FujiFilm FUJI DRI-CHEM NX700 User manual

1
Safe Usage and
Handling Precautions
3
Measurement
6
Maintenance
7
Quality Control
8
Troubleshooting
10
Other Functions
11
USM
2
Part Names and
Consumables
4
Applicable Usage
Methods
5
Loading Consumables
9
Function Menu
12
Specifications
13
Glossary
FUJI DRI-CHEM NX700
FUJI DRI-CHEM NX700i
7th Edition
897N201058J April 2022
INSTRUCTION MANUAL
FUJI DRI-CHEM
CLINICAL CHEMISTRY ANALYZER
EN
This Manual describes details on how to operate
the FUJI DRI-CHEM NX700/NX700i and cautions
to be observed when operating it. Please read this
manual thoroughly before actually operating the
FUJI DRI-CHEM NX700/NX700i. After reading
this manual, store it nearby the FUJI DRI-CHEM
NX700/NX700i so that you can see it whenever
necessary.

(i)
Introduction
897N201058J FDC NX700 Instruction Manual 2022.04
Thank you for purchasing the FUJI DRI-CHEM NX700 or FUJI DRI-CHEM NX700i.
Accompanying documents were originally drafted in the English language.
Installation may only be conducted by authorized service personnel.
<Intended Purpose>
The FUJI DRI-CHEM NX700 and FUJI DRI-CHEM NX700i (henceforth, the FDC NX700) is an in vitro
diagnostic medical device to automatically quantitate the concentration or the activity of the components
in blood or urine by colorimetric end-point, rate and ISE tests, 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 pur-
pose and correct operation.
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 o󰀩cial dealer and the competent authority of your country.
Trademark
“DRI-CHEM” is a trademark or a registered trademark of FUJIFILM Corporation.
Other holder’s trademarks
“QR Code” is registered trademark of DENSO WAVE INCORPORATED.
* This product adopts the font of ARPHIC TECHNOLOGY CO., LTD.
Copyright © 2017-2022 FUJIFILM Corporation. All rights reserved.

Introduction
(ii) 897N201058J FDC NX700 Instruction Manual 2022.04
The FDC NX700 is a diagnostic medical device, and this manual is available with all the series (FUJI
DRI-CHEM NX700 and FUJI DRI-CHEM NX700i; the former includes the PF (Plasma Filter) unit, and
the latter does not. So for the latter, sections that describe the unit can be skipped).
Name PF Unit
FUJI DRI-CHEM NX700 4
FUJI DRI-CHEM NX700i -
NOTE:4: The PF Unit is mounted on the device.
- : The PF Unit is not mounted on the device.

i
Table of contents
897N201058J FDC NX700 Instruction Manual 2022.04
1 Safe usage and handling precautions
1.1 Precautions (marks) used in this manual ……………………………………………… 1-1
1.2 Operation precautions …………………………………………………………………… 1-1
1.3 Biohazards and disposal ………………………………………………………………… 1-2
1.4 Warnings regarding explosives ………………………………………………………… 1-2
1.5 Warnings regarding electric shock ……………………………………………………… 1-3
1.6 Electromagnetic Compatibility (EMC) ………………………………………………… 1-3
1.7 Caution regarding moving parts ………………………………………………………… 1-4
1.8 Installation locations ……………………………………………………………………… 1-4
1.9 Action for Malfunction …………………………………………………………………… 1-5
1.10 Measurement results …………………………………………………………………… 1-6
1.11 FUJI DRI-CHEM slides…………………………………………………………………… 1-6
1.12 CRP measurement ……………………………………………………………………… 1-7
1.13 QC card system…………………………………………………………………………… 1-7
1.14 Handling samples ………………………………………………………………………… 1-7
1.15 Sampler cover …………………………………………………………………………… 1-8
1.16 Diluents and reference fluid……………………………………………………………… 1-8
1.17 FUJIFILM PF plasma filters ……………………………………………………………… 1-8
1.18 FUJI DRI-CHEM AUTO TIPS, FUJI Sample Tubes, and FUJI DRI-CHEM MIXING
CUPS ……………………………………………………………………………………… 1-9
1.19 Light source lamp ………………………………………………………………………… 1-10
1.20 Recording paper ………………………………………………………………………… 1-10
1.21 Labels ……………………………………………………………………………………… 1-11
1.22 Symbols …………………………………………………………………………………… 1-12
2 Part names and consumables
2.1 Part names ………………………………………………………………………………… 2-1
2.2 Touch panel screen names and functions……………………………………………… 2-5
2.2.1 Measurement-preparation screen …………………………………………… 2-5
2.2.2 Help screen ……………………………………………………………………… 2-7
2.3 Names and functions of software keyboard screens ………………………………… 2-9
2.4 Bundled items …………………………………………………………………………… 2-11
2.5 Consumables and optional items ……………………………………………………… 2-12
2.5.1 Consumables …………………………………………………………………… 2-12
2.5.2 Optional items …………………………………………………………………… 2-13
3 Measurement
3.1 Operation overview ……………………………………………………………………… 3-1
3.2 Measurement preparation ……………………………………………………………… 3-3
3.3 Basic measurements …………………………………………………………………… 3-7
3.3.1 Lamp off and measurement-start scheduling ………………………………… 3-14
3.4 Measurement results screen …………………………………………………………… 3-16
3.5 ISE test measurements ………………………………………………………………… 3-19
3.6 Dilution tests ……………………………………………………………………………… 3-21
3.7 CRP Tests ………………………………………………………………………………… 3-25
3.8 Shutting-down the FDC NX700 ………………………………………………………… 3-28

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ii 897N201058J FDC NX700 Instruction Manual 2022.04
3.9 Sample tubes for the FDC NX700 ……………………………………………………… 3-31
3.9.1 Blood collecting tubes…………………………………………………………… 3-31
3.9.2 FUJI Sample Tubes …………………………………………………………… 3-33
3.9.3 Sample racks …………………………………………………………………… 3-34
3.10 QC card system…………………………………………………………………………… 3-35
4 Applicable usage methods
4.1 CRP calibration …………………………………………………………………………… 4-1
4.1.1 Calibration measurement ……………………………………………………… 4-1
4.1.2 Configuring calibrator concentration ………………………………………… 4-6
4.1.3 Verifying calibration……………………………………………………………… 4-9
4.2 Interrupting sample application and STAT tests ……………………………………… 4-11
4.2.1 Interrupting and canceling sample application ……………………………… 4-11
4.2.2 Requesting a STAT test ………………………………………………………… 4-12
4.3 Manual sampling ………………………………………………………………………… 4-15
4.3.1 Measuring by manual sample application …………………………………… 4-15
4.3.2 Using a pipette…………………………………………………………………… 4-19
4.4 Tests using a plasma filter (PF) ………………………………………………………… 4-21
4.4.1 Measurement …………………………………………………………………… 4-23
4.4.2 Blood collecting tubes for tests using a PF …………………………………… 4-26
4.5 Retesting…………………………………………………………………………………… 4-27
4.6 Slide loading order when measuring different items simultaneously ……………… 4-30
4.7 Automatic acquisition of sample information (work lists) …………………………… 4-31
4.8 Batch change of sample types ………………………………………………………… 4-35
4.9 Measuring plasma and urine samples at the same time …………………………… 4-36
4.10 Editing sample numbers and sample IDs ……………………………………………… 4-38
4.11 Using the sample barcode reader (sold separately) ………………………………… 4-39
5 Loading consumables
5.1 Loading consumables …………………………………………………………………… 5-1
5.2 Setting tips ………………………………………………………………………………… 5-2
5.3 Loading mixing cups ……………………………………………………………………… 5-4
5.4 Loading diluent …………………………………………………………………………… 5-6
5.5 Loading reference fluid…………………………………………………………………… 5-9
6 Maintenance
6.1 Periodic maintenance items……………………………………………………………… 6-2
6.1.1 Items for daily and periodic inspection by the user ………………………… 6-2
6.1.2 Items for maintenance and inspection by repair personnel ………………… 6-3
6.2 Cleaning the air filters …………………………………………………………………… 6-4
6.3 Inspecting and cleaning the transfer bar, incubator, sample application unit, and
ISE unit …………………………………………………………………………………… 6-6
6.3.1 Reference plate level check …………………………………………………… 6-6
6.3.2 Cleaning the transfer bar, incubator, sample application unit, and ISE
unit ………………………………………………………………………………… 6-8
6.3.3 Reassembling parts and ending cleaning …………………………………… 6-15
6.4 Replacing recording paper ……………………………………………………………… 6-16
6.5 Replacing and cleaning the light source lamp ………………………………………… 6-17
6.6 Inspecting and Replacing the Sampler O-ring ………………………………………… 6-20
6.6.1 Inspecting the sampler O-ring ………………………………………………… 6-20
6.6.2 Exchanging the sampler O-ring ……………………………………………… 6-23
6.7 Cleaning the slide reading section ……………………………………………………… 6-26

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iii897N201058J FDC NX700 Instruction Manual 2022.04
6.8 Cleaning and replacing the reference fluid cap packing ……………………………… 6-27
6.9 PF unit maintenance……………………………………………………………………… 6-29
6.9.1 Cleaning the PF unit (sensor, reference plate, and suction pad) ………… 6-29
6.9.2 Inspecting the PF Suction Pad ………………………………………………… 6-31
6.9.3 Replacing the PF Suction Pad ………………………………………………… 6-34
6.9.4 Replacing the PF pump tube…………………………………………………… 6-37
7 Quality control
7.1 Control fluids ……………………………………………………………………………… 7-1
7.2 Measurement with control fluids ………………………………………………………… 7-1
7.3 Monitoring results ………………………………………………………………………… 7-1
7.4 Control mode ……………………………………………………………………………… 7-1
7.5 Troubleshooting quality control results ………………………………………………… 7-1
7.6 Control chart ……………………………………………………………………………… 7-2
8 Troubleshooting
8.1 Error display ……………………………………………………………………………… 8-1
8.1.1 Error log ………………………………………………………………………… 8-2
8.1.2 Error code and reference section table ……………………………………… 8-4
8.1.3 Printout reference table ………………………………………………………… 8-8
8.2 Troubleshooting …………………………………………………………………………… 8-10
8.2.1 Startup errors …………………………………………………………………… 8-10
8.2.2 Printer or LCD trouble…………………………………………………………… 8-10
8.2.3 Slide reading errors……………………………………………………………… 8-11
8.2.4 Sampler errors …………………………………………………………………… 8-11
8.2.5 Photometric system errors……………………………………………………… 8-20
8.2.6 Transfer Errors…………………………………………………………………… 8-22
8.2.7 Temperature Controller Errors ………………………………………………… 8-24
8.2.8 Circuit board signal errors ……………………………………………………… 8-26
8.2.9 QC card, PF card, and DI card errors ………………………………………… 8-31
8.2.10 Slide loading errors ……………………………………………………………… 8-33
8.2.11 ISE measurement errors ……………………………………………………… 8-35
8.2.12 PF errors ………………………………………………………………………… 8-37
8.2.13 Errors Related to Data Communication, Sample Barcode Reader………… 8-39
8.2.14 Calibration errors………………………………………………………………… 8-40
8.2.15 Other Errors ……………………………………………………………………… 8-43
8.3 Slide code table …………………………………………………………………………… 8-45
9 Function menu
9.1 Control……………………………………………………………………………………… 9-3
9.2 Normal mode ……………………………………………………………………………… 9-7
9.2.1 Date & Time settings …………………………………………………………… 9-8
9.2.2 Brightness • Volume …………………………………………………………… 9-8
9.2.3 Lamp management ……………………………………………………………… 9-9
9.2.4 Lot information …………………………………………………………………… 9-9
9.3 Mode function for administrator ………………………………………………………… 9-10
9.3.1 Language setting………………………………………………………………… 9-11
9.3.2 Host connection setting ………………………………………………………… 9-11
9.3.3 Calculated Parameter…………………………………………………………… 9-14
9.3.4 Unit conversion ………………………………………………………………… 9-16
9.3.5 Switch measurement range display …………………………………………… 9-17
9.3.6 Reference interval range setting ……………………………………………… 9-18
9.3.7 Sample No. /ID settings ………………………………………………………… 9-20
9.3.8 Work list selection setting ……………………………………………………… 9-20
9.3.9 Correlation coefficients ………………………………………………………… 9-21

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iv 897N201058J FDC NX700 Instruction Manual 2022.04
9.3.10 Lot compensation coefficients ………………………………………………… 9-25
9.3.11 Standard curve coefficients …………………………………………………… 9-27
9.3.12 Lot qualification ………………………………………………………………… 9-30
9.3.13 PF calibration coefficients ……………………………………………………… 9-31
9.3.14 Dilution setting …………………………………………………………………… 9-33
9.3.15 Tube setting for diluent & reference fluid……………………………………… 9-36
9.3.16 Print setting for measured result ……………………………………………… 9-36
9.3.17 Control fluid setting ……………………………………………………………… 9-37
9.3.18 Control measurement setting ………………………………………………… 9-38
9.3.19 Operator ID setting ……………………………………………………………… 9-38
9.3.20 Test item name setting ………………………………………………………… 9-39
9.3.21 Password setting ………………………………………………………………… 9-40
10 Other functions
10.1 Data communication ……………………………………………………………………… 10-1
11 USM (User Safety Mode)
11.1 Operator ID input when measurement start and in mode function ………………… 11-1
11.2 Difference of operable functions among operator ID level (OPE,ADM,EMG)……… 11-2
11.3 USM menu ………………………………………………………………………………… 11-5
11.3.1 Operator ID -Import……………………………………………………………… 11-5
11.3.2 Operator ID -Export……………………………………………………………… 11-7
11.3.3 Editing registered operator ID ………………………………………………… 11-9
11.3.4 Editing emergency ID ………………………………………………………… 11-11
12 Specifications
13 Glossary

1-1897N201058J FDC NX700 Instruction Manual 2022.04
1
Safe usage and handling precautions
This section contains the safety precautions that must be followed for safe operation of the FUJI
DRI-CHEM NX700 (For the remainder of the manual, FUJI DRI-CHEM NX700 is shortened to “FDC
NX700”). Before using this analyzer, please read this chapter carefully and follow the precautions given,
so that you can operate it correctly.
1.1 Precautions (marks) used in this manual
The following section lists the meaning of precautions (marks) used in this manual.
WARNING:
“Warning” indicates hazardous situations that may lead to serious injury, death,
or the transmission of infectious agents if the precaution is not followed.
CAUTION: “Caution” indicates hazardous situations that may lead to minor injury,
moderate injury, or physical damage if the precaution is not followed.
IMPORTANT:
“Important” indicates improper handling that could have an adverse e󰀨ect on
the accuracy of the measurement values if the precaution is not followed.
NOTE “Note” indicates procedures requiring special attention, instructions that
must be followed, supplementary explanations, etc.
1.2 Operation precautions
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 measure-
ment results.
The operators must be su󰀩ciently trained for the usage of sampler cover lock key and observe its
usage method and precautions. Store the lock key carefully so that it is not lost.
(Refer to Section 1.15)
The e󰀨ective period of service (service life) of this analyzer is 6 years after delivery (as long as us-
age precautions are observed and regular maintenance is performed). If you will use the analyzer
after the service life expires, consult with the manufacturer/seller beforehand. The use of medical
equipment that has exceeded its service life may increase the chance of safety and performance
problems.
Use consumables on or before their listed expiration date.
CAUTION:
CAUTION:
CAUTION:
CAUTION:CAUTION:
IMPORTANT:
1

1-2
1 Safe usage and handling precautions
897N201058J FDC NX700 Instruction Manual 2022.04
1.3 Biohazards and disposal
Items such as measured slides, tips, mixing cups, and sample tubes coated with samples such as
blood and urine, and cotton swabs and cloths used to clean the equipment are infectious industrial
waste. Process this waste in compliance with any applicable regulations in your country, such as
by incineration, melting, sterilization, or disinfection. Furthermore, when entrusting disposal to an-
other party, request processing from a contractor with a license for special management of industrial
waste processing work.
Items that may be contaminated with blood or urine are infectious industrial waste. When discarding
the main unit, follow applicable regulations in your country and dispose of it appropriately.
Process waste correctly, as stipulated by local law or any regulations that apply.
When discarding the FDC NX700 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 handling samples (blood or urine) and performing maintenance (cleaning the analyzer), al-
ways follow biohazard procedures (wear gloves, a lab coat, and safety goggles) in accordance with
the sample handling rules of your facility. If you accidentally touch a sample, immediately rinse the
contaminated area thoroughly under running water, and then disinfect the area. Seek medical assis-
tance if necessary.
Do not touch used slides and tips with bare hands as this may cause contamination. If you acciden-
tally touch a contaminated consumable, immediately rinse the contaminated area thoroughly under
running water, and then disinfect the area. Seek medical assistance if necessary.
When samples come in contact with the analyzer, immediately clean and disinfect it.
Before discarding the main unit, you must delete the measurement results (personal information)
stored on the main unit. Contact your dealer before discarding.
1.4 Warnings regarding explosives
As this equipment is not explosion-proof, be sure not to use ammable and explosive gas around
the equipment.
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
WARNING:
1