PRESCRIPTION EMBRACE
INSTRUCTIONS FOR USE
# EMB-SP069-B-201806
Rev 1.
1RY 2018
The information contained in this document is confidential and is the property solely of Empatica, S.r.l.. Any reproduction in part or in whole
without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
The information contained in this document is confidential and is the property solely of Empatica, S.r.l.. Any reproduction in part or in whole
without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
1
Table of Contents
Product Description 6
Introduction 7
Indication for use statement 8
Intended Environment 8
Intended Population 8
Precautions for Use 9
Warnings 9
Cautions 10
Synthesis of hazards 10
Prescription for Embrace in the US 17
Get to know Embrace 18
Types of seizures Embrace detects 19
Complex Partial Seizures 19
Absence seizures 19
Nonconvulsive seizures 19
Embrace's seizure detection system 20
Compatible phones and tablets 21
Apple iOS 21
Android 22
How Embrace works 24
What happens when there is a Bluetooth® disconnection? 24
What happens if the smartphone isn't connected to Internet? 24
Charging Embrace 25
Additional tips: 25
Embrace battery life 26
Checking Embrace’s battery level 27
Tell the time with Embrace 29
Embrace app 30
Embrace materials 31
Embrace water resistance 32
Limitations 32
Embrace and animals 33
Protecting your privacy 34
How we use your data 34
How you can manage your data 34
Additional protection for minors 34
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
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Phone Support 35
Empatica Account 36
Creating your Empatica Account 37
Step 1: Creating an Empatica Account is easy. 37
Step 2. Review the Privacy Policy 37
Step 3. Verify your email address 37
Step 4. Define your preferences 38
Step 5. Sign up for Clinical Trial 38
Editing your shipping address 39
Resetting your Empatica password 41
Updating your profile in the Empatica Account 44
Parental Consent for minors under 16 45
Changing my communication preferences 46
Exporting my data 47
Deleting my Empatica Account 48
What will be deleted? 48
What will remain? 48
The following information will remain but will be de-identified: 48
How to delete your account 48
GDPR FAQs for Embrace 49
What is GDPR? 49
How does GDPR apply to me? 49
What personal information does Empatica collect? 49
How does Empatica use my information? 49
How can I review and modify my privacy settings? 50
How can I ask to have my information deleted? 50
What personal data are available for your download upon request? 50
Seizure Report 51
How to add a new seizure 51
Research and Medical 56
Studies behind the Embrace 57
Consulting your physician about Embrace 58
Embrace and seizure prediction 59
Using Embrace with a Vagus Nerve Stimulator 60
Scientific literature behind Embrace 61
Wearing Embrace during an MRI or X-Ray scan 62
Seizure detection accuracy 63
Clinical Testing 64
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
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Understanding the importance of electrodermal activity 66
What affects EDA? 66
How does Embrace measure EDA? 66
What role does EDA play in Empatica’s seizure detection algorithm? 66
Allergic reactions to Embrace 67
Important Notes 67
Materials Used 67
Placing an Order 68
Package lost in transit 69
My Embrace is listed as “delivered”, but I can’t find it 70
How to order Embrace 71
FDA Cleared version of the Alert App 71
Investigational version of the Alert App 71
Shipping Embrace to your country 72
Cancelling your Embrace order 73
Insurance reimbursement for Embrace 74
Embrace Return Policy 75
Embrace warranty 76
Returning Embrace for a refund 77
Returning your Embrace for service 79
Embrace Subscriptions 80
Updating your billing details 81
What do do if you’ve subscribed to plan with a different Empatica Account. 82
What to do if you see a warning when subscribing to a plan 83
Available subscription plans 84
Purchasing a subscription plan 85
Using the Embrace without a subscription 86
Changing your subscription plan 87
Cancelling your subscription plan 89
Empatica Subscriptions Receipts 90
Subscription payment rejected 92
Refunds and subscriptions 93
Getting started with Embrace 94
What Embrace comes with 95
How to wear Embrace 96
Which wrist? 96
Positioning 96
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
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Setting up Embrace 97
Embrace LED lights Guide 99
The importance of being a Caregiver 101
Receiving Alerts 101
False Alarms 101
Added as a Caregiver by mistake 102
Get Started With Alert 103
Main functions of the Alert App 104
How the Alert app works 105
Setting up the Alert App 107
Alert App Statuses 108
Everything is OK 108
No Internet Connection 109
Bluetooth is off 110
Embrace not found/Embrace disconnected 111
Warning 112
Understanding Embrace Alerts 113
What Embrace Sync to Alert means 114
What Last Sync to Cloud means 115
False alarms 116
False alarms due to stimming 116
How to cancel alerts 117
Marking false alarms 120
Updating the Alert App 122
Adding Caregivers 123
Checking Embrace memory level 126
“Alert Storage” in the Alert app 127
Upgrading Embrace firmware 128
Caregivers and the Alert app 131
Light & Vibration setting 132
Turning off your Embrace 133
Yellow Cross on Embrace 134
Red X on Embrace 135
Red Triangle on Embrace 136
Troubleshooting Embrace 137
How to check if Embrace is working properly 138
Trouble with seeing time on Embrace 139
Embrace disconnections 140
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Alert installed on more than one Smartphone 141
Embrace taking too long to charge 142
Embrace isn’t charging 143
Lost or damaged charger 144
Pairing Embrace with a different smartphone 145
Embrace not transferring data 146
Difficulty upgrading Embrace firmware 147
Cleaning your Embrace 148
Troubleshooting the Alert App 149
Pairing Embrace with a different account 150
Trouble pairing Embrace 151
Transferring data from the Alert App 152
Trouble with Embrace Light & Vibration 153
“No internet connection” status 154
“Bluetooth off” status 155
“Embrace not found” status 156
Warning Notification 157
Alert Not Sent 158
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
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Product Description
The information contained in this document is confidential and is the property solely of Empatica, S.r.l.. Any reproduction in part or in whole
without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
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Introduction
The Embrace is a medical device that is intended to be used by people living with epilepsy.
The Embrace is a prescription only ( Rx Only ), single patient use, class II medical device according
to FDA 21 CFR Part 860.3 within US and a class 2a according to 93/42/CEE Directive within
Europe.
It is important that the caregiver maintains the same level of care as before the use of the
Embrace. The Embrace mainly consists of two components:
● The Embrace watch
● The Alert App
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
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Indication for use statement
The Embrace is a prescription only device that is indicated for use as an adjunct to seizure
monitoring of adults and children age 2 and up in home or healthcare facilities during periods of rest.
The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect
patterns that may be associated with generalized tonic clonic seizures in patients with epilepsy or at
risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired
wireless device that is programmed to initiate an alert to a designated caregiver. The System records
and stores data from Accelerometer, and EDA sensors for subsequent review by a trained healthcare
professional.
Limitations:
(i) For prescription use only.
(ii) The device is not intended to be used to guide medical therapy decisions
(iii) The safety and effectiveness of the Embrace System has not been established in monitoring
signals that may be associated with seizures other than convulsive seizures
(iv) The device is not intended to be used as a stand-alone monitoring device
(v) The device is not intended to be used during physical activity
(vi) The device does not predict seizure onset
Intended Environment
The Embrace is intended for use in home or healthcare environmentsGXULQJSHULRGVRIUHVW.
Intended Population
The Prescription Embrace is intended for use in adults and children age 2 and up with epilepsy or
at risk of having epilepsy.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
9
Precautions for Use
The Embrace is a class II medical device according to FDA 21 CFR Part 860.3 within the US. Risk
analysis has demonstrated that the Embrace can be considered a low risk pro!le device. It is
important to not reduce seizure management practices when using Embrace.
The Embrace 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.
Warnings
A. For the timely delivery of noti!cations to Caregivers, the following conditions must be met:
● The user wearing the Embrace watch remains within close proximity (< 30 ft) to the paired
smartphone running the Empatica Alert app.
● The paired smartphone must be connected to the internet.
● The Caregiver’s phone must be connected to a wired or wireless telephone network.
● The Alert app and/or Embrace does not show any warning message (i.e. RED led).
● The Embrace, paired smartphone, and caregiver phone must be charged and operating
properly.
B. Users who wear pacemakers, or have health conditions which might be sensitive to the tiny
electrical signals used by the Embrace in measuring EDA should always consult their physicians
before wearing an electronic device, including the Embrace watch.
C. If Embrace is used in a manner not speci!ed by the manufacturer the protection it provides could
be compromised.
D. Adult supervision is required. Due to the presence of small parts used in the Embrace it is
strongly advised that the device only be used on small children under adult supervision.
E. Use the Embrace only with original accessories provided by Empatica. Other cables and
accessories might impact the EMC performances.
F. The use of the accessory, transducer or cable with the Embrace other than those speci!ed may
result in increased emissions or decreased immunity of the Embrace.
G. Changes or modi!cations not expressly approved by the manufacturer could void the user’s
authority to operate the equipment.
H. Do not store the Embrace close to other electrical equipment.
I. Portable RF communications equipment, including antennas, can affect the Embrace, thus they can
be used no closer than 30 cm (12 inches) to any part of the Embrace.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
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J. Use USB power supply certi!ed with IEC 60950-1
K. The Embrace charger may generate heat; be careful when handling it during the charge.
Cautions
A. Do not place the Embrace watch over broken or damaged skin.
B. Do not use unapproved accessories with the Embrace watch.
C. The buckle and the face of the Embrace are made of aluminum and nickel-free chrome plated
metal, and the band is made of stretchy synthetic fabric material composed of Spandex 21% Nylon
79%. The electrodes are in surgical stainless steel (SUS316L), which should not cause any skin
reactions. Nevertheless, if a person has a known metal allergy or is generally sensitive to skin contact
with metals, please contact Empatica before wearing the device. Keep Embrace clean so that
bacteria and dirt do not build up and cause skin itching or irritation or impair sensing.
D. Check the Embrace for sharp edges and damage before each use. Do not use it if damaged.
E. Do not leave Embrace in environments in which the device may overheat beyond the
recommended environmental limits (such as a hot car). If the Embrace is left exposed to high
temperatures, allow it to cool before handling it to avoid potential skin burns.
F. Users should never attempt to wear the watch while charging the battery.
Synthesis of hazards
Risk #1: In the worst case, the user and/or caregiver could change their behavior and rely too much
on Embrace, leading to less than adequate supervision. It’s possible that Embrace may not detect
100% of all seizures or deliver alerts accordingly; therefore, there is still a possibility of death while
wearing Embrace.
Risk #2: Embrace detects the seizure and the alert is not received by the Caregiver in an appropriate
time frame because:
- The Bluetooth connection between Embrace and the secondary device fails .
- The secondary device fails to communicate with the noti!cation system (i.e., no internet
connection).
- The noti!cation system fails to ef!ciently deliver the call or SMS.
- The caregiver’s phone/the caregiver fails to receive the noti!cation.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
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Risk #3: It may occur that Embrace misidenti!es an activity as a seizure, when in reality, it is not.
This is called a “False Alarm”. If the wearer does not cancel them in time, it could cause both the user
and caregiver inconvenience and annoyance. Too many false alarms can lead caregivers to ignore
alerts or patients to stop using the device.
Risk #4: Biocompatibility (skin rash; contact dermatitis)
Electrodes are made of SUS316L. The band is made of polyester and polyurethane that are
commonly used in the textile industry. The band frame is made of aluminum and has a nickel-free
plating, a material commonly used in wearable devices. The top cover is made of anodized aluminum,
and the bottom cover is made of painted polycarbonate; both are materials commonly used in
wearable devices. Empatica conducted biocompatibility analysis according to the ISO 10993
standard and will monitor with post-market data the incidence of allergic reactions. The rate to date
has stayed below 1% of all users experiencing any dermatitis.
Risk #5: Failure in the software (!rmware or mobile app) could cause the algorithm, connectivity, or
communications to fail. We have implemented many tests, including quality and usability checks of
the software. We also have data quality checks on the server side that can help identify sensor
failures (although these should be rare). We have prepared a detailed analysis of this that we can
share. We deem these risks to be minimal.
Risk #6: Electrical safety and hardware failure/battery damage: The Embrace is designed to reduce
the risk of short circuits of battery voltage using a power supply unit. In addition, we conducted the
test for IEC 60601-1 and ISO 62133 to verify that risk mitigation is successful.
Risk #7: Electromagnetic compatibility
Very Low risk level – no harm – Design validation and veri!cation has been conducted and has
demonstrated that the Embrace is safe for use with other electronic devices. It is compliant with the
following standards:
IEC 60601-1-2:2007 (third edition)
FCC CFR 47 Part 15C e IC RSS-210_RSS-247 (Industry Canada)
ETSIEN301489-1e3V
There should be no precautions to be taken for any interference with the magnetic !elds, or to the
environmental conditions of use, both for the patient and/or the operator.
Risk #8: Security of IT system: The data transfer between Embrace and the mobile phone is
encrypted according to Bluetooth®. which can be lost during use if the subject does not wear the
watch snugly on the wrist.
Light condition - 100-500lx, Visual distance: 20-40 cm, Visual angle +-90° .
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Environmental condition - Temperature -20°C +70°C, Relative humidity 20% - 95%, Air pressure –
500hPa to 1200hPa, Acoustic level - not relevant.
Use frequency - It is extremely variable depending on user/practitioner prescription: Standard use is
continuous with the exception of charging time.
Proper storage after use - The Embrace should be properly stored. Do not expose Embrace to direct
sunlight, moisture, humidity or rain.
Product disposal - Dispose Embrace, charging dock, and USB cable in accordance with local
regulations. Do not dispose the battery with regular household waste. Recycle the package in
accordance with local regulations.
Use with other accessories (i.e. battery charger) - It’s forbidden to use the Embrace with
accessories, not approved by Empatica. It is prohibited to plug the Embrace into any power
supply/power adaptor that is not compliant with IEC 60950-1. Check with your retailer to ensure
compliance.
Battery preservation
The Embrace can be stored in its original box for a maximum of 1 month without charging. If the
Embrace will not be used for longer than 30 days, make sure to charge it at least once a month to
preserve the battery.
Disinfection before use
The Embrace is designed for repeated use by a single user. You can disinfect it using methyl alcohol or
soap and water.
MR Environment
The Embrace has not been evaluated for safety and compatibility in the MR environment. The
Embrace has not been tested for heating or migration in the MR environment.
Remote patient monitoring
The Alert app is not intended to be used for remote real time patient monitoring. Data can only be
transferred to the smartphone when Embrace is within the Bluetooth range.
EMC Environment
The Embrace needs special precautions regarding EMC and needs to be installed and used according
to EMC information given below.
Mobile RF communications equipment can affect Embrace functioning.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
13
Table 1
Guidance and Manufacturer’s declaration- electromagnetic emissions
The Embrace is intended for us in the electromagnetic environment speci!ed below.
The customer or the user of the Embrace should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment/ Guidance
RF emissions CISPR
11
Group 1
The Embraces uses RF energy only for its
internal function. Therefore its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions CISPR
11
Class B The Embrace is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
Harmonic
emissions IEC
61000-3-2
Not applicable
Voltage
"uctuations/
"icker emissions
A. IEC
61000-3-3
Not applicable
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
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Table 2
Guidance and Manufacturer’s declaration- electromagnetic immunity
The Embrace is intended for us in the electromagnetic environment speci!ed below. The customer or the
user of the Embrace should ensure that it’s used in such an environment.
IMMUNITY Test IEC 60601
test level
Compliance
level
Electromagnetic environmentguidance
Electrostatic discharge
(ESD)
EN 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood, concrete or
ceramic tile. If "oors are covered with
synthetic material, the relative humidity
should be at least 30%
Electrical fast
transient/burst IEC
6100-4-4
± 2 kV for power
supply lines
± 1 kV for
input/output
lines
Not applicable
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge IEC 61000-4-5 ± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Not applicable
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
Not applicable
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the Embrace
requires continued operation during
power mains interruptions, it is
recommended that the Embrace be
powered from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz) magnetic
!eld
EN 61000-4-8
30 A/m 30 A/m
Power frequency magnetic !elds should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
15
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
C. The Embrace is intended for use in the electromagnetic environment speci!ed below. The customer or the user of the Embrace
should assure that it is used in such an environment
IMMUNITY test
IEC 60601
TEST
LEVEL
Compliance
level
Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
6 Vrms
ISM 150 kHz to 80
MHz
3 Vrms
6 Vrms
Portable and mobile RF communications equipment should be
used no closer to any part of the Embrace, including cables,
than the recommended separation distance calculated
from the equation, applicable to the frequency of the
transmitter.
Recommended separation distance
d= 1,17"P
d= 2"P
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2,5 GHz
80% AM at 1kHz
10 V/m
d= 1,17 "P 80 MHz to 800 MHz
d= 2,33 "P 800MHz to 2,5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance
in meters (m).
Field strengths from !xed RF transmitters, as determined by
an electromagnetic site survey, a should be less than the
compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked
with the following symbol:
D. NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
E. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and re#ection
from structures, objects and people.
a. Field strengths from !xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to !xed RF transmitters, an electromagnetic site survey should be
considered. If the measured !eld strength in the location in which the Embrace is used exceeds the applicable RF
compliance level above, the Embrace should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the Embrace.
b. Over the frequency range 150 kHz to 80 MHz, !eld strengths should be less than 3 V/m.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
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Recommended distance between portable and mobile RF communications equipment and the
device
The device is intended for use in an environment in which radiated RF disturbances are controlled.
The customer or the user of the device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the device as recommended below, according to the maximum output power of
the communications equipment.
Rated maximum
output power of
transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1,17 # P d = 1,17 # P d = 2,33 # P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.70 3.70 7.37
100 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Note:
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and re"ection from structures, objects and people.
The information contained in this document is confidential and is the property solely of Empatica, S.r.l.. Any reproduction in part or in whole
without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
17
Prescription for Embrace in the US
A prescription is required for the Prescription version of Embrace. You’ll need to ask your physician
to upload the prescription using our platform.
If instead, you’d like to participate in the clinical trial, you’ll be able start using Embrace as soon as
you receive it, a prescription would not be necessary.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
18
Get to know Embrace
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
19
Types of seizures Embrace detects
Embrace is optimized to detect seizures involving convulsive movements and a spike in autonomic
stress with a duration of at least 20 seconds . These characteristics are generally associated with
tonic-clonic seizures.
We can’t guarantee that Embrace will detect every single generalized tonic-clonic seizure. It is not
meant as substitute to your current seizure monitoring practices, but rather to serve as a
supplement in expediting !rst-response time.
At the moment we cannot detect the following types of seizures:
Complex Partial Seizures
Embrace is not designed to detect these types of seizures because they usually do not generate
convulsions.
Absence seizures
These seizures are not detected by Embrace as they do not generate signi!cant motion and
autonomic responses.
Nonconvulsive seizures
Currently, Embrace cannot detect nonconvulsive seizures as the speci!c movement signature of
convulsions takes precedence in our algorithm . EDA also takes part in our algorithm, but since it is
more prone to "uctuation, relying too heavily on it would result in more false alarms.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
20
Embrace's seizure detection system
Embrace’s seizure detection is based on an algorithm we’ve developed that is designed to recognize
unusual movements and electrodermal activity variation.
Most devices on the market usually consider two threads of information: how strong and how long
you’re moving. Instead Embrace takes into account additional variables, such as 3-axis acceleration
and electrodermal activity variations , that accompany tonic-clonic seizures. In addition, we created
our algorithm using advanced machine learning methods, trained on data collected in epilepsy
monitoring units in hospitals.
To learn more about Embrace’s seizure detection algorithm we recommend this article:
Seizure
detection accuracy
We encourage you to learn more about how the Embrace works.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
21
Compatible phones and tablets
The Alert app is compatible with most iOS and Android devices.
Apple iOS
Any iOS device that can run iOS 9.3.5 or higher as long as they support Bluetooth® Low Energy
(BLE/4.0/Bluetooth Smart®).
We support:
● iPhone 5s
● iPhone 6
● iPhone 6 Plus
● iPhone 7
● iPhone 7 Plus
● iPhone 8
● iPhone 8 Plus
● iPhone X
We do support the following devices, however, the apps won't be fully optimized for them:
● iPhone 4s
● iPod 5th generation
● iPad 3rd generation
● iPad 4th generation
● iPad Air
● iPad Air 2
● iPad Mini
To check the current version of the operating system on your phone, please follow these steps:
On your phone go to:
1. Settings
2. General
3. About
4. Version
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22
Android
Devices running Android version 5.0 (Lollipop) or higher , as long as they support Bluetooth Low
Energy (BLE / 4.0 / Bluetooth Smart). We do not guarantee full compatibility with edited versions of
Android or Android tablets.
To check the current version of the operating system on your phone, please follow these steps:
1. On your phone go to Settings
2. About Phone/Device
3. Software
4. Android Version
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23
Please note: not all devices that list Bluetooth 4.0 in the speci!cations, actually support Bluetooth Low
Energy. We suggest contacting the manufacturer directly for complete information.
We do not support Windows and Blackberry phones.
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24
How Embrace works
Embrace is designed to detect and alert for tonic-clonic (convulsive) seizures.
In order to use your Embrace you will need:
● A
compatible smartphone/tablet with active Bluetooth® Low Energy and Internet
connection.
●
Alert App : sends alerts to your caregivers when a seizure is detected.
●
Embrace subscription : gives you access to the alert system and allows you to choose
additional features.
Embrace collects physiological data using its sensors (an EDA sensor, a gyroscope, an accelerometer
and a peripheral temperature sensor). It transmits this data to the Alert App on the paired
smartphone through Bluetooth® . The paired smartphone must be the user's phone, and it needs to
remain within Bluetooth® range (30 feet/10 meters).
Using internet , the Alert App sends an SMS and call to the activated caregivers so they can help in
the case of a seizure. Remember: Both Bluetooth and Internet connection are necessary for the
Alert noti!cations to be sent when Embrace detects a tonic-clonic seizure.
What happens when there is a Bluetooth® disconnection?
Whenever Embrace disconnects from Bluetooth® , it won't be able to alert for seizures. It will
continue to record your seizures on its internal memory for about 16-18 hours.
As soon as the Bluetooth® connection is restored, the information will be automatically transferred
to the smartphone, freeing up Embrace’s memory. Data transfer might take up to 1 hour and a half.
What happens if the smartphone isn't connected to Internet?
Alert calls and SMS are sent via Internet, so without it alerts cannot be sent to your Caregivers.
Remember that airplane mode disables internet connection and Bluetooth®.
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25
Charging Embrace
Your Embrace comes with a USB cable and a charging dock . It takes around 2 hours to fully charge
the device. When the Embrace is fully charged, a green LED circle will light up. When charging your
Embrace, be sure to have someone around that can provide help in the event of a seizure.
CHARGE YOUR EMBRACE WATCH VIDEO
(
https://youtu.be/A0Hr8sOCVlY?list=PLgJGJZB1txiZM26ruTUIFP5edSZv10NqK )
Follow these steps to charge your Embrace watch:
● Step One: Connect the charging dock to a powered USB port on a computer, a USB
wall
socket
, or a USB Power adapter connected to a power source.
● Step Two: Make sure the heart symbol matches the heart on the charging dock. If you
cannot see the symbol, simply make sure the electrodes on the bottom of the device !t into
the dents.
● Step Three: An orange light gradually !lls the LED circle on the Embrace indicating that it is
charging. This light will become green when it’s fully charged.
If your Embrace battery was drained, a white circle will illuminate a couple of seconds after
connecting the device to the charger, this indicates a reboot.
Additional tips:
When using a computer, make sure that it is connected to its external power supply, otherwise the
Embrace won’t charge or it may take longer to get a full charge.
For more info check:
It takes longer than two hours to charge my Embrace watch
My Embrace watch isn’t charging
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26
Embrace battery life
When fully charged, the Embrace battery will last 30 hours.
For optimal performance, we suggest charging the device for 2 hours daily . We recommend charging
Embrace when there’s someone around, so that you’re covered for the time you’re not wearing it. For
more information please read:
How Do I Charge My Embrace Watch?
You can easily check the battery level of your Embrace on the status page of the Alert App. When
the Embrace battery is low, you’ll receive a noti!cation on the paired smartphone, and your Embrace
will start blinking an orange light.
The Embrace battery levels are listed below:
● Full (30–25 hours)
● High (25–18 hours)
● Medium (18–10 hours)
● Low (10 to 1 hour)
● Charge now (1 hour or less)
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27
Checking Embrace’s battery level
You can view the battery level in the Alert app. You’ll !nd battery information in the Status tab.
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28
You will receive a noti!cation on the paired smartphone when the Embrace battery is low. Embrace
will also display a blinking orange light when it’s time to charge your watch.
Embrace battery level bars correspond to the number of hours of battery life left:
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29
Advanced tip : activate the Alert app in the noti!cations bar so that you can easily check the battery
level without opening the app. For Android devices, activation is automatic, to activate Noti!cations
Center for iOS devices, follow
these steps .
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30
Tell the time with Embrace
You can check the hour by tapping once on the Embrace cover . The blue light indicates the hour,
and the "ashing white light indicates the minutes. Your Embrace will automatically sync with the
time on your phone as soon as it is paired.
If you cannot see the time on your Embrace watch when you tap on its surface, please check if the
Light & Vibration mode is deactivated.
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31
Embrace app
Embrace works with one FDA cleared app: the Alert App.
The Alert App noti!es Caregivers upon the detection of a tonic-clonic seizure . In the US, it is
available only with a prescription or as part of a clinical trial.
Activating a
subscription plan is necessary for seizure detection and sending alerts to Caregivers.
With the purchase of your Embrace watch, you’ll receive a 30 day free trial of the Plus plan.
For more information check out the
Alert App section.
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32
Embrace materials
We take great care in selecting the highest grade materials when designing our devices so that you
have the most secure and comfortable experience
● Band: Polyester 80% and Polyurethane 20%
● Buckle: Aluminium, nickel-free chrome plated
● Case: Polycarbonate (PC) base and anodized aluminium\
● The electrodes: surgical stainless steel SUS316L. The SUS316L steel alloy contains nickel but
it has been carefully tested to ensure that it is compliant with safety regulations for watches
and jewellery.
These materials are not likely to cause any allergic reactions, if you would like further information
please see:
Allergic reactions to Embrace
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33
Embrace water resistance
Embrace can withstand swimming pools, sweat, rain, showers and snowball-!ghts. It has the IP67
certi!cation which means that it can be submerged in 1m (about 3.3 feet) of water for up to 30
minutes .
Limitations
Embrace shouldn’t be used in saltwater such as the ocean or saltwater swimming pools. In addition,
It shouldn’t be submerged in a hot tub or worn while deep sea diving.
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34
Embrace and animal s
Despite our immense love for animals, Embrace and its seizure detection system was designed to be
safe and comfortable for long-term wear by adults and children only. It has not been optimized to !t
animals at this time.
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35
Protecting your privacy
We take personal data security very seriously. As of May 25, 2018, we are in full compliance with the
General Data Protection Regulation (GDPR) and have extended its security bene!ts to all of our
customers worldwide.
How we use your data
We’ll use your personal data for the sole purpose of providing our services, and to contact you about
updates that could compromise the service if no action is taken.
You have the right to choose if you’d like to receive other updates, such as the blog, special offers,
and our latest research advancements.
We have recently updated our Privacy Policy so you can easily understand exactly what personal
information we collect and how it will be used.
How you can manage your data
You can always review and update your information and how we use it at any time. If you’d like to be
removed from our database, you can request a permanent removal of your account and personal
information. You can also ask us to export and send you your personal information.
Additional protection for minors
We !rmly believe that anyone underage minors should be specially protected from the collection of
personal data. We’ve implemented an additional security measure for them which maintains that
parental consent is provided for any Embrace user under the age of 16.
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36
Phone Support
We are available to answer your queries between 9:00 AM – 1:00 PM EST (Eastern Standard Time),
Monday - Friday at (866) 739-2049 or chat with us via our
website
If you want to reach us outside of these hours, please contact us by submitting a request or sending
us an email at support@empatica.com and we we'll respond promptly.
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37
Empatica Account
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38
Creating your Empatica Account
Your Empatica Account allows you to view information related to your Embrace order, shipment,
and subscription. It also allows you to view and download your monthly seizure reports.
Step 1: Creating an Empatica Account is easy.
Here are the simple steps to create your Empatica account:
If you’ve placed an order:
1. You should have received an email with the link to create your account. If you haven’t
received this email, follow the steps in the next section.
2. Click on the link in that email to get started.
If you haven’t placed an order:
1. Go to
this page .
2. Enter the email address you used to place your order in the email !eld and !ll in all the
necessary !elds.
3. Click on “Create My Account ”.
Step 2. Review the Privacy Policy
The privacy policy describes the collection of your personal information and how it’s used. Your
consent is required in order to use our services.
We’ll only send you emails you’ve given us permission to send you, unless it’s an important update
that affects your service.
You can always review and modify these settings directly in your
Empatica Account.
Step 3. Verify your email address
Once you !ll in the form, you’ll receive an email with an account veri!cation link. Please look for
the email in your Inbox, and click on “Verify my Email Address” button. If it does not work, click the
link below the button or copy and paste it into the address bar of your web browser.
Please note, if you are unable to !nd the email in the primary folder of your inbox, it is most likely
that the email may have reached the Spam/Junk folders.
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39
Step 4. De!ne your preferences
After verifying your email address, please proceed with the next step, which is de!ning your
preferences for the Embrace watch.
Step 5. Sign up for Clinical Trial
For users in the US, joining the clinical trial is an essential step to receive seizure detection and
alert delivery service.
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40
Editing your shipping address
You can easily change your address in your Empatica Account. Once your order has entered the
“Preparation” phase, it’s almost ready to ship, and unfortunately the address can not be changed.
To edit your address, follow these steps:
1. Sign in to your
Empatica Account .
2. Go to the Orders section .
3. Click on “Change my shipping info” .
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4. Make the necessary changes and click on “Update my shipping address”
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42
Resetting your Empatica password
Cannot access your account? Have you forgotten your password? Don’t to worry$ Please follow
these simple few steps to reset your password:
1. Go to the
Empatica Account login page .
2. Click on the “Forgot my password” button.
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3. Please enter the Email address as on your account and click on “Send me the reset link”
button.
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44
4. The next step is to !nd the password reset email in your inbox. Open it and click on “Choose a
New Password” The next step is to check your Inbox for the password reset email that was sent to
your email address and click on “Choose a new password”.
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45
5. You will be redirected taken to another page wherein you can could input your new
password.
6. Once you’ve set up a new password, you will receive an email con!rming it con!rmation for
the same.
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46
Updating your pro!le in the Empatica Account
You can change your personal information directly in your Empatica Account.
To modify your pro!le, follow these steps:
1. Log in to your Empatica Account.
2. Click on the “Account” tab in the top right corner.
3. Go to the “Update Pro!le” section.
4. Change the information that you’d like to modify.
5. Once, you’ve made the desired changes, click on “Update my pro!le”.
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47
Parental Consent for minors under 16
All users of the Embrace watch who are under the age of 16 need to provide Empatica with their
parent’s veri!able consent, as the U.S. Children’s Online Privacy Protection Act (
COPPA ) requires us
to obtain it before we collect, use or disclose their personal information. Obtaining your parental
consent allows us to protect the privacy of your child.
Parental Consent during account creation
When you insert a birthdate of a user under the age of 16, you will see a special form where to enter
the parents’ personal information.
Make sure the email address entered in the Parental Consent email !eld is different from the one
associated with your Empatica Account . Once you have entered all the necessary information, click
the Create Account button. An email will be sent to the parent’s email address with the link to
consent to the collection of personal information from their child.
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48
Changing my communication preferences
You can review and update your communication preferences directly from your Empatica Account
by clicking on
Communication Settings.
You can choose to start or stop receiving updates from Empatica about:
● Blog
● Special offers and discounts
● Product and research advancements
Please note that we will still inform you via email about updates to our service and how it’s running.
It isn’t possible to opt-out from System noti!cations as we cannot securely deliver our services
without them.
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49
Exporting my data
You can request a full account of your personal data to verify its accuracy. You can submit a request
to export your data through your Empatica Account, by clicking
here.
What will be included in the !le?
● Your seizure history
● Your personal information
It may take up to 30 days to receive the exported data in your inbox.
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50
Deleting my Empatica Account
Before you decide to delete your account, please note that it is permanent and cannot be undone . It
will also result in a full cancellation of our services to you.
What will be deleted?
● Personal Data (Full Name, Email address(es), Phone number, Date of birth)
● Caregiver(s) Data (Caregiver phone number, Caregiver email address)
● Parent email address (if any)
What will remain?
● Purchase information (orders, shipping address, invoices)
The following information will remain but will be de-identi!ed:
● Usage logs and data
● Physical details (height, weight, year of birth)
● Embrace processed data
How to delete your account
1. Log in to your Empatica Account
2. Go to Account tab and open Privacy Tools section, then click “Edit Privacy Settings”
3. Click on “ Delete My Account ”
4. Scroll down and click “ Delete My Account ”
5. Send us the “Delete Account” email. A brief explanation for the request would be
appreciated.
Please note, it may take up to 30 days to fully delete all of your information. We’ll notify you as soon
as the process has been completed.
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51
GDPR FAQs for Embrace
What is GDPR?
It stands for the General Data Protection Regulation, legislation passed by the EU and effective from
the 25th of May 2018. It's intended to give EU citizens more transparency and control in the use of
their personal data , and holds organizations accountable for how they collect, store, and process
that data .
How does GDPR apply to me?
We've implemented new security measures across the board, so regardless of whether you reside in
the EU, you'll bene!t from the new practices put into place. For any blog or newsletter subscribers,
we've made it super easy to select which topics you'd like to be noti!ed about . As an Embrace user,
you'll be able to request that we permanently delete your personal data or export it to you . You
can access your privacy tools and manage your communication preferences directly in your
Empatica
Account.
What personal information does Empatica collect?
We collect the minimum amount of data needed in order to provide our services. For example, in
order to deliver the Embrace and provide its service we ask for name, date of birth, and contact
details. The delivery of alerts requires that we collect the name and phone number of each Caregiver.
Detecting seizures requires that we process physiological data, such as acceleration, rotation,
temperature, and EDA. We also collect some technical information such as IP address, dates and
times of access to the app.
How does Empatica use my information?
Your personal information is used solely for completing a transaction (e.g., purchasing Embrace or a
subscription plan), delivering and improving our services (e.g., seizure detection, alert delivery), and
communicating with you (e.g., emails or noti!cations about important product updates pertinent to
its functionality).
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
52
How can I review and modify my privacy settings?
You can quickly and easily do this directly through your Empatica Account.
How can I ask to have my information deleted?
It's a simple request made through your Empatica Account. Please note this step is permanent, and
we would no longer be able to provide you with our services.
What personal data are available for your download upon request?
The following data are available for download: seizure history (including detected seizures as well as
those added manually), name, date of birth , your contact details , and the name and contact details
of your Caregivers . You can submit a request to export your data through your Empatica Account.
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53
Seizure Report
Keeping track of when seizures occur and what happened around that time helps you recognize
possible triggers. In your
Empatica account , you can view a monthly report of the detected seizures.
How to add a new seizure
In the report, you can not only see the seizures registered by Embrace but also add the ones that
were not detected. You can insert the missed seizures manually by tapping the lightning bolt icon at
the right bottom corner of your monthly graph (see also the article
Can Embrace work with any type
of seizure?
)
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54
You can add the date, exact time, duration of the seizure as well as any additional info. This will
provide a complete overview of your events in a clear and organized manner.
Insert notes and duration of seizures
To obtain a bigger picture of the history of your events, you can insert the exact duration of the
seizures as well any additional info that might be helpful for yourself or your physician. As time
passes you might forget what happened or how you felt before the seizure occurred. The Seizure
Report might serve as a helpful diary so you’ll never miss any signi!cant info.
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55
Mark a detected seizure as false alarm
If you notice any incorrectly displayed seizures you can mark them as false. They will not appear in
your Seizure Report; however, they will still be available on your Alert App.
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56
Print the report
You can share this report with others, i.e. your physician or family members. The reports provide a
neat summary of your events which you can print out, save as PDF or send via email. To do so, just
click the print button, this will open a print friendly page which can be printed or saved as PDF.
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57
This is an example of your report:
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58
Research and Medical
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59
Studies behind the Embrace
In 2007, the research team at MIT Media Lab lead by Prof. Rosalind Picard – Empatica’s Chief
Scientist – developed a wearable that measured autonomic activity. While trying to help people with
autism be better understood, Picard’s team found an unusually high response from one participant. It
turned out to be a seizure.
This led to new investigations with Boston Children’s Hospital . With data from over 90 patients , the
team learned they had built a more accurate method for seizure detection.
Their research was published in top peer-reviewed medical and engineering journals, such as
Epilepsia , patents were issued, and a version of their sensor was then used in hundreds of top labs,
universities, and hospitals.
In one of the published studies (
Poh et al. 2012b ), the vast majority of complex partial seizures in a
group of children caused a signi!cantly large autonomic response. This work has been replicated in
adults (
Thome-Souza et al. 2014 ) as well, however, their autonomic responses tended to be milder.
The published results cited above were from predicate devices. To view recent !ndings using
Embrace please see:
How Accurate is Embrace’s seizure detection algorithm
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
60
Consulting your physician about Embrace
We highly encourage that you consult your physician to determine if Embrace is right for your
needs. The below articles will make it easier to cover everything you may want to discuss with your
physician, including Embrace’s detection capabilities, algorithm, and the research behind it.
● Types of seizures Embrace detects Use this article with to determine with your physician if
Embrace is right for your seizure type.
● Get to know Embrace's seizure detection system Use this article to learn more about our
advanced machine learning algorithm used to detect tonic clonic seizures.
● Seizure Detection Accuracy Use this article to learn about the accuracy we've achieved so
far with Embrace.
● Scienti!c literature behind the Embrace Use this article to learn about the scholarly journals
that have published our !ndings.
● Studies behind Embrace Use this article to learn about the research behind Embrace.
● Understanding Electrodermal activity (EDA)? Use this article to learn more about EDA and
how we use it.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
61
Embrace and seizure prediction
Embrace cannot predict or prevent seizures . Our technology is designed to detect convulsive
seizures lasting longer than 20 seconds, to learn more, check out the
types of seizures Embrace can
detect.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
62
Using Embrace with a Vagus Nerve Stimulator
From our knowledge there shouldn't be any problems using an Embrace alongside a VNS , as
Embrace does not contain any magnetic parts. Actually, the VNS would be great to use alongside
Embrace, because it activates the parasympathetic branch of the autonomic nervous system. What
we measure with the Embrace arises from the sympathetic branch of the autonomic nervous system.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
63
Scienti!c literature behind Embrace
The research behind Embrace is based on scienti!c work published in two top medical journals , as
well as on additional studies that have replicated that work. The ways in which our sensors can help
revolutionize health are profound, and our goal is that people get the personalized advances in
treatments that can help them most. For this reason, we are involved in a variety of clinical trials that
use our sensors and analytics.
The !rst two peer-reviewed journal articles that published our !ndings were based on trials run at
Boston Children’s Hospital (*1 pediatric hospital in the USA) and Brigham and Women’s hospital in
Boston:
● Poh, M.Z., Loddenkemper, T., Reinsberger, C., Swenson, N.C., Goyal, S., Sabtala, M.C., Madsen,
J.R., and Picard, R.W., >Convulsive Seizure Detection Using a Wrist-worn Electrodermal
Activity and Accelerometry Biosensor>, Epilepsia, Mar 20, 2012.
Abstract
● Poh, M.Z., Loddenkemper, T., Reinsberger, C., Swenson, N.C., Goyal, S., Madsen, J.R., Picard,
R.W., >Autonomic Changes with Seizures Correlate with Postictal EEG Suppression>,
Neurology, Apr 25, 2012.
Abstract
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64
Wearing Embrace during an MRI or X-Ray scan
We strongly advise you not to wear Embrace during either an MRI or x-ray scan.
During an x-ray, the physician will usually ask you to remove all metal objects as it blocks visibility of
underlying structures. In the case of an MRI, it’s especially important to remove all metal objects as
they may be attracted by the the MRI’s magnets.
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65
Seizure detection accuracy
We are constantly validating and improving our algorithm; to test its accuracy we collaborate with
top hospitals.
162 patients provided overall 434.7 days (10,434.0 hours), with a median of 64 hours of data per
patient (min-max range = 3 - 386.8 hours) of ACM and EDA measurements.
The full details of this work are included in the table below:
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66
Clinical Testing
Clinical testing was performed to demonstrate the ability of the Embrace to function as an
assessment aid for monitoring for seizure related activity in the intended population and for the
intended use setting.
Patients:
162 patients diagnosed with epilepsy were admitted to the Epilepsy Monitoring Unit (EMU)
for standard care were enrolled in the studies: 94 children (49 males), ages 3 months -17
years, median: 11 years; 68 adults (29 males), ages: 18-63 years, median: 37 years.
Observed GTCS:
33 EMU patients experienced a total of 57 generalized tonic clonic seizures (GTCSs) while
129 EMU patients didn’t experience any seizure. The 57 recorded GTCSs included 13
primarily generalized tonic-clonic seizures and 44 secondarily generalized tonic-clonic
seizures. Every recorded seizure was classi!ed as epileptic. Seizures other than GTCSs were
discarded from the analysis.
Recorded data:
162 patients provided overall 434.7 days (10,434.0 hours), with a median of 64 hours of data
per patient (min-max range = 3 - 386.8 hours) of ACM and EDA measurements.
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67
Performance:
Positive percent agreement (PPA) was found to be 0.9649 (corrected PPA=0.9202), with a
95% con!dence interval of [0.8671; 0.9549], relative to a panel of three readers, and false
alarm rate (FAR) was found to be 0.8025 false alarms per 24 hours with a 95% con!dence
interval of [0.614, 1.031], corresponding to a mean FAR (average of FARs across patients) of
1.1331.
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68
Understanding the importance of electrodermal activity
Electrodermal activity is generated by the sweat glands on a microscopic level, and tends to increase
with emotional and physical stimuli.
Increases in EDA have been shown to occur with most generalized tonic-clonic seizures, therefore
making EDA plus motion a more reliable system for detecting seizures.
What affects EDA?
Several components can result in an elevated EDA, such as sports, excitement, and stress . In
addition, your own individual biochemical levels also play a role. EDA can also "uctuate based on
daily water intake and with certain medications . The measurements of electrodermal activity can be
affected by skin hydration and where the sensors are placed. For a more in-depth explanation of
EDA, you can check out our
website .
How does Embrace measure EDA?
Nerves transmit signals from the brain to the body. Some of the signals activate patches of sweat
glands, changing the conductance across the surface of the skin. Embrace measures subtle electrical
changes across the surface of the skin.
What role does EDA play in Empatica’s seizure detection algorithm?
EDA is part of our algorithm but does not take precedence over other factors , given its
susceptibility to variation. We’re analyzing characteristic EDA signatures during seizures so we can
decrease the number of
false alarms and re!ne Embrace’s algorithm.
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69
Allergic reactions to Embrace
Embrace is made of the highest quality of hypoallergenic materials (ISO 10993 compliant),
therefore it's very unlikely that you'll develop an allergic reaction from it. Contact our support team
(support@empatica.com) with a photo of the irritation if it doesn't go away in a few days.
Important Notes
Embrace should only be worn on the surface of healthy skin. We advise that you suspend or
discontinue use if the skin becomes red, itchy or if any pain is felt.
Without regular cleaning , skin irritation is more likely to occur, so please make sure to clean Embrace
regularly.
Materials Used
If you are allergic to the following materials , we don't recommend wearing Embrace:
● Top Cover:
○ Anodized aluminum
○ Polycarbonate (PC) light pipe
● Bottom cover:
○ Polycarbonate (PC) base
○ SUS316L electrodes (contains some nickel, but has been tested to ensure it is below
the safe limit for watches and jewelry)
○ XM7 screws
● Band Frame
○ Aluminum, nickel-free chrome plated
● Stretchable Band
○ Polyester: 80%
○ Polyurethane: 20%
○ Aluminium, nickel-free chrome plated buckle
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70
Placing an Order
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71
Package lost in transit
If you feel your package may have been lost in transit, please follow the instructions below:
● Verify the tracking number and delivery address.
● Double-check that your package has not been left at the front desk of your apartment
building, of!ce, or with a neighbor.
● Contact the courier and provide them with the tracking number so that they can look into it
further to try and locate the package.
If you’re still unable to locate it, reach out to
support@empatica.com and provide us with the
tracking number, so that we can look further into it.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
72
My Embrace is listed as “delivered”, but I can’t !nd it
If your tracking number states that the package has been delivered, but you can’t !nd it, please
follow the instructions below:
● Verify the shipping address in your Empatica Account.
● Look for a notice of an attempted delivery (which may be stuck to a door or mailbox).
● Carefully inspect the location around which your package was supposed to be delivered.
Sometimes packages are delivered in a discrete location such as under a doormat.
● Contact the courier listed in the shipment con!rmation email to track the package.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
73
How to order Embrace
You can order your Embrace directly on our Online Store .
You can select one of the following colors: Flamingo Pink, Sky Blue, Seoul Grey, Milan Black and
Boston Blue.
We ship every Thursday and the delivery may take three to !ve business days.
Follow these steps to order your Embrace:
1. Go to our
Online Store .
2. Choose the color you’d like, and any additional bands to personalize your look.
3. Insert your shipping details.
4. Proceed with payment.
5. Wait for Embrace to arrive within 10 business days.
Embrace hardware is cleared by FDA. When Embrace arrives you’ll be able to choose the FDA
Cleared version of the Alert App or the investigational version of the Alert App.
FDA Cleared version of the Alert App
After receiving your Embrace, you’ll need to provide us with a medical prescription so that you can
start using the FDA Cleared Alert App.
Investigational version of the Alert App
Empatica is continuously developing improvements to Embrace’s algorithm that are available under
clinical trials. You can optionally provide your consent to participate in the clinical trial in order to
use the investigational version.
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74
Shipping Embrace to your country
We ship Embrace under the incoterms DDU (delivery duties unpaid). Orders shipped outside of the
US and EU may be subject to import taxes, custom duties or fees. The person who will be receiving
the Embrace is responsible for covering these charges, we cannot predict or estimate the cost of
these fees.
Customers in the US can choose between the Prescription version of Embrace, or opting into our
clinical trial with the investigational device which uses the latest non-FDA Cleared software we’ve
developed.
Embrace cannot be shipped to the following countries because the Alert system is not available
there : North Korea (DPRK), Colombia, Indonesia, Malta, Macao, Ukraine, Ecuador, Peru, Cyprus,
Kuwait, Honduras, Guatemala, Mozambique and Iran.
S ome countries may prohibit access to the Play Store/App Store, so we recommend verifying that
you are able to download the apps.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
75
Cancelling your Embrace order
You may cancel your purchase only if the status is “Not Scheduled.” To check the status of your
order, go to the “Orders” section of your Empatica Account. If the status is “Not Scheduled” please !ll
in our
contact form or email support@empatica.com and we will proceed with the cancellation and
refund.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
76
I nsurance reimbursement for Embrace
Getting Embrace reimbursed by insurance depends on the patient’s speci!c plan and coverage
level.
Patients may ask you to !ll out this form to improve their chances of reimbursement:
● Embrace Pre-Determination-template-withFDAapproval.docx
We recommend the below articles if you’d like more information about Embrace:
● FDA Approval Summary
● Epilepsia 2017 journal results
●
PAME 2018 Poster
These materials can improve your chances of reimbursement; however please keep in mind that
this material may not guarantee reimbursement.
We suggest to contact your insurance agent directly for any questions regarding insurance coverage
of the subscription plan.
If you submit a request to get your Embrace or the subscription plan costs reimbursed, please let us
know about the outcome so that with this knowledge we can help the Embrace community.
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77
Embrace Return Policy
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78
Embrace warranty
If your Embrace stops working or does not function effectively within a year of regular use (within 2
years for EU residents), please email us at
support@empatica.com to resolve your issue. Make sure
to include a detailed description of the problem as well as the pictures whenever possible.
Empatica is not responsible for general wear and tear of product usage such as cosmetic damage (for
example scratches, discoloration or damage of the band during use).
● Lifespan of Embrace battery - 500 cycles
● If your Embrace watch needs servicing and it’s out of the warranty period, you will be
charged for the shipping and repair costs.
● Loss of the device isn’t covered by warranty
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79
Returning Embrace for a refund
If you wish to return your Embrace, please contact us and we’ll help you with the process.
1. Request a Return Merchandise Authorization (RMA)
Your Embrace(s) return requires an authorization from the Empatica Team.
Timing: Your RMA request will be processed within 5 business days.
You can send us an email to support@empatica.com including your current shipping address to
request for an RMA. For faster processing time, use the same email address associated with your
order.
Once your request is processed, you’ll receive an RMA document (PDF) summarizing the details of
your case. Please read it carefully and verify if your information is correct.
2. Ship your Embrace back to Empatica
In some cases Empatica will provide a pre-paid shipping label to facilitate the return delivery. If you
are returning your device for a refund, the charge for both shipping and return shipping will be
deducted from the total amount of your refund. If you are returning your device for services covered
under warranty, you will not have to bear any shipping costs.
Timing: Ship the device back within 5 business days of receiving the RMA document.
● Place the device in its original box and include all the accessories.
● Print, sign and include a copy of the RMA document in the package.
● Pack the Embrace box securely in a padded shipping envelope. (Note: Please do not use the
same envelope that the Embrace arrived in. Multiple shipping labels may cause transit or delivery
issues. You can use another padded envelope instead.)
● Attach the shipping label (if provided) included in the RMA document to the package
● Drop the package off at the nearest post of!ce or the nearest collection box, or arrange a
pickup with the courier.
N.B. Empatica does not assume any risk of loss or damage to the device(s) while in transit for return.
N.B. Empatica will not be responsible for any customs/VAT/duty charges upon return of devices.
3. Inspection of Returned Embrace
In case of a return for refund, before issuing the refund we need to be sure your Embrace is
functioning well and is not damaged (this includes also the band and the charger). In case of return
for service, this step will identify the cause of the issues that you are experiencing and will help
decide if we can repair your Embrace or if a replacement is required.
Timing: Once your Embrace(s) arrives at Empatica, our team will inspect the device within 10
business days of receipt.
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80
Some examples of failed inspections
● The Embrace has clear signs of physical damage
● Part(s) of the Embrace is missing
● The device was opened/ attempted to be opened
● Damaged Band/Charger/USB cable
4.a Receiving your refund
If your Embrace passes our inspection, we’ll proceed with a refund and send you an email you as and
when the refund is issued. The refund will not include original shipping fees. If you were provided
with a pre-paid shipping label, this amount will also be deducted from the total value of your refund.
Timing: The time frame for the issual of the refund is 10-14 business days.
Please note: Empatica reserves the right to change these policies or procedures at any time without
notice.
4.b Receiving your refurbished/replacement Embrace
Depending on the nature and complexity of the given issue, we will either ship back a refurbished
Embrace or send you a replacement.
Timing: Your returned Embrace will be inspected within 10 business days of receipt. We will then
ship back your device (or a replacement) within 10 days after inspection.
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81
Returning your Embrace for service
If your Embrace doesn’t work properly, you have 1 year from the delivery date to request
servicing.
Embrace very rarely requires servicing. Most often, the Embrace problem is software related and can
be solved remotely without the need for a the return.
To learn more about what’s covered, please read the
Embrace warranty .
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82
Embrace Subscriptions
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83
Updating your billing details
You can update your billing details by going to the '
Subscriptions ' section on your
Empatica Account.
To update, please follow the steps below:
- On the Subscriptions page, tap on 'Update Billing Details'
- Enter your new billing details and click 'Payment Info'
- On the next page, enter your card information and click 'Update my Billing Details'.
Your new billing information would be saved and your next payment would be deducted
from the new card information you have entered.
If you encounter any trouble updating your payment information, please write to us at
support@empatica.com
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84
What to do if you’ve subscribed to plan with a different Empatica Account.
The Embrace Subscription plan should be purchased using the account that you have used to pair the
watch. In the event that you have purchased the plan using another account, please follow these
steps:
● Launch the Alert App on the phone currently paired with the Embrace
● In the app, go to More QQ Settings QQ “Remove Embrace”
● In the smartphone open SettingsQQBluetooth®QQEmbraceQQForget device/Unpair
● Launch the Alert App again
● Log in using the email address and password of the account used to purchase the plan
● Follow the in-app instructions for pairing
Once you have paired the Embrace with the account you used to subscribe, the subscription plan
would re"ect in the app and would be automatically activated.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
85
What to do if you see a warning when subscribing to a plan
When making subscriptions purchases from the Alert app for iOS devices, you might see a >warning>
message (see the image below). Don’t worry though. Please just refresh the page - this should resolve
the issue. If the problem persists, please email us at support@empatica.com.
Once you purchase your subscription, open up the Alert app to explore your new plan.
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86
Available subscription plans
Empatica offers Lite, Standard and Plus subscription plans for the Embrace watch. Each plan is
comprised of different feature combinations that enables you to use Embrace at different capacities,
depending on your needs and !nancial resources.
See below table to explore what each subscription plan entails:
LITE STANDARD PLUS
$ 0.33/day
$9.90/month
$0.65/day
$19.90/month
$1.49/day
$44.90/month
Seizure detection and Alerts
Automatically alert your loved ones upon the
detection of a convulsive seizure.
Seizure History
View, print, and share your seizures.
Activated Caregivers
Number of people that will receive alerts when
a seizure is detected
1 3
Unlimited
Free trial
With the purchase of your Embrace, you get free access to 30 days of the Plus subscription plan,
which is the most comprehensive plan that we offer. Once the 30-day free trial period has expired,
you will be prompted to purchase the subscription plan that best suits your needs. If you select a
subscription plan and enter your billing details before the end of the 30-day free trial, you’ll get an
additional 30 days free of cost.
Please note that failure to subscribe for a plan will disable the sending of alerts to Caregivers once
the 30-day free trial period of the Plus plan expires.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
87
Purchasing a subscription plan
You can purchase a subscription plan directly from your Empatica Account. Please follow the steps
below:
1. Go to
myembrace.empatica.com/plans and sign in with your Empatica Account credentials
2. Select the subscription plan of your choice then click “Proceed with XXXX”
3. Con!rm the details of the plan you are purchasing and click “Pay Now XXX”
4. Enter your name and address and proceed to “Payment Info”
5. Fill in the required !elds with your billing details and click “Update Subscription”
That’s all it takes. You’ll be able to review your plan in your
Empatica Account .
You can cancel the subscription at any time, however we cannot refund subscription fees. For more
details please check:
●
How can I cancel my Embrace subscription plan?
● Can I get a refund for my subscription?
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88
Using the Embrace without a subscription
The Alert System will be disabled; therefore, your caregivers will no longer receive noti!cations
upon detection of a seizure.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
89
Changing your subscription plan
You can change (upgrade or downgrade) your subscription plan at any time.
● Open your Empatica Account and click ‘’View My Subscription Details’. You’ll be redirected to
your subscription page
● Click on “Update My Subscription” in the “Active Subscriptions” section
● Select a new plan and proceed with payment by clicking “Checkout”
● Review your subscription and click “Update Subscription”
The new plan will become active immediately after the upgrade/downgrade.
Upgrading your subscription plan
If you decide to upgrade your subscription plan, the difference between the prices will be used
towards the purchase of your new plan. This means that you’ll pay a prorated amount based on the
time left until your next billing cycle.
For example, if you’re using the Lite subscription plan (USD 9.90 a month) and you’d like to upgrade
to Plus (USD 44.90 a month) one week into the billing cycle, you’d pay USD 29.07. You’ll start paying
the full amount for the Plus plan from the second month.
Downgrading your subscription plan
If you’re downgrading an existing plan halfway through the billing cycle, the credit from the unused
portion of the previous plan will be deducted from the !rst-month fee of the new plan. This means
that you’ll pay a prorated amount based on the time left until your next billing cycle.
For example, if you’re using the Plus subscription plan (USD 44.90) and you downgrade to the
Standard plan (USD 19.90) a week into the billing cycle, you will have USD 20.76 left from your Plus
plan, so you won’t be charged when you make the switch from the Plus plan to the Standard plan.
At the beginning of the next billing cycle, you’ll be charged USD 17.35 to account for the USD 2.55
left from your Plus subscription. You’ll start paying the full amount for the Standard plan from the
following month.
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90
What happens once I’ve downgraded my subscription plan?
After downgrading your plan, the features covered by the previous subscription plan will no longer
be available. For example, if you downgrade from the Standard to the Lite Plan, the number of
activated Caregivers will decrease from 3 to 1 and you will not have access to the Standard features.
Changing from monthly to annual subscription plan
If you’d like to switch from a monthly to annual plan, please email us at support@empatica.com . If you
subscribe to the annual plan you will receive 12 months of service for the cost of 10 months.
If you are halfway through your monthly plan and decide to switch to an annual plan, the unused
portion of your monthly plan will be deducted from the price of the annual plan. You will be billed at
the time of the switch and the annual billing cycle will begin that day.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
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Adding or removing an add-on feature
Adding an add-on:
You can add an add-on to your subscription plan directly from your Empatica Account:
● Open your Empatica Account and click ‘’View My Subscription Details’. You’ll be redirected to
your subscription page.
● Click on “Update My Subscription” in the “Active Subscriptions” section.
● Click on “Add-ons” tab at the top of the screen.
● Select the add-on of your choice and click “Add”, then click “Checkout” and proceed by
clicking “Update Subscription”.
Removing an add-on:
You can remove an add-on at any time. To remove an add-on from your subscription plan:
● Open your Empatica Account and click ‘’View My Subscription Details’. You’ll be redirected to
your subscription page.
● Click on “Update My Subscription” in the “Active Subscriptions” section.
● Click on “Add-ons” tab at the top of the screen.
● Click on the “Purchased” tab in the box of the add-on you’d like to remove and click
“Checkout” and proceed by clicking “Update Subscription”.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
92
Cancelling your subscription plan
When you subscribe to a plan, it is automatically renewed every month/year. If you decide to
discontinue using Embrace subscriptions, you can cancel it - this means your subscription plan will
not be automatically renewed the following month.
If you want to disable auto-renewal in order to cancel your subscription, you can do so by contacting
us directly from your Empatica Account.
1. Open
Your Subscriptions page in your Empatica Account
2. Click “Learn more about auto-renewal”
3. Click “Contact our customer support”
4. An email window will pop up. Fill out the form and we’ll get back to you within 2 business
days.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
93
Empatica Subscriptions Receipts
This article has all the related information that will help you understand the receipts generated for
your chosen subscription plan and add-ons.
Once the free trial period ends, with every renewal of the subscription plan, a receipt for the
equivalent amount will be generated automatically for the amount of the purchased plan. Your
subscription plan will be renewed monthly or yearly, based on the option you choose. Each renewal
and change in plan (upgrade/downgrade) is associated with a receipt.
To locate your receipts:
1. Go to your
Empatica Account and click on “View My Subscription Details”.
2. You will be redirected to your
Subscriptions Page , which lists out all the information related
to your billing details, existing plans and receipts.
3. Under the ‘Receipts’ tab, click on a date to view or print the receipt of that particular
purchase of subscription plan.
Understanding your Receipts:
Payment Status:
1. PAID: If the transaction is successful, then your receipt will show the payment status as
‘Paid’.
2. NOT-PAID: If the transaction does not go through due to some issues, then the payment
status is termed as ‘Not Paid’. Some possible reasons for a payment decline could be:
● Incorrect card details
● Insuf!cient funds/credit
● Expired/blocked Card
In such cases, to ensure uninterrupted service, you could change the credit card with another one. If
you add another credit card, a charge will be attempted in the next 24 hours of the change. For more
information on the failed transaction, we recommend contacting your bank.
Some other examples of Subscription Receipts:
● Upgrade/Downgrade Subscription Plan: The following image shows you the format of
receipt when you upgrade/downgrade from one plan to another. In this particular example,
the subscription plan has been upgraded from Standard plan to Plus plan. The receipt
generated is for the amount that is to be paid after the change in plan.
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
94
● Excess credit: When you change from one plan to another, if there is an excess amount after
implementing the new plan, this is converted into credit which will automatically be applied
to the next receipt generated.
● Receipt with a Debt: If you choose to switch your subscription plan from one to another and
the new plan exceeds the available credit by a few cents/pennies, this amount will re"ect as a
debt on the current receipt. When a new receipt is generated, this de!cit will be debited
along with the charge for the chosen plan.
We refrained from enabling the possibility to cancel the subscription plan without contacting us to avoid the
situation when the user cancels the subscription accidentally, causing the interruption of the service.
Subscription Plans are not refundable, therefore please email us at least 2 business days before the
start of the next billing cycle so that you won’t be billed for the following month/year.
When a plan is canceled, the Alert System will be disabled when your subscription expires;
therefore, your caregivers will no longer receive noti!cations upon detection of a seizure.
You can easily renew a plan or subscribe to another plan from your Empatica Account.
What Happens If I Don’t Subscribe to any Plan?
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
95
Subscription payment rejected
If there is a problem with the payment of your subscription plan, we will notify you via email.
In case of a failed payment your subscription service will not be interrupted immediately. We will
make 3 attempts to bill your card. At each attempt we’ll send you an email noti!cation:
● The !rst attempt will occur one day after the failed attempt.
● The second attempt will be made 3 days later, and our last attempt will be made 3 days after
that.
● This amounts to a total of a 7 day grace period to update your billing details - this means your
subscription will not be cancelled for these 7 days while we’re attempting to bill your card.
There a few reasons why your regular subscription payment might have failed. Most common
reasons are:
● Expired or cancelled Credit Card - if this is the case, please contact your Credit Card issuer
to request a new card and update your billing details in your Empatica Account to ensure
uninterrupted service.
● Insuf!cient funds on your Credit Card - please restore the funds on your Card before our last
attempt to take the payment
If the payment doesn’t go through after 3 attempts, the service plan will be interrupted (alerts will
not be sent to Caregivers) until we have received payment.
You can update your billing information directly from your
Empatica Account :
1. Go to “ Your Subscription ” page and click “Update my billing details”
2. Enter your address and payment info and con!rm by clicking “Update my billing details”
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
96
Refunds and subscriptions
It is not possible to get a refund for subscriptions. If an existing plan is canceled halfway through the
billing period, you will be able to use up the subscription for the remaining month/year and the
subscription won’t be renewed after that. For more info about cancellation please refer to this
article:
How can I cancel my Embrace subscription plan?
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
97
Getting started with Embrace
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without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
98
What Embrace comes with
In the Embrace box you’ll !nd:
● Charging Dock
● Micro-USB cable
● Embrace watch
●
LED and ^uick start guide
The Embrace is packaged with utmost care. To see how to unbox your Embrace, check out this video:
https://www.youtube.com/watch?v=y_Vb5LFjr3^&feature=youtu.be&list=PLgJGJZB1txiZM26ruT
UIFP5edSZv10NqK
The information contained in this document is confidential and is the property solely of Empatica, S.r.l.. Any reproduction in part or in whole
without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2017. All rights reserved
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