Wellue viatom ER1 User manual

Heart Health Monitor
(ER1)
User Manual (EN)
Benutzerhandbuch (DE)
Manuale d'uso (IT)
Manual de usuario (ES)
Manuel de l'utilisateur (FR)

Contents
User Manual..........................................................English 1-17
Benutzerhandbuch..............................................Deutsch 18-35
Manuale d'uso..................................................... Italiano 36-53
Manual de usuario.............................................. Español 54-71
Manuel de l'utilisateu.........................................Français 72-89

1
Table of Contents
NOTICE 2
Introduction 2
Monitor Views 3
Getting Started 4
Wear ER1 Monitor 4
Start and Stop Recording 7
Install ECG Browser 7
Registration and Login 8
Make an Analysis 9
Warnings 10
Cleaning 13
Recycling 13
Troubleshooting 13
Appendix 14

2
NOTICE
It's not intended for medical use or treat. It's marketed as a
consumer wellness product.
Introduction
Thank you for choosing ER1 heart health monitor (hereinafter
ER1 monitor).
ER1 monitor is to acquire, record and store adult ambulatory ECG
data. The ECG data from ER1 monitor can be automatically
analyzed when uploaded to the accompanying PC software.
Composition
The ER1 monitor box contains:
ER1 main unit
A power/data cable for charging and exporting
A USB drive with the analysis software (ECG browser)
A pack of disposable electrodes (10 pieces)
Chest strap

3
Monitor Views
“R” symbol
Indicates this side should be placed rightwards.
LED indicator
With
light
Light
flashing
Yellow light: Low battery
Flash every 5 seconds: Standby
Flash when applied:
Synchronous with the heartbeat.
On
Green light: Fully charged
Yellow light: Charging
No
light
/
Battery depleted.
Electrode button
It is to use with chest strap, disposable electrode or
power/data cable.
Power contact
It is used to connect the power/data cable.

4
Getting Started
First Use
After removing the packing, charge the device at first for
activation.
Charge Battery
This device uses a rechargeable lithium battery. Charge it through
the following steps:
1. Connect the main unit with the power/data cable, as shown
below.
2. Connect the other end of the cable to the power source of 5V
output/USB connector, like laptop or power adapter.
Wear ER1 Monitor
Before wearing the ER1 monitor, you need decide to use which
way to apply it to your body. The device is designed for
application through the following two ways:
With electrodes
With chest strap
You can choose one way to apply it to acquire ECG data.

5
With Electrodes
1. Take two accompanying disposable electrodes and remove their
packing.
2. Connect the electrodes with the ER1 main unit, as shown
below.
3. Apply the device to the left chest, as shown below. The “R”
symbol is rightward and near the middle of sternal notch, and
the other end is leftward and 45° lower than the horizontal
level.

6
With Chest Strap
1 Take the accompanying chest strap and remove its packing.
2. Install the ER1 main unit to the strap, as shown below.
3. Moisten the electrode on the strap contacted the body with
clean water.
4. Adjust the chest strap length to suit your body.
5. Put on the strap with the “R” symbol at the right side, and then
position the strap under the breast, as shown below.

7
Start and Stop Recording
Start Recording
Once you wear the ER1 monitor, the device starts acquiring ECG
data.
Stop Recording
When 60 seconds elapse after you remove the ER1 monitor, the
monitor stops acquiring ECG data and saves it.
Attention
The device can store 10 recordings, 30 hours in total. When
the recordings exceed 10 pieces, or total time reaches 30
hours, the earliest data will be covered with a new one.
One single recording can only store 24 hours of data at
most.
For the safety of your data, export it to the ECG Browser
each time after you have measured ECG.
Install ECG Browser
When you want to analyze the acquired ECG data in your ER1
monitor, you need install the ECG browser in your PC or laptop.
Then you can import the data into the ECG browser and make
analysis online.

8
Follow the steps below to install the ECG browser:
1. Plug the USB drive accompanied to the USB connector on your
PC or laptop.
2. Copy the file of ECG Browser Setup vxx. exe to your local
drive.
3. Run the file.
4. Select the appropriate language.
5. Select the defaults until finish installation.
Registration and Login
When you first use this browser, you need register.
1. Run the on the desktop on your PC or laptop.
2. In the lower part of the pop-up screen, select “Register now”.
3. Enter email address, verification code, and password.
4. Select “Agree to and accept Terms of Use and Privacy Policy”.
5. Select “Register now” button.
After you have registered, you just run to log in each
time you use this browser.

9
Make an Analysis
1. Make sure that your PC or laptop have connected to the
Internet.
2. Connect the ER1 monitor to your PC or laptop with the
power/data cable.
3. Log in the ECG Browser.
4. Select the “Download Data” button.
5. Create or select a user. Then the data will automatically be
imported to the browser and shown in the task list.
6. Select “Go to analysis”.
7. Wait till the analysis result returned.
8. Select “View Report”.

10
Additional Operations:
Save the waveform data in PDF by selecting “Save as
PDF” in the “View Waveform” window.
Delete the recordings by selecting “Delete” button.
Analyze the data in batch by selecting “Batch Analysis”
button.
Set the storage directory in “Setting” window.
Change the password by selecting icon.
Attention
The report and waveform data are saved in the default
directory. If you change the storage directory, the
previously stored recordings will not be seen in the task
list.
The default directory is C:/User/AppData/Local/ECG
Browser/Data.
Warnings
General
Before using this device, read this manual carefully and fully
understand the warnings and risks.
Do not use acetone or other volatile solutions to clean the device.
Do not strongly collide or crush the device. If the casing is broken,
stop using it.
Do not disassemble the device at will, otherwise it may cause
machine malfunction or affect the normal operation of the device.
Keep the device out of the reach of children and pets.
The device should not be maintained while in use.

11
Analysis
The device is not intended to replace the medical diagnosis of a
professional physician.
The results of this device are for reference only and cannot be
directly used as a basis for clinical treatment.
The device cannot be used to diagnose a disease directly. Please
consult your doctor.
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.
The device is not a substitute for professional heart or other organ
function measurement equipment. Medical ECG measurement
requires more professional and complete measurements.
We recommend that you record your ECG waveform and the
analysis results, and provide them to your doctor if necessary.
Conditions and Environments
The device cannot be used with a defibrillator.
The device cannot be used during CT or magnetic resonance
imaging (MRI) test.
The device must not be used in a flammable environment (eg.
oxygen-rich environment).
Do not swim or submerge the device in the water. Do not immerse
the device in water or other liquids.
Do not place the device in the following environments: direct
sunlight, high temperature, high humidity, close to water or fire
sources, and high electromagnetic influence.
Do not placed the device in a pressure vessel or gas sterilization
equipment.
Try to avoid sweating. The sweat will degrade the contact between
the electrodes and the skin, and thus affect the recording quality.
Inspect loosened electrodes, that can degrade performance or cause
other problems.

12
Do not participate in violent or extensive physical activity in order
to make appropriate measurements.
The device is not intended for use by infants weighing less than 10
kg.
The device should not be used on people with sensitive skin or
allergies.
Battery
The built-in rechargeable lithium battery cannot be replaced.
Non-professionals shall not open the casing, and modify or replace
the battery.
Do not expose the main unit to high temperature such as ovens,
water heaters and microwave ovens. Overheating may cause
battery explosion.
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.
Lithium batteries capacity will decrease after charge-discharge for
300 times.
Electrodes
If you purchase the disposable electrodes on your own, the
electrode need have passed through a medical device registration.
Recommend to purchase the electrodes of the same model as the
accompanied ones. Using others despite the recommendation may
cause the analysis result inaccurate.
Check if the disposable ECG electrode has expired before use.
The disposable ECG electrodes shall not be applied to the
traumatized or scarred skin.
Disposable ECG electrodes need be used in contact with the skin.
If your skin is itching, irritating or ulcerated, stop using it
immediately.
The electrodes should not contact other conductive parts including
earth.

13
Cleaning
ER1 monitor and strap need to be cleaned regularly. Clean the
device per week.
Carefully wipe the device with a clean, soft cloth or cotton ball
with 75% medical alcohol or water.
Recycling
Do not casually dispose the main unit and its accessories at the
end of their service life. They shall be disposed in accordance
with local regulations. When they are intended to be discarded,
they must be sent to the appropriate facility for recycling.
Troubleshooting
Cannot acquire data normally.
Solution:
Charge the device. If the problem continues, contact the
distributor.
ECG waveform is of much interference.
Solution:
Adjust the position of ER1 monitor.
Replace the ECG disposable electrodes, or moisten the
chest strap with water.
Recordings cannot be imported into the ECG Browser.
Solution:
Charge the device.
Try another operating system.

14
Appendix
Specifications
Classification
EC Directive
MDD, 93/42/EEC
RED, 2014/53EU
ROHS 2.0, 2011/65/EU
Degree protection
against electrical shock
Type CF
Environment
Operating
Storage
Temperature
5 – 45°C
-25 – 60°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
72 hours (fully charged)
Charging input voltage
range
4.5 - 5.5v DC voltage

15
Charging time
2 hours (to 90% power)
ECG
Lead type
Single-lead ECG
Lead
Lead II
Input impendence
≥10MΩ, 10Hz
Linearity and dynamic
range
10mV (peak-to-valley)
Common mode
rejection
≥60dB
Frequency response
0.67 - 40 Hz
Gain error
Maximum error ±10%
Physical
Size
100×23×8.3 mm
weight
<35 g (with battery)
Expected service life
5 year
ECG Browser Installation Specifications
Hardware
CPU: P4 1.7GHz or above
Memory: 1GB or above
Storage: Free disk space greater than 200MB
Operating System
Support Windows 7 and 10

16
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 CF Applied Part
MRI unsafe. Presents hazards in all MR environments as
device contains strongly ferromagnetic materials.
IP22
Resistant to liquid ingress
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.

17
FCC Statement
FCC Warning:
FCC ID: 2ADXK-3613
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.

18
Inhaltsverzeichnis
HINWEIS 19
Einführung 19
Monitor-Ansichten 20
Erste Schritte 21
ER1 Monitor tragen 21
Starten und stoppen Sie die Aufzeichnung 24
EKG-Browser installieren 24
Registrierung und Anmeldung 25
Führen Sie eine Analyse durch 26
Warnungen 27
Reinigung 31
Recycling 31
Fehlerbehebung 31
Anhang 32