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 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).
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.
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 device readings 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.
Bloomlife Connects SW system requires clinical onboarding that includes electronic health record set up and clinical protocols.
3.2.2 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:
3.2.2.1 Blood Pressure Monitoring System
In accordance with the blood pressure monitor’s manufacturer, the standard cuff provided with the device (8.6-17.7in - 22-45cm / Medium to XL fitting size) has been cleared for use during pregnancy. In the event the cuff does not fit, please consult a medical professional as readings performed by this device with other cuff sizes 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
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, Bloomlife will contact the patient to onboard them. Onboarding will consist of the following:
4. Using Bloomlife Connects
4.1. Bloomlife Connects Set Up
During patient onboarding, Bloomlife will connect 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 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 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 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.
Please ensure that your device has good cellular connectivity. Poor cellular connectivity may result in data transfer delay, which may cause the provider to receive data from monitoring devices late or receive no data.
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 device off or put your device into airplane mode immediately after taking your measurement, otherwise it may result in data transfer delay, or error. 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.
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.
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.
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.
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.
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.
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.
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 Blood Glucose Monitoring System Feedback
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 device off or put your device into airplane mode immediately after taking your measurement, otherwise it may result in data transfer delay, or error. If you do not receive a text message within 10 minutes, contact Bloomlife. Follow your doctor’s recommendations based on the results displayed by the monitor. If you have an abnormal result, contact your doctor directly.
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.
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.
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.
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.
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.
In the event modifications to patient’s electronic medical records account are required (e.g. changing the patient Medical Record Number - MRN), the clinic must ensure that Bloomlife Connects remains associated with the updated account. Contact Bloomlife if Bloomlife Connects updates are also required prior to modifyng the account.
Device readings will also be available via the clinician portal. Providers will have accessto the portal as part of clinic onboarding.
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