Arkray Spotchem SP-4430 User manual

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
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
SPOTCHEM EZ SP-4430 OPERATING MANUAL DOC.No.OM-28573 REV.6 03/02
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
SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02
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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1-1 SP
-
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 SPOTCHEMReagent 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
30
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
SPOTCHEM EZ SP-4430 OPERATING MANUAL
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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
SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02
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 37for 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.
1
2 3 4 5 6
7 8
9 10 11 12 13
14
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. SelectYes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
MENU
0~9 (ten key)
-/.(hyphen/period)
ENTER
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1-1 SP
-
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.
1
2
3
4
5
6
7
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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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-
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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
SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02
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 )
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
Chapter 2
MEASUREMENT
2-1 Outline of Measurement
2-1-1 SPOTCHEMReagent 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.
SPOTCHEM EZ SP-4430 OPERATING MANUALDOC.No.OM-28573 REV.6 03/02
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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