BS-600 Operation Manual V8.0 en
BS-600 Operation Manual V8.0 en
BS-600 Operation Manual V8.0 en
Chemistry Analyzer
Operator’s Manual
Volume I
© 2015-2023 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2023-04.
i
Publication Information
Publication version Revision date Change description
ii
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)
owns the intellectual property rights to this Mindray product and this manual. This
manual may refer to information protected by copyright or patents and does not convey
any license under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the
written permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any
other derivative work of this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.
, , , , BeneView,
WATO, BeneHeart, are the trademarks, registered or otherwise, of Mindray in China
and other countries. All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.
iii
Responsibility on the Manufacturer Party
Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be
liable for errors contained herein or for incidental or consequential damages in
connection with the furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product,
only if:
all installation operations, expansions, changes, modifications and repairs of this
product are conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national
and local requirements; and
the product is used in accordance with the instructions for use.
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 personal injury.
Note
This equipment must be operated by skilled/trained clinical professionals.
iv
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:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
EC - Representative
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, 20537 Hamburg, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
v
vi
Preface
This manual contains the instructions necessary to operate the product safely and in
accordance with its function and intended use. Please read this manual thoroughly before
using the product. This manual is based on the maximum configuration and therefore
some contents may not apply to your product. It you have any questions, please contact
us.
Observance of this manual is a prerequisite for proper performance and correct
operation, and it ensures patient and operator safety. All graphics including screens and
printouts in this manual are for illustration purpose only and must not be used for any
other purposes. The screens and printouts on the product should prevail.
Preface-1
Preface
Preface-2
Safety Information
This chapter provides you with safety symbols used in this manual and their meanings,
summarizes the safety hazards and operating precautions that should be considered
seriously when the instrument is being operated, and lists the labels and silkscreen that
has been applied to the instrument and their indications.
Safety Information-1
Safety Information
Safety Symbols
Safety symbols are used in this manual in order to remind you of the instructions
necessary to operate the product safely and in accordance with its function and intended
use. A safety symbol and text constitutes a notice as shown in the table below:
Symbol Meaning
Caution
Biological risks
Safety Information -2
Safety Information
Summary of Hazards
Introduction
Observe the following safety precautions when using the product. Ignoring any of these
safety precautions may lead to personal injury or equipment damage.
WARNING
If the product is used in a manner not specified by our company, the protection provided
by the product may be impaired.
WARNING
When the MAIN POWER is turned on, users other than the servicing personnel
authorized by our company must not open the rear cover or side cover.
Spillage of reagent or sample on the product may cause equipment failure and even
electric shock. Do not place sample and reagent on the product. In case of spillage,
switch off the power immediately, remove the spillage and contact our Customer
Service Department or your local distributor.
WARNING
Do not touch such moving parts as sample probe, reagent probes, mixers, cuvette
wash station, sample carousel, reagent carousel and reaction carousel, when the
system is in operation.
Do not put your fingers or hands into any open part when the system is in operation.
WARNING
Eye injury could occur from light emission from the photometer lamp. Do not stare
into the lamp when the system is in operation.
If you want to replace the photometer lamp, first switch off the MAIN POWER and
then wait at least 5 minutes for the lamp to cool down before touching it. Do not
touch the lamp before it cools down, or you may get burned.
Safety Information-3
Safety Information
WARNING
Light emitted by the bar code reader may cause eye injury. Do not stare into the laser
beam radiated from the bar code reader when the system is in operation.
BIOHAZARD
Inappropriately handling samples, controls and calibrators may lead to biohazardous
infection. Do not touch samples, mixtures or waste with your bare hands. Wear gloves
and lab coat and, if necessary, goggles.
In case your skin contacts the sample, control or calibrator, follow the standard
laboratory safety procedure and consult a doctor.
WARNING
Reagents and concentrated wash solution are corrosive to human skins. Exercise caution
when using reagents and concentrated wash solution. In case your skin or clothes contact
them, wash them off with soap and clean water. If reagents or wash solution spills into
your eyes, rinse them with much water and consult an oculist.
Waste Hazards
Observe the following instructions to prevent environmental pollution and personal
injury caused by waste.
BIOHAZARD
Some substances contained in reagent, control, concentrated wash solution and
waste are subject to regulations of contamination and disposal. Dispose of the waste
in accordance with your local or national rule for biohazard waste disposal and
consult the manufacturer or distributor of the reagents for details.
Wear gloves and lab coat and, if necessary, goggles.
WARNING
Materials of the analyzer are subject to contamination regulations. Dispose of the waste
analyzer in accordance with your local or national rule for waste disposal.
Safety Information -4
Safety Information
WARNING
Ethanol is flammable substance. Please exercise caution while using ethanol around the
instrument in order to prevent fire and explosion.
WARNING
When the analyzer is not in use, for example, in repair, transportation or disposal process,
please clean and sterilize the parts (sample probe, reagent probe, etc.) or surfaces
that may cause biohazdards and remind the person who handles the device of the related
hazards.
Safety Information-5
Safety Information
CAUTION
Appropriate decontamination should be carried out in accordance with laboratory safety
regulations if reagent, sample or other liquids are spilled onto the equipment. In case of
large-amount liquid ingression, please contact our customer service department or the
local distributor.
No decontamination or cleaning agents can be used which could cause a HAZARD as a
result of a reaction with parts of the equipment or with material contained in it. Strong
acid or alkaline solutions are forbidden to clean the equipment.
If there is any doubt about the compatibility of the decontamination or cleaning agents
with parts of the equipment or with material contained in it, please contact our
customer service department or the local distributor.
CAUTION
Recommended detergent: water and 75% ethanol.
Prohibited detergent: materials that may corrode metals, for example, 3% hydrogen
peroxide.
The user shall perform regular cleaning to the cover of the analyzer. Use the specified
materials to clean the equipment only. For any damage to the instrument or other
accidents caused by using materials other than specified, Mindray will not provide any
warranty.
Mindray does not claim the validity of the listed chemicals in infection control. For
effective control of infection, please consult the Infection Prevention Department of the
hospital or the epidemic professionals.
Disinfection may damage the system to some extent. It is recommended to perform
disinfection only when necessary according to your laboratory protocol.
Do not use any cleaning agents which could cause a HAZARD as a result of a reaction with
parts of the equipment or with material contained in it.
If you accidentally spill hazardous material (for example, samples and reagents) on the
instrument, clean and disinfect the instrument. Recommended detergents and
disinfectants include water and 75% ethanol. Do not use materials that may corrode
metals (for example, 3% hydrogen peroxide). Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when
handling them and the contacted areas in the laboratory.
WARNING
Data should be transmitted in a closed network or virtual isolated network environment.
The laboratory is responsible for the security of the virtual isolated network
environment.
Make sure that the network authorization information (such as user information and
password) is secure and not obtained by unauthorized persons.
Please use Microsoft firewall and kill the virus regularly.
Safety Information -6
Safety Information
NOTE
As a health care provider, you may report the occurrence of certain events to SHENZHEN
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority
of the Member state in which the user and / or patient is established.
These events, include device-related death and serious injury or illness. In addition, as
part of our Quality Assurance Program, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS
CO., LTD. requests to be notified of device failures or malfunctions. This information is
required to ensure that SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
provides only the highest quality products.
Safety Information-7
Safety Information
Precautions on Use
Introduction
To use the product safely and efficiently, pay attention to the following operating
precautions.
Intended Use
WARNING
The instrument is an automated chemistry analyzer for in vitro diagnostic use in clinical
laboratories and designed for in vitro quantitative determination of clinical chemistries
in serum, plasma, urine and cerebrospinal fluid samples. Please consult us before you
use the instrument for other purposes.
When drawing a clinical conclusion, please also refer to patients’ clinical symptoms and
other test results.
Environment Precautions
CAUTION
Please install and operate the system in an environment specified by this manual.
Installing and operating the system in other environment may lead to unreliable results
and even equipment damage.
To relocate the system, please contact our Customer Service Department or your local
distributor.
Installation Precautions
NOTE
The safety of any system incorporating the equipment is the responsibility of the
assembler of the system.
Safety Information -8
Safety Information
CAUTION
Electromagnetic noise may interfere with operations of the system. Do not install
devices generating excessive electromagnetic noise around the system. Do not use such
devices as radio transmitters in the room housing the system. Do not use other display
monitors around the system.
Do not use other medical instruments around the system that may generate
electromagnetic noise to interfere with their operations.
Do not use this device in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these may interfere with the proper
operation.
The electromagnetic environment should be evaluated prior to operation of the device.
This device has been designed and tested to CISPR 11 Class A, and in a domestic
environment may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
CAUTION
It is the manufacturer's responsibility to provide equipment electromagnetic
compatibility information to the customer or user.
It is the user's responsibility to ensure that a compatible electromagnetic environment
for the equipment can be maintained in order that it will perform as intended.
Safety Information-9
Safety Information
Operating Precautions
CAUTION
Take the clinical symptoms or other test results of the patient into considerations
when making a diagnosis based on the measuring results produced by the system.
Operate the system strictly as instructed by this manual. Inappropriate use of the
system may lead to unreliable test results or even equipment damage or personal
injury.
When using the system for the first time, first run calibrations, and then QC tests to
make sure the system is in proper state.
Be sure to run QC tests every time when you use the system, otherwise the result may
be unreliable.
Do not uncover the reagent carousel when the system is in operation. Keep the
reagent carousel cover closed.
The RS-232 port on the analyzing unit is used for connection with the operation unit
only. Do not use it for other connections. Use the cables provided by our company or
your local distributor for the connection.
The operation unit is a personal computer with the operating software installed.
Installing other software or hardware on the computer may interfere with the system
operation. Do not run other software when the system is working.
Computer virus may destroy the operating software or test data. Do not use the
computer for other purposes or connect it to the Internet. If the computer is infected
by virus, please install anti-virus software to check for and clear virus.
Do not touch the display, mouse or keyboard with wet hands or hands with chemicals.
Do not place the MAIN POWER to ON again within 10 seconds since placing it to OFF;
otherwise the system may enter the protection status. If it does so, place the MAIN
POWER to OFF and place it to ON again.
Any serious incident that has occurred in relation to the device shall be reported to
the manufacturer and the competent authority of the country in which the user
and/or the patient is established.
CAUTION
Maintain the system strictly as instructed by this manual. Inappropriate maintenance
may lead to unreliable results, equipment damage or personal injury.
To wipe off dust from the system surface, use a soft, clean and moistened cloth
soaked with soap water rather than organic solvents such as ethanol. After cleaning,
wipe the surface dry with dry cloth.
Shut down and turn off the system and disconnect the power plugs before cleaning.
Take necessary measures to prevent water ingression, otherwise equipment damage
or personal injury may be caused.
Replacement of major parts as photometer lamp, sample probe, reagent probes,
mixers, and syringe must be followed by re-calibration.
Replacement of the photometer lamp should be done when the system power has
been switched off for at least 5 minutes.
If the system fails and needs servicing, contact our Customer Service Department or
your local distributor. The system may need to be stopped or transported during
servicing, which will probably cause biohazards, electric shock hazards and moving
part hazards. Exercise caution when prepare the system for servicing.
NOTE
Check the safe state of the equipment after repair. Make sure the equipment is safe and
then offer it to the customer.
CAUTION
To define such parameters as sample volume, reagent volume and wavelength, follow
the instructions in this manual and the instructions of reagents.
CAUTION
To prevent ISE electrodes from being damaged due to water scarcity, if the system, when
equipped with an ISE module, will be powered off for a long time, perform the electrode
storage maintenance.
Safety Information-11
Safety Information
Sample Precautions
CAUTION
Use samples that are completely free of insoluble substances like fibrin or suspended
matter; otherwise the sample probe may be clogged.
Medicines, anticoagulants or preservative in the samples may lead to unreliable
results.
Hemolysis, icterus or lipemia in the samples may lead to unreliable test results;
running a sample blank, therefore, is recommended.
Store the samples properly. Improper storage may change the compositions of
samples and lead to unreliable results.
Sample volatilization may lead to unreliable results. Do not leave the sample open for
a long period.
The system has a specific requirement on the sample volume. Refer to this manual for
proper sample volume.
Load samples to correct positions on the sample carousel before the analysis begins;
otherwise reliable results may not be obtained.
CAUTION
Use proper reagents, calibrators and controls on the system.
Select appropriate reagents according to the performance characteristics of the
system. Consult the reagent suppliers, our company or our authorized distributor for
details, if you are not sure about your reagent choice.
Store and use the reagents, calibrators and controls strictly as instructed by the
suppliers; otherwise, reliable results or best performance of the system may not be
obtained. Improper storage of reagents, calibrators and controls may lead to
unreliable results and bad performance of the system even in validity period.
Perform calibration after changing the reagents, otherwise reliable results may not
be obtained.
Contamination caused by carryover among reagents may lead to unreliable test
results. Consult the reagent suppliers for details.
NOTE
The system automatically stores the data to the built-in hard disk. Data loss, however, is
still possible due to mis-deletion or physical damage of the hard disk. You are
recommended to regularly archive the data to such medium as CDs.
To avoid the data loss caused by unexpected power failure, UPS (uninterrupted power
supply) is recommended.
WARNING
For operating instructions and precautions of the computer and printer, please refer to
their operation manuals.
External equipment connected to the analogue and digital interfaces must be authorized
and complied with relevant safety and EMC standards (e.g., IEC 60950 Safety of
Information Technology Equipment Standard and CISPR 22 EMC of Information Technology
Equipment Standard (CLASS B)). Any person, who connects additional equipment to the
signal input or output ports and configures an IVD system, is responsible for ensuring that
the system works normally and complies with the safety and EMC requirements. If you
have any questions, consult the technical services department of your local
representative.
WARNING
Make sure the vacuum pump tubing is connected properly without any twists or sharp
angles so that it can work normally.
Tubing and cables connected to the vacuum pump must be protected to prevent damage
and breaks due to human or other causes.
Set the vacuum pump on a solid flat platform or ground.
WARNING
When the tube or the part that contain liquid become aged or damaged, please stop its
use immediately and contact our customer service department or your local distributor
to check and replace it.
Safety Information-13
Safety Information
For the label marked with , please consult the related documentations in order to
find out the nature of the potential HAZARDS and any actions which have to be taken to
avoid them.
Check the labels regularly for cleanliness and integrity. If any of the labels becomes vague
or peels off, contact our Customer Service Department or your local distributor
for replacement.
The general meaning assigned to geometric shapes, safety colors and contrast colors for
safety signs are as follows:
Geometric Meaning Safety color Contrast color Graphical
shape symbol color
Prohibition Red White Black
Date of Manufacture
Manufacturer
CE marking.
Symbol Meaning
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 medical device
Biological risks
Caution
“ON” (Power)
“OFF” (Power)
Serial interface
Computer Network
Alternating current
Safety Information-15
Safety Information
Warning Labels
Biohazard warning
This label indicating the risk of biohazardous infection is located in the following
positions:
Sample probe
Waste outlet
Waste tank
Laser warning
This symbol and text located near the sample bar code reader and the reagent bar code
reader reminds you of not staring into the laser beam.
Upper cover
This symbol and text located on the transparent upper cover reminds you of not wipe the
upper cover with ethanol or other organic solutions.
ISE module
This symbol and text located in the side cover of the ISE module. Please turn off the main
power before opening the side door.
Safety Information-17
Safety Information
Preface ················································································································· 1
I
Volume I - Contents
II
Volume I - Contents
III
Volume I - Contents
IV
Volume I - Contents
5 Reagents ···········································································································5-1
V
Volume I - Contents
6 Calibration ········································································································6-1
VI
Volume I - Contents
VII
Volume I - Contents
VIII
Volume I - Contents
IX
Volume I - Contents
10 Chemistries ····································································································10-1
X
Volume I - Contents
XI
Volume I - Contents
XII
Volume I - Contents
15 Diagnostics·····································································································15-1
16 Maintenance···································································································16-1
XIII
Volume I - Contents
XIV
Volume I - Contents
XV
Volume I - Contents
Vocabulary ············································································································· 1
Index ···················································································································· 1
Bibliography ··········································································································· 1
XVI
1 System Description
This chapter describes the system from the installation, hardware, software and
specifications perspectives, including:
Installation requirements and methods of the instrument
Hardware components
Optional modules that can be configured with the instrument
Introduction and operation of software screens
Technical specifications
1-1
1 System Description
CAUTION
Install the instrument in a place meeting the requirements presented in this section;
otherwise, it will not perform as intended.
Installation environment
The system is for indoor use only.
The bearing platform (or ground) should be level (with gradient less than 1/200).
The bearing platform (or ground) should be able to support at least 300Kg weight.
The installation site should be well ventilated.
The installation site should be free of dust.
The installation side should not be in direct sun.
The installation site should be kept away from a heat or draft source.
The installation site should be free of corrosive gas and flammable gas.
The bearing platform (of ground) should be free of vibration.
The installation site should be kept away from large noise and power supply
interference.
Keep the system away from brush-type motors and electrical contact device that is
frequently switched on and off.
Do not use such devices as mobile phones and radio transmitter near the system.
The system should be installed in a place with altitude height between -400 to 4000
meters. In places with an altitude height between 2000m to 4000m, an external
vacuum pump should be employed.
Power supply
Connect the system to a power supply meeting the requirements specified in this
manual. For more information, refer to 1.5 System Specifications(page1-35).
The system is provided with a three-wire power cord, which has good grounding
performance.
The system should be connected to a properly-grounded power socket.
Grounding voltage must be configured.
WARNING
Make sure the power socket is grounded correctly. Improper grounding may lead to
electric shock or equipment damage. Check if the power sockets outputs voltage
meeting the specified requirements and has a proper fuse installed.
1-2
1 System Description
CAUTION
Operating the system in an environment other than the specified may lead to
unreliable test results. If the temperature or relative humidity does not meet the
above-mentioned requirements, use air-conditioning equipment.
CAUTION
The supplied water must meet the requirements of CLSI type II; otherwise
insufficiently purified water may result in misleading test results.
Flow: no less than 42L/H for average flow, and no more than 2L/M for transient peak
flow.
If you use water supply equipment, make sure that the water supply pressure is
within 100kPa-392kPa and the length of the inlet tubing is no longer than 10m.
Make sure that the outlet is no less than 50mm wide and no greater than 100mm
high, and the length of the waste tubing does not exceed 5 meters.
BIOHAZARD
Dispose of the waste liquid according to the local regulations.
After installing the instrument, connect it with the fluidic components as instructed in the
figure below.
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
CAUTION
When connecting the tubes, exercise caution to avoid folding or pressing them.
1-3
1 System Description
High Conc.
waste
Sensor
Vacuum pump
control
(optional)
Vacuum Pump( optional(
Vacuum
pump control
(optional)
FIL01 Outlet
Low Conc. Waste
Water Supply
Module(optional)
OUT1 OUT2 IN
Water tank
V01
DI water
Water unit
FIL01
Wall
Min. 500
Maximum of 3000
Min. 500
Operation Unit
720
Analyzing Unit
Front
1190
Min. 500
1-4
1 System Description
1-5
1 System Description
WARNING
The system should be installed only by technicians of or authorized by our company.
Before installation
When you receive the package, check it carefully. If you find any signs of mishandling or
damage, file a claim immediately with our Customer Service Department or your local
distributor.
After opening the package, check the delivered goods against the packing list, and then
visually check the system appearance. If you find anything missing or damaged, alert our
Customer Service Department or your local distributor immediately.
System relocation
If you want to relocate your system, contact our Customer Service Department or your
local distributor.
1-6
1 System Description
The operation unit, a computer configured with the operating software, controls the
analyzing unit to finish tests and produce test results.
The output unit is a printer used to print out test results and other data.
Accessories and consumables are components that are required for sample processing
and should be replenished regularly.
1-7
1 System Description
(1)
(2)
(7)
(3) (6)
(4) (5)
1. Probe R1 2. Probe R2
3. Reagent carousel 4. Left front door
5. Right front door 6. Sample Carousel
7. Sample probe 8. Cuvette wash station
9. Reaction carousel 10. Protective shield
Figure 1.5 Top view
(10)
(1)
(2) (9)
(8)
(3) (7)
(6)
(4)
(5)
1-8
1 System Description
(1)
(2) (9)
(8)
(3) (7)
(1)
(2)
1-9
1 System Description
(1) (1)
(5)
(2)
(1)
(1)
(4)
(3) (1)
1-10
1 System Description
(1)
(5)
(2)
(3)
(4)
1-11
1 System Description
(5)
(4)
(1)
(2)
(3)
1-12
1 System Description
WARNING
When the system is in operation, do not place any part of your body or any obstacle in
the route where the sample probe arm moves; otherwise, personal injury or equipment
damage may be caused.
(1)
1. Sample syringe
)
Sample containers
Sample containers are used to hold samples. The sample carousel supports different types
of sample containers.
Microtube: Φ14×25mm, 0.5ml (Beckman); Φ14×25mm, 2ml (Beckman);
Φ12×37mm, 2ml (Hitachi).
Primary tube or plastic tube: Φ12×68.5mm, Φ12×99mm, Φ12.7×75mm,
Φ12.7×100mm, Φ13×75mm, Φ13×95mm, Φ13×100mm,
Sample tubes varying in specification requires different minimum sample volumes. Each
sample tube must contain the minimum amount of sample; otherwise, correct aspirating
cannot be ensured. The minimum sample volume is the sum of the minimum sample
volume for analysis and the dead volume of the sample container.
The table below shows the dead volume of each type of sample container.
Table 1.2 Specification and dead volume of sample containers
Sample Container Specification Dead Volume
Sample tube Φ14×25mm, 0.5ml 70μl
Φ14×25mm, 2ml 150μl
1-13
1 System Description
Φ12.7×75 mm
Φ12.7×100 mm
Φ13×75 mm
Φ13×95 mm
Φ13×100 mm
NOTE
The refrigeration unit has a power supply independent of that of the analyzing unit. The
refrigeration unit is operational once the MAIN POWER is turned to the ON position.
1-14
1 System Description
(3)
(2)
(1)
CAUTION
Every day before analysis, remove the plugs on the reagent carousel in order to prevent
mechanical reset failure and bending the reagent probes. Restore the plugs after
finishing tests of the day.
Ensure that the reagent carousel is closed while the system is analyzing. Opening the
reagent carousel cover during analyzing will abort the analysis and invalidate the tests
that are running.
NOTE
The refrigeration system has its power supply independent of that of the analyzing unit,
and it will be put into service once the MAIN POWER is turned on.
One virtual reagent carousel (80 positions) is allowed. You’ll be reminded to change the
reagent carousel on which all reagent aspiration is finished.
To remove the reagent carousel,
Loosen the two retaining screws on the reagent carousel.
Grab the handle and pull the reagent carousel upward to remove it from the rotor.
To install the reagent carousel,
Align the positioning pins on the reagent carousel to the counterparts on base.
Set the reagent carousel and tighten the two retaining screws on the carousel.
1-15
1 System Description
(1) (9)
(2) (8)
(3) (7)
1-16
1 System Description
WARNING
When the system is in operation, do not place any part of your body or any obstacle in
the route where the reagent probe arm moves; otherwise, personal injury or equipment
damage may be caused.
(1)
1. Reagent syringe
Reagent bottle
The reagent carousel is compatible with the following reagent bottles: Mindray outer ring
reagent bottle 40ml and 20ml; Mindray inner ring reagent bottle 20ml, 40 ml and 62 ml.
Only inner ring 20ml, 40 ml and 62 ml reagent bottles can be placed on the inner ring,
and only outer ring 40ml and 20ml reagent bottle can be placed on the outer ring. When
you place 20ml reagent bottles of BS-800 series on the outer ring, use reagent bottles
adapters.
1-17
1 System Description
Reaction carousel
The reaction carousel rotates counter-clockwise, carrying the specified cuvette to reagent
dispensing position, sample dispensing position, mixing position and then washing
position successively.
The reaction carousel is circular and can hold 124 semi-permanent plastic cuvettes.
Reaction volume: 100μl-300μl.
The reaction carousel is capable of temperature control and provides a constant
environment at 37±0.3°C with fluctuation of ±0.1°C.
Figure 1.15 Reaction carousel
(4)
(3)
(1) (2)
Reaction cuvette
The plastic cuvette is provided by the factory The light pathlength of the cuvette is 5mm±
0.03mm, and its inside dimension is 5mm (length)*4mm (depth)*29mm (height).
When finishing a test, the system washes and dries the cuvette automatically for later
use.
1-18
1 System Description
(3)
(1) (2)
1-19
1 System Description
The table below shows the main technical parameters of the photometric system.
Table 1.3 Specifications of photometric system
Name Value
Light source Tungsten-halogen lamp, 12V/20W
Colorimetric Reaction cuvette
component
Light transmission Holographic concave flat-field gratings
component
Light transmission Reversed optics
mode
Signal detector Photodiode array
Measuring wavelength 12 wavelengths: 340nm, 380nm, 412nm,
450nm, 505nm, 546nm, 570nm, 605nm,
660nm, 700nm, 740nm and 800nm
Wavelength accuracy ±2nm
Measurement range 0-3.3A
Full width at half <10nm
maximum (FWHM)
(4)
(3)
(2)
(1)
1-20
1 System Description
(4)
(3)
(2)
(1)
CAUTION
Use the accessories, power cords and consumables manufactured or recommended by
our company in order to achieve the promised system performance and safety. If needed,
contact our customer service department or your local distributor.
For more information about accessories and consumables, refer to 16.1.2 Spare Parts
(page 16-2).
1-21
1 System Description
(1)
(2)
(3)
(4)
(5)
(6)
(7)
1-22
1 System Description
(1)
(2)
WARNING
The light radiated from the sample bar code reader may hurt your eyes. Do not stare into
the laser beam coming from the sample bar code reader.
1-23
1 System Description
(1)
WARNING
The light emitted by the reagent bar code reader may cause eye injury. Do not stare into
the laser beam coming from the reagent bar code reader.
(1) (4)
) )
(2) (3)
1-24
1 System Description
Chemistry Analyzer
DI water tank
6 7
4 5
1 2 8——Air vent
Make sure that there is sufficient space between the water supply module and the wall so
that it is convenient to connect or disconnect the power cord. Sufficient deionized water
should be prepared in the water tank when using the water supply module. Make sure the
water supply module is powered on before running. The module should be powered off if
not used for a long time.
If there is something wrong with the water supply module, please consult our customer
service department or your local distributor
1-25
1 System Description
) ) )
(4)
(1)
(2)
1-26
1 System Description
(1)
(3)
(2)
(4)
(5)
1-27
1 System Description
(5)
(1)
(2) (4)
(3)
1-28
1 System Description
: used to program patient samples and control samples, and view sample
carousel status.
1-29
1 System Description
: used to recall test results of patient samples and controls and view the result
statistics and test statistics.
Function window
The function window contains options, buttons and other controls used to perform
various functions of the system.
: Start icon. Select it to display the Start Conditions window, on which you are
allowed to start new analysis or resume early testing.
: Sample Stop icon. Select it to stop sample dispensing. And then you are allowed
: Emergency stop icon. Select it to stop all tests and other actions. To restore the
system into Standby status, execute the Home command.
: STAT icon. Select it to display the STAT Sample Program window, on which you
are enabled to program emergency samples quickly.
: Online help icon. Select it to display the online help of the current window,
where you will find description of parameters and operations.
1-30
1 System Description
Select
Move the mouse to make the pointer lap over the object that you want to select or edit,
and then press the left mouse button and release it quickly.
Double-click
Move the mouse to make the pointer lap over the object that you want to select or edit,
and then quickly press the left mouse button twice and release it.
Drag
Dragging is used to move the slider on a screen in order to choose a scale. Move the
mouse to make it stop over the slider, press and hold the left mouse button, move the
mouse left and right to adjust the slider to the desired scale.
Select the icon on the upper right corner to display the help topic related to the
current screen.
1-31
1 System Description
Figure 1.28 Accessing the online help from the main screen
Select the icon in front of each maintenance instruction or item to display the
relevant operating instructions.
Figure 1.29 Accessing the online help from the Maintenance window
Select the icon in front of each diagnostic test to display the corresponding
topic.
1-32
1 System Description
Figure 1.30 Accessing the online help from the Diagnostics screen
Select the icon in front of each error log to display the corresponding topic.
Figure 1.31 Accessing the online help from the Error Log screen
1-33
1 System Description
Select the button on the upper right corner of the main screen, or press the
shortcut combination key Alt+F1.
To view details of an error log, select the icon in front of the error log.
1 Select the icon on the upper right corner of the main screen, or press the
shortcut combination key Alt+F1.
2 Select the following tabs to view relevant information:
Contents: to navigate through all topics of the online help.
Index: to view topics related to the input keywords.
Search: to view topics containing the input keywords.
Favourites: to view your favorite topics.
3 Read the help topics. Move the scroll bar on the right side of the help window to view
more information.
4 Select to close the help window.
1-34
1 System Description
1-35
1 System Description
Mixer assembly
Table 1.8 Specifications of the mixer assembly
Parameter Description
Mixer assembly Composed of mixer, probe arm and probe rotor
Mixer Two mixers available, one sample mixer and one
reagent mixer
Reaction system
Table 1.9 Specifications of the reaction system
Parameter Description
Reaction carousel 124 positions available
Reaction temperature 37℃
Reaction cuvette Plastic cuvette 5mm×4mm×29mm (length × depth ×
height), light pathlength of 5mm±0.03mm
Reaction mixture volume 100μl-300μl
Photometric system
Table 1.10 Specifications of the photometric system
Parameter Description
Light transmission mode Holographic concave flat-field gratings
Light source 12V/20W tungsten-halogen lamp
Measuring wavelength 12 wavelengths: 340nm, 380nm, 412nm, 450nm,
505nm, 546nm, 570nm, 605nm, 660nm, 700nm,
740nm and 800nm
Measuring period 6 seconds
Water consumption
≤28L/H
1-36
1 System Description
Drainage module
Table 1.12 Specifications of the drainage module
Parameter Description
Power supply 100V-240V~, 50Hz/60Hz
Voltage fluctuation ±10%
Rated input power 50VA
Flux 1LPM
Tube length and connecting 12*18 mm braided tubes
method Connecting the analyzer and IN1/IN2,<5m
OUT and the discharge outlet,<10m
Weight 12.5Kg(±1)
Size(length*width* height) 436.5mm×312.8mm×287.7mm(±5mm)
Maintenance requirement No need to perform the maintenance procedure
1-37
1 System Description
Parameter Description
Weight 29.7±1.2kg
Size 478mm×425mm×466mm
Maintenance requirement Clean the dust screen monthly according to this
manual
Absorbance Accuracy
The absorbance accuracy shall meet the requirements in Table 1.14 .
Absorbance Stability
Absorbance change should not be greater than 0.01.
Absorbance Repeatability
Expressed by coefficient of variation (CV value), which should not be greater than 1%.
Sample Carryover
Sample carryover rate of should not be greater than 0.05%
1-38
1 System Description
The carryover rate of ISE module should meet the requirements in Table 1.16 .
The stability of the ISE module should meet the requirements in Table 1.16 .
The accuracy of the ISE module should meet the requirements in Table 1.16 .
The precision of the ISE module should meet the requirements in Table 1.16 .
The linearity of the ISE module should meet the requirements in Table 1.16 .
Table 1.16 Performance Requirements Of ISE Module
Parameter Carryover Stability Accuracy Precision Linearity
(△§) (△D) (B) (CV) (D)
K+ ≤1.5% ≤2.0% ≤3.0% ≤1.5% ≤3.0%
Na+ ≤1.5% ≤2.0% ≤3.0% ≤1.0% ≤3.0%
Cl- ≤1.5% ≤2.0% ≤3.0% ≤1.5% ≤3.0%
Limitations
Table 1.17 Interferences may affect the measurement results
Interferent
Limitations ascorbic acid
hemoglobin
lipemia
bilirubin
1.5.3 Contraindication
None.
1-39
1 System Description
Storage environment
Temperature: 0°C-40°C
Relative humidity: 30%-85%, without condensation
Altitude height: 50kPa-106kPa
1-40
1 System Description
1-41
1 System Description
1-42
2 General Operating Procedure
This chapter illustrates the methods of using the instrument and the routine operating
procedure in clinical laboratories. The common steps include:
Check before powering on
Powering on
Checking system status
Loading reagents
Calibration
Quality control
Programming routine samples
Programming STAT samples
Test status and test control
Daily maintenance
Powering off
Check after powering off
2-1
2 General Operating Procedure
2-2
2 General Operating Procedure
BIOHAZARD
While checking the waste tanks and tubing, wear gloves and lab coat, if necessary,
goggles.
1 Check if the high-concentration waste tank has been emptied. If not, empty it.
High-concentration waste output: 2.2L/H (including ISE waste).
2 Check if the low-concentration waste tubing is not bent and the sewer opening is
lower than the waste outlet of the system.
2-3
2 General Operating Procedure
Maximum of 1200mm
Chemistry analyzer
High-conc waste sensor
Maximum of 100mm
High-conc waste
6 7
Water unit
4 5
3
Low-conc waste sensor DI water
Drainage module 1 2
(optional) Low-conc waste Inlet filter
IN1 IN2 OU
T
Drain outlet
2-4
2 General Operating Procedure
2.3 Powering On
2.3.1 Turning On Water Supply, Water Supply Module, Drainage Module
and External Vacuum Pump
Turn on the water supply and the water supply module. Make sure the water pressure is
within 100kPa-392kPa. If needed, use an external vacuum pump.
If a drainage module has been configured, turn on the power.
(1)
(2)
2-5
2 General Operating Procedure
5 Turn on the display monitor of the computer installed with the Data Management
Software of LIS.
6 Turn on the computer of the operation unit.
7 Turn on the computer installed with the Data Management Software of LIS.
Note
If virtual reagent carousel is used, please make sure that the loaded one is the NO.1
reagent carousel before starting the operating software each time.
1 When the operation unit (computer) is turned on, the operating software will run
automatically.
If the system detects that the hardware and software environments of the computer
do not meet the requirements, a prompt message will appear to ask for your
confirmation to convert the screen resolution. If you cancel the conversion or the
conversion fails, you are allowed to abort the startup or reboot the system.
2 Enter the username and password in the Login window, and then select OK.
NOTE
The default username and password for administrator is Admin. Please note that the
password is case sensitive. You are recommended to change the password when
logging on the system for the first time in order to prevent others from abusing the
privileges of the administrator.
If an operator forgets his password, he may ask the administrator to log on the
system and delete the username and then redefine a username; or he may contact
our customer service department or your local distributor. If the administrator
forgets his password, contact our customer service department or your local
distributor.
3 When the startup check is passed, the main screen shows. The startup procedure is
finished.
The system will display prompt message when detecting unsatisfied environment
during the startup process. Please take actions according to the instructions in the
message box.
2-6
2 General Operating Procedure
CAUTION
To ensure accurate test results, do not start measurement until the system status
turns to Standby and the system has been turned on for about 20 minutes, so that
the light source and reaction temperature gets steady.
2-7
2 General Operating Procedure
LIS status
Check the LIS status indication in the system status area of the main screen:
2-8
2 General Operating Procedure
3 New alarm messages are indicated by corresponding colors. Select the help button in
front of a new alarm message to view relevant description and solutions.
4 Take actions according to the recommended solutions.
2-9
2 General Operating Procedure
2-10
2 General Operating Procedure
Maintenance procedure
1 Check the Utility button on the left of the main screen. If it appears in yellow, it
indicates that a maintenance procedure is expired.
2 Select Utility - Maintenance - Maintenance.
3 Check if the Scheduled Maintenance tab and maintenance frequency tabs appear
in yellow. If they do, it indicates that at least one maintenance procedure is expired.
4 Select the maintenance frequency tab appearing in yellow, find the expired
maintenance procedure, and then perform the maintenance.
5 Repeat steps 3 and 4 until the maintenance frequency tabs and maintenance
procedures are displayed in normal color.
Checking subsystems
1 Select Utility - Status.
2 Choose a subsystem tab;
3 Check the subsystem status. When abnormity occurs, troubleshoot errors with the
following methods:
If the cycle count of a component reaches certain limit and an alarm occurs,
replace the component or contact out customer service department or your local
distributor for replacement of the component.
If a component’s temperature is beyond the valid range or abnormal and an
alarm occurs, exit the operating software and switch off the analyzing unit
power. After that, switch on the analyzing unit power again and run the
operating software. If the error remains, contact out customer service
department or your local distributor for replacement of the component.
If the status of the fans is abnormal, exit the operating software and switch off
the analyzing unit power. After that, switch on the analyzing unit power again
and run the operating software. If the error remains, contact out customer
service department or your local distributor for replacement of the fan.
If a Hydropneumatic component is beyond the valid range or abnormal and an
alarm occurs, exit the operating software and switch off the analyzing unit
power. After that, switch on the analyzing unit power again and run the
operating software. If the error remains, contact out customer service
department or your local distributor for replacement of the component.
If a smart module is abnormal and an alarm occurs, exit the operating software
and switch off the analyzing unit power. After that, switch on the analyzing unit
power again and run the operating software. If the error remains, contact out
customer service department or your local distributor for replacement of the
component.
2-11
2 General Operating Procedure
Cycle count
The cycle count provides an approximation of a component’s usage, which can be useful
for estimating the maintenance frequencies or anticipating component failure.
Temperatures
The actual temperature and valid range of the deionized water, reagent carousel, reaction
carousel, and wash station are displayed.
Fans
The actual status of the reagent refrigeration fans, lamp housing fan, vacuum pump
cooling fan is displayed.
Hydropneumatic subsystem
Status for the Hydropneumatic subsystem shows: working status of various tanks.
The actual air pressure and valid range for air pressure equipment
Smart modules
Smart module status monitors the working status of each smart module, which includes
probes, mixers, carousels, cuvette wash station, ISE unit, etc.
2-12
2 General Operating Procedure
WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation
may be caused.
NOTE
Before loading biochemistry reagent, ensure that there are no air bubbles inside the
reagent bottle so as to avoid inaccurate test results.
If a chemistry is set with sample pretreatment, ensure that the chemistry reagent and
the pretreat reagent are loaded to the same reagent carousel; otherwise, the chemistry
cannot be run.
Manual load
When loading reagents manually, you need to enter the reagent information, which is the
only information source of the loaded reagents. You are allowed to input reagent
information before, during or after loading reagents to the reagent carousel. If loaded
reagents are bar-coded, the reagent information cannot be edited; otherwise, all reagent
information except for position, chemistry and reagent type can be edited. Manually
loaded reagents have the letter “M” (Manual) appearing near them.
2-13
2 General Operating Procedure
(1)
2-14
2 General Operating Procedure
CAUTION
If the system is running tests, after requesting reagent stop, do not remove the
reagent carousel cover until the countdown for reagent stop is 0, the system status
is Reagent Load, and the popup message is confirmed; otherwise, probe collision or
other error may occur.
11 Load reagents according to the reagent load list. Place the reagents in position 1-78
on the reagent carousel, and then uncap the reagent bottles.
12 Restore the reagent carousel cover.
13 Select End Load F2.
2-15
2 General Operating Procedure
Auto load
Auto load is to load bar-coded reagents to the reagent carousel, which are identified by bar
code scanning.
1 Check the system status and operate accordingly.
Standby: Proceed to the next step.
Running: Select Reagent - Reagent/Calibration, or select Reagent - Reagent
Carousel Status. Select Load F1 to stop reagent aspirating and dispensing.
Meanwhile Load F1 becomes No load F1.If you want to abort load, select No
load F1. When the countdown for reagent stop becomes 0 and the system
status is Reagent Load, a message box pops up. Select OK, and then proceed to
the next step.
Incubation: Proceed to the next step.
Sleep: Select Utility - Commands - Wake Up to wake up the system, and then
start loading reagents.
2 Select a reagent carousel from the dropdown box of Reagent Carousel.
3 Remove the reagent carousel cover.
CAUTION
If the system is running tests, after requesting reagent stop, do not remove the
reagent carousel cover until the countdown for reagent stop is 0, the system status
is Reagent Load, and the popup message is confirmed; reagent probe collision or
other error may occur.
4 Place the reagents in positions 1~78 of the reagent carousel and then uncap the
reagent bottles.
5 Restore the reagent carousel cover.
6 Select End Load F2.
If reagent barcode reader has been configured, the system scans all reagent positions
and read the following reagent information from the bar code:
Chemistry name
Reagent type
Days left
Lot number
Serial number and bottle type
2-16
2 General Operating Procedure
(1) (2)
NOTE
Before loading wash solution, ensure that there are no air bubbles inside the reagent
bottle so as to avoid affecting washing effects.
1 Check the system status and operate accordingly.
Standby: Proceed to the next step.
2-17
2 General Operating Procedure
NOTE
Before loading wash solution, ensure that there are no air bubbles inside the test tube so
as to avoid affecting washing effects.
1 Check the system status and operate accordingly.
Standby, Incubation or Sleep: Proceed to the next step.
Running: Select the button on the upper-right corner of the main screen to
stop sample aspirating and dispensing. When the countdown for sample stop
becomes 0 and the system status is Sample Load, proceed to the next step.
2 Remove the sample carousel cover.
3 Place sample probe wash in position D2 of the sample carousel.
2-18
2 General Operating Procedure
Running: Select the button on the upper-right corner of the main screen to
stop sample aspirating and dispensing. When the countdown for sample stop
becomes 0 and the system status is Sample Load, proceed to the next step.
2 Remove the sample carousel cover.
3 Place physiological saline in position W of the sample carousel.
4 Restore the sample carousel cover.
CAUTION
If the system is running tests, after requesting reagent stop, do not remove the
reagent carousel cover until the countdown for reagent stop is 0, the system status
is Reagent Load, and the popup message is confirmed; otherwise, Probe collision or
other error may occur.
6 Place the physiological saline for sample blanks and sample dilution in position W
(No.80) of the outer ring of the reagent carousel.
7 Restore the reagent carousel cover.
2-19
2 General Operating Procedure
8 Enter the following information of physiological saline for sample blanks and sample
dilution:
Volume %
Bottle type
Reagent alarm limit
9 Select Load F3.
10 Select Exit F5 to close the window.
11 Select End Load F2.
NOTE
Pretreat reagent can be only loaded on one reagent carousel. Make sure that it is on
the same carousel as the chemistry reagent set with sample pretreatment;
otherwise, the chemistry cannot be run.
6 Remove the reagent carousel cover.
7 Place the pretreat reagent in the defined position of the reagent carousel.
8 Restore the reagent carousel cover.
9 Enter the following information(manual load):
Volume (%)
Serial number
Expiration date
Lot number
Reagent type(R0)
2-20
2 General Operating Procedure
2-21
2 General Operating Procedure
2.6 Calibration
Running calibration is to calculate calibration factors for sample result calculation.
Generally, calibration is required when one of the following conditions occurs:
A new chemistry is configured.
QC alarms are given while the reagent, calibrator and control sample are within the
expiration date.
Reagent lot or bottle is changed.
The calibration factors of a chemistry are expired.
The ISE electrodes are adjusted or the ISE module is maintained.
The calibration rules are changed, such as calibration method, replicates,
concentration and calibrator.
The chemistry parameters are changed, such as primary wavelength, secondary
wavelength, blank time, reaction time, reagent volume (R1/R2/R3/R4), sample
volume, sample dilution parameters, reaction type, reaction direction, sample blank
and result unit.
The lamp, syringe or sample probe is replaced.
If any of the following chemistry parameters are changed, a calibration is required:
Primary wavelength
Secondary wavelength
Blank time
Reaction time
Reagent volume(R1/R2/R3/R4)
Standard sample volume, diluting sample volume and diluent volume
Reaction type
Reaction direction
Sample blank and result unit
Twin chemistries
Pretreatment parameters
For more information about calibration setup, refer to 3.3 Calibration Setup (page 3-25).
2-22
2 General Operating Procedure
Calibration tests can be canceled only when they have not been started or are
interrupted.
2-23
2 General Operating Procedure
Auto calibration
The system provides the auto calibration option. When the conditions are satisfied, the
system displays a message indicating calibration required and then stops running the
corresponding chemistry. The conditions for auto calibration include:
Calibration factors are expired
Reagent lot is changed
Reagent bottle is changed
For more information about auto calibration, refer to 6.5 Auto Calibration (page 6-11).
BIOHAZARD
Inappropriate handling of calibrators may lead to biohazardous infection. Do not touch
the calibrators directly with your hands. Wear gloves and lab coat, if necessary, goggles.
In case your skin contacts the calibrators, follow standard laboratory safety procedure
and consult a doctor.
CAUTION
Do not use expired calibrators; otherwise, unreliable test results may be caused.
1 Select Reagent - Reagent/Calibration.
2 Select a reagent carousel from the dropdown box of Reagent Carousel.
3 Select the down-arrow button on the right side of the screen to display the
biochemical reagents.
4 Select Load List F4.
2-24
2 General Operating Procedure
The calibrator list shows all requested chemistries as well as calibrators, positions,
concentration, lot number and expiration date.
NOTE
Calibrators of a chemistry must be placed and analyzed on the same sample
carousel.
1 Select on upper right corner of the main screen. The Start Conditions window
is displayed.
Figure 2.9 Start Conditions window
2-25
2 General Operating Procedure
The options include all positions defined for the control. The default is the position on
the first defined sample carousel in ascending numerical order. For more
information about control position assignment, refer to 3.4.2 Defining/Editing a
Control (page 3-32).
2-26
2 General Operating Procedure
If the chemistries included in a panel are not set up for QC parameters, they will not
be programmed for quality control.
6 If you want to run the QC test by the reagent lot number of the chemistry:
First select Options F2.
Then select reagent lot number for the chemistry.
Select Save.
7 Select Save F8
8 To program other controls, select Prev F4 or Next F5, and then repeat steps 3 and 7.
BIOHAZARD
Inappropriate handling of control samples may lead to biohazardous infection. Do not
touch the control samples directly with your hands. Wear gloves and lab coat, if
necessary, goggles. In case your skin contacts the control samples, follow standard
laboratory safety procedure and consult a doctor.
CAUTION
Do not use expired control samples; otherwise, unreliable test results may be caused.
The sample list shows all programmed patient samples, control samples and
chemistries, including the following information:
Program date and time
Sample ID or control name
Position
Patient name (of patient samples)
Chemistry
Sample status
3 Select Print F7.
Samples and controls are printed out respectively.
1 Select on upper right corner of the main screen. The Start Conditions window
is displayed.
2-27
2 General Operating Procedure
5 Select on upper right corner of the main screen. The Start Conditions window
is displayed.
6 Select OK.
When conditions for auto quality control on sample carousel are satisfied, the system
will run controls automatically for relevant chemistries through the sample carousel.
2-28
2 General Operating Procedure
Programming a sample
1 Select Program - Sample.
Figure 2.12 Sample screen
2-29
2 General Operating Procedure
5 Enter sample barcode in Barcode field or scan the barcode with a handheld barcode
reader
6 Enter sample comment or select one in the Comment field.
2-30
2 General Operating Procedure
2-31
2 General Operating Procedure
Batch programming
For batch-programmed samples, all program information such as sample information,
chemistries and patient demographics other than position, ID and bar code are the same.
1 Select Program - Sample.
2 Enter the sample ID of the first sample.
3 Enter the start position to place the samples.
4 Select a sample type from the Sample Type pull-down list.
5 Enter sample comment or select one in the Comment field.
9 If you want to run a chemistry with different parameter, enter the values in the
chemistry option area:
Sample Vol
Replicates
Predilution
Sample blank
Pretreatment
2-32
2 General Operating Procedure
10 Select OK.
11 Select Batch F3.
Figure 2.15 Program Batch window
4 To change the priority of the sample, select or deselect the STAT checkbox.
5 Enter the relevant patient information.
6 To restore the default patient information, select Restore F3.
7 Select Save F7 to save your input.
8 To edit demographics of other patients, select Prev F4 or Next F5.
9 Select Exit F8 to close the window.
2-33
2 General Operating Procedure
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult
a doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
NOTE
Before loading sample, ensure that there are no air bubbles inside the sample cup so as
to avoid inaccurate test results.
The sample list shows all programmed samples, controls and chemistries, including
the following information:
Program date and time
Sample ID or control name
Sample bar code or control lot number
2-34
2 General Operating Procedure
Position
Patient name of patient samples
Chemistry
Sample status
3 Select Print F7.
Samples and controls are printed out respectively.
1 Select on upper right corner of the main screen. The Start Conditions window
is displayed.
Figure 2.17 Start Conditions window
2-35
2 General Operating Procedure
4 If you do not want to use the default position, then enter the sample position.
5 Select a sample type from the Sample Type pull-down list.
6 Enter barcode in barcode field or scan the barcode with a handheld barcode reader.
7 Enter sample comment or select one in the Comment field.
11 If you want to run a chemistry with different parameter, enter the values in the
chemistry option area:
Sample Vol
2-36
2 General Operating Procedure
Replicates
Predilution
Sample blank
Pretreatment
12 Select OK.
13 Select Save F8.
2-37
2 General Operating Procedure
1 Select on upper right corner of the main screen. The STAT Sample Program
window is displayed.
Figure 2.19 STAT Sample Program window
2 Enter the sample ID. The first emergent sample on each day is numbered as 9001.
3 If you do not want to use the default position, then enter the sample position.
4 Select a sample type from the Sample Type pull-down list.
5 Select a sample tube type. The options include micro and standard.
6 Confirm the default chemistries.
7 To select more chemistries, perform the following steps:
Select Chems F3.
Choose chemistries and panels to be run for emergent samples.
Select Save F7.
8 Select Demog F1 to enter patient demographics.
9 According to your actual needs, select Options F2 to set up the following
parameters:
Sample volume
2-38
2 General Operating Procedure
Sample blank
Sample tube
Off-line dilution factor
Number of replicates.
Predilution factor
10 If you want to run a chemistry with different parameter, enter the values in the
chemistry option area:
Sample Vol
Replicates
Predilution
Sample blank
pretreatment
11 Select OK.
12 Select Save F7;
13 Select Close F8 to close the window.
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult
a doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
2 Select on upper right corner of the main screen. The Start Conditions window
is displayed.
Figure 2.20 Start Conditions window
2-39
2 General Operating Procedure
All or Partial. When you select Partial, you should specify a sample position range for
analysis.
6 Select OK.
2-40
2 General Operating Procedure
2-41
2 General Operating Procedure
The screen displays the inventory and calibration status of the biochemistry reagents.
When the reagent inventory is less than the alarm limit, the system will give an
alarm and mark the chemistry name and chemistries left with different colors.
Yellow: Warning. The number of chemistries left is lower than the alarm limit, or
the reagent is expired, or the calibration status of the reagent is Cal Time
Extended, Calculated, Edited or Cal Overridden.
Red: Serious. The number of chemistries left is 0, or at least one reagent type is
not loaded, or the calibration status of the reagent is Cal Failed, Cal Timed Out, or
Cal Required. The chemistry can still be requested but will not be run. The
ongoing tests containing the chemistry will be invalidated.
2-42
2 General Operating Procedure
2 View the status of calibrators, controls and samples on the sample carousel graph.
White: The position is not being used for analysis, or occupied by other objects,
or conflicts with another sample.
Grey: The sample is being programmed or rerun.
Dark green: The sample is dispensed into a reaction cuvette.
Red: All chemistries of the sample are run, but one or more of them have no
results.
Green: All chemistries of the sample are run and have test results.
Blue: The sample is being analyzed.
: Indicate invalid sample.
The sigh appears when duplicate sample bar code occurs, or positions of
controls and calibrators are occupied by patient samples, or invalid bar code
is detected. The conflicting positions of samples rather than controls and
calibrators can be released manually.
A bar code is deemed invalid if it contains invalid characters or exceeds the
length limit, or is detected in an idle position but has no corresponding
sample information or default panel for analysis.
Select Log F2 to find the specific causes.
The detailed information of the selected sample is displayed on the right side of the
screen:
Sample position
Sample status
2-43
2 General Operating Procedure
2-44
2 General Operating Procedure
The simulated reagent carousel graph is shown in the middle of the screen. Reagent
carousel status includes vacant, sufficient reagent, insufficient reagent, expired, and
invalid reagent, marked by different colors.
To cancel reagent stop and resume the test, select or No Load F1.
Select the icon on upper right corner of the screen, and then select OK. All
unfinished actions of the system are cancelled, all pumps and valves are turned off, and
the system enters the failure status.
To restore system failure, select Utility - Commands, and then select Home. To resume
2-45
2 General Operating Procedure
To run chemistries on the other reagent carousel, click to display the Start
Conditions window. Select the other reagent carousel, load reagents to it, and then select
OK to resume the test.
2-46
2 General Operating Procedure
2-47
2 General Operating Procedure
2-48
2 General Operating Procedure
2-49
2 General Operating Procedure
2-50
3 System Setup
This chapter introduces the basic setup options of the system, which include:
System options
Chemistries
Calibration
Quality control
3-1
3 System Setup
3-2
3 System Setup
Valid period is applicable to patient samples rather than calibrators and controls. Once
the collection time is entered, the system will calculate the valid period from the time
when the sample is collected; otherwise, the time when the sample is programmed will be
used for calculating the valid period.
3-3
3 System Setup
Viewing calibration status and requesting calibration: You can view calibration status
and time of each reagent lot, and request calibration accordingly. For more
information of reagent lot calibration, refer to Reagent lot calibration (Page 2-23).
Recalling calibration results: You can recall calibration results of each reagent lot on
the Biochemistry Calibration screen.
Auto calibration: Auto calibration by reagent bottle or lot is forbidden. When a
different reagent lot is used, the system will request and run calibration
automatically. Reagent lots with valid calibration factors will not be calibrated again
when used for measurement.
3-4
3 System Setup
3-5
3 System Setup
Substrate Depletion
Select a rerun mode from the pull-down list box. When selected, it means the analyzer will
rerun the tests with the selected mode automatically if the substrate ran out during
running.
Unselection means this item will not be checked.
Nonlinear
Select a rerun mode from the pull-down list box. If the calculated linearity is greater than
the defined linearity limit, the system will rerun the tests with the selected mode.
Unselection means this item will not be checked.
No Linear Interval
Select a rerun mode from the pull-down list box. It means that the system will rerun the
tests with the selected mode when the number of measuring points within substrate limit
is less than or equal to 3. This option applies to Kinetic method only.
Unselection means this item will not be checked.
No Calculation Interval
Select a rerun mode from the pull-down list box. If the number of measuring points within
linearity range is less than 2 during high-activity enzyme measurement, the linearity
range will be expanded. If the number of measuring points is less than 2 even when the
lag time is included, the system will rerun the tests with the selected mode. This option
applies to Kinetic method only.
Unselection means this item will not be checked.
Masking/Unmasking Chemistries
The Masking/Unmasking Chemistries option is used to disable chemistries, which will
still be displayed on the Sample, Quality Control and Reagent/Calibration screens.
Masked chemistries can be requested but will not be run for sample analysis.
3-6
3 System Setup
Dictionary setup
The Dictionary option is provided for setting up and managing frequent data information,
such as: result unit, sample type, sample comment, QC comment, etc.
For more information, refer to 11.6 Dictionary Setup (page 11-11).
Select language
The operating software is displayed by default in the same language as the current
operating software. You are allowed to change the language of the operating software.
Select System Setup - Instrument F1 - 5 Language, and then choose a language from
the following options: Chinese, English, Turkish, Russian, French, Portuguese, Italian,
Spanish, and Polish. Select OK to save the settings. The language you select will take effect
only when you reboot the operating software.
Software upgrading
By running the upgrade program, you are allowed to upgrade the operating software,
control software and ISE module software. For more information, refer to 11.7 Software
Upgrade (page 11-13).
3-7
3 System Setup
Manually enter the hour, minute and second, or move the cursor to hour, minute and
second, and then click the up/down arrows to adjust the time.
6 Choose a date format from the Order pull-down list.
yyyy-mm-dd: e.g. 2014-08-27
dd-mm-yyyy: e.g. 27-08-2014
mm-dd-yyyy: e.g. 08-27-2014
7 Choose a time format from the Time Format pull-down list.
24-hour: e.g. 14:33:27
12-hour: e.g. 02:33:27
8 To restore the date and time defaults, select Restore Defaults.
9 Select OK to save your input information.
10 Select Exit to close the window.
QC run length and auto QC
By choosing the QC Evaluation, you are allowed to set up the QC run length and auto QC
conditions.
For more information, refer to 7 Quality Control (page 7-1).
3-8
3 System Setup
Reagent/Calibration Setup
Via Reagent/Calibration option on instrument setup screen, you can configure whether
to automatically refresh the reagent with 0 inventory as available for test, when reagent
has been loaded and End Load F2 button is selected. For more information, refer to 5.5.4
Auto Refreshing Reagent Inventory (Page 5-8).
3-9
3 System Setup
3-10
3 System Setup
3-11
3 System Setup
Chem
Chemistry name is the only identity of a chemistry and must not be duplicate. A chemistry
name can be composed of up to 10 characters.
No.
No. is a unique number for chemistry. It can be left blank but must not be duplicate.
Chemistry number is composed of numbers, and it ranges from 1-400 for open-reagent
chemistries.
Sample type
Sample type refers to the samples to which the chemistry is applicable. The options
include serum, plasma, urine, CSF and other. The options available in the Sample Type
pull-down list are those supported by the chemistry, and the default is the default sample
type.
The system allows definition of chemistry parameters for more than one sample type,
including the processing parameters and error detection limits. During definition of
chemistries, the parameters should be firstly defined for serum sample, and then other
sample types. Such chemistries will be calibrated with serum sample parameters by
default.
Chemistry
Chemistry is the complete form of chemistry name. It can be composed of up to 50
characters. The input is not case sensitive. The Chemistry field can be left blank or
duplicate.
A chemistry is only represented by its print name on patient reports and appears on
other reports in the form of short name.
Print Name
Print name is displayed on patient reports representing a chemistry. It can be composed
of up to 15 characters. The print name can be edited and duplicate. When this field is left
blank, the short form of the chemistry name will appear on reports. A chemistry is
represented by its short name on all reports other than patient reports.
3-12
3 System Setup
Reaction Type
Reaction type is a measurement theory based on which chemistries are run for samples
and then calculated. The system supports three reaction types, which are Endpoint,
Fixed-time and Kinetic.
Table 3.1 Reaction types
Reaction Type Description
Endpoint Qualitative analysis is performed based on the absorption
spectrum and absorbed light intensity of the reactant when the
reaction becomes equilibrious.
Fixed-time For this reaction type, the reaction velocity is directly
proportional to the substrate concentration. As the substrate is
consumed continuously, the reaction velocity is decreasing
gradually, and so is the absorbance change rate. It will take a long
time for such reaction to become equilibrium, and the reaction
can get steady only after a delay.
Kinetic Kinetic, also called continuous monitoring method, is used to
continuously measure the multiple change points of a reactant or
substrate’s concentration which varies with the enzymatic
reaction, thus calculating the initial velocity of the enzymatic
reaction and then the enzyme activity. This reaction type is
mainly used for measurement of enzyme activity.
Reaction Direction
Reaction direction refers to the change trend of absorbance during the reaction process,
and includes two options:
Positive: indicates increasing absorbance with time.
Negative: indicates decreasing absorbance with time.
Primary Wavelength
The primary wavelength is chosen based on the light absorption features of the reactant
and used to measure the absorbed light intensity.
Options for primary wavelength include: 340nm, 380nm, 412nm, 450nm, 505nm, 546nm,
570nm, 605nm, 660nm, 700nm, 740nm and 800nm
Secondary Wavelength
The secondary wavelength is used to correct the absorbance measured at the primary
wavelength and eliminate the influence of noise, such as light flash and drift, and
scratches on cuvettes, etc. The two wavelengths cannot be equal.
Options for secondary wavelength include: blank, 340nm, 380nm, 412nm, 450nm, 505nm,
546nm, 570nm, 605nm, 660nm, 700nm, 740nm and 800nm
Unit
Changing the result units of the chemistries are allowed.
Changing the result units of both closed-reagent and open-reagent chemistries are
allowed. After changing the unit, you are required to update under the guidance of a
clinical professional calibrator concentrations, control concentrations and standard
deviations (SDs), reference ranges and offsets. Those test results calculated with the old
unit will remain unchanged.
Run calibration again after changing the result unit.
3-13
3 System Setup
Decimal
Decimal specifies the number of decimal places for test results. The decimal is allowed to
be edited. Up to 3 decimal places can be set up and respectively correspond to 0, 0.1, 0.01
and 0.001.
Table 3.3 Blank time and reaction time input ranges for fixed-time and Kinetic analysis
Fixed-time and Kinetic Blank Time Reaction Time
When the blank absorbance is read before the reaction begins,
Single-reagent 2≤N<P≤3 5≤L<M≤33
Double-reagent 5≤N<P≤15 16≤L<M≤33
Triple-reagent 16≤N<P≤41 46≤L<M≤74
Quadruple-reagent 46≤N<P≤56 57≤L<M≤74
When the blank absorbance is not subtracted,
Single-reagent N=P=0 5≤L<M≤33
Double-reagent N=P=0 16≤L<M≤33
Triple-reagent N=P=0 46≤L<M≤74
Quadruple-reagent N=P=0 57≤L<M≤74
3-14
3 System Setup
The blank time and reaction time are almost the same for both fixed-time and Kinetic
analysis, except that M-L≥2 is required for Kinetic analysis, that is, the reaction time
should include at least 3 measuring points.
NOTE
If aspirated volume for dilution and diluent volume are defined, ensure the total sum of
them is within 110μl~245μl; otherwise, the settings cannot be saved.
The diluent volume for standard, increased and decreased analysis can be defined in the
same way.
Decreased sample volume indicates the sample amount required for a decrement test. It
ranges from 1.5μl to 45μl with an increment of 0.1μl. The default is blank. A maximum of
one decimal is allowed.
Increased sample volume indicates the sample amount required for an increment test. It
ranges from 1.5μl to 45μl with an increment of 0.1μl. The default is blank. A maximum of
one decimal is allowed.
NOTE
If aspirated volume for dilution and diluent volume are defined, standard, decreased and
increased analysis will be performed with diluted sampled; otherwise, it will be done
based on standard, decreased or increased sample volume.
Sample Blank
Sample blank is similar to sample analysis except for use of equivalent amount of
physiological saline. Sample blank is used for removal of non-chromogenesis reaction,
such as influence of sample interference (Hemolysis, icterus and lipemia) on absorbance
readings. Sample blank is only effective for single-reagent endpoint chemistries.
Mark the Sample Blank checkbox with a tick. The chemistry will be sample blanked
before the reaction begins, and the Sample Blank checkbox on the Options and Rerun
windows will be selected automatically and cannot be modified.
Auto Rerun
The Auto Rerun option is used to rerun the chemistries when the auto rerun conditions
are satisfied.
Mark the Auto Rerun checkbox means enabling the auto rerun option.
For more information about auto rerun, refer to 8.2.4 Rerunning Samples (page 8-4).
3-15
3 System Setup
The second, third and fourth reagents are allowed only when the reagent(s) prior to them
are configured. For example, R2 can be set up with the prerequisite of R1; R3 with R1and
R2; R4 with R1, R2 and R3. If one of R2, R3 and R4 is removed, the remaining reagents
behind it will also be removed and appear in grey.
Diluent volume refers to the amount of diluent used for reagent dilution. The combined
volume of all reagents, reagent diluent and sample must be within 100μl and 300μl. If
your input does not satisfy the requirements of reaction mixture volume, the system will
display an error message. Check the sample volume, reagent diluent and reagent volumes
you have entered, and change them if necessary.
3-16
3 System Setup
Linearity Range
The linearity range indicates the measurable range of the system, during which the test
result is linear to the response R. Determine the linearity range according to the reagent
package insert.
Linearity range(standard): no more than 12 digits. The lower limit less than or equal
to the higher limit. The default is blank.
Linearity range(increased): no more than 12 digits. The lower limit less than or equal
to the higher limit. The default is blank.
Linearity range(decreased): no more than 12 digits. The lower limit less than or
equal to the higher limit. The default is blank.
The system compares the calculated sample concentration with the linearity range. When
the high limit is exceeded, the > sign will appear near the result; when the low limit is
exceeded, the < sign will appear.
The default is blank, which means not performing this check.
Linearity Limit
Linearity limit is only applicable to Kinetic analysis, in which the absorbance change is
linear to the reaction time. If the reagent undergoes substrate depletion, or the
photometer fluctuates, or the reaction mixture is not stirred evenly, the test results may
be unreliable. Therefore, the linearity of the measuring period is calculated and then
compared with the set linearity limit.
If the reaction data within the linearity range does not satisfy the linearity limit, the
system will flag the test result with “LIN” on the patient report.
The linearity limit can be any number between 0 and 1 with a maximum of 2 decimals.
The default is blank, which means not performing this check.
3-17
3 System Setup
Substrate Depletion
The Substrate Depletion option is only applicable to Kinetic and fixed-time analysis. It can
be obtained through the following formula:
Substrate depletion limit = Input substrate depletion limit + K(L1-Lb)
Where,
L1: refers to the absorbance of primary wavelength measured at the first measuring
point when sample is dispensed and stirred in sample analysis.
Lb: refers to the absorbance of primary wavelength measured at the first measuring
point when sample is dispensed and stirred in a reagent blank test or calibration
with 0-concentration calibrator.
K: correction factor of liquid volume
Results will not be adjusted when L1-Lb≤0 or the measurement is not a reagent blank or
0-concentration calibration. Substrate depletion is not applicable for calibrations.
We deem that substrate depletion occurs if the primary wavelength absorbance of the
first measuring point is greater than the substrate depletion limit in ascending reactions
or lower than the substrate depletion limit in descending reactions. When substrate
depletion occurs, the system will flag the test result with “BOE” in the patient report.
The substrate depletion limit can be any number within -33,000-33,000. The default is
blank, which means not performing this check.
Blank Response
The Blank Response specifies the allowable range of the response in a zero-concentration
calibrator analysis or a reagent blank test. The input range can be any number within
-33,000-33,000, and the low limit lower than the high limit.
If the response is beyond the set range, the system will flag the test result with “BLK”.
The default is -33,000-33,000; the field can be left blank.
On-board Stability
It refers to the number of days that the reagent can be kept valid since uncapped at the
first time.
The input range must be within 1-999 days. The default is blank.
3-18
3 System Setup
Twin Chemistry
Twin Chemistry is associated with the current chemistry, and the two chemistries are run
with the same reagent. Results of two twin chemistries are calculated in the same test.
The chemistry whose result will be firstly calculated should be defined prior to the
associated chemistry. Volume of the shared reagent and sample volume must be the same
for the two chemistries. Only the two chemistries that have had no reagents loaded can be
configured as twins.
For more information about twin chemistries, refer to “10.1 Twin Chemistries” (Page
10-2).
Prozone Check
The Prozone check can be performed in two ways: rate check and antigen addition.
Rate check:
You are required to set up the following six parameters for the rate check method, which
are Q1, Q2, Q3, Q4, PC and ABS. The unit is the same as the reaction time and blank time.
Enter the six parameters as follows:
Single-reagent chemistries: 5≤q1<q2<q3<q4≤33, “5” is the first measuring point
after the sample is dispensed and stirred.
Double-reagent chemistries: 16≤q1<q2<q3<q4≤33, “16” is the first measuring point
after R2 is dispensed and stirred.
Triple-reagent chemistries: 46≤q1<q2<q3<q4≤74, “46” is the first measuring point
after R3 is dispensed and stirred.
Quadruple-reagent chemistries: 57≤q1<q2<q3<q4≤74, “57” is the first measuring
point after R4 is dispensed and stirred.
PC: a number between -99999999 and 99999999, with four decimals.
ABS: any integer between -99999999 and 99999999.
Antigen addition:
For the antigen addition method, you need to enter the parameters, which are PCM, Q1,
Q2,Q3 and Q4.
When Q3=Q4=0, abslowlimit can not be entered.
74≥q2≥46, 44≥q1≥reaction end point.
If one parameter among PCM,Q1 and Q2 is not entered, the antigen addition method
is not applied.
3-19
3 System Setup
Sample Pretreatment
Enable the sample pretreatment function to pretreat patient samples with pretreatment
reagent for the chemistry. Sample pretreatment includes common pretreatment and blood
cell pretreatment.
Only when the Pretreatment checkbox is selected, common pretreatment, blood cell
pretreatment, pretreatment of calibrator and control can be enabled, and the pretreat
sample volume and pretreatment reagent volume can be set.
Pretreatment chemistries cannot be set with predilution factor. Setting pretreatment
parameters for the twin of a former chemistry is not allowed.
Common Pretreatment
Select this option to pretreat the samples other than whole blood samples. Probe aspirates
the sample from the top of the sample tube and then the sample is pretreated with
pretreatment reagent.
Blood Cell Pretreatment
Select this option to pretreat the whole blood samples. Probe aspirates the sample from
the bottom of the sample tube and then the sample is pretreatment with pretreatment
reagent.
Calibrator Pretreatment
When this option is enabled, the calibrators of the chemistry will be pretreated with the
pretreatment reagent during calibration test according to the set pretreat sample volume
and pretreatment reagent volume.
Control Pretreatment
When this option is enabled, the controls of the chemistry will be pretreated with the
pretreatment reagent during QC test according to the set pretreat sample volume and
pretreatment reagent volume.
Pretreat sample volume
Enter the pretreat sample volume within 1.5 μL - 45 μL, with an increment of 0.1 μL. The
default is 4 μL.
Pretreatment reagent volume
Enter the pretreatment reagent volume within 75 μL - 200 μL, with an increment of 0.5
μL. The default is 200 μL.
The sum of pretreat sample volume and pretreatment reagent volume must be within 110
μL - 245 μL.
3-20
3 System Setup
Refer to these steps to flag the qualitative result of ISE chemistries and calculations.
3-21
3 System Setup
3 Choose a chemistry.
4 Double click the Slope field and then input the slope.
Positive, negative and decimal numbers can be entered. The maximum input length
is 8 digits.
5 Double click the Offset field and then input the offset.
Positive, negative and decimal numbers can be entered. The maximum input length
is 12 digits.
6 Repeat step 3 to 5 to set up the slope and offset for other chemistries.
7 Select Save to save your input information.
8 To restore the factory settings of slope and offset, select Restore Defaults.
9 Select Close the exit the window.
3-22
3 System Setup
10 Select Save F7. The reference/critical range are displayed in the middle list.
Select Discard F6 to abort the input information, or
Select Set Defaults F1 to set the reference/critical range as the default for the
chemistry.
11 Select Prev F4 or Next F5 to set up reference/critical range for more chemistries.
3-23
3 System Setup
The selected reference/critical range is set as the default of the chemistry. The
system will check the test result, and if necessary, flag and rerun the chemistry. For
details of reference range flags, refer to Result display settings (page 3-4).
NOTE
The reference/critical range cannot be recovered once deleted. Think twice before
the deletion.
8 Select OK.
9 Select Exit F8 to close the window.
3-24
3 System Setup
You are allowed to assign one position of each sample carousel for the calibrator. The
fourth ring (center) of the sample carousel is used to carry calibrators and controls.
You may also place the calibrator on other idle positions of the sample carousel.
3-25
3 System Setup
Only .cif file can be imported; each .cif file stores information for one calibrator and
each time only one calibrator can be imported. When the system reads the calibrator
information, the following window is displayed:
Figure 3.11 Calibrator Definition window
3-26
3 System Setup
6 Select OK.
7 Assign positions for the calibrator.
8 Select Save to save your input information
9 Select Close to exit the window.
3-27
3 System Setup
3 Choose chemistries to which the calibrator is applicable, and then select the
corresponding Conc column and type in the calibrator concentration for it.
The concentration must be above 0.
A message box pops up indicating that parameters are changed and calibration is
required.
3-28
3 System Setup
3-29
3 System Setup
3-30
3 System Setup
3-31
3 System Setup
3.4 QC Setup
3.4.1 Introduction
Perform QC settings in the following order:
Define a control
Select chemistries
Set up control concentrations
Set up QC rules
3-32
3 System Setup
When the expiration date is exceeded, the control can still be programmed and
analyzed, while the system flags the test result in the Flag column to remind you of
replacing the expired control.
You are allowed to assign one position of each sample carousel for the control. The
fourth ring (center) of the sample carousel is used to carry calibrators and controls.
You may also place the control on other idle positions of the sample carousel.
9 Select OK to save your input information.
10 To define more controls, select New and repeat step 3 to 9.
11 Select Exit to exit the window.
4 Choose chemistries for the control. Use the left and right arrow buttons to display
more chemistries.
5 To choose all chemistries in the list, select Select All.
6 To deselect the chemistries, select Clear.
7 Select OK.
3-33
3 System Setup
To run quality control for special calibrations, you must define the mean value and SD;
otherwise, no control results will be calculated. If the sub chemistries of a special
calculation have no mean value and SD, QC evaluation will not be done and QC plot cannot
be recalled.
1 Select QC - QC Setup.
Figure 3.17 Setup screen
3 Select the Mean column of a chemistry and type in the average concentration for it.
The options include all units set for the chemistry. This field is uneditable for
open-reagent chemistry.
3-34
3 System Setup
3-35
3 System Setup
3-36
4 Operation Theories
This chapter gives brief introduction of the operation theories of the instrument, which
include:
Principles of measurement
Calibration math model and calculation of factors
Prozone check
4-1
4 Operation Theories
4.1 Overview
The system is a fully automated computer-controlled clinical chemistry analyzer allowing
the random selection of chemistries. It is capable of running a variety of chemistries based
on the operation theories and measurement principles.
The system performs measurement and generates the test results in the following
procedure:
Figure 4.1 Measurement workflow
AD value
Absorbance
Response
Calibration factors
QC conclusion
The system measures the light intensity through photoelectric conversion, linear
amplification and AD conversion, and then calculates the reaction mixture’s absorbance
and the absorbance change rate, that is, the response, based on which the calibration
factors are obtained. The system performance is evaluated according to the test results of
the control samples. If the system is working normally, you may start the analysis of
patient samples and the system will calculate the sample results with the calibration
factors.
4-2
4 Operation Theories
4-3
4 Operation Theories
4-4
4 Operation Theories
VR1 VS VR 2 VR 3
k4
VR1 VS VR 2 VR 3 VR 4
Where, VR1, VR2, VR3 and VR4 are the volumes of R1, R2, R3 and R4; Vs is the actual volume
of sample dispensed for reaction.
4-5
4 Operation Theories
[ S ]
[ S 0] kt1 kt 2
e e
That is, the change in substrate concentration is directly proportional to its initial
concentration within a fixed time interval. This is the common feature of rate
measurements. Within this interval, the absorbance change is directly proportional to the
analytes concentration. The fixed-time reaction is also called, rate reaction, first-order
Kinetic reaction and two-point Kinetic reaction.
It is available in single-interval and double-interval according to the input mode of
measuring points. In the double-interval reaction, the sample blank, which is the
absorbance change at two points within the incubation time, is subtracted from the
reaction absorbance.
The fixed-time measurements allow the check of substrate depletion at the two measuring
points. When detecting substrate depletion, the system will flag the test result with “BOE”
and give an alarm.
4-6
4 Operation Theories
4-7
4 Operation Theories
Determination of linearity
range
4-8
4 Operation Theories
Enter L and M
Enter substrate
depletion limit?
No
Yes
Yes
Substrate depleted Alarm of "NLN"
at L+2
No
No
The number (N) of measuring points within the substrate depletion limit is monitored for
different operations:
If N≥3, the linearity range includes all measuring points from the reaction start point
to the substrate depletion limit;
If N=2, the system will give the flag “NLN” while using two measuring points for
calculating the response.
If N=0 or 1, when Enzyme Linear Extension option is selected on the chemistry
parameter screen, enzyme linear extension will be enabled and the system gives the
flag “NLN”; when Enzyme Linear Extension option is not selected on the chemistry
parameter screen, enzyme linear extension will not be enabled and the system gives
the flag “NLN” too.
(T T ) ( A A)
i i
A LM' 60 * i L M'
(T T )
iL
i
2
Where,
L: start point of the linearity range
M’: end point of the linearity range
Ai: absorbance measured at measuring point i
A : average absorbance within L-M’
4-9
4 Operation Theories
Calculation of Response
The response in Kinetic measurements is calculated as follows:
R A LM' K A NP
k is the calculation factor and varies with the chemistry parameters.
Table 4.3 Calculation of response for Kinetic measurements
Kinetic Blank Time Reaction Time K
When the blank absorbance is read before the reaction begins,
Single-reagent 2≤N<P≤3 5≤L<M≤33 K1
Double-reagent 5≤N<P≤15 16≤L<M≤33 K2
Triple-reagent 16≤N<P≤41 46≤L<M≤74 K3
Quadruple-reagent 46≤N<P≤56 57≤L<M≤74 K4
When the blank absorbance is not subtracted,
Single-reagent N=P=0 5≤L<M≤33 0
Double-reagent N=P=0 16≤L<M≤33 0
Triple-reagent N=P=0 46≤L<M≤74 0
Quadruple-reagent N=P=0 57≤L<M≤74 0
Note: M-L≥2 indicates that at least 3 measuring points should be included within the
reaction time.
Where, A f , Ab and Au ,v are the absorbance change rates in the front part, back
part and at all measuring points of the reaction. These three values are calculated based
on the number of measuring points within the linearity range.
When N>8, A f is the absorbance change rate of the first 6 measuring points,
Ab of the last 6 measuring points, and Au ,v of all measuring points.
When 4 N 8 , A f is the absorbance change rate of the first 3 measuring
points, Ab of the last 3 measuring points, and Au ,v of all measuring points.
4-10
4 Operation Theories
When N 3, the system will not check the test results for linearity.
A A b A u ,v
When f
60 or 60 (unit: A/10000/minute), the system will
not check the test results for linearity.
The system will compare the calculated linearity with that defined for the chemistry, and
will flag the test result with “LIN” and given an alarm if the configured linearity is
exceeded.
Lag time
Reaction Time
Absorbance
Substrate depleted
In high-activity enzyme measurements, the substrate may be depleted quickly and the
reaction curve will appear obviously nonlinear (as a smooth curve). If the measurement
is performed based on the general procedure, the system will flag the test result with
“NLN” (no linearity interval), reminding the user to rerun the test after diluting the
sample. This will more or less bring troubles to the user.
Extending enzyme linearity range:
Suppose the reaction start time is t1 and the reaction time is tL-tM, then t1-tL is the lag
time.
If the number (N) of valid measuring points within tL-tM is less than 2 and too few to
calculate the response, the sample response can be obtained by extending the enzyme
linearity range.
Calculation of ⊿Amax:
The linearity range t1-tL’ without substrate depletion is found within the lag time t1-tL.
If the number (N) of valid measuring points within tL-tM is less than 2, the system will
not calculate the response but flag the test result with “ENC” (no calculation interval) and
give an alarm;
or the system calculates the reaction rate ⊿A=60*(Ai+1-Ai)/(ti+1-ti), i=1, 2…L’ with the
lag time t1-tL’. The maximum ⊿A is taken as the response of the sample. Therefore, the
enzyme linearity range is extended via the lag time. The results calculated by extending
the enzyme linearity range will be flagged with “EXP” and “NLN”.
4-11
4 Operation Theories
C 2 C1 C1
The formula contains two factors, K and R0, where K , and R0 R1 .
R2 R1 K
The calibration math model requires two calibrators. C1 and C2 are the concentrations of
calibrator 1 and 2; R1 and R2 are the responses of calibrator 1 and 2.
CiRi ( Ci )( Ri ) / n
K i 1
n
i 1
n
i 1
Ri
i 1
2
( Ri ) 2 / n
i 1
n
( Ci ) / n
R0 ( Ri ) / n i 1
i 1 K
4-12
4 Operation Theories
Logit–Log 5P
1
R R0 K
Calculation formula: 1 exp[ (a b ln C cC )]
The formula contains five factors, which are R0, K, a, b and c. The calibration math model
requires at least five calibrators, and calculates the five factors with the L-M method.
This math model has the same application with the Logit-Log 4P except for a higher
fitting.
Exponential 5P
R R0 K exp[ a ln C b(ln C ) 2 c(ln C ) 3 ]
Calculation formula:
The formula contains five factors, which are R0, K, a, b and c. The calibration math model
requires at least five calibrators, and calculates the five factors with the L-M method.
This calibration type is applied to the chemistries which have a calibration curve with the
response directly proportional to the concentration.
Polynomial 5P
R R0 R R0 2 R R0 3
ln C a b( ) c( ) d( )
Calculation formula: 100 100 100
The formula contains five factors, which are R0, a, b, c and d. The calibration math model
requires at least five calibrators. The response (R) of the first calibrator (with internal
converting concentration of 0) is R0, which is given.
R R0
x
Suppose, y ln C and 100 .
Then, y a bx cx dx
2 3
can be calculated with the least square method for
polynomial expressions.
Parabola
R aC 2 bC R0
Calculation formula:
The formula contains three factors, which are a, b and R 0. The calibration math model
requires at least three calibrators. The three factors can be calculated with the least
square method.
4-13
4 Operation Theories
Spline
R R0i ai (C C i ) bi (C Ci ) 2 ci (C Ci ) 3
Calculation formula:
The calibration math model requires 2-9 calibrators. Suppose the number of calibrators
R a b c
is n, then the calculation formula contains 4(n-1) factors, which are 0 i , i , i , and i .
Due to the subsection fitting, this math model has be best fit curves than other math
models.
4-14
4 Operation Theories
Concentration C
In the reaction of antigen and antibody, the amount of generated insoluble compound is
closely related to the proportion of antigen and antibody. The maximum amount of
compound will be generated at a proper proportion of antigen and antibody, at this point
least light is passed and the greatest absorbance is obtained. For other proportions, the
amount of insoluble compound will decrease with more light passed and lower
absorbance calculated. Therefore, samples with quite different concentrations may
generate the equivalent amount of insoluble antigen/antibody compound, and can have
the same test results without a Prozone check. The Prozone check, therefore, is
necessary for antigen-antibody reactions.
The Prozone limit is the allowable maximum or minimum PC when antigen excess does
not happen.
The Prozone check factors include:
PCM (Prozone check limit), q1, q2, q3 and q4.
Absorbance low limit: ABS
The Prozone check can be performed in two ways: rate check and antigen addition, which
are described in detail in the following sections.
4-15
4 Operation Theories
4-16
5 Reagents
This chapter provides you with functions and operating instructions associated with
reagent.
5-1
5 Reagents
5.1 Overview
5.1.1 Introduction
This chapter introduces the advanced application of the reagent module. Perform the
following operations according to the practical conditions in your laboratory:
Customizing reagent display
Sorting reagents
Setting up reagent inventory alarm limits
Checking reagent inventory
Loading bar-coded reagents
On-line load of reagents
Off-line load of reagents
On-line replacement of reagents
Off-line replacement of reagents
Unloading reagents
The ISE reagent/calibration screen is divided into three areas. The upper list shows the
ISE chemistries, calibration status, calibration date and calibration time left; the lower list
shows the volume, load date, expiration date, lot number and serial number of all wash
solutions and physiological saline; the function buttons at the bottom are used to access
relevant functions.
5-2
5 Reagents
Select the down-arrow button on the right side of the screen to display the biochemical
reagents.
Figure 5.2 Biochemistry reagent/calibration screen
The screen shows all configured biochemistry reagents, including the following
information:
Position: position of the reagent on the reagent carousel.
Chemistry: name of the chemistry.
Chemistries left: It refers to the minimum tests left of R0, R1, R2, R3 and R4. When
the number of chemistries left is 0, the chemistry is still allowed for programming
and measurement.
Reagent type: reagent type of a multi-reagent chemistry. It includes R0, R1, R2, R3
and R4.
Tests left: It refers to the remaining tests of each reagent bottle.
Days left: the difference of reagent expiration date and current date and the on-board
stability time, whichever the less. When a negative value is displayed, it indicates that
the reagent is expired and should be replaced immediately.
Lot number: lot number of the reagent. It can be input manually during reagent load.
Calibration status: calibration status of the chemistry, including, Cal Required,
Requested, Calibrated, Cal Failed, Cal Time Out, Cal Time Extended, Calculated, Edited,
Cal Overridden and N/A.
Time left: the time left when the calibration factors are expired. It will be displayed
only when the calibration status is Calibrated, Cal Time Out or Cal Time Extended.
When the time left is less than 30 minutes, the system displays a message indicating
calibration time out; when the calibration time is exceeded, the calibration factors
can no longer be used, and you are allowed to recalibrate the chemistry or extend the
calibration time.
5-3
5 Reagents
5-4
5 Reagents
5-5
5 Reagents
5-6
5 Reagents
5-7
5 Reagents
4 Select or deselect the option Auto Refresh Reagent Inventory, which is unselected
by default.
5 Click Save.
6 Click Exit to close the window.
5-8
5 Reagents
WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation
may be caused.
5-9
5 Reagents
WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation
may be caused.
CAUTION
Do not open the reagent carousel cover before the countdown is finished; otherwise,
probe collision or other error may occur.
4 To load non-bar-coded reagents, select OK and then Load F1, and remove the
reagent carousel cover; to load bar-coded reagents, just remove the reagent carousel
cover.
5 Place the reagents in correct positions:
Place the reagents in positions 1-78 of the reagent carousel.
The system will resume the tests or select the icon to start new test.
5-10
5 Reagents
WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation
may be caused.
5-11
5 Reagents
The system status area shows a countdown for reagent stop, and a message box will
be displayed when the countdown is finished.
CAUTION
Do not open the reagent carousel cover before the countdown is finished; otherwise,
probe collision or other error may occur.
5 To load non-bar-coded reagents, select OK and then Load F1, and remove the
reagent carousel cover; to load bar-coded reagents, just remove the reagent carousel
cover.
6 Remove the reagent.
7 Place the new reagent.
8 Restore the reagent carousel cover.
5-12
5 Reagents
The system will resume the tests or select the icon to start new test.
5-13
5 Reagents
5-14
5 Reagents
5-15
5 Reagents
5-16
6 Calibration
This chapter describes functions and operation instructions associated with calibration,
which include:
Calibration status and alarm indication
Calibrator dilution setup
Reagent blank
Auto calibration
Extending calibration time
Overriding a calibration
Rejecting a calibration
Calibration results recall
6-1
6 Calibration
6.1 Overview
In a calibration, the system measures the response of the calibrator with given
concentration, and then calculates the factors in the concentration-response equation. In
this way, a math equation about concentration and response is determined. The
concentration of a patient sample can be calculated based on the math equation and the
measured sample response.
When the calibration status is abnormal, the system will give an alarm and display the
calibration status with specific color. The system allows multiple concentrations of a
calibrator for multi-point calibration. The calibration factors can be adjusted through a
reagent blank test. When you set up the auto calibration conditions, the system will
automatically remind you of calibrating chemistries. Expired calibration factors can be
used again by extending the calibration time. You are allowed to override a failed
calibration and obtain results based on the failed calibration factors. Current calibration
factors can be rejected and the latest valid ones are used to calculate sample results.
6-2
6 Calibration
6-3
6 Calibration
5 Select a unit from the Unit dropdown box for the calibrator.
The options include all units set for the chemistry. This field is uneditable for
open-reagent chemistry.
6 Enter the final concentration of the diluted calibrator in the Conc field.
7 Enter the calibrator volume dispensed by the sample probe during calibration in the
Aspirated Vol field.
The input must be an integer multiple of 0.1 within 1.5μl-45μl. This field is required.
6-4
6 Calibration
8 Enter the calibrator volume used for diluting in the Neat Vol field.
The input must be an integer multiple of 0.1 within 1.5μl-45μl. This field can be left
blank.
9 Enter the diluent volume used for diluting in the Diluent Vol field.
The input must be an integer multiple of 0.5 within 75μl-200μl. This field can be left
blank.
NOTE
If the neat sample volume and diluent volume are defined, ensure that the sum of
the two volumes is within 110μl-245μl.
The two volumes must be defined or left blank simultaneously.
10 Select Save.
11 To define more concentrations for the calibrator, repeat step 5 to 9.
12 To set up dilution factors for other calibrators, repeat step 5 to 10.
13 Select Close to exit the window.
7 Change the concentration, sample volume, neat sample volume and diluent volume.
NOTE
If the neat sample volume and diluent volume are defined, ensure that the sum of
the two volumes is within 110μl-245μl.
The two volumes must be defined or left blank simultaneously.
8 Select Save.
9 Select Close to exit the window.
6-5
6 Calibration
Both the low and high limits must be an integer within -33,000-33,000. The default
is -33,000-33, 000, and it can be left blank.
Both the low and high limits must be an integer within -33,000-33,000.The default is
-33,000-33, 000, and can be left blank.
6-6
6 Calibration
6-7
6 Calibration
The response value current displayed is the updated reagent blank response.
6 Select the reaction data table to view the reagent blank reaction data.
Figure 6.3 Reagent blank reaction data
6-8
6 Calibration
The calibration results and reagent blank results of the chemistry are displayed in the
result list.
6-9
6 Calibration
6-10
6 Calibration
6-11
6 Calibration
Calibration time: The system will remind you in 30 minutes before the
calibration is timed out and display the chemistry’s calibration status with
yellow.
NOTE
If the Manage Reagents by Lot option on the System Setup screen is enabled,
Bottle Changed and Lot Changed will not appear. When a different reagent lot is
used, the system will request and run calibration automatically.
5 Select Save F7.
6 Select Prev F4 or Next F5 to set up the calibration rules for other chemistries.
7 Select Close F8 to close the window.
6-12
6 Calibration
7 Select OK. The calibration factors of the selected chemistry can be used without time
limit.
6-13
6 Calibration
CAUTION
Before overriding a calibration, make sure that the calibration factors are within the
acceptance limits of your laboratory. The magnitude of the error should be totally under
the control of your laboratory. Use of overridden calibration factors may lead to
unreliable results and influence the doctor’s diagnosis. Think twice before overriding a
failed calibration.
5 Select OK. The failed calibration factors of the selected chemistry can be used for
result calculation.
6-14
6 Calibration
6.8 Reject
6.8.1 Introduction
If the current calibration fails but sample analysis needs to be performed immediately,
you may use the Reject function to reject the current calibration factors, and use the
latest valid ones for calculating sample results, which will be flagged with "CALJ"..
Calibration factors of status other than Requested and Cal Required can be rejected.
Rejected calibration factors cannot be rejected again.
6-15
6 Calibration
The screen shows all the calibrations requested on the day, including the following
information:
Chemistry name
Lot number
Result flag
Calibration status
Run date and time
R0: reagent blank response
K: K factor
A, B, C and D: factors a, b, c and d in nonlinear calibration equations
Unit
2 Choose a chemistry from the Chem pull-down list.
3 Select Search F1.
The current calibration factors of the chemistry are displayed in the result list.
The calibration factors used within the specified period are displayed on the screen.
6-16
6 Calibration
Print F7
6-17
6 Calibration
7 Choose calibrators to recalculate in the left list. Move the scroll bar to view more
calibrators.
Choose the correct number of calibrators corresponding to the math model. For
more information, refer to 3.3.6 Setting up Calibration Rules (page 3-28).
The system will recalculate the calibration factors with the selected math model and
calibrators.
If the recalculation is succeeded, the new calibration factors will be displayed on
the Biochemistry Calibration screen with the calibration status shown as
Recalculated, and “CALR” will appear in the corresponding Flag column.
If the recalculation fails, the system will show a message box indicating the old
calibration factors will remain to be used.
9 To view the reaction curve of the selected calibrator, select Reac Curve F1.
10 Select Close F8 to close the window.
6-18
6 Calibration
4 Select a point on the curve. Relevant measuring period and absorbance are displayed
on the right of the window.
5 Select a filter condition from the following options:
None: observe reaction curve and data in the default mode.
Chemistry: observe reaction curve of the results for the selected test.
Calibrator: observe reaction curve of the results for the selected calibrator.
6 Choose the Reaction Data tab to view the reaction data.
Figure 6.13 Reaction Data tab page
6-19
6 Calibration
Reagent F1: to view the calibrators and reagents used in calibration, and
reagents for reagent blank test.
Sample Blank F2: to view the sample blank reaction curve and reaction data of
the calibrator.
Adjust F3: to adjust the absorbance display range of current reaction curve.
Refer to 8.12.8 Reaction Curve (Page 8-39) for details.
Prev F4: to view reaction curve and data of the previous calibration test.
Next F5: to view reaction curve and data of the next calibration test.
Print F7: to print the current reaction curve or data.
8 Select Close F8 to close the window.
The window shows the calibrators and reagents used in calibration, and reagents for
reagent blank test.
6-20
6 Calibration
The system will refresh the calibration results and curves with the input slope and
offset, and take the edited calibration factors as the defaults.
6-21
6 Calibration
6-22
6 Calibration
6-23
6 Calibration
6-24
7 Quality Control
7-1
7 Quality Control
7.1 Overview
7.1.1 Introduction
QC test is performed on samples provided with known concentration range of various
analytes by authority divisions or reagent suppliers. By comparing with the given range,
the test results obtained on this instrument can be used to judge if the instrument is in
normal status and the sample results are reliable.
To ensure the system performance, run control samples every time after you perform a
calibration, or change the reagent lot, or maintain and troubleshoot the instrument.
Program Running
Load control Recall QC Print real-time
control control
Daily operations samples results QC results
samples samples
7.1.3 QC Alarms
The system provides the real-time monitoring of quality controls, and check if the QC
results are under control when a QC run is finished. If the results exceed the reference
range, the system will give an audible alarm and shows an alarm message indicating the
chemistry name, control name and control rules. For instance, “Chemistry ALT control C1
1-3s out of control!”. In this situation, you should stop the analysis and find the causes of
the failure, and resume the analysis after solving the problem.
For QC alarms and corrective actions, refer to 17.5 Error Messages and Corrective Actions
(page 17-28).
7-2
7 Quality Control
The system checks the failed QC results for system error or random error and then flag
them accordingly. A “#” sign indicates a systematic error, and an asterisk “*” indicates a
random error. For more information about QC result flags, refer to 17.4 Data Alarm(page
17-11).
7-3
7 Quality Control
7.2 QC Evaluation
7.2.1 Introduction
The system provides the Westgard rules for evaluating QC results of the chemistries, and
give alarms and flags when the obtained QC results are beyond the reference range. Since
every chemistry may have one or more control samples, the QC results can be evaluated
with different rules accordingly. Those controls that are not included in any lots will be
evaluated as single controls.
(1) An asterisk “*” indicates a random error, which requires no special action but must
not be ignored.
(2) A “#” symbol indicates a systematic error, which requires special consideration.
7-4
7 Quality Control
Control data
No
>2S In-control
Yes No
Yes
12S Warning
No
No No No
13S 22S 41S 10X
Yes Yes Yes Yes
Out of control
5 Select OK.
7-5
7 Quality Control
(1) An asterisk “*” indicates a random error, which requires no special action but must
not be ignored.
(2) A “#” symbol indicates a systematic error, which requires special consideration.
The random errors in two-control evaluation correspond to those in single-control
evaluation as follows:
22SA\22SW corresponding to 22s.
41SA\41SW corresponding to 41s.
10XA\10XW corresponding to 10x.
The procedure of two-control evaluation is shown in the figure below:
Figure 7.3 Two-control evaluation workflow
Measured values of X
and Y controls
No
12S In control
Yes
No
No No No No No No No
13S 22SA R4S 22SW 41SA 41SW 10XA 10XW
Yes Yes Yes Yes Yes Yes Yes Yes
7-6
7 Quality Control
7-7
7 Quality Control
When Calibrated: select the checkbox to allow the system to run controls when
a chemistry is calibrated.
6 Choose controls to be run automatically.
One or more controls can be selected.
7 Select OK.
2 Select on upper right corner of the main screen. The Start Conditions window
is displayed.
3 Select OK. The system will insert a QC run in the current test queue.
7-8
7 Quality Control
7-9
7 Quality Control
7-10
7 Quality Control
7-11
7 Quality Control
Adding/Modifying comments
1 Select QC - Levey-Jennings.
2 Select a chemistry, QC date and controls, and then select Search F1 to query the
corresponding L-J chart.
3 Choose a QC point on the chart.
4 Select Comment F8, and then input comments for the QC point.
5 Select OK.
Select the QC point on the chart. The comments of this QC point are displayed in the
Comment area at the upper-right corner of the screen.
To delete the comments of a QC point, select the QC point on the chart, clear the
comments, and then select OK.
7-12
7 Quality Control
7-13
7 Quality Control
The result list shows all results of the control for the chemistry during the specified
period, as well as the set means and standard deviations.
Figure 7.10 Results screen
7-14
7 Quality Control
Sort QC results
The searched QC results can be rearranged by control or chemistry.
1 Search for desired QC results on the Results screen.
2 Select Sort F3.
Figure 7.11 Sort window
4 Select a point on the curve. Relevant measuring period and absorbance are displayed
on the right of the window.
7-15
7 Quality Control
Add QC comments
Comments can be added to specific QC result for special notice.
1 Search for desired QC results on the Results screen.
2 Choose a QC result in the result list.
3 Select Comment F5.
7-16
7 Quality Control
5 Select OK.
Archive QC data
The system allows archiving of QC results to a storage device. The file format is CSV and
the default file name is QCData.csv. which cannot be edited. QC results must not be
archived to the hard disk.
The archived QC results and data include the following information:
Table 7.4 Archived QC data types
ID Control Result Information
1 Chemistry type
2 Chemistry number
3 Chemistry name
4 Control number
5 Control name
6 Lot number
7 Control concentration
8 Standard deviation
9 Measured results
10 Flag
11 Run date
12 Reagent lot number
7-17
7 Quality Control
3 Select OK.
7-18
8 Sample Programming and Processing
This chapter provides description of functions and operating instructions about sample
analysis, which include:
Modifying/Adding samples and chemistries
Rerunning samples
Programming samples with increased or decreased volume
Programming diluted samples
Sample blank
Loading/Unloading samples
Viewing unpositioned samples and assign positions for them
Releasing finished samples
Viewing sample logs
Customizing sample information
Customizing patient demographics
Viewing sample and chemistry lists
Optimizing result display
Sample results recall
Test statistics and result statistics
8-1
8 Sample Programming and Processing
8.1 Overview
Sample programming can be performed in manual and auto modes, in batch or by single,
by rerunning or adding chemistry and samples, in common or quick STAT mode, and via
virtual sample carousels. Chemistries selected for samples include biochemical
chemistries, ISE chemistries, serum index, calculations, off-system chemistries and panels.
If a chemistry will not be used in your laboratory, you are allowed to mask it and remove
it from the chemistry list. Samples can be programmed and analyzed based on the
running options. Patient demographics should be entered before or during the
measurements. You may view the sample analyzing status through the Status screen. The
system allows the deletion of programmed and complete samples.
These functions and operations will be described in detail in the following sections.
8-2
8 Sample Programming and Processing
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult
a doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
1 Add samples to the existing programming according to 2.8.1 Programming Routine
Samples (page 2-29).
2 Confirm the program information.
3 Select the icon on the upper-right corner of the main screen to request for
sample stop.
4 Check the sample stop countdown in the system status area and wait until it comes
to 0.
5 Check the sample carousel indicators, and proceed to the next step when the
indicators are extinguished.
Flash: indicates that the corresponding carousel is rotating or is going to rotate.
ON: indicates that the corresponding carousel is stopped for sample aspirating
or that the sample probe is aspirating on the reaction carousel during test for
the diluted samples.
OFF: indicates that the corresponding carousel has no sample being aspirated
and will not rotate in the next period.
6 Place the added samples on the assigned positions of the sample carousel, and then
8-3
8 Sample Programming and Processing
3 Deselect chemistries you won’t run, and then select chemistries you desire to run.
4 Deselect panels you won’t run, and then select panels you desire to run.
5 Choose chemistries and panels to add to the sample.
6 Select Save F8.
If the system is running tests, it will analyze the added chemistries and panels
automatically.
If the system is in Standby status, select the icon on the upper-right corner
of the main screen.
8-4
8 Sample Programming and Processing
4 Type in the ID or bar code of the sample you desire to rerun or enter the barcode of
the sample.
5 Click Select.
Figure 8.2 Rerun Samples window
8-5
8 Sample Programming and Processing
Separate single samples with comma, e.g. 5, 7, 9; and connect multiple continuous
samples with a dash, e.g. 1-3.
5 Select Batch.
Figure 8.4 Rerun Batch window
The list includes all chemistries that have been enabled and configured. The selected
chemistries will be requested for rerunning the samples.
7 Select OK.
8 After confirming all rerun information, load samples to the assigned positions, and
8-6
8 Sample Programming and Processing
The sample volume is the same as that defined for the chemistry. If increased and
decreased volumes are defined for the chemistry, Increased and Decreased are
available here for selection.
13 If you want to run a chemistry with different sample volume, replicates and
predilution factor, enter the values in the chemistry option area:
8-7
8 Sample Programming and Processing
Sample Vol: sample volume required to run the chemistry. The sample volume
is the same as that defined for the chemistry. If increased and decreased
volumes are defined for the chemistry, Increased and Decreased are available
here for selection.
Predilution: ratio at which samples containing the chemistry will be prediluted
before being analyzed. When standard, increased and decreased sample volume
parameters are defined, the product between the sample dilution factor and the
predilution factor must not be greater than 134.
Sample blank: set up sample blank for chemistries.
Pretreatment: pretreat the sample.
14 Select Save.
15 Load samples to the assigned positions, and select to start the analysis.
If the sample is on the current sample carousel, it is analyzed automatically.
Otherwise, you should specify the sample carousel and position to start the
analysis.
The window shows the selected chemistry and samples, as well as sample ID, bar
code, sample volume in previous test, predilution factor, sample blank and off-line
dilution factor.
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8 Sample Programming and Processing
Predilution factor: The input range is 3-134, and the default is blank.
Off-line dilution factor: The input range is 2-9999, and the default is blank.
Sample blank: set up sample blank for chemistries.
Pretreatment:pretreat the sample.
8 Select OK.
9 Load samples to the original positions, and select to start the analysis.
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8 Sample Programming and Processing
6 The latest rerun result is the default one. To change the default result, choose a result,
and then select Set Defaults.
The Default column of the result shows Y, which stands for Yes.
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8 Sample Programming and Processing
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8 Sample Programming and Processing
18 Choose a chemistry.
19 Select a sample volume type in the Sample Vol column for the chemistry.
20 Enter the number of replicates.
21 Enter the predilution factor.
When standard, increased and decreased sample volume parameters are defined, the
product between the sample dilution factor and the predilution factor must not be
greater than 134.
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8 Sample Programming and Processing
23 Select Save.
24 Select the icon to start the analysis.
The system will run a sample blank when running calibrators, controls and samples
for the chemistry.
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8 Sample Programming and Processing
For the test of whole blood(centrifuged)sample, the parameters can be set up on the
chemistry parameter screen or on the chemistry options window and rerun window. On
the chemistry parameter screen, once sample pretreatment is selected, all the tests of this
chemistry will perform pretreatment. You can enable or disable pretreatment on the
chemistry options window or rerun window so that manually pretreated sample can be
tested.
Preparing sample
Put the centrifuged whole blood sample(2000rpm,5min) into the sample positions.
NOTE
For the tests with blood cell pretreatment, please prepare the centrifuged whole blood
sample. For the centrifuged whole blood sample,onlyΦ12×68.5 mm, Φ12×99 mm,
Φ12.7×75 mm, Φ12.7×100 mm, Φ13×75 mm, Φ13×95 mm, Φ13×100 mm anticoagulation
tubes can be used. The sample height in the tube should be no higher than 55mm and the
blood cell level should be no lower than 10mm. Microcups are not allowed. To ensure the
clinical performance and avoid the system alarm, EDTA anticoagulation tubes are
recommended.
If manual pretreatment is required due to abnormal test results, please deselect the
pretreatment option on the chemistry options window and the rerun window.
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8 Sample Programming and Processing
Check if the reagent and pretreatment reagent have been loaded and the reagent has
been calibrated.
12 Click .
CAUTION
Prepare the sample according to the procedure recommended by the tube manufacturer.
For collection and preparation of samples, please see the reagent Instructions for Use.
Use clean tubes, microcups and other disposable materials specified by the manufacturer.
Do not reuse disposables.
When using vacuum collection tube for sample collection, make sure that the cap of the
vacuum collection tube is clean.
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8 Sample Programming and Processing
Sample volume
The amount of sample required for a common measurement is 1.5-45μl, with an
increment of 0.1μl. Analysis with insufficient samples may lead to inaccurate results.
If a sample is exhausted during the analysis, the system will automatically invalidate all
incomplete chemistry of the sample. Before running samples, make sure that they are
sufficient in volume for analysis.
Loading samples
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
1 Check if the sample inside the sample tube is sufficient for analysis and the bar code
label is applied correctly.
2 Check the system status.
Unloading samples
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Caution
When unloading Φ16.5×92mm sample cups, remove the sample carousel, or press the
sample carousel with one hand and take out the sample cups with the other hand.
1 Check if the sample carousel and the sample probe have stopped moving.
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8 Sample Programming and Processing
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8 Sample Programming and Processing
(1)
(2)
(3)
The figure above shows the absorption spectrum of interferents in serum samples. (1)
refers to lipemia, (2) refers to hemolysis, and (3) refers to icterus.
The three interferents are selective to wavelength and have complex absorption
spectrums. They cannot be removed completely by means of double-wavelength
measurements. The serum index option can be used to analyze the interferents contained
in samples, helping clinical professionals to evaluate the test results, determining if the
sample is usable or if a sample blank test is needed.
Serum index test is single-reagent endpoint measurement, in which serum sample of 6μl
and physiological saline of 120μl are used. Six wavelengths are chosen to determine the
serum index. The equations of serum index are as follows:
Lipemia: primary wavelength of 660, secondary wavelength of 700.
Where,
B and F: determined by the absorption spectrum of lipemia and not adjustable.
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8 Sample Programming and Processing
4 Type in the print name of lipemia in the Print Name of the Lipemia area. Up to 15
characters can be entered.
The lipemia index will appear as the print name on patient reports and as “SI” on
other reports.
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8 Sample Programming and Processing
5 Type in the detection range in the first edit box of the Range field, and then enter a
flag in the first edit box of the Flag field.
For instance, type in “10” in the first edit box of the Range field in the Lipemia area,
and then enter “+” in the Flag field of the same row. If the lipemia volume (L1)
contained in a sample is lower than 10, the “+” sign will be added to the result in the
patient report. Type in “20” in the second edit box below the Range icon and “+-” in
the second edit box below the Flag icon. If the lipemia volume (L2) is greater than
10 and lower than 20, the result will be flagged with the “+-” sign. The cycle
continues. If the result is greater than L5, the six flag will appear on the patient
report.
6 Repeat step 4-5 to define ranges and flags for hemolysis and icterus.
7 Select Save F7.
8 Select Print F1 to print qualitative result flag settings and slope/offset parameters of
the SI chemistry.
9 Select Close F8.
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8 Sample Programming and Processing
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8 Sample Programming and Processing
10 To run the samples, select the icon on the upper-right corner of the main
screen.
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8 Sample Programming and Processing
5 Select OK.
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8 Sample Programming and Processing
When the time is reached, the system will release automatically all sample positions
in the status of Complete.
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8 Sample Programming and Processing
3 The screen shows the controls and patient samples that are not complete within the
recent 24 hours due to certain reasons.
4 To print the sample logs, select Print F7.
5 Select Exit F8 to close the window.
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8 Sample Programming and Processing
4 Find desired sample information and mark the corresponding Customize checkbox.
Click the checkbox again to deselect it.
5 Select Save.
6 Select Exit to close the window.
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8 Sample Programming and Processing
4 Select the desired information and the default value and then click Add.
5 Select the desired information and click Delete to delete it from the demographics
list.
6 Select Up, Down, Home and End button to adjust the displayed order of patient
demographics.
7 Select OK to save the settings or select Cancel to restore the previous settings.
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8 Sample Programming and Processing
The screen shows all requested chemistries, including the name, calibration status,
number of requests, and tests left.
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8 Sample Programming and Processing
4 Find desired chemistry, and mark the corresponding Low and High checkboxes.
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8 Sample Programming and Processing
The screen shows all samples and controls that are programmed and analyzed on
the current day. When certain test of a control sample or patient sample triggers a
data alarm, the sample will appear in yellow.
Figure 8.25 Current Results screen
The sample type includes R, E and C. R stands for routine sample, E for STAT sample,
and C for control.
The Host column indicates the transmission status of the sample. Y means that the
sample has been sent to the LIS host, and N means the opposite.
The Print column indicates the print status of the sample. Y means that the sample
has been printed, and N means the opposite.
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8 Sample Programming and Processing
Samples displayed in the sample list can be sorted by the sample category, sample ID,
status, position, completion time, program date/time, host, print, and review
columns.
3 When recalling results by sample, choose a sample in the left list. The right list
displays all results of the sample. When recalling results by chemistry, choose a
chemistry in the left list. The right list displays all results of the chemistry.
4 Choose the following buttons as needed:
Search F1: to inquire sample results.
Options F2: to delete, edit and print samples, recall rerun results, customize
result display options, recalculate results, compensate results, archive results,
and observe result trend.
Demog F3: to view patient demographics of the sample.
Reac Curve F4: to view the reaction curve and data of the selected test.
Rerun F5: to rerun a finished sample.
Review F6 to review the sample result.
Print F7: to print sample results.
Host F8: to transmit the selected sample results to the LIS host.
4 Select OK. The samples matching the condition are displayed on the screen.
5 Select a function button to perform relevant operations.
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8 Sample Programming and Processing
The screen shows all samples and controls that are programmed and analyzed
before the current day.
Figure 8.27 History Results screen
The sample type includes R, E and C. R stands for routine sample, E for STAT sample,
and C for control.
The Host column indicates the transmission status of the sample. Y means that the
sample has been sent to the LIS host, and N means the opposite.
The Print column indicates the print status of the sample. Y means that the sample
has been printed, and N means the opposite.
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8 Sample Programming and Processing
5 Select OK. The samples matching the condition are displayed on the screen.
6 Select a function button to perform relevant operations.
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8 Sample Programming and Processing
Patient demographics can be customized. For more information, please refer to 8.9
Customizing Patient Demographics.
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8 Sample Programming and Processing
5 Select a point on the curve. Relevant measuring period and absorbance are displayed
on the right of the window.
6 Select a filter condition from the following options:
None: observe reaction curve and data in the default mode.
Chemistry: observe reaction curve of the results for the selected test.
Sample: observe reaction curve of the results for the selected sample.
7 Choose the Reaction Data tab to view the reaction data.
Figure 8.31 Sample reaction data
8-40
8 Sample Programming and Processing
The window shows the calibration date and time; sample measurement date and
time; calibrators, reagents for reagent blank test; and reagents for sample analysis.
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8 Sample Programming and Processing
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8 Sample Programming and Processing
Print by Sample
Print by sample option allows you to print the test results of one or more samples when
they are recalled by sample.
1 Search for desired samples on the Current Results or History Results screen.
2 Choose the By Sample option.
3 To print single or multiple samples, select them in the sample list.
4 Select Print F7.
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8 Sample Programming and Processing
Print by Chemistry
Print by chemistry option allows you to print the test results of one or more chemistries
when they are recalled by chemistries.
Laboratory Version:
1 Search for desired samples on the Current Results or History Results screen.
2 Choose the By Chemistry option.
3 To print single chemistry in the chemistry list, select it; to print all chemistries, there
is no need to select them.
4 Select Print F7.
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8 Sample Programming and Processing
CAUTION
Edit Results function gives doctors with freedom to modify the results, and therefore,
must be used with cautions. Only users that have sufficient permissions are allowed to
edit results.
1 Select Result - Current Results or History Results.
2 Choose a result recall mode:
By sample
By chemistry
3 Select Search F1 to search for desired results.
4 Choose a sample or chemistry in the sample list which includes the off-system
chemistries as well.
5 Select Options F2.
6 Select Edit Results.
The screen shows the samples or chemistry and all measured results.
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8 Sample Programming and Processing
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8 Sample Programming and Processing
7 Choose a chemistry to edit, and then input result in the Final Result column.
On the Edit Results window- By sample (Current results), select Prev or Next to
locate the results that require editing.
For normal runs, only Complete chemistries can be edited.
For reruns, only the default result can be edited.
For off-system chemistries, the results can be edited at any time.
8 Repeat step 7 to edit other results.
9 Select Save to save your editing.
10 Select Exit to close the window.
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8 Sample Programming and Processing
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8 Sample Programming and Processing
3 Select Recalculate.
Figure 8.43 Recalculate window
Results of the selected chemistry for the specified samples are recalculated
automatically with the latest calibration factors and then displayed in the list at the
bottom.
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8 Sample Programming and Processing
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8 Sample Programming and Processing
The result trend curve of the selected chemistry is displayed on the window.
7 Move the cursor to certain point on the graphic trend. The actual result, final result,
completion time, reagent lot number, serial number, and calibration time are
displayed on the right of the window.
8 To show all results of repeated analysis or rerun tests, select the Include Replicate
Results checkbox.
9 To observe result trend of other sample tests, select Prev F1 or Next F2.
10 Select Exit F8 to close the window.
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8 Sample Programming and Processing
NOTE
It may take a long time to archive a large amount of results. You are recommended
not to archive results over one week each time.
2 Select Options F2.
3 Select Archive.
4 Select OK.
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8 Sample Programming and Processing
By Sample: To view all requested samples and the quantity of its requested
chemistries.
By Test: To view test requisitions and reagent volume for the chemistries.
3 Select or enter the start date and end date in the Date field. the start date cannot be
later than the end date.
4 Select Search F1.
All samples or tests requested during the period are displayed in the middle list of the
Tests screen.
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8 Sample Programming and Processing
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8 Sample Programming and Processing
Bar code
6 Click OK.
The chemistry, number of tests, mean, standard deviation, maximum value, minimum
value are displayed in the statistic results column. The statistic data include test time,
result, sample ID, bar code, patient ID, medical number, sample type, reference range,
sex and age.
7 Select Print F7 to print out the statistic graph and statistic data.
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BS-600
Chemistry Analyzer
Operator’s Manual
Volume II
Volume II - Contents
Preface ················································································································· 1
I
Volume II - Contents
II
Volume II - Contents
III
Volume II - Contents
IV
Volume II - Contents
5 Reagents ···········································································································5-1
V
Volume II - Contents
6 Calibration ········································································································6-1
VI
Volume II - Contents
VII
Volume II - Contents
VIII
Volume II - Contents
IX
Volume II - Contents
10 Chemistries ····································································································10-1
X
Volume II - Contents
XI
Volume II - Contents
XII
Volume II - Contents
15 Diagnostics·····································································································15-1
16 Maintenance···································································································16-1
XIII
Volume II - Contents
XIV
Volume II - Contents
XV
Volume II - Contents
Vocabulary ············································································································· 1
Index ···················································································································· 1
Bibliography ··········································································································· 1
XVI
9 Result Printouts
This chapter describes data archiving, print setup, auto print and manual print methods,
and result printouts.
9-1
9 Result Printouts
CAUTION
While importing chemistries, do not switch off the analyzing unit main power or exit the
operating software.
9-2
9 Result Printouts
All chemistries contained in the default parameter form are displayed in the
Available Chemistries list.
All imported chemistries are enabled by default and can be used for measurement. If
the result unit is changed, the corresponding chemistry must be recalibrated.
8 Select Exit.
9-3
9 Result Printouts
4 Select Import.
5 Select Load.
6 Locate the path of the parameter form, and then select a .csv file.
7 Select Open.
All chemistries contained in the parameter form are displayed in the Available
Chemistries list.
All imported chemistries with correct parameters are enabled by default and can be
used for measurement. If you change any of the following parameters of an
imported chemistry, recalibrate the chemistry:
Reaction type
Primary wavelength
Secondary wavelength
Reaction direction
Reaction time
Blank time
Result unit
Standard sample volume, diluting sample volume and diluent volume
Reagent volume (R1, R2, R3 and R4)
Sample blank
Twin chemistries
Pretreatment parameters
10 Select Exit.
Export chemistries
Open-reagent chemistries, as well as the processing parameters, error detection limits
and slope and offset, can be exported to a storage device.
1 Select Utility - Chemistries.
2 Select Config F3.
3 Select Options.
4 Select Export.
9-4
9 Result Printouts
8 Select Save.
9 Select Exit.
9-5
9 Result Printouts
Archiving QC data
The QC results and data can be archived to a storage device with the file name of
QCData.csv, which cannot be edited.
For more information of archiving QC data, refer to Archive QC data (page 7-17).
9-6
9 Result Printouts
3 Select a report type from the report list on the left of the window.
4 Select a template from the template list.
The template list includes all the report templates of the selected report type.
The template list has four columns. Only one template can be selected at the
same time.
5 Select one option from the check box:
Auto print patient report
Print after reviewal
Auto print QC report.
Auto print calibration report
6 Choose a printer type.
The system supports three types of printer, which include laser printer, inkjet printer
and stylus printer.
9-7
9 Result Printouts
You can edit the report templates as needed. Refer to 18 Template Modifying
Software for details.
9-8
9 Result Printouts
7 Click Customize to import the template you edited from a tmplt file.
The legal directory should be a portable storage device. The templates can be
imported in batch.
8 Click Import
The imported templates will be displayed in the template list.
9-9
9 Result Printouts
9-10
9 Result Printouts
9-11
9 Result Printouts
9-12
9 Result Printouts
9-13
9 Result Printouts
All inquired sample results and the results of the QC samples will be printed out.
Figure 9.10 Sample summary report
9-14
9 Result Printouts
9-15
9 Result Printouts
9-16
10 Chemistries
10-1
10 Chemistries
10-2
10 Chemistries
For defining methods of chemistries, refer to “3.2 Chemistries Setup” (Page 3-10).
Requesting calibration
Twin chemistries can be requested for calibration in the same way as normal chemistries.
When either of the twin chemistries is requested, the other twin will be requested
automatically, and finally both chemistries will be calibrated. You are allowed to recall the
calibration results, calibration curves and reaction curves of the two chemistries.
Programming controls
Twin chemistries can be requested for quality control in the same way as normal
chemistries. When either of the twin chemistries is requested, the other twin will be
requested automatically, and finally both chemistries will be run for quality control. You
are allowed to recall the QC results and QC reaction curves of the two chemistries.
10-3
10 Chemistries
10-4
10 Chemistries
10-5
10 Chemistries
Urine
CSF
Other
7 Type in the calculation’s full name in the Chemistry field.
8 Type in the print name of the calculation to appear on patient reports.
9 Choose a result unit from the Unit pull-down list.
10 Choose a result precision, that is, the number of decimal places.
The options include:
0
0.1
0.01
0.001
11 Edit the calculation formula:
Choose chemistries in the Chemistries list. The chemistries are then displayed
in the Formula field.
Choose numbers and operators in the Mathematical Symbols area to
constitute the calculation formula along with the chemistries.
To remove a chemistry, number or operator, move the cursor behind them and
select BS.
To clear the entire formula, select AC.
12 Select Flag qualitative results if you want to flag the qualitative results.
For more information, please refer to 3.2.5 Flag Qualitative Result
10-6
10 Chemistries
10-7
10 Chemistries
10-8
10 Chemistries
10.3 Panels
10.3.1 Introduction
A couple of chemistries combined together for certain clinical purposes can constitute a
panel, such as liver function, kidney function, etc. Panels can help fast programming of
samples.
Panels can be composed of biochemistries and ISE chemistries. The system allows a
maximum of 100 panels to be defined. Only users with sufficient permissions are allowed
to define, modify and delete panels.
At least one biochemistry should be selected. The three ISE chemistries (Na, K and Cl)
can be selected alone.
10-9
10 Chemistries
10-10
10 Chemistries
4 Select Off-system.
5 Select OK
Figure 10.7 Define/Edit chemistries
10-11
10 Chemistries
10-12
10 Chemistries
10-13
10 Chemistries
10-14
10 Chemistries
All chemistries in the Available Chemistries list are enabled and displayed in the
Configured Chemistries list.
6 Select OK.
6 Select OK.
10-15
10 Chemistries
10-16
10 Chemistries
10-17
10 Chemistries
3 Mark the Reagent checkbox of the contaminated, if the contaminator may cause
reagent cross-contamination with the contaminated. If the contaminator may cause
cuvette cross-contamination, mark the Cuvette checkbox of the contaminated.
4 Choose one or all contaminator chemistries that may contaminate other chemistries.
"ALL" means all chemistries may contaminate others.
"ALL" means all chemistries may be contaminated. All (the entire contaminator) to
All (the contaminated) is not permitted to set up.
10-18
10 Chemistries
Only when either of the contaminator or contaminated is ALL, you are enabled to
define wash cycle (1-5).
9 Select Define F1 and follow the above steps to set up other carryover pairs.
10 Select Close F8 to close the window.
10-19
10 Chemistries
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult
a doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
1 Load bar-coded samples to the sample carousel.
10-20
10 Chemistries
10-21
10 Chemistries
The marked chemistry will have a symbol appearing on its upper-left corner,
and will still be displayed on the Sample, Quality Control and
Reagent/Calibration screens.
10-22
10 Chemistries
10.10 Reflex
10.10.1 Introduction
The Reflex option allows related chemistries to be requested and run automatically when
the deciding biochemistry’s result is within specified range. Each biochemistry may
embrace multiple reflex conditions, and each condition may contain a maximum of 20
related chemistries.
Reflex conditions and related chemistries are open for observation, but only users with
corresponding permission are allowed to set, modify or delete reflex relation.
10-23
10 Chemistries
and: When the test result (concentration) is greater than certain value AND less
than certain value, the related chemistries will be requested and run
automatically.
Select an option and input the concentration range (0~9999.999).
8 Select OK.
The defined reflex relation is shown in the left list.
9 To define more relations for the current chemistry, repeat steps 6~8.
10 Select Exit to close the window.
11 To define reflex relations for other chemistries, repeat steps 1~10.
10-24
11 System Commands and Setup Options
This chapter provides descriptions of system commands and advanced setup options.
The system commands include:
Home
Stop print
Wake up
The advanced setup options include:
User and password setup
System timers for auto sleep, auto startup and auto awake
Dictionary setup
Software version upgrading
Software version
Voice tone setup
11-1
11 System Commands and Setup Options
11.1 Home
11.1.1 Introduction
The Home command is used to initialize the biochemistry system and the ISE module,
and to recover them from failures, making all components return to the home positions.
When the Home command is executed, the system status becomes Standby.
11-2
11 System Commands and Setup Options
11-3
11 System Commands and Setup Options
11-4
11 System Commands and Setup Options
NOTE
The default username and password for administrator is Admin. Please note that the
password is case sensitive. You are recommended to change the password when logging
on the system for the first time in order to prevent others from abusing the privileges of
the administrator.
If an operator forgets his password, he may ask the administrator to log on the system
and delete the username and then redefine a username; or he may contact our customer
service department or your local distributor. If the administrator forgets his password,
contact our customer service department or your local distributor.
11-5
11 System Commands and Setup Options
11-6
11 System Commands and Setup Options
11-7
11 System Commands and Setup Options
The options include N/A, 30, 60, 90, 120, 150, 180,210,240,270 and 300 and the
default is 60 minutes. N/A means the auto sleep timer is disabled
NOTE
If auto sleep is not enabled, some components, such as lamp, may get aged quickly
and degraded in performance. You are recommended to enable this option.
6 Select Save.
11-8
11 System Commands and Setup Options
When the interval is elapsed, the system will starts to sleep and the system status
becomes Sleep.
7 Select Exit.
NOTE
After setting up the auto startup time, ensure that the operation unit and the analyzer
are connected to power supply; otherwise, they cannot be started up automatically.
1 Select Utility - System Setup.
2 Select Instrument F1.
3 Select 1 Sleep/Awake.
4 Select 2 Auto Startup Setup.
Figure 11.4 Auto Startup Setup
5 Choose the weekday for auto startup, and then set up the specific time.
Any time within a week(from Monday to Sunday) can be defined for the system to
start up automatically.
6 Select Save.
When the date and time is reached, the system will be started up automatically if it is
off.
7 Select Close.
NOTE
After setting up the auto awake time, ensure that the operation unit and the analyzing
unit are connected to power supply; otherwise, they cannot be woken up automatically.
11-9
11 System Commands and Setup Options
5 Choose the weekday for auto startup, and then set up the specific time.
Any time within a week (from Monday to Sunday) can be defined for the system to
wake up automatically.
6 Select Save.
When the date and time is reached, the system will be woken up automatically if it is
sleeping.
7 Select Exit.
11-10
11 System Commands and Setup Options
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11 System Commands and Setup Options
Select Save.
To delete a data option:
Select desired data option in the data list.
Select Delete.
5 Select Close.
11-12
11 System Commands and Setup Options
11-13
11 System Commands and Setup Options
4 View the version number of the operating software, control software, database, and
ISE module software.
If a new version is released, upgrade the operating software while referring to 11.7
Software Upgrade (page 11-13). If no ISE module is configured, the ISE Software
Version area will be blank.
5 To view the version numbers of the smart module software, select Details.
11-14
11 System Commands and Setup Options
11-15
11 System Commands and Setup Options
4 Choose a voice tone from the pull-down list box, and then select the corresponding
Test button to test the voice effect until the proper one is found.
5 Select Save to save the settings.
11-16
12 Use of ISE Module
12-1
12 Use of ISE Module
Warning
The ISE module must be operated by skilled/trained doctors, nurses or clinical
professionals.
Warning
Exercise caution while using the ISE module. Prevent your hair, legs or other parts of your
body from being hurt by the driver parts.
BIOHAZARD
The serum samples remaining in the electrodes may contain a great number of viruses.
Wear gloves to prevent infection while operating around the electrodes.
Calibration precautions
CAUTION
Calibrate the ISE chemistries for serum and urine before starting the measurement. If
the result of a chemistry is based on the calibration factors of another chemistry, it may
not be accurate enough.
After changing electrodes or other consumables, perform a calibration. You are
recommended to perform calibration at least once every day to ensure accurate results.
Calibrator biohazards
BIOHAZARD
The calibrators contain preservatives. In case your skin contacts calibrators, wash them
off with soap and water. In case the calibrators spill into your eyes, rinse them with
water and consult an oculist. If you swallow them by mistake, see a doctor.
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12 Use of ISE Module
CAUTION
Use the calibrators specified by our company. Use of other reagents or calibrators may
result in unreliable results, or damage the Hydropneumatic system, or even shorten the
electrodes life span.
Prior to using the calibrators, check if they are within the expiration date.
Place them correctly; otherwise, it may cause unreliable results, or leak, or module
damage.
BIOHAZARD
The ISE wash solution is sodium hypochlorite. Use the ISE wash solution carefully to
prevent it from contacting your skins or eyes. If your skins or eyes contact the ISE wash
solution, rinse them off with fresh water and consult a doctor.
12-3
12 Use of ISE Module
12-4
12 Use of ISE Module
12-5
12 Use of ISE Module
Unit
The unit of K, Na and Cl is mmol/L which can be viewed but cannot be edited.
Decimal
The decimal of the result can be viewed but cannot be edited.
Measurement Range
The measurement range can be viewed but cannot be edited.
12-6
12 Use of ISE Module
12-7
12 Use of ISE Module
If it is the first time to load the ISE reagent, please enter Step 7; if not, unload the
reagent first.
Figure 12.3 Unload Reagent
12-8
12 Use of ISE Module
7 Remove the red caps from Reagent Pack first and push the wand just above the top
of Reagent Pack. Make sure that the three pipe adapters at the bottom of the wand
are opposite to those on the top of Reagent Package, then push down the wand to
Reagent Package. The wand will only fit one way. Once the wand is connected to the
reagent pack, place the reagent pack on the sliding tray
Figure 12.4 Installing Reagent Pack 1
NOTE
When installing ISE reagent pack, do not twist, press and squeeze the pipes of the
ISE Module otherwise the ISE pipes may be clogged.
Wear gloves and lab coat and, if necessary, goggles.
12-9
12 Use of ISE Module
8 Enter the number in Purge A/B field which can be any integer within 1-50 and the
default is 30.
9 Click Prime.
10 Select OK to calibrate ISE chemistry when Purge A/B is complete.
Running: Select the button on the upper-right corner of the main screen to
stop sample aspirating and dispensing. When the countdown for sample stop
becomes 0 and the system status is Sample Load, proceed to the next step.
2 Remove the sample carousel cover;
3 Place ISE wash solution in position D1 (No.88) of the sample carousel.
4 Restore the sample carousel cover;
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12 Use of ISE Module
Running: Select the button on the upper-right corner of the main screen to
stop sample aspirating and dispensing. When the countdown for sample stop
becomes 0 and the system status is Sample Load, proceed to the next step.
2 Remove the sample carousel cover.
3 Remove the ISE wash solution from position D1 (No.88) of the sample carousel.
4 Place the new wash solution.
5 Restore the sample carousel cover.
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12 Use of ISE Module
The input range is 1-9999, and the default is 8 hours. If the field is left blank, it
indicates that the calibration factors can be always used.
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12 Use of ISE Module
12-13
12 Use of ISE Module
12-14
12 Use of ISE Module
The screen shows the calibration factors that are being used for calculating results.
2 Select the History option button, and then select date range that the chemistry is
calibrated.
3 Select Search F1.
The calibration results of the chemistry are displayed in the result list.
The trend of the chemistry within the specified time period is displayed on the
screen. The trend type options will not include Reference Electrode when trends of
ISE Urine are being recalled.
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12 Use of ISE Module
12-16
12 Use of ISE Module
12-17
12 Use of ISE Module
12-18
12 Use of ISE Module
12-19
12 Use of ISE Module
12-20
12 Use of ISE Module
12-21
12 Use of ISE Module
For more information about ISE module maintenance, refer to 16 Maintenance (page
16-1).
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12 Use of ISE Module
12-23
12 Use of ISE Module
12-24
13 Use of Bar Code
The setup and operation instructions of the sample bar code reader and the reagent bar
code reader are depicted in this chapter. The sample bar code reader is used to identify
samples and obtain sample information by scanning the bar code label applied on sample
tubes. The reagent bar code reader scans the bar code labels automatically when the
reagents are loaded.
13-1
13 Use of Bar Code
13-2
13 Use of Bar Code
CAUTION
You are recommended to enable the check function for all symbologies in order to
prevent misreading of bar code.
13-3
13 Use of Bar Code
Input the start and end positions within the range of 1~115. The set positions will
be indicated by E (Emergent) on the sample carousel status screen. Samples placed
in the specified STAT positions will be taken automatically as emergent samples.
The Sample Crsl Bar Code and Auto Number Scanned Samples options are
selected by default.
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult
a doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
NOTE
When manually entering sample program information in bar code mode, ensure that the
input program information is consistent with the samples loaded to the sample carousel.
After the manually programmed samples are analyzed, they must be released manually
to leave space for other samples.
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13 Use of Bar Code
4 Select a patient sample range: All or Partial. When you select Partial, you should
specify a sample position range for analysis.
5 Select OK.
The system starts scanning the samples on the sample carousel and then analyzes
them according to the program information downloaded from the LIS host.
Method 2:
1 Place bar-coded samples on the sample carousel.
2 Select Program - Status.
3 Select Scan F5. The Scan window is displayed.
Figure 13.1 Scan window
Prior to selecting the Scan F5 button, ensure the following conditions have been
satisfied:
A sample bar code reader has been configured.
Sample bar code scanning is activated on the Sample Bar Code window.
The system status is Standby or Sample Stop.
4 Choose the scanning range.
All positions: to scan all positions on the sample carousel.
Specified positions: to scan the specified positions on the sample carousel. Input
the start and end scanning positions.
5 Select OK.
If a default panel has been defined, the scanned samples will be programmed with
the default panel; otherwise, chemistries should be requested for the samples.
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13 Use of Bar Code
The system scans the samples on the sample carousel to match the program
information, and then starts analysis.
Method 2:
1 Place bar-coded samples sequentially on the sample carousel.
If the auto numbering feature is enabled, the system will automatically number the
samples according to the order in which they have been placed. The start number
will be the next available one since the last sample is programmed.
If a default panel has been defined, the scanned samples will be programmed with
the default panel; otherwise, chemistries should be requested for the samples.
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13 Use of Bar Code
13-7
13 Use of Bar Code
The reagent information obtained from a bar code label cannot be modified.
CAUTION
You are recommended to enable the check function for all symbologies in order to
prevent misreading of bar code.
6 Define the total length of reagent bar code.
Type in the total length of the reagent bar code in the T field. The input range is
13-30 digits. The Interleaved 2 of 5 only supports bar code of even number
length.
Type in the start digit of the reagent bar code in the S field.
Type in the end digit of the reagent bar code in the E field.
7 Determine reagent bar code compositions.
Type in the number of digits for reagent information in the Digits field.
Type in the start digit of the reagent information in the S field.
Type in the end digit of the reagent information in the E field.
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13 Use of Bar Code
8 Select OK.
Warning
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probe.
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation
may be caused.
13-9
13 Use of Bar Code
CAUTION
If the system is running tests, after requesting reagent stop do not remove the
reagent carousel cover until the countdown for reagent stop is 0; otherwise, the
tests currently run will be invalidated.
4 Place the bar-coded reagents in idle positions and then uncap the reagent bottles.
5 Restore the reagent carousel cover.
6 Select End Load F2.
The system scans all reagent positions automatically and read reagent information
from the bar code.
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13 Use of Bar Code
13-11
13 Use of Bar Code
13-12
14 LIS and RMS
This chapter contains communication parameter setup of LIS and RMS, as well as sample
analysis and result transmission when an LIS is connected.
14-1
14 LIS and RMS
14.1 Overview
The chapter provides detailed description of the LIS and RMS.
Laboratory Information System (LIS) is an external host computer connected with the
chemistry analyzer through a fixed interface. The LIS is used to download sample
program information to the analyzer and receives results sent from the analyzer.
Check that your analyzer is equipped with a LIS. If needed, contact our customer service
department or your local distributor.
You should set up the communication parameters and results transmission methods prior
to using the LIS host.
Remote Management System (RMS) provides a platform of remote diagnosis and
maintenance based on the internet. The RMS allows transfer of data and files with the
chemistry analyzers in hospitals, and helps the service engineers to find, collect, analyze,
locate and solve the failures happening at the user end.
14-2
14 LIS and RMS
A dialog box pops up: Check the network cable connection prior to applying new
settings. Please check the connection of the network cable and then click OK to save
the settings.
14-3
14 LIS and RMS
14-4
14 LIS and RMS
Parameter Description
Mode Choose a data transmission mode for the analyzer and LIS
host. The available options are Unidirectional and
Bidirectional.
Unidirectional: You are only allowed to send results
and patient demographics to the host rather than
downloading sample programs from it.
Bidirectional: You are allowed to send results and
patient demographics to the host and downloading
sample programs from it.
Timeout Enter the time out limit for querying the LIS host. The
input range is 30s-60s, and the default is 30s.
If the time out limit is exceeded when you attempt to
download sample programs from, or send results to, or
connect the analyzer with the LIS host, the system will
give an alarm indicating communication timed out.
Auto Connect to LIS When the checkbox is selected, the system will connect
to the LIS host automatically when started up.
Retry after When the checkbox is selected, the system will try to
Disconnection reconnect the LIS host for every set interval once the
connection is interrupted.
Interval Input the time interval for which the system will try to
reconnect the LIS host for every set interval once the
connection is interrupted. The default is 30 seconds.
Send Complete When the checkbox is selected, the system will
Samples automatically send results to the LIS host after a sample
changes from In Progress to Complete. This function is
only applicable to samples analyzed on the current day
rather than those analyzed before.
Send Incomplete When the checkbox is selected, the system will
Samples automatically send results to the LIS host after a sample
changes from In Progress to Incomplete. This function is
only applicable to samples analyzed on the current day
rather than those analyzed before.
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14 LIS and RMS
Parameter Description
Advanced options Select Advanced. The Advanced window appears,
providing the following options:
Send Programmed Samples: When the checkbox is
selected, the system will automatically send the
program information to the LIS host once a single or
batch routine and STAT samples are programmed.
Rerun Finished Chemistries When Downloaded:
When the checkbox is selected, chemistries that have
been finished will be rerun if downloaded again. If
this option is not selected, they will be neglected.
Send Actual Results and Rerun Results: When the
checkbox is selected, all actual results and rerun
results of each chemistry will be sent to the LIS. If this
option is not selected, only the default result will be
sent.
Bypass Results Beyond Linearity Range: When the
checkbox is selected, those results that are beyond
the linearity range will not be sent to the LIS. If this
option is not selected, they will be sent.
Ignore Alarms for Unknown Chemistries: When the
checkbox is selected, the system will not give an
alarm if the samples downloaded from the LIS host
contain unknown chemistries without identification
code. If this option is not selected, an alarm will be
given indicating sample programming failure.
The screen shows the chemistries and code in two columns. The left column provides
all chemistries that have been defined and set up correctly; the right column shows
the code for identifying a chemistry on the LIS host.
4 Click on the Channel No. column of a chemistry, and then type in a code for it.
5 Repeat step 4 to define a code for other chemistries.
6 Select Save.
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14 LIS and RMS
14-7
14 LIS and RMS
To assign positions for multiple samples, enter the start position number in the
first edit box, and then the end position number in the second edit box. The
system will assign positions for the samples ascending according to the sample
ID.
9 Select OK.
10 Enter the sample ID on the Sample screen and edit the following information:
Position
STAT status
Sample type
Comment
Chemistries and panels
Sample options and chemistry options
11 Select Save F8.
12 Load the samples to the assigned positions on the sample carousel.
13 Select the icon on the upper-right corner of the main screen, set the test
conditions, and then select OK to start analysis .
14-8
14 LIS and RMS
14-9
14 LIS and RMS
4 Select Save.
14-10
14 LIS and RMS
14-11
14 LIS and RMS
A dialog box pops up: Check the network cable connection prior to applying new
settings. Please check the connection of the network cable and then click OK to save
the settings.
14-12
14 LIS and RMS
14-13
14 LIS and RMS
14-14
15 Diagnostics
This chapter provides test descriptions, test procedures, test results and corrective
actions for diagnosis in Sample and Reagent systems.
15-1
15 Diagnostics
15.1 Overview
Diagnostics consist of a series of tests and actions, which are used for troubleshooting
errors. These tests and actions are made to detect failures, but cannot be used to confirm
one specific failure. Users should make a judgment by integrating the information of
diagnosis and warnings with the failure characteristics. Diagnostic tests available in two
function modules are described in the table below.
Table 15.1 Categories of diagnostics
Function Module Description
Sample System Diagnostic tests here are used to detect failures of
components in Sample system.
Reagent System Diagnostic tests here are used to detect failures of
components in Reagent system.
Sensor Diagnosis Diagnostic tests here are used to detect failures of the
sensors.
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15 Diagnostics
Test procedure
1 Select Utility - Maintenance - Diagnostics.
2 Select Sample System tab.
3 Select Sample Probe Clog Detection.
4 Load one cuvette of water onto Position 1 on sample carousel, and click Next to
open the Sample Probe Clog Detection Diagnosis window.
Figure 15.1 Sample Probe Clog Detection Diagnosis window
15-3
15 Diagnostics
5 Click Start.
The system starts to run each test for sample probe clog detection. Tests include:
Basic Check
Wash Check
Clog Check
Sample Aspiration Check (1.5μL)
Sample Aspiration Check (45μL)
6 When tests are complete, the tested voltage and the level sense test data are displayed
on the screen.
7 Click Exit to close the window.
Test results
The testing result of each subitem is displayed on the screen. Judge if the result meets the
requirements by comparing with the corresponding reference value. “PASS” in the
PASS/FAIL column indicates the test is normal, while “FAIL” indicates the test fails and it
should be corrected based on the suggestions provided.
Corrective action
Table 15.2 Sample system obstruction detection reference range and corrective action
Test Type Test Item Reference Range Corrective Action
Basic Check Version of Clog / Contact our customer
Detection Board service department or
12V 10.8V-13.2V your local distributor.
5V 4.5V-5.5.V
Pressure of Clog 9psia-17psia
Detection Board
Clog Signal OK/Error/”/”
Wash Check Wash Pressure 30psia-45psia
Clog Check Final Result OK/Error/”/”
Sample P0p <9psi
Aspiration Check Final Result OK/Error/”/”
(1.5μL)
Sample P0p <9psi
Aspiration Check Final Result OK/Error/”/”
(45μL)
15-4
15 Diagnostics
An alarm message appears indicating that the sample probe aspirates nothing in the
aspiration positions and the analysis is stopped, and has confirmed that the failure is
not caused by probe clog.
An alarm message appears indicating that the sample probe contacts no liquid during
dispensing samples into reaction carousel and the analysis is stopped, and has
confirmed that the failure is not caused by neither reagent bubbles nor reagent
probe level sensing.
An alarm message appears indicating that problems related with level sensing occur
during dispensing samples in ISE module, and has confirmed it is not the problems of
ISE module itself.
An alarm message appears indicating that the sample probe contacts no liquid during
liquid dispensing (also called water testing), and the analysis is stopped.
An alarm message appears indicating that the sample probe contacts no liquid in the
wash well and the analysis is stopped, and has confirmed that it is not a
hydropneumatic failure.
Test procedure
1 Select Utility - Maintenance - Diagnostics.
2 Select Sample System tab.
3 Select Sample Probe Level Sense Test.
4 Place a tube with its 2/3 full of water in test position, and click Next to open the
Sample Probe Level Sense Test Results window.
Figure 15.2 Sample Probe Level Sense Test Results window
The default test position is position 1 on the sample carousel. To change the test
position, click Change Pos and enter a new number within the range from 1 to 90,
and then click Next.
5 Click Start.
The system will start to check the level sense board voltage of the sample probe, and
continuously detect level in the test position for 20 times.
6 When tests complete, the tested voltage and the level sense test data will be displayed
on the screen.
15-5
15 Diagnostics
Test results
The results shown are described below:
Level Sense Board Voltage Check Results
If the Actual value falls in the Reference range, the result is PASS, indicating the voltage of
the level detection board is normal; otherwise, the result is FAIL, indicating the voltage is
abnormal. You should correct it based on the suggestions provided.
Level Sense Test Data
The system will continuously check the lowering height of the sample probe for 20 times,
to judge if the lowering position is the vertical extreme position. If it is, abnormity exists.
If the extreme difference of 20 lowering heights is greater than 1mm, then the result
should be considered as abnormal, indicating that there are problems with connections of
sample probe and Printed Circuit Board Assembly (PCBA), PCBA power, output voltage
for level sense detection, or connections of level sense board and probe/mixer conversion
board, and vice versa. You should correct it based on the suggestions provided.
Corrective action
If the operating voltage of the level detection board is beyond the reference range of
2.8V-4.8V, contact our customer service department or your local distributor.
If the result of the level detection performance is abnormal, contact our customer service
department or your local distributor.
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15 Diagnostics
Test procedure
1 Select Utility - Maintenance - Diagnostics.
2 Select Reagent System tab.
3 Select Probe R1 Level Sense Test.
4 Place a bottle with its 2/3 full of water in position 1 of the reagent carousel, and click
Next to open Reagent Probe Level Sense Test Results window.
15-7
15 Diagnostics
The default test position is position 1 on reagent carousel. To change the test
position, click Change Pos and enter a new number within the range from 1 to 80,
and then click Next.
5 Click Start.
The system starts to check the level sense board voltage for probe R1, and
continuously detects level in the test position for 20 times.
6 When tests complete, the tested voltage and the level sense test data are displayed on
the screen.
7 Click Exit to close the window.
Test results
The results shown are described below:
Level Sense Board Voltage Check Results
If the Actual value falls in the Reference range, the result is PASS, indicating the voltage of
the level detection board is normal; otherwise, the result is FAIL, indicating the voltage is
abnormal. You should correct it based on the suggestions provided.
15-8
15 Diagnostics
Corrective action
If the operating voltage of the level detection board is beyond the reference range of
2.8V-4.8V, contact our customer service department or your local distributor.
If the result of the level detection performance is abnormal, contact our customer service
department or your local distributor.
Test procedure
1 Select Utility - Maintenance - Diagnostics.
2 Select Reagent System tab.
3 Select Probe R2 Level Sense Test.
4 Place a bottle with its 2/3 full of water in position 1 of reagent carousel, and click
Next to open Reagent Probe Level Sense Test Results window.
15-9
15 Diagnostics
The default test position is position 1 on reagent carousel. To change the test
position, click Change Pos and enter a new number within the range from 1 to 80,
and then click Next.
5 Click Start.
The system starts to check the level sense board voltage for probe R2, and
continuously detects level in the test position for 20 times.
6 When tests complete, the tested voltage and the level sense test data are displayed on
the screen.
7 Click Exit to close the window.
Test results
The results shown are described below:
Level Sense Board Voltage Check Results
If the Actual value falls in the Reference range, the result is PASS, indicating the voltage of
the level detection board is normal; otherwise, the result is FAIL, indicating the voltage is
abnormal. You should correct it based on the suggestions provided.
15-10
15 Diagnostics
Corrective action
If the operating voltage of the level detection board is beyond the reference range of
2.8V-4.8V, contact our customer service department or your local distributor.
If the result of the level detection performance is abnormal, contact our customer service
department or your local distributor.
15-11
15 Diagnostics
Test procedure
1 Select Utility - Maintenance - Diagnostics.
2 Select Sensor Diagnosis tab.
Figure 15.5 Sensor diagnosis window
15-12
15 Diagnostics
Test result
Sensor high level signal is indicated by “unblocked “while low level signal is indicated by
“blocked”.
Corrective action
Perform the operations: block or unblock the sensors and perform the diagnosis test.
Observe if the sensor signal is changed accordingly with your operations. If the displayed
status is changed accordingly, it means the sensor works normally; If the displayed status
is not changed with your operations, it means the sensor is abnormal and please contact
our customer service department.
15-13
15 Diagnostics
15-14
16 Maintenance
This chapter provides you with maintenance of the instrument, including frequently-used
maintenance commands and scheduled maintenance procedures. The purpose, time,
system status, precautions and steps of each maintenance procedure are described here.
16-1
16 Maintenance
16.1 Overview
16.1.1 Introduction
Maintenance of the system should be performed regularly by trained personnel to ensure
reliable performance and reduce unnecessary service calls. Even you are only an operator,
it is important for you to read this chapter. Your thorough understanding will help you
obtain the best performance of the system.
The Biochemistry Maintenance, ISE Maintenance and Scheduled Maintenance are
provided. The Biochemistry Maintenance and ISE Maintenance features provide a list of
the maintenance procedures that can be performed to optimize the system performance.
The Scheduled Maintenance Log feature allows you to understand what maintenance is
needed, when it is performed and who performed the procedure. It is capable of
reminding you of the maintenance that is due and keeping track of what is happened
during a maintenance procedure.
In the case of maintenance that is beyond your capability or not covered in this chapter,
contact our customer service department or your local distributor.
The maintenance frequencies stated in this manual are based on working for 5 hours a
day, that is 5*600=3,000 tests/day, and 5*600*25=75,000 tests/month.
Warning
Do not perform any maintenance procedures that are not described in this chapter;
otherwise, equipment damage or personal injury may be caused.
Do not touch the components other than those specified in this chapter.
Performing unauthorized maintenance procedures can damage the instrument and cause
personal injury, or invalidate the applicable warranty provisions in the service contract.
After performing maintenance, make verification to ensure that the system runs
normally.
Do not spill water or reagent on mechanical or electrical components of the system.
If the system is to be stored for a long time (over 1 week) or transported, contact our
customer service department or your local distributor to perform necessary maintenance
in order to ensure the system’s optimal performance in following use.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
16-2
16 Maintenance
16-3
16 Maintenance
16-4
16 Maintenance
16-5
16 Maintenance
16-6
16 Maintenance
Maintenance procedures
Provides frequently-used maintenance commands of the biochemistry system. Select a
maintenance command button to start the maintenance procedure.
Online help
Online help information is provided for each biochemistry maintenance command. Select
the icon to the left of a maintenance command to show relevant instructions.
Exit
Select this button to close the Maintenance window.
16-7
16 Maintenance
16-8
16 Maintenance
Maintenance procedures
Provides frequently-used maintenance commands of the ISE module. Select a
maintenance command button to start the maintenance procedure.
Online help
Online help information is provided for each ISE maintenance command. Select the
icon to the left of a maintenance command to show relevant instructions.
Exit
Select this button to close the Maintenance window.
16-9
16 Maintenance
16-10
16 Maintenance
Daily maintenance:
Check probes/mixers/wash wells
Check sample/reagent syringes
Check deionized water connection
Check waste tube connection
Check concentrated wash solution
Check sample probe wash solution
Clean electrode tubes
Weekly maintenance:
Clean sample/reagent probe exterior/ mixers
Special wash
Clean mixers
Cuvette check
Photometer check
Monthly maintenance:
Clean wash wells
Clean cuvette wash station and tubes
Clean filter core
Clean dust screens
Clean sample injection port
Pump calibration
Air bubble detector calibration
Three-month maintenance:
Clean DI water tank
Replace filter core
Six-month maintenance:
Replace lamp
Replace water inlet filter
Replace reference electrode
Other (As-needed/As-required):
Clean analyzer panels
Bar code maintenance
Clean sample compartment
Clean reagent compartment
Clean sample probe interior
Clean reagent probe interior
Replace sample probe
Replace probe R1
Replace probe R2
Replace sample mixer
Replace reagent mixer
16-11
16 Maintenance
16-12
16 Maintenance
16-13
16 Maintenance
16-14
16 Maintenance
16-15
16 Maintenance
16-16
16 Maintenance
16-17
16 Maintenance
Warning
The probes and mixers are sharp and vulnerable. To prevent injury and equipment
damage, exercise caution when working around the probes and mixers. Keep away from
the probes and mixers to avoid collision with them.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
How to do
1 Open the protective shield of the analyzer.
2 Select Utility - Maintenance - Maintenance - Biochemistry Maintenance.
3 Select Clean Probes/Mixers/Wash Wells.
4 Check the exterior of the probes/mixers for stains. If stains exist, perform the Clean
Sample/Reagent Probe Exterior or Clean Mixers procedure.
5 Select Continue to clean the reagent probe and sample probe interiors.
6 Check the liquid flow of the sample probe and reagent probe. If the liquid flow is
sprayed out or does not come out vertically, the probe may be clogged. Perform the
Special Wash Probes procedure,, and then check them again. If the abnormity
remains, perform the Clean Sample Probe Interior or Clean Reagent Probe Interior
procedure. If the abnormity still remains, perform the Replace Sample Probe or
Replace Reagent Probes procedure, or contact a service engineer.
16-18
16 Maintenance
Figure 16.4 Normal and abnormal liquid flows of sample probe and reagent probe
OK Error
7 Select Second Wash. The probe interior wash can be performed again.
8 Select Continue.
9 Observe the water flow of the probe/mixer wash wells, and check if the water
reaches to about 5mm of the probe/mixer from the tip. If it does, proceed to the next
step; otherwise, contact a service engineer.
10 Select Continue.
11 Select Done.
12 Select Scheduled Maintenance - Daily.
13 Mark the Select checkbox to the right of Check Probes/Mixers/Wash Wells.
14 Select OK to refresh the current date as the performance date.
15 Select Log, and then record comments and other important information for the
procedure.
16 Select OK to save your input information.
17 Restore the protective shield.
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16 Maintenance
System status
Make sure that the system status is Incubation or Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
How to do
1 Open the front door of the analyzer. You will see three syringes on the two side of the
water tank.
2 Check the T piece for leak.
3 Use dry gauze to wipe the T piece, and then check if the gauze is moistened.
If it is not, proceed to the next step.
If it is, tighten the T piece.
Check the T piece and plunger guide cap again. If the leak remains, check if the
washer inside the syringe connector is intact.
If the washer is damaged, replace it with a new one; otherwise, replace the
syringe.
4 Check the syringe interior for air bubbles. If yes, remove the air bubbles.
5 Check the plunger guide cap at the bottom of the syringe for leak.
6 Use dry gauze to wipe the plunger guide cap, and then check if the gauze is
moistened.
If it is, tighten the plunger guide cap.
Check the plunger guide cap again. If the leak remains, replace the syringe.
7 Check if the retaining screws at the bottom of the syringe are tightened.
If not, tighten them and proceed to the next step.
If yes, proceed to the next step.
8 Close the front door of the analyzer.
9 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Daily.
10 Mark the Select checkbox to the right of Check Sample/Reagent Syringes.
11 Select OK to refresh the current date as the performance date.
12 Select Log, and then record comments and other important information for the
procedure.
13 Select OK to save your input information.
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16 Maintenance
When to do
You are recommended to do this maintenance procedure every day before starting the
analysis.
System status
Make sure that the system is powered off, or the system status is Incubation or Standby.
How to do
1 Check that the water tank or other water containers have sufficient deionized water.
2 Check that the tubes are not bent or folded or leaking.
3 Check that the water supply module is powered on.
4 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Daily.
5 Mark the Select checkbox to the right of Check DI Water Connection.
6 Select OK to refresh the current date as the performance date.
7 Select Log, and then record comments and other important information for the
procedure.
8 Select OK to save your input information.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the waste in accordance with your local or national guidelines for biohazard
waste disposal.
How to do
1 Check if the waste drainage system works well, and make sure that the waste tube is
not bent or folded and the high-/low-concentration waste is drained properly.
2 Check if the high-concentration waste tank has been emptied. If not, empty it.
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16 Maintenance
3 If leak remains after performing the above-stated steps, contact our customer
service department or your local distributor.
4 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Daily.
5 Mark the Select checkbox to the right of Check Waste Tank Connection.
6 Select OK to refresh the current date as the performance date.
7 Select Log, and then record comments and other important information for the
procedure.
8 Select OK to save your input information.
Warning
Concentrated wash solution is corrosive to human skins. Wear gloves and goggles while
checking the concentrated wash solution. In case your hand or clothes contact the wash
solution, wash them off with soap and water. If the wash solution spills into your eyes,
rinse them with water and consult an oculist.
CAUTION
When the system is Initializing, it may be diluting the concentrated wash solution. Do not
try to fill concentrated wash solution until the system status becomes Standby.
How to do
1 Open the front door of the analyzer and check the concentration wash solution. If
necessary, fill more or replace the wash solution.
2 Close the front door of the analyzer.
3 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Daily.
4 Mark the Select checkbox in the same row as Check Concentrated Wash
Solution.
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16 Maintenance
CAUTION
You are recommended to replace the sample probe wash solution every day in order to
prevent probe clogging and cross contamination.
While the system is running tests, do not try to fill sample probe wash solution until the
system status becomes Standby.
How to do
1 Check the volume of the sample probe wash solution on the sample carousel position
D2.
2 If necessary, fill more or replace the wash solution.
3 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Daily.
4 Mark the Select checkbox in the same row as Check Sample Probe Wash
Solution.
5 Select OK to refresh the current date as the performance date.
6 Select Log, and then record comments and other important information for the
procedure.
7 Select OK to save your input information.
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16 Maintenance
Purpose
To remove the proteins and lipid remaining on the electrode surfaces.
When to do
You are recommended to perform this procedure after finishing all ISE tests of the day, or
before shutting down the system, or 50 samples are analyzed.
Materials required
ISE wash solution, 2ml sample tube
System status
Make sure that the status of both the biochemistry system and ISE module is Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
The wash solution may hurt your eyes and skins. Exercise caution while using the wash
solution. If your eyes contact the wash solution, rinse them off with fresh water and
consult a doctor.
CAUTION
Please use consumables recommended by our company. Use of other consumables may
degrade the system performance.
NOTE
After performing this procedure, recalibrate the ISE electrodes prior to starting analysis.
How to do
1 Select Utility - Maintenance - Maintenance - ISE Maintenance.
2 Choose Clean Electrode Tubes. The maintenance guide window shows.
3 Open the upper protective shield of the analyzer.
4 Fill a 2ml sample tube with at least 300μl ISE wash solution, and then load it to
position D1 on the sample carousel.
5 Select Continue. The system starts cleaning the ISE electrode tubes.
6 Select Done.
7 Select Scheduled Maintenance - Daily.
8 Mark the Select checkbox in the same row as Clean Electrode Tubes.
9 Select OK to refresh the current date as the performance date.
10 Select Log, and then record comments and other important information for the
procedure.
11 Select OK to save your input information.
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16 Maintenance
Warning
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes. If the probe is bent or damaged, replace it
immediately; otherwise, unreliable results may be obtained.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Switch off the analyzing unit power.
2 Rotate the probe arm to move the probe to a position convenient for cleaning, and
then use gauze soaked with ethanol to gently wipe the probe exterior. Clean the
probe tip until it becomes clear without stain.
Do not pull the probe horizontally to prevent probe damage.
3 Use gauze moistened with deionized water to clear the ethanol on the probe.
4 After finishing the cleaning, turn on the analyzing unit power switch.
5 Select Utility - Commands - Home to reset the probe.
6 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Weekly.
7 Mark the Select checkbox to the right of Clean Sample/Reagent Probe Exterior.
8 Select OK to refresh the current date as the performance date.
9 Select Log, and then record comments and other important information for the
procedure.
10 Select OK to save your input information.
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16 Maintenance
Warning
Exercise caution while working around the mixer. If it is bent or damaged, replace it
immediately; otherwise, unreliable results may be obtained.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Switch off the analyzing unit power.
2 Rotate the mixer arm to move the mixer to a position convenient for cleaning, and
then use gauze soaked with ethanol to gently wipe the mixer exterior until it
becomes clear without stain.
Do not pull the mixer horizontally to prevent damage.
3 Use gauze moistened with deionized water to clear the ethanol on the mixer.
4 After finishing the cleaning, turn on the analyzing unit power switch.
5 Select Utility - Commands - Home to reset the mixer.
6 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Weekly.
7 Mark the Select checkbox in the same row as Clean Mixers.
8 Select OK to refresh the current date as the performance date.
9 Select Log, and then record comments and other important information for the
procedure.
10 Select OK to save your input information.
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16 Maintenance
Purpose
To eliminate cross contamination among the sample probe, reagent probe, mixers,
cuvettes and wash station, and prevent waste from leaving in the waste tubes.
When to do
You are recommended to perform this procedure on weekly basis or when the equipment
is to be stored for a long time.
Materials required
Concentrated wash solution manufactured by our company
System status
Make sure that the system status is Standby.
How to do
1 Open the upper protective shield of the analyzer.
2 Place more than 50ml concentrated wash solution in position D of the reagent
carousel, and place more than 5ml concentrated wash solution in position D2 on the
sample carousel.
3 Select Utility - Maintenance - Maintenance - Biochemistry Maintenance.
4 Choose Special Wash.
5 Confirm if cuvette check is needed after the special wash. If it is, mark the checkbox
in front of Perform Cuvette Check.
6 Select Continue to continue, or select Exit to abort the special wash.
7 The system starts cleaning the sample probe, reagent probe, mixers, cuvettes and
wash station. To terminate the clean process, select Stop.
8 Perform the cuvette check procedure. Refer to 16.6.4 Cuvette Check (page 16-27) for
details.
9 Select Done.
10 Restore the upper protective shield of the analyzer.
11 Select Scheduled Maintenance - Weekly.
12 Mark the Select checkbox in the same row as Special Wash.
13 Select OK to refresh the current date as the performance date.
14 Select Log, and then record comments and other important information for the
procedure.
15 Select OK to save your input information.
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16 Maintenance
When to do
You are recommended to perform this procedure on weekly basis or after performing
special wash or after replacing the reaction cuvettes.
System status
Prior to performing the maintenance, make sure that the system has been power on for
over 10 minutes and the system status is Standby. Check if the reaction carousel has a
cuvette for each position. If not, load cuvettes.
Precautions
NOTE
When a cuvette is deemed dirty, clean or replace it immediately, and then perform the
cuvette check again.
Stains inside cuvettes will influence the photometric measurement. You are
recommended to perform the Cuvette Check after finishing the Special Wash procedure.
How to do
1 Select Utility - Maintenance - Maintenance - Biochemistry Maintenance.
2 Choose Cuvette Check.
3 Make sure that the lamp has been turned on for over 10 minutes. Select Continue
and then select Start. When finishing the check, the system refreshes the cuvette
status based on the check results. Record the cuvettes highlighted in yellow and
please replace the cuvettes highlighted in yellow. To abort the cuvette check, select
Stop.
The screen shows all cuvettes and highlights the dirty cuvettes with special color:
No color indication: normal cuvette
Yellow: dirty cuvette
4 Select Result. The Cuvette Check Results window appears and shows the latest
check result of the 124 cuvettes at all wavelengths.
5 Choose a cuvette in the result list. The Cuvette Status window pops up.
Choose the following buttons as needed:
|<: to view the first cuvette.
<: to view the previous cuvette.
>: to view the next cuvette.
>|: to view the last cuvette.
Print: to print the results currently displayed on the screen.
Exit: to close the Cuvette Status window.
6 Select Exit to close the Cuvette Check window.
7 Select Scheduled Maintenance - Weekly.
8 Mark the Select checkbox in the same row as Cuvette Check.
9 Select OK to refresh the current date as the performance date.
10 Select Log, and then record comments and other important information for the
procedure.
11 Select OK to save your input information.
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16 Maintenance
NOTE
Before checking the lamp, perform the Cuvette Check procedure and replace or clean
the dirty cuvettes; otherwise, the photometer check results are unreliable.
To ensure the photometer’s measurement performance, replace the lamp in the case of
weak light intensity.
How to do
1 Select Utility - Maintenance - Maintenance - Biochemistry Maintenance.
2 Choose Photometer Check. The following window appears.
3 Make sure that the lamp has been turned on for over 10 minutes. Select Continue
and then select Start. When finishing the check, the system displays the results and
refreshes the photometer status. To abort the photometer check, select Stop.
On the left of the screen shows the absorbance at each wavelength in the current
photometer check; on the right of the screen shows that of the previous photometer
check. By checking the results of the previous and current photometer check, you
may understand the status of the lamp.
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16 Maintenance
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16 Maintenance
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Switch off the analyzing unit power.
2 Open the upper protective shield of the analyzer.
3 Rotate the same probe, reagent probe and mixers to keep them away from the wash
wells.
4 Use clean cotton swabs moistened with NaClO to clean the wash wells.
5 After finishing the cleaning, turn on the analyzing unit power switch.
6 Select Utility - Commands - Home to reset the probes and mixers, check if the wash
wells have a normal water flow.
7 Select Utility-Maintenance - Maintenance, and then select Scheduled
Maintenance - Monthly.
8 Mark the Select checkbox in the same row as Clean Wash Wells.
9 Select OK to refresh the current date as the performance date.
10 Select Log, and then record comments and other important information for the
procedure.
11 Select OK to save your input information.
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16 Maintenance
When to do
This procedure should be performed on monthly basis.
Materials required
Gauze, ethanol, deionized water, waste container (large beaker)
System status
Make sure that the system status is Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for
biohazard waste disposal.
How to do
1 Open the upper protective shield of the analyzer.
2 Remove the cuvette wash station and use ethanol-moistened gauze to wipe the wash
probes and wipe blocks.
3 Use gauze moistened with deionized water to clear the ethanol on the wash probes.
4 Restore the wash station.
5 Select Utility - Maintenance - Maintenance - Biochemistry Maintenance.
6 Choose Prime Wash Station. The maintenance guide window shows. Select
Continue.
7 Enter the wash cycle (1~100). The default is 10.
8 Select Continue.
9 When the cleaning and priming are finished, select Done.
10 Restore the upper protective shield of the analyzer.
11 Select Scheduled Maintenance - Monthly.
12 Mark the Select checkbox in the same row as Clean Cuvette Wash Station and
Tubes.
13 Select OK to refresh the current date as the performance date.
14 Select Log, and then record comments and other important information for the
procedure.
15 Select OK to save your input information.
16 Select Utility - Commands, and then select Home to put the instrument into the
Standby status.
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16 Maintenance
When to do
This procedure should be performed on monthly basis.
Materials required
Tube brush or ultrasound cleaner
System status
Make sure that the system status is Standby.
How to do
1 Select Utility - Maintenance - Maintenance - Biochemistry Maintenance.
2 Choose Clean Filter/Water Tank, and then select Continue.
3 Open the front door of the analyzer, unscrew the caps of the concentrated wash
solution tank and diluted wash solution tank, and then remove the tanks. The DI
water filter appears in front of you.
4 Put a water container below the filter.
5 Remove the connectors from the DI water tank and the filter.
6 Tilt the filter assembly, loosen the filter cap and remove the filter core. Use a tube
brush to clean the filter core’s surface, or put it in an ultrasound cleaner for 10
minutes.
Figure 16.5 Remove deionized water filter core
Press the
filter Loosen the
filter cap
Filter core
Remove
the filter
core
7 Restore the filter core and filter cap according to the above-mentioned steps in
reversed order.
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16 Maintenance
8 Restore the connectors on the DI water tank and the filter assembly; install the
concentrated wash solution tank and diluted wash solution tank, and tighten the
caps.
9 Select Continue. The system starts priming the tubes with deionized water.
10 When the priming is complete, select Done.
If you perform this procedure while the instrument is off, start it up until the system
status becomes Incubation. Perform Clean Filter/Water Tank to remove air from
the fluidic tubes by priming deionized water.
NOTE
Use a suction cleaner to clean the dust screens while keeping them uninstalled, or use a
hair brush and fresh water to clean the dust screens after removing them from the
analyzer.
Do not reinstall the dust screens until they are dry completely.
Install the dust screens correctly to avoid gaps.
To clean the dust screens by knocking them at solid ground, find an appropriate place,
and then carefully knock them at the ground.
How to do
1 Switch off the analyzer’s main power.
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16 Maintenance
2 Open the front door of the analyzer and remove the dust screens by lifting in the
middle and pushing outwards.
Figure 16.6 Dust screens
3 Use the suction cleaner, or hair brush and fresh water to clean the dust screens, and
then dry them in air.
4 Reinstall the dust screens when they are dry.
5 Close the front door of the analyzer.
6 Power on the analyzer and run the operating software.
7 Make sure that the system status is Incubation or Standby.
8 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Monthly.
9 Mark the Select checkbox in the same row as Clean Dust Screens.
10 Select OK to refresh the current date as the performance date.
11 Select Log, and then record comments and other important information for the
procedure.
12 Select OK to save your input information.
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16 Maintenance
How to do
1 Make sure that the system status is Incubation or Standby.
2 Select Utility - Maintenance - Maintenance - ISE Maintenance.
3 Choose the Clean Sample Injection Port option.
4 Open the upper protective shield of the analyzer.
5 Open the cover of the ISE module.
6 Use clean cotton swab soaked with ethanol to wipe the sample injection port
(interior of the sample injection cup of the ISE module ) until it is clean; then use a
clean cotton swab soaked with DI water to wipe the interior and periphery of the
sample injection port.
7 Select Done.
8 Select Purge A and Purge B to prime the ISE module.
9 Select Scheduled Maintenance - Monthly.
10 Mark the Select checkbox in the same row as Clean Sample Injection Port.
11 Select OK to refresh the current date as the performance date.
12 Select Log, and then record comments and other important information for the
procedure.
13 Select OK to save your input information.
14 Restore the cover of the ISE module.
15 Restore the upper protective shield of the analyzer.
6 Select Done.
7 To view the detailed results, select Pump Calibration Result. The detailed results are
displayed in the data list.
8 Select Scheduled Maintenance - Monthly.
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16 Maintenance
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Select Utility - Maintenance - Maintenance - ISE Maintenance.
2 Choose Air Bubble Detector Calibration.
3 Select Start.
When the calibration is complete, the calibration results are displayed on the screen.
4 Select Done.
5 To view the detailed results, select Air Bubble Detector Calibration Result. The
detailed results are displayed in the data list.
6 Select Scheduled Maintenance - Monthly.
7 Mark the Select checkbox in the same row as Air Bubble Detector Calibration.
8 Select OK to refresh the current date as the performance date.
9 Select Log, and then record comments and other important information for the
procedure.
10 Select OK to save your input information.
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16 Maintenance
Press the dust screen and make it contact tightly with the groove.
Push it downward gently and make the lower end inserted into the groove as
well.
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16 Maintenance
3 Wash the removed dust screen with water and dry it.
16-39
16 Maintenance
DI water tank
4 Remove the quick connector from the outlet of the water tank, and then pull the
water tank outwards for a little to expose its opening.
5 Put a water container below the outlet of the DI water tank; insert another normally
open quick connector into the outlet to drain water into the water container. When
the DI water tank is emptied, proceed to the next step. Or you may close the outlet
with a solid plug, take out the water tank completely, and then empty it by inclining it.
Choose this method if there is little water inside the DI water tank.
6 Remove the tubes from the tank inlet, disconnect the liquid level floater signal cable
from the right panel of the water tank, take out the water tank completely, and then
remove the liquid level floater. Perform this step according to the figure below.
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16 Maintenance
Outlet connector.
Press to drain water
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16 Maintenance
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16 Maintenance
CAUTION
Too hot lamp may burn you. Do not replace the lamp until it gets cool.
Please use consumables recommended by our company. Use of other consumables may
degrade the system performance.
Do not touch the light entrance on the lamp housing or the lens in front of the lamp. In
case the light entrance is dirty, use cotton swabs moistened with absolute ethanol to
clean it.
How to do
1 Select Utility - Maintenance - Maintenance - Biochemistry Maintenance.
2 Choose Replace Lamp. The maintenance guide window pops up. Select Continue.
3 Make sure that the lamp has cooled down for 5 minutes, and then select Continue.
4 Remove the cover plate of the lamp.
5 Wear a pair of cotton or antistatic gloves, loosen the nuts on the cable terminals, and
then remove the O-ring connectors from the terminals.
6 Loosen the retaining screw on the left side of the lamp.
7 Remove the lamp from the lamp housing.
CAUTION
Do not hold the lamp by its bulb to prevent contamination and damage.
8 Install the retaining screw, O-ring connectors, cable terminal nuts and lamp cover
plate in the reversed order.
9 Select Continue.
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16 Maintenance
11 Select Log, and then record comments and other important information for the
procedure.
12 Select OK to save your input information.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
How to do
1 Select Utility - Maintenance - Maintenance - ISE Maintenance.
2 Choose Replace Electrode.
3 Select reference electrode, and enter the lot number and expiration date. Select Add
and then select OK.
4 Take out the insert from the new reference electrode, and ensure no crystallized salt
exists in and around it. If needed, clean the electrode with warm water. Meanwhile
make sure the red ball of the reference electrode floats on the internal fluid. Make
sure the O rings of all electrodes remain intact.
5 Select Continue.
6 Open the ISE side door and remove the cover of the shielding box.
7 Open the electrode case, take out the electrode, remove the tapes around its inside,
and then use clean tissue to wipe it.
8 Remove all electrodes from the ISE module.
9 Replace the old electrode and then press the compressor; place the reference
electrode at the bottom of the ISE module and make the rear part of the electrode
contact closely with the internal wall of the ISE module. Loosen the compressor and
ensure the electrodes are fixed tightly.
10 Restore other electrodes in the order of Cl, K, Na and spacer from bottom to top.
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16 Maintenance
NOTE
The Na, K and Cl electrodes are of the same size and shape. Ensure that the
electrodes are inserted in the correct order. If one of the electrodes cannot be
easily pushed into the housing, check the electrode first and then repeat the
installation process.
11 Select Continue.
NOTE
The new electrode can be calibrated successfully only after certain time period (at
least 30 minutes).
12 Select Done.
13 Restore the cover of the shielding box and close the side door of the ISE module.
14 Run ISE calibration.
15 Select Scheduled Maintenance - Other.
16 Mark the Select checkbox in the same row as Replace Reference Electrode.
17 Select OK to refresh the current date as the performance date.
18 Select Log, and then record comments and other important information for the
procedure.
19 Select OK to save your input information.
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16 Maintenance
Warning
Do not spill liquid on the analyzer. Liquid ingression may cause equipment damage.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for
biohazard waste disposal.
How to do
1 Make sure that the system is not running tests, and then open the protective shield.
2 Use clean gauze moistened with ethanol to clean the analyzer panels and carousel
covers.
3 Use wash solution to clean the screen and keyboard.
4 Restore the protective shield.
5 Select Scheduled Maintenance - Other.
6 Mark the Select checkbox in the same row as Clean Analyzer Panels.
7 Select OK to refresh the current date as the performance date.
8 Select Log, and then record comments and other important information for the
procedure.
9 Select OK to save your input information.
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16 Maintenance
Purpose
To clean the sample carousel assembly to ensure clear operating environment and
eliminate the risks of cross contamination.
When to do
Perform this procedure when samples are spilled into the sample compartment or dust is
found inside of it.
Materials required
Clean gauze, deionized water, ethanol, and cotton swabs
System status
Make sure that the system is not running any tests.
Precautions
Warning
Do not spill water or ethanol into the sample compartment to prevent equipment
damage.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for
biohazard waste disposal.
How to do
1 Make sure that the system is not running any tests.
2 Remove the sample carousel cover and sample carousel, and then store them
properly.
3 Use clean gauze soaked with deionized water or ethanol to clean the interior of the
sample compartment. If necessary, you can use gauze moistened with neutral wash
solution.
4 Use clean gauze soaked with deionized water or ethanol to clean the sample carousel,
and then use cotton swabs dipped with ethanol to clean the sample positions.
5 Install the sample carousel and the carousel cover.
6 Select Scheduled Maintenance - Other.
7 Mark the Select checkbox in the same row as Clean Sample Compartment.
8 Select OK to refresh the current date as the performance date.
9 Select Log, and then record comments and other important information for the
procedure.
10 Select OK to save your input information.
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16 Maintenance
Purpose
To clean the reagent carousel assembly to ensure clear operating environment and
eliminate the risks of cross contamination.
When to do
Perform this procedure when reagents are spilled into the reagent compartment or dust
is found inside of it.
Materials required
Clean gauze, deionized water, ethanol, and cotton swabs
System status
Make sure that the system is not running any tests.
Precautions
Warning
Do not spill water or ethanol into the reagent compartment to prevent equipment
damage.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for
biohazard waste disposal.
How to do
1 Make sure that the system is not running any tests.
2 Remove the reagent carousel cover and reagent carousel, and then store them
properly.
3 Use clean gauze soaked with deionized water or ethanol to clean the interior of the
reagent compartment. If necessary, you can use gauze moistened with neutral wash
solution.
4 Use clean gauze soaked with deionized water or ethanol to clean the reagent
carousel, and then use cotton swabs dipped with ethanol to clean the reagent
positions.
5 Install the reagent carousel and the carousel cover.
6 Select Scheduled Maintenance - Other.
7 Mark the Select checkbox in the same row as Clean Reagent Compartment.
8 Select OK to refresh the current date as the performance date.
9 Select Log, and then record comments and other important information for the
procedure.
10 Select OK to save your input information.
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16 Maintenance
Purpose
To clean the interior of the sample probe and avoid clogging.
When to do
Perform this procedure when you find that the sample probe is clogged and cannot
aspirate or dispense sample, or when the sample probe is detected with abnormal liquid
flow through the Check Probes/Mixers maintenance.
Materials required
Unclogging device (or needle), small slot-head screwdriver, small Philips-head screwdriver,
beaker, tweezers, deionized water, and thread syringe
System status
Make sure that the system status is not running any tests.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Recall the maintenance logs and check if the sample probe has been removed and
reinstalled for 3 times. If it has, prepare a new washer and moisten it with deionized
water. Store the washer properly to avoid being lost.
2 Switch off the analyzing unit power.
3 Loosen the screws on the arm cover and remove the cover from the arm base.
4 Press the circuit board with one hand and unplug the tube connector with the other
hand, and then use a small slot-head screwdriver to loosen the earthing wire on the
sample probe.
5 Use a small screwdriver to remove the retaining screw from the sample probe and
take out the spring.
6 While holding the connector on the sample probe with one hand, unscrew the tube
connector counterclockwise with the other hand until the tube connector is
disconnected. Remove the tube from the sample probe.
Exercise caution to prevent the washer from dropping out. If the washer drops out,
store it in a clear place for later installation. To replace the washer, take it out from
the tube connector.
9 When continuous water flow comes out of the sample probe in the same direction
with the probe, it indicates the cleaning procedure is finished successfully. Remove
the unclogging device. If water flow is still abnormal after unclogging, replace the
sample probe with a new one.
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10 Insert the sample probe downwards into the hole on the probe arm while aligning
the screw hole on the probe plate to the rod inside the arm.
11 To replace the washer, remove the old one from the tube connector and install the
new one. Connect the tube connector to the sample probe and then tighten it.
12 Fix the earthing wire of the sample probe to the earthing terminal inside the arm;
connect the probe connector to the liquid level detection board.
13 Sleeve the spring on the rod and tighten the retaining screw. Pay attention to the
spring direction and make the thread opening face downwards.
14 Pinch the sample probe by the part near the probe arm. Push the sample probe
upwards and then release it to check if the spring works well.
If it does, proceed to the next step.
If not, check if the spring is clamped or fixed too tightly.
15 Switch on the analyzing unit power, and then check if the No.D2 LED indicator on
the circuit board inside the probe arm is lit.
If it is, the liquid level detection system is normal.
If not, the liquid level detection system is abnormal. Contact our customer
service department or your local distributor.
16 Install the probe arm cover properly until you hear a click, and then tighten the
screws on it.
17 Pinch the sample probe by the part near the probe arm. Push the sample probe
upwards and then release it to check if the spring works well.
If it does, proceed to the next step.
It not, it indicates that the arm cover is not installed correctly. Reinstall the arm
cover and check the spring until it can move freely.
18 Execute the Home maintenance command or the Home system command. Check if
the water flow coming out of the sample probe is continuous and in the same
direction as the probe. If it is not, perform the Check Probes/Mixers procedure to
troubleshoot the problems.
19 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Other.
20 Mark the Select checkbox to the right of Clean Sample Probe Interior.
21 Select OK to refresh the current date as the performance date.
22 Select Log, and then record comments and other important information for the
procedure.
23 Select OK to save your input information.
24 Select Utility - Commands, and then select Home to put the instrument into the
Standby status.
16-51
16 Maintenance
When to do
Perform this procedure when you find that a reagent probe is clogged and cannot
aspirate or dispense sample, or when a reagent probe is detected with abnormal liquid
flow through the Check Probes/Mixers maintenance.
Materials required
Unclogging device (or needle), small slot-head screwdriver, small Philips-head screwdriver,
beaker, tweezers, deionized water, and thread syringe
System status
Make sure that the system status is not running any tests.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Recall the maintenance logs and check if the reagent probe has been removed and
reinstalled for 3 times. If it has, prepare a new washer and moisten it with deionized
water. Store the washer properly to avoid being lost.
2 Switch off the analyzing unit power.
3 Clean the reagent probe by referring to step 3 to 18 in 16.10.4 Clean Sample Probe
Interior.
4 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Other.
5 Mark the Select checkbox to the right of Clean Reagent Probe Interior.
6 Select OK to refresh the current date as the performance date.
7 Select Log, and then record comments and other important information for the
procedure.
8 Select OK to save your input information.
9 Select Utility - Commands, and then select Home to put the instrument into the
Standby status.
16-52
16 Maintenance
Precautions
Warning
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Prepare the new sample probe. Recall the maintenance logs and check if the sample
probe has been removed and reinstalled for 3 times. If it has, prepare a new washer
and moisten it with deionized water. Store the washer properly to avoid being lost.
2 Switch off the analyzing unit power.
3 Loosen the screws on the arm cover and remove the cover from the arm base.
4 Press the circuit board with one hand and unplug the tube connector with the other
hand, and then use a small slot-head screwdriver to loosen the earthing wire on the
sample probe.
5 Use a small screwdriver to remove the retaining screw from the sample probe and
take out the spring.
6 While holding the connector on the sample probe with one hand, unscrew the tube
connector counterclockwise with the other hand until the tube connector is
disconnected. Remove the tube from the sample probe.
Exercise caution to prevent the washer from dropping out. If the washer drops out,
store it in a clear place for later installation. To replace the washer, take it out from
the tube connector.
7 Remove the sample probe.
8 Insert the sample probe downwards into the hole on the probe arm while aligning
the screw hole on the probe plate to the rod inside the arm.
9 To replace the washer, remove the old one from the tube connector and install the
new one. Connect the tube connector to the sample probe and then tighten it.
10 Fix the earthing wire of the sample probe to the earthing terminal inside the arm;
connect the probe connector to the liquid level detection board.
11 Sleeve the spring on the rod and tighten the retaining screw. Pay attention to the
spring direction and make the thread opening face downwards.
12 Pinch the sample probe by the part near the probe arm. Push the sample probe
upwards and then release it to check if the spring works well.
If it does, proceed to the next step.
If not, check if the spring is clamped or fixed too tightly.
13 Switch on the analyzing unit power, and then check if the No.D2 LED indicator on
the circuit board inside the probe arm is lit.
If it is, the liquid level detection system is normal.
If not, the liquid level detection system is abnormal. Contact our customer
service department or your local distributor.
14 Install the probe arm cover properly until you hear a click, and then tighten the
screws on it.
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16 Maintenance
15 Execute the Home maintenance command or the Home system command. Check if
the water flow coming out of the sample probe is continuous and in the same
direction as the probe. If it is not, perform the Check Probes/Mixers procedure to
troubleshoot the problems.
16 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Other.
17 Mark the Select checkbox in the same row as Replace Sample Probe.
18 Select OK to refresh the current date as the performance date.
19 Select Log, and then record comments and other important information for the
procedure.
20 Select OK to save your input information.
21 Select Utility - Commands, and then select Home to put the instrument into the
Standby status.
Warning
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Prepare the new reagent probe. Recall the maintenance logs and check if the reagent
probe has been removed and reinstalled for 3 times. If it has, prepare a new washer
and moisten it with deionized water. Store the washer properly to avoid being lost.
2 Switch off the analyzing unit power.
3 Replace the reagent probe by referring to step 3 to 15 in 16.10.6 Replace Sample
Probe (page 16-52).
4 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Other.
5 Mark the Select checkbox to the right of Replace Probe R1 or Replace Probe R2.
6 Select OK to refresh the current date as the performance date.
16-54
16 Maintenance
7 Select Log, and then record comments and other important information for the
procedure.
8 Select OK to save your input information.
9 Select Utility - Commands, and then select Home to put the instrument into the
Standby status.
Warning
The mixer tips are sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the mixers.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Switch off the analyzing unit power.
2 Gently pull the sample mixer to its highest point and rotate it to a position
convenient to operate.
3 Use one mixer wrench to hold the mixer by the flat area, use the other mixer wrench
to hold the lock nut, unscrew the lock nut counterclockwise to loosen the mixer, and
then pull the mixer downwards to remove it and remove the lock nut.
CAUTION
When trying to pull out the mixer, concentrate your force in the direction of the axis
on the mixer arm. Biased force may damage the mixer and/or the axis.
16-55
16 Maintenance
4 Align the new mixer to the bigger hole of the retaining nut and gently screw it into
the nut until the end of the mixer is in line with the smaller hole of the nut.
Figure 16.10 Mixer and lock nut
Lock nut
Mixer
5 Pinch the mixer by the flat part and align the hole of the nut to the axis on the mixer
and push the nut onto the mixer until it reaches the end of the mixer. Use one mixer
wrench to hold the mixer by the flat area, use the other mixer wrench to hold the
lock nut, and then screw the lock nut clockwise to tighten the mixer.
CAUTION
When trying to push the mixer into the arm, concentrate your force in the direction
of the axis on the mixer arm. Biased force may damage the mixer and/or the axis.
Ensure the mixer is all the way pushed to the end.
When tightening the lock nut with the mixer wrench, use even force to prevent
beding the mixer rotor.
6 After replacing the bar, visually check whether the mixer is vertical to the bar arm.
If not, remove the mixer and reinstall it.
If so, proceed to the next step.
7 Pull the mixer arm to its highest point and rotate it back to a position above its wash
well.
8 Turn on the analyzing unit power switch.
9 Select Utility - Command; Perform the Home maintenance procedure.
10 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Other.
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16 Maintenance
11 Mark the Select checkbox in the same row as Replace Sample mixer.
12 Select OK to refresh the current date as the performance date.
13 Select Log, and then record comments and other important information for the
procedure.
14 Select OK to save your input information.
Warning
The mixer tips are sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the mixers.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Switch off the analyzing unit power.
2 Replace the reagent mixer by referring to step 2 to 9 in 16.10.9 Replace Reagent
Mixer (page 16-57).
3 Select Utility - Command - Home.
4 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Other.
5 Mark the Select checkbox in the same row as Replace Reagent mixer.
6 Select OK to refresh the current date as the performance date.
7 Select Log, and then record comments and other important information for the
procedure.
8 Select OK to save your input information.
16-57
16 Maintenance
When to do
Perform this procedure when you find air bubbles inside the sample syringe.
Materials required
Deionized water and beaker
System status
Make sure that the system is not running any tests.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Switch off the analyzing unit power, and open the front door of the analyzer.
2 Loosen counterclockwise the four retaining screws on top of the syringe, and then
remove the screws and the fixing blocks.
3 Loosen counterclockwise the retaining screw at the bottom of the syringe and then
remove it.
4 Hold the T piece with one hand and the syringe connector with the other hand.
Loosen the syringe counterclockwise and then remove the washer.
5 Soak the syringe connector in the deionized water beaker, pull the plunger head to
aspirate half syringe of deionized water, and then push the plunger head to remove
the air. Repeat this pull-push operation until the air bubbles are removed from the
syringe. Fill the syringe with half cylinder of deionized water to prevent new
bubbles.
6 Put the washer in the T piece. Hold the T piece with one hand and the syringe
connector with the other hand, and then screw the T piece clockwise.
7 Install the syringe on the bracket.
8 Install the fixing blocks and 4 retaining screws while having the retaining screws not
tightened.
9 Align the plunger head to the retaining screw at the bottom of the syringe, and then
tighten clockwise the retaining screw.
10 Pinch the plunger guide cap to adjust the syringe height. For the sample syringe,
make the syringe head over the upper fixing block for 7.5 scales; for the reagent
syringes, make the syringe head over the upper fixing block for 15 scales.
11 Tighten the four retaining screws on the fixing blocks.
12 Turn on the analyzing unit power switch.
13 Perform the Home maintenance procedure. Check the new syringe for leak and
bubbles, and if there is, perform the Check Sample/Reagent Syringes procedure.
14 Close the front door of the analyzer.
15 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Other.
16 Mark the Select checkbox in the same row as Remove Air Bubbles in Sample
Syringe.
17 Select OK to refresh the current date as the performance date.
16-58
16 Maintenance
18 Select Log, and then record comments and other important information for the
procedure.
19 Select OK to save your input information.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Switch off the analyzing unit power, and open the front door of the analyzer.
2 Remove the air bubbles in reagent syringe by referring to step 2 to 14 in 16.10.10
Remove Air Bubbles in Sample Syringe (page 16-57).
3 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Other.
4 Mark the Select checkbox in the same row as Remove Air Bubbles in Reagent
Syringe.
5 Select OK to refresh the current date as the performance date.
6 Select Log, and then record comments and other important information for the
procedure.
7 Select OK to save your input information.
16-59
16 Maintenance
Materials required
Fiber-free gloves, dry cloth or gauze, and reaction cuvettes
System status
Make sure that the system status is Standby or Stopped.
Precautions
Warning
While installing the reaction cuvettes, exercise caution to avoid scratching them. Do not
touch the optical surface of the reaction cuvettes. If the optical surface is polluted, the
obtained absorbance may be inaccurate.
While installing the reaction cuvettes, make sure that the optical surface is confronted
with the outside of the reaction carousel.
Wear gloves free of fibre and powder to avoid polluting the optical surface of the
reaction cuvettes.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
CAUTION
Please use consumables recommended by our company. Use of other consumables may
degrade the system performance.
NOTE
If a cuvette cannot be removed from the reaction carousel, remove 1 or 2 cuvettes to the
right of the cuvette, use a knife to remove the metal plate next to it, and then use your
hands or tweezers to take out the cuvette.
When serious problems occur such as overflow and require the reaction cuvettes to be
maintained, contact our customer service department or your local distributor.
How to do
1 Select Utility - Maintenance - Maintenance - Biochemistry Maintenance.
2 Choose Replace Cuvette.
3 Select Continue.
4 Remove the reaction carousel cover.
5 Type in the position number of the cuvette you want to replace.
The input range is 1-124. Only one position number can be entered each time.
6 Select Replace.
7 Wear a pair of gloves and remove the specified cuvette by pulling it outwards.
8 Install the provided or cleaned cuvette to the reaction carousel and make sure that
the cuvette bottom can no longer proceed.
9 Restore the reaction carousel cover.
10 Select Done. The system resets mechanically.
11 Perform the Cuvette Check procedure to check if the new cuvettes meet the
requirements.
16-60
16 Maintenance
16-61
16 Maintenance
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
CAUTION
Exercise caution not to spray water or ethanol or other liquids on the glass of the bar
code scanning window.
How to do
1 Remove the sample/reagent carousel covers and the carousels.
2 Use clean gauze to clean the bar code reader window inside the sample compartment
and reagent compartment. If necessary, you can use gauze soaked with ethanol or
deionized water. Make sure that there is no trace or dust left on the glass.
3 Install the carousels and carousel covers.
4 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Other.
5 Mark the Select checkbox in the same row as Bar Code Maint.
6 Select OK to refresh the current date as the performance date.
7 Select Log, and then record comments and other important information for the
procedure.
8 Select OK to save your input information.
16-62
16 Maintenance
System status
Make sure that the system status is not Running.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Select Utility - Maintenance - Maintenance - Biochemistry Maintenance.
2 Choose Clean Probes/Mixers Exterior.
3 Input the wash cycle (1~100).
4 Select Continue.
5 Select Done.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
NOTE
After performing this procedure, recalibrate the ISE electrodes prior to starting analysis.
How to do
1 Select Utility - Maintenance - Maintenance - ISE Maintenance.
2 Choose Replace Electrode.
3 Select desired electrodes, and enter the lot number and expiration date. Select Add
and then select OK.
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16 Maintenance
4 Select Continue.
5 Open the ISE side door and remove the cover of the shielding box.
6 Open the electrode case, take out the electrode, remove the tapes around its inside,
and then use clean tissue to wipe it.
NOTE
Take out the insert from the reference electrode, and ensure no crystallized salt
exists in and around it. If needed, clean the electrode with warm water. Meanwhile
make sure the red ball of the reference electrode floats on the internal fluid. Make
sure the O rings of all electrodes remain intact.
7 Remove all electrodes from the ISE module.
8 Replace the old electrode and then press the compressor; place the reference
electrode at the bottom of the ISE module and make the rear part of the electrode
contact closely with the internal wall of the ISE module. Loosen the compressor and
ensure the electrodes are fixed tightly.
9 Restore other electrodes in the order of Cl, K, Na and spacer from bottom to top.
10 Select Continue.
NOTE
The new electrode can be calibrated successfully only after certain time period (at
least 30 minutes). Some electrodes need to be activated by serum before
calibration.
11 Select Done.
NOTE
The Na, K and Cl electrodes are of the same size and shape. Ensure that the
electrodes are inserted in the correct order. If one of the electrodes cannot be
easily pushed into the housing, check the electrode first and then repeat the
installation process.
12 Restore the cover of the shielding box and close the side door of the ISE module.
13 Run ISE calibration.
14 Select Scheduled Maintenance - Other.
15 Mark the Select checkbox in the same row as Replace ISE Electrode.
16 Select OK to refresh the current date as the performance date.
17 Select Log, and then record comments and other important information for the
procedure.
18 Select OK to save your input information.
16-64
16 Maintenance
System status
Make sure that the status of the ISE module is Standby or Failure.
How to do
1 Select Utility - Maintenance - Maintenance - ISE Maintenance.
2 Choose Remove Reagent Pack.
3 Remove the tube of pump A and then reinstall the tube by switching the connectors
of the tube. Handle pump B in the same way.
4 Select Continue.
5 Install the tubes of pump A and B in the reverse direction and then select Continue.
The system executes purge A and B each for 30 times.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
16-65
16 Maintenance
How to do
1 Remove the reagent pack according to 16.10.17 Remove Reagent Pack (Page 16-64).
2 Select Utility - Maintenance - Maintenance - ISE Maintenance.
3 Choose Store Electrodes.
4 Select Continue.
5 Open the ISE side door and remove the cover of the shielding box.
6 Remove all electrodes from the ISE module.
NOTE
Reference electrode: Put back the insert to the cell of the reference electrode and
prevent the crystallized salt from clogging the cell. And then store the electrode in
an electrode case at the room temperature in a sun-shielding place.
Na, K, Cl electrode: Take out a little calibrator A from the reagent pack, inject it
into the cell of the electrode and seal it with tape. Make sure proper amount of
calibrator is injected into the cell of the electrode. Store the capped electrodes in
an electrode case at the room temperature in a sun-shielding place.
Note the storage temperature should be below 40℃.
7 Select Continue.
8 Restore the cover of the shielding box and close the side door of the ISE module.
9 Select Done.
10 Select Scheduled Maintenance - Other.
11 Mark the Select checkbox in the same row as Store Electrodes.
12 Select OK to refresh the current date as the performance date.
13 Select Log, and then record comments and other important information for the
procedure.
14 Select OK to save your input information.
When the calibration is finished, the progress box is closed automatically, and the
calibration results are displayed in the data list.
16-66
16 Maintenance
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
How to do
1 Remove the reagent pack according to 16.10.17 Remove Reagent Pack (Page 16-64).
2 Select Utility - Maintenance - Maintenance - ISE Maintenance.
3 Choose Replace Tubes and Pump and Calibrator.
4 Select Continue.
5 Select the tube type that you want to replace and then select OK.
6 Replace the old tube with a new one. Make sure the connectors and tubes are
correctly connected; otherwise ISE module failure may occur.
7 Select Continue.
8 After replacing the tubes, please load the reagent pack. Select Continue.
9 Select Done.
16-67
16 Maintenance
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Prepare a new syringe assembly and washer, put the plunger head in the deionized
water beaker to remove air from the syringe, and then moisten the washer in the
deionized water.
2 Switch off the analyzing unit power.
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16 Maintenance
3 Open the front door of the analyzer. You will see three syringes, reagent syringes to
the left of the water tank and sample syringe to the right.
4 Loosen counterclockwise the four retaining screws on top of the syringe, and then
remove the screws and the fixing blocks.
5 Loosen counterclockwise the retaining screw at the bottom of the syringe and then
remove it.
6 Hold the T piece with one hand and the syringe connector with the other hand.
Loosen the syringe counterclockwise and then remove the washer.
7 Soak the new syringe connector in the deionized water beaker, pull the plunger head
to aspirate half syringe of deionized water, and then push the plunger head to
remove the air.
8 If there is no washer inside the T piece, put the new washer in the T piece. Hold the
T piece with one hand and the syringe connector with the other hand, and then
screw the T piece clockwise.
9 Install the syringe on the bracket.
10 Install the fixing blocks and 4 retaining screws while having the retaining screws not
tightened.
11 Align the plunger head to the retaining screw at the bottom of the syringe, and then
tighten clockwise the retaining screw.
12 Pinch the plunger guide cap to adjust the syringe height. For the sample syringe,
make the syringe head over the upper fixing block for 7.5 scales; for the reagent
syringes, make the syringe head over the upper fixing block for 15 scales.
13 Tighten the four retaining screws on the fixing blocks.
14 Turn on the analyzing unit power switch.
15 Perform the Home maintenance procedure. Check if the new syringe has leak. If it
does, perform the Check Sample/Reagent Syringes procedure to check the syringe.
16 Close the front door of the analyzer.
17 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Other.
18 Mark the Select checkbox to the right of Replace Sample Syringe.
19 Select OK to refresh the current date as the performance date.
20 Select Log, and then record comments and other important information for the
procedure.
21 Select OK to save your input information.
16-69
16 Maintenance
When to do
Perform this procedure when the syringes are used for 300,000 times, or has leak or
other abnormal phenomena.
Materials required
Deionized water, beaker, and syringe assembly
System status
Make sure that the system is not running any tests.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1 Prepare a new syringe assembly and washer, put the plunger head in the deionized
water beaker to remove air from the syringe, and then moisten the washer in the
deionized water.
2 Switch off the analyzing unit power.
3 Replace the reagent syringe by referring to step 3 to 16 in 16.10.27 Replace Sample
Syringe(page 16-68).
4 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Other.
5 Mark the Select checkbox to the right of Replace R1 Syringe or Replace R2
Syringe.
6 Select OK to refresh the current date as the performance date.
7 Select Log, and then record comments and other important information for the
procedure.
8 Select OK to save your input information.
16-70
16 Maintenance
Precautions
Warning
The probe and mixer tip are sharp and may cause puncture wounds. To prevent injury,
exercise caution when working around the probes and mixers.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for
biohazard waste disposal.
How to do
1 Switch off the analyzing unit power.
2 Pull the probe/mixer arm to the highest point, and then rotate the arm to move the
probe/mixer to a position convenient to operate.
3 Wipe the rotor with clean gauze.
4 After finishing the cleaning, turn on the analyzing unit power switch.
5 Select Utility - Commands - Home to reset the probes and mixers.
6 Select Utility - Maintenance - Maintenance, and then select Scheduled
Maintenance - Other.
7 Mark the Select checkbox in the same row as Clean Rotors.
8 Select OK to refresh the current date as the performance date.
9 Select Log, and then record comments and other important information for the
procedure.
10 Select OK to save your input information.
Warning
Do not spill liquid on the analyzer. Liquid ingression may cause equipment damage.
16-71
16 Maintenance
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Note
Excessive bleach and DI water flushed into the ISE reagent pack waste bag may cause
waste bag over expansion and clog the Cal A & Cal B reagent flow.
To prevent this problem, connect to an old used-up reagent pack and follow the
procedures below.
How to do
1 Ensure the analyzer is on idle (standby) condition. Open the ISE cover on the right
side analyzer panel.
2 Remove the electrode housing cover. Remove the waste tube fitting from the bottom
of the right angle adaptor. Remove waste peri-pump tube from the pump bracket.
Refer to pictures below.
Right angle
Waste adaptor
peri-pump
3 Connect the waste tube fitting to a syringe and unclogging tool with 5 mL of
undiluted household bleach. Refer to pictures below.
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16 Maintenance
Unclogging Tool
4 Press the wand release button to remove the wand from the current in use ISE
reagent pack and keep it in a save place. Engage the wand to an old used-up reagent
pack.
5 Inject bleach into the ISE waste tube and soak the tube for 5 minutes. Discharge the
waste into the reagent pack.
Note: When the bleach cannot be injected into the ISE pack, remove the wand and
push down to open the waste valve manually with a sharp object, and then inject
again. If bleach can go through this time, the waste bag was clogged and cannot be
used. If bleach still cannot be injected, replacing the ISE wand is recommended.
Waste valve
6 Repeat this step with 5 mL of DI water without the 5 minutes of soaking time.
7 Remove the wand from the old use-up pack and re-install it back to the current in
use ISE pack. Re-install the waste tube fitting back to the ISE electrode housing right
angle adaptor and waste peri-pump tube back to the pump bracket. Re-install the
housing cover.
8 Calibrate ISE pump to ensure it passes, all reagents and waste flow are normal.
Calibrate all electrodes and run QC test to ensure they all pass within their given
range.
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16 Maintenance
16-74
17 Alarms and Troubleshooting
The following pages describe how to view and edit error logs and edit logs, and how to
locate failure and determine relevant corrective actions. Read this chapter thoroughly to
achieve the best performance of the instrument.
17-1
17 Alarms and Troubleshooting
Classification of failure
Failures are divided into the following types based on component, severity and
processing method:
Table 17.1 Classification of failure based on component
No. Failure by Component
1 Operating system
2 System communication
3 Database
4 Result calculation
5 Sample bar code
6 Reagent bar code
7 Host communication
8 Command execution
9 Sample probe unit
10 Probe R1 unit
11 Probe R2 unit
12 Sample mixer unit
13 Reagent mixer unit
14 Reaction carousel unit
15 Sample carousel unit
16 Reagent carousel unit
17 Wash station
18 Temperature unit
19 ISE unit
20 Light source
21 Cuvette wash station
22 Reagent refrigeration unit
23 Other
24 Home process
17-2
17 Alarms and Troubleshooting
17-3
17 Alarms and Troubleshooting
Error code
Each error has a unit code used for identification and locating probable causes and
solutions. An error code consists of 6 letters and numbers, such as “C01001”, in which “C”
indicates that the error occurs on the operation unit, “01” is the error description of
instrument connection, and “001” is the serial number of the error. Therefore, “C01001”
is described as “the first error of instrument connection on the operation unit”.
The following tables provide a summary of error codes for the operation unit and
analyzing unit.
Table 17.4 Error code of the operation unit
Error Code Description
C Indicates that the error occurs on the operation unit.
00-99 Indicates the specific component on which the error occurs.
00-Operating system
01- System communication
02-Database
03-Result calculation
04-Sample bar code
05-Reagent bar code
06-LIS host communication
07-Other
000-999 Serial number of the error.
17-4
17 Alarms and Troubleshooting
Help
Every error log is provided with online help information. Select the icon in front of
an error log. The descriptions, possible causes and solutions of the error are displayed.
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17 Alarms and Troubleshooting
Every error log contains the event ID, date/time, error description (by processing
method), event class (by subsystem) and symptom.
Choose the following buttons as needed:
Search F1: to search for error logs by date, event ID, symptom, or event class.
Refresh F2: to refresh the error logs based on the current search conditions.
Delete F3: to remove specified error logs on the screen.
Print F7: to print all error logs currently displayed on the screen.
17-6
17 Alarms and Troubleshooting
Every edit log contains the serial number, date/time, operator, event type and description.
Choose the following buttons as needed:
Search F1: to search for edit logs based on the occurring date.
Refresh F2: to refresh the edit logs based on the current search conditions.
Delete F3: to remove specified edit logs on the screen.
Print F7: to print all edit logs currently displayed on the screen.
17-7
17 Alarms and Troubleshooting
17-8
17 Alarms and Troubleshooting
Alarm tone
When an error occurs, the buzzer gives alarm tone reminding you to notice the error and
take corrective actions. Alarm tone can be adjusted manually or silenced.
Perform the following steps to adjust the alarm tone:
1 Select Utility - System Setup.
2 Adjust the alarm tone in the Alarm Volume field.
3 Test the alarm tone until it is satisfied.
4 To silence the alarm tone, drag the slider to the leftmost position of the scale.
5 Select Save F8 to save the adjustment.
Alarm message
When an error occurs, the system gives an alarm and displays the alarm message in the
second line of the prompt message area. For details of troubleshooting, refer to 17.5 Error
Messages and Corrective Actions (page 17-28).
Color highlight
An error will be indicated by highlighting relevant buttons and screen texts with different
colors. Yellow indicates a warning, and red indicates a serious warning or error.
Reagent button
Utility button
Alarm button
Select a button to access relevant function page, check for abnormities and take corrective
actions. When the problem is solved, the alarm indication disappears.
17-9
17 Alarms and Troubleshooting
Flag
Flag is also called data alarm. When calibration error or failure, or sample result error
occurs due to the sample, reagent or system failure, a flag will appear near the
corresponding calibration result or sample results.
Error log
All alarms are recorded in the error logs. By recalling the error logs you are enabled to
master the current status of the system and troubleshoot errors.
17-10
17 Alarms and Troubleshooting
17-11
17 Alarms and Troubleshooting
17-12
17 Alarms and Troubleshooting
17-13
17 Alarms and Troubleshooting
17-14
17 Alarms and Troubleshooting
17-15
17 Alarms and Troubleshooting
17-16
17 Alarms and Troubleshooting
17-17
17 Alarms and Troubleshooting
17-18
17 Alarms and Troubleshooting
17-19
17 Alarms and Troubleshooting
17-20
17 Alarms and Troubleshooting
17-21
17 Alarms and Troubleshooting
17-22
17 Alarms and Troubleshooting
17-23
17 Alarms and Troubleshooting
17-24
17 Alarms and Troubleshooting
17-25
17 Alarms and Troubleshooting
17-26
17 Alarms and Troubleshooting
17-27
17 Alarms and Troubleshooting
17-28
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Error: to move horizontally.
2. Failed to find the zero position:
The sample probe assembly is obstructed
when rotating.
3. Collision occurs during horizontal
movement:
The sample probe assembly is obstructed
when rotating.
4. Moving horizontally is not allowed in current
position:
The sample probe assembly is probably forced
to move vertically.
Sample syringe movement error.
1. Sensor status error:
The syringe assembly is probably forced to
move.
2. Failed to find the zero position:
The syringe assembly is probably jammed.
A01007 Sample probe Warning Sample probe collides / 1. Collision occurs during aspirating: 1. Collision occurs during aspirating:
unit with an obstacle when The sample probe collides with other object. Remove the obstacle, and then
aspirating recover failure by performing the
Sample position: Home maintenance procedure.
Sample ID/bar code:
Specific position:
A01021 Sample probe Error Clog detection board / Clog detection board communication error. Recover the failure. If this message
unit communication error. appears for 3 times, contact our
customer service department or your
local distributor.
A01022 Sample probe Warning Sample syringe / The aspirate volume is beyond the range of Define the aspirate volume correctly.
unit aspirates too much the syringe.
17-29
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Sample ID/bar code:
Position:
A01023 Sample probe Warning Sample syringe / The dispense volume is beyond the range of Define the dispense volume
unit dispenses too much the syringe. correctly.
Cuvette No.:
Sample ID/bar code:
Chemistry:
A01024 Sample probe Warning Insufficient sample / There is no sample or insufficient sample on 1. Check if the sample is sufficient,
unit Sample position: the designated position. and then try again.
Sample ID/bar code: 2. If the error remains, contact our
or customer service department or your
local distributor.
Sample probe level
detection failed.
A01027 Sample probe Error Sample is insufficient / There is no sample or insufficient sample on 1. Check if the sample is sufficient,
unit or contains air bubbles the designated position. and then try again.
Position: 2. If the error remains, contact our
Sample ID/bar code: customer service department or your
or local distributor.
Sample probe level
detection failed
Position:
Sample ID/bar code:
A01028 Sample probe Error Sample probe fails to / There is no deionized water, or the deionized 1. Check if the water supply is
unit detect liquid level water is not supplied normally. normal.
during cleaning 2. Recover the failure for 3 times. If
the error remains, contact our
Customer Service Department or
your local distributor.
A01029 Sample probe Warning Sample is insufficient / 1. The sample contains clots, or is too thick or 1. Check that the sample is
17-30
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
unit or contains fibrins and insufficient. preprocessed correctly; or check if
clots 2. The sample probe is clogged. the sample contains foreign matters
Position: such as clot. If it does, change the
Sample ID/bar code: sample.
or 2. Check if the sample is sufficient.
Sample probe clog 3. Clean the sample probe with wash
detection failed. solution. If the problem remains,
remove the sample probe and unclog
Position:
it, and then continue with the
Sample ID/bar code: measurement.
A01030 Sample probe Error Sample probe is / The sample probe is clogged. 1. Clean the sample probe with wash
unit clogged during solution. Remove the sample probe
cleaning and unclog it.
Sample ID/bar code: 2. If the problem remains, contact
Position: the manufacturer.
or
Sample probe clog
detection failed.
Sample ID/bar code:
Position:
A01033 Sample probe Warning Sample probe fails to / There is no reagent or insufficient reagent in 1. Check if R1 volume is sufficient
unit detect liquid level on the reaction cuvette. and the reagent bottle is free of air
reaction carousel bubbles, and then try again.
when dispensing. 2. If the problem remains, contact
Cuvette No.: the manufacturer.
Sample ID/bar code:
Chemistry:
or
Sample probe level
detection failed.
17-31
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Cuvette No.:
Sample ID/bar code:
Chemistry:
A01036 Sample probe Error Sample probe level / Level detection board communication error Recover the failure. If this message
unit detection board appears for 3 times, contact our
communication error customer service department or your
local distributor.
A01037 Sample probe Error Sample probe level / 1. The sample probe is not installed correctly 1. Check if the sample is installed
unit detection board or goes wrong. correctly or damaged.
self-calibrating failed 2. Level detection board communication error 2. Recover the failure. If your
attempt fails, contact our customer
service department or your local
distributor.
A01038 Sample probe Error Sample probe interior / Sample probe interior wash is abnormal. Contact our customer service
unit wash is abnormal. department or your local distributor.
A02006 Probe R2 unit Error Probe R2 vertical / Probe R2 vertical movement error Switch off the analyzing unit power
movement error 1. Sensor status error: and switch on it again. Recover
Position: The probe R2 assembly is probably forced to failure by performing the Home
Error: move vertically. maintenance procedure. If this
message appears for 3 times, contact
2. Failed to find the zero position:
our customer service department or
Or The probe R2 assembly is probably jammed. your local distributor.
3. Collision occurs during operation other than
Probe R2 horizontal aspirating:
movement error The probe R2 collides with other object.
Position: 4. Collision error:
Error: The collision remains.
5. Moving vertically is not allowed in current
Or position:
The probe R2 moves vertically in an unknown
R2 syringe movement position.
17-32
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
error Probe R2 horizontal movement error
Position: 1. Sensor status error:
Error: The probe R2 assembly is probably forced to
move horizontally.
2. Failed to find the zero position:
The probe R2 assembly is obstructed when
rotating.
3. Collision occurs during horizontal
movement:
The probe R1 assembly is obstructed when
rotating.
4. Moving horizontally is not allowed in current
position:
The probe R2 assembly is probably forced to
move vertically.
R2 syringe movement error.
1. Sensor status error:
The syringe assembly is probably forced to
move.
2. Failed to find the zero position:
The syringe assembly is probably jammed.
A02007 Probe R2 unit Warning Probe R2 collides with / 1. Collision occurs during aspirating: 1. Collision occurs during aspirating:
an obstacle when The probe R2 collides with other object. Remove the obstacle and then
aspirating recover the failure.
Reagent position:
Specific position:
A02021 Probe R2 unit Warning R2 syringe aspirates / The aspirate volume is beyond the range of Define the aspirate volume correctly.
too much the syringe.
Chemistry:
Position:
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A02022 Probe R2 unit Warning R2 syringe dispenses / The dispense volume is beyond the range of Define the dispense volume
too much the syringe. correctly.
Cuvette No.:
Sample ID/bar code:
Chemistry:
A02023 Probe R2 unit Warning Insufficient reagent / There is no reagent or insufficient reagent on 1. Check if the reagent is sufficient,
Chemistry: the designated position. and then try again.
Position: 2. If the error remains, contact our
Or customer service department or your
local distributor.
Probe R2 level
detection failed.
Chemistry:
Position:
A02025 Probe R2 unit Warning Probe R2 dispenses / 1. The probe R2 aspirates nothing. 1. Check if the reagent satisfies the
insufficient reagent requirement and is sufficient in
Cuvette No.: volume, and then try again.
Sample ID/bar code: 2. Recover the failure. If this
Chemistry: message appears for 3 times, contact
our customer service department or
your local distributor.
A02026 Probe R2 unit Error Probe R2 fails to / There is no deionized water, or the deionized 1. Check if the water supply is
detect liquid level water is not supplied normally. normal.
during cleaning. 2. If the error remains, contact our
customer service department or your
local distributor.
A02030 Probe R2 unit Error Probe R2 level / Level detection board communication error Recover the failure. If this message
detection board appears for 3 times, contact our
communication error customer service department or your
local distributor.
A02031 Probe R2 unit Error Probe R2 level / Level detection board communication error 1. Check if the reagent probe is
17-34
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
detection board installed correctly and intact.
self-calibrating failed 2. Recover the failure. If this
message appears for 3 times, contact
our customer service department or
your local distributor.
A02032 Probe R2 unit Warning Reagent is insufficient / 1. Air bubbles exist in the reagent bottle. 1. Check if the reagent bottle
or contains air bubbles 2. The reagent bottle does not meet the contains air bubbles, and then try
Chemistry: requirements. again.
Position: 2. Check if the reagent bottle meets
the requirements.
3. If the error remains, contact our
customer service department or your
local distributor.
A03006 Probe R1 unit Error Probe R1 vertical / Probe R1 vertical movement error Switch off the analyzing unit power
movement error 1. Sensor status error: and switch on it again. Recover
Position: The probe R1 assembly is probably forced to failure by performing the Home
Error: move vertically. maintenance procedure. If this
message appears for 3 times, contact
2. Failed to find the zero position:
our customer service department or
Or The probe R1 assembly is probably jammed. your local distributor.
3. Collision occurs during operation other than
Probe R1 horizontal aspirating:
movement error The probe R1 collides with other object.
Position: 4. Collision error:
Error: The collision remains.
5. Moving vertically is not allowed in current
Or position:
The probe R1 moves vertically in an unknown
R1 syringe movement position.
error Probe R1 horizontal movement error
Position: 1. Sensor status error:
17-35
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Error: The probe R1 assembly is probably forced to
move horizontally.
2. Failed to find the zero position:
The probe R1 assembly is obstructed when
rotating.
3. Collision occurs during horizontal
movement:
The probe R1 assembly is obstructed when
rotating.
4. Moving horizontally is not allowed in current
position:
The probe R1 assembly is probably forced to
move vertically.
R1 syringe movement error.
1. Sensor status error:
The syringe assembly is probably forced to
move.
2. Failed to find the zero position:
The syringe assembly is probably jammed.
A03007 Probe R1 unit Warning Probe R1 collides with / 1. Collision occurs during aspirating: 1. Collision occurs during aspirating:
an obstacle when The probe R1 collides with other object. Remove the obstacle and then
aspirating recover the failure.
Reagent position:
Specific position:
A03021 Probe R1 unit Warning R1 syringe aspirates / The aspirate volume is beyond the range of Define the aspirate volume correctly.
too much the syringe.
Chemistry:
Position:
A03022 Probe R1 unit Warning R1 syringe dispenses / The dispense volume is beyond the range of Define the dispense volume
too much the syringe. correctly.
17-36
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Cuvette No.:
Sample ID/bar code:
Chemistry:
A03023 Probe R1 unit Warning Insufficient reagent / There is no reagent or insufficient reagent on 1. Check if the reagent is sufficient,
Chemistry: the designated position. and then try again.
Position: 2. If the error remains, contact our
Or customer service department or your
local distributor.
Probe R1 level
detection failed.
Chemistry:
Position:
A03025 Probe R1 unit Warning Probe R1 dispenses / 1. The probe R1 aspirates nothing. 1. Check if the reagent satisfies the
insufficient reagent requirement and is sufficient in
Cuvette No.: volume, and then try again.
Sample ID/bar code: 2. Recover the failure. If this
Chemistry: message appears for 3 times, contact
our customer service department or
your local distributor.
A03026 Probe R1 unit Error Probe R1 fails to / There is no deionized water, or the deionized 1. Check if the water supply is
detect liquid level water is not supplied normally. normal.
during cleaning. 2. If the error remains, contact our
customer service department or your
local distributor.
A03027 Probe R1 unit Warning Water residues exist in / There is deionized water left in the reaction Recover the failure. If this message
the cuvette cuvette. appears for 3 times, contact our
Cuvette No.: customer service department or your
Sample ID/bar code: local distributor.
Chemistry:
Or
Probe R1 level
17-37
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
detection failed.
Cuvette No.:
Sample ID/bar code:
Chemistry:
A03030 Probe R1 unit Error Probe R1 level / Level detection board communication error Recover the failure. If this message
detection board appears for 3 times, contact our
communication error customer service department or your
local distributor.
A03031 Probe R1 unit Error Probe R1 level / Level detection board communication error 1. Check if the reagent probe is
detection board installed correctly and intact.
self-calibrating failed 2. Recover the failure. If this
message appears for 3 times, contact
our customer service department or
your local distributor.
A03032 Probe R1 unit Warning Reagent is insufficient / 1. Air bubbles exist in the reagent bottle. 1. Check if the reagent bottle
or contains air bubbles 2. The reagent bottle does not meet the contains air bubbles, and then try
Chemistry: requirements. again.
Position: 2. Check if the reagent bottle meets
the requirements.
3. If the error remains, contact our
customer service department or your
local distributor.
A03033 Probe R1 unit Warning Insufficient reagent is / The reagent is insufficient, or air bubbles exist 1. Check if the reagent is sufficient
dispensed or air in the reagent bottle. and the reagent bottle contains air
bubbles exist bubbles, and then try again.
Cuvette No.: 2. If the problem remains, contact
Sample ID/bar code: the manufacturer.
Chemistry:
Position:
Or
17-38
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Probe R1 level
detection failed.
A04006 Sample mixer Error Sample mixer vertical / Sample mixer vertical movement error Switch off the analyzing unit power
unit movement error 1. Sensor status error and switch on it again. Recover
Position: The sample mixer assembly is probably forced failure by performing the Home
Error: to move vertically. maintenance procedure. If this
message appears for 3 times, contact
2. Failed to find the zero position
our customer service department or
Or The sample mixer assembly is probably your local distributor.
jammed.
Sample mixer 3. Moving vertically is not allowed in current
horizontal movement position
error The sample mixer moves vertically in an
Position: unknown position.
Error: Sample mixer horizontal movement error
1. Sensor status error
The sample mixer assembly is probably forced
to move horizontally.
2. Failed to find the zero position
The sample mixer assembly is obstructed when
rotating.
3. Moving horizontally is not allowed in current
position
The sample mixer moves vertically in an
unknown position.
A04015 Sample mixer Error Sample mixer rotation / The mixer is obstructed by other object or Recover failure by performing the
unit error interfered by the reaction cuvette. Home maintenance procedure. If this
Rotation speed: message appears for 3 times, contact
Position: our customer service department or
your local distributor.
A05006 Reagent mixer Error Reagent mixer vertical / Reagent mixer vertical movement error Switch off the analyzing unit power
17-39
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
unit movement error 1. Sensor status error and switch on it again. Recover
Position: The reagent mixer assembly is probably forced failure by performing the Home
Error: to move vertically. maintenance procedure. If this
2. Failed to find the zero position message appears for 3 times, contact
our customer service department or
Or The reagent mixer assembly is probably
your local distributor.
jammed.
Reagent mixer 3. Moving vertically is not allowed in current
horizontal movement position
error The reagent mixer moves vertically in an
Position: unknown position.
Error: Reagent mixer horizontal movement error
1. Sensor status error
The reagent mixer assembly is probably forced
to move vertically.
2. Failed to find the zero position
The reagent mixer assembly is obstructed
when rotating.
3. Moving horizontally is not allowed in current
position
The reagent mixer moves vertically in an
unknown position.
A05016 Reagent mixer Error Reagent mixer / The mixer is obstructed by other object or Recover failure by performing the
unit rotation error interfered by the reaction cuvette. Home maintenance procedure. If this
Rotation speed: message appears for 3 times,
Position: contact our customer service
department or your local distributor.
A06006 Reaction Error Reaction carousel / Reaction carousel movement error Switch off the analyzing unit power
carousel unit movement error 1. Failed to find the home position and switch on it again. Recover
Error: The reaction carousel is obstructed or failure by performing the Home
blocked. maintenance procedure. If this
message appears for 3 times, contact
17-40
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
2. The coder missed steps our customer service department or
The reaction carousel is obstructed or your local distributor.
blocked.
3. The reaction carousel missed steps when
moving to the home position.
The reaction carousel is obstructed or
blocked.
A07006 Sample carousel Error Sample carousel / Sample carousel movement error Recover the failure. If this message
unit movement error 1. Failed to find the home position appears for 3 times, contact our
Error: The sample carousel is obstructed or blocked. customer service department or your
local distributor.
2. The coder missed steps
The sample carousel is obstructed or blocked.
3. The sample carousel missed steps when
moving to the home position.
The sample carousel is obstructed or blocked.
A07009 Sample carousel Error Sample bar code / The sample bar coder reader goes wrong due Recover the failure. If the error still
unit reader error to system failure. remains, contact our Customer
Service Department or your local
distributor.
A07010 Sample carousel Warning Sample bar code error / Sample bar coder reader does not work Try again. If your attempt fails,
unit Position: normally due to communication error. contact our customer service
department or your local distributor.
A07011 Sample carousel Error Sample bar code / Sample bar coder sending buffer is full due to Recover the failure or reboot the
unit sending buffer is full communication error. analyzing unit.
A09006 Reagent Error Reagent carousel / Reagent carousel movement error Recover the failure. If this message
carousel unit movement error 1. Failed to find the zero position appears for 3 times, contact our
Error: The reagent carousel is obstructed or blocked. customer service department or your
local distributor.
2. The coder missed steps
The reagent carousel is obstructed or blocked.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
3. The reagent carousel missed steps when
moving to the home position.
The reagent carousel is obstructed or blocked.
A09011 Reagent Error Reagent bar code / The reagent bar coder reader goes wrong due Recover the failure. If the error still
carousel unit reader does not work to system failure. remains, contact our Customer
normally Service Department or your local
distributor.
A09012 Reagent Warning Reagent bar code error / Reagent bar coder sending buffer is full due to Try again. If your attempt fails,
carousel unit Position: communication error. contact our customer service
department or your local distributor.
A09014 Reagent Error Reagent bar code / Reagent bar coder reader does not work Recover the failure or reboot the
carousel unit sending buffer is full normally due to communication error. analyzing unit.
Position:
A11005 Wash station Error Wash station / Wash station movement error Switch off the analyzing unit power
movement error 1. Sensor status error and switch on it again. Recover
Error: The wash station assembly is probably forced failure by performing the Home
to move. maintenance procedure. If this
message appears for 3 times, contact
2. Failed to find the home position
our customer service department or
The wash station assembly is obstructed by your local distributor.
other object.
3. The wash station collides with an obstacle
when moving.
The wash station collides with other object, or
the wash probes then collide with the reaction
carousel.
A11010 Wash station Error Releasing vacuum / 1. Solenoid valves SV23, SV25 or SV27 go 1. Check if the error is accidental.
failed wrong. 2. If the error is not accidental,
2. The vacuum pump goes wrong. contact our customer service
3. The vacuum pressure sensor goes wrong. department or your local distributor.
A11012 Wash station Warning Water supplying is too / 1. The water unit goes wrong. 1. Check the water unit.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
slow 2. The water supply valve goes wrong. 2. Check if the water supply tube is
3. The low-level floater of the water tank goes smooth.
wrong. 3. Check if the water level inside the
4. The water supply tube is bent. water tank is low (at the scale of 5L).
5. The outlet filter of the water supply tube is 4. Check if the error is accidental.
clogged. 5. If the error is not accidental,
contact our customer service
department or your local distributor.
A11013 Wash station Error Water tank is empty / 1. The water unit goes wrong. 1. Check the water unit.
2. The water supply valve goes wrong. 2. Check if the water supply tube is
3. The low-level floater of the water tank goes smooth.
wrong. 3. Check if the water level inside the
4. The water supply tube is bent. water tank is low (at the scale of 5L).
5. The outlet filter of the water supply tube is 4. Check if the error is accidental.
clogged. 5. If the error is not accidental,
contact our customer service
department or your local distributor.
A11014 Wash station Warning Filling diluted wash / 1. The solenoid valve SV06 goes wrong. 1. Check if the deionized water
solution tank is too 2. The restrictor ring is clogged. pump is opened and the pressure
slow 3. The inlet filter at the front panel is clogged. gauge reads between 25kPa-45kPa.
4. The deionized water circulating pump goes 2. Check the floater of the deionized
wrong. water tank.
5. The water tank is empty. 3. Check the floater of the diluted
wash solution tank.
6. The concentrated wash solution tank is
empty. 4. Check the floater of the
concentrated wash solution tank.
7. The concentrated wash solution pump goes
wrong. 5. Check if the error is accidental.
8. The low-level floater of the diluted wash 6. If the error is not accidental,
solution tank goes wrong. contact our customer service
department or your local distributor.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A11015 Wash station Error Insufficient diluted / 1. The solenoid valve SV06 goes wrong. 1. Check if the deionized water
wash solution 2. The restrictor ring is clogged. pump is opened and the pressure
3. The inlet filter at the front panel is clogged. gauge reads between 25kPa-45kPa.
4. The deionized water circulating pump P03 2. Check the floater of the deionized
goes wrong. water tank.
5. The water tank is empty. 3. Check the floater of the diluted
wash solution tank.
6. The concentrated wash solution tank is
empty. 4. Check the floater of the
concentrated wash solution tank.
7. The concentrated wash solution pump P05
goes wrong. 5. Check if the error is accidental.
8. The low-level floater of the diluted wash 6. If the error is not accidental,
solution tank goes wrong. contact our customer service
department or your local distributor.
A11016 Wash station Warning Insufficient / 1. The solenoid valve SV06 goes wrong. 1. Check if the deionized water
concentrated wash 2. The restrictor ring is clogged. pump is opened and the pressure
solution 3. The inlet filter at the front panel is clogged. gauge reads between 25kPa-45kPa.
4. The deionized water circulating pump P03 2. Check the floater of the deionized
goes wrong. water tank.
5. The water tank is empty. 3. Check the floater of the diluted
wash solution tank.
6. The concentrated wash solution tank is
empty. 4. Check the floater of the
concentrated wash solution tank.
7. The concentrated wash solution pump P05
goes wrong. 5. Check if the error is accidental.
8. The low-level floater of the diluted wash 6. If the error is not accidental,
solution tank goes wrong. contact our customer service
department or your local distributor.
A11017 Wash station Error Liquid accumulates in / 1. The solenoid valves SV21, SV22 or SV27 go 1. Check if the error is accidental.
primary vacuum wrong. 2. If the error is not accidental,
container 2. The low-concentration waste drain tube is contact our customer service
bent. department or your local distributor.
3. The degasser goes wrong.
17-44
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A11018 Wash station Error High concentration / 1. The waste pump P07 goes wrong. 1. Check if the error is accidental.
waste collector is full 2. The high-concentration waste drain tube is 2. If the error is not accidental,
bent. contact our customer service
department or your local distributor.
A11019 Wash station Error Low concentration / 1. The low-concentration waste drain tube is 1. Check if the error is accidental.
waste collector is full bent. 2. If the error is not accidental,
2. The low-concentration waste discharge contact our customer service
outlet is too high. department or your local distributor.
A11020 Wash station Error High concentration / 1. The high concentration waste tank is full 1. Check the high-concentration
waste tank is full 2. The floater of the high concentration waste waste tank. If it is full, replace the
tank goes wrong. waste tank, close the full tank and
dispose of the waste properly.
2. Check if the error is accidental.
3. If the error is not accidental,
contact our customer service
department or your local distributor.
A11027 Wash station Error Insufficient vacuum. / 1. The primary vacuum pump P08 goes wrong. 1. Check if the error is accidental.
Cleaning failed 2. The primary vacuum pressure sensor goes 2. If the error is not accidental,
wrong. contact our customer service
3. The connectors and tubes go wrong. department or your local distributor.
4. The primary vacuum container goes wrong.
5. Solenoid valves SV23, SV25 or SV27 go
wrong.
A11028 Wash station Error Water tank floater / 1. Water tank high level and low level floater 1. Check if the error is accidental.
logic error go wrong 2. If the error is not accidental,
contact our customer service
department or your local distributor.
A11029 Wash station Error Diluted wash solution / 1.High level and low level floater of diluted 1. Check if the error is accidental.
tank floater logic error wash solution container go wrong. 2. If the error is not accidental,
contact our customer service
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
department or your local distributor.
A11030 Wash station Error External Drain / 1. The drainage module is not turned on. Check if the drainage module is
Canister Overflow 2. The pump of the drainage module goes turned on.
wrong. 2. Check if the error is accidental.
3. High level and low level floater of the 3. If the error is not accidental,
drainage module go wrong. contact our customer service
4. The board of the drainage module go wrong. department or your local distributor.
5. The low-concentration waste tube is
twisted.
A11031 Wash station Error Insufficient vacuum / 1. The primary vacuum pump P08 goes wrong. 1. Check if the error is accidental.
degree of the primary 2. The primary vacuum pressure sensor goes 2. If the error is not accidental,
vacuum container wrong. contact our customer service
3. The connectors and tubes go wrong. department or your local distributor.
4. The primary vacuum container goes wrong.
5. Solenoid valves SV21, SV22, SV23, SV25 or
SV27 go wrong.
A11034 Wash station Error Cuvette wash syringe / The assembly is jammed or damaged. Switch off the analyzing unit power
movement error. and switch on it again. Recover
Error: failure by performing the Home
maintenance procedure. If this
message appears for 3 times, contact
our customer service department or
your local distributor.
A11035 Wash station Error Vacuum pressure is / 1. The primary vacuum pump P08 goes wrong. 1. Check if the error is accidental.
insufficient when the 2. The primary vacuum pressure sensor goes 2. If the error is not accidental,
wash station is wrong. contact our customer service
aspirating. 3. The connectors and tubes go wrong. department or your local distributor.
4. The primary vacuum container goes wrong.
5. Solenoid valve SV21, SV22, SV23, SV25 or
SV27 goes wrong.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A11036 Wash station Error Vacuum pressure / 1. The primary vacuum pump P08 goes wrong. 1. Check if the error is accidental.
change is too small 2. The primary vacuum pressure sensor goes 2. If the error is not accidental,
when the wash station wrong. contact our customer service
is aspirating. 3. The connectors and tubes go wrong. department or your local distributor.
4. The primary vacuum container goes wrong.
5. Solenoid valve SV21, SV22, SV23, SV25 or
SV27 goes wrong.
A12005 Temperature Warning Reaction carousel T1 1. The ambient temperature is out of range. 1. Check if the error is accidental.
unit temperature is out of 2. The temperature sensor goes wrong. 2. If the error is not accidental,
range (component error and cable error) contact our customer service
TDISP temperature: 3. The temperature protection switch goes department or your local distributor.
TS01: wrong. (component error and cable error)
TS02: 4. The heater goes wrong. (component error
TS03:(Adjusted and cable error)
temperature ∆T for 3 5. PCB error
Pt1000 sensors) 6. Parameters are lost.
7. Electromagnetic interference exists.
A12006 Temperature Warning Temperature of wash / 1. The ambient temperature is out of range. 1. Check the temperature of the
unit solution for cleaning 2. The temperature sensor goes wrong. deionized water for cleaning the
cuvettes is out of (component error and cable error) whole unit.
range 3. The temperature protection switch goes 2. Check if the water supply is
Temperature: wrong. (component error and cable error) normal and has the temperature
4. The heater goes wrong. (component error between 15°C-30°C.
and cable error) 3. Check if the error is accidental.
5. PCB error 4. If the error is not accidental,
6. Parameters are lost. contact our customer service
department or your local distributor.
7. Electromagnetic interference exists.
A12007 Temperature Warning Temperature of / 1. The ambient temperature is out of range. 1. Check the temperature of the
unit deionized water for 2. The temperature sensor goes wrong. deionized water for cleaning the
cleaning cuvettes is whole unit.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
out of range (component error and cable error) 2. Check if the water supply is
Temperature: 3. The temperature protection switch goes normal and has the temperature
wrong. (component error and cable error) between 15°C-30°C.
4. The heater goes wrong. (component error 3. Check if the error is accidental.
and cable error) 4. If the error is not accidental,
5. PCB error contact our customer service
6. Parameters are lost. department or your local distributor.
7. Electromagnetic interference exists.
A12008 Temperature Warning Temperature of / 1. The ambient temperature is out of range. 1. Check the temperature of the
unit deionized water for 2. The temperature sensor goes wrong. deionized water for cleaning the
cleaning the whole (component error and cable error) whole unit.
unit is out of range. 3. The temperature protection switch goes 2. Check if the water supply is
Real-time wrong. (component error and cable error) normal and has the temperature
Temperature: 4. The heater goes wrong. (component error between 15°C-30°C.
and cable error) 3. Check if the error is accidental.
5. PCB error 4. If the error is not accidental,
6. Parameters are lost. contact our customer service
department or your local distributor.
7. Electromagnetic interference exists.
A12009 Temperature Warning Internal temperature / 1. The ambient temperature is out of range. 1. Check if the air vent is blocked.
unit of the whole unit is 2. The cooling fan goes wrong. Clean the dust screen if it is blocked.
out of range 3. The dust screen is blocked. 2. Check if enough space is reserved
Temperature: 4. The air vent is blocked in the specified between the air vent and the wall. If
range. not, reallocate the instrument.
3. Check if the error is accidental.
4. If the error is not accidental,
contact our customer service
department or your local distributor.
A14006 Reagent Warning Reagent refrigeration / 1. The ambient temperature is out of range. 1. Check if the error is accidental.
refrigeration temperature is out of 2. The temperature sensor goes wrong. 2. If the error is not accidental,
unit range (component error and cable error) contact our customer service
17-48
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
3. The temperature protection switch goes department or your local distributor.
wrong. (component error and cable error)
4. The cooler goes wrong. (component error
and cable error)
5. The fan goes wrong. (component error and
cable error)
6. The recycle pump goes wrong. (component
error and cable error)
7. The refrigerant goes wrong.
8. PCB error
9. Parameters are lost.
10. Electromagnetic interference exists.
A14011 Reagent Warning Reagent refrigerating / 1. The fan is blocked. 1. Check if the error is accidental.
refrigeration fan 1 is abnormal 2. The fan is damaged. 2. If the error is not accidental,
unit 3. The power supply goes wrong. contact our customer service
department or your local distributor.
A14012 Reagent Warning Reagent refrigerating / 1. The fan is blocked. 1. Check if the error is accidental.
refrigeration fan 2 is abnormal 2. The fan is damaged. 2. If the error is not accidental,
unit 3. The power supply goes wrong. contact our customer service
department or your local distributor.
A14013 Reagent Error Light source fan is / 1. The fan is blocked. 1. Check if the error is accidental.
refrigeration abnormal 2. The fan is damaged. 2. If the error is not accidental,
unit 3. The power supply goes wrong. contact our customer service
department or your local distributor.
A14014 Reagent Warning Vacuum pump fan is / 1. The fan is blocked. 1. Check if the error is accidental.
refrigeration abnormal 2. The fan is damaged. 2. If the error is not accidental,
unit 3. The power supply goes wrong. contact our customer service
department or your local distributor.
A21001 Probe Interior Error Probe interior wash / The assembly is jammed or damaged. Switch off the analyzing unit power
Wash Unit syringe movement and switch on it again. Recover
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
error. failure by performing the Home
Error: maintenance procedure. If this
message appears for 3 times, contact
our customer service department or
your local distributor.
A22001 ISE unit Error Slope out of range, SLEX 1. Electrode installation incorrect. 1. Reinstall the electrode.
electrode: 2. Calibrator expired. 2. Replace the calibrator.
3. Electrode degenerated. 3. Replace the problematic electrode
4. Bubbles in reference electrode. and rerun.
5. Reference electrode has been used for a 4. Remove the electrode and clap on
long time. it to eliminate bubbles. Reinstall the
6. Electrodes interfered. electrode and run calibration.
7. Module or tubing temperature above 32℃. 5. Replace reference electrode and
rerun.
6. Troubleshoot the electrodes by
replacing them in different groups.
7. Monitor temperature, if too high,
relocate equipment.
A22002 ISE unit Error Air in sample. SMPA 1. Sample is insufficient or contain much 1.&2. Increase the sample volume.
Position: bubbles after dispensing. At least 90μl sample should be
2. No or insufficient sample has been prepared.
dispensed into the sample injection port. 3. Electrode is not installed
3. Liquid leakage due to that the electrodes correctly. Reinstall it.
are not properly installed. 4. Check the waste tube, and if
4. The waste pump tube is aging or broken. necessary, replace it.
A22004 ISE unit Error ISE unit cannot be / 1. ISE power supply failure. 1. Replace the 24V power supply
connected. 2. ISE communication cable failure. board.
3. Communication interface or pins failure. 2. Replace the ISE communication
4. ISE main control board failure. cable.
3. Replace the interface or pins.
4. Replace the ISE main control
board.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A22005 ISE unit Error ISE unit response error / 1. ISE communication cable failure. 1. Replace the ISE communication
2. Communication interface or pins failure. cable.
3. ISE main control board failure. 2. Replace the interface or pins.
4. Software failure. 3. Replace the ISE main control
board.
4. Upgrade the operating software or
reinstall it.
A22006 ISE unit Error Purge A and B failed. / 1. Leaks exist due to improperly-installed 1. Reinstall the electrode and check
electrode or missing O ring. for O ring.
2. Sample injection port or electrode inside is 2. Use warm water to clean and
clogged. unclog the sample injection port
3. Calibrator is exhausted. with fresh water and unclog the
4. Prime combinations are not enough. electrode tube. Check the reference
5. Pump tube is aging, blocked, or broken. electrode for crystallized salt.
6. Calibrator cannot be dispensed normally 3. Replace the reagent pack.
due to clogged reagent pack tube. 4. Increase the prime cycle.
5. Replace the pump tube.
6. Unclog the reagent pack tube with
warm water.
A22007 ISE unit Warning ISE reagent is going to / Calibrator is exhausted. Replace the reagent pack with a new
be exhausted. one.
A22008 ISE unit Error Voltage overflow, VOUT 1. Electrode or reagent pack failed. 1. Replace the problematic electrode
electrode: 2. Electrode is unsteady. and reagent pack.
3. New reagent pack is unsteady. 2. New electrode will become steady
4. Reference electrode has been used for over after 15 minutes since installed.
6 months. 3. Run a couple of calibrations after
5. ISE main control board failure. installing new reagent pack.
4. Replace the reference electrode.
5. Replace the ISE main control
board.
A22009 ISE unit Error Electrode slope drift. VDRF/ 1. Electrode or reagent pack failed. 1. Replace the problematic electrode
(during calibration) SLDR 2. Electrode is unsteady. and reagent pack.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Or 3. New reagent pack is unsteady. 2. New electrode will become steady
Electrode voltage 4. Reference electrode has been used for over after 15 minutes since installed.
drift. (during sample 6 months. 3. Run a couple of calibrations after
analysis) 5. ISE main control board failure. installing new reagent pack.
Electrode: 6. Ambient temperature fluctuates drastically. 4. Replace the reference electrode.
5. Replace the ISE main control
board.
6. Control the ambient temperature
to make the fluctuation within
+/-4℃.
A22010 ISE unit Error Voltage noise, NOIS 1. Electrode failure. 1. Replace the electrode.
electrode: 2. Environment interference. 2. Relocate the instrument.
3. ISE main control board failure. 3. Replace the ISE main control
4. Salt buildup around electrodes or tubes due board.
to fluidic leaks. 4. Clean the tubes and electrodes.
A22011 ISE unit Error Air in calibrator B PUGB 1. Calibrator B is exhausted. 1. Replace the reagent pack with a
2. Bubbles exist in calibrator tube B. new one.
3. Pump tube B is aging, blocked, or broken. 2. Perform purge B to remove
4. Waste pump tube B is aging, blocked, or bubbles.
broken. 3.&4. Replace the pump tube.
5. Sample injection port and fluidic path are 5. Clean the sample injection port
blocked or leaking. and reinstall electrodes.
6. Air bubble detector fails. 6. Replace the air bubble detector.
A22012 ISE unit Error Air in calibrator A PUGA 1. Calibrator A is exhausted. 1. Replace the reagent pack with a
2. Bubbles exist in calibrator tube A. new one.
3. Pump tube B is aging, blocked, or broken. 2. Perform purge A to remove
4. Waste pump tube B is aging, blocked, or bubbles.
broken. 3.&4. Replace the pump tube.
5. Sample injection port and fluidic path are 5. Clean the sample injection port
blocked or leaking. and reinstall electrodes.
6. Air bubble detector fails. 6. Replace the air bubble detector.
A22013 ISE unit Error ISE pump calibrating / 1. Pump tube is aging. 1. Replace the pump tube.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
failed! 2. Sample probe aspiration/dispensing failure. 2. Replace the sample probe.
A22014 ISE unit Error Air bubble detector / 1. Air bubble detector board is eroded due to Replace the bubble detector.
failure the leaks at the joint of sample injection port
and bubble detector.
2. Air bubble detector fails.
A22015 ISE unit Error Reading reagent pack / 1. Reagent pack is not installed. 1. Install reagent pack.
chip error 2. Reagent pack wand fails. 2. Replace the wand.
A22016 ISE unit Error Reagent pack chip / 1. Reagent pack is not installed. 1. Install reagent pack.
writing error. Unload 3. Reagent pack wand fails. 3. Replace the wand.
the reagent pack and
load it again.
A22017 ISE unit Error Air in ISE wash solution / 1. ISE wash solution is insufficient. 1. Place sufficient ISE wash solution.
2. Waste pump tube B is aging, blocked, or 2. Replace the pump tube.
broken. 3. Clean the sample injection port
3. Sample injection port and fluidic path are and reinstall electrodes.
blocked or leaking. 4. Replace the air bubble detector.
4. Air bubble detector fails.
A22018 ISE unit Error No fluid in tubing CALF 1. Waste pump tube B is aging, blocked, or 1. Place sufficient ISE wash solution.
broken. 2. Replace the pump tube.
2. Sample injection port and fluidic path are 3. Clean the sample injection port
blocked or leaking. and reinstall electrodes.
3. Air bubble detector fails. 4. Replace the air bubble detector.
A22019 ISE unit Error Saving calibration DEP 1. ISE communication cable failure. 1. Replace the ISE communication
result error 2. Communication interface or pins failure. cable.
3. ISE main control board failure. 2. Replace the interface or pins.
4. Software failure. 3. Replace the ISE main control
board.
4. Upgrade the operating software or
reinstall it.
A22021 ISE unit Error Command format or RESP 1. ISE communication cable failure. 1. Replace the ISE communication
execution error 2. Communication interface or pins failure. cable.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
3. ISE main control board failure. 2. Replace the interface or pins.
4. Software failure. 3. Replace the ISE main control
board.
5. Upgrade the operating software or
reinstall it.
A22022 ISE unit Error No fluid in tubing / 1. Waste pump tube B is aging, blocked, or 1. Place sufficient ISE wash solution.
broken. 2. Replace the pump tube.
2. Sample injection port and fluidic path are 3. Clean the sample injection port
blocked or leaking. and reinstall electrodes.
3. Air bubble detector fails. 4. Replace the air bubble detector.
A22023 ISE unit Error No reagent module has / 1. Reagent pack is not installed. 1. Install reagent pack.
been loaded. 2. Reagent pack wand fails. 2. Replace the wand.
A22024 ISE unit Error ISE response check RESP 1. The communication wire between ISE and 1.Replace the communication wire
code error the middle-layer unit goes wrong. 2.Change the interface or the pin.
2. Communication interface or pin error. 3.Change the main control board.
3.Main control board does not function.
4.Upgrade the software or reinstall
4.Software error the software.
A22025 / Error Equipment cannot be / 1. The serial port wire is not connected 1. Check the connection of the serial
connected 2. The power supply of the analyzer is off. port wire.
Unit: 2. Remove and replug in the serial
port wire.
3. Check whether the power supply
of the analyzer is on.
4. Perform the Home procedure.
5. Reboot the PC and the analyzer.
6. If the error still remains for
continuous three times after the
above procedures have been
performed, please contact our
customer service or your local
distributor.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A22026 / Error Configuring key / Key parameters are not configured 1. Turn off the analyzing unit power
parameters failed. and reswitch it on.
Unit: %s 2. If the error occurs for continuous
three times, please contact our
customer service or your local
distributor.
A22027 / Error Fluidic prime failed. / Fluidic is not primed. 1. Turn off the analyzing unit power
and reswitch it on.
2. If the error occurs for continuous
three times, please contact our
customer service or your local
distributor.
A22028 / Error Downloading key / 1.Downloading key parameters failed. 1. Turn off the analyzing unit power
parameters failed. 2. Reading the parameters from E2ROM failed. and reswitch it on.
Unit: 3.Configuring the parameters of the smart 2. If the error occurs for continuous
module failed. three times, please contact our
customer service or your local
distributor.
A22029 / Error Collecting dark / Collecting dark current failed. 1. Turn off the analyzing unit power
current failed. and reswitch it on.
2. If the error occurs for continuous
three times, please contact our
customer service or your local
distributor.
A22030 / Error Discharging primary / Discharging primary vacuum waste failed. 1. Turn off the analyzing unit power
vacuum waste failed. and reswitch it on.
2. If the error occurs for continuous
three times, please contact our
customer service or your local
distributor.
A22031 / Error Establishing vacuum / Establishing vacuum failed. 1. Turn off the analyzing unit power
17-55
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
failed. and reswitch it on.
2. If the error occurs for continuous
three times, please contact our
customer service or your local
distributor.
A22032 / Error Floater status error: / 1. Low level floater status of the water tank is 1. Check the water unit and the
Floater: empty. water supply tubes.
2. The low level floater status of the diluted 2. Check the floater status of the
wash solution container is empty. water tank, diluted wash solution
3. The floater status of the concentrated wash container, concentrated wash
solution container is empty. solution container, high
4. The floater status of the high concentration concentration waste container, low
waste container is full. concentration waste container and
the high concentration waste
5. The floater status of the low concentration
container
waste container is full.
3. Check the status of the primary
6. The status of the primary vacuum container
vacuum container.
is full.
4. Check if the error is accidental.
7. The status of the high concentration waste
container is full. 5. If the error is not accidental,
contact our customer service
department or your local distributor.
A22033 / Error Resetting probe / Resetting probe interior wash syringe failed. 1. Turn off the analyzing unit power
interior wash syringe and reswitch it on.
failed. 2. If the error occurs for continuous
three times, please contact our
customer service or your local
distributor.
A22034 / Error Resetting auto wash / Resetting auto wash syringe failed. 1. Turn off the analyzing unit power
syringe failed. and reswitch it on.
2. If the error occurs for continuous
three times, please contact our
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
customer service or your local
distributor.
A22035 / Error Releasing vacuum / 1.Electromagnetic valve SV23, SV25, or SV27 1. Turn off the analyzing unit power
failed. failure and reswitch it on.
2. Vacuum pump P08 failure 2. If the error occurs for continuous
3. Vacuum pressure sensor failure three times, please contact our
customer service or your local
distributor.
A22036 / Error Initializing sample bar / Sample bar code reader failed due to system 1. Recover failure by performing the
code reader failed. error. Home maintenance procedure.
2. If this error remains
contact our customer service
department or your local distributor.
A22037 / Error Initializing reagent bar / Reagent bar code reader failed due to system 1. Recover failure by performing the
code reader failed. error. Home maintenance procedure.
2. If this error remains
contact our customer service
department or your local distributor.
A22038 / Error Scanning reagent bar / Scanning reagent bar code failed. 1. Turn off the analyzing unit power
code failed. and reswitch it on.
2. If the error occurs for continuous
three times, please contact our
customer service or your local
distributor.
A22039 / Error Unmatched software / 1.Version inquiry instruction failed. 1. Turn off the analyzing unit power
version. 2. The version information of the control and reswitch it on.
software does not match the one stored in the 2. If the error occurs for continuous
operating software. three times, please contact our
customer service or your local
distributor.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C00007 Operating Error CPU performance low / The CPU is too busy. Reboot the computer and operating
system software. If this message appears for
3 times, contact our customer
service department or your local
distributor.
C00008 Operating Warning Printer cannot be / The printer is not powered on; the printer Check the printer connection; check
system connected cable is not connected; or no driver is if the printer is powered on and if
installed. the driver and default printer have
been installed.
C00011 Operating Error The last abnormal exit / The operating software is abnormal, or the Restart the operating software, and
system may cause carryover instrument power is cut off unexpectedly. execute the Special Wash
not handled. Execute maintenance command before
the Special Wash starting analysis.
maintenance
command before
starting analysis to
ensure accurate
results.
C00012 Operating Warning Sound card failure / No sound card is installed. Sound card failure. Reinstall the sound card or the sound
system Incorrect sound card driver. card driver.
C01001 Instrument Error Equipment cannot be / The serial cable is not connected; or the Check the serial port connection.
connection connected analyzing unit power is switched off. Replug the cable. Check if the
analyzing unit is powered on. Start
the initialization again. Restart the
computer and analyzing unit. If three
continuous attempts are failed,
contact our customer service
department or your local distributor.
C02001 Database Error Database initialing / The database file is damaged or lost. Reboot the computer and analyzing
failed unit. If three continuous attempts
are failed, contact our customer
service department or your local
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
distributor.
C02002 Database Error Database upgrade / The database file is damaged or lost. Reboot the computer and analyzing
failed unit. If three continuous attempts
are failed, contact our customer
service department or your local
distributor.
C02004 Database Warning Database backup / The database file is damaged or lost. Reboot the computer and analyzing
failed unit. If three continuous attempts
are failed, contact our customer
service department or your local
distributor.
C02005 Database Warning Reading/Writing / The database does not work normally. Reboot the computer and analyzing
database failed unit. If three continuous attempts
are failed, contact our customer
service department or your local
distributor.
C03001 Result Warning Result cannot be RCE Absorbance data for calculation is incomplete, Rerun the test. If the error remains,
calculation calculated or the dividend is 0. contact our customer service
Sample ID/bar code: department or your local distributor.
Position:
Chemistry:
C03002 Result Warning Absorbance out of ABS 1. Probe R1 dispenses insufficient reagent, or 1. Observe the reaction curve. If the
calculation range air bubbles exist in the reagent. absorbance of R1 is too high, check
Sample ID/bar code: 2. The reagent is placed in an incorrect the reagent for air bubbles and the
Position: position or is abnormal. syringe for leaking.
Chemistry: 3. The sample concentration is too high, 2. Check if the reagent has been
resulting in great response. placed in the correct position.
4. The absorbance data used for calculation is 3. Rerun the test after dilution.
incomplete (due to photoelectric data loss), or 4. Contact our customer service
the error of division by zero occurs. department or your local distributor.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C03003 Result Warning R1 blank absorbance RBK The reagent goes wrong; the cuvette is not Check if the reagent is sufficient
calculation out of range clear; the reaction cuvette is overflowed; or without air bubbles and the
Sample ID/bar code: insufficient reagent is dispensed. chemistry parameters are
Position: reasonable. If yes, replace the
reagent and then rerun the test.
Chemistry:
Check if the cuvette is normal. If the
error remains, contact our customer
service department or your local
distributor.
C03004 Result Warning Substrate depletion BOE The sample concentration is too high, and Check the reaction curve and the
calculation Sample ID/bar code: substrate depletion occurs during fixed-time substrate depletion limit. Rerun the
Position: measurements. test with diluted sample.
Chemistry:
C03005 Result Warning Result cannot be ENC The sample concentration is too high, and Check the reaction curve and the
calculation calculated substrate depletion occurs within the lag time substrate depletion limit. Rerun the
Sample ID/bar code: of rate check measurements. test with diluted sample.
Position:
Chemistry:
C03006 Result Warning Linearity limit out of LIN The measuring points for result calculation are Check the reaction curve and the
calculation range nonlinear, because the sample concentration substrate depletion limit. Rerun the
Sample ID/bar code: is too high, or the substrate depletion limit is test with diluted sample.
Position: not specified or unreasonable.
Chemistry:
C03007 Result Warning Prozone check error PRO Antibody excess occurs due to too high sample Check the reaction curve and the
calculation Sample ID/bar code: concentration. prozone check parameters. Rerun
Position: the test with diluted sample.
Chemistry:
C03008 Result Warning Sample concentration RRN The sample concentration exceeds the high Rerun the test with diluted sample.
calculation is higher than that of limit of the calibrator concentration.
the highest-level
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
calibrator
Sample ID/bar code:
Position:
Chemistry:
C03009 Result Warning Mixed blank MBK The reagent goes wrong; the cuvette is not Check if the reagent is sufficient
calculation absorbance out of clear; the reaction cuvette is overflowed; or without air bubbles and the
range insufficient reagent is dispensed. chemistry parameters are
Chemistry: reasonable. Check if the cuvette is
normal. Replace the reagent and
then rerun the test. If the error
remains, contact our customer
service department or your local
distributor.
C03010 Result Warning Blank response out of BLK The reagent goes wrong; insufficient reagent Check if the reagent is sufficient
calculation range is dispensed; the cuvette contains air bubbles; without air bubbles and the
Chemistry: the light drifts; or the cuvette is overflowed. chemistry parameters are
reasonable. Check if the cuvette is
normal. Replace the reagent and
then rerun the test. If the error
remains, contact our customer
service department or your local
distributor.
C03011 Result Warning Calibration DUP The difference between the maximum and Check if the acceptance limit is
calculation repeatability exceeds minimum response of the calibrator exceeds reasonable, troubleshoot the error,
limit. Chem: the specified limit. and then recalibrate.
C03012 Result Warning Calibration sensitivity SEN The difference of final response of the Check if the acceptance limit is
calculation exceeds limit. Chem: maximum and minimum concentration reasonable and the reagent and
calibrators exceeds the specified limit. calibrator are normal, and then
recalibrate.
C03013 Result Warning Calibration curve SD CSD The calculated standard deviation of the Check if the acceptance limit is
calculation exceeds limit, Chem: calibration curve exceeds the specified limit. reasonable and the reagent and
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
calibrator are normal, and then
recalibrate.
C03014 Result Warning Calibration DET The calculated determination coefficient of Check if the acceptance limit is
calculation determination the calibration curve exceeds the specified reasonable and the reagent and
coefficient exceeds limit. calibrator are normal, and then
limit, Chem: recalibrate.
C03015 Result Warning Calibration slope FAC The slope difference is applicable to linear Check if the acceptance limit is
calculation difference out of calibration only and refers to the K factor reasonable and the reagent and
range. Chem: (slope) difference between two adjacent calibrator are normal, and then
calibrations. It exceeds the specified limit. recalibrate.
C03016 Result Warning Calibration curve is MON The calibration data and calibration curve are Check if the calibrator is defined and
calculation not monotonic, Chem: not monotonic. placed correctly, and then
recalibrate.
C03017 Result Warning Calibration curve is COV For nonlinear calibration, a satisfying base Check that the reagent and
calculation not convergent, Chem: cannot be calculated and no calibration curve calibrator are normal, and then
is drawn. recalibrate. If the error remains,
contact our customer service
department or your local distributor.
C03018 Result Warning Chemistry: 1-2s The QC result is between ±2 and ±3 standard No actions are required.
calculation Control: 1-2s warning deviations from the assigned mean
concentration.
C03019 Result Warning Chemistry: 1-3s The QC result is greater than ±3 standard Check if the reagent is qualified and
calculation Control: 1-3s out of deviations from the assigned mean control is normal. If the error
control concentration. remains, contact our customer
service department or your local
distributor.
C03020 Result Warning Chemistry: 2-2s Results of two controls or two results of one Check if the reagent is qualified and
calculation Control: 2-2s out of control within a run are simultaneously control is normal. If the error
control greater than +2 or -2 standard deviations from remains, contact our customer
the assigned mean. service department or your local
distributor.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C03021 Result Warning Chemistry: R-4s One result of a run is greater than +2 standard Check if the reagent is qualified and
calculation Control: R-4s out of deviations from the assigned mean and the control is normal. If the error
control other greater than -2SDs. remains, contact our customer
service department or your local
distributor.
C03022 Result Warning Chemistry: 4-1s Results of two runs in two-control evaluation Check if the reagent is qualified and
calculation Control: 4-1s out of or four continuous results of a control are control is normal. If the error
control greater than +1 or -1 standard deviation from remains, contact our customer
the assigned mean concentration. service department or your local
distributor.
C03023 Result Warning Chemistry: 10-x Results of five runs in two-control evaluation Check if the reagent is qualified and
calculation Control: 10-x out of or ten continuous results of a control that are control is normal. If the error
control being compared are on the same side. remains, contact our customer
service department or your local
distributor.
C03024 Result Error Biochemistry test / 1. Software error Rerun the test. Reboot the operating
calculation period time out. 2. Operating system error software, analyzing unit and
Cannot continue computer. If the error remains,
contact our customer service
department or your local distributor.
C03026 Result Warning Photoelectric data is / Communication error. If the error persists, contact our
calculation lost customer service department or your
local distributor.
C03030 Result Error Photoelectric / 1. Software error 1. Rerun the operating software.
calculation measurement period is 2. Reboot the operation unit.
out of range 3. If the error remains, contact our
Sample ID/bar code: customer service department or your
Position: local distributor.
Chemistry:
C03031 Result Error Multiple consecutive / 1. Software error 1. Rerun the operating software.
calculation photoelectric
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
measurements are 2. Reboot the operation unit.
time out 3. If the error remains, contact our
Sample ID/bar code: customer service department or your
Position: local distributor.
Chemistry:
C04001 Sample bar code Warning Duplicate sample bar / Duplicate bar code is used. Replace the duplicate sample bar
code. code label.
Sample ID/bar code:
Position 1:
Position 2:
C04002 Sample bar code Warning Bar code has no / The sample of the bar code has not been Program the sample of the bar code.
corresponding programmed.
programming.
Sample ID/bar code:
Position:
C04006 Sample bar code Warning Sample is expired / The sample is loaded after its shelf life is The sample is expired. Replace the
Sample ID/bar code: exceeded. sample and program it again. Reject
Position: the expired sample. If the sample
shelf life is too short, change it to a
reasonable one.
C04008 Sample bar code Warning Sample bar code too / The bar code length is greater than the Redefine the bar code with no more
long. Position: maximum value of 27 digits. than 27 digits.
C04009 Sample bar code Warning Sample bar code is less / The sample bar code is too short, less than the Reprint the bar code and ensure it is
than 3 digits. minimum range of 3 digits. no less than 3 digits.
position:
C04012 Sample bar code Warning Sample bar code / Barcode information does not conform with Reset the barcode format or reprint
analysis error the barcode format the barcode and scan it.
Sample bar code:
Position:
17-64
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C05001 Reagent bar Warning Duplicate reagent bar / Incorrect reagent or reagent bar code is being Reprint the reagent bar code, or
code code used, or an invalid reagent bar code is being replace the reagent bottle with an
Reagent: used. Bar code is aligned with reagents, and invalid bar code.
Position 1: cannot be used again for new reagent when a
reagent is exhausted.
Position 2:
C05002 Reagent bar Warning Reagent bar code / Incorrect reagent bar code is being used, or Print the new reagent bar code with
code information error. reagent bar code is not configured reasonably. correct settings and check the bar
Position: The reagent bar code contains incomplete or code against the settings. Replace
incorrect reagent information, such as the reagent bottle, or contact the
expiration date, reagent volume, etc. reagent supplier.
C05003 Reagent bar Warning Reagent bar code / Incorrect reagent bar code is being used, or Check the reagent bar code settings,
code analysis error reagent bar code settings are incorrect. The or reprint the reagent bar code
Position: system fails to extract reagent information against the settings. Contact the
from the bar code. reagent supplier.
C05006 Reagent bar Error Wash solution position / Reagent rather than wash solution is placed in Reposition the reagent, or remove it
code on reagent carousel is the fixed wash solution position (D) on reagent from the fixed reagent position.
occupied by another carousel.
reagent
Position:
C05008 Reagent bar Error Physiological saline / Reagent rather than physiological saline is Reposition the reagent, or remove it
code position on reagent placed in the fixed physiological saline from the fixed wash solution
carousel is occupied position (W) on reagent carousel. position.
by another reagent
Position:
C06001 Host Error LIS initialization error / Host file is damaged or does not exist. Reinstall the operating software.
communication
C06002 Host Error LIS communication / Host parameters error Re-set or modify the host
communication parameter error communication parameters.
C06003 Host Error LIS communication / Communication error If the error occurs accidentally, send
communication error or receive the instruction again. If
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
the error still remains, contact our
customer service department or your
local distributor.
C06004 Host Error LIS host cannot be / Abnormal network connection or the LIS host Check LIS connection and network
communication connected is not started. cable. Check if LIS host and LIS
station can start normally.
C06005 Host Warning Sending sample results / Communication error If the error occurs accidentally, send
communication failed. or receive the instruction again. If
Sample ID/bar code: the error still remains, contact our
Position: customer service department or your
local distributor.
C06006 Host Warning Sending sample / Communication error If the error occurs accidentally, send
communication information failed. or receive the instruction again. If
Sample ID/bar code: the error still remains, contact our
Position: customer service department or your
local distributor.
C06007 Host Warning Inquiring sample / LIS host failure. If the error occurs accidentally,
communication information failed. neglect it. If the error occurs
Sample ID/bar code: frequently, contact the
Position: manufacturer of LIS or contact our
customer service department or your
local distributor.
C06008 Host Warning Downloading sample / Incorrect channel settings or insufficient or Check and re-set the chemistry
communication failed. redundant chemistries on the LIS host. correspondence between the
Sample ID/bar code: operating software and the LIS host.
Position:
C07003 Light source Error Light intensity is too / 1. The lamp is not installed correctly. 1. Check if the lamp is installed
weak 2. The cuvette is contaminated. correctly.
3. The lamp is aging. 2. Perform the diluted wash
4. The wash station dispenses liquid procedure and then the lamp check
procedure.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
incorrectly. 3. Replace the lamp.
5. The photoelectric collection board goes 4. Check if the wash station
wrong. dispenses liquid with correct volume
to reaction cuvettes.
5. If your attempt fails, contact our
customer service department or your
local distributor.
C07004 Light source Warning Cuvette blank out of / 1. The cuvette is contaminated. 1. Open the reaction carousel and
range 2. The lamp is aging. check if the lamp is turned on. If it is
Cuvette No.: 3. The lamp is not installed correctly. not, rerun the operating software.
4. The wash station dispenses liquid 2. Check if the lamp is installed
incorrectly. correctly.
5. The photoelectric collection board goes 3. Perform the diluted wash
wrong. procedure and then the cuvette
check procedure.
4. Replace or clean the failed
cuvette.
5. Replace the lamp.
6. Check if the wash station
dispenses liquid with correct volume
to reaction cuvettes.
7. If your attempt fails, contact our
customer service department or your
local distributor.
C07005 Light source Error Lamp is not turned on / 1. The lamp is damaged. 1. Open the reaction carousel and
2. The lamp cable is not connected properly. check if the lamp is turned on. If it is
3. The power board of the lamp is not not, rerun the operating software.
connected properly. 2. Check if the lamp cable is
4. The power supply of the analyzing unit is tightened.
disconnected. 3. Replace the lamp.
5. The photoelectric collection board goes 4. If your attempt fails, contact our
17-67
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
wrong. customer service department or your
local distributor.
C07006 Light source Error Light intensity is too / 1. A cuvette position has no cuvette installed. 1. Check if all cuvette positions have
strong 2. The circuit gain is too high and beyond the cuvettes installed.
measurement range. 2. Contact our customer service
department or your local distributor
to adjust the gain.
C07007 Light source Error Dark current is too / 1. The circuit gain is too high and beyond the If three continuous attempts are
high measurement range. failed, contact our customer service
Channel: 2. The photoelectric collection board goes department or your local distributor.
AD: wrong.
C07008 Light source Warning Lamp has exceeded its / 1. The lamp has been used for over 2000 1. Replace the lamp.
life span. Replace it hours. 2. Perform the Replace Lamp
immediately. 2. The lamp has been replaced incorrectly. maintenance procedure again.
C07009 Light source Error Water blank out of L! 1. The cuvette wash station is overflowing. 1. Check if the cuvette is
range (10X) 2. The lamp has been replaced incorrectly. overflowing.
3. Cuvette check is not performed after 2. Check if the Replace Lamp
maintenance. command is executed during lamp
4. The cable connectors are not tightened. replacement.
5. The retaining screw is not tightened. 3. Check if the Cuvette Check
command is executed after
6. The wash station dispenses insufficient
maintenance.
fluid.
4. Check if the cleaning liquid inside
7. The lamp is aged.
the cuvette is no less than half of the
8. The photometer goes wrong. cuvette.
5. Check if the cable connectors and
retaining screw of the lamp have
been tightened.
6. Check if the reaction curve
fluctuates irregularly. If yes, replace
the lamp.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
7. If the error remains, contact our
customer service department.
C07012 Other error of Warning Storage device error. / No U disk is inserted. No file is found in the U Check if a U disk is inserted or full.
operation unit Cannot import data disk, or file error, or file is damaged. The U Check if the storage device is
disk is locked or damaged. damaged.
C07013 Other error of Warning Storage device error. / No U disk is inserted. Insufficient disk space. Check if a U disk is inserted or full.
operation unit Cannot export data The U disk is locked or damaged. Check if the storage device is
damaged.
C07014 Other error of Warning Reagent exhausted / All reagents of the reagent type for the Refill or replace the reagent.
operation unit Chemistry: chemistry are less than the minimum limit. All
Position: reagents of the type are too little to be
detected.
C07016 Other error of Warning Insufficient wash / Insufficient wash solution on the reagent Refill the wash solution on the
operation unit solution carousel. reagent carousel.
Position:
C07017 Other error of Warning Wash solution is / The wash solution on the reagent carousel is Refill the wash solution on the
operation unit exhausted exhausted. reagent carousel.
Position:
C07022 Other error of Warning Less than X tests are / All reagents of the reagent type for the Refill or replace the reagent.
operation unit left in biochemistry chemistry are less than the minimum limit. All
reagent. Chemistry: reagents of the type are too little to be
detected.
C07023 Other error of Warning Chemistry: %s, 30 / The calibration factors will be expired. Recalibrate the chemistries.
operation unit minutes left for next
calibration.
C07027 Other error of Warning Calibrator %s has been / The calibrator is expired. Replace the calibrator.
operation unit expired
C07028 Other error of Warning Chemistry: %s, lot / The reagent is expired. Replace the reagent.
operation unit No.: %s, position: %s,
has been expired
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C07029 Other error of Warning Chemistry: %s, lot / The on-board stability time of the reagent Replace the reagent.
operation unit No.: %s, pack is too long.
position: %s, has
exceeded the
on-board stability time
C07034 Other error of Warning Insufficient / Insufficient physiological saline. Refill the physiological saline on the
operation unit physiological saline reagent carousel.
Position:
C07035 Other error of Warning Physiological saline is / Physiological saline is exhausted. Refill the physiological saline on the
operation unit exhausted reagent carousel.
Position:
C07036 Other Warning Chemistry: %s. / The calibration factors have been expired. Recalibrate the chemistry.
Calibration factors are
expired
C07037 Other Warning Reagent bottle / Serial number of the reagent is changed. Recalibrate the chemistry.
number of %s
chemistry is changed.
Please recalibrate
C07038 Other Warning Reagent lot number / Lot number of the reagent is changed. Recalibrate the chemistry.
of %s chemistry is
changed. Please
recalibrate
C07039 Other Warning Calibration factors / The calibration factors are expired. Recalibrate the chemistry.
of %s chemistry are
expired. Recalibrate
C07040 Other Warning Reagent exhausted / 1. The reagent is running out. Refill or replace the reagent.
Chemistry: 2. The reagent is too little to be detected.
C07041 Other Error ISE reagent is less / ISE reagent inventory is below the alarm limit Check the inventory. If the reagent is
than %s insufficient, load the reagent.
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17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C07042 Other Warning %s, lot number: %s, / One or more special reagents have been Replace them with new reagents.
position: %s, has been expired.
expired
17-71
17 Alarms and Troubleshooting
17-72
18 Template Modifying Software
The Template Modifying Software is affiliated with the Operating Software and used to
create or edit print templates, which illustrate the contents and format of patient reports.
The Template Modifying Software can be started separately or together with the
Operating Software. To start the Template Modifying Software, select the Edit button on
the Print page of the operating software.
The following sections introduce the Template Modifying Software by menus and
toolbars.
18-1
18 Template Modifying Software
Option Description
New Select New to create a template. The type of the template is
determined by the report that is currently selected on the report
window.
You can also use the shortcut key Ctrl+N instead.
After changing the currently-displayed template, select New to
display the following dialog box.
18-2
18 Template Modifying Software
Option Description
18-3
18 Template Modifying Software
Option Description
out.
The main screen will be hidden when you preview a template.
The tool bar on the Preview window is as follows.
18-4
18 Template Modifying Software
NOTE
The control(s) you have cut or copied can only be pasted on the current Template
Modifying Software rather than another one or other software.
Option Description
Cut Select this option to copy and delete single or multiple controls.
You can use the shortcut key Ctrl+X instead.
This option is available only when a control(s) is selected.
Copy Select this option to copy single or multiple controls.
You can use the shortcut key Ctrl+C instead.
This option is available only when a control(s) is selected.
Paste Select this option to paste the controls that are previously cut or
copied at the same place as where the controls are from.
You can use the shortcut key Ctrl+P instead.
This option is available only when a control(s) is cut or copied.
Delete Select this option to delete single or multiple controls
You can use the shortcut key Ctrl+D instead.
This option is available only when a control(s) is selected.
18-5
18 Template Modifying Software
Option Description
Common Enable or disable the common toolbar.
Tool
Draw Tool Enable or disable the draw toolbar.
Property Enable or disable the property window.
Window
Report Enable or disable the report window.
Window
Status Bar Enable or disable the status bar.
NOTE
You are recommended to select 100% when saving a template.
Option Description
Select
Select this option to change the mouse pointer to a .
NOTE
Selecting a control while holding the Ctrl key copies the control.
Line Select this option to insert a line in the editing area. The mouse
pointer changes into a +. Click once in the editing area and drag
the mouse to draw a line.
Rectangle Select this option to insert a rectangle in the editing area. The
mouse pointer changes into a +. Click once in the editing area and
drag the mouse to draw a rectangle.
Label Select this option to insert a label in the editing area. The mouse
pointer changes into a +. Click once in the editing area and drag
the mouse to draw a label.
Label is a type of text control and the contents on a label will not
change when printed.
18-6
18 Template Modifying Software
Option Description
Text Select this option to insert a text control in the editing area. The
mouse pointer changes into a +. Click once in the editing area and
drag the mouse to create a text.
The contents in a text control will be replaced by the actual test
data when printed.
Title Select this option to insert a title in the editing area. The mouse
pointer changes into a +. Click once in the editing area and drag
the mouse to create a title.
Title is a type of text control. The “%s” will be replaced by a
hospital name when printed. Please note “%s” is added by user and
not produced automatically.
Image Select this option to insert an image in the editing area. The mouse
pointer changes into a +. Click once in the editing area and drag
the mouse to create an image.
The image on the template is for illustration only and will be
replaced by corresponding curve graph when printed.
Option Description
Left Align the specified controls with the left of the lastly-selected
control.
Right Align the specified controls with the right of the lastly-selected
control.
Top Align the specified controls with the top side of the
lastly-selected control.
Bottom Align the specified controls with the bottom side of the
lastly-selected control.
Center H Align one or multiple controls to the horizontal center of current
template.
Center V Align one or multiple controls to the vertical center of current
template.
18-7
18 Template Modifying Software
Option Description
Even Space Arrange three or more controls with same space horizontally.
H
Even Space Arrange three or more controls with same space vertically.
V
Same Width Adjust the specified controls to the same width as the
lastly-selected control.
Same Height Adjust the specified controls to the same height as the
lastly-selected control.
Same Size Adjust the specified controls to the same width and height as the
lastly-selected control.
18.1.7 Set(S)
The Set menu only includes an option, Print ID. See the figure below.
Select Print ID. The Set Print ID dialog box is displayed. You can enable or disable the
print fields and view the corresponding ID of each field.
Option Description
Chinese Switch the screen language to Chinese. Not available.
18-8
18 Template Modifying Software
Option Description
English Switch the screen language to English. Not available.
Option Description
Version Select this option to view the version information of the
template modifying software.
18-9
18 Template Modifying Software
The following table shows the correspondence between the shortcut buttons and menu
options.
Button Menu Option
New File/New
Export File/Export
Delete File/Delete
Print File/Print
Preview File/Preview
Cut Edit/Cut
Copy Edit/Copy
Paste Edit/Paste
Delete Edit/Delete
Zoom View/25%-200%
Print ID Set/Print ID
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18 Template Modifying Software
The following table shows the correspondence between the shortcut buttons and menu
options.
Insert/Line
Insert/Rectangle
Insert/Label
Insert/Text
Insert/Title
Insert/Image
Format/Left
Format/Right
Format/Top
Format/Bottom
Format/Center H
Format/Center V
Format/Even Space H
Format/Even Space V
Format/Same Width
18-11
18 Template Modifying Software
Format/Same Size
18-12
18 Template Modifying Software
18.4.1 Page
When no control is selected, the property window shows the properties of the current
template, such as paper, print type, etc.
Parameter Description
Paper Define the paper type of the template. There are 9 common types
available.
If the paper width and height you defined are beyond the specified
range, Custom is displayed in the Paper field.
Paper Width Define the width of the template.
Combination Whether to print two reports on one piece of paper. Merging reports
Type is now not permitted. Not available.
18.4.2 Line
When a line control is selected, the property window shows the properties of the line.
18-13
18 Template Modifying Software
Parameter Description
ID Print ID of the line. The ID is 2.
Start X Set the X-coordinate value of the start point.
NOTE
The control coordinate originates from the upper-left corner of
the editing area, from which the X axis (positive) is extended
horizontally to the right and the Y axis (positive) vertically to the
bottom. The unit is mm.
Line Width Set the width of the line. The unit is mm.
Group No. A group gathers multiple controls that will be used frequently on
the template. e.g. a line of controls constitutes a group. The
group No. is 0 if not defined.
Line Color Set the color of the line.
18.4.3 Rectangle
When a rectangle control is selected, the property window shows the properties of the
rectangle.
18-14
18 Template Modifying Software
Parameter Description
ID Print ID of the line. The ID is 1.
Start X Set the X-coordinate value of the start point (upper-left corner).
Start Y Set the Y-coordinate value of the start point (upper-left corner).
Group No. A group gathers multiple controls that will be used frequently on
the template. e.g. a line of controls constitutes a group. The
group No. is 0 if not defined.
Frame Color Set the color of the frame.
18.4.4 Label
When a label control is selected, the property window shows the properties of the label.
18-15
18 Template Modifying Software
Parameter Description
ID Print ID of the label. The ID is 4.
Text Set the text on the label. It will be printed unchanged on actual
reports.
Start X Set the X-coordinate value of the start point (upper-left corner).
Start Y Set the Y-coordinate value of the start point.
Group No. A group gathers multiple controls that will be used frequently on
the template. e.g. a line of controls constitutes a group. The
group No. is 0 if not defined.
Bk Color Set the background color of the label.
Text Place Set the aligning mode of label text. It includes Left, Center and
Right.
Print Frame Enable and disable printing frame.
Text ID Set text ID for the control. When it is edited, the template is
refreshed.
18-16
18 Template Modifying Software
Parameter Description
Replace text Choose whether to use the defined text ID to replace the text of
the control.
18.4.5 Text
When a text control is selected, the property window shows the properties of the text.
Parameter Description
ID Print ID of the text. The default is 0 and means unknown ID.
Print ID indicates the meaning of the text. Correct printout can
be ensured only when print ID is set properly.
Name Set the contents to be displayed on the text control. It varies
from different IDs.
Text Set the contents displayed on the text control. It will be
replaced by actual data when printed.
Show Detail Enable or disable printing the control in group.
Start X Set the X-coordinate value of the start point (upper-left corner).
Start Y Set the Y-coordinate value of the start point.
Width Set the width of the text.
Group No. A group gathers multiple controls that will be used frequently on
the template. e.g. a line of controls constitutes a group. The
group No. is 0 if not defined.
Text Type Reserved parameter. The default is 0.
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18 Template Modifying Software
Parameter Description
Bk Color Set the background color of the text.
Text Place Set the aligning mode of the text. It includes Left, Center and
Right.
Print Frame Enable and disable printing frame.
18.4.6 Title
When a title control is selected, the property window shows the properties of the title.
Parameter Description
ID Print ID of the title. The ID is 5.
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18 Template Modifying Software
Parameter Description
Bk Color Set the background color of the title.
Text Place Set the aligning mode of title text. It includes Left, Center
and Right.
Print Frame Enable and disable printing frame.
Text ID Set text ID for the control. When it is edited, the template
is refreshed.
Replace text Choose whether to use the defined text ID to replace the
text of the control.
18.4.7 Image
When an image control is selected, the property window shows the properties of the
image.
Parameter Description
ID Print ID of the image. The ID is 3.
File Name Name of image file. Specify it in the picture folder and
draw it on the image control.
18-19
18 Template Modifying Software
Report type
Template list
18-20
Electronic Interface
Electronic Interface-1
Electronic Interface
Electronic Interface-2
Vocabulary
Absorbance
The difference between the amount of light entering a solution (incident light) and the
amount of light passing through the solution (transmitted light) without being absorbed,
to determine the concentration of the substance in the solution.
Analyzing unit
The analyzing unit, the analyzer, determines various clinical chemistries in samples and
displays the test results. It consists of the sample handling system, reagent handling
system, reaction system, cuvette wash station, photometric system, and mixer assembly.
Auto rerun
When a result is beyond the defined range or satisfies the defined conditions, the
chemistry will be run again.
Auto serum index
When the Auto Serum Index function is enabled, the system will select the SI chemistry
automatically for serum or plasma samples. The SI chemistry will also be requested
automatically when you program routine samples manually or by using the LIS host, or
program STAT samples, or program routine samples with the default panels.
Bar code reader
Fixed laser beam scanner. It scans the bar code label on sample tubes to identify samples
and match the obtained programming information with the scanned samples.
Batch program
Batch program is to program a group of samples with identical programming information,
with the exception of the sample ID.
Blank time
Blank time refers to the period between dispensing of the second reactant (reagent or
sample) in reversed order and of the last reactant (reagent or sample).
Bottle type
Volume of the reagent bottle.
Calibration curve
A calibration curve reflects the mathematical relation between calibrator concentration
and response. It is drawn based on the obtained response and the multiple values
between the minimum and maximum concentrations of the calibrator.
Calibration factor
Calibration factor is obtained based on the equation of calibrator concentration (known)
and response (calibration math model).
Vocabulary-1
Vocabulary
Vocabulary-2
Vocabulary
Download
To obtain sample programming information from the LIS host and match it with the
scanned samples. The system supports real-time and manual downloading of sample
programming information.
EMF
EMF stands for Electromotive Force. The ISE module determines the concentration of ion
by measuring the electromotive force of ion with ion selective electrodes. A calibrator with
constant concentration should have electromotive force within certain range.
Endpoint
The endpoint method, also called equilibrium method, is most ideal for measurements. In
endpoint measurements, the reaction reaches equilibrium after a period of time. Since
the equilibrium constant is quite high, it can be considered that all substrates (analytes)
have changed into products, and the absorbance of the reactant will not change any more.
The absorbance change is directly proportional to the analytes’ concentration.
Fixed-time
In fixed-time measurements, namely, rate measurements, the reaction velocity (v) is
directly proportional to the substrate concentration [S] within a specific period, that is,
v=k[S].
Flag
Flag is a manufacturer-defined symbol, which appears on patient reports or result list
when a result is beyond the user-defined reference range or exceeds the defined limits.
High-concentration waste
High-concentration waste is produced during the 1st-3rd phase of cuvette cleaning and
includes the ISE waste. It can be drained in a waste tank or to the sewer according to your
local or national regulations on waste liquid disposal.
History results
Stored results are those programmed and analyzed before the current day.
Increased
Increased indicates the sample volume required for analysis and can be defined on the
Define/Edit Chemistries window.
Initialization
Initialization is a series of operations automatically performed by the system during the
startup procedure. It includes parameters check, reset, testing, cleaning and priming.
Inventory check
Used to check the remaining volume of the biochemistry reagents, sample probe wash
solution and reagent probe wash solution and refresh the tests left and wash solution
volume on the Reagent/Calibration screen.
ISE
ISE is the abbreviation of Ion Selective Electrode. It consists of the Na electrode, K electrode,
Cl electrode, reference electrode, sampling and measuring channel, syringe, heat stabilizer,
degassing unit and waste discharger. The ISE module measures the concentration of Na, K
and Cl in serum, plasma and diluted urine.
Vocabulary-3
Vocabulary
K factor
C K ( R R0 )
K factor is manually input for single-point linear calibration formula
and used to calculate results.
Lamp
Lamp is located on the photometer assembly and used to measure the absorbance of
mixture in a reaction cuvette. It should be replaced regularly.
Linearity
Degree of linearity for a reaction curve or calibration curve. Reaction curve linearity is
available in fixed-time measurements, while calibration curve linearity specifies the
allowable concentration range for result calculation.
LIS
LIS stands for Laboratory Information System. It is a host computer and communicates
with chemistry analyzers through the internet interface.
L-J chart
A Levey-Jennings (L-J) chart, drawn based on the QC date (X) and test results (Y), shows
the QC result trend of a chemistry during the specified period. The graphical trends of up
to 3 controls can be displayed on one L-J chart and distinguished with different colors.
Lot number
Lot number is assigned to controls, calibrators or wash solutions of the same lot for
identifying manufacture date, quality, expiration date and other related information.
Low-concentration waste
Low-concentration waste is produced during the 4th-8th phase of cuvette cleaning. It can
be drained to the sewer of your laboratory.
Mask/Unmask chemistries
Used when a chemistry needs to be disabled temporarily due to abnormal result or
reagent exhaustion. The masked chemistry will have a symbol appearing on its
upper-left corner, and will still be displayed on the Sample, Quality Control and
Reagent/Calibration screens but not run for sample analysis. Masked chemistries
cannot be requested until they are unmasked.
Mixer
The system provides sample mixer and reagent mixer, which stir the mixture inside a
reaction cuvette when sample/R3 and R2/R4 are respectively dispensed.
Multi-sample report
Containing the results of multiple samples, and can be printed out on the Current Results
and History Results screens.
Off-line dilution
Prior to analysis, samples are diluted manually based on specific ratio.
Offset
Offset is a value added or subtracted to compensate a result. It is often used along with
the slope in the equation y=kx+b, in which k is the slope and b is the offset.
Off-system chemistry
All the chemistries that are not run by the analyzer are referred to as the off-system
chemistries.
Vocabulary-4
Vocabulary
Online help
Online help provides you with help information about the screens. If you do not
understand a parameter or an operation on a screen, you can go to the online help for
relevant information. Access the online help from the following screens:
Select the icon on the upper right corner to display the help topic related to the
current screen.
Select the button in front of each maintenance instruction or item to display the
relevant operating instructions.
Select the button in front of each error log to display the corresponding topic.
Click the button on a warning message window to display the corresponding
descriptions and solutions.
Press the shortcut combination key Alt+F1 to display the topics related to the
current screen or window.
Open-reagent chemistry
Open-reagent chemistry, an opposite of the closed-reagent chemistry, can be measured by
using the reagents provided by other manufacturers. It can be user-defined, edited and
deleted.
Operation unit
The operation unit, a computer configured with the operating software, controls the
analyzing unit to finish tests and produce test results.
Output unit
A printer used to print out test results and other data.
Panel
Consists of a couple of chemistries combined together for certain clinical purposes, such
as liver function, kidney function, etc. Panels can help fast programming of samples.
Patient demographics
Patient demographics contain information related to the patient and sample, such as
patient name, age, gender, collection date/time, etc.
Physiological saline
0.9% sodium chloride solution, used for reagent blank and sample dilution.
Predilution
Prior to analysis, samples are diluted automatically based on the defined dilution factor.
Primary wavelength
The primary wavelength is chosen based on the light absorption features of the reactant
and used to measure the absorbed light intensity. Options for primary wavelength include:
340nm, 380nm, 412nm, 450nm, 505nm, 546nm, 570nm, 605nm, 660nm, 700nm,
740nm and 800nm
Prime
Prime is an action to replace the reagents in tubing of the ISE module. A prime is required
to replace the reagents in tubing with new ones during the startup procedure or when a
reagent is changed.
Vocabulary-5
Vocabulary
Print name
Print name appears on a patient report representing a chemistry, and if left blank, will be
replaced by the short name of the chemistry.
Prozone check
Prozone check is intended to checking samples with quite different concentrations, which
may generate the equivalent amount of insoluble antigen/antibody compound and can
have the same test results. The Prozone check can be performed in two ways: rate check
and antigen addition.
Pull-down list
A control of the software screen or window. Select the down-triangle button on the right of
a pull-down list to show multiple options.
QC panel
Used for analysis of control samples.
QC rule
A set of rules to evaluate if the QC results are under control and the analyzing system is
stable. Examples of QC rule are 1-2s, 1-3s, etc.
QC summary
Contains the mean values and standard deviations of controls analyzed within the
specified period, as well as the set mean and SD value. The obtained results are compared
with the set values to judge if the system is working normally.
Qualitative analysis
Qualitative analysis is used to analyze every sample for the detection of lipemia,
hemolysis and icterus and calculate the numeric values of the index. If the volume of the
interferents contained in a sample is beyond the set range, a flag will be added to the
patient report.
Random error
An alarm of quality control monitoring. A random error may occur when the lowest and
highest values of QC results respectively exceed -2SD/-3SD and +2SD/+3SD.
Reaction carousel
Reaction carousel is a turntable, and used to hold reaction cuvettes and transmit each of
them to the photometric position for signal detecting and absorbance calculation.
Reaction curve
A reaction curve reflects the relationship of the absorbance measured at the primary
wavelength, secondary wavelength and primary-secondary wavelength. It is drawn based
on the absorbance of the sample-reagent mixture measured within the reaction period.
The system provides 4 types of reaction curves: calibration reaction curve, QC reaction
curve, sample blank reaction curve, and sample reaction curve.
Reaction cuvette
Reaction cuvette is a carrier in which reagents and samples react with each other and
then carried to the photoelectric position for signal detecting and response calculation.
Reaction direction
Reaction direction refers to the change trend of absorbance during the reaction process.
It includes positive and negative.
Vocabulary-6
Vocabulary
Reaction time
For endpoint analysis, the reaction time refers to the time span from the start point of the
reaction to the end point; for fixed-time and Kinetic analysis, it refers to the period from
reaction equilibrium to the end of monitoring.
Reagent blank
In the reagent blank test, the reagents react with the physiological saline, and the blank
absorbance is calculated to correct the calibration factors. Only the reagents that are in
Calibrated, Cal Time Out or Cal Required status can be requested for reagent blank.
Reagent carousel
The reagent carousel is located on left side of the analyzer panel. It holds reagent bottles
and carries each of them to the reagent aspirate position for aspirating.
Reagent carryover
Cross contamination between the reagent probe and the mixers. When the number of
tests between the contaminating chemistry and the contaminated is less than or equal to
the defined number (N), and no concentrated wash is inserted between the two
chemistries, it indicates that the reagents underlie the risk of carryover.
Reagent inventory alarm limit
Alarm limit of reagents and wash solutions. When the reagent inventory is lower than the
alarm limits during or before the analysis, the system will give an alarm and display the
reagent or wash solution name in yellow on the Reagent/Calibration screen.
Reagent probe
The reagent probe aspirates the specified amount of reagent from a reagent bottle and
then dispenses it into a cuvette for reaction and analysis. The system has one reagent
probe.
Reagent probe wash solution
CD80 alkaline concentrated wash solution. It is placed in position D of the reagent
carousel inner ring, and used for special cleaning the two reagent probes, sample mixer,
reagent mixer, and cuvettes, in order to prevent cross contamination.
Reference range
Reference range is a user-defined range consisting of low limit and high limit. When a
result is beyond the reference range, a flag will appear near the result.
Release
Used to clear the specified sample position or all positions on the current sample carousel.
When a sample is released, its results and programming information can be still recalled.
The released position can be used for programming of new samples.
Replicates
Number of times to run a test, to ensure accurate results.
Result statistics
Result statistics option can summarize the total chemistries and the distribution trend of
its results and provide the test data and graph.
Sample blank
Sample blank is similar to sample analysis except for use of equivalent amount of
physiological saline. Sample blank is used for removal of non-chromogenesis reaction,
such as influence of sample interference (Hemolysis, icterus and lipemia) on absorbance
readings.
Vocabulary-7
Vocabulary
Sample carousel
The sample carousel is located on right side of the analyzer panel. It holds sample tubes
and carries each of them to the sample aspirate position for aspirating.
Sample comments
Remarks for some special samples, such as, ** sample has hemolysis; ** sample needs to
be analyzed immediately, etc.
Sample log
Contains the controls and patient samples that are not complete within the recent 24
hours due to certain reasons. Based on the sample log you are allowed to rerun the
samples or take other actions for the controls and samples.
Sample panel
Used for analysis of patient samples.
Sample probe
The sample probe aspirates the specified amount of sample from a sample tube and then
dispenses it into a cuvette for reaction and analysis.
Sample probe wash solution
CD80 alkaline concentrated wash solution. It is placed in position D2 of the sample
carousel, and used for special cleaning the sample probe, sample mixer, reagent mixer,
and cuvettes, in order to prevent cross contamination.
Sample type
Type of sample. The sample type options include serum, plasma, urine, CSF and other.
Screen
Screen is a part of the software interface. It is rectangular and contains various controls,
such as edit box, function button, etc.
Secondary wavelength
The secondary wavelength is used to remove the interference in primary wavelength
values and eliminate the influence of noise, such as light flash and drift, and scratches on
cuvettes, etc. It cannot be the same as the primary wavelength.
Serial number
Sequence number of the reagent bottle.
Slope
Multiplied with the test result to make it consistent with that obtained on other
instruments. It is often used along with the offset in the equation y=kx+b, in which k is
the slope and b is the offset.
Special calculation
Special calculation is derived from calculation of certain chemistries and has specific
clinical purposes, such as A/G, TBil-DBil, etc.
Special wash
Special wash is to clean the sample probe, reagent probes, mixers and reaction cuvettes
by using the probe wash solution, with the aim of eliminating carryover and preventing
waste from leaving in the waste tubes.
Vocabulary-8
Vocabulary
Vocabulary-9
Vocabulary
Wash solution
All wash solution used by the instrument is CD80 alkaline concentrated wash solution.
According to usage, it can be divided into three types: concentrated wash solution (in the
front cabinet) for cleaning cuvettes, sample probe wash solution (in D2 of the sample
carousel) for special cleaning the sample probe, sample mixer, reagent mixer and cuvettes,
and reagent probe wash solution (in D of the reagent carousel) for special cleaning the
reagent probes, sample mixer, reagent mixer and cuvettes.
Westgard rule
Westgard rule is used for monitoring of quality control. In the Westgard rule, single rules
such as 12S, 13S, 22S and 41S are combined to evaluate results of single or multiple
controls.
Test statistics
On the Tests screen, you can view test requests and reagent application for each
chemistry during a period, and sample requests and the quantity of its chemistries
Vocabulary-10
Index
Index-1
Index
N
Noise and fuse, 1-41
Index-2
Index
Q S
QC alarms, 2-22, 7-2 Safety classification, 1-41
QC panel, 6
sample blank, 12, 2-19, 2-22, 3-15, 4-5, 4-6, 6-20, 7-10,
QC reports, 7-2, 11-3
7-16, 8-14, 8-41, 9-11, 6
QC rules, 3-32, 3-34, 3-35, 7-2
Sample blank, 12, 3-15, 4-5, 4-6, 6-20, 7-10, 7-16, 8-14,
QC summary, 7-18, 6
8-41, 9-11, 6
Qualitative, 10-11
sample blanked response, 4-5
Quality control, 2-1, 3-1, 7-2
Sample blanked response, 4-5
Quantitative, 10-11
Sample carousel, 1-10, 1-11, 1-35, 17-2, 17-3, 17-4, 17-41,
8
Sample carousel assembly, 1-10
Index-3
Index
Index-4
Bibliography
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productivity of analytical processes. AACC Press, Washington DC, 1986.
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