Manual - Element RC - ENG
Manual - Element RC - ENG
Manual - Element RC - ENG
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Thank you for choosing the element RC fully automated dry biochemistry analyzer.
This manual is configured to provide you with the following instructions:
Features, dimensions, principles of measurement, instructions for use, maintenance,
packaging, storage, and shipping. Please review this instruction manual carefully before use.
To ensure analyzer performance, please note all Warning, Caution and Prompt messages.
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TABLE OF CONTENTS
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5.1.1 Sample handing ..............................................................................................20
5.2 Test Rotor Preparation ...........................................................................................20
5.2.1 Reagent rotor storage and disposal.................................................................21
5.2.2 Pipette patient sample .....................................................................................22
5.3 Sample Test ...........................................................................................................23
5.4 Test Procedure Precautions ...................................................................................25
5.5 Print Results ...........................................................................................................26
5.5.1 Built-in printer print reports ..............................................................................26
SECTION 6: SERVICE AND MAINTENANCE .....................................................................27
6.1 Analyzer Cleaning ..................................................................................................27
6.2 Software Upgrade ..................................................................................................27
6.2.1 USB flash drive upgrade .................................................................................28
6.3 Troubleshooting .....................................................................................................29
SECTION 7: PACKING, STORAGE AND TRANSPORTATION ..........................................30
7.1 Packing, Storage and Transportation .....................................................................30
SECTION 8: EXPLANATION AND RISK WARNING ON EMC ...........................................31
8.1 Explanation and Risk Warning on EMC ..................................................................31
8.1.1 Operating Mode ..............................................................................................32
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SECTION 1: USING THIS MANUAL
1.1 Scope of Application
Those qualified to use this analyzer include:
1. Users who received operation training from qualified scil personnel.
2. Users who received the operation training from authorized distributors of scil.
scil reserves the right to revise the instructions and issue software updates.
No individual or organization may reproduce, modify or translate the contents of this manual
without the written consent of scil.
scil has the final interpretation of the contents of this manual.
The illustrations used in this manual are shown as representative samples, which may differ
from the actual products. If there is any difference, the physical product shall prevail.
Be sure to use the analyzer in accordance with the conditions specified in this manual.
Failure to do so may result in failure of analyzer or inaccurate test results.
Grounding
Do not modify the ground.
Protection
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1.3 element RC Analyzer Use
Follow the instructions below before operation:
❖ Please check the analyzer contents and packing list.
❖ Please read documents included with the analyzer.
WARNING
The analyzer should be protected from working in humid and corrosive environments. Do not
use flammable or explosive gas around the equipment.
Do not remove covers or other parts that are secured with screws to avoid electrical shock
that may result from exposure to hazardous voltage or injury from moving parts.
Wear protective gloves, lab coat and safety goggles.
It is the user’s responsibility to provide a compatible electromagnetic working environment to
ensure the analyzer will perform as intended.
The analyzer complies with the requirement of equipment emission and immunity in GB/T
18268. The analyzer is designed and tested according to Class A equipment in GB 4824.
Do not use this analyzer near strong radiation sources (such as unshielded FR sources), as
this may interfere with the normal operation of the analyzer.
CAUTION
BIOHAZARD
When handling samples (blood) and cleaning or maintaining the analyzer, always follow the
biohazard procedures in accordance with the sample handling rules of your facility.
Use proper protective gear (gloves, lab coat, safety goggles).
Used consumables such as rotors, tips, tubes and cloths used to clean the equipment are
infectious waste. Process this waste in compliance with any applicable local, state or country
regulations.
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When discarding the analyzer that may be contaminated with blood samples, follow
applicable regulations for your country and dispose of appropriately.
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SECTION 2: INTRODUCTION
2.1 Analyzer Appearance
Size: 7.87" (200 mm) width x 9.92" (252 mm) depth x 11.77" (299 mm) height
The element RC Analyzer features simple operation. The analyzer requires Li-Hep whole
blood, Li-Hep plasma or serum sample. Required sample volume is 100μl. Automatic sample
analysis is completed by pipetting patient sample in the test rotor and loading into the
analyzer.
The element RC Analyzer will report results after 12 minutes of analysis. The analysis results
are automatically displayed and printed after the analysis is completed. Furthermore, the
results are transmitted to the practice management software if the instrument is connected.
The Analyzer has four USB ports for connecting external printers, a mouse, keyboard, or
other supported devices.
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2.3 Detection Principle
element RC Analyzer is a bio-based analyzer with microcomputer. It is used in conjunction
with the available test rotors to detect the concentration of biochemical substances in the
patient sample, and utilizes the corresponding methods of end- point, rate, two-point method,
and the eight-segment wavelength synchronous detection.
element RC Analyzer uses the principle of absorption spectroscopy. The absorption
spectrum is mainly used for biochemical reaction tests, and its working principle is as follows:
Multiple sets of detection reagents are pre-loaded in the test rotor to form an independent
reaction chamber. The patient sample is added to the test rotor, and then the test rotor is
placed in the analyzer. The system is controlled by the computer processor, and the
biochemical substance in the blood enters the individual reaction chambers and chemically
reacts with the corresponding specific reagent to produce a color change. The absorption
spectrum is used to detect the change, and the calculation is performed by the analyzer
computer to determine the concentration of the biochemical substance present in the patient
blood sample. The turbidimetric method is mainly used for detection with immunochemical
tests, and the working principle is antigen/antibody complex. After binding, an immune
complex is formed, and the turbidity of the complex polymerization occurs within a pre-
defined time frame. When light passes through the solution, it can be absorbed by the
immune complex. The higher the immune complex, the more light is absorbed. The amount
of light absorbed is proportional to the amount of immune complex within a certain range.
The absorbance value is measured by the optical path component transmission, and the
content of the complex is proportional to the absorbance value. Similarly, when the amount
of the antibody is constant, the absorbance value is also proportional to the antigen content,
and the concentration and the content of the immune complex are analyzed to determine the
concentration of the immune complex.
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❖ Two microprocessors for controlling instrument and processing test calculations
(Constant temperature, temperature control components, and two-dimensional bar
code scanning acquisition component).
❖ A thermal printer for printing results (printer components).
❖ 7.0-inch color capacitor multi-touch screen (display screen).
❖ Multiple selection features related to testing and results processing (operating
software).
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2.8 Electromagnetic Compatibility Statement
❖ This equipment complies with GB/T18268.1–2010 (IEC61326–1:2005, IDT )
"Electromagnetic compatibility requirements for electrical equipment for measurement,
control and laboratory – Part 1: General requirements" and GB/T18268.26–2010
(IEC61326–2–6:2005, IDT ) Electromagnetic compatibility requirements for electrical
equipment for measurement, control and laboratory use Part 26: Particular
requirements for in vitro diagnostic (IVD) medical equipment.
❖ The following usage requirements should be strictly observed during use, otherwise
electromagnetic interference may be caused to other equipment or the electromagnetic
interference resistance of the equipment may be reduced or even the basic
performance may be lost.
❖ This equipment is designed and tested according to Class A equipment in GB4824. In
a domestic environment, this equipment may cause radio interference and precautions
may be required.
❖ Portable and mobile RF communications equipment may affect the description of
medical electrical equipment: Portable and mobile RF communications equipment may
affect the normal operation of this equipment, and portable and mobile RF
communications equipment should be guaranteed to meet certain spatial distances.
See Appendix A, “Recommended Isolation Distances Between Portable and Mobile RF
Communications Equipment and Equipment.”
❖ It is recommended to evaluate the electromagnetic environment before the equipment
is used. This equipment should not be used close to or stacked with other equipment.
Except for cables, connecting cables and other accessories sold by the manufacturer
as spare parts for internal components, the components cannot be replaced or repaired
without permission. Otherwise it may cause excessive electromagnetic interference or
disturbance.
❖ Do not use this device near strong radiation sources (such as unshielded RF sources)
as this may interfere with proper operation of the device.
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2.9 Technical Parameters
Sample type Lithium heparin whole blood, Lithium heparin plasma and serum
Cross infection 0
Light source 12 V/20 W, halogen tungsten lamp’s life span is over 2500 hours
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SECTION 3: INSTRUMENT INSTALLATION
3.1 Operating Environment
To ensure optimal performance, the instrument should be installed in accordance with the
following environmental conditions:
❖ Elevation not to exceed 6500 feet (2000 m)
❖ Temperature: 50ºF–86ºF (10ºC–30ºC)
❖ Relative humidity: 30%–70%
❖ Barometric pressure: 860 hPa ~1060 hPa.
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3.2 Installation
3.2.1 Installing the instrument
1. Remove the instrument from shipping carton and place it on a stable, level surface.
2. Inspect for any damage.
3. Connect the power cord to the analyzer.
4. Press the power switch at the back of the instrument, the indicator light will illuminate
below the screen. The system will enter startup and perform a self-test.
NOTE: 50 x 57 mm thermal printer paper has been installed during analyzer installation.
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SECTION 4: COMMON OPERATIONS
4.1 Startup
Startup screen: Initialization screen:
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4.2.1 Main Screen Buttons
1. Test
Run patient sample from this screen.
NOTE: Section 5.3 for further information.
2. Reports
Review prior test results. Select a report
and select to view results.
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3. QC
Quality control sample lot information and
target ranges can be added in the menu.
4. Settings
Configure the element RC Analyzer:
A. Information settings
B. Parameter settings
C. Print settings
D. Connection settings
E. Log export
F. Others
A. Information settings
Set analyzer date/time and enter clinic or
hospital name.
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B. Parameter settings
Change individual assays, such as units,
reference ranges, etc.
NOTE: Do not make changes to
parameters unless advised to do so by a
scil representative.
C. Printing settings
Select the internal printer and turn on
automatic results printing.
D. Connection settings
Select data transmission settings.
NOTE: Do not make changes to
parameters unless advised to do so by a
scil representative.
E. Log export
Export test result data to a USB device
(U:drive). USB device should be FAT32
formatted.
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5. Other settings
Do not make changes to parameters
unless advised to do so by a scil
representative.
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SECTION 5: TESTING AND RESULTS
5.1 Sample Requirements
WARNING
Always follow biohazard procedures in accordance with the sample handling rules of your
facility when handling samples (blood).
CAUTION
❖ Whole blood must be analyzed or transformed to plasma and serum within 30 minutes
after collection.
❖ Do freeze or shake the sample vigorously, this can hemolyze the sample.
❖ If the sample cannot be analyzed immediately after collection, it should be processed
into serum or plasma and stored in sealed sample tube at -20°C. Avoid repeated
freezing-thawing cycles.
❖ The patient should be fasted for 12 hours prior to glucose testing.
❖ Check the patient sample for clots or hemolysis. Avoid running icteric or lipemic
samples. The analyzer has a built-in centrifugal function - testing will begin after the
anticoagulated whole blood has been spun into plasma. Lithium heparin is the only
recommended anticoagulant, as it will not interfere with on biochemistry analysis.
❖ Always wear proper protective gear when handling patient samples.
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5.2.1 Reagent rotor storage and disposal
❖ Store test rotors in the refrigerator between 2–8°C.
❖ Remove test rotor from refrigerator and allow to warm up to room temperature for 20
minutes in sealed pouch prior to sample analysis.
❖ Test rotors in sealed pouches can be stored at room temperature for a maximum of 48
hours.
❖ Do not expose the test rotor to direct sunlight, or temperatures over 32°C.
❖ Remove test rotor from sealed pouch, hold the rotor by the edge only to avoid
contamination. Test rotors should be used within 10 minutes after opening the sealed
pouch. Once test rotors have been removed from the sealed pouch, they should not be
returned to the refrigerator.
❖ Patient information can be written on the test rotor in the grey area.
❖ Avoid marking or damaging the barcode at the center of the test rotor.
❖ Insert test rotor into analyzer immediately after pipetting patient sample. Do not shake
rotor after patient sample has been pipetted.
❖ Test rotors are single use only. Used test rotors should be disposed of in accordance
with regulations.
❖ Damaged test rotors should be disposed of immediately. Avoid contact with reagents
contained within rotors.
Labeling area
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5.2.2 Pipette patient sample
1. Use the supplied 100μl pipette and
disposable tip to pipette patient
sample into the sample port.
Fill the sample well to the fill line.
CAUTION
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5.3 Sample Test
Turn on the analyzer, if it is not already powered on.
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7. The analyzer scans the
QR code on the test
rotor and begins
countdown. Patient
information can be
added by touching
SAMPLE INFO.
8. Touch STOP to
terminate current
patient sample
analysis.
9. Touch OK when the
test is terminated.
CAUTION
Test rotor and patient sample will
no longer be valid after
terminating testing.
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5.4 Test Procedure Precautions
Analyzer
❖ Use grounded power supply and supplied power cord.
❖ Confirm the ambient temperature of the analyzer is 10ºC–30ºC.
❖ Do not disconnect power during operation.
❖ Close the drawer when the analyzer is not in use.
❖ Pinch hazard – keep fingers clear when analyzer drawer is opening and closing.
❖ Do not disassemble the analyzer.
Test Rotor
❖ Do not use expired test rotors. Check expiration date on sealed pouch.
❖ Store test rotors at 2ºC–8ºC. Use gloves when handling test rotors, handle test rotors
by the edges.
❖ After pipetting patient sample, place horizontally to prevent overflow.
❖ Test rotors are single use; do not re-use.
❖ Test rotors must be used within 10 minutes of removal from sealed pouch.
❖ Analyze test rotor immediately after pipetting patient sample.
Sample
❖ Whole blood should be used within 30 minutes after sampling to prevent hemolysis.
❖ Do not place sample in the refrigerator or shake vigorously.
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5.5 Print Results
5.5.1 Built-in printer print reports
Sample report
The results of the analysis are automatically stored,
and the user can choose to print using the built-in
printer.
The header information of the printed report includes:
hospital name, patient name, medical record number,
sample number, age range, gender, blood sample, test
rotor ID, instrument ID, software version and test time.
The printed result section has four columns, profile
name, test value result, reference range and units.
Results outside the reference range will be marked with
H (high) and L (low) next to the result and will not be
displayed until the header information of the printed
report is filled out.
WAT= internal check of the sample volume
EMP= internal self-check
CHE= absorbance monitoring
represents a chemical monitoring hole absorbance.
The above indicators are divided into three levels:
0—better 1—general 2—poor
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SECTION 6: SERVICE AND MAINTENANCE
The element RC Analyzer requires minimal maintenance to ensure optimal performance.
Casing
Clean the outside of the machine as needed with a mild detergent and a soft wet cloth. Do
not spray or pour any detergent or liquid directly onto the instrument. Dry the analyzer with a
soft dry cloth.
Display
Wipe the display regularly with a damp, lint-free towel.
NOTE: Clean and maintain the test chamber regularly, based on usage.
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6.2.1 USB flash drive upgrade
1. Prepare a file system for the USB drive in FAT32 format. If the format is incorrect or
cannot be confirmed, please format it on the computer and back up the data on the
USB flash drive before formatting.
USB drive formatting process: insert USB drive into the computer ► select the USB
drive ► right click ► format ► select "FAT32" file system ► start ► confirm ► format
completion prompt ► confirm.
2. Obtain the software compression package from scil’s Technical Support Services.
3. Unzip the upgrade package to get the "upgradepackage" directory, which should be
placed in the root directory of the USB drive.
4. Unplug the USB flash drive from the computer and plug it into the USB port on the back
of the analyzer.
5. Turn on the analyzer or restart the analyzer.
6. The analyzer starts and the software prompts the version upgrade information. Make
sure the upgraded version number is consistent with the version number of the
software compression package, then touch [Yes]. The software will begin the upgrade.
7. During the software upgrade process, the user will be prompted to complete the
upgrade. After the instrument upgrade is complete, the instrument will need to be
restarted. Turn the analyzer off and on again.
8. After the software upgrade is completed, it is automatically initialized, and the upgrade
is completed.
NOTE: If the upgrade fails [during upgrade], please restart the analyzer. If the upgrade is still
unsuccessful, please contact scil Technical Support Services.
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6.3 Troubleshooting
Description Solution
Mixing error, check sample for proper mixing or use
W2021, W2022, W2023, W2024,
serum / plasma to rerun the test
W2041, W2051
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SECTION 7: PACKING, STORAGE AND
TRANSPORTATION
7.1 Packing, Storage and Transportation
This instrument is packaged in a cardboard box outer shell and high-quality foam for shock
protection. Do not stack the analyzer.
Transportation temperature: -20ºC–55ºC
Storage temperature: 0ºC–40ºC
Relative humidity: ≤ 85%.
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SECTION 8: EXPLANATION AND RISK WARNING ON
EMC
8.1 Explanation and Risk Warning on EMC
This product has passed the EMC test and meets GB/T 18268.1–2010 "Electromagnetic
compatibility requirements for electrical equipment for measurement, control and laboratory
use - Part 1: General requirements" and GB/T 18268.26–2010 "Measurement, control and
laboratory Electromagnetic compatibility requirements for electrical equipment - Part 26:
Particular requirements for in vitro diagnostic (IVD) medical devices.
The following usage requirements should be strictly observed during use, otherwise it may
cause electromagnetic interference to other equipment or reduce the anti-electromagnetic
interference capability of this product, or even lose its basic performance.
This product belongs to Group 1 Class A equipment of GB 4824–2013 and is suitable for use
in all facilities that are not directly connected to the public low-voltage power grid of the
residential home.
Portable and mobile RF communications equipment may affect the description of medical
electrical equipment: Portable and mobile RF communications equipment may affect the
normal operation of this product, and portable and mobile RF communications equipment
should be guaranteed to meet certain spatial distances and specific requirements. See the
requirements in Table 4.
If the equipment cable connection is faulty, please contact our company for repair or
replacement, otherwise it may cause excessive electromagnetic interference. If the
equipment is faulty, please contact scil’s Technical Support Services. Do not repair or
replace the components yourself, otherwise it may cause excessive electromagnetic
interference.
WARNING
In addition to the transducers and cables sold by the manufacturer of the equipment or
system as spare parts for internal components, the use of accessories, transducers and
cables outside the specified regulations may lead to increased emission or reduced immunity
of equipment or systems.
WARNING
Devices or systems should not be used close to or overlay other devices. If they must be
used close to or overlay, they should be observed to verify that they can operate normally
under the configuration they are using.
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This product belongs to professional IVD equipment and needs to pay attention to the
following preventive warnings:
❖ The emission and immunity requirements specified in Tables 1 to 4 shall be met.
❖ It is recommended to evaluate the electromagnetic environment prior to use.
❖ Do not use this equipment near strong radiation sources (such as unshielded RF
sources), as this may interfere with normal operation of the equipment.
Basic performance
The equipment should work normally, and the bias of glucose (GLU) test results should meet
the requirements of 2.3 in the technical requirements.
Test method
Three measurements were made on the same quality control sample of GLU, and the
allowable error was calculated according to the method listed in 3.3 in the technical
requirements.
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Table 1 – Guide and manufacturer's statement—electromagnetic emissions. The product is
intended to be used in the electromagnetic environment specified.
Radio frequency emission Group 1 The product uses RF energy only for its internal
functions. Therefore, its RF emissions are low
GB 4824
and there is little possibility of interference with
electronic equipment.
Radio frequency emission Class A The product is suitable for use in all facilities
that are not directly connected to the home and
GB 4824
to the public low-voltage grid of the residential
home.
Harmonic emission Not applicable
GB 17625.1
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environments.
Voltage dip, short 0%Ut, Continue 1 0%Ut, Continue 1 Network power supply
interruption and voltage cycle cycle should have the quality
change on the power of use in typical
(On Ut, 100% sag) (On Ut, 100% sag)
input line commercial or hospital
environment.
GB/T17626.11
If the users of this
product need to run
continuously during
power interruption, it is
recommended to use
un-interruptible power
supply or battery power
supply.
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Table 3 – Guide and manufacturer's statement—electromagnetic immunity. The product is
intended to be used in the electromagnetic environment specified.
In formula:
P—Maximum output rated power of the
transmitter provided by the transmitter
manufacturer in Watt (W).
d—The recommended isolation distance
is in meters (m). Fixed RF transmitter field
strength, through the electromagnetic field
survey to determine, each frequency
range
B should be lower than the level in line
with.
Disturbance may occur near equipment
marked with the following symbol .
NOTE: For 80 MHz and 800 MHz frequencies, higher frequency band formulas should be
used.
NOTE: These guidelines may not be suitable for all situations. Electromagnetic propagation
is affected by the absorption and reflection of buildings, objects and human bodies. Fixed
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transmitters, such as wireless (cellular/cordless) telephones and ground mobile radio base
stations, amateur radios, AM/FM radio broadcasting and television broadcasting, cannot
accurately predict their electric field in theory. In order to evaluate the electromagnetic
environment of fixed radio frequency transmitter, the survey of electromagnetic field should
be considered. If the measured product is located in a place where the electric field is higher
than the above RF level, the product should be observed to verify its normal operation. If
abnormal performance is observed, supplementary measures may be necessary, such as
reorienting the direction or location of the product. In the whole frequency range from 150
KHz to 80 MHz, the Electric field should be less than 3 V/m.
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Table 4 – Recommended isolation distance between portable and mobile radio frequency
communication equipment and products.
100 12 12 23
NOTE: At 80 MHz and 800 MHz frequencies, the formula of higher frequency band should
be adopted.
NOTE: These guidelines may not be suitable for all situations. Electromagnetic propagation
is affected by the absorption and reflection of buildings, objects and human bodies.
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Service-Contact:
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