CA-270 OPERATOR's Manual

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WARRANTY
TRADEMARKS
The term of warranty of this analyzer is one year from the date of purchase.
Our company shall not be responsible for the following failures and damages for the warranty
period.
1. Failure/damage caused by the result of misuse.
2. Failure/damage caused by repair or alternation performed by any company other
than our company.
3. Failure/damage caused by the phenomenon which is due to other than our
product.
4. Failure/damage caused by the condition beyond the normal operating condition of
this analyzer such as the power supply and the installation environment.
5. Failure/damage caused by fire, earthquake, flood damage or other natural
disaster.
6. Failure/damage caused by shift or transportation performed by other than our
company after our installation.
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COPYRIGHT
Copyright of this document belongs to FURUNO ELECTRIC CO., LTD.
No part of this document shall be reproduced, transmitted, transcribed, stored in any retrieval
system, or translated into any language by any means, electronic or mechanical, including
photocopying and recording, for any purpose other than the purchase’s personal use without the
express written permission of FURUNO ELECTRIC CO., LTD.
COPYRIGHT OF INDY SOFTWARE

Portions of this software are Copyright © 1993-2003, Chad Z. Hower (Kudzu) and the Indy Pit
Crew – http://www.IndyProject.org/
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Contents
CHAPTER 1: PRINCIPLE MEASUREMENT ........................................................................................................................... 5
1.1 Absorbance measurement ................................................................................................................................ 5
1.2 Assay Techniques ............................................................................................................................................... 6
1.3 Blank measurement ......................................................................................................................................... 10
1.4 Calibration curve parameters .......................................................................................................................... 11
Chapter 2 Unit name and its function ...................................................................................................................... 16
2.1 General.............................................................................................................................................................. 16
2.2 Unit name ......................................................................................................................................................... 17
2.2.1 Analyzer overview ............................................................................................................................................ 17
2.2.2 Function for each unit ...................................................................................................................................... 19
Chapter 3 Basic operation ......................................................................................................................................... 22
3.1 Key operation ................................................................................................................................................... 22
3.2 Operation screen.............................................................................................................................................. 23
3.2.1 Icons .................................................................................................................................................................. 23
3.2.2 Status ................................................................................................................................................................ 25
3.3 Check prior and login ....................................................................................................................................... 27
3.3.1 Checks on the consumable parts ..................................................................................................................... 27
3.3.2 Check reagent volume ...................................................................................................................................... 28
3.3.3 Power OFF the operational PC ......................................................................................................................... 28
3.3.4 Power OFF the analyzer ................................................................................................................................... 28
3.4 Check calibration results ................................................................................................................................. 29
3.5 Check QC results............................................................................................................................................... 30
3.5.1 QC graph ........................................................................................................................................................... 30
3.5.2 QC Results (details) .......................................................................................................................................... 31
3.5.3 QC Results (Daily) ............................................................................................................................................. 32
3.5.4 QC Results (Cumulative) ................................................................................................................................... 33
Chapter 4 Test selection ................................................................................................................................................ 35
4.1 Sample setting .................................................................................................................................................. 35
4.2 Test selection.................................................................................................................................................... 35
4.2.1 Normal sample (N) ........................................................................................................................................... 38
4.2.2 Emergency sample addition (STAT) ................................................................................................................. 39
4.2.3 QC sample (Q) ................................................................................................................................................... 40
4.3 Test selection (other sample categories) ....................................................................................................... 41
4.3.1 Calibrator (C)..................................................................................................................................................... 41
4.3.2 Multi-Calibrator ................................................................................................................................................ 41
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4.3.3 Diluted calibration ............................................................................................................................................ 42
4.3.4 Blank sample ..................................................................................................................................................... 43
4.3.5 Mask .................................................................................................................................................................. 44
4.3.6 Orderless ........................................................................................................................................................... 44
4.3.7 Sample pipette wash ........................................................................................................................................ 45
4.3.8 ISE calibrator (option) ...................................................................................................................................... 45
4.3.9 ISE cleaning (option) ......................................................................................................................................... 46
4.3.10 ISE Etching (option) .......................................................................................................................................... 47
4.3.11 ISE activation (option) ...................................................................................................................................... 47
4.4 Template ........................................................................................................................................................... 48
4.5 Test selection (online) ....................................................................................................................................... 49
Chapter 5 Troubleshooting ............................................................................................................................................ 50
5.1 Procedures ........................................................................................................................................................ 50
5.1.1 Operation environment ................................................................................................................................... 50
5.1.2 Contact our technical support ......................................................................................................................... 50
5.2 Result problem .................................................................................................................................................. 50
5.2.1 When any troubleshooting is required ........................................................................................................... 50
5.2.2 Preparation of reagents, calibrators, and QC samples ................................................................................... 51
5.2.3 Frequent error patterns ................................................................................................................................... 51
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CHAPTER 1: PRINCIPLE MEASUREMENT
1.1 Absorbance measurement
A. Wavelengths
After mixing reagent and sample in the cuvette in the Incubation reaction unit, perform
absorbance measurement for reaction liquid in the Detector unit every 13 seconds. The
Detector unit disperses the light from halogen lamp as a source of l ight with a grading
method and measures 12 wavelengths (340, 380, 415, 450, 510, 546, 570, 600, 660, 700,
750, 800nm) at one time.
Wavelength(s) (to maximum 2 wavelengths) used for a result can be chosen from the
pre-specified 12 wavelengths.
B. Reaction time
Required reaction time for measurement varies depending on the applied reagent type.
R1 reagent + sample: approx. 10 min.

R1 + R2 reagent + sample: approx. 5 min. (R1) and approx. 5 min. (R2),
Measuring point: 23 points (R1) and 23 points (R2)

Measurement cycle: approx. 13 sec.
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1.2 Assay Techniques
There are two fundamental types: Endpoint assays and Rate Assays
Here are described on four assay techniques.
A. 1 Point End
This is an endpoint assay to measure the absorbance value after the specific tim e. When
one data collected for the specific measurement range, apply it as the absorbance. When
two data collected, the average value of them is applied as th e absorbance.
Dispense the reagent and measure the absorbance after the specific time. Under the
case as ( A: Absorbance of the measurement range, C: Water blank, B: Reagent blank).
⊿ABS = (A－C)－B
Specify by methods whether to apply reagent blank or not.

B. 2-Point End
This is an endpoint assay to measure absorbance values of 2 measuring points after the
specific time.
Absorbance is obtained from the difference between the initial and last points of the
specified measurement ranges.
Dispense the reagent and measure absorbance after the specific time.
Under the case as (A1 and A2: Absorbance of the measurement ranges, C: Water blank,
B: Reagent blank, d: correction coefficient),
⊿ABS = A2-C-B2 - d*(A1-C-B1)
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When the sample reaction only is required for reading, the sample is diluted after
dispensing R2 reagent, it results in the concentration difference between before and
after diluting. Dilution factor is applied for correcting the concentration diff erence in
dilution (after R2).
Dilution factor
d = (S+R1)/(S+R1+R2)
Where there is no volume difference between measurement range 1 and 2,
 The method for R1 reagent is applied.

 Both measurement ranges 1 and 2 are positioned after dispensing R2 No dilution
factor need to be applied in the above conditions.
⊿ABS = （A2-B2-C）- (A1-B1-C)
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C. 1 Point Rate
The 1 Point Rate assay is to measure the value of absorbance change per a unit of time.
Obtain the value of absorbance change per minute from the slope at the specified time
using least square approximation line based on data between the specified measurement
ranges.
The rate assay is to convert the absorbance slope per 1 minute in the linear gradient
range and obtain the value of the absorbance change.
Where ⊿ABSA: absorbance change per minute in sample, ⊿ABSB: absorbance change
per minute in reagent blank,
⊿ABS = ⊿ABSA - ⊿ABSB
Where there is no correction needed in reagent bank,

⊿ABS = ⊿ABSA
D. 2 Point Rate (Double Kinetic Assay)
The 2 Point Rate assay is to measure the absorbance change between the specified 2
points per unit time.
Perform measurement at two measurement ranges. Obtain the value of the
absorbance change per minute from the slopes at the specified time using least square
approximation line based on data between the specified measurement ranges.
Calculate the slope of the absorbance between measurement range 1 and 2.

Where: ⊿ABSA1 = slope of the absorbance in sample at measurement range 1,
⊿ABSB1 = slope of the absorbance in reagent blank at measurement range 1,
⊿ABSA2 = slope of the absorbance in sample at measurement range 2,
and ⊿ABSB2 = slope of the absorbance in reagent blank at measurement range 2,
⊿ABS = (⊿ABSA2-⊿ABSB2)- d*(⊿ABSA1-⊿ABSB1)
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Where: d = dilution factor,
d = (S+R1)/(S+R1+R2)
Where there is no correction needed in reagent bank,

⊿ABS = ⊿ABSA2- d*⊿ABSA1
Where there is no volume difference between measurement range 1 and 2,
 The method for R1 reagent is applied

 Both measurement range 1 and 2 are positioned after dispensing R2 reagent.
Above conditions, there is no need for applying the dilution factor.

Therefore: d=1
⊿ABS = (⊿ABSA2-⊿ABSB2)- (⊿ABSA1-⊿ABSB1)
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1.3 Blank measurement
A. Water blank measurement
Water blank measurement is to measure the absorbance after dispensing purified water
into the cuvette.
It is required for every cuvette that is used for measurement. The results will be
applied for correcting the differences between the cuvettes.
The results will be also applied for evaluating the condition of the cuvettes’ contamination.
B. Reagent blank measurement
Reagent blank measurement is to measure the absorbance of the cuvette conta ining
reagent. Correcting the sample absorbance by reagent blank value makes more
accurate measurement results.
There are four kinds of reagent blank measurements:
1. R1 reagent
2. R1 + R2 reagents
3. R1 reagent + purified water
4. R1 + R2 + purified water
For setting, select the [Chemistry Parameters 2] screen for specifying number of
measurement (Single to Triplicate) and reagent blank conditions (such as purified water
required or not) at the Reagent blank measurement at calibration.
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1.4 Calibration curve parameters
There are six calibration curve parameters for calculating measurement results. Below
are described on each calibrator, correction, ⊿ABS conversion formula, and concentration
conversion formula.
A. Factor
Enter the value of the slope obtaining by linear expression to specify. Intercept is
correctable by measuring blank sample (C1).
Calibrator: No calibration is required. This is only use for correction by C1 blank.

Absorbance change: ⊿ABS = ax + b (where x: concentration)
Where K: predefined by reagent test
B. Linear
Obtain the linear expression by measurement results of several calibrators.
Calibrator: More than 2 points required among C1 and C2-C7

Absorbance change: ⊿ABS = ax + b
Obtain ”a,b” the values of a and b by linear regression.
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C. Point to point
Obtain the linear expression among measuring points by several calibrators.
Calibrator: More than 3 points required among C1 and C2-C7 Absorbance change:
⊿ABS = ax + b
Obtain “a,b” by linear regression for each measuring point.
D. Log-Logit
Obtain the log formula by measurement results of several calibrators.
⊿ABS = k / (r + exp(-ax^3 - bx^2 - cx - d)) + 1)
E. Spline / Spline 2
Obtain the spline curve by measurement results of several calibrators.
⊿ABS = ax^3 + bx^2 + cx + d
Obtain max. 6 cubic equations by applying cubic equation for each measuring point (C1
to C7).
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Difference between “Spline” and “Spline2”
When using “Spline”, the lines at the measuring points (C1 to C 2) and (Cn-1 to Cn) show straight
linear regression if obtaining abnormal calibration curve. (Refer to Figure 2.2-19 and 2.2-20 below.)
When using “Spline2”, slopes between both ends of the calibration curves (C1 to C2) and (Cn-1 to
Cn) become zero.
Figure 2.3-19
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F. Exponential
Obtain the approximation formula of an exponential function by measurement results of
several calibrators.
Calibrator: More than 3 points required among C1 and C2-C7
Absorbance change: ⊿ABS = ax^3 + bx^2 + cx + d
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Chapter 2 Unit name and its function
Here is described on the outline of the analyzer the unit name and its function.
2.1 General
The analyzer is a desktop fully automated clinical chemistry analyzer with throughput of
270 tests per hour.
Connect to an external operational PC for operation. The measurement results can be

printed out from a printer.
This analyzer enables to connect to a host computer, when needed (ASTM Protocol
capable).
Seventy-two cuvettes, semi-disposable type, where the samples are reacted with reagents,
are located on the Incubation reaction unit (IRU), the inside of which is kept at 37ºC
constantly. After mixing reagent and sample in the cuvette in the Incubation reaction unit,
perform absorbance measurement for reaction liquid every 13 seconds. Wavelength(s) (to
maximum 2 wavelengths) used for a measurement can be chosen from 12 pre-specified
wavelengths.
The sample tray is detachable and can accommodate maximum 40 tube-holders and 10
cup-holders.The reagent tray is also detachable and can accommodate maximum 50
bottles. The Reagent container has a cooling function to keep a constant temperature (8 -
15ºC). The Barcode reading system as an optional unit enables to read information on the
reagents and samples.
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2.2 Unit name
2.2.1 Analyzer overview
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2.2.2 Function for each unit
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Figure 1.2 - 1
Figure 1.2 - 2
Function for each unit is follows.

No Unit Function
.
1 Incubation reaction unit This unit is regulated at 37±0.1ºC to promote liquid
reaction with 72 cuvettes capacity.
2 Detector unit Measures the absorbance of the reaction liquid during
reaction process.
Disperses the light from the halogen lamp as a source of
light with a grading method and measures 2 selected
wavelengths at one time.
3 Sample pipette unit Aspirates a sample from the Sample container and dispenses
it into the cuvette in the Incubation reaction unit or into the ISE
unit.
After dispensing the sample, the pipette is cleaned in the
trough after use.
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4 Reagent pipette unit Aspirates a reagent in the Reagent container and dispenses
it into the cuvette in Incubation reaction unit. After dispensing
the reagent, the pipette is cleaned in the
trough after use.
5 Stirrer unit It is paddle-type stirrer to mix the reagent and the sample
within the cuvette.
For stirring speed, select from 5 levels (low to high).
6 Washing unit Cleans the cuvettes after use.
7 Sample container Holds sample tubes or cups (maximum 40 sample tubes
and 10 sample cups). A barcode reader as an optional
unit allows sample identification from the barcode labels on
the bottles.
8 Reagent container Holds maximum 50 reagent bottles.
It is refrigerated at 8-15ºC when the analyzer is ON.
A barcode reader as an optional unit allows reagent
identification from the barcode labels on the bottles.
9 Sample syringe unit Aspirates and dispenses the samples or purified water by
moving its plungers up and down.
10 Reagent syringe unit Aspirates and dispenses the reagents or purified water by
moving its plungers up and down.
11 Wash syringe unit Aspirates and dispenses the wash solution or purified
water by moving its plungers up and down in Washing unit.
12 Supply water unit Supplies purified water or wash solution to the relevant
units, and discharges the wastewater into the external
tanks.
13 Trough unit Cleans the sample pipette, the reagent pipette, or the
stirrer.
14 Subtank unit Supplies purified water to each syringe after removing air
bubbles in the water.
15 External Tanks Each tank stores purified water or wash solution for
operation use, or wastewater generated from operation.
16 ISE unit Measures the concentration of sodium (Na), potassium (K)
(option) and chloride (CI) contained in serum, plasma, or urine by
ion electrodes.
17 Sample barcode
reader, Reads the barcode labels on the sample and reagent
Reagent barcode bottles.
reader (option)
18 Clot detection sensor It is installed in the sample syringe to detect any clots in the
unit (option) sample pipette.
19 Degassing unit Removes air bubbles in the purified water for stable
(option) measurement results.
20 External tank sensor Detects the liquid level within each tank and sends the
(option) report to the operational PC.
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Chapter 3 Basic operation
Here is described on basic operation of the analyzer.
3.1 Key operation

Operates the analyzer using the computer keyboard and mouse.
Functions for each key are as follows:
Button functions
[F1]: Start measurement
Press this key to start or restart measurement.
[F2]: Stop sampling
Press this key to stop dispensing of sample or reagent.
The window appears for modification of the reagent information.
However, measurement is continued only for the samples after dispensing.
[F3]: Emergency sample addition (STAT) Press this key to add an
emergency sample.
[F4]: Alarm
Press this key to display the alarm screen.
[F5]: Run (F5)
Press this key to switch to the [Run (F5)] menu.
[F6]: Parameter (F6)
Press this key to switch to the [Parameter (F6)] menu.
[F7]: Calibration (F7)
Press this key to switch to the [Calibration (F7)] menu.
[F8]: QC (F8)
Press this key to switch to the [QC (F8)] menu.
[F9]: System (F9)
Press this key to switch to the [System (F9)] menu.
[F10]: Maintenance (F10)
Press this key to switch to the [Maintenance (F10)] menu.
[F11]: Switch to tab menu (upward) within the selected menu. Press this key
to switch the tab menu upward.
[F12]: Switch to tab menu (downward) within the selected menu. Press this
key to switch the tab menu downward.
[Shift] + [F1]: Start orderless measurement
Press the above keys at the same time to start orderless measurement.
[Shift] + [Esc]: Alarm sound stop
Press the above keys at the same time to stop alarm sound.
[Ctrl] + [F2]: Emergency stop
Press the above keys at the same time to immediately stop operation.
[Ctrl] + [F2]: Emergency stop
Press the above keys at the same time to immediately stop operation.
10. [Ctrl] + [F5]: Print screen
Press the above keys at the same time to printout the current screen. This
function is not available during measurement process.
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3.2 Operation screen
3.2.1 Icons
Here is described on the icons and their functions displayed on the screen.
Button functions
Run (F5)
Press the icon to switch to the [Run (F5)] menu.
Monitor
Press this icon to switch to the [Monitor] screen.
Round
Press this icon to switch to the [Round] screen.
Test Selection
Press this icon to switch to the [Test Selection] screen.
Results
Press this icon to switch to the [Results] screen.
Inventory
Press this icon to switch to the [Inventory] screen.
Wakeup Setup
Press this icon to switch to the [Wakeup Setup] screen.
Auto Template
Press this icon to switch to the [Auto Template] screen.
Patient Information
Press this icon to switch to the [Patient Information] screen.
Daily Maintenance
Press this icon to switch to the [Daily Maintenance] screen.
Parameter (F6)
Press the icon to switch to the [Parameter (F6)] menu.
Chemistry Parameters 1
Press this icon to switch to the [Chemistry Parameters 1] screen.
Chemistry Parameters 2
Press this icon to switch to the [Chemistry Parameters 2] screen.
Chemistry Parameters for ISE
Press this icon to switch to the [Chemistry Parameters for ISE] screen.
Serum Indices
Press this icon to switch to the [Serum Indices] screen.
Calculated Test
Press this icon to switch to the [Calculated Test] screen.
Profile
Press this icon to switch to the [Profile] screen.
Order
Press this icon to switch to the [Order] screen.
Wash Program
Press this icon to switch to the [Wash Program] screen.
Calibration (F7)
Press the icon to switch to the [Calibration (F7)] menu.
Calibration Registration
Press this icon to switch to the [Calculation Registration] screen.
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Diluted Calibration
Press this icon to switch to the [Diluted Calculation] screen.
Multi-Calibrator
Press this icon to switch to the [Multi-Calibrator] screen.
Result of ISE Calibration
Press this icon to switch to the [Result of ISE Calibration] screen.
QC (F8)
Press the icon to switch to the [QC (F8)] menu.
QC Graph
Press this icon to switch to the [QC Graph] screen.
QC Results (Detail)
Press this icon to switch to the [QC Results (Detail)] screen.
QC Results (Daily)
Press this icon to switch to the [QC Results (Daily)] screen.
QC Results (Cumulative)
Press this icon to switch to the [QC Results (Cumulative)] screen.
QC Settings
Press this icon to switch to the [QC Settings] screen.
QC Sample Registration
Press this icon to switch to the [QC Sample Registration] screen.
System (F9)
Press the icon to switch to the [System (F9)] menu.
System Setup 1
Press this icon to switch to the [System Setup 1] screen.
Define Report Format
Press this icon to switch to the [Define Report Format] screen.
Reagent Registration
Press this icon to switch to the [Reagent Registration] screen.
Versions
Press this icon to switch to the [Versions] screen.
Backup Procedures
Press this icon to switch to the [Backup Procedures] screen.
System Setup 2
Press this icon to switch to the [System Setup 2] screen.
Definition
Press this icon to switch to the [Definition] screen.
Normal Range
Press this icon to switch to the [Normal Range] screen.
Maintenance (F10)
Press the icon to switch to the [Maintenance (F10)] menu.
Sequence
Press this icon to switch to the [Sequence] screen.
Water Blank
Press this icon to switch to the [Water Blank] screen.
Working Hour Counters
Press this icon to the [Working Hour Counters] screen.
Performance
Press this icon to switch to the [Performance] screen.
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Sensor
Press this icon to switch to the [Sensor] screen.
Volume Adjustment (for maintenance only)
Press this icon to switch to the [Volume Adjustment] screen.
Setup Password
Press this icon to switch to the [Setup Password] screen.
DTR Positioning
Press this icon to switch to the [DTR Positioning] screen.
Shutdown
Pop-up message appears for system shutdown.
Sleep
Displays the window for sleep mode.
In the operational mode: Before sleep setting window appears.
In the sleep mode: Confirmation window to wake-up from sleep mode appears.
Alarm (F4)
Press this icon to switch to the [Alarm] screen.
3.2.2 Status
The pop-up message indicating the system status appears in the upper left of the screen.
Following are the displayed messages.
1. Not ready
Not ready for connection between the analyzer and the operational PC. Or
the analyzer is OFF.
2. Pre-ready
The analyzer is ON, however, preparatory operation such as dispensing into
cuvettes and priming has not been completed.
3. Ready
It is ready for starting measurement.
4. Measurement
Measurement is performed.
5. STAT-measurement
Measurement for an emergency sample is performed as a priority.
Measurement for normal samples and QC samples is not performed.
6. MSStopping
Dispensing is stopped due to sample addition.
Or dispensing is completed.
7. ESStopping
Since an error occurs, dispensing is stopped.
8. Sleeping
The analyzer is in sleep mode.
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9. Maintenance
Maintenance procedures are performed.
10. Emergency Stop

The analyzer is emergency stopped due to errors or user’s operation.
11. Sampling stop in progress

The error that continuous dispensing is not performed occurs.
12. Sampling stop complete

The measurement has been completed after the dispensing interruption due
to an error.
13. Maintenance complete

Maintenance procedures are completed.
14. Em Stop in progress
Emergency stop is executed.
15. Em Stop Complete in progress

Ending procedure for Emergency stop is performed.
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3.3 Check prior and login
When starting up the operational software after power ON the analyzer and the
operational PC, the screen appears to enter log-in name and password.
Enter the log-in name and the password. Press icon.
3.3.1 Checks on the consumable parts
Maintenance (F10) > Working Hour Counters Check the condition for
each consumable part prior to measurement.
Check the following points on the external tank condition.
 Enough purified water in the purified water tank
 Enough capacity in the wastewater tank
 Enough wash solution in the wash solution tank
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3.3.2 Check reagent volume
Run (F5) > Inventory
Check whether the remaining volume of reagents in the Reagent container is enough for
running the ordered tests.
When applying the reagent barcode reader, click the [Reagent Scan] button every time
adding the reagent on the Reagent container to update the reagent information.
Click the [Reagent Scan] button to rotate the Reagent container and read the barcode
labels that includes the type, number, and full volume of each reagent.
3.3.3 Power OFF the operational PC

Shutdown
A. Power OFF
Power OFF the operational PC by the following procedure.
1. Click the “Shutdown” icon.
2. Then click the [Power Off] button.
3. The operational PC will be turned OFF automatically.
B. Cancel
1. Click the “Shutdown” icon.
2. Then click the [Cancel] button.
3. Returns to the operation screen.
3.3.4 Power OFF the analyzer

Turn OFF the power supply switch at the left side of the analyzer.
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3.4 Check calibration results
Calibration (F7) > Calibration Registration Confirm the calibration

results prior to measurement.
1. Select the Method No. from drop-down menu.
2. The calibration results and the curve are displayed for the selected method.
3. Two calibration results for the two reagent lot numbers (New and Old) can be
saved.
Select the Reagent Lot (New or Old) to display either of the calibration results.
4. After checking the results, perform calibration if necessary. Creates and updates
the calibration curves.
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3.5 Check QC results
Confirm the QC measurement data results at the beginning of a day of measurement.
3.5.1 QC graph
QC (F8) > QC Graph

This screen is available to display the QC graphical results indicating three colors to
indentify whether any error occurs.
Two display types (daily and cumulative) are selectable for QC graph from drop-down
menu.
A. Search area
This area enables to specify the QC measurement data results for search.
B. Graph area
This area enables to display QC graph that specified at the search area.
1. Display Type “Daily”
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2. Display Type “Cumulative”
3. Units for QC graphs

QC graph displays in number of data (N), Mean (X), Standard deviation (SD), Coefficient
of variance % (CV) by statistical calculation of all QC data by sample.
N: (number of data samples)
X: (Mean value)
SD: (Standard deviation)
CV: (Coefficient of variance)
Results with error are not included.
Graph indicates in the following color description.
(Black): NORMAL
(Yellow): WARNING
(Red): ERROR
3.5.2 QC Results (details)
QC (F8) > QC Results (Detail)

QC and the judgment results are displayed per measurement round by the specified
method item and date.
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A. Search area
B. Search result list

This area enables to display QC results list that specified at the search area.
3.5.3 QC Results (Daily)
QC (F8) > QC Results (Daily)

This screen indicates the summed up QC results for the specified QC samples per day.
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A. Search area
This area enables to specify the QC measurement data for search.

This area enables to display QC results in the method items that specified at the search
area.
3.5.4 QC Results (Cumulative)
QC (F8) > QC Results (Cumulative)

This screen indicates the summed up QC results for the specified QC samples for the
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specified period.
A. Search area

This area enables to display QC results in the method items that specified at the search area.
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Chapter 4 Test selection
4.1 Sample setting
Here is described on sample setting in the Sample container. There are two trays (Outer and
Inner) in the Sample container.
A. Outer tray
Layer 1: position # 1 - 20
Layer 2: position # 21 – 40
B. Inner tray
Inner tray: position # 41 – 50
C. Sample tubes and cups

1. Sample tubes (in Outer tray):
Diameter: 12 – 16 mm
Length: 75 – 100 mm
Since this analyzer does not have piercing function, remove the rubber cap from the sample
tube in advance.
2. Sample cups (in Inner tray):
Normal size: 17mm “ϕ” ×38mm (2.0ml)
Pediatric size: 14mm “ϕ” x 25mm (0.5ml)

D. Sample positioning
Measurement starts in numeric order accordingly. The samples in the Inner tray are measured
prior to those in the outer tray. Tray selection varies depending on the sample type.
When performing calibration at the same round, assign younger position # for the calibrators
than the position # for the normal samples.
4.2 Test selection
Run (F5) > Test Selection

Order a measurement test for each sample category (normal sample, emergency sample,
calibrator, and etc.).
Specify the location of the ISE wash solution and wash solution for the sample pipette wash on
this screen.
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1. Start
Specify the start position # in the Sample tray.
Select the position # (1 to 50) from drop-down menu.
Or specify the position directly from SID list.
For the samples with Barcode labels, do not specify position # and leave as blank.
The position # 41 to 50 is not available for normal and emergency samples.

2. End
Specify the end position # to copy or delete. (This is effective only when checking on “C/D”.)
⚫ Sample Barcode Reader (option)
When applying barcode reader for Sample ID, no position assignment is required.
Depending on the Sample category, reading barcode labels from barcode reader allows to
register and measure automatically.
For details, refer to the method list for each Sample category.
3. Sample Category
Sample Category Description

Normal Order registration for normal sample
STAT Order registration for emergency sample
Calibrator Order registration for calibrator
Multi Calibrator Order registration for multi-calibrator
Diluted Calibration Order registration for diluted calibrator
QC Sample Order registration for QC Sample
Blank Order registration for blank sample
Mask Registration for mask function
36
Orderless Registration for orderless measurement function
Wash Solution Order registration for Sample pipette wash solution
ISE Calibrator Order registration for H solution
ISE Cleaning Order registration for ISE cleaner
ISE Etching Order registration for Etching
ISE Activation Order registration for ISE Activator
4. Other funtion
Template Select the Template from drop-down menu.
Select the round to be edited. Select the round from “Current Round”
Round
(1st), “Next Round” (2nd) and “Round After Next” (3rd).
Cup Select “Normal” or “Pediatric” from drop-down menu.
Check the “Sample Barcode” ON when applying barcode reader to enter the
Sample Barcode
sample ID.
C/D Check “C/D” ON when copying or deleting the registered order.
E Check “E” ON when specifying normal sample as an emergency sample.
SID Enter the Sample ID.
Select the Sample Type (Serum, Urine, Plasma, or Others) from drop-down
Sample Type
menu.
Normal Range Select or enter the Normal Range from a pop-up window for registration.
PID Select or Enter the Patient ID (PID) from a pop-up window for registration.
Collection Date Enter blood collection date.
Physician Select or enter Physician name from a pop-up window for registration.
Department Select or enter the Department from a pop-up window for registration.
Select the Sample comment from drop-down menu if any registered

Sample Comment
information.
Specify measurement number for replicate measurement. (This is effective for
Number
normal sample and emergency sample.)
Select the Sample volume (Low, Normal, or High) for initial measurement from
Sample Volume drop-down menu. For the figures for each volume, specify in the [Chemistry
Parameters1] screen.
SID List Indicates information on the sample ID and its category, etc.
Restart Perform to restart measurement. (Effective only when adding a sample.)
Rotate Sample
It gives the Sample tray rotation. (Effective only when adding a sample.)
Container
It receives the order information from Host computer.
Acquire orders
It is effective in “On Line Batch” or “On Line Real time” mode.
Obtain order information that registered for future rounds. Order for “Next
Obtain the next
Round” will be transferred to “Current Round”, and order for “Round After Next”
order
will be transferred to “Next Round”. “RoundAfter Next” will be vacant.
Save Saves the setting.
37
5. Method display
This area indicates the method status for normal and ISE measurement in color description.
The highest warning (in RED) will be displayed if more than two warnings are applied.
Priority Background Warning description
High Red Calibration invalid or required.

Low Yellow QC measurement invalid or required.
- Gray The method is masked, or will not be
run.
4.2.1 Normal sample (N)

Measurement starts in “Pos” numerical order.
Inner tray is not available for normal samples.
A. Order setting procedure (with sample barcode reader)

1. Select "blank” on the Start# from drop-down menu.
2. Enter the Sample ID.
3. Specify the methods.
4. Check the method name ON to specify.
5. Click the “Save” icon to confirm the order.
B. Order setting procedure (without sample barcode reader)

1. Select the Start# from drop-down menu for a sample.
2. Select the sample cup (“Normal” or “Pediatric”) from drop-down menu.
3. Select “Normal” in the Sample category from drop-down menu.
4. To preferentially order a normal sample as Emergency, check ON at “E” when
adding the sample on the tray.
5. Enter “Sample ID”.
Available entry range: 3 to 15 digits
In the default setting, the assigned Pos. # automatically becomes the Sample ID.
6. Select or enter the Normal range.
In the default setting, it is “Human Auto”.
7. Select or enter the Patient ID from a pop-up window for registration
8. Specify blood collection date.
9. Select or enter the Physician, the Department, and the Sample Comment.
38
10. Specify the Number (number of measurement) for the selected method from drop-
down menu.
11. Specify the method.
12. Click the “Save” icon to save the order.
C. Copy procedure
To copy the same order to several sample orders,
1. Select the Start # as the beginning Position # for copying from drop-down menu.
2. Check “C/D" ON.
3. Select the End # as the end Position # for copying from drop-down menu.
4. When copying an existing order, no need to specify the methods.
5. When copying a new order to several positions, specify the methods for the copied
orders.
D. Delete procedure
1. Click the “Delete All” icon to delete all orders.
2. When deleting the specific order, select the SID or PID on the SID list and click the
“Delete” icon.
3. When deleting a series of SID, check “C/D” ON.
4. Specify the Start # and the End # and click the “Delete” icon.
4.2.2 Emergency sample addition (STAT)

Measurement starts in “Pos” numerical order. When adding an emergency sample
during measurement in process, the emergency measurement is given priority over the
normal samples. Inner tray is not available for emergency samples.

2. Specify the methods.
Check the method name ON to specify.
39
B. Order setting procedure (without sample barcode reader)
1. Select the Start# (among the designated STAT positions) from drop-down menu.
2. Select “STAT” in the Sample category from drop-down menu.
3. Select the sample cup.
Select the cup type (“Normal” or “pediatric”) from drop-down menu.
4. Specify the Sample ID.
5. Enter “Patient ID”. For registration, refer to “6.2.1. Normal sample (N)”.
4.2.3 QC sample (Q)

Order a QC sample measurement. Measurement starts in “Pos” numerical order
Both outer and inner trays are available for setting QC samples.
When setting the QC samples in inner tray, they are measured prior to those in outer tray.

No order registration is required except placing necessary QC samples in the Sample
container.
B. Order setting/Delete procedure (without sample barcode reader)
For the QC samples set in inner tray or without managing with barcode reader, follow the
procedure below.
1. Select the Start# from drop-down menu.
2. Select “QC sample” in the Sample category from drop-down menu.
3. Select the QC name from drop-down menu.
4. The registered method items are automatically selected.
5. Click the “Save” icon to save the order. The SID for the QC sample is listed on the
SID list.
6. For deleting, click the SID on the SID list, click “Delete” icon. For the deletion
confirmation, click the “Save” icon.
40
4.3 Test selection (other sample categories)
4.3.1 Calibrator (C)

Order a calibration measurement. Measurement starts in “Pos” numerical order.
Calibrator is available to set in both Inner and Outer trays. The calibrators in Inner tray
will be measured first.

No order registration is required except placing necessary calibrators in the Sample
container.
For the calibrators set in Inner tray or without managing with barcode reader, follow the
procedure below.
1. Specify the Pos. # (1 – 50) for calibrator from drop-down menu.
2. Select “Calibrator” in the Sample category from drop-down menu.
3. Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down menu.
4. Specify the method. When checking ON at the method name, its measurement will
be ordered.
The method that registered on the [Calibration Registration] screen is available to be
ordered.
6. For deleting, click the SID on the SID list, click the “Delete” icon. For the deletion
4.3.2 Multi-Calibrator
Order a multi-calibration measurement
Using a single set of calibrators, prepare several calibration curves for the methods.
Measurement starts in “Pos” numerical order.
Multi-Calibrators can be set in both Inner and Outer trays. The multi-calibrators in the
Inner tray will be measured first.
41
No order registration is required except placing necessary multi-calibrators in the Sample
container.
For the multi-calibrators set in Inner tray or without managing with barcode reader, follow
the procedure below.
Specify the Pos. # (1 – 50) for multi-calibrator from drop-down menu.

1. Select “Multi-Calibrator” in the Sample category from drop-down menu.
3. Select a multi-calibrator name on “MS” from drop-down menu.
4. The registered method items are ordered.
5. Select number of measurement on “No.” from drop-down menu. When performing
regular calibration, select "Full” on “No.” from drop-down menu. When performing
recalibration, select the calibrator # (C1 to C7) for calibrator on the SID list.
6. Click the “Save” icon to save the order. The SID for the Multi-Calibrator sampleis
listed on the SID list.
4.3.3 Diluted calibration

Prior to the measurement, conditions for diluting are required to be set on the [Diluted
Calibration] screen.
Diluted Calibrators are available to set in both Inner and Outer trays. The Diluted
Calibrator in the Inner tray will be measured first.
42
No order registration is required except placing necessary diluted calibrators in the
Sample container.
For the diluted calibrators set in Inner tray or without managing with barcode reader,
follow the procedure below.
1. Specify the Start# for the Diluted Calibrator from drop-down menu.
2. Select “Diluted calibration” in the Sample category from drop-down menu.
4. Specify the method. Check the method ON for the measurement order.
5. Click the “Save” icon to save the order. The SID for the Diluted calibration sample
is listed on the SID list.
4.3.4 Blank sample

Order a blank sample (C1: no-concentration calibrator) measurement for recalibration.
Measurement starts in “Pos” numerical order. Blank sample is available to set in both Inner
and Outer trays. The blank samples in Inner tray will be measured first.

No order registration is required except placing necessary blank samples in the Sample
container.
For the blank samples set in Inner tray or without managing with barcode reader, follow
the procedure below.
1. Specify the Start# for a blank sample from drop-down menu.
2. Select “Blank” in the Sample category from drop-down menu.
4. All of the methods registered on the [Parameter (F6)] > [Chemistry Parameters 2]
screen are ordered to correct a calibration curve using C1 Blank.
5. Click the “Save” icon to save the order. The SID for the blank sample is listed on the
SID list.
43
4.3.5 Mask
The Mask setting allows to set methods not performed. The methods indicate in a
measureable status that has analysis conditions, the calibration curves, and its reagents in
the Reagent container.
A. Mask selection/release
1. Select “Mask” in the Sample category from drop-down menu.

2. Select the Mask type (Normal, QC sample, or Calibrator) from drop-down menu.
3. The mask status on the methods is displayed.
4. By checking the method ON to unselect the mask, the method becomes unmasked
and measurable status.
5. To make all methods masked, click the [Mask All] button.
After clicking this button, it is changed into the [Clear All] button.
6. To make all methods unmasked, click the [Clear All] button.
4.3.6 Orderless
Orderless selection allows to perform measurement in all methods available for all
samples in the Sample container.
Prior to orderless measurement, specify the methods to be measured.
44
A. Setting procedure for orderless measurement
1. Select “Orderless” in the Sample category from drop-down menu.

3. Select the Normal range from the pop-up list by clicking the drop-down menu. It is
“Human Auto” as the default setting.
4. Specify the Number (number of measurement) for the selected method from drop-
down menu.
5. Specify the methods to be measured or not.
6. When checking ON at the method name, its measurement will be ordered.
4.3.7 Sample pipette wash

Register the position of the wash solution for cleaning the sample pipette.
With the sample barcode reader, the position of the wash solution is confirmed by reading
the barcode label.
Without the sample barcode reader, the wash solution position needs to be specified.
Apply Wash solution C-1 solution by making a 1% Wash solution C-1 solution.
A. Setting procedure for wash solution
1. Select the Start # from drop-down menu for the wash solution.
2. Select “Wash Solution” in the Sample category from drop-down menu.
B. Deletion procedure for wash solution
1. Select the Start # from drop-down menu for the wash solution.
2. Click the “Delete” icon to delete the order.
3. Click the “Save” icon to confirm the deletion.
4.3.8 ISE calibrator (option)

Register the position of ISE calibrator (H Solution) for ISE calibration. For the ISE
calibration, refer to “5.2.1 Perform ISE calibration.”
45
A. Setting procedure for ISE calibrator
1. Select the Start # from drop-down menu for the ISE calibrator.
2. Select “ISE Calibrator” in the Sample category from drop-down menu.
3. Click the “Save” icon to save the order
B. Deletion procedure for ISE calibrator
1. Select the Start# from drop-down menu for the ISE calibrator.
4.3.9 ISE cleaning (option)

Register the position of ISE Cleaner for ISE cleaning.
A. Setting procedure for ISE cleaning solution
1. Select the Start # from drop-down menu for the ISE cleaning solution.
2. Select “ISE Cleaning” in the Sample category from drop-down menu.
46
B. Deletion procedure for the ISE cleaning solution
1. Select the Start # from drop-down menu for the ISE cleaning solution.
4.3.10 ISE Etching (option)

Register the position of ISE etching solution for cleaning Na electrode.
A. Setting procedure for the ISE Etching
1. Select the Start # from drop-down menu for the ISE Etching.
2. Select “ISE Etching” in the Sample category from drop-down menu.
B. Deletion procedure for the ISE Etching
1. Select the Start # from drop-down menu for the ISE Etching.
3. Click “Save” icon to confirm the deletion.
4.3.11 ISE activation (option)

Register the position of ISE activator (serum or specific QC sample). ISE activation is
required for stable results after electrode replacement.
47
A. Setting procedure for the ISE activation
1. Select the Start # from drop-down menu for the ISE activator.
2. Select “ISE Activation” in the Sample category from drop-down menu.
B. Deletion procedure for the ISE activation
1. Select the Start # from drop-down menu for the ISE activator.
4.4 Template
Order a template order on the designated position that set the sample in the sample tray with
its specified methods as a set order.
The template is required to register in the [Auto Template] screen prior to selecting in the [Test
Selection] screen.
1. Select the template # in the Template from drop-down menu.
2. After selecting the template #, the following pop-up message appears to overwrite the order
information of the registered screen. To overwrite the information, click the [OK] button.
48
4.5 Test selection (online)
For online test order, host communication is required with either “Online real time” or “Online
batch mode”.
<When applying the Sample barcode reader>

When selecting “On line Real time” at the Host Communication Mode on the [System Setup 1]
screen, automatically receives orders from host connection and no need the order setting.
When selecting “On Line Batch” at the Host Communication Mode on the [System Setup 1]
screen, it needs to obtain orders from host communication.
<When not applying the Sample barcode reader>

When selecting “On Line Real time” at the Host Communication Mode on the [System Setup 1]
screen, it needs to register the position # and the SID to specify the position # manually placed
on the sample tray.
When selecting “On Line Batch” at the Host Communication Mode on the [System Setup 1]
screen, it needs to register the position # and the SID to specify the position # manually placed
on the sample tray. It also needs to obtain orders from host communication.
A. Order setting procedure (in the “On Line Batch mode” with the Sample barcode reader)
1. Select "blank” on the Start # from drop-down menu.
3. Click the [Acquire orders] button.
B. Order setting procedure (in the On Line Real time mode without the Sample barcode reader)
1. Select the Start # from drop-down menu.
3. Click the “Save” icon to confirm the order
C. Order setting procedure (in the On Line Batch mode without the Sample barcode reader)
1. Select the Start # from drop-down menu.
3. Click the [Acquire orders] button.
49
Chapter 5 Troubleshooting
5.1 Procedures
5.1.1 Operation environment
If any errors occur when using the analyzer, check the following points.
 Preparation and storing of reagents
 Preparation and handling of samples
 Operating instructions for the analyzer
 Maintenance procedure
5.1.2 Contact our technical support

When you contact our technical support regarding the measurement results or
mechanical problems, prepare the following information.
A. Operation problems
 Serial number
 Method information that assume problems
 Description on the problem
 Manufacturer's serial number and the lot number of the reagent, the calibrator,
and QC sample
 Latest results on the calibrator
 Latest results on the QC sample
 Measurement results
B. Instrument problems
 Serial number
 Software version number
 The relevant alarm message and the error description
 Other instruments or maintenance related information
5.2 Result problem

5.2.1 When any troubleshooting is required
The analytical errors include the results with flags and unexpected values. The
troubleshooting is required in the following cases.
 Error flags on the calibrator results.
 Error flags on the QC sample or normal sample results
50
 The QC sample results out of the normal range
Check the following points on results of the calibrators, the QC samples, or the normal
samples.
 The results on the specific method are high in all samples.
 The results on the specific method are low in all samples.
 Randomly resulted in the unexpected values.
 The unexpected values on all methods for the specific sample.
 The unexpected values in several results.
5.2.2 Preparation of reagents, calibrators, and QC samples

Check the following point on the widely plotted results.
When preparing reagents, calibrators, and QC samples, be sure to follow its procedure
described on each operator’s manual.
 Preparation of reagents
 Preparation of QC samples
 Preparation of calibrators
5.2.3 Frequent error patterns

A. The results on the specific method are high in all samples
Cause Action
Check the preparation of the calibrator. Check that
The calibration result is not correct. the calibration setting is appropriate. Re-calibrate if
necessary.
Check the temperature displayed in the screen. If
The temperature in Incubation Reaction unit is too high. the temperature does not indicate within 37+-0.1ºC,
contact our technical support.
The reagent has not been appropriately prepared. Check the preparation of the reagent.
The calibrator has not been appropriately prepared Check the preparation of the calibrator.
51
B. The results on the specific method are low in all samples.
Cause Action
Refer to its operator’s manual regarding the stability

The validity term of the reagent is expired.
of the prepared reagent.
The reagent has not been appropriately prepared. Check the preparation of the reagent.
The reagent has not been appropriately stored. For storing, refer to its operator’s manual.
Check the temperature displayed in the screen. If
The temperature in Incubation Reaction unit is too low. the temperature does not indicate within 37+-0.1ºC,
contact our technical support.
The calibrator has not been appropriately prepared. Check the preparation of the calibrator.
Check that there is no leakage or dripping on the

The dispensing volume of the reagent is too high.
joint area of the reagent dispensing system.
C. Randomly resulted in the unexpected values.
Cause Action
Perform pipette washing and confirm that enough volume

Contamination is observed in the sample pipette or the
of the wash solution is dispensed into the
reagent pipette.
trough area.
Fibrins are observed in the specific sample tubes or

Perform the sample pipette wash to remove fibrins.
the sample cups.
Check that the supply tube is positioned at the lower than

Insufficient volume supplied from the external tank. the liquid level. If any problems, contact our technical
support.
Check that the stirrer rotates at the center of the cuvette in

appropriate speed. Check the stirring condition whether
The insufficient stirring is observed.
there is no abnormal noise such as scratch sound in the
cuvette.
52
D. The unexpected values on all methods for the specific sample.
Cause Action
Perform new preparation of reagent referring to the

The reagent has not been appropriately prepared.
operator’s manual.
The validity term of the reagent is expired. The reagent Perform new preparation of reagent referring to the
is observed contamination. The reagent is discolored. operator’s manual.
E. The unexpected values in several results.
Cause Action
The liquid leakage is recognized at the dispensing

Check the tube connections at the pipette and the syringe.
system (the sample pipette or the reagent pipette).
Check the temperature displayed in the screen. If the

The temperature in Incubation Reaction unit is out of the
temperature does not indicate within 37+-0.1ºC, contact
expected range.
our technical support.
Check that the stirrer rotates at the center of the cuvette in

appropriate speed. Check the stirring condition whether
The insufficient stirring is observed.
there is no abnormal noise such as scratch sound in the
cuvette.
53

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1

COPYRIGHT OF INDY SOFTWARE

R1 reagent + sample: approx. 10 min.

Measuring point: 23 points (R1) and 23 points (R2)

Specify by methods whether to apply reagent blank or not.

⊿ABS = A2-C-B2 - d*(A1-C-B1)

Where there is no volume difference between measurement range 1 and 2,

 The method for R1 reagent is applied.

⊿ABS = （A2-B2-C）- (A1-B1-C)

Specify by methods whether to apply reagent blank or not.

Where there is no correction needed in reagent bank,

Calculate the slope of the absorbance between measurement range 1 and 2.

Where there is no correction needed in reagent bank,

 The method for R1 reagent is applied

Above conditions, there is no need for applying the dilution factor.

⊿ABS = (⊿ABSA2-⊿ABSB2)- (⊿ABSA1-⊿ABSB1)

B. Reagent blank measurement

Calibrator: No calibration is required. This is only use for correction by C1 blank.

Calibrator: More than 2 points required among C1 and C2-C7

Connect to an external operational PC for operation. The measurement results can be

Function for each unit is follows.

3.1 Key operation

10. Emergency Stop

11. Sampling stop in progress

12. Sampling stop complete

13. Maintenance complete

15. Em Stop Complete in progress

Enter the log-in name and the password. Press icon.

3.3.1 Checks on the consumable parts

Check the following points on the external tank condition.

 Enough purified water in the purified water tank

 Enough capacity in the wastewater tank

 Enough wash solution in the wash solution tank

Run (F5) > Inventory

3.3.3 Power OFF the operational PC

Power OFF the operational PC by the following procedure.

1. Click the “Shutdown” icon.

2. Then click the [Power Off] button.

3. The operational PC will be turned OFF automatically.

1. Click the “Shutdown” icon.

2. Then click the [Cancel] button.

3. Returns to the operation screen.

3.3.4 Power OFF the analyzer

Calibration (F7) > Calibration Registration Confirm the calibration

1. Select the Method No. from drop-down menu.

QC (F8) > QC Graph

1. Display Type “Daily”

3. Units for QC graphs

N: (number of data samples)

SD: (Standard deviation)

CV: (Coefficient of variance)

Results with error are not included.

Graph indicates in the following color description.

3.5.2 QC Results (details)

QC (F8) > QC Results (Detail)

B. Search result list

3.5.3 QC Results (Daily)

QC (F8) > QC Results (Daily)

B. Search result list

3.5.4 QC Results (Cumulative)