PATIENT FAQS
The FAQs below are designed to help you self-resolve issues that may come up when utilizing the Sensinel System in your home. In the event you need more detailed information, please refer to Patient Resources, including the Patient IFU and Patient Reference guide and/or contact customer support at 1-800-ANALOGD (1-800-262-5643).
General
The Sensinel System is intended for adults undergoing monitoring for cardiopulmonary conditions under the direction of a licensed medical professional to measure, record, and periodically transmit physiological data.
In less than 5 minutes per use, the Sensinel System collects many of the same measurements that your physician would collect during an office visit and sends them to the Sensinel clinical triage team.
The system is indicated for patients:
· Living with Heart Failure (HF)
· Living with Chronic Obstructive Pulmonary Disease (COPD)
· Recovering from a Coronary Artery Disease (CAD)-related event
· Taking diuretic medication
A prescription is required for patients to use the Sensinel System. Please consult with your doctor.
For Sensinel customer support, call 1-800-ANALOGD (262-5643) and select option #3.
For clinical questions or support while using the Sensinel System, please contact your cardiologist or the program manager at your heart failure clinic. If you have a life-threatening emergency or clinical issue that requires an immediate response, please dial 911 for your local Emergency Response Team.
The Sensinel™ Secure Wearable
Remove and place the Sensinel Secure Wearable in the Sensinel Base Station and connect it to the charging connector. This will immediately stop any unintended measurements.
To start a measurement, you must press and hold the blue button for precisely three (3) seconds (count “one Mississippi”, “two Mississippi”, “three Mississippi”) before releasing and starting the measurement.
Please note: Not waiting for three (3) seconds by pressing the blue button too quickly shows the battery level on the Secure Wearable. In contrast, pressing the blue button for greater than three (3) seconds places the device into Bluetooth advertising mode (for setup at the clinic only).
Make sure that:
• The Secure Wearable is fully disconnected from the Base Station when starting a measurement.
• The battery on the Secure Wearable has been charged to over 20% (by checking that the Base Station LEDs show yellow or green for sufficient charge or quickly pressing the device button on the Secure Wearable to show the battery level) . If it is not sufficiently charged a measurement will not begin and the Secure Wearable light will flash red and beep. Continue to charge the Secure Wearable until the Base Station LEDs indicate yellow or green for sufficient charge. This should not take more than thirty (30) minutes.
A blinking blue light on the Secure Wearable means that the button on the device was held down too long (greater than 10 seconds), which puts the device into Bluetooth advertising/pairing mode with the device’s mobile application (this is intended for clinician use only).
To get the device out of Bluetooth pairing mode, remove it and connect it back into the Base Station to reset it and then try taking your measurement again.
Make sure that the charging connector is attached correctly (and not upside-down). The bottom LED light on the Base Station should be lit up (after about a minute) and the LED bar on the device should be “pulsing green.”
You can check the battery charge level by quickly pressing the device button on the Secure Wearable or by plugging it into the Base Station, waiting about one minute, and checking the Base Station LEDs show yellow or green for sufficient charge.
Try unplugging the Base Station and moving it closer to a window (or other area where you know you have good cell service). Microwaves, walls, and other things inside your home can block cellular signal. You may also try moving the Base Station away from other large electronics (if possible). After these attempts, wait 24 hours to see if the issue resolves.
If indications of bad connectivity and/or a blinking red connectivity LED light persist for greater than 24 hours, call Sensinel customer support at 1-800-ANALOGD (262-5643) and select option #3.
To troubleshoot:
The most common cause for these types of errors are “contact” and “tilt” errors that are happening during measurements. This causes the measurements to take longer than the anticipated 5 minutes or less.
For contact (orange) errors:
Ensure that the adhesive is placed correctly on the Secure Wearable, checking that you can see all the round metal electrodes (5) under the clear hydrogel and that there is no air gap between the metal and the hydrogel.
Replace the adhesive if needed. The hydrogels may be dried out, preventing good measurement data. Remove the Secure Wearable, replace the adhesive using the instructions in the patient user guide, and try again.
Press down on all the sensor contact locations between the Secure Wearable and your chest to ensure that the entire adhesive surface of the Secure Wearable is contacting your skin.
In rare cases of extremely dry skin, you may need to slightly dampen the skin under the Secure Wearable in order to achieve good electrode/adhesive contact to the skin. This can be done using a baby wipe or wet wipe.
For tilt (yellow) errors:
Adjust your position to reflect a more upright position (position 1) or reclined position (position 2) until beeping stops.
Please note: These errors typically appear upon initiation of a measurement in either position and will automatically stop after 20 seconds and take the desired measurement. Contact your healthcare provider or clinical care team immediately if you are no longer able to achieve the two positions outlined in the initial baseline office visit.
If measurements continue to be longer than 5 minutes, try plugging the Secure Wearable into the Base Station to stop the measurement and try again. If this persists, try resetting the device.
PLEASE NOTE: Accurate measurements are important. As you troubleshoot alarms, keep in mind that after approximately one (1) minute, all errors will be disregarded, and the measurements will continue. However, these measurements may give poor data quality.
You can press the blue button when you are in the correct position to start the second part of the measurement immediately. Otherwise, you can wait for approximately one (1) minute and the measurement will proceed on its own without a button press.
This is okay. Take your time getting into position two (2). The Secure Wearable will still measure important parameters during this transition. However, do not press the blue button before you are settled in position two (2).
Try to reset the Secure Wearable by plugging it back into the charging cable in the Base Station. If resetting does not resolve the issue, the Secure Wearable will still take measurements and will record the position correctly, but there will be approximately twenty (20) seconds of tilt error chimes in the beginning.
If this issue continues and cannot be easily resolved at home, contact your provider to determine if the Secure Wearable needs to be baselined again or replaced.
Background noise and ambient light may impact your ability to hear sounds or see lights when using the Secure Wearable. In these instances, take measurements in a quiet setting with low lighting. For those who are hard of hearing, the sounds on the Secure Wearable may still be difficult to hear. The Secure Wearable lights are consistent with every sound and can be used to identify errors and measurement stages if sounds are difficult to hear. If the lights are difficult to see, low lighting, use of the mirror on the Base Station, and/or a handheld mirror can be used to better visualize the LED lights.
The Secure Wearable also makes sounds that can be used to identify errors and stages of the measurement. You can also look to see whether the light is blinking, fixed, or off. Use the Patient Reference Guide to identify the different stages of measurements or errors that are occurring with the light patterns.
Sounds can also help identify error occurrences or stages of the measurement. Use the Patient Reference Guide to identify the different stages of measurements or errors that are occurring with the sound patterns. If sounds are difficult to hear, you can also use the mirror on the Base Station or a handheld mirror to see the light patterns.
Sensinel System Home Setup
The top light on the Base Station should be green immediately after plugging it in. The light on the Secure Wearable should turn on after a few seconds. The bottom two lights on the Base Station may take up to several minutes to fully appear (especially if you are using the Base Station for the first time at home).
If this does not happen, try the following:
Ensure that the plug end is plugged into the base station and that the adaptor end is directly plugged into an electrical wall outlet, with the Secure Wearable connected to the magnetic charger inside the Base Station.
Try a different outlet in your home.
If the Secure Wearable and/or Base Station appear not to be working properly, try to reset the Secure Wearable by plugging it back into the charging cable in the Base Station.
The Sensinel System should ideally be set up permanently where you sleep and have strong cellular reception (like near a window), as your body should be at rest when you take your daily measurements (not right after movement). The location where you sleep is also generally a good place to be able to get into both body positions one (1) and two (2) which are needed in order to take reliable measurements.
Also make sure that the Sensinel Base Station is on a sturdy surface that will not tip over easily, as the base station is fairly heavy (and top heavy).
The Secure Wearable should be “pulsing green” when the magnetic charger is connected.
Make sure that the following conditions are met:
• The Sensinel Base Station is plugged into the wall and the top LED is green on the Base Station.
• The Base Station’s magnetic charger is plugged into the Secure Wearable in the appropriate position (there is a nub on the magnetic charger that should be on the bottom side of the Secure Wearable). Try re-plugging in the magnetic charging adaptor to the device and wait about 30 seconds.
• If the issue persists for several days, the Secure Wearable could be out of battery. Wait a few minutes to see if the Secure Wearable comes on.
Restart the Sensinel Base Station to resolve this issue.
The Sensinel System is intended for long-term (up to one year) once-or-twice daily monitoring. The Secure Wearable is not meant to be worn between measurements and should be removed and returned to the Sensinel Base Station directly following data collection.
Measurements should be initiated in the morning upon waking, and/or in the evening just before sleep. A care team will instruct the patient on how often and for how long to use the Sensinel System depending on the device prescription. Each measurement takes no more than 5 minutes, with half of the measurement in an upright seated position (Position 1) and half of the measurement in a reclined supine position (Position 2). Measurements are initiated with the large blue button on the Secure Wearable electronics housing.
Once measurements are complete and the Secure Wearable is returned and charging in the base station, data is automatically transmitted from the wearable to the base station, and then forwarded to the Sensinel Cloud Platform via wireless network.
This patient video provides more details on the Sensinel patient flow.
Travel
Traveling with the Sensinel System is encouraged, especially if you are traveling for a period of time greater than three (3) days. There is a leather strap on the Sensinel Base Station to allow you to easily carry the Secure Wearable inside the Base Station. Please note that the Sensinel System contains lithium ion batteries, which may need to be declared before traveling by plane.
Make sure that the Secure Wearable and the Base Station are plugged in to charge immediately upon arrival at your destination. Also note that the Secure Wearable adhesives are only meant to withstand the temperature range given at the back of the user guide and may lose their efficacy/stickiness if left in hot or cold environments for a sustained period of time.
If you are traveling to an area where your base station does not have cellular coverage, the Sensinel System will still record data up to approximately a month’s worth of measurements. This data will be available to your clinical team once the Sensinel System is back in a coverage zone.
If you are not able to bring your base station with you, the Secure Wearable has about a week of battery life and will store your measurements until you are able to plug the wearable back into your Base Station.
Yes, although it is not recommended as the Sensinel Base Station charges, stores, and protects the Secure Wearable. It also sends measurement data that is monitored daily to the triage team. However, if you must travel without your Base Station, the Secure Wearable does have about a week of battery life and will store measurements on the device until it is connected to the base station to charge and upload.
Sensinel System Care
To start a measurement, you must press and hold the blue button for three (3) seconds (count “one Mississippi”, “two Mississippi”, “three Mississippi”) before releasing.
Please note: Not waiting for a full three (3) seconds by pressing the blue button too quickly shows the battery level on the device. In contrast, pressing the blue button for greater than three (3) seconds places the device into Bluetooth advertising mode (for setup at the clinic only).
Make sure that:
• The Secure Wearable is fully disconnected from the base station when starting a measurement
• The battery of the Secure Wearable has been charged to over 20% either using the base station or a quick press of the device button. If it is not sufficiently charged a measurement will not begin and the wearable light will flash red and beep. Continue to charge the Secure Wearable until the base station LEDs indicate yellow or green for sufficient charge. This should not take more than thirty (30) minutes.
Use your household waste disposal method to throw away adhesives (they can be thrown in the trash as you would a Band-Aid but are not recyclable/compostable).
When applying new adhesives, check the expiration date on packaging. Do not use expired adhesives as they may not take measurements accurately.
Adhesives need to be changed:
• Once a week, or
• After more than 4 uses, or
• When the Secure Wearable no longer adheres well enough to the skin to complete a measurement, or
• When significant dirt, lint, hair, or dust is visible on the adhesive pads
To help prolong the life of each adhesive set, be sure to store the Secure Wearable inside the provided Base Station trays, adhesive-side down, covering them with the clear adhesive protective liners.
For additional details, please refer to page 20 of the Sensinel System Patient User Guide.
Do not use your Sensinel System if any component is damaged, especially if electronics and/or sharp edges are exposed. If any part of your system is dropped, broken, or otherwise stops working or fitting correctly, ADI will process a request for replacement.
Please contact customer support at 1-800-ANALOGD for replacement.
· Gently press down around the sensors at both round ends of the Secure Wearable
· Make sure the Secure Wearable is sticking well to your skin
· Ensure that the adhesives are applied properly to the Secure Wearable, covering the electrodes
· Moisten your skin with a baby wipe or a damp cloth
· Re-trim your chest hair, if applicable
You may need to replace your adhesives and re-apply the Secure Wearable.
Contact your healthcare provider to request a replacement Secure Wearable and schedule a fitting appointment for baseline measurement. DO NOT attempt to resize the device yourself.
It is recommended that measurements are taken in a quiet, peaceful location. Background noise (such as televisions, radios, conversations, loud kitchen appliances) will affect the quality of your measurements and your provider will not be able to clearly hear your heart sounds.
These are the hydrogels that help stick the Secure Wearable to the body and support collection of good measurement data. Leave them on when applying adhesives to the device.
Pay close attention when removing the liner from the gel adhesives to prevent them lifting off the device and being removed with the liner.
The small round sticker goes on the gold acoustic sensor. You need to remove its liner before putting the adhesive on the Secure Wearable by holding down the blue tab on the circular part and taking off the top clear liner layer. Then put the adhesive on the device and make sure that the round adhesive stays on the acoustic sensor when you use the device for the first time with the new adhesive. Refer to page 21 of the Sensinel Patient User Guide for detailed instructions.
Yes, the Secure Wearable can be cleaned, but it is not required. If needed, you can clean all exposed parts of the Secure Wearable by using a cloth dampened with water, baby wipes, or 70% isopropyl alcohol. Do not submerge the device in water or wash it. Do not clean the disposable adhesives.
New adhesives include a set of clear liners. Replace your current set of adhesives on the Secure Wearable so that they can be covered by the provided clear liners when not in use. The Secure Wearable should be placed in the Base Station trays with clear liners in place after use.
This Secure Wearable is not meant to be immersible, used in the shower or any other wet environment. The Sensinel System and its Secure Wearable are designed to be surface-cleanable only using a cloth dampened with water, baby wipes, or 70% isopropyl alcohol.
Seek or call for urgent care in your local area or contact your healthcare provider immediately if you think you are having a medical emergency.