Freestyle LIBRE PRO Operator'S Manual Download Page 1

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Operator’s Manual

FLASH GLUCOSE MONITORING SYSTEM

CAUTION:

Federal law restricts this device

to sale by or on the order of a physician.

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Summary of Contents for LIBRE PRO

Page 1: ...al FLASH GLUCOSE MONITORING SYSTEM CAUTION Federal law restricts this device to sale by or on the order of a physician Spine depth for perfect binding will be determined by supplier 944_rev C_cover in...

Page 2: ...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 Wea...

Page 3: ...30 Troubleshooting 31 Reader Does Not Power On 31 Problems at the Sensor Application Site 32 Problems Starting the Sensor 33 Problems Getting Sensor Data 34 Reader Error Messages 36 Perform a Reader T...

Page 4: ...actually in the range of 81 160 mg dL Therefore interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should only be based on the trends and patterns analyzed through time...

Page 5: ...s in interstitial fluid are unknown compared to circulating blood Taking medications with acetaminophen such as Tylenol and some cold medicines while wearing the Sensor may falsely raise Sensor glucos...

Page 6: ...luated The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in the user s glucose values during the wear period The FreeStyle Libre Pro F...

Page 7: ...Sensor Applicator Alcohol wipe Product insert Sensor Pack Used with the Sensor Applicator to prepare the Sensor for use Sensor Applicator Applies the Sensor to the patient s body The Sensor measures...

Page 8: ...valuation of a patient s glucose readings uploaded from the FreeStyle Libre Pro Flash Glucose Monitoring System in support of an effective diabetes health management program The Reader Home Screen pro...

Page 9: ...e Home Screen Note Charge the Reader if the battery level is low Only use the USB cable and power adapter included with the System 12am 00 back next Current Time CAUTION It is very important to set th...

Page 10: ...e site Using the Sensor After you assemble and apply the Sensor to your patient s body start the Sensor with the Reader and confirm it is working The Sensor stores glucose readings every 15 minutes fo...

Page 11: ...pared site to prevent unintended results or injury Step Action 3 Open the Sensor Pack by peeling the lid off completely Unscrew cap from the Sensor Applicator and set the cap aside 4 Line up the dark...

Page 12: ...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 Step Action 8 Gently pull the Sensor Applicator away fro...

Page 13: ...the Sensor is successfully started IMPORTANT The Sensor should not be worn for more than 14 days Data can be downloaded at anytime from Sensors that are on or off the body Before your patient goes hom...

Page 14: ...data before the next Sensor is downloaded Sensor can be used for up to 7 more days Sensor Data Received view next Days Recorded 7 done back To create reports connect Reader to a computer Getting Sens...

Page 15: ...to your facility s procedures See Maintenance and Disposal section Daily Graph The Daily Graph shows the Sensor glucose readings by day and the Target Glucose Range that is set on the Reader You can...

Page 16: ...uded USB cable into an electrical outlet using the included power adapter Then plug the other end of the USB cable into the USB port on the Reader OK Please charge the Reader to continue using it Low...

Page 17: ...get Range Set range displayed on Reader Daily Glucose graph Sounds Set tones and vibrations Time Date Change the Time or Date Language Change the language on the Reader option only available on Reader...

Page 18: ...er trying these steps contact Customer Service Maintenance and Disposal Cleaning You may clean the Reader using a damp cloth Gently wipe the exterior of the Reader and allow to air dry Maintenance The...

Page 19: ...he Sensor Apply and start a new Sensor Problems at the Sensor Application Site Problem What It May Mean What To Do The Sensor is not sticking to the patient s skin The site is not free of dirt oil hai...

Page 20: ...need to move away from potential sources of electromagnetic interference Display What It May Mean What To Do Sensor Starting The Sensor has not completed starting Wait for the reminder to check Sensor...

Page 21: ...stomer Service Perform a Reader Test If you think the Reader is not working properly you can check the Reader by performing a Reader Test Touch the Options symbol from the Home Screen select System St...

Page 22: ...Up to 14 days Sensor memory Up to 14 days glucose readings stored every 15 minutes Operating temperature 50 F to 113 F Sensor Applicator and Sensor Pack storage temperature 39 F to 77 F Operating and...

Page 23: ...nly be used with EN60950 1 rated computers Mean service life 3 years of typical use Power Adapter Abbott Diabetes Care PRT25611 Operating temperature 50 F to 104 F USB Cable Abbott Diabetes Care PRT21...

Page 24: ...tation Contains FCC ID N6C SXSDCAG IC 4908B SXSDCAG FCC Declaration of Conformity mark Sterilized using irradiation Not made with natural rubber latex CAUTION Federal law restricts this device to sale...

Page 25: ...eadings obtained from the System were compared to glucose readings obtained from theYSI to evaluate the performance of the System Three lots of sensors were evaluated in the study Agreement with YSI L...

Page 26: ...685 72 2 83 0 94 2 97 9 2 1 181 300 4449 73 9 86 2 96 9 99 2 0 8 301 400 541 70 1 86 7 97 2 98 9 1 1 401 500 34 55 9 88 2 97 1 100 0 0 0 Agreement on Day 1 againstYSI Reference The accuracy of GM vers...

Page 27: ...ose level Overall the Mean Absolute Relative Difference was 12 3 for the comparison withYSI reference The Median Absolute Relative Difference shows that half of the time the System was within 10 1 of...

Page 28: ...compared to the meter used in this study The performance presented here is not representative of a comparison to all blood glucose meters Table 5 Number and Percent of Results within BG Reference BG...

Page 29: ...ive differences Overall Accuracy against BG Reference Accuracy was measured by comparing the absolute relative difference between the System and reference BG values The absolute relative difference me...

Page 30: ...1 200 201 250 251 300 301 350 351 400 401 500 500 40 20 0 80 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 40 60 0 0 26 4 60 0 11 8 1 8 0 0 0 0 0 0 0 0 0 0 0 0 0 0 110 61 80 0 2 11 1 42 9 43 6 1 7 0 2 0...

Page 31: ...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 with LO GM Reading GM Glucose Level mg dL YSI mg dL N 40 40 50 51 60 61 70 71 80...

Page 32: ...eference 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 Absolute Relative Difference Mean Absolute Relat...

Page 33: ...ber and Percent of Results within BG 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 1087 61 8 74 1 91 5 96...

Page 34: ...6 5 120 144 2630 2725 96 5 144 168 3262 3356 97 2 168 192 4478 4617 97 0 192 216 5101 5223 97 7 216 240 3413 3531 96 7 240 264 5611 5759 97 4 264 288 7021 7184 97 7 288 312 6300 6400 98 4 312 336 1110...

Page 35: ...nterference received including interference that may cause undesired operation Changes or modifications not approved by Abbott could void the user s authority to operate the equipment Guidance and man...

Page 36: ...uld be that of a typical commercial or hospital environment IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment guidance Surge IEC 61000 4 5 1 kV differential mode 2 kV com...

Page 37: ...UT is the a c mains voltage prior to application of the test level IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 3Vrms 150 kHz to...

Page 38: ...in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 1 2 d 2 3 d a Field strengths from fixed transmitters such as base stations fo...

Page 39: ...ation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to th...

Page 40: ...AT OPERATION OFTHE READERWILL BE UNINTERRUPTED OR ERROR FREE AND ABBOTTWILL NOT BE LIABLE FOR ANY LOST PROFITS LOST SAVINGS OR OTHER SPECIAL PUNITIVE INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING DIRE...

Page 41: ...944_rev C_manual indd 76 9 23 16 9...

Page 42: ...urisdictions 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...

Page 43: ...t need to keep your Sensor Kit in a refrigerator you can as long as the refrigerator is between 39 F and 77 F The Sensor has been tested to withstand immersion into 3 feet 1 meter of water for up to 3...

Page 44: ...N ElsensorFreeStyleLibreProdebe retirarseantesderealizarunaimagenresonanciamagn tica RM unatomograf aaxialcomputarizada TAC oun tratamientotermoel ctrico diatermia dealtafrecuencia No sehaevaluadoele...

Page 45: ...rigin Contenu import Voir les articles pour conna tre leur pays d origine 71613 01 Abbott Diabetes Care Canada Mississauga Ontario L5N 3R3 Abbott Diabetes Care Inc 1360 South Loop Road Alameda CA 9450...

Page 46: ...7 Accurate Convenient and Insightful READER Start Sensor See Glycemic Profile Wear Up to 14 days Review CONTENTS 1 FreeStyle Libre Pro Reader 1 USB Cable 1 Power Adapter 1 Operator s Manual 1 Quick St...

Page 47: ...e I n c 1360South Loop Road Alameda CA945 0 2 A R T 2 6 9 5 0 R e v A 1 1 1 5 FreeStyleLibrePro Sensor Applicator XXXXXXXXXXX YYYY MM DD XXX ART26950_rev A pdf 1 11 30 15 6 33 PM P150021 Amendment ADC...

Page 48: ...uth Loop Road Alameda CA94502 A R T 2 6 9 5 1 R e v A 1 1 1 5 CustomerService 1 855 632 5297 SensorPack XXXXXXXXXXX XXX YYYY MM DD FreeStyleLibrePro ART26951_rev A pdf 1 12 1 15 12 12 PM P150021 Amend...

Page 49: ...s Care Inc 1360 South Loop Road Alameda CA 94502 1 855 632 5297 Manufacturer ART26942 Rev B 03 16 NDC 57599 0715 62 Type BF applied part Consult instructions for use Do not re use Catalog number Do no...

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