Professional Documents
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Fuji Drichem Nx600
Fuji Drichem Nx600
Fuji Drichem Nx600
INSTRUCTION MANUAL
Safe Usage and
Handling Precautions 1
Loading Consumables 5
Maintenance 6
Quality Control 7
Troubleshooting 8
Function Menu 9
Other Functions 10
USM 11
Specifications 12
Glossary 13
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
2nd Edition
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.
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 pur-
pose and correct operation. And, the equipment can be used in a near patient setting by Healthcare
professional.
CAUTIONS
1. No part or all of this manual may be reproduced in any form without prior permission.
2. The information contained in this manual may be subject to change without prior
notice.
3. FUJIFILM shall not be liable for malfunctions and damage resulting from installation,
relocation, remodeling, maintenance, and repair done by other than dealers specified
by FUJIFILM.
4. FUJIFILM shall not be liable for malfunctions and damage of FUJIFILM products due
to the use of products of other manufacturers not supplied by FUJIFILM.
5. FUJIFILM shall not be liable for malfunctions and damage resulting from remodeling,
maintenance, and repair using repair parts other than those specified by FUJIFILM.
6. FUJIFILM shall not be liable for malfunctions and damage resulting from negligence of
precautions and operating methods contained in this manual.
7. FUJIFILM shall not be liable for malfunctions and damage resulting from use under
environment conditions outside the range of conditions required for proper use of this
product, such as power supply, installation environment, etc. contained in this manual.
8. FUJIFILM shall not be liable for malfunctions and damage resulting from natural
disasters such as fires, earthquakes, floods, lightning, etc.
Regulation (EU) 2017/746 requires that any serious incident that has occurred in relation to the device
should be reported to the manufacturer or European Authorized Representative, and the competent
authority of your country. In case you become aware of any serious incident, please report immediately
to your local or our 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.
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
7 Quality Control
7.1 Control Fluids………………………………………………………………………………… 7-1
7.2 Measurement with Control Fluids………………………………………………………… 7-1
7.3 Monitoring Results………………………………………………………………………… 7-1
7.4 Control Mode………………………………………………………………………………… 7-1
7.5 Troubleshooting Quality Control Results………………………………………………… 7-1
7.6 Control Chart………………………………………………………………………………… 7-2
8 Troubleshooting
8.1 Error Display………………………………………………………………………………… 8-1
8.1.1 Error Log…………………………………………………………………………… 8-2
8.1.2 Error Code and Reference Section Table……………………………………… 8-4
8.1.3 Printout Reference Table………………………………………………………… 8-8
8.2 Troubleshooting……………………………………………………………………………… 8-10
8.2.1 Startup Errors……………………………………………………………………… 8-10
8.2.2 Printer or LCD Trouble…………………………………………………………… 8-10
8.2.3 Slide Reading Errors……………………………………………………………… 8-11
8.2.4 Sampler Errors……………………………………………………………………… 8-11
8.2.5 Photometric System Errors……………………………………………………… 8-19
8.2.6 Transfer Errors……………………………………………………………………… 8-21
8.2.7 Temperature Controller Errors…………………………………………………… 8-22
8.2.8 Circuit Board Signal Errors……………………………………………………… 8-24
8.2.9 QC Card, PF Card, and DI Card Errors………………………………………… 8-29
8.2.10 Slide Loading Errors……………………………………………………………… 8-31
8.2.11 ISE Measurement Errors………………………………………………………… 8-33
8.2.12 PF Errors…………………………………………………………………………… 8-36
8.2.13 Errors Related to Data Communication, Sample Barcode Reader…………… 8-37
8.2.14 Calibration Errors………………………………………………………………… 8-39
8.2.15 Other Errors………………………………………………………………………… 8-42
8.3 Slide Code Table…………………………………………………………………………… 8-44
9 Function Menu
9.1 Control………………………………………………………………………………………… 9-3
9.2 Normal Mode………………………………………………………………………………… 9-7
9.2.1 Date & Time Settings……………………………………………………………… 9-8
9.2.2 Brightness • Volume……………………………………………………………… 9-8
9.2.3 Lamp Management………………………………………………………………… 9-9
9.2.4 Lot Information……………………………………………………………………… 9-9
9.3 Mode Function for Administrator…………………………………………………………… 9-10
9.3.1 Language Setting………………………………………………………………… 9-11
9.3.2 Host Connection Setting………………………………………………………… 9-11
9.3.3 Calculated Parameter……………………………………………………………… 9-14
9.3.4 Unit Conversion…………………………………………………………………… 9-16
9.3.5 Switch Measurement Range Display…………………………………………… 9-17
9.3.6 Reference Interval Range Setting……………………………………………… 9-18
9.3.7 Sample No. /ID Settings…………………………………………………………… 9-20
9.3.8 Work List Selection Setting……………………………………………………… 9-20
9.3.9 Correlation 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
13 Glossary
“Warning” indicates hazardous situations that may lead to serious injury, death,
WARNING: or the transmission of infectious agents if the precaution is not followed.
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 measure-
ment 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 us-
age precautions are observed and regular maintenance is performed). If you will use the analyzer
after the service life expires, consult with the manufacturer/seller beforehand. The use of medical
equipment that has exceeded its service life may increase the chance of safety and performance
problems.
IMPORTANT:
Use consumables on or before their listed expiration date.
WARNING:
Items such as measured slides, tips, mixing cups, and sample tubes coated with samples such as
1 blood and urine, and cotton swabs and cloths used to clean the equipment are infectious industrial
waste. Process this waste in compliance with any applicable regulations in your country, such as
by incineration, melting, sterilization, or disinfection. Furthermore, when entrusting disposal to an-
other party, request processing from a contractor with a license for special management of industrial
waste processing work.
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), al-
ways follow biohazard procedures (wear gloves, a lab coat, and safety goggles) in accordance with
the sample handling rules of your facility. If you accidentally touch a sample, immediately rinse the
contaminated area thoroughly under running water, and then disinfect the area. Seek medical assis-
tance if necessary.
WARNING:
Do not touch used slides and tips with bare hands as this may cause contamination. If you acciden-
tally touch a contaminated consumable, immediately rinse the contaminated area thoroughly under
running water, and then disinfect the area. Seek medical assistance if necessary.
WARNING:
When samples come in contact with the analyzer, immediately clean and disinfect it.
WARNING:
As this equipment is not explosion-proof, be sure not to use flammable and explosive gas around
the equipment.
WARNING:
The voltage supplied to the equipment is AC 100 - 240 V. To avoid electrical shock, observe the fol-
lowing precautions. 1
• 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.
CAUTION:
Do not use other devices (such as mobile phone) which generate and can radiate radio frequency en-
ergy near the FDC NX600. Otherwise, physical damage or malfunction on the FDC NX600 may occur.
NOTE It is the manufacturer's responsibility to provide equipment electromagnetic compatibility
information to the customer or user. On the other hand, it is the user’s responsibility to
ensure that a compatible electromagnetic environment for the equipment can be main-
tained in order that the equipment will perform as intended.
WARNING:
Do not place your fingers near moving parts (sampler and consumable disk) when operating the
1 equipment, including during maintenance.
Also be sure not to get your fingers, hair, clothing, or accessories caught in moving parts.
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.
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
Ingress protection rating: IP00 (No Protection)
Operating temperature: 15 to 32 °C
Operating humidity: 30 to 80% RH (no vapor condensation)
(2) Use the equipment under the following electrical specifications.
Power supply voltage: single phase AC 100 - 240 V ±10%
Frequency: 50 to 60 Hz
Consumption current: 1.9 - 0.8 A
Type of protection against
electrical shock: CLASS 1 EQUIPMENT
(3) Use an independent outlet separate from other equipment.
(4) Make at least 10 cm of space behind and beside the equipment.
(5) Unplug the equipment from the AC outlet if it will not be used for an extended period of time.
CAUTION:
Hold the handle of the device when lifting or moving it.
Handle
CAUTION:
• When moving the device to another installation location, remove all slides, samples, diluent, refer-
ence 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.
CAUTION:
When the equipment generates unusual noise, smell, or smoke, immediately unplug the power ca-
ble, 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.
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.)
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. Further-
more, 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 tem-
perature for 5 minutes or more with the condition of the individual package before unwrapping and
using them. Otherwise, the measurement results and the analyzer operation may be 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.
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 1
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.
(2) A QC card contains the slide test name and the correction coefficient corresponding to the man-
ufacturing number (lot). Always use slides from the same box.
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.
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:
IMPORTANT:
Before using a FUJIFILM PF, refer to “Instructions for Use” provided with the PF, paying special at-
tention to the precautions concerning the samples measured and the blood collection tubes used.
1.18 FUJI DRI-CHEM AUTO TIPS, FUJI Sample Tubes, and FUJI
DRI-CHEM MIXING CUPS
NOTE In this manual, FUJI DRI-CHEM AUTO TIPS may be shortened to “tip”, FUJI Sample Tube
to “tube”, and FUJI DRI-CHEM MIXING CUPS to “mixing cup”.
FDC NX600 performs sample application automatically via the sampler. However, it is necessary to
prepare dedicated FUJI DRI-CHEM AUTO TIPS, FUJI Sample Tubes, and 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
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.
1
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 dis-
infection. Furthermore, when entrusting disposal to another party, request processing from a con-
tractor with a license for special management of industrial waste processing work.
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:
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 consuma-
bles and use used mixing cups (holes).
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.
1.21 Labels
The following safety labels are affixed to the FDC NX600.
1 Power button
Name-plate
1.22 Symbols
Sign Description
Biological risks
Power button
Power switch
LAN terminal
RS-232C connector
USB connector
This way up
2 Stacking limitation
Temperature limitation
Manufacturer
SN Serial number
Sign Description
Date of manufacture
1
EC REP Authorized representative in the European Community
CE mark of conformity
Importer
Near-patient testing
Printer
Power button
Disposal box
Sampler
Incubator cable
Incubator cover
Consumable disk
Air filter
(Louver)
USB connector
2 (For sample barcode reader only)
*Do not connect other USB
devices.
LAN terminal
CAUTION:
RS-232C connector
Do not remove the cover to
look into the QR code read- USB connector
er’s illuminator. It could impair Power inlet
your eyes. Power switch
Air filter
(Louver)
Disposal box
Sample rack
RE
Mixing cup
Tip rack
Sample application
unit cover
PF unit
2 PF sensor / suction
pad
PF reference plate
PF sample rack
RE
PF pump
1 Help button
1 Display the help screen.
1 1 button
The Measurement-preparation screen ap-
pears.
2 button
Return to the previous screen.
2 LCD
(LCD touch panel)
3 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 4 5 [OK] button
6 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.
Change the entry screen by using the [ABC], [abc], [123], or [-#/], button.
< When the [ABC] button is selected > < When the [abc] button is selected >
2
< When the [123] button is selected >
8 9 0 a
Slide cartridge 2
Slide weight 2
2 O-ring 2
Tip rack 1
Instruction manual 1
Installation method 1
NOTE The AC power cable is required to be compliance with any applicable regulations in your country.
2.5.1 Consumables
Name Package/unit
* FUJI DRI-CHEM AUTO TIPS 6 cases
FUJI Sample Tubes
FUJI HEPARIN TUBE (1.5 mL) 500×1 box
2
FUJI HEPARIN TUBE (0.5 mL) 500×1 box
FUJI PLAIN TUBE (1.5 mL) 500×1 box
* FUJI PLAIN TUBE (0.5 mL) 500×1 box
* Recording paper 6 rolls×1 box
* Light source lamp 1
* O-ring 4
Plasma Filter PF 50×1 bag
PF Suction Pad 1
PF Tube 1
* FUJI DRI-CHEM MIXING CUPS 50×1 box
Reference fluid cap packing 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.
2 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.
3
Checking the recording paper Refer to Section 3.2(2)
12 Tips
RE
(Refer to Section 5.2)
Step 2 - Measurement
Basic Refer to ISE test measurements Refer to Section 3.5
Dilution measurements Refer to Section 3.6
Section 3.3
measurements CRP measurements Refer to Section 3.7
2 Sample
1 Slide
RE
3
START button
ISE Slide
x5 Dil
CRP ISE Slide CRP
CM Slide CM Slide CM Slide x2 Dil
IMPORTANT:
3 IMPORTANT:
WARNING:
Do not touch used slides and tips with your bare
hands, as this may cause infection. If you acciden-
tally touch an item, immediately rinse the contami-
nated 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.
Press the
concave
section.
3
Cutter
opening
IMPORTANT:
Power switch
0013
NOTE The listing to the left is displayed during
start-up once a month. Perform the periodic
maintenance listed in Chapter 6.
IMPORTANT:
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 acci-
dentally 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
IMPORTANT:
Tips
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 acci-
dentally touch a sample, immediately rinse the contaminated area thoroughly under running water,
and then disinfect the area. Seek medical assistance if necessary.
3
IMPORTANT:
IMPORTANT:
RE
NOTE When the analyzer is connected to DMS, sample information can be acquired automati-
cally 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:
IMPORTANT:
When measuring a low concentration protein fluid (such as urine), some bubbles may appear dur-
ing measurement in the tip. If bubbles have formed during measurement, perform the measure-
ment again from the beginning.
WARNING:
IMPORTANT:
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.
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 normal-
ly, and an error may occur.
NOTE The start of measurement cannot be scheduled in manual sample application mode.
1 1 button
Close the measurement results screen, and
2 then return to the Measurement-preparation
screen.
2 Change sample No. button
Change the sample number for which meas-
urement results are to be displayed.
3 Feed button
3 Feed the recording paper with a fixed
4 amount.
3
5 4 Print button
Print all measurement results of the dis-
6 played sample.
5 Send button
Send the measurement results of the dis-
7 played sample to a PC (via DMS).
6 Retest button
8 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.
9 a 0 9
è Refer to Section 4.4
7 Result data scroll button
NOTE When the past test results are dis- Change the display of the measurement re-
played, the results are displayed just as sult data of the slide.
they were obtained using the settings 8 Sample No. tab
when they were measured, such as Unit
Tap to display the measurement results of
conversion, Correlation coefficients,
the selected sample number.
Reference interval range, Test item
name. The test results sent by the [Send] 9 Sample No. tab scroll button
button have also the same format. 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 cal-
endar is tapped, the measurement results of
that day are displayed.
è Refer to the next page.
IMPORTANT:
Analyzer cannot detect expiries of ISE slides if the installed software is version 1.0. Be sure manu-
ally that slides are still valid.
Otherwise, with the software version 1.1 or later is installed, analyzer can automatically detect ex-
piries 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 cal-
culated automatically, so the results can be reported without adjustment. 3
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.
Sample
type setting
Remaining
3 number of
mixing cups
Arrows pointing
5. Load a sample and slides.
right
矢印右向き Place the ISE slide in the slide cartridge with
the spotting hole above and the arrows point-
ing right. For details of the loading method, see
Section 3.3 (3).
WARNING:
IMPORTANT:
3 Bubbles may appear in the tip when diluting a plasma/serum sample more than 20 times or dilut-
ing 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 re-
sults 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 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 fac-
tor 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 registra-
tion screen
Dilution factor configured Default
×
for each sample dilution factor
• Dilution factor when not configured for each sample at the sample information regis-
tration screen
(Configured by [Dilution setting] in Mode function for administrator)
Dilution factor for each Default
×
test 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.
WARNING:
NOTE If the validity term has expired, a “#” warning mark is printed along with the measurement
results.
3 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 in-
formation registration screen. (When 2x has been set at the sample information registration
screen, the dilution factor is 42x.)
WARNING:
3 RE
CAUTION:
Power button
3
6. Tap [OK].
CAUTION:
CAUTION:
WARNING:
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.
Not measurable
測定不能範囲 10mm
10 mm 10mm
10 mm 測定不能範囲
Not measurable
測定可能範囲
Measurable 測定可能範囲
Measurable
75mm
75 mm
100mm
100 mm
30mm
30 mm 測定不能範囲
Not measurable
Not測定不能範囲
measurable 52mm
52 mm
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 meas-
ured. The following section provides information about general blood collection tube contents
and the inspection items that can be measured.
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 acci-
dentally touch a sample, immediately rinse the contaminated area thoroughly under running water,
and then disinfect the area. Seek medical assistance if necessary.
1.5 Upper
referring to the illustration to the left. The top sur-
face of the sample fluid must be within the shaded
3
検体上限
limit of
0.5 section of the tubes in the illustration.
sample
1.0 0.3 NOTE If the sample in the tube is below the suc-
Lower
分離用limit
of 検体下限
sample for tion limit mark, the analyzer will indicate an
0.5 separation 0.1 insufficient sample volume error.
Suction
吸引限界 limit
NOTE To aspire only the supernatant fluid (plasma)
of the centrifuged sample (and avoid aspi-
ration of red blood cells), at least 1.0 mL (for
0025
a 1.5 mL tube) or 0.3 mL (for a 0.5 mL tube)
of a whole blood sample for separation is
necessary.
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。
吸引限界
Suction limit NOTE: At least 50 µl of sample is needed.
富士チューブ サンプルカップ2ml
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.
1Sample rack body (4) 4Tube holder (1) 5Tube holder (1) 6Calibrator CP
for FUJI tube 1.5mL for FUJI tube 0.5mL holder (1)
0Pin (9)
H H
Note: There are upper- and lower-sides of spacers. Do not turn them upside down.
0 Pin
0 Pin
0 Pin
0 Pin
0 Pin
3
(f) Sample rack for φ16mm × 100mm when
using plasma filter PF Affix the label
0 Pin
0 Pin
0 Pin
0 Pin
0 Pin
0 Pin
0 Pin
0 Pin
Y
Y Calculation method
A variety of the reference fluids developed for FUJI
標Reference
slides.
The relationship between the actual measurement
yy22 values X (x1, x2, x3) and the standard values Y (y1, y2,
3 Y y3) is expressed by the formula Y=c+dX+eX2. The
lot compensation coefficients (c, d, and e) derived
yy11 from the formula are used to compensate for varia-
tions in X of each lot.
XX
x11 x22 x33
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.
QR code
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:
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:
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.
IMPORTANT:
4
6. Check the quantity of the consumables
(tips and mixing cups).
If consumables are insufficient, tap the [Set con-
sumables] 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:
CP
IMPORTANT:
4
15. When measurement ends, the Calibra-
tion measurement result screen is dis-
played.
NOTE Print the calibration measurement re-
sults and store them for the calibration
validity term. To print, tap the but-
ton.
IMPORTANT:
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 acci-
dentally 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.) 4
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 appli-
cation mode, the measurement value is calculated by a dilution factor.
5. Load slides.
For details of the loading method, see Section
3.3 (3).
RE
IMPORTANT:
IMPORTANT:
参照液
検体
搬送方向
(インキュベータ方向)
スライドの中央に点着する
Apply sample to the center
(比色スライ
of the ド)slide).
slide (CM
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 acci-
dentally touch a sample, immediately rinse the contaminated area thoroughly under running water,
and then disinfect the area. Seek medical assistance if necessary.
IMPORTANT:
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 ドに近づけます
a drop and then move it near the slide
IMPORTANT:
0057
sample,
内部に拡散 it diffuses
していきinside
ます
スライドが検体を吸い取りながら
0057
内部に拡散
スライ していきます ながら
ドが検体を吸い取り
0057
内部に拡散していきます
IMPORTANT:
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]
4 button is tapped, the analyzer may malfunction.
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.
IMPORTANT:
PF cards
(1) Overview
When the measurement values for filtered plasma are compared to the values for plasma sep-
arated 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 pro-
duction 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)
4.3.1 Measurement
IMPORTANT:
WARNING:
4
7. Tap the [START] button to start measure-
ment.
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 safe-
ty 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 regu-
lations in your country, such as by incineration, melting, sterilization, or disinfection.
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:
IMPORTANT:
Refer to the “Instructions for Use” of the plasma filter (PF) and always follow the instructions.
4
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
10mmの空き
10 mm of empty 1010mmの空き
mm of empty
space is necessary
スペースが必要です space is necessary
スペースが必要です
測定可能範囲
Measurable
測定可能範囲
Measurable 75mm
75 mm
100mm
100 mm
検体は
The required sample
φ13x75mm管で3ml以上
検体は volume is 3 mL or more for
The required sample volume 必要です
Ø13×75 mm tubes.
φ16x100mm管で6.5ml以上
is 6.5 mL or more for Ø16×100
0023
mmφ13x100mm管で6ml以上
tubes, and 6 mL or more
for必要です
Ø13×100 mm tubes.
NOTE Use PF sample racks with the following labels for tests using a PF.
4.4 Retesting
You can test again using the previous sample number, sample ID, sample type setting, and refer-
ence interval setting by tapping the (retest) button at the measurement results screen. Further-
more, when a measurement cannot be performed due to an error, you can skip the re-entry and re-
configuration 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.
IMPORTANT:
Do not retest GPT (ALT) of PF filtered plasma because its activity decreases over time.
WARNING:
4
4. Tap the [START] button to start retesting.
NOTE When a test is rerun, PF filtering process
is not performed.
図-4.5.2-1
(2) Measuring CM and ISE slides 4
We recommend loading an ISE slide last.
If an ISE slide is measured first, it might take extra
電解質
ISE time for measurement.
一般比色
CM slide
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
一般比色
CM slide
図-4.5.2-4
(4) Measuring CM slides that require dilution
図-4.5.2-2
tor, there are no restrictions on the stacking
order.
<Not recommended slide loading order>
図-4.5.2-4
diluent type error) occurs before the measurement,
and the measurement will be completed. Rerun the
CRP measurement from the beginning.
IMPORTANT:
IMPORTANT:
If the sample barcode reader malfunctions or the print quality of the barcode label is poor, incor-
rect barcode data may be read. Make sure that the barcode data (sample ID) printed in the meas-
urement 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.
4
<When inputting the sample ID>
バーコードを読み取ります
NOTE If there are not enough consumables (tips, mixing cups, diluent, reference fluid, etc.), sam-
ple application may be stopped.
WARNING:
During sample application, tap the [STOP] button to stop application, and then load the tips. Load-
ing is unsafe during sample application because the sampler and the consumable disk are mov-
ing.
Consumable display
RE
Tip rack
RE
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.
Consumable display
WARNING:
Used mixing cups are infectious industrial waste.
Process this waste in compliance with any appli-
RE cable regulations in your country, such as by incin-
eration, melting, sterilization, or disinfection.
WARNING:
During sample application, tap the [STOP] button to stop application, and then load diluent. Load-
ing is unsafe during sample application because the sampler and the consumable disk are mov-
ing.
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
5
may affect the measurement values.
Replace diluent for each test.
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).
RE
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:
5
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:
IMPORTANT:
5
RE
Reference fluid
To keep the performance of the FDC NX600 at its best, users must perform daily and periodic mainte-
nance, and designated repair personnel must perform maintenance. When repairs are necessary, con-
tact 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. Other-
wise, 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).
WARNING:
After inspection, always connect the power cord, switch on the power, and then check operation.
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 col-
orimetric slides and 240 ISE slides. (In the case of 240 days of use per year, 30 colorimetric
slides/day and one ISE slide/day)
IMPORTANT:
If the air filters are not cleaned, an increase in the temperature inside the analyzer may negatively
affect the measurement values.
Louver
Louver
6
1 IMPORTANT:
6
If the analyzer is used without setting the filters,
measurement values may be negatively affected.
2
WARNING:
Always wear gloves, a lab coat, and safety glasses while working.
If you accidentally touch a contaminant, immediately rinse the contaminated area thoroughly un-
der 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 af-
fect the measured values.
6.3.2 Cleaning the Transfer Bar, Incubator, Sample Application Unit, and
ISE Unit
(1) Cleaning the transfer bar
Thumbscrew
CAUTION:
6
Keep your fingers clear as the analyzer runs.
CAUTION:
WARNING:
Always unplug the power cord before the following procedure.
(2) Incubator
Panel unit
pedestal
3
1
Thumbscrew
5. Moisten the cloth with lukewarm water.
IMPORTANT:
IMPORTANT:
IMPORTANT:
IMPORTANT:
Measurement cell
Thumbscrew
Reference
plate
Reference Reference 12. Turn over the reference plate and clean
black plate white plate the white plate and black plate with a dry
cotton swab.
IMPORTANT:
Thumbscrew
Reference
plate
Probes
CAUTION:
IMPORTANT:
IMPORTANT:
NOTE Use the recording paper specified for the FDC NX600.
Press the
concave
section.
2. Remove the remaining recording paper.
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.
Lamp unit
Connector
Lens
IMPORTANT:
Connector
IMPORTANT:
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 un-
der 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 inac-
curate, which may negatively affect the measurement values.
IMPORTANT:
IMPORTANT:
CAUTION:
6
Keep your fingers clear as the sampler unit
and consumable disk move.
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.
6 CAUTION:
WARNING:
Always wear gloves, a lab coat, and safety glasses while working.
If you accidentally touch a contaminant, immediately rinse the contaminated area thoroughly un-
der running water, and then disinfect the area.
Seek medical assistance if necessary.
WARNING:
Dispose of contaminants used for cleaning as infectious waste.
6
RE
RE
RE
IMPORTANT:
If you do not clean and replace the reference fluid cap packing, the reference fluid will be concen-
trated, which may negatively affect the measurement values.
6
Reference
fluid cap
packing
Reference
fluid cap
packing
WARNING:
During maintenance, always wear gloves, a lab coat, and safety glasses.
If you accidentally touch a contaminant, immediately rinse the contaminated area thoroughly un-
der 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.
CAUTION:
PF reference plate
CAUTION:
WARNING:
Process used PF Suction Pad as infectious waste in compliance with any applicable regulations in
your country.
RE
Sample rack
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.
Holder (C) Tube (D) 3. Slide the holder (C) to the left and re-
move the tube (D) from the rotor.
Holder (C) Tube (H) 5. Slide the holder (C) to the left and load
the new tube (H) on to the rotor.
NOTE As shown in the diagram to the left,
align the base of the joint (E) with the
cover hole (F).
Cover hole (F) Joint (E) 6. Reattach the cover (B) using the screw
(A).
Front Marks
Joint (E)
Cover hole (F)
When attaching the cover (B), make
sure that the hooks are hooked and
interlocked.
Line
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 proce-
dure which you have to obey. Also, it is also recommended to do after major repairs are performed on
the analyzer.
NOTE Follow the descriptions in the “Instructions for Use” of control fluids.
Outside of display
area
7
Acceptable Acceptable
range range
lower limit upper limit
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 troubleshoot-
ing pages and rerun the measurement.
Error code
Additional information
8
NOTE Some error codes may show additional infor-
mation.
(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.
8
3. Tap an error.
The error details are displayed.
E0530, E0531 ISE measurement unit (self-test) error 8.2.11 (1) 8-33
E0532, E0533, Signal system error inside circuit board 8.2.8 8-24
E0537, E0538
E0534, E0535, Signal system error inside circuit board 8.2.8 8-24
E0536, E0539,
E0540
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, Temperature control error 8.2.7 8-22
E1505
IMPORTANT:
IMPORTANT:
Low
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.
(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.
Error
Error message Error condition Troubleshooting
code
W5110 Printer error No recording paper. Load recording paper onto the printer.
No paper. è Refer to Section 6.4
Set paper.
W5100, Printer error The printer is malfunc- Please contact your dealer for assis-
E5101, Contact your dealer in tioning. tance.
E5102, case the ERR repeats.
8 E5103
Error
Error message Error condition Troubleshooting
code
W0173 Slide identification The slide information Clean the slide reader, and then rerun
ERR on backside of the slide the measurement.
No slide information. could not be read cor- è Refer to Section 6.7
Check the slide. rectly. NOTE If the error occurs again, please
contact your dealer for assis-
tance.
Error
Error message Error condition Troubleshooting
code
E0082, Sample tip detection No tip can be detected The tip is not loaded correctly. Load
W0088 ERR on the sample nozzle a tip correctly, and then rerun the test
No tip detected. after mounting. from the beginning.
Set tips and rerun the è Refer to Section 5.2
tests from the begin- NOTE Set tips into all holes of the tip
ning. rack after this error has oc-
curred.
E0083, Reference fluid tip No tip has been de-
W0089 detection ERR tected on the refer-
No tip detected. ence fluid nozzle after
mounting.
Set tips and rerun the
tests from the begin- 8
ning.
E0084 Sample tip clogging A clog was detected If the error occurs again, please contact
ERR during mounting of the your dealer for assistance.
Rerun the tests from sample nozzle tip.
the beginning.
Contact your dealer in
case the ERR repeats.
W0096 No tip WARNING The number of tips Load tips in all holes of the tip rack.
Tip is insufficient. needed for measure-
Set tips and rerun the ment is insufficient.
test from the begin-
ning.
Error
Error message Error condition Troubleshooting
code
E0086 Sample tip eject ERR Tips cannot be dis- After analyzer shutdown, empty dis-
After analyzer shut- carded. posal box, and then turn the power ON.
down, please check
the disposal box.
Turn the power ON.
Error
Error message Error condition Troubleshooting
code
W0151 Lack of mixing cup There are not enough After you replace the mixing cups, re-
Lack of mixing cups. mixing cups. run from the measurement request.
Set mixing cup and re- è Refer to Section 5.3
run 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
Contact your dealer. your dealer for assistance.
Error
Error message Error condition Troubleshooting
code
W0120 Sample shortage Either the sample is Make sure that the sample volume in
Sample is insufficient. not loaded or the sam- the tube is within the measurable range
Check the sample. ple volume is insuffi- and an appropriate sample tube is used
cient. in the sample rack, and then rerun from
the measurement request.
W0060 Sample shortage There is not enough
Check the sample vol- sample volume.
NOTE If the sample volume is low, add
sample to the tube or perform
8
ume.
manual sample application.
Confirm that a sam-
ple rack matching the
sample tubes is used.
Error
Error message Error condition Troubleshooting
code
E0111 Aspiration clogging Clogging was detected The sample may contain fibrin deposits.
ERR (sample) during sample aspira- After checking the sample, rerun from
Clogging was detected tion. the measurement request.
during sampling. NOTE If the error occurs again, there
Check the sample. might be a piping system prob-
lem. Please contact your dealer
E0124 Aspiration clogging
for assistance.
ERR (diluted sample)
Clogging was detected
during sampling.
Check the sample and
diluent.
E0125 S p o t t i n g c l o g g i n g A clog was detected The sample may contain fibrin deposits.
ERR (diluted sample) during sample applica- After checking the sample, rerun from
Clogging was detected tion (dispensing). the measurement request.
during sampling. NOTE If the error occurs again, there
Check the sample and might be a piping system prob-
diluent. lem. Please contact your dealer
for assistance.
8
Error
Error message Error condition Troubleshooting
code
Sample application problem 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 bub-
bles 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 measure-
or FUJI tube is being used.
ment again.
(e) Inspect the sampler O-ring. (Refer
to Section 6.6.2)
IMPORTANT:
Error
Error message Error condition Troubleshooting
code
W0141 Surface detection ERR There is too much dilu- Follow the instructions of the error code
(diluent) ent volume. to replace the diluent or reference fluid,
Diluent volume is too and then rerun from measurement re-
much. quest.
Check the diluent vol- • Diluent è Refer to Section 5.4
ume. • Reference fluid è Refer to Section
5.5
W0142 Surface detection ERR There is too much ref-
NOTE Replace the diluent / reference
(reference fluid) erence fluid volume.
fluid container with a new one.
Reference fluid is too
Do not add diluent or reference
much.
fluid.
Check the reference
fluid volume.
Error
Error message Error condition Troubleshooting
code
E0121 Aspiration clogging Clogging was detected Be sure that FUJI tubes configured in
ERR (diluent) during diluent aspira- Tube setting for diluent and reference
Clogging was detected tion. fluid (è Refer to Section 9.3.15) are
during sampling. used. If there was a loading problem,
Check the diluent. replace the diluent and reference fluid,
and then rerun from the measurement
E0122 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 prob-
during 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.
Error
Error message Error condition Troubleshooting
code
W0070 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 meas-
ERR sampler has occurred. urement, and make sure that foreign
Sampler rotation error. matters such as tips and slides are not
stuck or left inside of the sampler.
E1000, S a m p l e r u p / d o w n Up-and-down move- NOTE If the error still occurs after
E1001, motor ERR ment error of the motor
switching the analyzer off and
E1003, Problem moving the
on, please contact your dealer
W1004 sampler up and down.
for assistance.
Perform inspection.
Contact your dealer.
IMPORTANT:
If a photometric system error has occurred, perform each troubleshooting step listed below and
rerun the measurement.
Error
Error message Error condition Troubleshooting
code
W0036 Soiled black plate The reference plate is Switch off the analyzer and clean each
WARNING dirty. part listed below.
Reference black plate • Clean the light source unit lens
soiled.
Clean the black plate. è Refer to Section 6.5
• Clean the reference plate
W0030 Lamp replacement The light intensity of
WARNING the light source lamp is è Refer to Section 6.3
Low light intensity. insufficient. • 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 assis-
tance. 8
E0511 Reference white plate The light intensity is
ERR changing during meas- CAUTION:
Contact your dealer. urement. 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
Error message Error condition Troubleshooting
code
E0050 Lamp replacement The light source lamp Switch off the power and replace the
Low light intensity. is burned out. light source lamp. Switch the analyzer
Replace the lamp. on again after replacement.
è Section 6.5
CAUTION:
Error
Error message Error condition Troubleshooting
code
E0900, Filter motor ERR Movement error of the Switch the analyzer off and on.
E0901, Problem with the inter- filter motor NOTE When the error is not resolved,
E0903, ference filter. please contact your dealer for
W0904 Contact your dealer. assistance.
E0902 Filter motor opera-
tion ERR
8 Problem with the inter-
ference filter.
Contact your dealer.
Error
Error message Error condition Troubleshooting
code
E5510 Slide slip ERR The slide stop position Contact your dealer and have the incu-
Contact your dealer. shifted during meas- bator pressure plate inspected.
urement.
Error
Error message Error condition Troubleshooting
code
E0200- Feed motor ERR Movement error of the The sample application unit or the incu-
E0203, Problem with the slide slide supply motor bator may be dirty or the disposal box
E0220- transfer system. may be full of slides and tips. Switch off
E0227 Perform inspection. the analyzer, and perform the following.
Contact your dealer. • Cleaning the disposal box
• Cleaning the incubator
E0210- Eject motor ERR è Refer to Section 6.3
E0213, Problem with the slide
W0214 transfer system. • Cleaning the sample application unit
Perform inspection. è Refer to Section 6.3
Contact your dealer. NOTE If the error occurs again, please
E0600- Incubator motor ERR Movement error of the contact your dealer for assis-
E0604 Problem with the incu- incubator motor of the tance.
bator. incubator
Perform inspection.
Contact your dealer.
E1600- C o n s u m a b l e d i s k The disk motor move- Turn the analyzer off after the meas-
E1603, motor ERR ment error in consum- urement, and make sure that foreign
W1604 Problem with the con- able disk motor matters such as tips and slides are not
sumable disk. stuck or left around the consumable
Contact your dealer. disk.
NOTE If the error occurs again, please
contact your dealer for assis-
tance.
Error
Error message Error condition Troubleshooting
code
E0565 ISE temperature con- When the measure- Please contact your dealer for assis-
trol ERR ment results are ap- tance.
Problem with ISE. pended with a “+” or “-”
Contact your dealer. mark or an error listed
to the left occurs, the
E1500 Temperature control temperature inside the Perform the following troubleshooting.
ERR incubator is outside the (a) Check the room temperature is
Check the ambient specified range. within 15 to 32 °C. If the tempera-
temperature. ture is out of the range, control the
Clean the air filter. room temperature.
Reboot the analyzer. (b) Switch off the power.
(c) Clean the air filter.
E1501, Temperature control
è Refer to Section 6.2
E1505 ERR
(d) Make sure that thumbscrews of the
Check the ambient incubator are tightened properly
temperature. and the incubator cable is connect-
Reboot the analyzer. ed to the connector properly.
E1510 ISE temperature con- èRefer to Section 6.3.3
trol ERR (e) Make sure that the sample ap-
Check the ambient plication unit cover is attached to
temperature. the analyzer properly. Tighten the
thumbscrews securely.
Clean the air filter.
(f) Leave the analyzer for about 10
Reboot the analyzer.
minutes to allow the interior to cool,
E1511, Temperature control and then switch on power.
8 E1515 ERR NOTE If the error occurs again, please
Check the ambient contact your dealer for assis-
temperature. tance.
Reboot the analyzer.
Error
Error message Error condition Troubleshooting
code
E1502 Temperature control When the measure- Switch off the power and connect the
ERR ment results are ap- incubator cable again.
Incubator temperature pended with a “$” mark NOTE After inserting the connector of
sensor disconnected. or an error listed to the the incubator cable, you must
Check the incubator left occurs, the incuba- turn it to the right to lock it.
cable. Contact your tor cable either is not
è Refer to Section 6.3.3
dealer. connected or has been
severed. NOTE If the error occurs again, please
E1503 Temperature control contact your dealer for assis-
ERR tance.
Incubator temperature
sensor damaged.
Contact your dealer.
E1512 ISE temperature con- Disconnection error of Please contact your dealer for assis-
trol ERR the ISE incubator tance.
ISE temperature con-
trol element damaged.
Contact your dealer.
Error
Error message Error condition Troubleshooting
code
E0035 Light too intense A circuit board signal If the error still occurs after switching
Light too intense. error has occurred. the analyzer off and on, please contact
Contact your dealer in your dealer for assistance.
case the ERR repeats.
Error
Error message Error condition Troubleshooting
code
E0540 ISE AD conversion A circuit board signal When an error occurs after turning the
initialization ERR error has occurred. power on and off, please contact your
For ISE measurement, dealer for assistance. Tests other than
turn the power SW ISE do not require a restart.
OFF and ON.
Contact your dealer in
case the ERR repeats.
Other parameters
besides ISE can be
measured.
E1750- Slide reading unit If the error still occurs after switching
E1755, failure the analyzer off and on, please contact
E1757 Contact your dealer. your dealer for assistance.
Error
Error message Error condition Troubleshooting
code
E4454 Memory loading ERR A circuit board signal Please contact your dealer for assis-
Contact your dealer. error has occurred. tance.
Error
Error message Error condition Troubleshooting
code
E4475, Memory initial-value A circuit board signal Please contact your dealer for assis-
E4478- recovery ERR error has occurred. tance.
E4481 Recovery performed
from backup memory.
Contact your dealer.
E4490 File deletion ERR Please contact your dealer for assis-
Contact your dealer in tance.
case the ERR repeats.
W4720 Clock setting WARN- The date and time Set the date and time using [Date &
ING have been reset. Time settings] in Normal mode. 8
Set date & time. è Refer to Section 9.2.1
Contact your dealer in If the error occurs again, please contact
case the ERR repeats. your dealer for assistance.
IMPORTANT:
Error
Error message Error condition Troubleshooting
code
W4721 Clock control failure A circuit board signal Set the date and time using [Date &
WARNING error has occurred. Time settings] in Normal mode.
Set date & time. è Refer to Section 9.2.1
Contact your dealer in
case the ERR repeats.
W4733 Power switch control Please contact your dealer for assis-
WARNING tance.
Contact your dealer.
W5002- USB memory read USB memory read er- Check the USB memory and retry ac-
W5019 ERR ror has occurred. cording to the error message.
Lack of necessary files If the error occurs again, please contact
in the USB memory. your dealer for assistance.
Check the USB memo-
ry, and then reselect a
menu.
Contact your dealer in
case the ERR repeats.
(Failed to copy files
from the USB memory.)
W5020 USB memory write A circuit board signal Please contact your dealer for assis-
ERR error has occurred. tance.
E5500 A b n o r m a l s a m p l e Signal system error When an error occurs after turning the
spreading on slide inside circuit board. power on and off, please contact your
Contact your dealer. dealer for assistance.
E5901 Software logic ERR A software error has Please contact your dealer for assis-
Contact your dealer. occurred. tance.
Error
Error message Error condition Troubleshooting
code
― ―
Spray by
pushing in
the end of the
nozzle about
50 mm.
Error
code
Error message Error condition Troubleshooting
8
W0170 No QC card info The QC card of the Read the QC card of the printed slide
No QC information. slides loaded in the code.
Read QC card. slide cartridge has not
been read.
W4010 No QC type info. There is no type infor- Read the corresponding QC card.
No type information mation for the corre-
corresponding to the sponding item.
slide.
Read QC card corre-
sponding to the slide.
Error
Error message Error condition Troubleshooting
code
W0137 No PF card info. The PF sample rack Read the PF card included with the PF.
No PF card info. has been identified,
Read PF card. but no PF card has not
been read.
Error
Error message Error condition Troubleshooting
code
W4012 No DI info. There is no DI card Please contact your dealer for assis-
No DI info found. Can- information. tance.
not read this card.
Contact your dealer.
Error
Error message Error condition Troubleshooting
code
W1700 QC card reader failure The card reader has Please contact your dealer for assis-
QC card reader dam- malfunctioned. tance.
aged.
Measurement is still
possible.
Contact your dealer.
W1703 QC card read ERR QC card read error Make sure the card is inserted at cor-
Check the QC card rect orientation.
direction and re-read it.
(Insert the QR code so
that it faces the far left
side.)
If the error occurs re-
peatedly, contact your
8 dealer.
W4011 QC card ERR Panel card read error Please contact your dealer for assis-
Cannot save data. tance.
W4013 QC card ERR A QC card data error Check whether the QR code of the QC
Check whether this is has occurred. card is dirty.
the correct QC card. NOTE When the error is not resolved,
please contact your dealer for
assistance.
W4014 QC card ERR The QC card cannot After mode function or sample applica-
Cannot read QC card be read at this time. tion ends, read the card again.
for “Mode Function
Underway” or “Spotting
Underway”.
Read again after mode
function ends, or after
spotting ends.
W4015 Expired QC card QC card has been Use QC cards that are before their ex-
QC card has expired expired. piration dates.
and cannot be used.
Error
Error message Error condition Troubleshooting
code
W0040 Incorrect sample The sample type se- Match the configuration by the [Sample
WARNING lected by the [Sample type] button and the sample type to
The sample type set type] button and the measure the slide to be used, and then
in analyzer does not sample type of the rerun the measurement from the begin-
correspond to the read slide do not match. ning.
sample type. (Example)
Set the sample type • Whole blood (W)
by SAMPLE key and slides were loaded
the slide’s sample type when either [P/S] or
corresponding to the [U] had been se-
sample. Rerun the lected by the [Sample
tests from the begin- type] button.
ning. • Plasma/serum (P)
slides were loaded
when [W] had been
selected by the
[Sample type] button.
W0041 Incorrect sample type The sample type set- Set the sample type to P/S.
WARNING ting of PF measure-
Although a PF sam- ment does not match.
ple rack is loaded, the
sample type setting is
not P/S.
W0042 Incorrect sample rack A re-run test for a Load a PF sample rack in which a
WARNING
Correct sample rack
measurement by us-
ing PF is attempted,
sample extracted by PF has been
loaded. 8
not set in place. but a rack other than
Check the sample a PF sample rack was
rack. loaded.
W0090 ISE slide direction The ISE slide is loaded Load the ISE slide in the slide cartridge
ERR in reverse. in the proper direction, and then meas-
Incorrect loading direc- ure again.
tion of ISE slide.
Check the ISE slide.
Error
Error message Error condition Troubleshooting
code
E0160 Incorrect diluent type Diluent type does not Use specified diluent for the test name,
error match the slide to be and rerun the measurement from the
Diluent type is incor- used. beginning.
rect.
Use specified diluent
for the test name.
W0175 No slide No slides are loaded in Load slides to be tested, and rerun the
Slides have not been the slide cartridge. tests from the beginning.
set.
Rerun the tests from
the beginning.
W5400 Expired slide The validity term of the Always use valid slides.
Slide is expired and slide has expired.
cannot be used.
IMPORTANT:
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.
Error
Error message Error condition Troubleshooting
code
E0530 ISE self test gain ERR An error was detected The analyzer must be restarted for an
For ISE measurement, during a self-test per- ISE measurement. If the error occurs
turn the power SW formed before the start again, please contact your dealer for
OFF and ON. of an ISE measure- assistance.
Contact your dealer in ment. Tests other than ISE do not require a
case the ERR repeats. restart.
Other parameters
besides ISE can be
measured.
Code: Description
E1 Drift error
E2 Impedance error
E8 Impossible measurement
NOTE If the error occurs again, please contact your dealer for assistance.
NOTE Refer to the “Instructions for Use” of the slide for the measurement range.
Error
Error message Error condition Troubleshooting
code
W0091 Unacceptable ISE An ISE measurement Check ISE measurement errors that oc-
test error has occurred, curred before this error, and then carry
ISE tests cannot run. and ISE measurement out the corresponding troubleshooting.
Turn the power SW cannot be started. After troubleshooting, turn the power
OFF and ON. Rerun of the device on and off, and then start
the tests from the be- measurement again from the begin-
ginning. ning.
W0092 Unacceptable ISE There was an attempt Measure an ISE slide using automatic
manual pipetting to measure an ISE sample application.
ISE test cannot be slide using manual
done in this test mode. sample application
Set a measurable slide measurement.
and redo the test from
the beginning.
8.2.12 PF Errors
Error
Error message Error condition Troubleshooting
code
E0133, PF sensor ERR A PF sensor error has Please contact your dealer for assis-
E0150 Contact your dealer. occurred. tance.
W0134 PF sampling ERR An error occurred dur- Clean the PF Suction Pad.
Error occurred during ing PF filtering. è Refer to Section 6.9.1
PF sampling.
Check for a PF leak.
E1300, PF motor ERR PF motor error move- Turn the power on and off. If the error
E1301, Problem with the plas- ment error occurs again, please contact your dealer
8 E1303, ma filter. for assistance.
E1304 Contact your dealer.
W1308 PF sensor ERR A PF sensor error has Please contact your dealer for assis-
Problem with the plas- occurred. tance.
ma filter.
Contact your dealer.
E1302 PF motor operation PF motor error move- Turn the power on and off. If the error
ERR ment error occurs again, please contact your dealer
Problem with the plas- for assistance.
ma filter.
Contact your dealer.
Error
Error message Error condition Troubleshooting
code
W4511 Type 4 LAN commu- Type 4 LAN communi- Check the host computer and type 4
nication ERR cation ERR settings.
Check whether the set- è 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 assis-
Contact your dealer in tance.
case the ERR repeats.
8
W4520 Incorrect work list in- The received work list Check the work list information.
formation information does not NOTE If the error occurs again, please
Check whether work list match specifications. contact your dealer for assis-
information for the host tance.
computer is correct.
Contact your dealer in
case the ERR repeats.
E6200, Communication ERR A communication error Please contact your dealer for assis-
E6201, Contact your dealer. has occurred. tance.
E6210
Error
Error message Error condition Troubleshooting
code
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
Check the barcode analyzer off and on.
reader connection.
W5331 Exceeded number of Barcode label error Check the barcode label.
characters from bar-
code reader
The number of input
characters from the bar
code reader exceeded
the capacity.
W5332 Barcode WARNING Barcode data error Check the input value and re-enter.
Check input value and
re-enter.
Error
Error message Error condition Troubleshooting
code
Error
Error message Error condition Troubleshooting
code
W0190 Wrong slide for cali- A slide not suited for Check the slide. Rerun the calibration
bration calibration has been process again.
A slide that does not loaded during the cali-
require calibration is bration process.
loaded. Check the
slide and perform the
calibration from the
beginning.
W0191 Wrong slide lot for A slide different from Load a slide of the specified lot, and
calibration the lot specified during then calibrate again.
A different lot of slide calibration has been
other than designated loaded.
in the calibration mode
is loaded. Load a slide 8
corresponding to the
designated lot and
perform the calibration
from the beginning.
Error
Error message Error condition Troubleshooting
code
E4200 Calibration ERR This error may occur Rerun 2 measurements for the printed
Invalid number of due to a lack of calibra- level.
slides tion data or no applica-
The number of meas- tion on the slide.
ured slides for the fol-
lowing calibration data
is insufficient or the
sample is unspotted.
Error
Error message Error condition Troubleshooting
code
E4201 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.
Error
Error message Error condition Troubleshooting
code
E4202 Calibration curve set- The wrong calibrator Check the expiration date and the set-
ting ERR (span error) may have been used. ting position of the calibrator, and then
Misplacement of cali- calibrate again from the beginning.
brator.
Check the level and
expiration date of the
calibrator and perform
the calibration from the
beginning.
E4205 Calibration calcula- Calibration calculation Calibrate again from the beginning.
tion ERR problem
Failed in calibration
calculation.
Do the calibration
again.
Error
Error message Error condition Troubleshooting
code
E4204 Calibration measure- Error marks such as Troubleshoot the printed errors and
ment ERR “ * ”, “ ? ”, and “$” are then calibrate again from the beginning.
Error in measured printed on the meas-
result. urement results.
After coping with the
printed error, perform
the calibration from the
beginning.
Error
Error message Error condition Troubleshooting
code
W0020 No disposal box Measurement was Insert the disposal box completely, and
Put Disposal box to started with the dis- then start measurement.
the end and then press posal box pulled out.
START key.
E0021 Disposal box open The disposal box was Close the disposal box, and then start
ERR open during measure- measurement again from the begin-
Disposal box opened ment. ning.
during measurement.
Close Disposal box
and run the tests from
the beginning.
W0022 Disposal box full The disposal box is full While a measurement is not being per-
Disposal box became of slides and tips. formed, discard the slides and tips in
full of slides and tips. the disposal box.
Discard slides and tips NOTE When there are 150 slides or
to empty the box when 75 tips in the disposal box, this
measurement is not in error occurs. If the disposal box
progress. 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.
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.
Error
Error message Error condition Troubleshooting
code
W4440 Setting value reset The settings have Check settings for the reference in-
WARNING been reset. terval range and the control fluid, and
The reference interval check correlation coefficients.
range setting, control
fluid setting, and corre-
lation coefficients have
been reset. Check the
settings.
W66xx Input value ERR The entered value is Check the entered value and enter it
Check input value and incorrect. again.
re-enter.
9.1 Control
This mode is used for measurement of control serum (FUJI DRI-CHEM CONTROL QP) and for per-
forming control surveys. When control mode is set, measurements are performed under the condi-
tions 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.)
IMPORTANT:
WARNING:
IMPORTANT:
Acceptable Acceptable
lower limit upper limit
IMPORTANT:
Calculation items display a value calculated from simultaneously measured values. Therefore, cal-
culation results are impacted by errors included in measurement values and the effects of interfer-
ing 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 meas-
ured 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.
NOTE BUN measured value in Unit (B) (mmol/l) is shown as molar concentration of Urea.
Next-page buttons
Next-page buttons
Next-page buttons
Tap the field of the test for which you want to con-
figure the transfer destination, and then tap the [OK]
button.
IMPORTANT:
Incorrect entry of “a” and “b” causes incorrect measurement results. Always make sure that the
entries (a, b) are correct.
IMPORTANT:
Method
Y
Y=X In order to obtain a better correlation, it is es-
(mg/dl)
Y=0.98X+5
sential to exercise caution regarding the amount
600 of data and the sample.
1. You can configure a and b values by sam-
ple type.
FDC
reference 2. The correlation function is independent of
other compensation functions.
3. 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),
9
0
X and the new values as (a2, b2), the result-
0 A 10 600 B
(mg/dl)
ing values for (a, b) will be determined ac-
Measurement using your instruments cording to the following formulas:
a=a1×a2
b=a1×b2+b1
FDC
reference
9 0
X
0 10 A B 600
(mg/dl)
Measurement using your instruments
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 us-
ing 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 Lot No. for which you want to
enter a lot compensation coefficient.
IMPORTANT:
NOTE The calibration curve coefficients of this setting are entered automatically by QC card read-
ing and calibration.
IMPORTANT:
NOTE When the button is tapped, values of the calibration curve coefficient configuration re-
sults are printed.
NOTE For the types of containers that can be used for diluent and reference fluid, refer to Section 5.4
and Section 5.5.
<Whole blood>
Na-K-Cl → GLU → NH3
IMPORTANT:
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.
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.
10
11
Measurement Result
OPE/ADM: When expired slide is used, EXP is indi-
cated instead of measurement result.
EXP is used not only on screen indica-
tion, but also on print and in communi-
cation.
This is also the case for CRP measure-
ment with expired calibration.
11
Mode function
OPE/EMG: Operable function is limited to [Control],
[Calibration], [START Manual pipetting]
and some maintenance functions.
11
11
11
11
11
11
11
11
11
NOTE Measurement count by use of Emergency ID cannot exceed the limit count.
11 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.
12
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
13