biovotion Everion User manual

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Everion
Instructions for Use
92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim

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Non-invasive physiological monitoring
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Contents
1. General Comments...........................................................................................................6
2. Everion Overview ..............................................................................................................7
3. Everion Components .......................................................................................................10
4. Initial operation...................................................................................................................13
Alternative method ......................................................................................................20
How to take off your Everion ..................................................................................22
5. Operation...............................................................................................................................23
Explanation of the windows and LED lights on your Everion..................23
Explanation of the LED lights on the Charger.................................................24
How to turn on your Everion...................................................................................25
How to charge your Everion....................................................................................26
How to turn off your Everion ..................................................................................29
How to perform a reset..............................................................................................30
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How to perform a self-test .......................................................................................31
6. Errors and Error Messages..................................................................................................32
Everion ...............................................................................................................................32
Charger..............................................................................................................................33
7. Connectivity .........................................................................................................................34
8. Cleaning..................................................................................................................................34
9. Storage ....................................................................................................................................35
10. Maintenance and Calibration.......................................................................................36
11. Re-use......................................................................................................................................36
12. Disposal ..................................................................................................................................37
13. Explanation of Symbols ...................................................................................................38
14. Safety .......................................................................................................................................40
Precautions......................................................................................................................47
Contra-indications........................................................................................................52
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Undesirable Side effects............................................................................................53
15. Customer Service ..............................................................................................................54
16. Warranty ................................................................................................................................54
17. Technical Information ......................................................................................................57
Frequency band(s) in which the radio equipment operates.....................62
Maximum radio-frequency power transmitted in the frequency
band(s) in which the radio equipment operates.............................................62
18. Regulatory Information...................................................................................................63
Declaration of conformity.........................................................................................63
FCC Warning note: ......................................................................................................64
IC Warning Statement................................................................................................66
RF Radiation exposure statement.........................................................................67
Trademarks ......................................................................................................................67
19. Manufacturer Information ............................................................................................68
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1. General Comments
Follow operating instructions
This Instruction for Use belongs to the Everion. It contains important Informa-
tion about use and maintenance. Please read the Instructions for Use before
using your Everion. Disregard of the Instructions for use may lead to serious
injury or to damages to the Everion.
App: Select the applicable app in the App Store. Availability may depend on your
mobile device.
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2. Everion Overview
Everion is a monitor that tracks your heart rate, heart rate variability, blood
oxygen saturation, blood pulse wave, respiration rate under rest, skin blood per-
fusion, activity, steps, skin temperature, barometric pressure and electrodermal
activity.
Sweat-proof and water-resistant design
Designed to be worn day and night
Up to 32 hours of battery life
About 180 minutes charging time to fully charge an empty battery
The Everion can be worn both indoors and outdoors
Heart rate and oxygen saturation are clinically validated vital signs. The follo-
wing vital signs are considered auxiliary values with no direct clinical relevance.
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• Heart rate variability is a measure of the variation of inter-beat intervals
and is an indicator of the state of the cardiovascular system.
• Blood pulse wave measures the shape and rhythmicity of the pulse wave.
• Respiration rate is an estimate of the breathing rate.
• Skin blood perfusion is an indicator of the perfusion of the skin under the
Everion.
• Activity tracks the general activity level of the user and yields a classication
such as walking, running, cycling and resting.
• Skin temperature measures the temperature of the skin under the Everion.
This value cannot be used as a substitute for a core temperature measure-
ment.
• Barometric pressure tracks altitude changes of the wearer while wearing
the Everion.
• Electrodermal activity (EDA) is the property of the human body that causes
continuous variation in the electrical characteristics of the skin, such as due
to sweating.
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This monitor is intended for tness and general wellness only. The monitor is not
intended for medical applications.
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3. Everion Components
Everion
The Everion is a wearable device
with multiple sensors for conti-
nuous vital sign monitoring.
LEDs
GSR electrode
photo sensor
reset window
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Armband with fasteners
This is an elastic band used to
attach the Everion to the upper
arm. It consists of:
elastic band
fastener
Measurement Band
This measurement band is used to
determine the correct band size
scale
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2
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Charger
The charger is used to charge the
Everion. It consists of:
red LED
power connector
blue standby LED
Power Cord
The power cord is used to power
the charger
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4. Initial operation
Before you put on your Everion, please make sure it is fully charged (see chapter
“Operation”).
Then put your Everion on your upper arm with the armband as can be seen in
the following images.
An alternative method for putting on your Everion is described at the end of this
chapter.
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Please take the measurement
band out of the box. It is already
assembled correctly
The measurement band is threa-
ded through both narrow slits
The reading in the middle
window determines the size of
your armband
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Choose the correct length for
the armband by measuring the
circumference of your upper arm
with the provided measurement
band as shown in the picture.
On the next page, you nd a
table with arm circumferences
and the corresponding armband
sizes.
If you feel the band size you
initially chose is too tight or too
loose, please choose the next
bigger or smaller size until it
feels comfortable.
Bend your arm during the measurement
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Bent arm circumference (cm) Armband size
19.0 – 21.5 XXS
22.0 – 24.5 XS
25.0 – 27.5 S
28.0 – 30.5 M
31.0 – 33.5 L
34.0 – 36.5 XL
37.0 – 39.5 XXL
40.0 – 42.5 XXXL
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Now hold your Everion in one
hand with the sensors facing
downwards
Place the rst fastener on your
Everion
Now snap the fastener onto your
Everion.
Press the fastener all the way
down until it rests in the lower
groove.
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Create a loop with the armband.
Attach the second fastener to
your Everion.
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Slip your Everion with the now
already attached armband over
your hand and up to your upper
arm:
on the outside of your upper arm
directly on the skin
about two ngers above your
elbow-crease.
If you are tall, you may need to
position it three to four ngers
above your elbow-crease.
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Alternative method
Position your Everion with the
attached armband:
on the outside of your upper arm
directly on the skin
about two ngers above your
elbow-crease.
If you are tall, you may need to
position it three to four ngers
above your elbow-crease.
92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim
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1
Table of contents
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