Empatica E4 User manual

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©2018
user’s manual

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©2018

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©2018
S TA RT TRAC KING N O W
empatica.com/get-started-e4

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INTRODUCTION
The Empaca E4 wristband is a wearable
wireless device designed for comfortable, con-
nuous, real-me data acquision in daily life.
The E4 contains four sensors:
• Photoplethysmography (PPG) to provide
blood volume pulse, from which heart rate,
heart rate variability, and other cardiovas-
cular features may be derived.
• Electrodermal acvity (EDA), used to mea-
sure sympathec nervous system arousal
and to derive features related to stress,
engagement, and excitement.
• 3-axis accelerometer, to capture mo-
on-based acvity.
• Infrared thermopile, reading skin tempera-
ture.
The E4 operates either in streaming mode
for real-me data viewing on a mobile device
using Bluetooth® low energy or in recording
mode using its internal memory.
Empaca provides soware tools that enable
your E4 data to be transferred securely and
easily to other devices:
• Empaca connect is a web applicaon for
storing, viewing, and managing E4 data.
The applicaon can be accessed from any
plaorm using a contemporary web brows-
er. To get started, set up a free account at:
• E4 Realme is a mobile App that provides
wireless streaming and visualizaon of
real-me E4 data on Bluetooth® Smart
Ready mobile devices including iPhone,
iPod touch, iPad, and many Android
phones and tablets. Free from the App
store or Google Play.
• E4 Manager is a desktop applicaon for
managing the E4. E4 manager runs on
macOS & Windows. It transfers data from
the E4 and uploads it securely to the
E4 Connect. Download for free at:
hps://www.empaca.com/product-e4-download
The E4 wristband is a class IIa Medical Device in the EU, according to CE Cert. No. 1876/MDD
(93/ 42/EEC Direcve)
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INTENDED USE AND USERS
Indicaon for use statement
The E4 is intended to be worn on the wrist for connuous collecon of physiological data in the
home and healthcare seng for use by healthcare professionals. This includes blood volume,
heart rate and physical acvity. The E4 is also intended for the measurement of electrodermal
response and physical acvity in paents with neurological disorders such as epilepsy.
The E4 is not intended as a primary diagnosis of epilepsy or detecon of seizures.
User types
• Paent – uses the device for a prolonged me and is being measured
• Operator - setup the work modality of the device and review the physiological data
User modalies
• Other the counter: The subject uses the E4 as a monitoring tool.
• Prescripon: A physician uses the device on a paent for monitoring its physiological data and
conducts studies on those data.
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A. PRECAUTIONS FOR USE
– including any error that might result from errant read and /or transfer of data
that affects the output of one or more sensor (i.e., Heart rate, EDA, Temperature, Accelerometers).
Very Low risk level – no harm – safe transfer protocols and fault detecon algorithms monitor the
validity of data. Moreover the E4 is not intended to diagnose a disease; only trained personnel may
interpret the data.
Current leakage through the EDA electrodes – The EDA circuit drives a small amount of ionic
current through the skin to operate: Max 100 µA as required by IEC 60601-1:2005
Very Low risk level – no harm – the E4 has been validated to be compliant with ISO 60601-1:2005
for the user.
- PPG LEDs are extremely bright; typically they are totally obscured
by contact with the skin. However the User can remove the E4 from the wrist, exposing the light
source.
Very Low risk level – no harm – the quanty of light is comparable with other light sources that Users
may be exposed in their daily environment. The User is advised to not look at the PPG LEDs for a
prolonged me.
Heat produced by PPG LEDs – PPG LEDs might produce heat
Very Low risk level – no harm – the LEDs are not in direct contact with the skin and the PPG window
the LEDs.
Very Low risk level – no harm – baeries have a low energy density and an explosion is a rare
The list below represents all aspects that should be considered as cauons resulng from Risk analysis of the E4.
The user is required to carefully read this manual before using the device.
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Aer a prolonged use above 24h, the user should inspect the skin and determine if a skin
irritaon was produced by the device. This is probably due to the mechanical interference
between the skin and the device (the E4 passed all biological safety tests). Thus in this situaon it
is suggested to stop the recording or switch the recording locaon, by placing the E4 in the other
wrist.
Water resistance
Very Low risk level – no harm – the device is splash proof and will operate normally aer contact
with sweat, rain or splashes. The device is not fully waterproof so the user should not submerge
it in liquid or wear it in the shower. In the event that there is water ingress into the case the User
will not be harmed, but the device may stop working.
Very Low risk level – no harm -the E4 is made of a well known biocompable material and the
Very Low risk level – no harm
demonstrated that the E4 is safe for use with other electronic devices. It is compliant with the
following standards:
• IEC 60601-1-2:2007 (third edion)
• FCC CFR47Part15b ed IC (Industry Canada)
• ETSIEN301489-1e3V
Portable and mobile RF communicaons equipment can affect the behavior of the E4. The
E4 needs special precauons regarding EMC and needs to be installed according to EMC
informaon.
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EMC Environment
Immunity
Test
EN 60601-1-2
Test level
Electrostatic discharge
(ESD)
EN 61000-4-2
6 kV contact
8 kV air
Power frequency
(50/60 Hz) magnetic
field
EN 61000-4-8
3 A/m
: 2007
Conducted RF
Radiated RF
Not applicable because of USB
cable lenght < 1m
3 V/m, 80 MHz to 2.6 GHz.
Real Time data streaming - The E4 realme app is not intended to be used for remote real
me paent monitoring. The real me data transfer happens only between the device and the
smartphone while being in the connecon range.
Ambient
wrist.
- 100-500lx, Visual distance: 20-40 cm, Visual angle +-90°
Use frequency
MR Environment - The Empaca E4 has not been evaluated for safety and compability in the
MR environment. The Empaca E4 has not been tested for heang or migraon in the MR
environment.
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B. GENERAL AGREEMENTS
Empaca E4 wristband is intended for use in
research sengs; therefore we disnguish the
Customer, who is usually a researcher managing
a group of devices for use in a study, and the
User, who is usually a research parcipant
wearing Empaca devices.
The purchase of an Empaca device is subject to
a purchase agreement between Empaca and
a legal enty that acquires the product, namely
the Customer. The Customer is responsible for
the maintenance of the Empaca products and
their proper use. Empaca is not responsible
for any damage caused by improper use of the
device.
The Customer is responsible for making
sure that Users are fully informed and have
consented before parcipang in any studies.
The Customer is responsible for keeping safe
any personal informaon of study parcipants
or Users.
are due to improper use of the device.
Empaca does not handle any personal
informaon linked to physiological data on
its servers; all physiological data will be de-
have a start me and duraon.
Empaca retains the right to update the exisng
products (E4-Firmware, Empaca connect, E4
realme applicaon and E4 manager) in order
to improve quality and reliability. Users will be
have the opon to upgrade the product or to
keep the version they have. Documentaons
will be periodically updated and distributed
from the Empaca web including changelogs
for each products.
This document is used for the sole purpose of
supporng both the Customer and the User. It
contains all the informaon that is useful for the
correct use of the device and its maintenance.
The present manual should be read carefully.
The Customer and User must strictly adhere to
the rules it contains.
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C. MANUFACTURER DETAILS
Produced by:
Street:
City:
Cap:
Tel:
Fax:
C.F.:
EROI:
Website:
Support:
Commercial name:
Models:
Commercializaon year:
Via Stendhal 36
Milano (MI)
20144
[phone]
[phone]
07462810966
IT 07462810966
E4 fam device for physiological signal monitoring
E4
2015
Empaca S.r.l may be referred to as Empaca or the Manufacturer.
D. USER TYPES
Personal use: In this scenario the paent and operator are equivalent.
The paent uses the E4 as a monitoring tool.
Professional use: In this scenario the E4 is prescribed by a medical professional to a
paents in order to monitor their physiological data and conduct studies on those data.
The operator is the trained medical praconer, while the paent is the person that will be
monitored.
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E. PRODUCT LABELING INFORMATION
• Manufacturer name “Empaca” and logo
embossed at the end of the strap.
• Product Name: E4
• Serial number composed of one
alphanumeric character followed by a
5-digit number, e.g. A00001, that uniquely
disnguishes each device.
¹ Empaca devices have an integrated Bluetooth® module from which the FCC id is inherited
S/N: A00064
Most of the labeling informaon is laser printed on the boom cover of the device. We also included
the following marks denong compliance to their corresponding standards:
Regulatory compliance:
• CE mark of conformity to the Medical Device Direcve 93/42/EEC, Class IIa
• FCC CFR 47 Part 15b
• IC (Industry Canada)
• RoHS
• MIC Japan: ID R 209- J00046
Laboratory tests:
Electromagnec compability
• IEC 60601-1-2:2014 (fourth edion)
• FCC CFR 47 Part 15b ed IC (Industry
Canada)
• ETSI EN 301 489-17 V2.2.1
Usability
• IEC 60601-1-6:2010 (third edion)
Safety
• IEC 60601-1:2005 (third edion)
•
0051
The E4 labeling system is compliant with the
requirements outlined in EN ISO 13485:2016/
AC:2018, Medical Device Direcve 93/42/EEC,
21 CFR 801 and 809.10.
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Package labeling and symbols descripon:
EC REP
LOT
DOC #E4-SP069-A-20150001
REF 12
Wearable Physiological Sensor Device
A comfortable and accurate wristband
to monitor physiological signals in
real-me.
0051
0051
Manufactured by:
Empaca S.r.l.
Milan, Italy
Represents compliance of E4 product with the Federal Communicaons Commission of
United States.
Represents compliance of E4 product with the European Community direcve on medical
devices 93/ 42/EEC.
Compliance of the E4 product with the Waste Electrical and Electronic Equipment
Direcve.
E4 has two metal contact points that are used by the EDA sensor. This is type BF part
which means that it may generate a leakage current when in contact with the skin.
ISO60601-1 safety test demonstrated that this part is safe.
To indicate that E4 intenonally generates RF signals for data transmission to a connected
device.
The E4 wristband uses Bluetooth® Low Energy to transfer data.
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F. WARRANTY AND SUPPORT
The E4 is covered by warranty as stated by the general sale terms, where the modalies are
described by which a broken or defecve device can be returned to Empaca. If a malfuncon
arises during the warranty coverage period and the malfuncon belongs to one of the categories
listed in the warranty statement, Empaca, aer a proper test of the device, will replace or repair
it. Any intervenon on the device done without the explicit indicaon by Empaca will void the
Issues NOT covered under warranty
• Damage to the main device case.
• Scratches or damage to the PPG sensor
lens.
• Damage to the wristband containing the
EDA electrodes caused by pull, torsion, or
rotaon of the band.
• Any issue in which the main case has been
opened.
The user is advised to check the Empaca support portal secon at:
for any issues related to the product.
This is the quickest way to receive help and common quesons are addressed there. If no soluon
is available to the problem, the user is advised to contact customer service at ,
which opens a cket within Empaca’s support system and issues a receipt to the Customer. A member
of the support team will reply by email. If further assistance is required the user might be asked to
engage in a live call or video conference for direct support. Once the issue has been resolved the
If Empaca support representaves are unable to resolve an issue remotely, an RMA will be issued.
to Empaca for servicing. Empaca will not be responsible for returned merchandise without an
executed RMA form.
Issues covered under warranty
• Manufacturing defect at unpacking me.
• Manufacturing defect happened during
device use.
•
baery within year).
Do not open the E4 case. Opening the E4 case will void the warranty.
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Transport and Handling
The E4 is shipped in a carton box, which can be recycled aer the unpacking. Each carton box may
contain one or more devices which are stored inside their original plasc box.
When the E4 is not in use it’s advised to place it inside its original plasc box to prevent any
accidental damage.
The E4 can be stored in its original box for a maximum of 1 month without charging.
If the E4 will not be used for a longer me we recommend charging the device at least once a
month.
Transportaon can be performed inside its original package or can be worn on the wrist like a
normal watch.
The E4 is designed to be suitable for repeated use by mulple Users. The Customer must ensure
that the device is properly disinfected before being transferred between individual Users to
prevent the transmission of skin diseases. This procedure is outlined in Chapter 8 of this manual
under the “Cleaning and Disinfecon” secon.
The E4 should be properly stored. Not exposed to direct sunlight, moisture, humidity or rain.
Product disposal
Use with children
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1. PACKAGE CONTENTS
The package of E4 contains:
1 E4 wristband - adjustable size
1 pair of silver (Ag) plated electrodes (installed)
1 pair of silver (Ag) plated replacement
electrodes
1 USB dock (for charging and data transfer)
1 USB cable (type MICRO–B)
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S/N: A00064
2. E4 WRISTBAND OVERVIEW
The E4 is worn like a wristwatch. All of the sensors are embedded in the device: the PPG sensor
and the temperature sensor are on the boom side of the device while the wristband holds the
EDA electrodes. The E4 is water resistant but it should not be submerged in liquids.
The picture below depicts an overview of the features of the E4:
Recording Mode:48+ Hours
Streaming Mode:24+ Hours
Form Factor
Wrist-watch like
Case size: 44mm x 40mm x 16mm
Weight: 25gr
Photoplethysmography (PPG)
Blood Volume Pulse
(supporng Hearth Rate Variability
analysis for stress and relaxaon)
Flash Memory 3-Axis Accelerometer
Movement and Acvity
Temperature
Skin conductance
Bluetooth® Smart
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2.1 TECHNICAL SPECIFICATIONS
The expected life of the device depends mainly on the baery life which is 2 years.
PPG sensor
• Sampling frequency 64 Hz (Non customizable).
• LEDs: Green (2 LEDs), Red (2 LEDs) Photodiodes: 2
units, total 15.5 mm
2 sensive area.
• Sensor output: Blood Volume Pulse (BVP) (variaon
of volume of arterial blood under the skin resulng
from the heart cycle).
• Sensor output resoluon 0.9 nW / Digit.
• Moon arfact removal algorithm:
• Combines different light wavelengths.
• Tolerates external lighng condions.
Infrared thermopile
• Sampling frequency: 4 Hz (Non customizable).
• Range:
• -40...85°C for ambient temperature
(if available)*.
• -40...115°C for skin temperature.
• Resoluon: 0.02°C.
• Accuracy ±0.2°C within 36-39°C.
EDA sensor
• Sampling frequency: 4 Hz (Non customizable).
• Resoluon: 1 digit ~900 pSiemens.
• Range: 0.01 µSiemens – 100 µSiemens.
• Alternang current (8Hz frequency) with a
max peak to peak value of 100 µAmps (at 100
µSiemens).
• Electrodes:
• Placement on the ventral (inner) wrist.
• Snap-on silver (Ag) plated with metallic core.
• Electrode longevity:
• 4–6 months
3-Axis accelerometer
• Sampling frequency: 32 Hz (Non customizable).
• High sensivity moon detecon across 3 axes:
X,Y, and Z.
• Default range ±2g.
• Ranges of ±4g or ±8g are selectable with custom
• Resoluon: 8 bits of the selected range.
E4 operang range:
• Relave Humidity 60 ±25% H.R.
Water resistance:
•
and will not be damaged or become unsafe if
exposed to vercally or nearly vercally dripping
water.
* This is not generally available but can be turned on with custom engineering work.
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Baery power supply and baery:
• Charging cradle with E4 charging interface and
standard Micro-B USB port.
• USB port, 5V, 250mA minimum supply
• Charging me: <2 hours.
• Baery Life in recording mode: >48 hours.
• Baery Life in streaming mode: >24 hours.
• Baery capacity: 300mAh
• Baery manufacturer: YJ Power
• Charging cycles: 500
• Life expectancy: 2 years
• Fully charge the E4 baery at least once a month
for opmal performance. When the device is stored
inside it’s original box. Materials
• Band: polyurethane.
•
• Lenses: polycarbonate.
• Electrodes: silver (Ag) plated.
• Charging terminals: gold (Au) plated.
Real-me clock
Recording Mode:
• 5s synchronizaon resoluon in recording mode.
• Average of 6 seconds in 6 million seconds dri.
Streaming Mode:
• Temporal resoluon up to 0.2 seconds with
connected device.
Bluetooth LE®
• Operang range: 10 meters
• Real me data streaming may be delayed by 1 sec.
Memory
• Session data is approximately 1MB per recording
hour.
• Device storage capacity exceeds 60 recording
hours.
Weight
• 40 grams | 1.41 ounces.
E4 size
• Max band circumference
• Min band circumference
• E4 Case length
• E4 Case width
• E4 Case height
mm inches
190 7.48
110 4.33
44 1.73
40 1.57
16 0.63
Charger size
• Charger length
• Charger width
• Charger height
mm inches
45 1.77
44 1.73
12 0.47
Hardware operang condions
• Relave humidity: 0-100% H.R.
• Admied air pressure: 100KPa ÷ 35Kpa.
Populaon
• Above 5 years old wrist circumference of 10 cm
• Skin: white to black, normal perfusion
• Light condion: any
• Use condion: stac &moon, connuos monitoring
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2.2 BIO COMPATIBILITY
The E4 has the following set of components which can be in contact with the skin.
Temperature Sensor
• Silicon
PPG Sensor
• Polycarbonate (LG-SC1004A)
Boom Cover
• Polycarbonate (SDI-EH3300HF-K2115)
• Glass Fiber 30%
Electrodes
• Silver coated with copper underlay on
brass
USB Terminals
• C3604BD(BC), Au Plated
It’s forbidden to use the E4 with injured skin or other types of skin diseases located in the area
where you plan to wear the E4.
Among all E4 users (thousands) we have been reported with two cases of allergic reacons of light
intensity (few days of persistence). Those people were also allergic to other types of substances.
Please contact immediately our support team for any issue related to this topic.
During summer, the mechanical interference between the E4 band and the skin may cause the skin
to become itchy. This is not related to any allergy but if this happens we suggest pausing the use
of the device for a few hours.
26
15
4
3
7
Top Cover
• Termoplasc polyuretane, SONGWON
S185A
Loop Band
• Termoplasc polyuretane, Dow
Corning EG4200
S/N: A00064
6
2
5
1
4
7
3
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3. BATTERY CHARGING
The E4 must be charged using a standard 5V USB 2.0 power source. In order to charge the device
you have to use the charging dock provided from Empaca. Connect the included USB cable to
the Micro-B port of the charging dock, connect the charging dock to the E4, and then plug the USB
cable into the power source.
Charging dock and USB cable
The charging dock is only used while charging
the E4; remove it before wearing the device.
It is a passive component and it is not water
resistant.
The charging dock has 4 metallic contacts
that match the ones on the E4. Make sure to
properly connect the charging dock, otherwise
the charging process will not start.
Remember to remove the dock from the E4 before
wearing the E4.
Charger
You can use a standard 5V USB charger with
the E4 such as the following:
• Chargers provided with mobile phones.
• Computer USB port.
• USB hubs (powered or un-powered).
Note that the charger should provide at least 250 mA
(0.25 A) of current output for an opmal charging me.
Charging
Charging mes depend on how drained the
baery is and on the current provided by the
charger. Typical charging me with daily use is
between 1 and 2 hours.
via USB to a power source.
2 - The LED will turn YELLOW indicang it
has received power and is charging.
3 - When E4 is fully charged, the LED will
turn a solid green.
Charging E4 wristband
©2020