Empatica E4 User manual

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empaca© 2015
user manual

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START TRACKING NOW
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
cardiovascular features may be derived.
• Electrodermal acvity (EDA), used to
measure 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
temperature.
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 browser. To get started, set up a free
account at:
hps://www.empaca.com/connect
• Empaca Realme is a mobile App
that provides wireless streaming and
visualizaon of real-me E4 data on
Bluetooth (r) Smart Ready mobile devices
including iPhone, iPod touch, iPad, and
many Android phones and tablets. Free
from the App store or Google Play.
• Empaca Manager is a desktop applicaon
for managing the E4. Empaca Manager
runs on OSX 10.8 (Mountain Lion) and
above, Windows desktop and Windows
8 tablet. It transfers data from the E4
and uploads it securely to the Empaca
Connect. Download for free at
https://www.empatica.com/product-e4-download

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INTENDED USE AND USERS
Indicaon for use statement
The E4 wearable sensor device is intended for use by either healthy individuals or paents under
a physician’s care for the connuous, non-invasive monitoring of blood volume pulse, peripheral
heart rate, electrodermal acvity, surface body temperature and physical acvity.
In healthy individuals, E4 device provides a means to capture and retrieve physiological data
useful in monitoring and maintaining health and well-being of the user.
When prescribed for a paent by a physician or other qualied healthcare professional, the
device is intended to capture physiological data that may be useful to the praconer in
monitoring basic vital signs, which may then prompt further monitoring using primary diagnosc
methods.
For example, the objecve physiological data that E4 collects can be examined by a physician or
clinician in the eld of epilepsy, to look for possible changes during dierent types of seizures,
such as generalized tonic-clonic seizures or complex paral seizures. Other experts in other elds
might examine the data provided by E4 to gain insights for their research in areas such as anxiety,
stress and sleep.
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. 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.
Empaca S.r.l is not responsible for damages inferable to the nal user, customer and person or animal that
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-
idened. Data is organized by Sessions that
have a start me and duraon.
Empaca retains the right to change the
products in the E4 family at any me without
nofying the customers or updang the
manuals that have already been distributed.
The Customer is responsible for updang the
copy of this manual that he/she already owns
with newer versions made available on the
Empaca website.
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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B. MANUFACTURER DETAILS
Produced by:
Street:
City:
Cap:
Tel:
Fax:
C.F.:
EROI:
Website:
Support:
Commercial name:
Models:
Commercializaon year:
Empaca S.r.l
Via Stendhal 36
Milano (MI)
20144
[phone]
[phone]
07462810966
IT 07462810966
www.empaca.com
support@empaca.com
E4 fam device for physiological signal monitoring
E4
2015
Empaca S.r.l may be referred to as Empaca or the Manufacturer.
C. 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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D. PRODUCT LABELING INFORMATION
The Empaca E4 labeling system is compliant with
the requirement outlined in EN ISO13485:2012
Each device is idened by:
• 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 Medical 93/ 42/EEC Direcve, class 2a
• FCC CFR 47 Part 15b
• IC (Industry Canada)
• RoHS
Laboratory tests:
Electromagnec compability
• IEC 60601-1-2:2007 (third 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)
• IEC 60601-1-11:2010 (rst edion)
0051

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Package labeling and symbols descripon:
EC REP
LOT
DOC #E4-SP069-A-20150001
REF 12
Wearable Physiological Sensor Device
The most 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 .
Unique idener of Noed body that cered the E4 product.
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 skink.
ISO60601-1 safety test demonstrated that this part is safe.

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E. 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
warranty and Empaca will not be responsible for any damage to the modied product.
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.
Support and frequently asked quesons (FAQ)
The user is advised to check the Empaca support portal secon at:
hp://support.empaca.com/hc/en-us 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 support@empaca.com,
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
support representave will close the cket and the Customer will receive a nocaon.
Return merchandise authorizaon (RMA)
If Empaca support representaves are unable to resolve an issue remotely, an RMA will be issued.
The Customer must ll in the RMA form and follow the instrucons provided to return the product
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.
• Signicant baery issues (50% of declared
baery within year).
Do not open the E4 case. Opening the E4 case will void the warranty.

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F. PRECAUTIONS FOR USE
The E4 is in the process of undergoing cercaon as a CE Medical class 2a device according to
ISO 13485:2012. Risk analysis has demonstrated that the E4 can be considered a low risk prole
device.
Funconal hazards – including any error that might result from errant read and /or transfer of data
that aects 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
aer design validaon and vericaon, which means that the amount of current produced is safe
for the user.
Eye exposion to LED light - 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
produces sucient insulaon to protect the skin from the levels of heat that may be produced by
the LEDs.
Baery
Very Low risk level – no harm – baeries have a low energy density and an explosion is a rare
event. Baeries are qualied before use and are also cered by the Supplier.
Synthesis of cauons
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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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.
Biocompability
Very Low risk level – no harm - the E4 is made of a well known biocompable material and the
manufacturer is qualied, ensuring that no contaminaon occurs during the manufacturing
process. Materials are outlined in Technical Specicaons secon.
Electromagnec compability
Very Low risk level – no harm – design validaon and vericaon has been conducted and has
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)
• FCCC FR47Part15bedIC (Industry Canada)
• ETSIEN301489-1e3V
There should be no precauons to be taken for any interference with the magnec elds, or to
the environmental condions of use.
Use Condion
Ambient - E4 can be used in domiciliary sengs, indoor or outdoor; it’s resistant to water but
cannot be immerged in water, can be lost by subject during use, should be worn ght to the
wrist.
Light condion - 100-500lx, Visual distance: 20-40 cm, Visual angle +-90°
Environmental condion - Temperature -10°C +40°C, Relave humidity 20% - 95%, Air pressure –
500hPa to 1200hPa, Acousc level - not relevant
Use frequency - It is extremely variable depending on subject/praconer prescripon:
Repeve use (once per day) or prolonged use (few minutes to 40hrs)

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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 it’s original plasc box to prevent any
accidental damage.
The E4 can be stored in it’s original box for a maximum of 1 month without charging.
If the E4 will not be used for a longer me we recommend to charge the device at least once a
month.
Transportaon can be performed inside it’s original package or can be worn on the wrist like a
normal watch.
Disinfecon before use
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.
Proper storage aer use
The E4 should be properly stored. Not exposed to direct sunlight, moisture, humidity or rain.
Product disposal
Dispose of the E4, the E4 baery, and the USB cable in accordance with local regulaons. Do not
dispose of the baery with regular household waste. Recycle you package in accordance with
local regulaons.
Use with other accessories (i.e. baery charger)
It’s forbidden to use the E4 with other accessories, unless normally approved by Empaca.
In parcular it’s forbidden to plug the E4 in any charger that is not complian with IEC 60950-1.
Use with children
The E4 does not require any parcular safety procedure when used with children.

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1. PACKAGE CONTENTS
The package of E4 contains:
1 E4 wristband - adjustable size
1 pair of stainless steel electrodes (installed)
1 pair of silver (Ag) replacement electrodes
1 USB dock (for charging and data transfer)
1 USB cable (type MICRO–B)
Package covers with Empaca Logo, Quick Start Guide and Cercaons

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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:
Event Mark Buon
Baery Life
Recording Mode: 36+ Hours
Streaming Mode: 20+ 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
Electrodermal Acvity
Skin conductance
Bluetooth® Smart

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2.1 TECHNICAL SPECIFICATIONS
The user should refer to the Technical Specicaon document to have a beer overview.
Below we will review only the main technical specicaons.
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 mm2 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 dierent 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.
• Semi-permanent (screw in design).
• SUS03 stainless steel (standard) or Silver (Ag)
plated with metallic core.
• Electrode longevity:
• Lifeme (SUS03)
• 4–6 months (Ag)
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
rmware.
• Resoluon: 8 bits of the selected range.
E4 operang range:
• Relave Humidity 60 ±25% H.R.
Water resistance:
• IP 22 - E4 is protected against inseron of ngers
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, 250mAh minimum supply Lithium
baery, 3.7V output.
• Charging me: <2 hours.
• Baery Life in recording mode: >36 hours.
• Baery Life in streaming mode: >20 hours.
• Baery model: 260mAh
• 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.
• Case: 70% polycarbonate + 30% glass ber.
• Lenses: polycarbonate.
• Electrodes: silver (Ag) plated and stainless steel.
• 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.
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.

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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
• Stainless Steel SUS 303F
• Brass, Ag Plated
USB Terminals
• C3604BD(BC), Au Plated
Precauons of use
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.
Known allergic reacons
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 becoume itchy. This is not related to any allergy but if this happen we suggest to pause the use
of the device for 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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ACTION WHAT TO DO WHAT YOU SEE NOTES
Charging the E4 Snap the E4 into the dock and
ax the dock via USB to a
power source.
The LED will turn GREEN
indicang it has received power
and is charging.
In less than 1-minute the LED
will turn solid yellow indicang
that it is charging.
Aer some me the LED
will power down and appear
BLACK/OFF indicang that the
device is fully charged.
If the Empaca Manager is
running, then the E4 will display
the colors associated with data
transfer prior to displaying the
charge indicaon colors.
Periodically the device GREEN
LED may alternate back on
during charging.
alternang solid o
when
charged
Charge indicator LED lights
Low baery indicaon
Low baery level is indicated with a yellow color i.e.
The only way to see the baery level of the E4 is to put it in streaming mode.
The baery level can be viewed in the Empaca Realme app.
WHAT IT MEANSWHEN YOU SEE IT
Aer powering on the E4 and it
is unplugged.
During recording.
During streaming.
Very Low baery level.
Low baery level.
Low baery level.
WHAT YOU SEE ON E4
alternang
alternang
alternang