EN
INSTRUCTION MANUAL
FUJI DRI-CHEM
CLINICAL CHEMISTRY ANALYZER
FUJI DRI-CHEM NX600
FUJI DRI-CHEM NX600i
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.
Safe Usage and
Handling Precautions
1
Part Names and
Consumables
2
Measurement
3
Applicable Usage
Methods
4
Loading Consumables
5
Maintenance
6
Quality Control
7
Troubleshooting
8
Function Menu
9
Other Functions
10
USM
11
Specifications
12
Glossary
13
2nd Edition
897N203029A January 2022
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 purpose 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 official 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.
897N203029A FDC NX600 Instruction Manual 2022.01
(i)
Introduction
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.
(ii)
897N203029A FDC NX600 Instruction Manual 2022.01
Table of Contents
1
Safe Usage and Handling Precautions
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
1.10
1.11
1.12
1.13
1.14
1.15
1.16
1.17
1.18
1.19
1.20
1.21
1.22
2
Part Names and Consumables
2.1
2.2
2.3
2.4
2.5
3
Precautions (marks) Used in This Manual……………………………………………… 1-1
Operation Precautions……………………………………………………………………… 1-1
Biohazards and Disposal…………………………………………………………………… 1-2
Warnings Regarding Explosives…………………………………………………………… 1-2
Warnings Regarding Electric Shock……………………………………………………… 1-3
Electromagnetic Compatibility (EMC)…………………………………………………… 1-3
Caution Regarding Moving Parts………………………………………………………… 1-4
Installation Locations……………………………………………………………………… 1-4
Action for Malfunction……………………………………………………………………… 1-5
Measurement Results……………………………………………………………………… 1-6
FUJI DRI-CHEM Slides…………………………………………………………………… 1-6
CRP Measurement………………………………………………………………………… 1-7
QC Card System…………………………………………………………………………… 1-7
Handling Samples…………………………………………………………………………… 1-7
Sampler Cover……………………………………………………………………………… 1-8
Diluents and Reference Fluid……………………………………………………………… 1-8
FUJIFILM PF Plasma Filters……………………………………………………………… 1-8
FUJI DRI-CHEM AUTO TIPS, FUJI Sample Tubes,
and FUJI DRI-CHEM MIXING CUPS……………………………………………………… 1-8
Light Source Lamp………………………………………………………………………… 1-9
Recording Paper…………………………………………………………………………… 1-9
Labels………………………………………………………………………………………… 1-10
Symbols……………………………………………………………………………………… 1-11
Part Names………………………………………………………………………………… 2-1
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
Names and Functions of Software Keyboard Screens………………………………… 2-8
Bundled Items……………………………………………………………………………… 2-10
Consumables and Optional Items………………………………………………………… 2-11
2.5.1 Consumables……………………………………………………………………… 2-11
2.5.2 Optional Items……………………………………………………………………… 2-12
Measurement
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
Operation Overview………………………………………………………………………… 3-1
Measurement Preparation………………………………………………………………… 3-3
Basic Measurements……………………………………………………………………… 3-7
3.3.1 Lamp Off and Measurement-start Scheduling………………………………… 3-14
Measurement Results Screen……………………………………………………………… 3-15
ISE Tests……………………………………………………………………………………… 3-18
Dilution Tests………………………………………………………………………………… 3-21
CRP Tests…………………………………………………………………………………… 3-25
Shutting-down the FDC NX600…………………………………………………………… 3-27
897N203029A FDC NX600 Instruction Manual 2022.01
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Table of Contents
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
4.2
4.3
4.4
4.5
4.6
4.7
4.8
5
Loading Consumables
5.1
5.2
5.3
5.4
5.5
6
Loading Consumables………………………………………………………………………
Setting Tips……………………………………………………………………………………
Loading Mixing Cups………………………………………………………………………
Loading Diluent………………………………………………………………………………
Loading Reference Fluid……………………………………………………………………
5-1
5-2
5-5
5-7
5-9
Maintenance
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
ii
CRP Calibration……………………………………………………………………………… 4-1
4.1.1 Calibration Measurement………………………………………………………… 4-1
4.1.2 Configuring Calibrator Concentration…………………………………………… 4-10
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
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
Retesting……………………………………………………………………………………… 4-24
Slide Loading Order When Measuring Different Items Simultaneously……………… 4-27
Automatic Acquisition of Sample Information (Work Lists)……………………………… 4-28
Editing Sample Numbers and Sample IDs……………………………………………… 4-30
Using the Sample Barcode Reader (Sold Separately)………………………………… 4-31
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
Cleaning the Air Filters……………………………………………………………………… 6-4
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
Replacing Recording Paper………………………………………………………………… 6-18
Replacing and Cleaning the Light Source Lamp………………………………………… 6-19
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
Cleaning the Slide Reading Section……………………………………………………… 6-30
Cleaning and Replacing the Reference Fluid Cap Packing…………………………… 6-31
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
897N203029A FDC NX600 Instruction Manual 2022.01
Table of Contents
7
Quality Control
7.1
7.2
7.3
7.4
7.5
7.6
8
7-1
7-1
7-1
7-1
7-1
7-2
Troubleshooting
8.1
8.2
8.3
9
Control Fluids…………………………………………………………………………………
Measurement with Control Fluids…………………………………………………………
Monitoring Results…………………………………………………………………………
Control Mode…………………………………………………………………………………
Troubleshooting Quality Control Results…………………………………………………
Control Chart…………………………………………………………………………………
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
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
Slide Code Table…………………………………………………………………………… 8-44
Function Menu
9.1
9.2
9.3
Control………………………………………………………………………………………… 9-3
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
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
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……………………………………… 9-35
9.3.16 Print Setting for Measured Result………………………………………………… 9-35
897N203029A FDC NX600 Instruction Manual 2022.01
iii
Table of Contents
9.3.17
9.3.18
9.3.19
9.3.20
9.3.21
9.3.22
Control Fluid Setting……………………………………………………………… 9-36
Control Measurement Setting…………………………………………………… 9-37
Operator ID Setting………………………………………………………………… 9-37
Test Item Name Setting…………………………………………………………… 9-38
Default Sample Type Setting……………………………………………………… 9-39
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 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
iv
897N203029A 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
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” indicates improper handling that could have an adverse effect on
IMPORTANT: the accuracy of the measurement values if the precaution is not followed.
NOTE
1.2
“Note” indicates procedures requiring special attention, instructions that
must be followed, supplementary explanations, etc.
Operation Precautions
CAUTION:
Before using this equipment, please read this Instruction Manual carefully so that you can operate
the equipment correctly.
CAUTION:
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 measurement results.
CAUTION:
The operators must be sufficiently 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)
CAUTION:
Do not modify the FDC NX600. Otherwise, the safety will not be guaranteed.
CAUTION:
The effective period of service (service life) of this analyzer is 6 years after delivery (as long as usage 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.
IMPORTANT:
Use consumables on or before their listed expiration date.
897N203029A FDC NX600 Instruction Manual 2022.01
1-1
1 Safe Usage and Handling Precautions
1.3
Biohazards and Disposal
WARNING:
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 another party, request processing from a contractor with a license for special management of industrial
waste processing work.
1
WARNING:
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.
WARNING:
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.
WARNING:
Before discarding the main unit, you must delete the measurement results (personal information)
stored on the main unit. Contact your dealer before discarding.
WARNING:
When handling samples (blood or urine) and performing maintenance (cleaning the analyzer), 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.
WARNING:
Do not touch used slides and tips with bare hands as this may cause contamination. If you accidentally touch a contaminated consumable, immediately rinse the contaminated area thoroughly under
running water, and then disinfect the area. Seek medical assistance if necessary.
WARNING:
When samples come in contact with the analyzer, immediately clean and disinfect it.
1.4
Warnings Regarding Explosives
WARNING:
As this equipment is not explosion-proof, be sure not to use flammable and explosive gas around
the equipment.
1-2
897N203029A FDC NX600 Instruction Manual 2022.01
1 Safe Usage and Handling Precautions
1.5
Warnings Regarding Electric Shock
WARNING:
The voltage supplied to the equipment is AC 100 - 240 V. To avoid electrical shock, observe the following 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.
WARNING:
Plug the power cable of the equipment into an outlet with a grounding receptacle. Otherwise, there
is risk of electrical shock.
WARNING:
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 fire.
WARNING:
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 off
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 different from that to which the other device(s)
are connected.
Consult the manufacturer or field service technician for help.
CAUTION:
Do not use other devices (such as mobile phone) which generate and can radiate radio frequency energy 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 maintained in order that the equipment will perform as intended.
897N203029A FDC NX600 Instruction Manual 2022.01
1-3
1
1 Safe Usage and Handling Precautions
1.7
Caution Regarding Moving Parts
WARNING:
Do not place your fingers near moving parts (sampler and consumable disk) when operating the
equipment, including during maintenance.
Also be sure not to get your fingers, hair, clothing, or accessories caught in moving parts.
1
WARNING:
During sample processing, ensure the sampler cover is closed and locked with the sampler cover
lock key to prevent injuries and biohazards. If your finger 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
WARNING:
Plug the power cable of the equipment into an outlet with a grounding receptacle. Otherwise, there
is risk of electrical shock.
CAUTION:
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
IP00 (No Protection)
Ingress protection rating:
Operating temperature:
15 to 32 °C
Operating humidity:
30 to 80% RH (no vapor condensation)
(2) Use the equipment under the following electrical specifications.
single phase AC 100 - 240 V ±10%
Power supply voltage:
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.
1-4
897N203029A FDC NX600 Instruction Manual 2022.01
1 Safe Usage and Handling Precautions
CAUTION:
Hold the handle of the device when lifting or moving it.
1
Handle
CAUTION:
• When moving the device to another installation location, remove all slides, samples, diluent, reference fluid, 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 flat 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 sufficient.
Failure to observe these precautions may result in unexpected errors or equipment malfunctions.
IMPORTANT:
When wax was used to clean the floor 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 affected.
1.9
Action for Malfunction
CAUTION:
When the equipment generates unusual noise, smell, or smoke, immediately unplug the power cable, and contact your dealer.
CAUTION:
Do not place any objects near the wall outlet so that the power cable can be easily unplugged.
CAUTION:
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.
897N203029A FDC NX600 Instruction Manual 2022.01
1-5
1 Safe Usage and Handling Precautions
1.10 Measurement Results
IMPORTANT:
Make a diagnosis in a comprehensive manner, considering other relevant test results or clinical symptoms.
1
IMPORTANT:
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.
IMPORTANT:
To maintain the accuracy of your test results, it is recommended to perform quality control on routine
bases by use of control fluids. (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”.
CAUTION:
Please confirm about the usable slide items in this device to your dealer for assistance.
WARNING:
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.
WARNING:
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. Furthermore, when entrusting disposal to another party, request processing from a contractor with a license
for special management of industrial waste processing work.
CAUTION:
Please read the Instructions for Use of the slides carefully and follow the instructions.
IMPORTANT:
• 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 temperature 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 affected.
• 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 identification information on the back of a slide.
• Do not reuse a slide.
NOTE Slide packages and containers for liquids such as diluent and reference fluid may change
without notice.
1-6
897N203029A FDC NX600 Instruction Manual 2022.01
1 Safe Usage and Handling Precautions
1.12 CRP Measurement
WARNING:
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.
IMPORTANT:
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 different 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 without QC information cannot be measured.
(2) A QC card contains the slide test name and the correction coefficient corresponding to the manufacturing number (lot). Always use slides from the same box.
1.14 Handling Samples
WARNING:
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 accidentally touch a sample, immediately rinse the contaminated area thoroughly under running water,
and then disinfect the area. Seek medical assistance if necessary.
IMPORTANT:
Sample preparations differ depending on the test. Read the “Instructions for Use” of the slides.
IMPORTANT:
When using plasma or serum, check that the samples have not undergone hemolysis, and that they
do not contain any fibrin deposits.
IMPORTANT:
When using whole blood, test the sample as soon as possible after drawing it.
In the case of whole blood, blood cell precipitation may affect the measurement results.
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1-7
1
1 Safe Usage and Handling Precautions
1.15 Sampler Cover
WARNING:
During sample processing, ensure the sampler cover is closed and locked with the sampler cover
lock key to prevent injuries and biohazards. If your finger 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
1.16 Diluents and Reference Fluid
CAUTION:
To ensure safe handling of diluent and reference fluid, refer to the handling methods in the “Instructions for Use” of each fluid 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.
IMPORTANT:
For diluents used in measurements that require dilution, refer to the “Instructions for Use” of the
slides.
IMPORTANT:
Use the reference fluid included with the ISE slides for ISE measurements. Refer to the “Instructions
for Use” of the slides.
IMPORTANT:
Use only specified products. Otherwise, errors or malfunctions may occur.
1.17 FUJIFILM PF Plasma Filters
NOTE FUJIFILM plasma filter PF is shortened to "PF" in this document.
IMPORTANT:
Before using a FUJIFILM PF, refer to “Instructions for Use” provided with the PF, paying special attention 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 specified 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
1-8
897N203029A FDC NX600 Instruction Manual 2022.01
1 Safe Usage and Handling Precautions
WARNING:
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.
WARNING:
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 disinfection. Furthermore, when entrusting disposal to another party, request processing from a contractor with a license for special management of industrial waste processing work.
IMPORTANT:
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.
IMPORTANT:
Use only specified products. Otherwise, errors or malfunctions may occur.
IMPORTANT:
When the power is shut off 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 consumables and use used mixing cups (holes).
1.19 Light Source Lamp
CAUTION:
The light source lamp gets very hot. Before replacing the lamp, turn the power off, 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 specified recording paper for the FDC NX600.
(2) If other recording paper is used, the printer head section may be damaged.
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1
1 Safe Usage and Handling Precautions
1.21 Labels
The following safety labels are affixed to the FDC NX600.
1
Power button
Sampler cover lock
key caution label
Biohazard label
 Refer to Section 1.15
Biohazard
label
High temperature caution label
Lamp caution
label
PF tube caution
label
Biohazard label
 Refer to Section 6.5  Refer to Section 6.5
Moving parts
caution label
 Refer to Section 6.9.4
Name-plate
NOTE: The example
above uses an
illustration for the
FDC NX600. For
the FDC NX600i,
the description of
the plate partially
differs.
1-10
Power switch
| : Depress to power ON
O : Depress to power OFF
USB
connector
RS-232C
connector
LAN
terminal
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1 Safe Usage and Handling Precautions
1.22 Symbols
Sign
Description
1
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
SN
Serial number
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1-11
1 Safe Usage and Handling Precautions
Sign
Description
Date of manufacture
1
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 identifier
Near-patient testing
1-12
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2
Part Names and Consumables
2.1
Part Names
NOTE The following is an illustration of the FDC NX600 (full option model). FDC NX600i has slight
difference.
Printer
2
Sampler cover
LCD (touch panel)
Power button
Sampler cover lock
Front bottom cover
Card reader
Disposal box
Sampler
Incubator cable
Plasma filter unit (PF unit)
Incubator cover
Consumable disk
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2-1
2 Part Names and Consumables
Air filter
(Louver)
USB connector
2
(For sample barcode reader only)
*‌Do not connect other USB
devices.
LAN terminal
CAUTION:
Do not remove the cover to
look into the QR code reader’s illuminator. It could impair
your eyes.
RS-232C connector
USB connector
Power inlet
Power switch
Air filter
(Louver)
2-2
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2 Part Names and Consumables
2
Disposal box
Light source lamp
Diluent holder
Slide cartridge
Reference fluid holder
Sample rack
RE
Mixing cup
Tip rack
Sample application
unit cover
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2 Part Names and Consumables
< Details of PF unit >
PF unit
2
PF sensor / suction
pad
PF reference plate
PF sample rack
RE
PF pump
2-4
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2 Part Names and Consumables
2.2
Touch Panel Screen Names and Functions
2.2.1 Measurement Preparation Screen (Top Screen)
If the power is switched on, the Measurement-preparation screen (top screen) is displayed after startup.
1 Help button
1
2
3
4
Display the help screen.
è Refer to Section 2.2.2
2
2 Function menu button
Display the function menu screen.
è Refer to Chapter 9
3 Work list button
5
Obtain order information from the host PC
via a DMS connection.
è Refer to Section 4.6
4 Clear button
6
7
8
9
0
a
CAUTION:
The touch panel does not have multi-touch input
function.
Do not touch plural points on the panel at the
same time.
Clear the entered information.
5Plasma filter (PF) production number (lot) display
Displays the lot number of the plasma filter
(PF) in use. Make sure this number matches
the production number (lot) of the plasma
filter (PF) in use.
6 Mixing cups
Displays the quantity of mixing cups. Tap to
replace the mixing cups.
è Refer to Section 5.3
7 Tips
Tap to replenish tips.
è Refer to Section 5.2
8 [START] button
Start a measurement.
9O perator ID button (displayed according to settings)
If tapped, you can enter the operator ID.
è Refer to Section 9.3.19
0 Feed button
Feed the recording paper a fixed length.
[STOP] button (displayed during
sample application operation)
If the [STOP] button is tapped during sample
application, tips are discarded, operation is
stopped, and the device enters a paused state.
a Measurement results button
Display the measurement results.
è Refer to Section 3.4
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2-5
2 Part Names and Consumables
2.2.2 Help Screen
You can tap the
button on the Measurement
preparation screen to check the procedures
about measurement, maintenance, consumable exchange, and other actions on the FDC
NX600.
2
2-6
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2 Part Names and Consumables
1
1
button
The Measurement-preparation screen appears.
2
button
Return to the previous screen.
2
2
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2 Part Names and Consumables
2.3
Names and Functions of Software Keyboard Screens
When data entry for operations and configurations is necessary, the software keyboard appears on the LCD automatically. Enter alphanumeric characters and symbols.
2
LCD
(LCD touch panel)
1
2
3
1 Alphabetical characters, numbers,
and symbols buttons
Enter alphabetical characters, numbers,
and symbols.
2
button
Delete all entered characters, and then
quit keyboard entry.
3 Move cursor buttons
Move the position of the cursor left or
right by one character.
4 [Clear] button
Delete all entered characters.
7
6
4
5 [OK] button
Confirm the entered characters.
5
6
button
Delete the character to the left of the
cursor.
7 [Space] button
Enter a space of one single character
width.
2-8
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2 Part Names and Consumables
Change the entry screen by using the [ABC], [abc], [123], or [-#/], button.
< When the [ABC] button is selected >
< When the [abc] button is selected >
< When the [123] button is selected >
< When the [-#/] button is selected >
8 9 0 a
8 [ABC] button
0 [123] button
9 [abc] button
a [- # /] button
Display the entry screen for uppercase alphabetical characters and numbers.
Display the entry screen for lowercase alphabetical characters and numbers.
897N203029A FDC NX600 Instruction Manual 2022.01
Display the entry screen for numbers, comma (,), and minus symbol (-).
Display the entry screen for symbols and
numbers.
2-9
2
2 Part Names and Consumables
2.4
2
Bundled Items
Recording paper
2 rolls
Slide cartridge
2
Slide weight
2
Light source lamp
1
O-ring
2
Tip rack
1
Sample rack assembly kit
1 set
Sampler leak check tool
2
PF leak check tool (For FDC NX600)
1
FUJI DRI-CHEM AUTO TIPS
1 case
FUJI PLAIN TUBE 0.5 (0.5 mL type)
1 pack
FUJI DRI-CHEM MIXING CUPS
1 pack
Manual pipette cover
1
European authorized representative label
1
Key (for sampler cover)
2
Instruction manual
1
Installation method
1
NOTE An AC power cable is not supplied as a bundled item.
Please prepare an AC power cable conforming to the specifications below:
<The requirements of the cable specifications for the FDC NX600>
Power voltage:
100V-120V
Requirements for the plug/connector: AC125V 10A
Requirements for the cable:
SVT 3/18AWG 60°C
Power voltage:
200V-240V
Requirements for the plug/connector: AC250V 10A
Requirements for the cable:
GTCE-3 1.0mm2 70°C
NOTE The AC power cable is required to be compliance with any applicable regulations in your country.
NOTE Do not change AC power cable to inappropriate one.
NOTE Specifications and capabilities are subject to change without notice.
2-10
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2 Part Names and Consumables
2.5
Consumables and Optional Items
To purchase the consumables or optional items listed below, please contact the dealer from whom
you purchased the FDC NX600.
2.5.1 Consumables
Name
* FUJI DRI-CHEM AUTO TIPS
FUJI Sample Tubes
FUJI HEPARIN TUBE (1.5 mL)
FUJI HEPARIN TUBE (0.5 mL)
FUJI PLAIN TUBE (1.5 mL)
* FUJI PLAIN TUBE (0.5 mL)
* Recording paper
* Light source lamp
* O-ring
Plasma Filter PF
PF Suction Pad
PF Tube
* FUJI DRI-CHEM MIXING CUPS
Reference fluid cap packing
Package/unit
6 cases
2
500×1 box
500×1 box
500×1 box
500×1 box
6 rolls×1 box
1
4
50×1 bag
1
1
50×1 box
5×1 bag
NOTE Parts names marked with “*” are the same parts packed with the FDC NX600.
Chemicals
FUJI DRI-CHEM CONTROL QP-L
FUJI DRI-CHEM CONTROL QP-H
FUJI DRI-CHEM CONTROL QN
FUJI DRI-CHEM REFERENCE FLUID RE
FUJI DRI-CHEM DILUENT DL (CRP)
FUJI DRI-CHEM CALIBRATOR CP (CRP)
NOTE Types of packages or containers for consumables are subject to change without notice.
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2-11
2 Part Names and Consumables
2.5.2 Optional Items
Name
* Sample rack assembly kit
* Slide cartridge
* Slide weight
Sample barcode reader
2
Package/unit
1 set
1
1
1
CAUTION:
The sample barcode reader specified for the FDC NX600 can be used.
Do not connect a barcode reader other than specified for the FDC NX600. Otherwise, physical
damage or danger of fire may result.
NOTE Parts names marked with “*” are the same parts packed with the FDC NX600.
NOTE Specifications and capabilities are subject to change without notice.
2-12
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3
Measurement
3.1
Operation Overview
On the FDC NX600, first load the consumables and other items to prepare for measurement (Step 1),
and then perform the actual measurement (Step 2).
Step 1 - Measurement preparation
Cleaning the disposal box
3
Refer to Section 3.2(1)
Checking the recording paper Refer to Section 3.2(2)
Starting the FDC NX600
Refer to Section 3.2(3)
Checking the date and time
Refer to Section 3.2(4)
Loading consumables
For dilution measurements
For CRP measurement
Diluent
Diluent for CRP
(Refer to
Section 5.4)
For ISE
measurements
Reference fluid
(Refer to
Section 5.5)
12 Tips
(Refer to Section 5.2)
3-1
Refer to Chapter 5
For dilution
measurements
Mixing cups
(Refer to
Section 5.3)
RE
897N203029A FDC NX600 Instruction Manual 2022.01
3 Measurement
Step 2 - Measurement
Basic
measurements
1
Refer to
Section 3.3
2
Slide
ISE test measurements  Refer to Section 3.5
Dilution measurements  Refer to Section 3.6
CRP measurements  Refer to Section 3.7
Sample
3
RE
Check
the tips
Check the sample type
Plasma/Serum
3
START button
Slide set order Refer to Section 4.5
To test CRP and
CM (Colorimetric) slide
To test CM
and ISE slide
To test CRP, CM,
and ISE slide
CRP
ISE Slide
CRP
CM Slide
CM Slide
CM Slide
ISE Slide
To test CM slides
that require dilution
x5 Dil
x2 Dil
Checking the measurement results
Refer to Section 3.3 (6)
Ending measurement
Refer to Section 3.3 (7)
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3-2
3 Measurement
3.2
Measurement Preparation
(1) Cleaning the disposal box
Empty the disposal box.
IMPORTANT:
If the disposal box is full, a slide transfer error or tip
disposal error may occur, which may negatively affect the measurement values.
3
IMPORTANT:
After emptying the disposal box, be sure to load the
disposal box. If the analyzer is used without the box,
the measurement results may be negatively affected.
WARNING:
Do not touch used slides and tips 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.
WARNING:
Used slides and tips are infectious industrial
waste. Process this waste in compliance with any
applicable regulations in your country, such as by
incineration, melting, sterilization, or disinfection.
3-3
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3 Measurement
(2) Checking the recording paper
Press the area shown in the illustration to release
the lock (1), and then lift up the cover (2).
Cover
1
2
Press the
concave
section.
3
Check the remaining recording paper (FUJI thermal
paper). If the recording paper is short for the measurement, replace the old roll with a new one.
è Refer to Section 6.4
Recording
paper
NOTE Before closing the cover, pull out the edge
of the recording paper.
NOTE Close the cover securely until it clicks.
Otherwise, the paper feed may fail and the
test results will not be printed out.
Recording
paper
Cutter
opening
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3-4
3 Measurement
(3) Starting the FDC NX600
Press the power button to start the FDC NX600.
NOTE If the equipment is connected to DMS,
switch on the equipment before starting
DMS. Failure to observe this precaution
could interfere with data transfer.
IMPORTANT:
3
If the power has been shut off during measurement
due to a power outage or other issue, replenish
the tips (refer to Section 5.2) and replace the mixing cups (refer to Section 5.3). The analyzer may
lose the information of the usage positions of the
consumables and use wells (holes) of used mixing
cups.
Power button
NOTE When the power switch is not in the ON position, push the switch to the " | " side.
Power switch
0013
3-5
NOTE The listing to the left is displayed during
start-up once a month. Perform the periodic
maintenance listed in Chapter 6.
897N203029A FDC NX600 Instruction Manual 2022.01
3 Measurement
(4) Checking the date and time
Check that the date and time displayed on the LCD
are correct.
If they are incorrect, set the date and time using
[Date & Time settings] in Normal mode.
è (Refer to Section 9.2.1)
IMPORTANT:
If the date and time are not adjusted correctly, the
analyzer may fail to determine the expiration of the
slides and calibration, and measurement results
might be incorrect.
(5) Loading consumables
Load the consumables (tips, mixing cups, diluent, and reference fluid) in accordance with the
type of measurement.
è Refer to Chapter 5
(6) Reading a QC card
QR code
The FDC NX600 can compensate for the differences of the slide production lots by reading the QC
card in the box of slides.
When [Warming up] or [Ready to test] appears on
the LCD, set the QR code on the left side, and then
insert the QC card into the reader fully.
è (Refer to Section 3.10)
NOTE If the QC card is dirty or folded, the read error may occur.
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3-6
3
3 Measurement
3.3
Basic Measurements
NOTE By default, this analyzer switches off the light source lamp to save lamp life when the analyzer has not been used for the time configured under [Lamp management] in Normal mode.
When the lamp is off, refer to Section 3.3.1 before operating the equipment.
WARNING:
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 accidentally touch a sample, immediately rinse the contaminated area thoroughly under running water,
and then disinfect the area. Seek medical assistance if necessary.
3
(1) Checking the LCD
When [Ready to test] appears on the LCD, make
sure that the analyzer is not applying samples.
NOTE You can stop sample application by pressing the [STOP] button.
NOTE During sample application, a new sample
for the next measurement cannot be loaded
on the analyzer.
(2) Setting tips
RE
Open the sampler cover, and then check the tip
rack has been loaded with tips. When there are not
enough tips, tap the tip display on the LCD to display the replacement screen, and then load the tips.
For details of the loading method, refer to Section
5.2.
IMPORTANT:
If the power has been shut off during measurement due to a power outage or other issue, replenish the tips and replace the mixing cups (refer to
Section 5.3). The analyzer may lose the information of the usage positions of the consumables
and use wells (holes) of used mixing cups.
Tips
3-7
897N203029A FDC NX600 Instruction Manual 2022.01
3 Measurement
(3) Loading samples and slides
WARNING:
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 accidentally touch a sample, immediately rinse the contaminated area thoroughly under running water,
and then disinfect the area. Seek medical assistance if necessary.
1. Open the packaging of the slide to be
used.
IMPORTANT:
Take out the required number of slides from the refrigerator, and allow them to reach room temperature 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 affected.
IMPORTANT:
After the package has been unwrapped, finish
measurement within 30 minutes.
2. Place slides to be measured in the slide
cartridge with the test name facing up.
Be sure to put the slide weight on top of
the stacked slides.
Slide weight
NOTE The item to be measured is determined
from the slide information on the back of
the slide.
Slide
NOTE ISE slides can also be loaded at the
same time as the slide cartridge. Including ISE slides, a maximum of 20 slides
can be loaded.
Slide cartridge
3. Load the slide cartridge while aligning
its orientation.
RE
897N203029A FDC NX600 Instruction Manual 2022.01
3-8
3
3 Measurement
4. Load the dedicated sample rack for the
blood collection tube or FUJI sample
tube to be used.
NOTE To avoid a suction error or malfunction,
use a sample tube that matches the label on the sample rack.
NOTE Refer to Section 3.9 for sample tubes
that can be used.
3
5. Remove the cap of the blood collection
tube or FUJI Sample Tube that contains
sample, and then load it on the dedicated sample rack.
NOTE Make sure there are no bubbles in the
sample in the blood collection tube or
FUJI Sample Tube. Use a centrifuge to
remove bubbles. If bubbles are present,
the sample may be detected incorrectly.
Blood collection tube
or FUJI Sample Tube
3-9
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3 Measurement
(4) Registering sample information
1
2
3
4
5
6
7
Enter or select the sample information (sample number, sample ID, reference standard, and sample type).
1 Enter the sample number using the software keyboard (Section 2.3).
2 Obtain order information from the host PC via a
DMS connection. è Refer to Section 4.6
3 Clear the entered information.
4 Enter the sample ID using the software keyboard
(Section 2.3).
5 Select a reference standard from the list.
6 Select a sample type from the list.
7 Select a dilution factor from the list.
è Refer to Section 3.6 and Section 9.3.14
NOTE When the analyzer is connected to DMS, sample information can be acquired automatically from the work list.
è Refer to Section 4.6
IMPORTANT:
The sample type of the sample, slide, and the sample type setting of the FDC NX600 must be same.
Otherwise, an incorrect measurement result will be obtained.
IMPORTANT:
Be sure to enter the correct sample number and sample ID.
IMPORTANT:
When measuring a low concentration protein fluid (such as urine), some bubbles may appear during measurement in the tip. If bubbles have formed during measurement, perform the measurement again from the beginning.
897N203029A FDC NX600 Instruction Manual 2022.01
3-10
3
3 Measurement
(5) Starting measurement
Close the sample cover, and then lock it with the
sampler cover lock key.
WARNING:
Ensure the sampler cover is locked during sample
processing to prevent injuries and infection.
When the display reads [Ready to test], the sampler cover can be opened.
3
Tap the [START] button to start measurement.
IMPORTANT:
Close the disposal box. If it is open, the measurement results will be affected.
3-11
897N203029A FDC NX600 Instruction Manual 2022.01
3 Measurement
3
When the spotting operation is completed, the
screen on the left is displayed and the time until the
measurement is completed is displayed.
Time until the end
of measurement
Measurement
start time
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3-12
3 Measurement
(6) Checking the measurement results
After measurement, tap the
button to check the
test results. The test results are printed out in the
order that the slides were loaded in the cartridge.
To retest (Section 4.4), tap the
3
(retest) button.
NOTE For the details of the measurement results
screen, refer to Section 3.4.
(7) Ending measurement
To complete the measurement, unlock the sampler cover and open it, and then remove the
measured sample.
NOTE When a measurement is not being performed, empty the disposal box as appropriate.
The disposal box can hold 100 slides and 50 AUTO TIPS. Always empty the disposal
box before these numbers are exceeded.
3-13
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3.3.1 Lamp Off and Measurement-start Scheduling
By default, when this analyzer has not been used for some time (a time from 20 through 240 minutes can be set) while [Ready to test] is displayed on the LCD, it switches off the light source lamp
to save lamp life. After the lamp is switched on again, the start of measurement can be scheduled
even when [Lamp warming up] is displayed on the LCD.
NOTE Do not use measurement-start scheduling for measurements using PF. (Refer to Section 4.3)
After inversion, whole blood samples start to get separated. PF filtering may not occur normally, and an error may occur.
NOTE The start of measurement cannot be scheduled in manual sample application mode.
The touch panel screen becomes darker when the
lamp is off. If the screen is tapped, the lamp switches on, and [Lamp warming up] is displayed on the
LCD. In the case of the Measurement-preparation
screen, the start of measurement is scheduled if the
[START (Reserve)] button is tapped.
If measurement is possible, it starts automatically.
NOTE To cancel a scheduled measurement-start,
tap the [STOP] button.
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3
3 Measurement
3.4
Measurement Results Screen
After measurement has ended, tap
then check the measurement results.
button, and
NOTE Results of the last 270 samples are backed
up in data.
Result data display area
3
3
< Display of measurement results >
1
Green: Within reference interval
Red: Outside reference interval
Or, when the measurement result
is not displayed due to an error
Lower limit of reference interval
Upper limit of reference interval
1
2
Green: ‌All measurement results are
within reference interval.
Red: ‌The results include values
outside the reference interval.
Or, when an error has occurred.
2
3
Measurement results that include values outside the reference interval are indicated by
, and the corresponding test name and value
become red. If tapped, the details screen appears.
will be indicated when an error has ocAnd,
curred.
will be indi* Also, in case of the following,
cated.
• When a colorimetric/ISE test result is outside
of the measurement range (determination
range) or the qualitative range
• When a result of calculated parameter is displayed by [****]
NOTE If measurement items that display H, L, #,
or other characters are tapped, the details
screen appears.
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< Buttons of the measurement results screen >
1
2
1
button
Close the measurement results screen, and
then return to the Measurement-preparation
screen.
2 Change sample No. button
Change the sample number for which measurement results are to be displayed.
3
4
5
6
3 Feed button
Feed the recording paper with a fixed
amount.
4 Print button
Print all measurement results of the displayed sample.
5 Send button
7
Send the measurement results of the displayed sample to a PC (via DMS).
6 Retest button
8
9
a
0
9
NOTE When the past test results are displayed, the results are displayed just as
they were obtained using the settings
when they were measured, such as Unit
conversion, Correlation coefficients,
Reference interval range, Test item
name. The test results sent by the [Send]
button have also the same format.
Perform the measurement again under the
same conditions for sample number, sample
ID, reference standard, and sample type.
Only the dilution factor can be changed.
è Refer to Section 4.4
7 Result data scroll button
Change the display of the measurement result data of the slide.
8 Sample No. tab
Tap to display the measurement results of
the selected sample number.
9 Sample No. tab scroll button
Change the display of the Sample No. tab.
This button is available when five or more
samples have been measured.
0 Date scroll button
Change the measurement date.
a Display calendar button
Display the calendar. If a date within the calendar is tapped, the measurement results of
that day are displayed.
è Refer to the next page.
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3
3 Measurement
< Calendar display >
1
1 Measurement month scroll buttons
Change the display of the calendar month.
2 Date buttons
2
Display the measurement results screen of
a date. The currently displayed date is displayed in blue.
NOTE Dates with no measurements are
displayed in gray and cannot be selected.
3
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3.5
ISE Tests
IMPORTANT:
Analyzer cannot detect expiries of ISE slides if the installed software is version 1.0. Be sure manually that slides are still valid.
Otherwise, with the software version 1.1 or later is installed, analyzer can automatically detect expiries of the ISE slides that will expire 2023 or later or whose lot numbers are 130000 to 139999.
NOTE When urine (U) is selected as the sample type for measurement, the dilution setting is set to
2x automatically. Therefore, diluent is needed in addition to reference fluid. The data is calculated automatically, so the results can be reported without adjustment.
NOTE Refer to the “Instructions for Use” of the slide for usable diluent for urine measurements.
NOTE Two tips are necessary for each slide; one for sample, the other for reference fluid.
1. Load the reference fluid.
For the reference fluid container (FUJI plain
tube 0.5 mL or 1.5 mL), use the container configured for [Tube setting for diluent & reference
fluid] in Mode function for administrator (Section
9.3.15).
For details of the loading method, refer to Section 5.5.
2. Check quantity of tips.
Reference fluid
• Loading tips è Refer to Section 5.2
3. Load diluent for urine sample measurement.
Also, check the quantity of mixing cups. If the
number is insufficient, replace with new ones.
• Loading mixing cups è Refer to Section 5.3
• Loading diluent è Refer to Section 5.4
NOTE When performing an ISE measurement
that requires dilution, use at least 3 tips
and 1 well.
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3
3 Measurement
4. Check the sample type setting.
Register sample information as necessary.
è Refer to Section 3.3 (4)
Sample
type setting
Remaining
number of
mixing cups
3
Arrows pointing
right
矢印右向き
5. Load a sample and slides.
Place the ISE slide in the slide cartridge with
the spotting hole above and the arrows pointing right. For details of the loading method, see
Section 3.3 (3).
NOTE The direction of the arrow on the slide is
opposite to the slide transport direction.
NOTE When you measure an ISE slide and
CM slide at the same time, we recommend loading the ISE slide last in the
cartridge.
è Refer to Section 4.5
6. Close the sample cover, and then lock it
with the sampler cover lock key.
WARNING:
Ensure the sampler cover is locked during sample
processing to prevent injuries and infection.
When the display reads [Ready to test], the sampler cover can be opened.
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7. Tap the [START] button to start measurement.
3
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3 Measurement
3.6
Dilution Tests
There are 2 types of dilution measurement.
• Dilute and measure automatically by using [Dilution setting] in Mode function for administrator to
preset dilution factors for each test and sample type.
è Refer to Section 9.3.14
• Dilute and measure all items to be measured by setting a dilution factor for each sample at the
sample information registration screen.
The second method at the sample information registration screen is explained in this section.
IMPORTANT:
3
Bubbles may appear in the tip when diluting a plasma/serum sample more than 20 times or diluting a urine sample. If bubbles have formed during dilution, perform the measurement again from
the beginning.
NOTE The results of measurements that included dilution are calculated automatically, so the results can be reported without adjustment.
NOTE The maximum number of dilution measurements from one mixing cup well (hole) is three.
When the diluted sample in the well is insufficient, the analyzer automatically dilutes using
the next well.
NOTE Do not dilute whole blood samples.
NOTE The default dilution factors designated by the manufacturer are as follows: ISE urine tests:
2x; CRP tests: 21x.
Excluding ISE tests, the following section explains the relationships among the dilution factor configured for each sample at the sample information registration screen, the dilution
factor for each test configured by [Dilution setting] in Mode function for administrator, and
the dilution factor designated by the manufacturer. For ISE tests, the analyzer ignores the
dilution factors configured for each sample or each test and using default dilution factor of
the manufacturer.
• Dilution factor when configured for each sample at the sample information registration screen
Dilution factor configured
for each sample
×
Default
dilution factor
• Dilution factor when not configured for each sample at the sample information registration screen
(Configured by [Dilution setting] in Mode function for administrator)
Dilution factor for each
test
×
Default
dilution factor
(Example) With a CRP measurement with the dilution factor for each sample or test
configured to 3x, the analyzer will automatically dilute 63x.
NOTE Only one type of diluent can be used to measure a sample.
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3 Measurement
(Example) When diluting Sample 2x
Diluent
1. Check the quantity of the consumables
(tips and mixing cups).
If consumables are insufficient, supplement or
replace them.
• Loading tips è Refer to Section 5.2
• Loading mixing cups è Refer to Section 5.3
2. Load the diluent.
• Loading diluent è Refer to Section 5.4
RE
3
3. Load a sample and slides.
For details of the sample and slide loading
method, refer to Section 3.3 (3).
4. Tap the [Dilution] button.
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3 Measurement
5. In the list, tap [x2].
-
: ‌Dilution is performed according to [Dilution
setting] in Mode function for administrator.
None: No dilution
NOTE If necessary, enter or choose other
sample information.
3
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6. Close the sample cover, and then lock it
with the sampler cover lock key.
WARNING:
Ensure the sampler cover is locked during sample
processing to prevent injuries and infection.
When the display reads [Ready to test], the sampler cover can be opened.
3
7. Tap the [START] button to start measurement.
8. The dilution factor is added on the test
result.
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3 Measurement
3.7
CRP Tests
NOTE Each time a new box of CRP slides is used, the new QC card must be read.
è Refer to Section 3.10
NOTE Calibration is necessary for CRP measurements under the following conditions.
• When the slide lot has changed
• When the validity term of calibration has expired (For the validity term, refer to the “Instructions for Use” of the slides)
3
NOTE If the validity term has expired, a “#” warning mark is printed along with the measurement
results.
NOTE Specified diluent and mixing cups are necessary for CRP measurements.
NOTE When the results of a measurement will exceed the measurement range, dilution can be
performed automatically at 21x or more by configuring the dilution factor at the sample information registration screen. (When 2x has been set at the sample information registration
screen, the dilution factor is 42x.)
Diluent for
CRP
1. Check the quantity of the consumables
(tips and mixing cups).
If consumables are insufficient, supplement or
replace them.
• Loading tips è Refer to Section 5.2
• Loading mixing cups è Refer to Section 5.3
NOTE When performing measurements that
require dilution, at least 2 tips are used.
NOTE When performing CRP tests that require
dilution at 2x or more, 2 wells (holes) of
mixing cups are used.
2. Load the diluent for CRP.
• Loading diluent è Refer to Section 5.4
3. Load a sample and slides.
CRP
CM slide
一般比色
図-4.9
3-25
For details of the sample and slide loading
method, refer to Section 3.3 (3).
NOTE When measuring a CRP slide and CM
slide at the same time, stack the CRP
slide last or first in the cartridge. If a CM
slide is measured before or after a CRP
slide, extra tips are used.
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3 Measurement
4. Set the sample type to [Plasma/Serum].
NOTE To further set the dilution factor to 3x for
CRP measurements, tap the [Dilution]
button, and then specify 3x.
è Refer to Section 3.6
NOTE If necessary, enter or choose other
sample information.
3
5. Close the sample cover, and then lock it
with the sampler cover lock key.
WARNING:
Ensure the sampler cover is locked during sample
processing to prevent injuries and infection.
When the display reads [Ready to test], the sampler cover can be opened.
6. Tap the [START] button to start measurement.
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3 Measurement
3.8
Shutting-down the FDC NX600
Sample
1. Remove the samples.
2. Remove the tubes of diluent and reference fluid from the analyzer.
Diluent
Reference
fluid
3
RE
Sampler cover
3. Close the sampler cover.
4. Make sure that measurement and mode
operation are not in progress.
CAUTION:
Do not switch off the power during measurement or
mode operation. Otherwise, the analyzer may malfunction. If the power was shut off during measurement, load tips and other consumables, and then
run the measurement again from the start. Always
replace mixing cups for dilution measurements.
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3 Measurement
5. Press the power button.
3
Power button
6. Tap [OK].
CAUTION:
Shutdown will be automatically performed after the
process completed. Make sure NOT to turn the
power switch off.
CAUTION:
Were you not able to operate on the screen, press
the power button at front to turn off the power.
NOTE When the analyzer will not be used for a
long time, set the power switch to the [○]
side.
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3 Measurement
7. Empty the disposal box.
WARNING:
Do not touch used slides and tips 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.
WARNING:
3
Used slides and tips are infectious industrial
waste. Process this waste in compliance with
any applicable regulations in your country,
such as by incineration, melting, sterilization,
or disinfection.
NOTE When disinfecting the disposal box, use
ethyl alcohol for disinfection or a 0.5%
sodium hypochlorite solution. When a
sodium hypochlorite solution was used,
wash the disposal box well and dry it
before use.
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3.9
Sample Tubes for the FDC NX600
The following sample tubes can be used on the FDC NX600.
•
•
•
•
•
• Ø16×100 mm blood collection tube (when
using PF)
• Ø13×100 mm blood collection tube (when
using PF)
• Ø13×75 mm blood collection tube (when using PF)
Ø16×100 mm blood collection tube
Ø13×100 mm blood collection tube
Ø13×75 mm blood collection tube
FUJI Sample Tube 1.5 mL
FUJI Sample Tube 0.5 mL
3.9.1 Blood Collection Tubes
(1) Size and effective liquid surface range of blood collection tubes that can be
used
Outer diameter of Ø16 indicates Ø15.0 to 16.6 mm and Ø13 indicates Ø12.0 to 13.3 mm. The
following illustrations show the design suction ranges. If the sample volume is low, use a FUJI
Sample Tube (1.5 mL or 0.5 mL).
Ø16
or Ø13×100 mm blood
collection tube
〈φ16またはφ13
x100mm採血管〉
10 mm
10mm
Not
measurable
測定不能範囲
Ø13×75
mm blood
collection tube
〈φ13
x75mm採血管〉
10
mm
10mm
Not measurable
測定不能範囲
Measurable
測定可能範囲
Measurable
測定可能範囲
75
mm
75mm
100
mm
100mm
30 mm
30mm
Not測定不能範囲
measurable
Not measurable
測定不能範囲
52
mm
52mm
Sample volume confirmation holes (left and right)
Load the blood collection tube with filled sample
in the rack, so that you can see the actual sample
through the holes.
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3
3 Measurement
(2) Tube contents and inspection items that can be measured
IMPORTANT:
Refer to the “Instructions for Use” of the slides for usable blood collection tubes and observe the
listed items.
IMPORTANT:
For contents, inspection items, cap colors, and other details, contact the manufacturer of the blood
collection tube to be used.
3
The tube contents of a blood collection tube determine which inspection items can be measured. The following section provides information about general blood collection tube contents
and the inspection items that can be measured.
Heparin blood collection tubes
• Inspection items: Applicable to all items. For GLU and NH3, measure the samples as soon
as possible after blood collection.
• General color of cap: Green (in Japanese market)
Plain (coagulant included) blood collection tubes
• Inspection items: All other than GLU and NH3
• General color of cap: Red (in Japanese market)
NaF blood collection tubes
• Inspection item: GLU (blood sugar) only
• General color of cap: Gray (in Japanese market)
EDTA blood collection tubes
• Inspection items: NH3 only. After blood collection, keep samples in ice and measure the
samples as soon as possible.
• General color of cap: Pale purple (in Japanese market)
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3.9.2 FUJI Sample Tubes
Use these tubes in the place of blood collection tubes when the sample volume is low.
WARNING:
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 accidentally touch a sample, immediately rinse the contaminated area thoroughly under running water,
and then disinfect the area. Seek medical assistance if necessary.
1.5
1.0
0.5
Upper
検体上限
limit
of
sample
Lower
limit
分離用
of 検体下限
sample for
separation
Make sure that the sample volume is sufficient by
referring to the illustration to the left. The top surface of the sample fluid must be within the shaded
section of the tubes in the illustration.
0.5
NOTE If the sample in the tube is below the suction limit mark, the analyzer will indicate an
insufficient sample volume error.
0.3
0.1
Suction
limit
吸引限界
0025
NOTE To aspire only the supernatant fluid (plasma)
of the centrifuged sample (and avoid aspiration of red blood cells), at least 1.0 mL (for
a 1.5 mL tube) or 0.3 mL (for a 0.5 mL tube)
of a whole blood sample for separation is
necessary.
NOTE Only 5 tests or fewer can be performed using a 0.3 mL whole blood sample with a
FUJI Sample Tube (0.5 mL).
Effective liquid surface range of a FUJI Sample Tube
Upper 検体上限
limit of sample
1.5
検体上限
0.5
1.0
0.3
0.1
0.5
吸引限界
注：検体は、50μl 以上必要です。
Suction
limit
吸引限界
富士チューブ
NOTE: At least 50 µl of sample is needed.
サンプルカップ2ml
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3
3 Measurement
3.9.3 Assembling the Sample Rack
Assemble the sample rack according to the type of blood collection tube and tube to be used.
IMPORTANT:
Incorrect assembly may cause bad suction, which may adversely affect the test results or cause a
failure.
<Assembly preparation>
The following parts are included in the bundled items.
3
NOTE The number in parentheses is the number of parts included in the bundled items.
NOTE The spacer (9) is are not used for the FDC NX600i.
2Tube holder (1)
for φ 16mm tube
1Sample rack body (4)
4Tube holder (1)
for FUJI tube 1.5mL
3Tube holder (1)
for φ 13mm tube
5Tube holder (1)
for FUJI tube 0.5mL
6Calibrator CP
holder (1)
0Pin (9)
Ｈ
Ｈ
aLabel (1)
7Spacer (1)
for 75mm tube
H = 54.5mm (long)
8Spacer (1)
for 100mm tube
H = 32mm (medium)
Ｈ
9Spacer (1)
for PF 75mm tube
H = 25mm (short)
Note: There are upper- and lower-sides of spacers. Do not turn them upside down.
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<Sample rack variations>
(a) Sample rack for φ16mm × 100mm
Affix the label
After setting the 8
spacer, insert the 2
tube holder
Set the 8 spacer (H=32mm)
(hole is down)
Insert the 0 pin
as shown
3
(b) Sample rack for φ13mm × 100mm
Affix the label
After setting the 8
spacer, insert the 3
tube holder
Set the 8 spacer (H=32mm)
(hole is down)
0 Pin
(c) Sample rack for φ13mm × 75mm
Affix the label
After setting the 7
spacer, insert the 3
tube holder
Set the 7 spacer (H=54.5mm)
(hole is down)
0 Pin
(d) Sample rack for FUJI sample tube 1.5mL
Affix the label
Insert the 4 tube
holder
0 Pin
0 Pin
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3 Measurement
(e) Sample rack for FUJI sample tube 0.5mL
Affix the label
Insert the 5 tube
holder
0 Pin
3
(f) Sample rack for φ16mm × 100mm when
using plasma filter PF
Affix the label
0 Pin
0 Pin
(g) Sample rack for φ13mm × 100mm when
using plasma filter PF
Affix the label
0 Pin
0 Pin
(h) Sample rack for φ13mm × 75mm when using plasma filter PF
Affix the label
Set the 9 spacer (H=25mm)
(hole is down)
0 Pin
0 Pin
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3 Measurement
(i)
Sample rack for calibrator CP
Affix the label
Insert the 6 calibrator CP
holder
0 Pin
0 Pin
3
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3 Measurement
3.10 QC Card System
(1) Overview
The QC card system compensates for variations between lots of FUJI DRI-CHEM slides and
ensures uniform performance.
Y
Y
標Reference
準液基準値 liquid standard value Y
3
Y
Calculation method
A variety of the reference fluids developed for FUJI
DRI-CHEM slides are measured on each lot of
slides.
The relationship between the actual measurement
values X (x1, x2, x3) and the standard values Y (y1, y2,
y3) is expressed by the formula Y=c+dX+eX2. The
lot compensation coefficients (c, d, and e) derived
from the formula are used to compensate for variations in X of each lot.
yy33
yy22
yy11
0030
x11
x22
x33
XX
スライド (補正前)
の実測値
Actual measurement
values
of slideX(before
compensation) X
(2) Inputting lot compensation coefficients using a QC card
The lot compensation coefficients are recorded on QC cards, and one QC card is packed with
each box of slides. When data is input from a new card, the previously stored lot compensation
coefficients are updated. Always read the new QC card when you switch to a new box of slides,
because each QC card also contains slide data essential for measurement, in addition to the lot
compensation coefficients.
NOTE The “e” values recorded on the QC cards are expressed as e×103.
NOTE The analyzer records the QC card information of up to 5 lots for each test. Reading QC
cards of more than 5 lots results in deletion of QC information starting from the oldest.
(3) Using QC cards
A QC card must be read when a new test slide will be used or when changing to a new lot of
slides.
Read the QC card while [Ready to test] or [Warming up] is displayed on the LCD.
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3 Measurement
Set the QR code on the left side, and then insert
the QC card into the card reader fully.
NOTE If the QC card is dirty or folded, the read
error may occur.
QR code
3
The slide test and production number (lot) are
displayed on the LCD and output to the printer
as well.
NOTE Do not insert another QC card while the
slide test and lot number are displayed.
NOTE When the analyzer beeps and the test
is not displayed, insert the QC card into
the card reader again.
(4) Using DI cards
When you receive DI cards from FUJIFILM due to a change of the slide’s manufacturing process, read the DI cards according to the instructions. The reading method is the same as for QC
cards.
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4
4.1
Applicable Usage Methods
CRP Calibration
4.1.1 Calibration Measurement
Calibrate when you start a new production number (lot) of CRP slides or when calibration has expired.
WARNING:
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.
IMPORTANT:
4
Perform the calibration measurement using Unit (A) (mg/dL).
IMPORTANT:
When the calibrator cap is opened, there may be a liquid film on the bottle opening. In this case,
always remove the film before the calibration process.
IMPORTANT:
The cap of the calibrator should not be open more than 5 minutes during a single calibration.
IMPORTANT:
Use a calibrator 10 times or less, even during its validity term.
IMPORTANT:
If the date and time are not adjusted correctly, the analyzer may fail to determine the expiration of
the slides and calibration, and measurement results might be incorrect.
NOTE When performing calibration measurements, the analyzer automatically dilutes the calibrator.
NOTE Let CRP diluent and calibrator stand until they reach room temperature before use.
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4-1
4 Applicable Usage Methods
1. Read the QC card via the analyzer.
Read the QC card of the slide to be calibrated.
è Refer to Section 3.10
2. Tap the
button.
3. Tap the [Calibration] button.
4
4. Check the displayed calibrator concentration settings (CP1, CP2, and CP3).
IMPORTANT:
When the calibrator concentration values are incorrect, calibration is not performed normally.
NOTE Refer to the “Instructions for Use” of the
calibrator.
NOTE You can change the calibrator concentration settings by tapping the [Settings]
button. In such a case, the administrator password must be entered at the
Administrator password entry screen.
For the calibrator concentration settings,
refer to Section 4.1.2.
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4 Applicable Usage Methods
5. Tap the [START Calibration] button.
The guide for setting consumables such as calibrators is displayed.
4
6. Check the quantity of the consumables
(tips and mixing cups).
If consumables are insufficient, tap the [Set consumables] button to replenish or replace them.
• Setting of tips è Refer to Section 5.2
• Setting of mixing cups è Refer to Section 5.3
7. Load the diluent for CRP.
• Loading diluent è See Section 5.4
IMPORTANT:
Always use diluent for CRP.
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4 Applicable Usage Methods
8. Prepare for measurement of calibrator
CP1.
NOTE A set of calibration requires 6 CRP
slides in total.
(a) Set the sample rack for the calibrator CP.
NOTE Set the sample rack securely so that it
does not rise up.
(b) Insert 2 CRP slides into the slide cartridge
and set them on the analyzer.
CP sample rack
4
CP
NOTE Set the slide cartridge securely so that it
does not rise up.
Otherwise, the slide reading error may
occur.
(c) Open the lid of the CP and place it in the
sample rack.
IMPORTANT:
The CP should be open no more than 5 minutes
during a single calibration.
(d) Close the sampler cover, and then lock it
with the sampler cover lock.
Diluent for CRP
IMPORTANT:
Always lock the sampler cover with a key during
sample processing to prevent injuries and infection.
When the display reads [Ready to test], the sampler cover can be opened.
4-4
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4 Applicable Usage Methods
9. Tap the [START] button. The CP1 calibration spotting screen is displayed.
4
10. After CP1 sampling, open the sampler
cover, take CP1 out from the sample
rack, and then firmly close the lid.
The CP2 calibration measurement start screen
is displayed.
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4 Applicable Usage Methods
11. Perform measurement of calibrator CP2.
Perform (b) to (d) of Step 8, and then tap
the [START] button.
The CP2 calibration spotting screen is displayed.
NOTE If a slide with a different lot number has
been loaded, an error screen is displayed.
4
If the [OK] button is tapped, the original
screen returns. Check the slide and
continue the measurement.
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4 Applicable Usage Methods
12. After CP2 sampling, open the sampler
cover, take CP2 out from the sample
rack, and then firmly close the lid.
The CP3 calibration start measurement screen
is displayed.
13. Perform measurement of calibrator CP3.
Perform (b) to (d) of Step 8, and then tap
the [START] button.
The CP3 calibration spotting screen is displayed.
4
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4 Applicable Usage Methods
14. After CP3 sampling, open the sampler
cover, take CP3 out from the sample
rack, and then firmly close the lid.
The calibration measuring screen is displayed.
4
15. When measurement ends, the Calibration measurement result screen is displayed.
NOTE Print the calibration measurement results and store them for the calibration
validity term. To print, tap the
button.
NOTE The calibration parameters are saved to
the analyzer automatically.
16. Tap the [OK] button to end calibration.
4-8
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4 Applicable Usage Methods
(Supplement) List display area
The lot numbers (6 digits) and validity terms of read
QC cards (CRP) are displayed in a list. Items are
displayed in the order the QC card was read. Items
within their validity term have their dates displayed
in black. The following items are displayed in red:
the date when the calibration validity term has expired, [Slide expired] when the validity term of the
slide has expired, and [Unexecuted] when calibration is not been performed.
4
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4 Applicable Usage Methods
4.1.2 Configuring Calibrator Concentration
Correct the calibrator concentration when the concentration included with the calibrator CP to be
used and the concentration in the calibrator concentration display area at the Calibration Lot No.
screen are different.
1. Tap the [Settings] button.
The administrator password entry screen appears.
4
2. Enter the administrator password, and
then tap the [OK] button.
The Calibrator concentration configuration
screen appears.
NOTE The administrator password is necessary when moving from the Function
menu screen to the Administrator function
screen.
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4 Applicable Usage Methods
3. Tap the [Input] field of each CP.
The software keyboard screen appears.
4
4. Enter a value, and then tap the [OK] button.
For the details of the software keyboard screen,
refer to Section 2.3.
IMPORTANT:
Enter the value using Unit (A) (mg/dL).
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4 Applicable Usage Methods
5. If the
button is tapped, the entered
values are registered, and the analyzer
returns to the Calibration Lot No. screen.
NOTE If the [Reset] button is tapped, the enbutton
tered values are reset. If the
is tapped, the entered values are registered and printed.
4
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4 Applicable Usage Methods
4.2
Manual Spotting (Colorimetric Slide)
4.2.1 Measuring by Manual Spotting (Colorimetric Slide)
WARNING:
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 accidentally touch a sample, immediately rinse the contaminated area thoroughly under running water,
and then disinfect the area. Seek medical assistance if necessary.
IMPORTANT:
In the case of a CM slide, use a dedicated pipette that matches the sample application volume
specifications in the "Instructions for Use" of the slide. Carefully read the operation method of the
pipette in Section 4.2.2. (Be aware that the sample application volume of GLU-W is 6 µL, which is
different from other slide items.)
NOTE Manual sample application is not possible with ISE slides.
NOTE When the [Dilution] button was used to configure the dilution factor in manual sample application mode, the measurement value is calculated by a dilution factor.
1. Prepare the pipette, slides, and a sample.
2. Tap the
897N203029A FDC NX600 Instruction Manual 2022.01
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4
4 Applicable Usage Methods
3. Tap the [START Manual pipetting] button.
4
4. Register the measurement information.
NOTE You can also display the measurement
results screen from the screen on the
left and request a retest.
è Refer to Section 4.4
5. Load slides.
For details of the loading method, see Section
3.3 (3).
Manual pipette cover
6. Place the Manual pipette cover on the
slide cartridge.
NOTE If the cover is not set, the analyzer may
fail to read the slide information and
cannot start the measurements.
RE
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4 Applicable Usage Methods
7. Aspirate the sample by using the pipette.
NOTE Refer to the “Instructions for Use” of the
slide for the amount of sample to be
aspirated (applied).
8. Prepare sample pipetting.
Hold the pipette and touch the tip mounted on
the pipette to the guide (your side corner) of the
Manual pipette cover.
(This helps position the tip in the center of the
slide.)
4
Guide the tip using your side corner.
9. Tap the [START] button.
A slide is transferred to the sample application
position.
10. Prepare so that sample application with
the pipette is always possible, and then
tap the [START] button.
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4 Applicable Usage Methods
11. After the progress bar has finished (all
□ change to ■), apply the sample to the
slide while [Spot now] is displayed.
The spotted slide is automatically transferred
to the measurement section after the display of
[Spot now] disappears.
IMPORTANT:
Apply the sample while the buzzer is sounding
(while [Spot now] is displayed). Otherwise, the
measurement results will be inaccurate.
IMPORTANT:
4
When applying sample to a CM slide, apply the sample within 1 mm of the center of the slide. Otherwise,
the measurement results will be inaccurate. Run the
measurement again.
参照液
搬送方向
(インキュベータ方向)
Apply
sample to the center
スライドの中央に点着する
of the
slide (CM
(比色スライ
ド)slide).
NOTE The LCD may not display [Wait] depending on the operation conditions.
12. To apply sample to the next slide, repeat
the procedure from Step 5.
13. Press the [HOME] button to end manual
sample application.
NOTE The sampler unit moves.
Apply sample to the center of the slide
(CM slide)
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検体
4 Applicable Usage Methods
4.2.2 Using a Pipette
WARNING:
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 accidentally touch a sample, immediately rinse the contaminated area thoroughly under running water,
and then disinfect the area. Seek medical assistance if necessary.
IMPORTANT:
Mount the tip securely into the nozzle of the pipette.
If mounting is poor, the tip may be dislodged, and the sample may scatter.
4
Applying samples to slides
1. Move the tip of the pipette near the slide.
2. Slowly push the push button and make a
drop.
液滴を作ってスライドに近づけます
液滴を作ってスライドに近づけます
Make 液滴を作ってスライ
a drop and then move
it near the slide
ドに近づけます
3. Place the drop on the center of the slide.
IMPORTANT:
液滴をスライドの中央に点着します
液滴をスライ
します
Place
the drop ドの中央に点着
on the center of
the slide
液滴をスライドの中央に点着します
Always make a drop at the top of the tip, and then
apply the sample to the slide. If the sample is
discharged to the slide surface without making a
drop, the measurement results may be affected.
While
the slide is absorbing
the
ながら
スライドが検体を吸い取り
sample,
it diffuses
内部に拡散
していきinside
ます
0057
0057
0057
スライドが検体を吸い取りながら
内部に拡散
していきます ながら
スライ
ドが検体を吸い取り
内部に拡散していきます
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4 Applicable Usage Methods
4.3
Tests Using a Plasma Filter (PF)
By using a PF, you can filter a plasma sample from a whole blood sample without using a centrifuge.
NOTE The FDC NX600i cannot measure using a PF.
IMPORTANT:
Read the “Instructions for Use” of the PF before measurement.
IMPORTANT:
Be sure to read the PF card when changing to a new production lot of PFs.
CAUTION:
Do not tap the [START] button when the sample has already been filtered by the PF. If the [START]
button is tapped, the analyzer may malfunction.
4
Precautions for samples
NOTE Use whole blood samples that have a hematocrit value (Hct) of 20 to 55%.
Up to about 350 μL of plasma (including 85 μL of dead volume) can be filtered.
The amount of filtered plasma decreases as the hematocrit value increases. In the case of
a hematocrit value of 55%, about 185 μL of plasma (including 85 μL of dead volume) can be
filtered.
The amount of filtered plasma depends on the hematocrit value and viscosity of the blood.
NOTE Hemolyzed samples provide inaccurate results.
NOTE If blood cells in a sample have precipitated, mix the sample, place it in a sample rack, and
then perform measurement immediately. Otherwise, the amount of filtered plasma may be
insufficient.
Precaution for blood collection tubes
IMPORTANT:
Use the blood collection tubes listed in Section 4.3.2.
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4 Applicable Usage Methods
PF cards
(1) Overview
When the measurement values for filtered plasma are compared to the values for plasma separated on a centrifuge, systematic differences may be found. Always read the PF card before
using a PF. The PF card contains information to compensate for these differences.
(2) Using PF cards
One PF card is included in one PF box (with 50 filters). Read a PF card in the same way a QC
card is read. Be sure to read the PF card when changing to a new box of PF. The imported production number (lot) is displayed on the Measurement-preparation screen. Make sure that this
number matches the production number (lot) of the PF in use. (è Refer to Section 2.2.1)
NOTE A PF card cannot be read during measurement.
4
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4 Applicable Usage Methods
4.3.1 Measurement
1. Prepare the slides.
2. Prepare the consumables.
Prepare the tips, mixing cups, diluent, and reference fluid as required.
• Loading tips è Refer to Section 5.2
• Loading mixing cups è Refer to Section 5.3
• Loading diluent è Refer to Section 5.4
• Loading reference fluid è Refer to Section
5.5
PF sample rack
4
4-20
3. Load the sample rack for PF and the
slide to be measured.
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4 Applicable Usage Methods
4. Load the sample.
(1) Place the specified amount of whole blood
sample in a blood collection tube.
NOTE The PF has about 3 mL of dead volume (that will be absorbed into the
filter). If the sample volume is low,
the filtered sample volume will be
too low for measurement. Furthermore, sample that was aspirated
into the PF filter cannot be reused.
NOTE If the sample volume is too high,
the sample may overflow from the
blood collection tube when the PF is
loaded. There must be empty space
in the tube. (Refer to Section 4.3.2.)
(2) Mix the whole blood sample in the blood
collection tube by turning it over five or six
times.
NOTE Make sure that bubbles do not form.
(3) Remove the cap from the blood collection
tube, and then put it on the PF sample rack.
(4) Insert a PF into the blood collection tube.
Make sure the PF does not rise from the
sample rack.
5. Register the measurement information.
IMPORTANT:
Tests using a PF measure filtered plasma, so always configure the sample type to [Plasma/Serum].
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4
4 Applicable Usage Methods
6. Close the sample cover, and then lock it
with the sampler cover lock key.
WARNING:
Ensure the sampler cover is locked during sample
processing to prevent injuries and infection.
When the display reads [Ready to test], the sampler cover can be opened.
4
7. Tap the [START] button to start measurement.
8. After measurement is ended, discard the
used PF, and then remove the sample
container.
WARNING:
When discarding used PF, always follow biohazard procedures (wear gloves, a lab coat, and safety goggles) in accordance with the sample handling rules of your facility. If any part of the body
comes in contact with a sample, immediately rinse the contaminated body part thoroughly under
running water and then use ethyl alcohol as a disinfectant. Seek medical assistance if necessary.
WARNING:
Used PF is infectious industrial waste. Process this waste in compliance with any applicable regulations in your country, such as by incineration, melting, sterilization, or disinfection.
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4 Applicable Usage Methods
4.3.2 Blood Collection Tubes for Tests Using a PF
NOTE The FDC NX600i cannot measure using a PF.
The following blood collection tubes can be used with PF measurements: φ16×100 mm, φ13×100
mm, and φ13×75 mm.
(Outer diameter of Ø16 indicates Ø15.0 to 16.6 mm and Ø13 indicates Ø12.0 to 13.3 mm.)
IMPORTANT:
Use blood collection tubes containing Heparin.
IMPORTANT:
Refer to the “Instructions for Use” of the plasma filter (PF) and always follow the instructions.
NOTE Do not use blood collection tubes that may cause the tip of the sample suction nozzle of the
PF to be physically blocked by additives or other materials.
NOTE As shown in the illustration below, the required sample volume is 6.5 mL or more for
Ø16×100 mm tubes, 6 mL or more for Ø13×100 mm tubes, and 3 mL or more for Ø13×75
mm tubes.
PF
PF
10
mm of empty
10mmの空き
space
is necessary
スペースが必要です
1010mmの空き
mm of empty
space
is necessary
スペースが必要です
Measurable
測定可能範囲
Measurable
測定可能範囲
75
mm
75mm
100
mm
100mm
検体は
The
required sample volume
φ16x100mm管で6.5ml以上
is 6.5 mL or more for Ø16×100
φ13x100mm管で6ml以上
mm
tubes, and 6 mL or more
for必要です
Ø13×100 mm tubes.
検体は
The required sample
φ13x75mm管で3ml以上
volume is 3 mL or more for
必要です
Ø13×75
mm tubes.
0023
NOTE Use PF sample racks with the following labels for tests using a PF.
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4 Applicable Usage Methods
4.4
Retesting
You can test again using the previous sample number, sample ID, sample type setting, and reference interval setting by tapping the
(retest) button at the measurement results screen. Furthermore, when a measurement cannot be performed due to an error, you can skip the re-entry and reconfiguration of the setting information by tapping the
(retest) button. When a PF measurement
is run again, the analyzer does not filter using the PF, but instead uses plasma that was previously
filtered by the PF.
IMPORTANT:
The
(retest) button is designed only to automatically enter the sample number and sample ID of
the previously measured sample. Do not use this button to retest samples from before the previous
sample.
CAUTION:
4
Do not tap the [START] button when the sample has already been filtered by the PF. If the [START]
button is tapped, the analyzer may malfunction.
Retesting after filtering by the PF
• When you will rerun a measurement using the PF, do not use the [START] button to restart the
measurement. Always use the
(retest) button.
• Make sure that the sample volume is sufficient.
• Make sure that the liquid surface of the filtered sample is level.
IMPORTANT:
Do not retest GPT (ALT) of PF filtered plasma because its activity decreases over time.
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4 Applicable Usage Methods
< How to retest >
1. When [Ready to test] appears on the
LCD, make sure that the analyzer is not
applying samples, and then load the
consumables and sample.
è Refer to Section 3.3
NOTE If the amount of remaining sample is
insufficient, run the test with manual pipetting.
è Refer to Section 4.2
2. Tap the
(retest) button on the measurement results screen screen.
NOTE The sample number or sample ID that
was measured just before is displayed.
NOTE In case of a sample scheduled for retesting,
is displayed.
NOTE Tap the [Dilution] button to set the dilution factor.
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4 Applicable Usage Methods
3. Close the sample cover, and then lock it
with the sampler cover lock key.
WARNING:
Ensure the sampler cover is locked during sample
processing to prevent injuries and infection.
When the display reads [Ready to test], the sampler cover can be opened.
4
4. Tap the [START] button to start retesting.
NOTE When a test is rerun, PF filtering process
is not performed.
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4 Applicable Usage Methods
4.5
Slide Loading Order When Measuring Different Items Simultaneously
NOTE Any order of slide stacking can be measured. However, please follow the recommended
slide stacking rules below. Otherwise, the analyzer may consume excessive amounts of disposal tips and cups.
(1) Measuring CRP and CM (colorimetric) slides
CRP
Always put a CRP slide first or last.
If a CRP slide is loaded between CM slides, an extra tip will be used.
CM slide
一般比色
図-4.5.2-1
4
(2) Measuring CM and ISE slides
ISE
電解質
CM slide
一般比色
We recommend loading an ISE slide last.
If an ISE slide is measured first, it might take extra
time for measurement.
If a CM slide is loaded after an ISE slide, an extra
tip will be used.
図-4.5.2-1
(3) Measuring CRP, CM, and ISE slides
Stack CM slides before CRP and ISE slides.
ISE
電解質
CRP
CM slide
一般比色
図-4.5.2-4
(4) Measuring CM slides that require dilution
5x
dilution
5倍希釈
2x
dilution
2倍希釈
図-4.5.2-2
If slides are configured with different dilution rates,
stack the slides so that slides with same dilution
factor are measured successively. Otherwise, extra
tips and mixing cups will be used.
NOTE If all CM slides have the same dilution factor, there are no restrictions on the stacking
order.
<Not recommended slide loading order>
CRP
電解質
CM
(Dil)
CRP
CM slide
一般比色
図-4.5.2-4
Only one loading position is prepared for the diluent
in this analyzer. In the example, diluent (purified
water etc.) for the colorimetric slide that requires dilution [CM (Dil)] is loaded and the measurement will
start. The next measurement requires the specified
diluent for CRP, so that an error (E0160 Incorrect
diluent type error) occurs before the measurement,
and the measurement will be completed. Rerun the
CRP measurement from the beginning.
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4 Applicable Usage Methods
4.6
Automatic Acquisition of Sample Information (Work Lists)
If the analyzer is connected to DMS, you can receive patient IDs and their sample information by
button at the Measurement-preparation screen before measurement.
tapping the
NOTE DMS is sold separately.
1. Tap the
button. The analyzer receives
a work list (a list of patients for the samples to be measured) from DMS.
4
The Work list index screen appears.
NOTE If there are no measurement requests,
the buzzer sounds, and the message
[There is no request information] is displayed.
NOTE The display of the list is configured by
[Work list selection setting] in Mode
function for administrator.
è Refer to Section 9.3.8
NOTE On DMS, "Sample No." is "Sample ID"
and "Sample ID" is "Patient ID”.
NOTE When there are multiple pages in a
list, you can scroll the pages using the
/
buttons.
NOTE If the [Cancel Work list] button is tapped,
the analyzer returns to the Measurement preparation screen.
2. Tap the sample information you want to
register.
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4 Applicable Usage Methods
The work list measurement items of the registered sample information are displayed.
NOTE If the
button is tapped, registration
is cleared.
NOTE The work list measurement items can
be printed by tapping the
button.
4
3. Tap the [OK] button to finish registration.
The Measurement preparation screen (top
screen) returns.
NOTE The work list button lights.
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4 Applicable Usage Methods
4.7
Editing Sample Numbers and Sample IDs
You can edit the sample number and sample ID of measurement results. You can also send edited
data to a host computer.
1. To edit the sample number, tap the [No.]
button at the measurement results screen
(Refer to Section 3.4).
4
2. Enter the administrator password, and
then tap the [OK] button.
The Sample number entry screen appears.
3. Edit the sample number, and then tap
the [OK] button.
The analyzer returns to the measurement results
screen.
NOTE You can also edit the sample ID using
the same procedure.
IMPORTANT:
Be sure not to make any entry errors.
NOTE The sample ID can also be edited by using
the barcode reader.
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4 Applicable Usage Methods
4.8
Using the Sample Barcode Reader (Sold Separately)
You can easily enter the sample ID and operator ID by using the optional sample barcode reader.
IMPORTANT:
If the sample barcode reader malfunctions or the print quality of the barcode label is poor, incorrect barcode data may be read. Make sure that the barcode data (sample ID) printed in the measurement results are correct.
NOTE Carefully read the instructions included with the sample barcode reader before using it. A
maximum of 13 alphanumerical characters can be input for a sample ID. Always use the
sample barcode reader under lighting at 3,000 lux or lower and avoid direct sunlight.
NOTE Always connect the cable of the sample barcode reader before switching on the FDC
NX600.
<When inputting the sample ID>
1. Tap the [Sample ID] field. The software
keyboard appears.
NOTE In the following cases, this operation
is not required. The barcode reading is
possible on the top screen (left):
• When the USM function is enabled.
• When the setting "Use operator ID" is
OFF (USM function is disabled).
è Refer to Section 9.3.19.
NOTE You can also enter the sample ID using
the barcode reader on the measurement
results screen.
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4
4 Applicable Usage Methods
2. Read the barcode of the sample using
the barcode reader.
After reading is complete, the analyzer makes a
beep sound. The sample ID is displayed on the
LCD and is registered.
バーコードを読み取ります
NOTE Position the sample barcode reader
properly facing to the barcode label.
Otherwise, an incorrect reading may occur.
NOTE Make sure the displayed ID is correct.
NOTE When reading a barcode again, tap the
[Sample ID] field, and then re-read the
barcode.
4
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4 Applicable Usage Methods
<When inputting the operator ID>
1. Tap the operator ID button. The software
keyboard appears.
4
2. Read the operator ID using the sample
barcode reader.
After reading is complete, the analyzer makes a
beep sound. The operator ID is displayed on the
LCD and is registered.
NOTE Position the sample barcode reader
properly facing to the barcode label.
Otherwise, an incorrect reading may occur.
NOTE Make sure the displayed ID is correct.
NOTE To re-input a barcode, tap the Operator
ID button, and then re-read the barcode.
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5
5.1
Loading Consumables
Loading Consumables
To load tips and mixing cups, tap the display of consumables to display the loading screen. When
loading is complete, press the [Finish] button to exit.
NOTE If there are not enough consumables (tips, mixing cups, diluent, reference fluid, etc.), sample application may be stopped.
NOTE Load consumables while the analyzer is not applying samples.
5
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5-1
5 Loading Consumables
5.2
Setting Tips
Tips are required for all measurements. Check the number of remaining tips on the LCD before performing measurements. If necessary, add new tips.
WARNING:
During sample application, tap the [STOP] button to stop application, and then load the tips. Loading is unsafe during sample application because the sampler and the consumable disk are moving.
1. With [Warming up], [Lamp warming up]
or [Ready to test] displayed on the LCD,
make sure that the analyzer is not applying samples.
2. Tap the consumables display on the
LCD.
5
Consumable display
3. The Consumables loading screen is displayed.
5-2
897N203029A FDC NX600 Instruction Manual 2022.01
5 Loading Consumables
4. Remove the tip rack from the consumable disk.
NOTE Always remove the tip rack from the
consumable disk before loading tips.
RE
Tip rack
5. Load tips in all holes of the tip rack.
NOTE Always set tips in all holes of the tip
rack.
5
6. Load the tip rack on the consumable
disk.
RE
Tip rack loading position
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5-3
5 Loading Consumables
7. Check that tips have been set in all holes
of the tip rack. And then, tap the [Replenish]
button of tips.
8. Tap the [Finish] button to exit.
5
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5 Loading Consumables
5.3
Loading Mixing Cups
Mixing cups are necessary for measurements requiring dilution (refer to Section 3.6) and CRP
measurements (refer to Section 3.7). Furthermore, mixing cups are also necessary when urine (U)
is selected for the sample type during an ISE measurement because measurement is performed
automatically at 2x dilution. (Refer to Section 3.5) Check the quantity of mixing cups on the LCD before measurement. If necessary, load new mixing cups. Each measurement uses one mixing cup. If
no mixing cups remain, a measurement cannot be run.
WARNING:
During sample application, tap the [STOP] button to stop application, and then load the mixing
cups. Loading is unsafe during sample application because the sampler and the consumable disk
are moving.
WARNING:
Always wear gloves when handling used mixing cups to avoid biohazards.
NOTE The quantity of mixing cups that can be
used is displayed on the LCD. When the
amount remaining is insufficient, a dilution
measurement cannot be performed.
1. With [Warming up] or [Ready to test] displayed on the LCD, make sure that the
analyzer is not applying samples.
2. Tap the consumables display on the
LCD.
Consumable display
3. The Consumables loading screen is displayed.
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5
5 Loading Consumables
Mixing cups
4. Remove the mixing cups from the consumable disk, and then set new mixing
cups.
WARNING:
RE
Used 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 disinfection.
5. Tap the [Replace] button of mixing cups.
6. Tap the [Finish] button to exit.
5
5-6
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5 Loading Consumables
5.4
Loading Diluent
Diluent is necessary for dilution measurements (refer to Section 3.6) and CRP measurements (refer
to Section 3.7). Dilution and CRP measurements each require a specified diluent. Before measurement, refer to the technical documentation for the diluent to be used. Furthermore, mixing cups are
also necessary when urine (U) is selected for the sample type during an ISE measurement because
measurement is performed automatically at 2x dilution. (Refer to Section 3.5)
WARNING:
During sample application, tap the [STOP] button to stop application, and then load diluent. Loading is unsafe during sample application because the sampler and the consumable disk are moving.
IMPORTANT:
Use specified tube for the diluent. Otherwise, measurement errors or malfunctions may occur.
The specified tubes for diluent are the FUJI PLAIN TUBE (1.5 ml and 0.5 ml).
IMPORTANT:
The diluent for CRP measurements evaporates progressively, and the concentration of the fluid
may affect the measurement values.
Replace diluent for each test.
NOTE For each CRP measurement, 0.1 mL of diluent is necessary.
NOTE Configure the type of diluent container to be used via [Tube setting for diluent & reference
fluid] in Mode function for administrator (refer to Section 9.3.15).
FUJI PLAIN TUBE
(1.5 ml)
FUJI PLAIN TUBE
(0.5 ml)
1.5
0.5
Suction
range
1.0
Pour diluent up to
this range
0.3
0.1
1. Prepare the diluent.
Suction
range
0.5
897N203029A FDC NX600 Instruction Manual 2022.01
Pour the following amounts into each type of
FUJI PLAIN TUBE.
For 1.5 mL tube: 1.0 to 1.5 mL
For 0.5 mL tube: 0.3 to 0.5 mL
NOTE The suction range is as shown on the
left.
When 0.5 mL of diluent was poured into
a FUJI PLAIN TUBE of 1.5 mL, one dilution is possible for a CRP measurement.
5-7
5
5 Loading Consumables
2. With [Warming up] or [Ready to test] displayed on the LCD, make sure that the
analyzer is not applying samples.
Diluent
3. Load a tube containing diluent.
RE
5
NOTE Tap the consumables display on the top
screen and select the [Diluent] tab to display the diluent setting guidance screen.
This operation is not required because only
the guidance screen is displayed.
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5 Loading Consumables
5.5
Loading Reference Fluid
Reference fluid is necessary for ISE measurements. (Refer to Section 3.5).
WARNING:
When handling reference fluid, follow biohazard procedures (wear gloves, a lab coat, and safety
goggles) in accordance with the medical handling rules of your facility. If you accidentally touch an
item, immediately rinse the contaminated body part thoroughly under running water.
WARNING:
Discard reference fluid according to the medical handling rules of your facility and related laws.
WARNING:
During sample application, tap the [STOP] button to stop application, and then load the reference
fluid. Loading is unsafe during sample application because the sampler and the consumable disk
are moving.
IMPORTANT:
Use a FUJI PLAIN TUBE (0.5 or 1.5 mL) for reference fluid. Otherwise, measurement errors or
malfunctions may occur.
Configure the type of container to be used via [Tube setting for diluent & reference fluid] in Mode
function for administrator (Refer to Section 9.3.15).
IMPORTANT:
Replace FUJI PLAIN TUBES (1.5 mL) within 24 hours.
Replace FUJI PLAIN TUBES (0.5 mL) for each measurement.
FUJI PLAIN TUBE
(1.5 ml)
1.0
FUJI PLAIN TUBE
(0.5 ml)
Pour reference fluid
within the range.
1. Prepare reference fluid.
Pour the following amounts into each type of
FUJI PLAIN TUBE.
For 1.5 mL tube: 1.0-1.5 mL
For 0.5 mL tube: 0.3-0.5 mL
0.5
0.3
NOTE Use reference fluid after it reaches room
temperature.
0.1
0.5
2. With [Warming up] or [Ready to test] displayed on the LCD, make sure that the
analyzer is not applying samples.
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5
5 Loading Consumables
Reference fluid
3. Load the tube containing the reference
fluid.
Press the lever to open the lid and load the container.
IMPORTANT:
Clean the cap of the reference fluid every time
you load the reference fluid.
è Refer to Section 6.8
NOTE Make sure the reference fluid cap is
closed properly.
5
RE
Reference fluid
NOTE Tap the consumables display on the top
screen and select the [Reference fluid] tab
to display the reference fluid setting guidance screen. This operation is not required
because only the guidance screen is displayed.
5-10
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6
Maintenance
6 Maintenance
To keep the performance of the FDC NX600 at its best, users must perform daily and periodic maintenance, and designated repair personnel must perform maintenance. When repairs are necessary, contact repair personnel.
WARNING:
When you clean the analyzer, always wear gloves, a lab coat, and safety goggles.
If you accidentally touch a contaminant, immediately rinse the contaminated area thoroughly under
running water, and then disinfect the area.
Seek medical assistance if necessary.
WARNING:
Always unplug the power cord before cleaning. (Cleaning of the transfer bar and cleaning around the
PF unit are excluded.)
WARNING:
Process contaminated swabs or cloths used for cleaning the analyzer as infectious waste.
CAUTION:
Before cleaning and maintaining the analyzer, get training from our technical support staff.
6
CAUTION:
Refer to each section for information about usable solvents for cleaning and decontamination.
CAUTION:
Do not use alcohol to clean the sampler cover (translucent). Otherwise, the surface will be damaged.
IMPORTANT:
After cleaning, always connect the power cord, switch on the power, and then check operation.
IMPORTANT:
If you do not perform the maintenance in this manual, the analyzer’s performance and specifications
will not be maintained, which may negatively affect the measurement values.
IMPORTANT:
Be sure to reassemble the parts removed for maintenance and tighten thumbscrews securely. Otherwise, measurement values may be negatively affected.
NOTE If the LCD (touch panel section) becomes soiled, use a soft cloth or a cloth soaked in a small
amount of ethyl alcohol to lightly wipe it.
NOTE When cleaning the outer covers of the equipment, wipe using a soft cloth moistened with water
or ethyl alcohol for disinfection (excluding the sampler cover).
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6 Maintenance
6.1
Periodic Maintenance Items
6.1.1 Items for Daily and Periodic Inspection by the User
Users must perform the daily and periodic maintenance and replacement of parts in the following table.
Location
Cleaning interval
Replacement interval
Procedure
Air filter
Once a month
-
-
Refer to
Section 6.2.
Transfer bar
Once every 3 months,
or as appropriate, such
as when inaccurate
measurement values
occur
-
-
Refer to
Section 6.3.
Incubator
Once every 3 months,
or as appropriate, such
as when inaccurate
measurement values
occur
-
-
Refer to
Section 6.3.
-
-
Refer to
Section 6.3.
Once every 3 months,
or as appropriate, such
as when inaccurate
measurement values
occur
-
-
Refer to
Section 6.3.
Recording paper
-
-
Appearance of red lines on both
sides of paper
Refer to
Section 6.4.
Light source lamp
-
-
When a lamp replacement error
Refer to
occurs, or when the cumulative
Section 6.5.
lighting time exceeds 1,000 hours
As appropriate, such as
when a slide transfer
Sample application unit
error or tip ejection error
occurs
6
Inspection
interval
ISE unit
Sampler O-ring
Once a week
Slide reading section
When slide reading
errors occur frequently
-
Reference fluid cap
packing
When replacing reference fluid
-
PF sensor
As appropriate, such as
when errors related to
PF extraction occur
Once a month
PF reference plate
PF Suction Pad
PF Tube
-
Once a month
-
Refer to
Section 6.6.
Once a year
Once every 3 months
Once every 2 years
Once every 2 years or when
the power has been off for one
month
Refer to
Section 6.7.
Refer to
Section 6.8.
Refer to
Section 6.9.
Refer to
Section 6.9.4.
WARNING:
After inspection, always connect the power cord, switch on the power, and then check operation.
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6 Maintenance
6.1.2 Items for Maintenance and Inspection by Repair Personnel
Designated repair personnel must perform the maintenance and replacement of parts in the following table.
Parts
Replacement interval
Interference filter
Once every 4 years
Syringe
Once every 3 years
Incubator pressure plate
Inspection once every 3 years
WARNING:
After inspection, always connect the power cord, switch on the power, and then check operation.
NOTE The standard number of slides used per year for this analyzer is assumed to be 7,200 colorimetric slides and 240 ISE slides. (In the case of 240 days of use per year, 30 colorimetric
slides/day and one ISE slide/day)
6
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6-3
6 Maintenance
6.2
Cleaning the Air Filters
The air filters should be checked and cleaned once a month.
IMPORTANT:
If the air filters are not cleaned, an increase in the temperature inside the analyzer may negatively
affect the measurement values.
NOTE Clean all 4 filters.
1. Switch off the analyzer power.
2. Remove the four louvers and pull out the
air filters located inside of the louvers.
Lift the louver upward 1 and then pull forward
2 to remove.
Louver
Louver
6
2
1
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6 Maintenance
3. Remove dust adhering to the filter with a
vacuum cleaner or running water.
Air filter
NOTE If you wash the filter with running water,
make sure it is dried well before setting
in the analyzer.
4. Insert the filter into the louver and put
the louver back in the analyzer.
Push up the louver 1 and then push it toward
2.
1
IMPORTANT:
2
If the analyzer is used without setting the filters,
measurement values may be negatively affected.
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6-5
6
6 Maintenance
6.3
Inspecting and Cleaning the Transfer Bar, Incubator, Sample Application Unit, and ISE Unit
Measuring results are affected by stains (from blood samples, etc.) inside of the incubator and ISE
unit. These parts should be checked and cleaned at least once every three months. When a slide
transfer error or a tip ejecting error occurred, clean the sample application unit.
WARNING:
Always wear gloves, a lab coat, and safety glasses while working.
If you accidentally touch a contaminant, immediately rinse the contaminated area thoroughly under running water, and then disinfect the area.
Seek medical assistance if necessary.
WARNING:
Dispose of contaminants used for cleaning as infectious waste.
IMPORTANT:
Staining of the incubator, spotting parts, and electrolyte parts with samples such as blood may affect the measured values.
6
6-6
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6 Maintenance
6.3.1 Reference Plate Level Check
Perform [Reference plate level check] before cleaning.
1. Tap the
button.
2. Tap the [Normal mode] button.
6
897N203029A FDC NX600 Instruction Manual 2022.01
6-7
6 Maintenance
3. Tap the [Reference plate level check]
button to run a check.
If check ends, the Check results screen appears.
4. Check the results of [Reference plate
level check].
When
has appeared in the check results,
cleaning is necessary. Tap the [OK] button. Using
the procedure on the following pages, clean the
transfer bar, incubator, sample application unit,
and ISE unit.
In the case of Level 1
soiling (0-49%)
In the case of Level 2
soiling (50-79%)
In the case of Level 3
soiling (80% or higher)
6
6-8
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6 Maintenance
6.3.2 Cleaning the Transfer Bar, Incubator, Sample Application Unit, and
ISE Unit
(1) Cleaning the transfer bar
1. Tap the [Cleaning mode] button in Normal
mode.
2. Remove the slide cartridge and the tip
rack from the analyzer.
3. Tap the [Start Cleaning] button.
NOTE Keep your fingers clear as the analyzer
runs.
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6
6 Maintenance
4. The screen to the left appears.
5. Loosen the 2 thumbscrews and pull the
sample application unit cover frontward
to remove it.
6
Thumbscrew
6. Remove the two slide transfer weights.
NOTE There are 2 types of slide transfer
weight, one each for CM tests and ISE
tests.
The slide transfer weight for CM tests has hooks
on the left, so lift up from the right before removing it. When installing it, insert the hooks before
loading it.
For CM
Slide transfer weight
For ISE
7. Use gauze or a cotton swab that has
been soaked in lukewarm or cold water
to wipe the staining of the removed slide
transfer weight.
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6 Maintenance
Transfer bar
8. Use gauze or a cotton swab that has
been soaked in lukewarm or cold water
to wipe the upper surface of the transfer
bar visible in the sample application unit.
9. Next, clean the incubator, sample application unit, and ISE test unit.
NOTE To quit the cleaning, attach the removed
slide transfer weight and sample application unit cover at their original positions, and then tap the
button to
return to the previous screen.
6
CAUTION:
Keep your fingers clear as the analyzer runs.
10. Tap the
power.
button to switch off the
CAUTION:
Keep your fingers clear as the analyzer runs.
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6-11
6 Maintenance
WARNING:
Always unplug the power cord before the following procedure.
(2) Incubator
1. Open the sampler cover and panel unit.
Remove the panel unit pedestal.
Panel unit
pedestal
6
Connector
Incubator cover
6-12
2. Unplug the connector of the incubator
cable (low end) by turning it to the left.
3. Remove the incubator cover.
897N203029A FDC NX600 Instruction Manual 2022.01
6 Maintenance
2
5
4
4. Loosen the 5 screws on the upper surface of the incubator, and then remove
the incubator.
3
1
Thumbscrew
5. Moisten the cloth with lukewarm water.
IMPORTANT:
Wring the cloth when it is soaked too much. If water gets inside the machine, it will cause rust.
6. Place the removed incubator on a flat
surface with the pressure plates facing
up.
IMPORTANT:
Put on gloves before beginning wiping.
Incubator pressure plate
7. If dirt is noticeable or a transport error occurs within the cleaning cycle, shorten the
cleaning cycle (to at least once a week).
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6-13
6
6 Maintenance
Tapered part
8. Wipe the tapered part of each pressure plate (the metallic luster taper part
around the black part).
NOTE Wipe the entire circumference as blood
stains may be difficult to see by eye.
9. Wipe the surface (black part) of each
pressure plate.
Surface
NOTE Wipe gently to avoid scratching, as it
will affect the measurement values.
IMPORTANT:
6
When wiping, change the cloth surface for each
cell. Otherwise, dirt may be transferred.
IMPORTANT:
Do not use a cotton swab.
The components of the cotton swab may negatively affect the measurement values.
IMPORTANT:
After cleaning, do not touch the pressure plate surface with your fingers.
This may affect the measurement values.
10. Wipe the lower part (measurement cells)
in the same way.
Measurement cell
6-14
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6 Maintenance
11. Loosen the 2 screws fixing the reference
plate and remove the plate from the analyzer.
Thumbscrew
Reference
black plate
Reference
plate
Reference
white plate
Photometer
12. Turn over the reference plate and clean
the white plate and black plate with a dry
cotton swab.
13. Clean the photometer head with a dry
cotton swab.
14. Load the reference plate.
Tighten the 2 thumbscrews evenly.
IMPORTANT:
Tighten the two thumbscrews securely. Otherwise,
the measurement results may be negatively affected.
Thumbscrew
Reference
plate
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6-15
6
6 Maintenance
(3) Sample application unit
1. Make sure that the sample application
unit cover and two slide transfer weights
were removed for cleaning of the transfer bar.
Sample application unit
6
2. Wipe the sample application unit with
gauze or a cotton swab moistened with
lukewarm or cold water.
(4) ISE unit probe
Make sure there is no dust on the six ISE probes.
When you clean the ISE probes, wipe off the dust
using a dry cotton swab.
NOTE Do not use solvents, such as methyl alcohol
or isopropyl alcohol.
Probes
CAUTION:
ISE probes are needle-shaped parts. Do not touch
them directly by hand. Be careful not to bend the
probes.
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6 Maintenance
6.3.3 Reassembling Parts and Ending Cleaning
1. Reassemble the incubator.
2
Align the arrow marks on the incubator and the
reference plate, and then tighten the 5 thumbscrews evenly by tightening opposing thumbscrews in numerical order (1 to 5).
5
4
3
1
IMPORTANT:
Thumbscrew
4 Incubator cable
3 Incubator cover
1 ‌Slide transfer
‌ anel unit
5P
weight
pedestal
2 Sample application unit
Incubator cable
Tighten the five thumbscrews securely. Otherwise,
the measurement results may be negatively affected.
2. Reassemble each part as shown in the
illustration on the left.
1 Load the slide transfer weights.
2 Load the sample application unit cover
and tighten the thumbscrews.
3 Load the incubator cover.
4 While aligned with the groove, plug the
connector of the incubator cable into the
incubator and then lock it by turning it to
the right.
5 Load the panel unit pedestal.
Incubator cover
IMPORTANT:
Tighten the thumbscrews securely. Otherwise, the
measurement results may be negatively affected.
IMPORTANT:
Be sure to attach the incubator cover. Otherwise,
the measurement results may be negatively affected.
NOTE When you insert the connector, make
sure not to twist or apply too much pressure to the cable. If the cable is twisted
more than once, it may break.
3. Close the panel section to end cleaning.
Run [Reference plate level check] again, and
then check the results.
è Refer to Section 6.3.1
NOTE Wait until the temperature of the incubator is steady.
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6-17
6
6 Maintenance
6.4
Replacing Recording Paper
When red lines appear along the sides of the recording paper, the printer is nearly out of paper, so
replace the recording paper roll with a new one.
NOTE Use the recording paper specified for the FDC NX600.
1. Press the section indicated in the illustration (1) to release the lock, and then
open the cover (2).
1
2
Press the
concave
section.
2. Remove the remaining recording paper.
6
3. Load the new recording paper.
NOTE If the paper replacement was performed
during a measurement, the measurement results might be printed out.
NOTE Set the paper roll so the paper is pulled
from under the paper roll as shown below.
OK
Incorrect
NOTE If the paper is loaded in reverse, no text
is printed on the thermal paper.
4. Pull the top end of the recording paper
out slightly, and then close the cover.
NOTE When setting a new recording paper,
pull the edge of paper out to where the
tape for fixing edge is affixed. Failure
to observe this precaution may cause
printing malfunction.
NOTE Close the cover securely until it clicks.
Otherwise, the paper feed may fail and
the test results will not be printed out.
6-18
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6 Maintenance
6.5
Replacing and Cleaning the Light Source Lamp
The average life of the lamp is about 1,000 hours. Replace the lamp if a lamp replacement error occurs or the cumulative lighting time of the lamp approaches 1,000 hours.
CAUTION:
The light source lamp gets very hot. Before cleaning the light source unit or replacing the light
source lamp, turn off the power, wait at least 5 minutes, and then check the lamp has cooled.
1. Pull out the disposal box, and then remove the front bottom cover.
6
Front bottom cover
2. Loosen the thumbscrew as shown in the
left figure and remove the lamp unit.
3. Unplug the connector of the light source
lamp and remove the lamp unit.
1
Thumbscrew
3
2
Lamp unit
Connector
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6 Maintenance
4. Wipe the light source unit lens using a
dry cotton swab.
Lens
5. Turn the thumbscrew of the lamp unit to
the left, remove the lamp, and then replace it with a new one.
Lamp base
IMPORTANT:
Tighten the thumbscrews securely. Otherwise, the
measurement results may be negatively affected.
6
Thumbscrew
IMPORTANT:
NOTE When you replace the lamp, hold it by
its base. Do not touch the glass surface
with bare hands.
Secure so that metal
hooks hold from above
the lamp housing.
6-20
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6 Maintenance
Thumbscrew B
2
3
1
6. Insert the connector of the light source
lamp.
7. Insert the lamp unit into the analyzer
with thumbscrew B facing up. Tighten
thumbscrew A securely.
IMPORTANT:
Tighten the thumbscrew securely. Otherwise, the
measurement results may be negatively affected.
Thumbscrew A
Connector
8. Attach the front bottom cover, load the
disposal box, and then switch on the
power of the FDC NX600.
NOTE Put the front bottom cover back horizontally as it was.
IMPORTANT:
Be sure to load the disposal box. If the analyzer
is used without the box, the measurement results
may be negatively affected.
9. After starting the analyzer, go to [Lamp
management] in Normal mode, and then
reset [Lamp ON time].
è Refer to Section 9.2.3
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6
6 Maintenance
6.6
Maintenance of Sampler O-ring
The sampler nozzle O-ring wears over time. Perform weekly cleaning, monthly inspection, and annual replacement.
WARNING:
When inspecting and replacing O-rings, always wear gloves, a lab coat, and safety goggles.
If you accidentally touch a contaminant, immediately rinse the contaminated area thoroughly under running water, and then disinfect the area.
Seek medical assistance if necessary.
IMPORTANT:
If you do not inspect and replace the sampler O-ring, the sample application volume will be inaccurate, which may negatively affect the measurement values.
6.6.1 Cleaning the Sampler O-ring
Clean the sampler O-ring once a week as follows.
1. Prepare a dry / damp gauze or cloth (eyeglass wipes, lint-free cloth, etc.).
6
2. Switch off the analyzer before cleaning.
3. Rotate the sampler part toward you.
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6 Maintenance
4. While holding the arm with one hand,
wipe the O-ring while rotating the damp
cloth 3 to 4 turns around the circumference. Next, wipe down from the top to
cover the entire circumference. Similarly,
wipe the other O-ring around the circumference and down from the top.
5. Use a dry cloth to lightly wipe the moisture from the O-ring portion. Remove
any foreign objects remaining on the
O-ring.
6. Perform a measurement and confirm that
no errors occur.
IMPORTANT:
Do not store the AUTO TIPS with the storage box
lid open. If AUTO TIPS contaminated with dust or
dirt are mounted to the nozzles, the dirt or dust
may adhere to the O-rings, causing dispensing/
dilution clogging errors or leak check failure.
IMPORTANT:
If dirt is noticeable or an error occurs, shorten the
cleaning cycle (once a week or more).
7. If an error occurs, inspect the sampler
O-ring (Refer to Section 6.6.2).
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6-23
6
6 Maintenance
6.6.2 Inspecting the Sampler O-ring
1. Tap the
button.
2. Tap the [Normal mode] button.
6
3. Tap [Sampler leak check].
6-24
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6 Maintenance
4. Follow the on-screen instructions to prepare for the leak check.
5. Tap the nozzle to be checked to select it,
and then run the leak check.
Once check ends, the Check results screen appears.
6
CAUTION:
Keep your fingers clear as the sampler unit
and consumable disk move.
6. Check the results of the [Sampler leak
check].
If the check results are [OK], it is not necessary
to replace the O-ring.
NOTE The check results can be printed by
button.
tapping the
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6 Maintenance
If the check results are [NG], tap the [Replace
O-ring] button, and then replace the O-ring
according to the following procedure.
NOTE The check results can be printed by
button.
tapping the
7. Once the check ends, open the sampler
cover, and then remove the sampler leak
check tool mounted on the sampler nozzle by hand.
6
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6 Maintenance
6.6.3 Exchanging the Sampler O-ring
The sampler nozzle O-ring wears over time. Replace it once a year.
WARNING:
Process used O-rings as infectious waste.
IMPORTANT:
If you do not replace the O-ring periodically, the sample application volume will be inaccurate,
which may negatively affect the measurement values.
IMPORTANT:
Be sure to use the O-ring designed for the FDC NX600. Otherwise, the sample application volume
will be inaccurate, and the measurement results may be negatively affected.
1. Remove the sample rack and slide cartridge.
2. Tap the
button.
6
3. Tap the [Normal mode] button.
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6 Maintenance
4. Tap [Replace O-ring].
5. Tap the [START] button.
The sampler nozzles turn to the replacement
position.
6
CAUTION:
Keep your fingers away as the sampler unit
moves.
6. Follow the on-screen instructions to
replace the O-ring.
If this button is tapped, the following explanation appears.
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6 Maintenance
7. Tap [Leak check] to check for leaks.
è Refer to Section 6.6.2
6
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6 Maintenance
6.7
Cleaning the Slide Reading Section
When a slide-detection error has occurred, dust and other soiling may be the cause. Clean the slide
reading section to avoid these errors.
WARNING:
Always wear gloves, a lab coat, and safety glasses while working.
If you accidentally touch a contaminant, immediately rinse the contaminated area thoroughly under running water, and then disinfect the area.
Seek medical assistance if necessary.
WARNING:
Dispose of contaminants used for cleaning as infectious waste.
1. Switch off the analyzer power.
2. Open the sampler cover and panel unit.
3. Remove the slide cartridge.
6
RE
4. Using your finger, move the transfer bar
under the right cover.
RE
5. Air blow from the gap where the slide
cartridge is placed, as shown in the left
figure.
RE
6-30
897N203029A FDC NX600 Instruction Manual 2022.01
6 Maintenance
6.8
Cleaning and Replacing the Reference Fluid Cap Packing
Clean the reference fluid cap packing each time the reference fluid is replaced.
Replace the reference fluid cap packing once every three months.
IMPORTANT:
If you do not clean and replace the reference fluid cap packing, the reference fluid will be concentrated, which may negatively affect the measurement values.
1. If reference fluid is loaded, remove the
reference fluid tube and discard it.
2. Remove the reference fluid cap packing
as shown in the illustration on the left.
6
Reference
fluid cap
packing
Cotton swab
3. Wipe off the reference fluid cap packing
using a cotton swab or gauze moistened
with lukewarm or cold water as shown in
the illustration on the left, and then allow
it to dry.
NOTE Replace it with a new cap if stains cannot be wiped off.
Reference fluid cap packing
897N203029A FDC NX600 Instruction Manual 2022.01
6-31
6 Maintenance
4. Set the reference fluid cap packing properly.
NOTE Do not touch the bottom side (reference
fluid side) of the reference fluid cap
packing.
Reference
fluid cap
packing
6
6-32
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6 Maintenance
6.9
PF Unit Maintenance
WARNING:
During maintenance, always wear gloves, a lab coat, and safety glasses.
If you accidentally touch a contaminant, immediately rinse the contaminated area thoroughly under running water, and then disinfect the area.
Seek medical assistance if necessary.
WARNING:
Dispose of contaminants used for cleaning as infectious waste.
6.9.1 Cleaning the PF Unit (Sensor, Reference Plate, and Suction Pad)
Clean when errors occurred during PF filtering.
1. Tap the
button.
6
2. Tap the [Normal mode] button.
897N203029A FDC NX600 Instruction Manual 2022.01
6-33
6 Maintenance
3. Tap [PF maintenance].
4. Tap the [Cleaning] button.
6
5. Remove the sample rack, mixing cup,
and tip rack.
6. Tap the [OK] button.
CAUTION:
Keep your fingers clear as the PF part moves.
6-34
897N203029A FDC NX600 Instruction Manual 2022.01
6 Maintenance
7. Clean according to the on-screen instructions.
8. Tap the [OK] button to end cleaning.
Surface of PF sensor
(glass surface)
6
PF Suction Pad
(black)
PF reference plate
9. Run the leak check.
è Refer to Section 6.9.2
NOTE If the check was [NG], exchange the PF
suction pad.
è Refer to Section 6.9.3
897N203029A FDC NX600 Instruction Manual 2022.01
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6 Maintenance
6.9.2 Inspecting the PF Suction Pad
The PF suction pad must be inspected monthly and replaced every two years.
1. Touch the [PF Maintenance] button as in
the previous section.
2. Tap the [Leak check] button.
6
6-36
897N203029A FDC NX600 Instruction Manual 2022.01
6 Maintenance
3. Follow the on-screen instructions to load
the PF sample rack and PF leak check
tool to the sample position, and then tap
the [START] button to run the leak check.
If check ends, the Check results screen appears.
CAUTION:
Keep your fingers clear as the PF part moves.
4. Check the results of the [Leak check].
If the check results are [OK], it is not necessary
to clean or replace the pad.
NOTE The check results can be printed by tapbutton.
ping the
If the check results are [NG], tap the [Cleaning]
button, clean the PF unit, and then run the leak
test again.
è Refer to Section 6.9.1
If this does not resolve the problem, tap the
[Procedure] button, and then check the assemblies of the PF pump tube or replace the tube,
referring to the displayed instructions.
NOTE If the [Result details] button is tapped,
the Advanced leak check results display
screen appears.
NOTE The check results can be printed by tapbutton.
ping the
5. Once the check ends, remove the PF
sample rack and PF leak check tool.
897N203029A FDC NX600 Instruction Manual 2022.01
6-37
6
6 Maintenance
6.9.3 Replacing the PF Suction Pad
Replace a PF suction pad once every 2 years.
WARNING:
Process used PF Suction Pad as infectious waste in compliance with any applicable regulations in
your country.
1. Touch the [PF Maintenance] button as in
the previous section.
6
2. Tap the [Suction pad] button.
The PF sampler rotates forward and stops.
6-38
897N203029A FDC NX600 Instruction Manual 2022.01
6 Maintenance
3. Remove the sample rack, mixing cups,
and tip rack.
RE
Sample rack
Tip rack
6
Mixing cups
4. Tap the
power.
897N203029A FDC NX600 Instruction Manual 2022.01
button to switch off the
6-39
6 Maintenance
5. Turn the PF Suction Pad in the direction
shown and remove it while loosening.
6. Install the new PF Suction Pad by turning it in the opposite direction.
NOTE Be sure to tighten the PF Suction Pad
securely.
7. Switch on the analyzer.
8. Run the leak check.
RE
If the check results are [NG], perform the replacement again. è Refer to Section 6.9.2
6
6-40
897N203029A FDC NX600 Instruction Manual 2022.01
6 Maintenance
6.9.4 Replacing the PF Pump Tube
WARNING:
Before the following procedure, always switch off the power of the analyzer, and unplug the power
cord.
Replace the PF pump tube once every 2 years. Replacement is also necessary if the PF has not
been used for one month or longer.
1. Remove the disposal box, and remove
the front bottom cover.
6
Front bottom cover
Cover (B)
Holder (C)
Screw (A)
Tube (D)
2. Loosen the screw (A) and remove the
cover (B).
3. Slide the holder (C) to the left and remove the tube (D) from the rotor.
897N203029A FDC NX600 Instruction Manual 2022.01
6-41
6 Maintenance
4. While pushing the head of joint (G), pull
the joint (G) to the right to remove the
tube (D).
PF pump
Joint (G)
Red tube (D)
Pull off joint (G) to the right Joint (G)
while pushing this part to
the right.
Holder (C)
5. Slide the holder (C) to the left and load
the new tube (H) on to the rotor.
Tube (H)
NOTE As shown in the diagram to the left,
align the base of the joint (E) with the
cover hole (F).
NOTE Set so that the two front marks face the
front.
6
6. Reattach the cover (B) using the screw
(A).
Cover hole (F) Joint (E)
Front Marks
Joint (E)
Cover hole (F)
When attaching the cover (B), make
sure that the hooks are hooked and
interlocked.
NOTE If attachment is incorrect, a “W0134 PF
sampling error” may occur.
Red tube (H)
Joint (G)
7. Insert the tip of the red tube (H) in the
joint (G) until the line.
Line
6-42
897N203029A FDC NX600 Instruction Manual 2022.01
6 Maintenance
8. Attach the front bottom cover.
NOTE Put the front bottom cover back horizontally as it was.
9. Attach the disposal box.
10. After the replacement, run the leak
check.
If the check results are [NG], perform the replacement again. è Refer to Section 6.9.2
6
897N203029A FDC NX600 Instruction Manual 2022.01
6-43
7
Quality Control
IMPORTANT:
To maintain the accuracy of your test results, it is recommended to perform quality control on routine
bases by use of control fluids. Perform quality control in compliance with local regulation and procedure which you have to obey. Also, it is also recommended to do after major repairs are performed on
the analyzer.
7.1
Control Fluids
Use the controls which are prepared for FUJI DRI-CHEM or which are recommended to use.
NOTE Follow the descriptions in the “Instructions for Use” of control fluids.
7.2
Measurement with Control Fluids
Measure with control fluids by following the same procedure as for measurement of patient samples.
Load the control fluid in the sample loading position of the sample rack, load a slide, and then measure.
7.3
Monitoring Results
Configure the target values and acceptable ranges for measurements from control fluid results, and
monitor for changes over time.
7.4
Control Mode
You can measure control liquid by using [Control] of the Function menu to configure the entered correlation coefficients “a” and “b” to a = 1 and b = 0 temporarily. This state is called Control mode.
è Refer to Section 9.1
After using this mode, always cancel control mode by tapping [HOME] on the LCD.
7.5
Troubleshooting Quality Control Results
If there is a discrepancy in the control fluid measurement results, confirm the following points, and
then measure the control fluid again.
• Make sure that the periodic cleaning and replacement of consumables listed in this manual are
being performed.
• Make sure the handling methods, storage conditions, usage limitations, and other details listed in
the “Instructions for Use” of slides have been observed.
If the control results are still a problem, please contact your dealer.
897N203029A FDC NX600 Instruction Manual 2022.01
7-1
7
7 Quality Control
7.6
Control Chart
1. Tap the
button.
2. Tap the [Control] button.
7
3. The measurement-preparation screen of
control mode appears.
4. Tap the
7-2
(graph display) button.
897N203029A FDC NX600 Instruction Manual 2022.01
7 Quality Control
5. Tap the button of the measurement item
to be viewed.
6. The control chart appears.
NOTE If the control liquid button is tapped, you
can change the control liquid to be displayed.
NOTE Measurement results of outside of
measurement range (@), disposal box
open (*), and expired slide (#) are not
reflected in the control chart.
NOTE If the measurement date is touched and
selected, and the show/hide button is
touched, the plot of these measurement
results can be hidden (or shown).
Show/hide
button
Acceptable
range
lower limit
Acceptable
range
upper limit
Measurement
result average
Outside of display
area
Control lot was
changed
Control lot was
changed
Outside of acceptable range
897N203029A FDC NX600 Instruction Manual 2022.01
7-3
7
7 Quality Control
7. If a measurement date is selected and
then the [Detail] button is tapped, the detail screen appears.
< Display of measurement results >
Green: when within the acceptable range of control
Red: when outside of the acceptable range of control
7
Acceptable
range
lower limit
Acceptable
range
upper limit
NOTE The acceptable range of control displays
the value entered for Range setting for
control (Refer to Section 9.3.17).
NOTE In case of ALPi and LDHi slides, the
display of “Test name” will not follow the
“Test Item Name Setting”, but “ALPi-PS”
or “LDHi-PS”.
But, the test name of each measurement result will follow the “Test Item
Name Setting”.
è Refer to Section 9.3.20.
7-4
897N203029A FDC NX600 Instruction Manual 2022.01
8
Troubleshooting
WARNING:
When you troubleshoot, always wear gloves, a lab coat, and safety goggles.
If you accidentally touch a contaminant, immediately rinse the contaminated area thoroughly under
running water, and then disinfect the area.
Seek medical assistance if necessary.
IMPORTANT:
If an analyzer malfunction (error) appears before or during measurement or warnings appear in the
measurement results, the measurement results may be inaccurate. Refer to the related troubleshooting pages and rerun the measurement.
8.1
Error Display
If an error occurs, an error message appears on the LCD.
< Example of display >
Error code
Content of error message
Additional information
NOTE Some error codes may show additional information.
(Example)
1050 (GLU-P slide code)
120001 (Lot number)
*Refer to Section 8.3 for slide codes.
NOTE The error messages listed in this document and the descriptions displayed on the LCD may
differ.
897N203029A FDC NX600 Instruction Manual 2022.01
8-1
8
8 Troubleshooting
8.1.1 Error Log
You can view the history of errors that occurred by using [Error log] in the function menu.
1. Tap the
button.
2. Tap the [Error log] button.
An error log list is displayed.
8
3. Tap an error.
The error details are displayed.
8-2
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
8
897N203029A FDC NX600 Instruction Manual 2022.01
8-3
8 Troubleshooting
8.1.2 Error Code and Reference Section Table
Error code
8
8-4
Error description
Reference
section
Reference
page
E0021
The disposal box was open during measurement
8.2.15
8-42
E0035
Photometric control system error
8.2.8
8-24
E0050
Light source lamp is burned out
8.2.5 (2)
8-20
E0080
Tip detection sensor error
8.2.15
8-42
E0082-E0085
Tip mounting error
8.2.4 (1)
8-11
E0086, E0087
Tip disposal error
8.2.4 (2)
8-12
E0111, E0112
Clogging error during sampling of sample
8.2.4 (5)
8-14
E0121, E0122
Clogging error during sampling of diluent
8.2.4 (8)
8-17
E0124
Clogging error during sampling of diluted sample
8.2.4 (5)
8-14
E0125
Clogging error during sampling of diluted sample
8.2.4 (5)
8-14
E0127, E0128
Clogging error during sampling of reference fluid
8.2.4 (8)
8-17
E0132, E0133,
E0150
PF errors
8.2.12
8-36
E0154
Mixing cup error
8.2.4 (3)
8-13
E0160
Incorrect diluent type error
8.2.10
8-32
E0200-E0203,
E0210-E0213,
E0220-E0227
Slide transfer error
8.2.6
8-21
E0300, E0301,
E0302
Reference white plate measurement error during
initial operation
8.2.8
8-24
E0509, E0510
Signal system error inside circuit board
8.2.8
8-24
E0511
Light intensity error
8.2.5 (1)
8-19
E0515, E0516,
E0517
Signal system error inside circuit board
8.2.8
8-24
E0530, E0531
ISE measurement unit (self-test) error
8.2.11 (1)
8-33
E0532, E0533,
E0537, E0538
Signal system error inside circuit board
8.2.8
8-24
E0534, E0535,
E0536, E0539,
E0540
Signal system error inside circuit board
8.2.8
8-24
E0565
ISE temperature control error
8.2.7
8-22
E0600-E0604
Incubator motor error
8.2.6
8-21
E0700-E0703
ISE measurement unit motor error
8.2.6
8-21
E0900-E0903
Interference filter motor error
8.2.5 (3)
8-20
E1000-E1003
Sampler vertical operation error
8.2.4 (9)
8-18
E1100-E1103
Sampler rotation error
8.2.4 (9)
8-18
E1200-E1203
Syringe operation error
8.2.4 (9)
8-18
E1300-E1304
Errors related to PF
8.2.12
8-36
E1400-E1403
Sample application unit feed error
8.2.6
8-21
E1500, E1501,
E1505
Temperature control error
8.2.7
8-22
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
Error code
Error description
Reference
section
Reference
page
E1502, E1503,
E1504
Temperature control error
8.2.7
8-23
E1510, E1511,
E1512, E1514,
E1515
ISE temperature control error
8.2.7
8-22
E1520, E1521
Installation environment temperature error
8.2.7
8-22
E1530, E1531,
E1532
Signal system error inside circuit board
8.2.8
8-25
E1600-E1603
Consumable disk operation error
8.2.6
8-21
E1750-E1755,
E1757
Slide reading control system error
8.2.8
8-25
E3900
Signal system error inside circuit board
8.2.8
8-25
E4200, E4201
Calibration error
8.2.14 (3),
(4)
8-39
E4202, E4203
Calibration error
8.2.14 (5)
8-40
E4204
Calibration error
8.2.14 (6)
8-41
E4205
Calibration error
8.2.14 (5)
8-40
E4401, E4403
Signal system error inside circuit board
8.2.8
8-25
E4410
Measurement result reference error
8.2.8
8-25
E4411
Control chart reference error
8.2.8
8-25
E4454, E4475,
E4478-E4481,
E4490, E4600E4613
Signal system error inside circuit board
8.2.8
8-26
E5101, E5102,
E5103
Printer error
8.2.2 (3)
8-10
E5500
Signal system error inside circuit board
8.2.8
8-28
E5510
Slide position offset during measurement
8.2.5 (4)
8-20
E5901
Signal system error inside circuit board
8.2.8
8-28
E6200, E6201,
E6210
Communication error
8.2.13 (1)
8-37
897N203029A FDC NX600 Instruction Manual 2022.01
8
8-5
8 Troubleshooting
Error code
8
8-6
Error description
Reference
section
Reference
page
W0020
The disposal box is open
8.2.15
8-42
W0022
The disposal box is full
8.2.15
8-42
W0030
Insufficient light intensity
8.2.5 (1)
8-19
W0036
Reference black plate soiling
8.2.5 (1)
8-19
W0040, W0041
The sample type configuration and sample type
of the slide do not match
8.2.10
8-31
W0042, W0043
Sample rack configuration error
8.2.10
8-31
W0060
Insufficient sample or calibrator volume
8.2.4 (4)
8-13
W0070
Sampler rotation error
8.2.4 (9)
8-18
W0088, W0089,
W0096
Sample tip detection error
8.2.4 (1)
8-11
W0090
The ISE slide is loaded in reverse
8.2.10
8-31
W0091, W0092
ISE measurement error
8.2.11 (3)
8-35
W0120
Sample surface cannot be detected
8.2.4 (4)
8-13
W0123, W0129
Liquid volume error
8.2.4 (7)
8-16
W0134, W0138
PF errors
8.2.12
8-36
W0137
PF card has not been read
8.2.9 (3)
8-29
W0140
Liquid volume error
8.2.4 (4)
8-13
W0141-W0144
Liquid volume error
8.2.4 (7)
8-16
W0151, W0152
Mixing cup error
8.2.4 (3)
8-13
W0170
QC card has not been read
8.2.9 (2)
8-29
W0173
The slide information has not been read
8.2.3
8-11
W0175
No slides have been set
8.2.10
8-31
W0180
Calibration has not been performed with an immuno-chemical test
8.2.14 (1)
8-39
W0190, W0191
Calibration error
8.2.14 (2)
8-39
W0214
Slide transfer error
8.2.6
8-21
W0500-W0503
Malfunction of the internal fan
8.2.15
8-42
W0704
ISE measurement unit motor error
8.2.6
8-21
W0904
Interference filter motor error
8.2.5 (3)
8-20
W1004
Sampler vertical operation error
8.2.4 (9)
8-18
W1104
Sampler rotation error
8.2.4 (9)
8-18
W1204
Syringe operation error
8.2.4 (9)
8-18
W1308
PF errors
8.2.12
8-36
W1404
Sample application unit feed error
8.2.6
8-21
W1604
Consumable disk operation error
8.2.6
8-21
W1700
Malfunction of the QC card reader
8.2.9 (5)
8-30
W1703
QC card read ERR
8.2.9 (5)
8-30
W4010
QC type has not been read
8.2.9 (2)
8-29
W4011
Panel card error
8.2.9 (5)
8-30
W4012
DI card error
8.2.9 (4)
8-30
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
Error code
Error description
Reference
section
Reference
page
8.2.9 (5)
8-30
W4013, W4014,
W4015
QC card error
W4440
Setting value reset warning
8.2.15
8-43
W4460-W4475,
W4477, W4483
Signal system error inside circuit board
8.2.8
8-26
W4500, W4501,
W4502
Serial communication error
8.2.13 (1)
8-37
W4510
LAN communication error
8.2.13 (1)
8-37
W4511
Type 4 LAN communication error
8.2.13 (1)
8-37
W4520
Error related to work list
8.2.13 (1)
8-37
W4720
Clock time error
8.2.8
8-27
W4721, W4733
Signal system error inside circuit board
8.2.8
8-28
W5000, W5020
Signal system error inside circuit board
8.2.8
8-28
W5002-W5019
USB memory read error
8.2.8
8-28
W5050
USB memory has not been inserted
8.2.8
8-28
W5100
Printer error
8.2.2 (3)
8-10
W5110
No recording paper
8.2.2 (3)
8-10
W5330-W5332
Sample barcode reader error
8.2.13 (2)
8-38
W5400
Expired slide
8.2.10
8-32
W66xx
Input value waring
8.2.15
8-43
I5920
Reboot warning
8.2.15
8-42
8
897N203029A FDC NX600 Instruction Manual 2022.01
8-7
8 Troubleshooting
8.1.3 Printout Reference Table
Printout
H
L
>
<
@
Meaning and conditions
Measurement value is higher than the upper limit of the
preset reference interval.
Measurement value is lower than the lower limit of the
preset reference interval.
Measurement value is higher the upper limit of the measurement range.
Measurement value is lower than the lower limit of the
measurement range.
The measurement values are reference values outside
the measurement range.
Troubleshooting
-
-
IMPORTANT:
Measurement values might be incorrect.
+ OR
- OR
+, -, $
*, ?
E
&
8
8-8
Measurement value of the ISE test is higher than the upper limit of the measurement range.
Measurement value of the ISE test is lower than the lower
limit of the measurement range.
Temperature control error during measurement.
Light intensity is fluctuating during measurement.
Unable to calculate the measurement result because
measurement was interrupted due to a transfer problem
or other error.
The measurement results are printed as [****].
Abnormally high measurement value. The glucose value
of the sample is high in a CRP measurement. In the case
of a Ca-P slide, the sample has not been applied.
Refer to Section 8.2.11
Refer to Section 8.2.11
Refer to Section 8.2.7
Refer to Section 8.2.5
Check whether other errors
have occurred, and then
perform the necessary troubleshooting.
Rerun the measurement.
Perform a dilution measurement by following the
“Instructions for Use” of
the slides.
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
#
The valid term of the slide has expired.
For immuno-chemical tests, the validity term of the slide or
the validity term of calibration has expired.
IMPORTANT:
The measurement value might be incorrect.
IMPORTANT:
Expired slides cannot be used. Always use valid
slides.
IMPORTANT:
Use slides within their
validity terms.
Analyzer will not show # whose means that ISE
slides have been expired if the installed software is
version 1.0.
Otherwise, with the software version 1.1 or later
is installed, analyzer will show # for the ISE slides
that expire 2023 or later or of lot number 130000 to
139999.
¥
NOTE Depending on the device settings, there may be
cases in which # is not displayed, and an expired
slide cannot be measured.
Problem with sample application on slide (not applied)
Rerun the measurement.
(Supplement) Measurement range
The measurement range (determination range) and the reference interval differ by measurement item. Their relation is shown below. For details, refer to the “Instructions for Use” of the
slides.
NOTE You can set the values of the reference interval by using [Reference interval range setting] in Mode function for administrator. (Refer to Section 9.3.6)
High
Measured value
Reference
interval
Measurement range
(Determination range)
Low
897N203029A FDC NX600 Instruction Manual 2022.01
8-9
8
8 Troubleshooting
8.2
Troubleshooting
8.2.1 Startup Errors
(1) The analyzer does not start after the power button is pressed.
Check that the power cable is properly connected. And, turn the power switch OFF and ON
again, and press the power button.
If the analyzer still does not start, please contact your dealer for assistance.
8.2.2 Printer or LCD Trouble
(1) Printed characters are too faint or dark
Please contact your dealer for assistance.
(2) White lines appear on printed characters or certain parts of characters are
missing.
The printer head has malfunctioned. Please contact your dealer for assistance.
(3) Printer errors
Error
code
8
Error message
Error condition
Troubleshooting
W5110
Printer error
No paper.
Set paper.
No recording paper.
Load recording paper onto the printer.
è Refer to Section 6.4
W5100,
E5101,
E5102,
E5103
Printer error
Contact your dealer in
case the ERR repeats.
The printer is malfunctioning.
Please contact your dealer for assistance.
(4) LCD is too faint or dark
Adjust the brightness using [Brightness • Volume] in Normal mode.
è Refer to Section 9.2.2
8-10
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
8.2.3 Slide Reading Errors
Error
code
W0173
Error message
Error condition
Slide identification
ERR
No slide information.
Check the slide.
The slide information
on backside of the slide
could not be read correctly.
Troubleshooting
Clean the slide reader, and then rerun
the measurement.
è Refer to Section 6.7
NOTE If the error occurs again, please
contact your dealer for assistance.
8.2.4 Sampler Errors
(1) When tip cannot be mounted
Error
code
E0082,
W0088
E0083,
W0089
Error message
Error condition
Sample tip detection No tip can be detected
on the sample nozzle
ERR
after mounting.
No tip detected.
Set tips and rerun the
tests from the beginning.
Reference fluid tip
detection ERR
No tip detected.
Set tips and rerun the
tests from the beginning.
No tip has been detected on the reference fluid nozzle after
mounting.
Troubleshooting
The tip is not loaded correctly. Load
a tip correctly, and then rerun the test
from the beginning.
è Refer to Section 5.2
NOTE Set tips into all holes of the tip
rack after this error has occurred.
8
E0084
If the error occurs again, please contact
Sample tip clogging A clog was detected
during mounting of the your dealer for assistance.
ERR
sample nozzle tip.
Rerun the tests from
the beginning.
Contact your dealer in
case the ERR repeats.
E0085
Reference fluid tip
clogging ERR
Rerun the tests from
the beginning.
Contact your dealer in
case the ERR repeats.
A clog was detected
during mounting of the
reference fluid nozzle
tip.
W0096
No tip WARNING
Tip is insufficient.
Set tips and rerun the
test from the beginning.
The number of tips
needed for measurement is insufficient.
897N203029A FDC NX600 Instruction Manual 2022.01
Load tips in all holes of the tip rack.
8-11
8 Troubleshooting
(2) When tip cannot be ejected
Error
code
Error message
Error condition
E0086
Sample tip eject ERR Tips cannot be discarded.
After analyzer shutdown, please check
the disposal box.
Turn the power ON.
E0087
Reference fluid tip
eject ERR
After analyzer shutdown, please check
the disposal box.
Turn the power ON.
Troubleshooting
After analyzer shutdown, empty disposal box, and then turn the power ON.
8
8-12
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
(3) When there are insufficient number of or no mixing cups
Error
code
Error message
Error condition
Troubleshooting
W0151
There are not enough
Lack of mixing cup
mixing cups.
Lack of mixing cups.
Set mixing cup and rerun the tests from the
beginning.
W0152
No mixing cup
Set mixing cup and rerun the tests from the
beginning.
E0154
Mixing cup detection Error of the mixing cup If the error still occurs after switching
sensor ERR
detection sensor.
the analyzer off and on, please contact
your dealer for assistance.
Contact your dealer.
After you replace the mixing cups, rerun from the measurement request.
è Refer to Section 5.3
(4) During a sample volume error
Error
code
Error message
Error condition
Troubleshooting
Either the sample is
not loaded or the sample volume is insufficient.
Make sure that the sample volume in
the tube is within the measurable range
and an appropriate sample tube is used
in the sample rack, and then rerun from
the measurement request.
W0120
Sample shortage
Sample is insufficient.
Check the sample.
W0060
Sample shortage
There is not enough
Check the sample vol- sample volume.
ume.
Confirm that a sample rack matching the
sample tubes is used.
W0140
S u r f a c e d e t e c t i o n There is too much
ERR (sample)
sample volume.
Sample volume is too
much.
Check the sample volume.
897N203029A FDC NX600 Instruction Manual 2022.01
NOTE If the sample volume is low, add
sample to the tube or perform
manual sample application.
8-13
8
8 Troubleshooting
(5) During a sample aspiration or application error
Error
code
E0111
Error message
Error condition
Aspiration clogging Clogging was detected
ERR (sample)
during sample aspiraClogging was detected tion.
during sampling.
Check the sample.
E0124
Aspiration clogging
ERR (diluted sample)
Clogging was detected
during sampling.
Check the sample and
diluent.
E0112
S p o t t i n g c l o g g i n g A clog was detected
ERR (sample)
during sample applicaClogging was detected tion (dispensing).
during sampling.
Check the sample.
E0125
S p o t t i n g c l o g g i n g A clog was detected
ERR (diluted sample) during sample applicaClogging was detected tion (dispensing).
during sampling.
Check the sample and
diluent.
8
8-14
Troubleshooting
The sample may contain fibrin deposits.
After checking the sample, rerun from
the measurement request.
NOTE If the error occurs again, there
might be a piping system problem. Please contact your dealer
for assistance.
The sample may contain fibrin deposits.
After checking the sample, rerun from
the measurement request.
NOTE If the error occurs again, there
might be a piping system problem. Please contact your dealer
for assistance.
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
(6) When application is poor
Error
code
Error message
Sample application problem
Error condition
Troubleshooting
Because the sample is Check the following points.
not applied to the slide, (a) Make sure that FUJI DRI-CHEM
the error mark [<] or [@]
AUTO TIPS are being used.
appears continuously. (b) Make sure that tips are not being
reused.
IMPORTANT: (c) Make sure that there are no bubbles on the sample surface in the
Measurement values
sample tube.
with an [@] mark
(d) Make sure that a sample rack that
might be incorrect.
matches the blood collection tube
Run the measureor FUJI tube is being used.
ment again.
(e) Inspect the sampler O-ring. (Refer
to Section 6.6.2)
IMPORTANT:
FUJI DRI-CHEM AUTO TIPS cannot
be reused.
NOTE If errors still occur often, please
contact your dealer for assistance.
8
897N203029A FDC NX600 Instruction Manual 2022.01
8-15
8 Troubleshooting
(7) During a diluent/reference fluid volume error
Error
code
Error message
Error condition
W0141
Surface detection ERR There is too much dilu(diluent)
ent volume.
Diluent volume is too
much.
Check the diluent volume.
W0142
Surface detection ERR There is too much ref(reference fluid)
erence fluid volume.
Reference fluid is too
much.
Check the reference
fluid volume.
W0123
Diluent is insufficient. There is not enough
Diluent is insufficient. diluent.
Check the diluent.
W0143
Diluent is insufficient.
Diluent is insufficient.
Check the diluent volume.
W0129
Insufficient reference There is not enough
fluid
reference fluid.
Reference fluid is insufficient.
Check the reference
fluid.
W0144
Insufficient reference
fluid
Reference fluid is insufficient.
Check the reference
fluid volume.
8
8-16
Troubleshooting
Follow the instructions of the error code
to replace the diluent or reference fluid,
and then rerun from measurement request.
• Diluent è Refer to Section 5.4
• Reference fluid è Refer to Section
5.5
NOTE Replace the diluent / reference
fluid container with a new one.
Do not add diluent or reference
fluid.
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
(8) During a diluent / reference fluid error
Error
code
E0121
E0122
Error message
Error condition
Troubleshooting
Aspiration clogging Clogging was detected
ERR (diluent)
during diluent aspiraClogging was detected tion.
during sampling.
Check the diluent.
Be sure that FUJI tubes configured in
Tube setting for diluent and reference
fluid (è Refer to Section 9.3.15) are
used. If there was a loading problem,
replace the diluent and reference fluid,
and then rerun from the measurement
Spotting clogging ERR Clogging was detected request.
(diluent)
during diluent applica- NOTE If the error occurs again, there
Clogging was detected tion.
might be a piping system probduring sampling.
lem. Please contact your dealer
Check the diluent.
for assistance.
E0127
Aspiration clogging Clogging was detected
ERR (reference fluid) during reference fluid
Clogging was detected aspiration.
during sampling.
Check the reference
fluid.
E0128
Spotting clogging ERR Clogging was detected
(reference fluid)
during reference fluid
Clogging was detected application.
during sampling.
Check the reference
fluid.
8
897N203029A FDC NX600 Instruction Manual 2022.01
8-17
8 Troubleshooting
(9) During a sampler drive system error
Error
code
W0070
E1000,
E1001,
E1003,
W1004
8
Error message
Error condition
S p o t t i n g p o s i t i o n Rotation error of the
Turn the analyzer off after the measERR
sampler has occurred. urement, and make sure that foreign
matters such as tips and slides are not
Sampler rotation error.
stuck or left inside of the sampler.
S a m p l e r u p / d o w n Up-and-down moveNOTE If the error still occurs after
motor ERR
ment error of the motor
switching the analyzer off and
Problem moving the
on, please contact your dealer
sampler up and down.
for assistance.
Perform inspection.
Contact your dealer.
E1002
Sampler up/down
motor operation ERR
Problem moving the
sampler up and down.
Perform inspection.
Contact your dealer.
E1100E1103,
W1104
Sampler movement Rotation error of the
motor ERR
sampler
Problem with sampler
movement.
Perform inspection.
Contact your dealer.
E1200,
E1201,
E1203,
W1204
Syringe motor ERR
Problem with the syringe.
Contact your dealer.
E1202
Syringe motor operation ERR
Problem with the syringe.
Contact your dealer.
8-18
Troubleshooting
Movement error of the
syringe motor
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
8.2.5 Photometric System Errors
IMPORTANT:
If a photometric system error has occurred, perform each troubleshooting step listed below and
rerun the measurement.
(1) During a fluctuation of light source intensity
Error
code
W0036
W0030
Error message
Error condition
Soiled black plate The reference plate is
WARNING
dirty.
Reference black plate
soiled.
Clean the black plate.
Troubleshooting
Switch off the analyzer and clean each
part listed below.
• Clean the light source unit lens
è Refer to Section 6.5
• Clean the reference plate
Lamp replacement The light intensity of
WARNING
the light source lamp is è Refer to Section 6.3
insufficient.
Low light intensity.
• Clean the photometer
Clean photometer.
è Refer to Section 6.3
After cleaning, switch on the power.
If the errors still occur after cleaning,
replace the light source lamp.
è Refer to Section 6.5
NOTE If the error occurs again, please
contact your dealer for assistance.
E0511
Reference white plate The light intensity is
CAUTION:
ERR
changing during measurement.
Contact your dealer.
The light source lamp gets very hot.
Before cleaning the light source unit
or replacing the light source lamp, turn
off the power, wait at least 5 minutes,
and then check the lamp has cooled.
Error marks “ * ” or “ ? ” are printed
on the results
897N203029A FDC NX600 Instruction Manual 2022.01
8-19
8
8 Troubleshooting
(2) When lamp is burned out
Error
code
E0050
Error message
Lamp replacement
Low light intensity.
Replace the lamp.
Error condition
The light source lamp
is burned out.
Troubleshooting
Switch off the power and replace the
light source lamp. Switch the analyzer
on again after replacement.
è Section 6.5
CAUTION:
The light source lamp gets very hot.
Before cleaning the light source unit
or replacing the light source lamp, turn
off the power, wait at least 5 minutes,
and then check the lamp has cooled.
(3) During an interference filter motor error
Error
code
Error message
Error condition
Troubleshooting
E0900,
E0901,
E0903,
W0904
Filter motor ERR
Movement error of the Switch the analyzer off and on.
Problem with the inter- filter motor
NOTE When the error is not resolved,
ference filter.
please contact your dealer for
Contact your dealer.
assistance.
E0902
Filter motor operation ERR
Problem with the interference filter.
Contact your dealer.
8
(4) Other errors
Error
code
E5510
8-20
Error message
Slide slip ERR
Contact your dealer.
Error condition
Troubleshooting
The slide stop position Contact your dealer and have the incushifted during measbator pressure plate inspected.
urement.
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
8.2.6 Transfer Errors
Error
code
Error message
E0200E0203,
E0220E0227
Feed motor ERR
Problem with the slide
transfer system.
Perform inspection.
Contact your dealer.
E0210E0213,
W0214
Eject motor ERR
Problem with the slide
transfer system.
Perform inspection.
Contact your dealer.
Error condition
Troubleshooting
Movement error of the The sample application unit or the incuslide supply motor
bator may be dirty or the disposal box
may be full of slides and tips. Switch off
the analyzer, and perform the following.
• Cleaning the disposal box
• Cleaning the incubator
è Refer to Section 6.3
• Cleaning the sample application unit
è Refer to Section 6.3
E0600E0604
Incubator motor ERR Movement error of the
Problem with the incu- incubator motor of the
incubator
bator.
Perform inspection.
Contact your dealer.
E0700,
E0701,
E0703,
W0704
Probe motor ERR
Problem with ISE.
Perform inspection.
Contact your dealer.
E0702
Probe motor operation ERR
Problem with ISE.
Perform inspection.
Contact your dealer.
NOTE If the error occurs again, please
contact your dealer for assistance.
Movement error of the
probe motor of the ISE
unit
8
E1400E1403,
W1404
Transfer change motor
ERR
Problem with the slide
transfer system.
Contact your dealer.
E1600E1603,
W1604
C o n s u m a b l e d i s k The disk motor movemotor ERR
ment error in consumProblem with the con- able disk motor
sumable disk.
Contact your dealer.
Movement error of the
ISE transfer motor of
the sample application
unit
897N203029A FDC NX600 Instruction Manual 2022.01
Turn the analyzer off after the measurement, and make sure that foreign
matters such as tips and slides are not
stuck or left around the consumable
disk.
NOTE If the error occurs again, please
contact your dealer for assistance.
8-21
8 Troubleshooting
8.2.7 Temperature Controller Errors
Error
code
E0565
E1500
8
Error message
ISE temperature control ERR
Problem with ISE.
Contact your dealer.
When the measurement results are appended with a “+” or “-”
mark or an error listed
to the left occurs, the
Temperature control temperature inside the
incubator is outside the
ERR
specified range.
Check the ambient
temperature.
Clean the air filter.
Reboot the analyzer.
E1501,
E1505
Temperature control
ERR
Check the ambient
temperature.
Reboot the analyzer.
E1510
ISE temperature control ERR
Check the ambient
temperature.
Clean the air filter.
Reboot the analyzer.
E1511,
E1515
Temperature control
ERR
Check the ambient
temperature.
Reboot the analyzer.
E1520,
E1521
Room temperature
WARNING
Check the ambient
temperature.
Reboot the analyzer.
8-22
Error condition
Troubleshooting
Please contact your dealer for assistance.
Perform the following troubleshooting.
(a) Check the room temperature is
within 15 to 32 °C. If the temperature is out of the range, control the
room temperature.
(b) Switch off the power.
(c) Clean the air filter.
è Refer to Section 6.2
(d) Make sure that thumbscrews of the
incubator are tightened properly
and the incubator cable is connected to the connector properly.
èRefer to Section 6.3.3
(e) Make sure that the sample application unit cover is attached to
the analyzer properly. Tighten the
thumbscrews securely.
(f) Leave the analyzer for about 10
minutes to allow the interior to cool,
and then switch on power.
NOTE If the error occurs again, please
contact your dealer for assistance.
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
Error
code
E1502
Error message
Error condition
Temperature control
ERR
Incubator temperature
sensor disconnected.
Check the incubator
cable. Contact your
dealer.
When the measurement results are appended with a “$” mark
or an error listed to the
left occurs, the incubator cable either is not
connected or has been
severed.
E1503
Temperature control
ERR
Incubator temperature
sensor damaged.
Contact your dealer.
E1504
Temperature control
ERR
Incubator heater disconnected.
Check the incubator
cable. Contact your
dealer.
E1512
ISE temperature con- Disconnection error of
trol ERR
the ISE incubator
ISE temperature control element damaged.
Contact your dealer.
E1514
ISE temperature control ERR
ISE heater disconnected.
Contact your dealer.
897N203029A FDC NX600 Instruction Manual 2022.01
Troubleshooting
Switch off the power and connect the
incubator cable again.
NOTE After inserting the connector of
the incubator cable, you must
turn it to the right to lock it.
è Refer to Section 6.3.3
NOTE If the error occurs again, please
contact your dealer for assistance.
Please contact your dealer for assistance.
8
8-23
8 Troubleshooting
8.2.8 Circuit Board Signal Errors
Error
code
8
Error message
Error condition
E0035
Light too intense
A circuit board signal
error has occurred.
Light too intense.
Contact your dealer in
case the ERR repeats.
E0300,
E0301,
E0302
Gain setting ERR
Contact your dealer in
case the ERR repeats.
E0509
AD conversion calibration ERR
Contact your dealer.
E0510
Faulty A/D controller
Contact your dealer.
E0515
DA conversion initialization ERR
Contact your dealer.
E0516
AD conversion reset
ERR
Contact your dealer.
E0517
AD conversion initialization ERR
Contact your dealer.
E0532,
E0533,
E0537,
E0538
ISE self test AD conversion ERR
For ISE measurement,
turn the power SW
OFF and ON.
Contact your dealer in
case the ERR repeats.
Other parameters
besides ISE can be
measured.
E0534,
E0535,
E0536,
E0539
ISE AD conversion
ERR
For ISE measurement,
turn the power SW
OFF and ON.
Contact your dealer in
case the ERR repeats.
Other parameters
besides ISE can be
measured.
8-24
Troubleshooting
If the error still occurs after switching
the analyzer off and on, please contact
your dealer for assistance.
Please contact your dealer for assistance.
When an error occurs after turning the
power on and off, please contact your
dealer for assistance. Tests other than
ISE do not require a restart.
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
Error
code
Error message
Error condition
Troubleshooting
E0540
ISE AD conversion A circuit board signal
initialization ERR
error has occurred.
For ISE measurement,
turn the power SW
OFF and ON.
Contact your dealer in
case the ERR repeats.
Other parameters
besides ISE can be
measured.
When an error occurs after turning the
power on and off, please contact your
dealer for assistance. Tests other than
ISE do not require a restart.
E1530,
E1531,
E1532
Temperature AD conversion ERR
Contact your dealer.
Please contact your dealer for assistance.
E1750E1755,
E1757
Slide reading unit
failure
Contact your dealer.
If the error still occurs after switching
the analyzer off and on, please contact
your dealer for assistance.
E3900
Internal communication ERR
Contact your dealer.
E4401,
E4403
Save ERR
Contact your dealer.
E4410
Measurement result
reference error
The number of measurement results, with
the new result, currently exceeds capacity.
The selected measurement result was deleted.
This measurement result cannot be
referred.
Control chart reference error
The selected chart is
not up-to-date with the
new measurement.
Please go back to the
parameter selection
screen and display the
chart again.
Please go back to the parameter selection screen and display the chart again.
E4411
897N203029A FDC NX600 Instruction Manual 2022.01
8
8-25
8 Troubleshooting
Error
code
8
Error message
Error condition
Troubleshooting
E4454
Memory loading ERR A circuit board signal
error has occurred.
Contact your dealer.
W4460
W4461
W4464
W4469
W4470
W4473
W4474
Memory recovery
WARNING (Example:
setting info.)
Recovery performed
from backup memory.
Contact your dealer.
W4462
W4463
Memory recovery
WARNING
Recovery performed
from backup memory.
Check whether the
setting for reference
intervals is correct.
Check whether the setting for reference
intervals is correct.
W4465
W4466
W4468
Memory recovery
WARNING
Recovery performed
from backup memory.
Check whether the QC
card is read by confirming the lot number.
If not, re-read the QC
card.
Check the lot information whether the
QC card has been read. If the card has
not been read, read the QC card again.
W4467
Memory recovery
WARNING
Recovery performed
from backup memory.
Check whether the QC
card is read by confirming the lot number.
If not, contact your
dealer.
Check the lot information whether the
QC card has been read. If the card has
not been read, contact your dealer for
assistance.
W4471
W4472
Memory recovery
WARNING
Recovery performed
from backup memory.
Check the control fluid
setting.
Check the setting for control fluids.
8-26
Please contact your dealer for assistance.
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
Error
code
Error message
Error condition
Troubleshooting
E4475,
E4478E4481
Memory initial-value A circuit board signal
recovery ERR
error has occurred.
Recovery performed
from backup memory.
Contact your dealer.
Please contact your dealer for assistance.
W4477
Memory recovery
WARNING
Recovery performed
from backup memory.
Check the Operator ID
setting.
Check the operator ID setting.
W4483
Memory recovery
WARNING (Password)
The administrator
password has been
returned to the default.
Contact your dealer in
case the ERR repeats.
If the error occurs again, please contact
your dealer for assistance.
E4490
File deletion ERR
Contact your dealer in
case the ERR repeats.
Please contact your dealer for assistance.
E4600E4613
Calculation ERR
Contact your dealer.
W4720
Clock setting WARN- The date and time
ING
have been reset.
Set date & time.
Contact your dealer in
case the ERR repeats.
Set the date and time using [Date &
Time settings] in Normal mode.
è Refer to Section 9.2.1
If the error occurs again, please contact
your dealer for assistance.
IMPORTANT:
If the date and time are not adjusted
correctly, the analyzer may fail to determine the expiration of the slides and
the calibration, and the measurement
results may not be accurate.
897N203029A FDC NX600 Instruction Manual 2022.01
8-27
8
8 Troubleshooting
Error
code
8
Error message
Error condition
Troubleshooting
W4721
Clock control failure A circuit board signal
WARNING
error has occurred.
Set date & time.
Contact your dealer in
case the ERR repeats.
Set the date and time using [Date &
Time settings] in Normal mode.
è Refer to Section 9.2.1
W4733
Power switch control
WARNING
Contact your dealer.
Please contact your dealer for assistance.
W5000
USB memory read
ERR
Contact your dealer.
W5002W5019
USB memory read USB memory read erERR
ror has occurred.
Lack of necessary files
in the USB memory.
Check the USB memory, and then reselect a
menu.
Contact your dealer in
case the ERR repeats.
(Failed to copy files
from the USB memory.)
Check the USB memory and retry according to the error message.
If the error occurs again, please contact
your dealer for assistance.
W5020
USB memory write A circuit board signal
ERR
error has occurred.
Contact your dealer.
Please contact your dealer for assistance.
W5050
No USB memory
USB memory can not
be recognized.
Insert USB memory.
If the error occurs again, please contact
your dealer for assistance.
E5500
A b n o r m a l s a m p l e Signal system error
spreading on slide
inside circuit board.
Contact your dealer.
When an error occurs after turning the
power on and off, please contact your
dealer for assistance.
E5901
Software logic ERR
Contact your dealer.
Please contact your dealer for assistance.
8-28
The USB memory is
not inserted.
A software error has
occurred.
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
8.2.9 QC Card, PF Card, and DI Card Errors
(1) When data is not displayed after a QC card is read
Error
code
Error message
Error condition
Problem reading QC
card information
―
Troubleshooting
Read the QC card again after making
sure its correct orientation.
If it does not improve, insert the air
blow nozzle into the QR code reader
slot and blow out the dust inside.
―
Spray by
pushing in
the end of the
nozzle about
50 mm.
(2) When QC information has not been read
Error
code
Error message
Error condition
8
Troubleshooting
W0170
No QC card info
No QC information.
Read QC card.
The QC card of the
slides loaded in the
slide cartridge has not
been read.
Read the QC card of the printed slide
code.
W4010
No QC type info.
No type information
corresponding to the
slide.
Read QC card corresponding to the slide.
There is no type information for the corresponding item.
Read the corresponding QC card.
(3) When a PF card has not been read
Error
code
W0137
Error message
No PF card info.
No PF card info.
Read PF card.
Error condition
Troubleshooting
The PF sample rack
Read the PF card included with the PF.
has been identified,
but no PF card has not
been read.
897N203029A FDC NX600 Instruction Manual 2022.01
8-29
8 Troubleshooting
(4) When a DI card has not been read
Error
code
W4012
Error message
Error condition
No DI info.
There is no DI card
No DI info found. Can- information.
not read this card.
Contact your dealer.
Troubleshooting
Please contact your dealer for assistance.
(5) Other precautions
Error
code
Error message
Error condition
Troubleshooting
W1700
QC card reader failure The card reader has
QC card reader dam- malfunctioned.
aged.
Measurement is still
possible.
Contact your dealer.
Please contact your dealer for assistance.
W1703
QC card read error
QC card read ERR
Check the QC card
direction and re-read it.
(Insert the QR code so
that it faces the far left
side.)
If the error occurs repeatedly, contact your
dealer.
Make sure the card is inserted at correct orientation.
W4011
QC card ERR
Cannot save data.
Panel card read error
Please contact your dealer for assistance.
W4013
QC card ERR
Check whether this is
the correct QC card.
A QC card data error
has occurred.
Check whether the QR code of the QC
card is dirty.
8
NOTE When the error is not resolved,
please contact your dealer for
assistance.
W4014
QC card ERR
The QC card cannot
Cannot read QC card be read at this time.
for “Mode Function
Underway” or “Spotting
Underway”.
Read again after mode
function ends, or after
spotting ends.
After mode function or sample application ends, read the card again.
W4015
Expired QC card
QC card has expired
and cannot be used.
Use QC cards that are before their expiration dates.
8-30
QC card has been
expired.
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
8.2.10 Slide Loading Errors
Error
code
Error message
Error condition
Troubleshooting
W0040
Incorrect sample
WARNING
The sample type set
in analyzer does not
correspond to the read
sample type.
Set the sample type
by SAMPLE key and
the slide’s sample type
corresponding to the
sample. Rerun the
tests from the beginning.
The sample type selected by the [Sample
type] button and the
sample type of the
slide do not match.
(Example)
• Whole blood (W)
slides were loaded
when either [P/S] or
[U] had been selected by the [Sample
type] button.
• Plasma/serum (P)
slides were loaded
when [W] had been
selected by the
[Sample type] button.
Match the configuration by the [Sample
type] button and the sample type to
measure the slide to be used, and then
rerun the measurement from the beginning.
W0041
Incorrect sample type The sample type setWARNING
ting of PF measurement does not match.
Although a PF sample rack is loaded, the
sample type setting is
not P/S.
Set the sample type to P/S.
W0042
Incorrect sample rack
WARNING
Correct sample rack
not set in place.
Check the sample
rack.
Load a PF sample rack in which a
sample extracted by PF has been
loaded.
A re-run test for a
measurement by using PF is attempted,
but a rack other than
a PF sample rack was
loaded.
8
A PF sample rack has Load a sample rack other than a PF
been loaded for a con- sample rack.
trol measurement.
A sample rack other
Load a sample rack for calibrator CP.
than for CP has been
loaded for a calibration
measurement.
W0043
N o s a m p l e r a c k No sample rack is
WARNING
loaded.
Sample rack is not set.
Set a sample rack.
W0090
ISE slide direction The ISE slide is loaded Load the ISE slide in the slide cartridge
in reverse.
in the proper direction, and then measERR
ure again.
Incorrect loading direction of ISE slide.
Check the ISE slide.
897N203029A FDC NX600 Instruction Manual 2022.01
Set a sample rack.
8-31
8 Troubleshooting
Error
code
Error message
Error condition
Troubleshooting
E0160
Incorrect diluent type Diluent type does not
error
match the slide to be
used.
Diluent type is incorrect.
Use specified diluent
for the test name.
W0175
No slide
Slides have not been
set.
Rerun the tests from
the beginning.
No slides are loaded in Load slides to be tested, and rerun the
the slide cartridge.
tests from the beginning.
W5400
Expired slide
Slide is expired and
cannot be used.
The validity term of the Always use valid slides.
slide has expired.
Use specified diluent for the test name,
and rerun the measurement from the
beginning.
IMPORTANT:
Slide validity may not be detected in
ISE tests.
è Refer to Section 8.1.3
NOTE Depending on the device settings, this warning may not be
generated.
8
8-32
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
8.2.11 ISE Measurement Errors
IMPORTANT:
ISE measurement values to which error codes have been appended (E1 - E8) may not be correct.
Perform the following troubleshooting and rerun the measurement.
(1) When a self-test error occurred
Error
code
Error message
Error condition
E0530
ISE self test gain ERR
For ISE measurement,
turn the power SW
OFF and ON.
Contact your dealer in
case the ERR repeats.
Other parameters
besides ISE can be
measured.
An error was detected
during a self-test performed before the start
of an ISE measurement.
E0531
ISE self test offset
ERR
For ISE measurement,
turn the power SW
OFF and ON.
Contact your dealer in
case the ERR repeats.
Other parameters
besides ISE can be
measured.
897N203029A FDC NX600 Instruction Manual 2022.01
Troubleshooting
The analyzer must be restarted for an
ISE measurement. If the error occurs
again, please contact your dealer for
assistance.
Tests other than ISE do not require a
restart.
8
8-33
8 Troubleshooting
(2) Errors are appended to measurement results
Check menu
Description
Drift check
Checking abnormal time course
(voltage) during testing
Impedance check
Checking the slide impedance
after completing a test
Over range check
Checking test result is within
the measurement range
Code:
During an ISE measurement, the checks listed
in the table to the left are performed.
If there is a problem with a measurement value,
an error code from E1 through E8 is appended
to the measurement result.
Description
E1
Drift error
E2
Impedance error
E3
Outside of the measurement range (This is not an analyzer malfunction.)
E4
Drift error and impedance error
E5
Impedance error and outside of the measurement range
E6
Drift error and outside of the measurement range
E7
Drift error, impedance error, and outside of the measurement range
E8
Impossible measurement
< When the error code is not E3 >
The sample or reference fluid may have not been sufficiently absorbed into the slide. Perform the following troubleshooting steps.
8
1. Inspect the sampler O-ring. è Refer to Section 6.6.2
2. Clean the spotting part and ISE probe unit. è Refer to Section 6.3.2
3. Make sure that the analyzer can measure correctly. è Refer to Chapter 7
NOTE If the error occurs again, please contact your dealer for assistance.
< When the error code is E3 >
There is no problem with the analyzer. The concentration of the sample is outside of the measurement range.
NOTE Refer to the “Instructions for Use” of the slide for the measurement range.
8-34
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
(3) Other Errors
Error
code
Error message
Error condition
Troubleshooting
W0091
Unacceptable ISE
test
ISE tests cannot run.
Turn the power SW
OFF and ON. Rerun
the tests from the beginning.
An ISE measurement
error has occurred,
and ISE measurement
cannot be started.
Check ISE measurement errors that occurred before this error, and then carry
out the corresponding troubleshooting.
After troubleshooting, turn the power
of the device on and off, and then start
measurement again from the beginning.
W0092
Unacceptable ISE
manual pipetting
ISE test cannot be
done in this test mode.
Set a measurable slide
and redo the test from
the beginning.
There was an attempt
to measure an ISE
slide using manual
sample application
measurement.
Measure an ISE slide using automatic
sample application.
8
897N203029A FDC NX600 Instruction Manual 2022.01
8-35
8 Troubleshooting
8.2.12 PF Errors
Error
code
8
Error message
Error condition
Troubleshooting
E0132
PF pressure ERR
Replace the PF pump
tube.
A pressure error ocReplace the PF Tube.
curred during the filter- è Refer to Section 6.9.4
ing process.
E0133,
E0150
PF sensor ERR
Contact your dealer.
A PF sensor error has
occurred.
W0134
PF sampling ERR
Error occurred during
PF sampling.
Check for a PF leak.
An error occurred dur- Clean the PF Suction Pad.
ing PF filtering.
è Refer to Section 6.9.1
W0138
Unacceptable PF
sampling WARNING
For PF measurement,
turn the power SW
OFF and then ON.
Contact your dealer in
case the ERR repeats.
Measurements other
than PF measurements
can be measured without turning the power
SW OFF and then ON.
A PF measurement
error has occurred,
and PF measurement
cannot be started.
Check PF measurement errors that occurred before this error, and then carry
out the corresponding troubleshooting.
After troubleshooting, turn the analyzer
on and off, and then start measurement
again from the beginning.
E1300,
E1301,
E1303,
E1304
PF motor ERR
PF motor error moveProblem with the plas- ment error
ma filter.
Contact your dealer.
Turn the power on and off. If the error
occurs again, please contact your dealer
for assistance.
W1308
PF sensor ERR
A PF sensor error has
Problem with the plas- occurred.
ma filter.
Contact your dealer.
Please contact your dealer for assistance.
E1302
PF motor operation PF motor error moveERR
ment error
Problem with the plasma filter.
Contact your dealer.
Turn the power on and off. If the error
occurs again, please contact your dealer
for assistance.
8-36
Please contact your dealer for assistance.
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
8.2.13 Errors Related to Data Communication, Sample Barcode Reader
(1) When a communication error occurs
Error
code
W4500,
W4501,
W4502
Error message
Error condition
Serial communica- Serial communication
tion ERR
error
Check the specifications and connection
of the communication
cable. Contact your
dealer in case the ERR
repeats.
Troubleshooting
Check the following: communication
cable, host computer, and communication destination settings.
è Refer to Section 9.3.2
NOTE If the error occurs again, please
contact your dealer for assistance.
W4510
LAN communication LAN communication
ERR
error
Check the specification
and the connection
of the communication
cable.
Contact your dealer in
case the ERR repeats.
W4511
Type 4 LAN commu- Type 4 LAN communi- Check the host computer and type 4
nication ERR
cation ERR
settings.
Check whether the setè Refer to Section 9.3.2
ting for type 4 or host
NOTE If the error occurs again, please
computer is correct.
contact your dealer for assisContact your dealer in
tance.
case the ERR repeats.
W4520
Incorrect work list in- The received work list
formation
information does not
Check whether work list match specifications.
information for the host
computer is correct.
Contact your dealer in
case the ERR repeats.
E6200,
E6201,
E6210
Check the work list information.
NOTE If the error occurs again, please
contact your dealer for assistance.
Communication ERR A communication error Please contact your dealer for assishas occurred.
tance.
Contact your dealer.
897N203029A FDC NX600 Instruction Manual 2022.01
8-37
8
8 Troubleshooting
(2) Sample barcode reader error
Error
code
Error message
Error condition
Troubleshooting
W5330
Barcode reader not The sample barcode
Connect the sample barcode reader to
connected
reader is not connected. the USB connector, and then turn the
analyzer off and on.
Check the barcode
reader connection.
W5331
Exceeded number of Barcode label error
characters from barcode reader
The number of input
characters from the bar
code reader exceeded
the capacity.
Check the barcode label.
W5332
Barcode WARNING
Barcode data error
Check input value and
re-enter.
Check the input value and re-enter.
8
8-38
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
8.2.14 Calibration Errors
(1) An immuno-chemical test has been performed without calibration.
Error
code
W0180
Error message
Error condition
Troubleshooting
Calibration not per- An immuno-chemical Perform the calibration.
formed
test has been perè Refer to Section 4.1
formed without calibraPerform calibration.
tion.
(2) A slide not suited for calibration has been loaded.
Error
code
Error message
Error condition
Troubleshooting
W0190
Wrong slide for calibration
A slide that does not
require calibration is
loaded. Check the
slide and perform the
calibration from the
beginning.
A slide not suited for
Check the slide. Rerun the calibration
calibration has been
process again.
loaded during the calibration process.
W0191
Wrong slide lot for
calibration
A different lot of slide
other than designated
in the calibration mode
is loaded. Load a slide
corresponding to the
designated lot and
perform the calibration
from the beginning.
A slide different from
Load a slide of the specified lot, and
the lot specified during then calibrate again.
calibration has been
loaded.
8
(3) Insufficient calibration data
Error
code
E4200
Error message
Calibration ERR
Invalid number of
slides
The number of measured slides for the following calibration data
is insufficient or the
sample is unspotted.
Error condition
Troubleshooting
This error may occur
Rerun 2 measurements for the printed
due to a lack of calibra- level.
tion data or no application on the slide.
897N203029A FDC NX600 Instruction Manual 2022.01
8-39
8 Troubleshooting
(4) Calibration result problem
Error
code
E4201
Error message
Error condition
Troubleshooting
Calibration variation The variation of meas- Rerun 2 measurements for the printed
error
urement values during level.
Variations in measured calibration is large.
value for the following
calibration are large.
(5) Standard curve configuration error
Error
code
Error message
Error condition
E4202
Calibration curve set- The wrong calibrator
ting ERR (span error) may have been used.
Misplacement of calibrator.
Check the level and
expiration date of the
calibrator and perform
the calibration from the
beginning.
E4203
Calibration curve setting ERR (range error)
Misplacement of calibrator.
Check the level and
expiration date of the
calibrator and perform
the calibration from the
beginning.
E4205
Calibration calcula- Calibration calculation
tion ERR
problem
Failed in calibration
calculation.
Do the calibration
again.
8
8-40
Troubleshooting
Check the expiration date and the setting position of the calibrator, and then
calibrate again from the beginning.
Calibrate again from the beginning.
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
(6) Measurement errors during calibration
Error
code
E4204
Error message
Calibration measurement ERR
Error in measured
result.
After coping with the
printed error, perform
the calibration from the
beginning.
Error condition
Error marks such as
“ * ”, “ ? ”, and “$” are
printed on the measurement results.
Troubleshooting
Troubleshoot the printed errors and
then calibrate again from the beginning.
8
897N203029A FDC NX600 Instruction Manual 2022.01
8-41
8 Troubleshooting
8.2.15 Other Errors
Error
code
8
Error message
Error condition
Troubleshooting
W0020
No disposal box
Measurement was
started with the disPut Disposal box to
the end and then press posal box pulled out.
START key.
Insert the disposal box completely, and
then start measurement.
E0021
Disposal box open
ERR
Disposal box opened
during measurement.
Close Disposal box
and run the tests from
the beginning.
Close the disposal box, and then start
measurement again from the beginning.
W0022
Disposal box full
The disposal box is full
Disposal box became of slides and tips.
full of slides and tips.
Discard slides and tips
to empty the box when
measurement is not in
progress.
While a measurement is not being performed, discard the slides and tips in
the disposal box.
E0080
Sample tip sensor
ERR
Contact your dealer.
Malfunction of the
sample tip sensor.
Please contact your dealer for assistance.
W0500
Rear fan 1 stop
Contact your dealer.
A fan error has occurred.
W0501
Rear fan 2 stop
Contact your dealer.
W0502
Intake fan stop
Contact your dealer.
W0503
Exhaust fan stop
Contact your dealer.
I5920
Turn the power ON
A long time has passed Switch the analyzer off and on.
30 days or more have since start-up.
passed from when the
analyzer was started.
For stable system
performance, turn the
power ON.
8-42
The disposal box was
open during measurement.
NOTE When there are 150 slides or
75 tips in the disposal box, this
error occurs. If the disposal box
is pulled out, it is determined
that the slides and tips were
discarded, and the disposal
count is reset. Always empty
the disposal box after pulling it
out.
897N203029A FDC NX600 Instruction Manual 2022.01
8 Troubleshooting
Error
code
Error message
Error condition
Troubleshooting
W4440
Setting value reset The settings have
WARNING
been reset.
The reference interval
range setting, control
fluid setting, and correlation coefficients have
been reset. Check the
settings.
Check settings for the reference interval range and the control fluid, and
check correlation coefficients.
W66xx
The entered value is
Input value ERR
Check input value and incorrect.
re-enter.
Check the entered value and enter it
again.
8
897N203029A FDC NX600 Instruction Manual 2022.01
8-43
8 Troubleshooting
8.3
Slide Code Table
Slide code
Test
Test code
Sample code
Slide code
Test
Test code
Sample code
GLU
-P
10
50
GGT
-P
30
50
BUN
-P
11
50
GOT/AST
-P
31
50
UA
-P
13
50
GPT/ALT
-P
32
50
TCHO
-P
14
50
CPK
-P
33
50
NH3
-P
15
50
LDH
-P
34
50
TG
-P
16
50
ALP
-P
35
50
CRE
-P
17
50
LAP
-P
37
50
TP
-P
18
50
CKMB
-P
38
50
ALB
-P
20
50
CHE
-P
39
50
TBIL
-P
21
50
AMYL
-P
43
50
Ca
-P
23
50
LIP
-P
44
50
IP
-P
24
50
TCO2
-P
45
50
DBIL
-P
25
50
CRP
-S
51
50
HDLC
-P
26
50
Na
91
00
Mg
-P
28
50
K
92
00
Cl
93
00
GLU
-W
10
00
NH3
-W
15
00
NOTE Slide codes are subject to change without notice.
Check the slide code printed on the slide box.
8
8-44
897N203029A FDC NX600 Instruction Manual 2022.01
9
If the
Function Menu
(Function menu) button is tapped, the Function menu screen appears.
Function menu list
Function menu items
Settings
Advanced settings
Calibration
—
—
Reference
section
4.1.1
Control
—
—
9.1
START
Manual pipetting
—
—
4.2
Date & Time settings
—
9.2.1
Brightness • Volume
Display brightness
9.2.2
Error sound
Other general sound
Lamp management
Lamp ON time
9
9.2.3
Lamp off timer setting
Lot information
Normal mode
Sampler leak check
—
Sample nozzle
9.2.4
6.6.2
Reference fluid nozzle
Replace O-ring
PF maintenance
—
6.6.3
Cleaning
6.9.1
Leak check
6.9.2
Suction pad
6.9.3
Reference plate level check
—
6.3.1
Cleaning mode
—
6.3.2
897N203029A FDC NX600 Instruction Manual 2022.01
9-1
9 Function Menu
Function menu items
Settings
Advanced settings
Language setting
—
Host connection setting
None
Reference
section
9.3.1
9.3.2
Serial connection
LAN connection
Calculated Parameter
—
9.3.3
Unit conversion
—
9.3.4
Switch measurement range display
—
Reference interval range setting
—
9.3.6
Sample No. /ID settings
—
9.3.7
Work list selection setting
Sample ID / Patient name
9.3.5
9.3.8
Patient ID / Patient name
Mode function for
administrator
Correlation coefficients
—
9.3.9
Lot compensation coefficients
—
9.3.10
Standard curve coefficients
—
9.3.11
Lot Qualification
—
9.3.12
PF calibration coefficients
—
9.3.13
Dilution setting
—
9.3.14
Tube setting for diluent & reference fluid
Diluent
9.3.15
Reference fluid
Print setting for measured result Number of printing sheets
9.3.16
Print order
Print with the ranges
Control fluid setting
—
9.3.17
Control measurement setting
—
9.3.18
Operator ID setting
—
9.3.19
Test item name setting
9
Display and printout
9.3.20
Data transmission
UREA setting
Error log
9-2
Default sample type setting
—
9.3.21
Password setting
—
9.3.22
—
—
8.1.1
897N203029A FDC NX600 Instruction Manual 2022.01
9 Function Menu
9.1
Control
This mode is used for measurement of control serum (FUJI DRI-CHEM CONTROL QP) and for performing control surveys. When control mode is set, measurements are performed under the conditions listed below.
• Correlation coefficients: follow [Control measurement setting] (Initial values disabled (a=1, b=0))
of the function menu.
• Measurement units: follow [Unit settings] of the function menu.
• Dilution conditions: dilution is not normally performed. (This can be configured at the Sample
information registration screen.)
NOTE When the analyzer is switched on again, control mode is canceled.
1. Prepare the slide to be measured, and
then load it on the analyzer.
2. Place the control fluid to be measured in
the tube, and then load it in the sample
position.
è Refer to Section 3.3 (3)
3. Tap the
button.
4. Tap the [Control] button.
9
897N203029A FDC NX600 Instruction Manual 2022.01
9-3
9 Function Menu
5. Enter or choose the sample information.
1
2
3
4
5
6
1 Enter the sample number using the software keyboard (Section 2.3).
2 Enter the sample ID using the software keyboard
(Section 2.3).
3 Select the control liquid from the list (when necessary).
4 Select the control liquid lot from the list (when
necessary).
IMPORTANT:
9
When you configure the control liquid lot, make
sure it matches the lot of the control liquid to be
used. If it does not match, the measurement may
not be valid.
5 For the sample type, generally (in the case of
QP-L, QP-H, and QE) select [Plasma/Serum].
6 For dilution, generally select [None].
9-4
897N203029A FDC NX600 Instruction Manual 2022.01
9 Function Menu
6. Close the sample cover, and then lock it
with the sampler cover lock key.
WARNING:
Ensure the sampler cover is locked during sample
processing to prevent injuries and infection.
When the display reads [Ready to test], the sampler cover can be opened.
7. Tap the [START] button to start control
measurement.
9
897N203029A FDC NX600 Instruction Manual 2022.01
9-5
9 Function Menu
8. After measurement, tap the
button to
check the measurement results.
IMPORTANT:
After using control mode, always tap the [HOME]
button to clear control mode.
<Display of measurement results>
Green: when within the acceptable range of control
Red: when outside of the acceptable range of control
Acceptable
lower limit
Acceptable
upper limit
NOTE The acceptable range of control displays the
value entered for [Control fluid setting] (see
Section 9.3.17).
9
9-6
897N203029A FDC NX600 Instruction Manual 2022.01
9 Function Menu
9.2
Normal Mode
General operators use this function menu to, for example, set the time and configure the brightness
of the LCD.
Settings
Advanced settings
Date & Time settings
Brightness • Volume
—
Display brightness
Reference
section
9.2.1
9.2.2
Error sound
Other general sound
Lamp management
Lamp ON time
9.2.3
Lamp off timer setting
Lot information
Sampler leak check
—
Sample nozzle
9.2.4
6.6.2
Reference fluid nozzle
Replace O-ring
PF maintenance
—
6.9.1
Leak check
6.9.2
Suction pad
6.9.3
Reference plate level check
—
6.3.1
Cleaning mode
—
6.3.2
897N203029A FDC NX600 Instruction Manual 2022.01
9
6.6.3
Cleaning
9-7
9 Function Menu
9.2.1 Date & Time Settings
This mode is used to set the date and time settings stored in the memory.
• Tap “ ” or “ ” to change the date and time
values.
• Configure the order of the year, month, and date
by using [Date format setting].
NOTE The analyzer must be restarted to enable
a change of [Date format setting].
The confirmation dialog for the poweroff will appear when
is tapped to
exit Normal mode. After the shutdown,
reboot the analyzer.
9.2.2 Brightness • Volume
You can configure the brightness of the LCD and buzzer sounds (error warning, measurement completed).
9
• Configure the brightness of the LCD using
and
to set the
[Display brightness]. Use
minimum and maximum brightness.
• Configure the buzzer sound when an error ocand
to
curs by using [Error sound]. Use
set the minimum and maximum.
• Configure the buzzer sound when measurement
ends by using [Other general sound]. Use
and
to set the minimum and maximum. If
is configured, the buzzer is muted.
9-8
897N203029A FDC NX600 Instruction Manual 2022.01
9 Function Menu
9.2.3 Lamp Management
Display and reset the cumulative illumination time of the lamp currently installed in the analyzer. Furthermore, choose whether to turn off the lamp automatically when the analyzer has not been used
for some time.
• You can check the cumulative illumination time
by using [Lamp ON time]. If the [Reset] button is
tapped, the cumulative illumination time is reset.
NOTE Reset the cumulative illumination time
of the lamp after replacing the lamp.
• If the [Lamp off timer setting] checkbox is selected, the lamp is switched off automatically after
some time. You can configure the time until the
lamp is switched off.
NOTE The default setting is 20 minutes.
9.2.4 Lot Information
The screen displays the lot information of currently registered QC cards. You can also print all currently registered lot information.
• When there are two or more pages that can be
displayed, tap the
and
buttons to scroll
the pages.
• If the
button is tapped, all currently registered lot information is printed.
NOTE Up to five lots are registered for one
test.
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9
9 Function Menu
9.3
Mode Function for Administrator
NOTE To display Mode function for administrator, open the Function menu page, tap the [Mode
function for administrator] button, and then enter the password.
NOTE In order to prevent other people from operating the analyzer, the input dialog for the
password will appear when no operation is
performed for a fixed period of time during
the operation of [Mode function for administrator].
Settings
Language setting
Host connection setting
9
Calculated Parameter
Unit conversion
Switch measurement range display
Reference interval range setting
Sample No. /ID settings
Work list selection setting
Correlation coefficients
Lot compensation coefficients
Standard curve coefficients
Lot Qualification
PF calibration coefficients
Dilution setting
Tube setting for diluent & reference fluid
Print setting for measured result
Control fluid setting
Control measurement setting
Operator ID setting
Test item name setting
Default sample type setting
Password setting
9-10
Advanced settings
—
None
Serial connection
LAN connection
—
—
—
—
—
Sample ID / Patient name
Patient ID / Patient name
—
—
—
—
—
—
Diluent
Reference fluid
Number of printing sheets
Print order
Print with the ranges
—
—
—
Display and printout
Data transmission
UREA setting
—
—
Reference section
9.3.1
9.3.2
9.3.3
9.3.4
9.3.5
9.3.6
9.3.7
9.3.8
9.3.9
9.3.10
9.3.11
9.3.12
9.3.13
9.3.14
9.3.15
9.3.16
9.3.17
9.3.18
9.3.19
9.3.20
9.3.21
9.3.22
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9 Function Menu
9.3.1 Language Setting
Configure the language to be used.
Tap the button of language to be configured.
NOTE Rebooting the device is necessary for the
setting to take effect. The confirmation dialog for the power-off will appear when
is tapped to exit Mode function for administrator. After the shutdown, reboot the analyzer.
9.3.2 Host Connection Setting
Configure the connection terminal and communication parameters to connect to the host computer
(PC). Furthermore, switch the built-in printer on or off.
• When you will not connect to a host computer,
set [None].
9
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9 Function Menu
• If [Serial connection] is set, configure the communication type and whether to output from the
printer. You can choose from 3 communication
types.
- Type 1: Bidirectional connection
- Type 2: Unidirectional connection (bidirectional
format)
- Type 3: Unidirectional connection (standard
format)
NOTE Rebooting the device is necessary for
the setting to take effect. The confirmation dialog for the power-off will appear
is tapped to exit Mode function
when
for administrator. After the shutdown, reboot the analyzer.
• If [LAN connection] is set, configure the communication type and whether to output from the
printer. You can choose from 4 communication
types.
- Type 1: Bidirectional connection
- Type 2: Unidirectional connection (bidirectional
format)
- Type 3: Unidirectional connection (standard
format)
- Type 4: Unidirectional connection (HL7 formatted)
was tapped, the LAN configuration
• When
screen appears. If an entry field is tapped, the
software keyboard (refer to Section 2.3) appears
so you can edit the value.
9
NOTE The following section shows the default
LAN settings.
FDC NX600 settings
IP address:192.168.100.1
Subnet mask:255.255.255.0
Port number:65535
Gateway: 0.0.0.0
PC settings
IP address:192.168.100.2
Port number:65535
NOTE Rebooting the device is necessary for
the setting to take effect. The confirmation dialog for the power-off will appear
is tapped to exit Mode function
when
for administrator. After the shutdown, reboot the analyzer.
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9 Function Menu
If the
button is also tapped when Type 4 was
selected, the settings screen of Type 4 of page 3
becomes active.
• Tap [Examination code] to select the standard for
examination item classification code to be used
in communication.
• Tap [MLLP setting] to set MLLP (Minimal Lower
Layer Protocol) in communication.
MLLP is applied to full message in comFull:
munication.
Custom: MLLP is applied to only at the end of
message in communication.
• Tap [Sample type] to select the sample type used
in communication.
NOTE Rebooting the device is necessary for the
setting to take effect. The confirmation dialog for the power-off will appear when
is tapped to exit Mode function for administrator. After the shutdown, reboot the analyzer.
9
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9 Function Menu
9.3.3 Calculated Parameter
You can configure the settings to calculate the following items from simultaneously measured values
and then display the results. Items registered for calculation have their measurement results displayed and printed.
Test name
LDL Cholesterol (LDL-C)
non-HDL Cholesterol
(non HDL-C)
Globulin
Calculation
test name
LDL
non-HDL
GLOB
Albumin/Globulin ratio
ALB/GLOB
Unit
Calculation formula
LDL-C = TCHO value - (HDL-C value + TG value/5) [mg/dL]
mg/dL LDL-C = TCHO value - (HDL-C value + TG value/2.2) [mmol/L]
or
mmol/L NOTE LDL-C is NOT calculated when the measured value of
TG exceeds 400 mg/dL (4.52 mmol/L).
mg/dL non-HDL = TCHO value - HDL-C value
or
mmol/L
g/dL or GLOB = TP value - ALB value
g/L
—
ALB/GLOB = ALB value / (TP value - ALB value)
BUN/CRE = BUN value/CRE value [mg/mg]
BUN/CRE = BUN value ×1,000/CRE value[(SI)]
BUN/Creatinine ratio
GOT/GPT ratio
(AST/ALT ratio)
Sodium/Potassium ratio
9
Anion Gap
BUN/CRE
GOT/GPT
(AST/ALT)
mg/mg
NOTE BUN measured value in SI unit (mmol/L) is
or
shown as molar concentration of Urea. BUN/
(SI)
CRE ratio in SI unit (molar ratio) is shown Urea
concentration/creatinine concentration ratio.
GOT/GPT = GOT value / GPT value
(AST/ALT = AST value / ALT value)
—
NOTE The calculation test name can be changed by
[Test item name setting] in the Mode function for
administrator. è Refer to Section 9.3.20.
Na/K
— Na/K = Na value/K value
mEq/L Anion Gap = Na value - (Cl value + TCO2 value)
Anion Gap
or
mmol/L
IMPORTANT:
Calculation items display a value calculated from simultaneously measured values. Therefore, calculation results are impacted by errors included in measurement values and the effects of interfering materials. Please understand that when you use the results for a diagnosis, you must make an
overall determination in combination with the measurement values is used in the calculation.
NOTE In the case of additional testing and retesting, items subject to calculation must be measured at the same time.
NOTE When there are two or more slides of the same item subject to calculation in the slides
measured at the same time, the initial measurement value is used.
NOTE When the measurement results of items subject to calculation exceed the measurement
range (determination range), the calculation results of this calculation item are displayed
and printed as "****".
NOTE When an item subject to calculation has expired, an (expiry) warning symbol (#) is displayed
and printed for the measurement results of this item and the calculation results.
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9 Function Menu
If the [Calculated Parameter] button is tapped in
Mode function for administrator, precautions for use
of calculation items are displayed. To use calculation items after confirming the precautions, tap the
[OK] button.
Configure the calculation items to be used.
NOTE If the QC card of an item to be used for calculation has not been read, the calculation
item is not displayed.
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9 Function Menu
9.3.4 Unit Conversion
Configure the main unit and secondary unit for each measurement item. The following table shows
the units that can be used for each configuration item and the conversion coefficient
Test
Test
code
Unit (A)
Unit (B) Conversion
coefficient
GLU
10
mg/dL
mmol/L 0.05551
BUN
11
mg/dL
UA
13
TCHO
Test
Test
code
Unit (A)
Unit (B) Conversion
coefficient
GGT
30
U/L
μkat/L 0.0167
mmol/L 0.357
GOT/
AST
31
U/L
μkat/L 0.0167
mg/dL
μmol/L 59.48
GPT/ALT
32
U/L
μkat/L 0.0167
14
mg/dL
mmol/L 0.02586
CPK
33
U/L
μkat/L 0.0167
NH3
15
μg/dL
μmol/L 0.7139
LDH
34
U/L
μkat/L 0.0167
TG
16
mg/dL
mmol/L 0.01129
ALP
35
U/L
μkat/L 0.0167
CRE
17
mg/dL
μmol/L 88.4
LAP
37
U/L
μkat/L 0.0167
TP
18
g/dL
g/L
10
CKMB
38
U/L
μkat/L 0.0167
ALB
20
g/dL
g/L
10
CHE
39
U/L
μkat/L 0.0167
TBIL
21
mg/dL
μmol/L 17.1
AMYL
43
U/L
μkat/L 0.0167
Ca
23
mg/dL
mmol/L 0.25
LIP
44
U/L
μkat/L 0.0167
IP
24
mg/dL
mmol/L 0.3228
TCO2
45
mmol/L
DBIL
25
mg/dL
μmol/L 17.1
CRP
51
mg/dL
HDL-C
26
mg/dL
mmol/L 0.02586
Na
91
mEq/L
mmol/L 1
Mg
28
mg/dL
mmol/L 0.4114
K
92
mEq/L
mmol/L 1
Cl
93
mEq/L
mmol/L 1
mmol/L 1
mg/L
10
NOTE Unit (B)= Unit (A)× Conversion coefficient
NOTE BUN measured value in Unit (B) (mmol/l) is shown as molar concentration of Urea.
• Tap the button of the unit to be used for each
measurement item.
9
Next-page buttons
9-16
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9 Function Menu
9.3.5 Switch Measurement Range Display
Switch the display method for data outside the measurement range (passing the upper/lower limit of
the determination range) for all tests.
• If [@] is configured, an [@] symbol is added to
indicate the displayed measurement value is
outside the measurement range.
• If [< / >] is configured, a value outside the measurement range is displayed by a [<] or [>] symbol.
9
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9 Function Menu
9.3.6 Reference Interval Range Setting
You can add, edit, and change the order of the reference interval names that can be selected when
registering sample information. (Refer to Section 3.3 (4)) Furthermore, you can set a reference interval for each sample type ([P/S, W] or [U]) of a reference interval name.
Adding and editing of reference interval names
Tap the
add.
button of the item you want to edit or
Next-page buttons
If an entry field is tapped, the software keyboard
(refer to Section 2.3) appears so you can edit the
test name and other details. To change the sample
type when configuring the reference interval, tap the
[P/S, W] button or [U] button.
9
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9 Function Menu
Changing the display order
Tap the
button of the test for which you want to
change the display order.
Next-page buttons
Tap the field of the test for which you want to configure the transfer destination, and then tap the [OK]
button.
9
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9 Function Menu
9.3.7 Sample No. /ID Settings
• Configure whether to display the sample number
in the measurement results under [Edit and print
No.].
• Configure whether to record the sequence number of the analyzer under [Store No.].
9.3.8 Work List Selection Setting
Configure whether to display the sample ID or patient ID at the Work list index screen.
9
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9 Function Menu
9.3.9 Correlation Coefficients
Enter, reset, or print the correlation coefficients for each sample type ([P/S,W] or [U]). For details,
refer to “Description of the correlation function” at the end of the document.
IMPORTANT:
Incorrect entry of “a” and “b” causes incorrect measurement results. Always make sure that the
entries (a, b) are correct.
Next-page buttons
Tap the [Data input] button.
button is tapped, all correlation
NOTE If the
coefficient settings are printed.
NOTE If the [Reset all tests] button is tapped, a
reset confirmation screen appears. To reset
the correlation coefficients of all measurement items, tap the [OK] button. To cancel
the reset, tap the [Cancel] button.
9
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9 Function Menu
Tap the button of the measurement item you want
to edit.
NOTE Only measurement items for which QC
cards have been read are displayed.
If the [Input] field of an item is tapped, the software
keyboard (refer to Section 2.3) appears so you can
enter the value.
To change the sample type, tap the [P/S], [W], or [U]
button.
NOTE If the [Reset] button is tapped, a reset confirmation screen appears. To reset the displayed correlation coefficients for the sample type of the selected measurement item,
tap the [OK] button. To cancel the reset, tap
the [Cancel] button.
NOTE If values are entered for "a" and "b" when
values have already been entered, the
current values are not discarded, and corrections are also applied. For details, refer
to following “Description of the correlation
function”.
9
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9 Function Menu
IMPORTANT:
Description of the correlation function
This function is designed to determine the correlation
between the measured data obtained using the FDC
NX600 and the data obtained using the conventional
measuring method with your own instruments.
Y
Y=aX+b
FDC
NX600
Conventional measuring method
using your instruments
Y
(mg/dl)
X
Y=X
Y=0.98X+5
600
The X-axis shows the measured data obtained using your instruments, and the Y- axis shows the
measured data obtained using the FDC NX600.
The correlation regression equation in this case is:
Y = aX + b
After values for the two coefficients (a, b) are registered in the analyzer memory, the FDC NX600
performs compensation calculations internally using the formula: X = (Y-b)/a. In this way, measured
data obtained using the FDC NX600 are adjusted to
match measured data that would be obtained using
your instruments.
Method
In order to obtain a better correlation, it is essential to exercise caution regarding the amount
of data and the sample.
1.
FDC
reference
2.
3.
0
0
A
10
600
B
X
(mg/dl)
Measurement using your instruments
897N203029A FDC NX600 Instruction Manual 2022.01
You can configure a and b values by sample type.
The correlation function is independent of
other compensation functions.
If values for (a, b) have already been input,
old values will not be canceled as follows. If
the old values are represented as (a1, b1),
and the new values as (a2, b2), the resulting values for (a, b) will be determined according to the following formulas:
a=a1×a2
b=a1×b2+b1
9-23
9
9 Function Menu
4. Depending on the values input for (a, b), the
apparent limits of the measurement range
will shift as follows.
(Example) GLU measurements
If a=1 and b=0 (Y=X), the measurement range is 10 to 600 mg/dl. But by
inputting regression coefficients as
shown, the lower limit changes to A
and the upper limit to B.
Printout example
Value
under the
measurement
range
If the regression formula is Y = 0.98X
+ 5:
A = 5 mg/dl
B = 607 mg/dl
Value
above the
measurement
range
Y
(mg/dl)
Y=1.1X-5
Y=X
600
If the regression formula is Y = 1.1X - 5:
A = 14 mg/dl
B = 550 mg/dl
FDC
reference
9
0
0 10 A
B
600
X
(mg/dl)
Measurement using your instruments
Printout example
Value
under the
measurement
range
Value
above the
measurement
range
9-24
If the measured data is below the
measurement range, an “@” mark is
added as shown in the example printout.
If the measured data is above the
measurement range, a “>” sign is printed as shown in the example printout.
IMPORTANT:
Reported values with “@” marks
may not be accurate. Run the measurement again.
897N203029A FDC NX600 Instruction Manual 2022.01
9 Function Menu
9.3.10 Lot Compensation Coefficients
Enter the lot compensation coefficients (c, d, and e) printed on the QC cards of slides. This mode is
needed if it is not possible to read the data directly because the QC card was lost or spoiled.
IMPORTANT:
Incorrect inputs for (c, d, and e) will cause incorrect measurement results.
Make sure that the inputs for (c, d, and e) are correct using this mode.
IMPORTANT:
When the slide type number was changed, even if the new values (c, d, and e) are entered by using this setting, the new standard curve information will not be updated. It is necessary to read the
QC card when the slide type number was changed.
The slide type number is the most significant digit of a lot number.
(Example) The slide type number of “Lot No.123456” is 1.
Tap the button of the “Measurement item - sample
type” you want to edit.
NOTE Only “Measurement item - sample type”
items that have been read from QC cards
are displayed as buttons.
NOTE Immuno-chemical items are not displayed.
NOTE Measurement items are displayed in ascending order of test code, and sample type
is displayed in the following order: [PS] and
[W].
9
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9 Function Menu
Tap the button of the Lot No. for which you want to
enter a lot compensation coefficient.
button is tapped, all lot compenNOTE If the
sation coefficient settings are printed.
If the [Input] field of an item is tapped, the software
keyboard (refer to Section 2.3) appears so you can
enter the value.
NOTE The most significant digit of a [Lot] number
(the type number) is fixed. Enter from the
second digit.
NOTE Incorrect entries will cause incorrect measurement results. Always make sure that the
displayed values are correct.
button is tapped, all lot compenNOTE If the
sation coefficient settings are printed.
9
NOTE For the expiration date for use (EXP), enter
xxxx-xx (four digits for the year and two digits for the month). Also enter the hyphen (-).
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9 Function Menu
9.3.11 Standard Curve Coefficients
The calibration curve coefficients (A, B, C, D, E, and F) of the QC card information can be entered.
IMPORTANT:
Incorrect entry of calibration curve coefficients causes incorrect measurement results.
Always make sure that the entered coefficients are correct.
NOTE The calibration curve coefficients of this setting are entered automatically by QC card reading and calibration.
<Configuring the lot number>
1. Tap the button of the measurement item
for which the calibration curve is to be
edited.
NOTE Only CRP items for which QC cards
have been read are displayed.
2. From the list display area, tap the lot
number for which the calibration curve
is to be edited.
List display area
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9
9 Function Menu
3. If the [Input] field of an item is tapped,
the software keyboard appears so you
can enter the value.
NOTE If the
button is tapped, the calibration curve coefficients are printed.
4. First tap the [Input] field of [Lot].
The Lot number entry screen (software keyboard screen) appears.
5. Enter a lot number, and then tap the [OK]
button.
NOTE The most significant digit (the type
number) is fixed. Enter from the second
digit.
The Calibration curve coefficient (A:) entry
screen (software keyboard screen) appears.
9
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9 Function Menu
<Configuration of calibration curve coefficients (A, B, C, D, E, and F)>
1. Enter the calibration curve coefficient
(A:), and then tap the [OK] button.
The Calibration curve coefficient (B:) entry
screen (software keyboard screen) appears.
2. Enter B through F using the same procedure.
<Configuring the expiration date for use>
For the expiration date for use (EXP), enter xxxxxx (four digits for the year and two digits for the
month).
NOTE Also enter the hyphen (-).
9
IMPORTANT:
Incorrect entries will cause incorrect measurement results.
Always make sure that the displayed values are correct.
button is tapped, values of the calibration curve coefficient configuration reNOTE When the
sults are printed.
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9 Function Menu
9.3.12 Lot Qualification
This function button appears (enabled) when USM function is enabled. It is possible to (dis-)qualify
slide LOTs which are registered in analyzer.
1. Select a slide name which needs to
change the setting.
2. (Dis-)qualification for selected slide LOT
can be changed by selecting [ON] or
[OFF] button.
NOTE When the disqualified slide lot is measured, the test result will be indicated as
“CHK QC” on screen, print and in communication.
9
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9 Function Menu
9.3.13 PF Calibration Coefficients
Configure the PF calculation correction coefficients.
Next-page buttons
Tap the [Data input] button.
button is tapped, all PF
NOTE I f t h e
calculation correction coefficients are
printed.
NOTE If the [Reset all tests] button is tapped, a
reset confirmation screen appears. To reset
the PF calculation correction coefficients of
all measurement items, tap the [OK] button.
To cancel the reset, tap the [Cancel] button.
Tap the button of the measurement item you want
to edit.
NOTE Only measurement items for which QC
cards have been read are displayed as buttons.
9
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9 Function Menu
If the [Input] field of an item is tapped, the software
keyboard (refer to Section 2.3) appears so you can
enter the value.
NOTE If the [Reset] button is tapped, a reset confirmation screen appears. To reset the PF
calculation correction coefficients of selected items, tap the [OK] button. To cancel the
reset, tap the [Cancel] button.
NOTE To cancel the configuration, tap the
button.
9
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9 Function Menu
9.3.14 Dilution Setting
You can configure the dilution factor and position of the diluent to be used for each measurement
item and sample type (PS and U). When a dilution factor is not configured for each sample on the
sample information registration screen, measurement is performed using the dilution factor configured here.
Next-page buttons
1. Tap the [Data input] button.
NOTE When the
button is tapped, all dilution
factor settings will be printed.
2. Tap the button of the measurement item
to be edited.
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9 Function Menu
3. For the dilution factor, tap a button, and
then select from [None], [2], [3], [4], [5],
or [10].
NOTE In the case of CRP, the selection menu
to the left appears.
9
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9 Function Menu
9.3.15 Tube Setting for Diluent & Reference Fluid
Configure the test tube type to be used for diluent and reference fluid.
NOTE For the types of containers that can be used for diluent and reference fluid, refer to Section 5.4
and Section 5.5.
Tap the button of the container you want to use.
9.3.16 Print Setting for Measured Result
Configure the print quantity (1 to 3 sheets) and print order of measurement results.
• Tap the print quantity you want to configure.
• For [Print order], you can select [Slide stacking
order] or [Fixing].
NOTE If [Fixing] is selected, printing occurs in the
following order.
<Plasma/serum and urine>
TP → ALB → TBIL → DBIL → GOT/AST
→ G P T / A LT → A L P → L D H → C H E
→ GGT → LAP → CPK → AMYL → TCHO
→ HDLC → TG → UA → BUN → CRE
→ Na-K-Cl → Ca → IP → Mg → GLU
→ CRP → NH3 → CKMB → LIP → TCO2
<Whole blood>
Na-K-Cl → GLU → NH3
• For [Print with the ranges], to print out the ranges
along with test results, check the checkbox.
NOTE By default, the checkbox is checked (enabled).
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9
9 Function Menu
9.3.17 Control Fluid Setting
Configure the control liquid name / lot number and acceptable range.
1. Tap the button of the control liquid to be
edited.
NOTE [-] (control liquid not registered) of Step
1 cannot be edited.
2. Tap a [Lot] button to choose a lot.
3. If you touch a display section (lower limit
or upper limit) of the acceptable range to
be edited, a software keyboard (Refer to
Section 2.3) appears so you can edit the
value.
IMPORTANT:
If the entry of the acceptable range is incorrect,
the judgement of the control measurement results
is incorrect. Always make sure that the entered
values are correct.
9
NOTE The units configured by the [Unit conversion] of the function menu are displayed.
NOTE If the acceptable range is changed, information from before the change is not
saved.
4. To edit a lot number, touch the [Lot editing] button, and then enter the number
using the software keyboard that appears.
NOTE To edit or add a control liquid name,
tap the button of a control liquid name,
and then enter the information using the
software keyboard that appears.
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9 Function Menu
9.3.18 Control Measurement Setting
Configure whether to enable the correlation coefficient when performing a control measurement.
To enable the correlation coefficient for a control
measurement, tap the checkbox to select it.
NOTE By default, the checkbox is cleared (not
enabled).
9.3.19 Operator ID Setting
NOTE When the USM function is disabled, the following setting will appear. In case that the USM is
enabled, refer to Section 11.3.
Configure whether to display the Operator ID at the Measurement-preparation screen and measurement results screen.
To display the operator ID, tap the checkbox.
NOTE By default, the checkbox is cleared (not
enabled).
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9
9 Function Menu
9.3.20 Test Item Name Setting
You can configure the display of item names. The names appear in the screen display and printed
paper of measurement results.
1
2
3
1 Choose the item names to be used for display
and printing.
2 Choose the names to be used for external communication output to the host computer.
The selection of [ALPi, LDHi]/[ALP, LDH] is the
display setting of the test name ALPi, LDHi.
This is not the display setting of the test name
ALP, LDH.
(ALPi and LDHi are slides compatible with the
IFCC method. Availability depends on the region of sale.)
NOTE If [ALP, LDH] is selected, ALPi, LDHi appears the same as ALP, LDH.
Check this setting again before testing.
3 Choose the item names to be used. Tap either
the [BUN] or [UREA] button.
NOTE When the name of BUN is changed to
UREA, or vice versa, set again the following items.
ITEMS
Reference interval
Correlation coefficient
Control fluid settings
9
NOTE When BUN/UREA is changed, the change
is reflected in the following items:
• Test Result
• Unit conversion
• Reference Interval setting
• Calculated Parameter
• Dilution factor Coefficients
NOTE Regarding the BUN ↔ UREA conversion
coefficient
UREA = BUN×2.14 [mg/dL]
UREA = BUN [mmol/L]
NOTE Rebooting the device is necessary for the setting to take effect. The confirmation dialog for
is tapped to exit Mode function for administrator. After the
the power-off will appear when
shutdown, reboot the analyzer.
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897N203029A FDC NX600 Instruction Manual 2022.01
9 Function Menu
9.3.21 Default Sample Type Setting
Set the default (initial setting) sample type.
Tap a sample type to select it.
9.3.22 Password Setting
When tapping the [Mode function for administrator] button on the Function menu screen, the password input may be required. The password can be changed here.
If the input field is tapped, the software keyboard
(refer to Section 2.3) appears so you can edit the
password.
NOTE A password can be 4 or 5 alphanumeric
characters long.
NOTE In the event of a password being lost,
please contact your dealer for assistance.
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9
10 Other Functions
10.1 Data Communication
The analyzer can transmit measurement results to a host computer or PC that has been approved
by IEC/UL60950-1 or IEC/UL62368-1.
To communicate, it is necessary to prepare the software and a cable to receive data. Before you use
this function for the first time, please contact your dealer for assistance.
NOTE Use a shielded LAN cable. Otherwise, electromagnetic interference may occur.
NOTE When a LAN or RS-232C cable is not connected, measurement results are not sent. Make
sure a cable is connected.
NOTE When connecting this analyzer to a network, make sure it is placed inside of the firewall to
avoid cybersecurity risks.
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11
USM (User Safety Mode)
11.1 Operator ID Input When Measurement Start and In Mode
Function
When measurement start button or function menu button is tapped, an Operator ID input display is
shown. Then, input Operator ID. If input operator ID is registered and also within expiry, the measurement starts or the function menu becomes active.
NOTE When not registered ID/expired ID/Emergency ID counted up to the maximum usage limit are input, measurement does not
start, nor mode function screen become active.
11
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11 USM (User Safety Mode)
11.2 Difference of Operable Functions among Operator ID Level
(OPE,ADM,EMG)
Operable functions are different depending on operator ID level.
NOTE OPE: Operator
ADM: Administrator
EMG: Emergency
Measurement Result
OPE/ADM: When expired slide is used, EXP is indicated instead of measurement result.
EXP is used not only on screen indication, but also on print and in communication.
This is also the case for CRP measurement with expired calibration.
EMG:
When expired slide is used in EMG,
measurement result with # mark is indicated.
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11 USM (User Safety Mode)
Mode function
OPE/EMG: Operable function is limited to [Control],
[Calibration], [START Manual pipetting]
and some maintenance functions.
11
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11 USM (User Safety Mode)
ADM:
All functions are operable.
11
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11 USM (User Safety Mode)
11.3 USM Menu
11.3.1 Operator ID -Import
1. Create Operator ID data and save it by use of Operator ID Editor.
* File name: dcn_uid_yyyymmddhhmmss.dat Ex) dcn_uid_20220425201612.dat
* For the detail, see the manual of the Operator ID Editor.
2. Create the following folder structure in your USB.
Rename the file which is created by the tool to [dcn_uid.dat],
Store it in the USB,
WData
└ GUI
└ dcn_uid.dat
*Please use FUJIFILM recommended USB only.
3. Select [Operator ID setting] in ADM
mode.
4. Select [Operator ID import].
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11 USM (User Safety Mode)
5. The left pop-up is shown. Then set USB,
and after a few seconds, select [OK].
6. The left pop-up will be shown when import is complete. Take off the USB and
then tap [Shutdown].
11
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11 USM (User Safety Mode)
11.3.2 Operator ID -Export
1. Select [Operator ID setting] in ADM
mode.
2. Select [Operator ID export].
3. The left pop-up is shown. Then set USB,
and after a few seconds, select [OK].
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11 USM (User Safety Mode)
4. The left pop-up will be shown when export is complete. Then tap [OK], and take
off the USB.
5. Operator ID data, [dcn_uid.dat], is stored in below folder structure below in the
USB.
WData
└ GUI
└ dcn_uid.dat
* Browsing and editing of dcn_uid.dat is possible in Operator ID Editor.
For the detail, see the manual of the Operator ID Editor.
11
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897N203029A FDC NX600 Instruction Manual 2022.01
11 USM (User Safety Mode)
11.3.3 Editing Registered Operator ID
Registered Operator ID can be edited as the following procedure.
NOTE Editable items are the expiry of ID and the level.
1. Select [Operator ID setting] in Mode
function for administrator screen.
2. Select [Operator ID setting].
3. Select an Operator ID which needs editing.
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11 USM (User Safety Mode)
4. To change the expiry, touch the expiry
field and edit it using the software keyboard.
5. To change the level, select either [ADM/
OPE].
11
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11 USM (User Safety Mode)
11.3.4 Editing Emergency ID
(Dis-)qualification of registered Emergency ID can be set.
Also measurement limit count by use of Emergency ID can be set.
1. Select [Operator ID setting] in Mode
function for administrator screen.
2. Select [Edit Emergency ID].
3. To (dis-)qualify the Emergency ID, tap
the checkbox.
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11 USM (User Safety Mode)
4. To edit the total limit count, select [Edit
emergency ID count].
5. To reset the current count, tap [Reset]
button.
To set a new limit count, select either [0],
[50] or [100].
In case of 0, emergency ID does not
function.
11
NOTE Measurement count by use of Emergency ID cannot exceed the limit count.
When the current count is up to the limit, the measurement by use of Emergency ID is not
possible.
In this case, reset the current count.
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897N203029A FDC NX600 Instruction Manual 2022.01
12 Specifications
Processing speed
128 tests per hour (simultaneous CM and ISE measurements)
Number of incubator cells
CM: 13; ISE: 1
Incubation temperature
37°C (CM) / 30°C (ISE)
Incubation time
1 to 6 minutes
Capacity for simultaneously
loaded slides
20
Slide lot information
Each item: maximum 5 lots
Sampler
(1) Sample application fluid
volume
50 µl or less (automatic switching)
(2) Dilution
Automatic dilution (maximum 21x dilution)
(3) PF filtering time
Max. 90 sec.
Slide ejection
Automatic ejection (max. 100 slides into the disposal box)
Used tip ejection
Automatic ejection (max. 50 tips into the disposal box)
Measurement wavelengths
400 nm, 415 nm, 505 nm, 540 nm, 577 nm, 600 nm, 625 nm, 650 nm
Light source
Halogen lamp (6 V, 10 W)
Measurement precision
σ<
= 0.0004 OD / 5 minutes
Measurement accuracy
Within ±0.005 OD (600 nm)
Display
7-inch color touch panel
Backup data of test results
For 270 samples
Printer
Thermal type (paper size: 58 mm x 25 m)
Warming up time
Approx. 10 minutes / 25°C, approx. 20 minutes / 15°C
Environmental conditions
Indoor use (6,000 cd/m2 (lux) or lower. 3,000 cd/m2 (lux) or lower
when using the sample barcode reader.)
Altitude: Up to 2,000m (810hPa)
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)
Storage and transport conditions Temperature: -10 to 50°C
Humidity: 10 to 90% RH (no vapor condensation)
Voltage used
Single phase AC; 100 - 240 V ±10%; 50 to 60 Hz
Consumption current
1.9 - 0.8A
Type of protection against electri- CLASS 1 EQUIPMENT
cal shock
Volume level
Within 70 dB (including buzzer sound)
Data transfer
RS-232C (1 port); USB (2 port); LAN (1 port)
External dimensions
(W) 470× (D) 360× (H) 370 mm
Weight
FUJI DRI-CHEM NX600: 28Kg
FUJI DRI-CHEM NX600i: 26Kg
897N203029A FDC NX600 Instruction Manual 2022.01
12
12-1
12 Specifications
Effective period of service
(service life)
6 years after installation
(This period is valid as long as the precautions for use are followed
and regular periodic maintenance is performed correctly.)
12
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13 Glossary
Glossary of the display & printout messages
NOTE Because the display spaces and printouts are limited, some abbreviations are used.
NOTE Periods will not be used after abbreviations on the display and printout messages.
Abbreviation
Meaning
AD
Analog/Digital
ADM
administrator
ave
average
Bef comp
Before compress
cali
calibration
charac
character
comm
communication
ctrl
control
DA
Digital/Analog
Decomp
Decompress
DL
FUJI DRI-CHEM DILUENT DL (CRP)
EMG
emergency
ERR
error
EXP
expiration
info
information
NG
No Good
OD
Optical Density
OPE
operator
Prob
problem
USM
User Safety Mode
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13-1
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