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Arkon PRT03831-xxx User's Manual

1. Tabs Guides Display Screen Displays glucose levels and other information xc m UU Receiver in Receiver Skin FreeSi Test Strip Port Where FreeStyle Test Strips are inserted to calibrate the receiver or manually check blood glucose levels UP and DOWN Arrow Buttons Used to move through lists to highlight options and change numbers r LEFT and RIGHT Option Buttons Used to select options shown on the screen The RIGHT Option button also asa turns the receiver on a A FreeStyle Navigator Sensor that you insert about 5 mm under your skin Each inserted sensor is intended to remain in place and provide a continuous glucose reading for up to 5 days The sensor is contained in the Sensor Delivery Unit b A wireless FreeStyle Navigator Transmitter Tx a small electronic device that connects to the sensor and sends glucose values to the receiver once every minute c A wireless FreeStyle Navigator Receiver Rx that captures and displays glucose measurements With the press of a button the receiver displays the glucose measurement taken from the sensor Note The receiver also has a built in FreeStyle Blood Glucose Meter that can be used for blood glucose testing The receiver should always be kept with you on a belt in a pocket or in a purse Section 1 Getting Acquainted Key features of the System Glucose CM 03 00A 85 NI Glucose Acknowledge
2. 2 Ensure that the code number mierea nedare Caution The code numbers MUST match to ensure accurate test results number on the test strip vial Compare the code number on the display with the code number on the vial of test strips If Then The numbers match a Press the RIGHT Option button Set b Go to Step 3 The numbers do a Use the UP DOWN Arrow buttons to change the NOT match code to match b Press the RIGHT Option button Set c Go to Step 3 e The screen changes If the numbers do NOT match to the Apply Sample a Press the LEFT Option button Back Sereen b Repeat Step 2 If the numbers match go to Step 3 Result The receiver will prompt you to Apply Sample Customer Care 1 866 597 5520 Section 7 Calibrate Your System Test Blood Glucose Manually 3 Select a test site Caution If you have hypoglycemia or hypoglycemia unawareness then test ONLY on your fingers Note 1 Vary the sites from test to test to avoid tenderness and to avoid creating calluses Note 2 Avoid moles veins bones and tendons Caution Always calibrate the p system using only a finger stick blood sample Do NOT use alternate site blood glucose measurements to calibrate the J system The receiver contains a built in FreeStyle Blood b Glucose Meter for performing calibration tests m BG Test Site We Calibration sites y If T
3. Hyperglycemic event two or more successive YSI measurements above the alarm threshold or one YSI measurement 696 above the alarm threshold True Threshold Alarm a threshold alarm that occurred 30 minutes from the start of a hypoglycemic or hyperglycemic event True Alarm Rate the percentage of time the glucose level was beyond the threshold and an alarm was activated Events Detected by True Threshold Alarms Total Events X 100 Missed Alarm Rate the percentage of time the glucose level was beyond the threshold and an alarm was not activated Events Not Detected by True Threshold Alarms Total Events X 100 False Threshold Alarm a threshold alarm that occurred when a YSI measurement within 30 minutes was not beyond the threshold setting False Alarm Rate the percentage of time an alarm occurred when glucose level was not beyond the threshold setting False Threshold Alarms Total Threshold Alarms X 100 Customer Care 1 866 597 5520 Detection of Low Glucose See Table 7 below for detection of low glucose As an example when the threshold alarm was set at 70 mg dL during the day 56 of the low glucose events were detected by FreeStyle Navigator Table 7 Low Glucose Detection Section 18 Appendix B Specifications 18 Appendix B Specifications cont DAY NIGHT Low Alarm Day True Day Missed Day False Night True NightMissed Night False Se
4. The absolute difference from the YSI reading is measured in mg dL if the YSI reading is 20 80 mg dL Table 5 Performance relative to YSI at different insertion sites Overall MeanAbsolute MARD by Insertion Site RelativeDifference Abdomn Axni 12 896 Std Dev 13 6 13 196 12 696 Customer Care 1 866 597 5520 Performance Over the Duration of Wear Section 18 Appendix B Specifications 18 Appendix B Specifications cont This section presents the performance data in a variety of ways to demonstrate the performance of the system over time during the entire sensor wear period The sensor is worn on the body for up to 5 days during which time the system has to be calibrated 4 times Typically the system has to be calibrated at 10 12 24 and 72 hours after sensor insertion Data presented in this section demonstrates how the sensor performs as a function of time Sensor Stability Tables 6a 6b show there is little difference in accuracy over the five days of sensor wear according to the Clarke Error Grid Analysis Table 6a and the Continuous Glucose Error Grid Analysis Table 6b Table 6a Clarke Error Grid Analysis by day of wear Day 1 Day 2 Day 3 Day 4 Day 5 Zone A 82 5 82 4 79 4 84 0 80 9 B 16 4 16 6 18 3 14 2 16 9 C 0 2 0 1 0 0 0 0 0 0 D 0 9 0 9 2 2 1 8 2 1 E 0 0 0 1 0 0 0 0 0 0 Overall Mean Absolute Relative Differ
5. Use the UP or DOWN Arrow button to select either the mm dd yy or the dd mm yy format Press the RIGHT Option button Set to accept your choice Result The Country Settings screen is displayed Go to Step 2c to decide what to do next Use the UP or DOWN Arrow button to highlight Time Format Press the RIGHT Option button Select to go to the Select Time Format screen Use the UP or DOWN Arrow button to select either the 12h or the 24h format Press the RIGHT Option button Set to accept your choice Result The Country Settings screen is displayed Go to Step 2c to decide what to do next m Section 16 Change Country Settings St ys 6 Change the Decimal Format a Use the UP or DOWN Arrow button to highlight Country Settings 08 30A Decimal Format Language English B Date Format mm dd yy b Press the RIGHT Option button Select to go to the Time Format 12h X Select Decimal Format screen c Use the UP or DOWN Arrow button to select either the x y or the x y format Decimal Format x y Back Select d Press the RIGHT Option button Set to accept your choice Result The Country Settings screen is displayed e Go to Step 2c to decide what to do next 7 Check your work Result A display that presents information in the format that you prefer You have done this procedure correctly when you are satisfied with the format the system uses to disp
6. Helpful Information Caution Do NOT use FreeStyle Control Solution for calibration Do NOT perform the control solution test when the system asks you to Do BG Test for calibration Results from Control Solution tests do NOT reflect your blood glucose level Important The control solution range is a target range for the control solution only It is NOT a target range for your blood glucose levels Important If your control solution test results continue to fall outside of the range printed on the test strip vial the receiver may not be working properly Do NOT use the system to test your glucose levels Call Customer Care Ensure accurate control solution results by doing the following e Use ONLY FreeStyle Control Solution and FreeStyle Test Strips e Replace the cap on the control solution vial immediately after using e Do NOT use your control solution past the expiration date or the discard date e Do NOT add water or any liquid to the control solution e Perform control solution tests only between 59 and 104 F 15 and 40 C For important test strip information including detailed storage and usage information refer to the FreeStyle Test Strip package insert Section 4 Perform a Control Solution Test ruwas oomi 1 Verify that your FreeStyle Control Solution is current Note FreeStyle Control Solution is good for three months after opening the bottle or until the expiration date pri
7. 04 09 05 08 30 A CANCEL Date Time Carbs 7 b Use the UP Arrow button or the DOWN Arrow t button to change the selected item erudi Note You can change the carbohydrate grams from Suen 0 to 350 grams in 1 gram increments c When you are done press the RIGHT Option button Set to save or cancel the event SAVE Set Customer Care 1 866 597 5520 Section 11 Add Events r sr wv 4 Record insulin events Hero 08 30A a Use the LEFT Option button Next to select which Insulin i i MT E A item to enter or change Type Units SAVE CANCEL Type RN Date Time n s ETE b Use the UP Arrow button or the DOWN Arrow button SAVE S to change the selected item CANCEL eret Note Your insulin choices are Rapid Intermediate Long Acting or Pre mix c When you are done press the RIGHT Option button Set to save or cancel the event Intermediate Long Acting a Use the LEFT Option button Next to select which perce en a item to enter or change Type Duration Intensity ve TIEN SAVE CANCEL Date Time Duration 0 30 i MS b Use the UP Arrow button or the DOWN Arrow button SAVE SAVE x to change the selected item Next Set Sn Note Your exercise choices are Sees en nec rA amt e Type Aerobics Walking Jogging Running Aerobics None Walking Low Swimming Biking Weights or Other Joggi Medi i 9 6 RU BS i WES e Duration 0 00 to 2 30 hrs minutes i
8. Customer Care available 24 hours a day 7 days a week at 1 866 597 5520 www continuousmonitor com This product and its use are protected under U S Patent Numbers 5 262 035 5 264 104 5 264 105 5 593 852 5 899 855 5 9 6 120 676 6 121 009 6 134 461 6 143 164 6 162 611 6 1 6 338 790 6 461 496 6 484 046 6 503 381 6 514 718 6 560 471 6 565 509 6 591 125 6 592 745 6 605 200 6 605 201 6 616 819 6 618 934 6 676 816 6 749 740 6 893 545 6 932 894 6 942 518 6 973 706 6 990 366 7 003 340 7 003 341 7 074 308 7 090 756 7 299 082 Abbott Diabetes Care Inc 1360 South Loop Road Alameda CA 94502 2008 Abbott ART16072 Rev A 05 08 603 5 965 380 6 071 391 6 103 033 6 284 478 6 299 757 6 329 161 C Abbott R Only reeStyle Navi Continuous Glucose S ator Monitoring System User s Guide M CAUTION Federal law restricts this device to sale by roh the order of a physician c Abbott Indications for Use The FreeStyle Navigator Continuous Glucose Monitoring System is indicated for continually recording interstitial fluid glucose levels in people ages 18 and older with diabetes mellitus for the purpose of improving diabetes management Readings and alarms about glucose levels from FreeStyle Navigator Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring Before adjusting therapy for diabetes management based on t
9. HAM radio transmitters Because of the coexistence of the FreeStyle Navigator radio connection and HAM transmitters there may be instances where the connection between your transmitter and receiver may be lost when in proximity to HAM radio equipment The FreeStyle Navigator system is designed to sense and notify you about a lost connection If your FreeStyle Navigator system loses the radio connection increase the separation distance between yourself and the transmitter by moving away from the HAM radio The FreeStyle Navigator radio connection should re establish itself You should note that HAM radio products can be fixed mobile or portable handheld walkie talkie type units Classification The transmitter and receiver are classified as follows Internally powered equipment e Type B equipment e Mode of operation for the receiver is continuous operation e Mode of operation for the transmitter is continuous operation with intermittent loading FCC Compliance Information Transmitter Model Number PRT03831 xxx FCC Rules Tested to comply with FCC Part 15 Class B Security Remote control Transmitter 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 2 This device must accept any interference received including interference that may cause undesired operation Note This equipment has been t
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11. yuaurdmba 3ruono qre u ur o2uo19j123ut Aue osneo 03 AJoyI JOU 21e pue Moy J9A ITE SUOISSIUIO TY IL UdSIO SHI zoJ z ul uorpung popuojug sir 107 A uo AS1 u Tq s sn WAS S IOyeStaeN 9 1S3314 OUT I dno g SUOISSIUIT IM oouepirnr Ju uruoasrAu 39039u9eurton3 1 suer duro 5 Sa suorssrurq JUSWUOIIAUD ue qns ut p sn SI jr FEY INSSE p nous ur s s J0jeStAeN o A15991 T atm JO 19SN IY JO JAWOJSNd JUL Mo oq pds JUIWIUOITAUD ITJIUSLWIOIIII IY ut ISN 107 p pu lut st urojs s 10je8IAeN 2 A152244 UL T AQEL suorssrurg orjouSeurod o 3 VOLIL pq s 121n3 egjnue y pue o ueprnz Section 19 Classification Compliance Declarat ion Appendix C 10N con t FCC Compliance Informat 19 Appendix C 2A9T 383 24 Jo uoneorldde 03 1011d ezoa sureur e ou sta x ped Azayqeq 10 Apddns 1240d ayqudnarayurun ue UI0JJ pa1oMod oq ootAop IY jeu popuoeururooot st 1 93 G 10J IN 966 gt suondnaojur surew Jamod 8utmp uoneaodo panunuo9 so A2 GZ 10J AN 9607 II F 00019 DAI soirnbor oorAop ay Jo 1osn Y JI J3u uruodrAu feyrdsoy 10 pardo Areg sop4o 19J AN 07 sour mdur Jeroueururoo e3Id e Jo yey q poys Ay penb 1 mod sureyy e qeorddy 30N op G 0 10 966 Ajddng 1amog uo sd q Se3poA jueuruo1iAuo ejrdsoq 10 pardo Areg IPOUI uoururoo 10 AY TF S P 00019 DAI Jerossurur09 erdh e Jo yey aq p nous Arpenb 19mMod surew e qeorddy Jon opouir enueJ9gtq 10J AN IF ad ns jueuru
12. Errors and Problems Sect OTSS L6S 998 94DO 491H0 ShO T MOT exerpeurrojug JA umrp lw H YSIH PAD Jogrursue4T Josuos MOU e jJosur pue nrursuen au Ld jou a1 surre y now ue 10 uro qoud 1ojjrursueiT I e ejdow oAnoveu suey g UON99S 998 BUTYIOM jou o1e IOSUIS ouo MAU V jlosur pue IOSU S IY MOWY suuie e AJ A 1redoud Suruorpuny jou st 10suos IYJ I o e dow oAnoveug suey nog IADA 91e7 IWONY ed UL 107 pajsissod sey uro qouq uonounj euu 1941935311 I o ejdow oAnoveu surrepy g UON aos pepue sey 10suos ay 1OSu9S M N ouo Mau jlosur pue JOSUIS IY AOWA JO aft ep c ay asnesaq SuNesado jou ase surrepy I 31osug oArpeurg surrepy 10d dins 91e7 1 urolsnO ed 19831 SLY I29AI929 V N 159 21 Je 1431 Surysepg urreje INOA peal pue uas U2215 IY JO utonoq esoon o IY 03 08 19AI9231 Y uo suol nq NAAOG po1e88r uooq 1sn sey oSessour y uo UT Suryseja V dQ pue uondo 441 pue LHOM ey Suisn Ag une Mou e pue suray nuaui IY Jo IUO ur are nox V N une peuidxo st 10suog OINEZ 19jjrursuedT e unfs 1no ur I98u0 ou 1osu s 10 uro qoud 1osuog e Jogrursuez pue J9AI9221 IY u29M 9q uon3 uuo2 IY YIM UOTIOIG Aeydstp y uo sreadde sty op uonoung jouueo suere osoon r YSIH pue moq peuroj1ad ST 1991 9poui soon D5 poo g woryerqiyes 1S1U 91 210Joq s10suas Mau JOJ PULIOU SI SIQT edessour sj nso1 so on 8 XC S ursefe ue yJIm no 3duroud
13. Je 9q p nous sp oy rougeur Aouanbayy 19M0q 2409 pue ZHOS W VE ZH09 pu ZH0S ut yc Kyunuru ppeLy NUSEN 960 4889 7e 2q poys 68T 00 NA yrprumq oAne o ou Ter1oyeur onoqu s qr po12400 are asreypsiq ITV A SF ISYA TIV Ax 9x asa SIO0 J JI 1 TUILIIO IO 3 D9uo3 poo aq p nous s1oo 4 8reu stq 1203007 AY px od1eqpsiq 10 Ax pF aBIeYSI neijsonpo g XY XL 960 4889 7e 2q poys C 1 109090HI yrprumq oAne o oy Terisyew onoqu s qr pa12400 are BPS ITY AX STE asreypsiq IV Ax SIF asa SIOO J JI 1 ITUTEIII IO 23212U00 poo aq p nous s1007 IBIEYISIA 1203007 AY SF IFIEYISIA 180V Ax 93 IBIEYISIA neisonpo g XY XL J9A T 5Sueriduro5 ooueprnz Ju uruoarAu IIUSeUIOIDITq urojs g 1OJeSTARN A 942 1S9 s jrunurui JUSWUOITAUD ue YONS ur pasn st 1 Jey INSSE p nous ur9js s IOJeSIACN o 4152214 IY JO 1osn JO IIWOJSNI aug MOTI pds juouruoJrauo rouSseuroJ 29 e IY ut ISN 10 popuojut st urojs s 10JESIAeN SA OUT Z AQEL yrunuruig 5ouSeuro3 29 uorje1e ooq s 191n32ejnue y pue suepm5 00019 III SUOISSIUIO IOX2I e qeorddy Jon suonenjong ISLA C 00019 DAI e qeorddy Jon SUOISSIUIO 2IUOULIEH sasodind nsourop 10j pasn surppmnq sorddns yey ysomjou Apddns 1amod o 8e3 0A Mo oi qnd y 03 po1 ouuoo pourp sou pue sjueurust qe1so IT AdSD nsourop Surpnpur sjuourqsi qe1so e ur ISN 10J o qe1rs st urojs s 101e8IAeN o 415991 IJL g sse suoIssturg JA
14. Press the RIGHT Option button Select to go to the Country Settings screen c Decide what you want to do this is displayed e Language 3 e Date 4 e Time 5 e Decimals 6 e None of the above 2d you are done changing the country settings 3 Change the Language Country Settings 08 30A Language English Date Format mm dd yy Time Format 12h Decimal Format x y Back Select d Press the LEFT Option button Back twice to return to the Main menu Go to Step 7 to check your work Use the UP or DOWN Arrow button to highlight Language Press the RIGHT Option button Select to go to the Select Language screen Use the UP or DOWN Arrow button to highlight the language that you want to use Press the RIGHT Option button Set to accept your selection Result The Country Settings screen is displayed Go to Step 2c to decide what to do next Customer Care 1 866 597 5520 Section 16 Change Country Settings wO 4 Change the Date Format Country Settings 08 30A Language English Date Format mm dd yy Time Format 12h Decimal Format x y Back Select 5 Change the Time Format Country Settings 08 30A Language English Date Format mm dd yy Time Format 12h Decimal Format x y Back Select Use the UP or DOWN Arrow button to highlight Date Format Press the RIGHT Option button Select to go to the Select Date Format screen
15. The data below demonstrates that there is little change in the system performance within each period Table 6d Distribution of the difference from the YSI in the different calibration windows Calibration Period Percent Readings Percent Readings Percent Readings Within 2096 of Within 3096 of Within 4096 of the YSI the YSI the YSI f Call First Calibration Period 80 88 94 typically occurs 10 hrs after sensor insertion First Third of Second Calibration Period is 24 28 Cal 2 typically occurs 12 hours Second Third of Second 83 94 98 after sensor insertion Calibration Period Final Third of Second Calibration Period 34 zZ 29 First Third of Third Calibration Period 34 E Cal 3 typically occurs 24 hours Second Third of Third 80 92 97 after sensor insertion Calibration Period Final Third of Third Calibration Period 30 al First Quarter of Final Calibration Period 36 2 26 Cal 4 Second Quarter of Final 84 92 96 Calibration Period typically occurs 72 hours after sensor insertion Third Quarter of Final I 80 93 98 Calibration Period Final Quarter of Final Calibration Period 32 di xd The absolute difference from the YSI reading is measured in mg dL if the YSI reading is at or below 75 mg dL Sample Glucose Traces The following figures show examples of glucose traces from the In Clinic study These traces are representative examples of excellent average and poor perfo
16. for example during exercise the cells consume glucose rapidly that drop is not seen in the bloodstream until later On average glucose levels in the ISF lag the glucose levels in capillary blood by 14 minutes This is a physiological phenomenon that can vary from one person to another Precision Data from two sensors inserted at different insertion sites was used to calculate the between sensor reproducibility Based on 312953 pairs of data sets the average between sensor reproducibility was 1096 Sensor Insertion Calibration and Sensor Wear Home Use Study Sensor insertion calibration and sensor wear were evaluated in a Home Use Study where 137 participants used the product on their own in a home environment The participants wore 8 sensors during the study period of 40 days They wore the sensors either on the arm or abdomen During the first 20 days of the study continuous glucose results were not visible to the participants During the following 20 days participants had access to the glucose measurements In addition to required calibration tests the participants performed 4 finger stick measurements a day using the built in FreeStyle meter The following information is based on the findings from this study When used as directed 96 896 of the total sensor insertions were successful 92 696 of the sensors were calibrated successfully and began producing glucose results within 12 hours after sensor insertion The median time for a suc
17. medium or high beep glucose level Short medium or long uu e Maximum detection most High vibration alarms approximately 30 minutes in advance of events e Intermediate detection Medium intermediate alarms approximately 20 minutes in advance of events eLow detection fewest alarms Low approximately 10 minutes in advance of events b Review or change your settings e Press the LEFT Option button Next to move from one field to the next e Use the UP DOWN Arrow buttons to change the setting in any field e Press the RIGHT Option button Set to accept the settings and return to the Alarms menu Note The receiver will respond with a brief sample of the alarm you selected c Decide what to do next If Then e You are setting reviewing or changing Continue to the next step all alarms e You are finished setting reviewing and Go to Step 11 changing alarms Customer Care 1 866 597 5520 Section 8 Set Review or Change the Alarm Settings waru 7 Set review or change the Data Loss alarms Important If you turn off your Data Loss alarms you must m a Er also turn off your Low Glucose High Glucose Projected Low Ow Glucose B High Glucose 275 and Projected High alarms Projected Low On a Select Data Loss from the Alarms menu Projected High Off e Use the UP DOWN Arrow buttons to highlight Data Main Select Loss Press the RIGHT Option button to se
18. should be inserted at least 1 inch from the previous site A pin on the sensor delivery unit that was designed to prevent accidental release of the sensor This pin must be removed before the sensor can be inserted Parts of the sensor delivery unit that release the sensor inserter from the sensor support mount The sensor support mount is designed to stay on your skin to hold the sensor in place and attach the sensor to the transmitter The blue release tabs release the sensor inserter from the sensor support mount after the sensor is inserted into the skin A safe place for disposal of sensor inserters and lancets A type of statistical report that shows a summary of glucose results in relation to your glucose targets over a one day period The practice of using a different location on the body each time you insert a new sensor The new Sensor should be inserted at least 1 inch from the previous site Products that can help prevent irritation or sensitivity problems at the sensor insertion site Section 20 Glossary 20 Glossary cont State of Health Event Statistical Reports Status Information System System Alarms System Menu Transmitter Tx Transmitter Receiver Connection Transmitter Sensor Support Mount Latch Transmitter Status Transmitter Tabs Unlink UP DOWN Arrow Buttons A record of health related events symptoms and other observations that may help you see patterns in your glucos
19. they cannot be relied on exclusively for notification of all low and high glucose conditions a low or high glucose condition more often than projected high and projected low glucose alarms see Example of a Projected High Glucose Alarm The alarm performance under performance characteristics alarm sounds before the glucose level reaches the for more information Therefore do NOT turn off the preset threshold value low and high glucose threshold alarms to rely just on the projected high and projected low glucose alarms High and low glucose threshold alarms can detect In order to get maximum notification of low and high glucose conditions use both the low and high glucose BEE threshold alarms AND the projected low and projected high glucose alarms Low Threshold 80 mg dL Example of a Projected Low Glucose Alarm The alarm sounds before the glucose level reaches the reset threshold value RE Customer Care 1 866 597 5520 Section 8 Set Review or Change the Alarm Settings About Glucose Alarms con t Follow the guidelines below when selecting your alarm settings for detection of high and low glucose conditions When the detection rate is maximum you will get the greatest number of alarms When the detection rate is minimum you will get the fewest number of alarms Threshold Projected Detection Alarm Alarm Rate ON Maximum High Sensitivity 30 min ON Intermediate Low Sensitivity 10 min
20. 0 22 3 0 0 81 120 3820 99 9 69 5 30 4 0 1 N A N A 121 240 11430 99 9 85 4 14 4 0 1 N A 0 0 241 3795 99 5 91 7 7 8 0 0 0 4 0 1 Overall 20362 98 3 81 7 16 7 0 1 1 6 0 0 N A means that the Clarke Error Grid does not consider the possibility of these zones in that concentration range Table 3b displays the same data as in table 3a on the Continuous Glucose Error Grid This is a modified error grid that is designed to evaluate the clinical accuracy of continuous glucose monitoring systems based on both glucose data points in time and the rate of change of glucose Table 3b Accuracy performance at different glucose levels using the Continuous Glucose Error Grid Analysis 70 mg dL lt YSI YSI lt 70 mg dL YSI gt 180 mg dL All Zone lt 180 mg dL N N N N Accurate 369 59 5 10407 98 9 8364 98 6 19140 97 5 Readings Benign 5 0 8 99 0 9 74 0 9 178 0 9 Errors Erroneous 246 39 7 22 0 2 41 0 5 309 1 6 Readings ALL 620 100 0 10528 100 0 8479 100 0 19627 100 0 Section 18 Appendix B Specifications 18 Appendix B Specifications cont Performance Relative to the Reference YSI Error grid analysis like the Clarke Error Grid Analysis and Continuous Glucose Error Grid Analysis is one way to evaluate the accuracy of the FreeStyle Navigator system The accuracy can also be assessed by analyzing the difference in the glucose results from the FreeStyle Navigator
21. 1 Vial of FreeStyle Control Solution and Insert 1 Vial of 50 FreeStyle Strips and Strip Insert 1 Warranty Registration Card e In addition the FreeStyle Navigator system can transfer data to a computer wirelessly using Bluetooth technology Important Notes The FreeStyle Navigator Continuous Glucose Monitoring System is designed as a complete system Use only the FreeStyle Navigator Sensor the FreeStyle Navigator Transmitter the FreeStyle Navigator Receiver and FreeStyle Test Strips e The system is intended for your personal use do NOT share your system with others Customer Care 1 866 597 5520 Section 1 Getting Acquainted What are the key parts of my system Your FreeStyle Navigator system includes the following major parts Sensor Measures your glucose level Sensor Tip Part of sensor inserted into your skin Locking Pin Prevents accidental discharge must be removed before insertion Insertion Button Pushes a tiny needle into the skin to place the sensor tip just under the surface of the skin Sensor Support Mount Stays on your skin after sensor is inserted Holds the sensor in place Attaches the sensor to the transmitter Sensor Inserter Inserts the sensor into the skin Must be disposed after inserting the sensor Release Tabs Releases the sensor inserter from the sensor support mount Adhesive Protective Liner Adhesive that is affixed to your skin
22. 160 161 Blood Glucose 12 53 62 Range 151 Target 117 118 Hyperglycemia Hyperglycemia 10 62 Hyperglycemia Alarm 72 95 Hypoglycemia Hypoglycemia 10 57 62 95 97 100 Hypoglycemia Alarm 71 95 Hypoglycemia Unawareness 11 57 Section 21 Index Section 21 Index 21 Index cont Icons 84 Insertion Sensor Insertion 41 Insertion Site 38 39 Insulin 112 113 Interference 165 Interstitial Fluid 1 10 162 Line Graph 4 119 Link 131 Meals 112 Mode Continuous Monitoring Mode 12 Blood Glucose Mode 12 Mute Alarms 78 Receiver Clean Your Receiver 128 Link The Receiver And Transmitter 133 Unlink The Receiver And Transmitter 132 Reconnect 82 Reconnect 82 Reports 117 124 Reset Reset User Settings 137 Sensor Change Sensor 35 Remove Sensor 37 Insert Sensor 41 Sensor Delivery Unit 2 3 39 40 Sensor Code 49 Sensor Life 151 Site Select An Insertion Site 38 Blood Glucose Test Site 57 Maintain Your Site 147 Site Rotation 147 Prepare Insertion Site 38 39 Specifications 151 Standard Deviation 121 State Of Health 113 122 Statistics 121 Status 90 91 Symbols 83 84 System Parts Of The System 3 Clean The System 127 Specifications 151 Calibrate Your System 53 Time Change The Time 22 Change The Time Format 143 Time For Calibration 54 Transmitter Clean The Transmitter 128 Link Transmitter And Receiver 133 Unlink Transmitter And Receiver 132 Change Battery In The Transmitter 16 Reconnec
23. 1O119 I9AI929M SULIe V 10119 I AI9337 RL lt lt lt plous 1u soon 8 MOT 1no Surqoeo1 1oJ q sojnurur 01 Apoyeurrxoudde sary Nod ANATISUIS MOT 01 19S U U AA pjousa1g soon 8 MOT 1no SuTYSeaI 1oJ q sojnurur oz Apoyeurxoudde sary Nod ADISU S umrpo 01 PS UJM pjousa1gi soon 8 MOT 1no SuTYySeaI 210J9q sojnurur oe Apoyeurxoudde sary nod ArAnrsues USIH 0 19S uayM pjoysery soon 8 Moy 1no Yeas uoos eur no jeu ojeorpur Sutgueqp ST 31 YSTYM Je IPI ou pue J A osoon 8 1no yey SuTUIeM L ue ST STU NW ason MOT p 15 o1rd WV sueaw N 324M KAaua n abessay uuejy 1 402 8ess ur were 0 puodsoq 10 ion Respond to Alarms Errors and Problems Sect 0cSS Z6 998 94DO 491H0 ShO JogrursueJ oov do1 sjsrs1ed qs uro qoud ay JI G uono s 398 IUO MAU L JSU pue IOSUOS IY 2A0UIO1 sojnurui 0 Joye s sis1od uro qoud Y j up s oui 0 poyoeye ATU sr yunou j10ddns sosuas ay yey axnsuq SULI UTYIIM J nyersdurs uns Suung Iosuos IY SutAOUI 1 1oJ q IE Jourojsn Ted se d asIMIIYIC uoresur 1osu s Jaye sInoy QT 1S1U IY urqirA s esdde a8essour snp Jr S uon2 S 23s JOSUIS MOU L 1J9SUI PUL IAOW uo MAU SUI pue JOSU9S 9AOUI9I Sjsts1od uro qoud y JJ soo Jou o1 yunou 310ddns 10suos y pue 19j1rumsuej oui yey pue paypeye Apur sr JOsuas ay Jey msuq Keme 08 0 uro qoJd au 107 sojnurur QG 10j VEM IOSUIS MAU p J19
24. 27 8 mmol L 8 Confirm you did NOT use Control Solution Press the RIGHT Option button to indicate that you did NOT use a Control Solution Press the RIGHT Option button to select No and press the RIGHT Option button again to view the continuous glucose results See Section 10 to respond to alarm messages if there are any Note If you do not select No for the Control Solution question in this step within two minutes the system automatically considers it a blood test Glucose BG 189 Control Solution Customer Care 1 866 597 5520 9 Remove and discard the test strip 10 Discard the lancet 11 Check your work Section 7 Calibrate Your System Test Blood Glucose Manually rw rwwa Important Test strips may be used only once Discard used test strips Note Use a sealed container such as a sharps container to avoid biohazards a Snap off the cap from the lancing device b Hold the lancet over a sharps container or other puncture proof container with a lid c Pinch the white clip that holds the lancet until the lancet falls into the container Result A properly calibrated receiver You have done this procedure correctly when m d d d L L LE CBE m Your hands and the test site have been cleaned with soap and water and thoroughly dried with a clean towel The code number in the receiver matches the code number for the t
25. Continuous Glucose Monitoring System may be idealized e Subjects saw on average 15 fingerstick results per day in the clinic and 8 fingerstick results per day at home This enables subjects to control their glucose levels better While subjects participated in the clinic portion of the study they were more limited in their activities than someone at home They were also provided with all their meals Subjects who are more active or with poor eating habits may create more challenging conditions for the FreeStyle Navigator Continuous Glucose Monitoring System The built in FreeStyle glucose meters used in the study were well maintained Because the built in FreeStyle meter is used to calibrate the FreeStyle Navigator Continuous Glucose Monitoring System performance may be poorer if the system is not well maintained It is important to carry out quality control checks on the system and code the system according to the manufacturers instructions to optimize performance of the FreeStyle Navigator Continuous Glucose Monitoring System Section 18 Appendix B Specifications 18 Appendix B Specifications cont Accuracy Table 1 below shows the distribution of all the data from the In Clinic study on the Clarke Error Grid Accuracy was assessed by comparing the differences between the FreeStyle Navigator system and the YSI laboratory reference The Clarke Error Grid Analysis evaluates the clinical relevance of the differences by dividing a corr
26. Main Alarms Glucose CM 85 4 N Stats 21 day 08 30A Highest CM 298mg dL amp Lowest CM 61 mg dL Ave CM 160 mg dL Std Dev 20 mg dL Above Target 1996 Next Back M Statistics Select Event Insulin Meals Exercise State of Health Generic Main Select Event Log 8a 12p 4p 8p 12a 4a Line Graph Your receiver comes with backlight capability to see the screen in dark environments The backlight can be turned on by pressing and releasing the DOWN Arrow button and then pressing and releasing the RIGHT Option button For more details on the different symbols and icons on the screen see Section 9 on Daily Use Customer Care 1 866 597 5520 Section 1 Getting Acquainted Using your system For Daily Activities You will be wearing a sensor and a transmitter at all times while you are using the system Keep the following in mind as you go about your normal routine e Only wear the sensor and transmitter on a flat surface of either your abdomen or the back of your upper arm Sleeping The sensor and transmitter should not interfere with your normal sleeping patterns As you get ready to go to sleep place the receiver within 10 feet to maintain the transmitter to receiver connection Bathing Do NOT wear the receiver while bathing or showering Do NOT allow the receiver to get wet However you can wear the sensor and transmitter while bathing or showering e Swimming
27. Navigator A YSI Reference X FreeStyle Calibration Night Time 11pm to 6am lt gt Figure 4 Sample of a Representative Poor Glucose Trace 200 I Aj a 4 100 4 o4 a a a EAEE 10 1 18 22 26 30 34 38 242 46 50 54 58 62 66 70 74 78 82 86 90 94 98 102 106 110 114 118 122 Sensor Time hours FreeStyle Navigator A YSI Reference X FreeStyle Calibration Night Time 11pm to 6am E Section 18 Appendix B Specifications 18 Appendix B Specifications cont Determination of Alarm Performance The threshold alarm is characterized below The projected alarm performance has not been established The performance of low and high glucose alarms was assessed in an in clinic study using 58 subjects with type 1 diabetes wearing one FreeStyle Navigator sensor on the arm and one sensor on the abdomen FreeStyle Navigator continuous data were masked from the subjects and investigators and the alarms were not turned on During 50 hours the subjects venous glucose was tested with a YSI 2300 Stat Plus glucose analyzer at 15 minute intervals Arm and abdomen data were pooled in the alarm analysis Alarm performance was evaluated in a retrospective analysis of the study data As alarm performance was developed retrospectively your results may vary from those reported below Definitions Hypoglycemic event two or more successive YSI measurements below the alarm threshold or one YSI measurement 6 mg dL below the alarm threshold
28. ON IAPS JOSUS Mau e jJosur jou prp nod jJ sax P S IOsuas Mou L poj1osur 1sn no JI L eposido rurooAqS0d q J242 esoon 8 MOT e Surjeo1 107 WIRD reouny e u INOA jo suorpuouruioooid JY MOJJOH og 033e4m pjousarq so5n 8 u8ru 1no Surqoeox 219Jeq samuru OT Aporeurrxoudde aaey nod Varanrsues MOT 01325 U UAA plous 1u soon 8 ysy mo Surqoeor 1oj q samuru oz Apoyeuurxoadde oAeuU no ArAnisues umrpo A o 9S uauM Por asoonys usrq noA Sura o10Joq sojnurur QF Apoyeurrxoudde saey nod HAntsu s YST 0 JOS UYM pjousarq so5n 8 u8ru MoA Year uoos eur nod yey ojeorpur SUISULYD ST 1 YOTYM Je ayer dU pue PAI 3so5n 8 1no jeu SuTUTEM Area up st STYT NW esoonpo u8rH popoloig W 1so 3q Keui s ou r J 1d po1ojs Inox 1 s 1 seu JOATIIOI JYJ INBYUOIIY uoreqnguoo JoAI9281 IY YIM po11noo0 10119 uy T ISOT SUAIA Y JTogjruisueg IY pue IOSUIS oq UIIM 9q uonoeuuoo AyneJ e oq APU 319 tosu s Mou e 1OSU S M N poj1esu 31esur jou prp nod pue sreadde adessaw s yJ JI U NOX ALH W Iosuos MOU e PHAP sey urojs s JYI JT p 15 1 q Josuas M N preusenp soon 8 MOT Jasoid 1no pouoeoi sey osoon 8 nog H esoon r MOT V sueaw N 3euM Aduebin abessay wuejy 1 402 9Sessour were 0 puodsoq E Section 10 Respond to Alarms Errors and Problems T MOT J exerpeuirojug Ay wnIpaW H YSIH jjnsa4 snonuiuoo IYI tu11fuo2 o 1521 apow 2soonjr poojg
29. Press the RIGHT Option button Select to display the System menu with Reconnect highlighted e Press the RIGHT Option button Select f Wait for the receiver to beep If it beeps e Twice The system is connected e Three times The system is not connected Make sure the battery in the transmitter is new and ensure that the receiver and transmitter are linked see Section 14 Note If the transmitter and receiver are connected properly the disconnect icon 2 will not appear on the screen Result An operational system You have done this procedure correctly when L The batteries have been installed and the battery doors have been closed securely d The old batteries have been disposed of properly L The transmitter and receiver have been reconnected Customer Care 1 866 597 5520 3 Set the Time and Date Section 3 Key Terms LEFT RIGHT Option Buttons a Main Menu m Receiver a System Menu Transmitter s UP DOWN Arrow Buttons Customer Care 1 866 597 5520 Section 3 Set the Time and Date 3 Set the Time and Date Purpose 10 ensure the correct time and date are associated with your data Start Do this procedure e The first time you use your FreeStyle Navigator system e When you install new batteries Materials your FreeStyle Navigator Receiver Helpful Information Important Be sure to set the date and time correctly The correctness of the line graph and statistical reports depen
30. Select Reports menu CM 60 CM 120 b Use the UP or DOWN Arrow button to highlight the CM 10 bc event you want to review or edit Insulin Back Select If you want to EI if y Then highlight review edit your Continuous glucose 10 minute intervals CM 10 measurements 60 minute intervals CM 60 120 minute intervals CM 120 e Blood glucose readings BG e Insulin events Insulin e Meal events Meals e Exercise events Exercise e State of health State of Health e Miscellaneous events Generic e Alarms history Alarm history e All events User Events 2 Cannot be edited c Use the RIGHT Option button Select to go to the highlighted report d Decide what to do next If you want to Then e Edit the event Go to Step 9 e Interpret the event Go to Step 8 e Review other events 1 Select the LEFT Option button Back to go to the Select Filter screen 2 Go to Step 7b e Stop reviewing events 1 Select the LEFT Option button Back to go to the Select Filter screen 2 Select the LEFT Option button to go to the Select Report screen 3 Go to Step 2 to decide what to do Customer Care 1 866 597 5520 Section 12 Review Reports and Edit Events steps OT 8 Interpret your events a Interpret the events using the notes about each type of event in the table below Event Notes CM e Each recorded measure is displayed on one screen with its CM 60 CM 120 date and time and CM 10 e Displays
31. T 330N S9po 10119 9POW 9Sso5n 5 poo g 0 puodsow Section 10 Respond to Alarms Errors and Problems Troubleshoot problems The problems you can troubleshoot in this Section are listed below and are arranged in the order of appearance Receiver The receiver will not turn on e The blood glucose test won t start after you apply a sample e Unexpected characters on the receiver display screen unusual or unexpected receiver screen appearance There is no glucose value on the screen Sensor Insertion e There is skin irritation at the sensor insertion site e The sensor support mount is not sticking to your skin e Discomfort when inserting the sensor e The system does not recognize a new sensor after attaching the transmitter to the sensor support mount Note Also see Appendix A on Site Maintenance Receiver and Transmitter Connection e You are not sure whether your receiver and transmitter are connected Calibration e The receiver does not prompt you to do a BG test for calibration Section 10 Respond to Alarms Errors and Problems The receiver will not turn on a Was the test strip inserted correctly the FreeStyle side was up as you inserted the end with the dark rectangle If YES go to Step c If NO repeat the test with a new strip taking care that the FreeStyle side is up as you insert the end with the dark rectangle until it stops b Did this solve your problem If
32. You may swim while wearing the sensor and transmitter Do NOT go deeper than 1 meter approximately 3 feet Note The connection between the transmitter and receiver is NOT maintained when the transmitter is underwater thus you will NOT receive continuous glucose readings However when you take the sensor and transmitter out of the water the continuous glucose readings will resume When Traveling by Plane Note Do NOT perform the upload data feature when you are on a commercial aircraft Follow the guidelines below when traveling Always check with local authorities prior to departure as rules and regulations may change without notice At the airport Notify the security personnel of the presence of the device when going through the security systems On the plane Check with your airline before departure whether the device will be permitted aboard the aircraft The airline companies set policies regarding the use of medical devices on board their flights If you want to disable the transmit function of the transmitter follow these steps 1 If you are currently wearing a sensor remove the sensor 2 Detach the transmitter from the sensor support mount and remove the battery from the transmitter 3 Program into the receiver that you have ended a sensor session 4 By removing the battery from the transmitter you have broken the connection between the transmitter and receiver You can set the data loss alarms and system alarms to a short
33. about saving your edits change SAVE to CANCEL Press the RIGHT Option button to save or cancel your edits Result The result will be an increased awareness of your glucose level history glucose level patterns and events that could affect your treatment plan You will have done this procedure correctly when d Your glucose targets are set correctly d You view and correctly interpret line graphs for any available period You correctly select and view any desired statistical summary for any of the available time periods You can review any of the available event history reports Your events have been edited to your satisfaction Customer Care 1 866 597 5520 13 Clean Your System Section 13 Key Terms Receiver Transmitter Contact Points Customer Care 1 866 597 5520 Section 13 Clean Your System 13 Clean Your System Pu FPOS To maintain the appearance of your system Start Do this procedure e Every time you change your sensor transmitter Any time the system needs cleaning Materials Make sure you have access to these materials before you begin e Mild soap Running water A clean soft lint free towel for cleaning and drying For example a dish towel e 70 isopropyl alcohol Helpful Information e Your FreeStyle Navigator system needs minimal maintenance aside from cleaning and battery replacement Avoid getting dust dirt blood control solution
34. actual measures at the indicated intervals Does NOT display averaged measures e Use the RIGHT Option button Next to move to the next recorded CM reading BG e Each BG measure is displayed on one screen with its date and time All BG measures are displayed e A check mark indicates that the measure was marked as a control e Use the RIGHT Option button Next to move to the next recorded BG screen Insulin Each recorded insulin event is displayed with type dosage in units date and time Meals Each recorded meal event is displayed with its carbohydrate value in grams date and time Exercise Each recorded exercise event is displayed with its description duration in hours and minutes intensity date and time State of Health e Each recorded event is displayed with its description date Can and time Alarm History Note Generic events do NOT include a description just a number that represents the event User Events b Go to Step 7d Section 12 Review Reports and Edit Events a s 9 Edit the event 10 Check your work Note You CANNOT edit your glucose measurements a Press the RIGHT Option button Edit Use the LEFT Option button Next to select the item you want to change Use the UP or DOWN Arrow button to change the selected item Repeat this process from Step 9b until you ve changed every item that you wanted to change Note If you change your mind
35. attached replace the sensor with a new sensor and then re attach the transmitter e Make sure that you establish communication between the receiver and transmitter by reconnecting them if necessary e After you attach your transmitter you must keep your receiver within 10 feet of the transmitter to maintain a consistent connection If the connection between the transmitter and receiver is broken you will not receive continuous glucose readings e The connection can also be affected by objects getting between the transmitter and receiver by nearby large metal objects and by some electronic devices that produce radio frequencies e If a connection alarm sounds move the transmitter closer to the receiver to restore the connection If you have trouble with the connection between the transmitter and receiver see Section 10 on troubleshooting Section 6 Attach Your Transmitter st DoT EN 1 Attach the transmitter to the sensor support mount a Position the transmitter over the sensor support mount so that the battery side faces the mount b Lower the transmitter onto the mount Note It helps to position the transmitter s connector directly over the round part of the keyhole Fig 1 as you lower the transmitter Result The transmitter fits flush against the mount and slides smoothly back and forth on the guide rails c Hold the transmitter between your forefinger and thumb and slide the transmitter until it cl
36. b Press the RIGHT Option button Select to display the Set Date Time screen Main 4 Set the time a Use the UP DOWN Arrow buttons to set the current hour Set Date Time Ge 304 05 10 2005 b Press the LEFT Option button Next to move to the minutes digits c Use the UP DOWN Arrow buttons to set the current minutes d Press the LEFT Option button Next to move to the AM or PM field e Use the UP DOWN Arrow buttons to select A AM or P PM f To set the date go to Step 5 Customer Care 1 866 597 5520 Section 3 Set the Time and Date steps Toomis 5 Set the date Set Date Time 08 30 A Eg 10 2005 6 Check your work a Press the LEFT Option button Next to move to the Month field b Use the UP DOWN Arrow buttons to set the current month c Press the LEFT Option button Next to move to the Date field d Use the UP DOWN Arrow buttons to set the current date e Press the LEFT Option button Next to move to the Year field f Use the UP DOWN Arrow buttons to set the current year g Confirm that your selections are correct If NO press the LEFT Option button Next and repeat this procedure from Step 5a If YES press the RIGHT Option button Set to accept your changes Result The screen displays the System menu h Press the LEFT Option button Main to return to the Main screen Result Your FreeStyle Navigator Receiver is oper
37. intended to remain in place and provide a continuous glucose reading for up to 5 days A number that you will find on the sensor delivery unit packaging This code number must be entered into the receiver after you insert a new sensor and before you complete the system calibration The sensor delivery unit is designed and packaged to enable safe insertion of the sensor into your skin The sensor delivery unit has 2 parts assembled and packaged together the sensor inserter with pre installed sensor which puts the tip of the sensor under your skin and the sensor support mount which stays on your skin to hold the sensor in place and which attaches the sensor to the transmitter The sensor inserter is a cylindrical shaped plastic cased device A pre cocked coiled spring is connected to a stainless steel needle used to guide the sensor for insertion With a single push of the insertion button the needle guides the sensor into the skin and is quickly withdrawn from the skin The Locking Pin is designed to avoid accidental discharge of the sensor inserter Do not remove the locking pin until the sensor support mount is adhered to the skin With a single push of the insertion button the needle guides the sensor into the skin and is quickly withdrawn from the skin The place on your body where you insert a sensor on either the abdomen or the back of the upper arm Always change the sensor insertion site each time a new sensor is used The sensor
38. its main use is for calibrating the system The system must be calibrated at approximately 10 12 24 and 72 hours after sensor insertion The system is calibrated using a blood glucose measurement performed in the Blood Glucose mode using the built in FreeStyle Blood Glucose Meter The receiver compares the reading it gets from the blood to the reading the sensor takes from the interstitial fluid Based on the calibration the receiver calculates real time glucose readings Allows you to add a new blood glucose measurement that is used for sensor calibration Use this feature only under the direction of a Customer Care representative or your healthcare team Use of this feature will discard all the earlier calibrations The sensor life will not be reset Blood from the tiny blood vessels in your body such as in the tip of your finger or alternate sites used to measure glucose levels in the Blood Glucose mode Capillary blood is also used for measuring glucose levels with traditional glucose meters Lets you view recent error codes related to the Continuous Monitoring mode These codes appear only when the system is not functioning properly Use this option only under the direction of a Customer Care representative or your healthcare team Conductive points that connect the transmitter to the sensor support mount Section 20 Glossary 20 Glossary cont Continuous Monitoring Mode Control Solution Test Data Loss Alarm Data Upl
39. not produce a usable sample The FreeStyle Lancing Device offers four different depth settings Move the dial to the desired setting as shown in the depth indicator window Level 1 is the shallowest depth Level 4 is the deepest To lance parts of the body other than the finger we recommend that you start at Level 2 and use the clear cap To lance your finger we recommend that you set the depth setting to its shallowest depth 1 and use the grey cap h Pull the dark grey cocking handle out until it clicks Note You may have already cocked the device in Step 4d i Prepare the site If you are using Then to stimulate blood flow A finger Warm your hand lower it to waist level and gently massage the finger e Your forearm Rub the test site vigorously until you feel it getting warm three to five seconds Section 7 Calibrate Your System Test Blood Glucose Manually LENS CI KEEN 5 Lance the site To lance your finger grey cap a Lightly touch the lancing device against the side of your fingertip b Press the release button c Put the lancing device down d Gently squeeze your finger if needed until a drop of blood the size of a pinhead forms To lance your forearm clear cap a Hold the lancing device against the test site b Press the release button c Continue to hold the lancing device against the test site as you i Inspect the test site through the cl
40. oj 19419991 21 1OJ WEA snonumuo9 Suronpoud jou st urojs g e V N og 0933euA sueay 31 3eym Kdus n aHessay uuejy adessaw ur1e e 0 puodsow Em Section 10 Respond to Alarms Errors and Problems T MOT J exerpeuirojug A umrp lw H YSIH uoneJqi eo uoreJqi e snorA 1d sa 10J 152 opour osoonjr poo g I9yJoue ULIOJIII 3Y WOJ 3u23ogrp 19A SEM 489 uoredqi e I Hg opey PORLA eo pide Suruey gt u q sary s oAo ssoon 8 1no UOTJLIQI ED 10J 789 opour osoon r JO JoAI2221 pue Jojjtursuez IY uo2Mjeq uoroeuuoo poo g e woad pue Inoy I eM po12ouuoo OU SI 9194 JO 2jo duroour sem 1ogjjrumsuez IY TIT o1 1Io jrursueJ pue JOATIOII IY JY ans Je UIOJJ UOTJLUIIOFUT IY sne2 q porrej UOTeIQIeD I Hg opey PORLA eo uoneiql e2 10 1593 A redoud SuplioA aq 1ou eur IY epour so52n 5 poo g e urioj1ed pue moy 1 eM 1osu s IY P9MOUS 1s31 opour so52n 5 poo g aur I ur 5g opoy Popea ed uoneJqi eo 10J 159 opour osoonjr poo g Joyjoue urojrod p o 00 10 Wem 197 Og ope duro u u pue meradur WOOL 0j I9A13991 IY SUU 00 SEM I9AI9991 IY sne2oq po reg uonedqipe I JOATIIOY po re4 ed UOTJLIQI ED 10 3523 opour ssoonpH uoneaqtr e2 1adoid 107 T ouruu 9T poolg Joyjour urroji d postd orursoAqSod u pue c c Tp 3ur 00 pue 09 uaamJ2q A soon 8 PAI soon 8 MOT e 10J oorApe s euorssojoud poollq e sp u ur 1s s Sy MOT 00 SEM SUTPRAI JS TOWT Og OPA
41. operate this equipment Customer Care 1 866 597 5520 20 Glossary Customer Care 1 866 597 5520 Section 20 Glossary 20 Glossary Adhesive Enhancers Alarms Alarms Menu Alarm Sensitivity Alarm Type Antiseptics Backlighting Blood Glucose Mode Calibration Calibration BG Capillary Blood CM Status Contact Points Products that can help the adhesive pad on the sensor support mount stick better to your skin Sounds vibrations or text that are used by the receiver to notify you of certain conditions A menu you can access from the Main menu From the Alarms menu you can turn an alarm on or off set its sensitivity and select alarm type A setting that you can adjust to trigger the Projected Low High Glucose alarms early warning alarms sooner or later The higher the sensitivity the sooner the alarm will sound Refers to the sound or vibration of the alarm Alarm types include low medium or high beeps and short medium or long vibrations Products that you can use at the sensor insertion site if you tend to develop infections A light inside the receiver that lets you see the display screen in the dark One of two modes in which the system functions the other is Continuous Monitoring mode In the Blood Glucose mode you can perform traditional blood glucose testing manually using a FreeStyle Test Strip and a drop of blood Although you can use the Blood Glucose mode whenever you wish
42. radiation there may be some interference Examples of possible sources of interference are store doorways store checkout counters metal detectors like those used in airport security systems or electronic surveillance devices and radio transmitting devices such as cellular phones 2 way radio and cordless phones Interference may occur in the vicinity of equipment marked with symbol If such interference happens it tends to be temporary This makes it unlikely that you will experience any noticeable difference in the performance of the system In the event of electromagnetic interference you may experience loss of communication between the receiver and transmitter you may see unrecognizable characters on the receiver display screen or you may not see continuous glucose results The system is designed to alert you of these conditions through audio beep or vibrate or visual icons unrecognizable characters on the screen or lack of glucose results means If you observe a significant change in your continuous glucose readings that you think is erroneous or if you feel the blood glucose measurement in the Blood Glucose mode is erroneous and you are close to an electromagnetic interference source move away from the source of interference and check to see if the condition fades away Always maintain a minimum separation distance from potential sources of electromagnetic interference see Tables 3 and 4 in this section for guidance Dependi
43. screen or inserting a strip to do a BG test If no buttons are pressed during the 1 hour muting period during which an alarm is active the alarm response period will elapse during the mute time and no further alarms will sound until the display has been activated Press the LEFT Option button Main on the Alarms menu to return to the main menu Result The result will be a receiver set up to alert you to your glucose conditions to system events and to activity progress in a way that you prefer You will have done this procedure correctly when the receiver provides alarms as you want it to Customer Care 1 866 597 5520 9 Daily Use Section 9 Key Terms BG Mode CM Mode Directional Glucose Trend Arrows Icon Receiver Transmitter Transmitter Receiver Connection Customer Care 1 866 597 5520 Section 9 Daily Use Daily Use Purpose To read and understand your display screen Start Do this procedure e Anytime you are using your system in the Continuous Monitoring mode Materials Your receiver Helpful Information e Your receiver and transmitter must be linked connected and calibrated in order to use the system in the Continuous Monitoring mode e When you sleep place the receiver on a high headboard or on a nearby dresser rather than clipping it to your bed clothing or taking it to bed Be aware that if the receiver is set to vibrate and if you place it too far from you you may not h
44. suggestions or help Customer Care 1 866 597 5520 11 Add Events Section 11 Key Terms m Events Exercise Event Generic Event Insulin Event LEFT RIGHT Option Buttons Meal Event State Of Health Event a UP DOWN Arrow Buttons Customer Care 1 866 597 5520 Section 11 Add Events 11 Add Events Pu rpose Tocreate a record of events that may affect your glucose levels Start Do this procedure any time you observe anything that may affect your glucose levels including your state of health and daily activities such as meals exercise and insulin dosages Materials your FreeStyle Navigator Receiver e Data and details about the event that you want to record Helpful Information Important To edit an event go to Section 12 Review Your Reports and Edit Events e Pressing the RIGHT Option button Set completes the entry of your event regardless of how much or how little detail you have provided e The current date and time are automatically recorded when you enter an event If you enter the event at a later time you must change the date and time of the event to when it actually occurred before you press the RIGHT Option button Set to save the event If you change your mind about saving the event use the UP DOWN Arrow button to change SAVE to CANCEL before you press the RIGHT Option button Set ET Yv 1 Access the Add Event screen from the Main menu Note If you don t press any buttons for 12
45. system when compared to the results from the YSI Table 4a shows an analysis of the measure of closeness of the FreeStyle Navigator system to the YSI It breaks the data into smaller groups based on the glucose value reported by the YSI The table reports the mean absolute difference for the data pairs in each of the smaller groups Table 4b shows the same data at different levels of glucose and further groups them by the amount of difference from the YSI Table 5 breaks out the overall performance relative to the YSI for the two sites of sensor insertion The overall median absolute relative difference for all the data pairs is 9 396 Table 4a Performance relative to YSI at different glucose levels Glucose mg dL Performance 20 40 Mean Absolute Difference 32 3 mg dL 41 80 Mean Absolute Difference 18 1 mg dL 81 120 Mean Absolute Difference 16 3 mg dL 121 240 Mean Absolute Relative Difference 11 0 2240 Mean Absolute Relative Difference 9 596 Table 4b Performance relative to YSI at different levels of glucose grouped by amount of difference from the YSI Glucose Range Number of Percent Within Percent Within Percent Within mg dL Paired Readings 20 ofthe YSI 30 ofthe YSI 40 ofthe YSI 20 40 22 31 8 54 5 72 7 41 80 1295 65 9 82 0 90 7 81 120 3820 69 5 85 2 92 7 121 240 11430 85 4 95 1 98 3 gt 241 3795 91 7 98 8 99 9 Overall 20362 82 3 93 1 97 0
46. the insertion if the batteries are running low Interferents In vitro and in vivo testing suggest that usual pharmacologic levels of ascorbic acid have no effect on the function of the system but salicylic acid has minimal effect In vitro testing suggests that normal physiologic levels of uric acid lipids and bilirubin do not affect system function The impact of oral hypoglycemic agents and other potential interfering substances has not been studied Section 5 Insert or Remove Your Sensor Important Things to Know About Getting Reliable Results Caution Movement of the sensor support mount or excessive perspiration at the sensor insertion site due to activities like vigorous exercise or bumping against objects may lead to poor adhesion of the support mount to the skin and then cause the sensor to dislodge If the sensor dislodges due to the sensor support adhesive failing to adhere to the skin you may get unreliable results or no results The system may not provide a warning in such circumstances Choose the proper sensor insertion site when inserting the sensor and prepare the site by following the instructions for site preparation Caution If your results from the Continuous Monitoring mode seem erroneous check and make sure that the sensor has not dislodged If you notice the sensor is dislodged from the skin or if you see that the adhesive on your overbandage or the sensor support mount is coming loose discard the old sensor and i
47. vibration mode in order to prevent the device from sounding alarms Once you put a new battery into the transmitter make sure to set the alarms to the original setting Note Insert a fresh battery into the transmitter after travel before inserting a new sensor You can always use your receiver to check your blood glucose manually in the Blood Glucose mode Section 1 Getting Acquainted How dol prepare my system for the first time When you are setting up your receiver for the first time perform all of the procedures listed below in the order that they are listed Check each procedure off when you complete it _j Install batteries in the transmitter first and then in the receiver see Section 2 _j Set the time and date see Section 3 _ Perform a control solution test see Section 4 Insert your sensor see Section 5 _ Attach your transmitter see Section 6 J Calibrate your receiver when prompted see Section 7 _ Set the alarms in the receiver see Section 8 Note This can be done while waiting to perform the first calibration Result Your system is operational Customer Care 1 866 597 5520 Section 1 Getting Acquainted Warnings Cautions And Important Notes Important Notes About System Performance The following items describe situations that could lead to inaccurate or unreliable continuous glucose results Cautions Movement of the sensor support mount or excessive perspiration at the
48. water or any other substance in the receiver s test strip port e Keep your receiver in its protective carrying case when you are not using it Note Your transmitter and receiver cannot be repaired when broken The transmitter should be removed from the sensor support mount and cleaned each time you remove a used sensor every 5 days Contact your healthcare team or Customer Care when you need to replace your transmitter or receiver They will suggest a proper way to dispose of the old parts e Your transmitter has a life of 2 years from the date of first use Replace the transmitter after that time period Do NOT use adhesive remover wipes or solutions containing ether or ether containing components for cleaning or removing residual adhesive from the transmitter or receiver These solutions can damage the casing of the receiver and transmitter Section 13 Clean Your System steps U REN 1 Clean your transmitter a Wash the transmitter with mild soap and water b Rinse the transmitter thoroughly under running water c Dry the transmitter thoroughly with a clean soft lint free towel d Shake any water out ofthe transmitter s contact points and blot on a clean dry lint free towel Contact Point 5 pid e Make sure that the contact points are clean dry and not excessively worn 2 Clean your receiver skin s Before cleaning the receiver skin remove it from the T receiver Wash the receiver s
49. you are not changing the receiver batteries at this time reconnect the transmitter and receiver then go to Check your work at the end of this Section Install or Replace the Receiver Batteries Note The receiver skin must be removed in order to access the receiver s battery door a Locate the battery door on the back of the receiver b Press down on the ridged part of the battery door to slide the battery door completely out c Remove old batteries if any and discard them properly Note Be sure to finish within 5 minutes to prevent losing the date and time settings d Insert the new batteries with the positive as shown Align the and signs of the batteries with the signs as shown in the battery compartment e Press each battery into its channel making sure the battery fits tightly Note The receiver will not operate if the batteries are not inserted in the proper direction f Replace the battery door with the tab facing the receiver g Align the edges of the door with the channel in the battery compartment h Slide the door into the receiver until it clicks i Match the screen on your receiver with ONE ofthe screens in the next table and perform the corresponding step Customer Care 1 866 597 5520 Section 2 Install or Replace Transmitter and Receiver Batteries Match what you see on your Receiver with ONE of the screen shots shown below If the display is Glucose CM The
50. 2 Titanium and Energizer Industrial batteries Other batteries may not provide expected battery life Height 2 05 in 5 2 cm Width 1 23 in 3 1 cm Depth 0 43 in 1 1 cm 0 48 oz 13 61 grams including battery Up to 30 days Up to 1 meter under water for no more than 30 minutes Section 18 Appendix B Specifications 18 Appendix B Specifications cont Receiver Size Receiver Weight Receiver Battery Life Automatic Shutoff Receiver Memory Calibration Calibration Time Blood Glucose Test Time for BG mode Blood Glucose Assay Method for BG mode Height 2 5 in 6 3 cm Width 3 24 in 8 2 cm Depth 0 88 in 2 2 cm 3 5 oz 99 2 grams including batteries Up to 60 days Built in blood glucose meter 2 minutes after last user action Receiver 12 seconds after last user action 60 days of normal use including continuous glucose readings stored every 10 minutes and daily blood glucose readings Date time will be remembered for 5 minutes after receiver battery removal Plasma equivalent e 1st calibration Must be performed at approximately 10 hours after a new sensor has been inserted The first calibration can be performed after the 10 hours Continuous glucose readings will NOT be reported until the 1st calibration is performed successfully e 2nd calibration Must be performed between 2 and 4 hours after the 1st calibration or continuous glucose wi
51. 3 System Calibration Time to Perform Calibration Sample Calibration Schedules Perform Blood Glucose Tests Interpret Your Blood Glucose Test Results Set Review or Change the Alarm Settings 67 78 About Glucose Alarms Choose Alarms Settings On Off Type beep vs vibrate and Glucose Alarm Threshold Set the Low and High Glucose Alarms Set Projected Early Warning Alarms What is Alarm Sensitivity Set Data Loss Alarms System Alarms and Progress Tones Mute Alarms Daily OC rnm 81 85 Maintain Connection Between the Transmitter and Receiver Interpret the Glucose Results in the Continuous Monitoring Mode Symbols Arrows and Icons Receiver Backlight Section 10 Section 11 Section 12 Section 13 Section 14 Section 15 Section 16 Section 17 Section 18 Section 19 Section 20 Section 21 Respond to Alarms Errors and Problems 89 108 Alarm Messages What are they What do they mean and What you should do Error Codes What are they What do they mean and What you should do Problems How to troubleshoot the problems you may encounter Add Events cs sev lE meu Ser reae ERES CDS 111 Enter Events Insulin Meals Exercise and State of Health Customize Generic Events Review Reports and Edit Events 117 Enter Glucose Targets View Line Graph View Statistics R
52. 3 to Inactive Day 4 to Party etc Note 2 Write down the meanings for each number as you assign them so you dont forget what they represent you dont have to assign meanings to all the numbers c When you are done press the RIGHT Option button Set to save or cancel the event 8 Check your work Result An electronic record of all events that may affect your glucose levels You have done this procedure correctly when the event records are complete and accurate Customer Care 1 866 597 5520 12 Review Reports and Edit Events Section 12 Key Terms Event History Reports Events Exercise Event Generic Event Glucose Targets Insulin Event LEFT RIGHT Option Buttons Line Graph Main Menu Meal Event Multi Day Statistics Reports Single Day Statistics State Of Health Event Statistical Reports UP DOWN Arrow Buttons Customer Care 1 866 597 5520 Section 12 Review Reports and Edit Events 12 Review Reports and Edit Events Pu rpose To review your glucose levels To help you and your healthcare team detect patterns in your glucose levels relative to your targets e To review a history of events that are important to your treatment plan e To edit event history Start e When you or your healthcare team want to know about your glucose levels or about events that may either explain your glucose levels or influence your treatment plan e When you need to make changes to your event history Mate
53. 5520 16 Change Country Settings Section 16 Key Terms LEFT RIGHT Option Buttons Receiver System Menu UP DOWN Arrow Buttons Customer Care 1 866 597 5520 Section 16 Change Country Settings 16 Change Country Settings Pu FDOSe To set the date and time formats the language and the decimal format Start Do this procedure when your requirements differ from the country setting currently being used by the system Materials Gather these materials before you begin Your requirements for displaying date time format and the other items mentioned in the purpose statement e Your FreeStyle Navigator Receiver Helpful Information Check with your healthcare team if you have any questions about your requirements If you dont press any button within 12 seconds the receiver screen will go blank and the last change will be lost if you haven t pressed the RIGHT Option button Select W PD ss 1 Access the System menu from the Main menu a Press the UP or DOWN Arrow button to highlight marn System Glucose Alarms b Press the RIGHT Option button Select to go to the Reports Select System screen Add Event Select Section 16 Change Country Settings a pomis 2 Access the Country Settings menu System Menu Data Upload Status Link Set Date Time Country Settings Main Select If you want to change how a Press the UP or DOWN Arrow button to highlight Country Settings b
54. 597 5520 15 Reset User Settings Customer Care 1 866 597 5520 Section 15 Reset User Settings 15 Reset User Settings Purpose To reset the user settings to the default values Start Do this procedure anytime you feel a need to return your settings to the factory defaults Materials your FreeStyle Navigator Receiver Helpful Information If you dont press any button within 12 seconds the receiver screen will go blank and the last change will be lost if you havent pressed the Select button Be careful to avoid making unintentional changes to the system settings and configuration Resetting user settings resets the following items to their default Note The units of glucose cannot be changed The default values are shown in brackets e High Glucose Target e Country Settings Local settings 180 mg dL 10 mmol L Date format Language Time format Decimal format Low Glucose Target 80 mg dL 4 4 mmol L e Displays for the items in the Add Event menu Insulin type Rapid Exercise intensity Medium Alarm Settings Med Beep nsulin Pu 1 pies State of Health Normal On Off Exercise type Walking Generic Event 1 Low beep Exercise duration 30 min Medium beep High beep e Strip Cal code 18 e Low Glucose Alarm Short vibe 65 mg dL 3 6 mmol L Medium vibe e Sensor Code 109 e High Glucose Alarm Longvibe 300 mg dL 16 7 mmol L Alarm Thresholds
55. 7 28 270 70 193 274 30 81 274 12 32 265 21 3 14 79 11 14 36 5 14 300 61 117 192 39 75 192 12 20 161 12 1 8 88 7 8 33 1 3 True Alarms are the percentage of time the glucose level was above the threshold and an alarm was activated Missed Alarms are the percentage of time the glucose level was above the threshold and an alarm was not activated False Alarms are the percentage of time an alarm occurred but the glucose level was not above the threshold setting n N is the n umber of observations divided by the total N umber E Section 18 Appendix B Specifications 18 Appendix B Specifications cont Measuring Glucose in Interstitial Fluid FreeStyle Navigator system measures glucose in the interstitial fluid ISF by means of a sensor that is inserted about 5 mm under the skin Interstitial fluid is the fluid between the body s cells Physiologic differences between the interstitial fluid and capillary blood may result in differences in glucose measurements Differences in glucose measurement between interstitial fluid and your finger may be observed during times of rapid change in blood glucose e g after eating dosing insulin or exercising Movement of nutrients oxygen and glucose from the blood into the cells happen across the ISF Therefore if the glucose in the bloodstream rises e g during meals that rise is not seen in the ISF until later Similarly if glucose levels in the ISF drop
56. 7 mmol L Perform the calibration test when your blood glucose is within the above range Your blood glucose is changing too rapidly This can happen during a meal or exercise activities or if you have taken insulin Give yourself an hour before you try to perform a calibration test again Do not perform a Blood Glucose mode test for calibration if you do not see the blood drop icon on the screen The skin temperature may be out of range the skin temperature has to be between 77 F 25 C and 104 F 40 C The sensor signal may be out of range or has changed relative to the last successful calibration Improper Blood Glucose mode testing Carefully follow the instructions in this Section to perform a BG test keep your hands clean enter the right strip code and choose finger for calibration tests to avoid errors from the Blood Glucose mode test The system will prompt you with alarm messages when your calibrations are unsuccessful See Section 10 for more information or call Customer Care You will have to perform additional Blood Glucose mode tests BG tests if your calibrations are unsuccessful Section 7 Calibrate Your System Test Blood Glucose Manually steps DoThis OOOO O 1 Insert a FreeStyle Test Strip into the receiver s test strip port a Insert the end with the dark rectangle b Gently push until the test strip stops Result The receiver will display the most recently used test strip code number
57. AoAuns lts orjougeuro2o o ue Aq p ururs p se s1ojrumsue JY WOI suj8uoJjs platy ur si ur UT o uejsrp uoneredas popuoururooo1 IY sr p pue 1o1nj egnueui 19jjrursuea IY 03 Surp100o M SNEM ur 1ojjruisue ou Jo Sure Jamod yndyno umumxew Iy st d WIM ZHDS 7 1 ZHI 008 w dfAegz p ZHW 008 ZHW 08 w dAzr p o uejsiq uoneredas p pu ururo5 z Jojrusue1 y jo Aduanbayy y 0 o qeor dde our amp puooas go eur oMp puooos g01 uonenb gt y Woy payepnsfes o uejsrp uoneredas popuoururoo125 uone npoW WV ZH uone hpoy WY ZHAI ucu so qeo gurpnpur TOIMEN H S IY Jo 11ed Aue 0 Jasop ou 68 W AOI 68 W AOL ysay Ayrunuru pasn aq pnoys ju urdmb suoneorunururo5 Tq ltqour pue l qejtod ZHIN000 ZHINOS ZHWO000 ZHIN08 parerpey X4 X1L ooueprnr juouruoJrAu rouseuro o q T9427 uei duro PATIS 359 Ayunwu JUSWUOIIAUD ue qns ut pasn st 1 FEY ansse p nous ur s s JOJeSTARN ASIA IY JO 1osn IY 10 I9WOJSN aur Aoj q Payads JUSWUOITAUD 3903uSeurono IY ur ISN 10 p pu lut st ur S s IOJSIARN I L ALL Grunurur rouZeurojoo q uoneie p q SIINPeznue pue o ueprnz Section 19 Appendix C Classification Compliance Declaration 19 Appendix C FCC Compliance Information con t Caution The radio receiver and transmitter of your FreeStyle Navigator system operate on the frequency of 433 6 MHz Primary users of this frequency band include amateur
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59. Fluid in vitro in vivo Lancet Lancing Device Lancing Device Cocking Handle Lancing Device Depth Indicator Window Lancing Device Depth Setting Lancing Device Lancet Cup Holder LEFT RIGHT Option Buttons Arrows shown on the receiver that let you know whether your glucose levels are stable increasing or decreasing and how quickly they are changing A measure of the amount of red blood cells in your body Notifies you when you go above your high glucose threshold a number you and your healthcare team will set The level you do not want your glucose level to rise above You and your healthcare team choose the level that is right for you and you set in the system The High Glucose alarm and the Projected High Glucose alarm use the high glucose threshold Simple graphic symbols that appear on the receiver display screen to alert you to system conditions or actions required A record of insulin doses injection or pump that you enter in the system to help you evaluate current therapy The time and date of an Insulin event are always recorded You may also enter the type of insulin and dose amount units The fluid in the tiny spaces between the cells in your body The system uses this fluid to measure your glucose levels The measuring of something out of the body For example in a test tube The measuring of something in the body A tiny sharp pointed disposable component used with the lancing device to obta
60. I C Ge M E Y d N wr Y ud W Z N Ext qo f oq o Pour GER J J Z E u ET 7 2 x CRI c IN d Section 2 Key Terms Alarm Icon Receiver Transmitter Battery Life Alkaline Batteries 357 HC Silver Oxide Battery Reconnect Customer Care 1 866 597 5520 Section 2 Install or Replace Transmitter and Receiver Batteries 2 Install or Replace Transmitter and Receiver Batteries Purpose Start Materials To ensure that your FreeStyle Navigator system has power to operate properly Do this procedure e The first time you use your FreeStyle Navigator system When the receiver displays the Low Battery message and alarm and the battery icon appears on the screen e When the receiver sounds an alarm and displays the Replace TX Battery with Next Sensor message Gather these materials before you begin 2 new AAA alkaline batteries for the receiver We recommend Energizer Max Energizer e2 Titanium and Energizer Industrial batteries Other batteries may not provide expected battery life e 1 Silver Oxide 357 HC battery for the transmitter coin e Your FreeStyle Navigator Receiver e Your FreeStyle Navigator Transmitter Helpful Information Caution It is important to use the correct type of batteries in the receiver otherwise the battery life may not be accurately monitored Important An alarm will sound and a battery icon wi
61. MO T 009 say Z ut Dg ope pexmbo eo a bessayy uue y V Em Section 10 Respond to Alarms Errors and Problems T MOT J exerpeuirojug JA wInTpeyy H YSIH jjnsa4 snonuijuoo IY tu11fuo2 o 1521 apow 2soonjr poojg v wofsad wajsds 10JVSIADN 21152244 ano WOLf sq nsaa asoonj8 snonuijuoo y uo pasvq JuawMasvuvU sajaquip 4of uauyvay SuYsnipv asofag uongnpD 4 re 1 urolsnOo JJL s1n220 10119 IY JJ eyep ISO STY ureguoo Jou TIM s310do1 INOJ SO SI 103295 STY UT ejep IU 31 pese1o pue Iso eq 80 o1 ur 107998 Jdn1109 e p312319D 1J AI 231 OY ydn1109 st 30 101stH T euros poydnu107 307 urere au oSpo wouxp y pereo Aqnjssooons u q seu So A1o1stH T pap 307 W PL uonoog 399 sax 129 es 3221100 st uoo15s ejdstp y uo sreadde yey qI 1931rumsuea ou jT qur PAPS epour Surojruojq snonunuo uad NUJU UW S I2AI9281 IY WON urojs g 129 og y ur oje1ado 03 urojs s IY 107 1essooou sr Jul xV JojrursueJ IY JO 329 01 UIYJIM 1 A192 1 IYJ IJd YL t nmusuezn IY o1 p yut JOU SI 13AI92 1 AJI TI JUNT apostda orur s 81 d u 94e soon 8 ys y e Sune n 107 ureoj ppouseug reoun e u INOA Jo SUOYLpUIWUOI IY MOJOJ esoon 3 uSru 1 s d 1no pouvoir sey so on 8 mox W SONY Ys WV Sup 10A jou oe surre e IY pue po ejdsrp aq 1ou IM sSurpeoz 9107219 tour ATJOLUT UOTJLAQI ED 10 1s opour so on 52 poo g e WIOJJeg peimboz y UTYIM p
62. Next to move from one field to the next e Use the UP DOWN Arrow buttons to change the setting in any field e Press the RIGHT Option button Set to accept the settings and return to the Alarms menu Note The receiver will respond with a brief sample of the alarm you selected c Decide what to do next Then You are setting reviewing or changing Continue to the next step all alarms e You are finished setting reviewing and Go to Step 11 changing alarms Customer Care 1 866 597 5520 Section 8 Set Review or Change the Alarm Settings rw 9 Set Progress Tones AlannSeuings a Select Progress Tones from the Alarms menu Projected Low On Projected High Off Data Loss 08 30A System Alarms Main Alarm Settings Progress Tones Select Setting Low Next Decide what settings you want e Turn progress tones on or off Set progress tones volume low or high b Review or change your settings e Press the LEFT Option button Next to move from one field to the next e Use the UP DOWN Arrow buttons to change the setting in either field e Press the RIGHT Option button Set to accept the settings and return to the Alarms menu Note The receiver will respond with a brief sample of the alarm you selected c Decide what to do next If e You want to mute alarms You are finished setting reviewing and changing alarms Then Go to Step 10 G
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64. Step 4b End viewing line graphs 1 Press the RIGHT Option button to return to the Select Time Period screen 2 Press the LEFT Option button Back to return to the Select Reports screen 3 Go to Step 2 to decide what to do next Section 12 Review Reports and Edit Events steps Doms LU 5 View a statistical summary of your glucose levels a Select Statistics from the Select Reports menu Stats 3 day 08 30A 5 A i Use the UP Arrow button or DOWN Arrow button Lowest CM 61 mg dL to highlight Statistics Ave CM 160 mg dL Std Dev 80 mg dL ii Press the RIGHT Option button Select to go to the Above Target 1996 Statistics screen Next back Note The Stats screen shows you a summary of glucose results relative to your glucose targets b Press the LEFT Option button Next to advance to the desired period Note You can view statistical reports for 1 3 7 14 21 or 28 day periods in that order Continue to Step 6 Customer Care 1 866 597 5520 Section 12 Review Reports and Edit Events steps eee 6 Select the desired statistical reading Note Statistics include ONLY continuous glucose results Glucose readings that were taken in the Blood Glucose mode are NOT included in the statistics a Use the UP Arrow button or DOWN Arrow button to highlight the statistic you want to review for the selected period If you want to know Then highlight e Your highest gluco
65. YES stop If NO continue with Step c fe Are the batteries installed correctly If YES go to Step d If NO Install the batteries correctly and reset time and date d The batteries may be dead replace existing batteries and reset time and date Repeat the test with a new test strip If this did not resolve your problem call Customer Care Note Whenever batteries are removed and replaced or re installed in the receiver you will have to reconnect the transmitter and receiver and insert a new sensor The Blood Glucose test won t start after you apply a sample Note Ensure that you apply your sample when the Apply Sample message appears on the display a Repeat the test using a LARGER sample on a new test strip b If this did not resolve your problem call Customer Care Customer Care 1 866 597 5520 Section 10 Respond to Alarms Errors and Problems Unexpected characters on the receiver display screen unusual or unexpected receiver screen appearance If Then The batteries are installed correctly If you are close to a source of electromagnetic interference see Appendix C for further details move away from the interfering source and see if the problem goes away If there is consistent interference from a source contact the manufacturer of the source or a certified electrician for help The batteries may have to be replaced Replace batteries with fresh ones and reset date a
66. al appointment that includes X ray MRI Magnetic Resonance Imaging CT Computed Tomography scan or another type of exposure to radiation keep your system and sensor away from the area Before exposure to such radiation discard any sensor you are wearing and insert a new sensor after the radiation session The effect of these types of radiation on the performance of the system has not been evaluated Helpful health related information The following pertain to your health and should always be kept in mind e The system is intended to assist you in better managing your diabetes by allowing you to know your glucose levels throughout the day Test results below 60 mg dL 3 3 mmol L mean your glucose levels are low e Test results above 240 mg dL 13 3 mmol L mean your glucose levels are high e Severe dehydration and excessive water loss may cause false low results If you believe you are experiencing severe dehydration consult your healthcare team immediately e If you get results below 60 mg dL 3 3 mmol L or above 240 mg dL 13 3 mmol L and do not have symptoms of hypoglycemia or hyperglycemia test your glucose using the Blood Glucose mode If you have symptoms of hypoglycemia or hyperglycemia or continue to get results below 60 mg dL 3 3 mmol L or above 240 mg dL 13 3 mmol L consult your healthcare team e If you are experiencing symptoms that are not consistent with your glucose test results consult your healthcare te
67. am Physiologic differences between the interstitial fluid and capillary blood may result in differences in glucose measurements Differences in glucose measurement between interstitial fluid and your finger may be observed during times of rapid change in blood glucose e g after eating dosing insulin or exercising Interstitial fluid ISF is the fluid between cells in the body Movement of nutrients oxygen and glucose from the blood into the cells happen across the ISF Therefore if the glucose in the bloodstream rises e g during meals that rise is not seen in the ISF until later Similarly if glucose levels in the ISF drop for example during exercise the cells consume glucose rapidly that drop is not seen in the bloodstream until later When testing your glucose levels in the Blood Glucose mode differences in the blood circulation in your finger or palm at the base of your thumb and other test sites forearm upper arm hand thigh or calf may result in different glucose readings Differences in blood glucose readings between your finger or palm at the base of your thumb and other test sites forearm upper arm hand thigh or calf may be observed after eating taking insulin diabetes medication or exercising Test your finger if you are testing for hypoglycemia or if you have hypoglycemia unawareness see next page for definition of hypoglycemia unawareness Changes in glucose levels may be observed in finger blood samples
68. are above or below your low and high glucose threshold values You will decide the low and high glucose threshold values based on input from your healthcare team If there is no glucose data you will not get glucose alarms A projected alarm is an alarm that provides an early warning of an event that is likely to occur if the current trend continues Projected alarms use the low and high glucose threshold values regardless of whether or not the low and high glucose alarms are turned on For example a projected low alarm lets you know when you are approaching your low glucose threshold value You will decide the amount of notice required whether you should be notified approximately 10 minutes 20 minutes or 30 minutes in advance of reaching your threshold value based on the input from your healthcare team e A data loss alarm warns you when glucose results are no longer available They occur when the sensor has expired when the transmitter receiver connection is broken when a calibration has expired or when the sensor is not working properly The data loss alarm cannot be turned off without turning off the glucose alarms Low Glucose High Glucose Projected Low Glucose and Projected High Glucose System alarms notify you of events like low battery or time to calibrate e Progress tones notify you of errors results and successful completion of steps in activities like Blood Glucose mode testing OVER Section 8 Set Review or Change t
69. arrows LL You can tell your current glucose level at a glance LL You maintain the connection between your transmitter and receiver or can reconnect the transmitter and receiver when the connection is lost J You can correctly interpret the icons that appear on the receiver screen Customer Care 1 866 597 5520 10 Respond to Alarms Errors and Problems Section 10 Key Terms Alarms Menu Calibration BG CM Status Calibration High Glucose Alarm Icon Low Glucose Alarm Projected High Alarm Projected Low Alarm Receiver Status Sensor Sensor Support Mount Status Information Transmitter Transmitter Receiver Connection Transmitter Status Customer Care 1 866 597 5520 Section 10 Respond to Alarms Errors and Problems 10 Respond to Alarms Errors and Problems Purpose To resolve alarm messages error codes or problems Start Do this any time you Receive either an alarm or an error code in the Continuous Monitoring mode or the Blood Glucose mode e Experience problems with your FreeStyle Navigator system Materials vou FreeStyle Navigator system Helpful Information Ee Caution For ALL alarms if you do not turn on the display of the receiver within the first hour of the notification of an alarm the receiver will stop beeping or vibrating No further alarms will sound beep or vibrate until the display has been activated Important Muting the alarms is not recommended duri
70. at does not repeat Can be muted e Is turned off when acknowledged The level of urgency is indicated in some of the following tables with H for high M for medium I for intermediate and L for low e The alarms are alphabetized in the following tables If you cannot find the information you need call Customer Care Section 10 Respond to Alarms Errors and Problems Status Information The receiver can provide you with a number of different types of Status Information Available Status Information is listed in the following table To access the Status information press the RIGHT option button twice to get to the Main menu and use the UP or DOWN arrow button to highlight System Select System by pressing the RIGHT option button Highlight and select Status from the System menu Status Information Description Removed Sensor Allows you to indicate you are removing a Sensor so the Data Loss Alarm will not set off Use this only if you are removing a sensor Note Once you select this option the system will The Sensor terminate any active sensor Did You Remove System Status Shows information about the System including Sensor life remaining in hours and time since System Status 08 30A valid data was transmitted in hours Sensor Life Left 000 000 Time Since Sensor Data Receiver Status Shows information about the receiver including serial number and software version may be useful Rece
71. ating with the correct time and date You have done this procedure correctly when _ The time is correct The date is correct Customer Care 1 866 597 5520 4 Perform a Control Solution Test Section 4 Key Terms Control Solution Test FreeStyle Control Solution FreeStyle Test Strips LEFT RIGHT Option Buttons Receiver UP DOWN Arrow Buttons Customer Care 1 866 597 5520 Section 4 Perform a Control Solution Test 4 Perform a Control Solution Test Pu rFPOS The purpose of the control solution test is to e Ensure that your receiver and test strips are working properly prior to calibration or blood glucose testing Check that you are following the correct testing procedure e Practice Blood Glucose mode testing without having to use your own blood A Control Solution test is not the same as a calibration See Section 7 for calibrating the system Start Do this procedure when you e Set up your receiver for the first time Open and begin using a new vial of test strips e Suspect that your receiver or test strips are not working properly e Suspect that your glucose test results are not accurate Suspect that your test results are not consistent with how you feel Drop damage or expose the receiver to liquids e Are advised by your healthcare team to do so Materials Gather these materials before you begin e FreeStyle Navigator Receiver e FreeStyle Control Solution FreeStyle Test Strips
72. cannot be set below 60 mg dL 3 3 mmol L Therefore it is not intended to notify you of severe hypoglycemia e The High Glucose alarm cannot be set above 300 mg dL 16 7 mmol L Therefore it is not intended to notify you of severe hyperglycemia It is important to use the correct type of batteries in the receiver otherwise the battery life may not be accurately monitored Do NOT immerse the receiver in water or in any other liquid Avoid getting water or any other liquid in the test strip port Changes or modifications not expressly approved by Abbott Diabetes Care Inc could void the users authority to operate the equipment The system should not be used in environments that are oxygen rich or that contain a combustible gas e The radio receiver and transmitter of your FreeStyle Navigator system operate on the frequency of 433 6 MHz Primary users of this frequency band include amateur HAM radio transmitters Because of the coexistence of the FreeStyle Navigator radio connection and HAM transmitters there may be instances where the connection between your transmitter and receiver may be lost when in proximity to HAM radio equipment The FreeStyle Navigator system is designed to sense and notify you about a lost connection If your FreeStyle Navigator system loses the radio connection increase the separation distance between yourself and the transmitter by moving away from the HAM radio The FreeStyle Navigator radio connecti
73. ceiver begins or completes certain activities Start Do this task e Immediately after you finish the first set up of your FreeStyle Navigator system When your healthcare team gives you new glucose threshold numbers e Anytime you get a Preferences Lost Reconfigure alarm message on the receiver e Anytime you replace your receiver e Anytime you want to change your alarm settings e Anytime you want to review your alarm settings Materials your FreeStyle Navigator Receiver e Low and high glucose threshold values from your healthcare team Helpful Information Caution The high and low alarms are intended to assist you in managing your diabetes and should not be exclusively used to detect hypoglycemia or hyperglycemia The alarms should always be used in conjunction with other indications of glycemic state such as your glucose level trend line graph etc Caution High and low glucose alarms are DIFFERENT from your glucose targets Low and high glucose alarms alert you when you ve crossed a certain low or high value Glucose targets allow the reports and line graphs to show how your glucose levels have been performing compared to your set targets Caution Before adjusting treatment for diabetes management based on the continuous glucose results from your FreeStyle Navigator system perform a Blood Glucose mode test to confirm the continuous result High and low glucose alarms let you know when your glucose levels
74. cessful first calibration was 10 1 hours The median duration of wear of calibrated sensors was 120 hours 8396 of sensor wears lasted at least 108 3 hours The median wear time for sensors inserted on the arm was 0 4 hours longer than for sensors inserted on the abdomen Skin Interaction Based on the examination of 124 study participants at a 21 day follow up the following incidence of skin issues were observed in 304 site exams Moderate to severe itching 1 6 of the time Moderate bruising 0 3 of the time Moderate erythema 1 096 of the time Moderate pain 0 396 of the time Rate of mild incidences for any individual category of skin issues above including edema rash induration bleeding and others was less than 596 Customer Care 1 866 597 5520 19 Appendix C FCC Compliance Information Customer Care 1 866 597 5520 Section 19 Appendix C Classification Compliance Declaration 19 Appendix C FCC Compliance Information Electromagnetic Interference and Your FreeStyle Navigator Continuous Glucose Monitoring System Important Information about Electromagnetic Interference The FreeStyle Navigator Transmitter and Receiver communicate using radio frequency waves The FreeStyle Navigator system has been designed to be reliable and immune to common electromagnetic interference so that it is not influenced by such interference However under rare circumstances if you happen to be in an environment of strong electromagnetic
75. connect the system after linking Section 9 Section 10 Respond to Alarms Errors and Problems The system does not prompt you with a message to do BG test for calibration If The system did not prompt you with a message recognizing a new sensor after you attached the transmitter to the sensor support mount And Then Follow the troubleshooting guidelines on sensor recognition It has been less than 10 hours after insertion of the sensor It has been more than 10 hours after the insertion of the sensor It has been more than 10 hours after the insertion of the sensor There is a icon on the screen You have received alarm messages on the receiver Wait for the 10 hour time period to end and allow the system to prompt you to do a BG Test for calibration Reconnect the transmitter and receiver Section 9 and allow the system up to 2 hours to prompt you to doa BG Test for calibration Acknowledge the alarm message take appropriate action and allow the system up to 2 hours to prompt you to do a BG Test for calibration If none of the above helps solve the problem replace the sensor Section 5 or call Customer Care Check your work Result Information on what to do in the event of alarm messages error codes or other common problems You will have done this task correctly when you have resolved the problem or contacted either your healthcare team or Customer Care for additional
76. ction is broken often e If you will not be using your receiver for an extended period of time remove the batteries from the receiver to preserve battery life To avoid draining the receiver s batteries be careful not to accidentally press and hold the receiver s buttons for a long period of time e After changing the batteries make sure that you reconnect the transmitter and receiver to establish communication between them e If you are replacing batteries on both the transmitter and receiver replace the battery in the transmitter first Section 2 Install or Replace Transmitter and Receiver Batteries Install or Replace the Transmitter Battery a Turn the circular battery door counterclockwise with either a coin or your fingernail Fig 1 b Carefully remove the battery door c Remove the old battery if any and discard it properly d Insert a NEW silver oxide 357 HC battery with the plus sign facing you Fig 2 Important When inserting the battery in the transmitter pay special attention to placing the battery straight in rather than at an angle Do not rock the battery back and forth as this can shorten the battery life e Replace the battery door and secure it in place by rotating clockwise Fig 3 Note The battery door must be closed securely to create a seal Do not apply excessive force when closing Excessive force can damage the plastic material of the battery door and the transmitter case If
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78. ds upon the date and the time being correct The receiver is on whenever batteries with sufficient charge are in the receiver o If the batteries are discharged or removed for 5 minutes or more you must reset the date and time If you make a mistake or want to exit from the Set Date Time screen simply leave the receiver alone for 12 seconds It will automatically turn off and any changes you made will be cancelled or cleared If you change the time and or date in the receiver the line graphs and statistical reports will be affected For example if you travel from one time zone to another and change the time to match the local time zone the appearance of your graph will be affected rw s lt ww 1 Go to the Main screen Note When setting the time and date after inserting the Glucose CM batteries start from Step 4 a Turn the display on b Press the RIGHT Option button a second time to display the Main screen If your transmitter and receiver are connected you will not see the 2X icon Section 3 Set the Time and Date 2 Go to the System screen Main a Press the DOWN Arrow button to highlight System Glucose Alarms b Press the RIGHT Option button Select to go to the Reports System Menu screen Add Event Select 3 Select Set Date Time from the System Menu screen Seen a Use the UP DOWN Arrow buttons to highlight Set Reconnect Date Time on the System Menu screen Data Upload Pen
79. e LEFT Option button Next to move from one field to the next e Use the UP DOWN Arrow buttons to change the setting in any field e Press the RIGHT Option button Set to accept the settings and return to the Alarms menu Note The receiver will respond with a brief sample of the alarm you selected Decide what to do next If e You are setting reviewing or changing all alarms e You are finished setting reviewing and changing alarms Then Continue to the next step Go to Step 11 Customer Care 1 866 597 5520 5 Set review or change your Projected Low glucose alarm Alarm Settings Low Glucose 70 High Glucose 275 Projected Low On Projected High Off Data Loss Main Select Decide what settings you want e Alarm on or off e Sensitivity e Alarm type Setting Low medium or high beep Short medium or long vibration If e You are setting reviewing or changing all alarms e You are finished setting reviewing and changing alarms Section 8 Set Review or Change the Alarm Settings waww a Select Projected Low from the Alarms menu e Use the UP DOWN Arrow buttons to highlight Projected Low e Press the RIGHT Option button to select Projected Low Alarm Settings 08 30A Projected Low Glucose A Sensitivity Low Setting Medium Beep Next Set If you want this much notice before reaching your Low glucose level e Maximum de
80. e Tabs Sensor Support Mount Transmitter Transmitter Tabs UP DOWN Arrow Buttons Customer Care 1 866 597 5520 Section 1 Getting Acquainted 1 Getting Acquainted Introduction Important Read all of the instructions in this Users Guide and the FreeStyle Test Strip package insert before using your FreeStyle Navigator Continuous Glucose Monitoring System Adjustments to your treatment should be done under the guidance of your healthcare team Your FreeStyle Navigator system continuously reads displays and records the glucose levels in the fluids found between the cells under your skin interstitial fluids It does this by using a small thin plastic sensor inserted just under the skin Your FreeStyle Navigator system provides you with continuous glucose readings in real time By having access to more frequent glucose measurements you can monitor your glucose levels and gain an understanding of patterns in your glucose levels This will help you and your healthcare team see how factors such as your diet insulin exercise and diabetes medication affect your glucose levels and to adjust your treatment plan accordingly Your FreeStyle Navigator system has a number of helpful features e Wireless communication between the transmitter and receiver e Disposable sensor that can be worn up to 5 days e Alarms to alert you to low or high glucose levels hypoglycemia or hyperglycemia before reaching those low and high gl
81. e UP DOWN Arrow buttons to change the code to match b Press the RIGHT Option button Set c Go to Step 5 e The screen changes to the Apply If the numbers did NOT match Sample screen Strip Code Cancel a Press the LEFT Option button Back b Repeat Step 4 If the numbers match go to Step 5 Section 4 Perform a Control Solution Test r w pomis 5 Apply control solution Important Do NOT apply control solution to both edges of the test strip Notes e Gently touch ONLY ONE EDGE of the test strip to the control solution next to one of the dark half circles If progress tones are turned on the receiver will beep to indicate that enough control solution was applied Result A stopwatch will appear on the display screen while the receiver measures the control solution The receiver will beep twice when the test results appear 6 Confirm that you used a control solution Press the LEFT Option button Yes to alert the receiver that you used a control solution for this test Glucose BG 08 30A 106 Control Solution Note If you do NOT select yes the system will record the result as a blood glucose result instead of a control solution result which can result in an incorrect statistical report Go to the next step Customer Care 1 866 597 5520 Section 4 Perform a Control Solution Test steps a 7 Evaluate the test results Co
82. e levels A comprehensive summary of glucose results relative to your glucose targets You can view statistical reports for 1 3 7 14 21 or 28 day periods Viewing this kind of information can help you see patterns in your glucose levels Information about the system and how it is working such as sensor time or battery life remaining A short name for the FreeStyle Navigator Continuous Glucose Monitoring System System messages For example low battery life time for calibration A menu available from the Main menu that is used to access status information and other functions Also called Tx A small electronic device that makes an electrical connection to the portion of the sensor that extends above the skin The transmitter processes the very low current signals it receives from the sensor and sends the glucose data to the receiver once every minute The wireless connection needed for the system to function The transmitter and the receiver must be within 10 feet of each other for the connection to be valid A connector that helps secure the transmitter to the sensor support mount Allows you to view the transmitter serial ID number and battery life remaining Connectors that help secure the transmitter to the sensor support mount The process of removing the transmitter ID from the receiver Once unlinked the receiver will no longer be paired with a specific transmitter Before beginning to use the system the receiver and t
83. e on their abdomen The FreeStyle Navigator system was calibrated with capillary finger stick measurements using the built in FreeStyle Blood Glucose Meter at approximately 10 12 24 and 72 hours after insertion of the sensor All measurements were performed by a trained clinic study staff or the subject During the study subjects came to the clinical center for frequent glucose samples measured once every 15 minutes on the YSI Yellow Springs Instrument STAT Plus Glucose Analyzer YSI measurements were performed in duplicate on venous whole blood and the FreeStyle measurements were performed in duplicate on capillary blood from the finger All YSI whole blood measurements were adjusted by applying a 12 correction factor based on a normal hematocrit value of 4596 Users and healthcare providers should consider that performance in this study might be idealized Participants enrolled in the clinical study and certain conditions of the study tend to result in above average glucose control This in turn may result in the appearance that the FreeStyle Navigator Continuous Glucose Monitoring System agrees with blood glucose levels better than it does under typical conditions Monitors that measure glucose in interstitial fluid often show better agreement to blood glucose levels when glucose levels are not changing rapidly or when glucose levels are not extremely low or high The following are some examples of why performance of the FreeStyle Navigator
84. e under our sole responsibility that the product FreeStyle Navigator Receiver Part Number PRT03410 xxx Complies with Part 15 of 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 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 e Reorient or locate the receiving antenna Increase the separation between the equipment and receiver e Consult the dealer or an experienced radio TV technician for help Caution Changes or modification to the device not expressly approved by Abbott Diabetes Care Inc could void the users authority to
85. ear cap ii Gradually increase pressure until the sample is the size of this dot Important Do NOT smear the sample as you do the next step d Lift the lancing device straight up Customer Care 1 866 597 5520 Section 7 Calibrate Your System Test Blood Glucose Manually steps POTN 6 Test the sample Proccessing C Cancel Do Not e Use test strips more than once Discard used test strips e Scrape the blood e Apply blood to the flat side of the test strip e Apply blood to the test strip when the test strip is out of the receiver e Apply blood to both edges of the test strip e Put blood or foreign objects into the receiver test strip port a Holding the receiver at a slight angle to the sample gently touch the half circle on the test strip to the sample Important Your blood glucose level must be between 60 and 300 mg dL 3 3 and 16 7 mmol L to be able to perform calibration tests If your blood glucose level is changing rapidly you may not be able to calibrate the system b Observe the receiver Then e The stopwatch icon does NOT Continue adding blood sample to the appear within 5 seconds SAME half circle for up to 60 seconds The receiver BEEPS ONCE only Enough blood has been used if Progress Tones are turned on The stopwatch icon appears The receiver is measuring your blood glucose level e The receiver BEEPS TWICE only The test is done Go to Step 7 i
86. ear it vibrate You must keep your receiver within 10 feet of the transmitter to maintain a consistent connection If the connection between the transmitter and receiver is broken you will not receive continuous glucose readings e The connection can also be affected by objects getting between the transmitter and receiver like nearby large metal objects and by some electronic devices that produce radio frequencies e As a periodic check turn your receiver on a few times everyday to make sure that it is still producing glucose results e As a periodic check turn on the low glucose alarm everyday to make sure that it sounds an alarm or vibrates based on your settings e If a connection alarm sounds adjust the placement of the receiver to restore the connection Step 2 of this Section describes how to maintain connection between the receiver and transmitter For general troubleshooting refer to Section 10 as well e If the display turns off press the RIGHT Option button to turn it back on Section 9 Daily Use r DoT 1 Decide what to do Connect your receiver and transmitter 2 e Reconnect your receiver and transmitter 2 e Interpret the CM screen 5 e Interpret icons on the CM screen 4 e Interpret icons on the Main screen 4 e Turn the receiver backlight on 5 2 Reconnect the receiver to the transmitter If the receiver has lost connection e For less than 30 minutes a Place the receiver
87. elation plot Figure 1 into five zones as described in Table 1 The YSI results and the corresponding glucose results from the FreeStyle Navigator system together called a data pair or matched data points determine what zone of the error grid the results fall into Table 1 also shows that glucose data measured by FreeStyle Navigator system on the arm and on the abdomen have similar distribution on the error grid This demonstrates that there is no difference in the performance of the system when worn on the abdomen or on the back of the upper arm Table 1 Clarke Error Grid Analysis Continuous glucose results from FreeStyle Navigator System mg dL vs the YSI mg dL Zone in the Clarke I Percentage in the Sensor Insertion Site N pairs of data 3 Error Grid different zones Abdomen Arm A 16627 81 7 81 5 81 8 B 3398 16 7 16 8 16 6 C 19 0 1 0 1 0 1 D 316 1 6 1 6 1 5 E 2 0 0 0 0 0 0 There is no difference between the performance of the Total 20362 system on the arm and the performance of the system on the abdomen Error Grid Explanation A Clinically accurate would lead to correct and safe treatment B Benign would lead to benign decisions or no treatment decisions C Overcorrection would lead to over correction of normal glucose levels D Failure to detect would lead to failure to detect and treat high or low glucose levels E Erroneous readings would lead to erron
88. en It is normal during typical usage to get multiple messages about failed calibrations Cal Failed or additional calibration requirements Cal Required The system automatically evaluates conditions for calibration and displays appropriate messages if those conditions are not met or if the calibrations fail This helps maintain system accuracy When you get these messages simply follow the prompts on the screen or guidelines in the Users Guide If you get too many messages please call Customer Care e Do NOT change batteries during a sensor wear Changing the batteries resets the system and will force you to remove the sensor If you need assistance please call Customer Care Customer Care 1 866 597 5520 Section 5 Insert or Remove Your Sensor Insert or Remove Your Sensor Purpose To insert remove or replace a small thin plastic sensor under your skin so that your FreeStyle Navigator system can continuously monitor your glucose level Start Do this procedure The first time you use your FreeStyle Navigator system e Every 5 days after that e Replace your sensor sooner than 5 days when There is any redness pain tenderness or swelling at the insertion site An error code displays on your receiver indicating a sensor problem e When replacing batteries Materials Gather these materials before you begin e Soap and water e Alcohol prep pads e A sensor delivery unit in its UNOPENED package e Yo
89. ence 12 6 12 3 14 1 11 9 13 0 MARD0 Table 6b Continuous Error Grid Analysis by day of wear Day 1 Day 2 Day 3 Day 4 Day 5 Zone Accurate 97 9 97 8 97 1 97 4 97 3 Readings Benign 1 0 12 0 7 0 8 0 8 Errors Erroneous 11 1 0 22 1 8 19 Readings Table 6c groups the difference between glucose results from the FreeStyle Navigator system and the YSI into different blocks within 2096 within 3096 and within 4096 from the YSI It shows there is little change in the difference from YSI over time thus demonstrating sensor stability Table 6c Difference from the YSI at different times after sensor insertion Time After Insertion Percent Readings Percent Readings Percent Readings hou na 10 Within 20 of the Within 30 of the Within 40 of the Sus YSI YSI YS 10 12 86 92 96 12 24 82 93 97 24 72 81 92 97 72 122 82 93 97 The absolute difference from the YSI reading is measured in mg dL if the YSI reading is at or below 75 mg dL Section 18 Appendix B Specifications 18 Appendix B Specifications cont Stability of Sensor Calibration FreeStyle Navigator system typically requires a calibration at 10 12 24 and 72 hours after insertion of the sensor This section presents information about the performance of the system by the 4 calibration periods The table Table 6d breaks each calibration period into smaller slots and summarizes the difference from YSI in each slot
90. eous treatment decisions Customer Care 1 866 597 5520 Section 18 Appendix B Specifications 18 Appendix B Specifications cont Table 2 is a summary of the statistics that describe how well data from the FreeStyle Navigator system correlates to the results from the reference method Glucose results from the FreeStyle Navigator system and the corresponding results from the YSI a total 20362 pairs of data points in the In Clinic study were used to determine the correlation Sind Table 2 Regression Analysis FreeStyle d y ER V Navigator System mg dL vs the YSI mg dL Fi me a a Slope 0 92 ZE Intercept 14 3 mg dL 9 md Correlation Coefficient r 0 93 N 20362 x 100 Range 25 533 mg dL Z od Overall mean bias 0 8 mg dL TTT TH 0 100 200 300 400 500 YSI Reference mg dL Table 3a displays the distribution of all the data from the In Clinic study on the Clarke Error Grid It breaks the data set into smaller groups based on the glucose value reported by the YSI For each of these smaller groups the table shows what percentage of data fall into different zones of the grid Table 3a Accuracy performance at different glucose levels using the Clarke Error Grid Analysis Reference Number of A and B A B C D E Glucose Level Paired 96 96 96 96 96 96 mg dL Readings 20 40 22 54 5 54 5 N A N A 45 5 0 0 41 80 1295 44 7 55 2 22 5 0
91. erform the steps to link the system Section 14 Make sure you reconnect the system after linking Section 9 Remove and insert a new sensor If none of the above solves the problem there may be something wrong with your transmitter Call Customer Care Customer Care 1 866 597 5520 Section 10 Respond to Alarms Errors and Problems You are not sure whether your receiver and transmitter are connected If You do not see the 2 icon on the screen Then Your system is connected You see the X icon You see the A icon and the reconnect procedure was unsuccessful You continue to see the icon even after replacing the battery in the transmitter You see the Link message on the screen There is no connection between the receiver and transmitter Reconnect the transmitter and receiver see Section 9 Check and make sure that the transmitter battery is not old or exhausted If the battery is old or exhausted then a Remove the sensor b Change the battery c Establish connection between transmitter and receiver d Insert a new sensor Wait for a couple of minutes after inserting the new battery to allow the system to recognize the new battery If after two minutes the system still does not recognize the new battery there is probably something wrong with your transmitter Call Customer Care Your system is not linked Perform the steps to link the system Section 14 Make sure you re
92. est strips The test site for calibration was a finger The test site for manual blood glucose testing was selected from any of the other test sites shown in Step 3 of this Section You used your finger if you have hypoglycemia unawareness You used the grey cap on the lancing device for a finger site Or you used the clear cap on the lancing device for a forearm site The lancing produced an adequate amount of blood without smearing You followed all of the notes in Step 6 when testing the blood You interpreted the test results according to Step 7 You selected NO in response to the receiver s inquiry Control Solution You disposed the lancet in a sharps container or in a puncture proof sealed container Customer Care 1 866 597 5520 8 Set Review or Change the Alarm Settings Section 8 Key Terms Alarm Menu Alarm Sensitivity Alarm Type Data Loss High Glucose Alarm High Glucose Threshold LEFT RIGHT Option Buttons Low Glucose Alarm Low Glucose Threshold Main Menu Progress Tones Projected High Alarm Projected Low Alarm Receiver System System Alarms UP DOWN Arrow Buttons Customer Care 1 866 597 5520 Section 8 Set Review or Change the Alarm Settings Set Review or Change the Alarm Settings Purpose To set the receiver to e Alert you when your glucose conditions change e Notify you when the receiver needs attention e Notify you when the re
93. ested 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 e Reorient or locate the receiving antenna e Increase the separation between the equipment and transmitter e Consult the dealer or an experienced radio TV technician for help Caution Changes or modification to the device not expressly approved by Abbott Diabetes Care Inc could void the users authority to operate this equipment Customer Care 1 866 597 5520 Section 19 Appendix C Classification Compliance Declaration 19 Appendix C FCC Compliance Information cont Receiver Model Number PRT03410 xxx Operating Environment For Home or Office Use DECLARATION OF CONFORMITY We Abbott Diabetes Care Inc 1360 South Loop Road Alameda California 94502 510 749 5400 Declar
94. eview the History of Events Edit Events Clean Your System Clean Your Transmitter Clean Your Receiver Clean Your Receiver Skin Link and Unlink your Transmitter and Receiver 131 Link and Unlink your System What is the Difference Between Linking and Reconnecting Reset User Settings Reset Settings Change Country Settings ccc cece cece eee nnn 141 Change Language Date and Time Formats Decimal Point format Appendix A Site Maintenance How to Maintain the Sensor Insertion Site How to Improve Sensor Adhesion Appendix B Specifications System Performance Specifications Appendix C FCC Compliance Information 165 Wireless Interference Glossary Definitions of Terms Used in This Guide Index PET 183 Find What You are Looking For De re s aa ee 908 ease aaa 127 s s le nla UR T e ace 137 TETTE 151 ERR I EU LU E i 175 114 124 128 133 138 144 162 171 180 184 1 Getting Acquainted Section 1 Key Terms Alarms Blood Glucose Mode Continuous Monitoring Mode FreeStyle Navigator Continuous Glucose Monitoring System FreeStyle Test Strips a in vitro s Interstitial Fluid LEFT RIGHT Option Buttons Receiver Receiver Display Screen Receiver Test Strip Port Reports Sensor Sensor Delivery Unit Sensor Inserter Sensor Insertion Button Sensor Locking Pin Sensor Releas
95. f Progress Tones are turned on e Your blood glucose results appear in the display takes an average of 7 seconds e The receiver beeps three times The test has failed Repeat the test Refer to Section 10 for error messages You get an error message and troubleshooting p Section 7 Calibrate Your System Test Blood Glucose Manually ru CT CENE 7 Interpret the blood glucose ES results Caution Low or high glucose measurements can indicate a potentially serious medical condition If And Then e Lo appears in You do NOT have low blood Repeat the test from Step 3 the display Lo glucose symptoms using appears when e Your finger the measured e A new test strip glucose result is less than 20 mg dL You have any of these symptoms Follow your healthcare lena ol sI mess Headache team s recommendations e Sweating N eonk s on for treating hypoglycemia e Nervousness This is your second test e Hiappearsin You do NOT have high blood Repeat the test from Step 3 the display Hi glucose symptoms with a new test strip appears when the measured You have any of these symptoms Follow your healthcare glucose result Fatigue e Excess urination teams recommendations is more than e Thirst Blurry vision for treating hyperglycemia 500 mg dL 27 8 mmol L This is your second test e The receiver displays results from 20 to Continue to Step 8 500 mg dL 1 1 mmol L to
96. f you anticipate an activity level that may require more adhesive place an over bandage over the transmitter AFTER connecting the transmitter to the sensor support mount Section 10 Respond to Alarms Errors and Problems Discomfort when inserting the sensor a Rub the insertion site with ice before inserting the sensor b If that doesn t work call Customer Care The system does not recognize a new sensor after attaching the transmitter to the sensor support mount Your transmitter and receiver are not connected Your receiver and transmitter are connected Contact Points Your system is not linked and you see the Link message on your screen Then You will see the icon on the screen Try establishing connection between the receiver and transmitter Ifthe system still does not recognize a new sensor in about 3 minutes remove the sensor and insert a new sensor Section 5 a Make sure that the transmitter is firmly attached to the sensor support mount and wait for 3 minutes to allow the system to recognize the sensor b Ifthe system still does not recognize the sensor remove the sensor Section 5 establish connection between the transmitter and receiver Section 9 insert a new sensor and attach the transmitter to the sensor support mount Section 6 Make sure that the contact points on the transmitter are dry clean and not excessively worn Your system may not be linked P
97. from the Select Report menu i Use the UP Arrow button or DOWN Arrow button to highlight Line Graph ii Press the RIGHT Option button Select to go to the Select Time Period screen b Select the time period 2 4 6 12 or 24 hours using the UP Arrow button or the DOWN Arrow button c Interpret the graph e Notice your glucose target range the shaded horizontal band e Notice your glucose level in mg dL along the left hand side at different times bottom line e Notice the trends and the times that your glucose level is outside of your target range e Notice how different events that you entered are located in relation to your glucose profile Events entered will be shown on the line graph with letters indicating the event T for Insulin M for meals E for exercise H for state of health and the number 1 thru 8 for a generic event Note The line shows both your continuous readings plotted every 10 minutes and your blood glucose readings the symbols on the line graph When viewing the line graph you can scroll forward on the time axis by pressing the UP Arrow button and you can scroll backward on the time axis by pressing the DOWN Arrow button You will not be able to see the date on the time axis d Decide what to do next If you want to Then e View a line graph for another 1 Press the RIGHT Option button to return time period to the Select Time Period screen 2 Go to
98. g Event History reports or Line Graph reports A type of report that incorporates the event information you enter For example histories of recent glucose results insulin doses carbohydrate content of meals exercise state of health etc A record of many popular forms of exercise You may also specify the intensity and duration of each exercise event A solution containing a known amount of glucose Used to perform Control Solution tests to make sure your receiver and test strips are working properly prior to calibration or blood glucose testing Also referred to as the system this device is designed to give people with diabetes a continuous reading of their glucose levels in real time A small strip into which you place a drop of blood to perform Blood Glucose mode tests You must use ONLY FreeStyle Test Strips with the system A record of any event that you or your healthcare team thinks is useful in evaluating glucose patterns You may assign up to eight generic events to observations of your choosing The high and low levels that you would like your glucose to stay between Used to make reports more meaningful Glucose targets are separate from and independent of the levels you may be using for high and low glucose alarms Customer Care 1 866 597 5520 Section 20 Glossary 20 Glossary cont Glucose Trend Arrows Hematocrit High Glucose Alarm High Glucose Threshold Icons Insulin Event Interstitial
99. g a meal or exercise your glucose levels may vary rapidly Try to time your sensor insertion so that your calibration times do not coincide with your regular meal or exercise activities Section 1 Getting Acquainted Important Things to Remember About System Calibration con t Important In clinical trials we observed that the sensor signal sometimes temporarily decreases from the true value This typically happens at night during sleep and recovers rapidly when the user moves or is awakened However in order to avoid being affected by this phenomenon the system should not be calibrated when the wearer is asleep You may not be able to calibrate the system if your glucose levels are changing rapidly e g during or after exercise meals or insulin dosing Under such conditions the system may not ask you to calibrate instead it will delay its request until conditions are acceptable You MUST successfully complete 4 calibration tests You will calibrate at approximately 10 12 24 and 72 hours after sensor insertion If you do not complete calibration tests successfully in the allotted time periods your glucose readings will NOT be displayed and alarms will be inactive The system may ask you to perform additional calibrations between 2nd and 3rd calibrations depending on the sensor signal In such cases you will be prompted with a message to do additional BG tests e The receiver will beep or vibrate to prompt you to do a calibrat
100. glucose levels A transmitter sends the glucose readings to the receiver Should only be used with FreeStyle Navigator system Transmitters and FreeStyle Navigator Sensors Blood Glucose Mode Glucose BG You will perform traditional blood glucose testing BG testing in the Blood Glucose mode using a FreeStyle Test Strip and a drop of blood You can use the Blood Glucose mode whenever you wish to perform a traditional blood glucose test It is also used for calibrating the system Blood Glucose mode tests used for calibrating the system can also be relied on like traditional blood glucose tests e Glucose BG at the top left of the display Built in FreeStyle Blood Glucose Meter e Measures glucose from a blood sample that you supply Uses a FreeStyle Test Strip to measure blood glucose levels Note Use ONLY FreeStyle Test Strips and Control Solution FreeStyle Lite Test Strips will not work in the receiver Other brands of test strips or control solution can give you inaccurate results The system typically works in the Continuous Monitoring mode It switches to the Blood Glucose mode when you insert a FreeStyle Test Strip into the receiver s test strip port In order to turn the Blood Glucose mode on you have to insert the test strip when the receiver is either turned off or when it displays the glucose screen Customer Care 1 866 597 5520 2 Install or Replace Transmitter and Receiver Batteries n X F na Er x
101. have not performed a BG Test for calibration You see an n icon on the screen Perform a BG test for calibration see Section 7 Follow the guidelines for trouble shooting connection between the transmitter and receiver Allow the system up to 1 hour to start displaying the glucose values on the screen If none of the above helps solve the problem replace the sensor Section 5 or call Customer Care Customer Care 1 866 597 5520 Section 10 Respond to Alarms Errors and Problems Skin irritation at sensor insertion site a Ensure that seams waistbands or other constrictive clothing or accessories do not cover the site causing friction b Inspect the site If the irritation is Then Around the edges of the adhesive Lift the edges slightly all around the or tape dressing Wherever the adhesive touches skin You may be sensitive to the adhesive or material consult your healthcare team to identify the best solution l c If none of the above works consult your healthcare team for other suggestions The sensor support mount is not sticking to your skin Note Do Step a through Step c BEFORE placing the sensor support mount on your skin a Clean the insertion site by washing with soap and water b Dry the site thoroughly with a clean towel c Wipe the area with an alcohol prep pad d If your skin type requires more adhesive than provided on the sensor support mount or i
102. he Alarm Settings About Glucose Alarms The FreeStyle Navigator system is designed to alert you when your glucose levels reach preset low or high values These values or threshold values can be programmed in the receiver for any individual These high and low glucose alarms or the threshold alarms are designed to alert you when your glucose levels cross these To values High Threshold 180 Low Threshold 80 mg dl Example of a High Glucose Threshold Alarm Example of a Low Glucose Threshold Alarm The alarm sounds when the glucose level crosses The alarm sounds when the glucose level crosses the preset threshold value the preset threshold value In addition to alerting you of a high or low glucose condition the system can also alert you before you reach such a high or low glucose condition These alarms are called the projected high and projected low glucose alarms They can be set at low medium and high sensitivities to alert you approximately 10 20 or 30 minutes before your glucose levels reach the high or low threshold values assuming your glucose keeps changing at the same rate You can turn all glucose alarms ON or OFF If the alarms are turned OFF you will not get any alarms High Threshold These alarms are designed to help you take action as soon as you are notified Projected low and projected 180 mg dl high glucose alarms increase the overall ability to detect a condition of low or high glucose However
103. he receiver to beep If it beeps e Twice The system is connected e Three times The system is not connected Make sure the battery in the transmitter is new and ensure that the receiver and transmitter are linked see Section 14 Note If the transmitter and receiver are connected properly the disconnect icon 7 will not appear on the screen Caution If the sensor dislodges due to the sensor support adhesive failing to adhere to the skin you may get unreliable or no results Improper site selection and improper site preparation may cause poor adherence to the skin Notes e Select a site ONLY on the back of the upper right arm on the back of the upper left arm or on your abdomen e Do NOT insert the sensor where another sensor was just removed See Site Selection in Appendix A e Rotate where you insert your sensor across several sites e Avoid areas where the edges of clothing may catch or rub against the sensor Avoid areas with scars moles stretch marks or lumps e Select an area of skin that stays flat during your normal daily activities no bending or creasing e Avoid areas with excess hair or consider shaving the area Choose a site that is at least 1 inch away from an insulin infusion site Customer Care 1 866 597 5520 Section 5 Insert or Remove Your Sensor r uw ry 6 Prepare the insertion site 7 Remove the sensor delivery unit from package 8 Remove the protective liner fro
104. he results and alarms from the FreeStyle Navigator Continuous Glucose Monitoring System traditional blood glucose tests must be performed The FreeStyle Navigator Continuous Glucose Monitoring System provides a built in blood glucose meter to confirm the continuous glucose result The FreeStyle Navigator Continuous Glucose Monitoring System provides real time readings graphs trends and glucose alarms directly to the user The FreeStyle Navigator Continuous Glucose Monitoring System is intended to be used in home settings to aid people with diabetes in predicting and detecting episodes of hypoglycemia and hyperglycemia and in clinical settings to aid health care professionals in evaluating glucose control The FreeStyle Navigator Continuous Glucose Monitoring System is available only by prescription Contraindications The FreeStyle Navigator Continuous Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging MRI How to Use this Guide This guide has many Sections arranged in a logical sequence that will be useful for the first time use and every use thereafter Most Sections begin with a purpose for that Section when to perform the steps in that Section materials required to perform the steps in that Section and important cautions warnings and helpful information The first page of each Section will be very useful when you are getting familiar with the system Once you are familiar with the system and t
105. he typical precautions you may find yourself relying less on the first page of the individual Sections The remainder of each Section describes the steps to perform the tasks The steps are organized in a simple manner to allow you to see what to do based on what you experience and based on where you are in that particular Section It is important that you go through the steps in the order that they have been presented Every Section also indicates if you have reached the end of the Section If you find it difficult to use the guide or if you seem lost or confused use the table of contents index glossary and appendices to help you The table of contents provides a list of Sections you will find in this guide and what each Section contains The appendices have useful information that you may want to refer to The glossary provides a list of terms and what they mean The index is a tool you could use to quickly find terms and items that you are looking for e FreeStyle Navigator and FreeStyle are registered trademarks of the Abbott Group of Companies in various jurisdictions e OpSite IV 3000 and Uni Solve are trademarks of Smith and Nephew Inc e Bluetooth wireless technology is a trademark of the Bluetooth SIG Inc e YSI 2300 STAT Plus Glucose Analyzer is a trademark of Yellow Springs Instrument Inc e Energizer Max Energizer e2 Titanium and Energizer Industrial Batteries are trademarks of the Eveready Battery Compa
106. hen e You are calibrating the system Select ONLY a finger for testing see red circles e You are simply doing a manual Select from among the sites shown glucose test and NOT calibrating including the circled areas a Section 7 Calibrate Your System Test Blood Glucose Manually LONE CIS RN EN 4 Prepare for lancing a Wash your hands and the selected test site with soap and water Make sure there is no lotion on the test site b Thoroughly dry your hands and the test site c Snap the cap off the lancing device Important Use a new sterile lancet for every test NEVER use a lancet for more than one person d Insert a new FreeStyle Lancet firmly into the white lancet cup holder Important Do not touch the exposed needle on the lancet e Hold the lancet firmly in place with one hand and use your other hand to twist off the rounded top f Replace the cap until it snaps or clicks into place If your test site is Use the grey cap e Your forearm or a test site other than the finger Use the clear cap Customer Care 1 866 597 5520 Section 7 Calibrate Your System Test Blood Glucose Manually rw 4 Prepare for lancing con t g Select the lancing device depth setting If you are lancing Then e A finger Set the depth setting to its shallowest depth 1 e Your forearm Start at Level 2 or higher if your experience with setting 2 does
107. ice to display the do Main menu Blood Glucose Mode b Use the UP or DOWN Arrow button to highlight or Relink to Transmitter System c Press the RIGHT Option button Select to display the System menu d Use the UP or DOWN Arrow button to highlight Link BG Relink e Press the RIGHT Option button Select to display the Link screen rm Press the LEFT Option button Unlink to unlink your transmitter from your receiver Note Unlinking your receiver from your transmitter will terminate your sensor If you proceed you will need to insert a new sensor after linking to your new transmitter A warning screen is displayed if you have a sensor in progress Press the button labeled Yes to continue unlinking g Press the LEFT Option key BG to operate your system in the Blood Glucose mode By choosing this option you have shut off the Continuous Monitoring mode Note You can now use your receiver to perform blood glucose measurements See Section 7 h Go to Step 1 to decide what to do next Customer Care 1 866 597 5520 Section 14 Link and Unlink Your Transmitter and Receiver steps P This 5555 3 Link your receiver to your transmitter a Place the receiver within 10 feet of the transmitter b Press the RIGHT Option button twice to display the Searching For Main menu eee c Use the UP or DOWN Arrow button to highlight System Cancel d Press the RIGHT Option button Select
108. icks into place Apply firm pressure as you slide the transmitter into place Fig 2 Note It is normal to see a gap between the transmitter and the support mount towards the top Fig 2 2 Confirm the transmitter is correctly attached to the sensor support mount a Look at the side of the transmitter where the bottom sits on the guide rails b Is there a space between the bottom edge of the transmitter and the top edge of the guide rails Then e No The transmitter is correctly attached Go to Step 3 Yes 1 Go to Section 5 to replace your sensor 2 Repeat this procedure to attach your transmitter Customer Care 1 866 597 5520 Section 6 Attach Your Transmitter r pomis 3 Apply an over bandage Optional Apply an over bandage to hold down the transmitter and pe Se sensor support mount Use an over bandage if you find wl Nm that the sensor support mount is not adhering well during r WELLEN Ad e daily activities SS Caution If your results from the Continuous Monitoring mode seem erroneous check and make sure that the sensor has not dislodged If you notice the sensor is dislodged from the skin or if you see that the adhesive on your overbandage or the sensor support mount is coming loose discard the old sensor and insert a new sensor Go to the next step 4 Enter the sensor code into your receiver a When you hear the receiver beep
109. ill reset parameters that may affect your system performance If you accept an incorrect transmitter ID when linking your Transmitter and Receiver your glucose readings will be incorrect Do NOT use the sensor delivery unit if the sterile package is open or damaged Important Once the code has been entered and you have hit the Set button you will not be able to change the sensor code number If you have entered the code incorrectly you will have to replace the sensor and enter the right sensor code If you choose the wrong sensor code you may get erroneous results from the sensor The code numbers MUST match to ensure accurate test results e Do NOT remove or replace the transmitter from the sensor support mount while wearing a sensor If you notice that the transmitter is not properly attached replace the sensor with a new sensor and then reattach the transmitter Important Things to Remember About System Calibration Caution Always calibrate the system using only a finger stick blood sample Do NOT use alternate site blood glucose measurements to calibrate the system The receiver contains a built in FreeStyle Blood Glucose Meter for performing calibration tests Important Your blood glucose level must be between 60 and 300 mg dL 3 3 and 16 7 mmol L to be able to perform calibration tests If your blood glucose level is changing rapidly you may not be able to calibrate the system For example durin
110. in a drop of blood for a Blood Glucose mode test A handheld piece of equipment that is used with a lancet to obtain a drop of blood for a Blood Glucose mode test A part of the lancing device that you pull to position the lancet for pricking the test site A window on the lancing device that shows you the depth setting you have chosen A part of the lancing device that lets you to adjust how deep the lancet pricks your skin A higher number means a deeper penetration of the lancet A part of the lancing device that holds the lancet in place when pricking your skin Buttons on the bottom of the receiver face that allow you to select options shown on the display screen The RIGHT Option Button also turns the receiver display screen on Section 20 Glossary 20 Glossary cont Line Graph Reports Link Low Glucose Alarm Low Glucose Threshold Meal Event Multi Day Statistics Progress Tones Projected High Alarm Projected Low Alarm Receiver Rx Receiver Display Screen Receiver Skin Receiver Status Receiver Test Strip Port Show continuous glucose lines plotted at 10 minute intervals for several different periods 2 4 6 12 or 24 hours This procedure is performed so that the receiver can be paired with a transmitter Once linked the receiver would know to accept information from that transmitter alone When shipped out of the factory the receiver and transmitter are already linked An ala
111. ion The receiver will display a blood drop icon and the message Do BG Test The system will prompt you with alarm messages when your calibrations are unsuccessful You will not have continuous monitoring until you have successfully completed the first calibration at least for the first ten hours after sensor insertion e If you get a request for a calibration or expect additional calibration requests during a time when you do not want to be disturbed e g sleep time you can choose to wait to perform additional BG tests at a later point in time If you choose to wait and the allotted time window for calibration has expired please note that you will not get glucose results until you have performed a successful calibration You can turn off the System Alarms or set to vibrate if you do not want to be disturbed by frequent requests for calibration In order to silence the alarms that warn you when the allotted time window for a calibration has expired you must turn off the data loss alarms and all the four glucose alarms Low Glucose High Glucose Projected Low Glucose and Projected High Glucose Before You Get Started Installation and operation of the FreeStyle Navigator Continuous Glucose Monitoring System requires using a specialized introducer needle to insert the glucose sensor into the skin Infection inflammation or bleeding at the glucose sensor insertion site are possible risks of inserting a sensor into your skin The gl
112. iver Status 08 30A when calling Customer Care as well as battery life Serial BAAH190 80020 r emaining SW Version 0 61 Battery Life 75 10096 Transmitter Status Shows the transmitter s serial number You may need to verify the serial number after linking to a new HUES ass transmitter This unique value is used by the receiver ann to accept data from only the transmitter the receiver AAAH298 80008 is linked to It also shows battery life remaining TX Battery 75 100 After replacing the battery once the system has recognized the new battery it will display battery life as 75 100 If there is no connection between the transmitter and receiver you will see 3 dashes instead of the battery life Customer Care 1 866 597 5520 Section 10 Respond to Alarms Errors and Problems Status Information con t Status Information Description CM Status Stores recent error codes related to the Continuous Monitoring mode may be useful when calling Customer Care CM Status Last Reset OK Note The CM Status screen shows information about Ce E calibration and sensor errors You can get information AE RA about why the system did not prompt you to perform a calibration Cart Cal xxx or why a calibration failed Cal Failed xxx or why continuous glucose readings are not displayed Sen Err xxx These numbers and information help troubleshoot your system performance The Customer Care
113. kin in mild soap and water T il Caution Do NOT immerse the receiver in water or in any other liquid Avoid getting water or any other liquid in the test strip port Wipe the outside of your receiver with a clean soft lint free towel dampened with either a mild soapy solution or 70 isopropyl alcohol 4 Check your work Result A clean transmitter receiver and receiver skin You have done this procedure correctly when All visible dust dirt grime and other foreign substances have been removed L The transmitter is thoroughly dry including the contact points Customer Care 1 866 597 5520 14 Link and Unlink Your Transmitter and Receiver Section 14 Key Terms BG Mode CM Mode Link Unlink Receiver Transmitter Customer Care 1 866 597 5520 Section 14 Link and Unlink Your Transmitter and Receiver 14 Link and Unlink Your Transmitter and Receiver Purpose To enable secure communication between your transmitter and your receiver Start Do this procedure e When you replace either your transmitter or your receiver Materials Gather these materials before you begin e Your receiver e Your transmitter Note Your system may need fresh batteries if it cannot establish communication Helpful Information Important You will NOT receive continuous glucose data while the transmitter and receiver are unlinked and all alarms associated with the Continuous M
114. lay information Customer Care 1 866 597 5520 17 Appendix A Site Maintenance Section 17 Appendix A Adhesive Enhancers s Antiseptics a Dressings m Site Rotation Skin Barriers Customer Care 1 866 597 5520 Section 17 Appendix A Site Maintenance 17 Appendix A Site Maintenance Introduction Careful site selection preparation and maintenance can help to lower the risk of infection and improve sensor adhesion In addition to site selection a number of helpful products are available Site Selection Site rotation helps prevent discomfort irritation bruising skin rashes and sensitivity to adhesives It is important for you to rotate across several sites and to insert sensors only in the abdomen or in the back of the upper arm ALWAYS change the insertion site each time a new sensor is used Rotating the sites in a predictable pattern may help you remember to rotate them evenly For example you may want to start in the upper right corner of your abdomen and then move one inch to the left when you insert a new sensor continuing in a circular direction Or you may want to start on the right arm at a high position move to a low position on the right arm then repeat on the left arm Helpful products Choose from the list of products below as needed e Antiseptics If you tend to develop infections at the sensor insertion site consider prepping the skin with an antiseptic Ask your healthcare team to recomme
115. lect Data Loss Alarm Settings Decide what settings you want Data Loss Alarm on or off Alarm type Setting Setting Low Bee Low medium or high beep n Short medium or long vibration b Review or change your settings e Press the LEFT Option button Next to move from one field to the next e Use the UP DOWN Arrow buttons to change the setting in any field e Press the RIGHT Option button Set to accept the settings and return to the Alarms menu Note The receiver will respond with a brief sample of the alarm you selected c Decide what to do next If Then e You are setting reviewing or changing Continue to the next step all alarms e You are finished setting reviewing and Goto Step 11 changing alarms p Section 8 Set Review or Change the Alarm Settings wr 8 Set System Alarms Alarm Settings 08 30A High Glucose 275 Projected Low On Projected High Off Data Loss System Alarms Main Select Decide what settings you want Alarm on or off Alarm type Setting Low medium or high beep Short medium or long vibration If Important If you turn off the System Alarms the receiver will NOT prompt you to do the calibration tests after you insert a new sensor a Select System Alarms from the Alarms menu Alarm Settings System Setting Low Beep Next b Review or change your settings e Press the LEFT Option button
116. ll appear on the screen when your receiver batteries are running low You must replace your receiver batteries the next time you replace your sensor Make sure to replace batteries before inserting your next sensor An alarm will sound and a message will appear on the screen when your transmitter battery is running low You have approximately 4 days of battery power remaining when this first happens Because you must insert a new sensor after each battery replacement you should replace the batteries just before you insert a new sensor For example if you drop your receiver and the batteries fall out you will have to insert a new sensor After installing the transmitter or receiver batteries allow a couple of minutes for the system to recognize new batteries You may then access the status of the battery life from the System menu in your receiver see Status Information in Section 10 If the batteries are new the status screen will show 75 10096 as remaining battery life If your receiver batteries are low and you fail to replace them they may run out without a warning and the receiver will neither display your glucose levels nor sound alarms The transmitter s battery life is estimated to be up to 30 days e The receivers battery life is estimated to be 60 days However battery life may be shorter than 60 days if your receiver s alarms are set to vibrate if you use backlighting frequently or if the transmitter receiver conne
117. ll not be reported The 2nd calibration can be performed after 4 hours continuous glucose reporting will resume after completing the 2nd calibration successfully e 3rd calibration Must be performed between 12 and 20 hours after the 2nd calibration or continuous glucose will not be reported The 3rd calibration can be performed after 20 hours continuous glucose reporting will resume after completing the 3rd calibration successfully e 4th calibration Must be performed between 48 and 56 hours after the third calibration or continuous glucose will not be reported The fourth calibration can be performed after 56 hours continuous glucose reporting will resume after completing the 4th calibration successfully Average of 7 seconds Coulometric electrochemical sensor Blood Sample Type for BG mode Whole blood capillary Hematocrit for BG mode 1596 to 6596 Customer Care 1 866 597 5520 Section 18 Appendix B Specifications 18 Appendix B Specifications cont Performance Characteristics Note Please consult your healthcare team on how to use the information in this section Performance of the FreeStyle Navigator Continuous Glucose Monitoring System was evaluated in a controlled clinical study The study was conducted in 3 centers and included a total of 58 subjects with diabetes Each subject wore two FreeStyle Navigator Sensors over a 5 day period The subjects wore one sensor on the back of the upper arm and on
118. lthough a typical calibration sequence will occur as shown each calibration has to be performed in a specific window of time e Ist calibration Must be performed at approximately 10 hours after a new sensor has been inserted The first calibration can be performed after the 10 hours Continuous glucose readings will NOT be reported until the 1st calibration is performed successfully e 2nd calibration Must be performed between 2 and 4 hours after the 1st calibration or continuous glucose will not be reported The 2nd calibration can be performed after 4 hours continuous glucose reporting will resume after completing the 2nd calibration successfully e 3rd calibration Must be performed between 12 and 20 hours after the 2nd calibration or continuous glucose will not be reported The 3rd calibration can be performed after 20 hours continuous glucose reporting will resume after completing the 3rd calibration successfully e 4th calibration Must be performed between 48 and 56 hours after the third calibration or continuous glucose will not be reported The fourth calibration can be performed after 56 hours continuous glucose reporting will resume after completing the 4th calibration successfully Customer Care 1 866 597 5520 Section 7 Calibrate Your System Test Blood Glucose Manually Helpful Information con t Some common reasons for unsuccessful calibrations Your BG test result is below 60 mg dL 3 3 mmol L or above 300 mg dL 16
119. m the sensor support mount a Wash your hands thoroughly with soap and water b Clean the selected insertion site area with soap and water c Rinse the area thoroughly and pat dry d Wipe the area with an alcohol prep pad Note 1 The insertion area MUST be clean and dry Otherwise e An infection could occur The sensor support mount may not stick to the site Note 2 Do NOT place a bandage on the insertion site before inserting the sensor The sensor may not penetrate the skin and the system will not work with a bandage under the sensor Caution Do NOT use the sensor delivery unit if the sterile package is open or damaged a Remove the sensor delivery unit from its sterile package by peeling off the foil on the back of the package b Save the package Note You will need the sensor code number on the back of the package later Important We recommend that you save the sensor kit carton or the sensor sterile package until the last sensor from your sensor kit has been used and discarded Saving the package will help you to have sensor lot information expiration dates and sensor code etc accessible when you need them a Bend the two piece protective liner slightly so you can see the seam between the two pieces b Peel away the smaller section c Peel away the larger section Section 5 Insert or Remove Your Sensor steps d Do This LU 9 Attach the sensor delivery unit to your
120. mpare the test results displayed on the screen to the range printed on the vial of test strips If the result And Then Falls WITHIN the Go to Step 8 range e Falls OUTSIDE of You ve repeated Call Customer Care the range the test You ve NOT Repeat the test from Step 1 with a repeated the test NEW test strip e Is an error message Go to Section 10 on troubleshooting Glucose BG 08 30A 106 Control Solution Yes 8 Check your work Result Control solution test results displayed on the receiver screen You have done this procedure correctly when The results are within the normal control solution range The used test strips have been discarded properly L The control solution tests are marked as control solution tests Customer Care 1 866 597 5520 5 Insert or Remove Your Sensor ectiom 5 Section 5 Key Terms Calibration Sensor Inserter Sensor Release Tabs Reconnect Sensor Insertion Button Sensor Support Mount Sensor Sensor Insertion Site Sharps Container Sensor Delivery Unit Sensor Locking Pin Transmitter Receiver Connection Now that you are ready to insert a sensor here are a few helpful tips Reconnect your transmitter and receiver BEFORE inserting a new sensor BEFORE inserting a new sensor program into the receiver that the old sensor has been removed e Make sure there are no messages or icons related to low battery conditions on the
121. n e Press the RIGHT Option button to see if the screen turns on e If screen turns on compare with the screens below and perform the matching steps e If screen does NOT turn on then repeat this procedure ensuring that the batteries are New Oriented properly in the battery compartment If the problem persists see Section 10 on troubleshooting e The receiver is working properly Go to Check your work You may not see the 4 icon if you have connection between the transmitter and receiver Reconnect the transmitter and receiver if you see the 2X icon Set Date Time 08 30 A 052510222005 Select Mode 08 30A Continuous Mode CM Blood Glucose BG e The time and date need to be set Go to Step 4 of Section 3 e Set the Time and Date After setting the time and date reconnect the transmitter and receiver Then Check your work e Select the mode that you want the system to operate in e Go to Section 14 to link the transmitter and receiver e Go to Check your work Section 2 Install or Replace Transmitter and Receiver Batteries Reconnect the Receiver to the Transmitter System Menu Reconnect Data Upload Status Link Set Date Time Main Select Check your work a Place the receiver within 10 feet of the transmitter b Press the RIGHT Option button twice to display the Main Menu screen c Use the UP or DOWN Arrow button to highlight System d
122. n 15 minute Swimming increments Biking x Weights Intensity None Low Medium or High Other i an c When you are done press the RIGHT Option button Set to save or cancel the event 6 Record state of health events a Use the LEFT Option button Next to select which History 08 30A 3 State Of Health A item to enter or change State of health SAVE 02 0202 08 30 A CANCEL Date Time Low Symptoms es b Use the UP Arrow button or the DOWN Arrow button SAVE S to change the selected item CANCEL B Note Your state of health choices are Normal Cold Sore Throat Infection Tired Stress Fever Flu Allergy Normal pip U Period Dizzy Alcohol Low Symptoms or High Cold Allergy S t SoreThroat Period ymptoms Lus Pet c When you are done press the RIGHT Option button Stress Low Symptoms Set to save or cancel the event Fever High Symptoms Section 11 Add Events STD 7 Record generic events a Use the LEFT Option button Next to select which item History 08 30A f Generic 1 to enter or change Event SAVE CANCEL Date Time 04 09 05 08 30 A Event b Use the UP Arrow button or the DOWN Arrow button ee to change the selected item SAVE CANCEL Note 1 There are eight generic event numbers that red you or your healthcare team can assign to specific events For example 1 can refer to Dining Out 42 x to Shopping
123. nd time The batteries are installed incorrectly Install batteries correctly and reset date and time a Reconnect the transmitter and receiver b Insert a new sensor c If this did not solve the problem call Customer Care BH Section 10 Respond to Alarms Errors and Problems m There is no glucose value on the screen If You are waiting for the first calibration It has been more than 10 hours after insertion of the sensor It has been more than 10 hours after insertion of the sensor And It has been less than 10 hours after the insertion of the sensor You see an icon on the screen You receive alarms for example skin temperature related alarms or connection alarms Then You will see an icon on the screen Wait for the system to prompt you to do a BG test for calibration Allow the system up to 2 hours to prompt you to do a BG Test for calibration Acknowledge the alarm take appropriate action for example bring the skin temperature within range or establish connection between the transmitter and receiver and allow the system up to 2 hours to prompt you to do a BG test for calibration The time window for calibration for example you have 2 hours to perform the second calibration see Section 7 has expired You have performed all the appropriate calibrations successfully You have performed all the appropriate calibrations successfully You
124. nd which antiseptic is best for you Dressings If you are having trouble with the sensor support mount sticking to your skin consider applying a bandage over the transmitter A variety of such bandages are available at your local pharmacy Ask your healthcare team to recommend which type of bandage is best for you Adhesive enhancers If you re having trouble getting the sensor support mount to stick to your skin you may want to try an adhesive enhancer Adhesive enhancers help the adhesive pad on the sensor support mount stick to your skin After applying this type of product be sure that the sensor insertion site is thoroughly dry before placing the sensor support mount on your skin Ask your healthcare team to recommend which adhesive enhancer is best for you e Skin barriers If you experience sensitivity to adhesives there are products that may help prevent irritation or sensitivity by placing a barrier between your skin and the sensor support mounts adhesive pad These products may also help the adhesive stick better Be sure to allow the skin to dry thoroughly before inserting the sensor or applying another tape or dressing Ask your healthcare team to recommend which skin barrier product is best for you Customer Care 1 866 597 5520 18 Appendix B Specifications Section 18 Appendix B Calibration Hematocrit m Interstitial Fluid Receiver m Transmitter Customer Care 1 866 597 5520 System Specifications Sec
125. nents to remove adhesive residue from the transmitter Adhesive remover solutions such as Uni Solve and others that contain ether components can damage the transmitter case We recommend using regular alcohol pads for cleaning adhesive residues Proceed to next step to end sensor session Section 5 Insert or Remove Your Sensor r w Sks CIS 3 End sensor session Did You Remove The Sensor 4 Reconnect the receiver to the transmitter System Menu Data Upload Status Link Set Date Time Main Select 5 Select an insertion site Abdomen cap Back of upper arm a Press the RIGHT Option button twice to get to the Main menu Press the UP DOWN Arrow button to highlight System Press the RIGHT Option button to select System Press the UP DOWN Arrow button to highlight Status Press the RIGHT Option button to select Status Press the RIGHT Option button to select Removed Sensor Press the RIGHT Option button to select Yes The system now knows you have removed the sensor If you are going to replace your sensor now continue to Step 4 we moan a Place the receiver within 10 feet of the transmitter b Press the RIGHT Option button twice to display the Main Menu screen c Use the UP DOWN Arrow button to highlight System d Press the RIGHT Option button Select to display the System menu with Reconnect highlighted e Press the RIGHT Option button Select f Wait for t
126. ng on your distance from the source of interference the strength of the interfering signal and the relative orientation between you and the source of interference you may or may not see or experience these conditions When in doubt move away from any likely source of electromagnetic interference If you experience consistent interference from any source contact the manufacturer or dealer for that source and have a trained technician assess the situation In addition please report any consistent interference issues to Abbott Diabetes Care Customer Care If you have a medical appointment that includes X ray MRI Magnetic resonance Imaging CT Computed Tomography scan or another type of exposure to radiation keep your system and sensor away from the area Before exposure to such radiation discard any sensor you are wearing and insert a new sensor after the radiation session The effect of these types of radiation on the performance of the system has not been evaluated Section 19 ion Classification Compliance Declarat Appendix C 10n con t i Informati lance FCC Compl 19 Appendix C OTSS L6S 998 I 94DO 491H0 ShO ZHWIS EEF ur Angp 6 29 ZHIN9S ccyo W ANP 6 CZ MOJ2q 2q INW 3 1 C SI Wed Lr MAO ee suorssrurq pojerpe 1o3rumsue1r juouruodTAuo peardsoq JO er1oururoo e3Id e ur uoneoo e31d e Jo onstoj e1euo aum Jomp urut c aum amp uru C 1 10909 DAI A
127. ng times when you are unable to interact with your receiver for instance when you are asleep Interacting with your receiver includes activities such as pressing the buttons viewing the screen or inserting a strip to do a BG test If no buttons are pressed during the 1 hour muting period during which an alarm is active the alarm response period will elapse during the mute time and no further alarms will sound until the display has been activated Press the RIGHT Option button to respond to a vibration or audio alarm e Press the LEFT Option button to turn off a text display message e See Section 8 Step 10 to mute all audible alarms for 1 hour e Alarms are given a level of urgency based on how soon you must respond Alarms act differently depending upon the level of urgency If the level of urgency is Then the alarm High H e Must never be ignored e Cannot be muted e Is the same as a medium urgency alarm in all other respects Medium M e Can be muted e Sounds three short beeps every 6 seconds for 1 minute or until you activate the display e Repeats every 5 minutes until acknowledged or fixed e Repeats every 15 minutes after acknowledged until fixed Intermediate I e Is the same as the medium urgency alarm except the intermediate alarm will stop and will not sound again After 1 hour When acknowledged Can be muted Low L e Does not need to be addressed right away e It is a single beep th
128. nsert a new sensor rw n 1 Decide what to do If you want to Change or remove your sensor Go to Step 2 e Insert your sensor Go to Step 4 Customer Care 1 866 597 5520 Section 5 Insert or Remove Your Sensor rw EN 2 Remove the sensor Fig 1 a Wipe a small amount of isopropyl alcohol around the edges of the sensor support mount Note You can use a regular alcohol prep pad from your local drugstore Grasp the top end of the adhesive the end nearest the sensor see Fig 1 and slowly peel it off your skin in one continuous motion Pull down on the adhesive at the bottom of the support mount the end farthest from the sensor see Fig 2 You will hear a click as the transmitter separates from the support mount d Discard the sensor support mount with the sensor m 0 ga i attached Important Do NOT discard the transmitter NEVER reuse the sensor support mount and sensor Gently wash the transmitter with soap and water Dry the transmitter thoroughly with a clean soft lint free cloth Be sure that you blot the sensor connector on the end of the transmitter If necessary use an alcohol wipe prep pad baby oil or a wet soapy washcloth to remove any adhesive left on your arm Dry your arm with a clean dry towel before continuing Important Do NOT use adhesive remover wipes containing ether or ether containing compo
129. nted on the label whichever comes first Count forward three months from the date you open a new bottle of control solution This is your discard date Write this date on the side of the control solution bottle Example You open the control solution on January 15th Count forward three months to April 15th This is the discard date that you record on the bottle a Locate the expiration date on the vial of FreeStyle Test Strips If strips are expired obtain a new vial of strips b Locate the code number you ll need it in a minute c Remove a single test strip from the vial d Close the vial tightly before continuing but do NOT put the vial away Customer Care 1 866 597 5520 3 Insert test strip into the receiver Section 4 Perform a Control Solution Test steps _ a a Turn the test strip so FreeStyle text faces up 4 Compare code numbers b Grasp the test strip by the end with the two half circles c Insert the end with the dark rectangle into the receiver at the lower left corner of the receiver Result The receiver display screen turns on and displays the Strip Code screen Note If the screen does not turn on refer to Section 10 on troubleshooting Compare the code number on the display with the code number on the vial of test strips If e The numbers match Then a Press the RIGHT Option button Set b Go to Step 5 e The numbers do NOT match a Use th
130. ny Inc BE Rx only For use by Glossary of Symbols STERILE Consult operating instructions A R FE Table of Contents E Section 1 E Section 2 E Section 3 E Section 4 E Section 5 E Section 6 E Section 7 E Section 8 E Section 9 Getting Acquainted u usus ww reme e ee Hr We sss ss care 1 12 Parts of the System Daily Activities and Traveling Preparing the System for the First Time Warnings Cautions and Important Notes Hypoglycemia Unawareness Modes of Operation Continuous Monitoring Mode CM and Blood Glucose Mode BG Install or Replace Transmitter and Receiver Batteries LL 15 18 Installing the Batteries in Your System Battery Types for the Transmitter and the Receiver When to Change the Batteries Set the Time and Date eee e eee eee eeees 21 23 Setthe Time and Date Perform a Control Solution Test 27 31 When to Perform a Control Solution Test How to Perform a Control Solution Test Insert or Remove Your Sensor 35 43 Insert Your Sensor Remove Your Sensor Sensor Insertion Sites Prepare the Insertion Site How Long Can You Wear the Sensor Reconnect the Transmitter and Receiver Attach your Transmitters u 47 50 Attach the Transmitter Sensor Code Calibrate your System Test Blood Glucose Manually 53 6
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132. o another For example you can go from the ON OFF field to the Glucose threshold field to the alarm setting field Choosing the UP DOWN Arrow button will allow you to choose the value you want for the field For example choose ON or OFF for the alarm choose a number for the threshold like 70 mg dL or choose medium beep or long beep for the alarm setting Review the alarm performance data in Section 18 for a detailed analysis of the effectiveness of the glucose alarms Customer Care 1 866 597 5520 Section 8 Set Review or Change the Alarm Settings r wp 3 Set review or change the Low Glucose alarm Caution The Low Glucose alarm cannot be set below Alarm Settings 60 mg dL 3 3 mmol L Therefore it is not intended to Mute Alarms icwiGlicase 70 notify you of severe hypoglycemia High Glucose 275 Projected Low On Projected High Off a Select Low Glucose from the Alarms menu Main Select e Use the UP DOWN Arrow buttons to highlight Low Glucose e Press the RIGHT Option button to select Low Decide what settings you want Glucose e Alarm on or off Alarm Settings Your threshold value HOIST a ON Note The alarm can only be set eni 70 between 60 and 139 mg dL f f 3 3 mmol L and 7 7 mmol L un Next Set e Alarm type Setting Low medium or high beep b Review or change your settings Short medium or long e Press the LEFT Option button Next to move from vibra
133. o to Step 11 Section 8 Set Review or Change the Alarm Settings rw 10 Mute all audible alarms for 1 hour Alarm Settings 08 30A Low Glucose 70 High Glucose 275 Projected Low On Projected High Off Main Select Alarm Settings Mute Alarms For One Hour Cancel 11 Return to the main menu 12 Check your work Note 1 You will still get vibration visual alarms will still be displayed and you will continue to get Low Glucose alarms Note 2 If you want to turn off all alarms for more than one hour you should turn off each alarm individually Exercise caution when turning off or muting alarms For example if you turn off the low and high glucose alarms you will NOT get low and high glucose alarms a Select Mute Alarms from the Alarms menu b Press the RIGHT Option button Select to mute alarms for 1 hour Note If you change your mind before you press the RIGHT Option button Select press the LEFT Option button Cancel to return to the Alarm screen without muting the alarms If the alarms are muted you will see a symbol indicating that the alarms are muted Once the alarms have been muted they cannot be turned on before the 1 hour expires Important Muting the alarms is not recommended during times when you are unable to interact with your receiver for instance when you are asleep Interacting with your receiver includes activities such as pressing the buttons viewing the
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135. oad Dressings Events Event History Reports Exercise Event FreeStyle Control Solution FreeStyle Navigator Continuous Glucose Monitoring System FreeStyle Test Strips Generic Event Glucose Targets One of two modes in which the system functions the other is Blood Glucose mode You will use this mode most of the time It displays the glucose level in your interstitial fluid continuously as measured by the sensor you place just beneath your skin Along with the glucose numbers this mode also displays a directional glucose trend arrow A test done with FreeStyle Control Solution in the Blood Glucose mode using the built in FreeStyle Blood Glucose Meter to ensure that the system is working properly in the Blood Glucose mode An alarm that tells you when you are about to lose data or when your alarms are about to stop working Data Loss alarms sound when the transmitter receiver connection is broken or when the sensor has expired The act of transferring data from your FreeStyle Navigator system to a computer Products that can be used as over bandages to cover the transmitter These can help the sensor support mount adhesive stick to your skin Activities and observations that can affect your glucose levels that you record in your system Reviewing events may help you to see patterns in your glucose levels and how you manage your diabetes Once entered into the system events may be viewed in several ways includin
136. ommend a sharps container or a puncture proof container with a tight lid Result An inserted sensor a removed sensor or a replaced sensor You have done this procedure correctly when d Ee m ie eee The system successfully recognized that you removed a sensor if you removed a sensor The site was selected and prepared according to the guidelines given in this procedure The receiver and transmitter were reconnected successfully The sensor support mount is tightly adhered to either your abdomen or the back of your upper arm The sensor is inserted in a site that is different from the site that was used for the last sensor The sensor is visible with the tip inserted into your skin The sensor inserter is disposed safely Customer Care 1 866 597 5520 Sec 10 om 6 Section 6 Key Terms LEFT RIGHT Option Buttons Receiver Sensor Code Sensor Support Mount s System Transmitter UP DOWN Arrow Buttons Customer Care 1 866 597 5520 Section 6 Attach Your Transmitter 6 Attach Your Transmitter Purpose To enable the transmitter to send glucose data to the receiver Start Do this procedure after inserting a new sensor Materials Your FreeStyle Navigator Transmitter with battery installed Helpful Information Important Do NOT remove or replace the transmitter from the sensor support mount while wearing a sensor If you notice that the transmitter is not properly
137. on or delayed reaction could cause an accident Hypoglycemia unawareness can develop for several reasons a Having frequent hypoglycemic episodes b Having long standing diabetes and autonomic neuropathy a form of diabetic neuropathy in which your body does not release its usual hormones to warn you of low blood glucose and to tell your liver to release glucose as a protective mechanism If you think you have hypoglycemia unawareness talk to your healthcare team um Section 1 Getting Acquainted What are the Continuous Monitoring mode and Blood Glucose mode Your FreeStyle Navigator system operates in two modes e Continuous Monitoring mode Glucose CM e Blood Glucose mode Glucose BG Freestyle Navigator Continuous Monitoring Mode Glucose CM The Continuous Monitoring mode is the mode you will use most of the time It continuously displays the glucose level in the fluid in the tiny spaces between your tissues interstitial fluid This glucose reading comes from the sensor you will place just beneath your skin and is updated every minute e Glucose CM at the top left of the display e The glucose reading is typically accompanied by a directional trend arrow that indicates how fast your glucose is changing and in what direction e Most frequently used mode e Measures glucose from interstitial fluid detected by a sensor in your skin Uses a sensor to measure
138. on should re establish itself You should note that HAM radio products can be fixed mobile or portable handheld walkie talkie type units Important Because you must insert a new sensor after each battery replacement you should replace the batteries just before you insert a new sensor For example if you drop your receiver and the batteries fall out you will have to insert a new sensor Warnings Keep your system and its components away from young children because There are small parts that may be dangerous if swallowed The control solution caps are choking hazards The test strip vial and sensor delivery unit packaging may contain a drying agent that could be harmful if inhaled or swallowed and may cause skin and eye irritation NEVER point a pre cocked sensor inserter toward the eyes face or any other body part where sensor insertion is not desired m Section 1 Getting Acquainted Before You Get Started con t If your results from the continuous monitoring mode do not reflect how you feel test your glucose using the Blood Glucose mode e If you observe a significant change in your continuous glucose readings that you think is erroneous or if you feel the blood glucose measurement in the Blood Glucose mode is erroneous and you are close to an electromagnetic interference source move away from the source of interference and check to see if the condition fades away e If you have a medic
139. onitoring mode will be turned off You MUST unlink your receiver from your old transmitter and link your receiver to your new transmitter whenever you replace your transmitter Once the transmitter and receiver are linked they don t have to be re linked or unlinked unless you want to link the receiver to a new transmitter If you attempt to link your receiver to a new transmitter you must replace the current sensor with a new sensor e You can still perform blood glucose measurements in the blood glucose mode while the transmitter and receiver are unlinked e Link is NOT the same as Reconnect Typically when you receive the system kit your receiver and transmitter are already linked your receiver knows which transmitter it is paired with The receiver will then accept data only from that transmitter Once your receiver and transmitter are linked you do not need to link them again unless you have had to unlink them if changing transmitter Reconnect see Section 9 Step 2 establishes connection if your receiver and transmitter have been temporarily moved beyond the normal range of communication 10 feet OVER Section 14 Link and Unlink Your Transmitter and Receiver as LL s 1 Decide what you want to do If you want to e Unlink your receiver from your transmitter e Link your receiver to your transmitter e Check your work 4 2 Unlink your receiver from your transmitter a Press the RIGHT Option button tw
140. or Medium Sensitivity 20 min OFF Minimum OFF None Caution Do NOT rely solely on the projected glucose alarms for detection of low or high glucose conditions Always use both the low glucose and high glucose threshold alarms AND the projected low and projected high glucose alarms for maximum notification of low or high glucose conditions OVER Section 8 Set Review or Change the Alarm Settings ST NN NN 1 Access the Alarms menu from the Main menu Note If you don t press any buttons within 12 seconds Main the receiver screen will go blank and the last change will Glucose gt be lost if you haven t pressed the Select button Reports System a Press the UP Arrow button or the DOWN Arrow Add Event button to highlight Alarms Select b Press the RIGHT Option button Select to go to the Alarms Setting screen 2 Decide what to do If you want to Then e Set review or change the Low glucose alarm Go to Step 3 e Set review or change the High glucose alarm Go to Step 4 e Set review or change the PROJECTED Low glucose alarm Go to Step 5 Set review or change the PROJECTED High glucose alarm Go to Step 6 e Set review or change the Data loss alarms Go to Step 7 e Set review or change the System alarms Go to Step 8 e Set Progress tones Go to Step 9 e Mute all audible alarms Go to Step 10 Note In all the subsequent steps choosing the Next button will allow you to go from one field t
141. ous glucose data to display the arrow Occasionally the arrow may not be displayed temporarily Refer to the Line Graph for recent glucose history Tells you what pressing the RIGHT Option button will do in this case it takes you to the Main screen Your current glucose level Follow the recommendations of your healthcare team to treat low glucose hypoglycemic and high glucose hyperglycemic episodes Caution Before adjusting treatment for diabetes management based on the continuous glucose results from your FreeStyle Navigator system perform a Blood Glucose mode test to confirm the continuous result Section 9 Daily Use rwws 4 Interpret the icons Note The directional trend arrows are different from the projected glucose alarms Section 8 For example you can have a projected low glucose alarm and still have a relatively stable trend arrow This Icon Means ren gt V ee r Your glucose is changing gradually changing at a rate of less than 60 mg dL hr 3 3 mmol L hr Your glucose is increasing moderately at a rate between 60 mg dL hr and 120 mg dL hr 3 3 mmol L hr and 6 7 mmol L hr Your glucose is decreasing moderately at a rate between 60 mg dL hr and 120 mg dL hr 3 3 mmol L hr and 6 7 mmol L hr Your glucose is increasing rapidly at a rate of greater than 120 mg dL hr 6 7 mmol L hr Your glucose is decreasing rapidly at a rate of greater than 120 mg dL h
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143. press the RIGHT Option button once to turn the receiver on Result The receiver screen says New Sensor Detected Have You Recently J Have You Recently Inserted a New Sensor Fig 1 Inserted a New Sensor New Sensor Detected Note Typically it may take up to 3 minutes after attaching the transmitter before the receiver beeps See Section 10 to troubleshoot if you do not get the sensor detection message Fig 1 b Press the RIGHT Option button Yes Note If you ever see this message at any other time EN press the LEFT Option button No FreeStyle Naviga PSS c Press the UP or DOWN Arrow button to change the ff number on the receiver screen to the number on the packaging Fig 2 Let We 01234567 Ger Pisae Sensor Code 105 pe i N Important Once the code has been entered and you Caution hevodenumbers MUSE have hit the Set button as instructed below you will not amio mare GRUT EE reas be able to change the sensor code number If you have entered the code incorrectly you will have to replace the sensor and enter the right sensor code If you choose the wrong sensor code you may get erroneous results from the sensor d Press the RIGHT Option button Set to accept the number on the screen Section 6 Attach Your Transmitter steps pomis EN 5 Check your work Result A transmitter ready to send glucose data You have done this procedure correctl
144. r 6 7 mmol L hr The system is processing a control solution or blood glucose sample in the Blood Glucose mode It is time to do a calibration See Section 7 The system is waiting until it is time to do something for example waiting to do the Ist calibration after inserting a sensor You don t need to do anything There is a problem with the transmitter receiver connection See Step 2 The alarm is muted It is time to replace the batteries in the receiver Install the new batteries just before you insert a new sensor See Section 2 This icon shows up for Blood Glucose mode test results that happened when the operating temperature was beyond the systems specified operating temperature range and may be less accurate Discard the test and repeat another test within the operating temperature range of the system Customer Care 1 866 597 5520 Section 9 Daily Use so Toms 5 Turn the Backlight on a In order to turn the backlight on your receiver has to ___ Press be turned off Ifthe receiver is on wait for 12 seconds First to allow the receiver to turn off __ Press b Press and release the DOWN Arrow button Then a Second immediately press and release the RIGHT option button Your receiver will turn on with a backlight 6 Check your work Result You are aware of your glucose levels and trends You have done this procedure correctly when J You correctly interpret the directional glucose trend
145. ransmitter have to be linked Buttons on the right face of the receiver that allow you to move through lists to highlight options Also used to change numbers Customer Care 1 866 597 5520 21 Index Customer Care 1 866 597 5520 21 Index Add Events 111 Adhesive Adhesion To Skin 40 105 Adhesive Enhancers 147 Adhesive Removers 37 Alarms Change The Alarms 67 Mute Alarms 78 Respond To Alarms 89 92 Glucose Alarms 67 74 160 161 Arrow Directional Glucose Trend Arrow 83 84 Arrow Buttons 3 Average 121 Backlight 4 85 Battery Replace Transmitter Battery 16 Replace Receiver Batteries 16 Battery Life 15 151 152 Blood Glucose Perform Blood Glucose Test 56 Blood Glucose Mode 12 Calibrate Calibrate Your System 53 Sites For Calibration 57 Time To Calibrate 54 Carbs 112 Clean Clean The Receiver 128 Clean The Transmitter 128 Clean The Insertion Site 39 Control Solution Perform Control Solution Test 27 Control Solution Expiration 28 Mark A Control Solution Test 30 Country Settings 141 143 Daily Use 81 Data Data Loss Alarm 67 75 Data Upload 5 Glucose Data And Reports 118 Date Change The Date 23 Change The Date Format 143 Edit Events 117 124 Error Respond To Error Messages 92 Error CodesIn BG Mode 100 Events AddEvents 111 Edit An Event 117 124 Markers On Line Graph 119 Exercise Add Exercise Event 113 Features 4 Glucose Glucose CM 12 Glucose BG 12 Trend 83 84 Alarm 67 74
146. receiver BEFORE inserting a sensor e When attaching the transmitter you may not always hear a click Place the transmitter about halfway over the sensor support mount and slide the transmitter back and forth to make sure it moves freely before you attach it You will feel a click as you slide it into place e After attaching the transmitter to a new sensor allow the system a few minutes to recognize a new sensor Reconnect the receiver and transmitter to make sure they are communicating e When responding to messages about sensor insertion and sensor removal choose the appropriate answer Yes or No e Do NOT use the Link Unlink feature unless you have received a new transmitter or receiver from the manufacturer To establish communication between them ALWAYS use the Reconnect feature Note Link is NOT the same as Reconnect e Avoid errors and messages related to calibration by following a few simple guidelines Do NOT calibrate if your blood glucose is higher than 300 mg dL 16 7 mmol L or lower than 60 mg dL 3 3 mmol L e If you have just exercised eaten or taken insulin your glucose levels may be changing rapidly Allow about an hour for the glucose levels to reach a relatively steady state before calibrating e The system automatically detects conditions that may not be suitable for calibration It may delay calibration requests in such instances Wait for the system to prompt you and LOOK for the icon on the scre
147. representative may ask you to access the CM Status information Back Calibration BG Allows you to add a new blood glucose reading used for calibration Use this selection ONLY at the request of a Customer Care representative Note Once you use this feature to successfully perform an additional calibration the system discards the parameters from the previous calibrations It begins to calculate glucose results based on this calibration When using the Calibration BG feature always perform an additional Blood Glucose mode test to confirm the first test This feature cannot be used in the first ten hours after sensor insertion Using this feature does not change the regular scheduled times for calibration Do You Want To Calibrate Alarms and Errors Display Description The system will notify you of any conditions that may need Gress CM 9300A your attention through messages that will be displayed on 8 5 your receiver screen You can find out what those messages mg dL NI mean and how to respond to them For example see Fig 1 The messages are arranged alphabetically in the table titled Glucose Respond to alarm message Acknowledge Main Fig 1 When you use your built in FreeStyle Meter to make measurements you may receive error codes on the receiver You can find out how to respond when you get those codes For example see Fig 2 Glucose BG Fr1 Fig 2 10 ion Respond to Alarms
148. rials Gather these materials before you begin e Your glucose targets your healthcare team can help determine these e Your receiver Helpful Information Your healthcare team will usually give you glucose targets Compare your actual glucose levels with these targets to see how you are doing Ask your healthcare team to tell you how your levels should compare to each target Glucose targets are DIFFERENT from the thresholds for low and high glucose alarms Low and high glucose alarms alert you when you ve reached the low or high threshold value Glucose targets allow the reports and line graphs to show how your glucose levels have been performing compared to your set targets rw 1 Access the Reports menu from the Main menu ET a Press the UP Arrow button or the DOWN Arrow Glucose button to highlight Reports Alarms b Press the RIGHT Option button Select to go to the System Select Reports screen Add Event Select Section 12 Review Reports and Edit Events E HEELS SNR 2 Decide what you want to do Note Your reports will be more meaningful if you set glucose targets Glucose targets give you something to compare your actual glucose levels with Decide what to do If you want to e Set glucose targets e See a line graph showing a history of your glucose levels e See a statistical summary of your glucose levels over time e Review or edit the events you have recorded in your recei
149. rm that tells you when you go below your low glucose threshold a number you and your healthcare team will set The level that you do not want your glucose level to fall below You and your healthcare team choose the level that is right for you and you set it in the system The Low Glucose alarm and the Projected Low Glucose alarm use the low glucose threshold Displays a list of options that allow you to perform many functions and view specific information A record of a meal and snack that you enter in the system to help you see patterns in your glucose levels The time and date are always recorded You may also record carbohydrate grams to help you count carbohydrates or determine insulin carbohydrate ratios A type of statistical report that shows a summary of glucose results in relation to your glucose targets over a specified number of days You can choose 3 7 14 21 or 28 day periods Communicate progress errors and successful completion of system activities such as Blood Glucose mode testing Provides an early warning when you are approaching your high glucose threshold Provides an early warning when you are approaching your low glucose threshold Also called Rx A wireless component of the system that looks and feels much like a traditional blood glucose meter However unlike traditional blood glucose meters the receiver can provide you with continuous glucose readings from the sensor The receiver also has a built in FreeSt
150. rmance of the system These traces show an overlay of the continuous glucose readings from the FreeStyle Navigator system and the blood glucose measurements made using the laboratory YSI reference The blood glucose measurements that were used to calibrate the system are marked with x in the traces Glucose results from the FreeStyle Navigator system are shown using circles and the glucose results from the laboratory reference YSI are shown using triangles Time hours since sensor insertion is on the horizontal axis and glucose value in mg dL is on the vertical axis Customer Care 1 866 597 5520 Section 18 Appendix B Specifications 18 Appendix B Specifications con t Figure 2 Sample of a Representative Excellent Glucose Trace 500 I 400 300 e Ss 20 100 4 ke gc Wal a a ap a a a OY a 10 14 18 22 26 30 34 38 42 46 50 54 58 62 66 70 74 78 82 86 90 94 98 102 106 110 114 118 12 Sensor Time hours FreeStyle Navigator A YSI Reference X FreeStyle Calibration Night Time 11pm to 6am gt Figure 3 Sample of a Representative Average Glucose Trace 500 I 400 4 1 A A P a I A aw ii E 30 7 n a4 g j wg 4 S mi falta a J 1 4 ix 18 LEM 3 Aad i4 4 gt D oi TT T TT ITT Pe u FL Da FF a ap TE Ta WC Lo a LEG EL DR 10 14 18 22 26 30 34 38 42 46 50 54 58 62 66 70 74 78 82 86 90 94 98 102 106 110 114 118 12 Sensor Time hours FreeStyle
151. rojs s 10JeSIAPN 9 3S3914 Vy pue juaurdmbo suorjeorunururo JY rqour pue o qe3110d u A1 q o uejsrp uorjeedos popuoururo ow Section 19 Classification Compliance Declarat ion Appendix C 10N con t FCC Compliance Informat 19 Appendix C UI A ueq sso aq prnous syysuans PIY HN 08 01 ZHAOST Suer Asuanbay ay 1940 q UI9 S S IOJESTARN 445991 IY Sureoo o1 10 Sunu rio 31 se uons Aressaoou oq ACUI s mse ur euonrppe paasosqo st Uewod eurouqe J uonedgodo euriou AyLI9A 0 paAJesqo aq p nous ur 1s s 10je3IAeN 2 4152244 IY 2 0qe A 29uer duro2 FY o qeordde oy spoooxo p sn s ur s s IOJeSIACN o 415221 IY UDI ur UOT LIO IY ur U 8u ns PPY Ju ur msp ur IY JJ p 1 ptsuo2 oq p nous oAuns IS on uSeuro01 ue s1ojjrusuedq TY P xy 0 INP JUIWUOITAUA 2rjougeuio12oo IY ssosse OJ Aot1n2oe YIM eon ro u poj rpaud aq Jouue9 jseopeodq OIPeI WA pue WY orpe1 1nojeure sorpe1 o Iqour puer pue sououdo o sso p102 1e nj 22 OPLI 107 SUOHLIS seq se YONs s1ojjruisue PIXY WON SYIFUINS p or e ejdood pue spalgo so1njonjs uro3j uomo pue uondaosqe Aq pappe st uoneSedoid on usSptuono q suonenys fe ur Adde jou Leu s ur pin8 asoyy z NON sardde oSue1 A uonboj 194814 ou ZHN 008 pue ZHW 083V T 930N v O Joqur s SurMo 0 IY YIM poxureur Jusurd nba jo Arria IY ur 12220 ACU 99U3 9J1 1U i q suei ou nb sj yes ur paa 22uerduroo ay uey ss oq PINOYS v
152. s e A sharps container Helpful Information Important Things to Remember About System Calibration The system is calibrated using a capillary whole blood glucose measurement performed in the Blood Glucose mode using the built in FreeStyle Blood Glucose Meter In order to calibrate the receiver compares the reading it gets from the blood to the reading the sensor takes from the interstitial fluid Based on the calibration the receiver calculates the glucose readings Do not use venous blood for calibrating the system Caution Always calibrate the system only using a finger stick blood sample Do NOT use alternate site blood glucose measurements to calibrate the system The receiver contains a built in FreeStyle Blood Glucose Meter for performing calibration tests Important Your blood glucose level must be between 60 and 300 mg dL 3 3 and 16 7 mmol L to be able to perform calibration tests If your blood glucose level is changing rapidly you may not be able to calibrate the system For example during a meal or exercise your glucose levels may vary rapidly Try to time your sensor insertion so that your calibration times do not coincide with your regular meal or exercise activities Important In clinical trials we observed that the sensor signal sometimes temporarily decreases from the true value This typically happens at night during sleep and recovers rapidly when the user moves or is awakened However in order to a
153. se reading e Your lowest glucose reading e Your average glucose reading How well you are maintaining your levels near the average value e The percentage of readings that are above your high glucose target e The percentage of readings that are within your glucose targets between the high and low targets e The percentage of readings that are below your low glucose target The average number of low glucose alarm events per day The average number of high glucose alarm events per day The average number of projected low alarm events per day early warnings e The average number of projected high alarm events per day early warnings Highest CM Lowest CM Ave CM Std Dev Note A small number indicates that most of your glucose readings are close to your average value A large number indicates that many of your glucose levels vary considerably from your average value Above Target Within Target Below Target Low Day High Day Proj Low Day Proj High Day b Press the LEFT Option button Next to view other periods Note You can view reports for 1 3 7 14 21 or 28 day periods in that order c Press the RIGHT Option button Back to return to the Select Reports screen d Go to Step 2 to determine what to do next e Section 12 Review Reports and Edit Events steps D SNR 7 Review or change your event history aS a Select Event History from the
154. seconds the Male receiver screen will go blank and the last change will be Glucose lost if you haven t pressed the Select button Alarms Reports a Press the UP Arrow button or the DOWN Arrow System button to highlight Add Event Select b Press the RIGHT Option button Select to go to the Select Event screen Section 11 Add Events Se Toms EN 2 Select the type of event you want to record Use the UP Arrow button or the DOWN Arrow button to highlight the type of event Select Event Insulin Meals Exercise State of Health Generic Main Select Ifthe event deals with Then Meals or snacks 1 Highlight Meals 2 Press the RIGHT Option button Select 3 Go to Step 3 e Details of an insulin dose injection or pump 1 Highlight Insulin 2 Press the RIGHT Option button Select 3 Go to Step 4 e Exercise 1 Highlight Exercise 2 Press the RIGHT Option button Select 3 Go to Step 5 e Your state of health 1 Highlight State of Health 2 Press the RIGHT Option button Select 3 Go to Step 6 e Symptoms e Other health related observations e Other events 1 Highlight Generic 2 Press the RIGHT Option button Select 3 Go to Step 7 Note For all the steps below make sure that you have entered the correct date and time 3 Record meal events a Use the LEFT Option button Next to select which ae oe ji item to enter or change Carbohydrate grams SAVE
155. sensor insertion site due to activities like vigorous exercise or bumping against objects may lead to poor adhesion of the support mount to the skin and cause the sensor to dislodge If the sensor dislodges due to the sensor support adhesive failing to adhere to the skin you may get unreliable results or no results The system may not provide a warning in such circumstances Choose the proper sensor insertion site when inserting the sensor and prepare the site by following the instructions for site preparation If your results from the Continuous Monitoring mode seem erroneous check and make sure that the sensor has not dislodged If you notice the sensor is dislodged from the skin or if you see that the adhesive on your overbandage or the sensor support mount is coming loose discard the old sensor and insert a new sensor The FreeStyle Navigator system includes built in self checks to detect conditions that may cause the sensor to not function properly On rare occasions the system may not be able to detect all such conditions for example if the adhesive peels up from your skin and you may get inaccurate results in the Continuous Monitoring mode If you believe your results are not reliable or are inconsistent with how you feel perform a Blood Glucose mode test to measure your glucose If the problem continues discard the old sensor and insert a new sensor e You should never reset your user settings when you are wearing a sensor This w
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157. skin E a Locate the top of the sensor support mount fon b Follow the instructions below as you place the sensor support mount adhesive side down on the insertion site Top of the Sensor Support Mount If you are Then Inserting the sensor on the Place the sensor support mount lengthwise back of your arm on your arm with the top of the sensor support mount facing your shoulder e Inserting the sensor on your Place the sensor support mount horizontally abdomen on your abdomen 10 Ensure that the adhesive pad is adhered to your skin a Hold the sensor delivery unit firmly in place b Smooth the adhesive pad against your skin Customer Care 1 866 597 5520 Section 5 Insert or Remove Your Sensor iu w s 11 Remove the locking pin 13 Remove inserter b Twist the locking pin a 1 4 a Grasp the top ofthe locking pin with your thumb and index finger turn in either direction until the locking pin clicks Pull thelocking pin away to remove it Note The sensor support mount adhesive will help keep the sensor support mount in place Caution Do NOT press the button until you are ready to insert the sensor Doing so may cause unintended results or injury Hold the sensor inserter as shown and press down on both sides of the button at the same time Important Do NOT press on the blue release tabs while pressing the button on the top of
158. sooner than in samples from alternate sites forearm upper arm hand thigh or calf If an alternate site must be used vigorous rubbing of the alternate site before lancing can help minimize this difference e Do not use the FreeStyle Navigator system for diagnosing diabetes testing newborns or testing arterial or venous blood Customer Care 1 866 597 5520 Section 1 Getting Acquainted What is Hypoglycemia Unawareness Hypoglycemia unawareness is a condition where you are having hypoglycemia but you do not have any of the usual warning symptoms such as rapid heartbeat sweating shakiness anxiety or a tingling sensation in your fingers or toes Those warning symptoms are either absent or greatly reduced Instead the first sign may be confusion or impaired thinking which makes it even more difficult to know if you are experiencing low blood glucose You could find yourself in the midst of a severe hypoglycemic episode without any warning at all Symptoms of Hypoglycemia Unawareness Because you would have missed the early warning signs of hypoglycemia the only signs or symptoms you may have would be due to the effects of low blood glucose on the brain e Irritability e Tiredness e Confusion Forgetfulness e Pale skin e Slurred speech e Loss of consciousness This condition is potentially dangerous because hypoglycemia confusion can occur without warning If you were driving a car or operating heavy machinery confusi
159. steps PL 555 1 Access the System menu from the Main menu Main a Press the UP or DOWN Arrow button to highlight Glucose System Alarms Reports b Press the RIGHT Option button Select to go to the AES System Menu screen Select m Section 15 Reset User Settings u steps U See 2 Access the Reset User Settings screen System Menu Status Link Set Date Time Country Settings Reset User Settings Main Select 3 Reset your settings Ifyou want to e Return your system to its default settings e Change your mind a Press the UP or DOWN Arrow button to highlight Reset User Settings b Press the RIGHT Option button Select to go to the Reset User Settings Screen Confirm what you want to do Then Press the RIGHT Option button Yes Note You will lose your personal settings Press the LEFT Option button No Note Your personal settings will be retained Are You Sure You Want To Reset to Default Caution You should never reset your user settings when you are wearing a sensor This will reset parameters that may affect your system performance No Yes 4 Check your work Result Your receiver with the settings you want You have done this procedure correctly when the receiver s settings match your desired settings _J Default settings OR LL Your personal settings if you changed your mind Customer Care 1 866 597
160. t 82 Travel Air Travel With The System 5 Trouble Shoot Errors In BG Mode 100 Problems 101 Alarm Messages 92 Water Resistance Bathing 5 Swimming 5 Customer Care 1 866 597 5520
161. tection most alarms approximately 30 minutes in advance of events e Intermediate detection intermediate alarms approximately 20 minutes in advance of events e Low detection fewest alarms approximately 10 minutes in advance of events Review or change your settings Then set the Sensitivity to High Medium Low e Press the LEFT Option button Next to move from one field to the next e Use the UP DOWN Arrow buttons to change the setting in any field e Press the RIGHT Option button Set to accept the settings and return to the Alarms menu Note The receiver will respond with a brief sample of the alarm you selected Decide what to do next Then Continue to the next step Go to Step 11 Section 8 Set Review or Change the Alarm Settings LDOEMENE KEAENN C I EN RN 6 Set review or change your Projected High glucose alarm a Select Projected High from the Alarms menu Alarm Settings e Use the UP DOWN Arrow buttons to highlight LOW elluaeee VO Projected High High GI 275 qu On e Press the RIGHT Option button to select Projected High Off Projected High Data Loss Alarm Settings 08 30A Projected High Glucose A Main Select Sensitivity Low Setting Medium Beep Decide what settings you want N m e Alarm on or off Sensitivity If you want this much notice Then set the Alarm type Setting before reaching your High Sensitivity to Low
162. the inserter Note You will feel a slight pinch as the sensor is placed just under your skin a Hold the sensor inserter and firmly squeeze the two blue release tabs at the inserter s base as you lift the inserter away from the sensor support mount Note Do NOT lift the inserter without squeezing the blue release tabs as this may dislodge the sensor support mount Section 5 Insert or Remove Your Sensor r w _wrwwwYia 14 Check the sensor support mount a Confirm the sensor support mount remains tightly adhered to your skin by sliding your finger along the edges of the adhesive pad and examine for any gaps in adhesion b Examine the area for a drop of blood You may see some blood from the insertion site If there is continuous bleeding that does not stop in a few minutes even after blotting with a clean cloth or swab repeat the procedure from Step 2 to remove the sensor support mount select a new site and insert a NEW sensor c Use a mirror to check that sensor is correctly placed Sensor is correctly placed You will see the tip of the sensor is inserted under the skin and the sensor is flush against the top edge of the sensor support mount Sensor is missing 1 Remove sensor support mount 2 Go to Step 1 to insert a new sensor Customer Care 1 866 597 5520 Section 5 Insert or Remove Your Sensor r 15 Discard the sensor inserter safely 16 Check your work We rec
163. tion one field to the next e Use the UP DOWN Arrow buttons to change the setting in any field e Press the RIGHT Option button Set to accept the settings and return to the Alarms menu Note The receiver will respond with a brief sample of the alarm you selected c Decide what to do next If Then e You are setting reviewing or changing Continue to the next step all alarms e You are finished setting reviewing and Go to Step 11 changing alarms Section 8 Set Review or Change the Alarm Settings steps DTN 4 Set review or change the High Glucose alarm Alarm Settings Mute Alarms Low Glucose 70 High Glucose 275 Projected Low On Projected High Off Main Select Decide what settings you want e Alarm on or off e Your threshold value Note The alarm can only be set between 140 and 300 mg dL 7 8 mmol L and 16 7 mmol L e Alarm type Setting Low medium or high beep Short medium or long vibration Caution The High Glucose alarm cannot be set above 300 mg dL 16 7 mmol L Therefore it is not intended to notify you of severe hyperglycemia Select High Glucose from the Alarms menu e Use the UP DOWN Arrow buttons to highlight High Glucose e Press the RIGHT Option button to select High Glucose Alarm Settings 08 30A High Glucose Alarm A 275 Setting Medium Beep Next Set Review or change your settings e Press th
164. tion 18 Appendix B Specifications 18 Appendix B Specifications Your FreeStyle Navigator system specifications are listed in the following table Operating Temperature Storage Temperature Operating Humidity Receiver Operating and Storage Altitude Operating Pressure Sensor Life Sensor Operating Skin Surface Temperature Glucose Result Range Glucose Assay Method for CM mode Power Source Transmitter Size Transmitter Weight Transmitter Battery Life Wearing Transmitter Under Water 40 F to 104 F 4 C to 40 C Store the transmitter and receiver between 14 F 10 C and 113 F 45 C Store the test strips and sensor delivery units between 37 F 3 C and 86 F 30 C Control solution should be stored between 50 F 10 C and 86 F 30 C 5 to 90 non condensing Sea level to 10 000 feet 3 048 meters 14 7 psia sea level to 10 1 psia 10 000 feet Up to 5 days 77 F 25 C to 104 F 40 C 20 to 500 mg dL 1 1 to 27 8 mmol L Amperometric electrochemical sensor using WIRED ENZYME technology Continuous subcutaneous measurement of glucose in interstitial fluid by a sensor inserted approximately 5mm under the skin Transmitter One silver oxide 357 HC battery small coin cell battery replaceable battery life is 30 days Receiver Two AAA alkaline batteries replaceable battery life is 60 days We recommend Energizer MAX Energizer e
165. to display the System menu Link e Use the UP or DOWN Arrow button to highlight Link Transmitter ID f Wait while the receiver searches for the transmitter AAAF293 80359 located eine you Note It may take the receiver up to 70 seconds to find the transmitter Result The receiver displays the transmitter s ID number AAAF293 80359 If the And this Then ID numbers is your e Are the same 1 Press the RIGHT Option button Yes Result The Main menu is displayed 2 Go to Step 4 Are NOT 1st attempt Press the Left Option button the same No The receiver will continue Verify that the ID to search for another transmitter number displayed in the vicinity on the screen is EE the same as the 2ndattempt Call Customer Care ID number on the bottom of your transmitter Caution If you accept an incorrect transmitter ID when linking your Transmitter and Receiver your glucose readings will be incorrect 4 Check your work Result A linked or unlinked transmitter and receiver You have done this procedure correctly when L Your system is linked when you wanted it linked Your system is unlinked when you wanted it unlinked link failed The ID number of the transmitter displayed by the receiver under the Transmitter Status menu item matches the ID on the transmitter label END OF Section 14 d d You called Customer Care after your 2nd attempt to d Customer Care 1 866
166. tting mg dL Alarms Alarms Alarms Alarms Alarms Alarms n N n N n N n N n N n N 65 46 56 121 54 65 121 19 18 95 80 12 15 20 3 15 41 11 27 70 56 98 176 44 78 176 16 21 132 79 19 24 21 5 24 40 14 35 75 59 130 219 41 89 219 9 15 161 72 23 32 28 9 32 37 14 38 85 61 189 308 39 119 308 7 17 228 65 22 34 35 12 34 33 14 43 True Alarms are the percentage of time the glucose level was below the threshold and an alarm was activated Missed Alarms are the percentage of time the glucose level was below the threshold and an alarm was not activated False Alarms are the percentage of time an alarm occurred but the glucose level was not below the threshold setting n N is the n umber of observations divided by the total N umber Detection of High Glucose See Table 8 for detection of high glucose As an example when the threshold alarm was set at 240 mg dL during the day 78 of the high glucose events were detected by FreeStyle Navigator Table 8 High Glucose Detection DAY NIGHT High Alarm Day True Day Missed Day False Night True Night Missed Night False Setting mg dL Alarms Alarms Alarms Alarms Alarms Alarms n N n N n N n N n N n N 180 89 561 630 11 69 630 11 68 628 69 29 42 31 13 42 7 3 44 240 78 295 376 22 81 376 12 47 393 41 12 29 59 17 29 25
167. ucose levels and when reaching those glucose levels e Graphs and statistics that show your glucose results in easy to understand formats e Directional glucose trend arrows that show if your glucose values are rising or falling and how fast Memory to hold up to 60 days worth of data Wireless communication capabilities to a personal computer Built in FreeStyle Blood Glucose Meter for performing blood glucose measurements e Event entry capabilities like meals exercise insulin and other e Backlit display Important Keep this Users Guide for future reference It will come in handy when you have to do procedures that you do not do often enough to remember Section 1 Getting Acquainted How are the parts packaged Your FreeStyle Navigator system comes with two kits e A System kit A Sensor kit The System Kit 1 FreeStyle Navigator Receiver in a Receiver Skin 2AAA Alkaline Batteries for the receiver 1 FreeStyle Navigator Transmitter 1 Silver Oxide 357 HC Battery for the transmitter 1 Belt Clip for the receiver 1 FreeStyle Lancing Device it 1 Finger Cap for the lancing device The Sensor Ki 6Sterile Sensor 1 es Guide a sensor and Product Insert Getting Started Guide 1 Silver Oxide 357 HC Replacement Battery for 1 Quick Reference Card Delivery Units each containing e transmitter 1 Welcome Card m 6Overbandages 12Alcohol Prep Pads 30 Sterile Lancets
168. ucose sensor should be removed if redness pain tenderness or swelling develops at the sensor insertion site Cautions Before adjusting treatment for diabetes management based on the continuous glucose results from your FreeStyle Navigator system perform a Blood Glucose mode test to confirm the continuous result Performance of the FreeStyle Navigator system has not been evaluated in pregnant women Performance of the system under conditions of fluctuating hydration levels such as during renal dialysis has not been evaluated Customer Care 1 866 597 5520 Section 1 Getting Acquainted Before You Get Started con t Cautions Low or high glucose measurements can indicate a potentially serious medical condition If you have hypoglycemia or hypoglycemia unawareness then test ONLY on your fingers The high and low alarms are intended to assist you in managing your diabetes and should not be exclusively used to detect hypoglycemia or hyperglycemia The alarms should always be used in conjunction with other indications of glycemic state such as your glucose level trend line graph etc High and low glucose alarms are DIFFERENT from your glucose targets Low and high glucose alarms alert you when you ve crossed a certain low or high value Glucose targets allow the reports and line graphs to show how your glucose levels have been performing compared to your set targets The Low Glucose alarm
169. ur transmitter Your receiver Helpful Information Important Keep the following in mind when inserting your sensor You will not have continuous monitoring data until you have successfully completed the first calibration at least for the first ten hours after sensor insertion You may not be able to calibrate the system if your glucose levels are changing rapidly For example during a meal or exercise your glucose levels may vary rapidly Try to time your insertion so that your calibration times do not coincide with your regular meal or exercise activities Note You should keep your sensor inserted for 5 days See the exceptions listed above under Start e The system will ask you to perform 4 calibrations at approximately 10 12 24 and 72 hours after inserting a new sensor See Section 7 You MUST change your sensor every 5 days to reduce the chance of infection The system automatically terminates a sensor session after 5 days Do NOT leave the sensor inserted for more than 5 days e Taking action at the first sign of irritation or discomfort will keep small issues from turning into larger or ongoing ones e You may not be able to perform the calibration after you eat until your glucose levels stabilize e See Appendix A Site Maintenance for additional helpful suggestions e Before inserting a new sensor make sure that there are no low battery messages displayed on the receiver This will help avoid data loss after
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171. ver e Quit and return to the Main menu 3 Set your glucose targets Then Go to Step 3 Go to Step 4 Go to Step 5 Go to Step 7 Press the LEFT Option button Main on the Reports menu a Select Glucose Targets from the Select Report menu Set Target Range i Press the UP Arrow button or DOWN Arrow button to highlight Glucose Targets Low Target El ii Press the RIGHT Option button Select to go to High Target 180 the Glucose Targets screen Next Enter your low glucose target using the UP or DOWN arrows Press the LEFT Option button Next to move to the High Glucose target setting Enter your high glucose target using the UP or DOWN arrows Press the RIGHT Option button Set to save the settings Result The settings are saved and the Select Report screen appears Return to Step 2 to decide what to do next Customer Care 1 866 597 5520 glucose level history Select Time Period 2 Hour 4 Hour 6 Hour 24 Hour back Select 8a 12p 4p 8p 12a 4a Note The line graph display range is between 20 mg dL 1 1 mmol L and 350 mg dL 19 4 mmol L Glucose values exceeding 350 mg dL 19 4 mmol L will be plotted as 350 mg dL 19 4 mmol L Glucose values falling below 20 mg dL 1 1 mmol L will be plotted as 20 mg dL 1 1 mmol L Section 12 Review Reports and Edit Events steps P UT 4 View a line graph of your a Select Line Graphs
172. void being affected by this phenomenon the system should not be calibrated when the wearer is asleep You may not be able to calibrate the system if your glucose levels are changing rapidly e g during or after exercise meals or insulin dosing Under such conditions the system may not ask you to calibrate instead it will delay its request until conditions are acceptable Section 7 Calibrate Your System Test Blood Glucose Manually Helpful Information con t e You MUST successfully complete 4 calibration tests You will calibrate at approximately 10 12 24 and 72 hours after sensor insertion If you do not complete calibration tests successfully in the allotted time periods your glucose readings will NOT be displayed and alarms will be inactive The system may ask you to perform additional calibrations between 2nd and 3rd calibrations depending on the sensor signal In such cases you will be prompted with a message to do additional BG tests The receiver will beep or vibrate to prompt you to do a calibration The receiver will display a blood drop icon and the message Do BG Test The system will prompt you with alarm messages when your calibrations are unsuccessful e You will not have continuous monitoring until you have successfully completed the first calibration at least for the first ten hours after sensor insertion e If you get a request for a calibration or expect additional calibration requests during a time
173. when you do not want to be disturbed e g sleep time you can choose to wait to perform additional BG tests at a later point in time If you choose to wait and the allotted time window for calibration has expired please note that you will not get glucose results until you have performed a successful calibration You can turn off the System Alarms or set to vibrate if you do not want to be disturbed by frequent requests for calibration In order to silence the alarms that warn you when the allotted time window for a calibration has expired you must turn off the data loss alarms and all the four glucose alarms Low Glucose High Glucose Projected Low Glucose and Projected High Glucose When to calibrate the system You will calibrate the system at approximately 10 12 24 and 72 hours after sensor insertion For example Insertion at night If you insert the sensor at 9 00 pm on Day 1 What happens in the example if the first calibration does the first calibration would be at 7 00 am on Day 2 not occur until 9 am on Day 2 the second calibration would be at 9 00 am on Day 2 The 2 hour delay will add on to the second third and fourth the third calibration would be at 9 00 pm on Day 2 calibration Second calibration will now happen at 11 am on day 2 and so on However sensor removal will still happen at the fourth calibration would be at 9 00 pm on Day 4 9 pm on Day 6 Sensor removal would be at 9 00 pm on Day 6 A
174. within 10 feet of the transmitter b Decide what to do next Then 1 Wait for the connection icon 2X to disappear automatically from the display to confirm connection 2 Go back to Step 1 of Section 9 e For 30 minutes or more System Menu 08 30A Reconnect Data Upload Status Link Set Date Time Main Select 1 Press the RIGHT Option button twice to display the Main Menu screen 2 Use the UP DOWN Arrow button to highlight System 3 Press the RIGHT Option button Select to display the System menu with Reconnect highlighted 4 Press the RIGHT Option button Select 5 Wait for the receiver to beep If it beeps e Twice the system is connected Go back to Step 1 of Section 9 e Three times the system is not connected Make sure the battery in the transmitter is new and ensure that the receiver and transmitter are linked see Section 14 Customer Care 1 866 597 5520 Section 9 Daily Use 3 Interpret the CM screen Press the RIGHT Option button to turn the display on Result The Glucose CM screen is displayed Location Description If CM appears here the receiver is operating in the Continuous Monitoring mode If BG appears here the receiver is operating in the Blood Glucose mode The current time of day The directional glucose trend arrow tells you the direction that your glucose levels are trending and how fast see Step 4 The system uses 15 minutes of continu
175. y when L The transmitter is securely attached to the sensor support mount You have applied an over bandage as necessary to hold down the transmitter and the sensor support mount _ The sensor code has been correctly entered into the receiver J You see an gt icon on the top right hand corner of the screen Customer Care 1 866 597 5520 7 Calibrate Your System Test Blood Glucose Manually Section 7 Key Terms BG Mode Calibrate Calibration BG Control Solution FreeStyle Test Strips Icon Lancet Lancing Device Lancing Device Cocking Handle Lancing Device Depth Indicator Window Lancing Device Depth Setting Lancing Device Lancet Cup Holder LEFT RIGHT Option Buttons Receiver Test Strip Port Sharps Container UP DOWN Arrow Buttons Customer Care 1 866 597 5520 Section 7 Calibrate Your System Test Blood Glucose Manually 7 Calibrate Your System Test Blood Glucose Manually Purpose Start Materials To ensure the receiver will calculate your glucose readings accurately Do this procedure e Each time the receiver prompts you with the message Do BG Test You will see a blood drop icon on the screen and you will also hear the system beep or vibrate e When you need to measure your blood glucose manually using the built in FreeStyle Meter e Soap water and a clean towel FreeStyle Test Strips e A FreeStyle Lancing Device e Your FreeStyle Navigator Receiver e Sterile lancet
176. yle Blood Glucose Meter that works as a traditional blood glucose meter when a FreeStyle Test Strip is inserted into the test strip port You can wear the receiver on your belt or carry it in your pocket or purse The rectangular window on the center of the receiver that displays glucose levels and other important information The receiver skin is an optional accessory for use with your FreeStyle Navigator Receiver Provides you with information regarding the receiver including serial number software version and remaining battery life This information can be accessed from your System menu item in the Main menu The slot on the lower left edge of the receiver where you insert the FreeStyle Test Strips to calibrate the system or perform Blood Glucose mode tests Customer Care 1 866 597 5520 Section 20 Glossary 20 Glossary cont Reports Sensor Sensor Code Sensor Delivery Unit Sensor Inserter Sensor Insertion Button Sensor Insertion Site Sensor Locking Pin Sensor Release Tabs Sensor Support Mount Sharps Container Single day Statistics Site Rotation Skin Barriers Information about your glucose levels shown in a way to help you and your healthcare team analyze changes in your glucose levels and your treatment plan such as changes in insulin doses carbohydrate intake etc Several types of reports are available The part of the system that you insert under your skin Each inserted sensor is

Arkon PRT03831-xxx User's Manual

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