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FAQs

Biosense® Device

The Biosense app offers metabolic programs, Fat Burn scores, daily goals, ketone trends, a fasting clock, data trends, and personalized insights.  You can see how long and deep you are in ketosis on any given day, comparing days, weeks and months of your ketosis journey. The daily ketone trends let you easily see the impact of different foods and exercise routines on your ketone levels. The app allows users to add notes and track your meals, fasts, and exercise with your ketone measurements.

The Biosense® device measures breath acetone, which is produced as a byproduct of ketogenesis. The concentration of acetone in the breath indicates your level of nutritional ketosis. The device represents breath acetone in scaled units called ACEs, from 0-40. The higher your ACEs, the more fat is being burned for fuel in your body. On the device you can easily see which ACE level corresponds to light, advanced or deep ketosis.

Biosense® contains a highly sensitive chemical sensor. To protect your device from potential contamination from solvents, such as hand sanitizer, nail polish and other harmful chemicals, store BIOSENSE® in the protective Mylar bag provided with the device. The Mylar bag is impermeable to most solvents and will provide better protection than other permeable bags and containers.

The Biosense® device uses patent-pending Deep Lung Sampling technology to perform breath acetone measurements. The consistent sampling of only the latter part of the exhalation enables the most accurate level of breath acetone detection for nutritional ketosis monitoring.

The Biosense® system is intended for self-testing of acetone (ketone bodies) in the breath. It is intended for home (lay user) or professional use in the management of patients seeking to reach or maintain nutritional ketosis. The system should not be used to diagnose or treat any disease or condition. Follow your healthcare professional’s advice before making any changes to your disease management program.

Biosense® is an FDA registered Class 1 medical device.

Battery life depends on the testing frequency. With an average testing frequency of 3-5 times per day, your battery will last up to 5 days.

Plug the device into a power source using the provided micro-USB charging cable.

To preserve the performance of the device it is best to clean it once a week. Remove the mouthpiece from the device before cleaning by gently squeezing its base and pulling it away from the device. Use a cloth and water to clean your mouthpiece. Do not use cleaning wipes that contain alcohol as this can negatively impact device performance.

If your device determines that extra sensor warmup or clearing is necessary, it will automatically activate the Smart Clean process. Periodic Smart Clean activations are a normal part of regular device use and do not indicate device malfunction.

Please, remember solvents like hand sanitizer, nail polish remover, and other aromatics may react with the sensor and force the device into this cycle.

Biosense® contains a highly sensitive chemical sensor. Solvents like hand sanitizer, nail polish remover, and other aromatics may react with the sensor and interfere with sensor preparation and clearing. If the sensor is affected by environmental solvent exposure or is otherwise unable to adequately prepare, a red indicator will appear on the screen and direct you to run a sensor Clean. On your device select Settings, scroll down to Clean, and select. This process takes approximately 10 minutes to complete and requires your device to be plugged into the charger.

Testing after consuming certain foods or drinks can result in false high measurements. For best results, wait 60 minutes after:

  • Eating
  • Smoking/vaping
  • Drinking sodas or flavored waters
  • Consuming items with flavorings such as:
    • Toothpaste
    • Mouthwash
    • Cough drips
    • Breath mints/Chewing gum
    • Lip balm
    • Artificial sweeteners

Do not test after consuming alcohol. For best results, wait until the next morning.

The color scale on the Biosense device gives you a quick and easy indication of your state of ketosis.

Once you connect to the Biosense® mobile app, your device’s clock will be automatically updated with the current time on your mobile device. The Biosense® will retain this clock setting until it is fully powered off or until it completely loses its battery. If you prefer to use the device without the mobile app, you will need to manually set the device clock. You can do this by pressing the MENU button on the device and selecting Set Time.

Yes! You can view your past 10 measurements by pressing the MENU button on the device and selecting History.

Up to 50 measurements can be stored on the device.

The device vibration is caused by an activated pump, which pulls your breath sample from the mouthpiece into the device interior. The pumping mechanism is a key component of the patent-pending Deep Lung Sampling technology, which enables highly accurate breath acetone sensing. The pump also activates during the sensor preparation phase. Two short vibrations also indicate that an action is required by the user.

In order to ensure the most accurate breath acetone sensing available, the Biosense® device must prepare its highly selective sensor to receive a breath sample. Failure to adequately prepare the sensor leads to performance that does not meet our accuracy standards.

Biosense® cannot be used while charging due to the safety risk associated with placing a charging device into your mouth.

The device Menu can be accessed from the PRESS START screen. Simply press the SETTINGS (gear) button to access. Scroll with the settings (gear) button and select with the checkmark button.

To provide the most accurate breath measurement possible, your Biosense® device uses a pump to clean the ketone sensor both before and after the measurement, and also to pull a breath sample into the device. The buzzing sound you hear is simply the pump doing its job! You can hear the pump running during the three stages of the measurement:

1) During the “PREPARING DEVICE” phase, the pump will run periodically to make sure the sensor is clean and ready for a measurement.

2) When you reach the “BLOW” screen, blowing into Biosense® will activate the pump again in order to pull a breath sample into the sensor for analysis.  Make sure to keep blowing until the buzzing stops (the pump will buzz twice when sampling is complete) to get the best measurement.

3) Once your results are shown, Biosense® will run the pump a final time in order to clean the breath sample out of the sensor. Cleaning the sensor at the end of the measurement maintains the accuracy of your sensor and helps to speed up the warm-up for your future measurements.

FAQs

Biosense® App

Yes, the Biosense® System includes a free app that is available in the Apple App Store for devices running iOS 11.0 or later. The Android version of the app is available in the Google Play Store for devices running Android 4.3 or later.

The Biosense® app offers ketone trends, personalized insights and individual goal setting. You can see how long and deep you are in ketosis on any given day, comparing days, weeks and months of your ketosis journey. The daily ketone trends let you easily see the impact of different foods and exercise routines on your ketone levels. The app allows users to add notes and track your meals, fasts, and exercise with your ketone measurements.

Your personalized Fat Burn Score provides a holistic overview of your overall metabolic health by taking into account two key markers: 1) your active minutes and 2) your ketone level (ACEs).  Your Fat Burn Score ranges from 0-100 and will help you better evaluate the success of your daily lifestyle choices.  Score categories include:  Perfect (100), Optimal (85+) – your metabolic health is strong, Good (70-84) – you are on your way to achieving your metabolic health goals, Be Aware (less than 70) – your metabolic health can be improved.

The sum of two, Fat Burn Contributors make up the Fat Burn Score. Your contributors answer deeper questions about how your body is responding to physical activity and nutrition. The key to achieving a higher Fat Burn Score is to complete your daily activity goal of 25 minutes and to achieve the ACEs target associated with your metabolic program. However, we know that life happens and there may be days when you’re less active or when your fat burn levels are down. The Fat Burn Score takes this into account. You always get credit for ACEs measurements >1 as a percentage of your your daily ACEs target, and you can earn bonus points when you exceed your active minutes goal.

Biosense® measures ketone levels in ACEs units. Our ACEs unit is approximately 10x the blood ketone value. For example, if the Biosense® device reads 10 ACEs, that corresponds to about 1.0mmol in blood. Keep in mind that this correspondence is dependent upon the individual and on several other factors. For example, blood and breath ketones do not change at the same rate. If you keep these factors in mind, 10x is a good rule of thumb. More information is available in our article, Understanding the ACE Unit.

If measuring ppm the relationship to ACEs is approximately 1 ppm : 2 ACEs. For example, if the Biosense® device reads 4 ACEs, that corresponds to 1.9 ppm. This relationship is non-linear.

Tap on the “Me” icon in the navigation bar at the bottom of your home screen. Once on the “Me” screen, tap on the gear icon in the upper right corner to access Settings. Once in Settings, tap on “My Measures” under the “Account” header to see your recent ACEs measurements. Swipe left on any measurement and the word “Remove” will appear. Tap on “Remove” to delete your ACEs measurement.

First, pair your device to the Biosense® app by tapping the device sync icon located on the navigation bar in the app.

In order to sync data, your device must be paired and the app must be open. If the Biosense® app is in the background or your phone is asleep, the app will not be able to receive data from the device.

Once you have paired your device and opened the app, the Biosense® device will send all previously unsent data during device wakeup AND/OR after a measurement is taken.

Download and open the “Biosense by Readout” app from the app store or google play store. Open the app and navigate to the Home screen. Turn on your Biosense by pressing the check button for three seconds. The device should display “PAIR TO APP TO SET TIME.” On the app, select the pairing icon in the bottom right corner. The popup message will show all devices in range. Your device will broadcast as “B” or “BIOSENSE” + your device’s serial number. Select your device from the list. The popup message will display “Your device is connected.” A blue dot on the Biosense screen indicates that the Biosense is paired to the app. For more details, visit mybiosense.com/pairing.

  1. Tap on the pencil located on the home screen just below the metabolic program
  2. Select from a menu of metabolic plans to learn more about each program
  3. Initiate a new program by selecting Start at the top right corner of the metabolic program menu screen
  1. Tap on the pencil located on the Time-in-Range screen just below the Time-in-Range heading
  2. Select your ACEs range preference and tap on done in the upper right corner of the screen.
  1. Tap on the floating plus icon.
  2. Tap on the icon of preference to access next screen and select done to save.

You can activate the Apple Health Kit and Google Fit integrations in the Biosense onboarding process or in settings by tapping on “Connected Apps” and activating the toggle switch.  The integration will automatically add in your profile information which includes birthday, weight, height and gender.  Exercise data is not included with this integration, but will be available in the future.

You can access the Time-in-Range feature by swiping left on the Home Screen one time.  You can access the Fasting Clock feature by swiping left on the Home Screen two times.  The three progress dots below the Home Screen indicate screen selection.
You can access your ACEs measurement data by swiping to the Time-in-Range feature or by selecting the “Trends” icon on your navigation bar.
FAQs

Ketone Testing

Guidelines for following a low-carb lifestyle are simple, well established, and easy to understand. But the truth is that people often react very differently to the same lifestyle change, and it can be quite difficult to tease out the effects certain foods have on your own metabolism. This is why measuring your ketones is essential if you want to fully reap the rewards of a low-carbohydrate lifestyle. Ketone tracking is hugely beneficial to first-time carb cutters, as these people often test out which choices might increase their ketone levels. But it’s also useful for anyone who has already reached nutritional ketosis and strives to stay there. After all, understanding what kicks you out of ketosis is just as valuable as understanding what puts you in it! On top of that, the factors that influence your ketone levels include far more than just the foods you eat. Your exercise patterns, the amount of sleep you get, and the degree of stress in your life can all nudge your metabolism in one direction or another. Tracking your ketones regularly allows you to be better informed about how your body reacts to these factors.

To see your personalized depth and duration of nutritional ketosis, perform a measurement at least 3-5 times per day with at least 1 hour between measurements. For best results, include a measurement before breakfast, lunch and dinner. To learn about how different foods and exercise routines affect your individual metabolism, test right before and then again 1 to 3 hours after each meal or exercise session. There is no upper limit to the number of tests per day. Your Biosense® device stores 100 measurements and shows up to 10 measurements in the History, which is accessible via the MENU button. Once you connect your device to the Biosense® app, you can view all your past measurements.

In addition to carbohydrates and fat, ketones represent a third class of energy substrates for your metabolism. Under conditions of carbohydrate restriction, your liver converts fats into the ketones acetoacetate (AcAc) and beta-hydroxybutyrate (BHB), which can be used for energy. Acetoacetate also breaks down into acetone, which is volatile and can be measured in the breath. AcAc and BHB both circulate in the blood and can interconvert within cells. Blood ketone meters measure BHB. Unused AcAc is excreted in the urine where it can be detected using urinary dipsticks. Urine tests provide a range of ketone levels rather than a discrete value. Further, AcAc levels in the urine decline after several weeks of keto-adaptation, which limits the utility of urine strips to track nutritional ketosis over time.

Our ACE unit is approximately 10x the blood ketone value. For example, if the Biosense® device reads 10 ACEs, that corresponds to about 1.0mmol in blood. Keep in mind that this correspondence is dependent upon the individual and on several other factors. For example, blood and breath ketones do not change at the same rate. If you keep these factors in mind, 10x is a good rule of thumb.

Our research shows high correlations between BhB and acetone. One of the key findings was that breath and blood ketones appear to be offset in time, with blood ketones usually changing first followed by breath ketones. You will likely see this with measurements. You may want to experiment…try measuring your blood ketones 1-2 hours before a breath measurement. There are many biological factors that affect the rate and equivalency of ketones.

We recommend waiting to take ketone measurements 1 hour after eating or drinking.

FAQs

Orders & Exchanges

Purchasers pay for standard UPS ground shipping. In the case of a return, you will be responsible for paying for your own shipping costs. Shipping fees are non-refundable. If you receive an exchanged Biosense®, there will be no shipping fees.

In most cases you can use your FSA/HSA account to purchase a Biosense®. If your current plan covers weight management & nutritional foods, Biosense® should be eligible for coverage. Biosense® is an FDA approved class one medical device for breath ketone monitoring.

If you have any questions, please contact our customer service team at support@mybiosense.com.

Biosense® orders generally ship within 4-6 business days. Biosense® is a high-demand medical device, and longer delivery times are possible if inventory levels are depleted.

After your order is placed you will receive an order confirmation email from the Biosense® team. When your device is fulfilled you will receive an additional email with a USPS tracking number. Click on the tracking number to see the status of your order. If you did not receive or have lost the shipping confirmation email, please contact support@mybiosense.com.

Biosense® sales tax is automatically determined at the time of purchase and added to the purchase price, depending on the location of the buyer. Some states have tax exemptions for medical devices, while others have annual sales thresholds before taxation occurs.

Currently, Biosense® is available in the US and Canada only. We plan to ship internationally in late 2023. We will announce any developments on our website, social media pages, and in our newsletter. If you would like updates, please sign up for our newsletter.

Biosense® comes with a 1-year limited warranty. The warranty covers defects or malfunctions in your new Biosense®. This warranty is valid for one year from time of shipment, and coverage terminates if you sell or otherwise transfer the device.

Readout Health will replace any defective or malfunctioning part at no charge within the warranty period. You will be responsible for any shipping fees. Any issue that is caused by abuse, misuse, or an act of God (such as a flood) are not covered. Also, consequential and incidental damages are not recoverable under the Biosense® warranty.

In order to be eligible for repairs under warranty you must contact Readout Health before returning Biosense® for repair. Please contact support@readouthealth.com to get answers to your questions.

Readout may provide a Return Authorization to review the device. Once your return is received into our system, you will receive a confirmation email. System processing occurs Monday through Friday. Please allow our team one business day, up to 24 hours, once the carrier arrives to receive product into our system. Readout Health does not accept returns without a Return Authorization. Once entered into our system, your return must be inspected by our Quality Assurance team. Please allow 3-5 business days for this process. If there are any questions regarding your return, we will contact you. Once inspection is complete, we will notify you of next steps. If there is a defect that cannot be addressed, a replacement will be sent at no charge. If you are expecting a return shipment, you will receive a shipping confirmation the day of the outbound shipment.

Readout Health will replace any defective or malfunctioning part at no charge within the warranty period. You will be responsible for any shipping fees. Any issue that is caused by abuse, misuse, or an act of God (such as a flood) are not covered. Also, consequential and incidental damages are not recoverable under the Biosense® warranty.

In order to be eligible for repairs under warranty you must contact Readout Health before returning Biosense® for repair. Please contact support@readouthealth.com to get answers to your questions.

Readout may provide a Return Authorization to review the device. Once your return is received into our system, you will receive a confirmation email. System processing occurs Monday through Friday. Please allow our team one business day, up to 24 hours, once the carrier arrives to receive product into our system. Readout Health does not accept returns without a Return Authorization. Once entered into our system, your return must be inspected by our Quality Assurance team. Please allow 3-5 business days for this process. If there are any questions regarding your return, we will contact you. Once inspection is complete, we will notify you of next steps. If there is a defect that cannot be addressed, a replacement will be sent at no charge. If you are expecting a return shipment, you will receive a shipping confirmation the day of the outbound shipment.

We only replace items if they are defective. Please contact support@mybiosense.com for assistance with your device. If the Technical Support team determines that your device is defective, they may issue a return authorization form (RAF). Once your return is received and inspected, we will send you an email to notify you that we have received your returned item and determine next steps and notify you. The exchange policy does not cover Biosense® devices damaged due to negligence or misuse. Proof of purchase is required for all exchanges. The customer will be responsible for paying shipping costs for returned item(s). Shipping fees are non-refundable. If the customer receives authorization for an exchanged Biosense®, there will be no shipping fees.

 

The Biosense® breath ketone meter is a single-user medical device (Class 1). We do not allow returns once it is used due to sanitation.

FAQs

Clinical

Biosense® manufacturer Readout Health completed a successful clinical trial in October, 2019 with 19 participants and over 1,200 data points, representing over 80% of global research data points on breath acetone (ketones). Jim McCarter, MD/PhD was the Principal Investigator and data was presented at the Metabolic Health Summit in Long Beach, CA on January 30, 2020. Key discoveries included high correlation between full-day blood and breath ketone exposures, as well as the significant variability of ketones throughout the day. These findings demonstrated the significant advantages of multiple measurements throughout the day for optimal accuracy.

Readout Health partners with leading academic research institutions that require non-invasive, accurate ketone measurements for chronic disease research studies. Readout Health executed a broad collaboration agreement with Washington University St. Louis in 2019 to support a variety of metabolic clinical trials. Academic inquiries should be directed to research@readouthealth.com.

FAQs

Troubleshooting

To charge your device, plug into an approved LPS power supply using the provided micro USB cable. A full charge can take up to 2 hours and is indicated by a red LED light underneath the mouthpiece. Once the device has reached a full charge, the red LED light will automatically shut off.

There are two possible reasons why your Biosense device may occasionally ask you to Try Again.

  1. If the device was not able to fully prepare the sensor to receive a breath sample, you will see a Try Again message. After this message, Biosense® will perform additional sensor preparation steps.
  2. If the device does not detect a breath at the Blow screen, you will see a Try Again message. This can happen if you blow too gently or if you simply forget to blow. After the Try Again message, Biosense® will revert back to the Press Start screen where you can attempt another breath sample.
  3. The alcohol in the hand sanitizer and the acetone in the nail polish remover can interfere with the Biosense® sensor and trigger a Try Again message. You should avoid using the Biosense® device immediately after using these products.

Blood and breath ketones are different. The short answer to this question is not always. To find out more check out our article about the differences and similarities of breath, blood and urine ketone measurements.

The condensation that appears is from the moisture of your breath. This is very common with the Biosense® device and the moisture should disappear after time. This does not affect the performance of the device. If you find that the markings do not disappear after each use please reply back to our support team and we will investigate further.

If your device determines that extra sensor warmup or clearing is necessary, it will automatically activate the Smart Clean process. Periodic Smart Clean activations are a normal part of regular device use and do not indicate device malfunction.

Please, remember solvents like hand sanitizer, nail polish remover, and other aromatics may react with the sensor and force the device into this cycle.

Biosense® contains a highly sensitive chemical sensor. Solvents like hand sanitizer, nail polish remover, and other aromatics may react with the sensor and interfere with sensor preparation and clearing. If the sensor is affected by environmental solvent exposure or is otherwise unable to adequately prepare, a red indicator will appear on the screen and direct you to run a sensor Clean.

On your device select Settings, scroll down to Clean, and select. This process takes approximately 10 minutes to complete and requires your device to be plugged into the charger.

To power off your Biosense® device press and hold the Start button for about 12 seconds. You can power off your device from any screen. To power back on, press and hold the Start button for about 3 seconds.

An overly gentle blow may not be detected. Make sure you are blowing with moderate strength. Continue blowing until you feel two short vibrations, which signals that a breath sample has been correctly obtained. If the device continues to report ‘Blow Undetected’, please, perform a Hard Reset. Press and hold the Checkmark/Start button for 13 seconds. You will see the logo disappear. Once the device is reset, press the checkmark button once more for 3 seconds until you see the Biosense® logo. Then, take a ACEs measurement.

If Biosense® does not detect your blow after three attempts, reset the device by holding the start (check mark) button on the device until the screen is off.

Make sure you have previously paired your Biosense® device to the app (See: How do I pair my Biosense® device to the app?). In order to sync data, the app and device must be paired and the app must be open. If device and app are paired and the app is open, the Biosense® device will send all previously unsent data to the app upon device wakeup AND after a measurement is taken.

Android/iOS If you are having difficulty pairing your device with the Biosense® app, turn off Bluetooth in your phone’s settings and close the Biosense® app. Go back to your phone’s settings and turn Bluetooth back on. Turn on/wake up your Biosense® device. Open the Biosense® app, go to Profile and select Pair my device. Select your device from the list. Your device name will appear as “B” or “BiosenseXXXX” (example: Biosense1234). If you have successfully paired, you will see a message that says Device Connected. Only Android requires that you grant the Biosense® app location permissions in order to utilize the Bluetooth feature. You can do this by navigating to Settings > Apps > Biosense and changing the permissions to allow Location.

FAQs

Data Privacy

Yes, your data is private. Please refer to our web and mobile app privacy policies.

While optional, setting up your account to include chronic conditions or diseases allows Readout Health to build content to support individuals with those conditions, including clinical trial links where nutritional ketosis therapy is being researched. Note that only de-identified patient data can be used to improve care, estimate the costs of care, and support public health initiatives.

FAQs

Biosense® Group Coaching Program

The Biosense® Coaching program is a weekly live program that includes real-time engagement with a Registered Dietitian. During each session, you will be provided a brief lecture followed by time to ask any questions you may have. Our coaches will break down how to incorporate both the app and device to help you successfully reach your health and wellness goals. Finally, our coaches will assist you in getting the most out of our app features so that you can stay engaged and motivated in between sessions. 

Week 1

Biosense® 101: Learn how to use the device to help validate and reach your goals. Be introduced to ketogenetic dietary patterns and fasting. Determine your “why.”

Week 2

Low-Carb: Make low-carb eating work for you with variations, benefits, and associations with various ketone levels.

Week 3

Fasting: Learn to incorporate fasting into your plan. Understand the benefits of fasting, the types of fasts, and fasting’s association with autophagy.

Week 4

Sustainable Behavior Change: Break down the hidden barriers of behavioral change to ensure the changes you make work for you and are sustained in the long run. Determine the next steps of your journey.

Biosense® Group Coaching is intended for use by healthy individuals who want to enhance their health and well-being and by individuals who wish to proactively manage their weight in an easy and healthful way. 

All group coaching programs are non-refundable, except where required by law or any applicable partner/services provider terms. Once your program is canceled, you will retain access to your account until the end of your current billing cycle. No partial refunds will be issued.

No. The Biosense Coaching program is only a dietary program and cannot advise you on medications, bloodwork, or diagnoses. Only your own physician can do that. Your Biosense coach may only advise you on diet-related items.

No, we do not offer medical primary care. Biosense® Group Coaching is a complement to—not a replacement for—your primary care provider or any other specialists currently involved in your medical care.

When you initially register for the program, you will receive an email with meeting instructions.  If you are unable to locate this email, please contact coaching@readouthealth.com and we will resend it to you.

If you have the passion and experience for healthy lifestyle coaching, we would love to hear from you.  Send your CV and other relevant qualifications to coaching@readouthealth.com and we will consider you as we add on to the team.

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