Professional Capability With The Platform User Guide

Professional Capability With The Platform

Product Information

Specifications

• Product Name: Tandem Source Platform
• Intended Users: Individuals with diabetes mellitus, caregivers, healthcare providers
• Supports: Tandem Diabetes Care insulin pumps
• Settings: Home and clinical settings

Product Usage Instructions

Home Screen
The home screen of the Tandem Source platform provides access to various functions and features. Navigate through the options using the designated buttons or touchscreen if available.

Explanation of Symbols
Understanding the symbols displayed on the platform is crucial for interpreting information accurately. Refer to the user manual for detailed explanations of each symbol.

Upload Data
To upload data from Tandem insulin pumps, follow these steps:

1. Ensure the pump is connected securely to the Trusted Computer.
2. Access the data upload function on the platform.
3. Follow on-screen prompts to initiate the data transfer process.

Data Privacy
Protecting user data is essential. Enable necessary security settings and follow guidelines provided in the user manual to maintain data privacy and confidentiality.

Security Settings
Adjust security settings as per your requirements to enhance data protection and prevent unauthorized access to sensitive information.

Automatic Updates
Enable automatic updates to ensure the platform is running with the latest features and security patches. Regularly check for updates to maintain optimal performance.

SECTION 1 Important Safety Information

Intended Use
The Tandem Source™ platform is intended for use by individuals with diabetes mellitus who use Tandem Diabetes Care™ insulin pumps, their caregivers, and their healthcare providers in home and clinical settings. The Tandem Source platform supports diabetes management through the display and analysis of information uploaded from Tandem insulin pumps.

Important User Information

• Thoroughly review all product instructions for warnings and other important user information before using Tandem Source. Medical devices, like other computer systems, can be vulnerable to cybersecurity risks, potentially impacting the safety and effectiveness of the device. Incorrect use of Tandem Source or your failure to follow the instructions, precautions and warnings in this user guide, may expose your computer to cybersecurity risks.
• Always use Tandem Source on a Trusted Computer using a web browser through a secure connection. A Trusted Computer is a computer controlled by your office that has the latest security patches for a supported operating system, including virtual machines used at healthcare provider’s offices.
• For local support in your area, see the contact information on the back cover of this user guide.
• You can request a printed copy of this user guide at any time, which we will send to you free of charge within seven days of your request. See the contact information on the back cover of this user guide.

Precautions
Use of security features on your Trusted Computer is important. These security features include:

• The use of a password or PIN to unlock the Trusted Computer.
• Making sure that your Trusted Computer has current security software.
• Keeping your software updated when prompted by your Trusted Computer.
• Some web pages can be unsafe and can affect your Trusted Computer just by visiting them. You should minimize visits to unknown websites and look for ‘https’ in the browser address or for the padlock symbol next to the URL when visiting websites.
• You can check system requirements at tandemdiabetes.com/support/tandem-source/professional. You can verify the tandemdiabetes.com certificate in the browser by clicking on the padlock symbol next to the URL.
• Exercise caution whenever you connect a Tandem pump to a Trusted Computer and remain in the presence of the pump at all times while the pump is connected to a Trusted Computer.
• Connecting the pump to a Trusted Computer that is attached to other equipment could result in previously unidentified risks to the patient, operator, or a third-party. The user should identify, analyze, evaluate, and control these risks.
• Subsequent changes to a Trusted Computer could introduce new risks and require additional analysis. These changes can include but are not limited to changing the configuration of the Trusted Computer, connecting additional items to the Trusted Computer, disconnecting items from the Trusted Computer, and updating or upgrading equipment connected to the Trusted Computer.

SECTION 2 Product Overview

• The Tandem Source™ platform is a secure web-based system that aims to help users monitor and understand insulin therapy and pump data uploaded from Tandem pumps. The tools and reports offered by the system allow people living with diabetes, their parents or guardians, and their authorized healthcare professionals to visualize such data.
• Patients (Personal users or Parent/Guardian users) and their authorized healthcare professionals (Professional users) can upload pump data to Tandem Source for view and analysis. Anyone with an established account can use Tandem Source without downloading or installing any software.

Regardless of who accesses Tandem Source or from where, there are a few common characteristics:

• Tandem Source is web-based and can be accessed using any compatible web browser.
• The data is hosted on web and database servers which are accessible only through a secure internet connection.

NOTE
For an up-to-date list of supported operating systems and browsers, please visit tandemdiabetes.com/support/tandem-source/professional.

Home Screen
When any Professional user logs into Tandem Source, the Patient List appears by default. The following diagram shows basic navigation at first login.

1. Home icon: Click this icon from any screen to open the Home screen.
2. Patient List icon: Click this icon from any screen to open the Patient List.
3. Upload Pump icon: Click this icon from any screen to open the Upload Pump screen. From the Home screen, you can also click Go to Upload Pump in the Pump Uploads tile.
4. Search bar: Search the Patient List for a specific patient by name or pump serial number.
5. Tandem Source footer: The footer contains links to useful information, including the About screen, the Help screen, and Tandem legal information.
6. Profile icon: Click this icon from any screen to open a dropdown menu and manage your Tandem Source account, including access to the Account Settings screen, access to the Clinic Settings screen, and the ability to log out of Tandem Source.
7. Help icon: Click this icon from any screen to open the Help screen.

Explanation of Symbols
The following are symbols (and their descriptions), which you may find in Tandem Source. These symbols tell you about the proper and safe use of the product. Some of these symbols may not be relevant in your region, and are listed for informational purposes only.

Explanation of Tandem Source Symbols

Symbol	Meaning	Symbol	Meaning
	Medical device		Manufacturer
	Catalogue number		Date of manufacture

SECTION 3 Manage Users

Professional user accounts are designed to be used by healthcare professionals who provide care for people who wear the pump. All Professional users can do the following:

• Upload and access patient data and reports for any patient that has authorized them to do so
• Add new patients to their clinic
• Remove patients from their clinic
  Additionally, Professional Administrator users can also:
• Add new Professional users (Administrator and Standard) to their clinic
• Change account type for existing Professional users
• Remove Professional users from their clinic
• Edit clinic name and address

NOTE
The clinic name is included in notifications that inform patients which healthcare teams have access to their therapy data.

Professional users always see the Home screen when they log in to the Tandem Source™ platform, which gives them the option to view reports, print reports, or upload pump data for any patient who has connected to their clinic. If a patient has not connected their account to your clinic, they must authorize you to view their data before they appear in your Patient List. See Connect to a Patient.

Create Professional Accounts
Only Professional Administrator users can add new Professional users (Administrator and Standard) to their clinic. We strongly advise that all Professional users have their own unique login credentials. Your clinic can have an unlimited number of Professional users.

Any Professional Administrator user can add a new Professional user to their clinic as follows:

1. Click the Profile icon in the upper right corner of Tandem Source, then click Clinic Settings from the drop-down menu.
2. Click Add User.
3. Enter the new user’s user name, email, and account type.
4. The user receives an email with a link that will allow them to verify their email address, set up their own password, and choose a security question.

NOTE
In order to maintain the security of each account, we require passwords to:

• Be unique from the last four passwords
• Contain at least eight characters
• Include at least one of each of uppercase character, lowercase character, symbol, and number

Update Professional User Account

• A Professional Administrator can change other Professional user accounts between Standard and Administrator. Navigate to the Clinic Settings screen and click the appropriate radio button in the row corresponding to that user.
• Changing user privileges does not require any action from the affected user.
• Any Professional user can change their personal information from the Account Settings screen (e.g., display language, password, contact information). Click the Profile icon in the upper right corner of Tandem Source, then click Account Settings.

Remove a Professional User
Professional Administrator users can remove a Professional user. Navigate to the Clinic Settings screen and click Remove in the row corresponding to that user. Clicking Remove generates a pop-up window; click Remove User in the pop-up window to remove that Professional user from your clinic.

Connect to a Patient
When you connect a Tandem pump to your computer to upload its data into Tandem Source, Tandem Source allows you to add the patient to your Patient list. Click Upload Pump in the left navigation bar or Go to Upload Pump on the Home screen.. The Upload Pump screen appears.

• If the patient has created a Tandem Source account and linked the pump to their account, they are added to your Patient List automatically. Upload their data as shown in Data Upload.
• If a patient on your Patient List has created a Tandem Source account, but their pump is not linked to their account, click Link Pump to Patient, then enter the patient’s name into the search bar and click their name when it appears in the search bar drop-down list. This generates a pop-up window.
• If the patient has not created a Tandem Source account, when you click Search, Tandem Source prompts you to add them to your Patient List. See Data Upload for instructions to temporarily upload data for patients who do not have a Tandem Source account.

The following example shows the Upload Pump screen for a patient who has not linked their pump to a Tandem Source account.

View Patient Data
You can access patient data that has already been uploaded to the Tandem cloud after those patients have connected their Tandem Source accounts to yours and authorized you to view their data. Locate the patient in the Patient list and click the Report icon to view their reports.

See Working with Patient Data to learn more about which reports Tandem Source can generate. You can also print and save Patient data reports as described in Save or Print Report.

Remove Patient
You can remove a patient from your Patient List if necessary. Remove a patient as follows:

1. Sign into your Tandem Source account.
2. Locate the patient in the Patient List using either the Search bar on the Home screen or the Patient List screen.
3. Click the Patient Management Menu icon to the right of the Print icon in the row corresponding to that user. A drop-down menu appears.
4. Click Remove Patient. This generates a pop-up window.
5. Click Remove Patient in the pop-up window. The Patient List displays a banner confirming that the patient is no longer connected to your clinic.

SECTION 4 Data Upload

After you create a Professional user account, you can use the Tandem Source™ platform to securely upload patient pump and therapy data.

NOTE

• For an up-to-date list of supported operating systems and browsers, please visit tandemdiabetes.com/support/tandem-source/professional.
• Tandem Source allows you to upload patient pump data and view their reports without installing any software.

Upload Data
Before connecting any Tandem pump to any computer for data upload, ensure you are logged into Tandem Source.

Existing Tandem Source User – Pump Linked to User
If the patient has created a Tandem Source account and you have added them to your Patient List, upload data from their Tandem pump as follows:

1. Click Upload Pump in the navigation bar at left or Go to Upload Pump on the Home screen. The Upload Pump page appears.
2. Insert the USB cable provided with the pump into your computer.
3. Insert the other end of the cable into the micro USB port on the pump. Align the Tandem logo on the cable with the Tandem logo on the pump.
   • If your browser displays a dialog box asking to connect to a COM port, click Tandem Virtual COM Port to highlight it, then click Connect.
4. From the Upload Pump screen, click Start Upload to begin the data upload. Tandem Source displays the patient’s name, date of birth, date of last upload, and pump description. A status bar shows upload progress. Never refresh your browser or leave the Upload Pump screen during data upload.
   NOTE
   Tandem Source displays an error message if any errors occur during data upload. Follow the instructions shown in the error message.
5. A banner appears when the data upload is complete. Click View Reports or Print & Save to review pump data as desired. See Working with Patient Data to learn more about which reports Tandem Source can generate.

Existing Tandem Source User – Pump Not Linked to User
If the patient has created a Tandem Source account, but they have not linked their pump to it, upload data from their Tandem pump as follows:

1. Click Upload Pump in the navigation bar at left to navigate to the Upload Pump screen.
2. Insert the USB cable provided with the pump into your computer.
3. Insert the other end of the cable into the micro USB port on the pump. Align the Tandem logo on the cable with the Tandem logo on the pump.
   If your browser displays a dialog box asking to connect to a COM port, click Tandem Virtual COM Port to highlight it, then click Connect.
4. From the Upload Pump screen, click Start Upload. Tandem Source displays a search bar.
5. Type the patient’s name into the search bar and click Search.
6. Select the patient from the menu below the search bar and click Link Pump to Patient. A pop-up window appears.
7. Click Link Pump to Patient in the pop-up window to upload the patient’s data. The Upload Pump screen shows their name, date of birth, date of last upload, and pump description.
   • A status bar shows upload progress. Never refresh your browser or leave the Upload Pump screen during data upload.
   • A confirmation banner appears when the pump has been linked to the patient’s Tandem Source account. This banner normally appears before data upload is complete.
     NOTE
     Tandem Source displays an error message if any errors occur during data upload. Follow the instructions shown in the error message.
8. A banner appears when the data upload is complete. Click View Reports or Print & Save to review pump data as desired. See Working with Patient Data to learn more about which reports Tandem Source can generate.

Guest User
If the patient has not created a Tandem Source account, Tandem Source will treat the patient as a Guest. Upload data from their Tandem pump as follows:

1. Click Upload Pump in the navigation bar at left to navigate to the Upload Pump page.
2. Insert the USB cable provided with the pump into your computer.
3. Insert the other end of the cable into the micro USB port on the pump. Align the Tandem logo on the cable with the Tandem logo on the pump.
   • If your browser displays a dialog box asking to connect to a COM port, click Tandem Virtual COM Port to highlight it, then click Connect.
4. From the Upload Pump screen, click Start Upload. The Upload Pump screen displays the connected pump’s software version and serial number as well as a search bar.
5. From the Upload Pump screen, click Add New Patient. A pop-up window appears.
6. Enter the patient’s name and date of birth into the pop-up window, then click Add Patient. A new pop-up window appears.
   • If the patient is already on your Patient List, but their pump is not linked to their Tandem Source account, the new pop-up window allows you to link the patient’s pump to their Tandem Source account.
7. Click Link Pump to Patient in the pop-up window to return to the Upload Pump screen and upload the patient’s data. A status bar shows upload progress. Never refresh your browser or leave the Upload Pump screen during data upload.
   NOTE
   Tandem Source displays an error message if any errors occur during data upload. Follow the instructions shown in the error message.
8. A confirmation banner appears when the data upload is complete. Click View Reports or Print & Save to review pump data as desired.

A Guest data upload does not affect data storage on the pump. After the patient creates their Tandem Source account and links the pump to it, this data will be included in their next pump upload.

NOTE
Data uploaded using the Guest feature is only available at the clinic where it was uploaded.

SECTION 5 Working with Patient Data

The Tandem Source™ platform creates reports using the data patients upload from their pumps. You can view these reports as soon as each upload is complete. This chapter describes how to configure Tandem Source before viewing specific therapy data, reports that are available for view, and saving or printing reports.

Glucose Range Color Coding
High glucose, low glucose, and target range values are color-coded in reports as follows:

• High Range = Orange
• In Range = Green
• Low Range = Red

Report Details
Tandem Source offers three standard reports:

• Overview – Provides a general overview of the patient’s therapy data.
• Daily Timeline – Shows glucose readings, basal insulin delivery, and boluses day by day.
• Pump Settings – Displays the pump settings, including all Personal Profiles and predictive technology usage (depending on patient pump software).

NOTE
Tandem Source only displays completed boluses. If a bolus was still in progress during the last pump data upload, that bolus will not appear in any reports.

Overview Report
The Overview report offers a summary of the patient’s pump and therapy data. The following summary information may be included in the default Overview report:

• Summary of CGM usage (e.g., average glucose reading, total time in target range, total time of use)
• If your patient does not have CGM data, BG entries on the pump appear instead
• Time in Range comparison between the current selected time period and the previous time period
• Summary of predictive technology usage (depending on patient pump software)
• A glucose trends graph showing a summary of glucose values during the selected period, including the median and interquartile range
• If your patient does not have CGM data, this graph is not displayed
• Summary of average daily insulin (e.g., total insulin delivered, basal insulin delivered, boluses delivered)
• Average daily bolus delivery, including different types and amounts of boluses delivered
• Average frequency of cartridge and infusion set changes

All glucose values shown in the Overview report are measured in mmol/L.

The following screen shows an example Overview report.

Glucose thresholds in the Overview report are set to a default target range of 3.9-10 mmol/L. Click the displayed target range above the report to open Glucose Thresholds dialog box and select a different preset target range.

Daily Timeline Report

• The Daily Timeline report shows glucose readings, basal and bolus insulin delivered, insulin suspension events, and other pump and therapy-related events that occurred during the selected date range. If a CGM is connected to the pump, this report also displays CGM data for the same timeframe.
• All glucose values shown in the Daily Timeline report are measured in mmol/L.
• On your computer, hover your cursor over certain events to display a tooltip with information about that event.

The Daily Timeline report displays the following therapy data elements:

The following screen shows an example Daily Timeline report. The default view includes a key that defines crucial icons. Click Key to collapse the key.

Glucose thresholds in the Daily Timeline report are set to a default target range of 3.9-10 mmol/L. Click the displayed target range above the report to open Glucose Thresholds dialog box and select a different preset target range.

Pump Settings Report
The Pump Settings report includes Personal Profiles associated with the patient’s account at the time of upload. This report is read-only and cannot be used to change any settings in the pump itself. All glucose values shown in the

Pump Settings report are measured in mmol/L. Pump settings shown on this report may include:

• Profiles used during the selected time period
• Tiles describing individual pump settings, including predictive technology settings (as appropriate for the patient’s pump), alert and alarm settings, and insulin delivery settings.

Save or Print Report

Using the Print Screen
Different areas within Tandem Source allow users to open the Print screen and save or print a report.

• From any report screen, click the Print icon in the upper right corner of the report screen.
• From the Upload Pump screen, click Print & Save following a completed data upload.
• From the list of connected patients, click the Print icon by any patient’s name.

Once the Print screen appears, select the desired date range and report(s) in the Select Reports window, then click Save Reports or Print Reports. If you selected Overview and/or Daily Timeline, you can also select a target glucose range in the Select Reports window.

If you save reports from the Select Reports window, Tandem Source saves them as PDF files.

Exporting Data from Report Screens
While viewing the Overview report or the Pump Settings report, you can copy the report contents as plain text to easily paste into other programs. Click Copy as Text at the top right of the desired report.

NOTE
Tandem Source only copies the name of the person who wears the pump. If the patient is connected to your clinic via a Parent/Guardian account, the copied plain text will not include the parent or guardian name.

While viewing the Daily Timeline report, click Export CSV to export the report contents to a CSV (Comma Separated Values) file.

Tandem Source exports CSV files to your Downloads folder by default.

• The default filename begins with CSV_[patient name] for easy identification. For example, for a patient named Tom Tandem, an exported CSV file begins with CSV_TandemTom. The filename also includes the date and time of export to prevent Tandem Source from overwriting old exports.
• You can open CSV files in any spreadsheet program (e.g., Microsoft Excel).

Select Data Set
Tandem Source displays data for the last two weeks by default, but you can select a preset date range or set a custom date range to determine how much data each report includes. The maximum viewable date range is 30 days.

Tandem Source generates some reports using only data from complete days to ensure that daily averages are represented accurately. Tandem Source defines a complete day as having at least 18 hours of cumulative basal data. If less than 18 hours of cumulative basal data was uploaded for any day in a selected date range, Tandem Source treats that day as incomplete.

• Incomplete days with some data may occur when a pump was connected to a computer for data upload or the first day a user started using the pump.
• Incomplete days with no data may include whole days before someone started using the pump or an extended period of discontinued pump therapy (e.g., the patient placed the pump in storage mode as described in the appropriate pump user guide).

Tandem Source processes data from incomplete days as follows:

• Data for incomplete days is included in calculations (e.g., average CGM, Time in Range).
• Aggregated daily statistics (e.g., total daily dose) exclude incomplete days.
• Both incomplete days and their data are excluded from statistics calculated using the entire selected date range (e.g., the average daily dose is calculated using only complete days and only basal data collected on those days).

The following example shows a banner for a date range that includes incomplete days.

Time/Date Change

• If the patient changed the time and/or date on their pump during a selected date range, Tandem Source treats the day(s) of the change as incomplete. Daily Timeline graphs are separated to reflect the change (e.g., if the time on the pump changed from 1:00pm to 4:00pm, no data appears on the first graph after 1pm for that day). This applies even if the pump time or date changed backwards (e.g., changing time zones while the patient was traveling).
• If the selected date range includes a pump time or date change, the Overview report and Daily Timeline report displays a banner describing the change and the affected day(s).
• The following example shows a banner for a date range that includes a pump time change.

The following example shows a Daily Timeline report for a date range that includes a date change.

Multiple Pumps
If the selected date range includes data from multiple pumps (e.g., the patient received a warranty replacement pump, the patient changed pump models), Tandem Source manages therapy data from each pump separately.

• On the Overview report and the Daily Timeline report, select which pump data set to view.
  • If you print or save these reports from the Print screen, Tandem Source creates one Overview report and one Daily Timeline report for each pump.
  • If you export the Daily Timeline report as a CSV file, one CSV file includes all pumps and sorts data by pump serial number within the file.
• The Pump Settings screen always shows settings for the most recently uploaded pump.
• Data uploaded from prior pumps is not erased when a patient links a new pump to their Tandem Source account.

The following example shows a banner for a date range that includes data uploaded from multiple pumps.

The following example shows the toggle on some reports to select data uploaded from different pumps.

SECTION 7 Miscellaneous

Data Privacy
Tandem Diabetes Care is firmly committed to your and your patients’ privacy. and we have implemented policies and practices designed to protect your and your patients’ personal data. In addition, we have implemented security safeguards to help keep your and your patients’ personal data safe and secure in our systems. Please visit our Privacy Notice for further information.

Security Settings
Tandem designed the Tandem Source™ platform with advanced security technology and features throughout. We understand that security is vital when transferring medical information and have built a system that ensures your information is kept safe and secure. Enterprise-class Secure Sockets Layer (SSL) encryption is used for data communications between your computer and the secure Tandem Source web application servers.

Automatic User Account Timeout
For security purposes, after 15 minutes of inactivity, Tandem Source automatically ends your session and signs you out. A notification message informs you that this has occurred. The security timeout applies to all accounts and cannot be changed.

Automatic Updates
Tandem Source will be updated periodically to better meet your needs. Generally, Tandem Source will update automatically and without interruption to its users.

Serious Incident Reporting
Report any serious incident that occurs in relation to this device to Tandem Diabetes Care or its local distributor. In Europe, also report to the competent authority of the Member State in which you reside.

Patents and Trademarks

• Covered by one or more patents. For a list of patents, see tandemdiabetes.com/legal/intellectual-property.
• Tandem Diabetes Care, the Tandem Diabetes Care logo, Tandem Source, t:slim X2, Basal-IQ and Control-IQ are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. Dexcom and any related logos and design marks are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. The Bluetooth® wordmark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Tandem Diabetes Care, Inc. is under license. All other third party marks are the property of their respective owners.

Tandem Diabetes Care, Inc.

• 12400 High Bluff Drive
• San Diego, CA 92130 US
• tandemdiabetes.com
• CANADA:
  (833) 509-3598|
  tandemdiabetes.ca
• UNITED STATES:
  (877) 801-6901
  tandemdiabetes.com
• OTHER COUNTRIES
  tandemdiabetes.com/contact

SECTION 6 Frequently Asked Questions

General Questions

Compatibility

• Is Tandem Source compatible with my operating system and browser?
  • For an up-to-date list of supported operating systems and browsers, please visit tandemdiabetes.com/support/tandem-source/professional.
• What pump versions does Tandem Source support?
  
  • Tandem Source only visualizes and provides data metrics for pump data generated with Basal-IQ technology version 6.3.1.1 and newer, or Control-IQ technology version 7.3.1 and newer. If you do not see data uploaded from a compatible pump, please contact Customer Technical Support.
• How do I know what software a pump has?
  
  • When you connect a compatible Tandem pump, the Upload Pump screen displays the pump software version. You can also check the pump software version as directed in the appropriate Tandem pump user guide.

Reports

Connecting Accounts

How many patients can I connect with?
You can connect with as many patients as you like. Note that connecting with a patient allows other Professional users in your clinic to access that patient’s data.

Can Tandem Source display data for more than one insulin pump?
Yes, Tandem Source can display data for each pump linked to a given patient’s account. This data can be used to generate the Overview report and the Daily Timeline report. If a patient has multiple pumps linked to their Tandem Source account, a toggle at the top of the respective report screen allows you to select which pump to display.

• Separate Overview reports and Daily Timeline reports are generated for each pump.
• The Pump Settings report only displays pump settings from the most recently uploaded pump.
• Linking a new pump to a patient’s Tandem Source account does not erase data uploaded from prior pumps.

Professional User Account Questions