Viatom Checkme Lite User manual

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Checkme Lite Health Monitor

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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, ifapplicable.
 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.
1. About Checkme
1.1 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.

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1.2 Outline
1 2
3
4
5
1. Touch Screen
2.
Internal SpO2sensor
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
(Put right thumb on it.)
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97
8
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.)

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1.3 Main Screen
The Main Screen is shown as below.
Press 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 taping 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.
1.4 Symbols
Symbol
Description
Manufacturer
Date of manufacture
SN
Serial number
Indicates a medical device that is not to be disposed of as unsorted
municipal waste.
Follow Instructions for Use.
Type BF Applied Part
No alarm system
MRI unsafe. Presents hazards in all MR environments as device
contains strongly ferromagnetic materials.
IP22
Resistant to liquid ingress

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CE marking
Authorized representative in the European community
UKCA marking
Authorized Representative in the United Kingdom
This product complies with the rules and regulations of the Federal
Communication Commission.
Non-ionizing radiation
Our products and packaging can be recycled, don't throw them away!
Find where to drop them off on the www.quefairedemesdechets.fr
site (Only applicable for French market).
This product complies with verpackG.
2. Getting Started
2.1 Power On/Off
Press the Home button to power on the device. Press and hold Home button for 2
seconds to power off thedevice.
2.2 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
3.1 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.

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Before using Oximeter
Before using Daily Check and Oximeter function, pay attention to the following points
in order to obtain precise measurements.

The finger inserted in SpO2sensor must be clean.
 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.

The Oximeter may not work if you have poor circulation. Rub your finger to
increase circulation, or place the SpO2sensor on another finger.
 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.

The pleth waveform displayed on the device is normalized.
Warnings and Cautionary Advices
 Limit finger movement as much as possible when using the Daily Check or
Oximeter, which might result in incorrect reading or analysis.
3.2 Daily Check
About Daily Check
Warnings and Cautionary Advices
 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
Tostart a Daily Check, follow the steps as below.
1. Tap the <Daily Check> icon in the
middle of the Main screen.

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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 SpO2sensor. Use the finger nail to
(1)
(4)
(2)
(3)
squeeze the edge of the SpO2sensor 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.
3.3 ECG 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

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Please keep stable posture and stay calm during the measurement. Movements may
result in interference and incorrect readings or analysis result.
Measuring without cable
Tostart an ECG Recorder measurement without 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 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 stay calm.
5. Once the device detects stable waveform, it will automatically start the
measurement. The 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.
Measuring with Cable
Tostart 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.

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 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;
5. The display will then show your ECG waveform.
The 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.
3.4 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
Tostart a 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 SpO2sensor as shown below. Relax your

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forefinger and do exert pressure.
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 SpO 2 sensor to the multi-functional connector.
2. Put your index finger or middle finger into the external SpO 2 sensor. Make
sure the cable is positioned along the top of the hand, and the
finger nail is in the position as shown below.
Finger nail position
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, SpO 2 and pulse rate.
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 SpO 2 data. The countdown bar
moves from left to right.

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6. When the bar is fully filled, the device will analysis your data, and then show the
measurement result.
4. Settings
4.1 Opening Settings Menu
To open the Settings menu, tap the <Settings> icon to open the menu as below.
4.2 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.
4.3 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.
4.4 Setting Date & Time
1. Choose <Date & Time>.
2. Tap “+” or “-” button to change the date and time.
4.5 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.
4.6 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.
4.7 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.
4.8 Factory Reset
1. In the Setting menu, choose <Factory Reset>, then tap <Yes>.

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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.
4.9 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.
5. Review
To open the <Data Review> menu, tap the <Data
Review> icon in Mainscreen.
5.1 Reviewing Daily Check
To review Daily Check records,
1. In the <Data Review> menu, select
<DailyCheck>.
2. Select one record to review more information as below.
In this menu, you can:
 Select to delete this measurement
 Select to replay the ECG waveform as
shown below.
 Select to return to the Daily Check list.
5.2 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.
5.3 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.

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6. Maintenance
6.1 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:
The battery is fully charged.
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.
Indicates that the battery is almost depleted and need
to be charged immediately. Otherwise the device will shut down automatically.
To charge the battery, connect the USB charging
cable as shown.
The device cannot be used for any measurement
during charging.
Use USB charging devices comply with electrical
safety standard, for example IEC 60950.
6.2 Care and Cleaning
Clean the device by carefully swabbing the device surface with a soft cloth swab
with water oralcohol.
6.3 Trouble Shooting
Problem
Possible Cause
Solution
The device does
not turn on.
1. The battery may be low.
2. The device might be
damaged
1. Charge the batteryand
try again.
2. Please contact with your
local distributor.
The ECG waveform
amplitude is small
The lead you choose is not
suitable for you.
Change another lead and
try again.
ECG waveform
drifts
1. The pressure exerted on
the electrode is not stableor
too much.
2. Hand or body may be
moving.
1. Hold the device stably
and gently.
2. Try to keep perfectly still
and test again.

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SpO2or pulse rate
1. Finger may not be
1. Remove finger and
shows no value, or
insertedcorrectly.
reinsert, as directed.
the number
2. Finger or hand may be
2. Try to keep perfectlystill
fluctuates
moving.
and test again.
“Error XX”
occurred.
Software or hardware
failure.
Restart the device. If the
error persists, contact with
authorized service center.
SpO2value is too
1. Finger pressed toohard.
1. Reinsert your finger
low when
2. Finger may not be
gently andstably.
measured using
insertedcorrectly.
2. Make sure your fingeris
integrated sensor.
in right position.
Have the device repaired by authorized service centers only, otherwise its warranty
is invalid.
7. 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 Number
Description
540-00192-00
ECG cable with 2 leadwires
540-00194-00
USB charging cable, micro D
560-00198-00
ECG electrode, 10 pcs
540-00193-00
external SpO2 sensor(optional)
8. Specifications
En v i r on me n ta l
Item
Operating
Storage
Temperature
5 to 45°C
-25 to 70°C
Relative humidity(noncondensing)
10% to 95%
10% to 95%
Barometric
700 to 1060 hPa
700 to 1060 hPa
Degree of dust & water resistance
IP22
Physical
Size
88×56×13 mm
Weight
64 g (main unit)

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Display
2.4” touch screen, color,backlit
Connector
Micro-D connector
Power Supply
Battery type
Rechargeable lithium-polymerbattery
Battery run time
Daily check: > 200 times
Charge time
Less than 2 hours to 90%
ECG
Lead type
Integrated ECG electrodes
Lead set
Lead I, lead II
Record length
30s
Sampling
500 Hz / 16 bit
Display Gain
1.25 mm/mV, 2.5 mm/mV, 5 mm/mV
10 mm/mV, 20mm/mV
Sweep speed
25 mm/s
Bandwidth
0.67 to 40Hz
Electrode offset potential
tolerance
±300 mV
HR measurement range
30 to 250 bpm
Accuracy
±2 bpm or ±2%, whichever isgreater
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)
Standards
Meet standards of ISO80601-2-61
Measurement accuracy verification: The SpO2accuracy 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 range
70% to 100%
SpO2 Accuracy(Arms)
80-100%:±2%, 70-79%:±3%
PR range
30 to 250 bpm
PR accuracy
±2 bpm or ±2%，whichever isgreater
PI range
0.5-15
Measurement summary
SpO2, PR, PI, Summary (Normal Blood Oxygen,Low
Blood Oxygen, Unable to analyze)

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Review
Waveform review
Full disclosure waveform
Storage
100 pcs of records
9. 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
Using accessories other than those specified in this manual may result in increased
electromagnetic emission or decreased electromagnetic immunity of the equipment.
The device or its components should not be used adjacent to or stacked with other
equipment.
The device needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided below.
Other devices may interfere with this device even though they meet the requirements of
CISPR.
When the inputted signal is below the minimum amplitude provided in technical
specifications, erroneous measurements could result.
Portable and mobile communication equipment may affect the performance of this device.
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 tests
Compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
The 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 electronic equipment.
RF emissions CISPR 11
Class B
The 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 test
IEC60601 test level
Compliance level
Electromagnetic
environment - guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the

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relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/output
lines
± 2 kV for power
supply lines
± 1 kV for input/output
lines
Mains power quality should
be that of a typical
commercial or hospital
environment.
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 powered from an
uninterruptible power supply
or a battery.
Power frequency
(50/60 HZ) magnetic
field IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: UTis the AC mains voltage prior to application of the test level.
Guidance and Declaration - Electromagnetic Immunity
The Health Monitor is intended for use in the specified electromagnetic environment. The customer or the user of
the Health Monitor should assure that it is used in such an environment as described below.
Immunity
test
IEC60601 test
level
Compliance
level
Electromagnetic environment - guidance
Conduced RF
IEC61000-4-6
3 Vrms 150
kHz to
80 MHz
outside ISM
bands
3 Vrms 150
kHz to
80 MHz
outside ISM
bands
Portable and mobile RF communications equipment
should be used no closer to any part of the system,
including cables, than the recommended separation
distance calculated from the equation appropriate for the
frequency of the transmitter. Recommended separation
distances:
Pd 2.1
Radiated RF
IEC61000-4-3
3 V/m 80
MHz to 2.5
GHz
3 V/m 80
MHz to 2.5
GHz
Recommended separation distances:
80 MHz～800 MHz:
Pd 2.1
800MHz-2.5GHz:
Pd 3.2
Where, Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey a, should be 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.

17
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
aField 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.
bOver frequency range 150kHz to 80MHz. For Resp field strength should be less than 1V/m.
Recommended separation distances between portable and mobile RF communications equipment and the
device
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
Pd 2.1
80 MHz - 800
MHz
Pd 2.1
800 MHz - 2.5 GHz
Pd 3.2
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.20
1.20
2.30
10
3.80
3.80
7.30
100
12.00
12.00
23.00
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.

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10. FCC Statement
FCC Warning:
FCC ID: 2ADXK-6621
Any Changes or modifications not expressly approved by the party responsible for compliance could
void the user's authority to operate the equipment.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause
undesired operation.
Note: This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates uses
and can radiate radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, 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 antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
-Consult the dealer or an experienced radio/TV technician for help.
The device has been evaluated to meet general RF exposure requirement. The device can be used
in portable exposure condition without restriction.