387 CB 3
387 CB 3
387 CB 3
CA-600 series
CHAPTER 1: Introduction
CHAPTER 2: Safety Information
CHAPTER 3: Design and Function
CHAPTER 4: Installation Environment
CHAPTER 5: Operation
CHAPTER 6: Display and Processing of
Analysis Results
CHAPTER 7: Output
CHAPTER 8: Quality Control
CHAPTER 9: Setting Standard Curve
CHAPTER 10: Instrument Setup
CHAPTER 11: Maintenance and Supplies
Replacement
CHAPTER 12: Troubleshooting
CHAPTER 13: Functional Description
CHAPTER 14: Technical Information
CHAPTER 15: Index
CHAPTER 16: Appendix (A)
KOBE, JAPAN
7. Output ...................................................................7-1
7.1 Automatic Printout of Analysis Data ....................................... 7-1
7.2 Output of Analysis Data .......................................................... 7-1
7.3 Example of Printout ................................................................ 7-3
1. Introduction
Thank you for purchasing a CA series automated blood coagulation
analyzer.
Please read this manual carefully before operating this product.
Keep this manual in a safe place for future reference.
Diagnostic Parameters
Manufacturer
SYSMEX CORPORATION
1-5-1 Wakinohama-Kaigandori
Chuo-ku, Kobe 651-0073
Japan
European Representative
SYSMEX EUROPE GmbH
EC REP Bornbarch 1, 22848 Norderstedt, Germany
Tel.: +49 40 5 27 26-0
Fax: Tel.: +49 40 5 27 26-100
Training Courses
CE-Mark
The system described in this manual is marked with a CE-mark which
confirms the compliance with the essential requirements of the following
European Directives:
98/79/EC on in vitro diagnostic medical devices
2011/65/EU on the restriction of the use of certain hazardous
substances in electrical and electronic equipment
EAC-Mark
The system described in this manual is compliant with the European ln-
Vitro Diagnostic (lVD) Directive and additionally marked with an EAC-
mark which confirms the compliance with applicable Technical
Revised July 2017
Risk of Infection
Indicates the presence of a biohazardous material or
condition.
Warning!
If this sign is ignored and the instrument is operated
incorrectly, there is a potentially hazardous situation
which could result in death or serious injury of operator,
or grave property damage.
Caution!
If this sign is ignored and the instrument is operated
incorrectly, there is a potentially hazardous situation
which may result in injury of operator, adverse effect on
results, or may cause property damage.
Caution, Hot
Indicates a risk of burns or other injury if the user fails to
observe the indicated instructions.
Information
Indicates what we would like you to know to maintain
instrument performance and prevent its damage.
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Note
Indicates information which will come handy in operating the
instrument.
1.4 Trademarks
• Sysmex is a registered trademark of SYSMEX CORPORATION.
• CA CLEAN is a trademark of SYSMEX CORPORATION.
• Dade, Actin, Berichrom, Ci-trol, Pathromtin, Multifibren,
INNOVANCE and Data-fi are trademarks of Siemens Healthcare
Diagnostics.
• VACUTAINER is a registered trademark of Becton, Dickinson and
Company.
• VACUETTE is a registered trademark of Greiner Bio-One GmbH.
• Other registered trademarks or trademarks referenced are property of
their respective owners.
The fact that a trademark is not explicitly mentioned in this manual does
not authorize its use.
2.7 Disposal of Waste Fluid, Waste Materials, and the Device .........2-7
2. Safety Information
This chapter explains precautions for safe use of this instrument.
Warning!
• Keep long hair, fingers and clothing away from
mechanical parts of the instrument.
• During analysis, do not open the light shield cover
and put in hands or fingers.
This could cause injury. When the light shield cover
is opened during analysis, the alarm sounds and the
operation stops.
• In the event that the instrument emits an abnormal
odor or any smoke, turn off its power supply
immediately and pull out the power plug from the wall
socket.
If the instrument is used continuously in that state,
there is a hazard that fire, electrical shock, or injury
may result. Contact your local service representative
for inspection.
• Take care not to spill blood or reagent, or drop wire
staples or paper clips into the instrument.
These might cause short circuit or smoke emission. If
such problem should occur, turn off the power supply
immediately and pull out the power plug from the wall
socket. Then contact your local service representative
for inspection.
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Warning!
• Do not touch the electric circuits inside the
instrument. Especially with wet hands there is a risk
of electric shock.
• Never put the power plug in any socket other than
that specified. When installing the instrument, be
sure to ground it. Otherwise, fire or electrical shock
will result.
• Take care not to damage the power cord, put a
heavy thing on it, or pull it forcibly. Otherwise, the
wire may become shorted or break, causing fire or
electrical shock.
• When connecting the instrument to a peripheral (host
computer, etc.), be sure to switch off the power
supply beforehand. Otherwise, fire or electrical shock
may result.
• Use the check-digit as much as possible. If the
check-digit cannot be used, the potential of the
incorrect reading of the barcode label may be
increased.
Caution!
• Read this manual carefully to operate the instrument
by the proper method. Keep it securely in a specified
location for future reference.
• This instrument must only be operated as instructed
in this manual.
Caution!
• Install in a place which is not subject to water splash.
• Install in a place which is not subject to adverse
effects of high temperature, high humidity, dust,
direct sunlight, etc.
• Do not give the instrument a strong vibration or
impact.
• Install at a place which is well ventilated.
• Avoid installation of the instrument near devices that
emit electrical interference, such as a centrifuge.
• Do not install near chemicals storage or in a place
where gas is generated.
Risk of Infection
• In principle, all parts and surfaces of the instrument
must be regarded as infectious.
• Never touch waste, or parts having been in contact
with waste, with bare hands.
• Should you inadvertently come in contact with
potentially infectious materials or surfaces,
immediately rinse skin thoroughly with plenty of
water, then follow the antiseptic regulations of your
laboratory.
• Be careful when handling samples. Always wear
latex or non latex examination gloves; otherwise
contamination could result. If a sample happens to
enter your eye or a cut, wash it off with plenty of
water, and immediately visit a physician.
• Control plasma may also be infectious. Wear latex or
non latex examination gloves during QC process. If
plasma happens to enter your eye or a cut, wash it
off with plenty of water, and immediately visit a
physician.
• Be sure to connect the instrument’s drain tubing to a
dedicated waste bottle.
• Use care when handling waste liquid. If it adheres to
the skin or clothing, wash it off using an antiseptic
solution.
• When performing any task on the instrument, such
as testing, maintenance, preparation, or post
processing, be sure to wear adequate personal
protective equipment, such as protective gloves, a
protective mask, protective eyewear, and a lab coat.
After completion of work, wash hands with
disinfectant to avoid the risk of infection with
pathogens etc.
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Warning!
• Do not directly touch the reagents. Reagents can
cause irritation of the eyes, skin and mucous
membranes.
• Should you inadvertently come in contact with
reagent, immediately rinse skin thoroughly with
water.
• If a reagent should get in your eyes, rinse thoroughly
with water and contact your physician immediately.
• If a reagent is accidentally swallowed, vomit or
induce vomiting by drinking copious amounts of
warm, salty water and contact your physician
immediately.
• CA CLEAN II is acidic. Be especially careful when
handling it. If eye or mouth contact occurs by
mistake, take emergency measures such as washing
the area with plenty of water; see a doctor if needed.
If you get the detergent on your hands, quickly wash
the area with plenty of water.
• CA CLEAN I is strongly alkaline. Full care must be
taken when handling it. If eye or mouth contact
occurs by mistake, take emergency measures such
as washing the area with plenty of water; see a
doctor if needed. If you get the detergent on your
hands, quickly wash the area with plenty of water.
• Extra care should be taken to make sure CA CLEAN
I is not mixed and used with acidic solutions such as
CA CLEAN II. Direct mixing of CA CLEAN I and an
acidic solution will result in the highly hazardous
release of poisonous chlorine gas.
• When handling samples or reagents, always wear
latex or non-latex gloves. Wear personal protective
equipment in accordance with local regulations!
After completion of work, wash hands with
disinfectant to avoid the risk of infection with
pathogens etc.
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Caution!
• Follow directions on reagent labelings.
• Avoid letting the reagent come in contact with dust,
dirt or bacteria.
• Reagents must not be used after their expiration
date.
• Handle reagents gently to avoid bubbling.
• Take care not to spill reagents.
• Handle and store reagents according to the
instructions provided with each reagent.
To maintain the storage stability of the reagents, they
should be stored cooled with their lids closed out of
the instrument in a refrigerator.
Leaving reagents for long periods with open caps
could affect data.
Risk of Infection
Always wear latex or non latex examination gloves when
performing maintenance work or inspection. Also use the
specified tools and parts. After work is over, wash the
hands in an antiseptic solution. There is a possibility that
those areas of the hand which came in contact with
blood could suffer infection.
Warning!
When carrying out inspection and maintenance of the
instrument, use only the specified tools and parts. Such
actions are dangerous and prohibited by the
Pharmaceutical Affairs Law.
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Risk of Infection
When discarding waste liquid, instrument consumables
and instrument, take proper steps to dispose of them as
medical, infectious and industrial wastes.
If they are contaminated with blood, there is a possibility
of bacterial infection occurring.
Warning!
Battery is installed in CA-600 series to store data.
When discarding the instrument, remove the battery.
If the instrument is thrown into fire, it may explode.
Battery
PCBNO.60027
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Waste Disposal
Risk of Infection
After becoming waste at end-of-life, this instrument and
its accessories are regarded as infectious. They are
therefore exempted from EU directive 2012/19/EU
(Waste Electrical and Electronic Equipment Directive)
and may not be collected by public recycling to prevent
possible risk of infection of personnel working at those
recycling facilities.
Warning!
• Do not dispose the instrument, accessories and
consumables via public recycling!
• Incineration of contaminated parts is recommended!
• Contact your local Sysmex service representative
and receive further instructions for disposal! Follow
local legal requirements at all times.
Caution!
Waste effluents from the instrument may contain
dangerous substances in it and decision about disposal
only has to be made by local water authority.
Decontamination
Warning!
Before decontaminating the instrument, be sure to turn
off the power supply and unplug the power cord. This is
necessary to avoid the risk of electric shock. When
cleaning the instrument, always wear protective gloves
and gown. Also, wash hands after decontamination
carefully with antiseptic solution first and with soap
afterwards. Do not open the instrument for
decontamination inside. This is executed only by Service
Technician.
Information
• To ensure decontamination of the instrument outer
surfaces, clean the instrument surface at the end of
the daily work. This has to be executed in the
following three situations;
- Regularly, at the end of a daily work,
- Immediately, during contamination with
potentially infectious material, and
- In advance of repair or maintenance by the field
technical service representative
• Wipe off the instrument surfaces using a cloth
soaked with a suitable decontamination solution.
Please use one-way cloths, e.g. made of paper or
cellulose. The cloth may be moistened in a way only
that no wetness may reach the inside of the
instrument.
• The indicated residence time of the decontamination
solution shall be observed.
• If required, you may afterwards remove normal
contaminations with commercial neutral detergent, in
case these could not be removed by the
decontaminant.
• As a last step the instrument shall be dried with a dry
one-way cloth.
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Front
(1)
(2)
Printer Head
(3)
(5)
(6)
(4)
1.
Caution!
When closing the light shield cover, be sure to hold the
handle.
If it is closed by holding other parts, the hand or finger may
get pinched or injured.
Be sure to fully open the light shield cover and check that it
will not fall down by its own weight.
If the light shield cover falls down, there is a risk of causing
injury on the head.
Also, do not place any object on the instrument covers.
2.
Caution!
When the probe has been lowered, move it until the probe
and the catcher lower surface are leveled, and then move
the arm.
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3.
Caution!
Do not apply excessive force to the sampler unit.
It may break.
4.
Risk of Infection
In principle, all parts and surfaces of the instrument must
be regarded as infectious.
5.
Caution, Hot
The printer head can get very hot when printing. Do not
touch.
6.
Caution!
Static electricity may damage the printer head. Do not
touch.
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Left Side
1.
Risk of Infection
When discarding used reaction tubes, always wear latex
or non latex examination gloves. After completion of work,
wash hands with disinfectant.
Handle all instrument parts as biologically hazardous.
There is a risk of infection with pathogens etc. Also,
medical waste and infectious waste should be properly
disposed of.
Take care not to spill waste liquid that may have collected
in the trash box.
Rear
1.
Risk of Infection
When draining the trap chamber, always wear latex or non
latex examination gloves. After completion of work, wash
hands with disinfectant.
Handle all instrument parts as biologically hazardous.
There is a risk of infection with pathogens etc.
2.
Warning!
As it is dangerous, be sure to pull out the power cord
before inspection.
To avoid risk of electric shock, disconnect the power cord
before replacing the fuse.
For continued protection against risk of fire, replace only
with fuse of the specified type and current ratings.
Otherwise, fire or electrical shock will result.
Warning!
Be sure to ground the instrument.
If grounding is not sufficient, there is a risk of electric
shock.
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1.
Caution!
Refill the rinse bottle with distilled water only.
When refilling, be careful not to allow dirt to adhere to the
(1)
float switch, etc.
1.
Risk of Infection
Handle the waste bottle and its contents supposing that
they are contaminated by a pathogenic organism. Do not
(1)
handle the waste bottle without wearing proper protective
equipment.
When disposing of waste, always wear latex or non latex
examination gloves. After completion of work, wash hands
with disinfectant.
Also, medical waste and infectious waste should be
properly disposed of.
2.9 Operators
Warning!
This instrument is clinical laboratory equipment for
screening.
When making clinical judgment based on analysis
results, the doctor must also consider clinical conditions
and other inspection results for an overall judgment.
Caution!
• Those who have no or only limited experience in
using the instrument are recommended to have
guidance or assistance from those with sufficient
experience.
• If the instrument has developed a problem by any
chance, a person in charge of it should take steps
within the range specified in Instructions For Use. As
to problems other than those mentioned, contact
your local Sysmex representative for repair.
• Instrument unpacking, installation, and confirmation
of initial operation must be done by your local
Sysmex representative.
3.1 Overview
Front
4. Built-in Printer
Warning!
Do not open the Light Shield Cover while analysing. Opening the cover will
suspend analysis and beep the alarm. Also, opening the cover and inserting your
hand may cause injury.
2. Sampler
The sampler has a load capacity of one sampler rack with 10 sample tubes. The sampler racks
are specific for Sysmex instruments. One rack can be set on the sampler at a time.
Pull out the Sampler toward you to load a rack. Once the rack is loaded, the sampler will
operate without the need for intervention by the operator.
Note
• The sampler unit is locked while sampling and dispensing. Once the status has become
ready to set samples, the sampler lock is released. You can pull out the sampler to set
samples on available positions on the rack in use, or to place a next rack to allow
continuous analyses.
• The sampler unit can also be pulled out by the STAT sample analysis procedure to
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Information
If there is a sample that has been already dispensed, this sample has to be
reanalyzed from the start.
Caution!
Use the provided vials to hold the CA CLEAN I detergent. If any vial higher than
50 mm is used, the Probe will be damaged permanently.
Caution!
Use the provided vials for the container to keep the Buffer. If any vial higher than
50 mm is used, the Probe will be damaged permanently.
Caution!
If any vial higher than 40 mm is used, the Probe will be damaged permanently.
Left Side
1. Power Switch
1. Power Switch
Turns the power ON or OFF.
Caution!
Please allow at least 5 seconds between turning the instrument OFF and back ON,
or the fuse may be blown.
Right Side
1. Trash Box
Used for storing used reaction tubes.
Trash Box Liner CA6 can be set in the trash box.
2. Host Computer Serial Connector
For connecting to the external host computer.
3. Hand-held Barcode Reader Connector
For connecting to the Hand-held barcode reader.
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Rear
Information
When the Rinse Bottle is to be opened, disconnect this tubing first to release the
pressure accumulated inside the Rinse Bottle. Failing to do this will splash the
pressurized rinse fluid.
Information
When the Rinse Bottle is to be opened, disconnecting this tubing first will splash the
pressurized rinse fluid. Disconnect the black tubing first.
5. Trap Chamber
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Prevents the waste fluid from flowing back to affect the vacuum pump, in the event of an
abnormality with the instrument.
Warning!
• To avoid risk of electrical shock, disconnect the power cord before replacing the
fuses.
• For continued protection against risk of fire, replace only with a fuse of the
specified type and current ratings.
9. Power Connector
For connecting the main power supply (via the supplied power cable).
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4. Installation Environment
Grounding
The power cord of each instrument uses the 3P plug. When the power
supply socket is 3P (with ground) type, simply plug it to the socket. The
type of cord and plug supplied depends on the source voltage for the
system.
Warning!
Proper use of the appropriate power cord assures
adequate grounding for the system. Failure to properly
ground the instrument bypasses important safety
features and may result in an electric hazard.
Note
The number of power supply sockets required is one.
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Installation Space
490
490
566
Caution!
Be sure to place the rinse bottle and waste bottle on the
base on which the instrument is set. Do not place them
on the instrument. They may cause the instrument to
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Installation Environment
Light
5. Using [↑] and [↓] keys, move the cursor to select Date or Time.
6. Using the numeric keys, set Date and Time, and press [Enter] key.
The parameter in the cursor position is set and the cursor will move
to the next parameter.
Information
• When entry is made in the wrong format, the setting
is not executed.
• If the number of day or month is a single digit, enter it
with a 0 preceding it.
• Enter the time in a 24-hour clock system.
5. Operation
1 2 3 4 5 6 7
The System Status Area displays [Sysmex] key, error message, analysis
status, and the status of externally connected instruments.
1. [Sysmex] key
Press this key to display Sysmex menu showing Error List,
Temperature, and Paper Feed. When the instrument develops an
error, causing the alarm to sound, [ALARM RESET] key appears.
Press [Error List] key to display Error History.
Press [Temperature] key to display temperatures of various units.
Press [P. FEED] key to feed printer paper.
For Sysmex Menu, refer to “12. Troubleshooting”.
2. Analysis Status
This indicates analysis status with the current instrument. “Ready”,
“Analyzing”, “Waiting” will appear.
3. Rack Replacement
This indicates whether the sample rack can be replaced or not.
4. HC (Host Computer)
Indicates the connection status with the host computer.
HC (no background color): Host computer is set to be connected.
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The data processing area displays analysis progress status, work list,
stored data list, reaction curve, quality control data, standard curve data,
instrument setup status, etc.
When the power supply is turned on, the work list screen (Main Menu
screen) appears.
The menu processing area always displays the menu for function
selection.
In selecting a menu, touch a key that shows a menu you want to see.
After power supply turn-on, when system check is completed, the Main
Menu appears. The Main Menu is the basic menu for selecting functions
of this instrument.
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Start 5.15
INTERR 5.22
Prev 5.21
Next 5.21
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When the rinse solution level is found low, replenish the rinse bottle with
distilled water. As to the procedure for replenishing rinse solution, refer
to “11.17 Replenish Rinse Solution”.
Caution!
When analysis is made with the rinse bottle lying flat,
there is a possibility that correct analysis result may not
be obtained. Make sure the rinse bottle is not lying flat.
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When waste liquid has collected in the waste bottle, discard the contents.
Regarding how to dispose of waste liquid, refer to “11.4 Dispose of
Waste”.
Risk of Infection
When disposing of waste, always wear latex or non latex
examination gloves. After completion of work, wash
hands with disinfectant. Handle all instrument parts as
biologically hazardous. There is a risk of infection with
pathogens etc. Also, medical waste and infectious waste
should be properly disposed of.
Information
When analysis is made with the waste bottle lying flat,
waste may flow back into the vacuum pump, causing the
pump to fail.
Make sure the waste bottle is not lying flat.
When used reaction tubes remain in the trash box, discard them.
As to discarding, refer to “11.3 Discard Used Reaction Tubes”.
Check to see the Built-in Printer has enough paper to handle the number
of samples expected that day.
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Open the cover and check to see there are no obstacles for analysis.
Note
• The detector and cooler reach an analysis-permitting
temperature in about 5 - 30 minutes after power turn-on.
• When the system is waiting for an analysis-permitting
temperature, the message “Not Ready” is displayed and
“Start” key is not displayed.
Note
[HC] key is displayed only when the system is set for manual
inquiry to the host computer. For detail, refer to “5.13 Manual
Inquiry”.
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Prepare Reagents
The amount of Owren’s Veronal Buffer per test includes the amount
used in dilution for each analysis parameter.
When analyzing the parameters that require two reagents, a rinse
operation is performed three times in total after dispensing samples and
reagents.
Thus the amount used per test is approximately 30 mL. However, the
number of rinse operations can be changed. (Refer to “10.8 Test
Protocol”.)
CA CLEAN I is used after the reagent is dispensed. The amount used for
one rinse is the amount of the reagent + 10 µL.
Caution!
• Prepare each reagent taking into consideration the
analysis parameters and the number of the samples
to be analyzed. Prepare extra volumes as shown
below, in addition to the required volumes for
analysis:
Each coagulation reagent: Approx. 0.6 mL
Distilled water: Approx. 500 mL
Owren’s Veronal Buffer: Approx. 0.9 mL
CA CLEAN I: Approx. 0.9 mL
CA CLEAN II: Approx. 0.3 mL
• The amount of reagent used in the initial operation
(rinse operation) after analysis starts is as follows:
Distilled water: Approx. 35 mL
CA CLEAN II: Approx. 50 µL
Owren’s Veronal Buffer: Approx. 200 µL (*)
(*)only when parameters are analyzed for the
Chromogenic Method or Immunoassay Method.
• The amount of reagent used for probe rinsing is as
follows.
Distilled water: Approx. 150 mL
CA CLEAN I: Approx. 125 µL
CA CLEAN II: Approx. 250 µL
• When the reagent lot changes and becomes
different from the one used to create the standard
curve, change the lot number of the reagent
information and set the standard curve again.
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Caution!
• Prepare a sufficient volume of reagent which takes
into consideration the minimum sample volume
required. When the volume of the reagent is
insufficient, sample may not be analyzed accurately.
• Use a Conical 4 mL sample cup (code No.424-1160-
8). If a different sample cup is used, the reagent may
not be aspirated correctly, which would influence the
analysis results.
1. Prepare Reagents.
Siemens
Dade® Innovin®
[ ] Prepare reagents as per the document supplied with each reagent.
Caution!
[ ]
2. Check that the analysis status display is “Ready”, and open the light
shield cover.
Warning!
Be sure to fully open the light shield cover and check that
it will not fall down by its own weight.
If the light shield cover falls down, there is a risk of
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Holder No. 11
Reagent bottles (each measuring 22 mm OD and 40 mm height), or
optional reagent holders and sample cups can be set in the reagent
rack. (Refer to “10.20 Reagent Name/Holder List”.)
4. Enter the reagent volume set on the reagent holder and press
[ENTER] key.
The value entered at the cursor position will be displayed. The
second line will automatically display the available reagent volume
to be used for the analyses.
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Note
• If the Reagent Volume Monitoring is set to “Valid”, each
time the reagent is dispensed, the volume for the test will
be subtracted from the entered value.
• Refer to “10.12 Setup of Reagent Volume Monitoring” for
the setting procedures.
• Refer to “10.11 Reagent Holder” for confirmation of vial
type.
Information
The reagent amount which was input is erased when the
power is turned OFF.
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Caution!
• When setting reaction tubes on the reaction tube
rack, be careful not to drop sweat or the saliva into
the reaction tube. This will alter the analysis result.
• Reaction tubes are intended for single use only.
Reaction tube rack
If used more than once, rewashed, or recycled,
inaccurate measuring results may be obtained due to
the effect of possible contamination. Inaccurate
results could lead to inappropriate patient diagnosis
or treatment.
Information
• Set the reaction tube rack securely to prevent the
tubes from unseating and rising; otherwise, the probe
might be damaged.
• The reaction tubes are set successively from the first
30
position (top on extreme right-hand column).
Therefore, make sure no position is left empty.
• Make ready some extra reaction tubes in addition to
the quantity needed for analysis.
• Be sure to use the supplied reaction tubes (SU-40).
Reaction tube (SUC-400A) for CS-2000i and other
reaction tubes manufactured by other companies
cannot be used.
Note
A maximum of 30 reaction tubes can be mounted on a reaction
tube rack. Since two reaction tube racks can be used, the
maximum number of reaction tubes that can be set is 60.
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2. Set the opened Trash Box Liner CA6 into the trash box.
3. Set the trash box in place.
Caution!
• If the Trash Box Liner CA6 is not inserted properly
into the trash box, it may not be possible to remove
the trash box from the instrument. Insert Trash Box
Liner CA6 into the trash box so that its bottom is flush
with the box.
• Insert the Trash Box Liner CA6 in the orientation of
the mark printed in the Trash Box Liner.
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Caution!
• Unless the standard curve is properly set, percent
activity, concentration, and other calculation
parameters cannot be reported.
• If calculation parameters are changed after the
plotting of a Standard Curve, data coordination will
become impossible. When calculation parameters
are changed, always perform standard curve
analysis again.
Caution!
If samples are left at room temperature for a long time,
they may deteriorate. Set samples to the sampler just
before analysis starts.
Also, if the sample volume is insufficient, use new
sample tubes to collect blood again.
1. Prepare plasma.
1) Add 1 part of 3.8%, 3.2% or 3.13% sodium citrate solution as
anticoagulant to 9 parts of venous blood, and mix the contents
thoroughly.
2) Centrifuge the blood tube directly after blood collection for 15
minutes at 1500 x g to 2500 x g. Please refer to CLSI guideline
H21-A5 for further details.
3) Affix Barcode Label (Option).
To ensure correct reading of a barcode, a barcode label has to be
affixed at the proper position.
4) Set, in the supplied sample rack, the centrifuged blood tube itself
or the plasma which has been removed and put into another test
60mm
A
tube.
Insert the test tube securely to the bottom of the rack.
When an optional sample barcode scanner is used, set barcode
18mm
Warning!
Affix the barcode label so that the bars on the label
would become horizontal when the rack is placed on the
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Caution!
Cautions about handling plasma:
• As its container, use a plastic or silicone-coated
glass tube.
• As anticoagulant, use 3.8%, 3.2% or 3.13% sodium
citrate solution. When any other anticoagulant than
this solution is used, it will cause a white precipitation
and lead to incorrect analysis results.
• Mix blood and sodium citrate solution in an accurate
ratio of 9 parts to 1 part, respectively. As the mixing
ratio varies, coagulation time also varies,
occasionally leading to incorrect analysis results.
• Samples must be analyzed within 4 hours of
collecting if stored cool.
Those samples that had more than 4 hours pass
after collecting and those kept in improper storage
condition will not give correct analysis results.
• Samples containing anticoagulants can, in certain
circumstances cause reaction curve errors which
may result in erroneous measuring times.
Plasma
Blood
layer
ID ID ID ID ID
8.0 - 10.6 11 12 13 14
Caution!
• The blood volumes shown above are the dead
volumes. (Prepare an extra volume for the parameter
to be analyzed.)
• If there is plasma only in the test tubes and the
sample volume is lower than the dead volume, air
may get aspirated and/or a “Probe Crash” or
“Sampling Error” may occur, preventing correct
analysis results from being obtained.
• If there is plasma only in the tubes, it is not
recommended to use the following tubes with a
double wall structure because their narrow inner
diameters and higher bottom positions cause a
higher possibility of a short sample error.
- VACUTAINER Plus Plastic Citrate Tube,
13 mm × 75 mm, 2.7 mL
- VACUETTE® Sandwich Coagulation Tube,
13 mm × 75 mm, 3.0 mL/3.5 mL
• If the sample volume of centrifuged samples is lower
than the dead volume, blood cells may get aspirated,
preventing correct analysis results from being
obtained.
Revised July 2017
Caution!
• When using test tubes with an outside diameter of 15
mm, remove the 13 mm tube adapters from the
sample rack beforehand.
When using test tubes with an outside diameter of 10
mm, remove the adapters from the sample rack and
mount the optional holder No. 113 (10 mm test tube
adapter) beforehand.
• When using sample cups, set the optional holder No.
70 beforehand.
• When using sample cups, avoid setting samples
which are low in plasma volume. Such samples will
cause the error of “Probe Crash”.
For samples, prepare the required volume plus 100
µL.
Sampler
Information
Unless the sample rack is correctly set, instrument
failure will result.
Press in the sample rack sensor (lower left) so that the
sample rack is level.
Sample Rack Sensor
Revised July 2017
With the instrument, all samples are analyzed according to the analysis
order.
Analysis information for 10 samples (1 rack filled) can be set at a time.
There are four procedures for setting sample ID Nos. and analysis
parameters:
• Manual setting with the numeric keys and analysis parameter
keys.
• Receiving sample ID Nos. and analysis parameters collectively
from the host computer (Refer to “5.13 Manual Inquiry”.)
• Manually entering sample ID Nos. so that analysis orders will be
automatically received from the host computer (Refer to
“5.14 Automatic Inquiry”.)
• Using sample ID Nos. that have been read with the optional
barcode scanner so that analysis information will be
automatically received from the host computer. (Refer to
“5.14 Automatic Inquiry”.)
Information
The instrument does not store analysis information. The
information is erased when power is turned off.
Information
• When an ID No. is not registered, this instrument
automatically assigns it. After power turn-on, it
begins with 000000000000001 (15 digits), which is
incremented by 1 at a time.
• Analysis results will not be stored in a QC File if a
Standard Curve is not set and QC parameters are set
as calculation parameters.
• If sample ID is “0”, automatic output to the host
computer and printout cannot be performed.
However, manual output to the host computer and
printout can be performed. If the power is turned off,
analysis results of sample ID “0” will be deleted from
the memory.
Note
To completely erase a registered sample ID No., position the
cursor over the number and press first [C] key then [Enter]
key.
Group Selection
A combination of analysis parameters, selected from three menus, can be
set. The analysis parameters that can be set are limited to those in the
selected group.
1. Press [Test Group] key on the Main Menu.
The Group Setting screen will be displayed.
Note
When the cursor is on a rack which has been or is being
analyzed, [Test Group] key is not displayed if an analysis
parameter is already set.
Note
When this [Test Group] function is used, the analysis at
various dilution ratios can be performed.
Example:
• + Fbg is a parameter that is analyzed with Fbg diluted to
1:20 (a half of the usual concentration).
• - Fbg is a parameter that is analyzed with Fbg diluted to
1:5 (2 times of the usual concentration).
Repeat
Assigns consecutive sample ID Nos. for one rack (10 samples), with the
cursor positioned at the top, and copies analysis parameter setting for all
subsequent samples.
1. Using [↑] and [↓] keys, specify a sample you want to repeat.
2. In the Main Menu screen or ID No. Entry screen, press [Repeat] key.
Information
When sample ID No. is “0” or it is for QC or Standard
Curve, [Repeat] cannot be executed.
Note
Revised July 2017
Information
• Inquiry is not performed for those samples on which
both ID Nos. and analysis parameters have been set.
• Inquiry is not performed either for those samples on
which ID Nos. have not yet been set.
Caution!
Remove any foreign matters, if exists, on barcode drive
mechanism.
Revised July 2017
Note
• Should any error occur in reading barcode labels, the
sample ID Nos. become “ERR0000000001” and increase
in sequence. Inquiry is not performed.
• Regarding the rack positions for those ID Nos. that have
been manually set, you can make inquiries to the host
computer using the manually set ID Nos, without reading
barcodes.
• Inquiries are not made for samples with registered analysis
parameters.
Information
• Before analysis, confirm that there is sufficient
amount of rinse solution in the rinse bottle, the waste
bottle will not be filled up during analysis, and the
trash box is not filled up with reaction tubes.
• Approx. 50 µL of CA CLEAN II is used for initial
cleaning. Before analysis, confirm the remaining
amount of CA CLEAN II is sufficient.
When the analysis is started, the initial rinse probe is started (approx
1.5 minutes) and “Analyzing” is displayed on the screen.
When the rinse probe is finished, the workload list is displayed and
the sample dispensing is started. The cursor position of the workload
list moves to the next compartment of the rack.
Information
When you have pressed [First Tube] key inadvertently,
causing the instrument to stop by error, then Continue
information for the reaction tubes is lost. In this case, set
the reaction tubes again from the first position, and press
[Start] key.
Note
• The first time the analysis is started after power switch on,
[Continue] key is not displayed.
• Automatic sensitivity adjustment of the detector is
performed when the first analysis starts after power-ON,
or when analysis starts after each interval of 24 hours.
(Refer to “5.17 Automatic Sensitivity Adjustment of the
Detector (for CA-660 Only)”.)
4. When all analyses are over, the alarm sounds “pip, pip, peep”.
If you want to continue analysis, when the message “Replace Rack?
No!” changes to “Replace Rack? YES!”, then samples can be set to
the next sample rack or the same sample rack. (Refer to “5.23 Add
Samples” for sample addition.)
Even during analysis, when the [INTERR] key changes to the
[Start] key, it will be possible to analyze samples in the next rack.
Warning!
During analysis, do not insert hands or fingers, either
through the gap in the light shield cover or by opening
the cover. This is to avoid the risk of injury. If you open
the light shield cover during operation, the alarm will
beep and the instrument will stop.
Revised July 2017
Caution!
When the power switch is turned off during operation,
the instrument will fail. Make sure the analysis has been
completed and the instrument status display is “Ready”
before turning off the power switch.
Information
During operation, the sampler cannot be pulled out as
the lock mechanism is activated to prevent injury and
damage to the instrument.
Note
RESTRICTIONS DURING OPERATION
• Only [Stored Data], [↑], [↓], [Repeat], [ID No. Entry],
[HC], [Prev], [Next] in the Main Menu can be used
during operation.
• Once registered, analysis information cannot be changed.
Note
The conditions for automatic transmission of maintenance
data are as follows:
• SNCS is connected.
• The connection setting “Mainte. auto send” must be set to
“Enable”.
Note
When Chromogenic Method parameters are included in the
parameters selected for group settings, adjustment is
performed for the Chromogenic Method detectors. When
Immunoassay Method parameters are included, adjustment is
performed for the Immunoassay Method detectors.
Note
Analysis can still be performed after the replace-detector
message has appeared.
Note
Analysis start process continues even if the message for
replacement is displayed.
Note
Analysis continues even if such an error occurs.
If such an error occurs, press the [ALARM RESET] key. Install the
trash box to recover from the error.
Risk of Infection
If the analysis is performed with the trash box removed,
the inside of the analyzer will be polluted since the
reaction tube polluted by blood drops into the analyzer.
When the error message is displayed, be sure to set the
trash box correctly.
While installing the trash box, be sure to put on the latex
or non latex examination gloves.
When cleaning the inside of the analyzer or disposing of
the reaction tube which dropped into the analyzer, be
sure to put on the latex or non latex examination gloves.
Note
If the trash box is installed, the error message will disappear.
The alarm, however, continues sounding until the [ALARM
RESET] key is pressed.
Revised July 2017
During analysis
Note
While the Interruption Confirmation screen is on, the
instrument is performing analysis.
When all analyses are completed with this screen on, the Main
Menu screen returns and “Ready” is displayed.
Note
The samples whose analysis has been canceled have “X”
displayed in the Work List.
Information
• Registered sample ID Nos. and orders cannot be
modified.
• Additional orders can only be registered to a position
after the final rack position of the registered orders.
Note
To cancel addition of orders, press [AddOrderCancel] key.
Note
To cancel registration of STAT samples, press [Cancel
STAT] key. Revised July 2017
Note
When [Start STAT] key is pressed without pulling out the
sampler, the message “Replace STAT Sample. OK?” will
appear. Press [Cancel] key, and STAT Sample Order Setting
screen returns without starting STAT analysis.
Note
• Rack Nos. 01-00, 02-00, 03-00, and 99-00 of STAT
samples are displayed and 99-00 is followed by 01-00.
• While STAT sample is being dispensed, [INTERR.] key
is not displayed.
Information
• Should the instrument need to be shut down in an
emergency, such as an unexpected outage of power
to the laboratory, immediately turn off the power
switch to the instrument.
• Note that the above-mentioned switch differs from
the emergency mechanical stop switch on the front of
the instrument. When the mechanical stop switch is
pressed, the mechanical system comes to a stop but
the power supply is not turned off.
Caution!
• When photo detection is stopped and discard/rinse
operation starts, the sample data being analyzed is
discarded.
Reanalyze sample data marked with “×” in the Work
List.
• If the sampler table is pulled out when the sample
probe is lowered in the tube, the sample probe will be
permanently damaged.
Note
Discard/rinse operation cannot be executed when, for
example, the sample probe could be damaged by doing so.
5.26 Shutdown
Confirm that the instrument status is “Ready” before turning off the
power switch.
At the conclusion of the day's analyses or after the instrument has been
run for at least 24 hours, perform the following daily maintenance:
1) Discard the used reaction tubes.
2) Dispose of waste fluids.
3) Remove dew from the reagent holders.
4) Clean the sample probe.
For detail, refer to “11. Maintenance and Supplies Replacement”.
Caution!
If the power is turned off when the rinse bottle or waste
bottle are lying flat, the solution may flow back into the
instrument.
Before turning off the power switch, confirm that the
bottles are not lying flat.
Revised July 2017
List Display
When [Stored Data] key on the Main Menu is pressed, the Analysis
Result screen appears. While the Graphic Display screen is on, press
[Return] key on Local Menu to view the analysis results.
Note
Using [Select Display] and [ID No./Seq] keys, you can
change a stored data to be displayed and its chronological
sequential arrangement. When the power switch is turned off
or the display is returned to the Main Menu, however, all
stored data return to the previous list in chronological analysis
sequence.
The Stored Data List Display screen can display up to 8 samples per
screen. When the first List Display screen appears after the power switch
is turned on, data of the last 8 samples is displayed. When latest analyses
are completed, those sample data are automatically added to the last of
the List. The List Display screen is composed of the analysis results,
showing 3 data parameters at a time, and the sample information. Use
Revised July 2017
When you press [Mark] key on the List Display screen, a mark ( ) can
be put on an analysis data in the current cursor position. The mark will
appear at left side of the data.
When an analysis data is already attached with a mark, pressing [Mark]
key causes the mark to be deleted.
Abnormal Flag:
Abnormal flags displayed on the right or left of an analysis data
indicate the following:
m (on right of ID No.): The data is a mean. The parameter has been
calculated from mean data of seconds or
ΔOD/min.
d (on right of ID No.): A dilution ratio other than 100% was used
for the data.
* (on left of data): Some kind of error has occurred, or there is
deviation in repeated analysis.
> (on left of data): A data that exceeds the Upper Report Limits
< (on left of data): A data that exceeds the Lower Report Limits
+ (on right of data): A data that exceeds the Upper Mark Limits
- (on right of data): A data that exceeds the Lower Mark Limits
Note
Abnormal flags are displayed according to the following
priority.
1. *
2. <, >
3. +, -
Graphic Display
1 11
2 12
3 13
4 14
5 15
6 16
7
8
9
10
7. Reaction curve
A graph is plotted with time on the horizontal axis and the scattered
light intensity or light absorbance variation on the vertical axis.
Time scale is shown at right end.
When the reaction curve graph area is pressed, the Graphic
Enlargement window will be displayed. Refer to “Graphic
Enlargement Window” described later.
8. Error code
Error code when an error occurs in analysis result
When there is no error, 0 appears.
9. dH
Increase of scattered light intensity in reaction process
10. CH No.
Detection channel in which analysis was conducted
11. Abnormal Flag
Abnormal flags displayed on the right or left of an analysis data.
12. Coagulation Time or Light Absorbance Variation
Time taken for coagulation or change in light absorbance
13. Analysis Temperature
Temperature of the detector at the start of analysis
14. Coagulation detection point
Coagulation detection point set
It is not displayed in case of analyses by Chromogenic Method and
Immunoassay Method.
15. Calculated Parameters
Activity percentage, PT ratio, INR (PT), (Fbg concentration), etc.
16. bH
Scattered light intensity at the start of analysis
Note
Reaction curve is not displayed when some error occurred
during analysis and no analysis data was obtained. The curve
is also not displayed for the mean data of repeated analysis.
Revised July 2017
When an analysis error has occurred, its detail can be displayed in the
window.
1. Press [Info.] key on the Graphic Display screen to display the Error
Detail window.
2. Press [Return] key of Error Detail Window.
The Error Detail window will be closed.
The reaction curve graph on the Graphic Display screen can be enlarged
on the window.
1. Press an area of the reaction curve graph on the Graphic Display
screen.
The Graphic Enlargement window will be displayed.
2. Press an area of reaction curve graph on the Graphic Enlargement
window.
The Graphic Enlargement window will be closed.
6.2 Search
With this program, a data can be moved to the top data point or the
bottom data point in the List Display, and samples that agree with
specified conditions can be searched from stored data.
Search by ID No.
Note
• To use the hand-held barcode reader, it is necessary to
make the connection setting to “Connected”.
When barcodes can be read by hand-held barcode reader,
an icon appears on the upper right of the screen.
• When sample ID is entered by hand-held barcode reader,
the entered sample ID is checked and if there is an
incorrect sample ID, a confirmation message appears.
Press the [Conf.] key to return to the Search by ID No.
screen, where ready for entering.
Search by Date
The first analysis data of a specified date can be displayed at the head of
the screen.
1. Press [Search] key on the Stored Data List Display screen.
The Local Menu for search will appear.
2. Press [Search Date] key.
The Search by Date screen will appear.
Revised July 2017
3. Enter Date.
Using the date numeric keys in the Search by Date screen, enter a
date by which to search.
4. Press [Enter] key on the date numeric keys.
Search by date begins from the sample in the current cursor position
toward the latest sample.
To cancel search by date, press [Quit] key on the date numeric keys.
5. A List is displayed in which analysis data of the date entered is listed.
When analysis data of the specified date is found, the a list of
analysis data will be displayed. The cursor is on the first analysis
data corresponding to the date entered.
When analysis data corresponding to the date entered is not found,
the Confirmation Message screen will appear.
Press [Conf.] key to return to the Search by Date screen.
Note
While analysis is in progress, the program is automatically run
in the analysis sequence.
Revised July 2017
All Data
Mean Data
As the condition for displaying a list, Mean Data can be specified.
When there is no sample to be displayed, the screen as shown at the left
will appear.
1. Press [Select Display] key on the Stored Data List Display screen.
The Local Menu for selecting a display will appear.
Not Output
As the condition for displaying a list, the data that have not yet output
can be specified.
1. Press [Select Display] key on the Stored Data List Display screen.
The Local Menu for selecting a display will appear.
2. Press [Not Output] key on the Local Menu.
The Not Output Data Selection screen will be displayed.
To cancel the selection, press [Return] key. The Stored Data List
Display screen will return.
3. On the Not Output Data Selection screen, press the key to select the
Not Output data to display. The selected data is indicated with a “v”.
To cancel the selection, press [Return] key. The screen will return to
the Stored Data List Display.
The “v” alternately appears or disappears each time the key is
pressed.
IP Not Output: Stored analysis data that have not yet output to the
built-in printer are displayed in the sequence
chosen, either ID No. sequence or analysis
sequence.
HC Not Output: Stored analysis data that have not yet output to the
host computer are displayed in the sequence
chosen, either ID No. sequence or analysis
sequence.
Information
When an output was performed with the display
condition “Not output data” selected, the output flag will
be changed but the data will remain in the “Not output
data” display even though the data has been output.
In this case, exit from the “Not output data” display by
pressing [Main Menu] key, or change the display
condition, to update the contents of the “Not output data”
display.
Revised July 2017
Note
• To use the hand-held barcode reader, it is necessary to
make the connection setting to “Connected”.
When barcodes can be read by hand-held barcode reader,
an icon appears on the upper right of the screen.
• When sample ID is entered by hand-held barcode reader,
the entered sample ID is checked and if there is an
incorrect sample ID, a confirmation message appears.
Press the [Conf.] key to return to the Search by ID No.
screen, where the input field is cleared and ready for
entering.
Caution!
There should be thorough control of sample ID Nos.
within the facility, so that when the sample ID No. is
changed, the new No. can be used to identify the patient.
Note
When ID No. sequence is chosen instead of analysis sequence,
change in sample ID No. will not automatically cause change
Revised July 2017
6.6 Deletion
With this program, Stored Data can be deleted.
Data to delete can be specified on the Local Menus for Current Data,
Marked Data, and All Data.
Note
Once deleted, data cannot be restored. Check carefully in
advance before deleting data.
Current Data
From the analysis data, the data in the current cursor position can be
deleted.
1. Press [Delete] key on the Stored Data List Display screen.
The Local Menu for deletion will appear.
2. Press [Current] key on the Local Menu.
The Deletion Confirmation screen will appear.
Marked Data
All Data
7. Output
Current Data
The data in the cursor position can be output to the built-in printer or the
host computer.
1. Press [Current] key on the Local Menu for external output.
The Select Device screen will appear.
2. Select the device on the Select Device screen.
[IP Graph] key: Analysis data (with graph) at the cursor
position is output to the built-in printer.
[IP List] key: Analysis data (without graph) at the cursor
position is output to the built-in printer.
[Host Computer] key: Analysis data at the cursor position is
output to the host computer. (Displayed
only when “Connected” is selected.)
[Return] key: Cancels the device selection and returns the
screen to the Local Menu for External
Output.
Revised July 2017
Information
Notice for the setting of [IP Graph].
• If the setting of “Format” in [Auto Val/Out] specified
from [Settings] is “Print + Graph”, data with a graph
will be printed out.
• If the setting of that is “Analysis”, analysis data will be
printed out. Even in this case, however, if the power
is turned off after the analysis, analysis data will not
be printed out but data with a graph will be printed
out.
• Even in the case of “Print + Graph”, if no reaction
curve is drawn, data without a graph will be printed
out.
• In the case of “Auto + Graph”, analysis data will be
printed out for analysis items with a coagulation
curve error.
Marked Data
The marked data can be output to the built-in printer or the host
computer.
1. Press [Mark] key on the Stored Data List Display screen to make a
mark.
When [Mark] key is pressed, the analysis data in the current cursor
position will be marked ( ). When the mark is already there, it will
disappear.
Press [Marked All Clear] key to remove all the marks.
2. Press [More] key.
Revised July 2017
All Data
All data can be output to the built-in printer or the host computer.
1. Press [All] key on the Local Menu for external output.
The Select Device screen will appear.
2. Select a device on the Select Device screen.
3. Output of all analysis data begins.
The screen of output in progress will appear.
If [Cancel] key is pressed on the screen of output in progress, the
output stops and the Select Device screen returns.
8. Quality Control
Quality control is performed to obtain high-reliability data over long
periods and also to constantly monitor the status of the instrument to
prevent problem in advance.
This instrument analyses control plasma and other standard samples (QC
samples) and performs statistical control of the results.
Caution!
Use the QC samples or reagent in accordance with the
usage described in each attached instruction.
Perform quality control at least once every 24 hours and
check that the instrument operates correctly.
Lot No. Sets a lot No. for samples to be used in quality control.
EXP. Sets an expiry date on samples to be used in quality control.
Control Name Set the control name of the QC data to send to SNCS.
1. On the Quality Control screen, display the QC Chart of the file to set
parameters for.
For how to display QC Chart, refer to “Select QC Chart” of
“8.4 Display QC Charts”.
2. Press [Settings] key on the Quality Control screen.
The current settings of the selected file are displayed on the QC
Settings screen.
Using [↑] and [↓] keys, move the cursor to select the parameters to
be set.
3. Set replicates using [Next Option] key.
Each time [Next Option] key is pressed, “1” and “2” are changed
alternately.
4. Set a control parameter using [Next Option] key.
Each time [Next Option] key is pressed, a parameter set as a
standard curve parameter is changed over.
Information
Analysis results will not be stored in a QC File if a
Standard Curve is not set and QC control parameters
are set as calculation parameters.
Note
• As control parameters, you can select the analysis
parameters set in Test Name and Standard Curve
Parameter setting.The parameters linked to the standard
curve are selected from the parameters which were set at
link source.
• When changing control parameters, delete all control data
of a QC File to be changed.
Revised July 2017
Information
In setting control limits, the following conditions have to
be met.
Note
Press [Auto Calc.] key, and the limit values will be
automatically calculated from QC data stored in the file, as in
the following.
changed, change the cursor position with [↑] and [↓] keys.
7. Press [Quit] key.
Setting by the numeric keys is completed.
Information
• When the entered date is in a wrong format, the
expiry date will not be corrected by pressing [Enter]
key. The cursor also does not move. Enter again in a
correct format.
• If you attempt to use the QC File that has passed its
expiry date, then the confirmation screen with the
error message will appear immediately after [Start]
key is pressed.
• The correct calculation parameters cannot be
obtained if they have expired.
For the items below, data read by hand-held barcode reader can be
entered.
• Lot No.
• Expiration date
• Target
• Upper Flag
• Lower Flag
Note
To use the hand-held barcode reader, it is necessary to make
the connection setting to “Connected”.
Information
• Check that the label lot No. of QC sample is the
same as that in reference value table attached, and
then read the barcode of the reference value table.
• Verify that the type of the control (e.g. normal,
pathologic) corresponds to the selected QC File.
• If the barcode of a different lot is read and input, the
condition of the instrument cannot be controlled
correctly.
• Barcodes can be used only for the QC sample
produced by Sysmex or Siemens.
Reference value table is not attached to some QC
sample.
• The upper stop and lower stop for analysis pause will
not be applied until auto calculating or manual setting
is performed.
Note
The lower stop for analysis pause is set to “0”, and the upper
stop for analysis pause is set to the maximum available value
automatically.
Note
Analysis data with “Slight Coagulation” and "Analysis Time
Over" error will be also stored. Other error data cannot be
stored.
Note
[Change Scale] key will appear only when there is data in a
file.
Note
The point mark “ ” indicates data where the results of QC
analysis exceed STOP-UL or are below STOP-LL.
Select QC Chart
Note
When the current parameter is one which has the QC Chart
displayed, press [Select File] key on the Quality Control
screen.
Note
The key for each file will display the date of the latest
analysis. Those files with no analysis date do not have any
data.
Revised July 2017
Note
• The conditions for automatic QC data transmission are as
follows:
• SNCS is connected.
• The connection setting “QC auto send” must be set to
“Enable”.
• The analysis parameter must be registered as SNCS
subject data in the QC parameters.
• Automatic QC data transmission starts after automatic
maintenance data transfer is complete.
Once the series of analyses has finished normally and the instrument
status is “Ready”, transmission starts and the Sending screen is
displayed.
Press [Cancel] key to stop the transmission process and return to the
Main Menu screen.
Note
[SNCS] key is displayed when SNCS is connected and the
parameter is registered as an analysis parameter subject to
SNCS in the QC parameters.
Note
[Delete] key is not displayed when the file has no data.
Caution!
Once data has been deleted, it cannot be recovered.
Revised July 2017
4. Using [←] and [→] keys on the Local Menu, move the cursors and
set the data range to be deleted.
Press the [Change Cursor] key to select the range-setting cursor.
The cursor position data area displays the data for the range-setting
cursor.
5. Press [Yes] key on the Local Menu.
The screen confirming the range to be deleted will be displayed.
Print All
Press the [Graph All] key or the [List All] key to start printing.
Note
• The number of data that can be printed is all data for either
180 or 60 points, selected by [Change Scale] key.
• A ∗ mark at the right edge of the printed list indicates that
quality control analysis results for that data exceeded
STOP-UL or fell below STOP-LL.
Revised July 2017
Note
• If the start date and end date are not entered, print all is
executed.
• If only the start date is not entered, printing of the range
from the oldest data to the end date is executed.
• If only the end date is not entered, printing of the range
from the start date to the most recent data is executed.
Note
When dates are specified, mean values, S.D., and C.V. are
recalculated over the specified period.
Note
• The number of data items printed is the data in the
specified period within 180 points or 60 points, as selected
with the [Change Scale] key.
• An asterisk “*” at the right end of a printed list indicates
Revised July 2017
Graphic printout
List printout
Revised July 2017
Data Display
1. Press [Standard Curve] key on the Main Menu screen.
The PT Standard Curve Data screen will appear.
The contents displayed on the Standard Curve Data screen are:
(M): Displayed when some of standard curve data is
manually input.
Cal Date: The date on which the Standard Curve is set
Reagent Name: Name of reagent
Lot No.: Lot No. of reagent (up to 12 digits)
EXP.: Expiry date of a reagent
<Standard Curve Data>
Activity/Concentration:
Percent activity or concentration.
Up to 6 points can be set for each parameter.
(A lower-position point indicates a lower activity
or concentration.) Displayed when activity or
concentration is set in [Select Param.] key.
Coagulation Time - Reaction Speed:
Coagulation time or reaction speed for 6-point
activity or concentration
Normal: Normal value used for finding the ratio. Displayed
when the ratio or INR is set by [Select Param.]
key.
ISI: International Sensitivity Index to calculate INR.
Displayed when INR is set by [Select Param.]
key.
Revised July 2017
Caution!
When analysis is made after expiry date has passed,
coagulation activity (PT ratio, PT-INR, etc.) cannot be
accurately calculated.
In processing [Lot No. Entry], set a new reagent Lot No.
and expiry date. When [Start] key is pressed after expiry
date passed, the message “Check Reagent Expiry”
appears, with the alarm sounding.
Note
[Next] key is displayed when dFbg or PT-INR Calibration is
set by [Select Param.] key of standard curve for PT
parameter.
Note
The key for analysis parameters which have been linked to the
standard curve is masked.
3. Press the analysis parameter key to display the standard curve data of
the selected analysis parameter.
When [Cancel] key is pressed, the screen will return to the original
data's standard curve data screen.
Graphic Display
1. Press [Graph] key on the Standard Curve Data screen.
The contents displayed on the Graphic Display screen are:
Standard Curve Graph:
Plots activity or concentration on X axis and
coagulation time or reaction rate on Y axis.
Expression: Displays a expression such as
Log P = a * Log T + b from the plotted data.
P: Coagulation activity (Concentration)
Revised July 2017
Note
When “Log Lin” or “Lin-Lin” is set on Select Parameters
screen, Correlation, rate, and offset are displayed.
Auto Dilution
Caution!
• Input the calibrator value as described in the
calibrator value table. If a wrong value is input, the
correct analysis result may not be obtained.
• If the calibrator value of a different lot is input, the
correct analysis result may not be obtained.
• When the reagent lot is changed, perform standard
curve analysis.
Note
To use the hand-held barcode reader, it is necessary to make
the connection setting to “Connected”.
Revised July 2017
Information
• Check that the label lot No. of calibrator is the same
as that in calibrator value table attached, and then
read the barcode of the calibrator value table.
• Barcodes can be used only for the samples produced
by Sysmex or Siemens.
Calibrator value table is not attached to some
samples.
5. Press [Select Dil. Set] key and select a series of dilution desired.
Note
The dilution series number indicates 1 - 12 for automatic
dilution series numbers, or “M” for manual dilution.
Revised July 2017
Information
Two or more points are required to start Standard Curve
Revised July 2017
analysis.
8. When analysis is over, the screen for checking whether to use the
analysis data as Standard Curve Data is displayed.
[Set] key: Sets the analysis data as Standard Curve data and
returns to the Standard Curve Data screen.
[Quit] key: Discards the analysis data and returns to the Standard
Curve Data screen.
[Next] key: Displays the Setting screen for a different calculation
parameter.
Information
When [Set] key is pressed, the standard curve that was
used up to that time is automatically saved to a backup
file. (Refer to “9.5 Standard Curve Files”.)
Press [Graph] key to display the new Standard Curve data as graph
(solid line with square plots).
When [Current Graph] key is pressed, the current Standard Curve
graph (dotted-line graph with triangular plots) will appear in
addition. Press it again to hide the current graph.
Press [Return] key to return to Standard Curve Data screen without
updating the new standard curve.
Note
The “d” in a graph indicates the difference in coagulation time
between the new and old Standard Curves at 1:1 as a deviation
amount.
Manual Dilution
Manual dilution 5. Use the numeric keys to enter the activity percentage or
Test-tube position on sample rack concentration for each point. For details about settings for this
calculation procedure, refer to “9.7 Set Calculation Parameters”.
To the left of the table is displayed the sample rack test-tube
positions. “1” indicates sample rack test-tube position 1.
Caution!
• Input the calibrator value as described in the
calibrator value table. If a wrong value is input, the
correct analysis result may not be obtained.
• If the calibrator value of a different lot is input, the
correct analysis result may not be obtained.
• When the reagent lot is changed, perform standard
curve analysis.
• When preparing a diluted sample, if it is prepared at
wrong dilution ratios, the correct analysis result may
not be obtained.
Information
Put the calibrator for the set value in the same sample
rack test-tube position as the number shown on the
settings screen.
Note
To use the hand-held barcode reader, it is necessary to make
the connection setting to “Connected”.
Information
• Check that the label lot No. of calibrator is the same
as that in calibrator value table attached, and then
read the barcode of the calibrator value table.
• Barcodes can be used only for the samples produced
by Sysmex or Siemens.
Calibrator value table is not attached to some
samples.
6. Use the numeric keys to input the analysis count for each point.
The analysis count can be set from 0 - 3.
The cursor can be moved with [↑] and [↓] keys.
7. Press [Start] key on the top right of the screen to begin analysis.
During analysis, the message “STD Analyzing. Please wait.” is
displayed.
Information
2 or more points are required in order to begin Standard
Curve analysis.
Revised July 2017
Information
When [Set] key is pressed, the standard curve that was
used up to that time is automatically saved to a backup
file. (Refer to “9.5 Standard Curve Files”.)
Press [Graph] key to display the new standard curve data as graph
(solid line with square plots).
Press [Current Graph] key to display the current (old) standard
curve graph (dotted line with triangular plots in addition). Press it
again to hide the current standard curve graph from the screen and
switch to the new standard curve.
Press [Return] key to return to Standard Curve Data screen without
updating the new standard curve.
Note
The “d” in a graph indicates the difference in coagulation time
between the new and old Standard Curves at 1:1 as a deviation
amount.
Revised July 2017
Caution!
• Input INR, % as described in the INR value table.
If a wrong value is input, the correct analysis result
may not be obtained.
• If the INR value of a different lot is input, the correct
analysis result may not be obtained.
• When the reagent lot is changed, perform standard
curve analysis.
Information
Put the calibrator for the set value in the same sample
rack test-tube position as the number shown on the
Settings screen.
Note
To use the hand-held barcode reader, it is necessary to make
the connection setting to “Connected”.
Revised July 2017
Information
• Check that the label lot No. of calibrator is the same
as that in INR value table attached, and then read the
barcode of the INR value table.
• Barcodes can be used only for the samples produced
by Sysmex or Siemens.
INR value table is not attached to some samples.
5. Use the numeric keys to input the analysis count for each point.
The analysis count can be set from 0 - 3.
The cursor can be moved with [↑] and [↓] keys.
Revised July 2017
Note
Entering the activity percentage (concentration) here, in
addition to the INR value, allows two types of Standard Curve
to be set: INR and activity percent.
7. Press [Start] key on the top right of the screen to begin analysis.
During analysis, the message “STD Analyzing. Please wait.” is
displayed. Each time [Next] key is pressed, the Setting screen for a
different calculation parameter is displayed.
Information
2 or more points are required in order to begin Standard
Curve analysis.
Information
When [Set] key is pressed, the standard curve that was
used up to that time is automatically saved to a backup
file. (Refer to “9.5 Standard Curve Files”.)
Press [Graph] key to display the new standard curve data as graph
(solid line with square plots).
Press [Current Graph] key to display the current (old) standard
curve graph (dotted line with triangular plots in addition). Press it
again to hide the current standard curve graph from the screen and
switch to the new standard curve.
Revised July 2017
Note
• The difference in coagulation time between the new and
current standard curves at 1:1 is displayed as deviation
amount d.
• If the INR calibrator is not used for calculation
parameter 1, follow the steps below.
1. Perform Standard Curve analysis for calculation
parameter 3 (INR) with the INR calibrator.
2. Make a note of the normal value and calculated ISI.
3. Set the calculation method for calculation parameter 3
to “ISI input”.
4. Perform Standard Curve analysis for calculation
parameter 1 with the activity percentage or
concentration calibrator.
5. Manually input ISI and normal value of 2 above.
Caution!
• ISI values for prothrombin time assays must be
entered directly as they appear on the current
reagent labeling. Also, enter the value calculated by
the managed method as the PT normal value. Any
changes of reagent lot, software upgrades, major
servicing, etc., require verification of the ISI value
and PT normal value. Failure to enter the correct ISI
value or PT normal value will cause incorrect
International Normalized Ratio (INR) results.
Revised July 2017
Note
• When the Standard Curve data is zero (0), it is judged as
no setting.
• In entering data, press numeric keys, then confirm by
pressing [Enter] key.
Normal value and ISI value can also be entered by hand-held barcode
reader (optional).
Note
To use the hand-held barcode reader, it is necessary to make
the connection setting to “Connected”.
Information
• Check that the label lot No. of the reagent is the
same as that in ISI value table attached, and then
read the barcode of the ISI value table.
• Barcodes can be used only for the samples produced
by Sysmex or Siemens.
Normal value and ISI value table is not attached to
some reagents.
• When the reagent lot changes and becomes different
from the one used to create the standard curve,
change the lot number of the reagent information and
set the standard curve again.
When setting the standard curve, check the ISI
value, normal value of PT and calibrator value of the
calibrator, and change those values if necessary.
Revised July 2017
Information
When [Set] key is pressed, the standard curve that was
used up to that time is automatically saved to a backup
file. (Refer to “9.5 Standard Curve Files”.)
Press [Graph] key to confirm the new Standard Curve (solid line
with square plots).
For detail, refer to “9.2 Standard Curve Analysis”.
Revised July 2017
Information
In the standard curve file, the file name and page
number are stated in the upper right of the screen.
• Manually-saved file
File No. 1 (1/4)
File No. 2 (2/4)
File No. 3 (3/4)
• Automatically-saved file
Backup (4/4)
Press [Graph] key to check the graph of the standard curve file (the
plot is a square solid line).
Press [Current STD] key to display the standard curve graph
currently in use.
Press it again to remove the standard curve graph currently in use
(the graph in which the plot is a triangle of dotted lines) from the
screen and switch to just the graph of the standard curve file.
Caution!
The standard curve information for all calculation
parameters (PT, activity %, INR and dFbg) is saved and
loaded as a set.
It is not possible to save and load standard curve
information for individual calculation parameters.
Information
The standard curve that was used up to that time is
automatically saved to a backup file.
It is not possible to save manually to a backup file.
Automatic Backup
When standard curve information is updated, the standard curve
information that was used up to that time is saved to a backup file.
Information
An automatic backup file will not be created, if only the
reagent information settings and/or calculation
parameter settings are updated.
Caution!
The standard curve information for all calculation
parameters (PT, activity %, INR and dFbg) is saved and
loaded as a set.
Revised July 2017
Caution!
It may not be possible to obtain accurate analysis results
if information for a different lot is loaded.
Information
The standard curve that was used up to that time is
automatically saved to a backup file.
Note
Expression, correlation, rate and offset are not printed in
standard curve file data.
Caution!
When the reagent lot changes and becomes different
from the one used to create the standard curve, change
the lot number of the reagent information and set the
standard curve again.
When setting the standard curve, check the ISI value,
normal value of PT and calibrator value of the calibrator,
and change those values if necessary.
1. Press [Lot No. Entry] key on the Standard Curve Data screen.
The Lot No. Entry Menu screen will appear.
2. Press [Reagent1] key, [Reagent2] key, etc. depending on which
reagent you want to set.
Lot No. Entry screen (character key screen) will appear.
Note
Regarding reagent selection key ([Reagent1] key etc.) in the
lower part of the screen, the number of the reagents set by
[Settings] → [Analysis Settings] → [Test Protocol] is
displayed.
Caution!
Lot No. • The barcode ID stuck to the reagent vial and the
reagent lot No. are not the same.
Reagent vial lot No.
• After reading the barcode, check the reagent lot No.
Change it if necessary.
Note
• Enter the expiry date in the format set in System Setting -
Date format; include “/” between numerals.
• When [Enter] key is pressed, the Lot No. Entry screen
will return.
Lot No. and expiry date can also be entered by hand-held barcode
reader (optional).
Note
To use the hand-held barcode reader, it is necessary to make
the connection setting to “Connected”.
Revised July 2017
Information
• Barcodes can be used only for the samples produced
by Sysmex or Siemens.
• When the reagent lot changes and becomes different
from the one used to create the standard curve,
change the lot number of the reagent information and
set the standard curve again.
• The barcode with lot information and expiry date is
not attached to some reagent.
When the reagent lot No. and expiry date are read correctly from a
2D barcode, a confirmation screen appears.
Press the [Register] key on the confirmation screen to enter the
values and return to the Lot No. Entry screen.
Press the [Cancel] key to cancel the entry, discard the values and
return to the Lot No. Entry screen.
Note
The decimal point mode selected here is also applied to the
data stored in the memory.
approximation
Lin-Lin: Real number - real number
linear approximation
Note
To create a Standard Curve by following the procedures of
“9.3 INR Manual Dilution Analysis”, set CalcItem3 to
“Calibration”. If “ISI Input” is selected, INR is calculated
based on the ISI value and normal value which were set in
“9.4 Manual Entry”. When the AKIMA method is selected, set
up the dilution ratio that covers a measurement range equally.
Please note that the measuring range must be defined in raw
values (dOD or seconds) and not in concentration units.
Otherwise the reading of the concentration results from the
standard curve might be incorrect.
Note
Units can be added. Refer to “How to Add Unit” described
later for details.
Revised July 2017
Caution!
If calculation parameters are changed after the plotting
of a Standard Curve, data coordination will become
impossible. When calculation parameters are changed,
always perform standard curve analysis again.
Note
9 different units are registered at time of shipment.
- (No Unit), %, mg/dL, g/L, U/mL, INR, µg/mL, µg/L, IU/mL
A maximum of 12 different units can be set.
Information
If there is no valid calculation parameter, [STD Calc] key
will not appear.
Information
• Standard curves for which the calculation method
was AKIMA or AKIMA(0) cannot be converted.
• The converted value is displayed as “*” in the
following cases:
When the calculated second count or dOD value is
negative
When the converted value overflows
When divide by zero occurs in the conversion
• The converted value is displayed as “0” in the
following cases:
When the calculated concentration or activity %
value is negative
Revised July 2017
Example of printout
Note
When the calculation method is set to “Log Lin” or
“Lin-Lin”, expression, correlation, rate, and offset are printed
out.
Revised July 2017
Follow the procedure shown below to display each setting screen, and
change the set values.
1. Press [Special Menu] key on the Main Menu screen.
The contents of the Main Menu will change over.
2. Press [Settings] key on the Main Menu screen.
The Setting Menu screen will appear.
3. Press a key for parameter to be set.
The screen for setting a desired parameter will appear.
4. Perform setting as required.
5. When the setting is completed, press [Quit] key or [Return] key.
The Renew Confirmation screen will appear.
Note
When Host Computer Status is set “Not Connected”, the keys
for HC will not appear.
Revised July 2017
2. Press the sample key you want to set. That key will be marked with
“v” which sets the sample.
Unless all samples are marked with “v”, automatic transfer/printout
is not performed.
Note
“v” mark appear and disappear alternately each time the key is
pressed.
The samples that can be specified are shown below. Output samples
can be set for both of IP (built-in printer) and HC (host computer).
Within Limit: Analysis data of a sample which has no abnormality
and error (QC and Standard Curve samples excluded)
Out of Limit: Analysis data of a sample which exceeded Mark
Limits (QC and error samples excluded)
Error Flag: Analysis data of a sample that developed some error
during analysis (QC and Standard Curve samples
excluded)
QC Sample: Analysis data measured for QC and standard curve
setting
3. Set a printout format for automatic printout by IP (built-in printer).
The Format will change over each time the key is pressed as follows:
• Print + Graph: The parameter data is automatically printed out
in list format and graph.
• No Graph: The parameter data is automatically printed out
in list format (data, time, sample ID, rack
position, result).
• Analysis: The parameter data is automatically printed out
in analysis format (detailed coag. curve
information and graph).
• Auto + Graph: When an error such as “Coag Curve Error” etc.
occurs on a parameter, the parameter data with
graph is automatically printed out in analysis
format.
• Auto No Graph: When an error such as “Coag Curve Error” etc.
occurs on a parameter, the parameter data
without graph is automatically printed out in
analysis format.
4. When setting is completed, press [Return] key.
The Renew Confirmation screen will appear. Press the appropriate
Revised July 2017
key.
3. Using [↑] key, [↓] key, [←] key, or [→] key, move the cursor to
select limit values to be set.
Move the cursor to a limit value to display the numeric keys.
Move the cursor to the lowermost position, and press [↓] key to
display the next page.
4. Using the numeric keys, enter the limit values and press [Enter] key.
The limit value in the current cursor position is set and the cursor
moves to the next limit value to be set.
Note
• When the lower limit value (-) is greater than the upper
limit value (+), judgement is handled in the following
manner.
•“-” mark if value > entered lower limit value
•No mark if value ≤ entered lower limit value
and value ≥ entered upper limit value
•“+” mark if value < entered upper limit value
Example:
When 200 is set for the lower limit (-) and 100 for the
upper limit (+), a value exceeding 200 is marked “-” and a
value less than 100 is marked “+”.
Revised July 2017
Note
• When “0” is assigned to both upper and lower limits or an
identical value is assigned to both the upper limit (+) and
lower limit (-), judgment is not made.
• Abnormal flags are displayed according to the following
priority.
1. *
2. <, >
3. +, -
Note
• Judgement is not performed if the “v” mark is removed
(parameters not used) from a set parameter when standard
curve parameters are set.
Parameters set here are common with parameters set for
Report Limit.
Revised July 2017
Note
Replication range can be set for seconds and ΔOD/min of
analysis results. It cannot be set for calculation parameters.
4. Using the numeric keys, enter the replication range and press [Enter]
key.
Settings in the cursor position will be set and the cursor will move to
the next parameter to be set.
Note
When “0” is set, the replication range will not be judged.
Note
Judgment parameters can be selected in the [Settings] →
[Data Check] → [Mark Limits] program. Refer to
“10.3 Judgment on Analysis Result”.
Note
• If the value is set to “0”, Report Limit judgement will not
be made.
• When both upper and lower limits are identical, judgment
will not be made.
• Abnormal flags are displayed according to the following
priority.
1. *
2. <, >
3. +, -
Note
When [FIX] key is pressed to update the setting, and the same
test name has been already set, a screen indicating that it is
impossible to update will be displayed. When [OK] key is
pressed, the Test Name Selection screen will appear. Reset a
test name.
Revised July 2017
Information
If the reagent name is changed, the analysis result may
change.
Fully confirm the name before changing. Only the use in
the factory settings is covered by our warranty.
3. Using [↑] and [↓] keys, move the cursor to specify a reagent to be
set.
If no reagent name is displayed, press [Next] key to display the next
page.
4. Press [Manual Entry] key on the Reagent Name Setting screen.
The Reagent Name Entry screen will appear.
Caution!
Do not set the reagent name to blank.
Note
When a reagent name that has been already set is entered, the
renewed setting will be canceled, and the Reagent Name
Setting screen will reappear. The cursor will be placed on the
canceled reagent name.
Caution!
The user is responsible for any change of the test
protocol, as the correct result might not be obtained.
4. Using [↑] and [↓] keys, move the cursor to specify a parameter to be
set.
• To reset the test protocol to default setting
Press [Default] key, and select a test protocol to be reset to
default setting. Refer to “Initialization of Test Protocol”.
• Link of standard curve for analysis parameters
When a specified analysis parameter and other parameters are
linked with standard curve, the following messages are
displayed.
Note
Please check any default setting loaded from the instrument’s
memory with regards to latest application information from
the reagent manufacturer.
Revised July 2017
Note
How to set test protocol differs depending on the detection
method.
• Clotting Method:
Coagulation detection point, maximum detection time,
sensitivity
• Chromogenic Method and Immunoassay Method:
Start point, end point, sensitivity, wave length
Information
The same parameter code cannot be set for more than
one parameter.
2) Manage. ID
Sets the Management ID.
Information
The management ID is associated with the information
of the barcode which is attached to the reagent, control,
and calibrator.
If the management ID is changed to a different one, the
correct value cannot be read from the barcode, and the
correct analysis result may not be obtained.
3) Detector
Determines the detection method.
Press [Analysis Method] key to select the detection method.
For selection of the detection method, refer to “Selection of
Detection Method”.
6) Sensitivity
Sets the sensitivity of the detector.
Press [Next Option] key to select the sensitivity.
• Low Gain
• High Gain
7) Wave length
Sets wave length of the light source. (Only for the Chromogenic
Method or Immunoassay Method)
Press [Next Option] key to select wave length.
• 405 nm Inc. (Chromogenic)
• 405 nm Dec. (Chromogenic)
• 575 nm Inc. (Immunoassay)
• 575 nm Dec.(Immunoassay)
Information
• With the Chromogenic Method, set to 405 nm Inc.
• With the Immunoassay Method, set to 575 nm Inc.
8) Sample Vol
Sets how much sample to aspirate.
The volume can be set within the range of 4 µL, in 1 µL
increments. If no diluent is used, set to 20 µL or more.
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9) Dil. Vol
Sets the reagent type and volume.
Press [Select Reagent] key to select the type of reagent. Refer to
“Selection of Reagent” described later.
The volume can be set within the range of 4 µL to 120 µL, in
1 µL increments.
If no diluent is used, enter 0 µL.
If diluent is used only when standard curve is created, set the
diluent name and enter 0 µL.
Information
Make sure that the sum of diluent volume and sample
aspiration volume will be within a range of 20 µL to
130 µL.
Information
Make sure that the sum of diluent volume and sample
aspiration volume for second step dilution will be within a
Revised July 2017
As for the setting position of diluent volume for second step dilution,
move the cursor using [↓] key to display the screen for setting
reagent.
14) Reagent 1
Sets the interval between the heating start time of sample and the
adding of reagent 1.
The interval can be set in 30-second increments, beginning from
a minimum setting of 30 seconds. However, if the rinse is set for
immediately after sample aspiration, then an additional 30
seconds is needed for each rinse cycle. In the same way, an
additional 30 seconds is needed for each rinse cycle if the rinse is
set for before reagent 1.
Information
Make sure that the entire volume in the reaction tube will
be 220 µL or less.
Information
When using a reagent, be sure to set the number of
following rinse cycles to 1 or above.
Information
When using a reagent, be sure to set the number of
following rinse cycles to 1 or above.
Note
When a setting condition is not met, the cursor will move to
the incorrect setting, and an error message will appear.
Selection of Reagent
On the setting position of Dil. Vol, Reag. Vol, Pre-Rinse and Post-Rinse
press [Select Reagent] key to display the Reagent Selection screen.
Using [↑] and [↓] keys, move the cursor to select a reagent. After the
selection, press [SELECT] key to set the specified reagent.
When a desired reagent is not displayed, press [Next] key to change over
the reagent display.
When [None] key is pressed, non-specified reagent (******) is set, then
the Test Protocol Entry screen will reappear.
When [Return] key is pressed, the selection is canceled, and the Test
Protocol Entry screen will reappear.
Note
Only the reagent names set in “10.7 Reagent Name” will be
displayed.
Caution!
When a test protocol is read, be sure to check the
content of the test protocol.
Information
• When a parameter is linked to the standard curve,
test protocol can be set for the Management ID,
parameter code, sample volume and diluent volume
only.
• For the final total volume of the aspirated sample
plus diluent, set the same volume as that used for the
common parameter (Master). For the other
parameters, the test protocol for the analysis
parameter (master) linked to the standard curve is
set.
• If a test protocol of the link source (master) is
changed in the setting of linking a parameter to the
standard curve, check the test protocols for the
parameters linked to the standard curve.
• When the link to the standard curve is canceled, the
test protocol for the analysis parameter (master)
linked to the standard curve is set except for the
setting of sample dilution.
Note
The following is the standard curve link setting at the time of
Revised July 2017
shipment.
10.9 Replication
This program allows setting replication for each analysis parameter.
When two or more analyses are set, the mean is calculated and displayed.
1. Press [Analysis Settings] on the Setting Menu screen.
The Analysis Setting Menu screen will appear.
2. Press [Set Replication] key on the Analysis Setting Menu screen.
The Replicate Setting screen will display replication for each
analysis parameter.
3. Using [↑] and [↓] keys, move the cursor to specify an analysis
parameter to be set.
4. Using the numeric keys, enter the replicates and press [Enter] key.
The replicates in the cursor position will be set and the cursor will
move to the next parameter to be set.
Note
The value that can be set as the replicates is 1 - 10.
Information
If [Add] key is pressed in the group with 5 parameters
registered, the Test Group Addition screen will not
appear.
Information
The same parameter cannot be added more than once
in the same group.
Revised July 2017
Note
+Fbg is an analysis parameter with an alternative dilution ratio
of 1:20 (2 times the usual Fbg concentration).
-Fbg is an analysis parameter with an alternative dilution ratio
of 1:5 (half the usual Fbg concentration).
+DDP is an analysis parameter with an alternative dilution
ratio of 1:8 the usual DDPl concentration.
+AdD is an analysis parameter with an alternative dilution
ratio of 1:8 the usual AdDD concentration.
+Ddi is an analysis parameter with an alternative dilution ratio
of 1:20 (8 times the usual Ddi concentration).
+vWF is an analysis parameter with an alternative dilution
ratio of 1:6 (3 times the usual vWF concentration).
-vWF is an analysis parameter with an alternative dilution
ratio of 1:1 (half the usual vWF concentration).
+WFa is an analysis parameter with an alternative dilution
ratio of 1:20 (4 times the usual WFa concentration).
-WFa is an analysis parameter with an alternative dilution
ratio of 4:5 (quarter the usual WFa concentration).
Note
When 13 or more of reagents or 5 or more in total of diluent
and rinse solution are set in a group, the changed setting will
be canceled, and the Test Group Setting screen will reappear.
Note
The numbers shown in the left column of the table indicate
those for reagent holders.
Note
The screen will display the reagents used for the parameters
that have been set in analysis groups.
6. Using [↑] and [↓] keys, move the cursor to select a reagent.
7. Press [Select] key.
The Reagent Holder Setting screen will reappear, and the selected
reagent will be set.
If no reagent is set, press [None] key instead of [Select] key.
8. Using [↑] and [↓] keys, move the cursor to specify a container for the
reagent to be set.
9. Press [Next Option] key to select a reagent container.
Each time you press the [Next Option] key, “GW5”, “PV-10”,
“Cup”, “SLD Vial” and “SIRC 3 mL” appear in sequence.
Symbol Meaning
GW5 Siemens GW5
PV-10 Push Vial PV-10 (22 mm OD x 40 mm high)
provided in supply parts
Cup Sample Cup Conical 4 mL (*)
SLD Vial Provided in supply parts
SIRC 3 mL Sysmex reagent vial 3 mL
Revised July 2017
Caution!
Set the container which is to be set in the reagent holder.
If the wrong container is set, correct analysis results
cannot be obtained.
Note
In the following cases, an error occurs when the [FIX] key is
pressed, and the Reagent Holder Setting screen will reappear.
The analysis parameter for which an error occurred will be
highlighted.
• A reagent has not been set for all parameters in the group.
• The reagents set for rinse solution and diluent have been
set to any of reagent holder Nos. 1 to 8.
Note
“v” mark appears and disappears alternately each time the key
is pressed.
Revised July 2017
Host Computer
This program allows setting the interface conditions for the host
computer.
1. Press [I/O Setting] key on the Setting Menu screen.
The I/O Setting Menu screen will appear.
2. Press [Host Computer] key on the Device Setting Menu screen.
The Host Computer Setting screen will display the currently-set
interface conditions.
Revised July 2017
3. Using [↑] and [↓] keys, move the cursor to specify a parameter to be
set.
4. Press [Next Option] key and specify the conditions.
A condition will change over each time you press [Next Option]
key.
The table below shows the interface conditions that can be set. (The
underlined values indicate the factory default setting.)
Status Sets connection with the host computer.
Select “Connected” or “Not connected”. If “Not connected” is set, display of
HC - which shows the status of external device - will disappear.
Baud Rate [BPS] Sets baud rate of RS232C.
Select from “600”, “1200”, “2400”, “4800”, “9600”.
Character Length Sets data bit length of RS232C.
Select “7-bit” or “8-bit”.
Stop Bit Sets stop bit length of RS232C.
Select “1-bit” or “2-bit”.
Parity Sets the protocol of RS232C parity check.
Select “None”, “Odd”, or “Even”.
Class Sets the protocol of transfer.
Select “Class A” (No response) or “Class B” (With response)
Interval [sec] Sets interval of transfer to the host computer.
Select “0”, “2”, “3”, “5”, “7”, “10”, “15”.
Inquiry Sets how to make inquiry.
Select “Auto” or “Manual”.
Format Sets output format.
Select “CA1000”, “CA500”, “ASTM” or “ASTM2”.
ACK Text Sets ACK Text mode.
Select “STX-ACK-ETX”, or “ACK/NAK”.
Flag format Set the combination of data mask indication and flag indication.
Select “Standard”, or “CA-500”.
Barcode Scanner
This program allows setting the conditions for using barcode scanner.
1. Press [I/O Setting] key on the Setting Menu screen.
The Device Setting Menu will appear.
2. Press the [Barcode Scanner] key on the Device Setting Menu.
The Barcode Scanner Setting screen will display the currently-set
usage conditions.
3. Using [↑] and [↓] keys, move the cursor to a parameter to be set.
4. Press [Next Option] key to set the conditions.
A condition will change over each time [Next Option] key is
pressed.
The table below shows the interface conditions that can be set. (The
underlined values indicate the factory default setting.)
Barcode Sets connection with the barcode scanner.
Scanner Select “Connected” or “Not connected”.
Kind 1-4 Sets the types of barcode.
None/ITF/NW-7/CODE39/JAN-13/JAN-8/CODE128
Selecting identical barcodes (excluding “None”) is an error.
Hand-held Sets connection with the hand-held barcode reader.
BCR Connected/Not connected
Check Digit Sets Check Digit.
None: No Check Digit.
Mod. 11: Modulus 11
W Mod. 11: Weighted Modulus 11
Mod. 43: Modulus 43
Mod. 10: Modulus 10
Warning!
• Use the check-digit as much as possible.
• If the check-digit cannot be used, affix the barcode
label so that the bars on the label are horizontal to
reduce the risk of the incorrect reading of the
barcode label.
Revised July 2017
Note
Check digit setting is common to the sample barcode scanner
and hand-held barcode reader.
Date/Time
3. Using [↑] and [↓] keys, move the cursor to select Date or Time.
4. Using the numeric keys, set Date and Time, and press [Enter] key.
The parameter in the cursor position is set and the cursor will move
to the next parameter.
Information
• When entry is made in the wrong format, setting is
not executed.
• If the number of day or month is a single digit, enter it
with a 0 preceding it.
• Enter the time in a 24-hour clock system.
key.
Date Format
Enter Password
Some programs on QC, standard curve, and analysis setting require a
password to limit the use of the instrument to authorized personnel.
When these programs are selected, the message “Enter Password” will
be displayed. Enter the pre-set password and press [Enter] key. If the
entered password agrees with the pre-set one, the program will be
executed.
Use a password properly as it is important in managing the instrument.
A password is a maximum of 12 digits consisting of numerics (0 - 9).
Revised July 2017
Note
When [C], [0], [Enter], [Quit], or [Fix] key is used to set as a
password, password check is not done, and the Password
Entry screen will be skipped.
3. Using the numeric keys, set a password and press [Enter] key.
When changing a password which was already set, “************”
is displayed. Enter the new password.
Note
Using numerals (0 - 9), set a maximum of 12 digits for a
password.
3. Using [↑] and [↓] keys, move the cursor to a parameter to be set.
4. Use [Next Option] key to turn the setting on or off.
“Enable” and “Disable” will be set alternately each time [Next
Option] key is pressed.
5. When setting is completed, press [Return] key.
The Update Confirmation screen is displayed, so press the
appropriate key.
Revised July 2017
Using [↑] and [↓] keys, move the cursor to the parameter to be set,
and press [Next Option] key to change over ON/OFF.
After the setting, press any of the following keys to perform printout
process.
[Print All Para.] key: Prints out all parameters regardless of ON/
OFF setting.
[Print Para.] key: Prints out only the parameter that has been set
to ON.
[Return] key: Returns to the Print Setting Menu screen
without printout.
3. Printout of set parameter will start.
The “Output in progress” screen will appear.
To cancel printout, press [Cancel] key.
Note
When [General Set Up] key or [Print Settings] key is
pressed, a password will not be printed out.
4. When printout is over, the Print Setting Menu screen will return. Revised July 2017
Daily Maintenance
Weekly Maintenance
Monthly Maintenance
• LED Calibration (Refer to Section 11.6.)
Yearly Maintenance
As Needed Maintenance
Supplies Replacement
Risk of Infection
Be sure to wear latex or non latex examination gloves
before starting maintenance. After completion of work,
wash hands with disinfectant. Handle all instrument parts
as biologically hazardous. There is a risk of infection with
pathogens etc.
Warning!
• When closing the light shield cover, be sure to hold
the handle.
If it is closed by holding other parts, the hand or
finger may get pinched or injured.
• Be sure to fully open the light shield cover and check
that it will not fall down by its own weight.
If the light shield cover falls down, there is a risk of
causing injury on the head.
• Turn the power off before performing maintenance
operations (excluding operations that require screen
handling) to prevent shock.
Risk of Infection
• The end of the sample probe is sharp. Handle with
sufficient caution.
• When cleaning the probe, always wear latex or non
latex examination gloves. Wipe off the sample probe
from top to bottom.
After completion of work, wash hands with
disinfectant. Handle all instrument parts as
biologically hazardous. There is a risk of infection
Revised July 2017
Caution!
If the probe is used for more than 60 tests, the data may
be affected by the accumulation of dirt. Perform rinse
probe.
4. Press [Set] key to start rinse operation. The message “Rinsing Probe
in progress” will appear. To stop rinse operation when “Rinsing
Probe in progress”, press [Cancel] key. However, after [Cancel] key
is pressed, some time may be required before the system returns to
“Ready” status.
Warning!
• CA CLEAN II is an acidic cleaning agent. It should
not come in contact with skin or clothing. If it happens
rinse skin or clothing with plenty of water to avoid
injury or damage.
• CA CLEAN I contains sodium hypochlorite. Be sure
to use CA CLEAN I and CA CLEAN II in different
containers. If CA CLEAN I is directly mixed with acid
solution such as CA CLEAN II, chlorine gas is
produced, which is very dangerous.
• Do not open the light shield cover until the screen
appears. If you put the hand or finger in, it may be
injured. If the cover is opened during operation, the
alarm rings and the operation stops.
Caution!
Revised July 2017
Note
CA CLEAN I, CA CLEAN II aspiration and probe rinsing
take about 6 minutes.
Risk of Infection
When discarding used reaction tubes, always wear latex
or non latex examination gloves. After completion of
work, wash hands with disinfectant. Handle all
instrument parts as biologically hazardous. There is a
risk of infection with pathogens etc. Also, medical waste
and infectious waste should be properly disposed of.
Take care not to spill waste liquid that may have
collected in the trash box.
1. Pull out the trash box from the instrument's right side panel.
Trash box
Information
• Once a week Trash Box Liner CA6 has to be
discarded alongside the used reaction tubes and a
new one has to be set. If Trash Box Liner CA6 is
used for a week or more, it can cause blockages in
the reaction tube trash, or it may break when
removed.
• Use the specified Trash Box Liner CA6.
Risk of Infection
When disposing of waste, always wear latex or non latex
examination gloves. After completion of work, wash
hands with disinfectant. Handle all instrument parts as
biologically hazardous. There is a risk of infection with
pathogens etc. Also, medical waste and infectious waste
should be properly disposed of.
1. Turn the cap of the waste bottle counterclockwise and take out the
Float switch float switch.
Cap
Warning!
Pay attention no waste is splashed around.
Be careful that no waste is splashed. If splashed, wear
latex gloves and wipe with gauze or a towel moistened with
1:2 diluted CA CLEAN I, then wipe with a towel moistened
Revised July 2017
3. Put the float switch into the waste bottle, and turn the cap clockwise
to tighten it securely. Check for any kink, etc. in the tube.
Caution!
• When the bottle becomes full of waste, the alarm will
sound and the confirmation screen will appear. Press
[Conf.] key and wait until Analysis Start Confirmation
screen or “Ready” appears (Interrupt process is
executed).
Then, discard waste by the procedure described
above. After discarding, close the waste bottle cap
and press [Start] key.
• When the bottle has become full after the dispensing
of all samples, the Analysis Start Confirmation
screen will not appear.
Information
When analysis is made with the rinse bottle lying flat,
there is a possibility that correct analysis result may not
be obtained.
Make sure the rinse bottle is not lying flat.
Cooling section
Revised July 2017
3. Insert paper towel or lint-free tissue into the four holes on the left
side of the reagent rack and wipe off any condensation.
4. Close the light shield cover.
Reagent rack
Note
If DFbg is not a required parameter, quarterly calibration is
required. The default setting for LED calibration is 30 days.
Please contact your local service representative if you need
this setting to be adjusted.
Press [OK] key, and perform the LED Calibration according to the
following procedures.
1. Press [Special Menu] key on the Main Menu screen to display
[Special Operate] key.
2. Press [Special Operate] key.
The Special Operation Menu screen will appear.
Note
The last calibration day and a present status can be checked by
pressing [Detector State] key.
Caution!
If the calibration process has failed, the message
prompting to restart LED calibration will be displayed.
Revised July 2017
15. Take out the calibrator for the calibration, and set the former reagent.
Caution!
If Trash Box Liner CA6 is used for a week or more, it can
cause blockages in the reaction tube trash, or it may
break when removed.
4. Install a new Rinse Filter so that the side with the black marking
enters to the Rinse Bottle. Tightly cap the cap of the Rinse Bottle.
Then, turn ON the power to resume normal operation.
Warning!
To avoid risk of electric shock, disconnect the power
cord before replacing the fuse.
1. Turn off the power supply and disconnect the power cord.
2. Remove the fuse cap holder.
Fuses
Remove the fuse cap holder at the rear panel while pushing its claw
up using a flat-tip screwdriver.
Fuse cap holder 3. Replace the fuses and attach the fuse cap holders.
Warning!
For continued protection against risk of fire, replace only
Claw with fuse of the specified type and current ratings.
Caution, Hot
The printer head can get very hot. Do not touch.
Caution!
Lever Static electricity may damage the printer head. Do not
Paper guide touch.
Printer paper
Revised July 2017
Paper guide
5. Press [Sysmex] key, then press [P. FEED] key on the Sysmex Menu
screen to feed printer papers.
6. Attach the printer cover.
Risk of Infection
When draining the trap chamber, always wear latex or
non latex examination gloves. After completion of work,
wash hands with disinfectant. Handle all instrument parts
as biologically hazardous. There is a risk of infection with
pathogens etc.
5. Press [Set] key. Water supply will begin and the message “Water
supply running” will appear. To stop water supply while it is in
progress, press [Cancel] key.
Note
Refilling the hydraulic line with rinse solution takes roughly
35 sec.
6. When water supply is finished, the screen will return to the Special
Operation Menu. Revised July 2017
Caution!
• The filter should be cleaned regularly.
If the filter gets clogged, it prevents the intake of air
from outside to the interior of the instrument through
the rear panel, potentially causing abnormal
temperature errors etc. It also encourages infiltration
of air through the reagent table cover, so that if the
reagents are left for long periods with their lids not
closed, condensation, or evaporation of the reagents,
could have an influence on data.
• Do not use water to wash the filter.
Note
Replace the filters with new ones if they are very dirty.
Arrow mark
Revised July 2017
Warning!
• Before cleaning the instrument, be sure to turn off the
power supply and unplug the power cord. This is
necessary to avoid the risk of electrical shock. When
cleaning the instrument, always wear latex or non
latex examination gloves. After completion of work,
wash hands with disinfectant. Handle all instrument
parts as biologically hazardous. There is a risk of
infection with pathogens etc.
• When cleaning the dried debris of the sample or
reagent, wear latex gloves and wipe off the debris
with a gauze or a towel moistened with 1:2 diluted
CA CLEAN I, then wipe with a towel moistened with
water, and finally wipe with a dry soft towel.
1. Wipe off stains using a cloth soaked with water and neutral
detergent.
2. Wipe the exterior using a dry cloth.
1. Open the light shield cover and check that it will not fall down with
its own weight.
2. Take out the reaction tube racks and reagent rack.
Reaction tube racks
3. Using a cloth soaked with water and neutral detergent, wipe off
Reagent rack
stains.
Clean likewise the reaction tube racks and reagent rack that were
taken out before.
4. Wipe off stains using a dry soft cloth.
5. Close the light shield cover.
Information
Never use any other cleaning solution than water and
neutral detergent. Otherwise, the surface coating may be
damaged.
Revised July 2017
Note
If another reagent should be come insufficient while
“Insufficient Reagent Check” message is displayed, the
message for this reagent will be displayed after [INTERR.]
key or [Cancel] key is pressed.
Note
• The parameters for those dispensed samples that have not
been dispensed with reagent will be marked with “X” in
Work List.
• If neither [INTERR.] key nor [Cancel] key is pressed for
some time, [Cancel] will be executed automatically.
Note
When [Cancel] key is pressed on the Insufficient Reagent
Revised July 2017
Caution!
Strictly follow the procedures described in the supplied
package insert or other application information provided
by the manufacturer of the reagent. Otherwise, correct
result will not be obtained.
5. Open the light shield cover and check that it will not fall down with
its own weight.
6. Set the reagent bottles in the reagent holder. If the sample cup holder
Sample cup
is set, feed reagent into the sample cups.
7. Close the light shield cover.
8. Press [Start] key or [Cancel] key on the Analysis Start Confirmation
screen.
[Start] key: Starts analysis after interruption.
Sample cup holder [Cancel] key: Stops analysis and returns the screen to the Main
Menu.
Information
The parameters marked with “X” in Work List must be
reanalyzed.
Note
The parameters whose analyses were interrupted or those
whose analyses failed are marked with “X” in Work List.
Information
The parameters marked with “X” in the Work List must
be reanalyzed.
Note
For setting the reagent volume monitoring, refer to
“10.12 Setup of Reagent Volume Monitoring”.
5. Take out the reaction tube rack and set the reaction tubes.
Reaction tube
6. Set the reaction tube rack on the specified place on the table stage.
Warning!
Reaction tubes are intended for single use only.
If used more than once, rewashed, or recycled,
Reaction tube rack inaccurate measuring results may be obtained due to the
effect of possible contamination. Inaccurate results could
lead to inappropriate patient diagnosis or treatment.
Information
The parameters marked with “X” on the Work List must
be reanalyzed.
Note
The parameters whose analyses were interrupted or those
whose analyses failed are marked with “X” in the Work List.
Caution!
Do not open the cap of the rinse bottle or waste bottle
until the Main Menu screen or Analysis Start
Confirmation screen is displayed.
Caution!
• When analysis is made with the rinse bottle lying flat,
there is a possibility that correct analysis result may
not be obtained. Make sure the rinse bottle is not
lying flat.
• If the power is turned off with the rinse bottles lying
flat, the solution may flow back into the instrument.
Before turning off the power switch, confirm that the
bottles are not lying flat.
• Do not touch the float switch and the inside of the
cap. If dust or dirt sticks to the cap inside, the bottle
inside may be contaminated, possibly leading to
incorrect results. If fingers happen to touch the cap
inside, wash them with rinse solution before
attaching.
• In removing the tube from the instrument, first turn
the cap leftward to release the accumulated internal
pressure beforehand. Otherwise, rinse solution will
spill over.
• When replacing the rinse bottle, do not leave the
instrument with the bottle removed for a long period.
Leaving the instrument with the bottle removed for
long periods may result in malfunction.
Note
The parameters whose analyses were interrupted or those
whose analyses failed are marked with “X” in Work List.
663-5117-3 Sample Tube Spacer 13 Phi 1 pc. for STAT Sample Holder
366-1793-6 Tube Holder No. 113 (White) 1 pc. for Sample Rack
363-2536-4 Holder No. 70 (Sample cup adapter) 1 pc. for Sample Rack
CW742798 Thermal Paper CL5840 5 pcs. Thermal paper for the built-in Printer
541-1352-1 Push Vial PV-10 10 pcs. Reagent vial
013-1771-4 SLD Vial Assy 10 pcs. Reagent vial
CM221346 Trash Box Liner CA6 10 pcs.
904-0721-9 Reaction Tube (SU-40) 3,000 pcs.
Warning!
• CA CLEAN I is a alkaline solution. Avoid contact with
it. If you get it on your skin or clothing immediately
wash it off with large volumes of water.
• CA CLEAN II is an acidic cleaning agent. It should
not come in contact with skin or clothing. If it happens
rinse skin or clothing with plenty of water to avoid
injury or damage.
• Extra care should be taken to make sure CA CLEAN
I is not mixed and used with acidic solutions such as
CA CLEAN II. Direct mixing of CA CLEAN I and an
acidic solution will result in the highly hazardous
release of poisonous chlorine gas.
Note
If you need to order supplies or replacement parts, please
contact your local representative.
12. Troubleshooting
12.1 Introduction
This chapter describes the error messages displayed with this instrument,
potential failures, and proper action that the operator should take in the
event of failures.
If the action described in this chapter should fail to restore the instrument
to normal status, contact your local service representative for assistance.
The major contents of this chapter are:
• Troubleshooting by Error Message
This section contains a list of the error messages displayed on the
LCD screen in the event of trouble, with corrective procedures.
• Sysmex Menu
This section describes Sysmex Menu at the upper left corner of the
Main Menu screen. This menu makes it possible to display
instrument's temperature, error list, and feed of printer paper.
• Special Operation
This section describes the programs necessary for maintenance of
this instrument and operation testing.
Troubleshooting Guide
Note
When the instrument develops an error, an error message
appears in the left lower corner of the LCD screen, and
[Sysmex] key changes to [ALARM RESET] key.
Note
• When an error occurs in a sample, the analysis data
relative to the error is displayed “***. *.”
• A parameter whose analysis has been interrupted has “X”
displayed in Work List.
• Repeat analysis is required in the case of either an
instrument error (shown as “X” in the Work List) or an
analysis error (shown as “***.*” in the stored Data and on
print out).
Corrective Action 1) Reduce the number of the tests entered for analysis.
[Invalid Settings]
Probable Cause 1) Problem in settings.
Corrective Action 1) Enter appropriate settings.
[No Paper]
Probable Cause 1) No printer paper is set.
Corrective Action 1) Set printer paper. Refer to “11.10 Supply Printer Paper”.
[Printer Error]
Probable Cause 1) The paper guide is not locked properly.
Corrective Action 1) Push the paper guide and lock it.
[Probe Crash]
Probable Cause 1) No or insufficient sample plasma or reagent in tubes or sample cups at sample aspiration
position or reagent aspiration position.
2) Something is preventing probe descending.
3) Probe is out of position.
Corrective Action 1) Prepare plasma and reagent in required volume.
2) Remove any foreign matters.
3) When the error recurs, the instrument may have a problem. Contact your local service
representative.
representative.
[Syringe Error]
Probable Cause 1) Syringe error during operation.
Corrective Action 1) When the error recurs, the instrument may have a problem. Contact your local service
representative.
Caution!
When a Vacuum Pump Error occurs, waste liquid may
collect in the trash box.
3) When the error recurs, the instrument may have a problem. Contact your local service
representative.
Caution!
“Caution: Review Curve” will accompany some of the
error messages. When this message is printed, review
the curve to determine if the result is acceptable.
Reanalyze the sample as needed.
Revised July 2017
ERR[416] Excessive antigen (only for Immunoassay Carry out dilution or take other steps, then
Range Over Method). reanalyze. On DDPl, analyze +DDP,
AdDD, +AdD.
ERR[528] The reaction curve could not be Reanalyze.
No polynomial adjust- approximated to a polynomial.
ment
ERR[656] During analysis of the reaction curve, Reanalyze.
Range in non-linear changes were non-linear, or else the curve
could not be approximated to a straight line.
Error List
Regarding messages for instrument errors and attention-calling errors, a
maximum of 100 messages are recorded and displayed.
1. Press [Sysmex] key.
The Sysmex Menu screen will appear.
Revised July 2017
Temperature
Monitored temperature of each place is displayed.
Note
When a set temperature is reached with power supply on,
“Ready” appears.
Note
The maintenance program can be executed only when the
instrument is displaying “Ready” or “Not Ready”. Analysis
operation and testing cannot be executed at the same time.
Priming
When this instrument is installed for the first time or it has been idle for
long time, there may be bubbles in the hydraulic line.
To get correct analysis results, it is necessary to execute this program and
supply rinse solution into the hydraulic line.
Note
At initial installation, the above operation is performed by
your local service representative.
Whether the electrical system and software system of this instrument are
operating properly or not can be checked by executing System Tests.
Perform the tests on the System Tests Menu screen. Follow the steps
shown below to display the screen.
1. Press [Special Menu] key on the Main Menu screen to display
[Special Operate] key.
2. Press [Special Operate] key.
The Special Operation Menu screen will appear.
3. Press [System Tests] key.
The System Tests Menu screen will appear.
Revised July 2017
LCD
Touch Screen
This program allows checking whether entry from the LCD touch panel
can be received properly or not. If it is normal, the panel at the touched
place is highlighted.
1. Press [Touch Screen] key on the System Test Menu screen.
The Touch Panel System Test screen will appear.
2. Press any place on the panel to test entry on the touch screen.
Note
• The touched place on the panel is highlighted.
When the same place is touched again, the display returns
to the original one.
• The touch panel can recognize a key of 20 lines x 40 rows.
3. To quit the touch panel system test, press the touch panel in the lower
right corner.
Revised July 2017
Host Computer
Note
• When Host Computer Status is set “Not Connected”,
[EchoBack], [DataText] and [Q & A] keys are not
displayed. “Not Connected” message is displayed on left
top side of the screen.
• If the host computer is set to “Class A”, then [EchoBack]
and [Q & A] keys are not displayed.
Printer
Example of printout
Barcode Scanner
Sensor Status
This program allows checking the status of the sensors attached to each
unit of the instrument.
1. Press [Sensor Status] key on the System Tests Menu screen.
The Sensor Status screen will appear.
Press [SW. clear] key to renew the sensor status.
Press [Reset Liq. Sens] key to reset the liquid level sensor.
Press [Mixing Motor] key to mix with the vibrating motor for 3 sec.
Press [Lock] key to lock the sampler.
Revised July 2017
SNCS Information
This program can read information from SNCS, and display SNCS
information.
1. Press [SNCS] key on the System Tests Menu screen.
The SNCS Information screen will appear.
2. Press [Read Info.] key on the SNCS Information screen.
Information is read from SNCS, and the SNCS information is
displayed.
3. To quit the program, press [Return] key.
Information
• When syringe cycles exceed 300,000, the error
message “Check Syringe Unit” is displayed each
time analysis begins.
• When operation times of the catch unit reach 25,000,
an error message appears every time starting the
analysis.
Revised July 2017
LED (Light
Emitting Diode)
Note
There are 6 different types of standard curve available on this
instrument as below. They can be selected in Standard Curve
setting program. Refer to “9.7 Set Calculation Parameters” for
the selection.
• Log Curve: Log - Log, point plotted graph
• Log Lin: Log - Log, linear graph
• Lin - Lin: Real - Real, linear graph
• Lin Curve: Real - Real, point plotted graph
Revised July 2017
• AKIMA
• AKIMA (0)
Calculation Principle
(a) Linear regression formulas are utilized to express the relationship
Y
Y between the clotting time and percent activity or concentration.
A The points are expressed as a straight line when plotted on a
B logarithmic scale.
C (b) In the example shown in the figure on the left below, the analysis
D data result for a certain sample (point X) plots between points C
X E F Z
and D. In this case, the percent activity or concentration is
calculated by a logarithmic formula, utilizing points C and D.
X
X: Percent Activity or Concentration (c) If analysis data results plot outside A through F, the percent
Y: Clotting Time activity or concentration is calculated by logarithmic formula
utilizing the nearest two points. For instance, the percent activity
or concentration of point Y is calculated by a logarithmic formula,
utilizing points A and B; and point Z is calculated by a logarithmic
formula utilizing points E and F.
The instrument has the ability to calculate a PT ratio value if the normal
PT value for the laboratory's patient population has been entered in the
PT Standard Curve setting menu. The International Normalized Ratio
(INR) will be printed as part of the sample result if the International
Sensitivity Index (ISI) of the thromboplastin reagent has been entered in
the PT Standard Curve setting menu.
The PT normal value and the ISI value may be manually entered in the
PT Standard Curve setting menu. Refer to “9. Setting Standard Curve”
for the procedure, if needed.
Information
ISI values for prothrombin time assays must be entered
directly as they appear on the current reagent labeling.
Any changes of reagent lot, software upgrades, major
servicing, etc., require verification of the ISI value.
Failure to enter the correct ISI value will cause incorrect
International Normalized Ratio (INR) results.
Sample
The optical system for the Transmitted Light Detection Method is shown
below.
Light transmitting a sample from the light source is separated into 575-
nm components by a filter. The separated light reaches a photodiode,
where the transmitted light is converted into electrical signals. The
change in the amount of this transmitted light is stored and calculated by
microcomputer, and the change in absorbance per minute (ΔOD/min) is
determined.
Sample
Note
Within a zone in which the antigen concentration is
excessively high, the prozone phenomenon can be seen in
which an increase in antigen concentration is met with a
decrease in the change in light absorbance.
When the prozone phenomenon occurs, the antibody
concentration will be lower than the actual value, and the
instrument will display an error message. When that happens,
Revised July 2017
dilute the sample to the dilution ratio that you wish and
reanalyze.
PT Flow
100 μL of PT reagent
37ºC
Measurement
3-minute 660 nm
Incubation
50 μL of Plasma
APTT Flow
37ºC 37ºC
Measurement
1-minute 3-minute 660 nm
Incubation Incubation
50 μL of Plasma
Note
• Any change in the APTT Incubation Time could affect the
analysis results significantly. Follow the reagent
manufacturer's instruction. Examine the optimum setting
at your laboratory before changing the APTT Incubation
Time.
• Each laboratory should follow the optimum APTT reagent
incubation time recommended by the reagent
manufacturer in the product package insert.
• This setting cannot be changed during an analysis
procedure.
Revised July 2017
Fibrinogen Flow
37ºC
Measurement
1-minute 660 nm
Incubation
10 μL of Plasma
37ºC
Measurement
1-minute 660 nm
Incubation
50 μL of Plasma
37ºC
Measurement
1-minute 660 nm
Incubation
50 μL of Plasma
Revised July 2017
PCcl Flow
37ºC
30-second
Incubation
5 μL of Plasma
37ºC 37ºC
Measurement
30-second 4-minute 660 nm
Incubation Incubation
BXT Flow
37ºC
Measurement
1-minute 660 nm
Incubation
50 μL of Plasma
Revised July 2017
LA1 Flow
37ºC
Measurement
1-minute 660 nm
Incubation
100 μL of Plasma
LA2 Flow
37ºC
Measurement
1-minute 660 nm
Incubation
100 μL of Plasma
37ºC 37ºC
Measurement
30-second 1-minute 660 nm
Incubation Incubation
5 μL of Plasma
Revised July 2017
37ºC
30-second
Incubation
5 μL of Plasma
37ºC 37ºC
Measurement
30-second 3-minute 660 nm
Incubation Incubation
10 μL of Plasma
37ºC 37ºC
Measurement
30-second 3-minute 405 nm
Incubation Incubation
Revised July 2017
40 μL of Dilution
10 μL of Plasma
37ºC 37ºC
Measurement
30-second 3-minute
405 nm
Incubation Incubation
20 μL of Dilution
37ºC 37ºC
Measurement
1-minute 8-minute 405 nm
Incubation Incubation
20 μL of Plasma
Revised July 2017
16 μL of Plasma
37ºC 37ºC
Measurement
30-second 1-minute
405 nm
Incubation Incubation
20 μL of Dilution
16 μL of Plasma
125 μL of Streptkinase
reagent 25 μL of Substrate
37ºC 37ºC
Revised July 2017
Measurement
30-second 5-minute 405 nm
Incubation Incubation
20 μL of Dilution
20 μL of Reagent (AT3)
37ºC
30-second
Incubation
20 μL of Plasma
37ºC 37ºC
Measurement
30-second 1-minute
405 nm
Incubation Incubation
37ºC 37ºC
ºC
Measurement
30-second 30-second 575 nm
Incubation Incubation
50 μL of Plasma
12 μL of Diluent 16 μL of Supplement
37ºC
30-second
Incubation
8 μL of Plasma
37ºC 37ºC
Measurement
30-second 2-minute 575 nm
Incubation Incubation
16 μL of Plasma
26 μL of Dilution
37ºC 37ºC
Measurement
30-second 4-minute 575 nm
Incubation Incubation
15 μL of Plasma
48 μL of Buffer 50 μL of WFAcII
37ºC
30-second
Incubation
12 μL of Plasma
20 μL of WFAcIII 20 μL of WFAcI
37ºC 37ºC
Measurement
30-second 240-second
575 nm
Incubation Incubation
Analysis Principles Coagulation Reaction Detecting A mixture of plasma and reagent is exposed to red light
Method (Scattered Light (660 nm). Turbidity change occurring when Fibrinogen is
Detection Method) transformed to Fibrin is detected as a change in its
scattered light, then coagulation time is measured.
Coagulation Point Detection Assume that scattered light intensity just after detection
Method (Percent Detection commencement is 0%, and the intensity when coagulating
Method) reaction has ended is 100%, then the time interval taken
until the scattered light set at the coagulation detecting
point has been reached is the coagulation time.
Chromogenic Method* Plasma, reagent, and substrate are mixed to start reaction,
(Colorimetric Method /Rate and change in extinction of pigment in free P-nitroaniline
Method) is detected and activity value is calculated.
Immunoassay Method* Sample and Latex reagent are mixed to start reaction, and
variation in absorbance of produced Latex clump is
detected and calculated.
Simultaneous Random analysis is possible.
5-parameter random (5 parameters from PT, APTT, Fbg, TT, Factor Deficiency, PCcl, BXT, LA1, LA2, AT, AT3,
Analysis BCPC, Hep, APL, Plg, DDPl, vWF and PFDP)
Detection Time Coagulation reaction is detected within maximum detection time and coagulation time is
measured.
Typical maximum detection time 100 sec. for PT
100 sec. for Fbg
190 sec. for APTT
30 sec. for AT3
180 sec. for D-Dimer
150 sec. for P-FDP
Maximum detection time that can be set 600 sec. for each parameter
Processing Capability PT single parameter analysis: 60 tests/h (Maximum)
• However, this is the value starting from the time the first result is output.
• The processing speed varies depending on the reagent used.
(*) CA-660 only
standard dilution).
Under 12.5% is analyzed via dilution in low
concentration mode (-vWF: 2:1
dilutioncompared to the standard dilution).
Analysis Range von Willebrand INNOVANCE® With an applicable reagent, the range
Factor % VWF Ac between 6.0% and 500.0% can be analyzed.
However, over 125.0% is analyzed via
dilution in high concentration mode
(+WFa: 1:4 dilution compared to the
standard dilution).
Under 25.0% is analyzed via dilution in low
concentration mode (-WFa: 4:1 dilution
compared to the standard dilution).
Display and Entry 4.5 in x 3.4 in liquid crystal display (with color LCD backlight)
Touch panel type
Printout Internal printer prints out analysis data and graphic prints
External Input/Output Bit serial voltage signal (RS-232C)
Cooling of Reagents The cooling unit performs cooling with the Peltier element*.
Reagent holder: 4-positions (15ºC±2ºC, when room temperature is 15 -
35ºC)
Reagent Dispensing The incubation pipette detects the reagent surface and aspirates/dispenses reagent with the
syringe.
Sample Dispensing The incubation pipette detects the sample surface, aspirates a sample with the syringe from a
tube on the rack, and dispenses it into a reaction tube in the reaction tube rack.
Reaction Tube Reaction tube: 60 MAX (30-tube rack x 2)
Detector Photo Detection Unit: 6 wells (4 wells for coagulation analysis, 1 well for
chromogenic analysis, and 1 well for Immunoassay
analysis*)
The light-emitting diode for photodetection is ON only
during analysis.
Heater Section: 6-well
Temperature Control Detector: 37ºC±1.0ºC
Sample Incubator Section: 37ºC±1.0ºC
Reagent Pipette: 37ºC±1.0ºC (When room temperature is 15 - 35ºC)
Cooling Unit*: 15ºC±2ºC
Time Taken to Reach Within 30 minutes after power supply turn-on (when room temperature is within the
Set Temperature temperature range of 15-35ºC)
STAT Sample Pro- The routine analysis can be interrupted for preferential processing of a specified sample
cessing contained in a sample collection tube.
Number of Stored Analysis data: 600 samples (a maximum of 3000 tests)
Samples
Quality Control X Control (L-J Control): 180 points x 6 files, 14 parameters
Revised July 2017
Automatic Transfer/Printout
IP HC
Within Limit: Valid Invalid
Out of Limit: Valid Invalid
Error Flag: Valid Invalid
QC Sample Valid Invalid
Format No Graph
Test Name
CA-620 CA-660
PT PT
APTT APTT
Fbg Fbg
TT TT
+Fbg +Fbg
-Fbg -Fbg
BXT VII
LA1 VIII
LA2 AT3
VII BCPC
VIII Hep
DDPl
+DDP
Reagents Name
CA-620 CA-660
PT THS PT THS
PT INN PT INN
PTT ACT PTT ACT
PTT FS PTT FS
PTT FSL PTT FSL
Revised July 2017
CA-620 CA-660
Fbg MFU Fbg MFU
TestThr TestThr
Thrombo Thrombo
Batrox Batrox
VII VII
VIII VIII
PC.DefP PC.DefP
PC.A.cl PC.A.cl
PC.APTT PC.APTT
LA1 LA1
LA2 LA2
Clean1 Clean1
Clean2 Clean2
OVB OVB
AT Buf
ATReag
ATSub
AT3Thro
AT3Subs
BCPCAct
BCPCSub
AT3Reag
FXaReag
HepSubs
DD.Pl.A
DD.Pl.R
Ad.DD.A
Ad.DD.R
DDi.DIL
DDi.Sup
DDi.BUF
DDi.REA
vWFBuf
vWFReag
AplReag
Revised July 2017
PlSubs
Strepto
PFDP.SB
CA-620 CA-660
PFDP.B
PFDP.L
SHP
WFAcI
WFAcII
WFAcIII
Test Group
CA-620 CA-660
Group 1 Group 2 Group 3 Group 1 Group 2 Group 3
PT PT PT PT PT PT
APTT APTT APTT APTT APTT AT3
Fbg Fbg Fbg Fbg Fbg Hep
TT TT TT TT +Fbg DDPl
AT3 -Fbg +DDP
Reagents Holder
Host computer
Barcode Scanner
Date Format
MM/DD/YY
14.3 Installation
Introduction
Make sure that the instrument is free from external flaws and check the
quantity of the provided parts.
Quantity
Part No. Description
CA-620 CA-660
424-1160-8 Sample Cup Conical (4mL) 1 1
541-0541-8 Reaction Tube 60 60
AH042068 Thermal Paper CL5840 2 2
BC963426 Fuse 250V 4.0A 2 2
Note
If you need to order supplies or replacement parts, please
contact your local representative.
Installation Space
Refer to “Installation Space” of “4.2 Installation Location”.
Information
Unless the fixing metals are removed, the instrument
cannot operate.
Information
Unless the retainer is removed, the instrument cannot
operate.
Revised July 2017
(1)
Cushioning
materials
Risk of Infection
When draining the trap chamber, always wear latex or
Revised July 2017
Connect the rinse bottle and the waste bottle to the nipples on the
instrument rear panel.
Information
• Even at a facility equipped with the waste channel
(drain system), the waste bottle should be
connected. Also, put the rinse bottle and the waste
bottle at the same level as the instrument.
Be sure not to use any other tube than the supplied
one; otherwise, the instrument's hydraulic system
Rubber tube may fail to operate properly.
• Remove the rubber tube that locks the float switch in
the rinse bottle and waste bottle. This rubber tube
serve to prevent vibration in transit.
Revised July 2017
Caution!
Confirm the power switch is OFF, at “O” before routing
the power cord. Make sure to ground the AC outlet;
otherwise, there is a hazard of electrical shock.
Power Connector AC outlet
Information
SNCS connector Confirm the power switch is OFF, at “O”, before routing
the connection cord; otherwise, there is a hazard of
electrical shock.
Note
• For connection settings for host computer communications
and the hand-held barcode reader, refer to “10.14 Devices
to Be Connected”. Also refer to “10.17 SNCS
Information” for connection settings for SNCS
communications.
• Host computer and SNCS connection cables are not
included in the supply parts.
Trash Box
Set Filters
Insert the filters NO. 598 (two pieces) all the way in until they hit the
back wall, with the arrow mark face up.
Make sure to insert the filters in line with the bottom plate guides of the
instrument.
Reaction Tube Rack Set the supplied reagent rack and reaction tube rack.
Affix Indication Mark (Label No. 966) on the reagent rack.
Revised July 2017
Reagent Rack
Connection
Connect an EIA RS-232C V.24 standard 9-pin D-SUB, female (body = female and pins = male)
connector (DB-9S) to the serial interface on the Main Unit rear panel. Fixing screws for this
connector have a thread which is measured in needs.
Input/Output Signals
Communication Format
Communication Settings
Setting program “Settings” - “I/O Setting” - “Host Computer” has to be executed to set the
interface parameters. Underlined items are selected as the initial configuration. Refer to
“10.14 Devices to Be Connected”.
Items Selections
Status Connected Not Connected
Baud Rate (BPS) 600 1200 2400 4800 9600
Character Length 7-Bit 8-Bit
Stop Bit 1-Bit 2-Bit
Parity None Even Odd
Revised July 2017
Items Selections
Format CA1000 CA500 ASTM
ACK Text STX-ACK-ETX ACK/NAK
Signal Level
Signal level of the RS-232C conforms to the EIA RS-232C V.24 standard.
Level Binary State Function
+3 V or Higher Logic “0”, Start Bit ON
-3 V or Lower Logic “1”, Stop Bit OFF
Interface Circuit
Output Circuit
VDD
Vss
MC145407 Driver
Input Circuit
15K
EMI Filter
5.4K
MC145407 Driver
Software
1. Code
ASCII codes are used in this interface.
Revised July 2017
2. General Function
Function Description
Analysis data output Auto Out -- This instrument automatically sends out analysis data
after each analysis has been completed.
Stored Data (batch output) -- This instrument sends out data from
the stored data in a batch.
Inquiry (output) and settings When this instrument makes an inquiry about order information for
from host computer (input) the Rack No. and Tube Position No., the host computer gives order
information and the sample ID number for each sample in the rack
to the instrument.
According to ID No. read by the optional barcode reader, the host
computer gives order information for each sample.
3. Framing of Text
STX (02 in hexadecimal code) is sent prior to data and ETX (03 in hexadecimal code) is sent
following data. The text length is within 255 bytes.
S E
T T
X X
Order of Transmission
4. Communication Protocol
The following 2 protocols are provided in the system. The factory configuration is Class A.
Refer to “10.14 Devices to Be Connected” for setting information.
Class Description
Class A One-way transmission to the host computer without requiring ACK (06 in
hexadecimal) nor NAK (15 in hexadecimal) from host computer.
Class B This instrument transmits data and then waits for ACK or NAK to complete the data
transmission, which is more secure transmission protocol.
Revised July 2017
5. Text Format
The following 3 kinds of formats are provided in the system.
Text Format Contents of Text
Analysis data format (output) Output analysis data.
When Auto Out is selected or when serial output of stored
data is performed, analysis data will be output.
Inquiry text for ID No. and This instrument asks host computer about parameter(s) or
parameter(s) settings about both ID No. and parameter(s).
Settings text for ID No. and Host computer responds to this instrument the analysis
parameter(s) parameter(s) or both ID No. and analysis parameter(s).
Class A
Data is transmitted in the form of a text or blocks. The host computer checks the start and end
characters as well as the parity bit received after each character, but does not transmit any
response. Therefore, the instrument will not wait for the response ACK (06 in hexadecimal) or
NAK (15 in hexadecimal) from the host computer and transmits data to the host computer in one
direction with two control signals (CTS and DSR) only.
This instrument transmits the following data without requiring data from the host computer in
Class A mode.
• Auto output of analysis data - Real-time output
• Output of stored data - Batch output
Data will be transmitted by the interval time set in the serial interface settings.
Interval
Host Computer
Class B
This class is identical to Class A except for the receiving side. When the host computer receives
transmitted data, the host computer transmits a response followed by a sequence. If necessary the
host computer also checks the contents of the text (or block). This instrument waits for the
response ACK or NAK from the host computer in addition to two control signals (CTS and DSR)
and transmits the next sample data upon receiving ACK from the host computer.
Revised July 2017
Note
“STX-ACK-ETX” and “STX-NAK-ETX” can be selected instead of ACK and NAK.
Refer to “10.14 Devices to Be Connected” for procedures.
Interval
This Instrument
DATA 1 T2 DATA 2
T1 A A
Host Computer C C
K K
Response
Time
2nd Transmission
This Instrument
DATA 1 DATA 1
N A
A C
Host Computer K
K
Revised July 2017
Interval Interval
This Instrument A
T3 C T2
Inquiry K
Inquiry
A Instruction Interval Interval
T3 C T4
Host Computer K
Response Processing
Time Time
Time Interval
The time interval between two data transmissions to the host computer can be selected with the
setting program. The interval time means the period after this instrument received the response of
ACK/NAK from the host computer until the instrument starts transmission of the next data in Class
B mode.
The instrument sends text after the “T2” interval. The interval time can be set in the serial interface
settings at 0, 2, 3, 5, 7, 10 or 15 seconds.
Revised July 2017
Time-Out Setting
When response time “T1” (shown in Figure C-5) or “T3” or processing time “T4” exceeds the
time-out setting, the instrument will terminate the communication. Time-out settings is fixed to 15
seconds.
Note
Processing time “T4” is the time that is required for the host computer to process setting
text.
Processing Time
For communication without the use of a control wire, response time “T1” or “T3”, and processing
time “T4” must be set to an interval of 0.2 seconds or longer. Contact your local service
representative for assistance.
If there is no order setting for parameter(s)
When a parameter is not analyzed, enter “000” for the parameter as the setting code.
When there is no analysis parameter order set in the host computer, enter “999” as the setting code.
When the instrument receives “999”, the instrument terminates inquiry about analysis parameters
of the samples in that rack, and no sample will be analyzed.
Transmission Errors
If this instrument detects an error after transmitting data, an error message will be displayed and
transmission of data will be terminated. The customer has to resolve the following error status to
transmit data again.
Error Message Description
Off Line DSR is OFF.
HC CTS Time Out CTS does not become ON within 5 seconds after entering a
command to transmit data to host computer (RTS turns ON).
HC Communication Error Parity Error, Overrun Error or Frame Error occurs.
HC ACK Code Error Host computer does not send a correct response code to this
instrument.
HC ACK Time Out Host computer does not send the response ACK nor NAK to
this instrument within 15 seconds after transmitting data.
HC Reception Count Error This instrument receives NAK after three retries, or failed to
receive data four times (transmits NAK 4 times).
HC STX Time Out After receiving ACK, this instrument does not receive set-
ting text within 15 seconds.
HC ETX Time Out After receiving STX, this instrument can not receive ETX of
setting text within 15 seconds.
Revised July 2017
Instruction Not Found in Host In response to analysis parameter of rack position #1, host
Computer computer sends “999” as the analysis parameter setting text.
(c) The decimal point is not sent. If necessary, add the decimal point on the host computer side
as shown in the example.
(d) Text Distinction Code I is “D” for the analysis data.
Text Distinction Code II is type of analysis data:
“1”: Normal single analysis data
“2”: Mean data of replication analyses.
Text Distinction Code III is always “21”.
(e) Block number and total number of blocks are both usually “01”.
The block number is the serial number of divided blocks.
The total number of blocks is the number of total blocks divided.
(f) Sample Distinction Code
Symbol Type of Data:
U Routine analysis data
E STAT analysis data
S Standard curve analysis data
C Quality control analysis data
(space, 20H) Type of sample is unknown.
(g) Date and time is the time when the analysis data was obtained. Date format conforms the
format set in the setting program. Zero suppression is not performed.
(h) Time is expressed in 24-hour clock system. Zero suppression is not performed.
(i) Rack No. indicates the 4-digit Rack No. assigned to each rack which is “0001” through
“0099”. STAT samples are assigned a sequential number by the system. Zero suppression is
not performed.
Note
A sequential number is the number counted up by one each time after turning ON the
power.
(j) Tube Position No. is the position number in which the sample was placed within a rack.
“01” through “10” can be set when the sample was set in a sample rack. “00” is output for
the STAT sample. Zero suppression is not performed.
(k) Sample ID number consists of 15 digits including hyphens “-” (2D in hexadecimal code).
Zero suppression is not performed. When No. of digits for the ID number is set in the
Settings, Output/Input, HC program, the most significant digit(s) are not output computer if
it is set lower than 15 digits.
(l) ID information indicates how the sample ID number was entered or read.
Symbol Description
M The sample ID number was entered manually.
Revised July 2017
Information
If sample ID was edited from the Stored Data screen, its sample ID attribute will
be “M”.
2: Activity percent/concentration
3: Ratio
4: INR
5: dFbg
Note
Additional parameter codes may be added in the future.
The host computer may receive a parameter code not mentioned above; therefore,
prepare a host computer program that will ignore such data of a parameter code.
• Data
Data is sent without a decimal point.
Data Units Output Format
Actual data → Data format
Coagulation time sec, s XXXX.X → XXXXX
Activity % % XXX.X → OXXXX
No unit X.XXX → OXXXX
PT ratio, INR XX.XX → OXXXX
Fbg concentration mg/dL XXX.X → OXXXX
g/L X.XXX → OXXXX
D-Dimer concentration μg/L XXXX → OXXXX
mg/L (FEU) XX.XX → OXXXX
Caution!
If your host computer receives PT ratio and INR with form of X.XX, contact your
local service representative.
Note
• X stands for a figure, O stands for a blank space (20 H).
• When the coagulation time could not be obtained because of an analysis error, an
asterisk (*) appears instead of “X” as the coagulation time. If there is an analysis
error of mean data, a slash (/) appears in stead of “X”.
• In case of no standard curve, illegal data, or if no coagulation occurs, an appropriate
number of hyphens “-” appear instead of “X”. Also if an analysis error occurs due to
a hardware problem, spaces (20 H) appear instead of “X”.
Revised July 2017
• Flag
A flag indicates whether or not an error occurred during analysis.
Flag Meaning
space No error
+ Over the Upper Patient Limit
- Under the Lower Patient Limit
* Error occurred during analysis, Fbg data exceeds the analysis range, or repli-
cate difference is too big.
d Coagulation time was obtained by re-dilution.
> Over the Upper Report Limit
< Under the Lower Report Limit
Note
• The “d” changes depending on the flag format in the host computer setting.
Standard: “d”
CA-500: “!”
Refer to “10.14 Devices to Be Connected”.
• The priority order of each flags is (*), (<) or (>), (+) or (-), (d) a space “ ” in that
order.
(e) Block number and total number of blocks are both usually “01”.
The block number is the serial number of divided blocks.
The total number of blocks is the number of total blocks divided.
(f) A space (20H) is sent for the Sample Distinction Code.
(g) Date and Time when the inquiry is made. Date is transmitted in the form set by the Setting
program. Time is expressed in 24-hour clock system. Zero suppression is not performed.
(h) Rack No. indicates the Rack No. for which the inquiry is made.
“0001” through “0099” can be set. Zero suppression is not performed.
(i) Tube Position No. is the position number in which the sample was placed within a rack. “01”
through “10” can be set. “00” is output for the STAT sample. Zero suppression is not
performed.
(j) Sample ID number indicates the sample ID number for which the inquiry is made. Sample
ID number consists of 15 digits including hyphens “-” (2D in hexadecimal code). When the
ID number of 13 digits or less is set, the set ID number is placed in the least significant digits
and space(s) (20 H) are padded to the most significant digits to fill up 15 digits.
When inquiry is made by the Rack No., sample ID number will be filled with spaces.
Note
When the barcode label could not be read due to an error or no label is attached on the
sample tube, the sample ID No. will become “ERR0000000001”.
(k) ID information indicates how the sample ID number was entered or read.
Symbol Description
M The sample ID number was entered manually.
A The sequential number was applied to the sample ID number automatically.
B The sample ID number was read by the barcode reader.
C The sample ID number was set by the host computer.
(space) The sample ID number was inquired from the host computer with the Rack No.
(l) Reserved and 11 spaces (20H) are filled.
(m) Data n
Parameter No. of Example
Characters
Parameter Code 3 Refer to Table “Parameter Code”.
( Reserved ) 6 All spaces (20H).
• Parameter Code
Parameter Code Parameter Parameter Code Parameter
040 PT 300 AT, AT3
050 APTT 310 APL
060 Fbg 320 Plg
500 +Fbg 330 BCPC
520 -Fbg 340 Hep
510 TT 610 DDPl
120 II 700 +DDP
150 V 610 AdDD
170 VII 700 +AdD
180 VIII 610 DDi
190 IX 700 +DDi
200 X 620 PFDP
210 XI 720 +PFD
220 XII 650 vWF
250 PCcl 660 -vWF
260 BXT 670 +vWF
270 LA1 800 WFa
280 LA2 810 +WFa
300 AT 820 -WFa
Note
Additional parameter codes may be added in the future.
The host computer may receive a parameter code not mentioned above; therefore,
prepare a host computer program that will ignore such data of a parameter code.
• Reserved
All characters are spaces (20H).
Revised July 2017
(d) Text Distinction Code I is “S” for the order information data.
Text Distinction Code II is type of inquiry:
“1”: The key word is “Rack No. and Tube Pos.”
“2”: The key word is “Sample ID No.”
Text Distinction Code III is “21”.
(e) Block number and total number of blocks are both usually “01”.
The block number is the serial number of divided blocks.
The total number of blocks is the number of total blocks divided.
(f) Sample Distinction Code
Symbol Type of Data:
U Routine analysis data
E STAT analysis data
S Standard curve analysis data
C Quality control analysis data
(g) Date and Time when the host computer ordered to the instrument. Date should be
transmitted in the form set by the Setting program in the instrument. Time should be
expressed in 24-hour clock system. Zero suppression is not performed.
(h) Rack No. indicates the Rack No. into which the sample test tube is placed.
“0001” through “0099” can be set. It is suggested that the STAT sample is assigned a
sequential number to distinguish from other STAT samples.
(i) Tube Position No. is the position number in which the sample is placed within a rack. “01”
through “10” can be set. “00” should be assigned for the STAT sample.
(j) Sample ID number consists of 15 digits including hyphens “-” (2D in hexadecimal code).
When the ID number of 13 digits or less is set, the set ID number is placed in the least
significant digits and space(s) (20 H) are padded to the most significant digits to fill up 15
digits.
When the sample is the Quality Control material, assign the QC file number as
“QC01_ _ _ _ _ _ _ _ _ _ _” through “QC06_ _ _ _ _ _ _ _ _ _ _” in which the obtained QC
data are to be stored. (“_” represents a space.)
(k) ID information indicates how the sample ID number was entered or read.
Symbol Description
C The sample ID number was downloaded from the host computer.
A The sequential number was applied to the sample ID number automatically.
B The sample ID number was read by the barcode reader.
M The sample ID number was entered manually.
(l) Reserved; 11 spaces (20H).
Revised July 2017
(m) Data n
Parameter No. of Example
Characters
Parameter Code 3 Refer to Table “Parameter Code”.
( Reserved ) 6 All spaces (20H).
• Parameter Code
Parameter Code Parameter Parameter Code Parameter
040 PT 320 Plg
050 APTT 330 BCPC
060 Fbg 340 Hep
500 +Fbg 610 DDPl
520 -Fbg 700 +DDP
510 TT 610 AdDD
120 II 700 +AdD
150 V 610 DDi
170 VII 700 +DDi
180 VIII 620 PFDP
190 IX 720 +PFD
200 X 650 vWF
210 XI 660 -vWF
220 XII 670 +vWF
250 PCcl 800 WFa
260 BXT 810 +WFa
270 LA1 820 -WFa
280 LA2 000 Not Analyzed
300 AT 999 Stop order inquiry for
300 AT3 the following sam-
310 APL ples in the racks.
Note
Additional parameter codes may be added in the future.
The host computer may receive a parameter code not mentioned above; therefore,
prepare a host computer program that will ignore such data of a parameter code.
14.6 ID Barcode
Applicable Barcodes
The types of barcodes acceptable to the instrument and the relation of the check-digit to each
barcode type are as follows:
Warning!
Use the check-digit as much as possible. If the check-digit cannot be used, the
potential of incorrect reading of the barcode label may be increased.
1. Sample ID No.
Type of Barcode Check-Digit No. of Digits for No. of Digits for
Sample ID No. Check-Digit
NW-7 (CODABAR)* Not Used 1 - 15 digits Not Applied
Modulus 11 1 - 15 digits 1 digit
W. Modulus 11 1 - 15 digits 1 digit
Modulus 10 1 - 15 digits 1 digit
CODE-39 Not Used 1 - 15 digits Not Applied
Modulus 43 1 - 15 digits 1 digit
CODE-128 Modulus 103 1 - 15 digits 1 digit
ITF (Interleaved 2 of 5) Not Used 1 - 15 digits Not Applied
Modulus 10 1 - 15 digits 1 digit
JAN-8 Modulus 10 7 digits 1 digit
JAN-13 Modulus 10 12 digits 1 digit
*: Start and Stop code can be any one of the characters “A”, “B”, “C”, “a”, “b” and “c”.
Note
When “C” or “c” is used, make sure that the number should not be the same as the
number of QC File No.
2. QC File No.
QC File No. can be read if printed with NW-7, CODE-39 or CODE-128.
Type of Barcode Check-Digit No. of Digits No. of Digits for
(File No. ) Check-Digit
NW-7 (CODABAR) *1 Not Used 4 to 13 digits *2 Not Applied
CODE-39 Either of “Use” or 4 digits “QC01”, Not Used or 1 digit
CODE-128 “Not Use” “QC02”, .... “QC12”
Revised July 2017
*1: Start and Stop code can be any one of the characters “C” and “c”.
*2: Possible applicable number is one of 1 through 9, and must be filled with the same
number in all digits.
Dimensions of Elements
Barcodes consists of five elements: a narrow bar, a narrow space, a wide bar, a wide space, and a
gap between characters. Each element has to comply with all of these equations:
(a) Narrow element ≥ 150 µm
(b) Wide element ≤ 1.2 mm
(c) Narrow element ≤ Gap between characters ≤ Wide element
Note
ITF does not require above mentioned item (c), since ITF does not use a gap between
characters.
For each character, the ratio of the wide element and the narrow element has to comply with all the
equations listed below:
(1) (2) (3)
Narrow(Max) Wide(Min) Wide(Max)
≤ 1.3 ≥ 2.2 ≤ 1.4
Narrow(Min) Narrow(Max) Wide(Min)
Here, the Narrow (Max) means the widest element of narrow elements in a character. The Narrow
(Min) means the narrowest element of narrow elements in a character. The Wide (Min) means the
narrowest element of the wide elements in a character and the Wide (Max) means the widest
element of wide elements in a character.
Optical Requirements
Max-Min
S(%) = x 100
Max
MAX
MIN
Bar element
Bar Height
Barcord Effective
Space Space
Length
Revised July 2017
Check-Digit
The barcode ID system requires the check-digit(s) to be added on the barcode label to improve the
reliability of the ID number.
Example No. 1:
Calculation of the check-digit for the JAN code 4912345 (7 digits) is shown below:
1. Add odd digits (counted from the least significant digit): 5 + 3 + 1 + 4 = 13.
Multiplied the sum by 3, as: 13 × 3 = 39
2. Add even digits: 4 + 2 + 9 = 15
3. Add the results of (1) and (2) above, as: 39 + 15 = 54
4. Check-digit is obtained by subtracting the right most digit of the sum of (3) above from 10 as:
10 - 4 = 6
Hence the check-digit is 6.
Example No. 2:
Calculation of the check-digit for the ITF code 524362 (6 digits) is shown below:
1. Add odd digits : 2 + 3 + 2 = 7.
Multiplied the sum by 3, as: 7 × 3 = 21
2. Add even digits: 6 + 4 + 5 = 15
3. Add the results of (1) and (2) above, as: 21 + 15 = 36
4. Obtain the check-digit as: 10 - 6 = 4
Hence the check-digit is 4.
However, in Example No. 2, the sum of the total number of the data digits and the check-digit
Revised July 2017
gives odd number 7 in this case. Therefore, “0” is added to the most significant digit (left most
digit) and check-digit is appended to the data, as 05243624.
(B) Modulus 11
This Modulus 11 method is used in the barcode symbology such as CODE-11, NW-7 and
CODABAR. Check digit computation method is shown as follows:
The following example uses the ID number 15-2345-6789.
1. Weight is multiplied to each digit as:
ID Number 1 5 - 2 3 4 5 - 6 7 8 9
× × × × × × × × × × × ×
Weight 3 2 1 10 9 8 7 6 5 4 3 2
3 10 0 20 27 32 35 0 30 28 24 18
The weight of the ID number is 3, 2, 1, .... 6, 5, 4, 3, 2 is applied to each one from the least
significant to the most significant digit. The position of the check-digit is in the least significant
digit of the ID number and its weight is 1.
2. Add each product as given below:
Sum = 3 + 10 + 0 + 20 + 27 + 32 + 35 + 0 + 30 + 28 + 24 + 18 = 227
3. Divide the sum by 11 and get the remainder. Then subtract the remainder from 11. The result
will be the check-digit.
227/11 = 20; remainder = 7,
11 - 7 = 4,
Hence the check-digit is 4.
Note that all symbols other than numbers are calculated as zero(0). The check-digit will be zero
(0) when the resulted check-digit is 10 or 11.
4. This check digit is appended to the ID number;
the barcode label is now 15-2345-67894.
5. When the ID Reader reads this barcode label, the instrument computes the check-digit(s) and
recognizes the read as a valid read if the remainder is 0 or 1.
Therefore, the first weight set is multiplied to each digit as given below:
NOTE: The weight for the 13th, 14th and 15th digit is 0 (zero).
ID Number 1 5 - 2 3 4 5 - 6 7 8 9
× × × × × × × × × × × ×
Weight 6 3 5 9 10 7 8 4 5 3 6 2
6 15 0 18 30 28 40 0 30 21 48 18
(D) Modulus 16
The Modulus 16 is the check-digit computation method used in NW-7 and CODABAR
symbologies. Since the NW-7 and CODABAR symbologies use 4 kinds of start/stop codes, these
start/stop codes are computed from the data digits.
The following example uses the ID number D998147D.
1. Add the values of all the data characters including the start and stop codes. The numerical
value of each of the data character is given below:
Character Value Character Value Character Value
0 0 7 7 . 14
1 1 8 8 + 15
2 2 9 9 A 16
3 3 - 10 B 17
4 4 $ 11 C 18
5 5 : 12 D 19
6 6 / 13
Sum = 19 + 9 + 9 + 8 + 1 + 4 + 7 + 19 = 76
2. Divide the sum by 16 and get the remainder. Then subtract the remainder from 16. The result is
the check-digit. When the remainder is 0, check-digit becomes 16. In such a case set the check-
digit to “0”.
76/16 = 4; remainder = 12,
16 - 12 = 4,
Hence the check-digit is 4.
3. This check-digit is appended to the left of the stop code in the ID number; the barcode label is
now D9981474D.
4. When the ID Reader reads this barcode label, the instrument computes the check-digit and
recognizes the read as a valid read if the remainder is 0.
(E) Modulus 43
Modulus 43 is the check digit computation method used in CODE-39 symbology. Each of 43
characters is assigned each value. All characters are converted into the value and computed.
The following example uses the ID number 258-416.
1. Add the values of all the data characters. The numerical value of each of the data characters is
given below:
Character Value Character Value Character Value
0 0 F 15 U 30
1 1 G 16 V 31
Revised July 2017
2 2 H 17 W 32
3 3 I 18 X 33
4 4 J 19 Y 34
Sum = 2 + 5 + 8 + 36 + 4 + 1 + 6 = 62
2. Divide the sum by 43 and get the remainder.
62/43 = 1; remainder = 19
3. Find the check-character. The check-character is that character whose value is equal to the
remainder. In this example, the letter “J” has the value of 19 which is equal to the remainder.
Therefore “J” is the check-character.
4. This check-character is appended to the ID number, after the least significant digit. The
barcode label is now “258-416J”.
19 3 3 19 73 HT i 73
20 4 4 20 74 LF j 74
Applicable Characters
The valid characters for the ID barcode system are numerals (0-9) and a hyphen (-).
CODABAR (NW-7) and CODE-39 may use the other characters such as alphabets, however the
instrument ID system does not recognize them. The ID number allows up to thirteen digits. The
application of hyphens in an ID number should adhere to the following rules:
1. Hyphens must be placed between other characters.
2. The ID number cannot begin or end with a hyphen.
3. Hyphens are included as part of the allowable maximum number of 13 characters.
4. When calculating check character of an ID number that includes hyphens, the hyphen in
CODABAR (NW-7) is calculated as 0 (zero), and hyphen in CODE-11 is calculated as 10 in
decimal. In the CODE-39 symbology, the hyphen is calculated as 0 (zero) for Modulus 11, and
as 36 for Modulus 43.
5. ITF cannot recognize the hyphen since this symbology does not allow such a character.
For the NW-7 (CODABAR) and CODE-39 symbologies, the ID number can consist a minimum of
1 digit, and a maximum of 13 digits. For the other symbologies, the minimum number of digits
depends on the symbology used and the application of the check-digit.
The instrument performs quality control by using the auto sampler. When using this program, the
barcode label is prescribed by the following:
CODABAR (NW-7)
The CODABAR (NW-7) employs the start/stop codes “a”, “b”, “c”, or “d”. The instrument defines
the ID number as the quality control data when the ID number is sandwiched by two start/stop
codes of “c” and has the same number in each digit.
For example, the ID number “c11111111c” is read as “File No. 1” of the quality control program.
CODE-128
CODE-128 employs alphabetical characters. Therefore, the instrument defines the ID number as
quality control data when the ID number is read as “QC-” and is followed by 8-digit Lot number.
Refer to “5.11 Prepare Samples” for the correct barcode label position.
Revised July 2017
15. Index
A Catcher Unit Replacing Message ..........................5-31
Add Samples ....................................................5-35 CE-Mark ...........................................................1-3
Addition of New Analysis Parameters .................10-33 Check and Drain Trap Chamber .........................11-13
Adjust LCD Contrast .......................................14-16 Check before Installation ..................................14-11
Affixing Barcode Label ....................................14-45 Check Connection Cord ........................................5-6
All Data .......................................... 6-10, 6-14, 7-3 Check Light Shield Cover .....................................5-6
Analysis Data Error .........................................12-14 Check Power Cord ...............................................5-6
Analysis Data Format .......................................14-24 Check Printer Paper .............................................5-6
Analysis Flow ...................................................13-8 Check Tube Trash Drawer .....................................5-6
Analysis Mechanism ..........................................13-7 Check-Digit ....................................................14-38
Analysis Status Display (Main Menu screen) ..........5-33 Class A ..........................................................14-20
Analyze STAT Sample .......................................5-36 Class B ..........................................................14-20
APL Flow Clean Instrument .............................................11-16
(When Berichrom® α2-Antiplasmin is used) ....13-14 Clean Sample Probe ...........................................11-2
Applicable Barcodes ........................................14-35 Clean the Instrument Exterior ............................11-16
Applicable Characters ......................................14-45 Clean the Instrument Interior .............................11-16
APTT Flow ......................................................13-8 Clotting Method Using Standard Curve .................13-2
As Needed Maintenance .....................................11-1 Coagulation and Scattered Light ...........................13-1
AT Flow CODABAR (NW-7) ........................................14-45
(When INNOVANCE® Antithrombin is CODE-128 .....................................................14-45
used) ........................................................13-12 Communication Format ....................................14-17
At the start of analysis ........................................5-32 Communication Settings ...................................14-17
AT3 Flow Confirm Automatic Output ....................................5-7
(When Berichrom® Antithrombin III (A) is Confirm Standard Curve .....................................5-16
used) ........................................................13-13 Connect Power Cord and Connection Cord ...........14-15
Attach Trap Chamber .......................................14-13 Connect Rinse Bottle and Waste Bottle ................14-14
Auto Dilution .....................................................9-3 Connection .....................................................14-17
Automatic Backup .............................................9-18 Contrast Adjustment for LCD Screen ......................4-3
Automatic Inquiry .............................................5-24 Current Data ............................................. 6-13, 7-1
Automatic Inquiry (with barcode scanner) ..............5-25 Cycle Counter .................................................12-22
Automatic Inquiry (without barcode scanner) ..........5-24
Automatic Maintenance Data Transmission D
(Option, when SNCS Is Connected) .................5-29 Daily Maintenance .............................................11-1
Automatic Printout of Analysis Data .......................7-1 Data Display ......................................................9-1
Automatic QC Data Transmission Data Processing Area ...........................................5-2
(Option, when SNCS Is Connected) .................8-10 Date Format ...................................................10-29
Automatic Sensitivity Adjustment of the Detector Date Specification Print ......................................8-16
(for CA-660 Only) ........................................5-30 Date/Time ......................................................10-28
Avoiding Infections .............................................2-4 DDi Flow
(When INNOVANCE® D-Dimer is used) ........13-16
B DDPl, AdDD Flow ..........................................13-15
Barcode Scanner ................................. 10-27, 12-21 Decontamination .................................................2-9
Basic Instrument Settings ......................................4-3 Delete QC Data .................................................8-14
Basic Operation of Setup Program ........................10-2 Delete QC File ..................................................8-13
BXT Flow ......................................................13-10 Deletion ...........................................................6-13
Design and Function ............................................3-1
Detection Principle of Chromogenic Method
C
Revised July 2017
Detection Principle of Immunoassay Method Hep Flow (When Berichrom® Heparin is used) .... 13-15
(D-Dimer, PFDP, vWF, WFa: CA-660 Only) .... 13-5 Host Computer .................................... 10-25, 12-20
Devices to Be Connected .................................. 10-25 How to Add Unit .............................................. 9-25
Diagnostic Parameters ......................................... 1-1 How to Replenish Reagent ................................ 11-17
Dimensions of Barcode Label ........................... 14-37 How to Select Parameters ................................... 10-5
Dimensions of Elements ................................... 14-36 How to Set Mark Limits ..................................... 10-4
Discard Used Reaction Tubes .............................. 11-4 How to Set Test Protocol .................................. 10-11
Display Analysis Result ..................................... 5-33
Display and Printout of Sample Data .................... 5-33 I
Display and Processing of Analysis Results ............. 6-1 ID Barcode .................................................... 14-35
Display QC Charts .............................................. 8-8 Initialization of Test Protocol ............................ 10-18
Display Screens and Operation Keys ...................... 5-1 Input/Output Signals ....................................... 14-17
Display Standard Curve ....................................... 9-1 Inquiry Data Format ........................................ 14-29
Displaying Standard Curve Files .......................... 9-16 INR Manual Dilution Analysis ............................ 9-10
Disposal of Waste Fluid, Waste Materials, and the Inspect Rinse Bottle ............................................ 5-5
Device ......................................................... 2-7 Inspect Waste bottle ............................................ 5-6
Dispose of Waste .............................................. 11-5 Inspection Before Turning ON the Power ................ 5-5
During analysis ................................................ 5-32 Installation .................................................... 14-11
Installation and Relocation ................................... 4-1
E Installation Environment ............................... 4-1, 4-3
Edit ID No. ...................................................... 6-12 Installation Location ..................................... 2-3, 4-1
Effective Barcode Length ................................. 14-45 Installation Space ..................................... 4-2, 14-12
Electromagnetic Compatibility (EMC) .................... 2-3 Instrument Setup .............................................. 10-1
Emergency Stop ............................................... 5-37 Instrument Specifications ................................... 14-1
Enter Password .............................................. 10-29 Intended Use ...................................................... 1-1
Entering setting items by hand-held barcode Interface Circuit ............................................. 14-18
reader (optional) ............................................ 8-5 Interrupt Analysis ............................................. 5-34
Error Corrective Procedure ................................. 12-2 Intrinsic Factor Assay Flow .............................. 13-12
Error Detail Window ........................................... 6-6 Introduction ...................................1-1, 12-1, 14-11
Error List ...................................................... 12-15
European Representative ...................................... 1-3 J
Example of Printout ............................................ 7-3 Judgment on Analysis Result .............................. 10-4
Execute Quality Control .............................. 5-17, 8-7
Extrinsic Factor Assay Flow ............................. 13-11
L
LA1 Flow ...................................................... 13-11
F LA2 Flow ...................................................... 13-11
Factory Settings ................................................ 14-7 LCD ............................................................. 12-19
Fibrinogen Flow ............................................... 13-9 LED Calibration ............................................... 11-7
Filter Inspection and Cleaning ........................... 11-15 Left Side ........................................................... 3-5
Front ................................................................ 3-1 Link of Standard Curve .................................... 10-18
Front Interior (When Opening Light Shield Cover) .... 3-3 List Display ....................................................... 6-1
Functional Description ....................................... 13-1 List Display/Graphic Display ................................ 6-1
Loading Standard Curve Files ............................. 9-18
G
General Information ................................... 2-1, 10-1 M
Graphic Display .......................................... 6-4, 9-2 Maintenance and Supplies Replacement ................ 11-1
Graphic Enlargement Window .............................. 6-6 Maintenance CheckList ...................................... 16-1
Grounding ......................................................... 4-1 Maintenance Data Transmission ........................ 12-23
Group Selection ................................................ 5-22 Maintenance of the Instrument .............................. 2-6
Revised July 2017
T
Technical Information ....................................... 14-1
Temperature .................................................. 12-16
Test Protocol ................................................. 10-11
Text Format ................................................... 14-24
Top Data/Bottom Data ......................................... 6-7
Touch Screen ................................................. 12-19
Trademarks ....................................................... 1-5
Training Courses ................................................ 1-3
Transmission Errors ........................................ 14-23
Transmitted Light Detection Method ........... 13-4, 13-5
Trash Box Monitoring ....................................... 5-31
Troubleshooting ............................................... 12-1
Troubleshooting Guide ...................................... 12-1
TT (Thrombin Time with Test
Thrombin Reagent) Flow ............................... 13-9
TT TC (Thrombin Time with
Revised July 2017
Discard used
reaction tubes
Dispose of waste
Initial
Day 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Maintenence item
Clean Sample Probe
Discard used
reaction tubes
Dispose of waste
Initial
WEEKLY MAINTENANCE
SUPPLIES REPLACEMENT
Replenish reagent
MONTHLY MAINTENANCE
LED Calibration
YEARLY MAINTENANCE
AS NEEDED MAINTENANCE
Replace fuse
Clean instrument
Revised July 2017
16.2 Reagents
Lot No. Expiry replaced on: replaced by: Lot No. Expiry replaced on: replaced by:
date (initial) date (initial)
Lot No. Expiry replaced on: replaced by: Lot No. Expiry replaced on: replaced by:
date (initial) date (initial)
Revised July 2017