Viatom ER2 User manual

I
Version Date Description Author
User's Manual(ECG
recorder)
Shenzhen Viatom Technology
Co., Ltd.
Document Number Reversion
42-DO-00281 A
Author Review Approval
© ViATOM TECHNOLOGY (UNPUBLISHED) ALL RIGHTS
RESERVED
This material is the proprietary information of ViATOM Technology. And
any use, reproduction, or distribution of the material contained herein, unless
specifically authorized by ViATOM Technology, is expressly forbidden and
would violate the rights and interests of ViATOM Technology.

II
ER2 ECG recorder
Contents
1. The basics...................................................................................... 1
2. Introduction................................................................................... 3
3. Using Instructions............................................................................ 6
4. Maintenance .................................................................................. 9
5. Accessories.................................................................................... 11
6. Specifications...............................................................................11
7. Electromagnetic compatibility....................................................11
User’s Manual

1
1. The basics
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.
1.1 Safety
Warnings and Cautionary Advices

Before using this equipment, please read this manual
carefully and fully understand the warnings and risks.
This device is not intended to replace the medical
diagnosis of a professional doctor.

The measurement results of this device are for reference
only and cannot be directly used as a basis for clinical
treatment.

We do not recommend the use of this device if you have a
pacemaker or other implantable device in your body.Please
follow the doctor's advice if necessary.
This device cannot be used with a defibrillator.

This device cannot be used during ct or nuclear magnetic
resonance (MRI) procedures.
This equipment must not be used in a flammable
environment (eg oxygen-rich environment).

This device is not intended for use by infants weighing
less than 10 kg.
Do not swim or submerge the device in the water.Do not
immerse the device in water or other liquids.

Do not use acetone or other volatile solutions to clean the
device.
Do not strongly collide or crush the device. If the casing is

2
broken, stop using it.

This device cannot be placed in a pressure vessel or gas
sterilization equipment.

Do not disassemble the device at will, otherwise it may
cause machine malfunction or affect the normal operation
of the device.
Keep this device out of the reach of children or pets、
pests.

This device should not be used on people with sensitive
skin or allergies.
This equipment cannot be placed in the following
environments: direct sunlight, high temperature, high
humidity, close to water or fire sources, and high
electromagnetic influence.
Users should try to avoid sweating. The sweat will affect
the contact between the electrodes and the skin, affecting
the quality of the measurement.

Users should inspect loosened electrodes, that can degrade
performance or cause other problems
Do not participate in violent or extensive physical activity
in order to make appropriate measurements.

The measurement results of this device cannot distinguish
all diseases.If your body feels unwell, you should consult
your doctor immediately, in addition to the measurement
results of this device.

Do not self-diagnose and take medication based on the
measurements of this device without consulting your
doctor.In particular, do not take new medications without
prior permission.

This device is not a substitute for professional heart or
other organ function measurement equipment. Medical
ECG measurement requires more professional and
complete measurements.

This device cannot be used to diagnose a disease
directly.Please consult your doctor.

3

We recommend that you record your ECG curve and the
results of the measurements and provide them to your
doctor if necessary.

Waste (including the equipment itself is scrapped) is
disposed of in accordance with relevant laws and
regulations.
When the ambient temperature is 20 ℃, the minimum and
maximum storage temperature from the product to ready
for use is 2H（the time required）.
The patient is the expected user.
Do not pile up the long tubing at the head of the bed,as it
may wrap around the head or neck of the patient during
sleep.
Li batteries capacity will decrease after charge discharge
for 300 times.

The electrodes (Applied parts) should not contact other
conductive parts including earth
2. Introduction
2.1 Intended Use
The product is intended to measure, review and store adults’
ECG data at home or in healthcare environment,does not contain
auto-analysis function.
2.1.1 Contraindications:
The product is not intended for use in patients with cardiac
pacemakers or other implantable devices.

4
2.2 About ER2
Figure 1
1. ECG electrode
It is used to connect the body surface and receive the
human body ECG signal.
2. LED indicator
Off: The device is not activation or battery is run out,
Green : the lead is off;
Green and flash(According to patient heart rate rhythm):
The device is working normally;
Green and flash(5 seconds apart): measurement completed
and the device is in normal standby mode, or when the
battery is fully charged;
Yellow : the device is charging, and it is off after being
fully charged;
Yellow and flash(5 seconds apart): the battery is
low(Standby mode);
Blue : The device is in Bluetooth connection and the device
1
1
3
2
4

5
is in normal standby mode;
Blue and flash(According to patient heart rate rhythm): The
device is working normally and The device is in
Bluetooth connection.
3. Charging interface
Used to connect the charging cable.
4. Charging base
For the product to charge.
2.3 Symbols
Symbol Significance
Type CF-Applied Part
Manufacturer
Authorized representative in
the European Community
This product complies with the Europea
Council Directive
93/42/EEC(Medical Device Directive)
Caution
，
Incorrect use may cause
personal injury and damages of goods.
Refer to instruction manual.
IP22
Protected against spraying water and
against access to hazardous parts with a
tool, per IEC 60529.
Follow Instructions for Use.
Non-ionizing radiation
SN Serial number
Indicate separate collection for electrical
and electronic equipment (WEEE).
0197

6
2.4 Product structure and composition
This product is mainly composed of ECG recorder main unit,
charging base, charging cable and strap (optional).
2.5 Software information
Software name: ECG recorder software
Release version：V1.0
3. Using Instructions
3.1 Before use
Warnings and Cautionary Advices
Before taking measurements, please pay attention to the
following points to ensure the accuracy of the measurement
data.

Use only the cables and accessories specified in this
manual.
This device has no alarm function and therefore does not
generate an audible alarm for the result of the
measurement.
Ungrounded equipment next to the patient and interference
from electrosurgery can cause waveform instability.
3.2 Open box to check
Please check the box carefully before unpacking.If you find any
damage, please contact the carrier or the company immediately
If the package is complete, unpack the package in the correct
way and carefully remove the device and other components
from the box. Check the device for any mechanical damage and

7
complete items.
If you have any questions, please contact us immediately.
Warnings and Cautionary Advices

Please save the box and packing materials for future
transportation or storage.
When handling packaging materials, you must follow local
regulations or the hospital's waste disposal system and
place the packaging materials out of reach of children.

The device may be contaminated by microorganisms
during storage, transportation and use. Please confirm
that the packaging is in good condition before use.

The date of manufacture and the date of use of the product
are listed on the label.
3.3 Boot
When the device is shipped from the factory, it is completely
inactive by default.The device should be charged to activate the
device before it is used for the first time.
3.4 Measuring process
3.4.1 Measurement methods
1
）
Finger measurement method:
Directly touch the ECG electrode with the thumb of both hands
(R on the silk screen indicates the right hand side, and L
indicates the left hand side), as shown in the following figure:

8
Figure 2
Wrong way of operation:
a. Shake your hands at will
b. Loose fingers during measurement
2
）
Strap measurement method:
Attach the main unit to the strap and then wear the strap with the
main unit attached to the precordium (the indicator light is
facing up) as shown below.
Figure 3
Precautions:
a. The ECG electrode must be in direct contact with the skin.
b. If the patient is exposed to dry skin, wipe the skin with a
damp cloth before measuring.
c. When using finger measurement, make sure that your left and
right hands are not in contact , otherwise the measurement
results will be affected.
d. When using the strap measurement method, if necessary,

9
remove the hair from the electrode part, then clean the skin with
water, and then apply the electrode after drying.
e. Do not speak and remain still during the measurement. Any
movement will affect the measurement results.
f. Please sit when measuring possible.
3.4.2 Measuring step
1）After selecting a measurement method, the device detects
that the ECG signal is automatically turned on, the signal light
changes to the green and flash , the device starts to measure, and
the device will emit a "drop" heartbeat sound.
2）When the measurement is over 30 seconds, the device will
emit a short beep, at which point the measurement can be ended
and the device will complete a 30 second-15 minutes data save.
3) When the patient continuous contact exceed 15 minutes, the
device measurement time is up, the device automatically turns
off, and the signal light changes to Green and flash(5 seconds
apart).The device will complete a 15 minute data save.
3.5 Data view
After the measurement is completed, the data measured in the
devicd can be transmitted to the mobile equipment for viewing
by Bluetooth.
Steps for data export by Bluetooth:
1) Turn on the Bluetooth function of the mobile equipment to
ensure that the Bluetooth function is turned on.
2) By pairing on the mobile equipment , after the pairing is
successful, the indicator light will turn into a steady blue light.
3) According to the prompts of the mobile equipment, data
export is implemented.
Precautions:
The device can store up to 10 part measurement data and up to
20 minutes of measurement data .In order to ensure that every
data you collect is able to be viewed smoothly, please export the

10
data in time after each measurement is completed.
3.6 Charging
This device uses a rechargeable lithium battery.charged by
connecting a laptop or a power adapter with charging cable.
Charging specific steps:
1. Place the main unit on the charging base and connect the
charging base through the charging cable.As shown below.
2. Connect the charging cable to the usb port with 5v output
voltage for charging.After entering the charging state, the
indicator light will turn yellow and steady; when the charging is
completed, the indicator light will go out.
Figure 4
Warnings and Cautionary Advices
The device cannot be used during charging, and if
choosing a third party charging adaptor (Class II ), select
one that complies with IEC60950 or IEC60601-1.
Keep out of reach when charging.
When the long-term storage is not in use, it is necessary to
periodically charge the device to maintain battery
performance.

11
4. Maintenance
Warnings and Cautionary Advices
Have the device repaired by authorized service centers only,
otherwise its warranty is invalid
4.1 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.
4.2 Battery
When the remaining battery power is low, the indicator light will
turn yellow and flash, and the device needs to be charged.
Warnings and Cautionary Advices

The built-in rechargeable lithium-ion battery cannot be
replaced.Non-professionals cannot open the enclosure and
modify or replace the battery.

Do not expose the main unit to high temperatures such as
ovens,water heaters and microwave ovens.Overheat ing of
the battery may explode.
Do not contaminate or modify the battery. Doing so may
cause the battery to leak, overheat, ignite or explode.

If the battery leaks, keep your skin and eyes free from
leaking liquids.If skin or eyes come into contact with
leaking liquid, rinse your skin or eyes immediately and go
to hospital for treatment.

Do not throw the battery into a fire. Doing so may cause
an explosion.
When the battery exceeds the service life or no longer
holds the power, you should contact the manufacturer for
disposal.To dispose of the battery, follow local laws for

12
proper disposal.
4.3 Cleaning
ECG recorder and straps need to be cleaned regularly;clean the
device per week. carefully swabbing the device with a clean,
soft cloth or cotton ball with medical alcohol or water.
4.4 Recycling
Disposal of waste, residues, etc., as well as device and
accessories at the end of their useful life shall not be disposed of
at random and shall be in accordance with local regulations.
When it is intended to discard this device, it must be sent to the
appropriate facility for recycling and recycling.
4.5 Problem solving
Problem Possible Cause Recommended
Action
The device
cannot perform
normal
acquisition
1. The battery is
low
2. Equipment
damage
1. Please charge the
device
2. Please contact
your local agent
ECG
waveform is
disordered, and
the clutter is
large
1. Measurement
method is
incorrect
2. Poor contact
of ECG electrode
1. Please re-measure
according to the
recommendations of
the manual
2. Please clean the
ECG electrode
according to the
method described in
the manual.

13
5. accessories
Serial number Accessory name Quantity
1 Charging base 1
2 Charging cable 1
3 Strap (optional) 1
Warnings and Cautionary Advices
Use only the accessories specified in this manual, and
using other accessories may damage the device.

A-1
7Specifications
Classification
Degree protection against
electrical shock Type CF
Protection against electric
shock Internally powered equipment
Electro-magnetic
Compatibility Group I, Class B
Apply part ECG electrode
Environmental
Item Operating Storage
Temperature 5 ~ 45°C -25 ~ 70°C
Relative humidity
(non-condensing) 10% ~ 95% 10% ~ 95%
Atmospheric pressure 700 ~ 1060 hPa 700 ~ 1060 hPa
Degree of dust&water
resistance IP22
Drop test 1.0 m
Power supply
Type of battery Rechargeable lithium polymer battery
Battery specification 3.7Vdc, 90mAh
Battery run time 48 hours (full state)
Charging input voltage
range 4.5 ~ 5.5v DC voltage
Charging time 2 hours (to 90% power)
ECG
Lead type Integrated ECG electrodes
Lead Lead I
Input impendence ≥10MΩ, 10Hz
Linearity and dynamic
range 10mV (peak-to-valley)

A-2
Common mode rejection ≥60dB
Frequency response 0.67 ~ 40 Hz
Gain error Maximum error ±10%
Physical
Size 92×32×8.2 mm
Packing size 172×113×59mm
weight <50 g (with battery)
Wireless connectivity Bluetooth connection support
Built-in Bluetooth 4.0 BLE
Expected service life 5 year
Bluetooth RF
Frequency range 2.402-2.480 GHz
GFSK Modulation
Wireless Quality of Service
(QoS)
Transmission Distance: 1.5m
Transmission Time: ≤10s for one
ECG record
Data integrity: 100%
Network topology Point-to-Point
Band width 1Mbps
Expected service life 5 years

B-1
8 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 ECG recorder is intended for use in the electromagnetic environment
specified below. The customer or the user of the model ECG recorder should
assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR
11
Group 1 The model ECG recorder 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 model ECG recorder 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
n.a.
Voltage fluctuations/
flicker emissions IEC
61000-3-3
Recommended separation distances between portable and
mobile RF communications equipment and the A&D unit

B-2
Recommended separation distances between RF wireless
communications equipment
The model ECG recorder is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer
or the user of The model ECG recorder can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and The model ECG recorder 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.

B-3
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.
Frequen
cy MHz
Maxim
um
Power
W
Distan
ce
IEC
60601
Test
Level
Compl
iance
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
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
450 2 0.3 28 28
710
0.2 0.3 9 9
745
780
810
2 0.3 28 28
870
930
1720
2 0.3 28 28
1845
1970
2450 2 0.3 28 28