SPOTCHEM EZ

SP-4430
Operating Manual
Premise

This manual contains important information on the functions of the

SPOTCHEM EZ SP-4430.

supplied by : ARKRAY, Inc.

This manual is issued by: ARKRAY, Inc.

Read carefully prior to starting up the unit.
It is recommended to retain this manual for future use.

This product conforms to Directive 89/336/EEC, as amended by

Directive 92/31/EEC, and to Directive 73/23/EEC. 89/392/EEC.
Introduction

The SP-4430 is an automated biochemical analyzer using a dry

chemistry system.

This manual contains outlines, instructions for the operation,

maintenance and troubleshooting for the SPOTCHEM SP-4430.
Before operating the SP-4430, read this manual carefully.
It is recommended to retain this manual for future use.

WARNING
Always be careful when handling blood samples or waste reagent
strips. Incorrect or imprecise procedures may result in exposure
to pathogenic microbes.

This analyzer must only be operated by those trained in proper

procedures for clinical testing and handling of hazardous waste.
Anyone who operates the analyzer for the first time must be
assisted by a trained person.

Never touch the Reagent Table, Centrifuge-equipped Multi Rack,

or other places where sample residue may collect with bare
hands. When performing maintenance, always wear protective
gloves to prevent exposure to pathogenic microbes.

Separate used samples, tips and protective gloves from general

waste and discard them according to local regulation on
biohazardous waste.

All rights reserved. Reproduction of this manual is forbidden.

The contents of this manual are subject to change without further notice.
Although we take all possible measures to ensure the contents of this manual, please notify your distributor
when you have questions, or find errors or omission.
Caution Marks

Pay careful attention to these caution marks in this Operating Manual.

Regarding accident resulting in injury or death.

To prevent infection of yourself or others from

WARNING pathogenic microbes, follow the instructions given
herein.
To prevent injuries to yourself or others, or material
CAUTION damages, follow the instructions described.

Regarding damage and performance of products.

Failure to follow the instructions may lead to incorrect

IMPORTANT results.

To prevent damage to the unit and assist you in making

NOTE best use of the capabilities of the analyzer, additional
explanations and notes are provided herein.
Reference information on operation, additional
explanations and related functions are provided herein.
Caution Stickers are adhered to the SP-4430 to
prevent accidents as below.
The descriptions are given on the following pages.

Biohazard cautions.
Wear protective gloves to prevent exposure to pathogenic microbes.

The centrifuge turn round at high speed.

Keep your hands off when mesurement is in process.
Biohazard cautions.
Wear protective gloves to prevent exposure to pathogenic microbes.

Biohazard cautions.
Wear protective gloves to prevent exposure to pathogenic microbes.
Contents
Automated biochemical analyzer, SP-4430

Premise 01
Introduction 02
Caution Marks 03
Caution Labels 04
Contents 05

Chapter 1 1-1 Outline 1-02

INTRODUCTION 1-1-1 Features 1-02
1-1-2 Measurement principles 1-03
1-1-3 Specifications 1-04
1-2 Shipping Carton 1-05
1-2-1 Analyzer 1-05
1-2-2 Accessories 1-06
1-3 Parts Description and Function 1-07
1-3-1 Front of the analyzer 1-07
1-3-2 Operator panel 1-08
1-3-3 Rear of the analyzer 1-09
1-4 Setting up the Analyzer 1-10
1-4-1 Cautions 1-10
1-4-2 Setting up the analyzer 1-12
1-4-3 First operation after setting up 1-13
1-4-4 Notes at transportation 1-15

Chapter 2 2-1 Outline of Measurement 2-02

MEASUREMENT 2-1-1 SPOTCHEM Reagent Strips 2-02
2-1-2 Normal measurement 2-03
2-1-3 Calibration 2-04
2-2 Cautions 2-06
2-2-1 Cautions 2-06
2-2-2 Handling samples 2-07
2-2-3 Handling Reagent Strips 2-07
2-2-4 Handling magnetic cards 2-08
2-2-5 Handling tips 2-08
2-2-6 Handling centrifuges 2-09
2-3 Preparation for Measurement 2-10
2-3-1 Preparation 2-10
2-3-2 Startup 2-11
2-3-3 Checks before measurement 2-12
2-3-4 Preparation of samples 2-13
2-4 Measurement 2-18
2-4-1 Normal measurement 2-18
 2-5 Calibration 2-28
2-5-1 Overview of calibration 2-28
2-5-2 Calibration by magnetic card 2-29
2-5-3 Calibration by calibrator kit 2-31
2-6 Interpreting measurement results 2-39
2-6-1 Printing normal measurement results 2-39
2-6-2 Printing calibration results 2-42

Chapter 3 3-1 Overview of SUB MENU 3-02

SUB MENU 3-1-1 Composition of SUB MENU 3-02
3-2 Measurement Results Menu 3-04
3-2-1 Print measurement results 3-04
3-2-2 Transmit measurement results 3-06
3-2-3 Delete measurement results 3-08
3-3 Parameter Menu 3-10
3-3-1 Print parameters 3-10
3-3-2 Enter parameters 3-13
3-3-3 Initialize parameters 3-17
3-3-4 Enter sample type 3-19
3-3-5 Copy standard range setting 3-21
3-4 Maintenance 3-23
3-5 Mode Menu 3-24
3-6 Built-in Clock Adjustment 3-25

Chapter 4 4-1 Outline of Maintenance 4-02

MAINTENANCE 4-1-1 Frequency of Maintenance 4-02
4-2 Daily Maintenance 4-03
4-2-1 Cleaning the Reagent Table 4-03
4-2-2 Cleaning the Tip Waste Case and Protective Cover 4-06
4-3 Periodic Maintenance 4-08
4-3-1 Replacement of Thermal Printer Paper 4-08
4-3-2 Cleaning the Optical Window 4-10
4-3-3 Cleaning the Nozzle 4-13
4-3-4 Replacement of Nozzle 4-16

Chapter 5 5-1 Error Messages 5-02

TROUBLESHOOTING 5-2 Trouble Messages 5-07
5-3 After sales service 5-11

Chapter 6 6-1 Transmission Specifications 6-02

APPENDIX 6-1-1 Protocol 6-02
6-1-2 Format 6-03
6-1-3 Format for measurement results (format 1) 6-04
6-1-4 Format for measurement results (format 2) 6-08
Chapter 1

INTRODUCTION
The SP-4430 is an automated biochemical analyzer using a dry
chemistry system. This chapter contains the information on the
functions and measurement principles of the SP-4430.

1-1 Outline
1-1-1 Features
1-1-2 Measurement principles
1-1-3 Specifications

1-2 Shipping Carton

1-2-1 Analyzer
1-2-2 Accessories

1-3 Parts Description and Function

1-3-1 Front of the analyzer
1-3-2 Operator panel
1-3-3 Rear of the analyzer

1-4 Setting up the Analyzer

1-4-1 Cautions
1-4-2 Setting up the analyzer
1-4-3 First operation after setting up
1-4-4 Notes at transportation
1-1 Outline Chapter 1 INTRODUCTION

1-1-1 Features

Compact and lightweight The footprint of the SP-4430 is as small as that of a

design notebook computer. It weighs only 5 kg and can be
easily carried by one person. The small unit contains
various components such as a display, printer, 1-
sample centrifuge and automatic tip disposal
mechanism. No water supply or drainage system is
required, therefore it is suitable for examinations in
schools or bedside in hospitals. Power consumption
is greatly reduced.

Energy-saving design Power consumption per 1 hour is approximately 50 W

on average (AC 100V, 60Hz when continuous
measurements are conducted).

Automatic Sampling The analyzer automatically absorbs samples set on the

Centrifuge-equipped Multi Rack and drops them on
reagent strips. Manual operation is not necessary, so
that the sampling amount becomes constant and
stable measurement results can be obtained.

Built-in centrifuge for The analyzer has a built-in centrifuge for 1 sample. By
1 sample placing the whole blood sample in the centrifuge tube
and setting it on the Centrifuge-equipped Multi Rack,
the operation, centrifugation suction sampling is
conducted automatically. This saves centrifugation of
whole blood samples before measurement.

Simple calibration using Calibration using magnetic cards Reagent Card are
magnetic cards provided with the Reagent Strips is possible, without
using the SPOTCHEM Calibrator Kit. By inserting
magnetic cards into the magnetic card reader,
differences between reagent strip lot number and daily
deviations are automatically calibrated.

Sample Control by Bar Optional Hand-held Bar Code Reader is available. By

code reading the bar code of each sample, the bar code is
automatically allocated as patient ID.

Online Network through With the optional Data Management Software and
two-way Transmission external devices, remote control of measurement
results and remote update of parameter settings are
possible.
1-1 SP-4430 Chapter 1 INTRODUCTION

1-1-2 Measurement principles

The light emitted from LED becomes monochromatic light of a certain wavelength after
passing through an optical fiber (Five different types of optical filters are provided, and the
optimum wavelength is selected for each test item). Monochromatic light is separated and
transmitted to the photometry section of each channel by ten optical fibers.

Photometry section

channel 1

channel 2

channel 3

channel 4

Optical channel 5
Fiber
channel 6

channel 7

channel 8

channel 9

Light source Reference

LED
Optical filters Monochromatic light of
(5 types) a certain wavelength

In each photometry section, the monochromatic light transmitted by the optical fibers is
irradiated on the reagent fields, which has a color reaction after sampling. Its reflected light
is read with 2 photodiodes, and the system calculates measurement results by end-point
assay (EPA) or reaction-rate assay (RRA).

Optical fiber

Photodiode

Reagent field
1-1 SP-4430 Chapter 1 INTRODUCTION

1-1-3 Specifications

Sample Serum, Plasma, Whole blood (Only Hb)

Measurement item General biochemical measurement items, 22 items
Measurement wavelength 5 wavelengths (405, 550, 575, 610 and 820 nm)
Measurement principle Optical measurement of reflection intensity of
reagent color reaction
Measurement Range Set for sach measurement item
Reagent Strip SPOTCHEM Reagent Strip
Processing speed 63 samples per hour
Minimum sample volume 6 the number of measurement items + 38 L:
serum, plasma
Sample consumption 4 6 L(per 1 measurement item): serum, plasma
Sample container Whole blood: exclusive whole blood sample tube
(Orange cap)
Centrifuge tube
Serum, plasma: exclusive serum sample tube
(Blue cap)
Simultaneous measurement 3 Single Reagent Strips or 1 Multi Reagent Strip
Maximum of 9 test items of continuous
measurement using Single Reagent Strips and a
Multi Reagent Strip is available.
Reagent reaction temperature 37
Light source LED and Interference filter
Calibration method Calibration by magnetic card (Reagent Card)
Calibration by Calibrator Kit
Data storage volume 100 tests
Display 20 digits 2 lines LCD
Built-in Printer 36-character thermal printer (58 mm width)
External Output RS-232C interface
Transmission Method Single or Two-way Transmission
Transmission Rate 300, 600, 1200, 2400, 4800, 9600bps
Measurement conditions Temperature: 10 30
Humidity: 20 80 % (Non-condensing)
Power supply AC100 120V, 220 240V
50/60Hz AC adapter method
Power input Max. 100VA
Dimensions 338 mm(W) 203 mm(D) 167 mm(H)
Weight Approximately 5.4 kg
1-2 Shipping Carton Chapter 1 INTRODUCTION

1-2-1 Analyzer

Open the package and confirm that all items are included.

1 Analyzer (S-4430)

2 Power cord

3 AC adapter 4 Accessory case

5 Operating 6 Warranty card with case,

manual Delivery label

NO. Item Description Qty.

1 Analyzer SP-4430 1
2 Power cord 1
3 AC adapter 1
4 Accessory case 1
5 Operating manual This book 1
6 Warranty card Warranty card with case, Delivery label 1set
1-2 Chapter 1 INTRODUCTION

1-2-2 Accessories

Open the package and confirm that all items are included.

1 Tip 2 Cleaning wire

3 Cleaner set 4 Nozzle set

5 Wrench set for nozzle replacement 6 Centrifuge tube

7 Tip waste case 8 Protective cover 9 Thermal printer paper

NO. Item Description Qty.

1 Tip 10 tips 1 Set
2 Cleaning wire Nozzle cleaning 1 Set
3 Cleaner set Brush, Cotton swab 1 Set
4 Nozzle set (EZ) Nozzle with O-ring 1 Set
5 Wrench set for nozzle replacement 2 Wrench, Adapter 1 Set
6 Centrifuge tube 10 pieces 1 Set
7 Tip waste case 2 pieces 1 Set
8 Protective cover 2 pieces 1 Set
9 Thermal printer papaer width 58 mm 1 Set
1-3 Parts Description and Function Chapter 1 INTRODUCTION

1-3-1 Front of the analyzer

12 Built-in printer 11 Magnetic card reader

10 Display

9 Operator panel

7 Black & white plates

13 Maintenance cover

1 Reagent table

3 Port

5 Tip hole

6 Tip waste case

4 Centrifuge
14 Protective cover
8 Table cover
2 Centrifuge-equipped Multi Rack

NO. Item

1 Reagent table For setting the Reagent Strip. The temperature is kept at 37 for the
reaction conditions of Reagent.

2 Centrifuge-equipped Multi Rack For setting the samples and tips. The centrifuge for 1 sample is built in.

3 Port For setting the samples.

4 Centrifuge For setting the whole blood samples that have not been centrifuged.

5 Tip hole For setting tips.

6 Tip waste case The container for used tips automatically discarded after sampling.
Filled with 5 measurements.

7 Black & white plates The standard reflection plates used for measurement of reflectivity.

8 Table cover Prevents entering the external light.

Slide forward the Reagent Table and Centrifuge-equipped Multi Rack to
open.

9 Operator panel For starting or stopping measurement and entering IDs.

10 Display Displays information such as operating state of the unit and error messages.

11 Magnetic card reader For inserting magnetic cards: Reagent Card and Calibration Cards.

12 Built-in printer Thermal-type printer. Prints out measurement results and setting conditions.

13 Maintenance cover Protects the Nozzle Driving Units. Also prevents the operator from contacting
the nozzle during measurement. There are top and side covers.

14 Protective cover Prevents the operator from contacting the Centrifuge Tube.
Also protects spilling of samples.
1-3 Chapter 1 INTRODUCTION

1-3-2 Operator panel

Item Function

START Starts measurement. Select Yes from the Yes/No option.

STOP Stops measurement. Select No from the Yes/No option.

Cancels entry.

FEED Feeds the built-in printer with paper while pressed.

MENU Switches the page on each menu display.

0~9 (ten key) Selects the menu number. Enter numerical values and ID.

-/.(hyphen/period) Selects item, move cursor , switch the page on the display,
and enter minus sign and decimal point.

ENTER Determines the entry.

Check message to proceed to the operation.
1-1 SP-4430 Chapter 1 INTRODUCTION

1-3-3 Rear of the analyzer

1 Power switch 3 Cooling Fan 5 B.C.R. 7 Paper holder

2 Power input terminal 4 COM. 6 CONT.

NO. Item Function

1 Power switch For turning on and off the power supply to the analyzer.

2 Power input terminal For the supplied AC adapter.

3 Cooling Fan For Ventilating heated air in the unit to prevent overheating.

4 COM. For the cable of the optional external device.

5 B.C.R. Jack for the bar-code reader (option).

6 CONT. For adjusting screen contrast. Turning clockwise to make

the screen darker, counterclockwise makes it brighter.

7 Paper holder For setting thermal printer paper.

1-4 Setting up the Analyzer Chapter 1 INTRODUCTION

1-4-1 Cautions

CAUTION 10cm or more

Before setting up the

analyzer, read the
following notes and
always take proper
safety precautions.

Allow a space of 10 cm or more between Operate the analyzer with power of the
the rear of the analyzer and the wall. correct voltage and frequency.
Failure to do so may cause overheating. Otherwise fire or damage may result.
Excessive load on the cable connection
may cause fire or incorrect measurement
results.

To avoid electric shock and/or fire, use Connect the power plug directly to an
the attached power cord to connect with outlet, not via an extension cord or
a power outlet. For details, contact your power tap. The power supply for the
distributer. analyzer is 100 VA. Before turning on the
power switch, make sure that the total
input of devices connected to a
receptacle of the same circuit doesn’t
exceed 1500 VA (100V, 15A).

Do NOT unnecessarily disassemble or Place the analyzer on a stable and level

modify the analyzer. Such actions may surface free of vibration. Failure to do so
invite danger of exposure to pathogenic may damage the analyzer, correct
microbes, and cause fire or damage. measurement results may not be obtained,
and injury may result. Do NOT place the
analyzer where there is a risk of falling.
1-1 SP-4430 Chapter 1 INTRODUCTION

CAUTION
Before setting up the
analyzer, read the
following notes and
always take proper
safety precautions.

Do NOT set up the analyzer where Avoid exposing the analyzer to direct
chemicals are stored nearby, or where sunlight, condensation and wind.
corrosive gases or electrical noise are Otherwise, correct measurement results
generated. They may damage the analyzer, may not be obtained, and may cause
and malfunctions and/or injury may occur. deformation or malfunction of the
Correct measurement results may not be analyzer.
obtained.

temperature humidity
10 30 20 80

To connect the analyzer to external Place the analyzer in a room at

devices, be sure to use proper cables to temperatures between 10 and 30
avoid electric shock and/or fire. For with humidity between 20% and 80%.
details, contact your distributor. Otherwise, correct measurement results
may not be obtained.

Make sure that the room is well ventilated when a large Be careful not to be put hands under the
amount of carbon dioxide is generated (when gas analyzer.
stoves, oil heaters and instantaneous water heaters are
used in the room). This is because the pH of the
Reagent Strips, which use an alkaline reaction reagent,
decreases under the influence of carbon dioxide and
correct measurement data may not be obtained.
1-4 Chapter 1 INTRODUCTION

1-4-2 Setting up the analyzer

The parts in the analyzer are secured firmly in order to prevent scratches
and/or damage due to transportation. Remove the fixing tapes before
setting up the analyzer. Read 1-4-1 “Cautions on installation” carefully
before setting up the analyzer.

1. Remove the fixing tape.

Remove the tape fixing the table
cover.

Open the maintenance cover and

remove the tape fixing the nozzle.

Reattach the maintenance cover.

2. Connect the power cord.

Make sure that the power switch on
the rear of the analyzer is OFF.

Connect the AC adapter to the

receptacle on the rear panel of the
analyzer, and plug the other end of
the cord into the AC outlet.

3. Connecting an external device (if necessary)

When using an external device,
connect the exclusive connecting
cable to COM on the rear panel of
the analyzer.
1-1 SP-4430 Chapter 1 INTRODUCTION

1-4-3 First operation after setting up

This section explains the way to load thermal printer paper, and set data
and time after turning on the power switch.

1. Turn on the power.

Turn on the power switch on the rear
panel of the analyzer.
“|” is displayed.

After the analyzer name and system

version are displayed, warm-up
starts.

For error correction or

About 10 minutes after (room
troubleshooting, “see Chapter
5 Troubleshooting”. temperature at 25 ), warm-up is
completed and the MAIN MENU is
displayed as shown at right.

2. Set the thermal printer paper.

Set the attached thermal printer
paper (See 4-3-1 “Thermal printer
paper replacement”).

3. Confirm the time and date.

Set the date and time (see “3-6
Built-in Clock Adjustment”).

IMPORTANT If the date is not set correctly, correct measurement results may not be
obtained and an error may occur.

4. Remove the fixing tape on the protective cover.

Press [1] on the MAIN MENU.
The Table Cover opens and the
Reagent Table and Centrifuge-
equipped Multi Rack slide forward.
1-4 Chapter 1 INTRODUCTION

1-4-4 Notes at transportation

Remove the tape fixing the

protective cover.

Set the maintenance cover and the

tip waste case.

Press [STOP] to close the table

cover.

If no key entry is made within 3

minutes after the Table Cover is
opened, an alarm beeps and
the Table Cover is closed.
If [STOP] key is pressed while
the message “CANCEL” is
displayed, the Table Cover
remains open and the Standby
screen is restored.

After the Table Cover is closed,

a message shown at the right is
displayed.
To restore the MAIN MENU,
press [STOP] key.
When [ENTER] key is pressed,
the Table Cover opens and the
Standby screen is restored.

5. Turn off the power.

When terminating the operation or
setting, turn off the power after
making sure that the MAIN MENU is
displayed.
1-4 Chapter 1 INTRODUCTION

1-4-4 Notes at transportation

When carrying the analyzer in cars, use an exclusive carrying case. The
carrying case is optional. Follow the following procedures to prevent
exposure to pathogenic microbes and damage to the analyzer.

WARNING Wear protective gloves to prevent exposure to pathogenic microbes.

1. Inspect the inside of the analyzer.

Press [1] on the MAIN MENU. The
Table Cover opens and the Reagent
Table and Centrifuge-equipped Multi
Rack slide forward.
The Standby screen is displayed.

Make sure that there are no used

Reagent Strips or samples. If any,
discard them.

When there are used tips in the Tip

Waste Case, discard them.

Press [STOP] to return to the MAIN

MENU and turn off the power
switch.

2. Placing analyzer into carrying case.

Place the analyzer, AC adapter and
power code in the carrying case.
Chapter 2

MEASUREMENT
The normal measurement and two types of calibration can be
done with the SP-4430. This chapter describes the outline and
operating procedures of each measurement.

2-1 Outline of Measurement

2-1-1 SPOTCHEM Reagent Strips
2-1-2 Normal measurement
2-1-3 Calibration

2-2 Cautions
2-2-1 Cautions
2-2-2 Handling samples
2-2-3 Handling Reagent Strips
2-2-4 Handling magnetic cards
2-2-5 Handling tips
2-2-6 Handling centrifuges

2-3 Preparation for Measurement

2-3-1 Preparation
2-3-2 Startup
2-3-3 Checks before measurement
2-3-4 Preparing samples

2-4 Measurement
2-4-1 Normal measurement

2-5 Calibration
2-5-1 Overview of calibration
2-5-2 Calibration by magnetic card
2-5-3 Calibration by calibrator kit

2-6 Interpreting measurement results

2-6-1 Printing normal measurement results
2-6-2 Printing calibration results
2-1 Outline of Measurement Chapter 2 MEASUREMENT

2-1-1 SPOTCHEM Reagent Strips

SPOTCHEM Reagent Strips (optional) must be used with this analyzer.

There are two types of SPOTCHEM Reagent Strips. Use the correct type
of strips for the measurement purpose.

Multi Reagent Strip

A Multi Reagent Strip has 5~6 reagent fields for analyzing various items including
normal screening, and liver or renal function screening.

Bar code Item name

Multi Reagent Strip

Single Reagent Strip

A Single Reagent Strip has only one reagent field on it. Several different reagent items
of Single Reagent Strips can be measured for one sample.

Bar code Item name

Single Reagent Strips

 Chapter 2 MEASUREMENT

2-1-2 Normal measurement

In normal measurement, more than one item can be measured at a time

for one sample. The Reagent Strip Table can hold three Single Reagent
Strips and one Multi Reagent Strip, so that simultaneous measurement of
up to nine items is available. The operating procedure of normal
measurement is described as shown below.
 Chapter 2 MEASUREMENT

2-1-3 Calibration

This analyzer provides two types of calibration: Calibration by magnetic

card (Reagent Card) and Calibration by Calibrator. Calibration must be
performed for all fields of Reagent Strips (see “2-5-1 Outline of
calibration” for details).

For calibration by Calibrator, the following two types of Calibrator Kit and Magnetic Card
(Calibration Card) are used.

SPOTCHEM Calibrator Kit

For use with all items except Hemoglobin

SPOTCHEM Calibrator Hb Kit

For use with Hemoglobin

Each Calibrator Kit contains Low and High lyophilized serum and a Calibration Card. For
detailed procedures, see the package insert of the Calibrator Kit.
 Chapter 2 MEASUREMENT

The flowchart of calibration.

2-2 Cautions Chapter 2 MEASUREMENT

2-2-1 Cautions

temperature
humidity

Before turning ON the power, reconfirm The analyzer has a temperature control If there is anything wrong with the
“1-4-1 Cautions” so that the analyzer is function in order to yield correct analyzer, or in case of odor or smoke,
always operated under proper measurement results at the room turn OFF the power immediately and
conditions. temperature of 10~30 . For more unplug. Otherwise the analyzer may
accurate measurement, measurement at be damaged and cause fire.
the room temperature of 20~25 and at
humidity of 30~60% is recommended.

If the analyzer is out of order, contact Do NOT put a container with samples Do NOT move the analyzer during
your distributor for repair. Do NOT in it on the analyzer. If samples spill measurement. Such movement may
attempt to repair or modify it by on the device, it may damage. cause malfunction, resulting in
yourself. It may damage the analyzer incorrect measurement results.
or get injured.

Perform proper maintenance following Do NOT place anything in front of the Use SPOTCHEM Reagent Strips only
the instruction to ensure high Table Cover. It automatically opens for the analyzer. The other types of
accuracy. during operation. Reagent Strips are unacceptable.
 Chapter 2 MEASUREMENT

2-2-2 Handling samples

Wear
protective gloves

Blood is used as a measurement sample Handling samples slightly differs

with this analyzer. Be aware that blood may depending on test items. Follow the
be contaminated with pathogenic microbes instructions on the package insert of
that may cause infectious disease. Exercise SPOTCHEM Reagent Strips.
utmost care whenever handling blood.
Incorrect or imprecise procedures may
result in exposure to pathogenic microbes.

2-2-3 Handling Reagent Strips

Do NOT use expired Reagent Strips. Take Reagent Strips out of the refrigerator Open a reagent strip package immediately
Do NOT use deteriorated strips of which the 20 minutes before measurement and allow before use. If the opened reagent strip is
reagent fields show any sign of discoloration them to reach room temperature (10 to left for a while, it will absorb water from the
or deformation, even if they are before the 30 ). Otherwise, correct measurement air or gather dust, which may result in
expiration date. Otherwise, correct results may not be obtained. incorrect measurement results.
measurement results may not be obtained.

Do NOT touch the reagent field on the When a new reagent strip box is
strip with fingers. Sebum on the opened, perform calibration by magnetic
reagent field may result in incorrect card using the supplied Reagent Card
measurement results. (see 2-5-2).
 Chapter 2 MEASUREMENT

2-2-4 Handling magnetic cards

Do NOT place a magnetic card close Do NOT scratch the magnetic surface Do NOT use a magnetic card (supplied
to a magnetic object (magnet, TV set, (stripe). Information on the magnetic with Reagent Strips or Calibrator) for
etc.) Information on the magnetic card card may become unreadable. SP-4420 or SP-4430 with other devices.
may become unreadable. The card may become jammed in the
device.

2-2-5 Handling tips

Do NOT touch the pointed end of a Tip Do NOT reuse a tip. Water-repellent
with bare hands. If it becomes soiled, treatment is applied to each tip so that
correct sampling may not be possible, the sample can be pipetted correctly.
resulting in incorrect measurement If it is rinsed, the coating will come off
results. and correct measurement results may
not be obtained.
 Chapter 2 MEASUREMENT

2-2-6 Handling centrifuges

Uncap
the tube

Samples with
extremely high hematocrit levels
Pipette 250 to 270 whole blood Heparin is contained as an anticoagulant. Samples with extremely high hematocrit
into the centrifuge tube. Insufficient Close the cap tightly after setting a levels may yield incorrect measurement
sample volume may result in incorrect sample, and invert it and use the sample results.
measurement results. Excessive volume after removing the cap.
may cause blood to stain the cover. Remove air bubbles or skin on the
surface of the sample, if any. Otherwise
they may cause incorrect measurement
results.
Wipe out the sample attached to the
outside of centrifuge tube before placing
it to the centrifuge, otherwise it may
cause spattering the sample.

Heparin

When it takes time before blood samples

collected are brought into the centrifuge,
the samples may begin to coagulate.
The samples, which show heavy
coagulation or deposition of fibrin, may
not be subjected to measurement.
A syringe containing heparin can be
used to prevent coagulation when it
takes time before the samples are
brought into the centrifuge, although the
machinecontains heparin.
2-3 Preparation for Measurement Chapter 2 MEASUREMENT

2-3-1 Preparation

Prepare necessary instruments as described in the following table before

starting Normal Measurement, Calibration by Magnetic Card or Calibration
by Calibrator.

IMPORTANT
Take the Reagent Strips out of the refrigerator
and leave them at room temperature (10
30 ) for 20 minutes. Single Reagent Strips

Multi Reagent Strip

IMPORTANT Using Reagent Strips without allowing

them to reach room temperature may
result in incorrect measurement results.
 Chapter 2 MEASUREMENT

2-3-2 Startup

The operating procedures from turning ON the power to the MAIN MENU
are described below.

NOTE Before turning ON the power, make sure that the maintenance cover is in
position. If light enters into the analyzer during initialization, an error will
occur.
Before turning ON the power, make sure that nothing is placed in front of
the Table Cover. The Table Cover opens during initialization. If there is an
obstruction, a problem may occur.

1. Turn ON the power.

To obtain the appropriate Turn ON the power at the rear of the
contrast on the screen, rotate
the contrast adjustment knob analyzer. When the power is ON, “|”
(“CONT.”) on the rear of the is displayed
analyzer.

The name of the analyzer and the

system version (“VXXXX” shown at
the right) are displayed and warm-up
starts.

The screen appears during warm-up

as shown at the right, and initialization
and self-check of each function are
performed.

Warm-up time depends on the About 10 minutes after (when at

room temperature.
25 ), warm-up is completed and the
MAIN MENU is displayed.
 Chapter 2 MEASUREMENT

2-3-3 Checks before measurement

Check each part before performing Normal Measurement or Calibration.

WARNING Wear protective gloves to prevent exposure to pathogenic microbes.

CAUTION Discard used samples, tips and protective gloves separately from general
waste according to the local regulations on biohazardous waste.

1. Thermal printer paper.

If a red line appears on both sides of
the printer paper, replace it with a
new roll (see“4-3-1 Thermal printer
paper replacement”).

2. Reagent Table.
Check the Reagent Table and clean
it if necessary (see “4-2-1 Cleaning
the Reagent Table”).

3. Centrifuge-equipped Multi Rack.

Make sure that the Centrifuge-
equipped Multi Rack has no used
samples in it. If any, discard them.

Install the Tip Waste Case.

4. Setting the parameters.

Set the parameters as necessary. If the same parameter settings are continuously
used, resetting is not necessary. See “Chapter 3 SUB MENU” for details.

IMPORTANT To check the present parameter settings, print them out (see “3-3-1 Printing
parameters”).
 Chapter 2 MEASUREMENT

2-3-4 Preparation of samples

Prepare samples as described below except for Hb and HDL-C, which

require different procedures (see pages 2-16 and 2-17 for sample
preparation for Hb and HDL-C). Test items may be added or changed in
the future. Read the package insert of SPOTCHEM Reagent Strips
carefully for details on handling samples.

WARNING Wear protective gloves to prevent exposure to pathogenic microbes.

The required volume of a serum or

plasma sample is“6x (number of
Sample Sample tube Required sample amount
test items)+38 ”.For example,
the required volume for 5 test
items is : 6 x 5 + 38 = 68 .
Serum or Plasma Serum sample tube (Blue cap) 6 (number of test items) 38 L
A Serum or Whole blood Sample
Tube has 2 lines marked on it for
Whole blood Whole blood sample tube (Orange cap) 250 L
100 and 500 .

Whole blood Centrifuge tube 250 L

Serum or plasma sample.

Prepare a Serum Sample Tube (blue cap). Blue cap

Pipette serum or plasma. If

measurement is not performed
immediately, cap the tube to prevent Serum sample tube
contamination or evaporation.

IMPORTANT Remove any air bubbles or skin on the surface of the sample.
They may cause incorrect measurement results.

The Whole blood Sample Tube Whole blood.

contains heparin as an
anticoagulant. Prepare a Whole blood Sample Tube Orange cap
(orange cap).
Uncap the tube and pipette whole blood.
Cap the tube tightly.

Whole blood sample tube

Invert the sample 5 to 6 times (see
“Inverting a sample” on the next page).
 Chapter 2 MEASUREMENT

Even if the sample stays at the

bottom after being inverted, Inverting a sample to mix
heparin is well mixed with the
sample. Do NOT shake the 1 Gently invert a sample tube.
tube vigorously.

2 In 3 seconds, invert the sample

again.

3 Wait for 3 seconds, and invert it

again.

4 Repeat the above procedure

several times.

To use a whole blood sample tube, prepare a centrifuge.

NOTE When using an optionally available

centrifuge , carefully read the
operating manual of the centrifuge.

Place the samples in the centrifuge

taking rotor balance into consideration
(see the block below).

Centrifuge the samples for 3 minutes

or more. It is not necessary to remove
the supernatant from the centrifuged
samples. Uncap the tubes and place
them directly in the sample rack.

IMPORTANT Remove any air bubbles or skin on the surface of the sample.
They may cause incorrect measurement results.

Ensuring rotor balance

Samples Dummy tube

Place sample tubes

symmetrically against the rotation
axis as illustrated at right. For
centrifugation of 1 or 5 samples, 1 Samples 2 Samples 3 Samples
use a dummy tube filled with an
equal amount of water to make a
total of 2 or 6 sample tubes.

4 Samples 5 Samples 6 Samples

 Chapter 2 MEASUREMENT

Using a centrifuge
Prepare a centrifuge.

A Centrifuge tube has 1 line Uncap the tube and pipette 250 of
marked on it for 250 .
heparinized whole blood or plain blood into
the centrifuge tube.

The centrifuge tube includes Heparin as an

anticoagulant.

Close the cap tightly after setting a sample,

and invert it.
Use the sample after removing the cap.

Wipe out the sample attached to the outside

of centrifuge tube before placing it to the
centrifuge, otherwise it may spattering the
sample.

Place samples in the centrifuge ( see“ 2-4-1

Normal measurement”).

IMPORTANT Remove any air bubbles or skin on the surface of

the sample. They may cause incorrect measurement
results.
Wipe out the sample attached to the outside of
centrifuge tube before placing it to the centrifuge,
otherwise it may cause spattering the sample .

IMPORTANT The samples may coagulate when it takes time

before the samples collected are brought into the
machine. Those showing heavy coagulation or
deposition of fibrin sometimes can not be measure.
A syringe containing heparin can be used to
prevent coagulation when it takes time before the
samples are brought into the centrifuge, although
the machine contains heparin.
 Chapter 2 MEASUREMENT

Measuring the Hb
When measuring Hb, dilute whole blood Orange cap
samples 6 times with distilled water.

Prepare a Whole blood Sample Tube (orange

cap). Whole blood sample tube

Uncap the tube and pipette the whole blood

sample into the tube.
Cap the tube tight.
Invert the sample several times ( see “2-14
Inverting a sample”). distilled water 200

Prepare a Serum Sample Tube(blue cap).

Pipette 200 of distilled water.
Pipette 40 of the prepared whole blood
Blue cap
sample into the above Serum Sample Tube.
Cap the tube tight. Serum sample tube
Invert the sample several times again.

distilled water 200

IMPORTANT Remove any air bubbles or skin on the surface of the

sample.
They may cause incorrect measurement results.
 Chapter 2 MEASUREMENT

If HDL-C reagent(direct method)

is used for measurement, this Using HDL-C Kits
procedure is unnecessary.
Prepare a Serum Sample Tube (blue cap).
Serum or plasma
Pipette 100 of serum or plasma.

Gently pipette 100 of HDL Separation

Reagent into the tube.

Cap the tube tight.

Blue cap
Invert the sample more than 10 times
following to “ 2-14. Inverting a sample” and
Serum sample tube
leave the sample about 5 minutes.

Separation Reagent 100

Centrifuge the samples for 3 minutes, taking
rotor balance into consideration(see page 2-
14).
Check if the supernatant is impure or there
is any skin or not. Removing the
supernatant is not necessary. Uncap the
tube and place it directly in the sample rack.
Serum or plasma
100

IMPORTANT Remove any air bubbles or skin on the surface of the

sample.
They may cause incorrect measurement results.
2-4 Measurement Chapter 2 MEASUREMENT

2-4-1 Normal measurement

This section describes the operating procedure of Normal Measurement.

In Normal Measurement, simultaneous measurement of up to nine items is
possible for one sample, using Single and Multi Reagent Strips.
Before measurement, make necessary preparation as instructed in “2-3
Preparation for Measurement”.

WARNING Wear protective gloves to prevent exposure to pathogenic microbes.

CAUTION Discard used samples, tips and protective gloves separately from general
waste according to local regulations on biohazardous waste.

CAUTION Be careful not to spill sample blood when uncapping the tube.

1. Display the Standby screen.

[START] key can be used Press [1] key on the MAIN MENU.
instead of [1] key.
The Table Cover opens and the
Reagent Strip Table and Centrifuge-
equipped Multi Rack slide forward.

The Standby screen is displayed as

shown at the right.

2. Check the time and date.

Make sure that the time and date on
the Standby screen is correct. If
not, set a correct time and date (see
“3-6 Built-in Clock Adjustment ”).

IMPORTANT If a wrong date is set, correct measurement results may not be obtained.
Before measurement, make sure that the date is correct.
 Chapter 2 MEASUREMENT

3. Check the lot number of Reagent Strips.

Press [2] key on the Standby screen.

The Confirm screen is displayed,

which indicates information of
Reagent Strips stored in memory.
To check numerous test items Check that the test items and lot
at one time, print out the lot
numbers of all items.
numbers of the Reagent Strips
Press [3] key on the Standby match with those shown on the
screen to print out all the lot
numbers.
screen (lot numbers are “XXXXXX” at
right). Lot number of a Reagent
Strip is printed on the rear side of
the aluminum foil package or on the
box.

IMPORTANT If the lot numbers of the Reagent Strips are different from those shown on
the screen, perform Calibration by magnetic card before measurement.

Besides [hyphen (-)] key, [0], [2], Press [hyphen (-)] key to check the
[4], [5], [6], and [8] keys can be
used in selecting items. information of the reagent strip you
[0] -> initially displayed item are using.
[2] -> last item
[4] -> previous item
[6] -> next item When confirmation is completed,
[8] -> first item
[5] -> first item of the Multi press [STOP] key. The Standby
Reagent Strip screen is restored.

If no key entry is made within 3

minutes after the Table Cover is
opened, an alarm beeps and
the Table Cover is closed.
If [STOP] key is pressed while
the message “CANCEL” is
displayed, the Table Cover
remains open and the Standby
screen is restored.

After the Table Cover is closed,

a message shown at the right is
displayed.
To restore the MAIN MENU,
press [STOP] key.
When [ENTER] key is pressed,
the Table Cover opens and the
Standby screen is restored.
 Chapter 2 MEASUREMENT

The number of the previous 4. Set measurement No. or ID (if necessary).

measurement No + 1 is displayed
as the initial number. ID of up to 13 characters can be set for each measurement. If ID setting is not
To perform measurement with necessary, move on to procedure 6. Rack slides forward.
the number, press [ENTER] key
to confirm. Once the power is The Standby screen is displayed as shown at the right.
turned off, the initial number
returns to 1. Press [1] key on the Standby screen.
The last entered ID is displayed. The measurement No. screen is
To perform measurement with displayed.
the same ID as shown on the
screen, press [ENTER] key. If
the MAIN MENU is restored, the Enter measurement No..
previous ID is cleared.
Up to 4 characters can be entered
To enter ID, use the numeric using numbers.
keys and [-/.] key.
Example: To enter “EZ”
[3] [3] [3] [9] [9] [9] [9] [9] Press [ENTER] key.
Example: To enter “SP”
[7] [7] [7] [7] [7] [-] [7] [7]
The following 12 signs can be The entered measurement No. is
entered by using [0] key.
’ stored in memory and the ID entering
screen is displayed.
To delete the last character, press
[MENU] key and [-/.] key
simultaneously.To restore the Enter ID. Up to 13 characters can be
initially shown ID, press [START]
key. entered using numbers, letters, and
symbols.
When the barcode reader
(optional) is used, manual entering
is not necessary.Read barcode is When the barcode reader is used, ID
automatically allocated as ID.
is automatically read by the reader.
When the barcode reader is
used a message “BARCODE
AVAILABLE” is displayed. Press [ENTER] key.

Press [hyphen (-)] key on the

Standby screen to switch the The entered ID is stored in memory
operation guidance at the lower and the Standby screen is restored.
part of the screen.

If no key entry is made within 3

minutes after the Table Cover is
opened, an alarm beeps and
the Table Cover is closed.
If [STOP] key is pressed while
the message “CANCEL” is
displayed, the Table Cover
remains open and the Standby
screen is restored.

After the Table Cover is closed,

a message shown at the right is
displayed.To restore the MAIN
MENU, press [STOP] key.
When [ENTER] key is pressed,
the Table Cover opens and the
Standby screen is restored.
 Chapter 2 MEASUREMENT

No set-up is available where 5. Set the sample type (when necessary).

sample type is not registered.
The registration can be made on Sample type can be set for each measurement. When sample type is not
the Parameter Menu. registered or measurement is made on the setting of basic type, skip the following
The sample type set for basic and proceed to the Step 6.
type is established as an initial
value. No setting is needed Press [6] key on the Standby screen.
when not changed.
The Sample type selecting screen is
displayed.

Besides [hyphen (-)] key, [4], Press [hyphen (-)] key to select the
and [6] keys can be used in
selecting sample type. sample type to measure.
[4] -> previous sample type
[6] -> next sample type
Press [Enter] key while the selected
Pressing [Start] key on the sample type is displayed.
Sample type selecting screen
starts measurement with the
displayed sample type without The selected sample type is set as
returning to the Standby screen.
the measurement sample type and
the Standby screen is restored.

6. Set the Tip.

Place the Tip in the Tip hole of the
Centrifuge-equipped Multi Rack
using a pair of tweezers.

IMPORTANT Do NOT touch the pointed end of

the Tip with fingers. If it is soiled,
correct measurement results may
not be obtained.

Make sure that the Tip Waste Case

is set in position.
 Chapter 2 MEASUREMENT

7. Set the samples.

Measurement of uncentrifuged whole blood.
Open the protective cover and place
the uncapped centrifuge tube in
position.

Close the cover.

NOTE Make sure the sample tubes are

uncapped, otherwise it may
cause breakage of centrifuge
tube and the Nozzle.
Set a sample after removing the
cap.

NOTE Make sure the protective cover is

closed properly.
If the protective cover remains
open, it may become troubled
and correct measurement results
may not be obtained.

Measurement of serum or plasma, or centrifuged samples.

Uncap sample tubes and place them
to the port of the multi-rack.

NOTE Make sure the sample tubes are

uncapped, otherwise it may
cause breakage of the Nozzle.

NOTE Make sure the protective cover is

closed properly.
If the protective cover remains
open, it may cause a trouble.
 Chapter 2 MEASUREMENT

Remeasurement (or additional measurement) with a centrifuge.

When measuring the once-measured sample with a centrifuge, such measurement can
be done at a reduced centrifugal time.

IMPORTANT When performing remeasurement or additional measurement , sample

quantity may be short. Shortage of sample amount may lead to incorrect
results due to sucking of blood cells or trouble because of abnormal rotation
of centrifuge. Make sure that the remaining sample amount is enough, and
perform remeasurement or additional measurement.

Press [0] key on the Standby screen.

The Centrifuge selecting screen is
displayed.
[On] is always displayed at the
beginning.

Every time when [0] key is To switch [On] and [Off] of

pressed on the Centrifugation
selecting screen, [On], and [Off] centrifuge, press [0] key on the
are displayed alternately. Centrifuge selecting screen.

IMPORTANT To perform the measurement on the screen of [No centrifugation], be sure to

use the centrifuged sample. If uncentrifuged sample is used, correct
measurement result may not be obtained.

8. Set the Reagent Strips.

In Normal Measurement, the following three settings are available.
Multi-type Reagent Strips and Single type Reagent Strip
Multi-type Reagent Strips only.
Single-type Reagent Strips only.
Choose one depending on the item to measure.

Set the Multi-type Reagent Strips.

Open the aluminum foil package
from the place written “ Open here
” until two-thirds of the Reagent
Strip is exposed.

Multi-type Reagent Strip

 Chapter 2 MEASUREMENT

Remove a Reagent Strip from the

aluminum foil package without
touching the reagent field with the
fingers.

reagent field

Place the Reagent Strips on the

Reagent Table by holding the right
side of the strip.

IMPORTANT Be sure to insert the end of a

Reagent Strip into the groove of the
Reagent Table so that the Reagent
Strip stays firmly in place. If the
Reagent Strips are bent or placed
out of the groove, it may become
jammed or correct measurement
results may not be obtained.

Set the Single-type Reagent Strips.

Open the aluminum foil package of a
Reagent Strip by tearing straight
down from the V-shaped notch. Tearing straight down
from the V-shaped notch

Single-Reagent Strip
1 te
st
 Chapter 2 MEASUREMENT

Remove the Reagent Strip from the

package without touching the
reagent field with fingers.

reagent field

Insert Reagent Strips on the

Reagent Table as shown at right.

IMPORTANT Be sure to insert the end of a

Reagent Strip into the groove of the
Reagent Table so that the Reagent
Strip stays firmly in place. If the
Reagent Strips are bent or placed
out of the groove, it may become
jammed or correct measurement
results may not be obtained.

9. Start the measurement.

To discontinue the measurement, Press [START] key. The Reagent
press [STOP] key to return to the
Standby screen.
Table and Centrifuge-equipped Multi
Rack slide backward and the Table
Cover is closed. The message
“Measuring ” is displayed.

After a while, approximate remaining

time is displayed.
The time displayed in [ ] changes at
every 30 seconds.
 Chapter 2 MEASUREMENT

As the measurement proceeds, the

display of approximate remaining
time changes to the ordinary time
indication.
The [ ] disappears and the time is
counted down by one second.

NOTE Do NOT open the maintenance cover or the Table Cover during
measurement. It will cause an error.

10. End measurement.

To print another sheet, press [4] When measurement is finished,
key on the Standby screen.
measurement results are printed out.
The Table Cover opens and the
Reagent Strip Table and the
Centrifuge-equipped Multi Rack
slide forward.

The Standby screen is restored.

The measurement result is Where measured results are not

repeatedly scrolled.
printed due to lack of printer paper,
press [5] key on the Standby screen
to display the latest measurement
results.

Press [5] key again to return the

Standby screen.

NOTE Only measurement item and its result are displayed. Channel numbers, unit
symbols and others such as are not displayed. When the details are to
be confirmed, thermal printer paper is set for allowing the results to be
available in print. To check the detailed results, set printer paper and print
out the measurement result.
 Chapter 2 MEASUREMENT

Remove any used Reagent Strips

and discard them.
When the message “DISCARD TIPS”
is displayed, remove the Tip Waste
Case and discard used tips.

Reattach the Tip Waste Case.

To discontinue measurement, press

[STOP] key to return to the MAIN
MENU.

NOTE The message “DISCARD TIPS” appears once every five measurements.
When the message is displayed, discard the tips. Otherwise, a trouble may
occur.

11. End measurement for the day.

After finishing all measurement for
the day, perform daily maintenance
(see “4-2 Daily Maintenance”).
2-5 Calibration Chapter 2 MEASUREMENT

2-5-1 Overview of calibration

Calibration is necessary to maintain measurement accuracy.

Calibration reduces unfavorable effects of reagent pack that changes
with time, eliminates gaps among lots or facilities, and maintains
measurement accuracy to a certain level.

Basically, calibration should be performed using the SPOTCHEM

Calibrator Kit for each type of Reagent Strips, but it requires a lot of time
to do so for all types of Reagent Strips.
To eliminate such inconvenience, this analyzer is designed to be able to
perform calibration for different Reagent Strips by inserting magnetic
cards (Reagent Card) storing the lot information of each reagent strip.
There are 2 methods for calibration with SP-4430.

1 Calibration by magnetic card

2 Calibration by calibrator kit (using an exclusive calibrator lit)

1 calibration is performed by inserting a magnetic card (Reagent card)

attached to each reagent strip into the magnetic-card reader.
2 calibration is performed using an exclusive calibrator. This calibration
should be performed every 6 months, when the Reagent Lot is changed
or the service representative considers that calibration is necessary. The
SPOTCHEM Calibrator Hb Kit is to be used for Hb items. The
SPOTCHEM Calibrator Kit is to be used for other items’ calibration.

There are two ways of calibration available, one is “1-Point Calibration”

using either Low or High Calibrator Solution and the other is “2-Point
Calibration” using both of Low and High solution. Make sure to perform
calibration according to the calibration conditions of each measurement
item by referring to “3-3-2 Entering parameters”.
 Chapter 2 MEASUREMENT

2-5-2 Calibration by magnetic card

By inserting “Reagent Card” attached to Single Reagent Strips or another

one attached to Multi Reagent Strips into a magnetic-card reader,
differences among lots and changes with time of reagent pack are
automatically calibrated.

IMPORTANT For the lot number of “Reagent Card” for magnetic calibration, use the same
lot number as that of the reagent strip currently in use (Magnetic cards
attached to the Reagent Strips in use). Calibration can not be performed with
magnetic cards with different lot number or magnetic cards with different
Reagent Strips.

Requirements Reagent Card

1. Set the calibration type as by magnetic card.

When changing the calibration type from calibration by calibrator kit (Cal.) to
calibration by magnetic card (CARD), change the setting “see 3-3-2 Enter
parameters”).
If the calibration type is already set as calibration by magnetic card, this operation
is not necessary.

2. Set the calibration condition.

“CARD” means calibration by Press [3] key on the MAIN MENU.
magnetic calibration card and
“Cal.” means calibration by The CALIBRATION MENU is
calibrator kit. displayed.

3. Insert Reagent Card.

Press [STOP] key to stop the Press [1] key on the CALIBRATION
calibration by magnetic card.
MENU.

Insert either strip of a Single or Multi

There is no order for inserting Card in the magnetic reader and
the stripes. Either stripe can be
inserted first.
slide the strip to the right.
 Chapter 2 MEASUREMENT

When the stripe is inserted, the

screen shown at the right is
displayed.

Insert the same stripe according the

message on the screen.
When the same stripe is inserted
twice, item number is displayed.
The inserted stripe number is
displayed with on the lower right
Insert the same stripes twice to screen.
read the stored information in
the magnetic cards.
Insert the remaining stripes twice
according to the message on the
screen.
When all stripes are inserted,
measurement item and lot numbers
are displayed.

About 2 seconds after, the Magnetic

card entry screen will be displayed.
Calibration by magnetic card is
completed.

4. End of calibration by magnetic card.

When the discontinuing the
calibration, press [STOP] key 3 times
to return to the MAIN MENU.
 Chapter 2 MEASUREMENT

2-5-3 Calibration by calibrator kit

Use the SPOTCHEM Calibrator Kit for calibration. For Hb items, use the
SPOTCHEM Calibrator Hb Kit.

WARNING Wear protective gloves to prevent exposure to pathogenic microbes.

CAUTION Discard used samples, tips and protective gloves separately from general
waste according to local regulations on biohazardous waste.

CAUTION Be careful not to spill sample blood when uncapping the tube.

1. Set the calibration type by calibrator kit.

When changing the calibration type from calibration by magnetic card (CARD) to
the calibration by calibrator kit (Cal.), change the setting by referring to “see 3-3-2
Enter parameters”).
If the calibration type is already set for calibrator kit, this operation is not necessary.

2. Display the calibration menu.

“CARD” means calibration by Press [3] key on the MAIN MENU.
magnetic calibration card and
“Cal.” means calibration by CALIBRATION MENU is displayed.
calibrator kit.

3. Prepare the reagent strip and calibrator.

Prepare the required amount of
Reagent Strips according to the
following table.

When performing the

calibration by calibrator kit
using Multi Reagent Strips,
calibration mode of each
measurement item (single item)
attached to Multi Reagent Strip
is used.
 Chapter 2 MEASUREMENT

To check the calibration mode and the

number of calibration times, press [3]
key on the CALIBRATION MENU to
display the Calibration information
checking screen. On this screen,
switch the items by pressing [hyphen
(-)] key to check calibration mode and
the number of calibration times.

Press [STOP] key to return to the

CALIBRATION MENU.

Prepare the required equipment and

calibrator (see “2-3-1 Preparation”).

Dissolve Low or High solution

according to the instructions on the
calibrator
package insert included in the
calibration card
calibrator kit.

distilled
water

A
B

Place 500 of Low and High

solution in the respective sample
tubes. Put the caps back on to
prevent evaporation or contamination
if calibration is not to be carried out blue cap
immediately.

Serum sample
tube

IMPORTANT Remove any air bubbles or skin on the surface of the calibrator, if any.
Failure to do so may result in obtaining incorrect measurement results.
 Chapter 2 MEASUREMENT

4. Insert calibration card.

To stop calibration, press Press [2] key on the CALIBRATION
[STOP] key.
MENU.
The Magnetic card entry screen is
displayed.
There is no order for inserting the
stripes. Any stripe can be inserted Insert the stripe of a calibration card
first.
in the magnetic card reader and
slide the card to the right.

When the stripe is inserted, the

message shown on the right is
displayed.

Insert the same stripe again

Insert the same stripes twice to according to the message on the
surely read the stored information
in the calibration cards.
screen.
When the same stripes are inserted
There is only one stripe for Hb,
this screen is not displayed.
twice, that stripe number is
displayed on the lower part of the
screen. The entered stripes are
displayed as .

Insert the rest stripes twice

according to the message on the
screen. When all stripes are
If no key entry is made within 3
minutes after the Table Cover inserted, lot number of the calibrator
opens, an alarm sounds and is displayed.
the Table Cover closes.
If press [STOP] key is pressed After that, the Calibration standby
while “CANCEL” is displayed, screen is displayed.
the Standby screen is restored
without closing the Table
Cover. The Table Cover opens, and the
After the Table Cover closes, Reagent Table and the Centrifuge-
the message shown on the equipped Multi Rack slide forward.
right is displayed.
To go back to the MAIN MENU,
press [STOP] key. The Calibration standby screen as
To go back to the Standby
screen, press [ENTER] key. shown on the right is displayed.
 Chapter 2 MEASUREMENT

When performing 1-point 5. Set the Tip.

calibration (High), proceed to
procedure 9. Set the tips in the tip hole of the
Centrifuge-equipped Multi Rack
using tweezers.

IMPORTANT Do NOT touch the end of the Tip

with bear hands. If the tips are
soiled, correct sampling may not
be done and this will lead to
incorrect calibration results.

Make sure that the Tip Waste Case

is set in position.

6. Set the calibrator “Low”.

Remove the caps and set the
calibrator “Low” to the port of the
Centrifuge-equipped Multi Rack.

NOTE Be sure to remove the caps before

calibration to avoid damage to the
nozzle.

NOTE Make sure that the protective cover

is closed before the measurement.
If the protective cover remains
open, it may cause a trouble.

7. Set the Reagent Strips.

IMPORTANT Be sure to insert the tip of the strip in the groove of the reagent table so that
the Reagent Strip stays firmly in place. If the strip is placed out of the groove,
it may cause jam or correct measurement results may not be obtained.

Calibration with Single-type Reagent Strips

Prepare Single-type Reagent Strips.
When performing 2-point calibration,
prepare twice as many Reagent
Strips as the number of times
calibration that will be performed.
For 1-point calibration, prepare the
same number of times calibration
that will be performed.
 Chapter 2 MEASUREMENT

Insert the Reagent Strips with the

same items, starting from the S1
channel on the Reagent Table.
If the number of calibration is set as
more than 3 for 2-point calibration,
calibration should be sperately
performed twice. In this case , set 3
Reagent Strips for the first
calibration.
(ex.: When the number of calibration
is 4, set 3 Reagent Strips for the first
calibration and 1 for the second .)

Calibration with Multi-type Reagent Strips

With Multi-type Reagent Strips, Prepare Multi-type Reagent Strips.

1-point calibration cannot be
performed. Prepare twice as many Multi-type
Reagent Strips as the number of the
times calibration that will be
performed.

Set the Strip on the Reagent Table

from the right hand side.
 Chapter 2 MEASUREMENT

8. Start measurement of the “Low” calibrator.

Press [STOP] key to stop the

Press [START] key. The Reagent Table
calibration, the Calibration and Centrifuge equipped Multi Rack
standby screen is restored.
move inside, and the Table Cover
closes. “Measuring…” is displayed.

Approximate remaining time is

displayed. The time displayed in [ ],
changes at every 30 seconds.

As the measurement proceeds, the

display of approximate remaining
time changes to the ordinary time
indication. The [ ] disappears and
the time is counted down by one
second.

When “Low” calibration is completed,

the Table Cover opens, and the
Reagent Table and Centrifuge-
equipped Multi Rack move forward.
The Calibration standby screen is
displayed.

When the number of calibration is

more than 3, repeat the procedure
from 5 to 8.

The Calibration standby screen

displays the name of the Reagent Strip
being calibrated, the measured
number of Low and High (L, H) and the
calibration times (N).
The cursor blinks at L or H according
the calibrator (Low or High) to be
calibrated next. The examples of the
screen at the right shows the number
of times of calibration is 2, Low has
already measured twice and High will
be measured next.
 Chapter 2 MEASUREMENT

When performing 1-point 9. Set the tip.

calibration for "Low" only,
proceed to procedure 13. Set the tip by following procedure 5.

10. Set the “High” Calibrator.

Press [STOP] key to stop Set the “High” Calibrator by following procedure 6.
calibration.
The Calibration standby screen
is restored.
11. Set the Reagent Strips.
Set the Reagent Strips by following procedure 7.

12. Measure the “High” Calibrator.

Measure the “High” Calibrator by following procedure 8.

13. End the calibration.

When calibration is completed, the
measurement results are printed.
The Table Cover opens, and the
Reagent Table and Centrifuge-
equipped Multi Rack slide forward.
The Calibration standby screen is
restored.

Remove the used Reagent Strips

and samples, and discard them.
 Chapter 2 MEASUREMENT

When a message, “Remove used

tips.” is displayed, remove the Tip
Waste Case and discard used tips.

Set the Tip Waste Case again.

NOTE The message, “Remove used tips.” is displayed every 5 measurements.

When this message is displayed, discard the used tips.
If measurement is continued, it may cause trouble.
2-6 Interpreting measurement results Chapter 2 MEASUREMENT

2-6-1 Printing normal measurement results

To print out the measurement results, Normal printing and Survey Mode
printing are available.
The Survey Mode has the following additional items to the print out of the
Normal mode.
These items are printed out when the Survey Mode is ON.
Measurement value which temperature conversion, unit conversion or
correlation correction is not applied.
Information on temperature conversion (temperature and temperature
conversion factor).
Information on unit conversion (unit and unit conversion factor).
Information on correlation correction (coefficient of correlation
correction).
 Chapter 2 MEASUREMENT

( 1 ) Normal printing

1 10 2

3 (Man) 4

5 6

When “Printing of measurement 1 Version.

results” is performed on the Measurement date and time : Date and time when [START] key is pressed.
2
Sub Menu, the results are Measurement number : The number is counted starting from 0001 (When the power is on.)
3
printed according to the
4 ID: Printed only when ID is set.
parameter settings of the
5 Name of the Multi Reagent Strip.
measurement. That is, if the
parameters are changed after 6 Lot Number of the Multi Reagent Strip.
the measurement (temperature 7 Measurement results of the Multi Reagent Strip.
or coefficient of correlation 8 Lot Number of the Single Reagent Strip. Used for S1, S2 and S3 channels from the left.
correction), the data after the 9 Measurement results of the Single Reagent Strip.
measurement is printed out. 10 Sample type : Printed only when set.

5~7 are printed only when the Multi Reagent Strip is measured.
8~9 are printed only when the Single Reagent Strip is measured.

<Details>
The temperature is printed when the temperature is set other than at 37 in the enzyme item.
(ex.: GGT)
“Over Max. Value” is printed when the measurement result is higher than the upper limit of the
measurement range. (ex.: UA)
“Under Min. Value” is printed when the measurement result is lower than the lower limit of the
measurement range. (ex.: LDH)
mark is printed when the measurement result is higher than the upper limit of the standard
range. (ex.: T-Pro)
mark is printed when the measurement result is lower than the lower limit of the standard
range. (ex.: Ca)
When prozone errors occur, the types of errors are printed. (ex.: Amy)
When the unit other than the conventional units is used or a coefficient of correlation
.
correction is entered is printed on the right of the first number of the measurement result.
(ex.: Alb)
 Chapter 2 MEASUREMENT

( 2 ) Survey Mode printing (for 1 item)

1
2
3
4
5

1 Measurement value which temperature conversion, unit conversion or correlation

correction is not applied.
2 Temperature. Printed out as ….. for the items other than enzyme items.
3 Temperature conversion factor. Conversion factor when the standard temperature is
Generally, mg (conventional 37
unit) is used for unit. To 4 Unit.“mg” is the conventional unit, “SI” is SI unit and “User” is units set by users.
change the unit, contact your 5 Unit conversion factor. Conversion factor when the conventional unit is standard.
distributor. Coefficient of correlation correction.
6
Coefficient set in the “Entering parameters” on the Sub Menu.
 Chapter 2 MEASUREMENT

2-6-2 Printing calibration results

The calibration results are printed when calibration by calibrator kit is

completed. The formats of the Single Reagent Strips and the Multi
Reagent Strips are slightly different.
Even when calibration errors (E 30 : Abnormal data) occur during the
calibration the calibration results are printed. In this case, Acal and Bcal
are printed as (Calibration factors are not set up.).

( 1 ) Calibration Result of Single Reagent Strip

1 2

3
4
5
6
7
8

1 Version.
2 Calibration date: The date when [START] key was pressed for the first time.
3 From the left, name of Multi Reagent Strip, item symbol, lot number and expiry date.
4 Lot no. of the calibrator. Read by the calibration card.
5 Displayed value of calibrator. Read by the calibration card.
6 Measurement value when calibration is not performed.
Printed out for the number of calibration times.
7 Average measurement value when calibration is not performed.
8 Calibration factor.
Factor of linear expression, Y=Acal • X+Bcal to convert the value X of (7) to value Y of (5).

For the items when calibration mode is L, the H part is blank.

For the items when calibration mode is H, the L part is blank.
 Chapter 2 MEASUREMENT

( 2 ) Calibration Result of Multi Reagent Strip

1 From the left, name of Multi Reagent Strip, item symbol, lot number and expiry date .
2 From the left, item name and item symbol.

For the items when calibration mode is L, the H part is blank.

For the items when calibration mode is H, the L part is blank.
Chapter 3

SUB MENU
With the SUB MENU, auxiliary operations other than normal measurement
and calibration can be performed.
This chapter describes the SUB MENU functions and operating procedure.

3-1 Overview of SUB MENU

3-1-1 Composition of SUB MENU

3-2 Measurement Results Menu

3-2-1 Print measurement results
3-2-2 Transmit measurement results
3-2-3 Delete measurement results

3-3 Parameter Menu

3-3-1 Print parameters
3-3-2 Enter parameters
3-3-3 Initialize parameters
3-3-4 Enter sample type
3-3-5 Copy standard range setting

3-4 Maintenance

3-5 Mode Menu

3-6 Built-in Clock Adjustment

3-1 Overview of SUB MENU Chapter 3 SUB MENU

3-1-1 Composition of SUB MENU

MAIN MENU
After the power is ON and warm-up is completed, the MAIN MENU is displayed.
In the MAIN MENU, normal measurement, calibration, and the SUB MENU are
available.

When [START] key is pressed

SUB MENU
on any screen of SUB MENU,
the MAIN MENU is restored. The SUB MENU consists of 2 pages. Press [MENU] key or [hyphen (-)] key to switch
the SUB MENU pages alternately between SUB MENU 1/2 and SUB MENU 2/2.
In the SUB MENU, there are several functions to be set and they are arranged in
layers. This chapter partly describes the SUB MENU.
Chapter 3 SUB MENU
3-2 Measurement Results Menu Chapter 3 SUB MENU

3-2-1 Print measurement results

If [STOP] key is pressed during Print measurement results stored in the memory (Max. 100 measurements).
operation, the previous screen
is restored.
The following three options for printing are available.
1. LATEST : The latest measurement result (one measurement).
In case of reprinting,
2. ALL : All measurement results (Max. 100 measurements)
measurement results are printed
starting from the latest result. stored in the memory.
3. SEARCH : The measurement results searched by
the date range and/or ID.

1. Display setting screen.

Press [2] key on the MAIN MENU.
SUB MENU 1/2 is displayed.

Press [1] key.

The MEASUREMENT RESULTS
MENU is displayed.

2. Select measurement results to print.

Press [1] key.
The Measurement result selecting
screen is displayed.

Select the measurement results to print by using the numeric keys.

1. LATEST : the latest measurement result (1 measurement)
2. ALL : all measurement results
3. SEARCH: the searched measurement results by date and ID

When LATEST or ALL is selected.

Printing starts immediately.
After printing is completed, the Measurement result selecting screen is restored.

When SEARCH is selected.

The display proceeds to “step 3”.
If the selected measurement is
not found in the data, “No
matching data” is displayed as
shown on the right.
Press [ENTER] key to return to
the Measurement Results
selecting screen.
 Chapter 3 SUB MENU

3. Enter search condition.

If designation of the range of Enter the dates of starting and
measurement dates (the dates
of starting and finishing finishing measurements by sliding
measurements) is unnecessary, the cursor using [hyphen (-)] key.
press [ENTER] key twice to
proceed to the next setting
screen. Press [ENTER] key. The ID entering

Be sure to enter correct dates screen is displayed. Press [ENTER]

to avoid inconsistencies. key when not searched by ID.

The 2-digit number of the

“year” section of the date Enter an ID search pattern for the
indicates the last 2 digits of
year and is interpreted as sample(s) to print by using numbers,
follows: alphabets, and symbols up to 13
00~89 -> 2000~2089
90~99 -> 1990~1999 characters.
Wildcards can be used to enter.
See 3-09 page for information
on wildcards.
Press [ENTER] key.
The selected measurement results
are printed out.

When the printing is completed, the

Measurement result selecting screen
is restored.

If the selected measurement

result is not found in the data,
“No matching data” is
displayed as shown on the
right.
Press [ENTER] key to return to
the Measurement result
selecting screen.

4. End printing.
Press [STOP] key three times to
return to the MAIN MENU.
 Chapter 3 SUB MENU

3-2-2 Transmit measurement results

If [STOP] key is pressed during Transmit measurement results (Max. 100 measurements) stored in the
operation, the previous screen
is restored.
memory.
The following three types for transmission are available.
In case of retransmission,
1. LATEST : The latest measurement result (one measurement).
measurement results are
printed out starting from the 2. ALL : All measurement results (Max. 100 measurements)
latest result. stored in the memory.
3. SEARCH : The measurement results searched by
the date range and/or ID.

1. Display setting screen.

Press [2] key on the MAIN MENU.
SUB MENU 1/2 is displayed.

Press [1] key.

The MEASUREMENT RESULTS
MENU is displayed.

2. Select measurement results to transmit.

Press [2] key.
The Select Results screen is
displayed.

Select the measurement results to transmit by using numeric keys.

1. LATEST : the latest measurement result (1 measurement)
2. ALL : all measurement results
3. SEARCH : the searched measurement results by date and ID

When LATEST or ALL is selected.

Retransmission starts immediately. After retransmission is completed, the
Measurement result selecting screen is restored.

When SEARCH is selected.

The display proceeds to “step 3”.
If the measurement result
selected is not found in the
data, “No matching data” is
displayed as shown on right.
Press [ENTER] key to return to
the Measurement result
selecting screen.
 Chapter 3 SUB MENU

3. Enter searching condition.

If designation of the range of Enter the dates of starting and
measurement dates (the dates
of starting and finishing finishing measurements by sliding
measurements) is unnecessary, the cursor using [hyphen (-)] key.
press [ENTER] key twice to
proceed to the next setting
screen. Press [ENTER] key. The ID entering

Be sure to enter correct dates screen is displayed. Press [ENTER]

to avoid inconsistencies. key when not searching by ID.

The 2-digit number of the

“year” section of the date Enter an ID searching pattern for the
indicates the last 2 digits of
year and is interpreted as sample(s) to print by using numbers,
follows: alphabets, and symbols up to 13
00~89 -> 2000~2089
90~99 -> 1990~1999 characters.
Wildcards can be used to enter.
See 3-09 page for information
on wildcards.
Press [ENTER] key.
The selected measurement results
are transmitted.

When the transmission is completed,

the Measurement result selecting
screen is restored.

If the selected measurement

result is not found in the data,
“No matching data” is
displayed as shown on the
right.
Press [ENTER] key to return to
the Measurement result
selecting screen.

4. End transmission.
Press [STOP] key three times to
return to the MAIN MENU.
 Chapter 3 SUB MENU

3-2-3 Delete measurement results

Delete all the measurement results stored in memory.

1. Display setting screen.

Press [2] key on the MAIN MENU.
SUB MENU1/2 is displayed.

Press [1] key.

The MEASUREMENT RESULTS
MENU is displayed.

2. Delete measurement results.

Press [3] key. The Password
entering screen is displayed.
Enter password “99”.
is displayed on the screen.

The Delete confirmation screen is

displayed.

Press [START] or [STOP].

If [START] key is pressed, the
measurement results are deleted
and the MEASUREMENT RESULTS
MENU is restored.
If [STOP] key is pressed, deletion is
canceled and the MEASUREMENT
RESULTS MENU is restored.

3. End Deletion.
Press [STOP] key three times to
return to the MAIN MENU.
 Chapter 3 SUB MENU

Wildcards
Wildcards can be used for ID search. Wildcards have two types of characters,
“? ” and “ ”, indicating a single or any number of characters.

“ ? ” indicates a single character.

“ ” indicates any number (including zero) of characters.

For instance, if “????” key is entered, 4-character IDs are retrieved. If “A ” is

entered, IDs starting with “A” are retrieved. The following table shows details.

Searching Pattern Meaning

Example 1 ????M 5-character ID ending with “M”
Example 2 AB?YZ 5-character ID starting with “AB” and ending with “YZ”
Example 3 AB YZ ID starting with “AB” and ending with “YZ”
Example 4 PQR ID including “PQR”
Example 5 N??? ID of 4 characters or more starting with “N”

This function is upper/lower case sensitive.

The characters “?” key or “ ” themselves cannot be searched for. (e.g. To search
IDs starting with [hyphen (-)] key by entering “? ”, the attempt will fail.)
A searching pattern with more than four asterisks (*) cannot be entered.
3-3 Parameter Menu Chapter 3 SUB MENU

3-3-1 Print parameters

Print the present parameter settings by each measurement item for

checking.

1. Display setting screen.

Press [2] key on the MAIN MENU.
SUB MENU 1/2 is displayed.

Press [2] key.

The PARAMETER MENU 1/2 is
displayed.

2. Print parameter settings.

Press [1] key.
The Measurement item selecting
screen is displayed.

Besides [hyphen (-)] key, [0], [2], Select measurement items to print
[4], [5], [6], and [8] keys can be
used in selecting items. by pressing [hyphen (-)] key.
[0] -> initially displayed item
[2] -> last item
[4] -> previous item Press [ENTER] key.
[6] -> next item Printing starts. After printing is
[8] -> first item
[5] -> first item of the Multi completed, the Measurement item
Reagent Strip selecting screen is restored.
If “ALL SINGLE” or “ALL MULTI”
is selected, parameter settings
of all the items for Single or Multi
Regent Strips are printed out
respectively.

To stop printing, press [STOP]

key. Printing stops and the
Measurement item selecting
screen is restored.

3. End Printing.
Press [STOP] key to return to the
MAIN MENU.
 Chapter 3 SUB MENU

Parameters can be printed by executing “Printing parameters”.

The formats are slightly different between Single Reagent Strips and
Multi Reagent Strips.

(1) Printing of single parameters

1 2

3
4
5
6
7
8

10
11
12

1 Version.
2 Printed date and time: The date and time when “printing of parameters” is executed.
3 From the left, item name, item symbol, lot number and expiry date.
4 Calibration type.
CARD means calibration by magnetic card and Cal. means calibration by calibrator kit.
5 Calibration factor
6 From the left, calibration mode (L&H, L, H), the number of calibration times, lot
The lot number and calibration number and calibration date.
date are printed only when
calibration by calibrator kit was 7 Coefficient of system's difference correction(Coefficient to use in the measurement
performed. calculates).
8 Temperature. Printed out as ….. for the items other than enzyme items.
mark is not printed when the
upper limit of the standard 9 Coefficient of correlation correction.
range is the same or higher Coefficient set in the “Entering parameters” in the SUB MENU.
than the upper limit of the
measurement range. 10 Measurement range. The lower limit and upper limit.
mark is not printed when the 11 Standard range. The lower limit and upper limit.
lower limit of the standard
range is the same or lower than 12 Sample types. The lower limit and upper limit of standard range for each sample
the lower limit of the types set. Printing is available only when sample type is set.
measurement range.
 Chapter 3 SUB MENU

(2) Printing of multi parameters

1
2

3
4

1 From the left, name of Multi Reagent Strip, item symbol, lot number and expiry
date.
2 Calibration type
CARD means calibration by magnetic card and Cal. means calibration by calibrator
kit.
3 Calibration factor.
4 Coefficient of system’s difference correction (Coefficient to use in the measurement
calculates).
The lot number and calibration
date are printed only when
calibration by calibrator kit was
performed.
 Chapter 3 SUB MENU

3-3-2 Enter parameters

If [STOP] key is pressed during

entry, the entry is canceled and Set parameters (measurement conditions) for temperature, coefficient
the cursor returns to the of correlation correction, normal value range, and calibration
previous “[ ]” or “< >”.
conditions. Regarding Multi-type Reagent Strips, setting of “calibration
If the previous setting is not conditions” only is possible. The other parameters conform to those
necessary to change, press preset for Single Reagent Strips.
[ENTER] key to proceed to next
“[ ]” or “< >”.
Temperature
This device consistently performs measurements under the condition of measurement
of 37 . It can also convert the measurement results to those measured at 30 or
25 and output the converted results. However, only enzyme values can be
converted.
Coefficient of correlation correction
This function allows your results obtained by this device to match the results by another
measurement method (reference method). Apply the regression equation Y = aX + b (X:
measurement result of the SP-4430, Y: the result obtained by the reference method.)
Enter coefficient values for a and b. For obtaining the coefficients of correlation
correction for a and b, contact your distributor.
mark is not printed when the Standard range
upper limit of the standard
When the measurement results are printed, “ ” or “ ”, is added on data out of the
range is the same or higher
than the upper limit of the standard range.
measurement range. When sample type is set, its corresponding standard range is applied.
mark is not printed when the
Calibration Conditions
lower limit of the standard
range is the same or lower than Set the type (calibrator or magnetic card) and the number of times of calibration for
the lower limit of the each measurement item.
measurement range.

1. Display setting screen.

Press [2] key on the MAIN MENU.
SUB MENU 1/2 is displayed.

Press [2] key. The PARAMETER

MENU 1/2 is displayed.

Press [2] key and the Password

entering screen is displayed.
Enter password “99”.

Press [ENTER] key.

The Measurement item selecting
screen is displayed.
 Chapter 3 SUB MENU

2. Select measurement items.

Besides [hyphen (-)] key, [0], [2], Select measurement items for
[4], [5], [6], and [8] keys can be
used in selecting items. parameters by pressing [hyphen (-)]
[0] -> initially displayed item key.
[2] -> last item
[4] -> previous item
[6] -> next item Press [ENTER] key.
[8] -> first item
[5] -> first item of the Multi The Temperature setting screen is
Reagent Strip displayed.

3. Set temperature.
Select the temperature from 37 ,
30 , and 25 by pressing [hyphen
(-)] key.
Note that items other than “enzyme”
have only one choice of 37 .

Press [ENTER] key.

The Coefficient factor setting screen
is displayed.

To enter minus signs and

4. Set coefficient factor.
decimal points , use [-/.] key.
Enter the coefficient factor “a” by
If [-/.] key is pressed first, a
minus sign is entered. To enter using the numeric keys. Any number
a decimal point, press [-/.] key
from 0 to 10000 can be entered.
after any number is entered.
e.g.) To enter “-12”
Press [-/.] [1] [2]
Press [ENTER] key. The cursor
e.g.) To enter “3.4” moves to the entry position for “b”.
Press [3] [-/.] [4]

e.g.) To enter “.5” Enter a coefficient factor “b” and

press [0] [-/.] [5].
press [ENTER] key. Any number from
If [-/.] [5] are pressed, the result
will be “-5”. -10000 to 10000 can be entered.
Press [ENTER] key. The Calibration
When the wrong key is pressed,
press the MENU key and [-/.] conditions setting screen is
key simultaneously to delete the
displayed.
last entered character.

If [START] key is pressed, the

5. Set calibration conditions.
initially displayed value is
restored. Select “Cal.” or “CARD” by pressing
[hyphen (-)] key.
Cal.: Calibration by Calibrator
CARD: Calibration by magnetic card
 Chapter 3 SUB MENU

Press [ENTER] key.

The cursor moves to the entry
position for the number of times of
calibration. Any number from 2 to 6
(times) can be entered.

Press [ENTER] key.

The Standard range setting screen is
displayed.

mark is not printed when the 6. Set the standard range.

upper limit of the standard
range is the same or higher When sample type is not set
than the upper limit of the
measurement range. Enter the lower limit of the standard
mark is not printed when the
lower limit of the standard range with the numeric keys.
range is the same or lower than
the lower limit of the
measurement range. Press [Enter] key.
The cursor moves to the entry
position for the upper limit value.

Enter the upper limit value with the

numeric keys.
Press [Enter] key.
The Entry check screen is displayed.

When sample type is set

On the standard range entering Enter the lower limit value of the
screen, a sample type is
displayed. standard range for the sample
type1.

Press [Enter] key to move the cursor

to a place for the upper limit value.

Enter the upper limit value with the

numeric keys and press [Enter] key.

Similarly, set the standard range for

When the sample type are set sample types 2 to 5.
only up to two, the standard
range entry for the sample
The Entry check screen is displayed.
types 3 to 5 will be omitted.
 Chapter 3 SUB MENU

7. Store all the parameter settings.

Press [START] or [STOP].
If [START] key is pressed, the
parameter settings are saved and
the Measurement item selecting
screen is restored.

If [STOP] key is pressed, the setting

is canceled and Measurement item
selecting screen of procedure 1 is
restored.

8. End setting.
If the setting is finished, press
[STOP] key three times to return to
the MAIN MENU.
 Chapter 3 SUB MENU

3-3-3 Initialize parameters

Initialize parameter settings to the factory setting values.

1. Display setting screen.

Press [2] key on the MAIN MENU.
SUB MENU 1/2 is displayed.

Press [2] key.

The PARAMETER MENU 1/2 is
displayed.

Press [3] key.

The Password entering screen is
displayed. Enter password “99”.
is displayed.

Press [ENTER] key.

The Measurement item selecting
screen is restored.

2. Initialize parameters.
Besides [hyphen (-)] key, [0], [2], Press [hyphen (-)] key to select a
[4], [5], [6], and [8] keys can be
used in selecting items. measurement item to initialize.
[0] -> initially displayed item
[2] -> last item
[4] -> previous item
[6] -> next item Press [ENTER] key.
[8] -> first item
[5] -> first item of the Multi The Initialize confirmation screen is
Reagent Strip displayed.
If “ALL SINGLE” or “ALL MULTI”
is selected, parameter settings Press [START] key or [STOP] key.
of all the items for Single or Multi
Regent Strips are printed out If [START] key is pressed,
respectively. parameters are initialized and the
Measurement item selecting screen
is restored.
If [STOP] key is pressed, initialization
is canceled and the Measurement
item selecting screen is restored.
 Chapter 3 SUB MENU

3. End Initialization.
If the initialization is finished, press
[STOP] key three times to return to
the MAIN MENU.

Factory setting values

The following measurement conditions are pre-set upon shipment at the factory.
Refer to the table when setting parameters.
The present parameter settings can be printed out ( See “3-3-1 Print Parameters” ).

Setting item and range Factory setting value

Temperature 25 , 30 , 37 37
Coefficient of a : 0 ~ 10000 a : 1.0
correlation b : -10000 ~ 10000 b : 0.0
Standard range L : 0 ~ 10000
Measurement range
H : -10000 ~ 10000
Calibration type Calibration type Cal. or CARD CARD
Number of times 2 to 6 (times) 2
 Chapter 3 SUB MENU

3-3-4 Enter sample type

Enter sample types to measure.

The entered types are printed out with the measurement results.
Maximum 5 different types can be set.

1. Display the screen.

Press [2] key on the MAIN MENU.
SUB MENU 1/2 is displayed.

Press [2] key.

The PARAMETER MENU 1/2 is
displayed.

Press [Menu] key or [-] key.

Press [4] key.

The Sample type 1 name entering
screen is displayed.

2. Enter the sample type.

The numeric keys and [-/.] keys Maximum 5 letters can be entered
can be used in selecting items.
For example, to entry “man” using numbers, letters, and symbols.
[6][6][2][2][2][2][6][6][6][6][6][6]

[0] key can be used to input Press [Enter] key.

the following 12 symbols The Sample type 2 name entering
which are
screen is displayed.

To delete the name, press [-]

key to make it blank. Press Similarly, enter the sample types 2
[Enter] key. to 5.
When no sample type is set, press
[Enter] key, with the space kept
blank.
 Chapter 3 SUB MENU

3-3-4 Input of identifiers for sample classifications

3. Setting the sample type to use on the basic setting.

In the end, set the sample type to
use on the basic setting.
The entered sample type is used as
the sample type unless a different
type is set at the time of
measurement.

Press [-] key to select sample type

to use as the basic setting, and
press [Enter] key.
The Entry check screen is displayed.

4. Saving the setting contents.

Press [Start] key or [Stop] key.
Pressing [Start] key saves the details
of the setting, and returns the screen
to the PARAMETER MENU 1/2.
If [Stop] key is pressed, the
PARAMETER MENU 1/2 is restored
without saving the setting contents.

5. End setting.
Press [STOP] key twice to return to
the MAIN MENU.
 Chapter 3 SUB MENU

3-3-5 Copy standard range setting

The standard range setting for a certain sample type can be copied in
all items to one for another sample type.
Copy is available only when two or more sample types are input.

1. Display setting screen.

Press [2] key on the MAIN MENU.
SUB MENU 1/2 is displayed.

Press [2] key.

The PARAMETER MENU 1/2 is
displayed.

Press [Menu] key or [-] key.

Press [5] key.

The Standard range setting copy
screen.
The cursor is in the sample type on
the original screen.

2. Selecting the standard range on the original screen.

Press [-] key to select the sample
type for which the standard range is
set on the original screen.

Press [Enter] key.

The cursor moves to the sample
type on the duplicate screen.
 Chapter 3 SUB MENU

3-3-4 Input of identifiers for sample classifications

3. Selecting the standard range of the duplicate screen.

Press [-] key to select sample type
on the duplicate screen for which
the standard range setting is
required.

Press [Enter] key.

The Entry check screen is displayed.

4. Saving the setting contents.

Press [Start] key or [Stop] key.
Press [Start] key to copy and save the
standard range. The PARAMETER
MENU 1/2 is restored.

Press [Stop] key to return the screen

to the PARAMETER MENU 1/2,
without duplicating the standard
range.

5. End setting.
Press [STOP] key twice to return to
the MAIN MENU.
3-4 Maintenance Chapter 3 SUB MENU

Proper maintenance is required to maintain the accuracy of the analyzer.

Select “Maintenance” on the SUB MENU to perform either daily
maintenance or periodical maintenance.

1. Preparation for the maintenance.

Press [2] key on the MAIN MENU.
SUB MENU1/2 is displayed.

Press [3] key .

The Table Cover opens, and the
Reagent Table and the Centrifuge-
equipped Multi rack slide forward.

When the message is displayed as

shown on the right, turn off the
power.

2. Perform maintenance.
Perform maintenance of each part.
( see “Chapter 4 MAINTENANCE” )

3. End maintenance.
Turn ON the power. Warm-up starts,
the Reagent Table and the
Centrifuge-equipped Multi rack slide
back to the original position, and the
Table Cover closes.

After the warm-up is completed,

MAIN MENU is restored.
3-5 Mode Menu Chapter 3 SUB MENU

The Survey Mode is canceled Switch to the Survey Mode. When measurement is performed in the
automatically when the power is
turned off.
Survey Mode, raw data as well as normal measurement results can be
printed out (see 2-6 “Interpreting measurement results” for details of
printouts).

1. Display setting screen.

Press [2] key on the MAIN MENU.
SUB MENU1/2 is displayed.

Press [MENU] key or [-/.] key.

SUB MENU 2/2 is displayed.

Press [4] key.

The MODE MENU is displayed.

Press [1] key.

The Survey mode setting screen is
displayed.

2. Switch to the Survey Mode.

Press [hyphen (-)] key.
Turn ON the Survey Mode.

Press [ENTER] key.

The message “Writing...” is
displayed and the MODE MENU is
restored.

3. End the Survey Mode.

If the setting is finished, press
[STOP] key three times to return to
the MAIN MENU.
3-6 Built-in Clock Adjustment Chapter 3 SUB MENU

Set the Date and time of the built-in clock. Once the date and time are
set, resetting is not necessary. However, resetting may be necessary in a
long time of use.

1. Display setting screen.

Press [2] key on the MAIN MENU.
SUB MENU1/2 is displayed.

Press [MENU] key or [-/.] key.

SUB MENU 2/2 is displayed.

Press [5] key .

The Password entering screen is
displayed. Enter password “99”.
is displayed on the screen.

Press [ENTER] key.

The Clock adjustment screen is
displayed.

2. Set the date and time.

If [STOP] key is pressed during Enter the present date by sliding the
operation, the setting is
canceled and the SUB MENU cursor with [hyphen (-)] key.
2/2 is restored.

If [START] key is pressed, the Press [ENTER] key. The cursor

initially displayed value is moves to the time entry position.
restored.

If [STOP] key is pressed during Enter the present time by sliding the
operation, the setting is
canceled and the date setting is cursor with [hyphen (-)] key.
restored.

For the time settings, only the Press [ENTER] key. The set date
hour and minute can be set. and time are stored, and the SUB
The cursor does not move to the
second position. MENU 2/2 is restored.

3. End Setting.
Press [STOP] key to return to the
MAIN MENU.
Chapter 4

MAINTENANCE
Proper maintenance is required to maintain satisfactory measurement.
This chapter describes maintenance and replacement of consumables.

4-1 Outline of Maintenance

4-1-1 Frequency of Maintenance

4-2 Daily Maintenance

4-2-1 Cleaning the Reagent Table
4-2-2 Cleaning the Tip Waste Case and Protective Cover

4-3 Periodic Maintenance

4-3-1 Replacement of Thermal Printer Paper
4-3-2 Cleaning the Optical Window
4-3-3 Cleaning the Nozzle
4-3-4 Replacement of Nozzle
4-1 Outline of Maintenance Chapter 4 MAINTENANCE

4-1-1 Frequency of Maintenance

The following table shows the parts requiring maintenance and the
frequency of maintenance. Perform daily or periodical maintenance
according to the table.

Cleaning part Frequency Page

Cleaning of Reagent Table Daily 4-03

Cleaning of Tip Waste Case Daily 4-06

Cleaning of Protective Cover 4-07

Replacement of When a red line appears on 4-08

Thermal Printer Paper both sides of printer paper

Cleaning of Optical Window Once every 2,000 measurements 4-10

Cleaning of Nozzle Once every 10,000 measurements 4-13

or once a year

Replacement of Nozzle When a trouble occurs or

4-16
once a year

WARNING Cleaning of the parts marked with “ ” on the table above requires user to
wear protective gloves to prevent exposure to pathogenic microbes.
Discard any replaced parts or used cleaning tools separately from general
waste according to local regulations on biohazardous waste.
4-2 Daily Maintenance Chapter 4 MAINTENANCE

4-2-1 Cleaning the Reagent Table

With numerous measurements, residue of sample and Reagent Strips

stay on the Reagent Table. When they are adhered to a new Reagent
Strip, correct measurement results may not be obtained or Reagent
Strips may be jammed inside.
Clean the Reagent Table daily after use to ensure that correct
measurement results can be obtained all the time. Also, clean the black
and white plates, and the Rubber Plate once a week. If those plates are
dusty, correct measurement results may not be obtained. Refer to the
next page for cleaning procedures. Perform occasional cleaning
between measurements if necessary.

Requirements Cleaning set (brush , cotton swabs),

Distilled water and Protective gloves

WARNING Wear protective gloves to prevent exposure to pathogenic microbes.

CAUTION Discard used samples, tips and protective gloves separately from general
waste according to local regulations on biohazardous waste.

1. Slide the Reagent Table forward.

Press [2] key on the MAIN MENU.
SUB MENU 1/2 is displayed.

Press [3] key .

The Table Cover opens, and the
Reagent Table and the Centrifuge-
equipped Multi Rack slide forward.

Turn OFF the power.

2. Clean the Reagent Table.

Brush off dust on the Reagent Table
with a cleaning brush toward you.
Be sure to brush dust toward you,
not toward the analyzer.
Otherwise, malfunction of the
analyzer may occur.
 Chapter 4 MAINTENANCE

Moisten a cotton swab with distilled

water and wipe out stains or dust
adhered to the Reagent Table.
Clean the groove well carefully, not
to break the lugs on the tip of the
groove.

If the Reagent Table is wet, wipe

using a dry cotton swab. If any fiber
is remained on the Reagent Table,
brush it off with the cleaning brush
again. Do not spill water on the
analyzer to avoid damage.

Wipe out dust adhered to the table

pins with a cotton swab.

Clean the black and white plates.

Cleaning the black and white plates (once a week)

The black and white plates are reflectors to measure standard values of reflectivity
NOTE
measurement. Be careful not to leave grease or scratch the plates by touching them
with bare hands. Otherwise, correct measurement results may not be obtained.

Requirements: soft cloth (cloth for

eyeglasses is preferable).

Carefully wipe out stains or dust adhered to

the black and white plates with a soft cloth.

Do NOT try to blow dust away with your

breath, which may cause fogging of the
plates. Use a soft cloth, a brush, or a
camera blower.

3. Clean the Rubber Plate. (Once a week)

Remove the top cover by sliding it to
the left.
 Chapter 4 MAINTENANCE

Moisten a cotton swab with distilled

water and wipe out stains or dust
adhered to the Rubber Plate.

If the Rubber Plate is wet, use a dry

cotton swab.

Attach the top cover by sliding to

the right.

4. End cleaning.
Turn ON the power. Warm-up starts
and the Reagent Table and the
Centrifuge-equipped Multi Rack
slide back to the original position,
and the Table Cover closes.

If the operation is completed, turn

OFF the power after the MAIN
MENU is displayed.
 Chapter 4 MAINTENANCE

4-2-2 Cleaning the Tip Waste Case and Protective Cover

The Tip Waste Case holds used tips.

Its capacity is for 5 measurements .Discard used tips and wash the Tip
Waste Case. Clean the Protective Cover if necessary.
A message suggesting the disposal of used tips is displayed every 5
measurements.

Requirements Alcohol, Cloth and Protective gloves

WARNING Wear protective gloves to prevent exposure to pathogenic microbes.

CAUTION Discard used samples, tips and protective gloves separately from general
waste according to local regulations on biohazardous waste.

1. Slide the Centrifuge-equipped Multi Rack forward.

Press [2] key on the MAIN MENU.
SUB MENU 1/2 is displayed.

Press [3] key .

The Table Cover opens and the
Reagent Table and the Centrifuge-
equipped Multi Rack slide forward.

Turn OFF the power.

2. Discard Tips.
Remove the Tip Waste Case from
the Centrifuge-equipped Multi Rack.

Discard tips.
 Chapter 4 MAINTENANCE

3. Disinfect and wash the Tip Waste Case.

Disinfect the Tip Waste Case with
alcohol and wash it with tap water.

Wipe it dry with a cloth.

4. Reattach the Tip Waste Case.

Put the Tip Waste Case into the
Centrifuge-equipped Multi Rack.

5. Disinfect and wash the Protective Cover.

Disinfect the Protective Cover with
alcohol and wash it with tap water.

Wipe it dry with a cloth.

6. End cleaning.
Turn ON the power.
Warm-up starts. The Reagent Table
and Centrifuge-equipped Multi Rack
slide back to the original position
and the Table Cover closes.

If the operation is completed, turn

OFF the power after the MAIN
MENU is displayed.
4-3 Periodic Maintenance Chapter 4 MAINTENANCE

4-3-1 Replacement of Thermal Printer Paper

When the printer paper runs out, a red line appears on both sides of the
printer paper. If the line is seen, replace it with a new roll. Approximately
500 measurements can be printed out on one roll of paper.

Requirements New thermal printer paper roll and Scissors

1. Cut printer paper.

Make sure that the MAIN MENU is
displayed.

Open the printer cover.

If paper remains in the printer, cut it

off with scissors and remove the
remained paper.
If no paper remains in the printer,
remove the tube and proceed to
Procedure 3.

2. Remove the remained paper.

Press the [FEED] key. Pick and
remove the remained paper, as it is
fed out.
 Chapter 4 MAINTENANCE

3. Prepare new printer paper.

Cut off a single turn of the paper of
new roll. Cut the top end straight to
avoid a paper jam.

4. Set new printer paper.

Place a new roll of paper in the
paper holder, with the paper end
facing up.

Insert the top of the paper end into

the slot. The paper starts to be
rolled and fed automatically.
To make the printer ready for
printing, press [FEED] key.
Press [FEED] key once.
The printer becomes ready for
printing.

5. Close the printer cover.

Close the printer cover until it clicks
into place.

NOTE Be careful not to touch the paper

cutter to avoid injury.
 Chapter 4 MAINTENANCE

4-3-2 Cleaning the Optical Window

If dust is adhered to the Optical Window, correct measurement result may

not be obtained due to improper detection of reflect on light caused by
fluctuation of wavelength. Clean the Optical Window once every 2,000
measurements.

Requirements Cotton swab, Distilled water and Protective gloves

WARNING Wear protective gloves to prevent exposure to pathogenic microbes.

CAUTION Discard used samples, tips and protective gloves separately from general
waste according to local regulations on biohazardous waste.

1. Move the Nozzle to stand-by position.

Press [2] key on the MAIN MENU.
SUB MENU 1/2 is displayed.

Press [3] key .

The Table Cover opens and the
Reagent Table and Centrifuge-
equipped Multi Rack slide forward.
The Nozzle Driving Unit moves to
the left end in the analyzer.

Turn OFF the power .

CAUTION Make sure the power is OFF before moving on to the next procedure.
Otherwise, it may cause injury by contacting with the driving unit of the
analyzer.

2. Lay the analyzer on its side.

Remove the Tip Waste Case from
the Centrifuge-equipped Multi Rack.

NOTE Make sure that all used Reagent

Strips, samples and tips are
removed.
 Chapter 4 MAINTENANCE

Turn over the analyzer carefully so

that the right side (to which small
legs are attached) faces down.
Do NOT hold the Table Cover while
turning the analyzer.

NOTE Do NOT damage the connecting

part of the Table Cover.
Be careful not to tip over the
analyzer to avoid damage.

3. Clean the Optical Window.

Remove the rubber cap on the
bottom of the analyzer.

Wipe out stains and dust adhered to

the Optical Window (transparent
glass plate) with a cotton swab
moistened with distilled water.

Wipe out remained cotton swab

fibers and moisture of the Optical
Window with a new dry cotton
swab. Check it the Optical Window
is clean and dust-free. Use a
flashlight to make the checking
easier.
 Chapter 4 MAINTENANCE

4. Restore the analyzer.

Reattach the rubber caps firmly to
the bottom of the analyzer.

Carefully turn over the analyzer to

the original position, without holding
the Table Cover.

NOTE Do NOT damage the connecting

part of the Table Cover.
Be careful not to tip over the
analyzer to avoid damage.

5. End cleaning.
Attach the Tip Waste Case to the
Centrifuge-equipped Multi Rack.

Turn ON the power.

Warm-up starts.The Reagent Table
and Centrifuge-equipped Multi Rack
slide back to the original position
and the Table Cover closes.

When the operation is completed,

turn OFF the power after the MAIN
MENU is displayed.
 Chapter 4 MAINTENANCE

4-3-3 Cleaning the Nozzle

With numerous measurements, sample blood residue may stay inside the
Nozzle and cause clogging.
Clean the Nozzle once every 10,000 measurements or once a year.

Requirements Nozzle cleaning wire, Tweezers,

Tissue paper and Protective gloves

WARNING Wear protective gloves to prevent exposure to pathogenic microbes.

CAUTION Discard used samples, tips and protective gloves separately from general
waste according to local regulations on biohazardous waste.

1. Move the Nozzle to stand-by position.

Press [2] key on the MAIN MENU.
SUB MENU 1/2 is displayed.

Press [3] key .

The Table Cover opens, and the
Reagent Table and Centrifuge-
equipped Multi Rack slide forward.
The Nozzle Driving Unit moves to
the left end in the analyzer.

Turn OFF the power.

CAUTION Make sure the power is OFF before moving on to the next procedure.
Otherwise, it may cause injury by contacting with the driving unit of the
analyzer.

2. Remove the cover.

Remove the top cover by sliding it to
the left.
 Chapter 4 MAINTENANCE

Remove the side cover.

3. Remove the Nozzle Tube.

Remove the Nozzle Tube from the
Nozzle using tweezers.

NOTE Do NOT scratch or damage the

Nozzle Tube.

4. Clean the Nozzle.

Insert the nozzle cleaning wire into
the Nozzle until its tip appears from
the other end.

Clean the inside of the Nozzle by

moving the wire up and down a
couple of times.

Wipe out the dust caming out of the

tip of the Nozzle with tissue paper.
 Chapter 4 MAINTENANCE

5. Insert the Nozzle Tube.

Remove the nozzle cleaning wire
from the Nozzle.

Pinch the Nozzle Tube with tweezers

and insert it into the tube joint.

6. Reattach the covers.

Put the side cover to the analyzer.

Attach the top cover by sliding to

the right.

7. End Cleaning.
Turn ON the power.
Warm-up starts. The Reagent Table
and Centrifuge-equipped Multi Rack
slide back to the original position,
and the Table Cover closes.

When the operation is completed,

turn OFF the power after the MAIN
MENU is displayed.

NOTE Before turning ON the power, make sure that the maintenance cover is
installed.
 Chapter 4 MAINTENANCE

4-3-4 Replacement of Nozzle

With numerous measurements, the O-ring attached to the Nozzle becomes

deteriorated.

Requirements Nozzle, Nozzle replacement tool and Protective gloves

WARNING Wear protective gloves to prevent exposure to pathogenic microbes.

CAUTION Discard used samples, tips and protective gloves separately from general
waste according to local regulations on biohazardous waste.

1. Move the Nozzle to stand-by position.

Press [2] key on the MAIN MENU.
SUB MENU 1/2 is displayed.

Press [3] key .

The Table Cover opens, and the
Reagent Table and Centrifuge-
equipped Multi Rack slide forward.
The Nozzle Driving Unit moves to
the left end in the analyzer.

Turn OFF the power.

CAUTION Make sure the power is OFF before moving on to the next procedure.
Otherwise, it may cause injury by contacting with the driving unit of the
analyzer.

2. Remove the cover.

Remove the top cover by sliding to
the left.
 Chapter 4 MAINTENANCE

Remove the side cover.

3. Remove the Tip Waste Case.

Loosen the fixing screws and
remove the tip ejector.

Remove the Tip Waste Case.

4. Replace the Nozzle.

Fasten the upper part using the
narrow side of the wrench.

Insert the adapter from the bottom

and rotate it using the wide side of
the wrench.

Attach a new Nozzle and fasten it

lightly by hand.

Tighten it firmly using two wrenches.

 Chapter 4 MAINTENANCE

5. Reattach the Tip Waste Case.

Put the Tip Waste Case by tightening
the screws.

6. Reattach the covers.

Put the side cover to the analyzer.

Put the top cover to the analyzer by 2

sliding it to the right.

7. End replacement.

NOTE Before turning ON the power, make sure that the maintenance cover is
installed.

Turn ON the power.

Warm-up starts. The Reagent Table
and Centrifuge-equipped Multi Rack
slide back to the original position,
and the Table Cover closes.

When the operation is completed,

turn OFF the power after the MAIN
MENU is displayed.
Chapter 5

TROUBLESHOOTING
When there is a failure in operation or a problem with the analyzer,
an error or trouble occurs. This chapter describes, the kinds of
errors / troubles, causes and remedy.

5-1 Error Messages

5-2 Trouble Messages
5-3 After sales service
5-1 Error Messages Chapter 5 TROUBLESHOOTING

When an error occurs, an alarm sounds and the error message appears The following errors are not
on the screen. printed when the magnetic
The error message is automatically printed in order to preserve the card is inserted.
E15 No MEAS data
error record (The following errors are only displayed, and not printed).
E21 Card misread
E24 Wrong card
E25 Wrong stripe

Description and error message Conditions and causes Remedy

The table cover was opened during Close the table cover correctly
measurement or warm-up. (Remove the foreign matter).
The maintenance cover was opened Set the maintenance cover in the
during measurement or warm-up. correct position.
The table cover is not properly closed
(Foreign matter is jammed).
The measurement was started without
closing the maintenance cover.

Power failure has occurred during The last measurement was invalid.
measurement. Restart measurement.
Power was turned off during
measurement.
The power cable was unplugged during
measurement.

A light source is deteriorated. If the same trouble occurs, contact

your distributor.

The white and black plate or window Clean the white and black plate or
plate is dirty. window plate ( see “4-2-1 Cleaning
the Reagent Table” and “4-3-2
Cleaning the Optical Window”).

Wear protective gloves in order to avoid exposure

WARNING to pathogenic microbes.

Reagent Strip is not set. Set Reagent Stripes correctly.

The bar code was not correctly read When calibrating, set the necessary
due to displacement or bending of the numbers.
Reagent Strip.
The Reagent Strip is not set in the
channel necessary for calibration.

Wear protective gloves in order to avoid exposure

WARNING to pathogenic microbes.
 Chapter 5 TROUBLESHOOTING

Description and error message Conditions and causes Remedy

When calibrating by calibrator kit, a Set the Reagent Strip correctly.

many Reagent Strip is set. Return to the menu because the
The bar code was not correctly read changing item is not allowed during
due to displacement or bending of the calibration by calibrator kit.
Reagent Strip.
Before calibration of an item is completed,
another item was attempted to be
calibrated.

Wear protective gloves in order to avoid exposure

WARNING to pathogenic microbes.

Used Reagent Strip is already used. Use a new Reagent Strip.

The reagent pad is colored because of Set the Reagent Strip correctly.
old Reagent Strips or inappropriate
preservation.
The reagent pad is dirty.
The bar code was not correctly read
due to displacement or bending of the
Reagent Strip.

Wear protective gloves in order to avoid exposure

WARNING to pathogenic microbes.

Reagent Card for the item to measure is Insert a magnetic card

not inserted. corresponding to the item.
The bar code was not correctly read Set the Reagent Strip correctly.
due to displacement or bending of the
Reagent Strip.
When this occurs in measurement with
a Multi Reagent Strip, Reagent Card for
a multi reagent is not inserted for
measurement.
A multi card for an item with no
information for measurement is inserted.
Wear protective gloves in order to avoid exposure
WARNING to pathogenic microbes.

Wrong calibration card was inserted. Insert the correct calibration card
The bar code was not correctly read again (Hb is a different card).
due to displacement or bending of the Set the Reagent Strip correctly.
Reagent Strip.

Wear protective gloves in order to avoid exposure

WARNING to pathogenic microbes.
 Chapter 5 TROUBLESHOOTING

Description and error message Conditions and causes Remedy

A sample vessel is misplaced. Set the sample correctly.

There is no sample or an insufficient Confirm the amount of the sample.
amount of sample. Be sure to use cuvettes in
A centrifuge tube was used in calibration by calibrator kit.
calibration by calibrator kit.

Wear protective gloves in order to avoid exposure

WARNING to pathogenic microbes.

The magnetic card was caught when Insert the magnetic card again.
inserted. Clean the head of the magnetic
The head of magnetic card reader is card reader.
dirty.

Wrong magnetic card was used (a Insert a correct magnetic card.

calibration card was inserted when the
display showed Reagent Card reading
or vice-versa).

The same stripe was inserted. Insert a different stripe.

During calibration, the difference of the Perform measurement again.

measured value and the display of
calibrator is extremely large.
The variations of the measured values
are extremely large in calibration.
Calibrator L and H might be set
oppositely in calibration.
Incorrect adjustment of calibrator.
 Chapter 5 TROUBLESHOOTING

Description and error message Conditions and causes Remedy

The clock is not correctly adjusted. Readjust the date and time.
The power was not connected for a long (see “3-6 Built-in Clock Adjustment”)
time (battery is dead).

The Reagent Strip has expired. Use a new Reagent Strip.

The clock is not correctly adjusted. Adjust the clock.
The clock is not correct because the Insert a new magnetic card.
power was not connected for a long
time.
When using a Reagent Strips from new
lot, the corresponding magnetic card to
the lot of the was not inserted.

External light entered because the table Close the table cover or the
cover or maintenance cover was slightly maintenance cover firmly.
opened. Change the direction of the
analyzer.

The table is dirty. Remove dust from the table.

The bar code was not correctly read Reset the Single Reagent Strip
due to displacement or bending of the correctly.
Reagent Strip. Confirm that foreign matter is not
Foreign matter is attached to the Single attached to the Single Reagent
Reagent Strip. Strip.

Wear protective gloves in order to avoid exposure

WARNING to pathogenic microbes.

The setting (such as baud rate) of the Confirm the setting of the hand-
hand-held bar code reader is incorrect. held bar code reader (such as baud
The hand-held bar code reader is not rate).
correctly connected. Connect the hand-held bar code
reader correctly.

Battery is exhausted. Charge the battery.

 Chapter 5 TROUBLESHOOTING

Description and error message Conditions and causes Remedy

When sampling, air bubbles or fibrin Remove air bubbles or fibrin.

was aspirated. Confirm the sample amount.
When sampling, the sample amount
was insufficient.

Wear protective gloves in order to avoid exposure

WARNING to pathogenic microbes.

Forgot to set the Tip Waste Case. Set the Tip Waste Case correctly.
The Tip Waste Case is not correctly set.

The cable is not connected. Connect the cable correctly.

The setting (e.g. baud rate) of the Confirm the setting (e.g. baud rate)
connected device (such as PC) is of analyzer connections (e.g. PC).
incorrect.

Failed to draw the sample and drop it to Check the sample amount and
the reagent correctly due to lack of remove fibrin if necessary.
sample amount or absorbing fibrin. Wipe off the sample adhered to
Failed to drop the sample to the reagent around the dropping hole.
correctly because the sample adheres Measure it with a different tip.
around the dropping hole.

The memory storing the measured If the same trouble occurs often,
results is defective. contact your distributor.
Power was cut while writing in memory
or deleting.

The memory storing the trouble history If the same trouble occurs often,
is detective. contact your distributor.
Power was cut while writing in memory
or deleting.

The memory storing the setup data is If the same trouble occurs often,
defective. contact your distributor.
Power was cut while writing in memory As the user setting value is
or deleting. initialized or is returned to the last
measured value, reset it (re-enter
it).
5-2 Trouble Messages Chapter 5 TROUBLESHOOTING

When a trouble occurs, an alarm sounds, and a trouble message is displayed. The trouble message
is automatically printed in order to preserve the trouble record.

When a trouble occurs during measurement, perform the measurement again. It may
have influenced the result obtained before the trouble occurred. Perform the
measurement again if the result is defective.

Description and trouble message Conditions and causes Remedy

The pressure does not increase since Clean the rubber plate.
the rubber plate is dirty or deformed. Check the tube.
The tube or pipe is clogged. If the same trouble occurs, contact
The tube connecting the nozzle with the your distributor. (NOTE: in cases
pump is disconnected. where the abnormality is detected
The tube connecting the pump with the when the power switch is turned
pressure-detecting sensor is on, it is necessary to turn on the
disconnected. power again after maintenance
because the measurement could
not be started).

The temperature inside the analyzer Confirm if the fan is rotating.

became too high because the fan had Confirm the temperature outside.
stopped. If the same trouble occurs, contact
The temperature outside exceeds the your distributor. (NOTE: in cases
range ( 10 30 ) suitable for where the abnormality is detected
operation. when the power is turned on, it is
necessary to turn on the power
again because the measurement
cannot be started).

Trouble occurred at the nozzle up-down Turn on the power again.

driving mechanism (hit an obstruction Confirm that there is no
when it moved downward or it was obstruction.
caught in the upward-movement). If the same trouble occurs, contact
your distributor.

Trouble occurred in the nozzle right-left Turn on the power again.

driving. Confirm that there is no
obstruction.
If the same trouble occurs, contact
your distributor.

The table cannot function because a Turn on the power again.

Reagent Strip is caught in the gap in the Remove the obstruction, if any.
table. Confirm that there is no obstruction
The Reagent Strip table cannot function in front of the table cover.
because there is an obstruction in front If the same trouble occurs, contact
of the table cover. your distributor.
 Chapter 5 TROUBLESHOOTING

Description and trouble message Conditions and causes Remedy

Trouble occurred in the pump-driving Turn on the power again.

mechanism. If the same trouble occurs, contact
your distributor.

The optimal gain could not be set. Turn on the power again.
If the same trouble occurs, contact your
distributor. (NOTE: If measurement is
started though trouble is detected
when the power turned on, trouble
occurs at the start of measurement,
and the measurement cannot be
performed).

Trouble occurred in the internal If the same trouble occurs, contact

calculation operation. your distributor.

LED is not lit. Turn on the power again.

LED is deteriorated. If the same trouble occurs, contact
your distributor.

Trouble occurred in an electrical Turn on the power again.

component. If the same trouble occurs, contact
your distributor.

Forgot to set tips. Set the tip.

Failure in setting tip mount.
 Chapter 5 TROUBLESHOOTING

Description and trouble message Conditions and causes Remedy

Failure to discard tip. Turn off the power, and remove the
tip from the nozzle.

White plate or black plate is dirty. Clean the white plate or black plate.
(Note: the case in which trouble is
detected when the power is turned
on, it is necessary to turn on the
power again after maintenance
since measurement cannot be
started).

The rotating rate of centrifuge is Remove the obstruction around the

defective. centrifuge.
It cannot rotate due to an obstruction Turn on the power again.
around the centrifuge. If the same trouble occurs, contact
Forgot to set centrifuge tube. your distributor.
Protective cover is not properly Set the centrifuge tube.
attached. Attach the protective cover properly.

Trouble occurred in the centrifuge front- Turn on the power again.

back driving mechanism. Confirm that there is no obstruction.
It cannot operate because of an If the same trouble occurs, contact
obstruction in the operating path of the your distributor.
centrifuge base.

Trouble with product information If the same trouble occurs, contact

memory storage. your distributor.
Power was cut while writing in memory
or deleting.

Trouble with mechanism information If the same trouble occurs, contact

memory storage. your distributor.
Power was cut while writing in memory
or deleting.

Trouble with optical system information If the same trouble occurs, contact
memory storage. your distributor.
Power was cut while writing in memory
or deleting.
 Chapter 5 TROUBLESHOOTING

Description and trouble message Conditions and causes Remedy

Trouble with parameter memory storage. If the same trouble occurs, contact
Power was cut while writing in memory your distributor.
or deleting.
5-3 After sales service Chapter 5 TROUBLESHOOTING

Warranty : A warranty is included in this packaging box. This warranty is necessary when the analyzer
requires repair. After filling in the necessary items and confirming the described contents,
keep the warranty in a safe place.

Repairs : When the analyzer does not function Contact your distributor.
well

Repair within the guaranteed period Repair is made under conditions of the
certificate.

Repair after the guarantee has A repair fee is necessary.

expired
Chapter 5 TROUBLESHOOTING
Chapter 6

APPENDIX

6-1 Transmission Specifications

6-1-1 Protocol
6-1-2 Format
6-1-3 Format for measurement result (format 1)
6-1-4 Format for measurement result (format 2)
6-1 Transmission Specifications Chapter 6 APPENDIX

6-1-1 Protocol

Transmission format Start-stop system (asynchronous) unidirectional transmission

by serial transmission format (in compliance with JIS X5101).

Data format One character consists of the following 11 bits.

Start bit: 1 bit
Data bit: 7 bits (ASCII code)
Parity bit: 1 bit (even)
Stop bit: 2 bits

Baud rate Baud rate can be selected out of the following 6 rates.
300, 600, 1200, 2400, 4800, 9600bps

Hand shake Suppression by CFT and RTS are possible. (Suppression is

not set by default.) XON/XOFF control is not available.

Time gap 2-second waiting time is inserted between each block (from
< ETX > or < ETB > to < STX >).

Forced finish Data transmission is sometimes forced to stop halfway by key

operation. It is not promptly stopped by pressing a key, but
transmission continues until < ETX > or < ETB > is output.
 Chapter 6 APPENDIX

6-1-2 Format

Block structure is regular. One block consists of start, data and end. This is illustrated
below in the following descriptions.

Start Data End

Start (S)
Start of each block is < STX >.
Start of block is expressed as S in the following illustrations.

Data
Data (text) of each block is the main body of transmission contents, and is expressed
by arrangement of ASCII characters.
< CR >, < LF >, < RS > or < US > is sometimes involved in data. Characters other than
these cannot be involved.

End (E)
End of each block is < RTX > or < ETB >.
< ETX > or < ETB > is distinguished by whether it is in the last block or not.
If it is in the last block, it is < ETX >, and if it is in the middle block, it is <ETB >.

The block end is expressed by E in the following illustrations.

 Chapter 6 APPENDIX

6-1-3 Format for measurement results (format 1)

The measurement result (format 1) is the same as the “regular format” in SP-4410 or SP-4420.
The receiving program designed to receive the measurement results of SP-4420 (regular format) can
normally receive the measurement results (format 1) of SP-4430.

Transmission data of measurement results (format 1)

When transmitting the measurement results with format 1, the number of blocks differs depending on the combination of
the reagent strips.

A. When only Multi Reagent Strips are measured.

S Header Multi Reagent Strip E

measurement results

B. When only Single Reagent Strips are measured.

S Header Single Reagent Strip E

measurement results

C. When Multi and Single Reagent Strips are measured.

S Header Multi Reagent Strip E S Single Reagent Strip E

measurement results measurement results

Format of header

Measurement date. Year (The last two digits of year), month (1~12), date (11~31). No zero
control. YMD format is always applied regardless of the date setting.

Measurement date. Time (01~23), Minute (01~59). No zero control.

When ID is available, ID is output. When there is no ID, only the first 10 digits are output. The
measurement number is expressed in 4 digits without zero control. For the measurement
number, blank is used for 0311~036.
 Chapter 6 APPENDIX

Format of Multi Reagent Strip measurement results

Name of Multi Reagent Strip

Item name

Abnormal mark
Within the range of standard values: Blank (20H)
Low value: <US>(1FH)
High value: <RS>(1EH)

Measurement value

Unit symbol
Temperature
37 : Blank(20H)
30 : “ + ”
25 : “ ”
Items other than enzyme: Blank

The same repetition as 023~044.

When the number of items is less than 6, the redundancy makes up for the blank (20H).
 Chapter 6 APPENDIX

Format of Single Reagent Strip measurement results

When only Single Reagent Strips are measured: Blank (20H)

When Multi Reagent Strips are measured: Fixed character string “SINGLE”
Item name
Abnormal mark
Within the range of standard values: Blank (20H)
Low value: <US>(1FH)
High value: <RS>(1EH)

Measurement value

Unit symbol
Temperature
37 : Blank(20H)
30 : “ + ”
25 : “ ”
Items other than enzyme: Blank

The same repetition as 023~044. No extra output is made.

The block length of this block changes according to the number of Reagent Strips (items). For
example, if the number of the Reagent Strips are 2 (2 items), the block length is completed as
66 bytes.
 Chapter 6 APPENDIX

Data errors
In the Multi Reagent Strip and Single Reagent Strip measurement results, data parts for each item (22 bytes including
end CR/LF) are output as follows when measurement errors occur.

Error in range or prozone (OVER)

Item name

Over the range: Fixed character string “OVER >”

Under the range: Fixed character string “UNDER >”
Prozone (OVER): Fixed character string “OVER >”
Over the range: Upper limit of measurement range
Under the range: Lower limit of measurement range
Prozone (OVER): Upper limit of measurement range

Temperature
37 : Blank(20H)
30 : “ + ”
25 : “ ”
Items other than enzyme: Blank

Prozone (CANT' MEAS) or calibration error by magnetic card

Item name

Error message
Prozone (CANT' MEAS): “CANT' MEAS ”
Magnetic card, CAL error, L: “CAL. ERROR L1”
Magnetic card, CAL error, H: “CAL. ERROR H1”
Temperature
37 : Blank(20H)
30 : “ + ”
25 : “ ”
Items other than enzyme: Blank
 Chapter 6 APPENDIX

6-1-4 Format of measurement results (format 2)

The measurement result (format 2) is the same as the “extended format” in SP-4410 or SP-4420.
The receiving program designed to receive the measurement results of SP-4420 (extended format)
can normally receive the measurement results of SP-4430 (format 2).

Transmission data of measurement results (format 2)

A. When only Multi Reagent Strips are measured.
When transmitting the measurement results with format 2, 1 item is output as 1 block. The order of the items are, Multi
Reagent Strip, Single Reagent Strip.

S Data in Item 1 E S Data in Item 2 E S Data in Item n E

The end of the block is all block <ETX>.

“data in item x”

When ID is available, ID is output. When there is no ID, only the first 10 digits are output. The
measurement number is expressed in 4 digits without zero control. For the measurement
number, blank is used for 031~036
Sample number types . For ID, “1”. For number , “0”

The maximum number of items in the measurement

The order of the maximum number of items

Measurement date. Year (The last two digits of year), month (1~12), date (1~31)
No zero control. YMD format is always applied regardless of the date setting

Measurement date, Time (0~23), Minute (0~59). No zero control

Data error.
Normal=0, Under the range=1, Over the range or prozone error (OVER)=2, Low value=3, High
value=4, Prozone error (CAN’T MEAS)=5, Calibration error by magnetic card L1=6, Calibration
error of magnetic card H1=7
37 : “ 0 ”
30 : “ 2 ”
25 : “ ”
Items other than enzyme: “ 0 ”
Name of Multi Reagent Strip (For Single Reagent Strip, blank (20H) is used)
Item name
Measurement value.
When the data error=1, lower value, the data error=2,5,6,7, upper values are applied

Unit symbol
83-00139F