FujiFilm DRI-CHEM NX10N User manual

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FUJI DRI-CHEM NX10N
7th Edition
897N120152H April 2022
INSTRUCTION MANUAL
FUJI DRI-CHEM
CLINICAL CHEMISTRY ANALYZER
EN
This Manual describes details on how to operate
the FUJI DRI-CHEM NX10N and cautions to be
observed when operating it. Please read this
manual thoroughly before actually operating
the FUJI DRI-CHEM NX10N. After reading
this manual, store it nearby the FUJI DRI-
CHEM NX10N so that you can see it whenever
necessary.
Safe Usage and
Handling Precautions
Component Names
and Functions
Principles of
Operation
Operations
Periodic Maintenance
Quality Control
Troubleshooting
Mode Settings and
Functions
Other Functions
Specifications/
Consumables
Glossary

(i)
897N120152H FDC NX10N Instruction Manual 04.2022
Introduction
Thank you for purchasing the FUJI DRI-CHEM NX10N.
Accompanying documents were originally drafted in the English language.
Installation may only be conducted by authorized service personnel.
<Intended Purpose>
The FUJI DRI-CHEM NX10N is an in vitro diagnostic medical device to automatically quantitate ammo-
nia in blood based on a colorimetric end-point with reectance photometry, using the FUJI DRI-CHEM
SLIDEs. Do not use the equipment for other purposes.
This equipment must be operated by Healthcare professionals who are familiar with its intended purpose
and correct operation. And, the equipment can be used in a near patient setting by Healthcare profes-
sional.
CAUTIONS
1. No part or all of this manual may be reproduced in any form without prior permission.
2. The information contained in this manual may be subject to change without prior
notice.
3. FUJIFILM shall not be liable for malfunctions and damage resulting from installation,
relocation, remodeling, maintenance, and repair done by other than dealers specified
by FUJIFILM.
4. FUJIFILM shall not be liable for malfunctions and damage of FUJIFILM products due
to the use of products of other manufacturers not supplied by FUJIFILM.
5. FUJIFILM shall not be liable for malfunctions and damage resulting from remodeling,
maintenance, and repair using repair parts other than those specified by FUJIFILM.
6. FUJIFILM shall not be liable for malfunctions and damage resulting from negligence of
precautions and operating methods contained in this manual.
7. FUJIFILM shall not be liable for malfunctions and damage resulting from use under
environment conditions outside the range of conditions required for proper use of this
product, such as power supply, installation environment, etc. contained in this manual.
8. FUJIFILM shall not be liable for malfunctions and damage resulting from natural
disasters such as fires, earthquakes, floods, lightning, etc.
Regulation (EU) 2017/746 requires that any serious incident that has occurred in relation to the device should be reported
to the manufacturer or European Authorized Representative, and the competent authority of your country. In case you
become aware of any serious incident, please report immediately to your local or our official dealer and the competent
authority of your country.
Copyright reserved.
Copyright 2013-2022 by FUJIFILM Corporation.
“DRI-CHEM” is a registered trademark of FUJIFILM Corporation.

897N120152H FDC NX10N Instruction Manual 04.2022 i
Contents
1. Safe Usage and Handling Precautions ......................................................1-1
1.1 Definition of Specific Safety Precautions ...............................................................1-1
1.2 Precautions Before Operating This Equipment......................................................1-1
1.3 Biohazards and Disposal .......................................................................................1-2
1.4 Explosive Hazards .................................................................................................1-2
1.5 Electrical Hazards..................................................................................................1-2
1.6 Electromagnetic Compatibility (EMC) ....................................................................1-3
1.7 Moving Parts..........................................................................................................1-3
1.8 Installation Site Requirements ...............................................................................1-4
1.9 Test Results for Diagnosis .....................................................................................1-5
1.10 Pipettes..................................................................................................................1-5
1.11 FUJI DRI-CHEM SLIDEs (NH3-WII / NH3-PII)........................................................1-6
1.12 QC Card System....................................................................................................1-6
1.13 Handling Samples..................................................................................................1-6
1.14 FUJI CLEAN TIPS .................................................................................................1-7
1.15 Warning Labels ......................................................................................................1-7
1.16 Symbols .................................................................................................................1-8
2. Component Names and Functions.............................................................2-1
2.1 Component Names................................................................................................2-1
2.2 Names and Functions of Display and Keyboard....................................................2-3
2.2.1 Display ..................................................................................................................................2-3
2.2.2 Keyboard...............................................................................................................................2-3
3. Principles of Operation...............................................................................3-1
3.1 Slide Loading .........................................................................................................3-1
3.2 Setting the Sample and Starting Measurements ...................................................3-1
3.3 Measurement.........................................................................................................3-1
3.4 Disposal of Consumables ......................................................................................3-1
INTRODUCTION
Contents

897N120152H FDC NX10N Instruction Manual 04.2022
ii
Contents
4. Operations..................................................................................................4-1
4.1 Preparations...........................................................................................................4-1
4.1.1 List for Daily Maintenance before Use ..................................................................................4-1
4.1.2 Preparations before Turning the Power on (Daily Maintenance before Use #1)...................4-1
4.1.3 Turning the Power on (Daily Maintenance before Use #2) ...................................................4-2
4.2 Measurements .......................................................................................................4-4
4.3 Daily Maintenance after Use..................................................................................4-8
4.4 QC Card System....................................................................................................4-9
4.5 Connecting to External Devices...........................................................................4-10
4.6 Sample Barcode Reader......................................................................................4-11
4.7 Sample ID ............................................................................................................4-13
5. Periodic Maintenance.................................................................................5-1
5.1 Periodic Maintenance ............................................................................................5-2
5.2 Cleaning the Photometer .......................................................................................5-3
5.3 Cleaning the Slide Loading Part and the Slide Transfer Part ................................5-4
5.4 Cleaning the Disposal Box.....................................................................................5-5
5.5 Cleaning the Air Filter.............................................................................................5-6
6. Quality Control ...........................................................................................6-1
6.1 Control Fluids.........................................................................................................6-1
6.2 Running the Control Fluid (the QN) .......................................................................6-1
6.3 Monitoring Results .................................................................................................6-1
6.4 Control Mode .........................................................................................................6-1
6.5 Troubleshooting for Quality Control .......................................................................6-1
7. Troubleshooting .........................................................................................7-1
7.1 Error Indications.....................................................................................................7-1
7.1.1 Error Codes Table .................................................................................................................7-1
7.1.2 Test Result Indications Table ................................................................................................7-1
7.2 Troubleshooting .....................................................................................................7-3
7.2.1 Startup Errors........................................................................................................................7-3
7.2.2 Transfer errors ......................................................................................................................7-3
7.2.3 Photometer errors .................................................................................................................7-3
7.2.4 Built-in clock errors ...............................................................................................................7-4
7.2.5 Fan errors .............................................................................................................................7-4
7.2.6 Test value errors ...................................................................................................................7-4
7.2.7 Temperature control errors....................................................................................................7-5
7.2.8 Host computer connection errors..........................................................................................7-6
7.2.9 Printer errors .........................................................................................................................7-6
7.2.10 Data errors ............................................................................................................................7-7
7.2.11 QC card reading errors .........................................................................................................7-7
7.2.12 Power source errors..............................................................................................................7-7
7.2.13 Irregular errors ......................................................................................................................7-7

897N120152H FDC NX10N Instruction Manual 04.2022 iii
Contents
8. Mode Settings and Functions.....................................................................8-1
8.1 Mode Function List and Mode Selection................................................................8-1
8.1.1 Mode List ..............................................................................................................................8-1
8.1.2 How to Select Each Mode.....................................................................................................8-2
8.2 Mode 0 - Changing Mode Type <Normal>.............................................................8-4
8.3 Mode 1 - Turning on the Control Mode (a, b canceled) <Normal> ........................8-5
8.4 Mode 2 - Setting Date and Time <Normal> ...........................................................8-6
8.5 Mode 3 - Setting Date Display Format <Normal>..................................................8-8
8.6 Mode 4 - Checking Test Data <Normal>................................................................8-9
8.7 Mode 5 - Printing all <Normal> ............................................................................8-12
8.8 Mode 6 - Displaying/Printing out Error Logs <Normal> .......................................8-14
8.9 Mode 7 - Displaying Temperature <Normal> .......................................................8-16
8.10 Mode 8 - Unit Conversion [Unit (A) / Unit (B) Switch] <Admini.>.........................8-17
8.11 Mode 9 - Switching Display Method for Values outside of
the Determination Range <Admini.>.....................................................8-18
8.12 Mode 10 - Correlation Coefficients (a, b) Settings <Admini.>..............................8-19
8.13 Mode 11 - Lot compensation coefficients (c, d, e) settings <Admini.>.................8-25
8.14 Mode 12 - Reference interval settings <Admini.>................................................8-28
8.15 Mode 13 - Selecting Language <Admini.>...........................................................8-32
8.16 Mode 14 - Beep Sound Settings <Admini.>.........................................................8-33
8.17 Mode 15 - Liquid crystal contrast adjustments <Admini.> ...................................8-34
8.18 Mode 16 - Editing sample ID <Admini.> ..............................................................8-35
8.19 Mode 31 - Administrator password setting <Admini.>..........................................8-37
9. Other Functions..........................................................................................9-1
9.1 Data Communication .............................................................................................9-1
9.2 External Printer ......................................................................................................9-1
10. Specifications/Consumables..................................................................10-1
10.1 Specifications and Bundled Items........................................................................10-1
10.1.1 Specifications......................................................................................................................10-1
10.1.2 Bundled Items .....................................................................................................................10-2
10.2 Consumables and Optional Item..........................................................................10-3
10.2.1 Consumables ......................................................................................................................10-3
10.2.2 Optional Item.......................................................................................................................10-3
11. Glossary.................................................................................................11-1

897N120152H FDC NX10N Instruction Manual 04.2022
iv
Contents

1 Safe Usage and Handling Precautions
1-1
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897N120152H FDC NX10N Instruction Manual 04.2022
1. Safe Usage and Handling Precautions
This section contains safety precautions which must be followed for the safe operation of the FUJI DRI-
CHEM NX10N (henceforth, the FDC NX10N).
Before using this equipment, please read this chapter carefully and follow the precautions given, so that you
can operate it correctly.
1.1 Definition of Specific Safety Precautions
Specific safety precautions are noted by the terms WARNING, CAUTION, IMPORTANT, and additional infor-
mation by NOTE. The respective meanings are as follows:
WARNING:
Indicates hazardous situations that may lead to serious injury, even death or the transmission of infectious
agents if the precaution is not followed.
CAUTION:
Indicates hazardous situations that may lead to minor or moderate injury or physical damage if the caution is
not followed.
IMPORTANT:
Indicates improper handling that could have an adverse effect on the accuracy of the measurement values if
the precaution is not followed.
NOTE: Indicates procedures requiring special attention, instructions that must be followed, supplementary explana-
tions, etc.
1.2 Precautions Before Operating This Equipment
CAUTION:
Before using this equipment, please read this Instruction Manual carefully so that you can operate the
equipment correctly.
Whenever you operate this equipment, be sure to observe the precautions described in this manual.
Failure to do so may subject you to injuries, cause property damage, or produce incorrect test results.
In the mode functions described in Section. 8, there are 2 kinds of modes: one is the administrator
mode, which can only be operated by administrators; another is the normal mode, which can be oper-
ated by normal operators. The important mode functions, which affect test results such as correlation
coefficients settings, can only be operated in the administrator mode. The administrator modes must be
operated only by the administrators who have the responsibility for the use of the analyzer. Inputting a
password in the password input dialogue allows the administrators to operate the administrator modes.
Do not modify the FDC NX10N. Otherwise, the safety will not be guaranteed.
The durability period for this equipment is 6 years after installation at your site. (This period is valid as
long as the precautions for use are followed and regular periodic maintenance is performed correctly.)
As the concerns for safety or performance will increase when this period of 6 years expires, please con-
sult your technical support for advice.

1 Safe Usage and Handling Precautions
1-2
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897N120152H FDC NX10N Instruction Manual 04.2022
1.3 Biohazards and Disposal
WARNING:
As used (contaminated) consumables (e.g., slides, tips, and sample containers) and contaminated
swabs or cloths used for cleaning the equipment are infectious waste, process the waste correctly in
compliance with any applicable regulations in your country, such as by incineration, melting, sterilization
or disinfection.
Process waste correctly, as stipulated by local law or any regulations that apply.
When discarding the FDC NX10N that incorporates the lithium battery, be sure to contact a licensed
waste disposal contractor because it cannot be disposed of as a general waste.
Not doing so may cause environmental pollution.
When discarding the equipment that may be contaminated with samples (whole blood or blood plasma),
be sure to process it correctly in compliance with any applicable regulations in your country because it
must never be disposed of as a general waste.
Before discarding the equipment, you must delete the measurement results (personal information)
stored on the equipment. Contact your dealer before discarding.
When handling samples (whole blood or blood plasma) and performing maintenance (cleaning the ana-
lyzer), always follow biohazard procedures (e.g., wearing gloves, lab coat, and safety goggles), referring
to the sample handling rules of your facility. If any part of the body comes in contact with samples, im-
mediately rinse the contaminated body part thoroughly under running water and then use ethyl alcohol
as a disinfectant. Seek medical assistance if necessary.
Do not touch used slides and tips with bare hands as this may cause contamination. If any part of the
body comes in contact with contaminated consumables, immediately rinse the contaminated body part
thoroughly under running water and then use ethyl alcohol as a disinfectant. Seek medical assistance if
necessary.
When samples (whole blood or blood plasma) come in contact with the analyzer components, immedi-
ately clean and disinfect the components.
1.4 Explosive Hazards
WARNING:
As this equipment is not explosion-proof, be sure not to use flammable and explosive gas around the equip-
ment.
1.5 Electrical Hazards
WARNING:
The power supply voltage applied to the equipment is AC100-240V.
To avoid electrical shock, observe the following precautions:
- Use the specified AC adapter designed for the equipment
- Avoid installation sites where water may splash, etc., on the equipment. For installing, leave at least
5 cm clearance on both sides of the equipment, 10 cm clearance behind the equipment.
- To ensure proper using of the AC adapter, correctly plug the AC power cable of the equipment to a
receptacle. If an abnormality is found in the AC adapter or the AC power cable, do not use it and con-
tact your technical support (dealer) for assistance.
- Before connecting the AC adapter to the equipment body, make sure that there is no damage to the
AC adapter.
- Make sure that all cables have been properly connected.
When plugging the AC power cable in or removing it from an outlet, be sure to hold onto the plug body,
not just the cable, to prevent damage to the cable. Any damage to the cable may cause electrical shock
or danger of fire.
Do not remove covers or other parts that are secured with screws to avoid electrical shock, which may
result from exposure to hazardous voltage, or injury from moving parts.