameter values). One screen displays a maximum of 8
sample results.
7-3
ID
Selecting gender
SELECT the desired item from the Gender drop-down list. Note that you can select blank
in case you are not aware of the patient gender.
This analyzer provides three ways for you to enter the patient age in years, in months and
in days. The first way is designed for the patients no younger than one year; the second for
the patients older than one month and younger than one year; the third for the patients
younger than one month. You can choose only one of the three ways to enter the patient age.
To enter the patient age in years: ENTER the desired number, an integer from 0 to 200, into
the Years box.
To enter the patient age in months: ENTER the desired number, an integer from 0 to 12, into
the Months box.
To enter the patient age in days: ENTER the desired number, an integer from 0 to 31, into the
Days box.
ENTER the number of the patients medical chart into the Chart No. box.
7-4
ENTER the number of the patients bed into the Bed No. box.
You can either directly ENTER the name of the department, from which the sample came,
into the Dept box or SELECT the desired department from the Dept pull-down list (if
there are previously saved departments in the list).
To enter the name of the person who sent the sample for analysis, enter the name into the
Sender box or SELECT the desired name from the Sender pull-down list (if there are
previously saved names in the list); to enter the name of the person who is to run (or has run)
the sample, enter the name into the Tester box or SELECT the desired name from the
Tester pull-down list (if there are previously saved names in the list) ; to enter the name of
the person who is to review the sample results, enter the name into the Reviewer box, or
SELECT the desired name from the Checker pull-down list (if there are previously saved
names in the list). All the three pull-down lists are capable of saving 30 entered names.
Yes button
When you have finished entering all the desired sample information, CLICK the Yes button
to save the changes and return to exit the edit window.
No button
If you do not want to save the entered information, CLICK the No button to return to exit the
edit window.
Adjusting histograms
If you are not satisfied with the obtained histograms, you can adjust them manually after you
have entered the administrator password.
The first three discriminators of the WBC histogram are adjustable. Note that if the WBC
result is less than 0.5 or non-numeric (***), the WBC histogram is not adjustable.
The first two discriminators of the RBC histogram are adjustable. Note that if the RBC result
is less than 0.2 or non-numeric (***), the RBC histogram is not adjustable.
The first two discriminators of the PLT histogram are adjustable. Note that if the PLT result is
less than 10 or non-numeric (***), the PLT histogram is not adjustable.
For example, to move the third discriminator of the following WBC histogram, follow the
procedure below to do so.
7-5
1. Press [ENTER] and the discriminator will become adjustable. See Figure 7-5;
7-6
Press [] or [] to move the cursor to the desired sample result and press [ENTER] to select
it. The selected sample result will be marked with a *, as sample 117 in Figure 7-12 shows.
7-8
Example1: To select the sample results of locations 1 to 5 (sample IDs:114 to 118 ), follow the
procedure below to do so:
1. Press [F2] to enter the Select window, as Figure 7-14 shows;
7-9
3. CLICK Exit to return to the sample table review screen. The * above those sample
results will disappear, as Figure 7-18 shows.
7-11
7-12
Special functions
To access the Special Functions screen, you must first select several (1 to 500) sample
results and then press [F5] to enter the Special Functions screen, as Figure 7-23 shows.
7-13
Reproducibility
See Figure 7-23 for the Special Functions screen open to all users. The screen consists of
two fields, the left displaying the available functions and the right displaying the 19
parameters and their reproducibility indices (Mean, Diff and CV).
If the selected samples are less than 3, the reproducibility indices are all 0. If the analysis
result of certain parameter is invalid (***), the corresponding index will also be invalid (***).
7-14
7-15
The x-coordinate represents how many sample results have been selected. The
y-coordinate represents the analysis results of the displayed parameters.
For every parameter, the upper dash line of its trend represents the upper limit of the
expected range, 10% above the mean, of the analysis result. In case of WBC in Figure
7-25, the upper limit is 10.2.
For every parameter, the lower dash line of its trend represents the lower limit of the
expected range, 10% below the mean, of the analysis result. In case of WBC in Figure
7-25, the lower limit is 8.4.
For every parameter, its mean is displayed between the values of the upper dash line
and of the lower dash line. In case of WBC in Figure 7-25, the mean is 9.3.
For every parameter, the three numbers on the right of its trend represents:
Mean the mean value of the saved results
Diff standard deviation of the saved analysis results
CV - Coefficient of Variation
n
Mean =
i =1
X i Mean
Diff =
n 1
CV =
)2
Diff
100%
Mean
where n represents how many sample results are selected and Xi is the result of the ith
analysis. If the selected samples are less than 3, the three indices will all be 0. If the analysis
result of certain parameter is invalid (***), the three indices will also be invalid (***). Under
these two circumstances, the three values on the left of the trends are the parameters means
and expected ranges set by the user (see Chapter 5.3.6).
Every point in the graph is interpreted as follows:
The darkened square that falls between the upper dash line and the lower dash line is
within the expected range. Otherwise, it is not. The blank square represents the sample
analysis either ran into errors or the result is out of the display range.
7-16
7-17
SELECT the desired item from the Gender drop-down list. Note that you can select blank
in case you are not aware of the patient gender.
You can either directly ENTER the name of the department, from which the sample came,
into the Dept box or SELECT the desired department from the Dept pull-down list (if
there are previously saved departments in the list,
Entering sample ID
ENTER the number of the patients bed into the Bed No. box.
ENTER the number of the patients medical chart into the Chart No. box.
ENTER the start date into the Start box; ENTER the end date into the End box.
CLICK Yes to start the search. The analyzer will search the saved sample results for
matches and report the conclusion at Search Result window, as Figure 7-29 shows. CLICK
Yes of the Search Result window to return to the searched sample review screen,. The
matches found are saved in a database called Searched and you can review them in either
the Table mode or the Histogram mode.
7-18
For every search, the analyzer can display a maximum of 500 matches.
The matches will be deleted if you have run another sample (including
background check), or deleted a sample result, or restarted the analyzer
after the search.
7-19
7-20
Press [] or [] to move the cursor to the desired sample result and press [ENTER] to select
it. The selected sample result will be marked with a *, as sample 118 in Figure 7-32 shows.
7-21
Example1: To select the sample results of locations 1 to 5 (sample IDs:114 to118 ), follow the
procedure below to do so:
1. Press [F2] to enter the Select window, as Figure 7-34 shows;
7-23
7-24
7-25
Special functions
To access the Special Functions screen, you must first select several (1 to 500) sample
results and then press [F5] to enter the Special Functions screen, as Figure 7-43 shows.
7-26
Reproducibility
See Figure 7-43 for the Special Functions screen open to all users. The screen consists of
two fields, the left displaying the available functions and the right displaying the 19
parameters and their reproducibility indices (Mean, Diff and CV).
If the selected samples are less than 3, the reproducibility indices are all 0. If the analysis
result of certain parameter is invalid (***), the corresponding index will also be invalid (***).
Trend
After entering the administrator password, you can enter the Special Functions screen
open to administrators, as Figure 7-44 shows. Press [F1] to access the Trend, which
displays the WBC, RBC, PLT, HGB, MCV and RDW-CV trends of the selected sample results.
The six trends are displayed in two screens, three trends in one, as Figure 7-45 and Figure
7-46 show. You can press [][] to switch between the screens. The selected results are
sequentially presented in the trend, newest at the utmost left (No. 1).
7-27
The x-coordinate represents how many sample results have been selected. The
y-coordinate represents the analysis results of the displayed parameters.
For every parameter, the upper dash line of its trend represents the upper limit of the
expected range, 10% above the mean, of the analysis result. In case of WBC in Figure
7-45, the upper limit is 10.2.
7-28
For every parameter, the lower dash line of its trend represents the lower limit of the
expected range, 10% below the mean, of the analysis result. In case of WBC in Figure
7-45 , the lower limit is 8.4.
For every parameter, its mean is displayed between the values of the upper dash line
and of the lower dash line. In case of WBC in Figure 7-45, the mean is 9.3.
For every parameter, the three numbers on the right of its trend represents:
Mean the mean value of the saved results
Diff standard deviation of the saved analysis results
CV - Coefficient of Variation
n
Mean =
i =1
X i Mean
Diff =
n 1
CV =
)2
Diff
100%
Mean
where n represents how many sample results are selected and Xi is the result of the ith
analysis. If the selected samples are less than 3, the three indices will all be 0. If the analysis
result of certain parameter is invalid (***), the three indices will also be invalid (***). Under
these two circumstances, the three values on the left of the trends are the parameters means
and expected ranges set by the user (see Chapter 5.3.6).
Every point in the graph is interpreted as follows:
The darkened square that falls between the upper dash line and the lower dash line is
within the expected range. Otherwise, it is not. The blank square represents the sample
analysis either ran into errors or the result is out of the display range.
7-29
ID
Selecting gender
SELECT the desired item from the Gender drop-down list. Note that you can select blank
in case you are not aware of the patient gender.
This analyzer provides three ways for you to enter the patient age in years, in months and
in days. The first way is designed for the patients no younger than one year; the second for
the patients older than one month and younger than one year; the third for the patients
younger than one month. You can choose only one of the three ways to enter the patient age.
To enter the patient age in years: ENTER the desired number, an integer from 0 to 200, into
the Years box.
To enter the patient age in months: ENTER the desired number, an integer from 0 to 12, into
the Months box.
7-31
ENTER the number of the patients medical chart into the Chart No. box.
ENTER the number of the patients bed into the Bed No. box.
You can either directly ENTER the name of the department, from which the sample came,
into the Dept box or SELECT the desired department from the Dept pull-down list (if
there are previously saved departments in the list).
To enter the name of the person who sent the sample for analysis, enter the name into the
Sender box or SELECT the desired name from the Sender pull-down list (if there are
previously saved names in the list); to enter the name of the person who is to run (or has run)
the sample, enter the name into the Tester box or SELECT the desired name from the
Tester pull-down list (if there are previously saved names in the list) ; to enter the name of
the person who is to review the sample results, enter the name into the Reviewer box, or
SELECT the desired name from the Checker pull-down list (if there are previously saved
names in the list). All the three pull-down lists are capable of saving 30 entered names.
Yes button
When you have finished entering all the desired sample information, CLICK the Yes button
to save the changes and return to exit the edit window.
No button
If you do not want to save the entered information, CLICK the No button to return to exit the
edit window.
Adjusting histograms
If you are not satisfied with the obtained histograms, you can adjust them manually after you
have entered the administrator password.
The first three discriminators of the WBC histogram are adjustable. Note that if the WBC
result is less than 0.5 or non-numeric (***), the WBC histogram is not adjustable.
The first two discriminators of the RBC histogram are adjustable. Note that if the RBC result
7-32
7-34
8.1 Introduction
Quality Control (QC) consists of strategies and procedures that measure the precision and
stability of the analyzer. The results imply the reliability of the sample results. QC involves
measuring materials with known, stable characteristics at frequent intervals. Analysis of the
results with statistical methods allows the inference that sample results are reliable.
Mindray recommends you run the QC program daily. A new lot of controls should be
analyzed in parallel with the current lot prior to their expiration dates. This may be
accomplished by running the new lot of controls twice a day for five days using any empty QC
files. The QC files calculate the mean, standard deviation and coefficient of variation for each
selected parameter. The instrument-calculated means of these ten runs should be within the
expected ranges published by the manufacturer.
This analyzer provides two QC programs QC with controls and X-B analysis.
Use the specified controls. Using controls other than the specified will lead
to misleading results.
Refer to the instructions of use of the controls for how to store and use the
controls.
8-1
Selecting a QC file
The analyzer provides 9 QC files for you to save QC settings and results. Every QC file can
save the results of a maximum of 31 QC runs. When the saved QC results have reached the
maximum number, the newest result will overwrite the oldest. You can press [F1] to switch the
QC files and the number will be given on the upper left of the screen. After selecting the QC
file, press [F2] to select the Whole Blood or Prediluted mode.
8-2
Editing QC settings
If there are saved QC results and settings, you need to delete them first. You can press [F5]
to enter QC Table screen to delete all the results, see Chapter 8.2.3 for details.
Press [F3] at Controls screen to enter the QC Edit screen (Figure 8-3).
ENTER the lot number of the control to be used into the Lot No. box, as Figure 8-4 shows.
ENTER the expiration date of the control to be used into the Exp. Date box, as Figure 8-5
8-3
ENTER the expected results (mean) and limits (range) respectively into the Mean and
Range boxes of the parameters to be included in the QC analysis, as Figure 8-6 shows.
Refer to the instructions of use of the control for information on the lot
number, expiration date, open-vial stability days, expected results and limits.
The entered expiration date should be either the expiration date printed on
the labeling or the open-vial expiration date. It is earlier.
8-4
The open-vial expiration date is calculated as follows: the date that vial is
opened + the open-vial stability days.
Deleting settings
Printing settings
Press [MENU] to exit to the system menu. A message box shown in Figure 8-7 will pop up, if:
1. There is a parameter for which you have entered only the expected result or the limit; or
2. There is a parameter whose expected result is less than or equal to the limit.
8-5
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
Keep the sample probe tip away from the tube bottom; otherwise the
aspiration volume may be inaccurate.
When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.
8-6
To delete the current result, press [DEL] and a message box will pop up, as Figure 8-9 shows.
CLCIK Yes to confirm the deletion.
Printing QC results
8-7
Prediluted Mode
1. Be sure the System Status area displays Ready;
2. Press [F2] to select the prediluted mode;
3. Press [DILUENT] and a message box will pop up to instruct you how to dispense the
diluent into the sample tube, as Figure 8-10 shows;
To delete the current result, press [DEL] and a message box will pop up, as Figure 8-12
shows. CLICK Yes to confirm the deletion.
Printing QC results
8-9
L-J Graph
At the Controls screen, press [F4] to enter the L-J Graph screen, as Figure 8-13, Figure
8-14 and Figure 8-15 shows.
8-10
The x-coordinate represents how many times the QC program has been run. The
y-coordinate represents the analysis results of the displayed parameters.
For every parameter, the upper dash line of its L-J graph represents the upper limit of the
expected range of the analysis result. The corresponding value (4.9 in case of the WBC
in Figure 8-13) equals Mean + Range and is displayed to the left of the line.
For every parameter, the lower dash line of its L-J graph represents the lower limit of the
expected range of the analysis result. The corresponding value (4.1 in case of the WBC
in Figure 8-13) equals Mean - Range is displayed to the left of the line.
For every parameter, its expected result (4.5 in case of the WBC in Figure 8-13) is
displayed between the values of the upper dash line and of the lower dash line.
For every parameter, the three numbers displayed to the right of its L-J graph represents:
Mean the mean value of the saved results, as the equation below defines,
n
Mean =
X
i =1
where n represents how many times the QC program has been run and Xi is the result
acquired from every QC analysis.
8-11
X i Mean
Diff =
n 1
)2
where n represents how many times the QC program has been run and Xi is the result
acquired from every QC analysis and Mean is the mean value derived from the first
equation.
CV Coefficient of Variation, as the equation below defines
CV =
Diff
100%
Mean
where Mean is the mean value derived from the first equation and Diff is the standard
deviation derived from the second equation.
The darkened square that falls between the upper and the lower dash lines is within the
control range. Otherwise, it is not. The blank square represents the QC analysis either ran
into errors or is out of the display range.
If you see any points fallen outside the control range, do the following steps until the problem
is solved. If all the steps have failed, contact Mindray customer service department or your
local distributor for assistance.
1. Check the lower left corner of the screen for error messages. Refer to Chapter 11
Troubleshooting Your Analyzer for solutions to any displayed error messages;
2. Check the L-J settings for inappropriate entries;
3. Do the background check. In case of an abnormal background result, refer to Chapter 11
Troubleshooting Your Analyzer for solutions;
4. Re-run the control;
5. Run another vial of control;
6. Check if the analyzer needs to be calibrated.
Other operations:
To print out the currently displayed L-J graph, press [PRINT]. To acquire help information,
press [HELP]. To return to the Controls screen, press [MENU]
QC Table
At the Controls screen, press [F5] to enter the QC Table screen, as Figure 8-16 shows,
where every screen displays the results of 6 QC analyses. You can press [PgUp] or [PgDn] to
switch to the previous or next screen to view other results.
8-12
8-13
8-14
8.3.1 QC Editing
Entering the X-B Table screen
Press [MENN] to enter the system menu. SELECT X-B analysis (Figure 8-19), to enter the
X-B Table screen, as Figure 8-20 shows.
8-15
ENTER the expected mean and range respectively into the Mean box and Range boxes
of the parameters to be included in the QC run.
Deleting settings
Printing settings
8-17
Press [MENU] to exit the X-B Edit screen. a message box will pop up to remind you to save
the changes, as shows. CLICK Yes to save the changes; CLICK No to abort the changes.
X-B Table
Follow the steps introduced in Chapter 8.3.1.
X-B Graph
At the X-B Table screen, press [F2] to enter the X-B Graph screen, as Figure 8-25 shows.
8-18
The x-coordinate represents the number of X-B analyses performed; the y-coordinate
For every parameter, its X-B graph can display a maximum of 500 points, 30 points per
screen. The time at which the sample was analyzed is displayed to the right of Time. The
current cursor position and the number of all the saved points are displayed to the right of
Loc./Total.
For every parameter, the upper dash line represents the expected result + limit;
For every parameter, the upper dash line represents the expected result limit;
For every parameter (e.g. MCV), the three numbers to the left of the X-B graph are
defined as follows:
95.0 expected result limit;
90.0 expected result;
85.0 expected result limit.
The points fallen between the upper and lower dash lines are within the expected ranges;
The points fallen outside the upper and lower dash lines are out of the expected ranges
If you see any points fallen outside the control range, do the following steps until the problem
is solved. If all the steps have failed, contact Mindray customer service department or your
local distributor for assistance.
1. Check the lower left corner of the screen for error messages. Refer to Chapter 11
Troubleshooting Your Analyzer for solutions to any displayed error messages;
2. Check the X-B settings for inappropriate entries;
3. Do the background check. In case of an abnormal background result, refer to Chapter 11
8-19
Press [] or [] to review the preceding or following screen; press [PgUp] or [PgDn] to review
the preceding or following result. The parameter value of the current point (the one the cursor
is located at) is displayed below the parameter. The location of the current point is displayed
in the No. field. The analysis time is displayed in the Time field.
8-20
9.1 Introduction
The purpose of the calibration is to maintain system accuracy. Quality of the calibration
depends on the calibration materials and reagents used. You should only use the calibrator
and reagents specified by Mindray for the calibration. Store and use the calibrator and
reagents as directed by their instructions for use.
Calibration may be performed with commercial calibrator or fresh whole blood samples. Only
the directly measured parameters WBC, RBC, HGB, MCV, PLT, and MPV may be calibrated.
9-1
9-2
Expected range
CV(%)
WBC
3.0
RBC
2.0
HGB
2.0
MCV
70.0 to 100.0 fL
1.0
PLT
5.0
At the Count screen, run a vial of high control three consecutive times and then
immediately run the diluent three consecutive times, calculate the carryover per the following
equation.
Carryover(%) =
The calculated carryovers shall meet the following requirements: WBC, RBC and HGB shall
be no greater than 0.5 % ; PLT shall be no greater than 1%.
It is recommended that you create a log table for your analyzer. This log table should contain
9-3
Calibration date
Supplier of calibrator
Lot number
Enter the administrator password as instructed in Chapter 5.2.1 and then choose one or
several parameters among WBC, RBC, HGB, MCV and PLT for calibration.
9-4
ENTER the lot number of the calibrator to be used into the Lot No. box.
ENTER the expiration date of the calibrator to be used into the Exp. Date box.
ENTER the expected results (mean) into the Mean box of the parameters to be included in
the calibration.
Refer to the instructions of use of the calibrator for information on the lot
number, expiration date, expected results and limits.
Open reagents are stable for 60 days. The entered expiration date should be
the open date + 60 days or the expiration date marked on the packaging of
the reagent, whichever is earlier.
9-5
Exit editing
When you have finished editing the desired settings, press [F2] to deactivate the edit boxes.
Use the Mindray- specified calibrator. Using calibrator other than the
specified will lead to misleading results.
Refer to the instructions of use of the calibrator for how to store and use the
calibrator.
In the prediluted calibration mode, you cannot dispense diluent from the
analyzer. It is recommended that you prepare at least 7 cups of diluent
before starting calibrating the analyzer in the prediluted mode.
Keep the sample probe tip away from the tube bottom, otherwise the
aspiration volume may be inaccurate.
When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
9-7
z
z
Figure 9-6 A message box to warn you about the invalid results
If the parameter values obtained are numeric, a message box will pop up to confirm the
validity of the results, as Figure 9-7 shows.
9-8
9-9
Other operations
9-10
At Fresh Blood screen, press [F1] to select the Whole Blood or Prediluted mode.
Selecting sample
When the mode is selected, press [F3] to choose the fresh blood sample whose reference
values you want to set.
Press [F2] to enable the edit boxes in the Mean column, as Figure 9-12 shows.
9-11
Figure 9-13 A message box to warn you about the invalid results
9-12
Follow the calibration steps of sample 1 to run at least another two fresh blood samples.
When you have obtained the calibration factors of at least 3 fresh blood samples, you can
press [F1] to enter the Calculate screen as Figure 9-16 shows.
9-14
Method one:
1. Prepare 3 to 5 normal fresh blood samples and run each one of them on a reference
analyzer at least 3 consecutive times. Calculate the mean (MEAN 1) and SD (SD 1) of
every sample.
2. Run the same samples on your analyzer for the same number of times and calculate the
mean (MEAN 2). The MEAN 2 should be within MEAN 1 2SD. If any of the samples
fails to reach the criterion, call Mindray customers service department or your local
distributor.
Method two:
At the Count screen, run the calibrator at least 5 consecutive times and calculate the
means of the results. The means should be within the expected ranges supplied by the
manufacturer. If not, contact Mindray customer service department or your local distributor.
Other operations
If you press [F2], a dialog box will pop up to warn you, as Figure 9-18 shows. Press [ENTER]
to return to the Fresh Blood screen.
9-15
If the valid results are less than three (the CV and new factors are not available yet).
If you press [F3], a dialog box will pop up to warn you about the data loss, as Figure 9-19
shows.
The left of the Manual" screen displays the available calibration modes Whole blood
and Prediluted. The right of the Manual screen displays the calibration factors of WBC,
RBC, HGB, MCV, PLT and the time the factors are saved.
Use the following formula to calculate the new calibration factor.
new factor =
Example:
Assuming for a certain calibrator, the expected WBC value (namely the reference value
9-17
The calculated new calibration factor should be within 75 to 125. If not, try to find out the
reason and if necessary, call Mindray customer service department or your distributor for
assistance.
If the reproducibility of the calibrated parameter does not meet the requirements of Table 9-1,
you must try to find out the reason and re-run the calibrator after you have solved the problem.
If necessary, contact Mindray customer service department or your local distributor for
assistance.
9-18
Other operations
9-19
Do not perform any maintenance procedures that are not described in this
chapter. Performing unauthorized maintenance procedures can damage
your analyzer.
10-1
Content of Maintenance
If you are to use this analyzer 24 hours a day, perform the Probe
cleanser cleaning procedure everyday.
When the analyzed samples add up to 20, the analyzer will perform
the auto-cleaning procedure.
Run the QC program everyday. See Chapter 8 Using the QC
Programs for details.
Every Month
As needed
you
see
other
error
messages,
see
10-2
Chapter
11
10-3
Diluent Prime
Rinse Prime
Lyse Prime
Zap Aperture
Flush Aperture
Lyse Test
Clean Bath
Drain Bath
Drain Tubing
Prepare to Ship
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
After installing new reagents, let the reagents stand for a while before using
them.
You should perform the Diluent prime procedure to prime the diluent tubing when
you have installed a new container of diluent without shutting the analyzer.
At the Maintenance screen, SELECT Diluent prime to prime the tubing and the priming
progress will be displayed at the bottom of the screen, Figure 10-3 shows. When the priming
is done, the screen will return to the initial state.
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
After installing new reagents, let the reagents stand for a while before using
them.
10-5
you have installed a new container of rinse without shutting the analyzer.
At the Maintenance screen, SELECT Rinse prime to prime the tubing and the priming
progress will be displayed at the bottom of the screen, as Figure 10-4 shows. When the
priming is done, the screen will return to the initial state.
After installing new reagents, let the reagents stand for a while before using
them.
10-6
You should perform the Lyse prime procedure to prime the lyse tubing when
you have installed a new container of lyse without shutting the analyzer.
At the Maintenance screen, SELECT Lyse prime to prime the tubing and the priming
progress will be displayed at the bottom of the screen, as Figure 10-5 shows. When the
priming is done, the screen will return to the initial state.
10-7
10-8
You can soak the bath and fluidic lines with the probe cleanser, an alkaline detergent, by
performing the Probe cleanser cleaning procedure. If your analyzer is to run 24 hours a
day, you should perform this procedure.
Follow the steps given below to do so:
1. At the Maintenance screen, move the cursor to Probe cleanser cleaning;
2. Present the cleanser to the probe and press [ENTER] to aspirate the cleanser. When you
hear the beep and the sample probe is out of the bottle, remove the cleanser. The
analyzer will start priming process, as Figure 10-8 shows;
10-10
You can use the E-Z cleanser, an enzyme based, isotonic cleaning solution and wetting agent,
to clean the tubing and bath by performing the E-Z cleanser cleaning procedure.
Follow the steps given below to perform the procedure:
1. At the Maintenance screen, move the item to E-Z cleanser cleaning;
2. Present the cleanser to the probe and press [ENTER] to aspirate the cleanser. When you
hear the beep and the sample probe is out of the bottle, remove the cleanser. This
analyzer will automatically prime the bath and fluidic lines with the aspirated cleanser and
the progress is displayed on the screen, as Figure 10-12 shows;
10-12
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
In case of any abnormal WBC counts or histograms, you can perform the Lyse test
procedure to check whether the lyse can be dispensed properly.
Follow the steps given below to do so:
1. Unscrew and remove the retaining screws with hands or screwdrivers (pointed by the
arrows shown in Figure 10-16) on the right plate;
10-14
10-15
10-16
10-17
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
You can perform the Drain tubing procedure to drain the fluidic system. Follow the steps
given below to do so:
1. Press the appropriate arrow keys ([][] [][]) as needed to move the cursor to Drain
tubing;
2. Remove the diluent, rinse and lyse pickup tubes from the back of the analyzer;
3. Press [ENTER] to start the draining process, as Figure 10-24 shows;
Figure 10-28 Flush the block and the interior of the probe
10. After the flushing is done, the screen returns to the initial state.
When the accumulated analyzed samples reach 150, a message box will pop up to remind to
10-20
10-21
10-22
10-23
This area displays the test groups. The available self-test items are divided into four groups,
Tubing, Machine, Valve and Circuit.
Press [F1] to select the desired group. The selected group is preceded by a .
10-24
This area displays useful information to help you move to the next step.
At this screen, if you want to acquire help information, press [HELP]; if you want to print out
the test results (except for the results of the tests), press [PRINT].
Count Time
It measures the duration of a WBC and RBC count, namely how many seconds it takes for
the aspirated fluid flows from the first sensor to the second.
Aperture(v)
Vacuum
Pressure
Filter
10-25
Syringe motor
The syringe motor controls the aspiration volume. This test checks whether the motor
functions normally.
Rotation motor
The rotation motor rotates the sample probe inside the analyzer. This test checks whether the
motor functions normally.
Elevator motor
The elevator motor controls elevation of the sample probe. This test checks whether the
motor functions normally.
This test checks whether the recorder or printer functions normally. If normal, when you press
[ENTER], the recorder or printer will print out a test page; if abnormal, the screen will display
the corresponding error message and you can see Chapter 11 Troubleshooting Your
Analyzer for solutions.
10-26
10-27
10.6 Log
The log records all the major events taking place during the running of this analyzer. It helps
the service engineers diagnose system errors.
Press [MENU] to enter the system menu and SELECT ServiceLog, as Figure 10-40
shows to enter the Log screen, as Figure 10-41 shows.
10-28
10-29
10-30
10-31
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
The relative position between the sample probe and probe wipe has influence on the analysis
results. In the accessory box, there is a sample probe localizer, as Figure 10-46 shows. You
need to use the localizer to adjust the position of the sample probe if you have replaced probe
wipe, or observed motor error, or incorrect analysis result. Also, as required by regular
maintenance, you should use the localizer to adjust the position of the sample probe monthly.
10-33
10-34
10-35
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
10-36
10-37
10-38
Make sure the power supply of the analyzer has been cut off before
maintenance.
If the recorder finishes a print action, wait at least 20 minutes until the
recorder head is cooled completely and then maintain the recorder.
Wipe off the alcohol remaining on the recorder head in time after cleaning
the recorder head.
Make sure the alcohol volatilizes completely before using the recorder to
print.
You should maintain the recorder every two months. Do as follows to maintain your recorder:
1. Turn off the analyzer and cut off the power supply;
2. Open the recorder door and take out the recorder paper;
3. Gently wipe the roller from left to right using cotton swabs;
4. Roll the roller and repeat step 3 to clean off all debris and stains on the roller;
5. Gently wipe the heating part of the recorder head from left to right using cotton swabs
dipped with alcohol (no drops) to clean off all debris and stains on the head;
6. Wipe off the alcohol remaining on the heating part of the recorder head using dry cotton
swabs;
7. Wait at least 20 minutes till alcohol on the heating part of the recorder head volatilizes
completely, and then install recorder paper and close the recorder door.
10-39
10-40
Unless otherwise instructed, always turn off the power before trying to fix
the error.
11-1
Possible cause(s)
The analyzer
cannot be
turned on.
Recommend action
drips
from analyzer
filter.
inside.
not work.
circuit.
11-2
Possible Cause(s)
Recommended Action
Ambient temp.
Abnormal ambient
abnormal
temperature or temperature
transducer error.
Blank
abnormal
1.
Contaminated diluent,
diluent lines or bath;
2.
Expired diluent.
HGB error
11-3
WBC clog
Inappropriate WBC
RBC clog
2. Inappropriate RBC
10.3.5.;
3. Inappropriate RBC
2. Inappropriate
communication settings.
Barcode error
analyzer;
2. Invalid bar-code.
Barcode
com
error
Printer
out
of
paper
Printer offline
Recorder
com
error
analyzer.
1. Print again;
analyzer;
print again;
2. Damaged recorder.
and
contact
Mindray
11-7
Lyse out
volume setting.
Diluent expired
expiration setting
Rinse expired
expiration setting
Lyse expired
expiration setting
Vacuum
error
filter
in Chapter 10.5.1;
2. If the test result is normal, the error will
be removed;
3. If the problem remains, replace the
filter as instructed by Chapter 10.11;
4. If the problem still remains after a new
filter has been installed, contact
Mindray customer service department
11-8
the board;
correct;
battery, etc.);
Syringe
motor
motor;
error
2. Damaged motor;
3. Poor connection between
the power drive board
and the CPU board;
photocoupler.
motor
error
5. Malfunctioning photo
coupler.
error
motor
3. Damaged motor;
Elevator
be removed;
3. If the problem remains, contact Mindray
4. Malfunctioning
Rotation
3. Damaged motor;
4. Poor connection between
the drive board and the
CUP board;
5. Malfunctioning photo
coupler.
11-9
Vacuum error
Pressure error
Diluent empty
Rinse empty
11-10
File error
Dynamic
memory error
analyzers memory.
+12 V power
error
power board.
-12 V power
error
power board.
power board.
11-11
12 Appendices
A
Index
analyzer
reagent, 5-5
name, 2-1
aperture
CV
flush, 10-8
definition, 7-16
zap, 10-7
formula, 7-16
diluent
connection, 4-5
aspiration, 3-2
definition, 2-13
bath
prime, 10-4
clean, 10-15
dilution, 3-3
drain, 10-16
dimensions, B-5
bubbles
environment, B-5
RBC, 11-6
error
WBC, 11-5
calibration
manual, 9-17
preparations, 9-3
procedures, 9-3
purpose, 9-1
clog
WBC, 11-4
controls, 2-14
count
principle, 3-1
procedure, 6-9
screen, 2-9
customize
gain, 5-13
other, 5-25
Appendices
printer out of paper, 11-7
RBC, B-3
WBC, B-3
Lymph#
definition, 3-7
formula, 3-7
Lymph%
definition, 3-6
formula, 3-6
lyse
connection, 4-7
definition, 2-13
E-Z cleanser
definition, 2-14
maintenance
gain
system, 10-3
set HGB gain, 5-15
MCH
definition, 3-10
formula, 3-10
Gran#
MCHC
definition, 3-7
definition, 3-10
formula, 3-7
formula, 3-10
Gran%
MCV
definition, 3-6
definition, 3-9
formula, 3-6
handshake, 5-9
Mid#
HCT
definition, 3-7
definition, 3-10
formula, 3-7
formula, 3-10
Mid%
HGB
definition, 3-6
carryover, B-3
formula, 3-6
definition, 3-7
MPV
definition, 3-11
NRBC, 3-6
humidity, B-5
ID, 6-9
password, 5-2
installation
PCT
requirement, 4-2
definition, 3-11
LCD, 2-6
formula, 3-11
leukocyte
PDW
granulocyte, 2-2
definition, 3-11
lymphocyte, 2-2
performance specifications
linearity range
PLT
PLT, B-3
definition, 3-11
A-2
Appendices
operating range, B-2
power
fuse, 4-2
rinse
voltage, 4-2
definition, 2-14
prediluted mode
prime, 10-5
analyzer, 6-19
sample
analysis, 6-9
review, 7-1
printer
sample probe
connection, 4-10
adjust, 10-32
format, 5-7
probe cleanser
shutdown, 6-28
use, 10-9
specification, B-1
probe wipe
system
clean, 10-19
self-test, 10-24
replace, 10-36
status, 10-23
QC
table
edit settings, 8-3
sample, 7-7
searched, 7-29
run, 8-6
throughput, B-2
table, 8-12
transmission
RBC
definition, 3-9
measurement, 3-9
troubleshooting, 11-1
unpacking, 4-4
RDW-CV, 3-10
valve
reagent
test, 10-26
connection, 4-5
WBC
required, 2-13
definition, 3-6
recorder
format, 5-7
weight, B-6
A-3
Specifications
B.1
Classification
B.2
Reagents
Diluent
M-18D DILUENT
Rinse
M-18R RINSE
Lyse
M-18CFL LYSE
Probe Cleanser
Calibrator
Specified by Mindray
Controls
Specified by Mindray
B.3
Parameters
Table B-1 Directly measured parameters and histograms
Parameter
Abbreviation
Default
9
WBC
10 /L
RBC
1012/L
Hemoglobin Concentration
HGB
g/L
Platelet
PLT
109/L
WBC histogram
WBC Histogram
RBC histogram
RBC Histogram
PLT histogram
PLT Histogram
Abbreviation
Default
Lymphocyte percentage
Lymph%
Mid%
Granulocyte percentage
Gran%
MCV
fL
Variation
RDW-CV
RDW-SD
fL
B-1
Appendices
Mean Platelet Volume
MPV
fL
PDW
Abbreviation
Default
9
Lymphocyte
Lymph#
10 /L
Mid-sized cell
Mid#
109/L
Granulocyte
Gran#
109/L
Hematocrit
HCT
MCH
pg
MCHC
g/L
PCT
B.4
Sampling Features
13 L
20 L
Aperture
Diameter
Length
80 m
70 m
B.4.3 Throughput
Less than 120 seconds/analysis
B.5
Performance specifications
Operating range
0.0 to 499.9
12
0.00 to 9.99
HGB (g/L)
0.0 to 300.0
MCV (fL)
0.0 to 250.0
0 to 2999
B-2
Appendices
Background result
WBC
0.3 109 / L
RBC
0.03 1012/ L
HGB
1g/L
HCT
0.5 %
PLT
7 109 / L
Linearity range
0.0 to 99.9
12
0.0 to 9.99
HGB (g/L)
0 to 300
0 to 999
B.5.4 Carryover
Parameter
Carryover
WBC
0.5 %
RBC
0.5 %
HGB
0.5 %
PLT
1%
Condition
CV(%)
4.0 to 15.0
3.0
3.00 to 6.50
2.0
HGB (g/L)
100 to 180
2.0
MCV (fL)
70 to 100
1.0
200 to 500
5.0
PLT(10 /L)
B.6
Input/Output Device
B-3
Appendices
B.6.1 Keypad
18-key keypad.
B.6.2 Keyboard
PS/2 keyboard.
B.6.5 Recorder
Built-in thermal recorder that supports two printing formats and auto printing.
50 +00.7 mm
B.6.7 Printeroptional
Epson LQ300k+ II
Epson 630K
B.6.8 Interfaces
A keyboard interface.
A power supply for the floppy disk driveonly to be used with the power cable supplied by
Mindray.
B.7
Power supply
Appendices
Fuse: AC 250 V T4 A
B.8
EMC Description
B.9
Sound
Maximal sound: 65 dB
Operating temperature:15 to 30 ;
Relative humidity: 30 % to 85 %;
Ambient temperature: 10 to 40
Relative humidity: 10 % to 93 %
B.12 Dimensions
Depth
Width
Height
B-5
Appendices
38.6 cm
32.2 cm
43.7 cm
B.13 Weight
Less than 23 kg
B.14 Contraindications
None.
B-6
C.1
Introduction
Then
Read the statement below the symbol. The statement is
alerting you to an operating hazard that can cause
personnel injury.
Read the statement below the symbol. The statement is
alerting you to a possibility of analyzer damage or unreliable
analysis results.
Read the statement below the symbol. The statement is
alerting you to information that requires your attention.
Read the statement below the symbol. The statement is
alerting you to a potentially biohazardous condition.
C.1.2 Limitations
Whenever the results are outside the normal limits, it is recommended that the laboratory
following whatever written protocol is in place for validating results.
If an error occurs, the analyzer displays the corresponding error message In case of errors
related to the fluidic system (such as clogging or bubbles), it is recommended that you re-run
the sample after removing the error.
If the PLT value is less than 100 109 / L, it is recommended the result be verified by a
microscope.
C.1.3 Maintenance
The maintenance instructions in Chapter 10 describe corrective and preventive procedures
that must be followed to ensure proper operation and performance of your analyzer.
C-1
Appendices
C.2
Warnings
Before turning on the analyzer, make sure the input voltage meets the above
requirements.
When moving the analyzer, face the front of the analyzer and carry it from
the bottom with hands!
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
To avoid personal injury, keep your clothes, hair and hands away from such
moving parts as the sample probe.
Unless otherwise instructed, always turn off the power before trying to fix
the error.
Make sure the power supply of the analyzer has been cut off before
maintenance.
C-2
Appendices
C.3
Cautions
Do not perform any maintenance procedures that are not described in this
chapter. Performing unauthorized maintenance procedures can damage
your analyzer.
Use only specified recorder paper. Otherwise, it may cause damage to the
recorder head, or the recorder may be unable to print, or poor print quality
may result.
Never pull the recorder paper with force when a recording is in process.
Otherwise, it may cause damage to the recorder.
Do not leave the recorder door open unless you install paper or remove
trouble.
Improper installation of recorder paper may jam the paper and/or result in
blank printout.
If the recorder finishes a print action, wait at least 20 minutes until the
recorder head is cooled completely and then maintain the recorder.
Wipe off the alcohol remaining on the recorder head in time after cleaning
the recorder head.
Make sure the alcohol volatilizes completely before using the recorder to
print.
C-3
Appendices
C.4
Notes
This analyzer adopts a fixed decimal point. You can enter the digits without
bothering to look for the [.] on the external keyboard.
The purpose of this analyzer is to identify the normal patient, with all normal
system-generated parameters, and to flag or identify patient results that
require additional studies.
Before connecting the power cord, make sure the power switch at the back
of the analyzer is placed in the off (O) position.
Retain the shipping carton and all the packing materials, as they can be
used for packaging if analyzer must be reshipped.
Store and use the reagents as directed by instructions for use of the
reagents.
When you have changed the diluent, rinse or lyse, run a background to see
if the results meet the requirement.
Pay attention to the expiration dates and open-container stability days of all
the reagents. Never use expired reagents.
After installing new reagents, let the reagents stand for a while before using
them.
The recorder paper is treated on one side for printing. To determine which
side is the printing side, gently scratch both sides with a fingernail and the
one with visible nail trace left is the printing side.
For the whole blood samples to be used for WBC differential or PLT count,
you shall store them at the room temperature and run them within 4 hours
C-4
Appendices
after collection.
If you do not need the PLT, MCV and WBC differential results, you can store
the samples in a refrigerator (2 to 8) for 24 hours. You need to warm the
refrigerated samples at room temperature for at least 30 minutes before
running them.
Mix any sample that has been prepared for a while before running it.
After mixing the capillary sample with the diluent, wait 5 minutes before
running the sample.
Keep the sample probe tip away from the tube bottom; otherwise the
aspiration volume may be inaccurate.
When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.
Fur and skin debris may block the aperture. Keep the sample clean before
using the analyzer to analyze it.
Use the specified controls. Using controls other than the specified will lead
to misleading results.
Refer to the instructions of use of the controls for how to store and use the
controls.
Refer to the instructions of use of the control for information on the lot
C-5
Appendices
number, expiration date, open-vial stability days, expected results and limits.
The entered expiration date should be either the expiration date printed on
the labeling or the open-vial expiration date. It is earlier.
The open-vial expiration date is calculated as follows: the date that vial is
opened + the open-vial stability days.
Use the Mindray- specified calibrator. Using calibrator other than the
specified will lead to misleading results.
Refer to the instructions of use of the calibrator for how to store and use the
calibrator.
When installing the analyzer, our authorized personnel will select a proper
communication protocol that matches the data management software
configured.
Remove the protective paper between the recorder head and the roller
inside the recorder before installing recorder paper.
C-6
C.5
Biohazard
C-7
D.1
Introduction
The BC-2800 provides two communication protocols. Which protocol to be used depends on
the sample ID digits that can be received by the data management software installed on the
external computer. If the sample ID upper limit to be received is 8 digits, the 8ID
communication protocol should be selected. If the sample ID upper limit to be received is 15
digits, the 15ID communication protocol should be selected.
The BC-2800 can transmit the sample data and QC data to an external computer (a host)
through its RS-232 serial port. The transmission can be conducted either automatically or
through the command of the operator after the completion of the sample analysis. Based on
the 8ID communication protocol, this section gives detailed discussion about the setup of
transmission parameter, RS-232 serial port and the data transmission format, therefore,
providing detailed information for the software engineers to program and for the user to
conveniently perform transmission.
D-1
Appendices
D.2
Connection
The BC-2800 can be connected with an external computer through a DB9 connector. The
pins of the DB9 connector are shown in Figure D-1.
D-2
Appendices
D.3
D.3.1 Description
Symbols
[ENQ]
0x05
[STX]
0x02
[EOT]
0x04
[EOF]
0x1A
[ETX]
0x03
[ACK]
0x06
[NACK]
0x15
"A"
0x41
"B"
0x42
"C"
0x43
"#"
0x30-0x39
"*"
0x2A
If the Lot No., Month, Day, Year are empty in QC Edit menu, the * (2A Hex) will be
transmitted to the host.
For all the data formats, if the data are marked *, then * (2A Hex) will be transmitted to the
host.
L1 Region to L8 Region are LI to L8 of eight histogram discriminators as shown in Figure D-2.
Figure D-2 L1 to L8
D-3
Appendices
Programming
If the Handshake is off, BC-2800 will transmit the body of the text without acknowledging the
presence of an external computer.
If the Handshake is on, BC-2800 will communicate with the external computer in following
procedures:
1. BC-2800 sends an ENQ (05 Hex), then waits up to 4 seconds for the external computer
to respond. If the external computer does not respond, then one more ENQ (05 Hex) is
tried. If it fails again, the analyzer aborts the transmission and reports a transmission
error;
2. The external computer must respond by sending an ACK (06 Hex). If any other response
is received, another ENQ (05 Hex) will be sent by the analyzer (maximum two ENQ [05
Hex] will be sent);
3. The analyzer then sends:
Body of text
EOT (04 Hex)
ETX (03 Hex)
4. Disconnection.
BC-2800 sends an ETX (03 Hex), then waits 4 seconds for the external computer to
respond. If no response is received, one more ETX ( 03 Hex) is sent, BC-2800 waits 4
seconds before giving up and gives alarm of communication error.
If the external compute responds ACK, the transmission is done successfully. If the external
computer responds NACK15 Hex, the analyzer repeat the transmission from step 3. If the
received response from the computer is neither ACK06 Hex nor NACK15 Hex, the
analyzer sends ETX ( 03 Hex) again.
[ENQ]
If handshake is disabled
[STX]
Version
##
ID length
###
###
##
Appendices
Parameter format
###
ID
########
Sample Mode
Month
##
Day
##
Year
####
Hour
##
Minutes
##
Seconds
##
WBC[10 /L]
###.#
###.#
Lymph#[10 /L]
9
Mid#[10 /L]
9
###.#
Gran#[10 /L]
###.#
Lymph%[%]
##.#
Mid%[%]
##.#
Gran%[%]
##.#
12
RBC[10 /L]
##.##
HGB[g/L]
###
MCHC[g/L]
####
MCV[fL]
###.#
MCH [pg]
###.#
RDW-CV[%]
##.#
HCT[%]
##.#
PLT[10 /L]
####
MPV[fL]
##.#
PDW
##.#
PCT[%]
.###
RDW-SD[fL]
###.#
Reserved
###############
Rm
R1
R2
R3
R4
Pm
Ps
Pl
L1 Region
###
L2 Region
###
L3 Region
###
L4 Region
###
L5 Region
###
D-5
Appendices
L6 Region
###
L7 Region
###
L8 Region
###
Reserved
################
###
###
###
[EOT]
If handshake is disabled
[EOF]
If handshake is enabled
[ETX]
[ENQ]
If handshake is disabled
[STX]
Version
##
###
##
###
File No.
Lot No.
######
Month
##
Day
##
Year
####
9
WBC[10 /L]
###.#
RBC[1012/L]
##.##
HGB[g/L]
###
PLT[10 /L]
####
9
Lymph#[10 /L]
###.#
Lymph%[%]
##.#
Gran#[10 /L]
###.#
Gran%[%]
##.#
HCT[%]
##.#
MCV[fL]
###.#
MCH[pg]
###.#
MCHC[g/L]
####
9
###.#
12
##.##
HGB Limit[g/L]
###
####
D-6
Appendices
Lymph# Limit[109/L]
###.#
Lymph% Limit[%]
##.#
###.#
Gran% Limit[%]
##.#
HCT Limit[%]
##.#
MCV Limit[fL]
###.#
MCH Limit[pg]
###.#
MCHC Limit[g/L]
####
[EOT]
If handshake is disabled
[EOF]
If handshake is enabled
[ETX]
[ENQ]
If handshake is disabled
[STX]
Version
##
###
##
###
Month
##
Day
##
Year
####
Hour
##
Minutes
##
9
###.#
12
RBC[10 /L]
##.##
HGB[g/L]
###
WBC[10 /L]
PLT[10 /L]
####
9
Lymph#[10 /L]
###.#
Lymph%[%]
##.#
Gran#[10 /L]
###.#
Gran%[%]
##.#
HCT[%]
##.#
MCV[fL]
###.#
MCH[pg]
###.#
MCHC[g/L]
####
Appendices
If handshake is enabled
[EOT]
If handshake is disabled
[EOF]
If handshake is enabled
[ETX]
D.4
Transmission
D-8
E.1
Introduction
The BC-2800 provides two communication protocols. Which protocol to be used depends on
the sample ID digits that can be received by the data management software installed on the
external computer. If the sample ID upper limit to be received is 8 digits, the 8ID
communication protocol should be selected. If the sample ID upper limit to be received is 15
digits, the 15ID communication protocol should be selected.
The BC-2800 can transmit the sample data and QC data to an external computer (a host)
through its RS-232 serial port. The transmission can be conducted either automatically or
through the command of the operator after the completion of the sample analysis. Based on
the 15ID communication protocol, this section gives detailed discussion about the setup of
transmission parameter, RS-232 serial port and the data transmission format, therefore,
providing detailed information for the software engineers to program and for the user to
conveniently perform transmission.
E-1
Appendices
E.2
Connection
The BC-2800 can be connected with an external computer through a DB9 connector. The
pins of the DB9 connector are shown in Figure E-1.
E-2
Appendices
E.3
E.3.1 Description
Symbols
Handshake symbol
During the communication, the two parties acknowledge the communication using these
symbols.
Field
name
Coding
ENQ
0x10
ACK
0x06
ETX
0x0F
Description
Communication
command
from
command
from
Special symbols
Coding
Description
MS
0x05
ME
0x0a
SE
0x04
FE
0x08
name
Special delimiter
Delimiter sign between message body, data segment and attribute field.
Field
name
Field
name
Coding
MD
SD
0x03
SD
FD
0x0C
FD
0x16
E-3
Description
Delimiter
between
MD
between
SD
between
FD
and SD
Delimiter
and FD
Delimiter
Appendices
and V
Field
Coding
Description
name
MD
CTR
QCR
QCC
Programming
The BC-2800 must communicate with the external computer when the Handshake is on in
following procedures:
1. During the communication connection, the BC-2800 sends an ENQ (10 Hex), then waits
up to 4 seconds for the external computer to respond. If the external computer does not
respond, then one more ENQ (10 Hex) is tried. If it fails again, the analyzer aborts the
transmission and reports a transmission error;
2. The external computer must respond by sending an ACK (06 Hex);
3. After the ACK (06 Hex) is received, the analyzer then sends data block;
4. After the sending, the BC-2800 sends an ETX (0F Hex), then waits 4 seconds for the
external computer to respond. If no response is received, one more ETX (0F Hex) is sent.
The BC-2800 waits 4 seconds before giving up and gives alarm of communication error.
FD field
FD definition of analysis parameter
FD
Description
Sample information
SampleID
Sample ID
Mode
TestTime
Test time, format: YYYY-MM-DD HH: MM: SS (if the digit is less than
10, add a 0 at the tens place)
Name
Name
E-4
Appendices
Gender
Group
AgeVal
Age value
AgeType
Dept
Department
ChartNo
Chart No. (the empty string will be sent if No. is not entered yet/a o is
entered)
BedNo
Bed No. (the empty string will be sent if No. is not entered yet/a o is
entered)
Sender
Sender
Tester
Tester
Checker
Checker
Analysis parameter
Val
Low
High
Unit
Flag
Suspect sign
Histogram alarm
Rm
R1
R2
R3
R4
Pm
Indicates blur demarcation between the platelet and red blood cell
area.
Ps
Pl
Histogram adjustment
SepWBCLyLeft
SepWBCLyMid
SepWBCGranMid
SepWBCGranRight
SepRBCLeft
SepRBCRight
SepPLTLeft
SepPLTRight
Histogram
DataLen
MetaDataLen
E-5
Appendices
length in scattergram data flow is 4; in histogram data flow is 1. If the field is
not included in binary data flow, the metadata length of binary data flow
defaults to 1.
HistoData
SD field
SD definition of analysis parameter
SD
FD
Sam
FD
pleInfo
Description
FD
2
Sa
mpleID
3
Mo
de
FD
7
Na
me
De
Ge
FD
10
Ag
FD
Be
FD
12
Se
pt
artNo
dNo
nder
FD1
FD2
FD3
FD4
FD5
Val
Low
High
Unit
Flag
Sample information
eVal
11
Ch
FD
6
nder
FD
9
FD
5
Te
FD
Ag
FD
4
stTime
eType
FD
Te
ster
FD
13
Ch
ecker
WBC
Lym
White
blood
cell
count
Lymphocytes
ph#
number
Mid#
Mid-sized cell
Gran
Granulocyte
Lym
Lymphocytes
#
ph%
percentage
Mid
Mid-sized
cell
percentage
Gran
Granulocyte
percentage
HGB
Hemoglobin
Concentration
RBC
Red
Blood
Cell
count
HCT
Hematocrit
MCV
Mean Corpuscular
Volume
MCH
Mean Corpuscular
Hemoglobin
E-6
Appendices
MCH
Mean Corpuscular
Hemoglobin
Concentration
RDW
Red
CV
Blood
Distribution
Cell
Width
Coefficient of Variation
RDW
Red
SD
Blood
Distribution
Cell
Width
Standard Deviation
PLT
Platelet count
MPV
Mean
Platelet
Volume
PDW
Platelet Distribution
Width
PCT
Alar
mFlag
F
D1
F
D2
R
m
SepL
ine
R
1
RBC
Histo
PLT
Histo
D4
R
F
D5
R
3
F
D6
R
4
F
D7
P
s
P
1
FD2
FD3
FD4
SepWB
SepWB
SepWB
SepWB
CLyMid
CGranMid
FD6
FD7
FD8
SepRB
SepRB
SepPLT
SepPLT
Left
Discriminator
information
CGranRight
FD5
CRight
Histogram alarm
D8
P
m
FD1
CLeft
Histo
D3
CLyLeft
WBC
Plateletcrit
Right
FD1
FD2
FD3
DataLen
MeteDataLen
WHistoData
FD1
FD2
FD3
DataLen
MeteDataLen
RHistoData
FD1
FD2
FD3
DataLen
MeteDataLen
PHistoData
WBC Histogram
RBC Histogram
PLT Histogram
FD field
FD definition of standard QC parameter
FD
Description
QC information
FileNo
File No
LotNo
Lot No
ExpDate
E-7
Appendices
digit is less than 10, add a 0 at the tens place)
Sample information
Mean
Range
Limit
Unit
Unit
SD field
SD definition of standard QC
SD
FD
StQCInfo
FD1
WBC
RBC
Description
FD2
FD3
Standard QC
FileNo
LotNo
ExpDate
information
FD1
FD2
FD3
Mean
Range
Unit
count
Red Blood Cell
HGB
count
Hemoglobin
PLT
Concentration
Lymph#
Lymph%
Gran#
Gran%
HCT
Platelet count
Lymphocytes
number
Lymphocytes
percentage
Granulocyte
Granulocyte
percentage
MCV
MCH
Hematocrit
Mean Corpuscular
Volume
Mean Corpuscular
Hemoglobin
MCHC
Mean Corpuscular
The same with those of WBC
Hemoglobin
Concentration
FD field
FD definition of running QC parameter
E-8
Appendices
FD
Description
QC information
FileNo
File No
LotNo
Lot No
TestTime
Sample information
Val
Unit
Unit
SD field
SD definition of running QC
SD
RunQCInfo
WBC
RBC
HGB
PLT
Lymph#
Lymph%
Gran#
Gran%
HCT
MCV
MCH
MCHC
FD
Description
FD1
FD2
FD3
Running QC
FileNo
LotNo
TestTime
information
FD1
FD2
Val
Unit
count
Red Blood Cell
count
Hemoglobin
Concentration
Platelet count
Lymphocytes
number
Lymphocytes
percentage
Granulocyte
Granulocyte
percentage
Hematocrit
Mean Corpuscular
Volume
Mean Corpuscular
Hemoglobin
Mean Corpuscular
E-9
Appendices
Hemoglobin
Concentration
E-10
Appendices
E.4
Transmission
E-11