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Operation Manual: BS-300 Chemistry Analyzer
Operation Manual: BS-300 Chemistry Analyzer
Operation Manual: BS-300 Chemistry Analyzer
Chemistry Analyzer
Operation Manual
2007 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operation Manual, the issued Date is 2007-07 (Version: 1.8).
,
,
,
trademarks or trademarks owned by Mindray in
other trademarks that appear in this manual are
without the intention of improperly using them.
respective owners.
,
are the registered
China and other countries. All
used only for editorial purposes
They are the property of their
WARNING:
It is important for the hospital or organization that employs this
equipment to carry out a reasonable service/maintenance plan.
Neglect of this may result in machine breakdown or injury of human
health.
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.
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.
This warranty shall not extend to:
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
Freight policy: The customer is responsible for freight charges when this
product is shipped to Mindray for service (this includes customs charges).
II
Company Contact
Manufacturer:
Address:
Tel:
Fax:
III
Preface
WARNING:
The BS-300 Chemistry Analyzer is to be operated only by clinical
professionals, doctors or laboratory experimenters trained and
authorized by Mindray or Mindray-authorized distributors.
System Description
Installation
Basic Operations
Advanced Operations
Maintenance
Troubleshooting
Calculation Methods
Appendix A
Specifications
Appendix B
Supplies
Appendix C
Index
Preface
Bold and Italic font indicates:
Safety Symbols
This chart explains the symbols used in this manual.
When you see
Then
WARNING:
BIOHAZARD:
CAUTION:
NOTE:
Preface
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 this product is disposed of correctly, you will
help prevent bringing potential negative consequences to the
environment and human health. For more detailed
information with regard to returning and recycling this
product, please consult the distributor from whom you
purchased the product.
In Vitro Diagnostic equipment
ON (POWER)
OFF (POWER)
ON (ANALYZING UNIT POWER)
OFF (ANALYZING UNIT POWER)
Graphics
All graphics, including screens and printout, are for illustration purposes only and
must not be used for any other purpose.
EC Representative
Name:
Address:
Phone:
0049-40-2513175
Fax:
0049-40-255726
Preface
Safety Precautions
Observe the following safety precautions when using the BS-300 Chemistry Analyzer.
Ignoring any of these safety precautions may lead to personal injury or equipment
damage.
WARNING:
If the system is used in a manner not specified by the manufacturer,
the protection provided by the equipment may be impaired.
Eye Protection
WARNING:
Light sent by the photometer lamp or the bar code scanner may hurt
your eyes. Do not stare into the lamp or the laser beam from the bar
code scanner when the analyzer is in operation.
Preface
Preventing Infection
BIOHAZARD:
Inappropriately handling samples may lead to biohazardous infection.
Do not touch the sample, mixture or waste with your hands. Wear
gloves and lab coat and, if necessary, goggles.
In case your skin contacts the sample, follow standard laboratory
safety procedure and consult a doctor.
WARNING
Materials of the analyzer are subject to contamination regulations.
Dispose of the waste analyzer in accordance with your local or
national guidelines for waste disposal.
Preface
Precautions on Use
To use the analyzer safely and effectively, pay attention to the following operation
notes.
Intended Use
WARNING:
The BS-300 Chemistry Analyzer (hereinafter referred to as the
BS-300) is a chemistry system that is designed for the in vitro
quantitative determination of clinical chemistries in serum, plasma,
urine, CSF and other samples. Please consult Mindray first if you want
to use the BS-300 for other purposes.
To draw a clinical conclusion, please also refer to the patients clinical
symptom and other test results.
Operator
WARNING:
The BS-300 is to be operated only by clinical professionals, doctors or
laboratory experimenters trained and authorized by Mindray or
Mindray-authorized distributors.
Environment
CAUTION:
Please install and operate the analyzer in an environment specified by
this manual. Installing and operating the analyzer in other environment
may lead to unreliable results and even equipment damage.
To relocate the analyzer, please contact Mindray Customer Service
Department or your local distributor.
Preface
Preface
Samples
CAUTION:
Use serum samples that are completely separated from blood clots or
urine samples that are free from suspended matter. If fibrin exists in
the serum samples or suspended matter exist in the urine samples,
the sample probe may be blocked.
Medicines, anticoagulants or preservative in the samples may lead to
unreliable test results.
Hemolysis, jaundice or chylomicron in the samples may lead to
unreliable test results, so sample blanks are recommended
Store the samples properly. Improper storage may change the
compositions of the samples and lead to unreliable results.
Sample volatilization may lead to unreliable results. Do not leave the
sample open for too long.
Not all the tests the reagents claim capable of analyzing can be
analyzed on the analyzer. Consult the reagent suppliers for detailed
information.
Certain samples need to be processed before being analyzed by the
analyzer. Consult the reagent suppliers for details.
The analyzer has a specific requirement on the minimum sample
volume. Refer to this manual for the proper sample volume.
Load the sample to proper tube positions on the sample disk before
the analysis begins; otherwise you will not obtain correct results.
Preface
Setting up BS-300
CAUTION:
You need to set up the analyzer strictly as instructed by this manual
before using it. To define such parameters as sample volume, reagent
volume and wavelength, consult instructions of reagents.
Backing Up Data
NOTE:
The analyzer automatically backs up the data to the built-in hard disk.
However, data loss is still possible due to mis-deletion or physical
damage of the disk. Mindray recommends you regularly back up the
data to such medium as CDs.
External Equipment
WARNING:
External equipment connected to the system, such as PC and printer,
shall be consistent with IEC 60950 or EN 60950.
Contents
Preface.......................................................................................................................................... 1
Who Should Read This Manual ............................................................................................. 1
What Can You Find in This Manual........................................................................................ 1
Conventions Used in This Manual ......................................................................................... 1
Safety Precautions ................................................................................................................. 4
Precautions on Use................................................................................................................ 6
Contents ........................................................................................................................................ i
1
1.2
2.3
2.4
Unpacking............................................................................................................ 2-1
Installation Requirements .................................................................................... 2-1
2.2.1
Installation Environment Requirements................................................ 2-1
2.2.2
Power Requirements............................................................................ 2-2
2.2.3
Temperature and Humidity Requirements............................................ 2-2
2.2.4
Water Supply and Drain Requirements................................................ 2-3
2.2.5
Space and Accessibility Requirements................................................. 2-3
Connecting the Tanks .......................................................................................... 2-4
2.3.1
Connecting the Deionized Water Tank ................................................. 2-4
2.3.2
Connecting the Waste Tank.................................................................. 2-4
ISE Unit (optional) Installation ............................................................................. 2-5
2.4.1
Installing Electrodes ............................................................................. 2-6
2.4.2
Installing Reagent Module.................................................................... 2-8
3.3
3.4
Contents
3.4.3
4
4.2
4.3
4.4
4.5
5.3
ii
Contents
5.4
5.5
5.6
5.7
6
Troubleshooting................................................................................................................ 6-1
6.1
6.2
5.3.5
Washing Waste Tank .......................................................................... 5-17
5.3.6
Cleaning Sample Disk/Compartment ................................................. 5-18
5.3.7
Cleaning Reagent Disk/Compartment................................................ 5-19
5.3.8
Cleaning Panel of Analyzing Unit ....................................................... 5-20
Monthly Maintenance ........................................................................................ 5-21
5.4.1
Cleaning Wash Well of Sample Probe ............................................... 5-21
5.4.2
Cleaning Wash Well of Reagent Probe.............................................. 5-21
5.4.3
Cleaning Wash Well of Mixing Bar ..................................................... 5-22
5.4.4
Cleaning Sample Probe Rotor............................................................ 5-23
5.4.5
Cleaning Reagent Probe Rotor .......................................................... 5-23
5.4.6
Cleaning Mixing Bar Rotor ................................................................. 5-24
Maintenance Every Six Months ......................................................................... 5-25
Irregular Maintenance........................................................................................ 5-25
5.6.1
Unclogging Sample Probe.................................................................. 5-25
5.6.2
Unclogging Reagent Probe ................................................................ 5-32
5.6.3
Replacing Sample Probe.................................................................... 5-38
5.6.4
Replacing Reagent Probe .................................................................. 5-38
5.6.5
Replacing Mixing Bar ......................................................................... 5-39
5.6.6
Replacing Plunger Assembly of Sample/Reagent Syringe ................ 5-43
5.6.7
Removing Air Bubbles ........................................................................ 5-45
5.6.8
Replacing Lamp ................................................................................. 5-46
5.6.9
Replacing Electrode (optional) ........................................................... 5-48
5.6.10
Replacing Reagent Module (optional)................................................ 5-49
5.6.11
ISE Unit Storage (optional)................................................................. 5-50
5.6.12
ISE Unit Re-activation (optional) ........................................................ 5-51
Maintenance Log ............................................................................................... 5-51
7.2
7.3
Appendix A
A.1
A.2
A.3
A.4
A.5
A.6
A.7
A.8
A.9
Appendix B
iii
Contents
Appendix C
Index........................................................................................................... C-1
iv
1 System Description
This chapter includes the following two sections:
Hardware Introduction
Software Introduction
The BS-300 Chemistry Analyzer is a chemistry system that is designed for the in
vitro quantitative determination of clinical chemistries in serum, plasma, urine, CSF
and other samples.
NOTE:
Not all the parameters the reagents claim capable of testing can be
tested on the analyzer. Consult the reagent suppliers for detailed
information.
1.1
Hardware Introduction
The BS-300 consists of the analyzing unit, operation unit, output unit, replacing parts
and consumables. The analyzing unit and the operation unit are as shown in Figure
1-1.
Figure 1-1 Overview of the analyzing unit and the operation unit
Analyzing Unit
Operation Unit
1-1
System Description
1-2
System Description
Figure 1-3 Front view
Connect the power cord to the power plug shown in Figure 1-3.
DEIONIZED WATER: If you choose to feed deionized water from the back of the
analyzing unit, pull the deionized water tubing into the unit from here;
D-SENSOR: If you choose to feed deionized water from the back of the analyzing
unit, pull the cable of the deionized water level detector into the unit from here;
1-3
System Description
WASTE: If choose to discharge waste from the back of the analyzing unit, pull the
waste tubing out of the unit from here;
W-SENSOR: If you choose to discharge the waste from the back of the analyzing
unit, pull the cable of the waste level detector out of the unit from here;
COM: It is the serial port for communication with the operation unit;
RESET: You can press this button to restart the analyzing unit when it stops
responding.
WARNING:
Press the RESET button only when the analyzing unit stops
responding. Do not press this button when the unit is working normally.
Otherwise, it may lead to system failure, unreliable analysis results or
serious unexpected consequences.
The sample disk is composed of two circles an inner circle and an outer circle. It
provides 60 tube positions, 30 on the inner circle and 30 on the outer circle. Every
tube position has an identification number. Positions 1-45 are for samples, E1-E5 for
emergency samples, S1-S6 for calibrators, C1-C3 for controls, and W for distilled
water. All the other positions except the position W can be used for samples, too.
The sample disk can hold six types of tubes micro sample cup, collection tube,
12mm68.5mm, 12mm 99mm, 12.7mm75mm and 12.7mm100mm.
To install the sample disk, keep the handle at the vertical position, align the central
hole of the handwheel to the rotor, gently lower the sample disk all the way down
(rotate the disk a bit as necessary) and move the handle back to the horizontal
position to secure the disk to the rotor. When you have finished installing the disk,
1-4
System Description
grab the handwheel and lightly pull it upward. If the disk remains secured, it means it
is well installed.
To remove the sample disk, first shift the handle from the horizontal position to the
vertical position. Then grab the handle or handwheel and pull the disk upward to
remove it from the rotor.
To load sample tubes, insert the tube into the tube holder until the bottom of the tube
contacts the groove on the tube rack.
To remove sample tubes, grab the tube and pull it upward to remove it from the tube
holder.
WARNING:
Before installing/removing the sample disk, make sure the analyzing
unit is turned off and the sample disk has stopped.
Before installing/removing the sample tubes, make sure the analyzing
unit is turned off and the sample disk has stopped.
Do not use sample tubes other than the specified.
Before running the analyzing unit, make sure that the sample disk
cover is closed and the round red mark on the cover is aligned with its
counterpart on the panel. Otherwise the sample probe may be
damaged.
If samples spill in the sample compartment or on the sample disk, be
sure to wipe the spills with cloth soaked with water or disinfector after
turning off the analyzing unit.
The built-in sample bar code scanner (optional) can read the bar code labels on the
sample tubes.
The bar code labels can be applied to the following sample tubes.
12mm 99mm
12.7mm75mm
12.7mm100mm
1-5
System Description
The bar code labels applied to the sample tubes must meet the following
requirements.
The bottom of the sample tube fully contacts the tube rack of the sample disk.
There is no obstruction between the scanner and the bar code labels.
Stick the bar code label to the sample tube so that the lower end of the bar code
label is 8-10mm above the bottom of the tube.
The length of the bar code label is no more than 55mm with blank areas of 5 mm
are provided at both sides of barcode.
Tube
Bar code label
5mm
no more than 55mm
5mm
8-10mm
Stick the entire surface of the label to the surface of the sample tube so it will not
peel.
When inserting the tube with bar code label into the sample disk, ensure the
center of the label is within the 2mm range, as shown in the figures below.
1-6
System Description
+2mm
NOTE:
Mindray recommends printing coding information beside barcode.
The bar code scanner can read the following bar code symbologies: Code 128 (Set A, B,
C), Code 39, Codabar, ITF (Interleaved 2 of 5), UPC/EAN, Code93
Feature size: 0.19-0.50mm
Length: 3-16
Thin bar: thick bar: 1:2.5-3
Height: 10mm or more
Printing: black print on white background; the minimum acceptable symbol grade
is Class C as defined in the ANSI MH10.8M Print Quality Specification.
NOTE:
To ensure the stability of reading Codabar, the length of it is no less
than 4.
The maximum number of digits will be determined after confirming that
the actual printed labels can be read properly.
1-7
System Description
sample from the designated sample tube and dispenses the aspirated sample to the
designated reaction cuvette.
Open the middle door of the analyzing unit and you will see the sample syringe (right)
and the reagent syringe (left). The sample syringe can aspirate/dispense 3-45l of
sample for clinical chemistry tests or 70l of sample for ISE tests (if the ISE unit is
connected) and its minimum scale is 0.5l.
Sample Syringe
To dispense the sample, the sample probe first moves to the sample tube to aspirate
certain amount of the sample, then to the reaction disk to dispense the aspirated
sample to a reaction cuvette and finally to the wash well for cleaning.
The sample probe can automatically detect the sample level. When the sample
probe contacts obstacles in the vertical direction, its safeguard will automatically
protect the probe from damage.
1-8
System Description
WARNING:
When the analyzing unit is running, do not place any part of your body
or any obstacle in the route the arm moves. Otherwise, it may lead to
personnel injury or equipment damage.
The reagent disk has two circles, inner circle and outer circle. There are 25 reagent
positions in each circle and the reagent disk has totally 50 reagent positions. The
reagent disk can hold the Mindray inner-circle bottles, Mindray outer-circle bottles,
Hitachi 7060 bottles, Hitachi 7170 bottles and Hitachi 20ml bottles.
The refrigerator can run 24 hours a day to keep the temperature at 4-10.
NOTE:
The refrigerator has a power supply independent of that of the
analyzing unit. It will be put into service once the POWER is turned on.
To install the reagent disk, keep the handle at the vertical position, align the central
hole of the handwheel to the rotor, gently lower the reagent disk all the way down
(rotate the disk a bit as necessary) and move the handle back to the horizontal
position to secure the disk to the rotor. When you have finished installing the disk, grab
1-9
System Description
the handwheel and lightly pull it upward. If the disk remains secured, it means it is
well installed.
To remove the reagent disk, first shift the handle from the horizontal position to the
vertical position. Then grab the handle or handwheel and pull the disk upward to
remove it from the rotor.
To load reagent bottles, insert the bottle into the bottle holder until the bottom of the
bottle contacts the groove on the bottle rack.
To remove the reagent bottle, grab the bottle and pull it upward to remove it from the
bottle holder.
WARNING:
Before installing/removing the reagent disk, make sure the analyzing
unit is turned off and the sample disk has stopped.
Before installing/removing the reagent bottles, make sure the
analyzing unit is turned off and the sample disk has stopped. When
installing the bottle, make sure the bottle bottom is in full contact with
the bottle rack.
Before running the analyzing unit, make sure that the reagent disk
cover is closed and the round red mark on the cover is aligned with its
counterpart on the panel. Otherwise the sample probe may be
damaged and cooling capacity of the refrigerator will be degraded.
If reagents spill in the reagent compartment or on the reagent disk, be
sure to wipe the spills with cloth soaked with water or disinfector after
turning off the analyzing unit.
1-10
System Description
Figure 1-10 Reagent dispenser
To dispense the reagent, the reagent probe first moves to the reagent bottle to
aspirate certain amount of the reagent, then to the reaction disk to dispense the
aspirated reagent to a reaction cuvette and finally to the wash well for cleaning.
The reagent probe can automatically detect the reagent level. When the reagent
probe contacts obstacles in the vertical direction its safeguard will automatically
function to protect the probe from damage.
WARNING:
When the analyzing unit is running, do not place any part of your body
or any obstacle in the route the arm moves. Otherwise, it may lead to
personnel injury or equipment damage.
1-11
System Description
1.1.1.6 Mixer
The mixer is composed of a mixing bar, bar arm and rotor, as Figure 1-12 shows.
The mixing bar thoroughly stirs the reaction mixture (reagents and sample) in the
reaction cuvette.
For the single-reagent test, the mixer starts to work after the sample is dispensed
into the reaction cuvette. For the double-reagent test, the mixer starts to work after
the sample or the second reagent is dispensed into the reaction cuvette. The mixing
bar moves to a position above the reaction disk, lowers into the cuvette, and rotates
to mix the mixture in the cuvette. After that, the bar moves to the wash well for
cleaning and de-watering.
NOTE:
Normally, the used-cuvette bucket can hold 80 segments of reaction
cuvettes (10 cuvettes per segment). Be sure to empty the bucket in
time so that excessive cuvettes will not overflow and contaminate the
cabinet.
Disposable cuvettes are adopted as the reaction cuvettes. Ten cuvettes are bound
together as one cuvette segment. The cuvette compartment can house 30 cuvette
segments, which are sufficient for 300 continuous tests.
1-12
System Description
When all the cuvettes of a cuvette segment have been used, the reaction disk
rotates the segment to the unloading position, and then the manipulator dumps the
used segment into the used-cuvette bucket and loads the new segment. When a
segment is taken from the cuvette compartment, the cuvette feeder pushes the next
segment to the loading position.
When there are less than 10 segments in the compartment, the analyzing unit,
though keeping working, will give an alarm. Seeing the alarm, you should, if you still
have more tests to do, add more segments to the compartment.
When all the segments in the compartment are used, the analyzing unit will stop first
loading cuvette segments, and then stop dispensing samples when all the segments
on the reaction disk are used. But it will keep working until all the scheduled tests are
done.
Present the cuvette segment to the entry of the cuvette feeder as Figure 1-13 shows
and gently push it toward inside. Load all the segments one by one until they are all
loaded. When you are done, click the Load Cuvette button (refer to 4.1.4.2 Reaction
Disk tab for details) to command the cuvette feeder to press the newly added
segments forward. Be sure not to load the segments as Figure 1-14 shows.
NOTE:
When loading cuvette segments to the entry of the cuvette
compartment, be sure to keep them upright. Remove the inclined
segments immediately upon seeing them and reload them the right
way.
Be sure to load the segments to the cuvette compartment in the right
direction (Figure 1-13). Reversely loaded segments (Figure 1-14) may
jam the loader and halts the analyzing unit.
Do not click the Load Cuvette button before completing adding all the
cuvette segments to the compartment. Otherwise, the loading
operation may fail.
1-13
System Description
Figure 1-14 Loading cuvette segments the wrong way
BIOHAZARD:
Be sure to load the used-cuvette bucket to the designated position on
the bottom plate. Otherwise, the used-cuvette may not be dumped into
the bucket and the spilled reaction mixture may contaminate and
corrode the cabinet.
Be sure to wear gloves, goggles and protective clothing when loading
or removing the used-cuvette bucket.
Be sure to dispose of the used-cuvette in compliance with the local
regulations.
The reaction disk holds the reaction cuvettes, in which the sample reacts with the
reagents and colorimetric readings are taken.
The temperature-controlled chamber provides for the reaction an environment of
consistent temperature.
The reaction disk can hold 8 cuvette segments (80 cuvettes). The cuvettes adopted
are
Disposable;
5mm6mm25mm (5mm optical path);
750l (capable of holding 180-500l of the reaction mixture).
1-14
System Description
BIOHAZARD:
Be sure to dispose of the used cuvettes in compliance with the local
regulations.
CAUTION:
The reaction cuvettes should not be re-used. Otherwise, the system
performance may be degraded.
During the analyzing process, the reaction disk rotates (counter-clock wise only) to
cuvette-loading position, sample-dispensing position, reagent-dispensing position, or
mixing position as needed. The colorimetric readings are taken when the specified
cuvette passes through the optical axis.
Specifications
9 optical paths with fixed interference filters.
Wavelengths: 340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 630nm, 670nm,
700nm
Half band-width: 12nm
Wavelength accuracy: 2nm
Measurement range: 0.1-4.0 Abs
Lamp: 12V 50VA tungsten-halogen
Movement
The measurement optical system consists of 9 optical paths. The absorbance is
taken when the reaction cuvette rotates to the correspond path. The analyzer can
measure the absorbance of 9 cuvettes simultaneously.
1-15
System Description
Figure 1-15 ISE unit (optional)
Pump module
ISE module
Reagent module to be
placed here
The ISE unit (optional) measures the concentration of Li+, Na+, K+ and Cl- in serum,
plasma and diluted urine.
The volume of the serum or plasma sample is 70l and that of the diluted urine
sample is 140l. The dilution ratio of the urine sample is 1:10 (1 part of urine sample
and 9 parts of urine diluent).
There are five electrodes including Li+, Na+, K+, Cl- and reference electrodes in the
ISE module. If the Li+ electrode is not selected, a spacer electrode is substituted for
it.
Reagent module is integrated with Calibrant A, Calibrant B, waste containers and a
chip which indicates the volume of the reagents.
1-16
System Description
1.2
Software Introduction
Header area
Displays the names of the operating software and the manufacturer.
Title bar
Displays the title of the current display area.
Menu area
Displays: [Routine], [Parameters], [Data], [System], [Help]. You can move the
mouse to any of the listed menu and click the left button of the mouse (hereinafter
referred to as click) to display its pull-down menu.
Pull-down menu
You can click the listed item of the pull-down menu to perform certain operation.
Small buttons
to view the user guide. You can also click Help Guide
Click the small button
to view the user guide. Refer to 4.5.2 Guide for details.
to exit the operating software. You can also click Routine
Click the small button
Exit to exit the software. Refer to 4.1.8 Exit for details.
1-17
System Description
Shortcut buttons area
Totally 13 buttons are available, which are:
,
,
,
,
,
,
,
click any of the buttons to perform certain operation quickly.
,
,
. You can
Display area
Displays settings, results, graphics and so on.
System status area
Displays the system status and reaction temperature.
Warning messages area
Displays the warning messages, including malfunction alarm messages and prompt
messages for mis-operation. When seeing the warning messages, refer to 6
Troubleshooting for solutions.
Period area
Displays how many periods (every period lasts 12 seconds) of test have passed
since the beginning of the first test after the latest power-on.
Time area
Displays current date and time.
Operator area
Displays the current operator who operates the system.
Tab
See the figure below for examples of the tab. Click the tab and you can access the
screen that it indexes.
1-18
System Description
Combo box
Click and a pull-down list will display, as the figure below shows. Click the
desired item to select it.
Combo box
Option button
Click the option button to select the option it represents. Note that for a given group
of option buttons, you can only select one of them.
Option button
Check box
Click the check box to select the option it represents and click it again to de-select it.
Note that for a given group of check boxes, you can choose more than one of them
at one time.
1-19
System Description
Check box
Edit box
You can enter characters from the keyboard in the edit box.
Edit box
Button
Click a button and you can access the function it indexes.
Scroll bar
When the contents to be displayed are too many for one screen, you can use the
scroll bar to see the hidden contents. Move the cursor to the scroll bar, press left
button of the mouse and hold it, then you can drag the scroll bar upward or
downward to see the hidden contents. Or you can press the key such as Page Up,
Page Down,oron the keyboard to see the hidden contents.
Scroll bar
1-20
System Description
1-21
2 Installation
WARNING:
The BS-300 should only be installed by Mindray-authorized personnel
only.
To facilitate the installation, you should prepare a place meeting the requirements
specified in 2.2 Installation Requirements. If you need to move the analyzer to
another site, please contact Mindray Customer Service Department or your local
distributor, who are the appropriate people for the moving job.
2.1
Unpacking
When you receive your analyzer, carefully inspect the package. If you see any signs
of mishandling or damage, file a claim immediately with Mindray Customer Service
Department or your local distributor.
After opening the package, check the delivered goods against the packing list as
well as the appearance of the analyzer. If you find anything missing or damaged,
alert Mindray Customer Service Department or your local distributor immediately.
2.2
Installation Requirements
CAUTION:
Make sure the analyzer is installed in a place meeting the following
requirements. Otherwise, it will not perform as promised.
2-1
Installation
CAUTION:
The analyzer radiates heat from its rear side when operating. A
well-ventilated environment helps keep the room temperature stable.
Use ventilation equipment if necessary. But if so, be sure not to
expose the analyzer to the direct draft that may lead to unreliable
results.
WARNING:
Make sure the power socket is grounded correctly. Improper grounding
may lead to electric shock and/or equipment damage.
Be sure to connect the analyzer to a power socket that meets the
above-mentioned requirements and has a proper fuse installed.
2-2
Installation
CAUTION:
When used in conditions other than the specified, the analyzer may
not provide reliable test results. If the temperature or relative humidity
does not meet the above-mentioned requirements, be sure to use
air-conditioning equipment.
BIOHAZARD:
Be sure to dispose of the waste according to the local regulations.
CAUTION:
The water to be used on the analyzer must meet the requirements of
the CAP Type II water. Insufficiently purified water may result in
misleading measurement.
Minimum500
WALL
710
Maximum2500
Operation
Unit
Analyzing Unit
980
Minimum500
F
R
O
N
T
Minimum500
Minimum500
2-3
Unit: mm
Installation
2.3
Put the pickup tubes and the sensor into the deionized water tank, then
close the cap of the deionized water tank clockwise.
Put the deionized water tank on the right of the extractable plate.
Plug the green connector to its counterpart on the analyzing unit and turn
the connector clockwise until secure.
Deionized Water Connector
(Green)
Pickup Tube
Plug the red connector to its counterpart on the analyzing unit and turn
the connector clockwise until secure.
Plug the BNC connector to its counterpart on the analyzing unit and turn
the connector clockwise until secure.
10
Put the waste tube and the sensor into the waste tank, then close the cap
of the waste tank clockwise.
2-4
Installation
6
Keep pressing the pin on the connector and grab the waste tap and insert
it to the connector.
BNC Connector
Waste Connector
Pin
Waste Tap
Waste Tube
2.4
Plug the BNC connector to its counterpart on the analyzing unit and turn
the connector clockwise until secure.
CAUTION:
Use the consumables recommended by Mindray. Other consumables
may degrade the system performance.
2-5
Installation
O-ring
2-6
Installation
4
Red sphere
Insert
Place the reference electrode inside the housing by pressing down the
compression plate and push it straight against the back of the housing.
Release the compression plate and ensure the electrode cannot be easily
moved.
Sample entry port
Housing
Remove the Chloride electrode from its protective packaging and place it
in the ISE module housing in the same way as the reference electrode.
Repeat the process for the Lithium electrode. If you do not select Lithium
electrode, repeat the process for the spacer electrode.
10
11
2-7
Installation
Take off the three red caps from the reagent module. Put the wand on the
module, press it down to connect to the module firmly. Then put the
module with the wand into the ISE unit.
2-8
Installation
8
Enter 20 into the edit box to the right of Time(s) and click the Purge AB
button.
2-9
3 Basic Operations
This chapter provides step-by-step procedures for operating the analyzer for basic
tasks.
3.1
Daily Procedure
3-1
Basic Operations
3.2
BIOHAZARD:
Wear gloves, goggles and protective clothing when performing the
below checks.
Check the power supply and make sure it can supply proper voltage for the
analyzer.
Check the connections among the analyzing unit, operation unit and printer. Make
sure the connections are right and secure. Check the power cords of the
analyzing unit, operation unit and printer and make sure they are well connected
to power sockets.
Check and make sure sufficient printing paper is prepared for the printer.
Check the sample and reagent syringes for leakage as instructed by 5.2.1
Checking Sample/Reagent Syringes.
Check the sample and reagent probes and make sure there is no fluid hanging on
the probe tips. If there is, please contact Mindray Customer Service Department
or your local distributor.
Check the connections of the deionized water and wastewater as instructed by
5.2.6 Checking Connection of Deionized Water and 5.2.7 Checking
Connection of Wastewater.
Check the sample probe and make sure it is neither dirty nor bent. If it is dirty,
wash it as instructed by 5.3.1 Washing Sample Probe; if it is bent, replace it as
instructed by 5.6.3 Replacing Sample Probe.
Check the reagent probe and make sure it is neither dirty nor bent. If it is dirty,
wash it as instructed by 5.3.2 Washing Reagent Probe; if it is bent, replace it as
instructed by 5.6.4 Replacing Reagent Probe.
Check the mixing bar and make sure it is neither dirty nor bent. If it is dirty, wash it
as instructed by 5.3.3 Washing Mixing Bar; if it is bent, replace it as instructed
by 5.6.5 Replacing Mixing Bar.
Check the cuvette compartment and make sure there are sufficient cuvettes in it.
If the cuvettes are not sufficient, add more cuvettes as instructed by 1.1.1.7
Reaction Cuvette Loader.
CAUTION:
You must prepare enough cuvettes for the upcoming analysis. If you
find the cuvettes are not enough, add more immediately.
Sometimes the new cuvettes are not as smooth as they should be.
Check the surface of the cuvettes for bumps and take necessary
measures to remove the found bumps before loading them to the
compartment. Otherwise, they may jam the analyzing unit.
3-2
Basic Operations
Check and make sure there is enough deionized water in the deionized water
tank as instructed by 5.2.8 Checking Remaining Deionized Water.
CAUTION:
You must prepare enough deionized water. If you find the deionized
water is not enough, add more deionized water to the tank.
Check the waste tank and make sure it is empty. If not, empty the tank as
instructed by 5.2.9 Emptying Waste Tank.
Check the used-cuvettes bucket and make sure it is empty. If not, empty the
bucket as instructed by 5.2.10 Emptying Used-Cuvettes Bucket.
3.2.2 Power-on
Power up the analyzer in the sequence presented below:
After you have logged on the WINDOWS operating system, you may
Double-click the
icon on the desktop to start the operating software; or
Click [START] [PROGRAM] or [ALL PROGRAMGS][BS-300 Chemistry
Analyzer Operating Software][BS-300 Chemistry Analyzer Operating Software]
to start the operating software.
The operating software will do the initialization procedure in the sequence presented
below:
3-3
Basic Operations
Shaking hands with the analyzing unit.
The system does the startup and warm-up procedures in the sequence presented
below and the analyzer will then enter the standby state:
NOTE:
You need to enter proper username and password to access the
control system. Use the initial username and password (username:
administrator; password: bs300) if this is the first time the control
system being used and then you may edit your own username and
password as instructed by 4.4.4 User.
CAUTION:
You may start the analysis once the initialization is finished. However,
Mindray recommends you wait until the temperature and photometric
system is fully stabilized, which is when the status box displays Idle
and the analyzer has been turned on for 30 minutes.
To set the options regarding the basic parameters of the system, refer to 4.4.2
Setup.
3-4
Basic Operations
To set the options regarding the hospital information, refer to 4.4.3 Hospital.
To set the options regarding test parameters and reference, refer to 4.2.1.1
Parameters tab and 4.2.1.2 Reference Range tab.
To set the options regarding calibrators and calibration, refer to 4.2.3.1 Calibrator
tab and 4.2.3.2 Rule tab.
To set the options regarding controls, QC rule and QC test, refer to 4.2.4.1
Control tab, 4.2.4.2 Rule tab and 4.2.4.3 Setup tab.
To set the options regarding the reagent parameters, refer to 4.2.2.1 Reagent
Disk tab.
To set the options regarding the carryover information among tests, refer to
4.2.1.5 Carryover tab.
To set the options regarding the printing parameters, refer to 4.4.7 Print.
3.3
Starting Analysis
3.3.1 Calibration
You must calibrate if this is the first time the analyzer being used.
CAUTION:
You need to run the calibration again when you change reagent lots,
test parameters, lamp or other conditions.
3-5
Basic Operations
To request calibrations, refer to 4.1.2 Calibration.
After requesting calibrations, you should load corresponding calibrators to their
assigned positions on the sample disk.
To run calibrations, refer to 4.1.5 Start.
A calibration run experiences 4 states: Requested, Waiting, Running, Finished.
You can check the results of the finished runs in the following ways.
To view the results at the StatusCalib. Test, refer to 4.1.4.4 Calib. Test tab.
To view the results at the StatusSample Disk, refer to 4.1.4.1 Sample Disk
tab.
To view the results at the CalibrationResult, refer to 4.2.3.3 Result tab.
If the ISE unit is connected, refer to 4.4.11.1 Calibration for detailed information
about running ISE calibration and check its results.
3.3.2 QC
To request QCs, refer to 4.1.3 QC.
After requesting QCs, you should load corresponding controls to their assigned
positions on the sample disk.
NOTE:
If the ISE unit (optional) is connected, ISE QC should be performed.
Please use Mindray-recommended controls for ISE QC.
To view the results at the StatusQC Test, refer to 4.1.4.5 QC Test tab.
To view the results at the StatusSample Disk, refer to 4.1.4.1 Sample Disk
tab.
To view the results at the QC Real-time Result /Daily Result /Day-to-day
Result, refer to 4.2.4.4 Real-time Result tab, 4.2.4.5 Daily Result tab or 4.2.4.6
Day-to-day Result tab.
3.3.3 Samples
To request samples, refer to 4.1.1 Samples.
You can request a STAT sample run in the way similar to an ordinary run, except that
you have to tick the check box to the right of STAT, as Figure3-1 shows. The
requested STAT run will be inserted into the current work list as Waiting and has
higher priority than other tests.
3-6
Basic Operations
Figure3-1 Requesting a STAT Sample Run
After requesting, load the samples to their corresponding positions on the sample
disk.
To run samples, refer to 4.1.5 Start.
A sample run experiences 4 states: Requested, Waiting, Running, Finished. You
can check the results of the finished runs in the following ways.
To view the results at the StatusSample Test, refer to 4.1.4.3 Sample Test
tab.
To view the results at the StatusSample Disk, refer to 4.1.4.1 Sample Disk
tab.
To view the results at the DataResultResults, refer to 4.3.4.1 Results tab.
CAUTION:
Sample run results can only be edited by authorized personnel.
To edit one or more sample run results, refer to 4.1.4.3 Sample Test tab or 4.3.4.1
Results tab for details.
To revise one or more sample run results, refer to 4.1.4.3 Sample Test tab or 4.3.4.1
Results tab for details.
3.4
Finishing Analysis
3-7
Basic Operations
3.4.2 Shutdown
After exiting the Windows operating system, switch off the following powers in the
presented order:
NOTE:
The refrigerator still functions after the ANALYZING UNIT POWER is
placed to OFF. To shut down the refrigerator, place the POWER to
OFF.
BIOHAZARD:
Exercise with caution. Wear gloves, goggles and protective clothing.
3-8
4 Advanced Operations
The chapter presents an introduction of the BS-300 operating software by menus.
The main interface of the operating software has five major menu groups:
4.1
Routine
Parameters
Data
System
Help
Routine
4.1.1 Samples
Click Routine Sample, or press F1 to enter the Request Sample screen, as
Figure4-1 shows. You can also enter the Request Sample screen by clicking the
short-cut button
4-1
Advanced Operations
Figure4-1 Request Sample screen
The Assays zone lists all available tests. You cannot request the assays followed by
a forbidden mark, such as
. The double-reagent assays, whose reagent
positions have already been set, are yellow-framed; the double-reagent assays,
whose reagent positions have not been set yet, are gray-framed. The selected assay
is followed by a tick. Only if an assay, whose dilution parameters have been set, is
selected after Dilution is selected, the tick is red. Otherwise, the tick is green.
The sample parameters are interpreted as follows.
Parameter
What it does
How to set
Sample
Disk
Sample No.
4-2
Advanced Operations
Parameter
What it does
How to set
Sample ID
Position
Tube
Type
Replicates
STAT
S. Blank
the
4-3
Advanced Operations
Click the Start button and the scanner will begin to work. The scanning
results will be displayed at the Result field.
4-4
Advanced Operations
4
If you want to download information of the scanned samples from the LIS
server, click the Download button.
NOTE:
The Download button is only available if you select
Real-time Download at the System SetupHost
Communication screen.
Click the Download All button and a dialog box pops up.
4-5
Advanced Operations
2
Click the Start button and the system will download all the sample
information from the LIS server.
If you want to cancel the downloading, click the Cancel button.
If there are samples that have been requested but not able to test, a
dialog box which is shown as the figure below will pop up to remind you.
You can click the Close button to exit the dialog box. Refer to the
following content To view requested but untestable samples for details.
4-6
Advanced Operations
1
Enter the bar code into the edit box to the right of Sample ID for the
current sample, or click the Browse button and find the sample whose
sample information you want to get from the LIS server.
sample
information
NOTE:
The system will download information only for the sample
that meets any of the following conditions:
(1) It has not been requested before;
(2) All the tests requested for it before are at Requested
status and Overwrite has been selected at the Host
Communication screen (refer to 4.4.2.4 Host
Communication tab).
To request samples
1
Click the desired test to select it; click it again to de-select it. The selected test will
be followed by a green tick. You may select multiple tests for a sample run.
You may also request a pre-defined profile or profiles and the selected profile or
profiles will also be followed by a green tick.
4-7
Advanced Operations
NOTE:
Routine sample can be requested on any virtual sample disk.
STAT sample can only be requested on the default virtual sample disk.
After the system is powered on, the sample disk 1 is the default at that
time.
If there are any sample runs in Waiting or Running status on a sample
disk, the disk is the default at that time.
If the system just finishes the runs on a sample disk, the disk is the
default at that time.
If you request a sample whose sequence number has been used on
the current day (the same No., but the different index) and youve set
the Sample ID and Type (sample type) for it, the system will consider
the Sample ID and Type of the former one as those of the current
sample. You can change the two parameters only at the
Demographics screen.
Click the Abnormal Sample button and a dialog box pops up. If there are
samples that have been requested but not able to test, they will be listed
in the dialog box.
4-8
Advanced Operations
3
If you want to run the untestable test, you have to find the cause why it is
untestable and take some actions. For example, if the test ALB has not
been calibrated, it will become testable after being calibrated.
If you want to add the sample to the requested test list, tick the combo
box to the left of the sample and click the Test button. If you want to
select all the samples, tick the combo box to the left of Select All.
You can see the selected sample at the Test Status screen.
If there are untestable tests for the selected sample, the tests will be
discarded and you will not see them at the Sample Test screen.
Click
or
NOTE:
Click
Click
After you have finished browsing samples, click the Browse button again
to quit the browsing mode.
Click
or
NOTE:
Click
Click
4-9
Advanced Operations
4
NOTE:
You can edit routine sample information here only if the
sample is in Requested status.
You cannot edit STAT sample information here because the
STAT sample is in Waiting status after it is requested.
Sample Disk, Sample No. and Replicates cant be edited.
You can edit Sample Type and Sample ID only at the
Demographics screen. Refer to 4.3.3 Demographics for
details.
If you do not want to change the assays for the sample, go directly to the
next step.
Otherwise, select tests and profiles in the Assays area or Profiles area.
If you want to add an assay or a profile, select it; if you want to delete an
assay or a profile, de-select it.
NOTE:
You can change the tests or profiles for the sample in any
status.
You can only delete a test or a profile for the sample in
Requested status.
Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes.
Repeat from step 2 to edit another sample run; or click the Browse button
again to quit the browsing mode.
Click
or
NOTE:
Click
Click
4-10
Advanced Operations
3
NOTE:
You can only delete the routine sample that is in Requested
status here.
You cannot delete the STAT sample here because the STAT
sample is in Waiting status after it is requested. If you want
to delete a requested STAT sample, refer to 4.1.4.1 Sample
Disk tab or 4.1.4.3 Sample Test tab for details.
4
Repeat from step 2 to delete another sample run; or click the Browse
button again to quit the browsing mode.
Click the Demographics button and the Demographics window will pop
up.
Refer to 4.3.3 Demographics for details.
4.1.2 Calibration
Click Routine Calibration, or press F2, or click the short-cut button
enter the Request Calibration screen, as Figure4-2 shows.
4-11
to
Advanced Operations
At the Request Calibration screen, all the available tests are listed. The tests
followed by forbidden marks, such as
, are those whose calibration
parameters have not been set yet and cannot be requested for calibrations. The
yellow-framed tests are the double-reagent tests whose reagent positions have
already been set. The gray-famed tests are the double-reagent tests whose reagent
positions have not been set yet. The selected test will be followed by a green tick.
You can select the desired sample disk (virtual disk) from the pull down list of the
Sample Disk filed. The default sample disk is Sample Disk1. The adopted
calibration rule and calibrator will be displayed in the Method and Calibrator fields
respectively.
Click below Sample Disk and select the desired sample disk from the
pull down list.
Click the desired test to select it; click it again to de-select it. The select
test will be followed by a green tick. You can select multiple tests for a
calibration run.
CAUTION:
You must run the calibration if this is the first time the analyzer using
Endpoint or Fixed-time method for double-reagent tests. For the
Kinetic method, you can directly input the K Factor without running the
calibration first (see 4.2.3.2 Rule tab).
You need to run the calibration when you have changed the reagents,
reagent lots, test parameters, lamp or other analysis conditions.
Before calibrating a double-reagent test that uses Endpoint method,
the system will run reagent blank test for it automatically.
4-12
Advanced Operations
4.1.3 QC
Click Routine QC, or press the F3 to enter the Request QC screen, as Figure4-3
shows. You can also enter the Request QC screen by clicking the shortcut button
.
The screen lists all available tests. The tests whose reagent positions have not been
, and you cannot
set yet are followed by a forbidden symbol, such as
request to run them. The double-reagent tests, whose reagent positions have
already been set, are yellow-framed; the double-reagent tests, whose reagent
positions have not been set yet, are gray-framed. The selected test is followed by a
green tick.
When any test is selected, its corresponding control information will be displayed in
the Controls filed. The default sample disk (virtual disk) is disk 1 and you should
select the appropriate sample disk to the actual arrangement.
NOTE:
If the auto QC function is enabled (see 4.4.2.1 Routine tab for details)
and the QC interval is not 0 (see 4.2.4.3 Setup tab for details), the
analyzer will automatically insert QC runs among sample runs and you
do not have to request additional QC runs.
If the ISE unit (optional) is connected, the ISE will be displayed in the
Assays field.
Please use Mindray-recommended controls for ISE QC.
To request a QC run
1
Click below Sample Disk and select the desired sample disk from the
pull down list.
4-13
Advanced Operations
2
Click the desired test to select it; click it again to de-select it. The selected
test will be followed by a green tick. You may select multiple tests for one
run.
.
3
4.1.4 Status
Click Routine Status or press F4 to enter the Status screen, as Figure 4-4
shows. You can also enter the Status screen directly by clicking the
button.
4-14
Advanced Operations
Sample Disk
Reaction Disk
Sample Test
Calib. Test
QC Test
As Figure 4-5 shows the Sample Disk tab consists of three major parts, a sample
disk diagram on the left, sample information and tests on the right and operating
buttons on the bottom.
The sample disk diagram illustrates two circles. Every position consists of two
color-coded rings, the inner ring and the outer ring:
4-15
Advanced Operations
Select the desired sample disk from the pull down list in the Sample Disk
field to check the corresponding sample and sample run information.
Click the desired position on the selected disk to check the corresponding
sample and its included tests.
Select the desired sample disk from the pull down list in the Sample Disk
field.
Click the desired position on the selected disk. Note that you can only
select a sample which test(s) is (are) all in Requested or Waiting status.
Click the Delete button and a dialog box will pop up to ask you to confirm
the deletion.
Click the OK button to confirm the deletion; click the Cancel button, for
any reason, to cancel deletion.
Select the desired sample disk from the pull down list in the Sample Disk
field.
Click the desired position on the selected disk. Note that you can only
select a sample which test(s) is (are) all in Finished status.
Click the Release button and a dialog box will pop up to ask you to
confirm the release.
Click the OK button to confirm the release; click the Cancel button, for
any reason, to cancel the release.
Select the desired sample disk from the pull down list in the Sample Disk
field.
Click the Clear button and a dialog box will pop up to ask you to confirm
the clearing.
Click the OK button to confirm the clearing; click the Cancel button, for
any reason, to cancel the clearing.
To rerun a sample
1
Select the desired sample disk from the pull down list in the Sample Disk
field.
Click the desired position on the selected disk. Note that you can only
rerun a routine or STAT sample.
4-16
Advanced Operations
3
Select the test or tests need to be included in the rerun. Click the check
box to select it. Click the check box again to de-select it.
To rerun the selected sample without dilution, go directly to the next step.
To dilute the selected sample before the rerun, tick the Diluted field. Only
if the dilution parameters of a test have already been set, the sample will
be diluted before the rerun.
Select the desired sample disk from the pull down list in the Sample Disk
field.
Click the desired position on the selected disk to check the corresponding
sample and its included tests.
Click the desired test. Note that you can only select a Finished test.
Click the Reaction Curve to check the reaction curve and data of the
selected blank runs.
There are two tabs at the Reaction Curve screen, the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
5
If you have no intention to view other results, go directly to the next step;
Otherwise, click the Previous or Next button at the Reaction Curve
window; or click the Close button and repeat from step 2.
4-17
Advanced Operations
6
As Figure 4-6 shows, the Reaction Disk tab consists of three major parts, a reaction
disk diagram on the left, test information, status and results on the right and
operating buttons on the bottom.
The reaction disk illustrates 80 reaction cuvette positions, all of which are
color-coded.
Click the desired cuvette in the reaction disk diagram. Note that you can
only check the reaction curve and data of the Finished runs.
4-18
Advanced Operations
2
Click the Reaction Curve to check the reaction curve and data of the
selected blank runs.
There are two tabs at the Reaction Curve screen, the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
If you have no intention to view other results, go directly to the next step;
Otherwise, click the Previous or Next button at the Reaction Curve
window; or click the Close button and repeat from step 1.
After loading the segments into the cuvette compartment, click the Push
Cuvettes button to command the cuvette feeder to press the newly added
segments forward.
NOTE:
The Push Cuvettes button is only to command the cuvette feeder to
press the cuvette segments forward.
As Figure 4-7 shows, the Sample Test tab consists of the following tabs:
Unfinished Samples
4-19
Advanced Operations
Results by Samples
Results by Tests
Unfinished Samples
The Unfinished Samples tab lists all the Requested, Waiting and Running samples
of the current day since the latest power-on.
Select a sample in the Samples field, then you can view the tests
requested for the selected sample.
Click the Delete button and the Delete Sample dialog box will pop up.
Click the Delete button to delete the select samples. After that, you can
see the status of the samples changed to Deleted.
Click the Close button to close the Delete Sample dialog box.
4-20
Advanced Operations
NOTE:
In the Delete Sample dialog box, you can click the Refresh button to
view current samples in Requested or Waiting status.
Click the Reaction Curve button to pop up the Reaction Curve screen
that shows the reaction curve of the selected test.
There are two tabs at the Reaction Curve screen, the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
If you have no intention to view other results, go directly to the next step;
Otherwise, click the Previous or Next button at the Reaction Curve
screen; or click the Close button and repeat from step 2.
4-21
Advanced Operations
Figure 4-9 Results by Samples tab
Enter the number of the start sample into the first dialog box that pops up
and then click the OK button. A second dialog box will then pop up.
Enter the number of the end sample into the second dialog box that pops
up and click the OK button to select the two samples and those between
them.
Click the Deselect button and a dialog box will pop up.
4-22
Advanced Operations
2
Enter the number of the start sample into the dialog box that pops up and
then click the OK button. Another dialog box will then pop up.
Enter the number of the end sample into the second dialog box that pops
up and click the OK button to de-select the two samples and those
between them.
Click Reaction Curve to check the reaction curve and data of the
selected test.
There are two tabs at the Reaction Curve screen, the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
If you have no intention to view other results, go directly to the next step;
Otherwise, click the Previous or Next button at the Reaction Curve
screen; or click the Close button and repeat from step 2.
Select the desired sample or samples in the Samples field. You can use
the Select button or select them one by one.
Click the Print Pat. Report button and a print preview window will pop up.
At the Print Preview window, you may choose Pr. Series (series printing)
for your impact printer; you may choose Pr. Current (printing current
page) or Pr. All (printing all pages) for other types of printers.
NOTE:
You can click
(to the
(to the
4-23
Advanced Operations
4
When the printing is done, click the Close button to exit the Print Preview
window.
Enter the new value in the edit box to the right of Result.
If you want to save the new results, click the Save button; otherwise, click
the Cancel button.
NOTE:
You can only edit sample results of the current day since the latest
power-on here.
Click the Print Daily Summary button and a dialog box will pop up to ask
you to confirm the printing.
4-24
Advanced Operations
2
Click the OK button to confirm the printing; click the Cancel button, for any
reason, to abort the printing.
Once you click the OK button, another dialog box will pop up to ask you to
select a printer.
Enter the date (the default is the current date) and click the OK button to
print out the patient results; click the Cancel button, for any reason, to abort
the printing.
If there is no result of the entered date, a dialog box will pop up to alert you.
Click the OK button to close the dialog box and abort the printing.
Results by Tests
The Results by Tests tab lists all the finished sample tests of the current day since
the latest power-on. You can print the test report and revise results through this tab.
4-25
Advanced Operations
Enter the number of the start test into the first dialog box that pops up and
then click the OK button. A second dialog box will then pop up.
Enter the number of the end test into the second dialog box that pops up
and click the OK button to select the two tests and those between them.
Click the Deselect button and a dialog box will pop up.
Enter the number of the start test into the dialog box that pops up and
then click the OK button. Another dialog box will then pop up.
Enter the number of the end test into the second dialog box that pops up
and click the OK button to de-select the two tests and those between
them.
4-26
Advanced Operations
2
Click Reaction Curve to check the reaction curve and data of the
selected test.
There are two tabs at the Reaction Curve screen, the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
If you have no intention to view other results on the current virtual sample
disk, go directly to the next step;
Otherwise, click the Previous or Next button at the Reaction Curve
screen; or click the Close button and repeat from step 2.
Select the desired test or tests. You can use the Select button or select
them one by one.
Click the Print Test Report button and a print preview window will pop
up.
At the Print Preview window, you may choose Pr. Series (series printing)
for your impact printer; you may choose Pr. Current (printing current
page) or Pr. All (printing all pages) for other types of printers.
When the printing is done, click the Close button to exit the Print Preview
window.
4-27
Advanced Operations
2
Select a test or tests. You can use the Select button or select them one
by one.
Enter values in the edit boxes to the right of Factor a: and Factor b:.
If you want to revise the tests with the formula Y=aX+b (Y stands for the
new result and X stands for the old result), click the Save button;
otherwise, click the Cancel button.
After clicking the Save button, you can see the test result in the Finished
Tests field have been changed to the new ones.
NOTE:
You can only revise the sample results of the current day since the
latest power-on here.
4-28
Advanced Operations
Figure 4-11 Calib. Test tab
Select a calibration test in the Assays field. You can view the basic
information and the status of the selected test and the results of the
Finished tests.
Select the desired calibration run in Requested or Waiting status. You can
only delete one run at a time.
4-29
Advanced Operations
2
Click the Reaction Curve and a window will pop up to display the
corresponding reaction curve.
There are two tabs in the Reaction Curve screen: the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
Go directly to the next step if you have no intention to check other results;
Otherwise, click the Previous or Next button to view other results (not
only the results of calibrations) or click the Close button and then repeat
from step 1.
4-30
Advanced Operations
Click the Calib. Curve button to display the calibration curve and the
calibration result.
To print the displayed curve and result, click the Print button.
3
4-31
Advanced Operations
Figure4-12 QC Test tab
Select a QC run in the Assays field. You can view the parameters and the
status of the selected run and the results of the Finished runs.
Click the Reaction Curve and a window will pop up to display the
corresponding reaction curve.
4-32
Advanced Operations
There are two tabs in the Reaction Curve screen, the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
Go directly to the next step if you have no intention to check other results;
Otherwise, click the Previous or Next button to view other results (not
only the results of QCs) or click the Close button and then repeat from
step 1.
Select the desired Requested QC run. You can only delete one run at a
time.
4-33
Advanced Operations
4.1.5 Start
Start is used to run the requested tests.
If the current tests are paused, Start will change to Resume that is used to continue
the paused tests.
Start tests
1
Click Routine Start or press F5, or click the short-cut button
pop up the following dialog box.
to
In the Select Samples dialog box, select a virtual sample disk to the right
of Sample Disk.
NOTE:
If there are any requested STAT samples on the current
default virtual sample disk, you can only select the disk.
4-34
Advanced Operations
3
In the Select Samples dialog box, select samples to be run in the Select
sample to be run field.
If you select All Samples, go directly to the step 5; if you select Selected
Samples, go to the next step.
NOTE:
If you select All Samples, the system will run all the
Requested samples (Waiting STAT samples included),
calibrations and QC tests.
If you select Selected Samples, the system will run some
Requested samples, calibrations and QC tests. When
Selected Samples is selected, the Select Samples field is
available.
In the Select Samples dialog box, select tests to be run in the Select
Samples field.
If you want to run sample tests, select the check box to the left of Sample
No. and enter the sample No. in the edit boxes to the right of it. The
system will run the Requested samples whose IDs are between the two
numbers (including the two numbers).
If you want to run calibration tests, select the check box to the left of
Calibration and select tests below it.
If you want to run QC tests, select the check box to left of QC and select
tests below it.
4-35
Advanced Operations
5
If you want to continue, click the OK button; otherwise, click the Cancel
button.
When you click the OK button, a dialog box will pop up.
Select a virtual reagent disk in the Select Reagent Disk dialog box.
If you want to run the selected tests, click the OK button; otherwise, click
the Cancel button and the system will not run the selected tests.
When you click the OK button, the status of the selected tests changes to
Waiting and the system will run the tests that use the reagents on the
selected virtual disk immediately.
NOTE:
If the system finishes the tests that use the reagents on the selected
virtual reagent disk, and there are waiting tests that use reagents on
the other disk, a dialog box will pop up to remind you.
Click the OK button to exit the dialog box.
After replacing the reagent disk, click the Resume button to continue
the tests that use reagents on the other disk. Refer to the following
contents for details.
Resume tests
1
If there is no test in Requested status but you need to replace the reagent
disk, the following dialog box will pop up.
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Advanced Operations
4
If there are tests in Requested status, the following dialog box will pop up.
If you want to continue the tests currently being paused, click Cancel
button;
If you want not only to continue the tests currently being paused but also
to run the tests in Requested status, select tests and click the OK button.
After that, if there is no need to replace the reagent disk, the system will
continue the tests; if you want to replace the reagent disk, a dialog box
will pop up.
Click Routine Probe Stop, or press F6, or click the short-cut button
to
stop the sample and reagent probes and the mixing bar without stopping the reaction
disk. You may use this function to add more samples or reagents without stopping
the analysis. This menu is only functional when the system is testing.
NOTE:
Do not put the probes and the bar on hold for too long. Otherwise,
certain analyses may be affected.
4-37
Advanced Operations
4.1.7 Stop
to stop the
NOTE:
Mindray recommends this stop function not be used unless it is
necessary (for instance the analyzer is experiencing problems). When
the analyzer is experiencing a serious problem, the analyzer will be
stopped automatically.
After the analyzer is stopped, all the remaining runs will be invalidated
and return to the Requested status, but the finished runs will be
saved. To continue these runs, click the short-cut button
4.1.8 Exit
When you have finished all analyses and the system is in the idle status, click
Routine Exit, or press F10, or to click the short-cut button
to exit the
control system. A dialog box will pop up to ask you to confirm the exiting operation.
Click the OK button and another dialog box will pop up to ask you to load detergents.
NOTE:
Please use Mindray-recommended detergents: 0.1mol/l hydrochloric
acid, or 0.5% (V/V) Javel water.
Use of other detergents may lead to inaccurate results. Do not use
other detergents.
4-38
Advanced Operations
Ensure acid and alkaline detergents are loaded to positions 45 and 47 respectively
and then click the OK button and the analyzer will start the following shutdown
procedure:
1
Carry out the washing procedure: washing the sample probe, reagent probe
and mixing bar for three times respectively with the acid and alkaline
detergents.
Wash the analyzing unit with deionized water as defined by Times of Auto
Washing(Startup/Shutdown) at the System SetupRoutine screen.
When the shutdown procedure is done, a dialog box will pop up to remind you that
you can shutdown the ANALYZING UNIT POWER to OFF safely. Click the OK
button to exit the control software.
NOTE:
Use this emergency exit function only when the analyzer is
experiencing a serious problem.
4.2
Parameters
4.2.1 Assay
The Assay Parameters screen is where you set parameters regarding the tests,
calculation tests, profiles, carryover and off-system tests.
To enter the Assay Parameters screen, click Parameters Assay, or press the
F11 key on the keyboard.
4-39
Advanced Operations
NOTE:
If you are not authorized to edit the test parameters, a dialog box will
pop up to ask you to enter the authorized user name and password.
At the Assay Parameters screen, shown in Figure 4-13, you can see the following
tabs:
Parameters
Reference Range
Calculation
Profile
Carryover
Off-system
4-40
Advanced Operations
The Parameters tab consists of three main parts, the upper part being the
parameters to be set for the selected test, the middle part being all the tests whose
parameters are set already, the lower part being the operating buttons.
In the middle part, yellow-framed tests are the double-reagent tests whose reagent
positions are set already; the gray-framed tests are the double-reagent tests whose
reagent positions are not set yet; the non-framed tests are the single-reagent tests.
Follow the instructions given below to set the parameters for the selected test.
Parameter
What it does
How to set
No.
It is the system-generated
number assigned to the
current test.
Assay
Type
Reaction
Units
4-41
Advanced Operations
Parameter
What it does
How to set
Precision
Prim.
Wave.
Defines
the
primary
wavelength to be used on
the test.
Sec.
Wave.
Defines
the
secondary
wavelength to be used on
the test.
Sample
Vol.
R1 Vol.
Defines
the
volume
(180-450 l) of the first
reagent to be dispensed for
the reaction.
R2 Vol.
Lin. Limit
The
analyzer
will
automatically calculate the
linearity
within
the
measurement
time
and
compare the result to the
line limit and flag the result
exceeding the defined limit.
The formula to calculate the
linearity is as follows:
(1)When more than 9 points
are measured
Linearity = (absorbance
change of the first 6 points
absorbance change of the
last 6 points)/(absorbance
change of all the points)
(2)When the 4 number of
measured points 8
Linearity = (absorbance
change of the first 3 points
4-42
Advanced Operations
Parameter
What it does
How to set
Applies
only
double-reagent tests.
to
Defines
whether
the
analyzer should check for
surplus antigen.
When the antibody reacts
with the antigen, the amount
of the product is closely
related to their proportion.
Only
the
appropriate
proportion can introduce the
maximum amount of the
product and when this
happens, the transmitted
light is minimized and the
4-43
Advanced Operations
Parameter
What it does
How to set
largest
absorbance
is
obtained.
Any
other
proportion will lead to a less
absorbance and when this
happens,
samples
of
significantly different antigen
concentrations may have the
same test results.
The
surplus
antigen
threshold (Antigen) refers to
the maximum or minimum
PC when there is no surplus
antigen.
It only applies to the
Endpoint
tests
to
be
analyzed
using
the
antigen-antibody
reaction.
When 1/3 of the reaction
time has elapsed, at least
80% of the reaction should
be finished. Otherwise, there
is surplus antigen.
Calculation:
(1)For the calibrator of the
maximum concentration:
threshold = 2*(absorbance
of the last point - absorbance
taken at 1/3 reaction time) /
(absorbance of the last point
+ absorbance taken at 1/3
reaction time)
(2)The
above
formula
applies to samples(including
controls) as well
(3)For
a
reaction, if:
descending
is
surplus
4-44
Advanced Operations
Parameter
What it does
How to set
if :
the calculated threshold of
the
sample
(including
controls) is greater than that
of
the
maximum-concentration
calibrator, and
the absorbance of the last
point
of
the
sample
(including controls) is less
than
that
of
the
maximum-concentration
calibrator
then
there
antigen.
Substrate
is
surplus
Defines
whether
the
analyzer should check for
surplus
substrate
and
applies only to the Kinetic
and Fixed time method.
4-45
Advanced Operations
Parameter
What it does
How to set
S. Volume
Ratio
Defines
the
allowed
absorbance range of the
mixture (reagents + sample)
of the double-reagent test.
The analyzer will flag the
blank result that is beyond
the defined range.
Full Name
Print No.
R1 Blank
Mix.
Blank
R.
Linearity
NOTE:
Please define the parameters as instructed by this operation manual
and the instructions of the reagent suppliers. Improper settings may
lead to unreliable test results.
4-46
Advanced Operations
Go to the middle part of the tab and click the desired test and then the
upper part will show the parameters of the specific test.
Click the Save button to save the setting; click the Cancel button, for any
reason, to ignore the setting.
NOTE:
If there are any obligatory parameters missing, once you
click the Save button, the analyzer will automatically
red-frame the missing parameters (or pops up a dialog box
to warning you about it) and disables the Save button. You
need to set the missing parameters and try to save the
settings again.
To delete a test
1
Go to the middle part of the tab and click the desired test.
Click the Delete button and a dialog box will pop up to ask you to confirm the
deletion.
Click the OK button to delete the test; click the Cancel button, for any reason,
to ignore the deletion.
NOTE:
Once you have confirmed to delete the selected test, the
analyzer will delete all the parameters, including the reagent
parameters, calibration parameters, and QC parameters,
related to the test. Ensure the right test is selected before
confirming the deletion.
4-47
Advanced Operations
To edit a test
1
Go to the middle part of the tab and click the desired test.
Go back to the upper part of the tab to edit the test as you need.
Click the Save button to save the change; click the Cancel button, for any
reason, to ignore the change.
Once you have clicked the Save button, if the changed parameters change
analysis conditions, a dialog box will pop up to remind you to re-calibrate.
Click the OK button. If the changed parameters do not change analysis
conditions, this dialog box will not pop up.
A dialog box will pop up to ask you whether to delete other parameters related
to this test.
If you click the OK button, the analyzer will save the changed parameters and
clear all other unchanged ones, including the corresponding reagent
parameters, calibration parameters, and QC parameters; if you click the
Cancel button, the analyzer will save the changed parameters and keep the
other related parameters unchanged.
NOTE:
Once you have clicked the OK button, the analyzer will
delete all the parameters, including the reagent parameters,
calibration parameters, and QC parameters, related to the
test. Ensure the right test is selected before confirming the
deletion.
4-48
Advanced Operations
Click the Reference Range tab to edit or view the expected means of the test, as
Figure 4-15 shows.
Parameter
What it does
How to set
Assay
Sample Type
Defines to which
type the sample
belongs.
Sex
Patient
Demographics
(Figure 4-16)
Defines
means for
different
Maximum
groups
defined.
expected
patients of
ages.
6 patient
can
be
4-49
Advanced Operations
Parameter
What it does
How to set
than one year, you can only enter 0s
to both the Months boxes. In case of
patients younger than one year, enter
the lower limit into the first Months
and the upper limit into the Months
limit. Both the entered values must be
0-12 and the upper limit must be
greater than or equal to the lower limit.
Default (Figure
4-17)
Click to the right of Assay and select the desired test from the pull
down list.
Click to the right of Sample Type and select the desired type from the
pull down list.
4-50
Advanced Operations
3
Click to the right of Sex and select the desired gender from the pull
down list.
The pre-set expected means will then be displayed.
Click to the right of Assay and select the desired test from the pull
down list.
Click to the right of Sample Type and select the desired type from the
pull down list.
Click to the right of Sex and select the desired gender from the pull
down list.
Tick the check box of the first patient group and set the Years, Months,
Lower Limit and Upper Limit field as instructed above.
Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes.
NOTE:
In case of inappropriate settings, a dialog box will pop up to
alert you once you have clicked the Save button.
4-51
Advanced Operations
Figure 4-18 Calculation tab
As Figure 4-18 shows, the Calculation tab consists of four major parts: the
parameters on the upper left, all the available tests on the upper right, calculation
formula on the middle and operating buttons on the bottom.
The parameters are interpreted as follows.
Parameter
What it does
How to set
No.
Assigns
a
system-generated number
to the current calculated
test.
Assay
Units
Precision
Defines
how
many
decimal places (0 - 6) the
test result should have.
Ref. Range
Full Name
Print No.
4-52
Advanced Operations
or
NOTE:
Click
Click
Select the tests to be involved in the calculation from the Assays field.
4-53
Advanced Operations
4
Click the Add to List button to add the selected tests to the calculation list.
NOTE:
In case you add inappropriate tests to the calculation list by
mistake, click the Clear button to clear the list and then
re-select appropriate tests to add to the list.
5
Edit the calculation formula by clicking a selected test from the calculation
list and click the Add to Formula button to add the test to the Formula
field. Clicking the digit buttons (0-9) and operator buttons (+, -, and so
forth) to associate the test with appropriated digits and operators as
needed by the desired calculation formula. Repeat this step on every
selected test until the desired calculation formula is completed.
NOTE:
To clear a mistake, click the Clear Formula button to clear
the formula and re-edit it the right way.
Example: to edit ALT-AST+TP, first select ALT from the calculation list and
then click the Add to Formula button to add the test to the Formula field.
Click the button to associate the ALT with the minus sign. Select AST
from the calculation list and click the Add to Formula button to add the
test to the Formula field, following the minus sign. Click the + button to
associate the AST test. Select TP from the calculation list and click Add to
Formula. Thus, the desired formula is completed.
Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes.
Select the test to delete from the pull down list on the middle left of the
screen.
4-54
Advanced Operations
2
Click the Delete button and a dialog box will pop up to ask you to confirm
the deletion.
Click the OK button to confirm the deletion; click the Cancel button, for
any reason, to cancel the deletion.
Select the test to edit from the pull down list on the middle left of the
screen.
NOTE:
In case you add inappropriate tests to the calculation list by
mistake, click the Clear button to clear the list and then
re-select appropriate tests to add to the list.
To clear a mistake, click the Clear Formula button to clear
the formula and re-edit it the right way.
3
Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes.
screen
4-55
Advanced Operations
Figure 4-19 Profile tab
As the figure shows, the Profile tab consists of three major parts: existing profiles
(groups) on the left, available tests (tests have no assigned reagent positions are
followed by a forbidden mark) on the right and operating buttons on the bottom.
Select the desired group from the pull down list of the Profile Name field
or from the Profile List field. The included tests will be followed a green
tick.
Enter an appropriate profile name into the edit box of the Profile Name
field.
Click the Save button to save the settings; click the Cancel button, for any
reason, to ignore the settings.
4-56
Advanced Operations
To delete a profile
1
Select the desired group from the pull down list of the Profile Name field
or from the Profile List field.
Click the OK button to confirm the deletion; click the Cancel button, for
any reason, to cancel the deletion.
To edit a profile
1
Select the desired group from the pull down list of the Profile Name field
or from the Profile List field.
Select or de-select the tests as you need. The selected tests will be
followed by a green tick. Clicking the ticked test again may de-select the
test.
Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes.
4-57
Advanced Operations
Figure 4-20 Carryover tab
As the figure shows, the Carryover parameters screen consists of three major parts:
current reagents listed in the current field on the upper, the reagents that may be
affected (contaminated) by the current reagents listed in the contaminated field on
the lower, and operating buttons on the bottom.
Note that the yellow reagents are the first reagents of the double-reagent tests and
the blue reagents are the second reagents of the double-reagent tests.
Click the desired reagent from the current field and the selected reagent
will be followed by a green tick. Check the contaminated field and the
tests followed by a red tick are those that may be affected by the current
reagent.
Select the desired reagent from the current field. The selected reagent will
be followed by a green tick. Clicking the ticked reagent again may
de-select it.
Check the contaminated field and click the reagents that may be affected
by the current test. The selected reagent will be followed by a red tick.
Clicking the ticked reagent again may de-select it.
Click the Save button to save the settings; click the Cancel button, for any
reason, to ignore the settings.
4-58
Advanced Operations
Click the desired reagent from the current field and the selected reagent
will be followed by a green tick. Check the contaminated field and the
tests followed by a red tick are those that may be affected by the current
reagent.
Click the Clear button and you will see all the red ticks have disappeared.
As the figure shows, the Off-system tab consists of mainly three parts: the
parameters on the upper left, the tests on the upper right and the operating buttons
on the bottom.
The parameters are interpreted as follows.
Parameter
What it does
How to set
No.
Assigns a system-generated
number to the current
calculated test.
Use
the
number.
4-59
system-generated
Advanced Operations
Parameter
What it does
How to set
Assay
Enter
the
desired
name
(maximum 20 letters) into the
edit box.
Precision
Units
Lower Limit
Print No.
Full Name
Property
Select
Quantitative
or
Qualitative from the pull down
list.
Upper Limit
Select the desire test from the test list and its parameters will be displayed
on the screen.
Click the Save button to save the settings; click the Cancel button, for any
reason, to ignore the settings.
4-60
Advanced Operations
2
Click the Delete button and a dialog box will pop up to ask you to confirm
the deletion.
Click the OK button to confirm the deletion; click the Cancel button, for
any reason, to cancel the deletion.
Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes.
4.2.2 Reagent
To enter the Reagent Parameters screen, click Parameters Reagent, or press
F12.
NOTE:
If you are not authorized to change the reagent parameters, a dialog
box will pop up to ask you to enter the authorized user name and
password.
4-61
Advanced Operations
Figure 4-22 Reagent Parameters screen
At the Reagent screen, Figure 4-22, you can see two tabs:
Reagent Disk
Inventory
The Reagents Disk tab is where you set the parameters regarding the reagents.
The Inventory tab is where you check the remaining reagents and print the checking
results.
4-62
Advanced Operations
Figure 4-23 Reagent Disk tab
What it does
Rgt. Disk
R1
R2
R1 Inventory
R2 Inventory
4-63
Advanced Operations
Parameter
What it does
When the remaining reagent is still more than half of the bottle,
the color bar appears green; When the remaining reagent is
between 1/4 and 1/2 of the bottle, the color bar appears yellow;
When the remaining reagent is less than 1/4 of the bottle, and
the color bar appears red.
The box to the right of the color bar displays how many tests
the remaining reagent is enough for.
R1 Bottle
R2 Bottle
Click to the right of Rgt. Disk and select the desired virtual reagent
disk from the pull down list.
Click to the right of Rgt. Disk and select the desired virtual reagent
disk from the pull down list.
Click to the right of Rgt. Disk and select the desired virtual reagent
disk from the pull down list. The positions of the reagents will be set on
the selected virtual reagent disk.
Click to the right of R1 or R2 and select the desired position from the
pull down list. Note that for the single-reagent test, you cannot select R2
position.
Click the Save button to save the settings; click the Cancel button, for any
reason, to ignore the settings.
NOTE:
When you have set (not changed) the reagent position for a
test, the analyzer will automatically take the reagent bottle
volume as the volume of the remaining reagent.
If any field is inappropriately set, the analyzer will warn you
about the wrong settings once you have clicked the Save
button.
4-64
Advanced Operations
Click to the right of Rgt. Disk and select the desired virtual reagent
disk from the pull down list.
Click the Clear button to clear the reagent positions set for the selected
test.
NOTE:
Once you have clicked the Clear button, the analyzer will
immediately clear all the reagent positions set for the
selected test without asking you to confirm the clearing.
Ensure the right test is selected before clicking the Clear
button.
Click to the right of Rgt. Disk and select the desired virtual reagent
disk from the pull down list.
Select a test.
If the new positions for the selected test are on the current virtual reagent
disk, go directly to the next step;
Otherwise, click the Clear button and then select the other virtual reagent
disk to the right of Rgt. Disk.
Select the bottle types to the right of R1 Bottle and R2 Bottle for the
reagents. For the single reagent test, R2 Bottle is unavailable.
Select the positions to the right of R1 and R2 for the reagents. For the
single reagent test, R2 is unavailable.
If you want to save the settings, click the Save button; otherwise, click the
Cancel button.
NOTE:
If some parameters are not set correctly, after you click the
Save button, the system will remind you.
Click the Def. Rgt. Disk button to pop up the following dialog box.
4-65
Advanced Operations
3
If you want to set the selected disk as the default reagent disk, click the
OK button; otherwise, click the Cancel button.
After you set the default reagent disk, the Reagent Disk tab and the
Inventory tab will display its reagent information.
Click the Reagent Disk tab, and then click the to the right of Rgt.
Disk and select the desired virtual reagent disk from the pull down list.
Refer to 4.2.2.1 Reagent Disk tab for details.
4-66
Advanced Operations
2
Click the Check button to view how much reagent is left in the selected
bottle and how many tests the remaining reagent is enough for.
Select the reagent(s) whose information you want to clear from the
reagent list.
Click the Print button to print the currently displayed reagent leftover
information.
4.2.3 Calibration
The Calibration screen is where you set the parameters regarding calibrators and
calibrations and view the calibration results.
To enter the Calibration screen, click Parameters Calibration, or press CTRL +
K.
NOTE:
If you are not authorized to edit the calibration parameters, a dialog
box will pop up to ask you to enter the authorized user name and
password.
4-67
Advanced Operations
Figure 4-25 Calibration screen
At the Calibration screen, Figure 4-25, you can see the following tabs:
Calibrator
Rule
Result
Click the Calibrator tab to display its contents, as Figure 4-26 shows. The tab
consists of 4 zones:
4-68
Advanced Operations
Calibrators zone displays such calibrator parameters as lot number, expiration
date, etc.
Positions zone (Figure 4-27) displays the positions of the calibrators.
Assays zone displays tests that related to the selected calibrator in Calibrators
zone.
Operating buttons such buttons as Add, Edit, etc.
Figure 4-27 Calibrator positions
Five virtual sample disks (Sample Disk1 - Sample Disk5) are displayed in the
Positions zone and every virtual disk has 6 calibrator positions (S1 - S6). The 0
position (default) means this virtual disk has no position set for the calibrator yet. You
cannot request a calibration run for a calibrator whose corresponding calibrator
positions on all the five virtual disks are 0s.
Click the desired calibrator in the Calibrators zone and check its
positions and tests in the Positions and Assays zones respectively.
4-69
Advanced Operations
Click the Add button and the Calibrator window will pop up.
The analyzer will automatically assign a number to the new calibrator and
you can only view in the No. field without altering it;
Enter calibrator name into the edit box to the right of Name;
Enter the lot number into the edit box to the right of Lot No.;
Click to the right of Conc. Level and select Low, Normal or High
from the pull down list as the concentration level of the calibrator;
Click to the right of Exp. Date and select the appropriate as the
expiration date of the calibrator.
NOTE:
Ensure the right expiration date is set so that the analyzer
can correctly judge whether the calibrator has expired.
3
Click the OK button to save the settings; Click the Cancel button, for any
reason, to ignore the settings.
NOTE:
If any field is inappropriately set, the analyzer will warn you
about the wrong settings once you have click the OK button.
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2
Click the Edit button and the Calibrator window will pop up.
The analyzer will automatically assign a number to the new calibrator and
you can only view in the No. field without altering it;
Enter calibrator name into the edit box to the right of Name;
Enter the lot number into the edit box to the right of Lot No.;
Click to the right of Conc. Level and select Low, Normal or High
from the pull down list as the concentration level of the calibrator;
Click to the right of Exp. Date and select the appropriate as the
expiration date of the calibrator.
Click the OK button to save the changes; click the Cancel button, for any
reason, to ignore the changes.
NOTE:
If any field is inappropriately set, the analyzer will warn you
about the wrong settings once you have clicked the Save
button.
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2
Click the Delete button and a dialog box will pop up to ask you to confirm
the deletion.
Click the OK button to confirm the deletion; Click the Cancel button, for
any reason, to abort the deletion.
NOTE:
Once you have confirmed the deletion, the analyzer will
delete all the parameters, including calibrator positions, tests
included, etc., related to the selected calibrator. Ensure the
right calibrator is selected before confirming the deletion.
You cannot delete a calibrator involved in calibrations that
are in process or have been requested.
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3
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2
or
(2) Assays zone lists all the available tests. The blue-framed tests are
those whose standard concentrations have already been set.
(3) Concentration zone defines the standard concentration for the
selected test. The standard concentration cannot be negative and if it
appears -1, it indicates you have not set the standard concentration for
the selected test yet.
(4) Operating buttons zone displays such buttons as Set, Delete, etc.
3
To set or change the standard concentration for a specific test, click the
Set button.
To delete the standard concentration of a specific test, click the Delete
button.
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4
Click the desired test in the Assays zone. The selected test will be
marked a green tick and click it again to de-select it. You can choose
multiple tests and set or delete their standard concentrations altogether.
Click the OK button to save the changes; click the Cancel button, for any
reason, to ignore the changes.
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Figure 4-28 Rule tab
Click the Rule tab to display its contents, as Figure 4-28 shows. The tab consists of
4 zones:
Operating buttons zones lists such buttons as Save, Cancel, Clear, etc.
Assays zone lists all the available tests. Those tests followed by forbidden
, have no reagent positions yet and you cannot set the
mark, such as
calibration parameters for them. The blue-framed tests are those whose
calibration parameters have already been set.
Rule zone defines the nine parameters regarding calibration requests.
Calibrators zone lists the calibrators that have already been set. The selected
calibrator will be preceded by a red tick; the expired calibrator will be preceded by
a red block.
Parameter
What it does
How to set
Method
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Parameter
What it does
How to set
K Factor
Enter
the
desire
integer(1-5) into the
edit box to the right of
Rerun Error Limit or
button on the
click
right of the edit box
until the desired value
is reached.
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Parameter
What it does
How to set
Interval
Enter
the
desired
integer (0-99) into the
edit box to the right of
Blank
Response
Sensitivity
on
Interval or click
the right of the edit box
until the desired value
is reached.
Coefficient
SD
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2
Click the test or tests. The selected tests will be followed by a green tick.
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5
NOTE:
You must determine the number of the calibrators to be used
according to the selected calibration rule. You can only
select calibrators whose standard concentrations have
already been set.
Click the Auto Dilution button and the Auto Dilution Setup window will
pop up.
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7
Enter concentrations in the ascending order into the edit boxes in the
Auto Dilution Setup window.
You must determine the number of the edit boxes to be entered as you
need. Leave the edit boxes that are not to be used empty.
Conc. 1 must be 0. It refers to the concentration of the distilled water in
position W of the sample disk.
The entered second concentration must be greater than or equal to 0.6%
of the concentration of the calibrator selected in the step 5.
The entered penultimate concentration must be less than or equal to
37.5% of the concentration of the calibrator selected in the step 5.
The entered last concentration must be the same with the concentration of
the calibrator selected in the step 5.
Following values are recommended where N is the number of
concentrations and C is the concentration of the calibrator selected in the
step 5.
N=3
N=4
N=5
N=6
N=7
N=8
Conc. 1
Conc. 2
0.375*C
0.25*C
0.125*C
0.0625*C
0.03125*C
0.015625*C
Conc. 3
0.375*C
0.25*C
0.125*C
0.0625*C
0.03125*C
0.375*C
0.25*C
0.125*C
0.0625*C
0.375*C
0.25*C
0.125*C
0.375*C
0.25*C
0.375*C
Conc. 4
Conc. 5
Conc. 6
Conc. 7
Conc. 8
Click the Save button to save the settings; Click the Cancel button to
at the top-right corner to exit the
ignore the settings. Then click
window.
Click the Save button to save the changes; Click the Cancel button, for
any reason, to ignore the changes.
NOTE:
If any field is inappropriately set, the analyzer will warn you
about the wrong settings once you have clicked the Save
button.
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2
Select the test or tests whose calibration settings you want to clear.
NOTE:
Once you have clicked the Clear button, the analyzer will
immediately clear all the calibration settings related to the
selected test without asking you to confirm the clearing.
Ensure the right test is selected before clicking the Clear
button.
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or
to select previous or
Click to the right of From (or To) and select the desired date to specify the
dates to be searched. The analyzer will search all the calibration runs taking
place during this specified period.
Click the Search button to start the search and the matches will be displayed in
the Results zone.
NOTE:
If no calibration run matches the specified conditions, a
dialog box will pop up to remind you no match is found.
Under this circumstance, go directly to step 6.
If you do not intend to check other calibration results, the operation is over;
otherwise, click the Unlock button and return to step 1.
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or
to check previous
Click to the right of From (or To) and select the desired date to
specify the dates to be searched. The analyzer will search all the
calibration runs taking place during this specified period.
2
Click the Search button to start the search and the matches will be
displayed in the Results zone. You cant go on unless there are matches.
Select the desired calibration rule from the pull down list to the left of
Method.
Click the Calculate button to start the calculation; click the Cancel button,
for any reason, to cancel the calculation.
or
to check previous
Click to the right of From (or To) and select the desired date to
specify the dates to be searched. The analyzer will search all the
calibration runs taking place during this specified period.
2
Click the Search button to start the search and the matches will be
displayed in the Results zone. You cant go on unless there are matches.
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4
NOTE:
You cannot select the calibration whose Default field
displays Yes.
Click the Delete button and a dialog box will pop up to ask you to confirm
the deletion.
Click the OK button to confirm the deletion; click the Cancel button, for
any reason, to cancel the deletion.
or
to check previous
Click to the right of From (or To) and select the desired date to
specify the dates to be searched. The analyzer will search all the
calibration runs taking place during this specified period.
2
Click the Search button to start the search and the matches will be
displayed in the Results area. You cant go on unless there are matches.
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5
Click the Default button to set the current calibration settings as the
default settings of the selected test. The Default field of the calibration will
display Yes.
NOTE:
This analyzer uses the default calibration settings to
calculate the sample concentrations.
This analyzer will automatically set the latest settings
(include the settings of calibration test, edit, calculation) as
the default.
or
to check previous
Click to the right of From (or To) and select the desired date to
specify the dates to be searched. The analyzer will search all the
calibration runs taking place during this specified period.
2
Click the Search button to start the search and the matches will be
displayed in the Results area. You cant go on unless there are matches.
Click the Data button. The Test Data dialog box is displayed. You can
view the data of selected calibration.
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6
4.2.4 QC
The QC screen is where you set the parameters regarding controls and QC runs and
view QC results.
To enter the QC screen, click Parameters QC, or press CTRL + I.
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NOTE:
If you are not authorized to change the QC parameters, a dialog box
will pop up to ask you to enter the authorized user name and
password.
At the QC screen, Figure 4-30, you can see the following tabs:
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Figure 4-31 Control tab
Click the Control tab to display its contents, as Figure 4-31 shows. The tab mainly
consists of 4 zones:
Controls zone displays such control parameters as lot number, expiration date,
etc.
Positions zone displays the positions of the controls.
Assays zone displays available tests that related to the selected control in
Controls zone.
Operating buttons such buttons as Add, Edit, etc.
Five virtual sample disks (Sample Disk1 - Sample Disk5) are displayed in the
Positions zone and every virtual disk has 3 control positions (C1 - C3). The 0
position (default) means this virtual disk has no position set for the control yet. The
Other means you can set other positions for the controls on the disk.
You cannot request a QC run for a control whose corresponding control positions on
all of the five virtual disks are 0s.
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Click the desired control in the Controls zone and check its positions and
tests in the Positions and Assays zones respectively.
Click the Add button and the Control window will pop up.
The analyzer will automatically assign a number to the new control and
you can only view in the No. field without altering it;
Enter control name into the edit box to the right of Name;
Enter the lot number into the edit box to the right of Lot No.;
Click to the right of Conc. Level and select Low, Normal or High
from the pull down list as the concentration level of the control;
Click to the right of Exp. Date and select the appropriate date as the
expiration date of the control;
Click to the right of Tube Type and select Large Tube or Small Tube
for the control.
NOTE:
Ensure the right expiration date is set so that the analyzer
can correctly judge whether the control has expired.
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3
Click the Save button to save the changes; Click the Cancel button, for
any reason, to ignore the change.
NOTE:
If any field is inappropriately set, the analyzer will warn you
about the wrong settings once you have clicked the Save
button.
Click the Edit button and the Control window will pop up.
The analyzer will automatically assign a number to the new control and
you can only view in the No. field without altering it;
Enter control name into the edit box to the right of Name;
Enter the lot number into the edit box to the right of Lot No.;
Click to the right of Conc. Level and select Low, Normal or High
from the pull down list as the concentration level of the control;
Click to the right of Exp. Date and select the appropriate date as the
expiration date of the control;
Click to the right of Tube Type and select Large Tube or Small Tube
for the control.
Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes
NOTE:
If any field is inappropriately set, the analyzer will warn you
about the wrong settings once you have click the Save
button.
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Click the Delete button and a dialog box will pop up to ask you to confirm
the deletion.
Click the OK button to confirm the deletion; Click the Cancel button, for
any reason, to abort the deletion.
NOTE:
Once you have confirmed the deletion, the analyzer will
delete all the parameters, including control positions, tests
included, etc., related to the selected control. Ensure the
right control is selected before confirming the deletion.
You cannot delete a control involved in QC runs that are in
process or have been requested.
The control positions that appear gray are occupied by other controls.
4
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Click the Concentration button and a Concentration window will pop up.
or
until
(2) Assays zone lists all the available tests. The blue-framed tests are
those whose standard concentrations have already been set.
(3) Concentration and SD zone defines the standard concentration and
SD for the selected test. Neither the standard concentration nor the SD
can be negative. When the Concentration or SD field displays -1, it
indicates the standard concentration or SD has not been set yet.
(4) Operating buttons zone displays such buttons as Set, Delete, etc.
3
If you want to set concentrations and SDs for ISE tests, select the check
box to the left of ISE.
To set or change concentration or SD, click the Set button.
To delete concentration or SD, click the Delete button.
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4
If you enter concentrations and SDs for ISE tests, go directly to the next
step.
Click the desired test in the Assays zone. The selected test will be
marked a green tick and click it again to de-select it. You can choose
multiple tests and set or delete their standard concentrations or SD
altogether.
Click the OK button to save the changes; Click the Cancel button, for any
reason, to ignore the change.
or
NOTE:
Please use Mindrayrecommended controls for ISE QC.
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Figure 4-32 Rule tab
Click the Rule tab to display its contents, as Figure 4-32 shows. The tab consists of
3 zones:
Independent zone
Control-related zone
Operating buttons zone
The QC rules can be divided into two categories: independent rules, such as
Cumulative Sum Check and Westgard Multi-rule, and control-related rules (not
related to controls), such as Accumulative Error and X-R. Note that you cannot set
the parameters of the control-related rules unless you have specified the controls to
be used.
As Figure 4-33 shows, all the available tests are listed on the left and the rules,
Cumulative Sum Check and Westgard Multi-rule, are listed on the right. The
Cumulative Sum Check rule has three sub-rules and you can choose one of the
sub-rules. The Westgard Multi-rule rule has six sub-rules and you can choose one
or more sub-rules.
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Figure 4-34 Control-related zone
As Figure 4-34 shows, all the available tests are listed on the left and the QC rule
parameters are listed in the Control, Accumulated Error and X-R zones.
Note that any test whose standard concentration and SD have not been set yet will
be followed by a forbidden mark, such as
NOTE:
If the ISE unit (optional) is connected, the ISE tests will be displayed in
the test list.
Select the desired test or tests. The selected test will be followed by a green
tick.
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4
Click the Save button to save the settings; click the Cancel button, for any
reason, to ignore the settings.
Repeat from step 2 to set the parameters for other tests, or click the check
box to the left of Independent again to de-select the field.
Select the desired test or tests. The selected test will be followed by a
green tick.
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4
To set the parameters: click button to the right of Control and select
the desired control from the pull down list; enter the desired E (limit of the
accumulated error) into the edit box to the right of Limit(E); enter the
desired SDR value in the edit box to the right SDR (for the X-R rule).
Click the Save button to save the settings; click the Cancel button, for any
reason, to ignore the settings.
Repeat from step 2 to set the parameters for other tests, or click the check
box to the left of Control-related again to de-select the field.
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Controls zone lists all the available controls.
Auto QC zone defines parameters regarding auto QC.
Operating buttons lists such buttons as Save, Clear, etc.
The tests, whose QC parameters have already been set, are blue-framed. The tests
whose reagent positions have not been set yet are followed by a forbidden mark,
such as
All the controls that have been set are listed in the Controls zone. The selected
tests will be preceded by a red tick and the expired test will be preceded by a red
mark.
You can set the interval of the automatic QC runs by entering the desired number
on the right of the edit box until the
into the edit box below Count or clicking
desired number is reached. To disable the auto QC function, enter 0 into the edit
box.
Select the desired test or tests. The selected parameter will be followed
by a green tick.
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3
Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes.
NOTE:
If any parameter is inappropriately set, the analyzer will alert
you after you have clicked the Save button.
NOTE:
Once you have clicked the Clear button, the analyzer will
immediately clear the QC settings related to the selected test
without asking you to confirm the clearing. Ensure the right
test is selected before clicking the Clear button.
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NOTE:
If the ISE unit (optional) is connected, ISE tests will be displayed in the
test list.
Select the desired test from the Assays zone. The selected test will be
followed by a green mark.
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3
Click the Search button to display the information, including the results,
QC graph, statistic data and QC status, of the last 10 control runs of the
selected test using the selected control or controls.
To print the displayed data and graph, click the Print button.
Click the Print button to print out the result and QC graph after checking
the result of a control run.
Select the desired test in the Assays field. The selected test will be
marked with a green block to the right of it.
Click the Data button. The Delete QC Data dialog box is displayed. You
can view and delete the measurement data of selected control.
Select one or more QC results you want to delete from the Delete QC
Data dialog box.
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5
Select Delete. The Enter User and Password dialog box pops up.
Enter correct user name and password and click OK. The selected results
are deleted.
Please note that the username you are entering should have the authority
to set up quality control. Otherwise you cannot delete the QC results.
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NOTE:
If the ISE unit (optional) is connected, ISE tests will be displayed in the
test list.
Click to the right of Date and select the desired date from the pull
down list to search the QC runs taking place within this date.
Click to the right of Rule and select the desired QC rule from the pull
down list.
Select the desired test from the Assays zone. The selected test will be
followed by a green mark.
Click the Search button to display the information, including the results,
QC graph, statistic data and QC status, of the last 10 control runs of the
selected test using the selected control or controls.
To print the displayed data and graph, click the Print button.
Click the Print button to print out the result and QC graph after checking
the result of a control run.
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Select the desired test in the Assays field. The selected test will be
marked with a green block to the right of it.
Click the Data button. The Delete QC Data dialog box is displayed. You
can view and delete the measurement data of selected control.
Select one or more QC results you want to delete from the Delete QC
Data dialog box.
Select Delete. The Enter User and Password dialog box pops up.
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6
Enter correct user name and password and click OK. The selected results
are deleted.
Please note that the username you are entering should have the authority
to set up quality control. Otherwise you cannot delete the QC results.
NOTE:
If the ISE unit (optional) is connected, ISE tests will be displayed in the
test list.
Click to the right of From (or To) and select the desired date to
specify the dates to be searched. The analyzer will search all the QC runs
taking place during this specified period.
Click to the right of Rule and select the desired QC rule from the pull
down list.
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3
Select the desired test from the Assays zone. The selected test will be
followed by a green mark.
Click the Search button to display the information, including the results,
QC graph, statistic data and QC status, of the last 10 control runs of the
selected test using the selected control or controls.
To print the displayed data and graph, click the Print button.
Click the Print button to print out the result and QC graph after checking
the result of a control run.
Select the desired test in the Assays field. The selected test will be
marked with a green block to the right of it.
Click the Data button. The Delete QC Data dialog box is displayed. You
can view the measurement data of selected control.
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Click the Close button to delete fromexit the Delete QC Data dialog box.
window.
4.3
Data
4.3.1 Export
Click Data Export or press CTRL + F to enter the Data exported screen, as
Figure 4-39 shows.
NOTE:
This analyzer automatically backs up its settings and test results.
Exporting data refers to saving some data to a file (.SHD file)
temporarily so that the data can be transmitted or updated. It is not the
same as backing up the database.
Mindray recommends this exporting function not be used unless it is
necessary.
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Figure 4-39 Data exported screen
As Figure 4-39 shows, the Data exported screen consists of the following fields:
Assay
Calibration
QC
Sample
Others
Assays
Separator
The item in blue font listed in the Assay, Calibration, QC and Sample fields is
test-related and you can select test in the Assays field for these items.
NOTE:
If the data to be exported includes the data of last year, Mindray
recommends the Start date be not before November 1. Otherwise,
you may not get the complete data.
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To export data
1
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Example2:
Follow the steps below to select: a) calibration parameters (Results in the
Calibration field) for all the tests; b) calibration results (Test Data in the
Calibration) for the tests analyzed on February 3, 2007 and February 4,
2007 only.
(1) Tick the check boxes to the left of Results and Test Data in the
Calibration field respectively.
(2) Select February 3, 2007 from the pull down list to the left of the From in
the Calibration field.
(3) Select February 4, 2007 from the pull down list to the left of To in the
Calibration field.
Example3:
Follow the steps below to select the UR results of the samples: a) sample
IDs are 1 - 10; b) analyzed on February 3, 2007 and February 4, 2007.
(1) Tick the check boxes to the left of Results in the Sample field
(2) Enter 1 and 10 into the edit boxes to the right of Sample No.
respectively.
(3) Select February 3, 2007 from the pull down list to the left of the From in
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the Sample field.
(4) Select February 4, 2007 from the pull down list to the left of To in the
Sample field.
(5) Tick the check box to the left of Sample in the Applied to field.
(6) Tick the check box to the left of UR in the Assays field.
Click the Export button and a dialog box will pop up.
Select the desired directory and file and click the Save button to save the
data. You may also click the Cancel button to cancel the exporting.
4.3.2 Import
Click Data Import or press CTRL + E to enter the Import Data screen, as Figure
4-40 shows. Note that you need a user name and password of the administrator
authority to enter the screen.
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Figure 4-40 Import Data screen
NOTE:
The imported data will overwrite the corresponding data in the
analyzers database. Before importing data, ensure the corresponding
data is exported to another file. You can only import data from .SHD
files.
Mindray recommends this importing function not be used unless
necessary.
To import data
1
Click the File button and a dialog box will pop up.
Select the desired file and click the Open button to open the selected file.
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3
Click the Import button to import the data into the database. A dialog box
will pop up when then importing is done. Click the OK button to close the
box.
4.3.3 Demographics
Click Data Demographics or press CTRL + A to enter the Demographics screen,
as Figure 4-41 shows. You can set patient information and add manual samples at
the screen.
(to the
Select the date when the patient sample was requested from the pull
down list to the right of Date. The current date is the default.
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2
,
,
or
to select the desired
You can click
patient, or you can enter the ID of the desired sample into the edit box to
the right of Move To and click the Move To button to go to the desired
sample.
Select the date from the pull down list to the right of Date. The current
date is the default.
Click the Add button to add a new manual sample whose No. (greater
than 9000) is generated by the system automatically.
If you want to save the new manual sample, click the Save button;
otherwise, click the Cancel button.
Select the date when the patient sample was requested from the pull
down list to the right of Date. The current date is the default.
,
,
or
to select the desired
You can click
patient, or you can enter the ID of the desired sample into the edit box to
the right of Move To and click the Move To button to go to the desired
sample.
Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes.
Select the date from the pull down list to the right of Date. The current
date is the default.
,
,
,
, or after
Click the buttons
entering the sample ID to the right of Move To, click the Move To, to
select a sample.
Click the Set as Default button to set the Sample Type (sample type),
Sender (doctor who sends the sample), Sent by (department from which
the sample is sent), Tester (doctor who analyzes the sample) and Tested
by (the laboratory to analyze the sample) as the default settings.
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NOTE:
The default setting is only available at the current screen. If you click
the Exit button to close the Demographics screen, the default setting
disappears and you need to set it again when you enter the screen the
next time.
4.3.4 Result
Click Data Result or press Ctrl + R to enter the Results & Statistics screen, as
Figure 4-42 shows.
At the Result & Statistics screen, you can see the following tabs: Results, Result
Statistics and Test Statistics.
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Click to the right of From (or To) and select the desired date to specify
the dates to be searched. The analyzer will search all the sample runs
taking place during this specified period.
NOTE:
In case of a year-to-year search, the start date must not be
earlier than November 1st of the previous year.
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3
Click the Search button to start the search and the matches will be
displayed.
NOTE:
If no sample run matches the specified conditions, a dialog
box will pop up to remind you no match is found.
Click the By Sample, and then select a sample to view its results.
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Search for the sample results. Refer to the previous section To view
sample results for details.
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NOTE:
You will see the Curve button except that you select LIS in
the Option field.
Click the Reaction Curve button to check the reaction curve and data of
the selected blank runs.
There are two tabs at the Reaction Curve screen, the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
4
If you do not want to check the results of other runs, go directly to the next
step;
Otherwise, click the Previous or Next button to check other runs (blanks,
samples, controls, or calibrations); or click the Close button and repeat
from step 2.
Click the option button to the left of Print in the Option field.
Click the Print Setup button to enter the Printing Setup screen. Refer to
4.4.7 Print for details.
Search for the sample results. Refer to the previous section To view
sample results for details.
Select By Sample.
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3
Click the option button to the left of Print in the Option field.
Select the sample or samples you want to print. You can select them by
clicking the Select button or ticking the check boxes directly.
NOTE:
Click the Select button, and a dialog box will pop up to ask
you to enter the start number of the sample.
When you finish printing, click the Close button to exit the Print Preview
screen.
Search for the sample results. Refer to the previous section To view
sample results for details.
Select By Sample.
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3
Click the option button to the left of Print in the Option field.
Select the sample or samples (5 is the maximum) you want to print. You
can select them by clicking the Select button or ticking the check boxes
directly.
Click the Combined Print button to pop up the Print Preview screen.
If you have intended to print out all the results, go directly to the next step;
Otherwise, click the Selected Assay button in the preview window to
select the tests to be printed out. Then after clicking the OK button, click
the Hide Assays button.
At the Print Preview screen, you may choose Pr. Series (series printing)
for your impact printer; you may choose Pr. Current (printing current
page) or Pr. All (printing all pages) for other types of printers.
When you finish printing, click the Close button to exit the Print Preview
screen.
Search for the sample results. Refer to the previous section To view
sample results for details.
Select By Test.
Click the option button to the left of Print in the Option field.
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4
Select the sample run or runs you want to print. You can select them by
clicking the Select button or ticking the check boxes directly.
NOTE:
Click the Select button, and a dialog box will pop up to ask
you to enter the start number of the run.
When you finish printing, click the Close button to exit the Print Preview
screen.
Search for the sample results. Refer to the previous section To view
sample results for details.
NOTE:
The To (end date) must be in the current year. Otherwise,
you cannot edit manual results.
Select By Sample.
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3
Click the option button to the left of the middle Edit in the Option field.
Select a sample or samples. If you select more than one sample, you will
set the same manual results for them.
If you want to save the setting, click the Save button; otherwise, click the
Cancel button.
Search for the sample results. Refer to the previous section To view
sample results for details.
NOTE:
The To (end date) must be in the current year. Otherwise, you
cannot edit sample results.
Select By Sample.
Click the option button to the left of the right Edit in the Option field.
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4
Select a sample.
If you want to save the setting, click the Save button; otherwise, click the
Cancel button.
Search for the sample results. Refer to To view sample results for details.
NOTE:
The End (end date) must be in the current year. Otherwise,
you cannot revise sample results.
Select By Test.
Click the option button to the left of Correct in the Option field.
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5
Select a sample run or runs. You can select them by clicking the Select
button or ticking the check boxes directly. If you select more than one runs,
you will set the same factors for them.
Enter factor a and b to the right of Factor a: and Factor b:. The system will
revise the results of the selected runs according to the formula Y=aX+b (Y
stands for the new result and X stands for the old result).
If you want to revise the results, click the Save button; otherwise, click the
Cancel button.
Search for the sample results. Refer to the previous section To view
sample results for details.
NOTE:
The To (end date) must be in the current year. Otherwise, you
cannot send sample results to the LIS in batch mode.
Select By Sample.
Click the option button to the left of LIS in the Option field.
Select a sample or samples. You can select them by clicking the Select
button or ticking the check boxes directly.
Click the Send button to send the results of the selected samples to the
LIS.
When the results are sent, a dialog box will pop up.
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NOTE:
There are two modes to send information to the LIS, the real-time
mode and the batch mode.
You can send information to the LIS in batch mode at any time only
except that when you select the Real Time Send at the System
SetupHost Communication screen and the system is testing.
Click the Close button to exit the Results & Statistics screen.
As Figure 4-44 shows, the search conditions are listed on the upper left of the
screen, such statistic data as SD and Mean on the lower left, expected range on the
upper right and statistic graph on the middle right.
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NOTE:
To specify the age range of the patients, enter the lower limit
of the range into the edit box to the right of Age Lower Limit
and the upper limit into the edit box to the right of Age
Upper Limit.
If you enter 0s into both the boxes, it means there is no
specific requirement on the ages.
Click the Search button and the analyzer will search for the matches and
present a statistic graph of the results found.
Click the Close button to exit the Results & Statistics screen.
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Figure 4-45 Test Statistics tab
Click the desired test and the corresponding reagent status will be displayed
on the right of the screen.
Click the Close button to exit the Results & Statistics screen.
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4.4
System
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Figure 4-46 System Status screen
Status
Others
As Figure 4-47 shows, you can check the status of the major components of the
analyzer.
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Note that the light intensity of the lamp is expressed in Photometer Lamp. The bar
to the right of the Photometer Lamp represents the light intensity of the lamp in
term of percentage, light intensity of a new lamp being 100%. When the light
intensity is normal, the bar is green. When the light intensity is more than 50%, the
bar is yellow. When the lamp is to be changed, the bar is red. If the system does not
detect the light of the lamp, the bar is white.
The Network displays if the system is connected to the LIS.
Click the Close button to close the System Status screen.
As Figure 4-48 shows, you can not only view the dark currents of various
wavelengths, but also check the movement of the cuvette loader and wash the
sample and reagent probes and mixing bar.
The list shows the dark currents and backgrounds of the nine wavelengths and one
reference wavelength. The dark current refers to the AD output of the wavelength
when the lamp of the photometer is not switched on. The backgrounds refer to the
AD outputs generated by the lights when there are no cuvettes in the optical paths.
When the analyzer is on standby, click the Test Dark Cur. button and the
readings will be displayed on the screen.
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When the analyzer is on standby, select the desired position and click the
Load Cuv. button to load/unload the segment to/from the selected
position.
To wash the sample and reagent probes and the mixing bar
1
When the analyzer is on standby, click the Enhanced Wash button and
the analyzer will use acid and alkaline detergents to wash the sample and
reagent probes and the mixing bar.
4.4.2 Setup
The System Setup screen is where you set options regarding the routine settings,
reruns, test units and LIS connection.
To enter the System Setup screen, click System Setup, or press Ctrl + F3. A
dialog box shown as the figure below will pop up.
Click Cancel and a dialog box will then pop up to ask you to enter your user name
and password. You must have the corresponding authority to enter the System
Setup screen.
NOTE:
Only authorized personnel can enter the System Setup screen.
At the System Setup screen, shown in Figure 4-49, you can see the following tabs:
Routine
Rerun
Units
Host Communication
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As Figure 4-49 shows, there are several fields you can set at the Routine tab.
Follow the instructions given below to do so.
Field
What it does
How to set
Alarm
When
Available Reagent
Not Enough For
Alarm Volume
Auto QC
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Field
What it does
How to set
Tests Arranged
NOTE:
Set a suitable value for the insufficient reagents alarm so that the
analyzer can alert you about insufficient reagents in time.
When you have finished setting the desired fields, click the Save button to save the
changes. A dialog box will then pop up to remind you the settings are saved, as
Figure 4-50 shows. Click the OK button to close the dialog box.
If you entered an improper value for any field, a dialog box will pop up to warn you
about the wrong setting after you clicked the Save button, as Figure 4-51 shows.
Seeing the dialog box, click OK button to close it and re-enter a proper value for the
field in question (insufficient reagents alarms, in case of Figure 4-51) and then save
the settings again.
When you have finished setting, you can click the Close button to exit the System
Setup screen.
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Click the Rerun tab to view the 9 available fields in it, as Figure 4-52 shows. Follow
the instructions given below to set them.
Field
What it does
How to set
Rerun
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Field
What it does
How to set
Beyond
Range
Response
Substrate
out
(Kinetic and Fixed
Time)
Surplus Antigen
No Balance Point
(Endpoint)
If no dilution parameters
are set for a test, the
sample run of it will not be
rerun automatically even if
no balance point is
detected.
When you have finished setting the desired fields, click the Save button to save the
changes. A dialog box will then pop up to remind you the settings are saved, as
Figure 4-53 shows. Clicks OK button to close the dialog box.
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Figure 4-53 A dialog to remind you the settings are saved
If you entered an improper value for any filed, a dialog box will pop up to warn you
about the wrong setting after you clicked the Save button. Seeing the dialog box,
click OK to close it and then re-enter a proper value for the field in question and then
save the settings again.
When you have finished settings, you can click Close to exit the System Setup
screen.
Click the Units tab (Figure 4-54) to set the units that will be used for the tests. Note
that all the units to be selected at other screens must be entered here.
Follow the instructions given below to add, edit or delete test units.
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2
Enter the desired unit into the edit box to the right of Units. In case of
tests without units, enter blank (press the Space key) into the edit box.
Click the Save button to save the entered unit; Click the Cancel button,
for any reason, to discard the entered unit.
Click to the right of Units to display the pull-down list and select the
desired unit.
Click the Save button to save the changes; Click the Cancel button, for
any reason, to ignore the change.
Click to the right of Units to display the pull-down list and select the
desired unit.
NOTE:
Once you click the Delete button, the software will immediately delete
the selected unit without asking you to confirm the deletion. Ensure the
right unit is selected before clicking the Delete button.
NOTE:
If you have no LIS server, the function of the screen is unavailable.
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Figure 4-55 Host Communication tab
In the Mode field, if you select Real-time Send, the system will
automatically send sample results to the LIS server as soon as the tests
of a sample are all finished; otherwise, you can only send sample results
to the LIS server in batch mode at the Results & Statistics screen. Refer
to 4.3.4.1 Results tab for details.
If you select Real-time Download, the system will automatically
download sample information from the LIS server when it is scanning bar
code labels; otherwise, you can only download sample information from
the LIS server manually.
For the same sample, if the information downloaded from the LIS server is
different from the existing, selecting Neglect means the system will ignore
the information downloaded repeatedly, selecting Overwrite means the
system will overwrite the existing information with the new, and selecting
Add means the system will add the newly-downloaded test information to
the existing ones.
Enter the IP address of the server on the right of IP Address in the Host
Computer field.
Enter the port on the right of Port in the Host Computer field.
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NOTE:
There are two modes to send information to the LIS, the real-time
mode and the batch mode.
You can send information to the LIS in batch mode at any time only
except that when you select the Real Time Send at the System
Setup screen and the system is testing.
If you do not want to check the connection between the system and the
LIS, go directly to the next step;
Otherwise, click the Test button to check the network connection. The
system will pop up a dialog box to tell you whether the connection is
successful.
If you want to connect the system to the LIS, click the Connect button;
Otherwise, click the Disconnect button.
4.4.3 Hospital
The Hospital Information screen is where you set the options regarding the
hospital and doctors.
To enter the Hospital Information screen, click System Hospital, or press CTRL
+ H. A dialog box will then pop up to ask you to enter your user name and password.
You must have the administrator authority to enter the Hospital Information screen.
NOTE:
You need the administrator authority to enter the Hospital
Information screen.
At the Hospital Information screen, shown in Figure 4-56, you can see three tabs:
Hospital
Doctors
All Doctors
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Follow the instructions given below to set them.
As Figure 4-56 shows, you can set hospital name and departments at this tab. The
hospital name you set here will appear on the patients assay reports, and all the
departments to be selected at other screens must be entered here.
Enter the desired hospital name into the edit box to the right of Name.
Click the Save button in the Name field to save the entered name.
Enter the desired department name in the edit box to the right of
Department.
Click the Save button in the Department field to save the entered name;
Click the Cancel button, for any reason, to discard the entered name.
Edit the selected department name in the edit box to the right of
Department.
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4
Click the Save button in the Department field to save the change; Click
the Cancel button, for any reason, to ignore the change.
Click the Delete button in the Department field to delete the selected
department.
NOTE:
Once you click the Delete button, the analyzer will immediately delete
the selected department, as well as all the doctors (see the next
section) belonging to this department without asking you to confirm the
deletion. Ensure the right department is selected before clicking the
Delete button.
Click the Doctors tab to show the available fields, as Figure 4-57 shows. All the
doctors to be selected at other screens must be entered here.
There are four buttons at the middle part of the Doctors tab, as Figure 4-58 shows.
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Figure 4-58 Buttons at the middle of the Doctors tab
Button
Function
Displays the information of the first doctor of the selected
department.
Displays the information of the previous doctor of the selected
department.
Displays the information of the next doctor of the selected
department.
Displays the information of the last doctor of the selected
department.
If there is no existing doctor information in the selected department, the arrows will
appear gray, indicating they are not usable at this moment.
Follow the instructions given below to add, edit or delete doctors to a selected
department.
Click to the right of Dept. to display the pull-down list and select the
desired department.
Click the Add button and the analyzer will automatically assign a number
to the new doctor. Note that you cannot change this number.
Enter the doctors name in the edit box to the right of Name.
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4
Enter the doctor s duty into the edit box to the right of Duty.
Click the Save button to save the change; Click the Cancel button, for
any reason, to ignore the change.
Click to the right of Dept. to display the pull-down list and select the
desired department.
Click the Save button to save the change; Click the Cancel button, for
any reason, to ignore the change.
Click to the right of Dept. to display the pull-down list and select the
desired department.
Click the Delete button to delete the information of the selected doctor.
NOTE:
Once you click the Delete button, the analyzer will immediately delete
doctor from the selected department without asking you to confirm the
deletion. Ensure the right doctor is selected before clicking the Delete
button.
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Click the All Doctors tab to view all the saved doctor information, as Figure 4-59
shows.
To view the information of all the doctors, you can click to the right of Dept. and
select All departments.
To view the information of doctors of a specific department, click to the right of
Dept. and select the desired department.
You can click the Close button to exit the Hospital Information screen.
4.4.4 User
Click System User or press CTRL + B and a dialog box will pop up, as Figure
4-60 shows, to ask you to enter the appropriate user name and password.
Figure 4-60 A dialog box to ask you enter the appropriate user name and password
Enter a user name and a password of the administrator authority to enter the User
Management screen, as Figure 4-61 shows.
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NOTE:
Only users of the administrator authority can enter the User
Management screen.
As Figure 4-61 shows, you can check the existing users or user groups at the User
Management screen.
Click User Management Add User to enter the Add User window.
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name.
Description: Enter additional information regarding the users duty, title or
the like.
Password: Enter the password to be used by the user.
Confirm: Re-enter the password here to confirm the entry.
Authority: Assign the new user to an existing user group or groups. Click
button to add the new user to all the existing user groups; click
to remove the new user from all the existing groups; click
button to add the new user to a selected group or groups; click
remove the new user from a selected group or groups.
to
Click the OK button to save the changes; click the Cancel button, for any
reason, to ignore the changes.
Click User Management Delete User and a dialog box will pop up to
ask you to confirm the deletion.
Click the OK button to confirm the deletion; click the Cancel button to
abort the deletion.
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Click User Management Edit User to enter the Edit User window.
Click the OK button to save the changes; click the Cancel button, for any
reason, to ignore the changes.
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2
Enter the user name and password as required and click the OK button
and another dialog box will pop up to ask you to enter the new user name
and password.
Click the OK button to save the changes; click the Cancel button, for any
reason, to ignore the changes.
4.4.5 Log
Click System Log or press CTRL + F2 to enter the Log Management screen, as
Figure 4-62 shows.
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Figure 4-62 Log Management screen
As Figure 4-62 shows, the Log Management screen lists as many as 300 alarm
messages. Once the saved alarm messages reach 300, the analyzer will
automatically save the messages into a .log file and the file name is the saving time.
Click Log Current to list the latest 300 (or less) alarm messages.
Look in:
File Name:
Open
Files of Type:
Cancel
Select the desired log file from the Log folder under the directory the
BS-300 operating software is installed and click the Open button to open
the selected log file.
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Click Log Clear and a dialog box will pop up to ask you to save the
current log to a .log file.
Click the OK button to save the log and then clear it; click the Cancel
button to clear the log without saving it.
4.4.6 Maintenance
Click System Maintenance or press CTRL + Q and a dialog box will pop up, as
Figure 4-63 shows, to ask whether you are maintenance personnel.
Figure 4-63 A dialog box to ask you whether you are maintenance personnel
Click the Cancel button and another dialog box will pop up to ask you to enter the
appropriate username and password, as Figure 4-64 shows.
Figure 4-64 A dialog box to ask you to enter username and password
Enter a username and password of the administrator authority to enter the System
Maintenance screen, as Figure 4-65 shows.
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Figure 4-65 System Maintenance screen
At the System Maintenance screen, the Sent Instructions field and the Received
Data field respectively display the instruction codes sent to the Analyzing Unit and
received by the Operation Unit.
NOTE:
Do not perform any maintenance action unless you are certain the
analyzer is on standby.
To lock data
1
If you feel the codes displayed in the Sent Instructions and Received
Data fields refresh too fast, click the Lock button, which then will become
the Unlock button, and the displayed data will stop changing. You can
click the Unlock button to resume the data refreshing.
To clear data
1
Click the Clear button to clear the Sent Instructions and Received Data
fields.
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Button
What it does
Click this button and the sample probe will lower into
the sample tube in the inner circle and stop when it
contacts the liquid surface or the tube bottom.
Click this button and the sample probe will lower into
the sample tube in the outer circle and stop when it
contacts the liquid surface or the tube bottom.
Into Cuvette
Click this button and the sample probe will lower into
the reaction cuvette and stop when it contacts the
liquid surface or the reaction cuvette bottom.
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NOTE:
Ensure the sample disk is placed in the home position or stopped at
certain tube position before clicking Into Inner Circle or Into Outer
Circle button. Otherwise, it may lead to probe collision.
Ensure the reaction disk is placed in the home position or stopped at
certain cuvette position before clicking Into Cuvette button.
Otherwise, it may lead to probe collision.
Button
What it does
Click this button and the reagent probe will lower into
the reagent tube in the inner circle and stop when it
contacts the liquid surface or the tube bottom.
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Button
What it does
Click this button and the reagent probe will lower into
the reagent tube in the outer circle and stop when it
contacts the liquid surface or the tube bottom.
Into Cuvette
Click this button and the reagent probe will lower into
the reaction cuvette and stop when it contacts the
liquid surface or the reaction cuvette bottom.
NOTE:
Ensure the reagent disk is placed in the home position or stopped at
certain reagent position before clicking Into Inner Circle or Into Outer
Circle button. Otherwise, it may lead to probe collision.
Ensure the reaction disk is placed in the home position or stopped at
certain cuvette position before clicking Into Cuvette button.
Otherwise, it may lead to probe collision.
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Button
What it does
Click this button and the mixing bar will lower into the
wash well.
Into Cuvette
Click this button and the mixing bar will lower into the
reaction cuvette.
Mix
Enter the desired integer into the edit box to the right
of Time and click the Mix button to lower the mixing
bar into the reaction cuvette and mix the specified
time (expressed in terms of units and every unit
stands for 20ms).
NOTE:
Ensure the reaction disk is placed in the home position or stopped at
certain cuvette position before clicking Into Cuvette or Mix button.
Otherwise, it may lead to bar collision.
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Button
What it does
NOTE:
Before operating the reaction disk, ensure the sample and reagent
probes and mixing bar are away from it. Otherwise, the moving disk
may bend the probes or bar.
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Button
What it does
Rotate Given
Given Position
Circles
to
NOTE:
Before operating the reagent disk, ensure the reagent probe is away
from it. Otherwise, the moving disk may bend the probes.
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Button
What it does
Rotate Given
Given Position
Circles
to
NOTE:
Before operating the sample disk, ensure the sample probe is away
from it. Otherwise, the moving disk may bend the probe.
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Button
What it does
S. Syringe Aspirate
S. Syringe Dispense
Reset S. Syringe
R. Syringe Aspirate
R. Syringe Dispense
Reset R. Syringe
NOTE:
When you have clicked the S. Syringe Dispense button, if there is no
enough liquid inside the sample syringe, the plunger will stop at the
home position.
When you have clicked the R. Syringe Dispense button, if there is no
enough liquid inside the reagent syringe, the plunger will stop at the
home position.
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Button
What it does
Push Cuvettes
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Button
What it does
Lamp On
Lamp Off
NOTE:
If nothing is to be run for a while and you have no intention to exit the
control system, you can turn off the lamp to maximize its service life.
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Button
What it does
Load
Start
Unload
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Button
What it does
Download Settings
4.4.7 Print
The Printing Setup screen is where you set the parameters regarding printing
reports.
To enter the Printing Setup screen, click System Print, or press CTRL + O.
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Figure 4-77 Printing Setup screen
At the Printing Setup screen, Figure 4-77, there are four tabs:
Patient Report defines parameters regarding the format of the patient report.
Test Report defines items to appear on the printed test report.
Others defines printing order and printer.
Report Header defines the report header.
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As Figure 4-78 shows, the items listed in the Required field are required to appear
on the patient report; the items listed in the Optional field are selectable items and
you can select any interested items to print on the patient report.
Tick the check boxes to the left of the desired items. Clicking the ticked
check box again can cancel the selection.
Click the Save button and a dialog box will pop up to tell you settings are
saved. Click the OK button to close the box.
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As Figure 4-79 shows, the items listed in the Required field are required to appear
on the test report; the items listed in the Optional field are selectable items and you
can select any interested items to print on the report.
Tick the check boxes to the left of the desired items. Clicking the ticked
check box again can cancel the selection.
Click the Save button and a dialog box will pop up to tell you settings are
saved. Click the OK button to close the box.
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2
Select the desired sequence number from the pull down list above Set
Printing Order.
Select the desired printer from the pull down list in the Default Printer
area.
Click the Default Printer button to set the selected printer as the default
printer.
The system will automatically print reports of the sample runs whose
results are within or beyond reference range. A ! symbol will be printed
next to the sample ID of abnormal sample runs.
Select the Flag Edited Results checkbox to flag the edited results on
patient report.
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NOTE:
The format of the printout may not be exactly the same as that
displayed in the print preview window.
Enter the desired header into the edit box to the right of Header.
Select the desired font from the pull down list to the right of Font.
Click the Setup button and a dialog box will pop up to tell you the settings
that have been saved. Click the OK button to close the box.
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4.4.8 Temperature
Click System Temperature or press CTRL + T and a dialog box will pop up, as
Figure 4-82 shows, to ask you whether you want to debug the temperature control
unit or check the temperature curve.
Figure 4-82 A dialog box to ask you whether to debug or to view curves
Click the Cancel button and another dialog box will pop up to ask you to enter
appropriate username and password, as Figure 4-83 shows.
CAUTION:
Only service engineers are authorized to debug the temperature
control unit.
Figure 4-83 A dialog box to ask you to enter username and password
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Figure 4-84 Temperature Control screen
As Figure 4-84 shows, you can see two tabs at the Temperature Control screen:
For every temperature curve, its x-axis represents the time and y-axis the
temperature.
The parameters are interpreted as follows.
Parameter
What it does
How to set
Precision
Defines
the
precision
of
temperature.
display
the
Range
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2
Click
or
NOTE:
Click
Click
When you have viewed the curve, click the History button to quit viewing
the history curve.
To lock a curve
1
To unlock a curve
1
4.4.9 Database
Click System Database or press CTRL + L and a dialog box will pop up, as
Figure 4-85 shows, to ask you to enter the appropriate user name and password.
Figure 4-85 A dialog box to ask you enter the user name and password
Enter the user name and password of the administrator authority to enter the
Database Maintenance screen as Figure 4-86 shows.
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Figure 4-86 Database Maintenance screen
NOTE:
You can only maintain the database when the analyzer is on standby.
This analyzer automatically backs up data. You only need to maintain
the database when the system alerts you that the database is
damaged.
Usually you do not need to delete the reaction curves. Deleting the
curves (only curves, not the results) only when you find insufficient
space left on the hard disk.
When the analyzer warns you about database damage, click the Repair &
Compress button to repair and compress current database.
Select the desired start date from the pull down list to the right of the
From.
Select the desired end date from the pull down list to the right of the To.
Click the Delete Reaction Curve And Data button to delete the curve of
the selected period.
Click the Delete All Reaction Curve And Data button to delete all the
curves.
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Click System Bar Code Scanner or press Ctrl+L and a dialog box shown as the
figure below will pop up.
Click the Cancel button and another dialog box shown as the figure below will pop
up.
Enter authorized user name and password to enter the Bar Code Scanner screen.
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Figure 4-87 Bar Code Scanner screen
The screen displays the bar code symbols that can be read by the built-in scanner.
You can select the ones that you need.
Select a symbology.
If you want the system to check the bar code of the selected symbology
after reading it, select the corresponding check box in the Check column.
NOTE:
To prevent from misreading, Mindray recommends you to
select the check box.
3
Enter the bar code length of the selected symbology into the
corresponding edit box in the Symbol Length column. The length is
between 3 and 16.
Repeat from step 1 to step 3 until all the symbologies you need are set.
Click the Save button and a dialog box will pop up to remind you that the
setup is completed.
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Figure 4-88 ISE screen
Calibration
Setup
ISE Unit
4.4.11.1 Calibration
The Calibration tab displays the calibration results and limits of the ISE tests and
you can calibrate them.
NOTE:
An ISE calibration should be run in case of any of the following
accidents:
(1) More ISE tests are to be run after the system is powered on;
(2) It has been eight hours since the last ISE calibration is run after the
latest power-on;
(3) More ISE tests are to be run after the daily cleaning procedure. But
Mindray recommends running an ISE calibration after the daily
cleaning procedure.
Click the Calibrate button and the system will calibrate the ISE unit.
4-177
Advanced Operations
4.4.11.2 Setup
The Setup tab is where you can set parameters for electrodes and tubing, set
coefficients for results correction and view information of the reagent module.
Parameter
What it does
How to set
Alarm Limit
(Days)
Alarm Limit
(Times)
(Electrode)
Replaced on
(Tube)
Replaced on
Expiration
Date
4-178
Advanced Operations
Parameter
What it does
How to set
Installation
Date
Total
Volume
Total volume
module.
reagent
Inventory(%)
Lot No.
Expired
Mode
Expired mode
module.
of
the
of
the
reagent
Click the Save button. The system will correct the results of the tests you
have set according to the formula Y=aX+b (Y means new result and X
means original result).
NOTE:
The system will save the new results only.
4-179
Advanced Operations
Parameter
What it does
How to set
Times
Button
What it does
Handshake
Pump Calib.
Maintenance
Bubble Calib.
Clean
Purge A
4-180
Advanced Operations
4.5
Button
What it does
Purge B
Purge AB
Save Sent
Save Received
Clear
ISE Reset
If there is something wrong with the ISE unit and ISE tests
cannot proceed, click this button to reset the ISE unit.
Help
Help
Version
Guide
4.5.1 Version
Click Help Version or press CTRL + S to enter the Software version screen.
4.5.2 Guide
Click Help Guide or press CTRL + F11 to view the on-line help document.
4-181
5 Maintenance
To ensure reliability, good performance and long service life of the system, regular
maintenance is required. Be sure to follow the instructions given below to maintain
the system. In case of problems beyond your ability or not covered in this chapter, be
sure to call Mindray or your local distributor in time.
WARNING:
Do not perform any maintenance procedures that are not described
in this chapter.
Do not touch the components other than the ones specified in this
chapter.
Performing unauthorized maintenance procedures can damage your
system, void any applicable warranty or service contract and even
cause personnel injuries.
After performing any maintenance actions or procedures, ensure
that the system runs normally.
For some maintenance actions or procedures, be sure to place the
POWER to OFF first.
Do not spill water or detergent on the mechanical or electrical
components of the system.
BIOHAZARD:
Wear gloves, goggles and protective clothing.
5.1
Preparation
The following things may facilitate your maintenance.
Tools
5-1
Maintenance
Brush (to wash tanks)
Detergents
Acid: 0.1mol/l hydrochloric acid
Alkaline: 0.5% (V/V) javel water
WARNING:
Poisonous gas will be produced if acid wash solution is mixed with
alkaline wash solution. Do not mix the acid wash solution with the
alkaline one.
CAUTION:
Mindray has specified the following enhanced wash solutions:
Acid wash solution: 0.1mol/l hydrochloric acid;
Alkaline wash solution: 0.5%(V/V) javel water.
Be sure to use the detergents recommendedenhanced wash solution
specified by Mindray. Otherwise, proper result may not be obtained.
Mindray recommends the acid and alkaline wash solutions be used
alternately. For instance, if the acid wash solution is used at current
startup, the alkaline one should be used at next startup.
Others
Ethanol
Disinfector
5.2
Daily Maintenance
5-2
Maintenance
2
Open the middle door of the analyzing unit and you will see both of the
syringes, the sample syringe on the right and the reagent syringe on the
left.
T-piece
5-3
Maintenance
If the flow remains abnormal after cleaning, contact Mindray Customer Service
Department or the distributor.
Make sure the system is on standby status, and ensure no part of the
system will motion.
Check how much detergent left in the bottle on position 45. If there is not
much left, add more detergent or install a new bottle of detergent.
Check how much detergent left in the bottle on position 47. If there is not
much left, add more detergent or install a new bottle of detergent.
5-4
Maintenance
Every wash consumes about 450l detergent when the system uses detergent to
clean the probes and the mixing bar.
Open the lower door of the analyzing unit and you will find the deionized
water tank on the right.
Deionized
Water Tank
Waste Tank
Used-Cuvettes
Bucket
Extractable
Plate
Check the connections between the two deionized water connectors (green
and red) and their counterparts on the analyzer.
Deionized Water Connector
(Green)
Pickup Tube
Check the connections between the pickup tubes and their connectors.
If not, go directly to the next step.
If you see leaks, wipe off the water with clean gauze and tighten the
connections and proceed to the next step.
5-5
Maintenance
7
Check the connection between the pickup tube and the tank cap.
If not, go directly to the next step.
If you see leaks, wipe off the water with clean gauze and tighten the
connection and proceed to the next step.
CAUTION:
Make sure the deionized water pickup tubes are neither blocked nor
bent.
NOTE:
If leaking remains, please contact Mindray Customer Service
Department or the distributor.
Open the lower door of the analyzing unit and you will find the waste tank
on the left.
5-6
Maintenance
3
Check the connections between waste connector and the waste tap of the
analyzing unit.
BNC Connector
Waste Connector
Pin
Waste Tap
Waste Tube
Check the connection between the waste tube and the tap.
If no leaks, go directly to the next step.
If you see leaks, wipe them off with clean gauze and tighten the waste
tube and then proceed to the next step.
Check the connection between the waste tube and the tank cap.
If no leaks, go directly to the next step.
If you see leaks, wipe them off with clean gauze and tighten the
connection and proceed to the next step.
CAUTION:
Ensure the waste tube is neither blocked nor bent. A blocked or bent
waste tube may lead to waste overflow that may damage the analyzing
unit.
NOTE:
If leaking remains, please contact Mindray Customer Service
Department or the distributor.
5-7
Maintenance
Open the lower door of the analyzing unit and you will see the deionized
water tank on the right.
4
5
CAUTION:
After removing the cap of the deionized water tank (together
with the pickup tube and level sensor), place it on a clean
table.
Unscrew (counter-clockwise) the tank cap and remove the cap together
with the pickup tube and the level sensor.
6
Screw (clockwise) the cap together with the pickup tube and the level
sensor back on to the tank until secure.
CAUTION:
Ensure the deionized water pickup tube is neither blocked nor bent.
5-8
Maintenance
1
Open the lower door of the analyzing unit and you will see the waste tank
on the left.
BIOHAZARD:
After removing the cap of the waste tank (together with the
tube and level sensor), place it on an appropriate place to
avoid biohazard contamination.
Unscrew (counter-clockwise) the tank cap and remove it together with the
waste tube and the level sensor from the tank.
5
Screw (clockwise) the cap (together with the waste tube and the level
sensor) back onto the tank until secure.
CAUTION:
Ensure the waste tube is neither blocked nor bent. A blocked or bent
waste tube may lead to wastewater overflow that may damage the
analyzer.
Open the lower door of the analyzing unit and you will see the
used-cuvettes bucket in the middle.
5-9
Maintenance
CAUTION:
Use the consumables recommended by Mindray. Other consumables
may degrade system performance.
Add solution supplied in the cleaning solution kit to top of label on the
powder bottle that is also supplied in the same kit and shake well to
prepare the cleaning solution.
The cleaning solution must be stored at 2-8C and discarded two
weeks after being prepared.
NOTE:
The maintenance is necessary to be performed when the ISE unit
(optional) is connected.
You should perform the maintenance once a day after all the samples
analyzed. Besides, if the samples of a day requested for the ISE tests
are 50 or more, you should perform the maintenance after 50 samples
are analyzed.
If you give the electrodes some time to stabilize after cleaning, you will
experience slightly better performance.
Click the Clean button and a dialog box will pop up to remind you to put
ISE cleaning solution to the position 45 on the sample disk.
Load about 200l of ISE cleaning solution to the position 45 on the sample
disk and click the OK button.
After cleaning, if there are samples requested for the ISE tests to be run,
calibration should be run first. But Mindray recommends running an ISE
calibration after cleaning.
5-10
Maintenance
5.3
Weekly Maintenance
BIOHAZARD:
Wear gloves, goggles and protective clothing when washing the probe.
Dispose of the used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
Remove the cover from the sample disk. Shift the disk handle from
horizontal position to vertical position. Grab the handle or handwheel and
pull the disk upward to remove it.
Pull the sample probe arm to the highest point by hand. Rotate the probe
arm to a position above the sample compartment and convenient to
operate.
5-11
Maintenance
4
CAUTION:
The tweezers may scratch the probe. Exercise caution when
using it to wash the probe. Avoid direct contact between the
tweezers and the probe. Do not use excessive force when
washing the probe. Otherwise it may bend.
NOTE:
Mindray recommends the acid and alkaline detergents be
used alternately for this purpose. For instance, if the acid
detergent was used for last cleaning, the alkaline detergent
would better be used for this time.
5
After washing, gently pull the probe arm to its highest point and rotate the
probe arm to move the probe to a position above the wash well.
CAUTION:
After washing the probe, be sure to rotate the probe to a
position above the wash well.
7
Keep the sample disk handle in the vertical position. Align the central hole
of the handwheel to the rotor and lower the sample disk all the way down.
Rotate the disk a bit as necessary during the lowering process. When the
disk is in place, shift the handle back to horizontal position to lock the disk
to the rotor.
To ensure the disk is secured, you may grab the handwheel and gently
pull it upward. If the disk does not loose, it means it is secured and you
can replace the cover; otherwise, re-install the disk.
5-12
Maintenance
BIOHAZARD:
Wear gloves, goggles and protective clothing when washing the probe.
Dispose of the used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
Remove the cover from the reagent disk. Shift the disk handle from
horizontal position to vertical position. Grab the handle or handwheel and
pull the disk upward to remove it.
Pull the reagent probe arm to the highest point by hand. Rotate the probe
arm to a position above the reagent compartment and convenient to
operate.
5-13
Maintenance
4
CAUTION:
The tweezers can scratch the probe. Exercise caution when
using it to wash the probe. Avoid direct contact between the
tweezers and the probe. Do not use excessive force when
washing the probe. Otherwise it may bend.
NOTE:
Mindray recommends the acid and alkaline detergents be
used alternately for this purpose. For instance, if the acid
detergent was used for last cleaning, the alkaline detergent
would better be used for this time.
5
After washing, gently pull the probe arm to its highest point and rotate the
probe arm to move the probe to a position above the wash well.
CAUTION:
After washing the probe, be sure to rotate the probe to a
position above the wash well.
7
Keep the reagent disk handle in the vertical position. Align the central hole
of the handwheel to the rotor and lower the reagent disk all the way down.
Rotate the disk a bit as necessary during the lowering process. When the
disk is in place, shift the handle back to horizontal position to lock the disk
to the rotor.
To ensure the disk is secured, you may grab the handwheel and gently
pull it upward. If the disk does not loose, it means it is secured and you
can replace the cover; otherwise, re-install the disk.
5-14
Maintenance
Pull the mixing bar arm to the highest point by hand. Rotate the bar arm to
a position convenient to operate.
CAUTION:
The tweezers can scratch the bar. Exercise caution when
using the tweezers to wash the bar. Avoid direct contact
between the tweezers and the bar. Do not use excessive
force when washing the bar. Otherwise it may bend.
NOTE:
Mindray recommends the acid and alkaline detergents be
used alternately for this purpose. For instance, if the acid
detergent was used for last cleaning, the alkaline detergent
would better be used for this time.
5-15
Maintenance
After washing, gently pull the bar arm to its highest point and rotate the bar
arm to move the bar to a position above the wash well.
CAUTION:
After washing the bar, be sure to rotate the bar to a position
above the wash well.
6
CAUTION:
The mixing bar is precisely fabricated. Replace the scratched or bent
bar once finding it. Refer to 5.6.5 Replacing Mixing Bar for details. .
Open the lower door of the analyzing unit and you will see the deionized
water tank on the right.
CAUTION:
After removing the cap of the deionized water tank (together
with the pickup tube and level sensor), place it on a clean
table.
Wash the tank interior with deionized water. Use a clean brush to clean the
interior if necessary.
Wash the pickup tube and the level sensor with deionized water. Use
clean gauze to wash them if necessary.
Wipe water off the tank exterior, pickup tube and sensor cable with clean
gauze.
5-16
Maintenance
9
10
11
Screw (clockwise) the cap (together with the pickup tube and level sensor)
back onto the tank until secure.
12
13
CAUTION:
Ensure the deionized water pickup tube is neither blocked nor bent.
Open the lower door of the analyzing unit and you will see the waste tank
on the left.
BIOHAZARD:
After removing the cap of the waste tank (together with the
tube and level sensor), place it on an appropriate place to
avoid biohazard contamination.
Unscrew (counter-clockwise) the cap (together with the waste tube and the
level sensor).
5
Wash the tank interior with clean water. Soak the tank with disinfector if
necessary.
Wash the waste tube and the level sensor with clean water.
5-17
Maintenance
9
Wipe water off the tank exterior, waste tube and sensor cable with clean
gauze.
10
Place the deionized water tank back onto the extractable plate.
11
Screw (clockwise) the cap (together with the waste tube and level sensor)
back onto the tank until secure.
12
13
CAUTION:
Ensure the waste tube is neither blocked nor bent. A blocked or bent
waste tube will lead to waste overflow that may damage the analyzing
unit.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the
sample disk/compartment.
Dispose of used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
Remove the cover from the sample disk. Shift the disk handle from
horizontal position to vertical position. Grab the handle or handwheel and
pull the disk upward to remove it.
Wash the disk with clean water and wipe it dry with clean gauze.
5-18
Maintenance
4
Keep the sample disk handle in the vertical position. Align the central hole
of the handwheel to the rotor and lower the sample disk all the way down.
Rotate the disk a bit as necessary during the lowering process. When the
disk is in place, shift the handle back to horizontal position to lock the disk
to the rotor. To ensure the disk is secured, you may grab the handwheel
and gently pull it upward. If the disk does not loose, it means it is secured
and you can replace the cover; otherwise, re-install the disk.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the
reagent disk/compartment.
Dispose of used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
5-19
Maintenance
2
Remove the cover from the reagent disk. Shift the disk handle from
horizontal position to vertical position. Grab the handle or handwheel and
pull the disk upward to remove it.
Wash the disk with clean water and wipe it dry with clean gauze.
Keep the reagent disk handle in the vertical position. Align the central hole
of the handwheel to the rotor and lower the reagent disk all the way down.
Rotate the disk a bit as necessary during the lowering process. When the
disk is in place, shift the handle back to horizontal position to lock the disk
to the rotor. To ensure the disk is secured, you may grab the handwheel
and gently pull it upward. If the disk does not loose, it means it is secured
and you can replace the cover; otherwise, re-install the disk.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the panel
of analyzing unit.
Dispose of used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
5-20
Maintenance
5.4
Wipe the panel of the analyzing unit with clean gauze (water or
disinfector-dipped gauze if necessary).
Monthly Maintenance
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the wash
well.
Dispose of used cotton sticks in accordance with your local or national
guidelines for biohazard waste disposal.
Pull the sample probe arm to its highest point. Rotate the arm away from
the wash well.
Clean the inside of and the place around the wash well with cotton sticks.
5-21
Maintenance
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the wash
well.
Dispose of used cotton sticks in accordance with your local or national
guidelines for biohazard waste disposal.
Pull the reagent probe arm to its highest point. Rotate the arm away from
the wash well.
Clean the inside of and the place around the wash well with cotton sticks.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the wash
well.
Dispose of used cotton sticks in accordance with your local or national
guidelines for biohazard waste disposal.
Pull the mixing bar arm to its highest point. Rotate the arm away from the
wash well.
5-22
Maintenance
3
Clean the inside of and the place around the wash well with cotton sticks.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the rotor.
5-23
Maintenance
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the rotor.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the rotor.
5-24
Maintenance
5.5
5.6
Use a screwdriver to unscrew the screws fixing the dust screens on the
middle door and remove the screens.
Use a screwdriver to unscrew the three screws fixing the back cover and
open the back cover.
Use a screwdriver to unscrew the four screws fixing the screens on the
back cover and remove the screens.
Install the screens back to the back cover and the middle door with
screws.
10
Irregular Maintenance
5-25
Maintenance
BIOHAZARD:
Wear gloves, goggles and protective clothing when removing the
probe.
Remove the cover from the sample disk. Shift the disk handle from the
horizontal position to vertical position. Grab the handle or handwheel and
pull the disk upward to remove it.
Pull the sample probe arm to its highest point. Rotate the probe to a
position above the sample disk and convenient to operate.
5-26
Maintenance
4
Grab the lower part of the arm cover with two hands and pull them slightly
outwards and remove the cover upward from the arm base.
Hold the probes fluid connector of probe with one hand and the tubing
connector with the other. Rotate tubing connector counter-clockwise until it
disconnects from the probe. Remove the tubing from the probe.
5-27
Maintenance
6
Press the circuit board with one hand and disconnect the probes circuit
connector from the board with the other hand.
CAUTION:
The probe arm is delicate. Exercise caution when
disconnecting the connector. Excessive force may damage
the connector and/or the circuit board.
7
Use a screwdriver to remove the retaining screw and take out the spring.
5-28
Maintenance
8
WARNING:
Save the removed probe at a safe place where it will neither
endanger people working around the area nor be damaged.
NOTE:
Exercise caution when pulling the probe away from the arm
so that the probe tip will not contact or even damage the
probe arm.
Slowly pull the probe away from the probe arm. Exercise caution so that
the gasket inside the probe will not drop out and if it does drop out, save it
at a clean place for later installation.
NOTE:
The probe tip is precisely fabricated. A bent or damaged probe will lead
to unreliable test results and should be replaced immediately upon
seeing. Refer to 5.6.3 Replacing Sample Probe for details.
BIOHAZARD:
Wear gloves, goggles and protective clothing when unclogging the
probe.
Dispose of the used needle in accordance with your local or national
guidelines for biohazard waste disposal.
CAUTION:
The probe tip is precisely fabricated. A bent or damaged probe will lead
to unreliable test results and should be replaced immediately upon
seeing. Refer to 5.6.3 Replacing Sample Probe for details.
5-29
Maintenance
BIOHAZARD:
Wear gloves, goggles and protective clothing when installing the probe.
Replace the spring and screw the retaining screw back onto the probe.
Pinch the probe by the part near the probe arm. Gently push the probe
upward and then release the probe to see if it can move freely. If so, proceed
to the next step; if not, check for errors and try again after removing the
errors.
CAUTION:
Exercise caution when connecting the probe. Excessive
force may bend the probe.
8
Add deionized water to a clean cup. Immerse the probe tip into the water by
2-3mm and the LED on the circuit board should be lighted. Take the probe tip
out of water, and the LED should go out. If the test succeeds, proceed to the
next step; if not, please contact Mindray Customer Service Department or
the distributor.
5-30
Maintenance
9
Check the marks inside the probe arm cover to see the orientation of the
cover. Install the cover back to the probe arm.
CAUTION:
The marks inside the probe arm cover are shown in the figure
below.
10
Pinch the probe by the part near the probe arm. Gently push the probe
upward and then release the probe to see if it can move freely. If so, proceed
to the next step; if not, the cover is not properly installed. Remove the cover
and re-install it and try this step again.
11
Pull the sample probe arm to its highest point. Rotate the probe to a position
above the wash well.
CAUTION:
After installing the sample probe, be sure to rotate the probe
to a position above the wash well.
12
Keep the sample disk handle in the vertical position. Align the central hole of
the handwheel to the rotor and lower the sample disk all the way down.
Rotate the disk a bit as necessary during the lowering process. When the
disk is in place, shift the handle back to horizontal position to lock the disk to
the rotor. To ensure the disk is secured, you may grab the handwheel and
gently pull it upward. If the disk does not loose, it means it is secured and
you can replace the cover; otherwise, re-install the disk.
13
Place the ANALYZING UNIT POWER to ON. The system will automatically
reset the probe and wash it with deionized water.
5-31
Maintenance
CAUTION:
The probe tip is precisely fabricated. A bent or damaged probe will lead
to unreliable test results and should be replaced immediately upon
seeing.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when removing the
probe.
Remove the cover from the reagent disk. Shift the disk handle from the
horizontal position to vertical position. Grab the handle or handwheel and
pull the disk upward to remove it.
5-32
Maintenance
3
Pull the reagent probe arm to its highest point. Rotate the probe to a
position above the reagent disk and convenient to operate.
Grab the lower part of the arm cover with two hands and pull them slightly
outwards and remove the cover upward from the arm base.
Hold the probes fluid connector with one hand and the tubing connector
with the other. Rotate tubing connector counter-clockwise until it
disconnects from the probe. Remove the tubing from the probe.
5-33
Maintenance
6
Press the circuit board with one hand and disconnect the probes circuit
connector from the board with the other hand.
CAUTION:
The probe arm is delicate. Exercise caution when
disconnecting the connector. Excessive force may damage
the connector and/or the circuit board.
7
Use a screwdriver to remove the retaining screw and take out the spring.
WARNING:
Save the removed probe at a safe place where it will neither
endanger people working around the area nor be damaged.
NOTE:
Exercise caution when pulling the probe away from the arm
so that the probe tip will not contact or even damage the
probe arm.
Slowly pull the probe away from the probe arm. Exercise caution so that
the gasket inside the probe will not drop out and if it does drop out, save it
at a clean place for later installation.
5-34
Maintenance
NOTE:
The probe tip is precisely fabricated. A bent or damaged probe will lead
to unreliable test results and should be replaced immediately upon
seeing. Refer to 5.6.4 Replacing Reagent Probe for details.
BIOHAZARD:
Wear gloves, goggles and protective clothing when unclogging the
probe.
Dispose of the used needle in accordance with your local or national
guidelines for biohazard waste disposal.
NOTE:
The probe tip is precisely fabricated. A bent or damaged probe will lead
to unreliable test results and should be replaced immediately upon
seeing. Refer to 5.6.4 Replacing Reagent Probe for details.
BIOHAZARD:
Wear gloves, goggles and protective clothing when installing the probe.
Replace the spring and screw the retaining screw back onto the probe.
5-35
Maintenance
4
Pinch the probe by the part near the probe arm. Gently push the probe
upward and then release the probe to see if it can move freely.
If so, proceed to the next step.
If not, check for errors and try again after removing the errors.
CAUTION:
You must shape the tubing inside the reagent probe arm into
a ring.
Add deionized water to a clean cup. Immerse the probe tip into the water by
2-3mm and the LED on the circuit board will be lighted. Take the probe tip
out of water, and the LED will go out.
If the test succeeds, proceed to the next step.
If not, please contact Mindray Customer Service Department or the
distributor.
5-36
Maintenance
9
Check the marks inside the probe arm cover to see the orientation of the
cover. Install the cover back to the probe arm.
CAUTION:
The marks inside the probe arm cover are shown in the figure
below.
10
Pinch the probe by the part near the probe arm. Gently push the probe
upward and then release the probe to see if it can move freely.
If so, proceed to the next step.
If not, the cover is not properly installed. Remove the cover and re-install it
and try this step again.
11
Pull the reagent probe arm to its highest point. Rotate the probe to a position
above the wash well.
CAUTION:
After installing the reagent probe, be sure to rotate the probe
to a position above the wash well.
12
Keep the reagent disk handle in the vertical position. Align the central hole of
the handwheel to the rotor and lower the reagent disk all the way down.
Rotate the disk a bit as necessary during the lowering process. When the
disk is in place, shift the handle back to horizontal position to lock the disk to
the rotor. To ensure the disk is secured, you may grab the handwheel and
gently pull it upward. If the disk does not loose, it means it is secured and
you can replace the cover; otherwise, re-install the disk.
13
Place the ANALYZING UNIT POWER to ON. The system will automatically
reset the probe and wash it with deionized water.
5-37
Maintenance
NOTE:
The probe tip is precisely fabricated. A bent or damaged probe will lead
to unreliable test results and should be replaced immediately upon
seeing. Refer to 5.6.4 Replacing Reagent Probe for details.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when replacing the
probe.
CAUTION:
Please use consumables recommended by our company. Other
consumables may degrade the system performance.
BIOHAZARD:
Dispose of the bent or damaged sample probe in accordance
with your local or national guidelines for biohazard waste
disposal.
2
CAUTION:
After installing the sample probe, be sure to rotate the probe
to a position above the wash well before installing the
sample disk.
5-38
Maintenance
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when replacing the
probe.
CAUTION:
Please use consumables recommended by Mindray.
consumables may degrade the system performance.
Other
BIOHAZARD:
Dispose of the bent or damaged reagent probe in
accordance with your local or national guidelines for
biohazard waste disposal.
2
CAUTION:
You must shape the tubing inside the reagent probe arm into
a ring.
5-39
Maintenance
WARNING:
The sample probe tip is sharp and can cause puncture wounds. To
prevent injury to your hands or arms, exercise caution when working
around the probe.
When replacing the bar, pinch the bar only by the knurled part and do
not touch the other part of the bar. Protect the flat par of the mixing bar
from scratches.
BIOHAZARD:
Wear gloves, goggles and protective clothing when replacing the
mixing bar.
Dispose of the damaged mixing bar in accordance with your local or
national guidelines for biohazard waste disposal.
CAUTION:
Please use consumables recommended by Mindray.
consumables may degrade the system performance.
Other
Prepare a new mixing bar. Wash the flat part of the new bar with
detergent-dipped gauze or cotton sticks and then wipe it dry with
deionized water-dipped gauze.
Gently pull the bar to its highest point and rotate it to a position convenient
to operate.
5-40
Maintenance
4
Pinch the bar by the knurled part with one hand and unscrew
(counter-clockwise) the retaining nut with the other until the mixing bar
looses. Pull the bar downward to remove it and remove the nut.
CAUTION:
When trying to pull out the bar, concentrate your force in the
direction of the axis on the bar arm. Biased force may
damage the bar and/or the axis.
Align the mixing bar to the bigger hole of the retaining nut and gently
screw it into the nut until the end of the bar is in line with the smaller hole
of the nut.
Pinch the mixing bar by the knurled part and align the hole of the nut to the
axis of the mixing bar and push the nut onto the bar until it reaches the
end of the bar. Tighten the nut (screw clock-wise) with the other hand.
CAUTION:
When trying to push the bar into the arm, concentrate your
force in the direction of the axis on the bar arm. Biased force
may damage the bar and/or the axis.
Ensure the bar is all the way pushed to the end.
5-41
Maintenance
7
After replacing the bar, visually check whether the bar is vertical to the bar
arm.
If yes, proceed to the next step.
If not, repeat step 5 to remove the bar and re-install it.
Pull the bar arm to its highest point and rotate it back to a position above
its wash well.
CAUTION:
After installing the mixing bar, be sure to rotate the mixing
bar to a position above its wash well before turning on the
analyzing unit.
9
Place the ANALYZING UNIT POWER to ON. The system will automatically
reset the bar and wash it with deionized water.
10
Click Into Wash Well and observe whether the mixing bar is aligned to the
center of the wash well. If not, please contact Mindray Customer Service
Department or the distributor.
Set the Time to 100 and click Mix. The bar should start to rotate after
enters the reaction cuvette. Observe whether the rotation is normal and
pay attention to abnormal sound. If the rotation is not normal or the
abnormal noise is heart, please contact Mindray Customer Service
Department or the distributor.
5-42
Maintenance
CAUTION:
Please use consumables recommended by Mindray.
consumables may degrade the system performance.
Other
Follow the procedure given below to replace the plunger assembly of sample or
reagent syringe.
1
Open the middle door and you will see both of the syringes, the sample
syringe on the right and the reagent syringe on the left.
T-piece
Syringe Connector
Upper Retaining Screw
Space Bar
Syringe
5-43
Maintenance
3
Prepare a new plunger assembly (shown in the figure below) and soak the
plunger tip in deionized water to eliminate bubbles.
+
Plunger Button
Plunger Rod
Plunger Tip
CAUTION:
There may be residual water in the syringe. Exercise caution
when removing it. Do not drop water onto the analyzing unit.
Grab the T-piece with one hand and the syringe connector with the other
hand and unscrew (counter-clockwise) the syringe. Exercise caution so that
the gasket on the syringe does not drop out and if it does, store it in a clean
place for later installation. Replace the gasket if it has been disassembled
for 2 to 3 times. Otherwise leakage may occur or sampling precision be
affected.
7
CAUTION:
There may be residual water in the syringe. Exercise caution
when pulling the plunger assembly out. Do not drop water onto
the analyzing unit.
The plunger rod of the sample syringe is slender. Exercise
caution when working on it. Excessive force may bend it.
Unscrew (counter-clockwise) the plunger guide cap and pinch the plunger
button to gently pull the plunger assembly from the syringe.
Syringe Connector
Syringe
CAUTION:
The plunger rod of the sample syringe is slender. Exercise
caution when working on it. Excessive force may bend it.
Pinch the new plunger assembly by the plunger button and carefully insert
the plunger tip into the syringe and push it all the way to the end. Screw
(clockwise) the plunger guide cap until secure.
5-44
Maintenance
9
Immerse the syringe connector into deionized water. Pinch the plunger
button, pull it to aspirate half syringe of deionized water and then push it to
expel the deionized water and the air from the syringe.
10
Grab the T-piece with one hand and the syringe connector with the other
hand. Screw (clockwise) the syringe into the T-piece until secure.
11
12
Install the space bar and two upper retaining screws. Note that do not
tighten the screws now.
13
Align the plunger button to the lower retaining screw of the plunger and
screw (clockwise) the screw until secure.
14
Pinch the plunger guide cap to adjust the syringe. Our company
recommends the upper edge of the space bar reach the fourth line (the 4l
line of the sample reagent, or the 40l line of the reagent syringe) of the
scale on the syringe.
15
16
17
Enter the System Maintenance screen and set the Volume (SS. Syringe)
or Volume (R. Syringe) to the maximum value(45 for the sample syringe
and 450 for the reagent syringe ). Click S. Syringe Aspirate or R. Syringe
Aspirate and the syringe should start aspirating. After the syringe finishes
the motion, click S. Syringe Dispense or R. Syringe Dispense and the
syringe should start expelling. You may repeat this action several times.
Refer to 4.4.6.7 Fluid Path tab for details. Pay attention to bubbles during
the aspiration/dispensing process.
Go to the next step if no bubble is found.
If there are bubbles observed during the process, they may be caused by
the air leak between the syringe and the T-piece. Uninstall the syringe and
re-install it. If the bubbles are found again, please contact Mindray
Customer Service Department or the distributor.
18
BIOHAZARD
To prevent biohazard contamination, always wear gloves, goggles and
protective clothing when doing the maintenance.
Dispose of the waste in accordance with your local or national
guidelines for biohazard waste disposal.
Loosen the screws on the syringe cover and remove the cover. You can
see the two reagent syringes on the left and sample syringe on the right.
Loosen the four upper retaining screws of the syringe, then remove the
screws and space bar.
5-45
Maintenance
4
Loosen the four lower retaining screws of the syringe and remove the
syringe from the holder.
Pull the plunger gently outwards until you can not proceed any more, and
then push it quickly. Repeat this pull-push operation until the air bubbles
are removed from the syringe.
CAUTION:
Be sure not to push the plunger to the end tip; otherwise the
syringe may be damaged.
Place the syringe on the holder. Install the space bars and tighten the
upper retaining screws.
NOTE:
The upper edge of the upper space bar must reach the 7th scale
on the syringe.
When fixing the retaining screws, be sure to tighten them
alternately with equilibrium force.
7
CAUTION:
Please use consumables recommended by Mindray.
consumables may degrade the system performance.
Other
NOTE:
Do not touch either the light entrance of the lamp housing or the lens in
front of the lamp. In case the entrance is dirty, clean it with
ethanol-soaked defatted cotton.
Place the POWER to OFF. Wait at least 15 minutes for the lamp and its
housing to cool down.
WARNING:
After working for a while, the lamp and its housing are
usually hot enough to burn you. Do not proceed with this
procedure until they have cooled down.
5-46
Maintenance
2
Unscrew the two lower screws on the back of the lamp housing and
remove the radiator from the housing.
Pinch the lamp base with one hand and press the lever on the left of the
base.
Pinch the new lamp by its base and insert the lamp pins into the mounting
holes, the larger pin into the larger hole and the smaller pin into the
smaller hole, on the base.
5-47
Maintenance
7
Close the upper part of the back of the analyzing unit and tighten the
screws.
CAUTION:
Use the consumables recommended by Mindray. Other consumables
may degrade system performance.
NOTE:
The maintenance is necessary to be performed when the ISE unit
(optional) is connected.
If you run no more than 100 samples requested for the ISE tests a day, replace the
electrodes according to the following recommended schedule:
Li+ Electrode
+
6 months
Na Electrode
6 months
K+ Electrode
6 months
Cl- Electrode
6 months
Reference Electrode
6 months
If you run more than 100 samples requested for the ISE tests a day, replace the
electrodes according to the following recommended schedule:
Li+ Electrode
+
3,000 samples
Na Electrode
10,000 samples
K+ Electrode
10,000 samples
Cl- Electrode
10,000 samples
Reference Electrode
10,000 samples
5-48
Maintenance
4
Take the electrode(s) out from the housing by pressing down the
compression plate(s).
NOTE:
Because the electrodes must be installed sequentially, you
have to take out the electrode to be replaced and those (or
that) over it from above to below. For example, there is no
other electrode over the Li electrode, so you just need to
take it out; There are four electrodes over the reference
electrode, so you have to take out all the five electrodes from
above to below.
Install the new electrode. Refer to the 2.4.1 Installing Electrodes for
details.
CAUTION:
Use the consumables recommended by Mindray. Other consumables
may degrade system performance.
NOTE:
The maintenance is necessary to be performed when the ISE unit
(optional) is connected.
Take out the reagent module. Press the yellow button on the wand and
take off the wand from the module. Then put the three red caps back to
the module that were taken off when the module was installed.
5-49
Maintenance
CAUTION:
Use the consumables recommended by Mindray. Other consumables
may degrade system performance.
NOTE:
The maintenance is necessary to be performed when the ISE unit
(optional) is connected.
The ISE unit (optional) should be on power all the time. In some cases
that the POWER will be shut down for a long time more than half an
hour, the following steps should be performed.
Click the Clean button and a dialog box pops up to remind you to place
ISE cleaning solution to the position 45 on the sample disk.
Load about 200l of the cleaning solution to the position 45 on the sample
disk.
Click the Purge A button and after the instruction is executed, repeat this
step for another two times.
Take out the reagent module. Press the yellow button on the wand and
take off the wand from the module. Then put the three red caps back to
the module that were taken off when the module was installed.
10
11
12
13
14
Take all the electrodes out from the housing from above to below by
pressing down the compression plates.
15
Put the reference, Na+ and Cl- electrodes into their individual sealed bags.
5-50
Maintenance
16
Aspirate a small volume of Calibrant A from the port of the reagent module
with a syringe and inject it into the lumens of the K+ and Li+ electrodes until
the lumens are full.
Cover both ends of the lumens with tapes to prevent the Calibrant A flows
from the lumens.
Put the K+ and Li+ electrodes into their individual sealed bags.
17
CAUTION:
Use the consumables recommended by Mindray. Other consumables
may degrade system performance.
After completing the following steps, ensure to calibrate the ISE tests
before testing.
NOTE:
Before reusing the ISE unit (optional) that has been stored, you must
complete the following steps.
5.7
If necessary, soak the reference electrode in warm water until the lumen of
the electrode has been cleared of salt build-up.
Install a new reagent module to the ISE unit. Refer to 2.4.2 Installing
Reagent Module for details.
Maintenance Log
See the following tables for the parts to be maintained and the maintenance
schedules. Please copy them every month and place a check mark in each day
column for the maintenance items in the list after performing maintenance.
5-51
Maintenance
Daily Maintenance
Month: Year:
Maintenance Record
Daily Maintenance
Checking Detergents
10
11
12
13
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Month: Year:
Weekly Maintenance
1
Maintenance Record
1
5-52
Maintenance
Monthly Maintenance
Month: Year:
Maintenance Record
Monthly Maintenance
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Month: Year:
Maintenance Record
Month: Year:
Irregular Maintenance
1
Replacing Lamp
10
11
12
Maintenance Record
1
5-53
6 Troubleshooting
This chapter presents all error messages and recommended measures, which
should be taken in time once any error occurs.
If the recommended measures fail to solve the problems, contact Mindray or your
local distributor.
When an error occurs, its corresponding error message will be displayed on the
lower left side of the screen, as Figure 6-1 shows.
The log will record the time, level, code and message of every error (except for the
level-11 error) to facilitate you to troubleshoot the analyzer. Refer to 4.4.5 Log for
details about the log.
Figure 6-1 Error messages are displayed on the lower left side of the screen
6.1
6-1
Troubleshooting
Severity: Warning
Level
Definition
Negligible errors
Errors to be flagged
Errors to invalidate an
analysis
20
Errors caused by
unavailable samples
Errors to
reagents
invalidate
30
Errors caused by
unavailable reagents
31
Definition
6-2
Troubleshooting
Level
Definition
Errors caused by
cuvette loader only
(reaction disk not
affected)
13
Errors caused by
unavailable deionized
water or full wastetank
Definition
Definition
Definition
10
6-3
Troubleshooting
Level
Definition
12
Definition
11
NOTE:
All errors except for those of level 11 will be recorded in the log. When
a level-11 error occurs, the operating system will display the error
message and exit the operating software after the error is confirmed by
the operator.
6.2
Corrective Measures
WARNING:
When troubleshooting the analyzer, first find out whether it is
necessary to switch off the POWER or ANALYZING UNIT POWER.
Wear gloves, goggles and lab coat if necessary.
6-4
Troubleshooting
Error code
Error Message
Level
100000001
Parity error.
100000002
100000003
Incomplete instruction.
100000004
100000005
100000006
100960100
100960101
100960102
100960103
100960104
100960105
100960106
100960107
100960200
10
100960300
100960500
6-5
Corrective Measure
Troubleshooting
Error code
Error Message
Level
100960900
100960901
100960902
100960903
100960904
100960905
100960906
100961000
100961100
100961200
100961400
100961500
100961600
100961800
100961900
100962000
10
100962001
10
6-6
Corrective Measure
Troubleshooting
Error code
Error Message
Level
100962002
10
100962003
10
100969000
100969100
101280100
31
101280101
31
101280102
31
101280103
31
101280104
31
101280105
31
101280200
10
101280300
101280400
101280401
101280402
101280403
101280404
101280405
6-7
Corrective Measure
Troubleshooting
Error code
Error Message
Level
101280406
101280500
101280600
101280700
Speed configuration
unreasonable.
101280800
101280900
101281000
101281100
101281200
101281300
System instruction
unreasonable.
101281400
101281500
Commissioning
unreasonable.
101281600
parameter
parameter
parameter
beyond
beyond
beyond
or
limit
limit
or
or
Corrective Measure
limit
or
confirmation
not
6-8
Troubleshooting
Error code
Error Message
101281701
Level
9
Corrective Measure
Turn off the analyzing unit and then
(1) Check the sample syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(2) Check the sample probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(3) Check the deionized water tank as instructed by 5.2.8 Checking
Remaining Deionized Water.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101281800
Ensure the sample disk rotates well as instructed by 4.4.6.6 S. Disk tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101281801
Ensure the sample disk rotates well as instructed by 4.4.6.6 S. Disk tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101281802
101281803
Ensure the sample disk rotates well as instructed by 4.4.6.6 S. Disk tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Turn off the analyzing unit and check if the sample tubes are placed too
high on the sample disk.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
6-9
Troubleshooting
Error code
Error Message
101281804
101281902
Level
Corrective Measure
Other errors have higher priority.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Check the sample syringe as instructed by 4.4.6.7 Fluid Path tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101281903
101282000
(1) Turn off the analyzing unit and clean the sample disk rotor.
(2) Turn on the analyzing unit and check the sample probe as instructed
by 4.4.6.1 S. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101282001
(1) Turn off the analyzing unit and clean the sample disk rotor.
(2) Turn on the analyzing unit and check the sample probe as instructed
by 4.4.6.1 S. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101282002
(1) Turn off the analyzing unit. Clean the sample disk rotor.
(2) Turn on the analyzing unit and check the sample probe as instructed
by 4.4.6.1 S. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
6-10
Troubleshooting
Error code
Error Message
101282100
101282107
31
Turn off the analyzing unit and clear the obstacles from the path of the
vertical movement of the sample probe.
101282108
Turn off the analyzing unit and pinch the sample probe and push it upward
to check whether the spring can move freely.
101282101
101282102
Level
Corrective Measure
Check the sample probe as instructed by.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101282200
101282300
6-11
Troubleshooting
Error code
Error Message
101282400
Level
31
Corrective Measure
Turn off the analyzing unit.
(1) Check whether the sample tubes are placed too high on the sample
disk.
(2) Check the sample syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the sample probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(4) Check whether the sample probe is bent or scratched. Replace the
damaged probe as instructed by 5.6.3 Replacing Sample Probe if
necessary.
(5) Clean the sample probe as instructed by 5.3.1 Washing Sample
Probe.
If this error occurs frequently, contact our company or your local distributor.
101282600
101289000
101289100
101289200
101440100
31
101440101
31
101440102
31
101440103
31
101440104
31
101440105
31
6-12
Troubleshooting
Error code
Error Message
Level
101440200
10
101440300
101440400
101440401
101440402
101440403
101440404
101440405
101440406
101440500
101440600
101440700
Speed configuration
unreasonable.
101440800
101440900
101441000
101441100
101441200
parameter
beyond
limit
or
6-13
Corrective Measure
Troubleshooting
Error code
Error Message
Level
101441300
System instruction
unreasonable.
101441400
101441500
Commissioning
unreasonable.
parameter
or
101441600
101441701
parameter
beyond
beyond
limit
limit
or
Corrective Measure
(1) Check whether the deionized water tank is empty and add more
deionized water to the tank as necessary.
(2) Check the sample syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the sample probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101441800
101441801
6-14
Troubleshooting
Error code
Error Message
101441802
31
101441803
101441804
101441900
Level
Corrective Measure
Check the reagent disk as instructed by 4.4.6.5 Rgt. Disk tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Turn off the analyzing unit and check the types of the reagent bottles.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Other errors have higher priority.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Check the reagent probe as instructed by 4.4.6.2 R. Probe tab. Check the
reagent syringe as instructed by 4.4.6.7 Fluid Path tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101441902
101441903
101442000
(1) Turn off the analyzing unit. Clean the sample disk rotor.
(2) Turn on the analyzing unit and check the reagent probe as instructed
by 4.4.6.2 R. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
6-15
Troubleshooting
Error code
Error Message
101442001
Level
5
Corrective Measure
(1) Turn off the analyzing unit. Clean the sample disk rotor.
(2) Turn on the analyzing unit and check the reagent probe as instructed
by 4.4.6.2 R. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101442002
(1) Turn off the analyzing unit. Clean the reagent disk rotor and.
(2) Turn on the analyzing unit and check the reagent probe as instructed
by 4.4.6.2 R. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101442100
101442101
101442102
101442107
31
6-16
Turn off the analyzing unit and clear the obstacles in the path of the
vertical movement of the reagent probe.
Troubleshooting
Error code
Error Message
101442108
Level
9
Corrective Measure
Turn off the analyzing unit and pinch the reagent probe and push it upward
to see whether it can move freely.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101442110
101442200
101442300
6-17
Troubleshooting
Error code
Error Message
101442400
Level
31
Corrective Measure
Turn off the analyzing unit and
(1) Check the types of the reagent bottles.
(2) Check the reagent syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the sample probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(4) Check whether the sample probe is bent or scratched. Replace the
damaged probe as instructed by 5.6.4 Replacing Reagent Probe if
necessary.
(5) Clean the reagent probe as instructed by 5.3.2 Washing Reagent
Probe.
If this error occurs frequently, contact our company or your local distributor.
101442600
101449000
101449100
101449200
101600100
31
101600101
31
101600102
31
101600103
31
101600104
31
101600105
31
6-18
Troubleshooting
Error code
Error Message
Level
101600200
10
101600300
101600400
101600401
101600402
101600403
101600404
101600405
101600406
101600500
101600600
101600700
Speed configuration
unreasonable.
101600800
101600900
101601000
101601100
101601200
parameter
beyond
limit
or
6-19
Corrective Measure
Troubleshooting
Error code
Error Message
Level
101601300
System instruction
unreasonable.
101601400
101601500
Commissioning
unreasonable.
101601600
101601700
parameter
parameter
beyond
beyond
limit
or
Corrective Measure
limit
or
confirmation
not
(1) Turn off the analyzing unit. Clean the mixing bar rotor.
or
(2) Turn on the analyzing unit and check the mixing bar as instructed by
4.4.6.3 Mixing Bar tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101601701
(1) Turn off the analyzing unit. Clean the mixing bar rotor.
(2) Turn on the analyzing unit and check the mixing bar as instructed by
4.4.6.3 Mixing Bar tab .
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101601702
(1) Turn off the analyzing unit. Clean the mixing bar rotor.
(2) Turn on the analyzing unit and check the mixing bar as instructed by
4.4.6.3 Mixing Bar tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
6-20
Troubleshooting
Error code
Error Message
101601707
Level
7
Corrective Measure
Other errors have higher priorities.
Check the mixing bar as instructed by 4.4.6.3 Mixing Bar tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101601800
(1) Turn off the analyzing unit. Clean the mixing bar rotor.
(2) Turn on the analyzing unit and check the mixing bar as instructed by
4.4.6.3 Mixing Bar tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101601802
(1) Turn off the analyzing unit. Clean the mixing bar rotor.
(2) Turn on the analyzing unit and check the mixing bar as instructed by
4.4.6.3 Mixing Bar tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101602000
6-21
Troubleshooting
Error code
Error Message
101602100
Level
6
Corrective Measure
Turn on the analyzing unit and check the manipulator as instructed by
4.4.6.10 Autoloader tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101602101
101602200
101602201
101602202
101602203
101602204
101602205
101602206
101602207
6-22
Troubleshooting
Error code
Error Message
101602208
Level
0
Corrective Measure
Check the remaining cuvettes and add more cuvettes as needed.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
101602209
button.
button.
101609100
101609200
101760100
31
101760101
31
101760102
31
6-23
Troubleshooting
Error code
Error Message
Level
101760103
31
101760104
31
101760105
31
101760200
10
101760400
101760401
101760402
101760403
101760404
101760405
101760406
101760500
101760600
101760700
101761100
101761200
Attempted target
unreasonable.
101761300
temperature
beyond
limit
or
6-24
Corrective Measure
Troubleshooting
Error code
Error Message
Level
101769000
101769100
101769200
101920100
31
101920101
31
101920102
31
101920103
31
101920104
31
101920105
31
101920200
10
101920300
101920400
101920401
101920402
101920403
101920500
101920600
101920700
101920800
6-25
Corrective Measure
Troubleshooting
Error code
Error Message
Level
101920900
101921000
101921100
101921200
101921300
System instruction
unreasonable.
101921400
parameter
beyond
limit
or
Corrective Measure
101921402
101921500
101929000
101929100
101929200
6-26
Troubleshooting
Error code
Error Message
102409000
Level
12
Corrective Measure
Shut down the analyzing unit and start it again. Enter the System
Maintenance screen, select the Others tab and click the Download
Settings button.
If the error still appears, contact our company or your local distributor.
111282100
111282101
111282102
6-27
Troubleshooting
Error code
Error Message
111282106
Level
2
Corrective Measure
Turn off the analyzing unit and
(1) Check whether the sample tubes are placed too high on the sample
disk.
(2) Check the sample syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the sample probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(4) Check whether the sample probe is bent or scratched. Replace the
damaged probe as instructed by 5.6.3 Replacing Sample Probe if
necessary.
(5) Clean the sample probe as instructed by 5.3.1 Washing Sample
Probe.
If this error occurs frequently. Contact Mindray Customer Service
Department or your local distributor.
111282110
111282400
111442100
6-28
Troubleshooting
Error code
Error Message
111442101
111442102
111442106
Level
Corrective Measure
Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Turn off the analyzing unit and
(1) Check the types of the reagent bottles.
(2) Check the reagent syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the reagent probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(4) Check whether the reagent probe is bent or scratched. Replace the
damaged probe as instructed by 5.6.4 Replacing Reagent Probe if
necessary.
(5) Clean the reagent probe as instructed by 5.3.2 Washing Reagent
Probe.
If this error occurs frequently. Contact Mindray Customer Service
Department or your local distributor.
111442110
6-29
Troubleshooting
Error code
Error Message
111442400
Level
9
Corrective Measure
Turn off the analyzing unit and
(1) Check the types of the reagent bottles.
(2) Check the reagent syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the reagent probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(4) Check whether the reagent probe is bent or scratched. Replace the
damaged probe as instructed by 5.6.4 Replacing Reagent Probe if
necessary.
(5) Clean the reagent probe as instructed by 5.3.2 Washing Reagent
Probe.
If this error occurs frequently, contact our company or your local distributor.
111601700
(1). Turn off the analyzing unit. Clean the mixing bar rotor
(2) Turn on the analyzing unit. Check the mixing bar as instructed by
4.4.6.10 Autoloader tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
111601701
(1) Turn off the analyzing unit. Clean the mixing bar rotor
(2) Turn on the analyzing unit. Check the mixing bar as instructed by
4.4.6.10 Autoloader tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
6-30
Troubleshooting
Error code
Error Message
111601702
Level
9
Corrective Measure
(1) Turn off the analyzing unit. Clean the mixing bar rotor
(2) Turn on the analyzing unit. Check the mixing bar as instructed by
4.4.6.10 Autoloader tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
111601707
Other errors have higher priorities. Check the movement of the mixing bar
at the maintenance screen.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
111602000
111602001
121442100
121442101
6-31
Troubleshooting
Error code
Error Message
121442102
121442110
131282100
131282101
131282102
131282110
Level
Corrective Measure
Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
6-32
Troubleshooting
Error code
Error Message
162240000
Level
12
Corrective Measure
Enter the ISE Maintenance screen of the operating software and click the
Handshake button.
If the error remains, shut down the analyzer unit and start it again. Enter
the System Maintenance screen, select Others tab and click the
Download Settings button.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
200000001
Turn off the analyzing unit and check whether the ambient temperature
falls into the specified range.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
200000002
Turn off the analyzing unit and check whether the ambient temperature
falls into the specified range.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
200000003
200000004
200000005
Check whether the ambient temperature falls into the specified range.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Check whether the ambient temperature falls into the specified range.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Check whether the ambient temperature falls into the specified range.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
6-33
Troubleshooting
Error code
Error Message
200000006
200000007
Level
Corrective Measure
Check whether the ambient temperature falls into the specified range.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Turn off the analyzing unit and check whether the ambient temperature
falls into the specified range.
Contact Mindray Customer Service Department or your local distributor.
200000008
Turn off the analyzing unit and check whether the ambient temperature
falls into the specified range.
Contact Mindray Customer Service Department or your local distributor.
201280005
201280006
201280007
20
201280009
201280010
6-34
Troubleshooting
Error code
Error Message
201440005
201440006
201440007
30
201440009
Level
Corrective Measure
201440010
201600009
6-35
Troubleshooting
Error code
Error Message
Level
201600010
Corrective Measure
Check the manipulator as instructed by 4.4.6.10 Autoloader tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
201600011
201600012
201600013
201600014
Robotic arm
compartment.
didn't
grab
new
Re-cuvette
from
201600015
201600016
6-36
Troubleshooting
Error code
Error Message
201600017
201600018
Level
loading
new
cuvette.
Corrective Measure
Check the manipulator as instructed by 4.4.6.10 Autoloader tab.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
Turn off the analyzing unit and empty the used-cuvette bucket as
instructed by 5.2.10 Emptying Used-Cuvettes Bucket.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
201600019
Check the remaining cuvettes in the cuvette compartment and add more
cuvettes as needed.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
210000001
13
Check and empty the waste tank as instructed by 5.2.9 Emptying Waste
Tank. If the error remains, contact Mindray Customer Service Department
or your local distributor.
210000002
13
Check and refill the DI water tank. If the error remains, contact Mindray
Customer Service Department or your local distributor.
400000001
10
(1) Turn off the POWER and check the connection between the analyzing
unit and the operation unit.
(2) Use the emergency exit function to exit the control system.
If this error remains, contact our company or your local distributor.
400000002
10
Use the emergency exit function to exit the control system and then restart
it.
If this error remains, contact our company or your local distributor.
6-37
Troubleshooting
Error code
Error Message
Level
400000010
10
Corrective Measure
Use the emergency exit function to exit the control system and then restart
it.
If this error remains, Contact Mindray Customer Service Department or
your local distributor.
400000012
400000016
System initialization
abnormal.
error.
Main
unit
connection
10
(1) Turn off the POWER and check the connection between the analyzing
unit and the operation unit.
(2) Use the emergency exit function to exit the control system and then
restart it.
If this error remains, contact our company or your local distributor.
400000100
400000204
400000209
400000216
400000220
10
Check the connection between the analyzing unit and the operation unit,
or change the serial port. Then run the control system again.
If the error remains, change the lamp or contact our company or your local
distributor.
6-38
Troubleshooting
Error code
Error Message
400000221
Level
10
Corrective Measure
Check the connection between the analyzing unit and the operation unit,
or change the serial port. Then run the control system again.
If this error remains, Contact Mindray Customer Service Department or
your local distributor.
400000225
Check the remaining reagents for the test and add reagents to the bottles
as needed.
If the error remains, contact Mindray Customer Service Department or
your local distributor.
400000251
400000252
400000253
400000254
400000255
400000276
10
6-39
Troubleshooting
Error code
Error Message
Level
Corrective Measure
400000281
400000282
Re-calibrate.
400000283
400000284
Reagent out.
30
Check the remaining reagents of the test and add reagents as needed.
400000287
10
400000288
400000289
400000290
6-40
Troubleshooting
Error code
Error Message
400000291
Level
10
Corrective Measure
Use the emergency exit function to exit the control system and then restart
it.
If this error remains, Contact Mindray Customer Service Department or
your local distributor.
400000292
10
400000293
10
This error is triggered by other errors. Check the causes of the root errors
and take the recommended corrective measures. Use the emergency exit
function to exit the control system and then restart it.
If this error remains, contact our company or your local distributor.
400000294
10
This error is triggered by other errors. Check the causes of the root errors
and take the recommended corrective measures. Use the emergency exit
function to exit the control system and then restart it.
If this error remains, contact our company or your local distributor.
400000296
Rerun or recalculate
500000001
LIS: Unconnected
500000002
6-41
Troubleshooting
Error code
Error Message
500000005
Level
0
Corrective Measure
Check if the LIS server is power on and can work properly.
Check if the line between the system and the LIS can work properly.
If this error remains, contact our company or your local distributor.
500000010
500000011
500000012
500000013
6-42
Troubleshooting
Error code
Error Message
500000014
Level
0
Corrective Measure
Downloading or sending the message again.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000015
500000016
500000017
500000018
6-43
Troubleshooting
Error code
Error Message
500000019
Level
0
Corrective Measure
Downloading or sending the message again.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000020
500000021
500000031
500000032
6-44
Troubleshooting
Error code
Error Message
Level
Corrective Measure
500000099
Ensure there is no sample information of the current day in the LIS server.
If there is, check the LIS server.
500000101
Shut down the analyzing unit and start it again. Enter the System
Maintenance screen, select the Others tab and click the Download
Settings button.
If the error still appears, contact our company or your local distributor.
500000102
Shut down the analyzing unit and start it again. Enter the System
Maintenance screen, select the Others tab and click the Download
Settings button.
If the error still appears, contact our company or your local distributor.
600000001
12
Enter the ISE Maintenance screen of the operating software and click the
Handshake button.
If the error remains, shut down the analyzing unit and start it again. Enter
the System Maintenance screen, select the Others tab and click the
Download Settings button.
If the error still appears, contact our company or your local distributor.
600000002
12
Enter the ISE Maintenance screen of the operating software and click the
Handshake button.
If the error remains, shut down the analyzing unit and start it again. Enter
the System Maintenance screen, select the Others tab and click the
Download Settings button.
If the error still appears, contact our company or your local distributor.
600000003
6-45
Troubleshooting
Error code
Error Message
Level
Corrective Measure
600000010
600000011
Replace the K electrode with a new one. If the error remains, contact
Mindray Customer Service Department or your local distributor.
600000012
Replace the Li electrode with a new one. If the error remains, contact
Mindray Customer Service Department or your local distributor.
600000013
Replace the Cl electrode with a new one. If the error remains, contact
Mindray Customer Service Department or your local distributor.
600000014
Replace the reference electrode with a new one. If the error remains,
contact Mindray Customer Service Department or your local distributor.
600000015
600000016
600000020
Replace the Na electrode with a new one. If the error remains, contact
Mindray Customer Service Department or your local distributor.
600000021
Replace the K electrode with a new one. If the error remains, contact
Mindray Customer Service Department or your local distributor.
600000022
Replace the Cl electrode with a new one. If the error remains, contact
Mindray Customer Service Department or your local distributor.
600000023
Replace the Li electrode with a new one. If the error remains, contact
Mindray Customer Service Department or your local distributor.
600000024
Replace the reference electrode with a new one. If the error remains,
contact Mindray Customer Service Department or your local distributor.
600000030
6-46
Troubleshooting
Error code
Error Message
600000031
Level
0
Corrective Measure
Restart the system.
If the error remains, replace with a new reagent module.
If the error still remains, contact our company or your local distributor.
600000032
Replace with a new reagent module. If the error remains, contact Mindray
Customer Service Department or your local distributor.
600000033
Replace with a new reagent module. If the error remains, contact Mindray
Customer Service Department or your local distributor.
6-47
Troubleshooting
NOTE:
Only one error code of the ISE unit has a format of 8 characters that is
<S0000000>. You can look it as <S000000>.
You can find all the seven numbers in the table below digit by digit and then know
what is wrong with the ISE unit. Each digit represents a certain error. Each row
represents where the error locates in.
When the system reminds you of ISE error, you can open the log to find the error
code.
For example, when you see 0001000, because the number 0 means no error, you
need only to find where the 1 locates in the Digit 4 column. You will find it locates in
the Na+ row and you will know there is something wrong with the Na+ electrode.
Error
Digit
1
Digit
2
Digit
3
Digit
4
Digit
5
Digit
6
Digit
7
Air in Calibrant A
Air in Calibrant B
Air in Cleaner
Air in Segment
Pump Calibration
No Flow
Bubble Detector
Reagent Module
Reagent
Read
Chip
Reagent
Write
Chip
Store Calibration
Value Error
Command Error
No Error
Na+
K+
Na+, K+
Air
Sample/Urine
in
6-48
Troubleshooting
Error
Digit
1
Digit
2
Digit
3
Digit
4
Digit
5
Digit
6
Digit
7
Li+
Li+, Na+
Li+, K+
Cl-
Cl-, Na+
Cl-, K+
Cl-, Li+
Cl-, Li+, K+
The following table lists the corrective measures of the ISE unit errors.
NOTE:
The measures are all sequential, that means only after you perform the
first step and the error remains, you need to go to the second step.
Contact Mindray Customer Service Department or your local distributor if
the errors not listed in the table below occur.
If the corrective measures in the table below have been performed but
the error remains, contact our company or your local distributor.
Digit No.
Character
Corrective Measure
Digit 1
Digit 1
Digit 1
(S or B not
displayed)
Digit 1
6-49
Troubleshooting
Digit No.
Character
Corrective Measure
Digit 1
Digit 4
1,2,4,8
Digit 4
3,5-7,9,A-F
Digit 5
1,2,4,8
Digit 5
3,5-7,9,A-F
Digit 6
1,2,4,8
Digit 6
3,5-7,9,A-F
Digit 7
1-7
6-50
7 Calculation Methods
7.1
Reaction Types
The analyzer can perform calculations for three reaction types:
Endpoint
Fixed-time
Kinetic
7.1.1 Endpoint
The endpoint reaction is the most ideal. The reaction reaches equilibrium after
certain period. Because the equilibrium constant is very large, it can be considered
that all substrates have changed into products, and the absorbance of the reacting
liquid does not change any more. The absorbance change is proportional to the
amount of the product present.
t1
t2
t3
As shown in Figure 7-1, t1 is the time when the reagent is added, and t 2 is the
time when the sample is added. The reaction starts when they are mixed. At t 3 the
reaction reaches the equilibrium and the absorbance reading is taken. The reaction
time is t 3 t 2 .
The Endpoint reaction is not subject to such condition changes as enzyme
concentration, pH value and temperature, as long as the changes are not significant
enough to affect the reaction time.
7.1.2 Fixed-Time
For the fixed-time reaction, the reaction velocity (v), within a specific period, is
proportional to the substrate concentration [S], namely, v=k[S]. As the substrate is
7-1
Calculation Methods
consumed continuously, the reaction velocity becomes smaller and smaller, and so
does the change rate of the absorbance. It takes much time for such a reaction to
reach the equilibrium. Theoretically, the absorbance reading can be taken at any
time. The reaction can, however, become steady only after a delay because it is
complicated at the beginning and there are miscellaneous reactions due to the
complex serum compositions. For any first order reaction, the substrate
concentration [S] at a specific time (t) during the reaction is:
[S ] = [S 0 ] e kt
Where,
[S0]
- velocity constant
Within the interval between t1 and t 2 , the relationship between [S] (delta
substrate concentration) and [S0] is:
[ S 0] =
[ S ]
kt1
kt 2
That is, within a fixed time interval, the delta substrate concentration is proportional
to the original substrate concentration, which is the generality of the first order
reactions. Within this interval, absorbance change is proportional to the substrate
concentration. See Figure 7-2.
t1 t2
t3
t4
As shown in Figure 7-2, t1 is the time when the reagent is added and t 2 is the
time when the sample is added. From t 3 the reaction becomes steady and t 4 is
the time to stop monitoring the reaction. The absorbance readings are respectively
taken at t 3 and t 4 .
Methodologically, the fixed-time method requires more than the endpoint method
does. All factors that have effects on the reaction velocity, such as pH, temperature
and enzyme concentration, must keep constant in the two-point analysis. In addition,
the timing must be precise and the calibration is necessary.
7-2
Calculation Methods
7.1.3 Kinetic
For the kinetic reaction, the reaction velocity is not related to the substrate
concentration and remains constant in the reaction process. As a result, for a given
wavelength, the absorbance of the reacting liquid changes evenly, and the change
rate (A/min) is proportional to the activity or concentration of the subject, which is
usually the enzyme.
In fact, it is impossible for the substrate concentration to be large enough, and the
reaction will no longer a zeroth order reaction when the substrate is consumed to a
certain degree. Therefore, the theory only stands within certain period. In addition,
the reaction can become steady only after a certain period because the reaction is
complicated at the beginning and there are miscellaneous reactions due to the
complex serum compositions. All reagent manufacturers have strict specifications for
these two periods. See Figure 7-3.
t1
t2 t3
tn
As shown in Figure 7-3, t1 is the time when the reagent is added. t 2 is the time
when the sample is added. From t 3 the reaction becomes steady. t n is the time to
stop testing the reaction. t 3 t 2 is the time delay, and t n t 3 is the monitoring
time.
7.2
Calculation Process
The figure below shows the measurement and calculation flow of the analyzer.
AD Value
Absorbance
Response
Calibration Parameter
Test Result
QC Result
QC Conclusion
7-3
Calculation Methods
I0
It
As shown in Figure 7-4, when a parallel monochromatic light beam whose intensity
is I 0 goes through a flow cell (whose length is L ) containing a solution (whose
concentration is C ), some photons are absorbed, and the intensity is attenuated
from I 0 to I t , so the absorbance A of this solution is:
A = Lg
It
I0
Where,
It
I0
- transmissivity
The analyzer measures the light intensity through the photo-electric conversion,
linear amplification and A/D conversion. For the light intensity signal I i of Channel i,
the AD output Di is:
Di = K pe K a K ad I i
Where,
- data of Channel i
Ii
So,
Ai = lg
Ii0
D
= lg i 0
Ii
Di
7-4
Calculation Methods
Where,
Ai
- absorbance of Channel i
Di 0 - background AD output
Di
In theory, when the lights are off, the AD output of each channel will be zero. In
practice, because of the existence of dark currents, there is still a background
output Dibackground , which should be deducted. Then, the complete absorbance
formula should be:
Ai = lg
Di 0 Dibackground
Di Dibackground
t1
t2
t3
As shown in Figure 7-5, t1 is the time when the reagent (volume: V) is added. t2
is the time when the sample (volume: S) is added. The reaction starts when they are
mixed. At t 3 the reaction reaches the equilibrium and the absorbance reading is
taken.
R = Rs RSMPB
7-5
Calculation Methods
Both of
Where,
Rs
RSMPB - response of sample blank. If the sample blank has not been requested,
RSMPB =0.
At 3
- absorbance at
t3
K1 =
V
; otherwise, K1 1.
V +S
t1
t2
t3
t4
As shown in Figure 7-6, t1 is the time when reagent 1 (volume: V1) is added. t 2 is
the time when the sample (volume: S) is added. Then, reagent 1 and the sample are
mixed. t 3 is the time when the reagent 2 (volume: V2) is added. Then, reagent 2 is
mixed into the reaction liquid. At t4 the reaction reaches equilibrium. t3 t2 is the
incubation period, and t 4 t 3 is the reaction time. So,
R = Rs RRB
7-6
Calculation Methods
Both of
Where,
At4
- absorbance at t 4
An
t1 t2
t3
t4
As shown in Figure 7-7, t1 is the time when the reagent (volume: V) is added and
t 2 is the time when the sample (volume: S) is added. t 3 is the time from which the
reaction becomes steady. t4 is the time the test on the reaction is stopped.
Absorbance is taken respectively at t 3 , t4 and the response R is:
R=
At4 At3
t4 t3
7-7
Calculation Methods
Double-wavelength
The response is:
R=
Where,
At41
At42
At31
At3 2
t1
t2 t3
tn
As shown in the figure, t1 is the time when the reagent (volume: V) is added. t 2 is
the time when the sample (volume: S) is added. t 3 is the time from which the
reaction becomes steady. tn is the time when the test on the reaction is stopped.
Double-wavelength
The calculation method is similar to that for the single-wavelength reaction. The only
difference is that the absorbance at a certain point is equal to the primary
wavelength absorbance minus the secondary wavelength absorbance.
7-8
Calculation Methods
- calibrator response
- calibration parameter
K=
R
.
C
This calibration method requires only one calibrator. For most enzyme tests, you can
input the factor directly (input value F=1/ K ) without any calibration.
R - calibrator response
C - calibrator concentration (or activity)
K , b - calibration parameters
This calibration method adopts two calibration parameters: K and
K=
R2 R1
C 2 C1
7-9
b.
Calculation Methods
b = R1 (
R2 R1
) C1
C 2 C1
This calibration method requires two calibrators. C 1 and C 2 are respectively the
concentrations of calibrator 1 and calibrator 2. R 1 and R 2 are respectively the
responses of calibrator 1 and calibrator 2.
R - calibrator response
C - calibrator concentration (or activity)
K , b - calibration parameters
This calibration method adopts two calibration parameters: K and
n
K=
b.
i =1
Ci
i =1
i =1
( Ci ) 2 / n
i =1
b = ( Ri) / n [ i =1
i =1
i =1
i =1
i =1
i =1
Ci 2 ( Ci) 2 / n
]( Ci ) / n
i =1
C i is the concentration of
1
1 + exp[(a + b ln C )]
Where,
- calibrator response
K , R 0, a , b - calibration parameter
7-10
Calculation Methods
This calibration method adopts four parameters: K ,
R 0, a and b .
This calibration method requires at least four calibrators. The concentration (or
activity) of calibrator 1 is 0, and the corresponding R is equal to R 0.
This calibration method is applied to the calibration curve that the response becomes
smaller and smaller with the concentration increase. See Figure 7-9.
C1
C2
C3
C4
Logistic-Log 5P
Calibration formula:
R = R0 + K
1
1 + exp[ (a + b ln C + cC )]
Where,
- calibrator response
K , R 0, a , b , c
- calibration parameter
b and c .
This calibration method requires at least five calibrators. The concentration (or
activity) of calibrator 1 is 0, and the corresponding R is equal to R 0.
The applications of the calibration method are the same with that of Logistic-Log 4P,
but this method has a higher fitting.
Exponential 5P
Calibration formula: R = R0 + K exp[a ln C + b(ln C ) + c(ln C ) ]
2
Where,
- calibrator response
K , R 0, a , b , c
- calibration parameter
7-11
b and c .
Calculation Methods
This calibration method requires at least five calibrators. The concentration (or
activity) of calibrator 1 is 0, and the corresponding R is equal to R 0.
This calibration method is applied to the calibration curve that the response
increases sharply when the concentration reaches a specific value. See Figure 7-10.
C1 C2
C3
C4
C5
Polynomial 5P
Calibration formula:
ln C = a + b (
R R0
R R0 2
R R0 3
) + c(
) + d(
)
100
100
100
Where,
- calibrator response
R 0, a , b , c , d
- calibration parameter
b , c and d .
This calibration method requires at least five calibrators. The concentration (or
activity) of calibrator 1 is 0, and the corresponding R is equal to R 0.
This calibration method is applied to the calibration curve that the response
increases sharply when the concentration reaches a specific value.
Parabola
Calibration formula: R = aC 2 + bC + c
Where,
- calibrator response
a, b, c
- calibration parameter
7-12
Calculation Methods
This calibration method adopts three parameters: a ,
b and c .
Spline
Calibration formula: R = R0i + a i (C C i ) + bi (C C i ) + ci (C C i )
2
Where,
- calibrator response
R0i , ai , bi , ci
C=
R
K
Where,
K - calibration parameter
Or,
C = RF
Where,
F - input factor.
7-13
Calculation Methods
C=
Rb
K
Where,
K, b - calibration parameters
C=
Rb
K
Where,
K, b - calibration parameters
a ln(
C = EXP(
K
1)
R R0
)
b
Where,
R0, K, a, b
- calibration parameters
Logistic-Log 5P
Obtain the positive real root with the dichotomy method.
Exponential 5P
Obtain the positive real root with the dichotomy method.
Polynomial5P
C = exp( a + b (
R R0
R R0
R R0
) + c(
)2 + d (
)3 )
100
100
100
Where,
R0, a, b, c, d
- calibration parameters
Parabola
7-14
Calculation Methods
Obtain the positive real root of the following linear quadratic equation:
aC 2 + bC + c R = 0 .
Spline
Obtain the positive real root with the dichotomy method.
Definition
There is 1 point falling out of the range from
the average+2SD to the average-2SD.
QC Conclusion
Warning
13S
Out-of-control (random
error, system error)
22S
Out-of-control (system
error)
R4S
Out-of-control (random
error)
41S
Out-of-control (system
error)
10X
Out-of-control (system
error)
7-15
Calculation Methods
QC conclusion flow:
QC Data
No
within control
12S
Yes
No
13 S
Yes
No
22 S
R4 S
Yes
No
No
41 S
Yes
Yes
No
10 x
Yes
out-of-control
7.2.5.2 X -R
This rule obtains the difference (R) between two tested values (X1 and X2) of a same
control, and then compares it with the input SDR. If R is larger than 2SDR or smaller
than -2SDR, the rule considers it out-of-control. The value of SDR should be obtained
in the following procedures: After pre-testing the control, test it continuously for 20
days. Test it twice before and after adding the sample everyday. Obtain the SDR of
the difference (R) between two tested values (X1 and X2).
Threshold (k)
CS-(1.0SD: 2.7SD)
1.0SD
2.7SD
CS-(1.0SD: 3.0SD)
1.0SD
3.0SD
CS-(0.5SD: 5.1SD)
0.5SD
5.1SD
When the QC value overruns the value of k (larger than the upper limit or
smaller than the lower limit), the system starts to calculate the cumulative
sum.
7-16
Calculation Methods
6
When the cumulative sum overruns the control limit h (larger than the
upper limit or smaller than the lower limit), the system considers it
out-of-control.
2nd day
3rd day
7.2.5.5 Twin-plot
+3SD
+2SD
-2SD
-3SD
-3SD -2SD
+2SD +3SD
The QC chart, which can sensitively indicate system errors and random errors, is present to
help you make a QC conclusion.
7.3
7-17
Calculation Methods
Es - the potential developed under standard conditions
RT/nF - a temperature dependent constant, termed the slope(s)
Log - base ten logarithm function
- activity coefficient of the measured ion in the solution
C - concentration of the measured ion in the solution
The calculation process of the concentration of the ion in the sample is as the following steps.
First, the module measures the potential of the calibrant A and calibrant B and calculates the
slope S of the electrode with the formula below.
S=
EA EB
C
log A
CB
where,
S the slope of the electrode
EA the potential of the calibrant A
EB the potential of the calibrant B
CA the concentration of calibrant A
CB the concentration of calibrant B
Second, the module calculates the concentration of the ion in the sample with the formula
below.
C X = C A 10
E X E A
S
Where,
Cx the concentration of the ion in the sample
Ex the potential of the sample
CA the concentration of the calibrant A
EA the potential of the calibrant A
S the slope of the electrode
7-18
Appendix A
A.1
Specifications
Technical Specifications
Throughput: maximum 300tests/h; if the ISE unit (optional) is connected,
maximum 420tests/h (Na, K and Cl included) or maximum 480tests/h (Na, K, Cl
and Li included)
Tests analyzed simultaneously: 48 (single-reagent) / 24 (double-reagent); if the
ISE unit (optional) is connected, 3 (Na, K and Cl included) or 4 (Na, K, Cl and Li
included) tests are added
Test types: Endpoint, Fixed-time and Kinetic. All supporting monochromatics and
bichromatics
Sample volume: 3l-45l; for the ISE unit (optional), 70l serum, 70l plasma,
140l diluted urine; precision: 0.5l
Sample Disk: 60 sample tube positions; 5 virtual disks for maximum 300 samples
Compatible sample containers: micro-tubes, collection tubes and test tubes of the
following
sizes:
12mm68.5mm,
12mm99mm,
12.7mm75mm,
12.7mm100mm
STAT samples: can be inserted immediately for analysis with higher priority
Sample probe: with a built-in level detector; equipped with bump collision
safeguard; capable of tracking sample level
Washing function: automatically washing interiors and exteriors of sample probe
Auto rerun
Mixing bar: for single-reagent tests, it functions immediately (within the same
period) after sample dispensing; for double-reagent tests, it functions immediately
(within the same period) dispensing of the second reagent.
A-1
Specifications
Photometric system: interference filters of various wavelengths; static fiber optics
Wavelength: 340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 630nm, 670nm,
700nm
Measurement period: 12 seconds
Measurement range: 0.1-4.0 Abs
Lamp: tungsten-halogen; 12V, 50VA
A.2
Power Requirements
Power supply: 100-130V/200-240V~, 50/60Hz, three-wire power cord and
properly grounded
Input power: 1000VA
A.3
Environmental Requirements
A.4
Temperature: 15- 30
Humidity: 35% - 80%, no condensation
Atmospheric pressure: 800 hPa - 1,060 hPa
Above-sea-level height: -1,300feet- 6,500 feet
-400m-2,000 m
A.5
Other Specifications
The analyzing unit meets the requirements of EN 61326:2003, Class A
Sound data: 70dB
Fuse: 250VAC T1.6A
250VAC T2A
250VAC T6.3A
250VAC T10A
A.6
Input/Output Devices
PC Keyboard
PC Mouse
Printer
Display
A-2
Specifications
A.7
Interface
LIS interface: HL7 interface developed by Mindray
Interface between Analyzing Unit and Operation Unit: RS-232
A.8
The bar code labels can be applied to the following sample tubes.
12mm 99mm
12.7mm75mm
12.7mm100mm
A.9
K+
1.00-8.00
Na+
100.0-200.0
Cl-
50.0-150.00
Li+
0.2-3.50
Analyte (urine)
K+
5-200
Na+
10-500
Cl-
15-400
A-3
Appendix B
Supplies
To ensure personal safety and system performance, use only supplies manufactured
or recommended by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Contact
Mindray Customer Service Department or your local distributor for details.
Part Number
Location
Remarks
Lamp
BA30-10-06365
Lamp box
Replacing part
Replace it when
1) It serves for
over 1000h; or
2) The system
prompts.
Plunger
assembly
reagent syringe
of
0040-10-32317
Reagent
syringe
Replacing part
Replace it when
1) It serves for 3
months;
2) It runs for
100,000 times; or
3) It is seriously
damaged.
0040-10-32303
0040-10-32303
BA30-30-06753
Connection
part
between the
sample
syringe and
the T-piece
Replacing part
Connection
part
between the
reagent
syringe and
the T-piece
Replacing part
Reagent
probe arm
Replacing part
Replace it when
the
sample
syringe
is
disassembled for
2 - 3 times.
Replace it when
the
reagent
syringe
is
disassembled for
2 - 3 times.
Replace it when
1) It serves for 1
year; or
2) It is damaged
or bent.
B-1
Supplies
Description
Part Number
Location
Remarks
BA30-30-14978
Sample
probe arm
Replacing part
Replace it when
1) It serves for 1
year; or
2) It is damaged
or bent.
0040-10-32307
Nut on the
sample
probe
Replacing part
Replace it when
1) The sample
probe
is
disassembled for
2 - 3 times; or
2) The sample
probe is replaced
with a new one.
0040-10-32307
Nut on the
reagent
probe
Replacing part
Replace it when
1) The reagent
probe
is
disassembled for
2 - 3 times; or
2) The reagent
probe is replaced
with a new one.
Mixing bar
BA30-20-06775
Mixing
arm
bar
Replacing part
Replace it when
it is damaged.
A4 copy paper
0150-10-00381
Printer
Consumable
Reaction cuvette
BA30-20-15179
Reaction
disk
Consumable
BA30-20-15058
Reagent
disk
Consumable
BA30-20-15059
Reagent
disk
Consumable
+
K electrode (optional)
BA34-10-63641
ISE
unit
(optional)
Consumable
BA34-10-63642
ISE
unit
(optional)
Consumable
BA34-10-63639
ISE
unit
(optional)
Consumable
BA34-10-63644
ISE
unit
(optional)
Consumable
Reference
(optional)
BA34-10-63640
ISE
unit
(optional)
Consumable
electrode
B-2
Supplies
Description
Part Number
Location
Remarks
BA34-10-63643
ISE
unit
(optional)
Consumable
Kit
BA34-10-63645
ISE
unit
(optional)
Consumable
BA34-10-63673
ISE
unit
(optional)
Consumable
BA34-10-63671
ISE
unit
(optional)
Consumable
ISE control
BA34-10-63669
ISE
unit
(optional)
Consumable
Spacer
(optional)
Cleaning
(optional)
electrode
Solution
B-3
Appendix C
Index
calibration result............. 4-31, 4-83
Circle
clinical...........................................1
Combo box...............................1-19
administrator...................3-4, 4-141
Communication......................... 1-4
Assembly
reagent disk................................ 1-9
backgrounds............................... 3-4
decimal.....................................4-42
C-1
Index
Detector
Door
middle........................................ 1-8
Equilibrium.............................. 5-46
maintenance ..................................7
Gasket...................................... 5-44
mixer ........................................1-12
C-2
Index
optical path .....................1-14, 1-15
R1 blank ...................................4-46
Position
reaction disk diagram ...............4-18
tube ............................................ 1-4
reagent blank .................. 4-15, 4-46
position for reagent 1............... 4-63
reagent bottle...1-9, 1-10, 1-11, 3-5,
3-8, 4-64, 4-66
response range........................4-137
C-3
Index
Sample
probe...................................1-4, 1-7
probe arm................................... 1-7
probe rotor ................................. 1-7
sample cup ................................. 1-4
sample disk7, 8, 1-4, 1-5, 1-10, 3-5,
3-6, 3-7, 3-8, 4-3, 4-12, 4-13,
4-15, 4-16, 4-17, 4-69, 4-89,
4-120
urine ..............................................8
serum ............................................ 8
Syringe
reagent ....................................... 1-8
C-4
Index
C-5