1. Introduction
2. Safety
3. Overview
4. Using Bloomlife Connects SW
5. Troubleshooting
6. Privacy and Security
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Disclaimer
Bloomlife Conncets should only be used in the manner specifically set forth in this Instructions for Use (IFU).
Use of Bloomlife Connects in a manner not expressly described in this user manual may lead to improper product performance, the potential for hazard, and will void all warranties of any kind that are extended by Bloomlife in connection therewith.
Use of Bloomlife Connects in a manner not expressly described in this user manual may lead to improper product performance, the potential for hazard, and will void all warranties of any kind that are extended by Bloomlife in connection therewith.
About this Manual
This manual provides a step-by-step guide to using the Bloomlife Connects SW. Please read this user manual carefully before starting to use the Bloomlife Connects SW. If any part of this manual is unclear, please contact Bloomlife customer support for assistance at:
Email: support@bloomlife.com
Phone: 1 (315) 599-3280
We recommend that you always keep this manual for reference.
Email: support@bloomlife.com
Phone: 1 (315) 599-3280
We recommend that you always keep this manual for reference.
Important Notes
- The content of this manual is subject to change without notice.
- Some of the illustrations or descriptions in this manual may vary due to changes or improvements in Bloomlife Connects SW.
1. Introduction
1.1. Use of Bloomlife Connects
This manual provides the information necessary to operate Bloomlife Connects SW. It is required that you read this manual for understanding of how the Bloomlife Connects SW system works.
Do not use Bloomlife Connects SW before you read and fully understand the contents provided in this User Manual.
Do not use Bloomlife Connects SW for any purpose other than those for which it is intended. The use of Bloomlife Connects SW for unintended purposes could lead to a delay in condition monitoring.
1.2. Bloomlife Overview
Bloomlife Connects SW is a software system that connects patients and providers. Providers define clinical protocols within the system. Patients at home can share data from monitoring devices with their care provider and receive provider feedback on data per clinical protocol. The Bloomlife Connects SW system does not provide real-time data.
Bloomlife Connects SW is intended for use with the commercially available medical devices specified in this manual.
1.3. Device intended use
Bloomlife Connects SW is indicated for transferring, storing, and visualizing data between patients and providers using cleared 510(k) medical devices.
1.4. Labels and Symbols
The following table shows a list of symbols that may appear throughout this manual, on accompanying documents, on the packaging or the actual system parts. An explanation is provided next to each symbol.
Consult instructions for use
Warning or Caution
2. Safety
2.1 Contraindications
Contraindications are conditions under which the device should not be used because the risk of use clearly outweighs any possible benefit.
Bloomlife Connects SW should not be used in any of the situations described below:
Bloomlife Connects SW should not be used in any of the situations described below:
- Bloomlife Connects SW is not intended to provide diagnosis of the data transferred or visualized, it does not modify the data, and it does not control the functions or parameters of the connected device(s).
- Bloomlife Connects SW is not intended to acquire, process, or analyze a pattern or signal from a signal acquisition system.
- Bloomlife Connects SW is not intended to support time-critical decision-making and/or replace or direct the health care provider’s judgment.
- Bloomlife Connects SW is not intended to provide a specific preventative, diagnostic, treatment course or follow-up directive.
- Bloomlife Connects SW is not intended to provide time-critical alarms or alerts intended to trigger potential clinical intervention to assure patient safety.
- Bloomlife Connects SW is not intended for active patient monitoring requiring timely response to clinical context (e.g. in-hospital patient monitoring) and/or clinical condition (disease or diagnosis).
2.2 General Warnings and Precautions
Warnings alert about a situation which, if not avoided, could result in death or serious injury, or potential serious adverse reactions and safety hazards.
Precautions warn of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user/patient or damage to the equipment or other property. It is also used to alert against unsafe practices.
Precautions warn of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user/patient or damage to the equipment or other property. It is also used to alert against unsafe practices.
- Bloomlife Connects SW system and cleared device shall only be used by the assigned individual. Always follow your provider's recommendations based on the data displayed on the cleared device.
- The cleared device data is transferred to the Patient’s electronic medical record by the Bloomlife Connects SW system. Usage of the Bloomlife Connects SW System by anyone other than the assigned individual may lead to incorrect data on patient records which may impact the provider’s assessment.
- Text messages sent by the Bloomlife Connects SW system are intended to remind the individual of next steps and support your provider's instructions and recommendations, not replace them. Follow your provider's instructions and recommendations based on the values displayed on your device.
- Please make sure you have strong cellular connection prior to using the device and do not use the system outside the US. If you have an abnormal measurement but do not receive a text message or have questions, contact your provider directly.
3. Overview
3.1. How Bloomlife Connects SW works
- Step 1: Clinic sets up clinical protocols in the system
- Step 2: Provider identifies and writes an order for the system
- Step 3: Bloomlife onboards the patient
- Step 4: Patient receives specified device
- Step 5: Bloomlife contacts the patient to set up the Bloomlife Connects SW system, including reminders to take blood pressure per clinical protocol
- Step 6: Patient takes data using specified device and receives SMS per clinical protocol
- Step 7: Provider reviews data in the patient’s electronic medical record
3.2 Bloomlife Connects SW Requirements
3.2.1 Clinic Onboarding
The clinic is responsible for creating a clinical protocol for the use of Bloomlife Connects SW. The clinical protocol defines device reading thresholds, cadence of readings, and messages sent to the patient. For instance, a clinical protocol might define normal and abnormal blood pressure or blood glucose ranges.
The clinical protocol established during onboarding will define the clinical feedback sent to the patient after data transfer.
The clinic is also responsible to approve any associated devices used with the system.
The clinical protocol established during onboarding will define the clinical feedback sent to the patient after data transfer.
The clinic is also responsible to approve any associated devices used with the system.
Bloomlife Connects SW system requires clinical onboarding that includes electronic health record set up and clinical protocols.
3.2.2.1 Associated Device Requirements
The instructions for use of any associated devices shall be used to operate the monitor properly. The following associated device(s) are compatible with the system:
- iBloodPressure 1.0, Model SMBP802-GS-003
- iBloodPressure 1.0, Model SMBP802-GS-004
In accordance with the iBloodPressure manufacturer, please consult a medical professional before using this device during pregnancy as readings performed by this device may not be accurate during pregnancy.
Review the blood pressure monitor’s IFU to ensure proper use and troubleshooting of the device.
Associate devices will only work within the US cellular network. Any readings taken outside of the US will not be delivered to your clinic.
3.2.2.2 Blood Glucose Monitoring System:
- iGlucose Essential Blood Glucose Monitoring System, SMBGM-TMB-2282-G
Review the blood glucose monitoring system’s IFU to ensure proper use and troubleshooting of the device.
Associate devices will only work within the US cellular network. Any readings taken outside of the US will not be delivered to your clinic.
3.2.3 Patient Cell Phone Requirements
A cell phone (e.g. smartphone) with text message capability is required to use the Bloomlife Connects SW system.
Contact Bloomlife immediately if your cell phone number changes.
3.2.4 Patient Onboarding
Once a provider order has been created, will contact the patient to onboard them. Onboarding will consist of the following:
- Confirm the patient’s contact information including address, email, and phone number
- Confirm the patient has a smartphone
- Confirm the patient’s insurance and coverage
- Email the patient a confirmation document for electronic signature
4. Using Bloomlife Connects SW
4.1. Bloomlife Connects SW Set Up
During patient onboarding, Bloomlife will the associated device to the patient’s Electronic Medical Record (EMR).
Bloomlife will contact the patient after the associate device(s) are received to confirm the link between the device and the EMR. The patient can also request reminders to be set up through the Bloomlife Connects SW system for when to use the associate device(s).
All readings taken with the associated device(s) will be sent directly to the patient’s EMR.
Bloomlife will contact the patient after the associate device(s) are received to confirm the link between the device and the EMR. The patient can also request reminders to be set up through the Bloomlife Connects SW system for when to use the associate device(s).
All readings taken with the associated device(s) will be sent directly to the patient’s EMR.
Bloomlife Connects SW transfers data from commercially available medical devices directly into the patient’s electronic medical record. Only the patient shall use the assigned medical device to monitor their condition in accordance with the clinic’s order.
4.2 Taking a Blood Pressure Reading
Follow the device’s instructions to take a reading. The device will display the reading. Patients should follow their physician’s recommendations based on displayed reading.
Follow your doctor's recommendations based on the values displayed on the device.
4.2.1 Blood Pressure Feedback
The blood pressure monitor is cellularly enabled and will automatically send the blood pressure reading to the cloud. After a reading has been taken, the data will be sent to the clinic and a text message will be sent directly to the patient’s phone to provide clinical feedback per the previously established clinical protocols.
Do not turn your cell phone off or put your cell phone into airplane mode before you receive the text message. If you do not receive a text message within 10 minutes, contact Bloomlife. Follow your doctor’s recommendations based on the blood pressure displayed by the monitor. If you have an abnormal result, contact your doctor directly.
There are three types of text messages as shown below. Please note that the text message displayed below are examples, your clinic will determine the exact text message language you receive.
Message specified by your provider or clinic to confirm that your data was sent to your doctor
Example: Success! Your blood pressure reading was sent to your doctor. Based on your doctor’s feedback, your blood pressure is normal.
Example: Success! Your blood pressure reading was sent to your doctor. Based on your doctor’s feedback, your blood pressure is normal.
Message specified by your provider or clinic to request a second reading taken after 15 minutes due to an abnormal blood pressure reading:
Example: Based on your doctor’s feedback, your blood pressure looks elevated. If you are experiencing shortness of breath, headache, nauseas, or any other symptoms, please call your clinic right away at xxx-xxx-xxxx.
If you are not experiencing symptoms, Your doctor recommends waiting 15 minutes and taking a new reading – sit down, relax as best you can, and reposition the cuff before taking your blood pressure again.
Example: Based on your doctor’s feedback, your blood pressure looks elevated. If you are experiencing shortness of breath, headache, nauseas, or any other symptoms, please call your clinic right away at xxx-xxx-xxxx.
If you are not experiencing symptoms, Your doctor recommends waiting 15 minutes and taking a new reading – sit down, relax as best you can, and reposition the cuff before taking your blood pressure again.
Message specified by your provider or clinic to either contact your clinic or seek clinical support due to abnormal blood pressure.
Example: Your provider recommends going to your labor and delivery hospital immediately.
Example: Your provider recommends going to your labor and delivery hospital immediately.
If a second reading is required, follow the clinical instructions for taking your blood pressure. After the second reading has been taken, the data will be sent to the clinic and one of the two types of text messages will be sent:
Message specified by your provider or clinic to confirm that your data was sent to your doctor
Example: Success! Your blood pressure reading was sent to your doctor. Based on your doctor’s feedback, your blood pressure is normal.
Example: Success! Your blood pressure reading was sent to your doctor. Based on your doctor’s feedback, your blood pressure is normal.
Message specified by your provider or clinic to either contact your clinic or seek clinical support due to abnormal blood pressure.
Example: Your provider recommends going to your labor and delivery hospital immediately.
Example: Your provider recommends going to your labor and delivery hospital immediately.
Follow your doctor's recommendations for taking your blood pressure. If required to take a second reading, the text message will repeat these recommendations.
4.2.2 Patient electronic medical record
The blood glucose monitoring device is cellularly enabled and will automatically send the blood glucose reading to the cloud. After a reading has been taken, the data will be sent to the clinic and a text message will be sent directly to the patient’s phone to provide clinical feedback per the previously established clinical protocols.
Do not turn your cell phone off or put your cell phone into airplane mode before you receive the text message. If you do not receive a text message within 10 minutes, contact Bloomlife. Follow your doctor’s recommendations based on the blood glucose displayed by the monitor. If you have an abnormal result, contact your doctor directly.
There are two types of text messages as shown below. Please note that the text message displayed below are examples, your clinic will determine the exact text message language you receive.
Message specified by your provider or clinic to confirm that your data was sent to your doctor.
Example: Let's get some more information about that measurement for your provider. Please log into the app to get started.
Example: Let's get some more information about that measurement for your provider. Please log into the app to get started.
Message specified by your provider or clinic to request a second reading taken after 15 minutes due to an abnormal blood glucose reading:
Example: Looks like your blood sugar is a little low. Within the next 5 minutes, please eat a simple carb snack, wait 15 minutes, and recheck. A 15g snack (e.g. 1 cup milk or 1/2 cup of juice) should bring your blood glucose up about 20 points. If you are experiencing shaking, sweating, numbness around your mouth, confusion, tiredness, or other concerning symptoms, please call your clinic right away at xxx-xxx-xxxx.
Example: Looks like your blood sugar is a little low. Within the next 5 minutes, please eat a simple carb snack, wait 15 minutes, and recheck. A 15g snack (e.g. 1 cup milk or 1/2 cup of juice) should bring your blood glucose up about 20 points. If you are experiencing shaking, sweating, numbness around your mouth, confusion, tiredness, or other concerning symptoms, please call your clinic right away at xxx-xxx-xxxx.
If a second reading is required, follow the recommendations from the clinic and take a second measurement. Based on the measurement, there will either be another set of instructions from the clinic or you will be asked to log more information about your reading.
4.2.3 Logging measurement feedback
If you are monitoring your blood glucose, you will be asked to log into a patient portal to provide information for each measurement. The information you provide enables your care team to monitor and understand your data.
During onboarding, you will receive an email to log into the patient portal and create a password. Information on how to use the portal will be provided through the onboarding video in the patient portal.
After onboarding, you may view your blood glucose data at any time. Every time you take a measurement, a link will be provided so that you can log into the patient portal and provide information on that measurement.
During onboarding, you will receive an email to log into the patient portal and create a password. Information on how to use the portal will be provided through the onboarding video in the patient portal.
After onboarding, you may view your blood glucose data at any time. Every time you take a measurement, a link will be provided so that you can log into the patient portal and provide information on that measurement.
4.2.4 Patient electronic medical record
The device reading will be sent directly into the patient’s electronic medical record. Per the clinical protocols, abnormal readings will trigger notifications to the appropriate clinical staff.
Device readings will also be available via the clinician portal. Providers will have access to the portal as part of clinic onboarding.
Device readings will also be available via the clinician portal. Providers will have access to the portal as part of clinic onboarding.
5. Troubleshooting
Issue
Recommend Action
No SMS received
Blood pressure monitor is not working
Refer to the Blood Pressure Monitoring System Instruction for Use to troubleshoot.
If the system is still not working as expected, contact Bloomlife Support.
If the system is still not working as expected, contact Bloomlife Support.
Blood glucose monitoring system is not working
Refer to the Blood Glucose Monitoring System Instruction for Use to troubleshoot.
If the system is still not working as expected, contact Bloomlife Support.
If the system is still not working as expected, contact Bloomlife Support.
Patient/Clinic Portal issues
6. Privacy and Security
6.1. Cybersecurity
Scope
The scope of the system with respect to the patient and clinicians
Responsibility
For Bloomlife Connects , Bloomlife Connects is responsible for the environment. There are no user responsibilities to use this system.
Users are responsible for the security of their mobile devices and management of their passwords. It is recommended to have a passcode for mobile devices and (e)SIM cards.
Providers are responsible for the security of their EHR.
Users are responsible for the security of their mobile devices and management of their passwords. It is recommended to have a passcode for mobile devices and (e)SIM cards.
Providers are responsible for the security of their EHR.
Cybersecurity of Bloomlife Connects Platform
The Bloomlife Connects Platform is deployed within the BioT platform, which maintains a SOC2, runs routine penetration tests and is built in compliance with HIPAA, FDA GxP and GDPR.
Cybersecurity of Bloomlife Connects Platform
The Bloomlife Connects Platform is deployed within the BioT platform, which maintains a SOC2, runs routine penetration tests and is built in compliance with HIPAA, FDA GxP and GDPR.
Protection of critical functionality
Parameters that control critical functionality of data transfer between patient and provider are stored securely, per user, in the Cloud. The Cloud’s security infrastructure protects against unauthorized access and modification of these parameters.
Confidentiality Controls
All communication pathways where data is transmitted are protected with TLS 1.2, which has been verified through scanning the interfaces
- Smart Meter calling the device plugin lambda is using TLS 1.2
- BioT calling the controller plugin lambda is using TLS 1.2
- The AWS scheduler invokes the lambda directly and not over HTTP
- End points that the MDDS calls into, namely BioT and Athena, have the following being enforced:
- TLS 1.3 for BioT and
- TLS 1.2 for Athena as it does not support 1.3
- Qualys SSL Scan was run against the MDDS endpoints with the following scoring. Note: AWS has not yet disabled older versions of TLS, which is driving lower scores; however, the endpoints are using TLS1.2 or TLS1.3 as described above:
- Smart Meter Device Plugin Lambda: B because of TLS < 1.2 (AWSs limitation)
- Controller Plugin Lambda: B because of TLS < 1.2 (AWS limitation)
- BioT endpoint: B because of TLS < 1.2 (AWS limitation)
- Athena endpoint: A only supports TLS 1.2
- Smart Meter management portal: B because of TLS < 1.2 (AWS limitation)
- BioT portals: B because of TLS < 1.2 (AWS limitation)
Availability Controls
- Bloomlife Connects SW has been designed with multi-region architecture, composed of completely independent deployments on various locations around the world, providing high availability.
- Bloomlife Connects SW has no impact on the patient device functionality, it only receives and transmits data
- If Bloomlife Connects SW becomes unavailable, we recommend patients to contact Bloomlife Connects SW
Integrity Controls
- Integrity Verification- The 3rd party smart meter uses a pre-shared key to generate a HMAC with SHA256 of the patient's reading and sends the HMAC and patient data to Smart Meter Device Plugin Lambda. The pre-shared key is retrieved from the AWS Secrets Manager and when the lambda receives reading data, a HMAC with SHA256 is generated using the pre-shared key. The HMAC is compared with the one sent from the 3rd party sSmart Meter to ensure the reading data received is correct. If the HMAC's do not match, then the request is dropped and an exception is logged.
- Code Signing - AWS Signer is used to perform code signing on the Lambda Code developed for this product. The binary files are uploaded to AWS Signer and a signed binary is generated, which is deployed to the Lambdas. The code is verified before it is launched, as the Lambda function makes a call to AWS Signer to verify the signature is valid. If the signature is not valid, the code does not run.
Backup and Restore
The device uses the Cloud to backup and restore recorded data.
Version Identification
The current Bloomlife Connects SW version number can be requested by sending an email to Bloomlife Support at support@bloomlife.com
Repudiation Protection
Event logging is performed on the Cloud (authentication events, session data updates).
Cybersecurity Updates and Patches
Please keep your mobile platform operating system up to date. It is recommended to have anti-virus and anti-malware installed and up to date.
Contact Bloomlife to report cybersecurity related issues at:
Contact Bloomlife to report cybersecurity related issues at:
6.2. HIPAA Compliance
Bloomlife Connects SW was designed to comply with the Health Insurance Portability and Accountability Act (HIPAA).