ember
non-invasive hemoglobin tracking system
user guide
Page 1: ...ember non invasive hemoglobin tracking system user guide ...
Page 2: ...ome an advocate of Ember and Cercacor technology Sincerely The Ember Team at Cercacor Welcome TM TM 2 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 own...
Page 3: ...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 3 ...
Page 4: ...tphone with Bluetooth 4 0 capabilities to operate running iOS 8 2 or newer For a list of devices and operating systems that the Ember system works with please visit www cercacor com 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 ...
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Page 6: ...stances 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 ...
Page 7: ...e the device and or sensor in order to avoid 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 dispose...
Page 8: ...connecting blinking sequence displayed for 3 seconds bluetooth connected Press and hold for 3 seconds for Bluetooth pairing Press and hold for 6 seconds for a Hard Reset 8 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: ...eate an account Follow the screen prompts until your account is created Connecting Ember to your smartphone 9 Congratulations You have now created an account Next letʼs connect 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 b...
Page 10: ... 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 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 Make sure your Ember device is within a close range approx 50ʼ of your smartphone ...
Page 11: ...p 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 If problem persists contact support cercacor com Be sure to include a complete description of the problem ...
Page 12: ...y into the sensor Use the same posture and remain still during 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 1 12 ...
Page 13: ...our 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 Be sure not to move around during the measurement Refrain from talking coughing or sneezing during the measurement During the measure...
Page 14: ...a Plethesmography waveform Pleth Capture button Target ranges and averages are only available if you create an account Average value of your measurements for last 30 days with the same activity Measurement credits remaining Live Results 14 Adam Wilson Hemoglobin 15 2 g dl 12 20 15 8 Avg Pulse Rate 62 bpm 50 85 58 Avg PI 5 2 Capture 200 Cell 12 23 PM 99 ...
Page 15: ...s onto the display area Tap to change or set the type of activity Tap to share your result Tap to delete this measurement Units of measure can be adjusted in the Options tab Tap to minimize view and return to the Measure tab Captured Results 15 Adam Wilson 12 23 PM Hemoglobin 15 2 g dl 12 20 14 1 Avg Pulse Rate 62 bpm Activity Notes First of Day None 50 85 58 Avg PI 5 2 Details ...
Page 16: ...e ment was taken 16 Adam Wilson 12 23 PM Hemoglobin 15 2 g dl 12 20 16 2 Avg Pulse Rate 62 bpm Activity Notes First of Day None 150 85 58 Avg PI 5 2 Details Pulse Rate 15 2 g dl bpm 62 12 50 85 58 Avg 16 2 Avg PI 4 2 Activity Resting Notes None Details Temperature Humidity Barometric Pressure Weather Condition Precipitation UV Index 78 F 15 29 95 Partly Cloudy 5 4 Data provided by Climate 220 MSL ...
Page 17: ...al more parameters if installed 17 Wednesday Nov 2 2016 12 23 PM PI 5 2 OC 12 Activity Notes First of Day None Wednesday Nov 2 2016 12 23 PM OC 12 ml dl 10 15 11 Avg Pr 62 bpm 50 85 58 Avg Hgb 15 2 g dl 150 85 14 1 Avg SpO2 99 150 100 98 Avg PI 5 2 Activity Notes First of Day None Hemoglobin 15 2 g dl 12 20 14 1 Avg Pr 62 bpm 50 85 58 Avg SpO2 99 150 100 98 Avg Details Details ...
Page 18: ...e and biologi cal 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 under stand the intensity of your workouts and the fluid volume shifts and or recovery times Additionally you may be able to learn the extent to whic...
Page 19: ...ute 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 work out is a great benefit of using Ember to get an understan...
Page 20: ...king your SpO with specific activities throughout the day with Ember may help you understand the quality of your oxygen exchange 20 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 ...
Page 21: ...imes 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 A measure of the dynamic changes in the perfusion index that occur during the respiratory cycle In mechanically ventaliated patients PVI has been correlated as an indicator for how well patients respond to fluids If you track PVI m...
Page 22: ...VI 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 vas...
Page 23: ...hrase 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 your measurement value has a red box behind 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 Adam Wilson 12 23 PM Hemoglobin Low g dl 12 20 14 1 Avg Pulse Rate 92 bpm Activity Notes First of Day None 50 8...
Page 24: ...es on gener al 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 knowl edge and goals Cell 12 23 PM 95 Measure History Options Options Custom Ranges Hgb Upper Limit 15 g dl 12 g dl 85 bpm 65 bpm Hgb Lower Limit Pr Upper Limit Pr Lower Limit Customize Activites Create New i ...
Page 25: ...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 Hemoglobin synthesis disorders Hemoglobinopathy or Vascular disease Elevated Bilirubin Carbon Monoxide and or Methemoglobin Low arterial perfusion or low arterial o...
Page 26: ...ce to the device and sensor during measurement Check sensor placement reduce ambient light and remove nail polish if present Use a finger with no deformities or nail abnor malities and always use the same finger Make sure your hands are not cold by rubbing your hands together vigorously for 10 seconds Adam Wilson 19 Capture 200 Cell 12 23 PM 99 Incomplete Measurement ...
Page 27: ...ch measurement and cannot be saved for use at a later date If you run out of credits your Ember device will still measure all other parameters except hemoglobin and oxygen content Both hemoglobin and oxygen content will only display when you have sufficient hemoglobin credits Ember Unlimited Cell 12 23 PM 63 Redeem Unlock Parameter 24 99 49 99 Buy Buy 25 Credits 50 Credits Type unlock code 25 cred...
Page 28: ...r com When you purchase an unlock code a one time use code will be sent to you to unlock the additional parameters The code used to unlock additional parameters is specific to your Ember sensor and not your iOS device This means that the new measurement parameters once unlocked are available anywhere that your Ember sensor is used As long as the iOS device has sufficient measurement credits then H...
Page 29: ...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 trai...
Page 30: ...f 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 wrkout for the best comparison of exercise on your baseline 30 Adam Wilson PI 5 2 19 Stop 200 Cell 12 23 PM 99 Use Type of Activity Skip First of Day Pre Workout...
Page 31: ...een Sets Select this activity for measurements taken within 5 minutes before you begin a workout Select this activity if you are between any sets or intervals of your training Pre Workout Select this activity for measurements that are taken within 1 minute after you stop your workout Post Workout 31 ...
Page 32: ... Select this activity within a few minutes before you drink at least 6 oz of fluid or have a meal Pre Hydration Select this activity for measurements at rest where you have not exercised or hydrated for at least an hour Resting 32 Select this activity when you take a measurement 30 minutes after drinking at least 6 oz or eating a meal Post Hydration ...
Page 33: ...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 can not All other graphs support filtering of General or filtering of Pre Post custom activities 33 Cell 12 23 PM 95 Done Back Create New Activity Activity type Pre Post General Choose an icon Pre Basketball Post Ba...
Page 34: ...General Activity Icons Pre Activity Icons Post Activity Icons The available choices for General and Pre Post custom activity icons 34 ...
Page 35: ...tical Y axis displays the units of measure for the parameter you are viewing 35 Results Table 27 Day Oct 14 15 5 68 61 110 70 62 98 60 60 15 1 16 8 16 0 15 7 15 9 16 2 15 4 6 30 PM Oct 14 7 00 AM Oct 13 5 30 PM Oct 13 4 30 PM Oct 13 7 04 AM Oct 12 5 32 PM Oct 12 4 37 PM Oct 12 6 58 AM Time Hgb Pr g dl bpm Trend Hgb i August Sept 12 13 14 15 16 17 18 g dl 19 Oct 2016 Nov ...
Page 36: ...elevation Each large bubble contains about a week of measurements The horizontal X axis represents time This graph reads like a clock Each degree is about one day of measurements The seasonal quadrants have an averaged value presented 36 Seasonal Hgb i Elevation Hgb i ...
Page 37: ... blue and represents your first parameter The right vertical Y axis is purple and represents your second parameter Trend color fades when no data present 37 Daily Ranges Hgb i S S M T W T F 12 13 14 15 16 17 18 19 g dl First of Day Pre Workout Post Workout Sep 5 12 2016 Daily Ranges Hgb Pr i bpm g dl 17 16 15 14 110 90 70 50 40 60 80 100 9 13 9 6 9 20 9 27 Sept 6 27 2016 Pr Hgb ...
Page 38: ... 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 Collected Data ...
Page 39: ...quid 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 pertroleum based or acetone solutions or other harsh solvents to clean the Ember device These substances erode the de...
Page 40: ...ications Battery Type Hours of Operation Charging Time Standby Power Mode Storage Temperature Range Operating Temperature Range Operating Humidity Range Dimensions Approx Weight 3 7V nominal 500mAh 120 measurements 2 5 hours 20 days 40 to 149 F 40 to 65 C 41 to 113 F 5 to 45 C 20 95 non condensing 115mm x 56mm x 12 9mm 75g Ember Device ...
Page 41: ...om Parameter Specifications Note For further information on pulse rate accuracy please see page 20 Display Range Hemoglobin Accuracy Trend Precision 10 24 g dl grams deciliter 1 g dl at 1 SD Standard Deviation 0 7 g dl at 1 SD 0 4 g dl at 1 SD Measurement Range Pulse Rate Accuracy 25 240 bpm beats per minute 3 bpm at 1 SD ...
Page 42: ...ex Measurement Range Oxygen Saturation Accuracy between 70 100 0 100 Measurement Range Oxygen Content Accuracy 0 35 ml dl Measurement Range Accuracy 0 05 20 10 of the displayed value 2 at 1 SD Dependent on Hgb and SpO2 ...
Page 43: ...43 Respiration Rate Measurement Range Pleth Variability Index Accuracy Not applicable 0 100 Measurement Range Accuracy 0 150 rpm respirations per minute 1 rpm at 1 SD ...
Page 44: ...ources 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 measu...
Page 45: ...on 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 ment of the trend accuracy of the device rather than measures of usability and repeatability ...
Page 46: ...Cercacor support cercacor com 1 800 610 8522 www cercacor com LAB 00051K_DIGITAL_User_Guide ...
