FujiFilm FUJI DRI-CHEM NX600 User manual

1
Safe Usage and
Handling Precautions
3
Measurement
6
Maintenance
7
Quality Control
8
Troubleshooting
10
Other Functions
12
Specifications
11
USM
2
Part Names and
Consumables
4
Applicable Usage
Methods
5
Loading Consumables
9
Function Menu
Glossary
FUJI DRI-CHEM NX600
FUJI DRI-CHEM NX600i
2nd Edition
897N203029A January 2022
INSTRUCTION MANUAL
FUJI DRI-CHEM
CLINICAL CHEMISTRY ANALYZER
13
EN
This Manual describes details on how to operate
the FUJI DRI-CHEM NX600/NX600i and
cautions to be observed when operating it.
Please read this manual thoroughly before
actually operating the FUJI DRI-CHEM NX600/
NX600i. After reading this manual, store it
nearby the FUJI DRI-CHEM NX600/NX600i so
that you can see it whenever necessary.

(i)897N203029A FDC NX600 Instruction Manual 2022.01
Introduction
Thank you for purchasing the FUJI DRI-CHEM NX600 or FUJI DRI-CHEM NX600i.
Accompanying documents were originally drafted in the English language.
Installation may only be conducted by authorized service personnel.
<Intended Purpose>
The FUJI DRI-CHEM NX600 and FUJI DRI-CHEM NX600i (henceforth, the FDC NX600) 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. And, the equipment can be used in a near patient setting by Healthcare
professional.
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 © 2020-2022 FUJIFILM Corporation. All rights reserved.

Introduction
(ii) 897N203029A FDC NX600 Instruction Manual 2022.01
The FDC NX600 is a diagnostic medical device, and this manual is available with all the series (FUJI
DRI-CHEM NX600 and FUJI DRI-CHEM NX600i; 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 NX600 4
FUJI DRI-CHEM NX600i -
NOTE:4: The PF Unit is mounted on the device.
- : The PF Unit is not mounted on the device.

i897N203029A FDC NX600 Instruction Manual 2022.01
Table of Contents
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…………………………………………………… 1-8
1.19 Light Source Lamp ……………………………………………………………………… 1-9
1.20 Recording Paper ………………………………………………………………………… 1-9
1.21 Labels ……………………………………………………………………………………… 1-10
1.22 Symbols …………………………………………………………………………………… 1-11
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 (Top Screen) …………………………… 2-5
2.2.2 Help Screen ……………………………………………………………………… 2-6
2.3 Names and Functions of Software Keyboard Screens ……………………………… 2-8
2.4 Bundled Items …………………………………………………………………………… 2-10
2.5 Consumables and Optional Items ……………………………………………………… 2-11
2.5.1 Consumables …………………………………………………………………… 2-11
2.5.2 Optional Items …………………………………………………………………… 2-12
3 Measurement
3.1 Operation Overview ……………………………………………………………………… 3-1
3.2 Measurement Preparation ……………………………………………………………… 3-3
3.3 Basic Measurements …………………………………………………………………… 3-7
3.3.1 Lamp O󰀨 and Measurement-start Scheduling ……………………………… 3-14
3.4 Measurement Results Screen…………………………………………………………… 3-15
3.5 ISE Tests…………………………………………………………………………………… 3-18
3.6 Dilution Tests ……………………………………………………………………………… 3-21
3.7 CRP Tests ………………………………………………………………………………… 3-25
3.8 Shutting-down the FDC NX600 ………………………………………………………… 3-27

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ii 897N203029A FDC NX600 Instruction Manual 2022.01
3.9 Sample Tubes for the FDC NX600……………………………………………………… 3-30
3.9.1 Blood Collection Tubes ………………………………………………………… 3-30
3.9.2 FUJI Sample Tubes …………………………………………………………… 3-32
3.9.3 Assembling the Sample Rack ………………………………………………… 3-33
3.10 QC Card System ………………………………………………………………………… 3-37
4 Applicable Usage Methods
4.1 CRP Calibration …………………………………………………………………………… 4-1
4.1.1 Calibration Measurement ……………………………………………………… 4-1
4.1.2 Conguring Calibrator Concentration ………………………………………… 4-10
4.2 Manual Spotting (Colorimetric Slide) …………………………………………………… 4-13
4.2.1 Measuring by Manual Spotting (Colorimetric Slide) ………………………… 4-13
4.2.2 Using a Pipette ………………………………………………………………… 4-17
4.3 Tests Using a Plasma Filter (PF) ……………………………………………………… 4-18
4.3.1 Measurement …………………………………………………………………… 4-20
4.3.2 Blood Collection Tubes for Tests Using a PF ………………………………… 4-23
4.4 Retesting…………………………………………………………………………………… 4-24
4.5 Slide Loading Order When Measuring Di󰀨erent Items Simultaneously …………… 4-27
4.6 Automatic Acquisition of Sample Information (Work Lists)…………………………… 4-28
4.7 Editing Sample Numbers and Sample IDs …………………………………………… 4-30
4.8 Using the Sample Barcode Reader (Sold Separately) ……………………………… 4-31
5 Loading Consumables
5.1 Loading Consumables …………………………………………………………………… 5-1
5.2 Setting Tips………………………………………………………………………………… 5-2
5.3 Loading Mixing Cups …………………………………………………………………… 5-5
5.4 Loading Diluent …………………………………………………………………………… 5-7
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 ………………………………………………… 6-7
6.3.2 Cleaning the Transfer Bar, Incubator, Sample Application Unit,
and ISE Unit ……………………………………………………………………… 6-9
6.3.3 Reassembling Parts and Ending Cleaning …………………………………… 6-17
6.4 Replacing Recording Paper……………………………………………………………… 6-18
6.5 Replacing and Cleaning the Light Source Lamp ……………………………………… 6-19
6.6 Maintenance of Sampler O-ring ………………………………………………………… 6-22
6.6.1 Cleaning the Sampler O-ring…………………………………………………… 6-22
6.6.2 Inspecting the Sampler O-ring ………………………………………………… 6-24
6.6.3 Exchanging the Sampler O-ring ……………………………………………… 6-27
6.7 Cleaning the Slide Reading Section …………………………………………………… 6-30
6.8 Cleaning and Replacing the Reference Fluid Cap Packing ………………………… 6-31
6.9 PF Unit Maintenance …………………………………………………………………… 6-33
6.9.1 Cleaning the PF Unit (Sensor, Reference Plate, and Suction Pad) ……… 6-33
6.9.2 Inspecting the PF Suction Pad ………………………………………………… 6-36
6.9.3 Replacing the PF Suction Pad ………………………………………………… 6-38
6.9.4 Replacing the PF Pump Tube ………………………………………………… 6-41

Table of Contents
iii897N203029A FDC NX600 Instruction Manual 2022.01
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 …………………………………………………… 8-19
8.2.6 Transfer Errors…………………………………………………………………… 8-21
8.2.7 Temperature Controller Errors ………………………………………………… 8-22
8.2.8 Circuit Board Signal Errors …………………………………………………… 8-24
8.2.9 QC Card, PF Card, and DI Card Errors ……………………………………… 8-29
8.2.10 Slide Loading Errors …………………………………………………………… 8-31
8.2.11 ISE Measurement Errors ……………………………………………………… 8-33
8.2.12 PF Errors ………………………………………………………………………… 8-36
8.2.13 Errors Related to Data Communication, Sample Barcode Reader………… 8-37
8.2.14 Calibration Errors ……………………………………………………………… 8-39
8.2.15 Other Errors ……………………………………………………………………… 8-42
8.3 Slide Code Table ………………………………………………………………………… 8-44
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 Coe󰀩cients ………………………………………………………… 9-21
9.3.10 Lot Compensation Coe󰀩cients ………………………………………………… 9-25
9.3.11 Standard Curve Coe󰀩cients …………………………………………………… 9-27
9.3.12 Lot Qualication ………………………………………………………………… 9-30
9.3.13 PF Calibration Coe󰀩cients …………………………………………………… 9-31
9.3.14 Dilution Setting…………………………………………………………………… 9-33
9.3.15 Tube Setting for Diluent & Reference Fluid…………………………………… 9-35
9.3.16 Print Setting for Measured Result……………………………………………… 9-35

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iv 897N203029A FDC NX600 Instruction Manual 2022.01
9.3.17 Control Fluid Setting …………………………………………………………… 9-36
9.3.18 Control Measurement Setting ………………………………………………… 9-37
9.3.19 Operator ID Setting ……………………………………………………………… 9-37
9.3.20 Test Item Name Setting ………………………………………………………… 9-38
9.3.21 Default Sample Type Setting…………………………………………………… 9-39
9.3.22 Password Setting ……………………………………………………………… 9-39
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 Di󰀨erence 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 Specications
13 Glossary

1-1897N203029A FDC NX600 Instruction Manual 2022.01
1
Safe Usage and Handling Precautions
This section contains the safety precautions that must be followed for safe operation of the FUJI
DRI-CHEM NX600 (For the remainder of the manual, FUJI DRI-CHEM NX600 is shortened to “FDC
NX600”). 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)
Do not modify the FDC NX600. Otherwise, the safety will not be guaranteed.
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:CAUTION:
IMPORTANT:
1

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1 Safe Usage and Handling Precautions
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 NX600 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.
Before discarding the main unit, you must delete the measurement results (personal information)
stored on the main unit. Contact your dealer before discarding.
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.
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

1-3897N203029A FDC NX600 Instruction Manual 2022.01
1 Safe Usage and Handling Precautions
1.5 Warnings Regarding Electric Shock
The voltage supplied to the equipment is AC 100 - 240 V. To avoid electrical shock, observe the fol-
lowing precautions.
• Avoid installation locations in which water may splash on the equipment.
• Make sure that the equipment is properly grounded to a protective earth lead for indoor wiring.
• Make sure that all cables have been properly connected.
Plug the power cable of the equipment into an outlet with a grounding receptacle. Otherwise, there
is risk of electrical shock.
When plugging the power cable in or removing it from an outlet, be sure to hold onto the plug body,
not just the cable. Otherwise, the power cable may be damaged and cause electric shock or re.
Do not remove covers or other parts that are secured with screws. Doing so may result in electrical
shock from exposure to hazardous voltage or injury from moving parts.
1.6 Electromagnetic Compatibility (EMC)
This equipment conforms to the following emission and immunity requirements:
- IEC 61326-2-6:2012 (Class B)
- EN 61326-2-6:2013 (Class B)
- IEC 61326-2-6:2005 (Class B)
- EN 61326-2-6:2006 (Class B)
• The electromagnetic environment should be evaluated prior to operation of the equipment.
• Do not use this equipment in close proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources), as these may interfere with the proper operation.
However, there is no guarantee that interference will not occur in a particular installation. If this equipment
does cause harmful interference to other devices, which can be determined by turning the equipment o󰀨
and on, the user is encouraged to try to correct the interference by one or more of the following measures.
• Reorient or relocate the receiving device.
• Increase the separation between the equipment.
• Connect the equipment into an outlet on a circuit di󰀨erent from that to which the other device(s)
are connected.
Consult the manufacturer or eld service technician for help.
Do not use other devices (such as mobile phone) which generate and can radiate radio frequency en-
ergy near the FDC NX600. Otherwise, physical damage or malfunction on the FDC NX600 may occur.
NOTE It is the manufacturer's responsibility to provide equipment electromagnetic compatibility
information to the customer or user. On the other hand, it is the user’s responsibility to
ensure that a compatible electromagnetic environment for the equipment can be main-
tained in order that the equipment will perform as intended.
WARNING:
WARNING:
WARNING:
WARNING:
CAUTION:
1

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1 Safe Usage and Handling Precautions
1.7 Caution Regarding Moving Parts
Do not place your ngers near moving parts (sampler and consumable disk) when operating the
equipment, including during maintenance.
Also be sure not to get your ngers, hair, clothing, or accessories caught in moving parts.
During sample processing, ensure the sampler cover is closed and locked with the sampler cover
lock key to prevent injuries and biohazards. If your nger touches a tip that has sample inside, the
sample may scatter and cause infection.
When the display reads [Ready to test], the sampler cover can be opened.
1.8 Installation Locations
Plug the power cable of the equipment into an outlet with a grounding receptacle. Otherwise, there
is risk of electrical shock.
Avoid the following installation sites.
• Places where spills or water leakage may occur.
• Places where the equipment is exposed to direct sunlight.
• Places near sources of heat such as heaters.
• Places where the temperature may drastically change.
• Places where the equipment is subject to vibration or its support table is unstable.
(1) Install the equipment in the following environmental conditions.
Installation environment: Indoor use (do not expose to direct sunlight)
Illumination: 6,000 cd/m2(lux) or less(3,000 cd/m2(lux) or less when using
the sample barcode reader)
Atmospheric pressure: 810 hPa or more (equivalent to altitude 2,000 m)
Transient overvoltage category: II
Pollution degree: 2
Ingress protection rating: IP00 (No Protection)
Operating temperature: 15 to 32 °C
Operating humidity: 30 to 80% RH (no vapor condensation)
(2) Use the equipment under the following electrical specications.
Power supply voltage: single phase AC 100 - 240 V ±10%
Frequency: 50 to 60 Hz
Consumption current: 1.9 - 0.8 A
Type of protection against
electrical shock: CLASS 1 EQUIPMENT
(3) Use an independent outlet separate from other equipment.
(4) Make at least 10 cm of space behind and beside the equipment.
(5) Unplug the equipment from the AC outlet if it will not be used for an extended period of time.
WARNING:
WARNING:
WARNING:
CAUTION:
1

1-5897N203029A FDC NX600 Instruction Manual 2022.01
1 Safe Usage and Handling Precautions
Hold the handle of the device when lifting or moving it.
Handle
• When moving the device to another installation location, remove all slides, samples, diluent, refer-
ence uid, mixing cups, tips, and other consumables beforehand.
• Do not set the device on its side or upside down while moving it.
• Place the device on a at and stable stand.
• When the device is subject to vibrations, such as when being moved by vehicle, it is necessary to
secure the moving parts within the device. Contact your dealer.
• The weight of 28kg is supported by 4 portions of rubber feet. The load on each portion is approx.
7kg. Make sure that the load bearing of the table at the installation location is su󰀩cient.
Failure to observe these precautions may result in unexpected errors or equipment malfunctions.
When wax was used to clean the oor of the installation location, make sure that wax will not adhere
to slides and the device. If wax has adhered, the measurement results may be a󰀨ected.
1.9 Action for Malfunction
When the equipment generates unusual noise, smell, or smoke, immediately unplug the power ca-
ble, and contact your dealer.
Do not place any objects near the wall outlet so that the power cable can be easily unplugged.
In case of emergency, clearance at the back of the equipment is required so that the power cable
can be removed from the inlet of the equipment.
CAUTION:
CAUTION:
IMPORTANT:
CAUTION:
CAUTION:
CAUTION:
1

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1 Safe Usage and Handling Precautions
1.10 Measurement Results
Make a diagnosis in a comprehensive manner, considering other relevant test results or clinical symptoms.
When an equipment problem (error) appears before or during measurement, or a warning appears
in the measurement results, the measurement results may not be accurate. Refer to Chapter 8,
Troubleshooting, and then rerun the measurement.
To maintain the accuracy of your test results, it is recommended to perform quality control on routine
bases by use of control uids. (Refer to Chapter 7.)
1.11 FUJI DRI-CHEM Slides
NOTE For the remainder of the manual, FUJI DRI-CHEM slide is shortened to “slide”.
Please conrm about the usable slide items in this device to your dealer for assistance.
Do not touch used slides with bare hands as this may cause infection. If you accidentally touch an
item, immediately rinse the contaminated area thoroughly under running water, and then disinfect
the area. Seek medical assistance if necessary.
Used slides are infectious industrial waste. Process this waste in compliance with any applicable
regulations in your country, such as by incineration, melting, sterilization, or disinfection. Further-
more, when entrusting disposal to another party, request processing from a contractor with a license
for special management of industrial waste processing work.
Please read the Instructions for Use of the slides carefully and follow the instructions.
• The slides should be stored in a refrigerator still wrapped to avoid humidity, light, and heat.
• Take out the required number of slides from the refrigerator, and allow them to reach room tem-
perature for 5 minutes or more with the condition of the individual package before unwrapping and
using them. Otherwise, the measurement results and the analyzer operation may be a󰀨ected.
• Complete the measurement within 30 minutes after unwrapping the individual package.
• Do not touch the center part (both sides) of a colorimetric slide.
• Do not touch the thread bridge part of an electrolyte slide.
• Do not scratch the identication information on the back of a slide.
• Do not reuse a slide.
NOTE Slide packages and containers for liquids such as diluent and reference uid may change
without notice.
IMPORTANT:
IMPORTANT:
IMPORTANT:
CAUTION:
WARNING:
WARNING:
CAUTION:
IMPORTANT:
1

1-7897N203029A FDC NX600 Instruction Manual 2022.01
1 Safe Usage and Handling Precautions
1.12 CRP Measurement
As calibrator CP is derived from blood, it should be handled in the same way as a patient sample.
When handling calibrator CP, always 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 assistance if necessary.
CRP measurements require periodic calibration. For details, refer to the “Instructions for Use” of the
slides and “Section 3.7 CRP Tests” in this document.
1.13 QC Card System
(1) A QC card is packed together with CM (Colorimetric) slides in the same box. Before you start
using a new lot of CM slides, read the QC card using the card reader.
The analyzer can record up to 5 lots per test, so you can mix and use slides of di󰀨erent lots.
Store the read QC card in the box it came in until the accompanying lot of slides has been used
up.
NOTE When QC information exceeds 5 lots, the oldest QC information is deleted. Slides with-
out QC information cannot be measured.
(2) A QC card contains the slide test name and the correction coe󰀩cient corresponding to the man-
ufacturing number (lot). Always use slides from the same box.
1.14 Handling Samples
When handling samples (blood or urine), always follow biohazard procedures (wear gloves, a lab
coat, and safety goggles) in accordance with the sample handling rules of your facility. If you acci-
dentally touch a sample, immediately rinse the contaminated area thoroughly under running water,
and then disinfect the area. Seek medical assistance if necessary.
Sample preparations di󰀨er depending on the test. Read the “Instructions for Use” of the slides.
When using plasma or serum, check that the samples have not undergone hemolysis, and that they
do not contain any brin deposits.
When using whole blood, test the sample as soon as possible after drawing it.
In the case of whole blood, blood cell precipitation may a󰀨ect the measurement results.
WARNING:
IMPORTANT:
WARNING:
IMPORTANT:
IMPORTANT:
IMPORTANT:
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1 Safe Usage and Handling Precautions
1.15 Sampler Cover
During sample processing, ensure the sampler cover is closed and locked with the sampler cover
lock key to prevent injuries and biohazards. If your nger touches a tip that has sample inside, the
sample may scatter and cause infection. When the display reads [Ready to test], the sampler cover
can be opened.
1.16 Diluents and Reference Fluid
To ensure safe handling of diluent and reference uid, refer to the handling methods in the “Instruc-
tions for Use” of each uid or follow the chemical handling rules of your facility (wear gloves, a lab
coat, and safety goggles). If you accidentally touch an item, immediately rinse the contaminated
body part thoroughly under running water. Seek medical assistance if necessary.
For diluents used in measurements that require dilution, refer to the “Instructions for Use” of the
slides.
Use the reference uid included with the ISE slides for ISE measurements. Refer to the “Instructions
for Use” of the slides.
Use only specied products. Otherwise, errors or malfunctions may occur.
1.17 FUJIFILM PF Plasma Filters
NOTE FUJIFILM plasma lter PF is shortened to "PF" in this document.
Before using a FUJIFILM PF, refer to “Instructions for Use” provided with the PF, paying special at-
tention to the precautions concerning the samples measured and the blood collection tubes used.
1.18 FUJI DRI-CHEM AUTO TIPS, FUJI Sample Tubes, and FUJI
DRI-CHEM MIXING CUPS
NOTE In this manual, FUJI DRI-CHEM AUTO TIPS may be shortened to “tip”, FUJI Sample Tube
to “tube”, and FUJI DRI-CHEM MIXING CUPS to “mixing cup”.
FDC NX600 performs sample application automatically via the sampler. However, it is necessary to
prepare dedicated FUJI DRI-CHEM AUTO TIPS, FUJI Sample Tubes, and specied blood collection
tubes and FUJI DRI-CHEM MIXING CUPS.
The FUJI Sample Tubes include the following types.
• FUJI HEPARIN TUBE 1.5 mL
• FUJI HEPARIN TUBE 0.5 mL
• FUJI PLAIN TUBE 1.5 mL
• FUJI PLAIN TUBE 0.5 mL
WARNING:
CAUTION:
IMPORTANT:
IMPORTANT:
IMPORTANT:
IMPORTANT:
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1-9897N203029A FDC NX600 Instruction Manual 2022.01
1 Safe Usage and Handling Precautions
Do not touch used tips, tubes, and mixing cups with your bare hands as this may cause infection. If
you accidentally touch an item, immediately rinse the contaminated area thoroughly under running
water, and then disinfect the area. Seek medical assistance if necessary.
Used tips, tubes, and mixing cups are infectious industrial waste. Process this waste in compliance
with any applicable regulations in your country, such as by incineration, melting, sterilization, or dis-
infection. Furthermore, when entrusting disposal to another party, request processing from a con-
tractor with a license for special management of industrial waste processing work.
Always use new FUJI DRI-CHEM AUTO TIPS, FUJI Sample Tubes, blood collection tubes, and
FUJI DRI-CHEM MIXING CUPS for each sample. Do not reuse old ones.
Use only specied products. Otherwise, errors or malfunctions may occur.
When the power is shut o󰀨 during test processing, such as by a power outage, replenish tips and
replace mixing cups. The analyzer may lose the information of the usage positions of the consuma-
bles and use used mixing cups (holes).
1.19 Light Source Lamp
The light source lamp gets very hot. Before replacing the lamp, turn the power o󰀨, wait at least 5
minutes, and then check that the lamp has cooled.
(1) The light source lamp is a precision halogen lamp. Do not touch the glass surface of the lamp
with your bare hands.
(2) The lamp is a consumable with a lifetime. Always keep a spare lamp on hand in case the lamp
burns out.
1.20 Recording Paper
(1) Use specied recording paper for the FDC NX600.
(2) If other recording paper is used, the printer head section may be damaged.
WARNING:
WARNING:
IMPORTANT:
IMPORTANT:
IMPORTANT:
CAUTION:
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1.21 Labels
The following safety labels are a󰀩xed to the FDC NX600.
Moving parts
caution label
Biohazard
label
Biohazard label PF tube caution
label
Biohazard label
Power button
High tempera-
ture caution label
Lamp caution
label
Power switch
| : Depress to power ON
O : Depress to power OFF
Name-plate
NOTE: The example
above uses an
illustration for the
FDC NX600. For
the FDC NX600i,
the description of
the plate partially
di󰀨ers.
Sampler cover lock
key caution label

Refer to Section 1.15

Refer to Section 6.9.4

Refer to Section 6.5

Refer to Section 6.5
USB
connector
RS-232C
connector
LAN
terminal
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1.22 Symbols
Sign Description
Warning, Caution, Important, consult documents
Biological risks
High temperature caution
Power button
Power switch
LAN terminal
RS-232C connector
USB connector
Fragile item, handle carefully
Protect from rain
This way up
2
Stacking limitation
Temperature limitation
Manufacturer
S
N
Serial number
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1-12 897N203029A FDC NX600 Instruction Manual 2022.01
1 Safe Usage and Handling Precautions
Sign Description
Date of manufacture
EC REP
Authorized representative in the European Community
In vitro diagnostic medical devices
CE mark of conformity
Importer
Consult an electronic Instructions for Use (e-IFU)
Unique device identier
Near-patient testing
1