Arkray Spotchem SP-4430 User manual

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83-00140F Printed in Japan

DOC.No.OM-28573 REV.6 03/02

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

Premise

This manual contains important information on the functions of the SPOTCHEM EZ SP-4430

Distributed by : A.Menarini I.F.R. srl

Diagnostics Division

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 European Directive 98/79/EC.

SPOTCHEM EZ SP-4430 OPERATING MANUAL DOC.No.OM-28573 REV.6 03/02

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.

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.

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

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 pathogenic microbes, follow the instructions given herein.

To prevent injuries to yourself or others, or material damages, follow the instructions described.

Regarding damage and performance of products.

Failure to follow the instructions may lead to incorrect results.

To prevent damage to the unit and assist you in making best use of the capabilities of the analyzer, additional explanations and notes are provided herein.

IMPORTANT

NOTE

Reference information on operation, additional explanations and related functions are provided herein.

SPOTCHEM EZ SP-4430 OPERATING MANUAL DOC.No.OM-28573 REV.6 03/02

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

Chapter 1 INTRODUCTION

Chapter 2 MEASUREMENT

Automated biochemical analyzer, SP-4430

Contents

Premise Introduction Caution Marks Caution Labels Contents

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

2-1 Outline of Measurement

2-1-1 SPOTCHEMⅡ 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 Preparation of samples

2-4 Measurement

2-4-1 Normal measurement

01 02 03 04 05

1-02 1-02 1-03 1-04 1-05 1-05 1-06 1-07 1-07 1-08 1-09 1-10 1-10 1-12 1-13 1-15

2-02 2-02 2-03 2-04 2-06 2-06 2-07 2-07 2-08 2-08 2-09 2-10 2-10 2-11 2-12 2-13 2-18 2-18

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Chapter 3 SUB MENU

Chapter 4 MAINTENANCE

Chapter 5 TROUBLESHOOTING

Chapter 6 APPENDIX

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

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

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

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

6-1 Transmission Specifications

6-1-1 Protocol 6-1-2 Format 6-1-3 Format for measurement results (format 1) 6-1-4 Format for measurement results (format 2)

2-28 2-28 2-29 2-31 2-39 2-39 2-42

3-02 3-02 3-04 3-04 3-06 3-08 3-10 3-10 3-13 3-17 3-19 3-21 3-23 3-24 3-25

4-02 4-02 4-03 4-03 4-06 4-08 4-08 4-10 4-13 4-16

5-02 5-07 5-11

6-02 6-02 6-03 6-04 6-08

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

SPOTCHEM EZ SP-4430 OPERATING MANUAL

DOC.No.OM-28573 REV.6 03/02

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.

Chapter 1

INTRODUCTION

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

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1-1 Outline

Chapter 1 INTRODUCTION

■Compact and lightweight design

■Energy-saving design

■Automatic Sampling

■Built-in centrifuge for

1 sample

■Simple calibration using magnetic cards

■Sample Control by Bar code

■Online Network through two-way Transmission

1-1-1 Features

The footprint of the SP-4430 is as small as that of a 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, 1sample 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.

Power consumption per 1 hour is approximately 50 W on average (AC 100V, 60Hz when continuous measurements are conducted).

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.

The analyzer has a built-in centrifuge for 1 sample. By 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.

Calibration using magnetic cards

Reagent Card are

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.

Optional Hand-held Bar Code Reader is available. By reading the bar code of each sample, the bar code is automatically allocated as patient ID.

With the optional Data Management Software and external devices, remote control of measurement results and remote update of parameter settings are possible.

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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.

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).

1-1 SP

4430

Chapter 1 INTRODUCTION

1-1-2 Measurement principles

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4430

Chapter 1 INTRODUCTION

1-1-3 Specifications

Sample Measurement item Measurement wavelength Measurement principle

Measurement Range Reagent Strip Processing speed Minimum sample volume

Sample consumption Sample container

Simultaneous measurement

Reagent reaction temperature Light source Calibration method

Data storage volume Display Built-in Printer External Output Transmission Method Transmission Rate Measurement conditions

Power supply

Power input Dimensions Weight

Serum, Plasma, Whole blood (Only Hb) General biochemical measurement items, 22 items 5 wavelengths (405, 550, 575, 610 and 820 nm) Optical measurement of reflection intensity of reagent color reaction Set for sach measurement item SPOTCHEMⅡReagent Strip 63 samples per hour 6

× the number of measurement items + 38μL:

serum, plasma 4

6μL(per 1 measurement item): serum, plasma

Whole blood: exclusive whole blood sample tube (Orange cap) Centrifuge tube Serum, plasma: exclusive serum sample tube (Blue cap)

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.

37 ℃ LED and Interference filter Calibration by magnetic card (Reagent Card)

Calibration by Calibrator Kit 100 tests 20 digits

2 lines LCD 36-character thermal printer (58 mm width) RS-232C interface Single or Two-way Transmission 300, 600, 1200, 2400, 4800, 9600bps Temperature: 10

Humidity: 20 80 % (Non-condensing) AC100

120V, 220 240V

50/60Hz

AC adapter method Max. 100VA 338 mm(W)

203 mm(D) 167 mm(H)

Approximately 5.4 kg

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1-2 Shipping Carton

Chapter 1 INTRODUCTION

1-2-1 Analyzer

Open the package and confirm that all items are included.

Description

SP-4430

This book

Warranty card with case, Delivery label

NO.

1 2 3 4 5 6

Item

Analyzer Power cord AC adapter Accessory case Operating manual

Warranty card

Qty.

1 1 1 1 1 1set

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1-2

Chapter 1 INTRODUCTION

1-2-2 Accessories

Description

10 tips Nozzle cleaning Brush, Cotton swab Nozzle with O-ring 2 Wrench, Adapter 10 pieces 2 pieces 2 pieces

width 58 mm

NO.

1 2 3 4 5 6 7 8 9

Item

Tip Cleaning wire Cleaner set Nozzle set (EZ) Wrench set for nozzle replacement Centrifuge tube Tip waste case Protective cover Thermal printer paper

Qty.

1 Set 1 Set 1 Set 1 Set 1 Set 1 Set 1 Set 1 Set 1 Set

Open the package and confirm that all items are included.

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Chapter 1 INTRODUCTION

1-3 Parts Description and Function

1-3-1 Front of the analyzer

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

For setting the samples and tips. The centrifuge for 1 sample is built in. For setting the samples. For setting the whole blood samples that have not been centrifuged. For setting tips. The container for used tips automatically discarded after sampling.

Filled with 5 measurements. The standard reflection plates used for measurement of reflectivity. Prevents entering the external light.

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

For starting or stopping measurement and entering IDs. Displays information such as operating state of the unit and error messages. For inserting magnetic cards: Reagent Card and Calibration Cards

Thermal-type printer. Prints out measurement results and setting conditions. Protects the Nozzle Driving Units. Also prevents the operator from contacting

the nozzle during measurement. There are top and side covers. Prevents the operator from contacting the Centrifuge Tube.

Also protects spilling of samples.

NO.

2 3 4 5 6

7 8

9 10 11 12 13

Item

Reagent table

Centrifuge-equipped Multi Rack Port Centrifuge Tip hole Tip waste case

Black & white plates Table cover

Operator panel Display Magnetic card reader Built-in printer Maintenance cover

Protective cover

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1-3

Chapter 1 INTRODUCTION

1-3-2 Operator panel

Function

Starts measurement. SelectYesfrom the Yes/No option.

Stops measurement. SelectNofrom the Yes/No option. Cancels entry.

Feeds the built-in printer with paper while pressed.

Switches the page on each menu display.

Selects the menu number. Enter numerical values and ID.

Selects item, move cursor , switch the page on the display, and enter minus sign and decimal point.

Determines the entry. Check message to proceed to the operation.

Item

START

STOP

FEED

0~9 (ten key)

-/.(hyphen/period)

ENTER

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4430

Chapter 1 INTRODUCTION

1-3-3 Rear of the analyzer

Function

For turning on and off the power supply to the analyzer.

For the supplied AC adapter.

For Ventilating heated air in the unit to prevent overheating.

For the cable of the optional external device.

Jack for the bar-code reader (option).

For adjusting screen contrast. Turning clockwise to make the screen darker, counterclockwise makes it brighter.

For setting thermal printer paper.

Item

Power switch

Power input terminal

Cooling Fan

COM.

B.C.R.

CONT.

Paper holder

NO.

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1-4 Setting up the Analyzer

Chapter 1 INTRODUCTION

1-4-1 Cautions

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

Allow a space of 10 cm or more between the rear of the analyzer and the wall. Failure to do so may cause overheating. Excessive load on the cable connection may cause fire or incorrect measurement results.

Operate the analyzer with power of the correct voltage and frequency. Otherwise fire or damage may result.

Do NOT unnecessarily disassemble or modify the analyzer. Such actions may invite danger of exposure to pathogenic microbes, and cause fire or damage.

Place the analyzer on a stable and level surface free of vibration. Failure to do so may damage the analyzer, correct measurement results may not be obtained, and injury may result. Do NOT place the analyzer where there is a risk of falling.

To avoid electric shock and/or fire, use the attached power cord to connect with a power outlet. For details, contact your distributer.

Connect the power plug directly to an outlet, not via an extension cord or power tap. The power supply for the 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).

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4430

Chapter 1 INTRODUCTION

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

Do NOT set up the analyzer where chemicals are stored nearby, or where corrosive gases or electrical noise are generated. They may damage the analyzer, and malfunctions and/or injury may occur. Correct measurement results may not be obtained.

Avoid exposing the analyzer to direct sunlight, condensation and wind. Otherwise, correct measurement results may not be obtained, and may cause deformation or malfunction of the analyzer.

To connect the analyzer to external devices, be sure to use proper cables to avoid electric shock and/or fire. For details, contact your distributor.

Place the analyzer in a room at temperatures between 10

and 30 with humidity between 20% and 80%. Otherwise, correct measurement results may not be obtained.

Make sure that the room is well ventilated when a large amount of carbon dioxide is generated (when gas 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.

Be careful not to be put hands under the analyzer.

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1-4

Chapter 1 INTRODUCTION

1-4-2

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.

Setting up the analyzer

Remove the fixing tape.1.

Remove the tape fixing the table cover.

Open the maintenance cover and remove the tape fixing the nozzle.

Reattach the maintenance cover.

Connecting an external device (if necessary)3.

When using an external device, connect the exclusive connecting cable to COM on the rear panel of the analyzer.

Connect the power cord.2.

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.

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4430

Chapter 1 INTRODUCTION

1-4-3

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

First operation after setting up

Turn on the power.1.

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.

About 10 minutes after (room temperature at 25℃), warm-up is completed and the MAIN MENU is displayed as shown at right.

For error correction or troubleshooting, “see Chapter 5 Troubleshooting”.

SPOTCHEM EZ

S Pー４４３０ V XXXX

Wa r m i n g u p

・・・

／

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

Set the thermal printer paper.2.

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

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

Confirm the time and date.3.

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

Remove the fixing tape on the protective cover.4.

Press [1] on the MAIN MENU. The Table Cover opens and the Reagent Table and Centrifugeequipped Multi Rack slide forward.

IMPORTANT

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1-4

Chapter 1 INTRODUCTION

1-4-4 Notes at transportation

Turn off the power.5.

When terminating the operation or setting, turn off the power after making sure that the MAIN MENU is displayed.

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

Remove the tape fixing the protective cover.

Set the maintenance cover and the tip waste case.

Press [STOP] to close the table cover.

Cove r i s c l os i ng . ／

Back to MENU（STOP） Back to MEAS（ENTER）

Cove r i s c l os i ng .

Stop（STOP）

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.

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1-4

Chapter 1 INTRODUCTION

1-4-4

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.

Notes at transportation

Wear protective gloves to prevent exposure to pathogenic microbes.

Inspect the inside of the analyzer.1.

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.

Placing analyzer into carrying case.2.

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

S t a n d b y ２０００ー０６ー１０

I D（１） I N FO（２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

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SPOTCHEM EZ SP-4430 OPERATING MANUAL

DOC.No.OM-28573 REV.6 03/02

Chapter 2

MEASUREMENT

2-1 Outline of Measurement

2-1-1 SPOTCHEMⅡ 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

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.

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2-1 Outline of Measurement

Chapter 2 MEASUREMENT

2-1-1

SPOTCHEMⅡ 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.

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.

SPOTCHEMⅡ Reagent Strips

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2-1-2

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.

Normal measurement

Chapter 2 MEASUREMENT

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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.

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Chapter 2 MEASUREMENT

The flowchart of calibration.

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2-2 Cautions

Chapter 2 MEASUREMENT

2-2-1 Cautions

Before turning ON the power, reconfirm “1-4-1 Cautions” so that the analyzer is always operated under proper conditions.

The analyzer has a temperature control function in order to yield correct measurement results at the room temperature of 10~30

. For more accurate measurement, measurement at the room temperature of 20~25

and at

humidity of 30~60% is recommended.

Do NOT put a container with samples in it on the analyzer. If samples spill on the device, it may damage.

Do NOT move the analyzer during measurement. Such movement may cause malfunction, resulting in incorrect measurement results.

If there is anything wrong with the analyzer, or in case of odor or smoke, turn OFF the power immediately and unplug. Otherwise the analyzer may be damaged and cause fire.

If the analyzer is out of order, contact your distributor for repair. Do NOT attempt to repair or modify it by yourself. It may damage the analyzer or get injured.

Perform proper maintenance following the instruction to ensure high accuracy.

Do NOT place anything in front of the Table Cover. It automatically opens during operation.

Use SPOTCHEM Reagent Strips only for the analyzer. The other types of Reagent Strips are unacceptable.

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Chapter 2 MEASUREMENT

2-2-2 Handling samples

Handling samples slightly differs depending on test items. Follow the instructions on the package insert of SPOTCHEM Reagent Strips.

Blood is used as a measurement sample with this analyzer. Be aware that blood may be contaminated with pathogenic microbes that may cause infectious disease. Exercise 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 or deteriorated strips of which the reagent fields show any sign of discoloration or deformation, even if they are before the expiration date. Correct measurement results may not be obtained.

Take Reagent Strips out of the refrigerator 20 minutes before measurement and allow them to reach room temperature (10 to 30

). Otherwise, correct measurement

results may not be obtained.

Open a reagent strip package immediately before use. If the opened reagent strip is left for a while, it will absorb water from the air or gather dust, which may result in incorrect measurement results.

Do NOT touch the reagent field on the strip with fingers. Sebum on the reagent field may result in incorrect measurement results.

When a new reagent strip box is opened, perform calibration by magnetic card using the supplied Reagent Card (see 2-5-2).

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Chapter 2 MEASUREMENT

2-2-4 Handling magnetic cards

2-2-5 Handling tips

Do NOT place a magnetic card close to a magnetic object (magnet, TV set, etc.) Information on the magnetic card may become unreadable.

Do NOT scratch the magnetic surface (stripe). Information on the magnetic card may become unreadable.

Do NOT use a magnetic card

(supplied

with Reagent Strips or Calibrator)

for SP-4420 or SP-4430 with other devices. The card may become jammed in the device.

Do NOT touch the pointed end of a Tip with bare hands. If it becomes soiled, correct sampling may not be possible, resulting in incorrect measurement results.

Do NOT reuse a tip. Water-repellent treatment is applied to each tip so that the sample can be pipetted correctly. If it is rinsed, the coating will come off and correct measurement results may not be obtained.

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Chapter 2 MEASUREMENT

2-2-6 Handling centrifuges

Pipette 250 to 270 whole blood into the centrifuge tube. Insufficient sample volume may result in incorrect measurement results. Excessive volume may cause blood to stain the cover.

Heparin is contained as an anticoagulant. Close the cap tightly after setting a sample, and invert it and use the sample after removing the cap. 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.

Samples with extremely high hematocrit levels may yield incorrect measurement results.

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.

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2-3

Preparation for Measurement

Chapter 2 MEASUREMENT

2-3-1

Prepare necessary instruments as described in the following table before starting Normal Measurement, Calibration by Magnetic Card or Calibration by Calibrator.

Preparation

IMPORTANT

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

Using Reagent Strips without allowing them to reach room temperature may result in incorrect measurement results.

IMPORTANT

SPOTCHEM EZ SP-4430 OPERATING MANUAL

DOC.No.OM-28573 REV.6 03/02

To obtain the appropriate contrast on the screen, rotate the contrast adjustment knob (“CONT.”) on the rear of the analyzer.

Chapter 2 MEASUREMENT

2-3-2 Startup

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

Turn ON the power.1.

Turn ON the power at the rear of the analyzer. When the power is ON, “|” is displayed

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.

About 10 minutes after (when at 25

), warm-up is completed and the

MAIN MENU is displayed.

Warm-up time depends on the room temperature.

SPOTCHEM EZ

S Pー４４３０ V XXXX

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.

Wa r m i n g u p

・・・

／

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

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Chapter 2 MEASUREMENT

2-3-3 Checks before measurement

Thermal printer paper.1.

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”).

Reagent Table.2.

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

Centrifuge-equipped Multi Rack.3.

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

Install the Tip Waste Case.

Check each part before performing Normal Measurement or Calibration.

Setting the parameters.4.

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

Wear protective gloves to prevent exposure to pathogenic microbes.

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

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

IMPORTANT

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DOC.No.OM-28573 REV.6 03/02

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.

The required volume of a serum or plasma sample is“6x (number of test items)+38

”.For example, the required volume for 5 test items is : 6 x 5 + 38

= 68 .

A Serum or Whole blood Sample Tube has 2 lines marked on it for 100

and 500 .

Serum or plasma sample.

Prepare a Serum Sample Tube (blue cap).

Pipette serum or plasma. If measurement is not performed immediately, cap the tube to prevent contamination or evaporation.

Whole blood.

Prepare a Whole blood Sample Tube (orange cap). Uncap the tube and pipette whole blood. Cap the tube tightly.

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

The Whole blood Sample Tube contains heparin as an anticoagulant.

Wear protective gloves to prevent exposure to pathogenic microbes.

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

IMPORTANT

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

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

Chapter 2 MEASUREMENT

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.

Inverting a sample to mix

Gently invert a sample tube.

In 3 seconds, invert the sample again.

Wait for 3 seconds, and invert it again.

Repeat the above procedure several times.

Even if the sample stays at the bottom after being inverted, heparin is well mixed with the sample. Do NOT shake the tube vigorously.

Ensuring rotor balance

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

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

IMPORTANT

NOTE

When using an optionally available centrifuge , carefully read the operating manual of the centrifuge.

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Chapter 2 MEASUREMENT

Using a centrifuge

Prepare a centrifuge.

Uncap the tube and pipette 250

of 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”).

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

A Centrifuge tube has 1 line marked on it for 250

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.

IMPORTANT

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

Chapter 2 MEASUREMENT

Measuring the Hb

When measuring Hb, dilute whole blood samples 6 times with distilled water.

Prepare a Whole blood Sample Tube (orange cap). 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”).

Prepare a Serum Sample Tube(blue cap). Pipette 200

of distilled water.

Pipette 40

of the prepared whole blood sample into the above Serum Sample Tube. Cap the tube tight. Invert the sample several times again.

Remove any air bubbles or skin on the surface of

the sample. They may cause incorrect measurement

results.

IMPORTANT

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DOC.No.OM-28573 REV.6 03/02

Prepare a Serum Sample Tube (blue cap).

Pipette 100

of serum or plasma.

Gently pipette 100

of HDL Separation

Reagent into the tube.

Cap the tube tight.

Invert the sample more than 10 times following to

“ 2-14. Inverting a sample” and

leave the sample about 5 minutes.

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.

Using HDL-C Kits

If HDL-C reagent(direct method) is used for measurement, this procedure is unnecessary.

Chapter 2 MEASUREMENT

Remove any air bubbles or skin on the surface of

the sample. They may cause incorrect measurement

results.

IMPORTANT

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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”.

Display the Standby screen.1.

Press [1] key on the MAIN MENU. The Table Cover opens and the Reagent Strip Table and Centrifugeequipped Multi Rack slide forward.

The Standby screen is displayed as shown at the right.

Check the time and date.2.

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 ”).

[START] key can be used instead of [1] key.

S t a n d b y ２０００ー０６ー１０

I D（１） I N FO（２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

Wear protective gloves to prevent exposure to pathogenic microbes.

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

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

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

IMPORTANT

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DOC.No.OM-28573 REV.6 03/02

Check the lot number of Reagent Strips.3.

Chapter 2 MEASUREMENT

Press [2] key on the Standby screen.

The Confirm screen is displayed, which indicates information of Reagent Strips stored in memory. Check that the test items and lot numbers of the Reagent Strips match with those shown on the 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.

To check numerous test items at one time, print out the lot numbers of all items. Press [3] key on the Standby screen to print out all the lot numbers.

【 S ー０１：G G T 】（１／３０）【XXXXXX CARD】

Press [hyphen (-)] key to check the information of the reagent strip you are using.

When confirmation is completed, press [STOP] key. The Standby screen is restored.

Besides [hyphen (-)] key, [0], [2], [4], [5], [6], and [8] keys can be used in selecting items. [0] -> initially displayed item [2] -> last item [4] -> previous item [6] -> next item [8] -> first item [5] -> first item of the Multi

Reagent Strip

Cove r i s c l os i ng .

Stop（STOP）

Back to MENU（STOP） Back to MEAS（ENTER）

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

IMPORTANT

S t a n d b y ２０００ー０６ー１０

I D（１） I N FO（２）

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

The number of the previous measurement No + 1 is displayed as the initial number. To perform measurement with the number, press [ENTER] key to confirm. Once the power is turned off, the initial number returns to 1.

The last entered ID is displayed. To perform measurement with the same ID as shown on the screen, press [ENTER] key. If the MAIN MENU is restored, the previous ID is cleared.

To enter ID, use the numeric keys and [-/.] key. Example: To enter “EZ” [3] [3] [3] [9] [9] [9] [9] [9] Example: To enter “SP” [7] [7] [7] [7] [7] [-] [7] [7] The following 12 signs can be entered by using [0] key.

’

To delete the last character, press [MENU] key and [-/.] key simultaneously.To restore the initially shown ID, press [START] key.

When the barcode reader (optional) is used, manual entering is not necessary.Read barcode is automatically allocated as ID.

When the barcode reader is used a message “BARCODE AVAILABLE” is displayed.

Press [hyphen (-)] key on the Standby screen to switch the operation guidance at the lower part of the screen.

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.

Set measurement No. or ID (if necessary).

ID of up to 13 characters can be set for each measurement. If ID setting is not necessary, move on to procedure 6. Rack slides forward. The Standby screen is displayed as shown at the right.

Press [1] key on the Standby screen. The measurement No. screen is displayed.

Enter

measurement No.. Up to 4 characters can be entered using numbers.

Press [ENTER] key.

The entered

measurement No.

is stored in memory and the ID entering screen

is displayed.

Enter ID. Up to 13 characters can be entered using numbers, letters, and symbols.

When the barcode reader is used, ID is automatically read by the reader.

Press [ENTER] key.

The entered ID is stored in memory and the Standby screen is restored.

Chapter 2 MEASUREMENT

S t a n d b y ２０００ー０６ー１０

I D（１） I N FO（２）

Ｎｏ . ＜

ー

＞

Cove r i s c l os i ng .

Stop（STOP）

Back to MENU（STOP） Back to MEAS（ENTER）

ID＜

ー

＞

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DOC.No.OM-28573 REV.6 03/02

Chapter 2 MEASUREMENT

Set the sample type (when necessary).

Sample type can be set for each measurement. When sample type is not registered or measurement is made on the setting of basic type, skip the following and proceed to the Step 6.

Press [6] key on the Standby screen. The Sample type selecting screen is displayed.

Press [hyphen (-)] key to select the sample type to measure.

Press [Enter] key while the selected sample type is displayed.

The selected sample type is set as the measurement sample type and the Standby screen is restored

No set-up is available where sample type is not registered. The registration can be made on the Parameter Menu.

The sample type set for basic type is established as an initial value. No setting is needed when not changed.

Besides [hyphen (-)] key, [4], and [6] keys can be used in selecting sample

type

. [4] -> previous sample type [6] -> next sample type

Pressing [Start] key on the Sample type selecting screen starts measurement with the displayed sample type without returning to the Standby screen.

S t a n d b y ２０００ー０１ー１９

I D（１） I N FO（２）

S t a n d b y ２０００ー０１ー１９

Ｓａｍｐｌｅ［Ｍａｎ］

S t a n d b y ２０００ー０１ー１９

I D（１） I N FO（２）

Set the Tip.6.

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

Make sure that the Tip Waste Case is set in position.

Do NOT touch the pointed end of the Tip with fingers. If it is soiled, correct measurement results may not be obtained.

IMPORTANT

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Chapter 2 MEASUREMENT

Set the samples.7.

Open the protective cover and place the uncapped centrifuge tube in position.

Close the cover.

Measurement of uncentrifuged whole blood.

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.

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

Measurement of serum or plasma, or centrifuged samples.

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 become troubled and correct measurement results may not be obtained.

NOTE

Make sure the protective cover is closed properly. If the protective cover remains open, it may cause a trouble.

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Chapter 2 MEASUREMENT

Press [0] key on the Standby screen. The Centrifuge selecting screen is displayed. [On] is always displayed at the beginning.

To switch [On] and [Off] of centrifuge, press [0] key on the Centrifuge selecting screen.

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.

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.

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.

IMPORTANT

Every time when [0] key is pressed on the Centrifugation selecting screen, [On], and [Off] are displayed alternately.

Set the Multi-type Reagent Strips.

Set the Reagent Strips.8.

Open the aluminum foil package from the place written “

Open here

” until two-thirds of the Reagent

Strip is exposed.

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.

S t a n d b y ２０００ー０１ー１９

I D（１） I N FO（２）

S t a n d b y ２０００ー０１ー１９

ＣＮＴＲＦＧ＝［OＮ］

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Chapter 2 MEASUREMENT

Remove a Reagent Strip from the aluminum foil package without touching the reagent field with the fingers.

Set the Single-type Reagent Strips.

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

Place the Reagent Strips on the Reagent Table by holding the right side of the strip.

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.

IMPORTANT

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Chapter 2 MEASUREMENT

Remove the Reagent Strip from the package without touching the reagent field with fingers.

Insert Reagent Strips on the Reagent Table as shown at right.

Start the measurement.9.

Press [START] key. The Reagent 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.

Me a s u r i n g

・・・

Stop（STOP）

To discontinue the measurement, press [STOP] key to return to the Standby screen.

IMPORTANT

Me a s u r i n g

・・・

［３：００］

Stop（STOP）

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

Me a s u r i n g

・・・

０１：２３

Stop（STOP）

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.

To print another sheet, press [4] key on the Standby screen.

End measurement.

When measurement is finished, 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.

Where measured results are not 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.

Pr int ing

・・・

／

S t a n d b y ２０００ー０６ー１０

I D（１） I N FO（２）

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.

The measurement result is repeatedly scrolled.

S t a n d b y ２０００ー０６ー１０

Ｔ−Ｐｒｏ：９ . ２ , Ａｌｂ：

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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.

End measurement for the day.

11.

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

NOTE

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

Remove used t i ps .

OK（ ENT ER ）

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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.

Calibration by magnetic card

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”.

SPOTCHEM EZ SP-4430 OPERATING MANUAL

DOC.No.OM-28573 REV.6 03/02

Insert a card.

（STOP）

Chapter 2 MEASUREMENT

2-5-2 Calibration by magnetic card

Set the calibration condition.2.

Press [3] key on the MAIN MENU. The CALIBRATION MENU is displayed.

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.

“CARD” means calibration by magnetic calibration card and “Cal.” means calibration by calibrator kit.

Set the calibration type as by magnetic card.1.

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.

１.CARD ２.Ca l . ３ . I n f o r m a t i o n （１／１）

Press [STOP] key to stop the calibration by magnetic card.

Insert Reagent Card3.

Press [1] key on the CALIBRATION MENU.

Insert a strip of Reagent Card in the magnetic reader and slide the strip to the right.

There is no order for inserting the stripes. Either stripe can be inserted first.

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.

IMPORTANT

Requirements

Reagent Card

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

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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

screen.

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.

Insert the same stripes twice to read the stored information in the magnetic cards.

End of calibration by magnetic card.4.

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

I n s e r t a c a r d . Sー０１

Anot her s t r ipe ■２

I n s e r t a c a r d . Sー０１

【GGT 】【XXXXXX】

Insert a card.

Th e s ame s t r i p e

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

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DOC.No.OM-28573 REV.6 03/02

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.

Display the calibration menu.2.

Press [3] key on the MAIN MENU. CALIBRATION MENU is displayed.

“CARD” means calibration by magnetic calibration card and “Cal.” means calibration by calibrator kit.

Set the calibration type by calibrator kit.1.

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.

Prepare the reagent strip and calibrator.3.

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.

Wear protective gloves to prevent exposure to pathogenic microbes.

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

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

１.CARD ２.Ca l . ３ . I n f o r m a t i o n （１／１）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

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 package insert included in the calibrator kit.

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 immediately.

【 S ー０１：G G T 】（１／３０）【L&H N＝３】

Chapter 2 MEASUREMENT

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.

IMPORTANT

１.CARD ２.Ca l . ３ . I n f o r m a t i o n （１／１）

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Chapter 2 MEASUREMENT

To stop calibration, press [STOP] key.

There is no order for inserting the stripes. Any stripe can be inserted first.

Insert calibration card.4.

Press [2] key on the CALIBRATION MENU. The Magnetic card entry screen is displayed.

Insert the stripe of a calibration card 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 according to the message on the screen. When the same stripes are inserted 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 inserted, lot number of the calibrator is displayed. After that, the Calibration standby screen is displayed.

The Table Cover opens, and the Reagent Table and the Centrifugeequipped Multi Rack slide forward.

The Calibration standby screen as shown on the right is displayed.

Insert the same stripes twice to surely read the stored information in the calibration cards.

There is only one stripe for Hb, this screen is not displayed.

If no key entry is made within 3 minutes after the Table Cover opens, an alarm sounds and the Table Cover closes. If press [STOP] key is pressed while

“CANCEL” is displayed, the Standby screen is restored without closing the Table Cover.

After the Table Cover closes, the message shown on the right is displayed. To go back to the MAIN MENU, press [STOP] key. To go back to the Standby screen, press [ENTER] key.

Inseart a card.

Th e s ame s t r i p e .

Inseart a card. Cal.

A n o t h e r s t r i p e ■２３４

Standby

＝０ H＝０ N＝？

Inseart a card. Cal.

【CALーCARD 】【XXXXXX】

Cove r i s c l os i ng .

Stop（STOP）

Insert a card.

Th e s ame s t r i p e

Back to MENU（STOP） Back to CAL （ENTER）

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Chapter 2 MEASUREMENT

Set the Tip.5.

Set the tips in the tip hole of the Centrifuge-equipped Multi Rack using tweezers.

Make sure that the Tip Waste Case is set in position.

When performing 1-point calibration (High), proceed to procedure 9.

Set the calibrator “Low”.6.

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

Set the Reagent Strips.7.

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.

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.

IMPORTANT

NOTE

Be sure to remove the caps before calibration to avoid damage to the nozzle.

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.

IMPORTANT

NOTE

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

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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 .)

With Multi-type Reagent Strips, 1-point calibration cannot be performed.

Calibration with Multi-type Reagent Strips

Prepare Multi-type Reagent Strips. 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.

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Chapter 2 MEASUREMENT

Press [STOP] key to stop the calibration, the Calibration standby screen is restored.

Start measurement of the “Low” calibrator.8.

Me a s u r i n g

・・・

Stop（STOP）

Me a s u r i n g

・・・

０１：２３

Stop（STOP）

Standby TーPro L＝２ H

＝０ N＝２

Press [START] key. The Reagent Table and Centrifuge equipped Multi Rack 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 Centrifugeequipped 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.

Me a s u r i n g

・・・

［３：００］

Stop（STOP）

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Set the tip.9.

Set the tip by following procedure 5.

When performing 1-point calibration for "Low" only, proceed to procedure 13.

Chapter 2 MEASUREMENT

End the calibration.

13.

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

restored.

Remove the used Reagent Strips and samples, and discard them.

Press [STOP] key to stop calibration. The Calibration standby screen is restored.

Set the “High” Calibrator.

10.

Set the “High” Calibrator by following procedure 6.

Set the Reagent Strips.

11.

Set the Reagent Strips by following procedure 7.

Measure the “High” Calibrator.

12.

Measure the “High” Calibrator by following procedure 8.

Pr int ing

・・・

／

Standby

＝０ H＝０ N＝？

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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.

Remove used t i ps .

OK（ ENT ER ）

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.

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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).

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Chapter 2 MEASUREMENT

( 1 ) Normal printing

Version. Measurement date and time : Date and time when [START] key is pressed. Measurement number : The number is counted starting from 0001 (When the power is on.) ID: Printed only when ID is set. Name of the Multi Reagent Strip. Lot Number of the Multi Reagent Strip. Measurement results of the Multi Reagent Strip. Lot Number of the Single Reagent Strip. Used for S1, S2 and S3 channels from the left. Measurement results of the Single Reagent Strip. 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)

1 2 3 4 5 6 7 8 9

When “Printing of measurement results” is performed on the Sub Menu, the results are printed according to the parameter settings of the measurement. That is, if the parameters are changed after the measurement (temperature or coefficient of correlation correction), the data after the measurement is printed out.

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Chapter 2 MEASUREMENT

( 2 ) Survey Mode printing (for 1 item)

Measurement value which temperature conversion, unit conversion or correlation correction is not applied. Temperature. Printed out as ….. for the items other than enzyme items. Temperature conversion factor. Conversion factor when the standard temperature is 37 Unit.“mg” is the conventional unit, “SI” is SI unit and “User” is units set by users. Unit conversion factor. Conversion factor when the conventional unit is standard. Coefficient of correlation correction. Coefficient set in the “Entering parameters” on the Sub Menu.

2 3

4 5 6

Generally, mg (conventional unit) is used for unit. To change the unit, contact your distributor.

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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

Version. Calibration date: The date when [START] key was pressed for the first time. From the left, name of Multi Reagent Strip, item symbol, lot number and expiry date. Lot no. of the calibrator. Read by the calibration card. Displayed value of calibrator. Read by the calibration card. Measurement value when calibration is not performed. Printed out for the number of calibration times. Average measurement value when calibration is not performed. 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.

1 2 3 4 5 6

7 8

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Chapter 2 MEASUREMENT

( 2 ) Calibration Result of Multi Reagent Strip

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

1 2

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DOC.No.OM-28573 REV.6 03/02

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.

Chapter 3

SUB MENU

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

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3-1

Overview of SUB MENU

Chapter 3 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.

SUB MENU

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.

When [START] key is pressed on any screen of SUB MENU, the MAIN MENU is restored.

3-1-1 Composition of SUB MENU

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Chapter 3 SUB MENU

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3-2

Measurement Results Menu

Chapter 3 SUB MENU

3-2-1 Print measurement results

If [STOP] key is pressed during operation, the previous screen is restored.

In case of reprinting, measurement results are printed starting from the latest result.

Display setting screen.1.

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

Print measurement results stored in the memory (Max. 100 measurements). The following three options for printing are available.

1. LATEST : The latest measurement result (one measurement).

2. ALL : All measurement results (Max. 100 measurements)

stored in the memory.

3. SEARCH : The measurement results searched by

the date range and/or ID.

Press [1] key. The MEASUREMENT RESULTS MENU is displayed.

Select measurement results to print.2.

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.

１. La tes t ２. ALL ３ . S e a r c h （１／１）

No data matched.

OK（ ENT ER ）

１.Resu l t s ２. PARAM

３.Maintenance （１／２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

１.Pr i nt ２.Send

３.Delete （１／１）

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Chapter 3 SUB MENU

If designation of the range of measurement dates (the dates of starting and finishing measurements) is unnecessary, press [ENTER] key twice to proceed to the next setting screen.

Be sure to enter correct dates to avoid inconsistencies.

The 2-digit number of the “year” section of the date indicates the last 2 digits of year and is interpreted as follows: 00~89 -> 2000~2089 90~99 -> 1990~1999

See 3-09 page for information on wildcards.

End printing.4.

Press [STOP] key three times to return to the MAIN MENU.

Enter search condition.3.

Enter the dates of starting and finishing measurements by sliding the cursor using [hyphen (-)] key.

Press [ENTER] key. The ID entering screen is displayed. Press [ENTER] key when not searched by ID.

Enter an ID search pattern for the sample(s) to print by using numbers, alphabets, and symbols up to 13 characters. Wildcards can be used to enter.

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.

Dat e ＜９９ー０１ー０１＞ Y M D

t o ＜００ー１２ー３１＞

ID＜＊＞

Pr int ing・・（４／１５）／

stop（STOP）

１. La tes t ２. ALL ３ . S e a r c h （１／１）

No data matched.

OK（ ENT ER ）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

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Chapter 3 SUB MENU

3-2-2 Transmit measurement results

If [STOP] key is pressed during operation, the previous screen is restored.

In case of retransmission, measurement results are printed out starting from the latest result.

Transmit measurement results (Max. 100 measurements) stored in the memory. The following three types for transmission are available.

1. LATEST : The latest measurement result (one measurement).

2. ALL : All measurement results (Max. 100 measurements)

stored in the memory.

3. SEARCH : The measurement results searched by

the date range and/or ID.

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

Display setting screen.1.

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

Press [1] key. The MEASUREMENT RESULTS MENU is displayed.

Select measurement results to transmit.2.

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”.

１. La tes t ２. ALL ３ . S e a r c h （１／１）

No data matched.

OK（ ENT ER ）

１.Resu l t s ２. PARAM

３.Maintenance （１／２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

１.Pr i nt ２.Send

３.Delete （１／１）

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Chapter 3 SUB MENU

End transmission.4.

Press [STOP] key three times to return to the MAIN MENU.

Enter searching condition.3.

Enter the dates of starting and finishing measurements by sliding the cursor using [hyphen (-)] key.

Press [ENTER] key. The ID entering screen is displayed. Press [ENTER] key when not searching by ID.

Enter an ID searching pattern for the sample(s) to print by using numbers, alphabets, and symbols up to 13 characters. Wildcards can be used to enter.

Press [ENTER] key. The selected measurement results are transmitted.

When the transmission is completed, the Measurement result selecting screen is restored.

If designation of the range of measurement dates (the dates of starting and finishing measurements) is unnecessary, press [ENTER] key twice to proceed to the next setting screen.

Be sure to enter correct dates to avoid inconsistencies.

The 2-digit number of the “year” section of the date indicates the last 2 digits of year and is interpreted as follows: 00~89 -> 2000~2089 90~99 -> 1990~1999

See 3-09 page for information on wildcards.

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.

Dat e ＜９９ー０１ー０１＞ Y M D

t o ＜００ー１２ー３１＞

ID＜＊＞

Send ing・・（４／１５）／

stop（STOP）

１. La tes t ２. ALL ３ . S e a r c h （１／１）

No data matched.

OK（ ENT ER ）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

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Chapter 3 SUB MENU

3-2-3 Delete measurement results

Display setting screen.1.

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

Delete all the measurement results stored in memory.

Press [1] key. The MEASUREMENT RESULTS MENU is displayed.

Delete measurement results.2.

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.

End Deletion.3.

Press [STOP] key three times to return to the MAIN MENU.

Password ＜＞

Cancel（STOP）

De l et e？

Yes（START） No（STOP）

１.Resu l t s ２. PARAM

３.Maintenance （１／２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

１.Pr i nt ２.Send

３.Delete （１／１）

１.Pr i nt ２.Send

３.Delete （１／１）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

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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.

Meaning

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

Example 1 Example 2 Example 3 Example 4 Example 5

Searching Pattern

????M AB?YZ

PQR

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.

Chapter 3 SUB MENU

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3-3 Parameter Menu

Chapter 3 SUB MENU

3-3-1 Print parameters

Display setting screen.1.

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

Print the present parameter settings by each measurement item for checking.

Press [2] key. The PARAMETER MENU 1/2 is displayed.

Print parameter settings.2.

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

Select measurement items to print by pressing [hyphen (-)] key.

Press [ENTER] key. Printing starts. After printing is completed, the Measurement item selecting screen is restored.

End Printing.3.

Press [STOP] key to return to the MAIN MENU.

Reagent Strip

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.

［ S ー０１：G G T ］（１／３０）

１.Resu l t s ２. PARAM

３.Maintenance （１／２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

１.Pr i nt ２. I nput

３.Initialyze （１／２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

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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.

Version. Printed date and time: The date and time when “printing of parameters” is executed. From the left, item name, item symbol, lot number and expiry date. Calibration type. CARD means calibration by magnetic card and Cal. means calibration by calibrator kit. Calibration factor From the left, calibration mode (L&H, L, H), the number of calibration times, lot number and calibration date. Coefficient of system's difference correction(Coefficient to use in the measurement calculates). Temperature. Printed out as ….. for the items other than enzyme items. Coefficient of correlation correction. Coefficient set in the “Entering parameters” in the SUB MENU. Measurement range. The lower limit and upper limit. Standard range. The lower limit and upper limit. Sample types. The lower limit and upper limit of standard range for each sample types set. Printing is available only when sample type is set.

(1) Printing of single parameters

1 2 3 4

5 6

8 9

10 11 12

The lot number and calibration date are printed only when calibration by calibrator kit was performed.

mark is not printed when the upper limit of the standard range is the same or higher than the upper limit of the measurement range.

mark is not printed when the lower limit of the standard range is the same or lower than the lower limit of the measurement range.

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Chapter 3 SUB MENU

(2) Printing of multi parameters

From the left, name of Multi Reagent Strip, item symbol, lot number and expiry date. Calibration type CARD means calibration by magnetic card and Cal. means calibration by calibrator kit. Calibration factor. Coefficient of system’s difference correction (Coefficient to use in the measurement calculates).

3 4

The lot number and calibration

date are printed only when

calibration by calibrator kit was

performed.

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Chapter 3 SUB MENU

Set parameters (measurement conditions) for temperature, coefficient of correlation correction, normal value range, and calibration conditions. Regarding Multi-type Reagent Strips, setting of “calibration conditions” only is possible. The other parameters conform to those preset for Single Reagent Strips.

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

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.

Standard range

When the measurement results are printed, “ ” or “ ”, is added on data out of the standard range. When sample type is set, its corresponding standard range is applied.

Calibration Conditions

Set the type (calibrator or magnetic card) and the number of times of calibration for each measurement item.

3-3-2 Enter parameters

If [STOP] key is pressed during entry, the entry is canceled and the cursor returns to the previous “[ ]” or “< >”.

If the previous setting is not necessary to change, press [ENTER] key to proceed to next “[ ]” or “< >”.

Display setting screen.1.

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.

［ S ー０１：G G T ］（１／３０）

１.Resu l t s ２. PARAM

３.Maintenance （１／２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

１.Pr i nt ２. I nput

３.Initialyze （１／２）

Password ＜＞

Cancel（STOP）

mark is not printed when the upper limit of the standard range is the same or higher than the upper limit of the measurement range.

mark is not printed when the lower limit of the standard range is the same or lower than the lower limit of the measurement range.

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Chapter 3 SUB MENU

Select measurement items.2.

Select measurement items for parameters by pressing [hyphen (-)] key.

Press [ENTER] key. The Temperature setting screen is displayed.

Set temperature.3.

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.

Set coefficient factor.4.

Enter the coefficient factor “a” by using the numeric keys. Any number from 0 to 10000 can be entered

Press [ENTER] key. The cursor moves to the entry position for “b”.

Enter a coefficient factor “b” and press [ENTER] key. Any number from

-10000 to 10000 can be entered. Press [ENTER] key. The Calibration conditions setting screen is displayed.

Reagent Strip

To enter minus signs and decimal points , use [-/.] key. If [-/.] key is pressed first, a minus sign is entered. To enter a decimal point, press [-/.] key after any number is entered. e.g.) To enter “-12” Press [-/.] [1] [2]

e.g.) To enter “3.4” Press [3] [-/.] [4]

e.g.) To enter “.5” press [0] [-/.] [5]. If [-/.] [5] are pressed, the result will be “-5”.

When the wrong key is pressed, press the MENU key and [-/.] key simultaneously to delete the last entered character.

If [START] key is pressed, the initially displayed value is restored.

［ S ー０１：G G T ］（１／３０）

Temperature ［３７］ Sー０１

Cor r . a＜＿１ . ０００＞ Sー０１ b＜０ . ０００＞

C o r r . a ＜１ . ０４５＞ Sー０１ b＜０ . ０００＞

Temperature ［３０］ Sー０１

Set calibration conditions.5.

Select “Cal.” or “CARD” by pressing [hyphen (-)] key. Cal.: Calibration by Calibrator CARD: Calibration by magnetic card

Ca l . Type［CARD］ Sー０１ N ＜２＞

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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.

Set the standard range.6.

Enter the lower limit of the standard range with the numeric keys.

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.

Ca l . Type［CARD］

Sー０１ N ＜２

＞

Norma l L＜＿１０＞ Sー０１ H＜１５００＞

When sample type is not set

N o r m a l L ＜１０＞

Sー０１ H＜＿

１５００＞

Save？

Yes（START） No（STOP）

Enter the lower limit value of the 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 sample types 2 to 5. The Entry check screen is displayed.

When sample type is set

Save？

Yes（START） No（STOP）

【Ｍａｎ】 L＜１０＞

Sー０１ H＜＿

１５００＞

【Ｍａｎ】 L＜＿１０＞

Sー０１ H＜１５００＞

On the standard range entering screen, a sample type is displayed.

When the sample type are set only up to two, the standard range entry for the sample types 3 to 5 will be omitted.

mark is not printed when the upper limit of the standard range is the same or higher than the upper limit of the measurement range.

mark is not printed when the lower limit of the standard range is the same or lower than the lower limit of the measurement range.

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Chapter 3 SUB MENU

Store all the parameter settings.7.

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.

End setting.8.

If the setting is finished, press [STOP] key three times to return to the MAIN MENU.

Wr i t i ng

・・・

／

［ S ー０１：G G T ］（１／３０）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

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Chapter 3 SUB MENU

3-3-3 Initialize parameters

Display setting screen.1.

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.

Initialize parameter settings to the factory setting values.

Initialize parameters.2.

Press [hyphen (-)] key to select a measurement item to initialize.

Press [ENTER] key. The Initialize confirmation screen is displayed.

Press [START] key or [STOP] key. If [START] key is pressed, 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.

Reagent Strip

If “ALL SINGLE” or “ALL MULTI” is selected, parameter settings of all the items for Single or Multi Regent Strips are printed out respectively.

［ Sー０１：G G T ］（１／３０）

Initialize?

Yes（START） No（STOP）

１.Resu l t s ２. PARAM

３.Maintenance （１／２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

１.Pr i nt ２. I nput

３.Initialiｚｅ（１／２）

Password ＜＿＞

Cancel（STOP）

［ Sー０１：G G T ］（１／３０）

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

The present parameter settings can be printed out ( See “3-3-1 Print Parameters” ).

Factory setting values

The following measurement conditions are pre-set upon shipment at the factory. Refer to the table when setting parameters.

Chapter 3 SUB MENU

End Initialization.3.

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

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

25 , 30 , 37 a : 0 ~ 10000 b : -10000 ~ 10000 L : 0 ~ 10000 H : -10000 ~ 10000 type Number of times

Setting item and range Temperature Coefficient of

correlation Standard range

Calibration

Factory setting value

37 a : 1.0 b : 0.0

Measurement range CARD

Calibration type Cal. or CARD 2 to 6 (times)

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Chapter 3 SUB MENU

3-3-4 Enter sample type

Display the screen.1.

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.

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

Enter the sample type.2.

Maximum 5 letters can be entered using numbers, letters, and symbols.

Press [Enter] key. The Sample type 2 name entering screen is displayed.

Similarly, enter the sample types 2 to 5. When no sample type is set, press [Enter] key, with the space kept blank.

The numeric keys and [-/.] keys can be used in selecting items. For example, to entry

“

man

”

[6][6][2][2][2][2][6][6][6][6][6][6]

[0] key can be used to input the following 12 symbols which are

To delete the name, press [-] key to make it blank. Press [Enter] key.

１.Resu l t s ２. PARAM

３.Maintenance （１／２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

１.Pr i nt ２. I nput

３.Initialiｚｅ（１／２）

４ . Ｔｙｐｅ５ . Ｃｏ p ｙ

（２／２）

ＲＥＦｖａｌｕｅ１ｎａｍｅ

＜＿

＞

ＲＥＦｖａｌｕｅ１ｎａｍｅ

＜Ｍａｎ

＞

ＲＥＦｖａｌｕｅ２ｎａｍｅ

＜＿

＞

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Chapter 3 SUB MENU

3-3-4 Input of identifiers for sample classifications

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.

Saving the setting contents.4.

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.

ＲＥＦｖａｌｕｅｂａｓｅｔｙｐｅ

＜Ｍａｎ＞

Save？

Yes（START） No（STOP）

End setting.5.

Press [STOP] key twice to return to the MAIN MENU.

Wr i t i ng

・・・

／

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

１.Pr i nt ２. I nput

３.Initialiｚｅ（１／２）

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DOC.No.OM-28573 REV.6 03/02

Chapter 3 SUB MENU

3-3-5 Copy standard range setting

Display setting screen.1.

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.

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.

Selecting the standard range on the original screen.2.

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.

１.Resu l t s ２. PARAM

３.Maintenance （１／２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

１.Pr i nt ２. I nput

３.Initialiｚｅ（１／２）

４ . Ｔｙｐｅ５ . Ｃｏ p ｙ

（２／２）

ＰＲＥＳＳＰＣ＞＞ＮｅｘｔＳＰＣ

［

Ｍａｎ

］［

Ｍａｎ

］

ＰＲＥＳＳＰＣ＞＞ＮｅｘｔＳＰＣ

［

Ｍａｎ

］［

Ｍａｎ

］

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

Chapter 3 SUB MENU

3-3-4 Input of identifiers for sample classifications

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.

Saving the setting contents.4.

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.

Save？

Yes（START） No（STOP）

End setting.5.

Press [STOP] key twice to return to the MAIN MENU.

Wr i t i ng

・・・

／

ＰＲＥＳＳＰＣ＞＞ＮｅｘｔＳＰＣ

［

Ｍａｎ

］［

Ｗｏｍａｎ

］

１.Pr i nt ２. I nput

３.Initialiｚｅ（１／２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

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DOC.No.OM-28573 REV.6 03/02

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.

Preparation for the maintenance.1.

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 Centrifugeequipped Multi rack slide forward.

When the message is displayed as shown on the right, turn off the power.

Perform maintenance.2.

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

End maintenance.3.

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.

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

Ready .

Please turn off .

１.Resu l t s ２. PARAM

３.Maintenance （１／２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

3-5 Mode Menu

Chapter 3 SUB MENU

Display setting screen.1.

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.

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

The Survey Mode is canceled

automatically when the power is

turned off.

Switch to the Survey Mode.2.

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

Press [ENTER] key. The message “Writing...” is displayed and the MODE MENU is restored.

End the Survey Mode.3.

If the setting is finished, press [STOP] key three times to return to the MAIN MENU.

１.Su rvey （１／１）

Sur vey ［OFF］

Wr i t i ng

・・・

／

Sur vey ［ ON］

１.Resu l t s ２. PARAM

３.Maintenance （１／２）

１.Measur e ２. Submenu

３ . C a l i b r a t e （１／１）

４.Mode ５.C l ock （２／２）

１.Measur e ２. Submenu

３ . C a l i b r a t e （１／１）

SPOTCHEM EZ SP-4430 OPERATING MANUAL

DOC.No.OM-28573 REV.6 03/02

Set the date and time.2.

Enter the present date by sliding the cursor with [hyphen (-)] key.

Press [ENTER] key. The cursor moves to the time entry position.

Enter the present time by sliding the cursor with [hyphen (-)] key.

Press [ENTER] key. The set date and time are stored, and the SUB MENU 2/2 is restored.

If [STOP] key is pressed during operation, the setting is canceled and the SUB MENU 2/2 is restored.

If [START] key is pressed, the initially displayed value is restored.

If [STOP] key is pressed during operation, the setting is canceled and the date setting is restored.

For the time settings, only the hour and minute can be set. The cursor does not move to the second position.

End Setting.3.

Press [STOP] key to return to the MAIN MENU.

Chapter 3 SUB MENU

3-6

Built-in Clock Adjustment

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.

Display setting screen.1.

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

Dat e ＜００ー０６ー０１＞Y M D

T i m e ＜１２：３４：００＞

Password ＜＿＞

Cancel（STOP）

D a t e ＜００ー０６ー１２＞YMD

T i m e ＜１２：３４：００＞

D a t e ＜００ー０６ー１２＞ Y M D

Time ＜１

２：３４：００＞

D a t e ＜００ー０６ー１２＞ Y M D

T i m e ＜１２：５＿

：００＞

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.

１.Resu l t s ２. PARAM

３.Maintenance （１／２）

１.Measur e ２. Submenu ３ . C a l i b r a t e （１／１）

４.Mode ５.C l ock （２／２）

１.Measur e ２. Submenu

３ . C a l i b r a t e （１／１）

SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02

SPOTCHEM EZ SP-4430 OPERATING MANUAL DOC.No.OM-28573 REV.6 03/02

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

Chapter 4

MAINTENANCE

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

Arkray Spotchem SP-4430 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual