Frequently Asked Questions

 

Find our quick start guide, product information, and answers to questions here.

BIOSENSE™ Device
BIOSENSE™ App
Ketone Testing
Orders & Returns
Clinical
Troubleshooting
Data Privacy
FAQs

BIOSENSE™ Device

The BIOSENSE™ device measures your ketones with a simple breath and shows if you are in nutritional ketosis. BIOSENSE™ also helps you learn how  lifestyle factors like diet and exercise routines impact your metabolism. The BIOSENSE™ app lets you view your personalized depth and duration of nutritional ketosis and track your progress towards your ketone goals.
 

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.

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. 
 
The BIOSENSETM device uses a lithium-ion enclosed battery. You can charge your BIOSENSE device using the provided Micro USB charging cable and an approved LPS power supply (maximum rating 5V/1A). Your device can take up to 2 hours for a full charge. If the red light indicator is seen through the mouthpiece your device is charging.
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 BIOSENSETM 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.
 
Your BIOSENSETM device storage holds 100 measurements. Once your device storage reaches 100 measurements, your oldest measurement will be overwritten by your newest. All measurements upload automatically to the mobile app when the device connects.
 
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.

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.

BIOSENSE measures ketone levels in ACEs units. Our ACEs unit is approximately 10x the blood ketone value. For example, if the BIOSENSETM 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.

The Ketone Score is a summary of the depth and duration of your nutritional ketosis each day. It is calculated using the area under the curve (AUC) on your Trends screen on the mobile app. The deeper your nutritional ketosis and the longer you maintain it, the higher your Ketone Score will be. In the app, we provide a default Ketone Score goal of 120. This is equivalent to maintaining a ketone level of 5 ACEs, the level where most people enter nutritional ketosis, for 24 hours (5 x 24  = 120). You can view your Ketone Score on the Goals screen of the mobile app. If you want to customize your Ketone Score goal, you can do so in the Profile section of the app.

The more measurements you take each day, the more accurately your Ketone Score will reflect your true metabolic activity. If you take at least 3 measurements per day (including one in the afternoon) and one measurement the next morning, the app will provide an extrapolation of your curve through your sleeping hours. The mobile app needs at least 3 measurements to make this extrapolation in order to avoid making inaccurate assumptions about your metabolic activity overnight. Additional measurements will provide a more accurate reflection of your area under the curve, indicative of your true metabolic activity.

Our Trends graph shows an extrapolation of your curve through time as long as measurements are taken within 16 hours of each other. If there is a ketone measurement lapse exceeding 16 hours the curve will end and start again at the following measurement. 

First, pair your device to the BIOSENSETM app (see: How do I pair my BIOSENSE device to 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 BIOSENSETM device will send all previously unsent data during device wakeup AND/OR after a measurement is taken. You may also manually sync data during these periods using the blue sync button in the upper-right hand corner of the Home screen on the BIOSENSETM app.
Turn on the BIOSENSE device and enable Bluetooth on your phone. Open the BIOSENSE app and navigate to the Profile page by pressing the Profile button at the bottom of the screen. Select Pair a device and select your device from the device 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. After the BIOSENSE device and app are manually paired for the first time, they will automatically connect each time the app is open and the BIOSENSE device is on and nearby.
 

Yes. You will still need to first sync your data using the BIOSENSE™ app in order to view your ketone data in other integrated third party apps.

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 BIOSENSETM 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 BIOSENSETM 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 BIOSENSETM 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

Free standard shipping via USPS is included in the purchase of BIOSENSE . However, you will be responsible for paying for your own shipping costs for returning your item. Shipping fees are non-refundable. If you receive an exchanged BIOSENSE, there will be no shipping fees.

At the moment, we are not listed in any FSA/HSA marketplaces, but we are pursuing this in 2020. As soon as we are eligible, we will announce this on our website and our social media pages.

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.
 
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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 later this year. 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 BIOSENSETM warranty.

In order to be eligible for repairs under warranty you must contact Readout Health before returning BIOSENSE™ for repair.  Please contact support@mybiosense.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@biosense.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. 

Extend offers you the option to purchase additional protection for your BIOSENSETM for one or two years. This coverage starts after your standard 1-year limited warranty expires. What’s covered:

  • Mechanical and electrical failures caused by normal wear and tear, as well as damage caused directly by a power surge

What’s not covered:

  • Accidental damage
  • Damage caused by abuse or misuse

How do I file a claim?

CLICK HERE for more information from Extend. Can’t find your answer in our support center? Contact us directly at support@mybiosense.com

FAQs

Clinical

BiosenseTM 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.
 

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.

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.
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