• Ember User Guide

    Non-invasive hemoglobin tracking system
    measuring up to 9 parameters

    Welcome!

    We are very excited you have chosen Ember to fulfill your training and exercise needs. If at anytime you have questions, please feel free to reach out to us at Cercacor. We are committed to doing what we can to ensure you become an advocate of Ember and Cercacor technology.

     

    Sincerely,
    The Ember Team at Cercacor

    *Equipment and software pictured in this user guide is based on information available at the time. Android App may not include all features pictured or described. Actual product offerings may vary from those shown or may be subject to availability delays or discontinuance.

    Cercacor, the Cercacor logo and Ember are trademarks of Cercacor Laboratories, Inc. Apple, the Apple logo, iPhone and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc.

    Contents

  • Indications for Use

    Ember is intended for use by athletes or their trainers to help measure and track hemoglobin, pulse rate, perfusion index, oxygen saturation, oxygen content, respiration rate, pleth variability index, carbon monoxide or methemoglobin. It is intended to be used by individuals 13 years or older with a finger width of 22mm or less. This product is not a medical device.*

     

    The Ember system consists of the device, sensor, and mobile app. The Ember device requires a smartphone with Bluetooth 4.0 capabilities to operate, running iOS 9.0 or newer or Android 5.0 or newer.

    *This product is not intended to monitor or alleviate a physiological condition or disease state. Individuals who need a device to monitor a medical condition should contact their physician. Ember is not meant to replace laboratory measurements nor is it intended for medical use. If you want more accurate hemoglobin assessments, please use invasive methods using properly conducted Cyanmethemoglobin assay or properly conducted and calibrated Coulter Counter testing.

  • Safety

    WARNING:

    • Reduce possibility of entanglement or strangulation when using and storing sensor cable.
    • Explosion hazard. Do not use Ember in the presence of flammable substances in combination with air, oxygen-enriched environments, or nitrous oxide.
    • Avoid risk of an electric shock by only plugging in the Ember sensor into the device sensor port.  Also, do not plug the Ember sensor into any other equipment except Cercacor devices.
    • Only use a UL Listed power adapter that meets LPS or Class 2 limits rated 5V, minimum 0.5A.
    • Do not incinerate battery.

    CAUTION:

    • The first iOS or Android smart device that you connect Ember to will be the device the smart device that gets your 200 included measurement credits.  Credits are not transferable between smart devices.
    • Do not lift the Ember device by the cable or sensor.
    • Discontinue use of the product if it appears to be damaged in any way. Immediately contact customer support. 
    • Do not attempt to adjust, repair, open, or disassemble the device and/or sensor in order to avoid personal injury or damage to device.
    • Do not submerge device and/or sensor under water or cleaning solution, which will cause severe damage.
    • To prevent electric shock, avoid placing device on surfaces with visible liquid spills. Do not soak or immerse the device in liquids, and only use cleaning solutions sparingly.
    • The Ember device and sensor should be properly disposed as electronic waste. 
  • Getting Started

    Ember device diagram

     

     

    CREATE AN ACCOUNT (Creating an account is optional, but highly recommended)

    • Download the free “Ember by Cercacor” app from the Apple App Store or Google Play.
    • After you open the app, tap the “Sign Up” text at the bottom of the page to create an account. Follow the screen prompts until your account is created. 
    • Congratulations! You have now created an account. Next let’s connect Ember to your smartphone.

     

    Connecting Ember to your smartphone

     

    • The Ember device is shipped in sleep mode when you first receive it. To wake it up press the button for 3 seconds and then a series of blinking rectangles will appear. Now it is visible to the “Ember by Cercacor” app.
    Troubleshooting your connection to the Ember device
    • Check your battery level by pressing the button on the side of the Ember device to check if there is sufficient charge. 
    • Make sure your Ember device is within a close range (approx. 50’) of your smartphone. 
    • If prior steps do not work, try force quitting the app. To force quit the app, double click the home button on your iPhone then swipe up to close the app. 
    • If your Ember device does not show within the “find device list”, press and 
      hold the Ember button for 3 seconds until the LED lights blink in a sequence from
      the center out. 
    • If prior steps do not work and your Ember device does not connect to the app or is still having trouble taking measurements, then press and hold the button on the side of the Ember device for 6 seconds. This will enable a hard reset of the Ember device.   
    • It is not recommended to delete the Ember by Cercacor App as this may delete all of your measurement credits. 

    If problem persists, contact support@cercacor.com. Be sure to include a complete description of the problem.

  • Taking a Measurement

    1. Begin by placing the sensor on a finger free of deformities. It is best to use the pinky (smallest) finger of your non-dominant hand. It is recommended to not use nail polish for best accuracy and repeatability of measurements. Blue or green nail polish significantly affect the accuracy of the measurement.

    • The cable should be in a straight line off the tip of your finger. 
    • Always use the same finger for every measurement.  Ensure your finger is all the way into the sensor. 
    • Use the same posture and remain still during each measurement. 

     2. Tap to check the parameters you want included on your next measurement. Once you are ready, tap the “Start” button. The measurement time varies and can be as fast as 30 seconds. Be patient, the system will populate results as they are acquired.

    For best results measuring with Ember:

    • Be sure not to move around during the measurement.
    • Refrain from talking, coughing, or sneezing during the measurement.
    • During the measurement, a question related to the activity will be displayed.  
    For best results collecting data with Ember:
    • Be sure to answer the activity question to get more value from your graphs.
    • Take the time to add subjective emotional and pain states after each measurement.

    3. Your measurement results will be displayed on the screen. When you tap the “Capture” button, the numbers displayed will be saved in your history. The gauge to the right of the display tells you your target range based on your age and biological sex (must have an account for gauges to be enabled). You can customize the target range based on your individual goals by accessing the “Options” tab of the app (see page 26).

    Live Results

    Captured Results

    Measurement Details

    When you enable the Ember by Cercacor app to track GPS location, each measurement you take will log the location and capture the outdoor climatic details where your measurement was taken.

     

    * Please keep in mind these details are not measured by Ember but from
    published data from an outdoor sensor within a similar zip code

    Rearranging Layouts

    Out of Range Results

    If your results display “Low” instead of a numeric value for hemoglobin, it indicates that your value was below 10 g/dl and is too low to present a number. If you receive the phrase “High” instead of a numeric value, it indicates that your value was above 24 g/dl and is too high to present a number. If you have impurities of CO or Met then your SpO2 values may not be accurate. If SpO2 values are lower than 90% CO values may not display in some cases. If Met is greater than 2%, the value for CO will not display.

     

    If your value has a red box around it, the value is out of your set ranges. These ranges can be adjusted to your specific needs in the “Options” tab of the App.

    The default ranges displayed on your results screen can be adjusted within the “Options” tab of the Ember app.

     

    The default values are from published sources on general population ranges based on biological sex and age.

    We recommend you set your own custom ranges based on input from your trainer or your own personal goals.

    Inaccurate readings can be caused by:

    User Factors

    • Using the sensor on a deformed finger or placing it incorrectly.
    • Moving or talking during a measurement.
    • Electromagnetic Interference (EMI) from items such as computer displays and/or
    • LCD TVs.
    • High intensity lights (including pulsating strobe lights or sunlight) directed on the sensor.
    • Externally applied coloring (such as nail polish).

    Other Factors

    • Hemoglobin synthesis disorders, Hemoglobinopathy, or Vascular disease.
    • Elevated Bilirubin, Carbon Monoxide and/or Methemoglobin.
    • Low arterial perfusion or low arterial oxygen saturation levels.

    Note: Some of these may cause incomplete measurements see pg. 28.

    Add paragraph text here.

    Incomplete Measurement

    If you take a measurement and receive the “Incomplete” pop-up dialogue, please check the following and try your measurement again.

     

    • Be sure you have the correct region selected under “Power Line Frequency” settings in the Options menu.
    • Protect the sensor from bright sunlight.
    • If the problem persists contact support@cercacor.com and mention code that is displayed
  • Parameter Descriptions

    Your Ember device is capable of measuring numerous parameters depending on your model or the number of parameter upgrades that you have installed.

    Hemoglobin (Hgb)

    The protein contained in red blood cells that is responsible for delivery of oxygen to the tissues. The range of hemoglobin values can vary based on your age and biological sex. For adults 18 years and over at rest, hemoglobin values can be between 12-15.5 g/dl for females and 13-17.2 g/dl for males. Tracking your Hgb first of day and Pre/Post specific activities such as workouts or hydration may help you understand the intensity of your workouts and the fluid volume shifts and/or recovery times. Additionally, you may be able to learn the extent to which elevation training increases your Hgb and how long the effect lasts after returning to sea level.

    Pulse Rate (Pr)

    The number of beats your heart takes per minute (bpm) as detected from the pulsation at your finger tip. At rest values range between 50-85 bpm however fit individuals typically have lower resting heart rates. This is because their heart is more efficient and effective with each beat that it requires fewer beats per every minute. Tracking your pulse rate first of day and pre and post workout is a great benefit of using Ember to get an understanding of the intensity of your workouts as well as the impact over time to your fitness level on your first of day pulse rate.

    Perfusion Index (PI) 

    The strength of blood flow/circulation at your finger tip measured as a percentage (%). Values for PI range from 1-20%.

    Oxygen Saturation (SpO2 )

    The amount of hemoglobin that is saturated with oxygen expressed as a percentage (%). At rest you should be greater than 95% oxygen saturated and after an intense workout you may go less than 85%. The lower your SpO2 the less effective your muscles and tissues are for performance. Tracking your SpO2 with specific activities throughout the day with Ember may help you understand the quality of your oxygen exchange.

    Oxygen Content (OC)

    The total amount of oxygen bound to hemoglobin. This value is derived from your hemoglobin and oxygen saturation levels in millilitres per decilitre of oxygen (ml/dl). At rest values can range between 15.2 - 23 ml/dl. By tracking this number with Ember, you may discover that you have better endurance and performance when your OC is trending higher.

    Respiration Rate (RR)

    The number of respiratory cycles you complete per minute (rpm). A respiratory cycle is the entire inhalation (breathing in) and exhalation (breathing out) from your lungs. Values can range from 15-20 respiratory cycles at rest. Tracking your RR multiple times per day with Ember may help you understand the impact exercise has on your respiratory cycle and provide feedback on how effective your breathing becomes over time.

    Pleth Variability Index (PVI)

    A measure of the dynamic changes in the perfusion index that occur during the respiratory cycle. In mechanically ventilated patients PVI has been correlated as an indicator for how well patients respond to fluids. If you track PVI multiple times per day we are excited to hear from you how this helps your training, planning or wellness. It is suggested to establish your baseline PVI by measuring it over several days, at the same time, in the same body position, at the same breathing rate and depth of breathing. An ideal time to measure PVI is in the morning before you get out of bed. An increase in PVI compared to your baseline PVI may indicate increased dehydration, increased breathing effort, or other factors. A decrease in PVI compared to your baseline PVI value may indicate greater levels of hydration, decreased breathing effort, or other factors. Multiple factors other than hydration and breathing effort can affect PVI, including breathing rate, depth of breathing, body position, body movement, vascular tone, blood flow to the finger, and cardiovascular abnormalities.

    Carbon Monoxide (CO)

    A measure of the percentage (%) of hemoglobin that is bound to Carbon Monoxide in arterial blood and unable to bind oxygen. Non-smokers should have less than 2.3% while heavy smokers (> 2 packs a day) may be as high as 9%. CO levels as low as 4% can cause significant reduction in exercise performance. Tracking your CO values can help you see how changes in location or behavior can help minimize CO exposure and maximize your body’s oxygen-carrying capacity.

    Methemoglobin (Met)

    A measure of the percent (%) of hemoglobin that is in the oxidized state (Met) in arterial blood and unable to bind oxygen. Met values can normally range between 1 – 1.5 %. Met can accumulate as a result of diet high in nitrates or nitrites or strenuous exercise. Tracking your Met values can help you see how changes in diet or exercise routine can help minimize Met and maximize your body’s oxygen-carrying capacity.

  • In App Purchase and Unlocking Parameters


     


     

    Each Ember device comes preloaded with 200 measurement credits. Credits are required to measure Hemoglobin (Hgb), Oxygen Content (OC), Carbon Monoxide (CO) and Methemoglobin (Met). All other parameters do not require credits. Hgb and OC require 1 credit while CO and Met require 2 credits. If you do not have anymore credits these parameters will not display and will be dashed out in light grey.

     

    Credits are smart device specific so if you are buying credits they are only applicable on that specific iOS or Android device and they cannot be transferred or replaced if your device is lost, damaged, or stolen.
     

    Unlocking Parameters

    Depending on the Ember model you have, you may need to unlock parameters to enable more measurement values. If you would like your Ember to measure additional parameters unlock codes can be purchased online at www.cercacor.com.

     

    When you purchase an unlock code, Cercacor’s tech support team will contact you to unlock the additional parameters. The unlocked parameters are specific to your Ember sensor and not your iOS and Android smart device. This means that the new measurement parameters once unlocked are available anywhere that your Ember sensor is used. As long as the iOS or Android smart device has sufficient measurement credits then Hemoglobin and oxygen content will display as well if you have CO and Met credits those will display.

  • Reviewing Features

    A very exciting feature about the Ember device is the ability to review your historical data in different ways. The more you participate, by measuring frequently and choosing activities associated with each measurement, the more powerful your graphs become. We recommend you measure 3 times per day using these activities: First of day, Pre Workout, and Post Workout.

    Explore and enjoy graphs by using pinch to zoom, pan and even rotate your device to take advantage of landscape view. Graphs can be shared via SMS, email, and popular social networking sites to share your progress with friends, coaches, trainers, and teammates.

    Activities

    Every time you take a measurement, the app will ask you to associate an activity. By using the same finger, same posture, same time of day, and associating the measurement to a specific activity you will have a more powerful and precise historical review of your data. Consistency is important to get reliable trends in hemoglobin.

     

    We recommend measuring the first thing every day before you get out of bed. We also recommend measuring 5 minutes before a workout and then within 1 minute after you workout for the best comparison of exercise on your baseline.

    If you want to create specific custom activities you can do so in the “Options” tab. New activities can be General or they can be a Pre/Post combination.

    Pre/Post activities are designed for measurements where you want to track your Ember results before and after a sport or training activity.

     

    For example you may want to track how swimming impacts your hemoglobin. Pre/Post combinations are available to be viewed within the Daily Ranges graph to see comparisons throughout the day while General activities cannot. All other graphs support filtering of General or filtering of Pre/Post custom activities.

    The available choices for General and Pre/Post custom activity icons.

    Ember Custom Icons

    Inputting Perceived Values

    Take the time to assign a numeric value for your First of Day, Post Workout, or Post Hydration to allow Ember to plot those values versus your measured parameters.

    Ember_Rated Perceived Exertion

    Tracking Pain

    Your state of pain can have an impact your parameters. After each measurement on Ember tap the pain button and add if your level of pain from “No pain” to the “Worst” pain. By tracking your levels of pain, you can review over time on the multi-parameter graph if an increase in pain level is increasing your pulse rate or other parameters.

    You can also review pain levels over an entire year to find out if you have more pain during a specific season.

    Pain Scale

    Emotions and Feelings

    Your emotions can have an impact on your sympathetic nervous system and thus affect your parameters. By tracking your emotional state, you may gain insight into what training plans or recovery techniques are best suited to achieve the emotional state you desire. Spin the wheel to find the feeling that best represents you after each Ember measurement.

    Use the multi-parameter graph to see how your parameters respond during trends in emotional states or review an entire year of emotions on the seasonal graph to see if you spent more time happy or sad.

    Emotional states and feelings

  • History

    Collected Data

    All measurements are stored locally on your iOS or Android device. We recommend you create a Cercacor account so that your data is safely backed up and stored in the cloud automatically when your phone is connected to the Internet.

    Since your physiology is affected by environmental factors, your measurements will automatically capture various details based on your location, for example, the weather and elevation.
     

    Note: The Cercacor privacy policy can be viewed online at http://privacypolicy.cercacor.com or within the Cercacor app under the “Options” tab.

  • Cleaning

    The outer surface of the device can be cleaned with a soft cloth dampened with a mild detergent and warm water solution or isopropyl alcohol.

     

    • Do not allow liquids to enter the interior of the device.
    • Do not soak or immerse the device or sensor in any liquid.
    • Use the cleaning solution sparingly.  Excessive solution can flow into the device or sensor and cause damage to internal components.
    • Do not touch, press, or rub, the Ember device or sensor with abrasive cleaning compounds, such as: devices, brushes, or rough-surface materials.
    • Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Ember device.  These substances erode the device’s materials and device failure can result.
  • Specifications

    For more information on Regulatory and Safety Notices open the “Options” tab in the Ember app and then go to “Regulatory”section.

    Parameter Specifications

    Accuracy Notes

    The accuracy of Ember in measuring Hgb has been shown in controlled studies to be 1 gram per deciliter (g/dl) at one standard deviation. This means that under the specific controlled conditions of those studies, 68% of the Hgb values measured on the Ember device fell within +/- 1 g/dl when compared to a calibrated and properly used invasive laboratory reference method used to measure Hgb. The protocols for the accuracy testing of the device are available from Cercacor. Please note that such testing isolates, as well as possible, the accuracy of the device from other sources of error.

    Usability and repeatability are separate measures from accuracy, but are frequently confused with accuracy, and the error contribution from these other measures can create an impression about device accuracy that does not reflect actual device accuracy.
     
    An internal study was conducted to evaluate the effectiveness of non-invasive Hgb to detect changes in Hgb and the precision of measurements from the device. The trend accuracy in this study, defined as its ability to detect changes in Hgb values was shown to be +/- 0.7 g/dl at one standard deviation. The precision, defined as the closeness of two or more measurements to one another, was shown to be +/- 0.4 g/dl at one standard deviation. This was a controlled study designed to isolate measurement of the trend accuracy of the device, rather than measures of usability and repeatability.

     

    The accuracy of Ember in measuring pulse rate in the range of 25 – 240 beats per minute is +/- 3 beats per minute at one standard deviation, under no motion condition. This accuracy is for plus or minus one standard deviation, which encompasses 68% of the measurements. This accuracy was measured using bench top testing against a BioTek Index 2 simulator. This does not reflect testing on people or in a user setting.

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    1 (800) 610 - 8522

    support@ercacor.com

    www.cercacor.com

     

    40 Parker Irvine, CA 92618, USA

     

     

     

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Limitation of Liability

NEITHER CERCACOR, ITS SUPPLIERS OR LICENSORS, NOR ANY OTHER PARTY INVOLVED IN CREATING, PRODUCING, OR DELIVERING THE SERVICE WILL BE LIABLE FOR ANY DAMAGES WHATSOEVER, INCLUDING BUT NOT LIMITED TO, INCIDENTAL, SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, LOST PROFITS, LOSS OF DATA OR GOODWILL, SERVICE INTERRUPTION, COMPUTER DAMAGE, MOBILE DEVICE DAMAGE, SYSTEM FAILURE OR THE COST OF SUBSTITUTE SERVICES ARISING OUT OF OR IN CONNECTION WITH THE USE OF OR INABILITY TO USE OUR SERVICE AND OUR CONTENT, WHETHER BASED ON WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE), PRODUCT LIABILITY OR ANY OTHER LEGAL THEORY, AND WHETHER OR NOT CERCACOR IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGE, EVEN IF A LIMITED REMEDY SET FORTH HEREIN IS FOUND TO HAVE FAILED OF ITS ESSENTIAL PURPOSE.  SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE EXCLUSION OR LIMITATION MAY NOT APPLY TO YOU, IN WHICH CASE SUCH EXCLUSION OR LIMITATION APPLIES TO THE FULLEST EXTENT ALLOWABLE UNDER THE APPLICABLE LAW.

IN NO EVENT WILL CERCACOR’S TOTAL LIABILITY ARISING OUT OF OR IN CONNECTION WITH THESE TERMS OF USE OR FROM THE USE OF OR INABILITY TO USE THE SERVICE EXCEED THE AMOUNTS YOU HAVE PAID TO CERCACOR FOR USE OF OUR SERVICE.

Indemnity

You will indemnify and hold harmless Cercacor and its officers, directors, employees and agents, from and against any claims, disputes, demands, liabilities, damages, losses, and costs and expenses, including, without limitation, reasonable legal and accounting fees arising out of or in any way connected with (i) your access to or use of Our Service, (ii) Your PI, or (iii) your breach of any warranties made by you hereunder or your violation of any other provision of these Terms of Use.  We reserve the right to assume control of the defense of any third-party claim that is subject to indemnification by you, in which event you will cooperate with us in asserting any available defenses.

Disclaimer of Warranties

OUR SERVICE (OTHER THAN OUR PRODUCT) IS PROVIDED “AS-IS”, WITHOUT ANY WARRANTY OF ANY KIND.  WITHOUT LIMITING THE FOREGOING, WE EXPLICITLY DISCLAIM ALL WARRANTIES, INCLUDING BUT NOT LIMITED TO, THE WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, AND ANY WARRANTIES ARISING OUT OF COURSE OF DEALING OR USAGE OF TRADE.  

We make no warranty that Our Service, Our Content or Forums will meet your requirements or be available on an uninterrupted, secure, or error-free basis.  We make no representations or warranties regarding the quality, accuracy, timeliness, completeness or reliability of Our Service, Our Content or Forums.  Any use of Our Service, Our Content or Forums is at your own risk.

We will use reasonable care in providing Our Service (including Our Cloud Service), but, to the maximum extent permitted by applicable law, WE DO NOT GUARANTEE OR WARRANT THAT ANY DATA YOU MAY STORE OR ACCESS THROUGH THE SERVICE WILL NOT BE SUBJECT TO INADVERTENT CORRUPTION, LOSS OR DELETION, AND WE SHALL NOT BE LIABLE SHOULD SUCH CORRUPTION, LOSS OR DELETION OCCUR.  It is your responsibility to maintain appropriate alternate backup of your data.

Our Product is covered by a limited warranty.  

Termination

If you violate these Terms of Use, we reserve the right to deactivate your account or terminate your right to use Our Service, at our sole discretion, at any time and without notice or liability to you.  Upon any such termination, we may delete Your PI, your Non-Personal Content and other information relating to your account.  You may cancel your account at any time by contacting us at support@cercacor.com or by calling us at 1 (800) 610-8522 and selecting Support.

Copyright Policy

We respect the intellectual property rights of others and we expect our users to do the same.  It is our policy, in our sole discretion and when appropriate, to terminate accounts of users who may infringe or repeatedly infringe the rights of copyright holders.

To submit a copyright infringement notification to us, please submit a notification pursuant to the Digital Millennium Copyright Act ("DMCA") by providing the below-specified Agent with the following information in writing:
•	A physical signature of a person authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.
•	Identification of the copyrighted work claimed to have been infringed, or, if multiple copyrighted works are covered by a single notification, a representative list of such works.
•	Identification of the material that is claimed to be infringing or to be the subject of infringing activity and that is to be removed or access to which is to be disabled, and information reasonably sufficient to permit the service provider to locate the material.
•	Information reasonably sufficient to permit the service provider to contact the complaining party, such as an address, telephone number, and, if available, an electronic mail address at which the complaining party may be contacted.
•	A statement that the complaining party has a good faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law.
•	A statement that the information in the notification is accurate, and under penalty of perjury, that the complaining party is authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.
You acknowledge that if you fail to comply with all of the requirements of the preceding paragraph, your DMCA notice may not be valid. Please see 17 U.S.C. § 512 for more information regarding the DMCA and DMCA notifications.

Our Agent to Receive Notification of Claimed Copyright Infringement can be reached as follows:

By Email: legal@cercacor.com
By Mail:
DMCA Designated Agent
Attn: Legal Department
Cercacor Laboratories, Inc.
40 Parker
Irvine, CA 92618

Export Control

The United States and certain other countries control the export of products and information. You agree to comply with such restrictions and not to export or re-export Our Product, Our Content or other portion of Our Service to countries or persons prohibited under export control laws. By purchasing Our Product or by accessing our Service, you are agreeing that you are not in a country where such export is prohibited and that you are not on the U.S. Commerce Department's Table of Denial Orders or the U.S. Treasury Department's list of Specially Designated Nationals. You are responsible for compliance with the laws of your local jurisdiction regarding the import, export, or re-export of Our Product, Our Content or our Service. 

General 

Except as otherwise stated herein, these Terms of Use constitute the entire and exclusive understanding and agreement between Cercacor and you regarding Our Service, and these Terms of Use supersede and replace any and all prior oral or written understandings between Cercacor and you regarding Our Service and Our Content.  If for any reason a court of competent jurisdiction finds any provision of these Terms of Use invalid or unenforceable, that provision will be enforced to the maximum extent possible and the other provisions of these Terms of Use will remain in full force and effect.

Except to the extent provided below in this paragraph, all legal issues arising from or related to the use of Our Service or Our Content will be construed in accordance with and determined by the laws of the State of California applicable to contracts entered into and performed within the State of California without respect to its conflict of laws principles. By using Our Service, you agree that the exclusive forum for any claims or causes of action arising out of your use of Our Service is the United States District Court for the District of California, or any California State court, sitting in Orange County, California, USA. You hereby irrevocably waive, to the fullest extent permitted by law, any objection which you may now or hereafter have to the laying of the venue of any such proceeding brought in such a court and any claim that any such proceeding brought in such a court has been brought in an inconvenient forum.

You may not assign or transfer these Terms of Use, by operation of law or otherwise, without Cercacor’s prior written consent.  Any attempt by you to assign or transfer these Terms of Use without such consent will be null.  Cercacor may freely assign or transfer these Terms of Use without restriction.  Subject to the foregoing, these Terms of Use will bind and inure to the benefit of the parties, their successors and permitted assigns.

Any notices or other communications provided by Cercacor under these Terms of Use, including those regarding modifications to these Terms of Use, will be posted on our website.  

Cercacor’s failure to enforce any right or provision of these Terms of Use will not be considered a waiver of such right or provision.  The waiver of any such right or provision will be effective only if in writing and signed by a duly authorized representative of Cercacor.  Except as expressly set forth in these Terms of Use, the exercise by either party of any of its remedies under these Terms of Use will be without prejudice to its other remedies under these Terms of Use or otherwise.

Contact Us

Please contact us if you have any questions about these Terms of Use.
Cercacor Laboratories, Inc.
Attn: Legal Department
40 Parker
Irvine, CA 92618
legal@cercacor.com


2. Two-Year Limited Warranty

Cercacor Laboratories, Inc. (“Cercacor”) warrants to the original purchaser that our products will be free from defects in materials and workmanship under normal use for a period of two years from the date of purchase.  Within this period, we will, at our sole option, repair or replace any components that fail in normal use at no charge to the purchaser.  This warranty does not apply to: (i) cosmetic damage, such as scratches or nicks, (ii) damage caused by accident, abuse, misuse, water, flood, fire, earthquake or acts of nature or external causes, (iii) damage to a product that has been modified or altered without our written permission, (iv) damage to a product that has been connected to cables that have not been provided by us, (v) damage caused by service performed by anyone who is not authorized by us, (vi) damage caused by failure to use the product in accordance with the instructions for use, or (vii) damage to, or damage caused by, your smartphone or other third party products.  

The product is not cleared by FDA as a medical device and should not be used to monitor hemoglobin in connection with a medical condition.  

We do not warrant that the operation of the product will be uninterrupted or error-free.  

We retain the exclusive right, at our sole discretion and to the extent permitted by law, to: (i) repair the product using new or refurbished parts, or (ii) replace the product with a new or refurbished product.  If we elect to replace your product and the originally purchased product is no longer available, we will replace your product with a current model that has features equal to or better than your originally purchased product.  Any repaired or replacement product will be warranted for the remainder of the original warranty period or thirty (30) days, whichever is longer, or for any additional period of time that may be required by law in your jurisdiction.  THIS REMEDY SHALL BE YOUR SOLE AND EXCLUSIVE REMEDY.

THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, WHICH MAY VARY FROM JURISDICTION TO JURISDICTION.

THE WARRANTIES AND REMEDIES CONTAINED HEREIN ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES EXPRESS, IMPLIED, OR STATUTORY, INCLUDING ANY LIABILITY ARISING UNDER ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, STATUTORY OR OTHERWISE. IN JURISDICTIONS WHERE SUCH WARRANTIES CANNOT BE DISCLAIMED, THE DURATION AND REMEDIES OF SUCH WARRANTIES ARE LIMITED TO THE DURATION OF THIS EXPRESS WARRANTY AND  REMEDIES DESCRIBED IN THIS WARRANTY.  SOME JURISDICTIONS DO NOT ALLOW LIMITATIONS ON IMPLIED WARRANTIES, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU.

IN NO EVENT SHALL CERCACOR BE LIABLE FOR ANY INCIDENTAL, SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES, OR FOR ANY TRAFFIC FINES OR CITATIONS, WHETHER RESULTING FROM THE USE MISUSE OR INABILITY TO USE THE PRODUCT OR FROM DEFECTS IN THE PRODUCT. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU.

In order for us to evaluate your product, we require that you return to us both the device and the sensor.  We will be unable to provide warranty service if we do not receive both the device and the sensor.

We will provide shipping at no charge to you if you are shipping your purchase to us within the United States.  You must pay for shipping if you are shipping your purchase to us from outside the United States.

US Warranty Service

To obtain warranty service in the United States:
•	Request a Return Merchandise Authorization (RMA) number from us.  To request an RMA, please contact us at support@cercacor.com or call us at 1 (800) 610-8522 and select Support.  Please note the purchaser’s name and order number.  We will send you an RMA number and a shipping label via email.
•	Take your returned product to your nearest Fedex location.  Securely pack both the device and sensor along with your RMA number in standard packaging materials available at Fedex.  
•	Affix your preprinted shipping label to the box.
•	Please retain your shipment tracking number for proof of shipment.  

International Warranty Service

To obtain warranty service outside the United States:
•	Request a Return Merchandise Authorization (RMA) number from us.  To request an RMA, please contact us at support@cercacor.com or call us at 1 (800) 610-8522 and select Support.  Please note the purchaser’s name and order number.  We will send you an RMA number via email. 
•	Securely pack both the device and sensor along with the RMA number.
•	Ship the product, freight charges prepaid, to:

Cercacor Laboratories, Inc.
Attn: Support
40 Parker
Irvine, CA USA 92618

•	Please retain your shipment tracking number for proof of shipment.

3.  30 Day Return Policy

You may return your purchase for a full refund for any reason within 30 days of purchase.  We will provide return shipping at no charge to you within the United States.  You must pay for return shipping if you are returning your purchase from outside the United States.

US Returns

To return your product for a full refund, including sales tax and standard shipping charges paid to us on the original order (if any), and receive free shipping of your return, all of the following conditions must be met:
•	Obtain a Return Merchandise Authorization (RMA) number from us.  To request an RMA, please contact us at support@cercacor.com or call us at 1 (800) 610-8522 and select Support.  Please note the purchaser’s name and order number.  We will send you an RMA number and a shipping label via email.  
•	The returned product must be in good physical condition, contain all accessories originally included in the purchase, and include the original packaging.
•	Take your returned product to your nearest Fedex location.  Securely pack the returned product in its original packaging, including all accessories included in the purchase, along with your RMA number in standard packaging materials available at Fedex. 
•	Affix your preprinted shipping label to the box.
If you return your product without an RMA number, without all of the accessories included in the purchase, or without the original packaging, we will charge you a restocking fee equal to 15% of the original price.
We will process your refund within 14 days of receipt of the returned product.

International Returns

To return your product for a full refund, including VAT and standard shipping charges paid to us on the original order (if any), all of the following conditions must be met:
•	Obtain a Return Merchandise Authorization (RMA) number from us.  To request an RMA, please contact us at support@cercacor.com or call us at 1 (800) 610-8522 and select Support.  We will send you an RMA number via email.
•	The returned product must be in good physical condition, contain all accessories originally included in the purchase, and include the original packaging.
•	You must return your purchase to us within 14 days of your notifying us of your decision to return your purchase.
•	Securely pack the returned product in its original packaging, including all accessories included in the purchase, along with your RMA number.
•	Ship the returned product, freight charges prepaid, to:

Cercacor Laboratories, Inc.
Attn: Support
40 Parker
Irvine, CA USA 92618

•	Please retain your shipment tracking number for proof of return.

If you return your product without an RMA number, without all of the accessories included in the purchase, or without the original packaging, we will charge you a restocking fee equal to 15% of the original price.
We will process your refund within 14 days of receipt of the returned product.


4.Regulatory and Safety Notices
 
US: Federal Communications Commission (FCC) Statements
 
This device complies with part 15 of the FCC Rules.
 
Operation is subject to the following two conditions:
 
1.      This device may not cause harmful interference, and
2.      This device must accept any interference received, including interference that may cause undesired operation.
 
FCC Warning to User:
 
Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
 
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception, which can be determined by turning
the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
·         Reorient or relocate the receiving antenna.
·         Increase the separation between the equipment and receiver.
·         Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
·         Consult the dealer or an experienced radio/TV technician for help.
 
FCC ID:   X44-E0001

Canada: Industry Canada (IC) Statements
 
IC Notice to Users in English/French according to RSS-Gen section 8.4:
 
This device complies with Industry Canada’s license-exempt RSSs. Operation is subject to the following two conditions:
 
1.      This device may not cause interference; and
2.      This device must accept any interference, including interference that may cause undesired operation of the device.
 
Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes:
 
1.      l’appareil ne doit pas produire de brouillage;
2.      l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement.

IC ID:       7362C-E0001

European Union (EU) – Declaration of Conformity


Cercacor Laboratories Inc. declares under our sole responsibility that our hemoglobin monitor, Ember, Model E001 to which this declaration relates is in conformity with the Radio and Telecommunications Terminal Equipment Directive 1999/5/EC, and thereby authorized to apply the CE Mark on Ember.