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cercacor Ember User Manual

Non-invasive hemoglobin tracking system
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non-invasive hemoglobin tracking system

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Summary of Contents for cercacor Ember

  • Page 1 system...
  • Page 2 The Ember Team at Cercacor 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...

  • Page 3: Table Of Contents

    Contents Indication for Use ..................4 Safety ....................6 Getting Started ..................8 Taking a Measurement ................12 Parameter Descriptions ................. 18 In App Purchase and Parameter Unlock ............ 27 Reviewing Features ..................29 Cleaning ....................39 Specifications ....................40...

  • Page 4: Indication For Use

    *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.

  • Page 6: Safety

    • 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.
  • Page 7 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.

  • Page 8: Getting Started

    USB Type C Charge the battery by connecting the Ember device to your computer using the included USB Type C cable, or connecting the Ember device to a power outlet using a UL Listed power adapter (LPS or Class 2)
  • Page 9 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.
  • Page 10 • 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.
  • Page 11 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.

  • Page 12: Taking A Measurement

    Taking a Measurement Begin by placing the sensor on a finger free of deformities. It is best to use the ring or middle 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.
  • Page 13 Once you are ready, tap the “Start” button within the app. The measurement time varies and can be as fast as 30 seconds. Be patient, the system will ask you to try again if it cannot get a result within 90 seconds. •...
  • Page 14 Live Results Measurement credits Cell 12:23 PM remaining Adam Wilson Parameter title Average value of your Hemoglobin measurements for last 30 Measured value days with the same g/dl activity* Units of measure Measurement needle Pulse Rate Parameter display area Upper limit target range* Parameter well Lower limit target range* Plethesmography...
  • Page 15 Captured Results Tap to minimize view and Adam Wilson 12:23 PM return to the “Measure” Tap to learn more about Hemoglobin the parameter Units of measure can be adjusted in the “Options” g/dl Tap and hold to rearrange parameters onto the The ranges can be Pulse Rate display area...
  • Page 16 Measurement Details Cell 12:23 PM Adam Wilson 12:23 PM Location map Hemoglobin When you enable the Ember by Details... Cercacor app to track GPS location, Elevation Irvine, CA 16.2 each measurement you take will log g/dl g/dl the location and capture the outdoor Elevation 220’...
  • Page 17 Rearranging Layouts Wednesday Wednesday 12:23 PM 12:23 PM Nov. 2, 2016 Nov. 2, 2016 Hemoglobin Tap and hold on any parameter to rearrange its location in the display area or g/dl g/dl move from the parameter well into the display area ml/dl Swipe left or right to reveal Activity...

  • Page 18: Parameter Descriptions

    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.
  • Page 19 Tracking your pulse rate first of day and pre and post work out 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.
  • Page 20 (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...
  • Page 21 (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.
  • Page 22 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 breath- ing. 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.
  • Page 23 Out of Range Results Adam Wilson 12:23 PM Hemoglobin If you take a measurement and receive the phrase “Low” instead of a numeric value for hemoglobin, it indicates that your value was below 10 g/dl and is too g/dl low to present a number. If you receive the phrase “High”...
  • Page 24 12:23 PM Options The normal ranges displayed on your results screen can Custom Ranges be adjusted within the “Options” tab of the Ember app. Hgb Upper Limit The default values are from published sources on gener- 15 g/ dl al population ranges based on biological sex and age.
  • Page 25 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. •...
  • Page 26 Incomplete Measurement Cell 12:23 PM Adam Wilson If you take a measurement and receive the “Incom- plete” pop-up dialogue, please check the following and try your measurement again. Reduce excessive motion or interference to the • device and sensor during measurement. Check sensor placement, reduce ambient light, •...

  • Page 27: In App Purchase And Parameter Unlock

    If you run hemoglobin (Hgb) measurements. Learn More... out of credits, your Ember device will still measure all other parameters except hemoglobin and oxygen $49.99 Credits content. Both hemoglobin and oxygen content will only...
  • Page 28 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 parame- ters the unlock code can be purchased online at www.cercacor.com.

  • Page 29: Reviewing Features

    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.
  • Page 30 Activities Cell 12:23 PM Adam Wilson 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.
  • Page 31 This should be performed when you first wake up before First of Day your feet touch the ground. Select this activity for measurements taken within 5 minutes Pre Workout before you begin a workout. Select this activity if you are between any sets or intervals Bewteen Sets of your training.
  • Page 32 Select this activity for measurements at rest, where you Resting have not exercised or hydrated for at least an hour. Select this activity within a few minutes before you drink at Pre Hydration least 6 oz. of fluid or have a meal. Select this activity when you take a measurement 30 Post Hydration minutes after drinking at least 6 oz.
  • Page 33 Choose an icon Pre/Post activities are designed for measurements Pre Basketball Post Basketball Pre Cycling where you want to track your Ember results before and after a sport or training activity. For example you may Pre Basketball Post Basketball Pre Cycling want to track how swimming impacts your hemoglobin.
  • Page 34 The available choices for General and Pre/Post custom activity icons. General Activity Icons Pre Activity Icons Post Activity Icons...
  • Page 35 History Trend Graph Results Table Results Table - 27 Trend - Hgb g/dl A list view of all Vertical (Y-axis) Time g/dl measurement displays the units Oct 14 6:30 PM results. Swipe to of measure for Oct 14 the left to reveal 7:00 AM the parameter Oct 13...
  • Page 36 Seasonal Graph Elevation Graph The vertical, This graph reads Y-axis, Elevation - Hgb Seasonal - Hgb like a clock. represents the elevation. Each degree is about one day of Each large measurements. bubble contains about The seasonal a week of quadrants have measurements.
  • Page 37 Daily Ranges Multiparameter The left vertical, View the Y-axis, is blue Daily Ranges - Hgb, Pr Daily Ranges - Hgb legend for First and represents g/dl First of Day Pre Workout Post Workout g/dl of Day, Pre your first and Post parameter.
  • Page 38 Collected Data All measurements are stored locally on your iOS device. We recommend you create a Cercacor account so that your data is safely backed up and stored in the cloud automati- cally when your phone is connected to the Internet.

  • Page 39: Cleaning

    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.

  • Page 40: Specifications

    41 to 113 F (5 to 45 C) Operating Humidity Range 20 - 95% (non-condensing) Dimensions 115mm x 56mm x 12.9mm Approx. Weight For more information on Regulatory and Safety Notices open the “Options” tab in the Ember app and then go to “Regulatory”section.
  • Page 41 0.7 g/dl at 1 SD Precision 0.4 g/dl at 1 SD Note: For further information on Hgb accuracy, trend, or precision, please see page 18-19 or visit http://accuracy.cercacor.com. Pulse Rate Measurement Range 25 - 240 bpm (beats per minute) Accuracy 3 bpm at 1 SD Note: For further information on pulse rate accuracy, please see page 20.
  • Page 42 Perfusion Index Measurement Range 0.05- 20 % Accuracy +/- 10 % of the displayed value Oxygen Saturation Measurement Range 0 - 100 % Accuracy 2 % at 1 SD (between 70 - 100%) Oxygen Content Measurement Range 0 - 35 ml/dl Accuracy Dependent on Hgb and SpO...
  • Page 43 Respiration Rate Measurement Range 0 - 150 rpm (respirations per minute) Accuracy < 1 rpm at 1 SD Pleth Variability Index Measurement Range 0 - 100 % Accuracy Not applicable...
  • Page 44 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.
  • Page 45 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.
  • Page 46 Cercacor 1 (800) 610 - 8522 support@cercacor.com www.cercacor.com LAB-00051K_DIGITAL_User_Guide...

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