Table of Contents

Introduction – about RETENTION  4                                                                      

RETENTION mobile app. 4

Pre-specified subgroup analyses include. 4

Data points 4

Extra Measurements 5

Devices – Equipment 5

Alternative devices 5

When to use it for each device – Medical approach. 5

Data collected from smart sensors and devices on a daily basis will be: 5

Timeframe. 6

How to take each measurement correctly. 6

Heart rate. 6

Warnings. 7

Steps encounter 7

Warnings. 7

Sleep quality. 7

Warnings. 7

Oxygen saturation. 7

Warnings. 7

Blood pressure. 8

Warnings. 8

Body weight 9

Warnings. 9

Temperature. 9

Warnings. 9

Sign in & Setup the Devices 10

Smartwatch. 10

Watch pairing. 10

Watch sync 11

Charts. 12

Activity. 13

Oximeter 14

Oximeter Pairing. 14

Oximeter sync 14

Pressure gauge. 15

Pressure gauge pairing. 15

Pressure gauge sync. 15

Scale. 16

Scale Pairing. 16

Scale sync 16

Manual Insertion. 17

Thermometer 17

Temperature input screen. 17

VAD. 18

VAD input screen. 18

USER MANUAL

Introduction – about RETENTION

The primary goal of the RETENTION project is to develop an integrated platform that gathers and analyses health-related data flows, with further analysis of day-by-day Heart Failure study participants’ activities. Such continuous data collection and processing will later provide the input for personalized interventions that support the healthy and independent living of the study participants.

This collection will be performed by:

• continuously monitoring and collecting medical, clinical, physiological, behavioral, psychosocial, and real- world data of the patients
• analyzing these data using innovative model-driven big data analytics, statistical, artificial intelligence and machine learning techniques
• detecting patterns in the HF disease progression and the quality of life of the patients
• cross checking and validating them against the clinical literature
• offering transparent, explainable and verifiable decision-making capabilities that leverage the evidence produced by the underlying data analysis.

RETENTION mobile app

This document provides the user manual of the RETENTION application including a demo data and how – to – use instructions. The RETENTION app is an IoT – architecture project. The main goal is to monitor (collect and analyze) a heart patient’s measurements while he is at this home using standard – easy to find- devices. It should also be noted that RETENTION will abide to all principles of GDPR including the principles of lawfulness, fairness and transparency, purpose limitation, and data minimization.

Pre-specified subgroup analyses include

• The three patient categories (HF, LVAD and HT)
• Males and Females
• Patients with a hospitalization less than three months from the enrolment
• Patients older than 60 years

Data points

• Smartwatch (Heart rate, Steps encounter, Sleep quality)
• Oximeter (Oxygen saturation)
• Pressure gauge (Blood pressure) – excluding patients with LVAD
• Weight scales (Body weight)
• Temperature (Manual entry)
• VAD (Manual entry)

The above devices send the collecting data to a cell phone app via Bluetooth (BLE).

Extra Measurements

The following data will be additionally collected for patients with VAD:

• Controller parameters
• Alarms
• RPMs
• Power consumption
• Flow
• Pulsatility index
• Driveline exit site evaluation (photographic evidence) as early signs of infection

Devices – Equipment

• Application edge (mobile device)
  • Samsung A13
• Watch – Garmin
  • Garmin Venue SQ
• Oximeter – OMRON
  • Omron P300 Intelli IT pulse oximeter
• Pressure gauge
  • Omron M7 Intelli IT
• Weight scales -OMRON
  • Omron HN 300T2 Intelli IT

Alternative devices

• Application edge (mobile device)
  • Samsung A03s
• Watch – Garmin
  • Garmin Venue SQ 2
• Pressure gauge
  • Omron M4 Intelli IT

When to use it for each device – Medical approach

Data collected from smart sensors and devices on a daily basis will be:

• Weight (once per day)
• Blood pressure (morning)– excluding patients with LVAD
• Heart Rate (continuous by wearing the Smartwatch)
• Peripheral capillary oxygen saturation (morning, evening)
• Sleep: deep and light sleep phases, sleep interruptions
• Steps, distance, floors climbed, calories consumed

Timeframe

How to take each measurement correctly

Heart rate

• Continuous measurements while wearing the Smartwatch.
• Your device is already been paired.

In case of malfunction follow the instructions here.

• The value will be synced to the RETENTION app.

In case of sync problem follow the instructions here.

Warnings

• Do not install Garmin app since it hijacks our app
• You need to wear your Watch all the time, exception: its charging time

Steps encounter

Daily and continuous measurements while wearing the Smartwatch.

• Your device is already been paired.

In case of malfunction follow the instructions here.

• The value will be synced to the RETENTION app.

In case of sync problem follow the instructions here.

Warnings

• Do not install Garmin app since it hijacks our app
• You need to wear your Watch all the time, exception: its charging time

Sleep quality

Daily measurements while wearing the Smartwatch.

• Your device is already been paired.

In case of malfunction follow the instructions here.

• The value will be synced to the RETENTION app.

In case of sync problem follow the instructions here.

Warnings

• Do not install Garmin app since it hijacks our app
• You need to wear your Watch all the time, exception: its charging time

Oxygen saturation

To measure your oxygen saturation, use the finger – oximeter. Do this twice a day (morning, evening).

• Your device is already been paired.

In case of malfunction follow the instructions here.

• Place the device on your finger so that it fits properly in its opening.
• Sit still during the measurement.
• The value will be synced to the RETENTION app.

In case of sync problem follow the instructions here.

Warnings

• Its preferable to have bleach your nails if they are painted.
• The oximeter should be applied to warm, not cold or frozen limbs.
• Avoid sunlight or other lights as they may affect the measurement.

Blood pressure

Use the pressure gauge in order to measure your blood pressure. Do this daily in the morning. Excluding patients with LVAD.

• Your device is already been paired.

In case of malfunction follow the instructions here.

• Place and fix the cuff on your left or right arm.
• It should approximately at heart level, just above the elbow.
• Tight the tape.
• It is recommended that you should be seated with your back supported by your seat.
• Press the ON / OFF button to start inflating the cuff.
• There will be an indication of your systolic / diastolic pressure and pulse
• Remove the cuff
• The value will be synced to the RETENTION app.

In case of sync problem follow the instructions here.

Warnings

• The pressure should be taken after at least 5 – 10 minutes of rest and relaxation.
• One hour before you take your blood pressure, you should be fasting and have no coffee. In addition, smoking may affect the measurement.
• If you have been exercising, allow at least 2 hours before measuring.
• Make sure the environment where the measurement is taken is quiet and pleasant in terms of temperature.
• Your arm should be relaxed and resting.
• Your legs should not be crossed and you should not talk at the time of the measurement.
• Do not wear tight clothing, especially tight sleeves on the arm where you will be taking the measurement.
• The size of the air chamber of the cuff plays a role in the accuracy of your measurements.
• When you first start measuring your blood pressure, the measurement should be taken on both hands. If you find a difference of up to 1.5 millimeters of mercury between the two hands, don’t worry. It is a common phenomenon. If there is a bigger difference, the doctor will tell you what to do. For subsequent measurements, use the arm that shows the highest pressure.
• For a safe result, you should take 3 measurements each time. Each one should be about 1-2 minutes apart. Never take the first measurement into account. Calculate the average between the second and the third.

Body weight

Once per day.

• Your device is already been paired.

In case of malfunction follow the instructions here.

• Step on the scale
• Wait until the result appears
• Step off the scale
• The value will be synced to the RETENTION app.

In case of sync problem follow the instructions here.

Warnings

• It is best to weigh yourself as soon as you wake up, before you drink water or eat something and after using the toilet.
• Don’t weigh yourself at night, as fluid retention, eating meals or even fatigue can show up to two kilos more.
• Don’t weigh yourself after your workout.
• Weigh yourself without clothes on and always on the same scale.
• Always check that your scale is resting on the floor.

Temperature

• Daily measurements.
• Place the thermometer and wait until the finishing time according to its instructions.
• See the result.
• Manually insert the measurement at the ‘Temperature’ field following the instructions.

Warnings

• Wait at least 1 hour after intense exercise or a hot bath before taking your body temperature.
• Wait 20 to 30 minutes after smoking, eating or swallowing hot or cold liquid.

Sign in & Setup the Devices

In order to setup the application, the first sign in should be as an admin using the following credentials:

By clicking on ‘Submit’ you can proceed either as a patient or a care giver.

Smartwatch

Watch pairing

• Tap on Watch icon
• Select ‘Scan’ button
• Select your device from the list with the available devices in order to be connected
• Complete the information asked. (Height, weight, sleep time, wake up time)
• Save

Watch sync

• Tap on ‘Measures’ pane
• Select ‘Paired Devices’
• Your Watch will be automatically synced

            Charts

By the time your Watch is synced you can extract the Sleep, Step and Heart rate graphs following the next steps:

• Tap on the ‘Measures’ pane
• Tap on the ‘Charts’ option
• You will see the following screen

Heart Rate

Activity

The option ‘Activity’ provides the number of steps, distance and calories performed by the patient. To see them:

• Tap on ‘Measures’ pane
• Select ‘Activity’.
• Tap on ‘Sync’

Oximeter

Oximeter Pairing

• Tap on ‘Oxygen level’ icon
• Tap on ‘Scan’ button
• Press oximeter power button for 3 sec
• The index ‘P’ will appear on oximeter screen
• Your oximeter is pairing

Oximeter sync

• Tap on ‘Oxygen – level’ icon
• Your Oximeter measurements will be automatically synced
• You can see the history of your measurements by clicking on ‘PAST VALUES’

Pressure gauge

Pressure gauge pairing

• Tap on ‘Blood Pressure’ icon
• Tap on ‘Scan’ button
• Press the Bluetooth button for 3 seconds on the back of the pressure gauge machine or until the P appears on the monitor Your device will be paired

Pressure gauge sync

• Tap on ‘Blood Pressure’ icon
• Your Blood Pressure measurements will be automatically synced
• You can see the history of your measurements by clicking on ‘DIASTOLIC/SYSTOLIC VALUES’

Scale

Scale Pairing

• Tap on ‘Body weight’ icon
• Tap on ‘Scan’ button
• Press the Bluetooth button for 5 seconds or until a P appears on the monitor
• Your device will be paired

Scale sync

• Tap on ‘Body weight’ icon
• Your Body weight measurements will be automatically synced
• You can see the history of your measurements by clicking on ‘PAST VALUES’

Manual Insertion

Thermometer

Temperature input screen

• Tap on ‘Measures’ pane
• Tap on ‘Temperature’
• Manually input values

VAD

VAD input screen

• Tap on the ‘others’ icon
• Tap on the VAD icon
• Manually Input Values

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