Vion 880E User manual

870E
Instruction for Use
Version / V1.2EN
Thank you for purchasing Vion.880E.
Please read the instructions before use.

TABLE OF CONTENTS
General Notes 1
APP Download 29
Signs and Symbols 2 Cleaning and Maintenance 30
Important Safety Notes 3
Product Description
Main Features 5
Package Contents 6
Hardware Description 7
LCD Display 8
Preparation Before Taking Measurement
Battery Installation 9
Battery Life and Replacement 10
Messages 31
Trouble Shooting 32
Technical Specifications 33
Cautions before Taking Measurement 11
Taking Measurement
Operation Procedure 12
Common Wrong Operations 14
Results Display
Measurement Results 15
Reviewing Results 16
BP ECG Studio
System Requirements 17
Installation 18
System Authentication 20
Downloading ECG Data to Computer 22
Main Window 24
Configuration 27

General Notes Signs and Symbols
1. This Instruction for Use is for Vion.880E/870E.
2. This is an Electrocardiogram (ECG) device that provides referential data that
could be taken into consideration by medical professionals and enables
self-health monitoring.
3. Self diagnosis or treatment is dangerous behavior. Please don’t use the
electrocardiogram or data generated by the device to diagnose yourself.
Consult with medical professionals if you notice any change in your
condition, regardless of the measurement results.
4. The measurement result provided by the device only reflects the
measurement taken at the moment.
5. The electrocardiogram cannot show all variations and symptoms of the heart
disease, please consult with medical professionals when feeling discomfort
with your heart.
6. Please follow the national requirement to dispose unit/accessories/waste
products/residues/batteries etc.
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Following signs and symbols are used in the Instruction for Use, on the packaging
and label of the device and accessories :
Type CF applied part
The product is with Bluetooth
function
ATTENTION, should
read the Instruction for Use
Protection against solid foreign
objects of 12.5 mm Ø and
greater and against vertically
falling water drops when
enclosure tilted up to 15°
Consult Instruction for Use
This way up
Manufacturer
Fragile
Date of manufacture
Keep dry
Reference number
Keep away from sunlight
Serial number
Permissible operating
temperature and humidity
Batch number
Permissible storage/transport
temperature and humidity
2
Signs and Symbols
General Notes

INDICATION FOR USE INDICATION FOR USE
Vion. ECG Pen (Model: 880E/870E) is intended to be used in
measuring heart rate, recording and analyzing ECG signal, then
storing and displaying general information for adult population
who are concerned about their heart conditions during everyday
life. This Vion ECG Pen 880E/870E allows users to record
transient cardiac events up to 9 leads voluntarily anytime or at
the time of symptomatic cardio discomfort (when used under the
instructions of a physician). The recorded ECG signals can be
promptly transferred to personal mobile devices such as
computers(870E not applicable) or cellular phones. At the same
time, these data can be transmitted to physician as reference
immediately, during office visits, or for telemedicine purpose.
This device is capable of measuring and displaying up to 9
individual channels of electrocardiogram (ECG) rhythms. Vion
ECG Pen 880E/870E can also detect the presence of atrial
fibrillation, bradycardia, tachycardia, and normal sinus rhythm
(when prescribed or used under the care of a physician). This
device is intended to be used by healthcare professionals,
patients with known or suspected heart conditions, and healthy
individuals.
While Vion ECG Pen 880E/870E is a state of the art home-use
ECG medical device for self-monitoring and record-keeping of
users’ cardio conditions, but it is not intended to substitute a
conventional 12 leads ECG diagnostic tool.
Users with implanted pacemakers are not recommended to use
this device.

Important Safety Notes
It is not recommended to use this device with a cardiac pacemaker or other
implanted devices. Be sure to follow your doctor’s instruction if necessary.
Do not use this device during an MRI scan.
Do not use this device with a defibrillator.
Do not expose this device to static electricity. Always disperse any static
electricity from your body before handling this device.
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Do not submerge (or immerse) the device in water or liquid. Do not clean the
device with acetone, or other volatile solution.
Do not put the device in autoclaves, or gas sterilization devices.
Avoid hitting, dropping, stamping, shaking of the device.
Do not disassemble this device that may result in damage, malfunction, or
abnormal operation.
Do not use this device on people with sensitive skin or allergies.
Do not use the device if there are wounds on your contacted area
or skin irritation/inflammation on/near the contacted area while
performing measurement
Do not use this device for children weighing less than 10 kgs.
The electrodes of this device should not come in contact with other
electrically conductive parts, including earth ground.
Do not store/expose the device in the following environments:
Locations exposed to direct sunshine, high temperature or humidity,
heavy dirt, near water or fire, and under high electromagnetic influence.
Do not use other USB extension cord besides the companion USB
extension set to connect the device with computer. The companion USB
extension set is especially designed for avoiding electrical shock if come in
direct contact with electrodes when connecting to computer.(870E N/A)
Do not leave this device unattended with infants or persons who cannot
express their consent.
Do not operate this device in a moving vehicle (car, airplane).
Do not use mobile phones, or other devices that emit electromagnetic fields
near this device which may result in incorrect operation of the device.
Remove batteries if won't be using this device for some time, to prevent
battery to expand, leak and possibly destroy the device.
Important Safety Notes
Important Safety Notes

 Store the device in safe place to avoid small parts swallowed by
children in any circumstances.

Under the environment temperature of 40°C, the temperature of applied
part (ECG electrodes) will reach 42°C highest.
This device has not been validated for use on pregnant patients.
Keep the components of the device out of the reach of infants, toddlers or children.
This device contains small parts(such as batteries) that may cause a choking
hazard if swallowed by infants, toddlers or children.
1Static electricity may cause damage to the electronic components. To prevent
electrostatic damage to the device, ensure your body is free of static electricity before
using the device. Contact with earthed objects or devices, increase humidity, and
moisturize skin can effectively reduce the cause of electrostatic damage.
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Product Description
Main Features Package Contents
Vion. 880E/870E can record personal electrocardiogram (ECG) for
approximately 30 seconds of an adult individual.
Instant Feedback after Measurement
This device automatically provides referential results analyzed from the
recorded 30 seconds ECG data.
Handheld ECG Measurement
The handheld ECG design provides great convenience for home use. This
patented ergonomic design not only makes detection easier, but also enables
signals to be acquired with better resolution and be more conducive for
analysis.
Multifunctional Software(870E not applicable)
BP ECG Studio software can assist you to :
Download ECG data.
Configure your device.
Review measurement records in chronicle order.
Display ECG waveforms to doctors for reference.
Your package should include the following items.
Main Unit
Vion.880E/870E
Accessories
USB extension set (870E not applicable)
1
Instruction for Use
2 x coin-typed batteries (trial use)
BP ECG Studio CD(870E not
applicable)
Bluetooth 4.0
With Bluetooth 4.0 technology, this device ideally provides real-time display
of your measurement on Smartphones/Tablets for a great portability of
reviewing your records anytime, anywhere.
1 The USB extension set is for downloading ECG data to your computer.
Do not use other USB extension cord besides the companion USB extension set to
connect the ECG Pen with computer. The companion USB extension set is especially
designed for avoiding electrical shock if come in direct contact with electrodes when
connecting to computer.
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Product Description
Product Description

Product Description
Hardware Description LCD Display
Top Electrodes
Heartbeat LED
Power Button
Press 3 sec to turn on/ off.
Detection Switch
Micro USB Port
Battery Cover
Bottom Electrode
1
Heartbeat Indicator: Flashes in sync with heartbeats during measurement.
2
Heart Rate:
During recording: Displays the real-time heartbeat.
During reviewing: Displays the average heart rate of each measurement.
3 Battery Level Indicator: Shows current battery level.
4
USB Connection: Displays the status of USB connection.(870E not applicable)
5 Digits Display:
During ECG Recording : Displays the 30 seconds count down.
During Reviewing : Displays the sequence numbers of stored records.
6
Bluetooth Connection: Displays the status of Bluetooth connection.
7
Time: Displays date and time.
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Product Description
Product Description

Note: Turn the device off before replacing
batteries.
Preparation before Taking Measurement
Battery Installation Battery Life and Replacement
Turn the device upside down.
Remove the battery cover by inserting the tip of your finger into the
opening of the cover.
Install two CR2032 coin-typed batteries by following the + (positive) and
- (negative) polarities indicated on the battery compartment.
Slide back the battery cover until it clicks into place.
Install or replace the batteries by following the + (positive) and- (negative)
polarities indicated on the battery compartment.
When the battery level indicator appears only
with 1 bar left, the batteries are nearly running
out, please replace new batteries timely.
Two new “CR2032” coin-typed batteries will last for approximately 500
measurements.
Please use same brand and type of batteries and replace all batteries at the
same time. Avoid using used and new batteries together.
Do not use rechargeable batteries.
Remove batteries if won't be using this device for some time, to prevent the
device from being damaged.
Please dispose waste batteries according to applicable local regulations.
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Preparation before Taking Measurement
Preparation before Taking Measurement

Preparation before Taking Measurement
Cautions before TakingMeasurement
Taking Measurement
Operation Procedure
Please read the cautions below to correctly measure your personal ECG :
Do not attempt to use this device over or through clothing.
Press the po
If the electrodes are dirty, please use a soft cloth or a cotton swab moistened
with disinfectant alcohol to clean dirt from the surface.
If your skin or hands are dry, moisten them with damp cloth before taking
measurement.
Do not let your right hand in contact with your body during the measurement,
and avoid heavily pressing the top and bottom electrodes to influence the
accuracy of measuring.
Do not use the device in upside down position.
Top Electrodes
Do not move or talk while taking measurement and keep the balance of your
body to avoid influencing the accuracy of measurement result
Ideally perform the measurement either sitting down or lying down. Do not
stand up to take the measurement.
Click
Taking Measurement
Preparation before Taking Measurement

+Taking Measurement
Operation Procedure
There are three different methods of taking the measurement. Start with
measurement method A, “right index finger-chest.” If this method does not
deliver measurements, or delivers only unstable measurements (“EE” is
frequently displayed), switch to method B “left index finger-chest” and, if
necessary, to method C ”left hand-right hand.”
The most suitable method/ procedure depends on the heart configuration
(shape of the heart) of each individual user. If it is not possible to take stable
measurements using a given measurement method, this could have a
harmless cause such as the shape of the heart. However, the cause may also
be an illness or disease.
Note: Measurement method C offers maximum comfort, but offers a much
lower measurement stability than methods A or B.
Press the on/ off button for about three seconds to turn the device on. The
device shows the full display.
WARNING
If segments are missing, stop using the device and immediately
contact customer services. To test whether the full display is
completely displayed, hold the On/Off button when switching on the
device.
+Taking Measurement
Measurement Method A
“right index finger-chest” (approximately corresponds to “lead 2”)
1. Press the power button for 3 seconds to turn on your ECG Pen.
2. Lay your right index finger on the two top electrodes of the device
and hold the ECG Pen face up in your hand.
3. You can determine the correct position for placing
the lower electrode of the device against your chest
using the following methods:
Place the bottom electrode of the ECG Pen on
bare skin about 5 centimeters (2 inches) below your left nipple supported
by the ribcage, and press it GENTLY until you hear the click sound.
Draw an imaginary line from the front of your armpit downwards. At
the same time, draw an imaginary line going up 10cm from the lowest rib on
the left side of your body. Place the lower electrode of the device at the
point where these two lines meet.
Draw an imaginary line from the bottom of the centre of your chest
(sternum) to the left. At the same time, draw an imaginary line from the
front of your armpit downwards. Place the lower electrode of the device at
the point where these two lines meet.

+Taking Measurement
Press it GENTLY until you hear the click sound.
Note: Do not press the electrodes hardly. Excessive muscle tension will cause
unnecessary noise.
Measurement Method B
“left index finger-chest” (approximately corresponds to “lead 3”)
1. Press the power button for 3 seconds to turn on your ECG Pen.
2. Lay your left index finger on the two top electrodes of the device
and hold the ECG Pen face up in your hand.
+Taking Measurement
3. You can determine the correct position for placing the lower electrode of
the device against your chest using the following methods:
Place the bottom electrode of the ECG Pen on bare skin about 5
centimeters (2 inches) below your left nipple supported by the ribcage, and
press it GENTLY until you hear the click sound.
Draw an imaginary line from the front of your armpit downwards. At
the same time, draw an imaginary line going up 10cm from the lowest rib on
the left side of your body. Place the lower electrode of the device at the
point where these two lines meet.
Draw an imaginary line from the bottom of the centre of your chest
(sternum) to the left. At the same time, draw an imaginary line from the
front of your armpit downwards. Place the lower electrode of the device at
the point where these two lines meet.
Press it GENTLY until you hear the click sound.
Note: Do not press the electrodes hardly. Excessive muscle tension will cause

Taking Measurement
unnecessary noise.
Measurement Method C
“left hand-right hand” (approximately corresponds to “lead 1”)
1. Press the power button for 3 seconds to turn on your ECG Pen.
2. Place your right index finger on the two top electrodes of the device.
Place a finger of your left hand on the lower electrode.
3. Press the lower electrode until you hear or feel a click.
Press it GENTLY until you hear the click sound.
Note: Do not press the electrodes hardly. Excessive muscle tension will cause
unnecessary noise.
Note: Please note that there must be no skin contact between your right and
left hand (measurement method C) or hand and chest (measurement
methods A/B). Otherwise, the measurement cannot be taken correctly. Do
Taking Measurement
not move during the measurement, do not speak and hold the device still.
Movements of any kind will falsify the measurements.
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Taking Measurement
Operation Procedure Common Wrong Operations
The device starts beeping, and the Digits
Display flashes for a few seconds, indicating
the measurement is about to start.
Please avoid the following operations:
The right index finger is not in
sufficient contact with top electrodes.
Measuring over or through clothing.
WRONG WRONG
The measurement will be completed after
30 seconds, and you may see the results
shown on the LCD.
Holding the device in the wrong
direction.
Holding the device with left hand.
WRONG WRONG
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Note: Ifthebottomelectrodeisreleasedwithin 3 secondsatthebeginning ofyour
measurement, the measurement will beaborted.
Note: The latest measurement will replace the oldest one when the memory is full
(36 measurements).
Taking Measurement
Taking Measurement

Note1: Method ofdetermining a PAUSE-Indicate one oremore pauses in the
cardiac cycle, each of which is longer than 2 seconds.
Note2: Method ofcalculating heart rate-Take the R-R duration between two identical
points of consecutive ECG waveforms and divide it into 60.
The resulting equation: Heart Rate = 60/(R-R interval)
Result Display
Measurement Results Reviewing Results
The ECG measurement result will display as follows : For reviewing the previous records, you may:
: Normal Result
: Slow Heart Rate (<60 bpm)
Bradycardia
: Fast Heart Rate
(>100bpm)
Tachycardia
: Paused Heartbeat
: Irregular Rhythm
: Abnormal Waveform
Press the button for 3 seconds to turn
on the device. The LCD displays the total
number of records stored.
Press the button again, and the LCD
displays the average heart rate of the latest
measurement and the Digits Display shows
the sequence number of stored records.
Please retake the measurement if the displayed heart rate is flashing,
which indicates ECG signals are unstable or weak.
By pressing the button repeatedly, the result will be shown in a
cyclic order.
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Result Display
Result Display

BP ECG Studio
(870E not applicable)
System Requirements
BP ECG Studio
Installation
Before installing BP ECG Studio, please check the system requirements
listed below.
Please use the companion CD to install BP ECG Studio.
Insert the CD to your computer. Browse the CD and double click
Setup.exe to start the installation.
Select language and continue
the process.
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Read and accept the license
agreement.
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BP ECG Studio
BP ECG Studio
Operating
System
Windows 7 or higher
Recommended
Hardware
Intel Core i3-3220 3.30 GHz or higher
1 GB of RAM or more
1 GB of hard disk free space or more
Screen Resolution: 1280 x 1024 or higher

BP ECG Studio
Installation System Authentication
Select the folder for installing Click [Install] to start the
The process of system authentication will be needed as BP ECG Studio is
executed for the first time.
BP ECG Studio. installation process.
Double click the icon to run
BP ECG Studio.
The following message will be
displayed.
BP ECG
Studio
Click [Finish] to complete the
installation process.
Then, the icon will be shown
on the desktop.
Connect the USB extension
set with your device and
plug it into the USB port of
your computer.
The system will automatically
check the presence of your
device.
BP ECG
Studio
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BP ECG Studio
BP ECG Studio

BP ECG Studio
System Authentication Downloading ECG Data to Computer
Click [OK] to complete the
authentication process.
Then, the main window of
BP ECG Studio will be launched.
To download ECG data to your computer:
Run BP ECG Studio.
Create a new user account by
clicking .1
BP ECG
Studio
Fill in user information.2Plug the connector of USB extension
set into USB port of your computer.
1 You need to select a user account to log in every time. You may also delete the user
account by clicking .
2 The mandatory fields marked with “ ” CANNOT be changed once been set.
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BP ECG Studio
BP ECG Studio

BP ECG Studio
Downloading ECG Data to Computer Main Window
Make sure the connection is
established. Click to enter data download.
Disconnected
Connected
Click[Download]to download
data from the device.1
Records will be added into Data
List at the right column.
Electrocardiogram Trace
Grid Color Options
Click to change the grid color into green or red.
Scale Adjustment
Zoom in / Zoom out / Reset the scale of signals.
Result Display
1 If you want to delete the data after downloading, please select ” Delete data after
download complete ”.Note: Please be aware that MD Biomedical will not be responsible
for the loss of data and/or information in your computer.
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BP ECG Studio
BP ECG Studio

BP ECG Studio
Data List
Main Window
Help
About
Main Window
Measurement Note
Note your symptoms, Medications or activities related to the measurement
for further reference.
Multilingual Converter
Click to change the interface to preferred languages.
USB Connection Status
Disconnected / Connected
Functions Menu
Open the on-line Instruction
for Use of BP ECG Studio.
Delete
Delete the selected ECG data
from computer.
Provide version and copyright
information.
User information
Edit the user information.
Download
Download data from the device
to computer.
Configure
Configure your device.
Print
Print out the ECG/ BP data in a
report format.
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BP ECG Studio
BP ECG Studio