Abbott FreeStyle LibrePro Operator'S Manual Download Page 63 | Manualshive

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Table 12: Number and Percent of Results within YSI Reference

Day

Number

of GM-

Reference

Pairs

Within

±15% /

±15 mg/dL

Within

±20% /

±20 mg/dL

Within

±30% /

±30 mg/dL

Within

±40% /

±40 mg/dL

Outside

±40% /

±40 mg/dL

1

2117

64.5

77.7

92.1

97.3

2.7

2-5

4036

68.0

80.9

94.2

98.2

1.8

6-9

2919

71.5

84.3

95.7

99.0

1.0

10-13

2214

80.4

90.4

97.9

99.1

0.9

14

1037

84.7

91.3

98.0

99.3

0.7

60

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Summary of Contents for FreeStyle LibrePro

Page 1: ...Operator s Manual FLASH GLUCOSE MONITORING SYSTEM CAUTION Federal law restricts this device to sale by or on the order of a physician ...

Page 2: ...cations 3 Getting to Know the System 7 Reader Kit 8 Sensor Kit 9 FreeStyle Libre Pro Software 11 Setting up the Reader for the First Time 12 Using the Sensor 14 Applying the Sensor 15 Starting the Sensor 19 Patient Wear 21 Getting Sensor Data 22 Removing the Sensor 25 Charging the Reader 26 ...

Page 3: ...ems at the Sensor Application Site 32 Problems Starting the Sensor 33 Problems Getting Sensor Data 34 Reader Error Messages 36 Perform a Reader Test 37 Customer Service 37 System Specifications 38 Labeling Symbols 42 Performance Characteristics 44 Electromagnetic Compatibility 64 Limited Warranty 74 ...

Page 4: ...Reader Symbols Symbol What It Means View previous next screen Options Low battery Battery charging Confirm Sensor reminder Communication strength Data to report 1 ...

Page 5: ... the detection of glucose level excursions above or below the desired range facilitating therapy adjustments Interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should be based on the trends and patterns analyzed through time using the reports available IMPORTANT The device may inaccurately indicate hypoglycemia The results of the clinical study conducted for this de...

Page 6: ...patterns in the user s glucose values during the wear period WARNING The FreeStyle Libre Pro Flash Glucose Monitoring System contains small parts that may be dangerous if swallowed CAUTION Performance of the System when used with other implanted medical devices such as pacemakers has not been evaluated Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin If ...

Page 7: ...ection Not suitable for re sterilization Further exposure to irradiation may cause inaccurate results Interfering Substances Taking ascorbic acid vitamin C while wearing the Sensor may falsely raise Sensor glucose readings Taking salicylic acid used in some pain relievers such as aspirin and some skin care products may slightly lower Sensor glucose readings The level of inaccuracy depends on the a...

Page 8: ...tion properly If the Sensor Kit package or contents or the Reader appear to be damaged do not use as there may be a risk of electric shock no results and or infection Store the Sensor Kit between 39 F 77 F While you don t need to keep the Sensor Kit in a refrigerator you can as long as the refrigerator is between 39 F 77 F Store the Sensor Kit between 10 90 non condensing humidity The System does ...

Page 9: ... 1 inch away from an insulin injection site The Sensor should not be worn more than 14 days Readings are not obtained after 14 days The Sensor should be removed prior to exposing it to an X ray machine The effect of X rays on the performance of the system has not been evaluated The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in th...

Page 10: ... can be used to gather data from FreeStyle Libre Pro Sensors on multiple patients When opening the Reader Kit and Sensor Kit check that the contents are undamaged and that you have all parts listed If any parts are missing or damaged contact Customer Service IMPORTANT Safety information about the System is in this Operator s Manual Read all of the information in the Operator s Manual before using ...

Page 11: ... The Reader is used to start the Sensor on a patient and gather their glucose readings Multiple patients can have their Sensor started by the same Reader USB Port Used to charge the Reader and connect it to a computer Touchscreen Home Button Turns the Reader on off and takes you to the Home Screen from any other screen 8 ...

Page 12: ...ures and stores glucose readings when worn on the body It initially comes in two parts one part is in the Sensor Pack and the other part is in the Sensor Applicator By following the instructions prepare and apply the Sensor on the back of the patient s upper arm The Sensor has a small flexible tip that is inserted just under the skin The Sensor can be worn for up to 14 days Sensor Measures glucose...

Page 13: ...m Home Screen 10 23pm Start New Sensor Get Sensor Data Time Current time set on the Reader Battery Level Battery charge remaining Options Touch to view or change the Reader s options Get Sensor Data Touch to download all glucose readings from the Sensor into the Reader Start New Sensor Touch to start a new Sensor 10 ...

Page 14: ...g systems Go to www FreeStyleLibrePro com and follow onscreen instructions to download and install the software INTENDED USE The FreeStyle Libre Pro software is intended for use by health care professionals to aid in the review analysis and evaluation of a patient s glucose readings uploaded from the FreeStyle Libre Pro Flash Glucose Monitoring System in support of an effective diabetes health man...

Page 15: ...ton to turn on the Reader 2 If prompted use the touchscreen to select your preferred language for the Reader Touch OK to continue Note Use the pad of your finger Do NOT use your fingernail or any other object on the screen 3 Set the Current Date using the arrows on the touchscreen Touch next to continue 11 back next Current Date June 2017 12 ...

Page 16: ... mg dL the Daily Graph display range is 0 350 mg dL for ease of review on screen 6 done back While using the Reader press the Home button to return to the Home screen The Reader now indicates how to return to the Home Screen from any other screen Touch done to go to the Home Screen Note Charge the Reader if the battery level is low Only use the USB cable and power adapter included with the System ...

Page 17: ... The Sensor Pack and Sensor Applicator are packaged as a set separately from the Reader and have the same Sensor code Check that the Sensor codes match before using the Sensor Pack and Sensor Applicator Sensor Packs and Sensor Applicators with the same Sensor code should be used together or Sensor glucose readings may be incorrect CODE FreeStyleLibre SensorPack A b b o t t D i a b e t e s C areLtd...

Page 18: ...o bending or folding Choose a site that is at least 1 inch 2 5 cm away from an insulin injection site To prevent discomfort or skin irritation you should select a different site other than the one most recently used 2 Clean application site with an alcohol wipe and allow site to dry before proceeding This helps the Sensor stay attached to the body Note The area MUST be clean and dry or the Sensor ...

Page 19: ...the dark mark on the Sensor Applicator with the dark mark on the Sensor Pack Press firmly down on the Sensor Applicator until it comes to a stop 5 Lift the Sensor Applicator out of the Sensor Pack Lid Cap CAUTION Do NOT use if the Sensor Pack or the Sensor Applicator seem to be damaged or already opened Do NOT use if past expiration date 16 ...

Page 20: ...repared site and push down firmly to apply the Sensor to the body CAUTION The Sensor Applicator now contains a needle Do NOT touch inside the Sensor Applicator or put it back into the Sensor Pack CAUTION Do NOT push down on the Sensor Applicator until placed over prepared site to prevent unintended results or injury 17 ...

Page 21: ...e Sensor may cause bruising or bleeding If there is bleeding that does not stop remove the Sensor and apply a new one at a different site 9 Make sure the Sensor is secure after application Put the cap back on the Sensor Applicator Discard the used Sensor Pack and Sensor Applicator according to your facility s procedures Sensor 18 ...

Page 22: ...ader beeps when the Sensor has been started You can check the Sensor has successfully started in 2 minutes Note If communication is not established within 15 seconds the Reader displays a prompt to try again Touch OK to return to the Home Screen and touch Start New Sensor to start the Sensor 10 23pm Start New Sensor Get Sensor Data Check Sensor status when prompted in minutes OK Sensor Starting 2 ...

Page 23: ...o check the Sensor status Hold the Reader within 1 5 inches 4 cm of the Sensor to verify Sensor is working 5 Touch OK to go to the Home Screen Reminder yes no Check Sensor Status Sensor can be used for up to 14 more days OK Sensor Working 20 ...

Page 24: ...nloaded at anytime from Sensors that are on or off the body Before your patient goes home review and give them the Living with Your FreeStyle Libre Pro Sensor section of the insert in the Sensor Kit CAUTION Intense exercise may cause the Sensor to loosen due to sweat or movement of the Sensor If the Sensor becomes loose the Sensor readings may be unavailable or unreliable Your patient should retur...

Page 25: ...r within 1 5 inches 4 cm of the Sensor If sounds are turned on the Reader will beep when all the data has been successfully downloaded from the Sensor This may take up to 5 seconds Note If communication is not established within 15 seconds the Reader displays a prompt to try again Touch OK to return to the Home Screen and touch Get Sensor Data again 10 23pm Start New Sensor Get Sensor Data 22 ...

Page 26: ...tware User s Manual The User s Manual can be found in the Help Menu of the software Touch done to return to the Home Screen Note The Home Screen will show this symbol near the top of the screen when there is new Sensor data in the Reader that has not been transferred to a computer A report should be generated from this data before the next Sensor is downloaded Sensor can be used for up to 7 more d...

Page 27: ...d selecting Target Range Notes If you want the graph to show the current patient s target range set their target range before downloading their data The graph displays glucose readings up to 350 mg dL Glucose readings above 350 mg dL are displayed at 350 mg dL For sequential readings above 350 mg dL a line is displayed at 350 mg dL 12 am 6 am 12 pm 6 pm 12 am 350 250 150 50 OK Daily Graph mg dL 22...

Page 28: ... if the Reader reports a problem with the Sensor currently in use Step Action 1 Pull up the edge of the adhesive that keeps the Sensor attached to the skin Slowly peel away from the skin in one motion Note Any remaining adhesive residue on the skin can be removed with warm soapy water or isopropyl alcohol 2 Discard the used Sensor according to your facility s procedures See Maintenance and Disposa...

Page 29: ...rt on the Reader OK Please charge the Reader to continue using it Low Battery Charging CAUTION Be sure to select a location for charging that allows the power adapter to be easily unplugged Notes You must charge the Reader when the battery is low to keep using the Reader To fully charge the battery charge the Reader for at least 3 hours Only use the USB cable and power adapter included with the sy...

Page 30: ...sor or System Status or change settings on the Reader like Time Date or Sounds Step Action 1 To get to the Options menu touch the Options symbol on the Home Screen 10 23pm Start New Sensor Get Sensor Data Check Sensor Status Target Range Sounds 1 2 Options 27 ...

Page 31: ...nly available on Readers with multiple languages System Status Check Reader information and performance View System Information The Reader will display information about the system including Reader serial and version numbers Sensor serial number for most recently downloaded Sensor Sensor version for most recently downloaded Sensor Sensor start date and time for most recently downloaded Sensor Sens...

Page 32: ... to check that the display is showing all pixels sounds including both tones and vibrations are working and the touchscreen is responding when touched View Event Logs A list of events recorded by the Reader which may be used by Customer Service to help troubleshoot the System Touch OK when you are done 29 ...

Page 33: ...sposal This product should be disposed of in accordance with all applicable local regulations related to the disposal of electronic equipment batteries sharps and materials potentially exposed to body fluids Contact Customer Service for further information on the appropriate disposal of system components CAUTION Do NOT place the Reader in water or other liquids Avoid getting dust dirt water or any...

Page 34: ...o resolve the error Reader Does Not Power On Problem What It May Mean What To Do Reader does not power on after you press the Home Button Reader battery is too low Charge the Reader Reader is outside of its operating temperature range Move the Reader to a temperature between 50 F and 113 F and then try to power it on If the Reader still does not power on after trying these steps contact Customer S...

Page 35: ...having and or cleaning the site with soap and water 3 Follow the instructions in Applying and Starting the Sensor sections Skin irritation at the Sensor application site Seams or other constrictive clothing or accessories causing friction at the site Ensure that nothing rubs on the site The patient may be sensitive to the adhesive material Follow your facility s procedures for handling skin reacti...

Page 36: ... new one Otherwise return to the Home Screen to get Sensor data Communication Error The Reader was unable to communicate with the Sensor Hold the Reader within 1 5 inches 4 cm of the Sensor Note You may need to move away from potential sources of electromagnetic interference Replace Sensor The System has detected a problem with the Sensor Apply and start a new Sensor 33 ...

Page 37: ...thin 1 5 inches 4 cm of the Sensor for up to 5 seconds New Sensor Found The Sensor was never started If you would like to begin using this Sensor touch Yes Communication Error The Reader was unable to communicate with the Sensor Hold the Reader within 1 5 inches 4 cm of the Sensor Note You may need to move away from potential sources of electromagnetic interference 34 ...

Page 38: ...nutes No Data Available There is no data available to download Sensor data is usually available for download 80 minutes after a Sensor was started Try again after this time Sensor Error There is no data available from this Sensor The Sensor may not be working If the Sensor was recently applied wait 1 hour and try again If this doesn t work contact Customer Service 35 ...

Page 39: ...n the Reader connect the Reader to a computer Or to overwrite with data from the current Sensor touch yes Reader Error Messages Display What It May Mean What To Do E 2 Reader error Turn off the Reader and try again If the error reappears contact Customer Service E 9 Reader error Turn off the Reader and try again If the error reappears contact Customer Service 36 ...

Page 40: ...e The Reader Test will perform internal diagnostics and will allow you to check that the display sounds and touchscreen are working properly Customer Service Customer Service is available to answer any questions you may have about the FreeStyle Libre Pro Flash Glucose Monitoring System Please go to the back cover of this manual for your Customer Service phone number System Info Reader Test Event L...

Page 41: ...or glucose assay method Amperometric electrochemical sensor Sensor glucose reading range 40 to 500 mg dL Sensor size 5 mm height and 35 mm diameter Sensor weight 5 grams Sensor power source One silver oxide battery Sensor wear period Up to 14 days 38 ...

Page 42: ...nsor Applicator and Sensor Pack storage temperature 39 F to 77 F Operating and storage relative humidity 10 90 non condensing Sensor water resistance IP27 Can withstand immersion into 3 ft one meter of water for up to 30 minutes Operating and storage altitude 1 250 ft 381 meters to 10 000 ft 3 048 meters 39 ...

Page 43: ...rce One lithium ion rechargeable battery Reader battery life 2 weeks of typical use Reader Sensor memory 1 Sensor Reader operating temperature 50 F to 113 F Reader storage temperature 4 F to 140 F Operating and storage relative humidity 10 90 non condensing Reader moisture protection Keep dry 40 ...

Page 44: ...Cable Abbott Diabetes Care PRT21373 Length 37 inches 94 cm Security measures The communication between Reader and Sensor is a short range near field communication method making it difficult to interfere with or intercept data that is being transferred The Sensor and Reader are protected by proprietary data format memory mapping and cyclic redundancy check CRC generation and verification of data Qu...

Page 45: ...ber Batch code Do not use if package is damaged Type BF applied part Keep dry CODE Sensor code Non ionizing radiation Do not re use Caution MR unsafe Humidity limitation Contains FCC ID N6C SXSDCAG IC 4908B SXSDCAG FCC Declaration of Conformity mark Sterilized using irradiation Not made with natural rubber latex 42 ...

Page 46: ...evice to sale by or on the order of a physician This product contains electronic equipment batteries sharps and materials that may contact bodily fluids during use Dispose of product in accordance with all applicable local regulations 43 ...

Page 47: ...sing theYellow Spring Instrument Life Sciences 2300 STAT Plus Glucose Lactate Analyzer YSI YSI is a laboratory grade glucose and lactate analyzer of whole blood and plasma and is a widely recognized standard in laboratory analysis of blood glucose Glucose readings obtained from the System were compared to glucose readings obtained from theYSI to evaluate the performance of the System Three lots of...

Page 48: ...ithin 20 20 mg dL Within 30 30 mg dL Within 40 40 mg dL Outside 40 40 mg dL Overall 12323 71 8 83 8 95 2 98 5 1 5 40 50 30 53 3 83 3 93 3 100 0 0 0 51 80 505 58 4 73 3 89 1 96 0 4 0 81 180 7373 68 3 80 2 93 7 98 0 2 0 181 300 4115 79 0 90 4 98 3 99 5 0 5 301 400 286 84 6 96 5 99 7 100 0 0 0 401 500 14 85 7 100 0 100 0 100 0 0 0 45 ...

Page 49: ...re presented in Table 2 Overall 83 6 of results were within 20 mg dL 20 of theYSI reference Table 2 Number and Percent of Results withinYSI Reference GM Glucose Level mg dL Number of GM Reference Pairs Within 15 15 mg dL Within 20 20 mg dL Within 30 30 mg dL Within 40 40 mg dL Outside 40 40 mg dL Overall 12323 71 7 83 6 94 9 98 2 1 8 40 50 28 17 9 28 6 50 0 71 4 28 6 51 80 586 54 1 70 6 88 2 94 2 ...

Page 50: ...g dL for values below 80 mg dL by hourly intervals The results are presented in Table 3 Table 3 Number and Percent of Results withinYSI Reference Time Interval hour Number of GM Reference Pairs Within 15 15 mg dL Within 20 20 mg dL Within 30 30 mg dL Within 40 40 mg dL Outside 40 40 mg dL 0 2 235 60 9 73 2 92 8 98 3 1 7 2 4 552 67 4 77 7 90 4 96 4 3 6 4 6 557 61 4 74 3 89 2 95 9 4 1 6 8 534 65 5 8...

Page 51: ...ther the System glucose value was on average higher or lower than the reference glucose value The Mean Absolute Relative Difference gives an indication of the average percent disagreement between the GM and the reference Table 4 shows the absolute difference measures by glucose level Overall the Mean Absolute Relative Difference was 12 3 for the comparison withYSI reference The Median Absolute Rel...

Page 52: ...Relative Difference Mean Absolute Relative Difference Overall 12323 10 1 12 3 40 50 30 14 2 15 8 51 80 505 12 5 15 5 81 180 7373 10 7 12 9 181 300 4115 8 7 10 1 301 400 286 7 8 8 8 401 500 14 4 2 7 2 For reference values 80 mg dL the mean and median absolute differences mg dL are presented instead of mean and median absolute relative differences 49 ...

Page 53: ...stem readings that were within 15 20 30 and 40 for reference values 80 mg dL and above and 15 mg dL 20 mg dL 30 mg dL and 40 mg dL for values below 80 mg dL The results are presented in Table 5 Overall 79 4 of results were within 20 mg dL 20 of BG reference Please note that different blood glucose meters have different levels of performance compared to the meter used in this study The performance ...

Page 54: ...1918 66 5 79 4 93 4 97 9 2 1 40 50 152 57 2 66 4 86 8 92 8 7 2 51 80 841 68 4 80 6 93 6 98 1 1 9 81 180 6397 65 7 78 5 92 6 97 4 2 6 181 300 3719 66 5 80 2 94 1 98 7 1 3 301 400 695 71 7 83 5 97 3 99 3 0 7 401 500 114 81 6 90 4 97 4 99 1 0 9 Comparison to BG was performed using the FreeStyle Precision blood glucose meter Different performance may be expected when compared to other models of blood ...

Page 55: ... the System glucose value was on average higher or lower than the reference glucose value The Mean Absolute Relative Difference gives an indication of the average percent disagreement between the GM and the reference Table 6 shows the absolute difference measures by glucose level Overall the Mean Absolute Relative Difference was 13 9 for the comparison with BG reference The Median Absolute Relativ...

Page 56: ...19 1 51 80 841 10 0 12 6 81 180 6397 10 9 13 5 181 300 3719 10 9 12 9 301 400 695 9 1 11 3 401 500 114 7 1 9 2 Comparison to BG was performed using the FreeStyle Precision blood glucose meter Different performance may be expected when compared to other models of blood glucose meters For reference values 80 mg dL the mean and median absolute differences mg dL are presented instead of mean and media...

Page 57: ...ple when theYSI glucose results are within the 81 to 120 mg dL range you can expect the GM values were less than 40 mg dL 0 2 of the time between 40 and 60 mg dL 1 8 of the time between 61 and 80 mg dL 9 0 of the time between 81 and 120 mg dL 61 4 of the time between 121 and 160 mg dL 26 7 of the time between 161 and 200 mg dL 0 8 of the time and above 201 mg dL 0 0 of the time 54 ...

Page 58: ... 0 8 0 0 0 0 0 0 0 0 0 0 0 0 2472 121 160 0 0 0 1 0 4 12 4 60 8 25 0 1 2 0 0 0 0 0 0 0 0 0 0 3338 161 200 0 0 0 0 0 1 1 1 16 8 49 8 31 5 0 6 0 1 0 0 0 0 0 0 2853 201 250 0 0 0 0 0 0 0 1 0 8 9 6 62 0 26 6 0 8 0 0 0 0 0 0 1937 251 300 0 0 0 0 0 0 0 0 0 0 0 1 11 3 56 6 29 8 2 1 0 0 0 0 892 301 350 0 0 0 0 0 0 0 0 0 0 0 0 0 0 12 4 53 1 33 2 1 3 0 0 226 351 400 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 35 0 35 0...

Page 59: ...urrence between the GM and YSI reference glucose when GM reads LO For example when GM reads LO you can expect thatYSI glucose values were less than 40 mg dL 16 7 of the time between 40 and 50 mg dL 0 0 of the time between 51 and 60 mg dL 0 0 of the time between 61 and 70 mg dL 16 7 of the time between 71 and 80 mg dL 0 0 of the time and above 80 mg dL 66 7 of the time Table 8 Concurrence Analysis ...

Page 60: ...ues were less than 200 mg dL 0 0 of the time between 200 and 300 mg dL 0 0 of the time between 301 and 400 mg dL 0 0 of the time between 401 and 500 mg dL 100 of the time and above 500 mg dL 0 0 of the time Table 9 Concurrence Analysis with HI GM Reading GM Glucose Level mg dL YSI mg dL N 200 200 300 301 400 401 500 500 500 HI 0 0 0 0 0 0 100 0 0 0 2 57 ...

Page 61: ...alculating the percentage of System readings that were within 15 20 30 and 40 for reference values 80 mg dL and above and 15 mg dL 20 mg dL 30 mg dL and 40 mg dL for values below 80 mg dL The results are presented in Table 12 for GM vs YSI reference and in Table 13 for GM vs BG reference Table 10 Difference Measures by Day YSI Reference YSI Reference Day Number of GM Reference Pairs Median Absolut...

Page 62: ...tive Difference Mean Absolute Relative Difference 1 1087 11 9 15 0 2 5 4005 11 9 14 6 6 9 3432 11 7 14 5 10 13 2841 9 8 12 5 14 553 8 3 10 6 Comparison to BG was performed using the FreeStyle Precision blood glucose meter Different performance may be expected when compared to other models of blood glucose meters 59 ...

Page 63: ...Reference Pairs Within 15 15 mg dL Within 20 20 mg dL Within 30 30 mg dL Within 40 40 mg dL Outside 40 40 mg dL 1 2117 64 5 77 7 92 1 97 3 2 7 2 5 4036 68 0 80 9 94 2 98 2 1 8 6 9 2919 71 5 84 3 95 7 99 0 1 0 10 13 2214 80 4 90 4 97 9 99 1 0 9 14 1037 84 7 91 3 98 0 99 3 0 7 60 ...

Page 64: ...mg dL Outside 40 40 mg dL 1 1087 61 8 74 1 91 5 96 9 3 1 2 5 4005 64 4 77 6 92 2 97 7 2 3 6 9 3432 64 4 78 2 92 9 97 4 2 6 10 13 2841 71 0 83 4 95 7 98 8 1 2 14 553 80 7 90 2 96 9 99 6 0 4 Comparison to BG was performed using the FreeStyle Precision blood glucose meter Different performance may be expected when compared to other models of blood glucose meters 61 ...

Page 65: ...able glucose readings reported by all sensors by sensor operational hour thatproducedatleastoneGMreadingduringtheclinicalstudyoverthe14 daywearperiod Thepercentageof availableGMreadingsispresentedincomparisontothenumberofexpectedGMreadingsbasedonthenumberof hoursofsensorwear Overall 96 9 153 169GMreadingsoutofexpected158 052 ofGMreadingswereavailable Table 14 GM Availability Operational Hour No Hi...

Page 66: ...estimate how long a sensor will work over 14 days 34 sensors were evaluated to determine how many days of readings each sensor provided Results show that 85 3 of sensors lasted for the intended 14 day wear duration Adverse Events No device related serious adverse events occurred during the study Mild skin irritation such as erythema edema rash bleeding itching bruising scaling skin and induration ...

Page 67: ... the System The System should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the System should be observed to verify normal operation in the configuration in which it will be used 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 thi...

Page 68: ...issions CISPR 11 Class B Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions Not applicable The System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The System is suitable for use in all establishments other than domestic and those directly connecte...

Page 69: ...omagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input...

Page 70: ...t lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds Mains power quality should be that of a typical commercial or hospital environment If the user of the System requires c...

Page 71: ...dance Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level 68 ...

Page 72: ...00 4 6 6Vrms 150 kHz to 80 MHz 6Vrms Portable and mobile RF communications equipment should be used no closer to any part of the System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 1 2 d 69 ...

Page 73: ...s the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2These guidelines may not apply in a...

Page 74: ...t due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the System is used exceeds the applicable RF compliance level above the System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the System b Over the freque...

Page 75: ...etic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the System as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12...

Page 76: ...all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Font License 2013 Abbott Licensed under the Apache License Version 2 0 the License you may not use this file except in compliance with the License You may obtain a copy of the License at http www apache org licenses LICENSE 2 0 Unless required by applicable law or agreed to in wri...

Page 77: ...oes not cover disposable accessories extends only to the original purchaser and is not assignable or transferable This warranty does not affect or preclude any other rights which you may have by law TOTHE EXTENT POSSIBLE UNDER LAW THE FOREGOING ARE ABBOTT S ONLYWARRANTIES FORTHE READER AND STATEYOUR EXCLUSIVE REMEDIES ABBOTT MAKES NO OTHERWARRANTIES EXPRESS OR IMPLIED AND ABBOTT EXCLUDES AND DISCL...

Page 78: ...fic legal rights and you may also have other rights that vary from state to state FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc LIMITEDWARRANTY SERVICES If you do not agree to the terms and conditions of this LimitedWarranty you may return the FreeStyle Libre Pro reader for a full refund within 30 days of purchase You must have proof of purchase i e a copy of the dat...

Page 79: ...es Care Inc in various jurisdictions Other trademarks are the property of their respective owners Patent https www abbott com patents Distributed by Abbott Diabetes Care Inc 1360 South Loop Road Alameda CA 94502 USA Customer Service 1 855 632 5297 Monday through Friday 8AM to 8PM Eastern StandardTime www FreeStyleLibrePro com ...

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