mobile app v 2 - personalized pk...software version document issue date document number/revision...

Software Version Document Issue Date Document Number/Revision Version 2.0 04/2018 VV-00959404, rev.1.0

MOBILE APP v 2.0 USER MANUAL


WELCOME TO myPKFiT

Welcome to myPKFiT: your digital logbook for tracking your hemophilia A treatment and estimated FVIII levels in real time. myPKFiT is intended for persons with hemophilia A and their caregivers. It is designed with the intention to make it convenient for you to record your bleed and infusion events and track your estimated FVIII levels following a prophylactic infusion.

myPKFiT was tested on Apple smartphone devices using iOS 10 and 11 and Android smartphone devices using Android 6 and 7.


GET STARTED

DOWNLOAD

Download myPKFiT from the Apple iTunes or Google Play store.

SIGN UP

1. Set an email and password

2. Agree to Terms of Use, Privacy Notice, and Risk Information documents

CREATE PROFILE

1. Set your profile name

2. Add a profile photo (Optional)

3. Scan a myPKFiT QR Code provided by your Healthcare Professional within 30 days of its generation

4. Confirm your infusion schedule and default dosing

5. Allow notifications (Optional)


CREATE A SECOND PROFILE

CREATE NEW PROFILE

1. Press the down arrow next to your profile name at the top of the screen

2. Press Create New

3. Follow the same steps as when you created your first profile


HOW DO I LOG IN?

Once you have completed the sign-up process, open up myPKFiT to log in.

The username is the email address that was used to create the account.

The password is used the first time you sign into the app for all profiles associated to an account. As an additional security measure, you can register your fingerprint (if your mobile device supports fingerprint ID). This fingerprint ID is used to log you into the application. The application automatically logs you out after 15 minutes of inactivity.

Please note if multiple fingerprints are associated with an account, the fingerprint ID will allow access to application of any of those fingerprint ID’s on the device.

Sign In


CAN I WORK OFFLINE?

Yes, the application will allow you to view your estimated FVIII levels. If you enable the FACTOR METER Preview in Settings, you can view your current estimated FVIII levels straight from the Sign In screen without having to log into the application or without a network connection.

If you swipe the Sign In screen, your FACTOR METER detail screen will display your estimated FVIII levels. You can view the estimated FVIII levels of all profiles associated to the account by changing the profile just as you would in the application.

Please note that these estimated FVIII levels will not include any data entered for your account from another device from the last time you have logged into the application. Please log into myPKFiT to view the most up to date FVIII levels.


HOW IS MY TREATMENT DATA STORED?

Your data is synchronized with the cloud as you save. A copy is also stored on your local device for improved application performance. When your data is synchronized, it is encrypted. If you lose your device, you do not lose your data. As long as you obtain another mobile device and can log into your account, you can access your data from the cloud.


HOME The Home screen is where you find commonly used functions for myPKFiT. It displays your adherence rate since you began using the application and consecutive days bleed free. You can toggle between the two features by pressing the arrow on the tile. The information about your 3 latest prophylaxis infusions and next scheduled prophylaxis infusion is located on the Infusions tile. A navigation bar is also present at the bottom of the application for easy navigation to Home, Logs, FACTOR METER, Calendar, and Settings screens.


HOW DO I LOG A BLEED? Log a bleed directly from the home screen.

In order to log a bleed, you need to fill out all the required fields (indicated with an asterisk*). You will need to indicate where the bleed occurred. There is a front and back view, which can be toggled. Tap the area where the bleed occurred. Once you have selected a general area, you can specify the exact location. For example, if you selected the right arm, you will be given the option to select in which part of the right arm the bleed occurred. Select the appropriate area.

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SPECIFY THE FOLLOWING DETAILS:

Date & Time The date and time when you choose to log a bleed Bleed Location Auto-populated when you choose a location of the body selector screen

Bleed Type Specify the type of bleed Cause of Bleed Indicate how the bleed occurred Activity at the Time of Bleed (Optional) Provide information on the activity will help your physician to understand and monitor your treatment.

Pain Level (Optional) Indicate the amount of pain you felt when the bleed occurred.

Photo (Optional) If your mobile device supports taking photos, selecting this function will activate your camera to capture and save a picture.

Save Once all mandatory fields are filled in, you will be able to save your record. It will update the myPKFiT calendar accordingly.

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HOW DO I LOG AN INFUSION? Log an infusion directly from the home screen.

Infusions can be recorded either as part of a prophylaxis treatment or to treat a bleed. You can access the log infusion screens via the home screen.

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SPECIFY THE FOLLOWING DETAILS: Product This is a read only field set by the QR code scanned Date & Time Enter the date and time of the infusion Total Dosage (IU) Enter the total amount of factor used during the infusion Reason for Infusion Indicate if the infusion is part of a prophylaxis treatment therapy or to treat a bleed Infusion Site (Optional) Specify where you infused the product. Vial Details (Optional) Save the vial lot number found on the product label on the vial, or on the box it came in. Save Once all mandatory fields (marked with an asterisk*) are filled in, you will be able to save your record. It will update the myPKFiT calendar accordingly.

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FACTOR METER

The FACTOR METER displays your estimated FVIII levels in the form of a battery timeline Time Left in Green

Zone The amount of time left in the green zone set by your healthcare professional Time Left in Red Zone The amount of time until you reach the healthcare professional’s defined red zone Future Estimated FVIII Level The estimated FVIII level at a certain time in the future FACTOR METER Battery - A visual representation of the current estimated FVIII level

Slider - Allows you to move the time into the future to see your estimated FVIII level at that future time

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FACTOR METER ZONES

The FACTOR METER battery shows your estimated factor level over time. If your healthcare professional has defined green, yellow and red zones for your FVIII level, the battery color changes according to your current factor level. Please discuss these settings and the differences among these zones with your healthcare professional.

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FACTOR METER ACTIVATION

Scan QR Code Upon creating a profile, you need to scan a valid myPKFiT QR code. The scanned QR code is valid for 18 months. You may scan a new QR code from the Settings screen, when your QR code expires.

Log Prophylactic Infusion The FACTOR METER is only activated after you logged a prophylactic infusion according to your product’s label.

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HOW DOES THE CALENDAR

WORK?

The myPKFiT calendar is designed to provide you with a visual overview of your past events and future scheduled events.

THE CALENDAR IS

COLOR-CODED AS

FOLLOWS:

Bleed

Indicated by a purple drop Prophylaxis Infusion

Indicated by an orange or green circle (depending on your product)

Scheduled Infusion Indicated by a circle with a purple outline Missed Infusion Indicated by a black circle with a line through it

Treat a Bleed Infusion Indicated by an orange or green circle within a circle (depending on your product)

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If you have multiple events happening on the same day, such as both a bleed and an infusion, both indicators will be displayed. In this example, a bleed and an infusion would be indicated by a purple drop and an orange or green circle. You may edit or delete your past events by pressing on the event (which are arranged chronologically with the most recent event displayed at the top). Make sure to press on Save once you have finished editing the event.

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HOW DOES LOGS WORK?

Logs provides you with a visual overview of your past events related to a profile. Selecting a specific bleed or infusion event will take you to that event where you can update or delete it. You can also export your bleed and infusion data.

DATA TYPES:

Prophylaxis Infusions Represented by an orange or green circle (depending on product)

Bleeds Represented by a purple drop

Missed Infusions Represented by a purple circle with an X inside the grey vial

Treat A Bleed Infusions Represented by an orange or green circle (depending on product)

ACTIONS:

Export Select the data for export

Filter Select criteria to filter to display specific records

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HOW DOES DATA EXPORT WORK?

Data export is designed to allow you to share your infusion and bleed data with an email recipient of your choice.

Recipient Email Choose an email to send your report to

Date Range Choose the range of dates for the data

Export Format Export the data via a CSV file or PDF export contained in a zip file

Data Type Exports will contain all records during the date range. Data can be further filtered in a third-party program

Passcode Set a 4-digit pin code in a next step to securely export the data. This code will need to be entered in order to open the .zip file.

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WHAT SETTINGS CAN I CHANGE?

Settings allows you to control the details associated with your account and profiles.

Profile Details - You may modify the information associated with the current profile including: name, photo, infusion schedule, and scanning a new QR Code. You also have the option to delete the profile

Export Data - You can export all data associated with the current profile

Change Email /

Change Password - You may change the email and password associated with your account Enable FACTOR METER Preview – You may enable or disable the ability to view the FACTOR METER without logging into your account. *Note: All profiles associated to an account will be visible from the FACTOR METER Preview screen if enabled

Log Out - You may log out of the current account

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User Manual - You may view this user manual

Contact Us - View the various means to contact Shire for support. * Note: This should not be used in case of medical emergency

Documents - View the Terms of Use, Privacy Notice, and Risk Information documents


WHAT IS IN PROFILE DETAILS?

Profile Picture Upload a profile photo

Name Update the name displayed for your profile

Scan New QR Code When you meet with your Healthcare Professional and you receive a new QR Code, you can scan it from this screen

Delete Profile Delete the profile and all data associated with that profile including: bleeds, infusions, and profile information

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WHAT IS MY INFUSION

SCHEDULE?

Infusion Schedule is designed to provide you a simple way to set your prescribed infusion schedule and time.

INTERVAL

Product – A read only field to display your current prescribed factor therapy from your myPKFiT QR code

Frequency - The time between infusions prescribed by your Healthcare Professional

Time of Infusion - The time of day you are prescribed to complete your infusion

Actual Total Dosage (IU) - The total dosage prescribed by your healthcare professional

Start Date – The day your infusion schedule will begin

CUSTOM The Custom schedule displays an irregular schedule

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set by your Healthcare Professional.

Day - The day of the infusion prescribed by your Healthcare Professional

Time of Infusion – The time of day you are prescribed to complete your infusion

Actual Total Dosage (IU) - The total dosage prescribed by your healthcare professional

Scroll bar - Scroll down to see and set the Week 2 schedule


HOW CAN I SET UP NOTIFICATIONS IN myPKFiT?

You must enable Notifications in order to receive reminders of when to infuse and when you have reached the red zone. Notifications can be enabled or disabled from your device’s settings and you must grant myPKFiT the ability to send you notifications.

Log Infusion Notification A notification can be sent to notify you of the time you should infuse based on your infusion schedule

Reach the Red Zone Notification A notification can be sent to notify you when you have reached the red zone. Please discuss with your Healthcare Professional what actions should be taken when you reach the red zone.

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WARNING MESSAGES

The following are warning messages displayed throughout the application with their meaning and possible course of action. Application Use Warning Message Precaution / Tip

Invalid myPKFiT QR

Code

The Clinic Patient ID <Patient ID> does not match the previously scanned Clinic Patient ID for this profile. Please confirm that this is the correct myPKFiT Report.

The Clinic patient ID is set in myPKFiT Web application by your healthcare professional. Please verify you are scanning your myPKFiT report.

Invalid non-myPKFiT

QR Code

You have scanned an invalid QR Code. Please scan the code found in your myPKFiT report. If problems persists, go to the ? icon on the scanner screen for troubleshooting tips.

Please ensure you are scanning a valid myPKFiT QR code.

Expired report This report was generated more than 30 days ago. Please scan a QR code that was generated within the past 30 days.

Please ensure you are scanning the most recent myPKFiT QR code provided by your healthcare professional.

Scan QR Code

Difficulty

We are having difficulty scanning your QR Code. Please try again. If problems persists, go to the ? icon on the scanner screen for troubleshooting tips.

The QR code reader is having trouble scanning your myPKFiT QR code. Please refer to the QR scanner help screen indicated by the ? icon.

Existing myPKFiT

Report Scan

This report is already active. Please scan a QR code that is not currently active.

This myPKFiT QR code has already been scanned by another profile. Please ensure you are using the correct myPKFiT QR code.

Non-matching

Patient ID

The Clinic Patient ID <Patient ID> does not match the previously scanned Clinic Patient ID for this profile. Please confirm that this is the correct myPKFiT Report.

Please ensure you are using the correct myPKFiT QR code and not one for another user profile.

Previously Used

myPKFiT Report

This report for <Patient ID> is already linked to user profile: <Profile name> Would you like to unlink this report from <profile name> and link it to the current profile?

This myPKFiT QR code has already been scanned by another profile on your account. Please ensure you are using the correct myPKFiT QR code.

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Application Use Warning Message Precaution / Tip

Invalid Frequency

Intervals Infusion

Schedule

Sorry, you cannot set frequency intervals outside of the range of <XX-XX> hours. Please follow prescribing instructions provided by your healthcare provider.

When entering a custom schedule, you cannot set an interval outside of the approved label. Please verify your schedule with your healthcare professional.

Past Start Date

Infusion Schedule

You cannot enter a past date. When entering the start date for your infusion schedule it must be today or in the future.

Existing Profile

Name

The profile name <XXXX> already exists. Please enter a new name.

Each profile name must be unique per account.

Delete Profile Are you sure you would like to delete this profile? All data associated with this profile will be deleted.

If the profile is deleted, all data for that profile will be deleted and cannot be recovered.

Past Infusion / Bleed

Logged

This infusion happened over 12 hours ago. Are you sure you are logging the correct date and time?

Logged date and time: <Value entered>

Please verify the time entered for the infusion. This will affect your estimated FVIII level.

Future Infusion/

Bleed Entry

Logged date and time: You cannot enter a future date or time.

You cannot enter an infusion/ bleed for a future time. Please verify the time/date entered.

Delete Infusion Are you sure you would like to delete this infusion?

If the infusion is deleted, your current estimated FVIII level could be affected.

Delete Bleed Are you sure you would like to delete this bleed?

If the bleed is deleted, your entry will be deleted and cannot be recovered.

Incorrect Infusion

Amount

The total dose is not within the range of <XX - XX> UI/kg. Please follow the instructions provided by your healthcare professional.

myPKFiT only allows for dosing per the label approved in your country. Please ensure you have entered the correct value or meet with your healthcare professional to discuss your treatment regimen.

Select Date of Export

Data

End date must be later than Start date. Please try again.

You must select a valid date range.


Application Use Warning Message Precaution / Tip

Cannot Log in Your email address or password is invalid. Please try again.

You have entered either the wrong email address or password related to your account. Please use Forgot Password if you are unable to remember your password.

Password Reset Your reset password link has already expired or has already been used. Please to ‘Forgot Password’ again.

You have already used the password reset link in your email once or it has been longer than 10 days since you requested to change your password. Please use Forgot Password again.

Unknown Email

Address

The email address provided was not recognized. Please try again.

Please verify you have entered the email address associated with your account.

Existing Email

Address

The email address already exists. Please choose another one.

While creating an account, you have entered an email address that already exists in the database. Please try Forgot Password or use another email address to sign up.

Change password The previous password entered is not correct.

You have entered a password incorrectly. Please verify that you have entered the correct password before trying to change your password.

myPKFiT Unavailable myPKFiT is currently not available in your country. At this time, the only functionality available is exporting your data.

myPKFiT is no longer available in your country at this time. Please discuss your regimen tracking options with your healthcare professional.

Unsaved Changes You have unsaved changed. Are you sure you want to leave this screen? Any unsaved changes will be lost.

If you leave the screen before pressing Save, you will lose the data that was entered.

Lost Network

Connection

This feature is only accessible when a network connection is available. Please try again once a network connection is restored.

If you lose your network connection some features in the application are not available. Once you regain a network connection, those features will be available.


Baxalta U.S. Inc., an entity of Shire PLC Bannockburn, IL 60015 USA

MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St. Ingbert | Germany

Baxalta, ADYNOVATE and myPKFiT are trademarks of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc. Any other trademarks, product brands or images appearing herein are the property of their respective owners.

© Copyright (2018) Baxalta Incorporated. All Rights Reserved.