Viatom Pd-30092 Checkme Lite Health Monitor User Manual

Viatom Pd-30092 Checkme Lite Health Monitor User Manual

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viatom PD-30092 Checkme Lite Health Monitor

viatom-PD-30092-Checkme-Lite -Health-Monitor-product

Checkme Lite Health Monitor User’s Manual

Warnings and CautionaryAdvices

  •  We recommend not to use this device if you have a pacemaker or other implanted devices. Follow the advice given by your doctor, if applicable.
  •  Do not use this device with a defibrillator.
  •  Do not use this device during MRI examination.
  • Never submerge the device in water or other liquids. Do not clean the device with acetone or other volatile solutions.
  •  Do not drop this device or subject it to strong impact.
  • Do not place this device in pressure vessels or gas sterilization device.
  • Do not dismantle the device, as this could cause damage or malfunctions or impede the operation of the device.
  •  This device is not intended for use by people (including children) with restricted physical, sensory or mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a person who has responsibility for their safety or they receive instructions from this person on how to use the device.
  •  This device displays changes in the heart rhythm and blood oxygenation etc. which may have various different causes. These may be harmless, but may also be triggered by illnesses or diseases of differing degree of severity. Please consult a medical specialist if you believe you may have an illness or disease.
  •  Do not self-diagnose or self-medicate on the basis of this device without consulting your doctor. In particular, do not start taking any new medication or change the type and/or dosage of any existing medication without prior approval.
  •  The device has no alarms and will not sound if the measurement reading is too low or too high.

About Checkme

Intended Use
The Checkme Lite health monitor is intended to be used for measuring, displaying, storing and reviewing of multiple physiological parameters including ECG and pulse oxygen saturation (SpO2) in home or healthcare facilities environment.ECG is intended for use with adult.The data and results provided by this device are for pre-check screening purpose only and cannot be directly used for diagnostic or treatment.

 Outline
viatom-PD-30092-Checkme-Lite -Health-Monitor-fig1

  1. Touch Screen
  2.  Internal SpO2 sensor
  3.  Micro-D connector It connects with mirco-D cable for charging.
  4.  Home button
    •  When the monitor is off, press this button to power it on.
    •  When the monitor is on, press and hold it for 2 seconds to turn it off.
    • During operation, press this button will switch to Main Screen or return to upper menu.
  5.  ECG right electrode
    viatom-PD-30092-Checkme-Lite -Health-Monitor-fig2
  6.  Speaker
  7.  ECG left electrode
    (Put it to your left palm, left abdomen or left knee.)
  8.  Neck stripe hole
  9.  ECG back electrode
    (Put right forefinger or middle finger on it.)

Main Screen
The Main Screen is shown as below.viatom-PD-30092-Checkme-Lite -Health-Monitor-fig3Press an icon in the Main Screen will start a measurement, activate a function, or open corresponding menu.
The device will enter Main Screen when:

  • No operation is detected for 60 seconds in result screen, the device will automatically switch to Main Screen.
  • Pressing the Home button in other screen interface.
    You can change the sound volume by tapping the button on the left of the screen, then tap the <Volume> area. Or you can also go to the Setting menu to change it.

Symbols

SymbolDescription
viatom-PD-30092-Checkme-Lite -Health-Monitor-fig21 

Manufacturer

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig22 

Date of manufacture

SNSerial number
viatom-PD-30092-Checkme-Lite -Health-Monitor-fig24
Indicates a medical device that is not to be disposed of as unsorted municipal waste.
viatom-PD-30092-Checkme-Lite -Health-Monitor-fig25 

Follow Instructions for Use.

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig26 

Type BF Applied Part

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig27 

No alarm system

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig28
MRI unsafe. Presents hazards in all MR environments as device contains strongly ferromagnetic materials.
IP22Resistant to liquid ingress
viatom-PD-30092-Checkme-Lite -Health-Monitor-fig29 

CE marking

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig30 

Authorized representative in the European community

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig31
 

UKCA marking

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig33 

Authorized Representative in the United Kingdom

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig34 

Non-ionizing radiation

Getting Started

  1.  Power On/Off
    Press the Home button to power on the device. Press and hold Home button for 2 seconds to power off thedevice.
  2. Initial Settings
    The first time when the Checkme is powered on, you can set up your Checkme step by step. You can also change the settings in the <Settings> menu.
  3.  Using Checkme
    •  Prior to Use Before using ECG Before using Daily Check or ECG Recorder function, pay attention to the following points in order to obtain precise measurements.
    •  If your skin or hands are dry, moisten them before taking the measurement.
    •  During the measurement, do not touch your body with the hand with which you are taking the measurement.
    • Please note that there must be no skin contact between your right and left hand. Otherwise, the measurement cannot be taken correctly.
  • Stay still during the measurement, do not speak and move.
  •  If possible, take the measurement when sitting instead of standing.

Before using Oximeter
Before using Daily Check and Oximeter function, pay attention to the following points in order to obtain precise measurements.

  1.  The finger inserted in SpO2 sensor must be clean.
  2.  Any of the following conditions may cause inaccurate measurements, including but not limited to:
    • Flickering or very bright light
    •  Poor blood circulation
    •  Low hemoglobin
    •  Hypotension, severe vasoconstriction, severe anemia or hypothermia
    • Nail polish, artificial nails
    •  Any tests recently performed on you that required an injection of intravascular dyes.
  3.  The Oximeter may not work if you have poor circulation. Rub your finger to increase circulation, or place the SpO2 sensor on another finger.
  4.  The Oximeter measures oxygen saturation of functional hemoglobin. High levels of dysfunctional hemoglobin (caused by sickle cell anemia, carbon monoxide, etc.) could affect the accuracy of the measurements.
  5.  The pleth waveform displayed on the device is normalized. Warnings and CautionaryAdvices
  6. Limit finger movement as much as possible when using the Daily Check or Oximeter, which might result in incorrect reading or analysis.

Daily Check About Daily Check

Warnings and CautionaryAdvices
To ensure better tracking of your health status, it is strongly suggested that every Daily Check measurement is made at the same time period when your body is in the relative same situation. E.g., every morning when get up, or every night before go to bed. Daily Check measurement is a function that combines the measuring of ECG (Electrocardiograph) waveform, HR (heart rate), SpO2 (blood oxygenation) and PI (Pulse Index). It takes only 20 seconds to collect your vital signs before giving results.
Using Daily Check
To start a Daily Check, follow the steps as below.

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig4

  1. Tap the <Daily Check> icon in the middle of the Main screen.
  2.  Hold the device according to the instruction, keep the device at the same level as your heart, and keep stable posture and stay calm. Don’t exert too much pressure on the ECG electrode, which may result in EMG (electromyograph) interference. Just hold gently and ensure good contact with the ECG electrode. Do not exert pressure on the finger that put in the SpO2 sensor. Just fit it inside but gently to ensure good blood perfusion.
    1.  Put the right forefinger into the built-in SpO2 sensor. Use the finger nail to squeeze the edge of the SpO2 sensor cover, then move in upward to the left to raise it up as shown below.
    2.  Press the right thumb on the right electrode.
    3.  Press the right middle finger on the back electrode.
    4.  Press the left electrode to the left palm.
  3.  Once the device detects stable waveform, it will automatically start the measurement. The countdown bar moves from left to right.
  4.  When the bar is fully filled, the device will analysis your data, and then show the measurement result.

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig6ECG Recorder

Different methods of taking the ECG measurement are available on Checkme. The ECG recorder offers two different methods to measuring ECG:

  •  Lead I: right hand to left hand
  • Lead II: right hand to left abdomen or left knee

Measuring without cable
To start an ECG Recorder measurement without cable,

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig7

  1. If the device is power off, press the Home button.
  2.  In the Main Screen, tap the <ECG Recorder> icon.
  3. Choose the method A or B.
  4. Follow the instruction according to the mode you selected.
    • Press the right thumb on the right electrode;
    • Press the right forefinger on the back electrode;
    • For Lead I, press the left electrode to the left palm;
    • For Lead II, press the left electrode to the left lowe abdomen;
      Do not press the device too firmly against your skin, which may result in EMG ( electromyography ) interference. After you finish the above steps, hold the device stably and staycalm.
  5.  Once the device detects stable waveform, it will automatically start the measurement. Thea countdown bar moves from left to right.
  6.  When the bar if fully filled, the device will analysis your data, and then show the measurement result.

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig8

Measuring with Cable
To start an ECG Recorder measurement with cable

  1.  If the device is power off, press the Home button.
  2.  In the Main Screen, tap the <ECG Recorder> icon.
  3.  Choose the method C or D.
  4.  Follow the instructions to connect the ECG cable and place the ECG electrodes.
    viatom-PD-30092-Checkme-Lite -Health-Monitor-fig9
    • Sit down or stand, stay calm;
    • Palms facing up, place an electrode in the middle of right wrist;
    •  For method C, place another electrode in the middle of left wrist;
    •  For method D, place another electrode in the left lower abdomen;
      viatom-PD-30092-Checkme-Lite -Health-Monitor-fig10
  5. The display will then show your ECG waveform. viatom-PD-30092-Checkme-Lite -Health-Monitor-fig11The device will monitor your ECG continuously, however no data will be saved until you press the button.
  6.  Press the button to start collecting your ECG data. The countdown bar moves from left to right.
  7.  When the bar is fully filled, the device will analysis your data, and then show the measurement result.

Oximeter
The Checkme Health Monitor measures the amount of oxygen in your blood (SpO2), your pulse rate (PR) and pulse index (PI). The oxygen saturation (SpO2) is measured and displayed as a percentage of full capacity.

Measuring without cable

To start an Oximeter measurement without cable,

  1.  If the device is power off, press the home button.
  2. In the Main Screen, tap the “Pulse Oximeter” icon.
  3. Insert the forefinger into the built-in SpO2 sensor as shown below. Relax your forefinger and do exert pressure.viatom-PD-30092-Checkme-Lite -Health-Monitor-fig12
  4.  When the device detects stable waveform, it will automatically start the measurement. The countdown bar moves from left to right.
  5.  When the bar is fully filled, the device will analysis your data, and then show the measurement result.

Measuring with Cable (Optional)

  1. Connect the external SpO2 sensor to the multi-functional connector.
  2.  Put your index finger or middle finger into the external SpO2 sensor. Make sure the cable is positioned along the top of the hand, and the finger nail is in the position as shown below.viatom-PD-30092-Checkme-Lite -Health-Monitor-fig13
  3.  If the device is power off, press the Home button. Tap the <Pulse Oximeter> icon.
  4.  The display will then show your PLETH waveform, SpO2 and pulse rate.viatom-PD-30092-Checkme-Lite -Health-Monitor-fig14 The device will monitor your ECG continuously, however no data will be saved until you press the button
  5. Press the button to start collecting your SpO2 data. The countdown bar moves from left to right.
  6.  When the bar is fully filled, the device will analysis your data, and then show the measurement result.
    viatom-PD-30092-Checkme-Lite -Health-Monitor-fig15

Settings

Opening Settings Menu
To open the Settings menu, tap the <Settings> icon to open the menu as below.

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig16

Changing Sound Volume
In the Settings menu, tap the <Volume> area to change the volume directly. Or use the quick setting by tapping the area on the left side of the screen.

Changing Brightness
In the Settings menu, tap the <Brightness> area to change the Brightness directly Or use the quick setting by tapping the area on the left side of the screen.

Setting Date & Time

  • Choose <Date & Time>.
  • Tap “+” or “-” button to change the date and time.

Turning on/off Voice Guide
In the Settings menu, tap the <Voice Guide> area to turn on/off voice guide directly. Or use the quick setting by tapping the area on the left side of the screen.

Choosing Language

  1. In the Settings menu, choose <Language>.
  2. Choose the language from the list.
  3.  Press the Home Button to return to the Settings menu

Erasing Data
In the Setting menu, tap <Erase All Data>, and then <Yes>. Please be noted that all measurements saved in the device will be deleted.

Factory Reset
In the Setting menu, choose <Factory Reset>, then tap <Yes>. All measurements, user information and other settings saved in the device will be deleted, and the device will be restored to the factory default settings.

Bluetooth connection
Install the latest APP on your smartphone (support BLE Bluetooth) from App Store (iOS) or Google Play (Android). Switch on the device bluetooth in Setting-Bluetooth and run the APP, then the data will be downloaded automatically.

Review

To open the <Data Review> menu, tap the <Data Review> icon in Mainscreen.

Reviewing Daily Check
To review Daily Checkrecords,

  1. In the <Data Review> menu, select<DailyCheck>.
  2.  Select one record to review more information as below.

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig18In this menu, you can:

  • Select to delete this measurement
  • to replay the ECG waveform as shows below
  • Select to return to the Daily Check list.

viatom-PD-30092-Checkme-Lite -Health-Monitor-fig19

Reviewing ECG Recorder
To review ECG Recorder records, in the <Data Review> menu, select <ECG Recorder>. The operations you can perform is almost the same with Daily Check.

Reviewing Oximeter
To review Oximeter records, in the <Data Review> menu, select <Oximeter>. The operations you can perform is almost the same with Daily Check.

Maintenance

Battery
This monitor is designed to operate on rechargeable Lithium-ion battery. The battery is charged automatically when the monitor is connected to a powered USB port. On-screen battery symbols indicate the battery status as follow:

  1. The battery is fully charged.
  2. The solid portion represents the remained battery energy. If the solid portion moves from left to right, then it means that the battery is being charged.
  3. Indicates that the battery is almost depleted and need to be charged immediately. Otherwise the device will shut down automatically.
  4. To charge the battery, connect the USB charging cable as shown.
  5. The device cannot be used for any measuremen during charging.
  6. Use USB charging devices comply with electrica safety standard, for example IEC 60950.

Care and Cleaning
Clean the device by carefully swabbing the device surface with a soft cloth swab with water or alcohol.

Trouble Shooting

ProblemPossible CauseSolution
The device does1. The battery may be low.1. Charge the battery and
not turn on.2. The device might betry again.
damaged2. Please contact with your
local distributor.
The ECG waveform amplitude is smallThe lead you choose is not suitable for you.Change another lead and try again.
ECG waveform1. The pressure exerted on1. Hold the device stably
driftsthe electrode is not stableorand gently.
too much.2. Try to keep perfectlystill
2. Hand or body may beand test again.
moving.
SpO2 or pulse rate1. Finger may not be1. Remove fingerand
shows no value, orinsertedcorrectly.reinsert, asdirected.
the number2. Finger or hand may be2. Try to keep perfectlystill
fluctuatesmoving.and test again.
“Error XX” occurred.Software orhardware failure.Restart the device. If the error persists, contactwith authorized service center.
SpO2 value is too1. Finger pressed toohard.1. Reinsert yourfinger
low when2. Finger may not begently andstably.
measured usinginsertedcorrectly.2. Make sure your fingeris
integrated sensor.in right position.

Accessories

Warnings and Cautionary Advices
Use accessories specified in this chapter. Using other accessories may cause damage to the device or not meet the claimed specifications.

Part NumberDescription
540-00192-00ECG cable with 2 leadwires
540-00194-00USBcharging cable, micro D
560-00198-00ECGelectrode, 10 pcs
540-00193-00external SpO2 sensor(optional)

Specifications

Environmental
ItemOperatingStorage
Temperature5 to 45°C-25 to 70°C
Relative humidity(noncondensing)10% to 95%10% to 95%
Barometric700 to 1060 hPa700 to 1060 hPa
Degree of dust & water resistanceIP22
Physical
Size88×56×13 mm
Weight64 g (main unit)
Display2.4” touch screen, color,backlit
ConnectorMicro-USB connector
Power Supply
Battery typeRechargeable lithium-polymerbattery
Battery run timeDaily check: > 200 times
Charge timeLess than 2 hours to 90%
ECG
 

Lead type

 

Integrated ECG electrodes

Lead setLead I, lead II
Record length30s
Sampling500 Hz / 16 bit
 

Display Gain

1.25 mm/mV, 2.5 mm/mV, 5 mm/mV

10 mm/mV, 20 mm/mV

Sweep speed25 mm/s
Bandwidth0.67 to 40Hz
Electrode offset potential

tolerance

 

±300 mV

HR measurement range30 to 250 bpm
 

Accuracy

±2 bpm or ±2%, whichever is greater

Heart rate is calculated based on average of every 5 to 30 QRS complex.

 

 

Measurement summary

 

Heart rate, QRS duration, Rhythm analysis (Regular ECG Rhythm, High Heart Rate, Low Heart Rate, High QRS Value,. Irregular ECG Rhythm, Unable to analyze)

StandardsMeet standards of ISO 80601-2-61
Measurement accuracy verification: The SpO2 accuracy has been verified in human experiments by comparing with arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurement are statistically distributed and about two-thirds of the measurements are expected to come within the specified accuracy

range compared to CO-oximetermeasurements.

SpO2 range70% to 100%
SpO2 Accuracy(Arms)80-100%:±2%, 70-79%:±3%
PR range30 to 250 bpm
PR accuracy±2 bpm or ±2%,whichever isgreater
PI range0.5-15
 

Measurement summary

SpO2, PR, PI, Summary (Normal Blood Oxygen, Low Blood Oxygen, Unable to analyze)
Review
Waveform reviewFull disclosure waveform
Storage100 pcs of records

Electromagnetic Compatibility

The device meets the requirements of EN 60601-1-2. All the accessories also meet the requirements of EN 60601-1-2 when in use with this device.
Warnings and CautionaryAdvices

  1.  Using accessories other than those specified in this manual may result in increased electromagnetic emission or decreased electromagnetic immunity of the equipment.
  2.  The device or its components should not be used adjacent to or stacked with other equipment.
  3. The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below.
  4.  Other devices may interfere with this device even though they meet the requirements of CISPR.
  5.  When the inputted signal is below the minimum amplitude provided in technical specifications, erroneous measurements could result.
  6.  Portable and mobile communication equipment may affect the performance of this device.
  7.  Other devices that have RF transmitter or source may affect this device (e.g. cell phones, PDAs, and PCs with wireless function).
Guidance and Declaration – Electromagnetic Emissions
The Health Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Emission testsComplianceElectromagnetic environment – guidance
RF emissions CISPR 11Group 1The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in

nearby electronicequipment.

RF emissions CISPR 11Class BThe device is suitable for use in all establishments,                                          including             domestic establishments and those directly connected to the public low-voltage power supply  network that supplies buildings used for domestic

purposes.

Harmonic emissions

IEC61000-3-2

Class A
Voltage Fluctuations / Flicker Emissions IEC

61000-3-3

Complies
Guidance and Declaration – Electromagnetic Immunity
The Health Monitor is intended for use in the electromagnetic environment specified below. The

customer or the user of the Health Monitor should assure that it is used in such an environment.

Immunity testIEC60601         test

level

Compliance levelElectromagnetic

environment – guidance

Electrostatic discharge (ESD) IEC± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete
61000-4-2or ceramic tile. If floors are

covered withsynthetic material,

the relative humidity should be at

least 30 %.

Electricalfast± 2 kV for power± 2 kV for powerMains power quality
transient/burstsupply linessupply linesshould be that of a typical
IEC 61000-4-4± 1 kV for± 1 kV forcommercial or hospital
input/output linesinput/outputenvironment.
lines
Surge

IEC 61000-4-5

± 1 kV line(s) to line(s)

± 2 kV line(s) to

earth

± 1 kV line(s) to line(s)

± 2 kV line(s) to

earth

Voltage dips, short Interruptions      and Voltage variations on power supply input lines

IEC 61000-4-11

<5 % UT

(>95 % dip in UT) for 0.5 cycle

40 % UT

(60 % dip in UT) for 5 cycles

70 % UT

(30 % dip in UT) for 25 cycles

<5 % UT

(>95 % dip in UT) for 5 s

<5 % UT

(>95 % dip in UT) for 0.5 cycle

40 % UT

(60 % dip in UT) for 5 cycles

70 % UT

(30 % dip in UT) for 25 cycles

<5 % UT

(>95 % dip in UT) for 5 s

Mains power quality should be that of a typical commercial or hospital environment. If the user of our product requires continued operation during power mains interruptions, it is recommended that our product be poweredfrom an uninterruptiblepower

supply or abattery.

Power frequency (50/60 HZ) magnetic field IEC 61000-4-83 A/m3 A/mPower                frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital

environment.

Note: UT is the AC mains voltage prior to application of the test level.
Immunity testIEC60601

test level

Compliance levelElectromagnetic         environment        – guidance
Conduced RF3 Vrms 1503 Vrms 150 kHzPortable and mobile RFcommunications
IEC61000-4-6kHz totoequipment should be used no closer to
80 MHz80 MHzany part of the system, including cables,
outside ISMoutside        ISMthan the recommended separation
bandsbandsdistance calculated from the equation
appropriate for the frequency of the
transmitter. Recommended separation

distances: d = 1 .2 P

Radiated RF IEC61000-4-33 V/m 80 MHz to

2.5 GHz

3 V/m 80 MHz to

2.5 GHz

Recommended separationdistances: 80 MHz~800 MHz: d = 1 .2 P

800MHz-2.5GHz: d = 2 .3 P

Where, P is the maximum outputpower rating of the transmitter in watts(W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, shouldbe less than the compliance level in each frequency range b.

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz to 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance  is observed, additional measures may be necessary, such as re-orienting or relocating the device.

b Over frequency range 150kHz to 80MHz. For Resp field strength should be less than 1V/m.

equipment and thedevice
The Health Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Health Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and  mobile RF communications equipment (transmitters) and the monitor as recommended below,

according to the maximum output power of the communications equipment.

Rated            max. output power of transmitter(W)Separation distance according to frequency of the transmitter (m)
150 kHz – 80 MHz

d = 1 .2 P

80        MHz        –       800

MHz d = 1 .2 P

800 MHz – 2.5

GHz              

d = 2 .3 P

0.010.120.120.23
0.10.380.380.73
11.201.202.30
103.803.807.30
10012.0012.0023.00
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected

by absorption and reflection from structures, objects and people.

 

Documents / Resouces

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