Arkray SPOTCHEM D-00 QR User manual

D-00 QR i
1Premise
Thank you for purchasing our operation unit, the SPOTCHEM D-00 QR SD-9811.
This manual contains important information on the functions of the SPOTCHEM D-00 QR SD-9811.
This manual is issued by ARKRAY, Inc.
Read carefully prior to starting up the unit.
It is recommended to retain this operating manual for future use.
The SPOTCHEM D-00 QR (SD-9811) control unit is intended for the operation of SD-3810, SD-4810 and
SD-4820, which are intended for the quantitative and automated measurement of several physiological
markers in whole blood, serum, and plasma. This control unit is intended for use with SPOTCHEM D reagent
strips/plates/packs. Sample types vary depending on reagent. For information about the analyte, the function
and the target disease/condition as well as the intended use population, please refer to the reagent instructions
for use. For in vitro diagnostic use and professional use only.
This product conforms to the EMC Standard IEC61326-2-6:2012(EN61326-2-6:2013).
Class of emission: CISPR 11 Class A
This instrument is an IVD medical instrument.
This product conforms to Regulation (EU) 2017/746.
The electromagnetic environment should be evaluated prior to operation of the device. Do not use this device
in close proximity to sources of strong electromagnetic radiation, as these may interfere with the proper
operation.
NOTE: This instrument has been tested and found to comply with the limits for a Class A digital device, pursuant to part
15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when
the instrument is operated in a commercial environment. This instrument generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the operating manual, may cause harmful
interference to radio communications. Operation of this instrument in a residential area is likely to cause harmful
interference in which case the user will be required to correct the interference at his own expense.

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2 Introduction
Read this operating manual thoroughly before using the instrument. This operating manual gives an outline of the instrument and
the proper procedures for operation and maintenance.
Follow the instructions in this operating manual in order not to defeat the purpose of protective features of the instrument.
If you have had or could have had any serious incident related to the device, please report it directly to the manufacturer or through
the authorised representative and to your local regulatory authority.
If you want to obtain information included in this operating manual in a language other than English, contact your distributor.
©2020 ARKRAY, Inc.
• It is strictly prohibited to copy any part of this operating manual without the expressed consent of ARKRAY, Inc.
• The information in this operating manual is subject to change without notice.
• ARKRAY, Inc. has made every effort to prepare this operating manual as best possible. Should you discover anything
strange, incorrect or missing, contact your distributor.
• BE CAREFUL WHEN HANDLING BLOOD.
This system (SPOTCHEM D-Concept) uses blood as sample. Blood may be
contaminated by pathogenic microbes that can cause infectious diseases.
Improper handling of blood may cause infection to the user or other individuals
by pathogenic microbes.
• This system is to be operated by qualified persons only. A qualified person is one
having adequate knowledge of clinical testing and the disposal of infectious
waste. Thoroughly read this operating manual before use.
• Discard used instruments in accordance with local regulations for biohazardous
waste.
NOTE:
• This instrument is precision equipment. Be careful when handling it and do not subject it to strong shocks or vibration.
• Do not place a collection cup or any other vessel containing a sample or other liquid on the unit. The sample or other
liquid can get inside the instrument and damage it.

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3 Symbols
The following symbols are used in this operating manual and labels on this instrument to call your attention to specific
items.
For the meaning of symbols indicated on the labels (including the shipping box) not described below, refer to the
leaflet included in the package.
For your safety
For optimal performance
Follow the instructions given here to prevent exposure to pathogenic microbes.
Follow the instructions given here to prevent injury and property damage.
IMPORTANT: Follow the instructions given here to obtain accurate measurement results.
NOTE: Information useful for preventing damage to the instrument or parts and other important information you should
keep in mind.
REFERENCE: Additional explanations that help you make the best use of the instrument and information on related
functions.

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4 About the Operating Manuals
The following operating manuals are provided with each SPOTCHEM D-Concept instrument.
Read the operating manuals for each measurement unit after first reading the “SPOTCHEM D-00 QR Operating
Manual”.
SPOTCHEM D-00 QR (operation unit) Operating Manual (this manual)
First read this manual.
The SPOTCHEM D-00 QR is an operation unit that can be connected to a measurement unit or existing model for
operating and making settings of the connected unit(s). This operating manual describes the necessary operations for and
how to make the various settings for taking measurements.
* There is also a 2D code type operation unit, SPOTCHEM D-00 QR. However, both units are described as “D-00” in this
manual.
SPOTCHEM D-01 (measurement unit) Operating Manual
The SPOTCHEM D-01 is a measurement unit that uses the SPOTCHEM D reagent pack to take various measurements.
This operating manual describes the method of measurements and maintenance.
SPOTCHEM D-02 (measurement unit) Operating Manual
The SPOTCHEM D-02 is a measurement unit that uses the SPOTCHEM D single reagent, multiple reagent and electrolyte
plate to take various measurements. This operating manual describes the method of measurements and maintenance.
SPOTCHEM D-03 (measurement unit) Operating Manual
The SPOTCHEM D-03 is a measurement unit that uses the SPOTCHEM D single reagent and multiple reagent to take
various measurements. This operating manual describes the method of measurements and maintenance.

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5 Caution Labels
This instrument has several caution labels on the areas that have potential dangers. Please learn potential dangers
warned by each label and observe the precautions described below.
Rear side
Power input terminal
This is the power cord connector. Use the included power cord to prevent electrical
shock and fires. Do not use any other electrical cords. When the power does not
turn on, the fuse could be blown. Please contact your local distributor.
1
1

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Table of Contents
Chapter 1 Before Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1-1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1-1-1 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1-1-2 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1-2 Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1-2-1 Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1-2-2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1-2-3 Accessories Packing Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1-3 Part Names and Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1-3-1 Front Side of Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1-3-2 Rear Side of Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
When connecting external devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1-4 Operator Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1-5 Measurement Unit Connection and Display . . . . . . . . . . . . . . . . . . . 1-10
1-6 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
1-6-1 Precautions for Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
1-6-2 Precautions for Moving the Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
1-6-3 Fixing the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
1-6-4 Connecting the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Chapter 2 Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2-1 Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2-1-1 Status Indication Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2-1-2 Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2-1-3 Setting Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2-1-4 Message Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2-2 Menu Screen Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Moving menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
2-3 Setting Screen Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2-3-1 Setting Screen Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Cursor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Setting screen operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2-3-2 Changing Set Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2-3-3 Entering Characters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Entering characters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Moving the cursor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Deleting characters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
2-3-4 Entering Numbers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
2-3-5 Entering Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
2-3-6 Entering Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
2-4 Message Screen Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
2-5 Operation when an Error Occurs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

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Chapter 3 Connecting Existing Models . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3-1 Existing Models that Can be Connected . . . . . . . . . . . . . . . . . . . . . . . 3-2
3-2 Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3-2-1 Connecting the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3-2-2 Startup Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3-3 Operation and Results Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
3-3-1 Measurement Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
3-3-2 Display of Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
SP-4430 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
SI-3510 / SI-3511 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
SE-1520 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
3-3-3 Printing of Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
SP-4430 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
SI-3510 / SI-3511 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
SE-1520 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Chapter 4 Menu Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4-1 Menu Screen Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Settings available on the menu screen . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4-2 Entering the Measurement Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4-3 Entering the Sample ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Sample ID restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Entering multiple sample IDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
4-4 Measurement Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4-4-1 Search for Measurement Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Maximum number of measurements to be stored in the memory . . . . 4-6
Search criteria and parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Using wildcards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4-4-2 Checking and Printing Measurement Results. . . . . . . . . . . . . . . . . . . . . . 4-9
Reading the search screen and operable buttons . . . . . . . . . . . . . . . . 4-9
4-5 Sub Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
4-5-1 Clock Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
4-5-2 Option Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
4-5-3 Option Setting Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
4-5-4 Trouble List Search. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Maximum number of cases to be stored in the memory . . . . . . . . . . 4-19
Search criteria and parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
4-5-5 Checking and Printing Trouble List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Trouble list screen and available operations . . . . . . . . . . . . . . . . . . . 4-22
4-5-6 Turning On/Off Measurement Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

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Chapter 5 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5-1 Disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5-2 Setting the Printing Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Chapter 6 Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6-1 Message Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6-2 Warning Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
6-3 Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
6-4 Trouble Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Chapter 7 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7-1 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

D-00 QR 1-1
1-1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1-1-1 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1-1-2 Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1-2 Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1-2-1 Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1-2-2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1-2-3 Accessories Packing Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1-3 Part Names and Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1-3-1 Front Side of Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1-3-2 Rear Side of Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
When connecting external devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1-4 Operator Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1-5 Measurement Unit Connection and Display . . . . . . . . . . . . . . . . . . . . . 1-10
1-6 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
1-6-1 Precautions for Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
1-6-2 Precautions for Moving the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
1-6-3 Fixing the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
1-6-4 Connecting the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Chapter 1 Before Use
This chapter describes what should be known before using this instrument.