Viatom PB-20 User manual

Portable ECG MONITOR
Model：PB-20
Content
1. The Basics........................................................................................................................................................................................... 2
1.1 Safety.................................................................................................................................................................................................. 2
1. Introduction........................................................................................................................................................................................3
1.1 Intended Use......................................................................................................................................................................................3
1.2 Contraindications...............................................................................................................................................................................4
1.3 About Portable ECG monitor............................................................................................................................................................4
1.4 Main Screen....................................................................................................................................................................................... 5
1.5 Result Screen......................................................................................................................................................................................5
1.6 Symbols.............................................................................................................................................................................................. 6
2. Getting Started...................................................................................................................................................................................6
2.1 Unpacking.......................................................................................................................................................................................... 6
2.2 Power On/Off.....................................................................................................................................................................................7
2.3 Initial Settings.....................................................................................................................................................................................7
3. Using the device................................................................................................................................................................................ 7
3.1 Prior to Use........................................................................................................................................................................................ 7
Before using ECG........................................................................................................................................................................................ 7
3.2 ECG Recorder.....................................................................................................................................................................................8
About ECG Recorder.................................................................................................................................................................................. 8
Measuring with Cable.................................................................................................................................................................................9
4. Settings............................................................................................................................................................................................... 9
4.1 Opening Settings Menu.................................................................................................................................................................... 9
4.2 Turning On/Off Bluetooth.............................................................................................................................................................. 10
4.3 Setting ECG Length......................................................................................................................................................................... 10
4.4 Changing User Mode...................................................................................................................................................................... 10
4.5 Changing Brightness....................................................................................................................................................................... 10
4.6 Turn on/off voice............................................................................................................................................................................. 11
4.7 Setting Date & Time........................................................................................................................................................................11
4.8 Erase Data........................................................................................................................................................................................ 11
4.9 Factory Reset....................................................................................................................................................................................11
4.10 Identify Software Version................................................................................................................................................................11
5. Review ECG Recorder......................................................................................................................................................................11
6. Maintenance.................................................................................................................................................................................... 12
6.1 Warranty...........................................................................................................................................................................................12
6.2 Battery.............................................................................................................................................................................................. 12
6.3 Cleaning..............................................................................................................................................................................................2
6.4 Trouble Shooting...............................................................................................................................................................................2
7. Accessories......................................................................................................................................................................................... 2
8. Specifications..................................................................................................................................................................................... 1
9. FCC Statement................................................................................................................................................................................... 2
10. Electromagnetic Compatibility......................................................................................................................................................... 2
User’s Manual

1. The Basics
Caution: Federal law restricts this device to sale by or on the order of a physician.
This manual contains the instructions necessary to operate the product safely and in accordance with its
function and intended use. Observance of this manual is a prerequisite for proper product performance and
correct operation and ensures patient and operator safety.
This manual is based on the maximum configuration of
Portable ECG monitor
.
1.1 Safety
Warnings
Before using the device, please ensure that you have read this manual thoroughly and fully understand
corresponding precautions and risks.
This device has been designed for practical use, but is not a substitute for a visit to the doctor.
The data and results displayed on the device are for reference only and cannot be directly used for
diagnostic interpretation or treatment.
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.
Users should always consult their physician if they notice changes in their health.
Messages after measurement report heart rate and heart rhythm only.
This device neither detects nor measures all heart rate, heart rhythm and heart waveform changes,
especially those related to ischemic heart conditions.
Do not use this device with a defibrillator.
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. Children should be supervised around the device
to ensure they do not play with it.
Do not allow the electrodes of the device to come into contact with other conductive parts
(including earth).
Do not use the device with persons with sensitive skin or allergies.
Do not store the device in the following locations: locations in which the device is exposed to
direct sunlight, high temperatures or levels of moisture, or heavy contamination; locations
near to sources of water or fire; or locations that are subject to strong electromagnetic
influences.
Do not swing the device with the strip, which may result in injury.
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.
Vital signs measurements, such as those taken with this device, cannot identify all diseases.
Regardless of the measurement taken using this device, you should consult your doctor

immediately if you experience symptoms that could indicate acute 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.
This device is not a substitute for a medical examination or your heart or other organ
function, or for medical electrocardiogram recordings, which require more complex
measurements.
It is not possible to use this device to diagnose illness or diseases. This is exclusively the
responsibility of your doctor.
We recommend that you record the ECG curves and other measurements and provide them
to your doctor if required.
Do not use the product in the area of HF surgical equipment, MRI, or CT scanner, or in an
oxygen rich environment.
The battery intended to be changed only by service personnel with the use of a tool, and
replacement by inadequately trained personnel may result in damage or burn.
The patient is an intended operator.
Do not carry out the servicing and maintenance while the product is in use.
The patient can safely use all the functions of the product, and the patient can maintain the
product by carefully reading Chapter 6.
This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in
locations where RF is restricted, such as on an aircraft. Turn off the Bluetooth feature in this
product and remove batteries when in RF restricted areas. For further information on
potential restrictions refer to documentation on the Bluetooth usage by the FCC.
DO NOT use this product with other medical electrical (ME) equipment simultaneously. This
may result in incorrect operation of the product and/ or cause an inaccurate blood pressure
readings and/ or EKG recording.
Sources of electromagnetic disturbance may affect this product (e.g. mobile telephones,
microwave cookers, diathermy, lithotripsy, electrocautery, RFID, electromagnetic anti-theft
systems, and metal detectors), please try to stay away from them when making
measurements.
The use of accessories and cables other than those specified or provided by manufacture
could result in increased electromagnetic emission or decreased electromagnetic immunity of
the product and result in improper operation.
Interpretations made by this product are potential findings, not a complete diagnosis of
cardiac conditions. All interpretations should be reviewed by a medical professional for clinical
decision-making.
DO NOT use this product in the presence of flammable anesthetics or drugs.
DO NOT use this product while charging.
Remain still while recording an ECG.
The detectors of ECG have been developed and tested on Lead I and II recordings only.
Do not sterilize this unit in an autoclave or gas sterilizer (EOG, formaldehyde, high density
ozone, etc.)
Do not wash this unit with water.
This product doesn’t provide on-device data backup function.
1. Introduction
1.1 Intended Use
The Portable ECG monitor is intended to be used for measuring, displaying, reviewing and storing
of ECG data and Heart Rate for adult population in home or in healthcare facilities.

The device is intended to give some suggested symptoms such as regular heart beat, irregular
heart beat, low HR and high HR.
1.2 Contraindications
The product is not intended for use in patients with cardiac pacemakers or other implantable
devices.
1.3 About Portable ECG monitor
product name: Portable ECG monitor
Product model: PB-20
1. Touch Screen
Use the pad of your finger to tap or swipe on the touch screen. Do not use your fingernail or
any other object to tap the screen.
2.
LED indicator

Off: the monitor is turned off;

Green: the monitor is turned on, and working normally; or when the battery is fully
charged;

Blue: the battery is being charged;

Red and flash: the battery is low;
3.
Multi-functional micro D connector
It connects with external ECG cable, or charging cable.
4.
Home, Power On/Off

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, pressing this button will switch to Main Screen or return to upper menu.
5.
Round electrode
Use right thumb to press on it.
6.
Strip electrode
Put it to your left palm, left abdomen or left knee.
7.
Neck stripe hole (neck stripe not provided)
8.
Back electrode
Use right index finger or middle finger to press on it.

9. ECG cable with 2 lead wires
Connect the micro D connector side to the device and the other side to your left/right wrists or
right clavicle /left lower abdomen.
1.4 Main Screen
The Main Screen is shown as below.
User Mode: Single
User Mode: Dual
Tapping a button in the Main Screen will start a measurement, activate a function, or open
corresponding menu.
1.5 Result Screen
This device provides ECG Recorder For each measurement, a Result report will be provided after
the measurement is finished. An example is shown below.
1. Measured parameters and readings
2. Buttons

Select button to start a measurement again.
Select button to review waveform.
Press button to open the help information.
In the Result Screen, if there is no operation for 1 minutes, the device will automatically return
to upper menu until it powers off.
1.6 Symbols
1.7 Abnormal ECG
Display content Conditions
High HR(Fast heart rate) More than 100/ min
Low HR(Slow heart rate) Less than 60/ min
Irregular beat
No R-waves detected for 2 seconds and more
R-R variation rate is more than 10% of the normal
intervals
R-R interval is less than 80% of the normal intervals
When PVC detected
Regular beat None of the above
2. Getting Started
2.1 Unpacking
Before unpacking, examine the packing case carefully for signs of damage. If any damage is
detected, contact the carrier or us. If the packing case is intact, open the package and remove the
equipment and accessories carefully. Check all materials against the packing list and check for any
mechanical damage. Contact us in case of any problem.
Warnings

Save the packing case and packaging material as they can be used if the device must be
reshipped.
Keep the warranty card, which is useful within the period of warranty.

When disposing of the packaging material, be sure to observe the applicable waste control
Symbol Meaning
Application part type BF
Manufacturer
Symbol for “ENVIRONMENT PROTECTION – Waste electrical products
should not be disposed of with household waste. Please recycle where
facilities exist. Check with your local authority or retailer for recycling
advice”.
IP22
Against ingress of solid foreign objects ≥12.5mm diameter, against
dripping (15° tilted)
MRI unsafe, presents hazards in all MR environments as device contains
strongly ferromagnetic materials.
Follow operating instructions
Non-ionizing radiation
Battery indicator

regulations and keep it out of children’s reach.

The equipment might be contaminated during storage and transport. Before use, please
verify whether the packages are intact. In case of any damage, do not apply it to patients.
2.2 Power On/Off
Press the Power On/Off button to power on the device. Press and hold Power On/Off button for 2
seconds to power off the device.
2.3 Initial Settings
The first time Portable ECG monitor is powered on, you can follow the steps below to set up your
monitor.
3. Using the device
3.1 Prior to Use
Warnings
Use only cables, and accessories specified in this manual.

The device has no alarms and will not sound if the measurement reading is too low or too
high.
Before using ECG
Before using ECG Recorder function, pay attention to the following points in order to obtain precise
measurements.
The ECG electrode must be positioned directly against the skin.
If your skin or hands are dry, moisten them using a damp cloth before taking the measurement.
If the ECG electrodes are dirty, remove the dirt using a soft cloth or cotton bud dampened with
disinfectant alcohol.
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 hold the device still. Movements of any kind will
affect the measurements.
If possible, take the measurement when sitting and not when standing.
Warnings
When connecting external electrodes and/or patient cables, make sure that the connectors never
come into contact with other conductive parts, or with earth. In particular, make sure that all of the
Step User Interface Action
1
Tap the “+” or “-” button to change the
date, month and year.
Then tap .
2
Tap the “+” or “-” button to change the
time.
Then tap .
3
The Main Screen shows when you finish
the steps as above.

ECG electrodes are attached to the patient, to prevent them from contacting conductive parts or
earth.
If using the ECG for long-term monitoring, periodically inspect the electrode application site to
ensure skin quality. If the skin quality changes, replace the electrodes or change the application
site.
Do not use this device during defibrillation.
Interference from a non-grounded instrument near the patient and electro surgery interference
can causes problems with the waveform.
Warnings

Limit finger movement as much as possible when using ECG Recorder which might result in
incorrect reading or measurement result.

The Portable ECG monitor is MR unsafe. Do not use this device in an MR environment as it
contains strongly ferromagnetic materials. Induced current could potentially cause burns.
3.2 ECG Recorder
About ECG Recorder
Warnings
Before using this function, please read the Section 3.1.
Different methods of taking the ECG measurement are available on Portable ECG monitor.
The ECG recorder offers four different methods to measuring ECG. Tap the <External> icon to
switch between two pages.
As shown above, from left to right, there are:

Method A: Lead II, right hand to left leg or right hand to left abdomen

Method B: Chest Lead , right hand to left chest
（
Left electrode touches left chest, 2 inch
below the nipple
）

Method C: Lead I, left hand to right hand
Model External require using external ECG cable and electrode, which is a bit more complicated,
but offers better measurement. A message of "Note: Use ECG cable to measure for higher accuracy”
will be show when chooses the method without the ECG cable. No matter which method you
choose to measure ECG, please keep stable posture and stay calm during the measurement.
Movements may result in interference and incorrect readings or measurement result.
Generally, it is recommended to use method A or B in most situations if the ECG waveform

amplitude is too small for better interpret.
Measuring with Cable
To start an ECG Recorder measurement without cable,
1. In the HeartCheck model, tap the <External> icon.
2. Choose the <Lead I> named method A or <Lead II> named method B.
3. Follow the instructions to connect the ECG cable and place the ECG electrodes.

For method A, palms facing up, place electrodes marked with L/R in the middle of
left/right wrist respectively;

For method B, place electrodes marked with R/L in the right clavicle/left lower abdomen
respectively;
It is important to maintain good contact with the ECG electrodes in order to achieve an
accurate ECG reading. If the device does not detect good contact between the electrodes and
the skin, the warning “Touch electrodes properly” will be displayed. Do not press the device
too firmly against your skin, which may result in EMG (electromyograph) interference. After
you finish the above steps, hold the device stably and stay calm.
4. Once the device detects stable waveform, it will automatically start the measurement. The
countdown bar moves from left to right.
5. When the bar if fully filled, the device will show the measurement result.
Please refer to Section 1.7 to understand the result screen.
4. Settings
4.1 Opening Settings Menu
To open the Settings menu,
1. Press the Home button to enter the Main Screen.
2. Tap the <Settings> icon to open the menu as below.

In the Settings menu, you can
Tap and button to page up or down
Tap home button to close the Settings menu
4.2 Turning On/Off Bluetooth
Portable ECG monitor has built-in Bluetooth wireless connectivity, which enables exporting
measured records from the device to mobile devices use Bluetooth protocol.
To turn on the Bluetooth:
1. Switch on the device Bluetooth in Setting->Bluetooth.
2. Make sure the phone Bluetooth is enabled.
3. Select the product ID from the phone, then the product will be paired successfully with your
phone.
4. You can export the measured data including ECG data to you phone.
Note:
The Bluetooth technology is based on a radio link that offers fast and reliable data transmissions. The
Bluetooth uses a license-free, globally available frequency range in the ISM band-intended to ensure
communication compatibility worldwide.
The pairing and transmitting distance of wireless function is 1.5 meters in the normal. If the wireless
communication is delay or failure between the phone and the product, you will try to narrow the
distance between the phone and the product.
The product can pair and transmit with the phone under the wireless coexistence environment (e.g.
microwaves, cell phones, routers, radios, electromagnetic anti-theft systems, and metal detectors), but
other wireless product may still interface with pairing and transmission between the phone and the
product under uncertain environment. If the phone and the product display inconsistent, you may need
to change the environment.
4.3 Setting ECG Length
1. In the Setting menu, choose <ECG Length>.
2. Change the mode between 30s ,60s and 5min.
4.4 Changing User Mode
1. In the Settings menu, tap <User Mode>.
2. Change the mode between Single and Dual.
4.5 Changing Brightness
In the Settings menu, tap <Brightness> to change brightness

4.6 Turn on/off voice
In the Settings menu, tap the <Voice> to turn off voice directly. “ ” means the voice is turned on.
4.7 Setting Date & Time
1. In the Settings menu, tap <Date & Time>.
2. Tap “+” or “-” button to change the date, then tap .
3. Tap “+” or “-” button to change the time.
4. Tap to finish the setting.
4.8 Erase Data
1. In the Settings menu, tap the <Erase All Data>
2. Tap <Yes> to erase all data, tap <NO> to cancel option.
4.9 Factory Reset
1. In the Settings menu, tap the <Factory Reset>
2. Tap <Yes> to load default settings, tap <NO> to cancel option.
4.10 Identify Software Version
Choose <About> in the <Settings> menu to identify the software version of your device. Telling the
version information when reporting a problem may help to identify and solve your problem.
5. Review ECG Recorder
Tap the <History>icon to review measurement result and waveform. In this menu, you can choose a
record from the list.
In this menu, you can,

Select to delete this

measurement

Select to replay the ECG

waveform as shown below.
When the ECG waveform is being replayed, you can


Select to change the waveform amplitude.

Press Home button to return Daily Check list.
After the ECG waveform is replayed, it will automatically return to the previous interface.
Select to return to the previous interface.
Note: the capability of storing 100 measurements(30s/one meter or 60s/one meter) or 25
measuremets(5min/one meter)
ECG Measurement Principle
The product collects the ECG data through the potential difference of the body surface
through the ECG electrode, and obtains accurate ECG data after being amplified and filtered,
then displays through the screen.
6. Maintenance
Warnings

Have the device repaired by authorized service centers only, otherwise its warranty is
invalid.
6.1 Warranty
The product is warranted to be free from defects in materials and workmanship within warranty
period when used in accordance with the provided instructions. The warranty extends only to the
end user. We will, at our option, repair or replace without charge the product covered by the
warranty. Repair or replacement is our only responsibility and your only remedy under the
warranty.
6.2 Battery
The product is designed to operate on rechargeable Lithium-ion battery. The battery is charged
automatically when the monitor is connected to an adapter which can output electronic power
and is approved by IEC 60601-1
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,
1. Connect the smaller end of the charging cable to the multi-functional connector, as shown
below.
2. Connect the other end of the USB charging cable to the USB charging port.
3. Please make sure that the LED is blue
4. When the LED turns to green, it means the battery is fully charged. Then you can unplug the
USB cable.
Warnings
The product cannot be used (including measurement and review) during charging.

When choosing a third-party USB charging device, select one that complies with IEC 60950.

The service life of the battery will depend on the conditions of use, but on average it will
support 500 charging / discharging cycles.
6.3 Cleaning
Warnings

Have the device repaired by authorized service centers only, otherwise its warranty is
invalid.

Clean the device per week, carefully swabbing the device surface with a soft cloth or cotton
swab with rubbing 70% alcohol.
Do not pour alcohol directly on or into the device.
6.4 Trouble Shooting
6.5 Disposal
Batteries and electronic instruments must be disposed of in accordance with the locally
applicable regulations, not with domestic’s waste.
7. Accessories
Warnings
Use accessories specified in this chapter. Using other accessories may cause damage to the
device or not meet the claimed specifications.
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 battery and try
again.
2. Please contact with your local
distributor.
Low battery indicator is
blinking
The battery is low.
Charge the battery and try again.
The ECG waveform
amplitude is small
The lead you choose is not
suitable for you.
Change another lead and try
again.
ECG waveform drifts or
disappears and “Touch
electrodes properly”
displayed.
1. The pressure exerted on
the electrode is not stable
or 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.
“System Error”
occurred.
Software or hardware
failure.
Restart the device and measure
again. If the error persists, mark
down the error number and
contact with your local distributor.
Part Number Description
540-00192-00 ECG cable with 2 lead wires, snap
540-00194-00 Charging / Data Cable
560-01701-00 Carry Case

8. Specifications
Classifications
Degree protection against electrical
shock
Type BF
Protection against electric shock Internally powered equipment
Electro-magnetic Compatibility Group I, Class B
Apply part ECG electrode
Environmental
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
Drop test 1.0 m
Physical
Size
88×56×13 mm
Packing size
171.5*113.5*59.5mm
Weight
Less than 80 g (main unit)
Display
2.4” touch screen, color, backlit
Wireless connectivity
Built-in Bluetooth dual mode, support 4.0 BLE
Power Supply
Battery type Rechargeable lithium-polymer battery 580 mAh
Charge time Less than 2 hours to 90%
ECG
Lead type
Integrated ECG electrodes
External ECG cable and electrodes
Lead set
Lead I, lead II,Chest Lead
Sampling rate
500 Hz
Sampling accuracy
16 bit
Display Gain
1.25 mm/mV, 2.5 mm/mV, 5 mm/mV
10 mm/mV,20 mm/mV
Sweep speed
25 mm/s
Frequency response
External
：
0.05 to 40 Hz
Internal
：
0.67 to 40Hz
Input impendence
≥10MΩ, 10Hz
Linearity and dynamic range
10mV (peak-to-valley)
Common mode rejection
≥60dB
HR measurement range
30 to 250 bpm
Accuracy
±2 bpm
Bluetooth RF
Frequency range 2.402-2.480GHz
Durable period for Pulsebit EX
Expected service life 5 years

9. FCC Statement
FCC ID: 2ADXK-6623
1. 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. (2) This device must accept any
interference received, including interference that may cause undesired operation.
Note: The grantee is not responsible for any changes or modifications not expressly approved by
the party responsible for compliance. Such modifications could void the user’s authority to
operate the equipment.
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. his 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..
9.1Reference to Standards
10. Electromagnetic Compatibility
The device meets the requirements of IEC 60601-1-2.
Warnings and Cautions
• This device should not be used in the vicinity or on the top of other electronic equipment such
as cell phone, transceiver or radio control products. If you have to do so, the device should be
observed to verify normal operation.
• The use of accessories and power cord other than those specified, with the exception of cables
sold by the manufacturer of the equipment or system as replacement parts for internal
components, may result in increased emissions or decreased immunity of the equipment or
system.
Guidance and manufacturer’s declaration
– electromagnetic emissions
The model Portable ECG monitor is intended for use in the electromagnetic environment
specified
below. The customer or the user of the model Portable ECG monitor should assure that it is used
in
such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1
The model Portable ECG monitor 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.
IEC60601-1:2005+A1:2012
IEC60601-1-2:2014
IEC/EN60601-1-11:2015
IEC60601-2-47: 2012
FCC part 15

RF emissions CISPR 11 Class B The model Portable ECG monitor 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 IEC
61000-3-2 Class A
Voltage fluctuations/
flicker emissions IEC
61000-3-3
Complies
Recommended separation distances between RF wireless communications equipment
The device is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the device can help prevent electromagnetic
interference by maintaining a minimum distance between RF wireless communications equipment
and the device as recommended below, according to the maximum output power of the
communications equipment.
Frequenc
y MHz
Maximum
Power
WDistance IEC 60601
Test Level
Complia
nce
Level
Electromagnetic Environment -
Guidance
385 1.8 0.3 27 27 RF wireless communications
equipment should be used no closer
to any part of the device, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
450 2 0.3 28 28
710
0.2 0.3 9 9
745
780
Recommended separation distances between portable and mobile RF communications equipment
and the A&D unit
The model Portable ECG monitor is intended for use in an electromagnetic environment in
which
radiated RF disturbances are controlled. The customer or the user of The model Portable ECG
monitor can help prevent electromagnetic interference by maintaining a minimum distance
between
portable and mobile RF communications equipment (transmitters) and The model Portable ECG
monitor as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of transmitter (m)
150kHz to 80MHz
P
V
d]
5.3
[
1

80MHz to 800MHz
P
E
d]
5.3
[
1

800MHz to 2.7GHz
P
E
d]
7
[
1

0.01 0.12 0.04 0.07
0.1 0.37
0.12
0.23
1 1.17 0.35 0.70
10 3.70 1.11 2.22
100 11.70 3.50 7.00
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.

frequency of the transmitter.
Recommended separation distance
Where P is the maximum output
power rating of the ransmitter in
watts (W) according to the
transmitter
manufacturer and d is
the recommended separation
distance in meters (m). Field
strengths from fixed RF transmitter,
as determined by an electromagnetic
site survey, should be less than the
compliance level in each frequency
range. Interference may occur in the
vicinity of equipment marked with
the following symbol:
810
2 0.3 28 28
870
930
1720
2 0.3 28 28
1845
1970
2450 2 0.3 28 28
5240
0.2 0.3 9 9
5500
5785
Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Guidance and manufacturer’s declaration – electromagnetic immunity
The model Portable ECG monitor is intended for use in the electromagnetic environment specified
below. The customer or the user of The model Portable ECG monitor should assure that it is used
in
such an environment.
Immunity test IEC 60601 test
level
Complian
ce level Electromagnetic environment – guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3Vrms
150kHz to
80MHz
10V/m
80MHz to
2.7GHz
N/A
10V/m
Portable and mobile RF communications equipment
should be used no closer to any part of The model
Portable ECG monitor, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
80MHz to 800MHz
800MHz to 2.7GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
ashould 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 and 800 MHz, 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.

aThe ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to
6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0
MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07
MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0
MHz to 54,0 MHz.
b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency range 80 MHz to 2,7 GHz are intended to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into patient areas.
For this reason, an additional factor of 10/3 has been incorporated into the formulae used in
calculating the recommended separation distance for transmitters in these frequency ranges.
c 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 whichThe model Portable ECG monitor is used exceeds the applicable RF compliance
level above, The model Portable ECG monitor should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating The model Portable ECG monitor
d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Shenzhen Viatom Technology Co., Ltd (Hereinafter called Viatom) owns the intellectual property
rights to this Viatom product and this manual. This manual may refer to information protected
by copyrights or patents and does not convey any license under the patent rights of Viatom, nor
the rights of others. Viatom intends to maintain the contents of this manual as confidential
Guidance and manufacturer’s declaration – electromagnetic immunity
The model Portable ECG monitor is intended for use in the electromagnetic environment
specified
below. The customer or the user of The model Portable ECG monitor should assure that it is
used
in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2 kV，± 4 kV，± 8
kV，± 15kV air
± 8 kV contact ±
2 kV，± 4 kV，± 8
kV，± 15kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the 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
n.a. n.a.
Surge
IEC61000-4-5
± 1 kV line to line
±2 kV line to earth n.a. n.a.
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0% UT0,5cycle
At
0°,45°,90°,135°,180°,
225°,270°and 315°,
0% UT1cycle
and 70% UT25/30
cycles
Single phase:at 0°
n.a. n.a.
Power frequency
(50/60 Hz)
magnetic field IEC
61000-4-8
30A/m, 50/60Hz 30A/m,50/60Hz
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.

information. Disclosure of the information in this manual in any manner whatsoever without the
written permission of Viatom is strictly forbidden.
Contents of this manual are subject to changes without prior notice. All information contained in
this manual is believed to be correct. Viatom shall not be liable for errors contained herein nor
for incidental or consequential damages in connection with the furnishing, performance, or use
of this manual.
PN：255-01761-00 Version:A Sep, 2019
Shenzhen Viatom Technology Co., Ltd.
4E, Building 3, Tingwei Industrial Park, No. 6 Liufang Road, Block 67, Xin’an
Street, Baoan District, Shenzhen, Guangdong, 518101, P.R. China