Académique Documents
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CA-500
CHAPTER 1: INTRODUCTiON
CHAPTER 2: SAMPLE ANALYSIS
CHAPTER 3: WORK LIST
CHAPTER 4: DISPLAY AND PROCESSING OF ANALYSIS RESULTS
CHAPTER 5: MAINTENANCE AND SUPPLIES REPLACEMENT
CHAPTER 6: QUALITY CONTROL
CHAPTER 7: SETTING STANDARD CURVES
CHAPTER 8: TROUBLESHOOTING
CHAPTER 9: FUNCTIONAL DESCRIPTION
CHAPTER 10: INSTRUMENT SETUP
APPENDIX A: MENU TREE
APPENDIX B: INSTALLATION
, APPENDIX C: TECHNICAL INFORMATION
INDEX
SYSMEX CORPORATION
KOBE, JAPAN
Copyright © 1997-1999 by SY,SMEX CORPORATION
All rights reserved. No part of this Operator's tylanual may be Code No. 461-2047-7
r",produced in any form or by any means whatsoever without PRINTED IN JAPAN
prior IjIrilten permission of SYSMEX CORPORATION. Date of Last Revision: September 1999
Sysmex is a registered trademark of SYSMEX CORPORATION.
CA CLEAN I is a trademark of SYSMEX CORPORATION.
Actin, Ci-Trol, Data-Fi and Innovin are registered trademarks of Dade International Inc.
Dade is registered trademark of Dade Behring Inc.
Patient names and doctor names are entered for information and illustration purposes only, and
do not imply real specific persons.
The CA-500 has been thoroughly tested before shipment, and has been packaged carefully to
prevent damage from shipping and handling. Reagents and options have also been sent and
will arrive at approximately the same time as the analyzer. Follow these guidelines when the
system arrives:
• Check to see that the arrows on the sides of the packages are pointing up. If the arrows
do not point up, remark this information on the bill of lading.
• Visually inspect the outside of the package for rips, dents, or possible shipping damage.
Document any sign of damage on the bill of lading, regardless of how insignificant it
may appear. This is for your protection!
• Notify your service representative that the CA-500 system and its components have
arrived.
• Wait for your service representative to unpack the system and open the packages.
• Follow the unpacking and storage instructions provided on the outside of the package.
Special requirements such as refrigeration are clearly marked on the outside of the
carton and will be included in the unpacking instructions and package inserts.
WARRANTY INFORMATION
This Warranty does not cover any defect, malfunction, or damage due to:
2. Failure to use, operate, service, or maintain the product in accordance with the
applicable Sysmex Operator's Manual
3. Failure to use the appropriate reagents or chemicals specified for the product
CHAPTER 1: INTRODUCTION
1. INTRODUCTION 1-1
2. STRUCTURE OF THIS MANUAL 1-2
3. PREMISES FOR SIGNS 1-3
4. INSTRUMENT OVERVIEW, ANALYSIS PARAMETERS,
AND DETECTION PRINCIPLE 1-4
5. ENSURE SAFE OPERATION OF THE INSTRUMENT 1-6
6. DISPLAY SCREENS AND OPERATION KEYS 1-10
7. PASSWORD 1-12
8. EMERGENCY SHUTDOWN 1-13
9. TYPES OF ALARM 1-13
10. INSTALLATION ENVIRONMENT 1-14
10.1 Installation and Relocation 1-14
10.2 Grounding 1-14
10.3 Installation Space 1-15
10.4 Installation Environment 1-16
11. INSTRUMENT SPECIFICATIONS 1-17
1. INTRODUCTION 3-1
2. MANUAL SETTING 3-2
2.1 Setting of Sample ill Nos 3-2
2.2 Setting of Analysis Parameters 3-3
2.3 Repeat. 3-3
2.4 Group Selection 3-4
3 MANUAL INQUIRy 3-5
4. AUTOMATIC INQUIRY (WITHOUT BAR CODE SCANNER) 3-6
5. AUTOMATIC INQUIRY (WITH BAR CODE SCANNER) 3-7
1. INTRODUCTION 10-1
2. SETUP OF AUTOMATIC TRANSFERIPRINTOUT 10-2
3 JUDGMENT ON ANALYSIS RESULT .. ; 10-5
3.1 Mark Limits 10-5
3.2 Fbg Analysis Range 10-8
3.3 Replication Range 10-10
3.4 Report Limit 10-12
4. ANALYSIS SETUP 10-14
4.1 Replication 10-14
4.2 Test Protocol l0-16
4.3 Setup of Reagent Volume Monitoring 10-21
4.4 Setup of Test Name 10-23
4.5 Reagent Name 10-25
4.6 Reagent Holder 10-27
5. DEVICES TO BE CONNECTED 10-29
5.1 Host Computer 10-29
5.2 Bar Code (Only for Instrument with Bar Code Scanner) 10-32
6. SETUP OF TEST GROUP 10-34
7. SYSTEM SETUP 10-36
7.1 Dateffime 10-36
7.2 DateFormat 10-38
7.3 Password 10-40
8. PRINTOUT OF SETTINGS 10-42
APPENDIX B: INSTALLATION
1. INTRODUCTION B-2
2. CHECK BEFORE INSTALLATION B-3
3. INSTALLATION SPACE B-4
4. REMOVE SHIPPING CLAMPS B-5
5. ATTACH TRAP CHAMBER B-7
6. CONNECT RINSE BOTTLE AND WASTE BOTTLE B-8
7. CONNECT POWER CORD AND CONNECTION CORD B-9
8. SET PRINT PAPER B-I0
9. ADJUST LCD CONTRAST B-12
10. REPLENISH RINSE SOLUTION B-13
11. SET TUBE TRASH DRAWER B-15
12. SET REAGENT RACK AND REACTION TUBE RACK B-16
13. INSTALL SAMPLER WITH ill BAR CODE SCANNER (Option) B-17
INDEX
1. INTRODUCTION
The Sysmex® Automated Blood Coagulation Analyzer CA-500 Series is a compact fully-
automated analyzer capable of 5-parameter random analysis for in vitro diagnostic use in clinical
laboratories.
The CA-500 series is available in four types: CA-51O, CA-520, CA-530, and CA-540. The
major differences in these types are listed below. In this manual, the CA-500 Series is called the
CA-500 from here on.
Model Reagent Cooling Function Optional Chromogenic Unit Bar Code Scanner
CA-51 0 -- -- Option
CA-520 -- -- 0
CA-530 0 0 Option
CA-540 0 0 0
CHAPTER 1 should be read before starting operation of the CA-500. This chapter gives the
overview of this instrument. The main contents of CHAPTER 1 are as follows:
Instrument Overview
Describes in general the CA-500, analysis parameters, and optional components.
Instrument Specifications
Lists the instrument specifications.
Appendix A: Menu Tree Reference data for instrument setting procedure, host
Appendix B: Installation computer specifications, bar code specifications, etc.
Appendix C: Technical Information
&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 output, or will cause property damage.
CAUTION: Indicates what we would like you to know to maintain instrument performance
and prevent its damage.
NOTE: Indicates information which will come handy in operating the instrument.
Document Conventions
A menu is selected by pressing a key shown on LCD. These keys appear within square
brackets.
For example: [Reagent Volume], [Regent], [Stored Data], [t], [-!]
III
III
Option
Meaning of Signs
&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 on Diagnosis
&WARNING
• In the event the instrument emits abnormal odor or any smoke, turn off its power
supply Immediately and pUll off 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 Sysmex service representative for inspection.
• Take care not to spill blood or reagent, or drop wire staples or paper clips into the
Instrument.
Those might cause short circuit or smoke emission. If such trouble should occur, tum off the power
supply immediately and pull off the power plug from the wall socket. Then contact Sysmex service
representative for inspection.
• During analysis, do not open the light shield cover and put in hands or fingers.
That could cause injury.
When the light shield cover is opened dUring analysis, the alarm sounds and the operation stops.
• When discarding waste liquid and Instrument consumable, take proper disposing
steps as medical and Ineffective wastes.
If they are contaminated with blood, there is a possibility of bacterial infection occurring.
&WARNING
&CAUTION
Use of reagents
• After unpacking, be sure not to allow dust, dirt, or bacteria into the reagents.
• Do not use reagents that passed the expiration period.
• A reagent is a chemical substance employed for extemal diagnosis and cannot be used for any
medical treatment.
• Handle a reagent gently to prevent formation of bubbles.
• Take care not to spill a reagent. If it has spilled, wipe it off immediately using a wet cloth or
something.
• Follow other instructions described on reagent containers.
Wl 2A TT
6 I13 oFb9 11
4
~T3ID Pray
Rack 10 No. 12345 I
I
• -- --
Data Processing Area
01-02
01-03
01-04
- - ---
- - - --
I Next
01-05 - - - --
t I I I Repaat I 10 No.
Entrv
I HC
Menu Processing Area
Stored
Dala
I ac I Standaed
Curve
I Test
Group
I Speclel
Manu
Contrast
Adjust Dial
7. 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.
Enter Password
8. EMERGENCY SHUTDOWN
Should the analyzer need to be shut down in an emergency, as an unexpected outage of power to
the laboratory, immediately turn off the power switch to the main unit.
Note that the above-mentioned switch differs from the emergency mechanical stop switch (red
switch) on the front of the instrument. When the red mechanical stop switch is pressed, the
mechanical system comes to a stop but the power supply is not turned off.
9. TYPES OF ALARM
The CA-500 alarm emits 5 different sounds:
Sounds when sampling and dispensing of all set samples are completed and the rack
becomes ready for replacing.
10.2 Grounding
The power cord of each instrument employs 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.
The dimensions ofthe instrument are shown below. The power cord is 1.8 ill long.
• Be sure to place rinse bottle and waste bottle on the base on which
&CAUTION
the instrument is set. Do not put them on the instrument, or there is a
possibility the instrument may breakdown or fail to produce correct
results.
ModeJ Reagent Cooling Function Optional Chromogenic Unit Bar Code scanner
CA-51 0 - I· - Option
CA-520 - - 0
CA-530 0 0 Option
CA-540 0 0 0
Reagents Required
(1) PT Prothrombin Time Reagent: 100 ilL
(2)APTT Activated Partial Thromboplastin: 50~
Calcium Chloride Solution: 50~
(3) Fbg Thrombin: 50~
Buffer: 90~
(4)TT Thrombin Time Reagent: 50~
(5)TTO Thrombotest: l25~
Buffer: 30~
(6) NT Normotest: l25~
Buffer: 40~
(7)AT3 AT3 Thrombin reagent: lOO~
AT3 Substrate: 100 J.lL
Buffer: 130 J.lL
Required, in addition to those listed above, are two rinse solutions per test: a maximum each of
roughly 24 mL of distilled water and the same amount of CA-CLEAN I as the reagent amount
required for the analysis.
Analysis Principles
1 • Bioactivity Method
(1) Coagulation Reaction Detecting Method (Scattered Light Detecting Method)
A mixture of plasma and reagent is exposed to red light (660 nm). Turbidity change
occurring when Fibrinogen is transformed to Fibrin is detected as a change in its scattered
light, then coagulation time is measured.
2 • Chromogenic Method
(1) Colorimetric Method (Rate Method)
Plasma, reagent, and substrate are mixed to start reaction, and change in extinction of
pigment in free P-nitroaniline is detected and activity value is calculated.
Analysis Range
(1) Fibrinogen Concentration
The range between 25 mg/dL and 1000 mg/dL can be analyzed.
However, over 500 mg/dL is analyzed via dilution in low concentration mode (I :20
dilution).
Under 50 mg/dL is analyzed via dilution in high concentration mode (1:5 dilution).
Detection Time
Coagulation reaction is detected within maximum detection time and coagulation time is
measured.
Typical maximum detection time: 100 sec. for PT, Fbg
190 sec. for others
Maximum detection time in Auto Extension mode: 600 sec. for each parameter
Reproducibility
Prothrombin Time (PT): c.v. 2% or less
Activated Partial Thromboplastin Time (APTT): C.V. 2% or less
Fibrinogen (Fbg): C.V. 4% or less
Thrombin Time (TT): C.V. 10% or less
Thrombotest (TTO): C.V. 4% or less
Normotest (NT): C.V. 4% or less
Antithrombin ill (AT3): C.V. 5% or less
The above data are variation coefficients of coagulation time (seconds) when Dade Ci-Trol®
Level I (control plasma) were analyzed 10 times, with the following reagents used:
Printout
Internal printer prints out analysis data and graphic prints
External Input/Output
Bit serial voltage signal (RS-232C)
Sample Dispensing
The incubation pipette detects sample surface, aspirates a sample with the syringe from a tube on
the rack, and dispenses it out into a reaction tube in the reaction tube rack.
SAMPLE TUBE
Sample Tube: 60 MAX (30-tube rack x 2)
Detector
Photo Detection Unit: 4-well (5 wells for CA-530 and CA-540, 1 well added for AT3
photo detection)
Heater Section: 6-well
Temperature Control
Detector: 37°C±O.5°C
Sample Incubator Section: 37°C±O.5°C
Reagent Pipette: 37°C±O.5°C (When room temperature is 15 - 35°C)
Cooling Unit: 15°C±2°C
Quality Control
)( Control (L-J Control): 180 points x l2files, 7 parameters
Standard Curve
6 points. 7 parameters
Electrical Rating
Rated Voltage: 117 V AC ± 10%, or 230 V AC ± 15%
Frequency: 50Hz or 60 Hz
Power consumption: 310 VA or less (with CA-51O)
(Main unit) 320 VA or less (with CA-520)
380 VA or less (with CA-530)
400 VA or less (with CA-540)
Heat Compensation Required: Approx. 1365 BTUIh (344 kca1lh)
1. INTRODUCTION
This chapter describes the operation procedures from the start-up of this instrument to
shutdown.
2. START-UP
2.1 Inspection Before Turning ON the Power
1. Inspect Rinse Bottle
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 Chapter 5, Section 6.3:
Replenish Rinse Solution.
• When analysis is made with the rinse bottle laid down, there is a
& CAUTION possibility that correct analysis result may not be obtained. Make
sure the rinse bottle is standing upright.
CAUTION: • When analysis is made with the waste bottle laid down, waste may
flow back into the vacuum pump, causing the pump to fail.
Make sure the waste bottle is standing upright.
CA-500
Check in Progress
s ysmex IFaad
Y
Ranlaca Rack? YESI
HC IP I Start
Main Menu Group 1
rnI 2 TT
"b W~bg114 ID
;
T3
I Prev
Rack
, 10 No. 1 2 3 4 5
01-02
01-03
01-04 --- --- --- --
-- I Next
01-05 --
I I I I Repeat I
10 No.
Entrv
I HC
Stored
Data
I QC I Standard
Curve
I Tast
Groue
I Special
Manu
(1) Confirm that the System Status area displays "HC" and "IP."
Ready HC IP
S ysmex Re lace Rack? YESI Start
Main Menu Group 1
1 oPT 12~PTT113 oFbgW ~T31 D Prey
Rack 10 No. 1 2 3 4 5
01-02
• -- -- -- --
01·03
01·04 - - - --
-- Next
01-05 - - - --
HC
Stored
Data I
NOTE: • [HC] key is displayed only when the system is set for manual inquiry
to the host computer. For detail, refer to Chapter 3, Section 3:
MANUAL INQUIRY.
3. REAGENT PREPARATION
3.1 Prepare Reagents
Prepare coagulation reagents needed for analysis, Owren's Veronal Buffer, and rinse solution.
Refer to the package insert of each reagent for more information.
Table 2-3-1: Reagent Consumption
Parameter Reagent Consumption per Test
PT PTReagent 100 ilL
APTT APTT Reagent 50 ilL
Calcium CWoride Solution 50 IlL
Fbg Thrombin Reagent 50 IlL
Owren's Veronal Buffer 90UL
TI Thrombin Time Reagent 50 ilL
TIO Thrombotest Reagent 125 ilL
Owren's Veronal Buffer ·30 IlL
NT Normotest Rea.e;ent 125 IlL
Owren's Veronal Buffer 40 IlL
ATI Dade® Antithrombin ill kit
Thrombin Reagent 100 flL
Substrate lOOUL
Owren's Veronal Buffer 130 IlL
Rinse Solution Distilled Water (Rinse Bottle) Max. 24 mL per test
CACLEANI the same amount as the reagent
required for an analysis
The amount of Owren's Veronal Buffer per test includes the amount used in dilution for each
analysis parameter.
The amount of the distilled water used is approx. 8 mL per a rinse operation, and approx. 24
mL per test for the 2-reagent analysis such as APTT or AT3. In the 2-reagent analysis, three-
rinse operations are performed during analysis; after dispensing sample and after dispensing two
reagents.
&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
• The amount of the reagent used in cleaning after analysis starts:
Distilled water: Approx. 20 mL
CA CLEAN I: Approx. 125 JlL
The amount of extra reagents required vary according to the container used.
Sample cup conical (2 mL or4 mL): Approx. 0.15 mL
Dade Behring 4 mL vial: Approx. 0.6 mL
TIO, NT 3 mL vial: Approx. 0.6 mL
Push Vial PV-10 (22 rnm OD x 40 rnm high): Approx. 0.9 mL
&CAUTION • Strictly follow the instructions as given in the package insert furnished
with each reagent. Otherwise, you will fail to obtain correct analysis
result.
&CAUTION • Always set the reagents at the specified positions to obtain correct
results.
• Be sure to set CA CLEAN I in Holder No. 11 (as shown in the upper
right area).
s ysmex IreadY
ReDlace Rack? YESI
HC IP
1 3 5 7 9 11
PT Fbg APTT CaCL 2 Rinse
5.0mL O.OmL O.OmL O.OmL O.OmL O.OmL
4.8mL O.OmL O.OmL O.OmL O.OmL O.OmL
2 4 6 8 10 12
AT3.T AT3.S Buffer
O.OmL O.OmL O.OmL O.OmL O.OmL O.OmL
O.OmL O.OmL O.OmL O.OmL O.OmL O.OmL
MaIn
Menu
IP He
I
PT
IDD
5.0mL
( 4) Enter the reagent volnme 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.
By pressing [i] key and [-I-] key, movement can be effected to the preceding or following
reagent holder No.
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 Chapter 10, Section 4.3: Setup of Reagent Volume Monitoring
for the setting procedures.
sysmex l~eadY
Renlace Rack? YES I
He IP I
Enter Reagent Volume
RENEW SETTING?
Cancel I I FIX
I I Continue
t Reaction Tube
;.
Reaction Tube Rack
&CAUTION • When setting reaction tubes on the reaction tube rack, be careful not to
drop the sweat or the saliva into the reaction tube. This will alter the
analysis result.
CAUTION: • Set the reaction tube rack securely to prevent the tubes from unseating
and rising; otherwise, probe might be damaged.
• The reaction tubes are set successively from the first (top on extreme
right-hand column). Therefore, make sure no port is left empty.
& CAUTION • Unless the standard curve is properly set, PT ratio, PT-INR and other
calculation parameters cannot be reported.
sysmex IReDlaee
ready Rack? YES!
He IP I
Standard Curve PT
TO Cal Date 1997105110
% sec Lot No. EXP.
100.0 11.4 PT Ape.63 199715/10
50.0 17.4
25.5 27.9
12.5 52.6 Ref. 123456789012 1997/5110
6.5 0.0
3.1 0.0
Normal 11.4
151 1.73
I Standard
Analvsis
I Manual
Entry
I Select
Paramo
Select
Test
I Graph I Print I LotEntrvN°'1 Meln
Menu
sysmex !ready
ReD lace Rack? YESI
HC IP I
Standard Curve PT
PT% Cal Date 1997/05/10
% sec Lot No. EXP.
100.0 11.4 PT Ape.s3 1997/5/10
50.0 17.4
25.5 27.9
12.5 52.6 Ref. 123456789012 1997/5/10
6.5 0.0
3.1 0.0
Normal 11.4
lSI 1.73
PT IAPTT IFbg IAT3 I
I I I Cancel
sysmex l~eadY
ReDlaee Rack? YESI
HC IP I
Standard Curve PT
PT% Cal Date 1997/05/10
% sec Lot No. EXP.
100.0 11.4 PT Ape.63 1997/5/10
50.0 17.4
25.5 27.9
12.5 52.6 Ref. 1234567890t2 1997/5/10
8.5 0.0
3.1 0.0
Normal 11.4
lSI 1.73
PT IAPTT IFbg IAT3 I
I I I Cancel
X control: Uses the data from the mean of two consecutive analyses. Since a mean value is
used as control data, this control is virtually free of reproducibility influences at
analysis.
L-J control: Uses the data from a single analysis of control material. Compared with X
control, therefore, this control is sensitive to reproducibility influences at
analysis.
7. PREPARE SAMPLES
Set sample tubes or dispensed sample cups on the sampler rack.
3) Set, in the furnished sample rack, the centrifuged blood tube itself or the plasma which
has been removed and put into another test tube.)
Insert the test tube securely to the bottom of the rack.
1.0 mL (Centrifuged)
Plasma
O.5mL O.5mL
., .,
O.3mL
~
or mora
~
or mora
O.3mL
or mora or mora Blood
..L ..L layar
10 10 ID 10 10 10
<1>9.4 -10.6 <I> 11 <I> 12 <I> 9.4 -10.6 <I> 11 <I> 12
O.6mL O.7mL
.,
O.4mL
.-
O.5mL
or mora
~ ~
or mora
or more or mora
..L .L
10 10 10 10
<1>13 <1>14 <1>13 <1>14
Minimum-required volume of plasma-only sample Minimum-required volume of centrifuged sample
&CAUTION • The blood volumes shown above are definitely the minimum volumes.
Prepare an extra volume for a parameter to be analyzed.
• When using test tubes with an outside diameter of 15 mm, remove the
fumished 13 mm tube adapters from the sample rack beforehand.
When using test tubes with an outside diameter of 10 mm, remove the
furnished adapters from the sample rack and mount the optional holder
No. 113 (010 mm test tube adapter) beforehand.
• When using the sample cups, set the optional holder No. 70
beforehand.
• When using the sample cups, avoid setting samples which are low in
blood volume. Such samples will cause the error of 'Sample Probe
Crash."
As plasma volume, prepare the required volume pius 100 ~.L.
sample Rack
~.
sample Rack Sensor
Jc-~
~".J)
.
sarnPler~
Figure 2-7-4: Setting the Sample Rack
CAUTION: • Unless the sample rack is not correctly set, instrument failure will result.
Push in the detent at the lower left of the sample rack before setting it.
1) Manual setting with the numeric keys and analysis parameter keys
2) Gaining ID Nos. ·and analysis parameters collectively from the host computer
3) Manually entering ID Nos. so that analysis orders will be automatically received from the
host computer
4) Using ID Nos. that have been read with the optional bar code scanner so that analysis
order information will be automatically received from the host computer.
9. START ANALYSIS
With completion of analysis preparation and registration of analysis information, the instrument
is now ready to start analysis.
First
I Continue [ Tube
Then, the screen displays "Analyzing", and the cursor position in the work load list moves
to the next rack.
s eadY
Ir
ysmax Reclaee Rack? NOI HC IP II NTE RR
Main Menu Group 1
- - - --
01-03
01-04
01-05
123-456-78904
123-456-78905 --
I I j I Repeal I ID No.
Entrv
I HC
Stored
Data
I
CAUTION: • 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].
NOTE: • The first time the analysis is started after power switch on, [Continue]
key is not displayed.
( 4) Completion of Analysis
When all analyses are over, the alann sounds "pip, pip, peep."
If you want to continue analysis, when the message "Rack not replaceable" changes to
"Replace Rack? YES!", then the next sample can be set.
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 open the light shield cover and enter hands or
fingers. 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.
CAUTION: • During operation, the sampler cannot be pUlled out as the lock
mechanism is activated to prevent injury and damage to the instrument.
• When the power switch is tumed 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.
Prey
,Rack, 10 No.
, 1 2 345
• -• •
02·02
02·03
123·456-78902
123·456·78903
-
-
-
- - - - I Next
02·04 123·456·78904 - - - - -
02·05 123·456·78905 - - - - -
I I j I Repeat I I~n~~' I He
Stored I
Data
S Ready He IP
ysmex Re lace Rack? YESI
Slored Dala All Seq 0/142(142)
10 No. PT PT APTT
sec % sec
, I
123·456·78902 88.1 32.1
123·456·78902 88.1 32.1
123·456-78902 m 88.1 32.1
123·456-78905 88.0 32.0
123·456-78906 87.9 32.2
123·456-78907 88.0 31.9
123·456-78906 87.9 32.0
I Mark
Graph Main
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-- ...
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bH[ 56] dH[ 123]
60 CH No. [1J
- I - I 1 I j I Info
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10 No. I Oulput I Delele I Return
(sec) 6C ER2 (8 ec ) bU
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98 dH
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101
CH No. 1 CH No. 1
02·02
02·03
ID No.
123·456·78902
123·456·78903
; . 1 2 3 4 5
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- - -- --- I
Prey
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02·04 123·456·78904 - - - --
02·05 123·456·78905 - - - --
ID No. I
I I j I Repeal I Enlrv HC
Stored
Data
I
Sy
smex
Itnalyzlng
Reoiace Rack? NOI
He IP I
Interrupt Dispense ?
INTERR I I STAT
I I Cancel
sysmex l~eadY
Replace Rack? YESI
He IP I
Group 1
WI 2A TT
W~114 ID T3
....
: :
Rack
01-06
01-07
01·08
01-09
01-00
10 No.
123-456-78901
123-458-78902
123·456·78903
123-456-78904
000-00001
.- ..
....
1 2 3 4 5
0000-
0000-
-
--
Order remains.
OK?
I Start
I I Cancel
I
NOTE: • The samples whose analysis has been canceled have "X" displayed
in the Work Ust.
Wl 2A
bTT W oFbgl14 ~T3ID
Rack 10 No. 1 2 3 4 5' Gancel
01·06 123·456·78901 @@@@ - I "TAT
01·07 123·456·78902 @-@@ -
01·08 123·456·78903 @@- @ -
01·09 123·456·78904 0000 -
• II
•• •• •• •
10 No. I
I Enl'v HC
NOTE: • When [Start STAll 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.
Sysmex Ir'allin
g
Replace Rack? YESI
He IP I
Group 1
I Start [ I Cancel
I
( 6) Analysis is completed.
When STAT analysis is completed, analysis of the original rack continues.
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.
To cancel a STAT sample, press [Cancel STAT] key. Analysis of the original rack is
resumed.
(2) When the Mechanical Stop switch is pressed during photo detection, the
screen for confirming whether to stop photo detection comes on.
Sy l~nalYZlng H<; IP I
srnex Reolace Rack? NOI
Mechanical Slop
Stop AnalysIs?
Please walt until analysis Is completed
Yea I
s ysmex I~nalyzlng
Renlace Rack? NOI
He IP I
Mechanical Slop
Yes I No I
IAnalyzing
Sysmex IReDlace Rack? NOI
Mechanical Stop
Discard/Rinse in progress
Please walt;
(6) When an unanalyzed order remains, the screen for choosing whether to
continue analysis comes on.
Sysmex Ireedy
Replace Rack? YES I
He IP I
Group 1
~12A:'W ~W :13 ID
Rack
01·06
01-07
01-08
01-09
01-00
IDNo.
123-456-78901
123-456-78902
123·456·78903
123-456-78904
000·00001
.- ..
....
1 234 5
•••• -
0000-
0000_
-
Order remains.
OK?
I Slart
I I Cancel
I
15. SHUTDOWN
1. INTRODUCTION
With the CA-500, all samples are analyzed according to an analysis order.
Analysis information for 10 samples (1 rack filled) can be set at a time.
There are four procedures for setting sample ill Nos. and analysis parameters:
NOTE: • The CA-500 does not store analysis information. The information is
erased when power is tumed off.
2. MANUAL SETTING
Analysis setting is performed on the Root Menu screen.
ID No. 12345 7
t
-02
I
123-456-78902
•
0-0--
-03 123-458-7891>3 00-0-
-04 123-456-78904 0000-
-05 123-456-78905 0000-
Repeet
NOTE: • Press [C] with the cursor positioned at a registered sample 10 No., and
the sample 10 No. is totally erased.
2.3 Repeat
Assigns consecutive sample ill Nos. for one rack (10 samples), with the cursor positioned at the
top, and copies analysis parameter setting for all subsequent samples.
(1) Using [I] and [t] keys, specify a sample you want to repeat.
Sysmex IrReDlace
eadY
Rack? YES I
HC 1PI Start
Main Menu Group 1
~12A:r113 oFb9 11
4
~T3ID
Rack 10 No. 1 2 3 4 5
I Prey
••
02-02 123-456-78902
• ••
0-0-
02-03 123-456-78903 00-0- I Next
02-04 123-456-78904 0000-
02-05 123-456-78905 0000-
I I I I Repeat I 10 No.
Entrv
I HC
Slored
Data
I QC I Standaed
Curve
I Test
Group
I Special
Menu
NOTE: • When the cursor is on a rack which has been or being analyzed, if an
analysis parameter is already set, [Test Group] key is not displayed.
NOTE: • Using this [Test Group] function, Fbg with dilution magnification
changed can be displayed.
(1) + Fbg is a parameter that is analyzed with Fbg diluted to 1:20 (a
half of the usual concentration).
(2) - Fbg is a parameter that is analyzed with Fbg diluted to 1:5 (double
of the usual concentration).
3. MANUAL INQUIRY
When the CA-500 is bidirectionally connected with the host computer, analysis infonnation for
one rack (10 samples), based on rack Nos., can be received prior to analysis. For this purpose,
the host computer needs to be set in the conditions shown below. For detail, refer to Chapter 10.
Section 5.1: Host Computer.
Connection: Connected
Class: Class B
Inquiry: Manual
Sysmex l~eadY
Renlace Reck? YESI HC IP I Start
Main Menu Group 1
•
Rack
I ,
10 No. 1 234 5
•
02·02
02-03
02·04
123-456-76902
123-456-76903
123-456·76904
0 0-
0 0 - 0-
0000-
I Next
I I I I Repeat I 10 No.
Entrv
I HC
Stored
Data
1 QC I Standaed
Curve
I Test
Graue
I Special
Menu
Sysmex IrReDlace
eadY
Rack? NOI He IP I Start
Main Menu Group 1
~12A:r113~W~T3ID I Prey
Rack
.
10 No. 1 2 3 4 5
-- -- -- --
--
02·02 123·456·78902 Next
02·03 123·456·78903 I
02-04 123-456·78904 - - - --
02·05 123-456-78905 - - - --
Inquire In progress.
Please wait.
NOTE: • Should any error occur in reading bar code labels, sample ID No.
begins with "ERR0000000001" and increases in sequence.
Inquiry is not performed.
• Regarding the rack positions for those ID Nos. that have been
manually set, you can inquire the host computer via the manually set ID
Nos. without reading bar-codes.
• The sample registered the analysis parameters is not inquired.
1. INTRODUCTION
The CA-500 displays analysis results and information that helps interpret analysis results, and
outputs them to external devices. This chapter describes the processing of analysis results,
including display of stored data and output to external devices. The major contents are listed
below:
SEARCH
Samples that agree with specified conditions can be searched from among stored data. This
chapter describes how to search.
SELECT DISPLAY
The kinds of data to be displayed in a List can be selected from among the stored analysis data.
This chapter describes how to select the display data.
DELETION
Applicable data in stored data can be specified and deleted. This chapter describes how to delete
data.
s !readY
ysmex ReDlace Rack? VESI
He 'PI
SIDred Dala All Sea 0/142(142)
JD No.
,
123·456·78902
123-456-78902
. PT
sec
11.6
11.4
PT
0/0
88.1
88.1
APTT
sec
32.1
32.1
123-456-78902 m 11.5 88.1 32.1
123-456-78905 11.7 88.0 32.0
123-456-78906 11.6 87.9 32.2
123-456-78907 11.8 88.0 31.9
123-456-78908 11.5 87.9 32.0
- I - I I I I I Mark
Main
Graph I Prey
I Next I More I Menu
NOTE: • Using [Select Display] key and [10 NoJSeq] key, 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 that 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 comprises up to 3 pages -each carrying the results for 3
parameters in one page of laterally-arranged analysis results and sample information. Use [~]
key or [~] key to tum over pages.
Key Operation on List Display screen
[Prev] key: Rolls down one display screen (8 samples).
[1]: Moves the cursor up one sample position.
When the cursor is at the top of the screen, the List rolls down.
[,1.] key: Moves the cursor down one sample position.
When the cursor is at the bottom of the screen, the List rolls up.
[Next] key: Rolls up the List one screen (8 samples).
[~] [~]: Turns over a page (roll sideways).
[Mark] key: Attaches or deletes marking.
When you press [Mark] key on the List Display screen, a mark (II) 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.
He IP I
Sysmex I~~~c. Rack? YES!
Stored Data All Seo 21142(142)
10 No. PT PT APTI
sac % ~
123-456-78901 11.5 B8.2 32.IJ
123-456-?8902 11.8 88.1 32.1
123-156-78902 11.4 88.1 32.1
123-456-78902 m 11.5 88.1 32.1
1123-466-78905
8123-456-78900 :u ~~
H'
~
123-466-78908
- I - I I I I I Mark
s l~eadY
ysmex Reolace Rack? YESI
HG IP I
Stored Data All Seq 0/142(142)
ID No.
I
123-456-76902
123-456-76902
PT
sec
11.6
11.4
..
PT
%
88.1
86.1
APTT
sec
I
32.1
32.1
123-456-76902 m 11.5 88.1 32.1
123-456-76905 11.7 88.0 32.0
123-456-76905 11.6 87.9 32.2
123-456-76907 11.8 88.0 3ui
123-456-76906 11.5 87.9 32.0
- I - I t I I I Mark
Main
Graph I Prey
I Next I More I Menu
2) Abnormal Flag
Abnormal flags displayed on the right or left of an analysis data indicate the
following:
(1) m (on right ofID No.): A mean data
(2) ! (on right ofID No.): A data analyzed with dilution ratio changed
(3) * (on left of data): Some error or disparate in replication
A data that exceeds Fbg analysis range
(4) > (on left of data): A data that exceeds the Upper Report Limits
(5) < (on left of data): A data that exceeds the Lower Report Limit
(6) + (on right of data): A data that exceeds the Upper Mark Limits
(7) - (on right of data): A data that exceeds the Lower Mark Limits
NOTE: • "m" or n!" flag is displayed on the right of sample ID No. in the
arrangement of "m !"
• ,,*n has a higher display priority than n>n and ,,<n flags.
sysmex I ReDleoe
Ready
Rack? YESI
HC IP I
Stored Data All Saq 0/142(142)
DATE TIME SEQ ID No. RACK OUT
I .
12/31 12:57 2 123-456-78002 0102 HP
12/31 12:58 3 123-451>-78902 0103 HP
12/31 12:59 4 123-456-78902 0104 HP
12/31 12:56 5 123-458-78905 0105 HP
12/31 12:57 6 123-456-78906 0106 HP
12/31 12:58 7 123-456-78007 0107 HP
12/31 12:59 8 123-458-78906 0108 HP
- I - I I I I I Mark
2) TIME
The time the analysis result was obtained.
3) SEQ
A sequential sample number counted from power tum-on.
4) ID No.
A sample No. entered by operator, transmitted from host computer, and read by bar
code scanner.
5) RACK
The rack number and tube position number are displayed as follows:
6) OUT
Data output flag:
H: When output to the host computer, the display disappears.
P: When output to the built-in printer, the display disappears.
(9)
(8)
(10)
==t~~§~~~~~~~d (16)
Change Return
Scale
(2) In No.
Sample ID No. entered by operator, transmitted from host computer, and read by bar code
scanner
(9) dB
Increase of scattered light intensity in reaction process
(10) CB No.
Detection channel in which analysis was conducted
(16) bH
Scattered light intensity at the start of analysis
NOTE: • CoagUlation curve is not displayed when some error occurred during
analysis and no analysis data was obtained. For a mean data of
replication either, that curve is not displayed.
(1) Press [Info.] key on the Graphic Display screen to display the Error Detail
window.
S IRead Y
ysmex Replace Rack? YESI
HC IP I
Slored Dala 0/142(142)
10 No. 123-4513-78901 33.0·C
01..Ql 1998112/31 17:28
<PT :100.0%> • 23.4 sec(50)
Temp Error
~ BO
I Return
3. 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
s IFeady
ysmex RaDlaca Rack? YESI
HC IPI
Stored Data All Saq 0/142(142)
10 Nc. PT PT APTT
.ac % .ac
••
123·456·76902 11.6 "
68.1 32.1
123·456·76902 11.4 88.1 32.1
123·456·76902 m 11.5 88.1 32.1
123·456·76905 11.7 88.0 32.0
123·456·78908 11.6 67.9 32.2
123·456·76907 11.6 88.0 ~~.9
123·456·76906 11.5 67.9 2.0
Top I
6ottom I Search I Seq I S~~~~~
Dis la
I
De eta I 10Edit
No. I 0 utput I AIIClear
Markad I Return
s Ir
eady
ysmex Reolaee Rack? YESI
HC IPI
....
Stored Data All Seq 0/142(142)
10 No. PT
sec ~} APTT
sec
•
123-456-76902 11.6 66.1 32.1
•
123-456-78902 11.4 88.1 32.1
123-456-78902 m 11.5 88.1 32.1
123-456·78905 11.7 88.0 32.0
123-456-78906 11.6 87;9 32.2
123-456-78907 11.8 66.0 31.9
123-456·78908 11.5 67.9 32.0
- I - I t I j I
Search
10 No.
I Search
Date
I I Return
ID No.
''M4. a.·
(5) The List is displayed in which analysis data of the sample ID No. entered
is listed at the head.
When analysis data of the specified ill No. is found, the List will indicate the analysis data
at the head of the screen. The cursor is on the analysis data corresponding to the ill No.
When analysis data corresponding to an entered ill No. is not found, the message shown
below will appear on the screen.
Press [Conf.] key to return to the Search by ill No. screen.
Sy I
Ready
smex RaDlaea Raek? YES I
HC IP I
Stored Data - Search by ID No.
Not found
I Cent.
YY/MMIDD
' . . . .@
Not found
I Conf.
s ysmex l~eadY
Renlece Rack? YESI
He 1PI
Stored Data All 10 No. 0/142(142)
10 No. PT PT APTT
sec % sec
123·456·78902
• 11.6 88.1 32.1
123·456·78902 11.4 88.1 32.1
123·456·78902 m 11.5 88.1 32.1
123·456·78905 11.7 88.0 32.0
123·456·78906 11.6 87.9 32.2
123·456·78907 11.8 88.0 31.9
123·456· 78908 11.5 87.9 32.0
Top I BOUom I Search I Seq I S~~~i~
Dis la
Delete I Edit
10 No.
I Output I k1i't~:adr I Return
[ill No.] key: The analysis data are listed as rearranged in the sample ill No. sequence.
[Seq] key: The analysis data are listed as rearranged in the chronological analysis
sequence.
5. SELECT DISPLAY
With this program, the type of data to be list-displayed can be selected from all stored data.
(3) Press [Select Display] key on the Stored Data List Display screen.
The Local Menu for selecting a display will appear.
lfead
Y
S ysmex ReDlaee Rack? YESI
HC IPI
Stored Data All Seq 0/142(142)
ID No. PT PT APTT
sec % sec
•
123-456-78902 11.8
•
66.1
•
32.1
123·456-78902 11.4 88.1 32.1
123-456-78902 m 11.5 88.1 32.1
123·456·78905 11.7 88.0 32.0
123-456-78906 11.6 87.9 32.2
123-456-78907
123·456·78908
11.8
11 5 :~.g 31.9
32.0
- I - I t I I I
All
I Mean I Not
Outout
I I Cancel
123·456·78902
123-456·78902
•
PT
sec
11.6
11.4
..
PT
%
88.1
88.1
APTT
sec
32.1
32.1
123·456·78902 m 11.5 88.1 32.1
123·456·78905 11.7 88.0 32.0
123·456-78906 11.6 87.9 32.2
123·458·78907 11.8 88.0 31.9
123·456·78908 11.5 87.9 32.0
Top I Bottom t Search I Seq I .!'~~~~~
Dis la
Delala I Edit
10 No.
I output I AIIClear
Marked I Return
No Data
I ConI.
Press [Conf.] key to return to the Stored Data List Display screen.
(3) Press [Select Display] key on the Stored Data List Display screen.
The Local Menu for selecting a display will appear.
Top
..I
123-456-78908
123-456-78907
Bottom
m
m
I
11.6
11.8
Search I
87.9
88.0
I
Seq I
32.2
31.9
•
Select
OisDlev
Delete I Edit
10 No.
I output I Marked
AIiClear I Return
(3) Press [Select Display] key on the Stored Data List Display screen.
The Local Menu for selecting a display will appear.
I Return
(5) Select Not Output data to be displayed on the Not Output Data Selection
screen.
Press the desired Not Output Data key and display "V."
To cancel the selection, press [Return] key. The screen will return to the Stored Data List
Display.
"V u appears and disappears alternately each time c::::::::J 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 from ill No. sequence and analysis
sequence.
He Not Output: Stored analysis data that have not yet output to the host computer are
displayed in the sequence chosen from ill No. sequence and analysis
sequence.
s IFeady
ysmex Rentace Rack? YESI
He 'PI
Stored Data All Seq 0/142(142)
10 No. PT PT APTT
, eec % 'ec
I : I
123-456-78902 11.6 88.1 32.1
123-456-78902 11.4 88.1 32.1
123·456·78902 Ii< 23.6;. *100.0+ *48.0+
123·456~78905 11.7 88.0 32.0
123-458-78906 11.8 87.9 32.2
123~466-78907 11.8 88.0 31.9
123-456-78908 '1 • "7." 32. n
- I - I t I I I Mark
Main
Graph I Prey
I Next I More
I Menu
NOTE: • When an output was performed with the display condition "Not output
data" was 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, once 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.
6. EXTERNAL OUTPUT
With this program, you can output specified data to the built-in printer or the host computer.
The data to be output to an external device can be specified via Local Menu of Current Data,
Marked Data, and All Data.
(3) Press [Output] key on the Stored Data List Display screen.
The Local Menu for external output will appear.
Sysmex WeadY
Reo-lace Rack? YES!
HC IPI
liP Graph
liP List
I Host computer
I Return
S ysmex I~dy
Renlaee Raek? YES I
HG IP I
Output In progress
I Cancel
(3) 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 the marks completely.
(5) Press [Output] key on the Stored Data List Display screen.
The Local Menu for external output will appear.
(6) Press [Marked] key on the Local Menu to display the Select Device screen.
(3) Press [Output] key on the Stored Data List Display screen.
The Local Menu for external output will appear.
7. EDIT ID NO.
With this program, ill No. of cursor-specified analysis data can be changed.
(4) Press [Edit ID No.] key on the Stored Data List Display screen.
The Edit ill No. screen will display Dateffime, Rack position, and sample ill No.
Ready He IP
S ysmex Re lace Rack? YESI
Slored Dala - Edit 10 No.
Dala/Tlma
02/28 20: 28
Rack
34-01
Current ID No.
000000000000035
New 10 No.
000000000000035
(6) Press [Enter] key or [Quit] key on the ID No. numeric keys.
[Enter] key: Changes sample ill No. and returns you to the Stored Data List Display
screen.
[Quit] key: Cancels editing sample ill No. and returns you to the Stored Data List Display
screen.
8. DELETION
With this program, Stored Data can be deleted.
Data applicable for deletion can be specified on the Local Menu each for Current Data, Marked
Data, and All Data.
S ysmex IRenlace
Ready
Rack? YESI
He IPI
Stored Data All Seq 0/142(142)
10 No.
123·456·78902
123·456·78902
•
PT
sec
11.6
11.4
..
~Z
.,
88.1
88.1
APTT
sec
•
32.1
32.1
123·456·78902 m 11.5 88.1 32.1
123·456·78905 11.7 88.0 32.0
123·456·78906 11.6 87.9 32.2
123·456·78907 11.8 88.0 31.9
e
123·456·78908 11.5 87.9 32.0
- I - I I I I I
Current I Marked I All
I I Cancel
s IReady
ysmex Renlece Rack? YES I
HC IP I
Stored Data
Set I I Cancel
(3) Press [Mark] key on the Stored Data List Display screen and make a mark.
When [Mark] key is pressed, the analysis data in the current cursor position will be marked
<-). If the mark is already there, it will disappear.
Press [Marked All Clear] to remove the entire mark.
(5) Press [Delete] key on the Stored Data List Display screen.
The Local Menu for deletion will appear.
S ysmex IRaDlaca
Ready
Rack? YES I
He IP I
Storad Data
Sat I I Cancel
(7) Press [Set] key or [Cancel] key on the Deletion Confirmation screen.
[Set] key: Deletes marked analysis data.
[Cancel] key: Cancels deletion and returns you to the Local Menu for deletion.
(3) Press [Delete] key on the Stored Data List Display screen.
The Local Menu for deletion will appear.
IReady
Sysmex RaDlaca Rack? YESI
He IP I
Slored Dala
Sal I I Cancel
(5) Press [Set] key or [Cancel] key on the Deletion Confirmation screen.
[Set] key: Deletes all analysis data.
[Quit] key: Cancels deletion and returns you to the Local Menu for deletion.
1. INTRODUCTION
To ensure the instrument will serve you in the optimal operating condition, it requires periodic
maintenance. Follow the maintenance schedule as described below and keep the result in the
Maintenance Checklist.
• DAILY MAINTENANCE
Clean Sample Probe
Discard Used Reaction Tubes
Dispose of Waste
Remove Dew from Reagent Rack (CA-530 and CA-540 Only)
• YEARLY MAINTENANCE
Replace Rinse Filter
• AS NEEDED MAINTENANCE
Supply Printer Paper
Replace Fuse
Check and Drain Trap Chamber
Prime Rinse Solution to Hydraulic line
Clean Instrument
This chapter describes supplies replacement in addition to those inspection items mentioned
above:
• SUPPLIES REPLACEMENT
Replenish Reagent
Replenish Reaction tubes
Replenish Rinse Solution
Carefully read the following WARNINGS and CAUTIONS before conducting maintenance of
the instrument and replacing supplies, to ensure safe operation.
l' WARNING • Be
LD
sure to wear rubber gloves before starting maintenance. After the
maintenance is completed, wash hands with antiseptic solution. If
hands should be contaminated by blood or something, there is a
hazard of infection by pathogenic bacteria.
Discard used
=
til
=
~
Q
reaction tubes ~ ~
> §
Dispose of waste
"""
Z ~
Remove dew from 1-3 ~
l."!:l
reagent holder'
Z ~
Initial >
Z
S;
~
~ i:I:l
• CA-530 and CA-540 only et:l
l."!:l
SUPPLIES REPLACEMENT ~ ~
== Q
Maintenance Item Date!lnltlal Date/lnRlal l."!:l
~
DatallnRial Date/Initial Datellnltlal Date/lnRlal Dalallnitial
Replenish reagent ~
~
Replenish reaction tubes ~ "':3
AS NEEDED MAINTENANCE
Maintenance Item Date/Initial Datellnltial DatallnRlal Date/Initial DatallnRlal Datellniliel Datellnltlal
Supply printer paper
Replace fuse
Check and drain trap chamber
Prime rinse solution to hydraulic line
Clean Instrument
MAINTENANCE AND SUPPLIES REPLACEMENT
3. DAILY MAINTENANCE
3.1 Clean Sample Probe
Clean the sample probe by the following procedure:
(1) Press [Special Menu] key on the Root Menu screen.
The contents of the Root Menu will change over.
(2) Press [Rinse Probe] key on the Root Menu screen.
The Rinse Probe screen will display "OK to rinse Probe?"
Ready He IP
Sysmex Ra lace Rack? YES I
Rinse Probe
OK to rinse Probe ?
Sat I , Cancel
sysmex !ready
Reolaee Rack? YES I
He IPI
Rinse Probe
I Cancel
~
Reaction Tube Trash Drawer
Float Switch
• When the bottle becomes full of waste, the alarm will sound and the
& CAUTION confirmation screen will appear. Press [Cont] 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 is over, 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.
CAUTION: • When analysis is made with the waste bottle laid down, waste may
flow back into the vacuum pump, causing the pump to fail.
Make sure the waste bottle is standing upright.
3.4 Remove Dew from Reagent Rack (CA-530 and CA-540 Only)
After completion of the day's analyses or once in 24-hour continuous operation, check to see
that dew has not formed on the reagent rack. Remove any if found.
4. YEARLY MAINTENANCE
4.1 Replace Rinse Filter
Rinse Filter is placed in the tubing between the Rinse Bottle and the instrument rear panel nipple.
Replace the rinse fIlter once every year, as follows.
(1) Turn OFF the instrument power.
If you failed to turn OFF the instrument power, the rinse fluid may splash when you
opened the Rinse Bottle lid.
(2) Turn the lid of the Rinse Bottle counterclockwise.
Then, open the lid to release the pressure accumulated in the Rinse Bottle.
(3) Remove the Rinse Filter.
Disconnect the tubings from the Rinse Filter.
NOTE: • Prepare a damp towel or a tissue paper to receive the rinse fluid
dropping from the tubings.
5. AS NEEDED MAINTENANCE
5.1 Supply Printer Paper
When the built-in printer has run out of paper, replenish printer paper by the following
procedure:
(1) Remove the printer cover.
The printer cover can be removed by raising its lower edge.
L IU
I~
I Ready
I Replace Rack? YESt
He; IP I
Sysmex
I Error List
I Temperature
I P. FEED
MaIn
I Menu
&WARNING • When fuses are blown, be sure to turn off the power supply and
disconnect the power cord before replacing the fuses. This is to
avoid the risk of electrical shock.
(1) Tum off the power supply and disconnect the power cord.
& CAUTION • Use fuses of the specified type and current rating. This is to avoid
the risk of smoke emitting.
&WARNING • In draining the trap chamber, always wear rubber gloves. Upon
completion of operation, wash hands with antiseptic solution.
If hands are contaminated with blood or something, there is a hazard
of infection by pathogenic bacteria.
( )
o 0
o
o 0 I V Trap Chamber
e~Loosen
Float must be inside. 7~
Sysmex l~eadY HC IP I
Renlece Rack? YES!
Special Operation
I System Tesls
I
I Cycle Counter I
Main
I Menu
(3) Press [Rinse & Prepare] key on the Special Operation Menu screen.
The Supply Liquid Confrrmation screen will display the message "Water Supply?"
s Ir
eedY
ysmex Renlace RaCk? YES!
Supply Liquid
HC IPI
Waler supply ?
Sel I I Cancel
(4) Press [Set] key or [Cancel] key on the Supply Liquid Confirmation screen.
[Set] key: Executes water supply.
[Cancel]: Cancels water supply and returns the screen to the Special Operate
Menu.
NOTE: • Refilling the hydraulic line with rinse solution takes roughly 35 sec.
S ysmex weedY
Renlace Rack? YES!
He (PI
Supply Liquid
I Cancel
&WARNING • Before cleaning the instrument, be sure to tum 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 rubber gloves. Upon
completion of cleaning, wash hands with antiseptic solution. If hands
should be contaminated with blood or something, there is a hazard of
infection by pathogenic bacteria.
CAUTION: • Never use any other cleaning solution than water and neutral detergent.
Otherwise, the surface coating may be damaged.
6. SUPPLIES REPLACEMENT
6.1 Replenish Reagent
When reagent has become insufficient, the error message "Insufficient Reagent (l - 12)" will
appear, and the alarm will sound. Replenish the reagent of the displayed No. (1 - 12).
IINTERR·I I Cancel I
NOTE: • The parameters for those dispensed samples that have not been
dispensed with reagent will be marked with "X" in Work List.
• When you press neither [INTERR.] key nor [Cancel] key, [Cancel] key
will be executed some time later.
~12~113 ~W : T3
ID
Rack IDNo. 1 2 3 4 5
01·06 123·456·78901 x ••• -
01-07 123·456-78902 x- •• -
01·08 123-456-78903 x ••• -
01-09 123·456·78904 0000-
01·00 000-00001 0000-
Order remains.
OK?
I Slarl
I I Cancel
I
CAUTION: • The parameters marked with "X· in Work List must be reanalyzed.
I Continua I Rrst
Tuba
When the reagent volume monitoring is set Valid, the remaining volume is calculated in Work
List. When the reagent volume estimate value is "0" or less, the message "Check Reagent
Volume" will appear.
Sysmex IrRack
eadY
not replaceable
HC IP I
Group 1
I Start
I I Cancel
I
Figure 5-6-5: Reagent Volume Check Screen
CAUTION: • The parameters marked with ·X· in Work Ust must be reanalyzed.
NOTE: • When analysis begins by pressing [Start] key, the reagent volume
monitoring function does not work.
• For setting the reagent volume monitoring, refer to Chapter 10, Section
4.3.
IWaltlng
Sysmex IReplace Rack? NOI
No Reaction Tubes
Pleass wall until the stetIJs becomes Ready.
Set Reaction Tubes
after the SlallJs beoomes Ready.
I ConI. I
!ready He IP I
Sysmex Replace Rack? YES!
Group 1
~12':TTI13 :a11 4 : T3 ID
Rack
01·06
01·07
01-08
01·09
10 No.
123·456·78901
123-456·78902
123·458·78903
123·456·78904
....
.- ..
....
1 2 3 4 5
0000-
-
--
01-00 000-00001 0000-
Order remains.
OK?
I Start
I I Cancel
I
Figure 5-6-7: Analysis Start Confirmation Screen
~Reaction Tube
I-
Reaction Tube Rack
(7) Press [Start] key or [Cancel] key on the Analysis Start Confirmation
screen.
[Start] key: Starts analysis after interruption.
[Cancel] key: Interrupts analysis and returns to the Root Menu screen.
CAUTION: • The parameters marked with "X" on Work List must be reanalyzed.
I Gonf. [
~12A:TTI13 ~W ;T3 I D
Rack
01-06
01-07
01·0B
01-09
IDNo.
123-456-78901
123·456·78902
123-456-78903
123-456-78904
....
.- .. -
....
1 234 5
0000-
-
-
01-00 000-00001 0000-
Order remains.
OK?
I Start
I I Gancel
I
& CAUTION • Do not open the cap of the rinse bottle or waste bottle until the Root
Menu screen or Analysis Start Confirmation screen is displayed.
J.:\ • When analysis is made with the rinse bottle laid down, there is a
illCAUTION possibility that correct analysis result may not be obtained. Make
sure the rinse bottle is standing upright.
J.:\ • Do not touch the float switch and the inside of the cap. If dust or dirt
illCAUTION sticks to the cap inside, the bottle inside may be contaminated,
possibly leading to incorrect result. If fingers happen to touch the cap
inside, wash it with rinse solution before attaching.
• In removing the tube from the instrument, tum the cap leftward to
release the accumulated internal pressure beforehand. Otherwise,
rinse solution will spill over.
424-1251-0
Sample Cup Conical 2 mL
F.\ • CA CLEAN I is a alkaline solution. Avoid contact with it. If you get it
ill WARNING on your skin or clothing immediately wash it off with excess water.
1. INTRODUCTION
Quality control is to check daily that correct analysis results are being obtained all the time.
Specifically, quality control of analysis data aims at correctness (correct values) and precision
(repeated analyses producing an identical value, namely, reproducibility).
L-J control: Uses data of a single analysis on a QC sample. The L-J control is
susceptible to effects of reproducibility so that its control range is wider
than )( control.
2. DISPLAY QC CHARTS
QC data is displayed in the Quality Control screen which is the initial screen of QC Program.
When you press [QC] key on the Root Menu screen, the Quality Control screen will appear.
Ready HC IP
S ysmex Rs lace Rack? YESI
Quality Control Lot. No TR-453
File No. PT QCOI EXP. 1998/10/31
Mean 100.0% Cursor
SO 3.3% 100.0%
CV 3.3% 1995/5/21
N 50 15:09
Stop-UL 110
Flag-UL 107
100
Flag-LL 93
Stop·LL 90
Delete Main
Menu
The QC Chart shows the latest 60-point data. By pressing [Change Scale] key, you can select the
latest 60-point data or the stored 180-point data.
([Change Scale] key will appear only when there is data in a me.)
~~~ce
HC IP
Sysmex Rack? YES!
Quality Control Lot No
Flte No. PT QCO 1 r-,=,EX",-P-;.'=:-"""""''-'1
Mean 100.0% Cursor
SO 3.3% 100.0%
CV 3.3% 1996/5/21
N 180 15:09
Slop-UL 110
F1ag·UL 107
100
F1ag-LL 93
Slop-LL 90
Delete Main
Menu
3. SELECT QC CHART
The CA-500 stores 12 different QC Files for each parameter.
To delete, set, or print a QC File, the QC Chart of the desired QC File has to be displayed.
NT Cancel
S ysmex Weedy
ReDlace Rack? YES I
HC IP I
Quality Conlrol
File NO.PT QCOl
I
QCOl
5/21 I I QC02
5/21 I I QC03
5121 I
I QC04
5121 I I
QC05
5121 I I QC06
5121 I
I QC07
I I QC08
I I QC09
I
I QC010
I I QC11
I I QC12
I
I Cancel
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.
4. DELETE QC FILE
To start Quality Control anew, the existing data in the QC Files has to be deleted. Specifically, to
change the type or lot of control plasma, it is necessary to delete the existing data in the f:tles.
This program allows deleting the data in X and L-J control f:tles (QCDl - QCl2).
NOTE: • [Delete] key is not displayed when the file has no data.
Yea Cancel
W eadY
S ysmex Reolace Rack? YES!
HC IP I
Quelity Control
Set I I Cancel
5. SETTING
To execute the QC Program, it is necessary to set replication, control parameters, control limits,
Lot No., and expiry date.
(1) Display the QC Chart of the desired file to be set on the Quality Control screen.
For how to display QC Chart, refer to Section 3: SELECT QC CHART in this chapter.
s ysmex l~eadY
Renlace Rack? YESI
HG IP I
QG - Settings
File No. PT QG01
~T%
Replicates
Parameter
Llml1 15.0%
Uppar Stop 13.0<1/0
Upper Flag 11.0%
Target 9.0%
Lower Flag 8.0%
Lower Slop TPG-747
Lot No. 1998/10/31
EXP.
t I I I Auto
Calc. I Next
Opllon
I Return
NOTE: • As control parameters, you can select the analysis parameters set in
Test Name and Standard Curve Parameter setting.
• When changing control parameters, delete all control data of a QC File
to be changed.
Ready HC IP
S ysmex Re lace Reck? YESI
ac - Settings
File No. PT aCOl
Replicates 1
Parameter PT%
Limit
Upper Stop Ya
Upper Flag 13.0%
Target 11.0%
Lower Flag 9.0%
lower Stop 8.0%
Lot No. TPC-747
EXP. 1998/10/31
s Ir
eadY
ysmex Reolaae Raak? YESI
HC IP I
QC - Settings
File No. PT QC01
Repllaates 1
Parameter PT-aat
Limit
Upper Stop
Upper Flag 13.0%
~
Target 11.0%
Lower Flag 9.0 0jg
Lower Stop 8.0%
Lot No. TPC-747
EXP. 1998/10/31
I I I I Auto
Cala.
I Next
Ootlon I Return
Not aarrect IImli value.
NOTE: • Press [Auto Calc.] key, and the limit values will be automatically
calculated from QC data stored in the file, as in the following.
Target: Mean of control data
Upper Rag: Mean of control data + 2SD of control data
Lower Rag: Mean of control data - 2SD of control data
Upper Stop: Mean of control data + 3SD of control data
Lower Stop: Mean of control data + 3SD of control data
Ready HC IP
S ysmex Re lace Rack? YES!
QC - Settings
File No. PT QC01
Ready HCIP
Sysmex Re lace Rack? YESI
QC - Settings
File No. PT QC01
Replicates 1
Parameter
Limit
Upper Slop 15.0%
Upper Flag 13.0%
Target 11.0%
Lower Flag 9.0%
Lower Stop 8.0%
Lot No. TPC-747
EXP.
NOTE: • When the entered date is in a wrong format, the expiry date will not be
corrected by pressing [Enter]. Since the cursor either does not move,
operate all over again and enter 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] is pressed.
(13) Press [Return] key on the Quality Control Setting screen. The Renew
Confirmation screen will appear.
sysmex I~eady
Renlace Rack? YESI
HC IP I
QC - Setting
RENEW SETTING ?
Cancel I I FIX
I I Continue
6. DELETE QC DATA
When this process is selected, two cursors will be displayed, and the data between those cursors
can be deleted from the QC Chart.
(1) Display the QC Chart from which you want to delete QC data.
For how to display the QC Chart, refer to Section 3: SELECT QC CHART in this chapter.
Ready HC IP
S ysmex Re lace Rack? YESI
Quality Control Lol No TR·463
File No. PT QC01 EXP. 1998/10/31
Mean 100.0% Cursor
SD 3.3% 100.0%
CV 3.3% 1996/5/21
N 50 15:09
Stop-UL 110
Fleg-UL 107
100
93
90
Yes Cancel
Yes Cancel
(4) Using [~] and [~] on the Local Menu, move the cursors and set the data
range to be deleted.
Each time [Change Cursor] is pressed, the range-setting cursor can be selected.
The cursor position data area displays the data for the range-setting cursor.
Yes Cancel
Ir eadY
S ysmex Reolaoe Raok? YESI
HC IP I
Quality Control
Enter
I I Canoel
7. PRINTOUT
The QC data can be printed by the built-in printer by the following procedure:
NOTE: • The number of data that can be printed is all data of 180 or 60 points
selected by [Change Scale] key.
s l~aadY
ysmex Ranlaea Rack? YESI
HC IP I
Quality Control
Output In progress
I Cancel
Typical printout
________ Printout Date and Hour
C CHART
Parameter_____ 1'39~/05-'24 18:30 FileName
-----PT
Exp.Da1:e
GlCOI
Lo1:. No COL19'3 23 1-1
/09/15
30 amp 1 e =====---------
Lot No.
l§f7/04/25 14: 13
S+" -UL
~ Expiration
~
OF -LL
Number of Samples
~
I
~
i'
1: p- L
/ / ,
Si:op-UL Date and Hour of Latest Data
Me~§
S1:0P-M·~
li2:
..2~sec
ssc
~
Flas-
TARI3
!1 .2ssc
.osee
Flae-LL
S1:op-LL !O.
1 • 8sSC
sse
1. INTRODUCTION
In the human body, it is of great importance for the blood to clot where necessary within
required time.
In coagulation test, whether coagulation percent activity is normal or not is calculated by
comparing with normal pooled plasma taken as an index of 100%. The usual practice of
calculating coagulation activity is to compare subject's percent activity with a standard curve -
plotted using normal human plasma. Typical instances are PT normal time for calculating PT
ratio and lSI values for calculating PT-INR. Thus it is necessary to prepare a correct standard
curve. This chapter describes how to plot a standard curve.
s ysmex l~eadY
RaDlaea Rack? YES I
HC IP I
Standard Curve PT
Pro Cal Data 1997/05/10
% sac Lot No. EXP.
100.0 11.4 PT Ape.63 1997/5110
50.0 17.4
25.5 27.9
12.5 52.6 Raf. 123456789012 1997/5/10
6.5 0.0
3.1 0.0
Normal 11.4
lSI 1.73
NaxlPaae I I
Standard
Analvsls
I
Manual
Entrv
I Seleel
Paramo
Select
Test
I Graph I Print I Lot N°'1
Enlrv Return
NOTE: • [Next Page] key is displayed when dFbg is set by [Select Param.] key
of standard curve for PT parameter.
(2) Press [Select Test] key on the Standard Cnrve Data screen.
s ysmex IrRenlaee
eadY
Aaek? YESI
HC IP I
Standard Curve PT
PToo Cal Date 1997/05/10
% sec Lot No. EXP.
100.0 11.4 PT Ape.63 1997/5/tO
50.0 17.4
25.5 27.9
12.5 52.6 Ref. 123456789012 1997/5/10
6.5 0.0
3.1 0.0
Normal 11.4
lSI 1.73
PT IAPTT IFb9 IAT3 I
I I I Cancel
S IReady
ysmex IReD lac. Rack? YESI
Standard Curve PT
Log P
Expression Log P=a*Log T+b
Correlation r ~-O.999
rate a ~-B.663a+OO
I Return
offset b ~ 1.993a+02
(2) Display the standard curve data of a parameter you want to set.
For detail information, refer to Section 2: DISPLAY STANDARD CURVE in this chapter.
(3) Press [Standard Analysis] key on the Standard Curve Data screen.
S Ready He IP 51 a r1
ysmex Re lace Rack? YESI
Standard Curve PT
1 PT% Re lie.
100.0%
50.01)/0 3
Dilution 25.0% 3
Series 12.5% 3
~.~~ g
0.0 mg/dL
(4) Press [Select Dil. Set] key and select a series of dilution desired.
The dilution ratios are listed below.
(5) Enter activity or concentration for 111. After entry, other 5-point activity
or concentration is automatically calculated.
(6) Enter replicates at each dilution point using the numeric keys.
Replicates can be set 0 - 3.
The cursor can be moved by pressing [i] and [J,].
(7) Press [Start] key at the right upper corner of the screen.
While analysis is going on, the message "STD Analyzing Please wait." is displayed.
IReady
Sysmex IRenlace HC IP I
Rack? YESI
Standard Curve PT
Renllcales
11.4 sec 3
17.4 sec 3
27.9 sec 3
52.6 sec 3
~.~ ~~~ ~
Normal 11.5 sec
lSI 0.00
SID Analyzing
Please wall.
NOTE: • Two or more points are required to start Standard Curve 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.
sysmex IrRenlace
eady
Rack? YES I
HC IP I
Standard Curve PT
PT% Re lIeBtes
1 UU.U"ro 11.4 sec 3
50.0°/(1 17.4 sec 3
25.0% 27.9 sec 3
12.5% 52.6 sec 3
6.;3'~/" ~.~ ~~~ ~
Normal 11.5 SO"
lSI 0.00
I Graph
QulI I I set I
Press [Graph] key to confIrm the new Standard Curve 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. Press it again to erase the current graph.
Ready HC IP
Sysmex R lace Rack? YESI
Standard Curve PT
d = 0.0
Log T
Log P
Expression Log P=a*Log T+b Log P
Correlation r =-0.999
rate a =-9.663e+00 Return
offset b = 1.993e+02
NOTE: • The difference in coagulation time between new and current Standard
Curves in 100"10 activity (Fbg concentration 200 mg/dL) is displayed
as disparate width d.
Ready HG IP
S ysmex Re lace Rack? YESI
Standard Curve PT
PT%
100.0% 11.4 see
50.0% 17.4 sec
25.0% 27.9 sec
12.5% 52.6 sec
6.3% 0.0 sec
o
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.
[Set] key: Sets the entered data as Standard Curve data and returns to the Standard
Curve screen.
[Quit] key: Discards the entered data and returns to the Standard Curve screen.
sysmex l~eadY
ReDlaea Rack? YES I
He IP I
Standard Curve PT
PT% Re lie.
00.U70 11.4 saC 3
50.0% 17.4 Sac 3
25.0% 27.9 sec 3
12.5% 52.6 sec 3
~.~~ ~.~ ~~? 0
n
Nomal 11.5 sec
151 0.00
Next
I I Graph
Quit I I Set
I I Continue
NOTE: • Standard Curve data require 2 or more points. When renewal is made
at less than 2 points, the message ·Set more than two points" will
appear. In this case, set the Standard Curve properly.
Press [Graph] key to confIrm the new Standard Curve (solid line with square plots).
For detail, refer to Section 3.1: Standard Curve Analysis in this chapter.
NOTE: • Regarding reagent selection keys in the lower part of the screen, the
number of the reagents set by [Settings] ~ [Analysis Settings] ~
[Test Protocol] is displayed.
Sysmax ~:a~ce
HC [P
Rack? YESI
Standard Curve PT
~:a~lce
HC IP
Sysmex Rack? YESl
Standard Curve PT
ili,iln.leO.i"
NOTE: • Enter the expiry date in the format set in System Setting - Date format;
include nf' between numerals.
• When [Enter] key is pressed, the Lot No. Entry screen will retum.
(7) When settings are changed, the Renew Confirmation screen appears.
When no changes made in settings. the Standard Curve Data screen returns.
sysmex IFeady
Renlace Rack? YESI
HC IP I
RENEW SETTING ?
Cancel I I FIX
I I Continue
(1) Press [Select Param.] key on the Standard Curve Data screen.
The contents of the settings will appear.
s l~eadY
ysmex ReDlace Rack? YES!
HC IP I
Standard Curve PT
Number
Calc Item Units Format C. Method
V 11 I PT% I % I x x x. x ILog Curre
V
12 1 PT·R
1
- 1 xx.xx I
V
13 1
PT·INR
I - I xx.xx I
V
14 1 DFbg
1
mg/dl I xxx.x I
sysmex l~eadY
Renlace Rack? YES I
HC IP I
Standard Curve PT
[CHG.] key: Each time this key is pressed, characters change in the order of capital
alphabet --? small alphabet --? numeric keys.
[BS] key: Deletes one character to the left of the cursor.
(4 ) Select units.
Each time [Units] key is pressed, units change over. Each time the unit is selected,
"Number Format" is displayed.
sysmex l~eadY
Renlace Rack? YES I
He IP I
Standard Curve PT
Units
-
-
%
mg/dL
giL
UlmL
2) Press [Add] key to enter a unit from the character key screen.
[CRG.] key: Each time this key is pressed, characters change in the order of capital
alphabet -t small alphabet -t numeric keys.
[BS] key: Deletes all data.
sysmex IrRenlace
eadY
Rack? YES I
He IP I
RENEW SETTING ?
Cancel I I FIX
I I Continue
s ysmex IrReolace
eadY
Rack? YES I
HC IP I
RENEW SETTING ?
Cancel I I FIX
I I Continue
If CAUTION • If unit (decimal point position) and calculation method are changed
LD after the plotting of a Standard Curve, data coordination will become
impossible. When a unit is changed, always set a new Standard
Curve, Mark Limits Settings, Fbg Analysis Range Settings and Report
Limits Settings.
s l~eadY
ysmex Renlace Reck? YES I
HC IP I
Slanderd Curve
Output In progress
I Cancel
1997/05/24
STANDARD
PT 1997 ....05/24
PT
2000/00'-00
PT~
100·8r. 12.1sec:
50. r. 15.~sec:
25. Or. 23. see:
0.0r. O.Osee:
0.0r. O. Osee:'
0.0r. O.Osee:
NORMAL 12.1sec:
151 1. 10
LosCurve
~
Figure 7-6-2: Example of Printout
1. INTRODUCTION
This chapter describes the error messages displayed with the CA-500, 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 Sysmex service representative for assistance.
The major contents of this chapter are:
Sysmex Menu
This section describes Sysmex Menu at the upper left corner of the Root 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.
[Q]
QC Data Error 8-15
QC Limit Error 8-17
QC Limit Error (STOP) 8-17
[R]
Replace SaInpleRack 8-12
Replace SaInple Rack Drawer 8-13
Replace STAT saInple 8-12
Replenish Rinse Reagent 8-8
Reset SaInple Rack 8-12
[S]
Sampling Error (Position) 8-10
Set more than two points , 8-17
Set Sample Rack 8-13
Standard Curve Error 8-17
Stored Data Error 8-15
Syringe Error 8-11
[T]
Temp. Error (High)/Cooler 8-7
Temp. Error (Low)/Cooler 8-7
Temp. Error (High)!Detector 8-7
Temp. Error (Low)!Detector 8-7
Temp. Error (High)/Incubator 8-7
Temp. Error (Low)/Incubator. 8-7
Temp. Error (High)/Room 8-7
Temp. Error (Low)/Room 8-7
Temp. Sensor Error /Cooler 8-7
Temp. Sensor Error !Detector. :. : 8-7
Temp. Sensor Error /Incubator 8-7
Temp. Sensor Error /Room 8-7
Tube Catch Error (Position) 8-9
Tube Release Error (Position) 8-9
Turned Off During Operation 8-18
[V]
Vacuum Pump Error '.'.' ".'.' 8-7
Voltage Low Limit. '" 8-19
[W]
Waste Bottle is full 8-8
[X]
X Axis Home Position Error. , 8-8
[Y]
Y Axis Home Position Error 8-8
[Z]
Z Axis Home Position Error 8-9
Z Axis Down Error 8-9
7. Analysis Errors
8. Memory Errors
No Paper 8-15
Printer Error 8-15
HC OffLine 8-16
HC Communication Error 8-16
HC CTS Time Out 8-16
HC ACK Code Error 8-16
HC Transmission Count Error 8-16
HC Reception Count Error 8-16
HC ACK Time Out. 8-16
HC STX Time Out 8-16
HC ETX Time Out 8-16
Instructions Not Found In HC 8-17
When the instrument developed an error (any of those mentioned above), an error message
appears in the left lower comer of the LCD screen, and [Sysmex] key changes to [ALARM
RESET] key.
(1) Press [ALARM RESET] key to stop the alarm.
When the [ALARM RESET] key is pressed, the error message in the left lower corner of
the screen is deleted, and the error is recorded in the Error List.
Start
Prey
01·02
01·03 Next
01·04
01·05
He
Stored Special
Data Menu
Enter Work List
Probable Cause 1) The silicone tube is disconnected from the rinse bottle or waste bottle.
2) The cap on the rinse bottle or waste bottle is not securely tightened.
3) The trap chamber is full.
4) Pump failure or tube disconnection in the instrument.
2. Temperature Errors
[Temp. Error (High)/lncubator]
[Temp. Error (Low)/lncubator]
[Temp. Error (High)/Detector]
[Temp. Error (Low)/Detector]
[Temp. Error (High)/Cooler]
[Temp. Error (Low)/Cooler]
[Temp. Error (High)/Room]
[Temp. Error (Low)/Room]
Corrective Action 1) When the error recurs, the instrument may have some problem.
Contact Sysmex service representative.
3. Chamber Error
[Waste Bottle is full]
4. Motor Error
Probable Cause 1) Reaction tubes have not discarded and remain in the incubation block or
detector.
2) Something is impairing Z-mechanism operation.
3) Z-mechanism move error.
4) The tube trash drawer is full.
Corrective Action 1) Remove any reaction tubes lying on the analysis stage.
2) When the error recurs, the instrument may have some problem. Contact
Sysmex seNice representative.
Corrective Action 1) Remove any reaction tubes that are lying on the analysis stage or being
gripped.
2) When the error recurs, the instrument may have some problem. Contact
Sysmex seNice representative.
5. Dispense Error
[No Sample (Rack Position)]
Probable Cause 1) Some orders still remain probably because analysis interruption or
mechanical stop was performed.
Corrective Action 1) If the analysis for the order not analyzed is necessary, restart the analysis
after the interruption operation is completed and the instrument is ready to
analyze.
[Probe Crash]
[Syringe Error]
Corrective Action 1) When the error recurs, the instrument may have some problem. Contact
Sysmex service representative.
6. Sampler error
[Replace Sample Rack] <Attention-calling message>
Probable Cause 1) The rack was lifted or removed during analysis interruption.
2) Sample rack sensor failure.
Probable Cause 1) Sample rack that has been completed analysis remained.
2) Failure of sample rack sensor.
3) The sampler drawer was not pulled out for the rack replacement.
4) Failure of sampler drawer sensor.
Corrective Action 1) Pull out the sampler drawer and replace the STAT sample.
2) Check the STAT sample was replaced correctly.
3) Check any dirt or foreign matlers around rails of the sampler drawer and
remove if any.
4) When the error recurs, the instrument may have some problem. Contact
Sysmex service representative.
Probable Cause 1) The sampler was pulled out before analysis began.
2) Failure of the sampler pullout sensor.
7. Analysis Error
[Coag. Curve Error]
Corrective Action 1) Refer to Section 2.5: Analysis Data Error in this chapter.
Probable Cause 1) One had failed to set expiry date or made selting error.
Corrective Action 1) Set the expiry date by pressing [Standard Curve]-t [Lot No. Entry].
Probable Cause 1) One had failed to set expiry date for control plasma or made setting error.
8. Memory Error
[Invalid Settings]
[No Paper]
[printer Error]
Probable Cause 1) The lever to set printer paper is not pushed down.
Corrective Action 1) Push down the lever. Refer to Chapter 5, Section 5.1.
Corrective Action 1) Check the error log in the host computer side.
Corrective Action 1) Check the error log in the host computer side.
Probable Cause 1) Communication with the host computer exceeded Time Out (15 sec.).
Probable Cause 1) When inquiry was made to the host computer. No Order (000) was sent
back.
Probable Cause 1) QC analysis result exceeded the set ranges of Upper or Lower Limit.
Corrective Action 1) Check whether control plasma expiry date has passed or not.
Check also whether it has been kept properly.
Probable Cause 1) QC analysis result exceeded the set range of Upper Stop or Lower Stop
Limit.
Corrective Action 1) Check whether control plasma expiry date has passed or not.
Check also whether it has been kept properly.
Probable Cause 1) Standard Curve analysis points are no more than two.
Corrective Action 1) Discard any reaction tubes remaining in the detector wells and re-test.
Corrective Action 1) Discard any reaction tubes remaining in the detector wells and re-test.
Probable Cause 1) The light shield cover is open when beginning operation/during operation.
Probable Cause 1) The tests entered for analysis exceed the remaining reaction tubes (A
maximum of 60 tests).
Corrective Action 1) Reduce the number of the tests entered for analysis.
NOTE: • "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.
3. SYSMEX MENU
Press [Sysmex] key in the upper left corner of the Root Menu screen to display the Sysmex
Menu screen.
This section explains about Sysmex Menu.
I Ready HC IP I
I Renlace Rack? YESI
Sysmex
I Error List
I Temperature
I P. FEED
Main
I Menu
I_dy
IAer;lace Rack? YES!
Error LIst
Date Time Error Log
02128 20: 15 He Off Line
02/28 20: 28 HC Off Line
03/06 18:31 He Off Line
03/08 18:33 He Off line
03/06 18: 35 He Off Line
03/06 18: 38 HC Off Line
03/06 18: 43 He Off Line
03/06 18: 49 No Reaction Tubes
03/10 14: 21 Sel more than two points
03/11 16:43 Interrupt by Mechanical Stop
I Return
(4) Press [Main Menu] key on the Sysmex Menu screen to return to the
original screen.
3.2 Temperature
Monitored temperature of each place is displayed.
NOTE: • When a set temperature is reached with power supply on, "Ready"
appears.
l~eadY HC IP I
ReDlace Rack? YESI
Temperature
Cooler 14.9·C
Detector 37.1·C
Nozzle 36.9·C
Room 24.3·C
I Return
I Raady
I Raplace Rack? YESI
He IP I
Sysmex
IErrDr List
I Temperature
I P. FEED
Main
I Manu
4. SPECIAL OPERATION
The CA-500 incorporates a system test program for checking that the electrical system and
software system are operating properly and a program for instrument maintenance.
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.
4.1 Priming
When the CA-500 is installed for the fIrst time or it has been idle for long time, Owren's Veronal
Buffer, etc. is sometimes found sticking in the hydraulic system.
To get correct analysis results, it is necessary to execute this program and clean the hydraulic
line.
For Priming, refer to G.hapter 5, Section 5.4: Prime Rinse Solution to Hydraulic Line.
1. LCD
This program checks whether LCD display can be performed properly or not.
(1) Press [Special Menu] key on the Root Menu screen to display [Special Operate]
key.
S IRaady
ysmex IRanlaca Rack? YESI
System Tests
I Touch Screen
I Host Computer
I Printer
I Barcode Scanner
I Return
(5) When any place on the panel is pressed, the display screen changes over.
Three display screens in all are available,
(1) Press [Special Menu] key on the Root Menu screen to display [Special Operate]
key.
(5) Press any place on the panel to test entry on the touch screen.
•
••
Panel Teat (Finish Pos. Lin 19 Gol. 39)
(6) To quit the touch panel system test, press the touch panel in the lower
right corner.
3. Host Computer
This program allows testing connection of the host computer.
(1) Press [Special Menu] key on the Root Menu screen to display [Special
Operate] key.
4. Printer
This program allows test printing to the built-in printer.
(1) Press [Special Menu] key on the Root Menu screen to display [Special
Operate] key.
Output In prograss
I Cancel
5. Barcode Scanner
...
1
2
3
4
5
INot Ready
S ysmex IReolacB Rack? YES I
Barcode Scanner
ORG Sensor : 0
6
7
8
9
10
I Return
When the bar code scanner is set to "Not connected," [Return] key alone can be effectively
displayed.
[Return] key: Quits the program. (Returns to the System Tests Menu.)
...1
2
3
4
5
I~OI Ready
ysmex Ren)ace· Rack? YES I
Barcode Scanner
u", READING
123456789
A1234567A
***
HC IP I
ORG Sensor : 0
6
7
6
9
10
6. Sensor Status
This program allows checking the status of the sensors attached to each unit of the instrument.
(1) Press [Special Menu] key on the Root Menu screen to display [Special
Operate] key.
S
ysmex
I~ot Ready
Renlace Rack? YES'
He IP I
Sensor Status 1997/3/ 4
15: 39
Mechanical Stop 0 VerO.116
Cover Open Switch 0
Probe Crash Sensor 0
liqUid Sensor 0
Sample Rack
Sample Tabl.
Rlns. Bottle
••
0
Waste Bottle Full 0
TUbe catch
•
12345678
DIP SWitch 00000000
SW.cl.ar I Liq.Sens
Reset I Vibrate I Lock I Return
(1) Press [Special Menu] key on the Root Menu screen to display [Special
Operate] key.
s Iready
ysmex ReDlace Rack? YESI
HC IP I
Cycle Counter
I Return
Syringe Cycles: The No. of cycles that the syringe motor has turned to measure a
predetermined volume of reagent or plasma. One count is made per cycle.
No. of Cycles: The accumulated total No. of counts that the instrument has made
analysis. One parameter is counted once.
NOTE: • When syringe cycles exceed 300,000, the error message "Check
Syringe Unit" is displayed each time analysis begins.
1. INTRODUCTION
This chapter explains the detection principles, analysis methodology, individual analysis
procedures and hardware components employed by the CA-500.
• Analysis Flow
Describes the flow of analyzed parameters through the instrument.
• Instrument Components
Presents a brief functional description of the CA-500 with component nomenclature and
charts.
• Reagents
Describes the instrument's reagents.
• Reference Procedure
Contains a short list of reference materials.
Sample EO
c:::
~
,$:> Photo Diode
"".,,~
-r.
"""'Ck- Light Emitting Diode (LED)
The correlation between scattered light intensity and elapsed time is shown in Figure 9-2-2.
Warmed plasma is rapidly mixed with warmed reagent. Immediately after mixing, scattered light
intensity is low (step I). As coagulation proceeds, the sample becomes turbid due to fibrin clot
formation and the scattered light intensity increases drastically (steps 2-3). When coagulation is
complete, the scattered light intensity stabilizes (step 4).
The CA-500 stores this change in scattered light intensity in memory, and constructs a
coagulation curve.
,EJEBmE2J
E
O'J
~-~-~-~-~
~
'0
STEP1 STEP2 STEP3 STEP4
*~
1iiffi
~ £ 1----'---
Time
This method allows determination of the coagulation time even on those specimens
demonstrating only a slight change in scattered light intensity. As a result, the CA-5oo may be
effectively utilized for a low-fibrinogen plasma sample that has an almost imperceptible change
in scattered light intensity or a slowly clotting plasma sample with a long clotting time.
1000/0 --------------~-------~--
dH
50% ----------- I (Intensity change)
I
I
I
0% 1----<':-- - - -:- - - - - - - - - - - -
I
Coagulation Time
NOTE: There are 3 different types of standard curve available on the CA-500
as below. They can be selected in Standard Curve setting program.
Refer to Chapter 7, Section 5: Set Calculation Parameters for the
selection.
I
FUNCTIONAL DESCRIPTION
Calculation Principle
(a) Linear regression fonnulas are utilized to express the relationship between the clotting time
and percent activity or concentration. The points are expressed as a straight line when
plotted on a logarithmic scale.
(b) In the example shown in Figure 9-2-5 below, the analysis data result for a certain sample
(point X) plots between points C and D. In this case, the percent activity or concentration
is calculated by a logarithmic fonnula, utilizing points C and D.
(c) If analysis data results plot outside A through F, the percent activity or concentration is
calculated by logarithmic fonnula utilizing the nearest two points. For instance, the
percent activity or concentration of point Y is calculated by a logarithmic fonnula, utilizing
points A and B; and point Z is calculated by a logarithmic fonnula utilizing points E and F.
The CA-500 has the ability to calculate a PT ratio value if the normal PT value for the
laboratoryts patient population has been entered in the PT Standard Curve setting menu. The
Internatiol1al Normalized Ratio (INR) will be printed as part of the sample result if the
International Sensitivity Index (lSI) of the thromboplastin reagent has been entered in the PT
Standard <Curve setting menu.
The PT n~al value and the lSI value may be manually entered in the PT Standard Curve
setting mlu. Refer to Chapter 7: Set Standard Curve for the procedure, if needed.
PT ratio = -';P~T;O--n-or-~--'ali"'"v-a~l-ue-
=
t actual clotting time of PT sample
PT normal value = normal PT value for the laboratory's patient population
NOTE: For customers in the United States: The Derived Fbg test has not been
approved by the Food and Drug Administration (FDA) for use on the CA-
500. This method is not currently available in the United States.
By monitoring scattered light intensity during PT analysis, the Llli is detennined when the
coagulation reaction reaches its end point. The Fbg concentration is derived from the PT
standard curve which has already been determined.
Conventional Fbg reagents are not utilized.
Scattered Light Intensity
dH
(Intensity change)
Coagulation Time
Figure 9-2-6: Detennination of Llli
The standard curve for calculating derived Fbg concentration is set during PT standard curve
analysis by monitoring the total change in scattered light intensity of the undiluted sample.
Refer to Chapter 7: Setting Standard Curve.
mg/dl
dH (Intensity change)
Figure 9-2-7: Standard Curve for Derived Fbg Calculation
Normal Range:
The normal range for the PT-derived Fibrinogen has been found to be approximately the same as
the Clauss Fibrinogen assay. Each laboratory must verify that this normal range is appropriate
for its patient population.
Linearity limits:
Through testing, the linearity limits have been found to be 50 - 700 mg/dL. The manufacturer
recommends that any PT-derived Fibrinogen sample with a value above 700 mg/dL be diluted
until the result is below 700 mg/dL. Any sample with a PT-derived fibrinogen result below 100
mg/dL should be confirmed by performing a Clauss fibrinogen assay.
3. DETECTION PRINCIPLE
The chromogenics analysis is performed for a quantitative analysis of AT3. This chromogenic
unit is built-in the models CA-530 and CA-540.
Sample EEJ
/
Light Emitting Diode (LED)
Filter
o Photo Diode
4. ANALYSIS MECHANISM
The CA-500 performs an analysis according to the procedure described below:
(1) When the samples are set in a sample rack loaded in the Sampler, place the rack at the
appropriate analysis position. Analysis begins at the sample in Tube Position No. 1
according to the preset analysis setting for each sample.
The test tubes in the sample rack are then placed at the sample aspiration position one after
another.
(2) The Heater Probe aspirates the required volume of plasma from the sample rack.
The required sample volume is calculated automatically from the number of test parameters
and the replication count specified for each of the samples.
(3) The Heater Probe then dispenses the aspirated sample into a reaction tube in a sample tube
rack (cooling well).
(4) The reaction tube containing a sample plasma is then transferred to the incubation well by
the catcher hand, and incubated (warmed) for a specific amount of time.
(5) The Heater Probe aspirates a certain amount of a specified reagent from the reagent vial in
the reagent rack. The aspirated reagent is warmed for a certain period of time in the Heater
Probe.
(6) The sample catcher transports the reaction tube to the reagent dispensing position, and the
incubated reagent is dispensed into the reaction tube while being held by the catcher hand.
(7) The Sample catcher mixes the sample with reagent by vibrating the reaction tube while
holding it.
(8) Then the reaction tube is transported to a detection well and illuminated with a red light at
660nm.
(9) The clotting time for the sample in the Detection Well is then calculated according to the
Photoelectric Scattered Light Intensity Detection Method
(10) After the procedure, the sample catcher transports the reaction tube and discards it in the
tube trash drawer.
5. ANALYSIS FLOW
The required volumes of reagent and sample, and the analysis flow for each parameter, are
described in this section. Refer to the package insert of each reagent for more information.
5.1 PT Flow
Table 9-5-1: Sample Volume - PT
Analysis Sequence
100 ilL of PT reagent
- Measurement
3-minute
Incubation
50 J.1L qf Plasma
Figure 9·5-1: PT Flow
Analysis Sequence
50 J.lL of APTT reagent 50 J.lL of 0.02M CaCI2
...
- - Measurement
1-minute 2, 3, 4 or 5-minute
Incubation Incubation
50 J.lL of Plasma
Figure 9-5-2: APTT Flow
NOTE: • Any change in the APTI Incubation lime could affect the analysis
results significantly. Follow the reagent manufacturer's instruction.
Examine the optimum setting at your laboratory before changing the
APTI Incubation Time. Draw a new standard curve after the new APTI
Incubation Time is set.
• Each laboratory should follow the optimum APTI reagent incubation time
recommended by the reagent manufacturer in the product package insert.
• This setting can not be changed during an analysis procedure.
• The factory configuration is set at 120 sec at time of shipment.
Analysis Sequence
90 J.lL of Buffer 50 fJ.L of Thrombin reagent
... ...
+ 3-minute
Incubation
o ---PO Measurement
10 J.lL of Plasma
Figure 9-5-3: Fbg Flow
NOTE: • The CA-500 dilutes the high Fbg concentration sample, which has a
measured fibrinogen level of greater than 500 mg/dL, with dilution ratio of
1120 ( 5 !J.L of plasma with 95 !J.L of buffer) and performs a fibrinogen
analysis. The obtained result is multiplied by 2 and reported.
• The CA·500 dilutes the low Fbg concentration sample, which has a
measured fibrinogen level of less than 50 mg/dL, with dilution ratio of 1/5
(20 !J.L of plasma with 80 !J.L of buffer) and performs a fibrinogen
analysis. The obtained result is multiplied by 0.5 and reported.
Analysis Sequence
50 III of Thrombin Time reagent
- - Measurement
3-minute
Incubation
Analysis Sequence
30 III of Buffer 125 III of Thrombotest reagent
... ...
+ 3-minute
Incubation
- - Measurement
20 III of Plasma
Figure 9-5-5: TIO Flow
Analysis Sequence
40 J.Ll of Buffer
...
+ 3-minute
Incubation
• - Measurement
10 III of Plasma
Analysis Sequence
...
+
10 III of Plasma
...
+ 30-seconds
Incubation
- - - Measurement
10 III of Dilution
--- -----
.-/
/
V
/
@ LCD Contrast Adjustment Knob
Y§ v
1\ ® Sampler
V
~
LJ LJ
CAUTION: Do not open the Light Shield Cover while analyzing. Opening the
cover will suspend analysis and beep the alarm. Also, opening the
cover and inserting your hand may cause a result of injury.
CAUTION: If there is a sample that has been already dispensed, this sample has to
be reanalyzed from the first.
(6) 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 a sampler at a time.
Pull out the Sampler toward you to place a rack. Once the rack is loaded, the sampler will
operate without the need for intervention by the operator.
NOTE: • Sampler unit is locked while sampling and dispensing. Once all the samples
in the rack have been dispensed, the sampler lock is released and you can
pull out the sampler to place a next rack to allow a continuous analyses.
• Sampler unit can also be pulled out by the STAT sample analysis
procedure to allow an analysis of a STAT sample.
@ CA CLEAN I Holder
@ Sampler G Buffer Holder
@ ID Bar Code Reader @ STAT Sample Rack
Figure 9-6·2: Main Unit - Front Interior View When Opening the Light Shield Cover
1.\ • If any vial higher than 40 mm is used, the Probe will be damaged
illCAUTION permanently.
(4) Sampler
Can hold one sampler rack.
(6) Probe
Pipettes the sample plasma, and dispenses heated reagent into the reaction tube.
• Use the provided vials for the container to keep the Buffer. If any vial
& CAUTION higher than 40 mm is used, the Probe will be damaged permanently.
CD Power SWItch
@ Cooler Unit
J.:\ • Do not tum the power ON and OFF repeatedly at short intervals. This
illCAUTION will overload the fuse and the fuse may be blown.
~ @ Memory Card
@ Pressure Pump
@ Solenoid Valve
for for Sample As .
@ DIPSwitch
@Reaction Tube Trash
® Vacuum Pump
6.5 Rear
a a
CD Trap Chamber
® Fuse Holder
® Float Switch Connector
for Waste Bottle CV Power Connector
® Vacuum Nipple
for Waste BOWe
® Waste Outlet Nipple
Figure 9-6-5: Main Unit - Rear View
(4) Pressure Supply Nipple for Rinse Bottle (Colored with Black)
To be connected via a tube with the Rinse Bottle.
CAUTION: When the Rinse Bottle is to be opened, disconnect this tubing first to
release the pressure accumulated inside the Rinse Bottle. Failing this
will splash the pressurized rinse fluid.
CAUTION: When the Rinse Bottle is to be opened, disconnecting this tubing first
will splash the pressurized rinse fluid. Disconnect the black tubing first.
&WARNING • To avoid risk of electrical shock, disconnect the power cord before
replacing the fuses.
& WARNING • For continued protection against risk of fire, replace only with a fuse of
the specified type and current ratings.
7. REFERENCE PROCEDURES
The National Committee for Clinical Laboratory Standards (NCCLS) provides the following
reference method information:
H2l-A2, "Collection, Transport, and Processing of Blood Specimens for Coagulation Testing
and Performance of Coagulation Assays"
H28-T, "One-Stage Prothrombin Time"
H29-T, "Activated Partial Thrombin Time"
H30-T, "Procedure for the Determination of Fibrinogen in Plasma"
You can obtain these procedures for a small fee by writing to the following address.
After instrument installation, stability should be monitored through the use of established quality
control procedures.
You should promptly perform maintenance or troubleshooting whenever you note significant
shifts or trends in quality control data. Also the operator should confmn reagent integrity,
complete all maintenance procedures and operate the instrument as described in this operator's
manual.
1. INTRODUCTION
The CA-500 will be installed and set up by Sysmex service representative. However, this
program can be utilized to change settings of the instrument.
This chapter describes how to apply this setup program.
Analysis Setup
Analysis settings on parameters, reagents, etc. can be made.
Devices to be Connected
External device conditions, including host computer interface conditions and bar code scanner
usage conditions, can be set up.
System Setup
CA-500 system status can be set up:
· Dateffime: Sets date/time of the built-in clock.
· Date format: Sets date format.
· Password: Sets a password which executes important programs.
Printout of Settings
The settings can be printed out by the built-in printer.
IP HC
Within Limit V V
Oul of limit V V
Error Flag V V
QC Sample V V
Print
Forma1
I +Gmpll I Return
NOTE: • When Host Computer Status is set "Not Connected", the keys for HC
will not appear.
(4) 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
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 samples excluded)
QC Sample: Analysis data measured for QC and standard curve setting
(5) Set a printout format for automatic printout by IP (huilt-in printer).
The Format will change over each time the key is pressed as follows:
No Graph Analysis
Auto + Graph: When an error such as "Coag Curve Error" and etc. occurs on a
parameter, the parameter data with graph is automatically printed out
in an analysis format.
Auto No Graph: When an error such as "Coag Curve Error" and etc. occurs on a
parameter, the parameter data without graph is automatically printed
out in an analysis format.
RENEW SETTING ?
Canoe I I I FIX
I I Continua
Dala. Cheek
IMark LimIts
IFbg Limits
IAepllc. Limits
IReport Limits
I Return
(5) Using [i], [J-], [f-], or [~] key, move the cursor to select limit values to
be set.
Move the cursor to a limit value to display the numeric keys.
(6) Using the nnmeric 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 "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.
• When the lower limit value (-) is greater than the upper limit value (+),
"_" mark> value entered as lower limit ~ [No mark] ~ value entered as
upper limit> +" mark.
II
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 "+".
No mark is put on any value between 100 and 200.
RENEW SETTING ?
Cancel I I FIX
I I Continue
t I I I
- I - I Next
ODtlDn I Quit
RENEW SETTING ?
s ysmex IrRenlace
eady
Rack? YESI
He IP I
Fbg Limits
Test
Name L.L. U.L. Units
Fbg •• 500.0 mg/dL
-LJ L...LJ L...L
=r:Jo=JD:::
:::TIo:::JCL
- I - I
=UCJ~
r--c--, IQijjf
sysmex IrReolaee
eadY
Rack? YESI
He IP I
RENEW SETTING ?
Cancel I I FIX
I I Continue
Ready He IP
Sysmax Re lace Rack? YESI
RepHe. Limits
Test Difference
Name %
PT
APTT 2
Fbg 2
AT3 2
2
2
2
(5) Using [i] and rJ.], move the cursor to select analysis parameters.
(6) 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.
s ysmex l~eadY
Aenlace Aack? YES!
He IP I
AENEW SETTING ?
Cancel I I FIX
I I Continue
(5) Using [1] and [J,], move the cursor to specify a parameter to be set.
(6) Using the numeric keys, enter the report limits and press [Enter] key.
Settings in the cursor position will be set and the cursor will move to the next parameter to
be set.
s ysmex IFead Y
Renlace Reck? YESI
HC IP I
RENEW SETTING ?
Cancel I I FIX
I I Continue
4. ANALYSIS SETUP
4.1 Replication
This program allows setting replication for each analysis parameter. When two or more analyses
are set, the mean is calculated and displayed.
Test
Name Re lIcates
PT
APTT
Fbg
AT3
(5) Using [t] and [J,] keys, move the cursor to specify an analysis parameter
to be set.
(6) 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.
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He IP I
RENEW SETTING ?
Ga.ncel I I FIX
I I Continue
Sample
011.
Vol
Vol ......... 50ul
Oul
2nd. Dil.
D.Samp
011.
Vol
Vol
........
......... Oul
Oul
I I I I Next
ODtlon
I I Return
(6) Using [i] and [,1,], move the cursor to specify a parameter to be set.
(7) Using the numeric keys, enter the test protocol and press [Enter] key.
Test protocol in the current cursor position will be set and the cursor will move to the next
parameter to be set.
The detail of test protocol entry is listed below.
1) Detection:
Detection method is determined as per analysis parameter.
(l) Activity Method - PT
(2) Activity Method - APTT
(3) Activity Method - Fbg, Derived Fbg
(4) Activity Method - TI
(5) Activity Method - TIO
(6) Activity Method - NT
(7) Activity Method - Others
(8) Chromogenic Method
3) Maximum Detection Time: Sets maximum detection time. (Linear end point
in the case of chromogenic method)
It can be set within a range of 100 sec - 600 sec.
With the chromogenic method, set a linear regression end point.
For start point + 15 sec or over, setting in I sec increments is possible.
CAUTION: • Make sure that the sum of diluent volume and sample aspiration volume
will be within a range of over 20 III up to 130 ilL.
CAUTION: • Make sure that the sum of diluent volume and sample aspiration volume
will be within a range of over 20 III up to 130 ilL.
When the cursor is in the last line on the screen shown in Figure 10-4-4 and [J-] key is
pressed, a screen shown in Figure 10-4-5 will appear.
Ready He IP
S ysmex Re lace Rack? YES!
Test Protocol
Name
Reagent 1
Reag. Vol.
Deter.
Reegent2
Reeg. Vol.
Deter.
Reagent 3
Reag. Vol.
Deter..
9) Reagent 1: The adding time interval is set from the heating start time of
reagent 1.
From 30 sec later, adding time can be set in 30 sec increments.
NOTE: • Make sure that the entire volume in the reaction tube will be less than
250 ilL.
11) Reagent 1 Rinse Solution: Set the number of tiIiles to rinse with Reagent 1.
Reagent holder number can be chosen from numerals 9 - 12, and will be displayed together
with reagent name if set.
The number of times to rinse can be set up to 3 times. It can be set in an extent of xO - x3.
When not rinsing, enter O.
sysmex l~aadY
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He IP I
RENEW SETTING ?
Cancel I I FIX
I I Continue
NOTE: • When a setting condition is not met, the cursor will move to the incorrect
setting, with error message displayed.
[Continue] key: Returns to the Test Protocol Entry screen and allows continuous
operation.
[Cancel] key: Cancels the renewed setting and returns to the Test Protocol screen.
I) When analysis protocol is changed, the parameter code used in the host communication
has to be changed.
2) Press the parameter code key in the Standard Curve screen. Then enter the parameter
code.
s ysmex l~eadY
Reolaee Rack? YESI
HC IP I
Standard Curve PT
PT" Cal Data 1997/05/10
% sec Lot No. EXP.
100.0 11.4 PT Ape.63 1997/5/10
50.0 17.4
25.5 27.9
12.5 52.6 Ref. 123456789012 1997/5/10
8.5 0.0
3.1 0.0
Normal 11.4
151 1.73
NextPaae I
Iparameterl
Code
Standard I Man~:1
Analvsls Entr
Select
I Paramo
Select
Test I Graph I Print I LotEntrvNo. I Return
(4) Press [Alarm Settings] key on the Analysis Setting Menu screen.
The Reagent Volume Monitoring Setting screen will display the current settings.
When Valid is set, "V" mark will appear.
Sysmex IReelace
IRw~
Rack? YES I
~PI
Settings - Shert Reagent Menltor Mode
I Return
(5) Press c=J key. "V" mark will appear in the key to validate the setting of
reagent volume monitoring. .
NOTE: • "Vn mark appears and disappears alternately each time the key is pressed.
Sysmax weady
RAnlace Rack? YESI
He IP I
RENEW SETTING ?
Cancel I I FIX
I I Continue
6 I I Return
NOTE: • Parameters that can be set vary depending on its product series
(presence of optional chromogenic unit).
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eady
Rack? YESI
He IP I
RENEW SETTING ?
Cancel I I FIX
I I Continue
[Cancel] key: Cancels the renewed setting and returns to the Analysis Setting Menu
screen.
t I I Manual
Entrv
I I Return
Sysmex IFead y
Renlac. Rack? YES!
He IP I
RENEW SETTING ?
Cancel I I FIX
I I Continue
t I I I Next
DDtion
I I Return
Symbol Meaning
D-4 Dade Behring 4 mL reagent vial
D-3 Dade Behring 3 mL reagent vial
ReagViai Push Vial PV-lO
(22 mm OD x 40 mm high)
provided in accessories
Cup Sample Cup Conical
2mLor4mL
RENEW SETTING 1
Cancel I I FIX
I I Continua
5. DEVICES TO BE CONNECTED
This program allows setting the interface conditions for transmitting data to the host computer
and the conditions for using the bar code scanner or other external devices.
[Barcode] key is displayed only on the device with the bar code scanner.
I
Host Computer
I
Barcode Scanner
I Return
s l~eadY
ysmex Renlace Rack? YESI
HC IP I
Host Computer
Status
Baud Rate [BPS]
.
2400
Char. Length 7
Slop BII 2
Parily Bit Even
Class Class A
Interval [sec] 2
Inquiry Manual
Format CA1000
Ack Text ACK
t I I I Nexl
Dellon
I I Return
sysmex y
IFeed
Renlac. Reck? YES!
He IP I
RENEW SETTING ?
Cancel I I FIX
I I Continue
5.2 Bar Code (Only for Instrument with Bar Code Scanner)
This program allows setting the conditions for using bar code.
(4) Press the [Barcode Scanner] key on the Device Setting Menu.
The Barcode Scanner Setting screen will display the currently-set usage conditions.
Ireedy
Sysmex Renlece Rack? YES I
HC IP I
Barcode Scanner
Status
Check Digit None
Kind1 ITF
Klnd2 NW-7
KindS CODE39
Klnd4 JAN-8
I I I I Next
Ootlon
I I Return
(5) Using [t] and [J,], move the cursor to a parameter to be set.
RENEW SETTING ?
Cancel I I FIX
I I Continue
Clear I
I - I - I Add I Return
NOTE: -If [Add] key is pressed in the group registering 5 parameters, the Test
Group Addition screen will not appear.
(6) Press the key for an analysis parameter to be added on the Test Group
Addition screen.
An analysis parameter whose key was pressed is added to the test group, and the cursor
moves to the next number.
NOTE: • +Fbg is the analysis parameter with dilution ratio of 1:20 (a half of the
usual concentration).
-Fbg is the analysis parameter with dilution ratio of 1:5 (double of the
usual concentration).
• When Fbg dilution rate is changed in analysis procedure, [+Fbg] key
and [-Fbg] key are not displayed in the following cases:
• When diluent is not used
• When the dilution rate is magnified 2 times or 1/2 time the usual
value, a minimum and maximum of aspiration volume are
exceeded.
• When the second step dilution is set
RENEW SETTING ?
Canoel I I FIX
I I Continua
[Continue] key: Returns to the Test Group Setting screen and allows continuous
operation.
[Cancel] key: Cancels the renewed setting and returns to the Setting Menu screen.
7. SETUP OF SYSTEM
This program allows setting the CA-500 system status.
7.1 Date/Time
With this program, date and time can be set.
The CA-500 has a built-in clock, so there is no need to set date and time every day. Should
the power be turned off, the built-in clock is powered by an internal battery.
(3) Press [General Set Up] key on the Setting Menu screen.
The General Set Up Menu screen will appear.
IDelelTIme
IDate Format
IPassword Setting
I Return
He IP
Sysmex ~:afZce Rack? YES!
DatefTlme
Date e eli
Time 16:35:38
(5) Using n] and [J-], move the cursor to select Date or Time.
10-36 Sysmex CA-500 Operator's Manual-- Revised September 1999
INSTRUMENT SETUP
(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.
sysmex IrReDlace
eady
Rack? YES I
He IP I
RENEW SETTING ?
[Cancel] key: Cancels the renewed setting and returns to the General Set Up Menu
screen.
(3) Press [General Set Up] key on the Setting Menu screen.
The General Set Up Menu screen will appear.
(4) Press [Date Format] key on the General Set Up Menu screen.
The Date Fonnat Setting screen will display the currently-set date fonnat.
S IReady
ysmex IRenlace Rack? VESI
Date Format
I Return
(5) Press the key that indicates a date format and select a format.
Each time you press the Date Fonnat key, the indication changes over as follows:
YYIMM/DD""",* :MMIDDIYY """'* DDIMMIYY
s ysmex IrReolace
eady
Rack? YES!
He IP I
RENEW SETTING ?
Cancel I I FIX
I I Continue
7.3 Password
A sensitive program, under supervision of personnel in charge, requires entry of a password for
its execution.
This program allows setting or changing a password.
NOTE: • When [C], [0], [Enter], [Quit], or [Fix] is used to set as a password,
password check is not done, and the Password Entry screen will be
skipped.
(3) Press [General Set Up] screen on the Setting Menu screen.
The General Set Up Menu screen will appear.
(4) Press [Password Setting] key on the General Set Up Menu screen.
The Password Setting screen will appear.
When a password is already set, enter it on the Password Setting screen displayed.
(5) Using the numeric keys, set a password and press [Enter] key.
s ysmax IrReolace
eadY
Rack? YESI
HC IP I
RENEW SETTING ?
C-anceJ I I FIX
I I Continue
[Cancel] key: Cancels the renewed setting and returns to the General Set Up Menu
screen.
8. PRINTOUT OF SETTINGS
This program allows printing out the settings by the built-in printer.
Execution of Settings Printout
(1) Press [Special Menu] key on the Root Menu screen.
The contents of the Root Menu will change over.
(2) Press [Settings] key on the Root Menu screen.
The Setting Menu screen will appear.
(3) Press [Print Settings] key on the Setting Menu screen.
The Print Setting Menu screen will appear.
s ysmex l~eedY
RaDIace Rack? YESI
HC IP I
Print settings
Oulput In progress
I Cancel
NOTE: • When [General Set Up] key or [All Set Data] key is pressed, a
password will not be printed out.
(5) When printout is over, the Print Setting Menu screen will return.
I A Root Menu I
- a1 T
- a2 J..
- a3 Repeat
- a4 ID No. Entry
- a5 HC (*)
- a6 Stored Data - b6 Set Reagents
- a7 QC - b7 Settings
- a8 Standard Curve - b8 Rinse Probe
- a9 Test Group - b9 Special Operate
- a10 Special Menu b10 Special Menu
D Prev
Next
(*) Appears when the host computer is set to "Connected," "Class B," and
"Manual" in Device settings.
There are keys that do not (cannot) function depending on the instrument's
specifications, settings, or operating status. Those keys are not displayed.
a6-7 Yes
-I a5 Select Paramo
a6-10 Cancel
a5-6 IAdd Unit
---I a7 Print
a5-101 Quit
---I a8 Select File
-I a6 Select Test
a6-1 PT
a8-1 aC01
a6-2 APTT
a8-2 aC02
a6-3 Fbg
a8-3 aC03
a6-4 TT
a8-4 aC04
a6-5 TIO
a8-5 aC05
a6-6 NT
a8-6 aC06
a6-7 AT3
a8-7 aC07
a6-10 Cancel
aB-8 aC08
a8-9 aC09
a8-10 aC10 - a7 Graph '3
a8-11 aC11
- a8 Print '3
a8-12 aC12
- a9 Lot No. Entry
a8-13 Cancel a9-6 Reagent 1
a9-7 Reagent 2
,
4
a9-8 Reagent 3 '5
--I a9 Select Test I a9-9 Ref.
a9-1 PT a9-10 Cancel
a9·2 APTT
a9·3 Fbg --I a10 I Main Menu 1
a9-4 TT
a9-5 TTO
a9-6 NT : If set, password has to be entered.
a9-7 AT3 '1: This item is displayed only when ac data is stored.
119-10 Cancel '2: This item is displayed only when dFbg parameter is
selected in the calculation parameter setting.
a10 I Main Menu Refer to Chapter 7, Section 5 for the procedure.
'3: This item is displayed only when calculation parameter
is set. Refer to Chapter 7, Section 5 for the procedure.
'4: This item is displayed only when the parameter requires
the second reagent.
'5: This item is displayed only when the parameter requires
the third reagent.
H a4 I/O Setting I
a4-1 Host Computer
a4-2 Barcode Scanner
a4-3 Return
H a5 Test Group I
---l a6 General Set Up I
a6-1 Dateffime
a6-2 Date Format
Password Selting
la6-4 Return
·APPENDIX B: INSTALLATION
1. INTRODUCflON B-2
13. INSTALL SAMPLEIl WITII ill BAA CODE SCANNEll (Option) B-17
1. INTRODUCTION
This product is a clinical test instrument. Sysmex representative is responsible for unpacking,
installing, and initial setup to ensure its proper and safe operation. The next several pages will
give some essential information for installation of this instrument.
3. INSTALLATION SPACE
To ensure that the instrument performs to its full extent, it should be installed at an
appropriate place.
• Select a place where the power supply is located close.
In collecting waste, always use the furnished waste bottle.
• Secure a space for maintenance and service. Giving consideration to heat radiation by
the instrument, provide at least 50 cm clearance between the wall and the instrument's
side panels, rear and top panels.
The instrument dimensions are shown below. The power cord is 1.8 m long.
Table B-2:
Be sure to place the rinse bottle and waste bottle on the base which
&CAUTION
the instrument is set. Do not put them on the instrument, or there is
a possibility the instrument may break down or fail to produce
correct results.
CAUTION: • Unless the fixing metals are removed, the instrument cannot operate.
(3) Move the sample probe unit by hand to a place where it is easy to operate.
Remove the sample probe retainer.
(4) Raise the sample probe by hand to a place where it is easy to operate.
Remove the catcher retainer.
&WARNING When draining the trap chamber, always wear rubber gloves. After
completing the operation, be sure to wash handsin anti-septic
solution. If hands should be contaminated with blood or the like,
there is a hazard of being infected by pathogenic bacteria.
CAUTION: • Even at a facility equippedwith 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 furnished one; otherwise,
the instrument's hydraulic system may fail to operate properly.
CAUTION: • Remove the rubber tube that locks the float switch in the rinse bottle
and waste bottle. This rubber tube served to prevent vibration in
transit.
7 Power Connector
.....-ACoutial
Confirm the power switch is OFF, at "0," before routing the power
&CAUTION cord. Make sure to ground the AC outlet; otherwise, there is a
hazard of electrical shock.
LJ LJ
CAUTION: • Confirm the power switch is OFF, at "0," before routing the connection
cord; otherwise, there is a hazard of electrical shock.
NOTE: • For setting host computer interface parameters, refer to Chapter 10:
Section 5. 1: Host Computer.
• The connection cord for the host computer is not included in the
accessories.
I Ready
I Replace Rack? YESt
Sysmex
I Error· List
I Temperature
I P. FEED
Main
I Menu
IReady
S ysmex IReolece Reck? VESI HC IP I
Special Operation
I-R-In-Se-&-p-re-pa-re-----,
I System Tests
I Cycle Counter
Main
I Menu
(3) Press [Rinse & Prepare] key on the Special Operation Menu screen.
The Supply Liquid Confirmation screen will display the message "Water supply?"
sysmex !ready
Reolace Rack? VESI
HC IPI
Supply Liquid
Water supply ?
Set I I Cancel
(4) Press [Set] key or [Cancel] key on the Supply Liquid Confirmation screen.
[Set] key: Executes water supply.
[Cancel]: Cancels water supply and returns the screen to the Special Operate Menu.
NOTE: • Filling the hydraulic line with rinse solution takes 35 sec or so.
s Ir eadY
ysmex ReDlaee Rack? YESI HC 'PI
Supply Liquid
I Cancel
Reagent Rack
Figure B-21: Setting the Reagent Rack and Reaction Tube Rack
(1) Remove the left side panel of the CA·500 main unit.
Loosen the screws as shown to remove the panel.
2) Remove the duct cover for the sampler slide rail by sliding it backward.
(3) Attach the slide rail to the sampler with the ID bar code scanner.
Screws
2) Attach the slide rail to the sampler with the ID bar code scanner.
Mount the duct-attached slide rail to the sampler onto the side where the cable
protrudes. All four screws should be temporarily tightened.
3) Insert the cable from the sampler into the slide rail duct.
(4) Install the sampler with the ID bar code scanner to the CA-500 main unit.
1) While fmger-pushing the stopper lever to release the stopper, push in the
sampler a few centimeters on the inner rails of the CA·500 main unit.
CAUTION: • Until you are sure the sampler with ID bar code scanner will not
disconnect, do not let go hands.
CAUTION: • The table lock is only 1 mm apart from the lock guide arms. In
pushing, take care not to allow the lock guide arm to contact the under
panel.
5) Repeat pushing in and pulling out the sampler with ill bar code scanner
several times.
6) With the sampler pulled out in parallel, fully tighten the screws that were
temporarily tightened before.
7) Make sure that the sampler with ill bar code scanner will slide in and out
smoothly.
(6) Attach the left side panel ofthe CA-500 main unit.
(7) Now the CA-500 needs setting up, which is serviceman's function.
The following technical information has been included for your reference.
1. SERIAL INTERFACE FOR HOST COMPUTER C-2
1.1 Connection C-2
1.2 Input/Output Signals C-2
1.3 Communication Format C-2
1.4 Baud Rate/Character Structure C-2
1.5 Signal Level C-3
1.6 Interface Circuit. C-3
1.7 Software C-4
1.8 Class A C-5
1.9 Class B C-6
1.10 Transmission Errors C-9
2. TEXT FORMAT C-l0
2.1 Analysis Data Format C-I0
2.2 Inquiry Data Format C-14
2.3 Order Information Data Format.. C-17
3. ill BAR CODE C-20
3.1 Applicable Bar Codes C-20
3.2 Dimensions of Elements C-21
3.3 Requirements on Wide/NarrowRatio C-21
3.4 Optical Requirements C-22
3.5 Dimensions of Bar Code Label C-23
3.6 Check-Digit. C-24
3.7 Applicable Characters C-31
3.8 Effective Bar Code Length C-31
3.9 Quality Control Bar Code Label.. , C-31
3.10 CODABAR (NW-7) C-31
3.11 CODE-128 C-32
3.12 AffIxing Bar Code LabeL C-32
1.1 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 an inch thread.
VDD
OUT
Vss
MC145407 Driver
IN
MCl45407 Receiver
1.7 Software
L Code
ASCII codes are used in this interface.
2. General Function
Table C-4: General Functions
FUNCTION DESCRIPTION
Auto Out -- The CA-500 automatically sends out
1. Analysis data output analysis data after each analysis has been completed.
Stored Data (batch output) -- The CA-500 sends out
data from the stored data in a batch.
When CA-500 inquires order information by the Rack
2. Inquiry (output) and settings No. and Tube Position No., the host computer gives
from host computer (input) order information and the sample ID number for each
sample in the rack to CA-500.
According to ID No. read by the optional bar code
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.
m_ _1TI
Order of Transmission
Figure C-3: Order of Transmission
4. Communication Protocol
The following 2 protocols are provided in the system. The factory configuration is Class
A. Refer to Chapter 11, Section 5.1: HC Settings 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 The CA-500 transmits data and then waits for ACK or NAK to complete the
data transmission, which is more secure transmission protocol.
5. Text Format
1.8 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 CA-500 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.
The CA-500 transmits the following data without requiring data from the host computer
in Class A mode.
CA·500
Host Computer
1.9 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).
The CA-500 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.
The CA-500 transmits analysis data text to the host computer in the following sequence.
(1) The CA-500 transmits analysis data text to the host computer.
(2)
(3)
The host computer sends ACK (06 H) when the data is received correctly, and
sends NAK (15 H) if a communication error occurs.
If the reply is ACK, the CA-500 will complete communication. If the reply is
e
NAK, the CA-500 will send the same text again (retrying up to 3 times).
(4) If the reply is still NAK after sending the same text in the third time, the CA-500
terminates the communication.
Interval
CA·500 I DATA 1 f- T2--1 DATA 2 I
A
C
Host Computer Response K
Time L....--
2nd Transmission
CA·500
I DATA 1 DATA 1 I
Host Computer
e (2) The host computer verifies the received data and responds by sending NAK (15H)
when an error exists. When no error exists, host computer sends ACK (06H) and
the order information text that was inquired.
(3) If the CA-5oo receives NAK from the host computer, CA·500 re-sends the inquiry
text (retrying up to 3 times). If the CA-500 receives NAK after 3 retries, the CA-
500 terminates the communication.
If the CA-5oo receives ACK, CA-5oo veriftes the order information text and sends
NAK when an error exists. When no error exists, CA-500 sends ACK to the host
computer.
(4) If the host computer receives ACK from the CA-500, the host computer completes
the communication of order information for one sample.
If NAK is received from the CA-5oo, the host computer re·sends the order
information text to the CA-5oo (retrying up to 3 times).
Interval Interval
~
CA-500 ~ T3 -'> A ~ T2-'>
C 1------,
I Inquiry K Inquiry/
~ Instruction Interval Interval
Host Computer ~ T3 -'> K <f- T4-'>
~
Response Processing
TIme TIme
3. Time Interval
Time interval between two data transmissions to the host computer can be selected with
the setting program. The interval time means the period after the CA-500 received the
response of ACKINAK from the host computer until the CA-500 starts transmission of
the next data in Class B mode.
The CA-500 sends text at the "T2" interval as shown in Figure C-6 above. Data will be
transmitted by interval time set in the serial interface settings at 0,2,3,5,7, 10 or 15
seconds.
4. Time-Out Setting
When response time "Tl" (shown in Figure C-5) or "T3" or processing time "T4"
(shown in Figure C-6) is over the time-out setting, the CA-500 will terminate the
communication. Time-out settings is fixed to 15 seconds.
NOTE: Processing time "T4U is the time that is required for the host
computer to process setting text.
5. Processing Time
When the loop-back is ignored, set the response time "T1" or "T3", and processing time
"T4" must be set 0.2 seconds or longer. Contact Sysmex service representative for
assistance.
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 CA-500 receives "999", the instrument terminates inquiry about
analysis parameters of the samples in that rack, and no sample will be analyzed.
2. TEXT FORMAT
The CA-500 transmits (I) Analysis Data, (2) Inquiry Data, and (3) Order Information Data.
This data is distinguished by the Text Distinction Code 1. Text Distinction Code I is "D" for
the Patient Sample Data, "R" for the Inquiry Data, or "S" for the Order Infonnation Data.
(a) =
Text Length 54 + (9 x n) bytes
The text length varies depending on the number of parameters.
Analysis data should not exceed 255 characters. If it exceeds 255 characters, the
analysis data will be divided into blocks.
(b) The order of transmission is from the top parameter to the bottom. The data sent is the
most significant digit fIrSt, i.e., left to right. Zero suppression is not performed.
(c) The decimal point is not sent. If necessary, add the decimal point on the host computer
side as shown in the example.
(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.
(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.
G) 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 ill number consists of 15 digits including a hyphen "-" (2D in hexadecimal
code). Zero suppression is not performed. When No. of digits for the ill number is set
in the Settings, OutputlInput, HC program, the most significant digit(s) are not output
computer if it is set lower than 15 digits.
(1) ill information indicates how the sample ill number was entered or read.
Symbol Description
M The sample 10 number was entered manually.
A The sequential number was applied to the sample 10 number automatically.
B The sample 10 number was read by the bar code reader.
C The sample 10 number was downloaded from the host computer.
• Parameter Code
Table C·13: Parameter Codes
Parameter Parameter Parameter Parameter
Code Code
041 PT (clot time) 301 AT III %)
042 PT{%) 501 +Fbg clot time)
043 PT (PT ratio) 502 +Fbg concentration)
044 PT (lNR) 511 TT (clot time)
051 APTI (clot time) 521 -Fbo (clot time)
061 Fbg (clot time) 522 -Fbg (concentration)
062 Fbo (concentration)
081 Thrombotest (clot time)
082 Thrombotest (%)
091 HDt (clot time)
092 HDt (%)
• Data
Data is sent without a decimal point as shown in Table C-14.
Table C-14: Data Format
Output Format
Data Units Actual data ~ Data format
Coagulation time sec,s XXXX.X ~XXXXX
Activity % % XXX.X ~OXXXX
No unit X.XXX ~OXXXX
PT ratio, INR X.XX ~OOXXX
Fbg concentration mg/dL OXXX.X ~OXXXX
gIL OX.XXX ~OXXXX
NOTE: • X stands for a figure, 0 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 ax"
as the
coagulation time. If there is an analysis error of mean data, a
slash (I) 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".
• Flag
A flag indicates whether or not an error occurred during analysis.
Table C-1S: Flags
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
reolicate difference is too bio.
! Coagulation time was obtained by re-dilution.
> Over the Upper Report Limit
< Under the Lower Report Limit
NOTE: The priority order of each flags is (*), «) or (», (+) or (-), (!)
a space" "in that order.
(a) =
Text Length 54 + (9 x n) bytes
The text length varies depending on the number of parameters.
Inquiry data should not exceed 255 characters. If it exceeds 255 characters, the inquiry
data will be divided into blocks.
(b) The order of transmission is from the top parameter to the bottom. The data sent is the
most significant digit fIrst, i.e., left to right. Zero suppression is not perfonned.
(c) The decimal point is not sent. If necessary, add the decimal point on the host computer
side as shown in the example.
(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.
(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 a hyphen "-" (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 bar code label could not be read due to an error or no
label is attached on the sample tube, the sample 10 No. will
become "ERR0000000001".
(k) ill information indicates how the sample ill number was entered or read.
Symbol Description
M The sample 10 number was entered manually.
A The sequential number was applied to the sample 10
number automatically.
B The sample 10 number was read by the bar code
reader.
C The sample 10 number was set by the host computer.
(space) The sample 10 number was inquired from the host
computer with the Rack No. 0
(m) Datan
Table C-18: Data Format
Parameter No. of Example
Characters
Parameter Code 3 Refer to Table C-19.
( Reserved) 6 All spaces (20H).
• Parameter Code
Table C-19: Parameter Codes
Parameter Parameter Parameter Parameter
Code Code
040 PT 300 AT III
050 APTI 500 +Fba
060 Fba 520 -Fba
080 Thrombotest
090 Hot
• Reserved
All characters are spaces (20H).
(b) The order of transmission is from the top parameter to the bottom. The data sent is the
most significant digit fIrst, i.e., left to right. Zero suppression is not performed.
(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 "S" for the order information data
Text Distinction Code IT is type of inquiry:
"I": The key word is "Rack No. and Tube Pos."
"2": The key word is "Sample ill 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.
(g) Date and Time when the host computer ordered to the CA-500. Date should be
transmitted in the form set by the Setting program in the CA-500. 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.
"000 I" 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 ill number consists of 15 digits including a hyphen "-" (2D in hexadecimal
code). When the ill number of 13 digits or less is set, the set ill 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
"QCOC " through "QCI2 " in which the obtained
QC data are to be stored. ("_" represents a space.)
(k) ill information indicates how the sample ill number was entered or read.
Symbol Description
C The sample 10 number was downloaded from the host
computer.
A The sequential number was applied to the sample 10
number automatically.
B The sample 10 number was read by the bar code
reader.
M The sample 10 number was entered manually.
(m) Datan
Table C·23: Data Format
• Parameter Code
Table C-24: Order Information Parameter Codes
Parameter Parameter Parameter Parameter
Code Code
040 PT 300 AT III
050 APTT 500 +Fba
060 Fba 520 -Fba
080 Thrombotest 000 Not Analvzed
090 Hot Stoo order inauirv for the
999 followina samoles in the
rack.
• If there is no setting parameter in response to the inquiry from the CA-500 by the ill
number, host computer is requested to send "000" as the parameter code.
• If there is no setting parameter in response to the inquiry from the CA-500 by the Rack
number, host computer is requested to send "999" as the parameter code. If the CA-500
receives "999", it stops inquiring on the following samples that are in the same sample
rack.
3. In BAR CODE
3.1 Applicable Bar Codes
The types of bar codes acceptable to the CA-500 and the relation of the check-digit to each
barcode type are as follows:
*: Start and Stop code can be anyone of the characters "A", "B", "C", "a", "b" and "c".
NOTE: When "C" or "e" is used, make sure that the number should not be the
same as the number of QC File No.
*1: Start and Stop code can be anyone 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.
NOTE: ITF does not require above mentioned item (c), since ITF does not
use a gap between characters.
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.
PCS = R~Rb
s >
- 0.45
The measuring method conforms to the JIS (Japanese Industrial Standards) B9550, "5.3
Optical Characteristics ofBar Code Symbols".
The bar code reader defines the white and black by the reflected light intensity when the light
is applied to the label at an angle of approximately 25°. Therefore, most of the reflection of
the label surface should be diffused reflection. For example, a laminated label may cause
specular reflection, which will increase the reflection directivity too much and cause the ill
reader to miss scan lines. See the following figures.
When a bar element is magnified, the following may be observed. The variation coefficient
(S) in the width of a bar should be less than or equal to 20%.
S(%)=M::m x 100
MAX
MIX
Bar element
(a) The leading and trailing spaces should be greater than or equal to 5 rom.
(b) The effective length of bars should be less than or equal to 40 rom. This length is related
to the ease of placing the label. The physical absolute maximum length is 48 nun.
(c) The bar height should be greater than or equal to 20 rom. This height is theoretically
required to be at least 10 rom to scan lines. However, a label of which bar height is only
10-20 rom may cause problems as the tube may rotate to sufficiently prevent the
instrument from reading the bar code.
I
Bar Height
L
Space Barcode Effective Space
Len th
(d) For rack label, the bar height should be 6 rom or greater.
3.6 Check.Digit
The bar code ill system requires the check-digit(s) to be added on the bar code label to
improve the reliability of the ill number.
(1) The least significant digit (right most digit) and all digits that occur on the odd position
from right to left within the data digits are defined as odd digits. All the digits are
divided into two groups, odd digits and even digits.
(2) Add all odd digits. Multiply the sum by 3.
(3) Add all even digits.
(4) Add the result of (2) and result of (3) above.
(5) Subtract the foremost (least significant) digit from 10 to obtain the check-digit. In case
of the ITF, the total number of the digits must be an even number. In such case, add "0"
to the most significant digit (left most digit).
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 x 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 x 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
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 bar code symbology such as CODE-II, NW-7 and
CODABAR. Check digit computation method is shown as follows:
ID Number 1 5 - 2 3 4 5 - 6 7 8 9
x x x x x x x x x x x x
WeiQht 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 ill number and its weight is 1.
(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 except the numbers are calculated as zero(O). The check-digit will
be zero (0) when the resulted check-digit is 10 or 11.
(5) When the ill Reader reads this bar code label, the instrument computes the check-
digit(s) and recognizes the read as a valid read if the remainder is 0 or 1.
ID Number 1 5 - 2 3 4 5 - 6 7 8 9
x x x x x x x x x x x x
Weicht 6 3 5 9 10 7 8 4 5 3 6 2
6 15 0 18 30 28 40 0 30 21 48 18
ID Number 1 5 - 2 3 4 5 - 6 7 8 9
x x x x x x x x x x x x
Weicht 5 8 6 2 10 4 3 7 6 8 5 9
5 40 0 4 30 16 15 0 36 56 40 81
(7) When the ID Reader reads this bar code label, the instrument computes the check-digit
by using the first weight set and recognizes the read as a valid read if the remainder is O.
If the remainder is not 0, the instrument computes the check-digit by using the second
weight set and recognizes the read as a valid read if the remainder is O.
(D) Modulus 16
The Modulus 16 is the check-digit computation method used in the 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.
(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:
(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".
(3) This check-digit is appended to the left of the stop code in the IDnumber; the bar code
label is now D9981474D.
(4) When the ID Reader reads this bar code label, the instrument computes the check-digit
and recognizes the read as a valid read if the remainder is O.
(E) Modulus 43
Modulus 43 is the check digit computation method used in the CODE-39 symbology. Each of
43 characters is assigned each value. All characters are converted into the value and
computed.
(1) Add the values of all the data characters. The numerical value of each of the data
characters is given below:
(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 ill number, after the least significant digit. The
bar-code label is now "258-416J".
(1) All characters except the stop code are converted to their corresponding values according
to the table.
(2) The fIrst character, such as "Start (Code A)", indicates that the Code A set is used until
other code set is specifIed. Multiply the most signifIcant digit by 1, multiply the second
digit by 2, multiply the third digit by 3, and so on.
(5) Convert the remainder to the corresponding character in the table. This is the check-
digit.
The following example uses the ill number Start (Code A) 123-4567.
(1) Convert each character into values using Code A set, and multiply by the weight.
(4) The corresponding character for the value 5 is %. Hence the check-digit is %.
DEL
FNC3
-
90
91
92
93
94
95
96
•
~.
43 K K 43 97 FNC2 FNC2·· 97
44 L L 44 98 SHIFT SHIFT 98
45 M M 45 99 CODEC CODEC 99
46 N N 46 100 CODEB FNC4 CODEB
47 0 0 47 101 FNC4 CODE A CODE A
48 P P 48 102 FNC1 FNC1 FNC1
49 Q Q 49 103 START (Code A)
50 R R 50 104 START (Code B)
51 S S 51 105 START (Code c\
52 T T 52 STOP
53 U U 53
The valid characters for the ill bar code system are numerals (0-9) and a hyphen (-).
CODABAR (NW-7) and CODE-39 may use the other characters such as alphabets. The CA-
500 ill system does not recognize them. The ill number allows up to thirteen digits. The
application of hyphens in an ill number should adhere to the following rules:
3.11 CODE-12S
CODE-128 employs alphabetical characters. Therefore, the instrument defmes the ill number
as quality control data when the ill number is read as "QC_" and is followed by 8-digit Lot
number.
[L]
LCI) ------------------------------------ 9-18, 8-24
Light Absorbance I)etection ---------------- 9-1 0
Light Shield Cover --------------------------- 9-1 8
Light Shield Open---------------------------- 8-18
Liquid Crystal I)isplay (LCI))--------------- 9-18
List l)isplay ------------------------------------ 4-3
List msplay/Graphic msplay------------4-1, 4-2
Lot ~o.----------------------------------------- 7-2
[Q] [S]
QC Charts, Display ---------------------------- 6-2 Sample Aspiration Volume ---------------- 10- 17
QC Chart, Select ------------------------------- 6-4 Sample Distinction Code------ C-lO, C-11, C- I8
QC Data, Delete ----------------------------- 6-13 Sample ID No. --------44,4-6,C-ll,C-15,GI8,C-20
QC Data Error ------------------------------- 8-15 Sample Incubation Wells-------------------- 9-20
QC File, Delete -------------------------------- 6-6 Sample Infonnation Screen-------------------4-5
QC Limit Error ------------------------------ 8-17 Sampler---------------------------------9- I 8, 9-20
QC Limit Error (STOP) --------------------- 8-17 Sampling Error (Position) ------------------ 8-10
QC Sample ----------------------------------- 10-3 Search--------------------------------------4-I, 4-9
Quality Control Methods --------------------- 6-1 Search by Date------------------------------- 4-11
Search by ill No. ---------------------------~--4-9
[R] Second Step Dilution, Diluent Volume --- 10-1 7
Second Step Dilution,
Rack---------------------------------------------4-5 Sample Aspiration Volume ---------------- 10-17
Rack No.------------------------ C-11, C-15, C-18 Select Display -------------------------- 4-1, 4-13
Rack No.trube Position No. ------------------4-6 Select QC Chart ------------------------------ 6-4
Reaction Tube Rack ------------------------- 9-20 Sensitivity------------------------------------ 10-1 7
Reaction Tube Trash ------------------9-20, 9-23 Sensor Status --------------------------------- 8-30
Reagent 1------------------------------------10-18 SEQ -------------------------------------------- 4-5
Reagent 1 Rinse Solution ------------------10-18 Serial Interface for Host Computer ----------C-2
Reagent 1 Volume -------------------------- 10-18 Set Calculation Parameters-------------7-1, 7-13
Reagent 2, Reagent 3 ----------------------- 10-18 Set More Than Two Points------------------ 8-17
Reagent Holder ----------------------------- 10-27 Set Print Paper ------------------------------- B-1 0
Reagent Holders (Cooler)------------------- 9-20 Set Reaction Tube Rack--------------------- B-16
Reagent Name--------------------------7-2, 10-25 Set Reaction Tubes ---------------------------- 2-9
Reagent Preparation --------------------------- 2-5 Set Reagent Infonnation --------------- 7-1, 7-11
Reagent Rack-------------------------- B-16, 9-20 Set Sample NOS. and Analysis Parameters 2-16
Reflective Characteristics of Set Sample Rack ----------------------------- 8-13
the Label Surface ---------------------------- C-22 Set Standard Curve -----------------------7-1, 7-5
Register Reagent Volume --------------------- 2-7 Set Tube Trash Drawer---------------------- B- I5
[T] [X]
SYSMEX CORPORATION
1·5·1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan
PHONE: 078-265-0500, FAX: 078-265-0524
URL=http://www.sysmex.co.jp/
SYSMEX UK LIMITED
Sunrise Parkway, Linford Wood (East), Milton Keynes,
Buckinghamshire, MK14 6QF, U.K.
PHONE: 01908-669555, FAX: 01908-669409
PRINTED IN JAPAN
EP Evaluator PT
Prepared for: laboratory - TItus Regional MedIcaJ center
By: Dade SehrllUl- Glasgow, DE
Supporting Statistics
Corr Cost (R): 0.9995 PoinlB (PlottedfTeta!}: 35/35
Bias: 0.2 PairedTTest 5.93
XMean+/-SD: 13.7:1:5.7 T Probability: <0.001
Y Mean +/- so: 13.9:1: 5.8 Degrees Freedom: 33
std Dev Diffs: 0.2
ExperimenmlDescription
X Method YMethod
Exper. Datil: 16 Mar 2000 16 Mar 2000
Rep SO: 1.0 1.0
Result Ranges: 10 to 32 10to 33
Units: sec eec
Comment (nnovln 526931 Innovln 526931
..
81
i1
0.25 --•• •
---~---.--------------------
• •• •
•
~ 21 0
•
-0.25
14
•
-0.5
36 6 12 18 24 30 36
•
4.4
••
..
~, . •
i1:
~
2.2
0
... •
• ... .
•
•
If •
-2.2
-4.4
•
6 12 18 24 30 36
Experimental Results
Specimen X Result Y Result Bias Specl!!1en X Result YResuIt Bias
1 SPecoo1 9.5 9.8 0 19 SPeCD19 9.5 9.8 0
2 SPeCDD2 20.5 20.6 0 20 SPECD2D 16.4 16.9 1
3 SPECDD3 13.1 13.5 0 21 SPECD21 16.8 17.0 0
4 SPeC004 19.6 19.7 0 22 SPECD22 11.1 11.3 0
5 SPECDOS 31.0 31.6 1 23 SPECD23 9.6 10.1 0
6 SPeCDD6 16.3 16.2 0 24 SPECD24 11.0 11.1 0
7 SPECD07 15.6 15.7 0 25 SPECD25 32.4 32.8 0
8 SPECDD8 11.2 11.6 0 28 SPECD28 21.1 21.2 0
9 sPECDll9 22.9 23.0 0 27 SPeCD27 10.6 10.6 0
10 SPEC010 10.2 10.3 0 28 SPEC028 11.1 11.6 1
11 SPeCDll 11.1 11.1 0 29 SPECD29 11.1 11.3 0
12 SPEC012 9.8 9.9 0 30 SPEC030 10.3 10.7 0
13 SPECD13 10.9 10.9 0 31 SPECD31 10.6 11.1 0
14 SPEC014 10.6 10.7 0 32 SPECD32 11.1 11.1 0
16 SPECD15 11.6 11.9 0 33 SPECD33 10.5 10.8 0
16 SPECD15 10.7 10.7 0 34 SPECD34 11.3 11.6 0
17 SPECD17 10.7 10.3 0 36 SPECD36 10.4 10.5 0
18 SPeCD18 10.4 10.8 0
Values with an "X" were excluded from the caIcuIatlons. Outliers '0' were $0 excluded.
I!E Release: CUA 1.2.8.60 £1'1 P200sYilYPYMNtYslUD] 9DpYright 1.1·11l1l9 by David Q. Rhoads AMooIates.lno.
EP Evaluator PTT
Prepared for: Laboratory - TItus Reglonal MedIoaJ Center
By: Dade Behring - Glasgow, DE
Regression Analysis
Supporting Statistics
Corr Coef (R): 0.9948 POints (Plotted!TotaI): 35/35
Bias: 0.1 Paired T Test 1.66
X Mean +/- SO: 30.2:1: 4.9 T Probability; 0.11
Y Mean +/- SO: 30.4:1: 4.7 Degrees Freedom: 33
std Dev Diffs: 0.5
ExperimenglDescription
X Method YMethod
ExJ:ler. Date: 16 Mar 2000 16 Mar 2000
Rep SO: 1.0 1.0
Result Ranges: 25 to 46 25 to 45
UnillJ: sec sec
Comment Actin FSL 527316 Actin FSL 527316
EE! Release: CLIA 1.2.8.60 [T1P200sYBYPYMNtYstllDj Coprright 1991-1999 by David iiI. flItoada Assoclates.IRO.
EP Evaluator PT Level1
Prepared for: Laboratory - TItus Regional Medical center
By: Dade Behring - Glasgow, DE
Instrument: CA540 A2285
Concennation: seconds
Simple Precision
I,'··'.·",••
Mean
I;?···'··.·.·••'· .•·;•.· .· · ,· ·•. .•. . • •.• .•.•. . . . . . . . . . . . . . . . . . · •· • •·, ·. ,·. • •'· '• & ••
Standard Deviation (SO)
12.65 sec
0.09
_.I···.. II,· IIi·,·.····.Ii··'.,.·.. iiI·,.···,,·•• ,•· .·.·, · .'.• •. • •·,• • .• ·•· .· ·.· ·,• ;i
Coefficient of Variation (CV)
95°,(, Confidence for Mean
0.7
12.62 to 12.69
Number of Specimens eN> 20 250 Range 12.48 to 12.83
Precision Plot
3
2
• • Supporting Data
Analyst: Unda Nash
• •• •••••• • Analysis Oate: 14 Mar 2000
Ei
CI) 0 Units: sec
-1
• • •• • Comment: PT Innovin 526931 Citrol1
528125
-2 • ••
-3
0 4 8 12 16 20
Specimen Number
Precision Data
Index Results Index Results Index Results Index Results
1 12.7 6 12.5 11 12.7 16 12.8
2 12.6 7 12.6 12 12.7 17 12.5
3 12.7 8 12.7 13 12.7 18 12.5
4 12.7 9 12.7 14 12.6 19 12.7
5 12.8 10 12.7 15 12.6 20 12.6
Simple Precision
I; I·;••· •· •·.•· •. .•· • • • • • • • •·•••.• •· • .• .• . · • f·.·.r.·.· · . . . • • •. • • .• • • • • • .• • • .• .• ;...............1iI• •ilIff.·.· . •. •.•. •. .•. •. • ,...............•. . . · · •• 1·· .·.;•• • • .•·• ·• • • • •·•·• 1
Mean 46.00 sec Coefficient ofVariatlon (CV) 0.5
Standard Deviation (SO) 0.23 95% Confidence for Mean 45.90 to 46.10
Number of Specimens (N) 20 2SDRange 45.54 to 46.46
Supporting Data
Analyst: Unda Nash
Analysis Date: 14 Mar 2000
Units: sec
Comment: PT Innovin 526931 Citrol 3
528328
Precision Data
Index Results Index Results Index Results Index Results
1 45.6 6 46.0 11 46.1 16 45.9
2 46.3 7 45.6 12 46.2 17 46.6
3 46.1 8 46.1 13 45.7 18 46.1
4 46.1 9 46.1 14 46.0 19 45.8
5 45.6 10 46.1 15 45.8 20 45.8
Simple Precision
Precision Plot
3
-3
0 4 8 12 16 20
Speelmen Number
Precision Data
Index Results Index Results Index Results Index Results
1 30.8 6 30.6 11 30.7 16 30.5
2 30.6 7 30.5 12 30.5 17 30.9
3 30.5 8 30.5 13 30.8 18 30.7
4 30.5 9 30.8 14 30.6 19 30.5
5 30.8 10 30.4 15 30.5 20 30.5
Simple Precision
Ii; ···.iI•.·• •. . · ·•. ·.·.··..•. . . (iI;; • • . • • •.•. . . . . • ·• • • rr.·. ..............&i,IIiEfl••..• I· · ·•· •· .• • ·.·.···.i ..·· · · ·.· · ·•· · . . . . . . . . . . . . . . . . . . . . . . . . . .•••.. .•. .•.•.•. . .·.•. i• • • • ; · •1
Mean 62.92 sec Coefficient of Variation (CV) 0.7
standard Deviation (SD) 0.43 95% Confidence for Mean 62.73 to 63.11
Number of Specimens (N) 20 2SDRange 62.07 to 63.77
Precision Plot
3
2
Supporting Data
1 • Analyst: Unda Nash
• • • Analysis Date: 14 Mar 2000
is
II) 0 • • • • Units: sec
•• •• • • • Comment Actin FSL 527316 Citrol3
-1 • • • 528328
•
-2
-3
0 4 8 12 16 20
Specimen Number
Precision Data
Index Results Index Results Index Results Index Results
1 62.8 6 63.1 11 62.8 16 63.4
2 62.7 7 62.3 12 62.9 17 64.4
3 62.6 8 62.8 13 62.9 18 63.0
4 63.2 9 62.7 14 62.8 19 62.8
5 62.9 10 62.6 15 63.1 20 62.6
Simple Precision
I;:I· ,•. i.·.··i··· ·····.·.·.·.·········.··r··· ...{{ ...........•....•...{.• ··••I.:•. :·.• •I•· • · • • .•·••··.•.• · .•· .•:· • JliPil.~. ·.;.·.··iII • .•.• iI·III.:.·.• I.I··.;1
···.I····.:··•••..:.·•..·••·•·.••..•.•·••
Precision Plot
3...---------------,
Supporting Data
• • Analyst: Unda Nash
•• • •• Analysis Date: 14 Mar 2000
~ 0 •• •••• Units: mg/dl
• • ••• Comment Thrombin 527513 Citrol1
-11- 528125
•
-21-
Specimen Number
Precision Data
Index Results
--------
Index
-------- Results Index Results Index Results
1 257.4 6 263.3 11 263.3 16 257.4
2 260.3 7 260.3 12 260.3 17 246.4
3 260.3 B 257.4 13 257.4 16 263.3
4 263.3 9 260.3 14 257.4 19 263.3
5 266.3 10 260.3 15 254.5 20 266.3
Simple Precision
Precision Plot
3
21-
• Supporting Data
•
11- ••• Analyst WOOa Nash
Analysis Date: 14 Mar 2000
is
II • 0 • •
01- Units: mgldl
l/)
•• • •
• Comment Thrombin 527513
• •
-11- • Abnormal lib control
-2 • •
-3
0 4 8 12 16 20
Specimen Number
Precision Data
Index Results Index Results Index Results Index Results
1 94.8 6 93.3 11 96.0 16 95.2
2 92.6 7 89.8 12 96.8 17 89.5
3 95.2 8 94.8 13 93.7 18 93.7
4 98.0 9 92.2 14 97.6 19 93.0
5 93.0 10 96.4 15 91.9 20 95.2
Date
0.6
43.8
•• •
••
• •
..Q.6
• •
31.3
-1.2
•
25 \...-..&:..-1----"35'---...
4 2 - -...
49-----1
21 56 21 28 35 42 49 56
zsroBiiiI
4.4
••
• •
2.2 • ••
•••
j
'Ii!
I a
.-.
.: ••
• • • •
lL
•• • •
-2.2 •
-4.4
•
21 28 35 42 49 56
Experimen~IResulm
Speelmen X Result Y Result Bias Specimen X Result YResult Bias
1 SPeCD01 30.4 30.4 0 19 SP!C1119 27.7 27.4 0
2 SPECOO2 31.3 39.2 0 20 SPE!C020 28.9 29.6 1
3 SPeCD03 29.2 29.2 0 21 SPEC021 28.4 28.4 0
4 SPeC004 29.2 29.1 0 22 SPeC022 29.3 29.6 0
5 SPI!CDOli 39.8 40.0 0 23 SPEC023 30.0 29.7 0
6 SPI!CD06 28.1 28.3 0 24 SPEC024 28.4 27.0 ·1
7 SPI!CD07 35.9 35.6 0 25 SPI!C025 46.0 45.3 ·1
8 SPECD08 25.5 28.1 0 26 SPEC028 38.4 38.5 0
9 SPI!CD08 39.8 39.0 -1 27 SPEC027 28.6 28.2 0
10 SPI!C010 26.8 27.0 0 28 SPeC028 27.6 27.9 0
11 SPEC011 33.4 33.3 0 29 SPI!C029 28.3 28.6 1
12 SPI!C012 27.9 28.0 0 30 SPeC030 27.2 27.& 0
13 SPeeD13 28.7 29.2 1 31 SPI!C031 27.& 27.9 0
14 SPEeD14 28.3 26.8 1 32 SPI!C032 31.1 32.1 1
15 SPeeD1& 24.7 25.3 1 33 SPEC033 26.& 27.& 1
16 SPEC016 27.8 26.4 1 34 SPEC034 26.9 27.7 1
17 SPeeo17 28.9 27.8 1 35 SPI!C035 28.4 27.2 1
18 SPI!C018 27.3 27.4 0
Values with an "X" were exoIuded from the calculallons. OutUars '0' ware also exoIuded.
EE Release: CUA 1.2.8.60 [r1P200SYBYPYMNlYsOIO] Copyright 1661-1999 by DavId G. Rhoads Associates, Inc.
EP Evaluator Fibrino9!!!
Prepared for: Laboratory - Titus Regional MedIcal Center
By: Dade Behring - Glasgow, DE
Supporting Statistics
Corr Coef (R): 0.9629 Points (PlottedlTotaI): 35135
Bias: -12.3 PaIred T Test 2.87
X Mean +/- SO: 364.7 ± 87.1 T Probability: 0.007
Y Mean +/- SO: 352.4 ± 74.6 Degrees Freedom: 33
Std Oev Oiffs: 25.3
experimental Description
X Method YMethod
Exper. Date: 16 Mar 2000 16 Mar 2000
RepSD: 1.0 1.0
Result Ram:!es: 236 to 574 236 to 545
Units: mgldl mgldl
Comment Thrombin 527513 Thrombin 527513
Date
I--~~I /
/
/
1 - . MeanStBS I
/
/ -ZSroBI8lI
~Iol!.~. • •
./
,
540 /. o
. .
-II. •
/
/
--------~----
.
-------------
i
/
/
I
/
•••
•
450
•
~ .,
il
~
380
270 -120
•
180 -160'---.......---'..,---...0.--.......- - - - '
120 360 480 600 720 120 240 360 480 600 720
9 •
.e.: • • •
.. ......
01---+'''''-.''.''-----=.------1
....... •
•
-18
•
·27
Experimental Results
SpecII!!en X Result YResult Bias Specimen X Result YResult Bles
1 SPl!ClI01 414 402 ·12 19 SPeC018 441 433 .14
2 SPl!ClI02 567 545 -22 20 SPeco2ll 355 36ll 14
3 SPI!ClI03 279 276 0 21 SPEC021 361 342 ·18
4 SPI!ClI04 345 321 -11 22 SPeC022 315 311 3
5 SPeCllOS 422 39S ·27 23 SPEC023 438 417 ·21
6 SPEC006 393 379 -11 24 SPI!C024 441 441 -e
7 SPl!ClI07 574 441 ·133 25 SPI!C02S 430 417 ·13
I SPI!ClIOI 236 236 0 2ll SPI!C02lI 43ll 425 -13
9 SPl!C006 416 501 15 27 SPI!C027 287 288 2
10 SPl!C010 422 385 -34 21 SPI!C028 307 308 2
11 SPEC011 407 385 ·19 29 SPEC028 307 284 -13
12 SPl!C012 441 417 -30 30 SPI!C030 401 382 ·25
13 SPIlC013 291 288 -5 31 SPEC031 213 279 8
14 SPI!C014 311 280 ·21 32 SPEC032 291 280 -1
15 SPeC015 251 257 8 33 SPI!C033 313 352 ·21
18 SPEC018 251 25S 4 34 SPeC034 283 288 3
11 SPEC017 288 327 28 35 SPeC035 345 322 -23
11 SPI!C018 301 301 -5
Values with an "X" were excluded from the caloulaIlons. OuUlers ·0· were also exGluded.
Ell Release: CUA 1.2.1.&0 [T1P200sYBYPYMNtYsDIOJ Copyrighl1981.1899 by David G. RItaads Associates, Inc.