FujiFilm DRI-CHEM NX10N User manual

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

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

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

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

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

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

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

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897N120152H FDC NX10N Instruction Manual 04.2022
NOTE: Turn off the equipment before removing the AC adapter.
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 NX10N. Otherwise, physical damage or malfunction on the FDC NX10N 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 electromag-
netic environment for the equipment can be maintained in order that the equipment will perform as intended.
1.7 Moving Parts
WARNING:
Do not place your hands near the moving part whenever operating the equipment including maintenance.
Also use care not to get your hands, hair, clothing, or accessories caught in moving part.
CAUTION:
Connect the AC adapter to the connector for AC adapter connection.
If AC adapter is not used, unplug the AC power cable from the receptacle. Do not leave the equipment
alone in an energized state for an extended period of time.

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1.8 Installation Site Requirements
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:
Location: Indoor use
Illumination: Below 6,000 cd/m² (lux)
(Below 3,000 cd/m² (lux) when using the sample barcode reader)
Altitude: Up to 2,000 m
Transient overvoltage category: II
Pollution degree: 2
Operating temperature: 15 to 32 ºC (59 to 89 ºF)
Operating humidity: 30 to 80% RH (no vapor condensation)
(2) Use the equipment under the following electrical requirements:
Voltage limit: 100 - 240V~
Frequency: 50 - 60 Hz
Supply voltage fluctuations: ± 10%
Rated current: 0.6 A
Phase: Single
Type of protection against
electrical shock: CLASS 2 EQUIPMENT
(3) Plug the FDC NX10N into an independent AC outlet separate from other devices.
(4) Empty space is necessary at least 10 cm on the back and 5cm on the both sides of the equipment.
(Empty space on the back is necessary to unplug the AC power cable connector from the appliance
inlet of the equipment.)
(5) Unplug the equipment from the AC outlet if it will not be used for an extended period of time.
Do not place objects in the vicinity of the AC outlet so that the AC power plug can be unplugged imme-
diately if an abnormality occurs in the equipment.
When carrying the equipment, hold the equipment with both hands by placing your fingers on both lower
sides of the equipment. Be careful not to get your fingers caught when placing the equipment on a table
or the like.
If you notice any abnormalities such as strange noise, smell or smoke being emitted from the equip-
ment, immediately remove the AC power plug from the AC outlet.

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897N120152H FDC NX10N Instruction Manual 04.2022
1.9 Test Results for Diagnosis
CAUTION:
Use the AC adapter supplied with this equipment. Failure to do so may lead to the failure of the equipment or
inaccurate test results.
1.10 Pipettes
IMPORTANT:
Make a diagnosis in a comprehensive manner, considering other relative test results or clinical situation.
Always use the FUJI DRI-CHEM SLIDEs (NH3-WII / NH3-PII) and samples corresponding to those
slides. If a different slide and a sample are mistakenly used, it may produce inaccurate test results.
In case that an analyzer malfunction error (s) is (are) displayed (printed) before/during test processing,
or warning indications are printed out along with test results, the test results may NOT be accurate. Re-
fer to Sec. 7 Troubleshooting and rerun the tests.
To maintain the accuracy of your test results, daily quality control is necessary. Perform quality control
using control fluids.
When the fan does not work, contact your technical support (dealer) for assistance. Continuous use of
the equipment despite the failure of the fan may lead to inaccurate test results produced with improper
temperature control.
IMPORTANT:
Always use a pipette that dispenses 10 μL with accuracy. (Pipetting accuracy 10±0.3 μL)
A tip to be used for the pipette must be FUJI CLEAN TIPS (henceforth, “ tip”). Use new tip for each
sample.
Properly install a tip to the pipette nozzle. Failure to do so may cause accidental detachment of the tip,
resulting in the spread of sample.

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897N120152H FDC NX10N Instruction Manual 04.2022
1.11 FUJI DRI-CHEM SLIDEs (NH3-WII / NH3-PII)
NOTE: (Henceforth, FUJI DRI-CHEM SLIDE is shortened into “slide” in this manual.)
CAUTION:
Please read the “Instructions for Use” of the slides carefully and follow the instructions.
NOTE: Types of slide packages and containers for liquids (e.g., diluent, reference fluid) are subject to change without
notice.
1.12 QC Card System
(1) QC cards are packed together with slides in the same box. Before you start using a new lot of slides,
read the QC card using the QC card reader. It is nevertheless advisable to store the QC card in the box it
comes in until the accompanying lot of slides has been used up.
IMPORTANT:
Always match the test name / production number (lot) of QC card read by the reader to the test name / pro-
duction number (lot) of slides to be used. If those do not match, it may produce inaccurate test results. The “test
name” indicates FUJI DRI-CHEM SLIDE NH3-W II or NH3-P II.
(2) The test name, lot compensation coefficients are recorded on a QC card. Only use slides from the same
box for measurements after reading in a QC card.
1.13 Handling Samples
WARNING:
When handling samples (whole blood or blood plasma), always follow biohazard procedures (e.g., wearing
gloves, lab coat, and safety goggles), referring to the sample handling rules of your facility. If any part of the
body comes in contact with samples, immediately rinse the contaminated body part thoroughly under run-
ning water and then use ethyl alcohol as a disinfectant. Seek medical assistance if necessary.
IMPORTANT:
Please carefully read the “Instructions for Use” included with the slides and follow the instructions to handle
slides.
WARNING:
Do not touch used slides with bare hands as this may cause contamination. If any part of the body
comes in contact with used slides, immediately rinse the contaminated body part thoroughly under run-
ning water and then use ethyl alcohol as a disinfectant. Seek medical assistance if necessary.
As used slides are infectious waste, process the waste correctly in compliance with any applicable regu-
lations in your country, such as by incineration, melting, sterilization or disinfection.
IMPORTANT:
The slides should be stored in a refrigerator [2-8 ºC (35.6-46.4 ºF)] without unwrapping to avoid humid-
ity, light, and heat.
Only the required number of slides should be taken out of the refrigerator and warmed up to room tem-
perature before unwrapping the individual packages.
Complete the measurement within 30 minutes after unwrapping the individual package.
Do not touch the center part of the surface or the back of the slides.
Do not scratch (damage) the printed dot-code on the backside of the slides.
A new slide must be used for each measurement. Do not reuse.

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1.14 FUJI CLEAN TIPS
NOTE: Henceforth, FUJI CLEAN TIPS can be shortened into “tip”.
Manual pipetting is used with the FDC NX10N. The proprietary tip from FUJI CLEAN TIPS is required to be
attached to a pipette.
1.15 Warning Labels
Warning labels and safety labels on the FDC NX10N are:
Name-Plate
Biohazard label
High temperature
caution label *
Power switch
| : Depress to power ON
O : Depress to power OFF
* The photometer and the upper heater (Refer to P2-1) may become
extremely hot when an abnormality occurs in the analyzer. To
open the pipette cover for cleaning or other purposes, make sure
that they are completely cooled down after turning off the analyzer
before opening the pipette cover.
IMPORTANT:
Do not touch the tip-end. It may cause damage to water repellent.
Do not contact the tip-end with other devices. It may cause contamination of water repellent.
This product does not allow autoclave treatment before use.
Please store at room temperature.

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1.16 Symbols
Sign Description
Warning, Caution, Important, consult documents
Biological risks
High temperature caution
Power switch
Fragile item, handle carefully
Protect from rain
This way up
11
Stacking limitation
Temperature limitation
Manufacturer
S
N
Serial number
Country of manufacture
Date of manufacture
EC REP
Authorized representative in the European Community
In vitro diagnostic medical devices
CE mark of conformity

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Sign Description
Importer
Consult Instructions for Use
Unique device identifier
Near-patient testing

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2 Component Names and Functions
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2. Component Names and Functions
2.1 Component Names
Disposal box
Keyboard
Display
Power switch
QC card reader
Pipette guide
Slide loading
part
Pipette cove
r
[Measurement Part]
Photometer
Pipette cover
Upper heater
Transfer frame
Slide transfer part
Reference black plate
/ Reference white plate

2 Component Names and Functions
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USB (A type) x 2
USB (B type)
Air Filter
Connector for AC
adapter connection
AC Adapter
The mark is the mark of the
Class II device.