Viatom ER2 User manual

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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© ViATOM TECHNOLOGY (UNPUBLISHED) ALL RIGHTS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.

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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

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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

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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.

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
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.

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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

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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

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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

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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:

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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,