Abbott-freestyle PRT03831-xxx Manuel d'utilisateur

Customer Care available 24 hours a day, 7 days a week at: 1-866-597-5520www.continuousmonitor.comis product and its use are protected

Section 1 – Key Terms n Alarms  n Blood Glucose Mode  n Continuous Monitoring Mode  n FreeStyle Navigator Continuous Glucose Monitoring Syst

Status Informatione receiver can provide you with a number of dierent types of Status Information. Available Status Information is listed in the fol

OVERAlarms and ErrorsStatus Information (con’t) CM Status.Stores recent error codes related to the Continuous Monitoring mode (may be useful when call

OVERHigh – H, Medium – M, Intermediate – I, Low – LRespond to alarm message:Alarm Message Urgency What It Means What to Do ___ ___ ___N/A •Systemis

OVERRespond to alarm message: (con’t)Alarm Message Urgency What It Means What to DoHigh – H, Medium – M, Intermediate – I, Low – LAlarms Inactive Skin

OVERRespond to alarm message: (con’t)Alarm Message Urgency What It Means What to DoHigh – H, Medium – M, Intermediate – I, Low – LCal Required: Redo B

OVERRespond to alarm message: (con’t)Alarm Message Urgency What It Means What to DoHigh – H, Medium – M, Intermediate – I, Low – L† Caution: Before ad

OVER† Caution: Before adjusting treatment for diabetes management based on the continuous glucose results from your FreeStyle Navigator system, perfor

OVERRespond to alarm message: (con’t)Alarm Message Urgency What It Means What to Do† Caution: Before adjusting treatment for diabetes management based

OVERRespond to alarm message: (con’t)Alarm Message Urgency What It Means What to DoHigh – H, Medium – M, Intermediate – I, Low – LReplace Receiver Bat

OVERRespond to alarm message: (con’t)Alarm Message Urgency What It Means What to DoHigh – H, Medium – M, Intermediate – I, Low – LTransmitter Error Al

1OVER1 Getting AcquaintedIntroductionImportant: Read all of the instructions in this User’s Guide and the FreeStyle® Test Strip package insert before

OVERRespond to Blood Glucose Mode error codes. (Note: ere is no Error 5) If error code isAnd you have any of these symptoms ThenEr1• Weakness• Swea

OVERTroubleshoot problemse problems you can troubleshoot in this Section are listed below and are arranged in the order of appearance.Receiver• e r

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, re

OVERUnexpected characters on the receiver display screen, unusual or unexpected receiver screen appearance.a. Reconnect the transmitter and receiver.

If none of the above helps solve the problem, replace the sensor (Section 5) or call Customer Care. There is no glucose value on the screen. If And

OVERSkin irritation at sensor insertion site.a. Ensure that seams, waistbands, or other constrictive clothing or accessories do not cover the site cau

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. If

OVERYou are not sure whether your receiver and transmitter are connected.You do not see the icon on the screen.Your system is connected.You see the

The system does not prompt you with a message to do BG test for calibration.If none of the above helps solve the problem, replace the sensor (Section

11 Add Events

How are the parts packaged?Your FreeStyle Navigator system comes with two kits:A System kit.•A Sensor kit.•The System Kit1 FreeStyle Navigator Recei

Section 11 – Key Terms n Events n Exercise Event n Generic Event n Insulin Event n LEFT/RIGHT Option Buttons n Meal Event n State Of Health Ev

11OVER11 Add EventsPurpose To create a record of events that may aect your glucose levels.Start Do this procedure any time you observe anything tha

SAVECANCELNote: For all the steps below, make sure that you have entered the correct date and time.Steps Do This2. Select the type of event you want

OVERNote: For all the steps below, make sure that you have entered the correct date and time. Steps Do This 4. Record insulin events.a. Use the LEF

Steps Do This7. Record generic events.a. Use the LEFT Option button (Next) to select which item to enter or change (Event, SAVE/CANCEL, Date, Time)

12 Review Reports and Edit Events

Section 12 – Key Terms n Event History Reports n Events n Exercise Event n Generic Event n Glucose Targets n Insulin Event n LEFT/RIGHT Option

12OVER12 Review Reports and Edit EventsPurpose • Toreviewyourglucoselevels.• Tohelpyouandyourhealthcareteamdetect patterns in your gluc

Steps Do This2. Decide what you want to do.Note: Your reports will be more meaningful if you set glucose targets. Glucose targets give you something

OVERSteps Do This4. View a line graph of your glucose level history.a. Select Line Graphs from the Select Report menu.i) Use the UP Arrow button or

OVERWhat are the key parts of my system?Your FreeStyle Navigator system includes the following major parts:A FreeStyle Navigator Sensor that you inser

Steps Do This5. View a statistical summary of your glucose levels.a. Select Statistics from the Select Reports menu.i) Use the UP Arrow button or D

OVERSteps Do This6. Select the desired statistical reading.Note: Statistics include ONLY continuous glucose results. Glucose readings that were taken

Steps Do This7. Review or change your event history.a. Select Event History from the Select Reports menu.b. Use the UP or DOWN Arrow button to highl

OVERSteps Do This8. Interpret your events.a. Interpret the events using the notes about each type of event in the table below:b. Go to Step 7d.CM(CM

Steps Do This9. Edit the event. Note: You CANNOT edit your glucose measurements.a. Press the RIGHT Option button (Edit).b. Use the LEFT Option butto

13 Clean Your System

Section 13 – Key Terms n Receiver n Transmitter n Contact PointsCustomer Care: 1-866-597-5520

13OVER13 Clean Your SystemPurpose To maintain the appearance of your system.Start Do this procedure:•Everytimeyouchangeyoursensor(transmitter

Steps Do This1. Clean your transmitter.a. Wash the transmitter with mild soap and water.b. Rinse the transmitter thoroughly under running water.c.

14 Link and Unlink Your Transmitter and Receiver

Your receiver comes with backlight capability to see the screen in dark environments. e backlight can be turned on by pressing and releasing the DOWN

Section 14 – Key Terms n BG Mode n CM Mode n Link/Unlink n Receiver n Transmitter Customer Care: 1-866-597-5520

14OVER14 Link and Unlink Your Transmitter and ReceiverPurpose To enable secure communication between your transmitter and your receiver.Start Do thi

Steps Do This1. Decide what you want to do.2. Unlink your receiver from your transmitter.a. Press the RIGHT Option button twice to display the Mai

Steps Do This3. Link your receiver to your transmitter.a. Place the receiver within 10 feet of the transmitter.b. Press the RIGHT Option button tw

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15 Reset User Settings

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15OVER15 Reset User SettingsPurpose To reset the user settings to the default values.Start Do this procedure anytime you feel a need to return your

Steps Do This2. Access the Reset User Settings screen. a. Press the UP or DOWN Arrow button to highlight Reset User Settings.b. Press the RIGHT Opt

16 Change Country Settings

OVERUsing your systemFor Daily ActivitiesYou will be wearing a sensor and a transmitter at all times while you are using the system. Keep the followin

Section 16 – Key Terms n LEFT/RIGHT Option Buttons n Receiver n System Menu n UP/DOWN Arrow ButtonsCustomer Care: 1-866-597-5520

16OVER16 Change Country SettingsPurpose To set the date and time formats, the language, and the decimal format.Start Do this procedure when your req

Steps Do This2. Access the Country Settings menu.a. Press the UP or DOWN Arrow button to highlight Country Settings.b. Press the RIGHT Option button

OVERSteps Do This4. Change the Date Format.a. Use the UP or DOWN Arrow button to highlight Date Format.b. Press the RIGHT Option button (Select) to

Steps Do This6. Change the Decimal Format. a. Use the UP or DOWN Arrow button to highlight Decimal Format.b. Press the RIGHT Option button (Select

17 Appendix A: Site Maintenance

Section 17 – Appendix A n Adhesive Enhancers n Antiseptics n Dressings n Site Rotation n Skin BarriersCustomer Care: 1-866-597-5520

1717 Appendix A: Site MaintenanceIntroductionCareful site selection, preparation, and maintenance can help to lower the risk of infection and improve

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18 Appendix B: Specications

How do I prepare my system for the first time?When you are setting up your receiver for the rst time, perform all of the procedures listed below in th

Section 18 – Appendix B n Calibration n Hematocrit n Interstitial Fluid n Receiver n TransmitterCustomer Care: 1-866-597-5520

18OVER18 Appendix B: SpecicationsOperating Temperature 40º F to 104º F (4º C to 40º C).Storage Temperature Store the transmitter and receiver betw

Receiver Size Height: 2.5 in. (6.3 cm). Width: 3.24 in. (8.2 cm). Depth: 0.88 in. (2.2 cm).Receiver Weight 3.5 oz. (99.2 grams) – including batteri

OVERPerformance CharacteristicsNote: Please consult your healthcare team on how to use the information in this section.Performance of the FreeStyle Na

18 Appendix B: Specications (con’t)Accuracy Table 1 below shows the distribution of all the data from the In-Clinic study on the Clarke Error Grid.

OVER18 Appendix B: Specications (con’t)Table 2 is a summary of the statistics that describe how well data from the FreeStyle Navigator system correl

18 Appendix B: Specications (con’t)Performance Relative to the Reference (YSI)Error grid analysis (like the Clarke Error Grid Analysis and Continuou

OVER18 Appendix B: Specications (con’t)Performance Over the Duration of WearThis section presents the performance data in a variety of ways to demon

18 Appendix B: Specications (con’t)Stability of Sensor CalibrationFreeStyle Navigator system typically requires a calibration at 10, 12, 24 and 72 h

OVERFigure 2. Sample of a Representative ‘Excellent’ Glucose TraceFigure 3. Sample of a Representative ‘Average’ Glucose TraceFigure 4. Sample of a Re

OVERWarnings, Cautions And Important NotesImportant Notes About System Performance e following items describe situations that could lead to inaccurat

18 Appendix B: Specications (con’t)Determination of Alarm Performance e threshold alarm is characterized below. e projected alarm performance has

OVER18 Appendix B: Specications (con’t)Detection of Low Glucose See Table 7 below for detection of low glucose. As an example, when the threshold al

18 Appendix B: Specications (con’t)END OF Section 18Measuring Glucose in Interstitial FluidFreeStyle Navigator system measures glucose in the inters

19 Appendix C: FCC Compliance Information

Customer Care: 1-866-597-5520 164 Section 18 Appendix B: Specifications

19OVER19 Appendix C: FCC Compliance InformationElectromagnetic Interference and Your FreeStyle Navigator® Continuous Glucose Monitoring SystemImportan

19 Appendix C: FCC Compliance Information (con’t)Guidance and Manufacturer’s Declaration – Electromagnetic EmissionsTable 1. e FreeStyle Navigator sy

OVER19 Appendix C: FCC Compliance Information (con’t)Transmitter Radiated Emissions for ENEN 300 220-3Must be below107.5 dBuV/m @433.56MHz83.1 dBuV/m

19 Appendix C: FCC Compliance Information (con’t)Recommended separation distance between portable and mobile RF Communications equipment and the FreeS

OVER19 Appendix C: FCC Compliance Information (con’t)Guidance and Manufacturers’ Declaration – Electromagnetic Immunity.Table 4. e FreeStyle Navigato

Important Things to Remember About System Calibration (con’t)Important: In clinical trials, we observed that the sensor signal sometimes temporarily d

19 Appendix C: FCC Compliance Information (con’t)Caution: e radio receiver and transmitter of your FreeStyle Navigator system operate on the frequenc

OVER DECLARATION OF CONFORMITYWe, Abbott Diabetes Care Inc.1360 South Loop RoadAlameda, California 94502510-749-5400Declare under our sole responsibil

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20 Glossary

Customer Care: 1-866-597-5520 174 Section 19 Appendix C: Classification/Compliance/Declaration

20OVER20 GlossaryAdhesive EnhancersProducts that can help the adhesive pad on the sensor support mount stick better to your skinAlarmsSounds, vibrati

Continuous Monitoring ModeOne of two modes in which the system functions (the other is Blood Glucose mode). You will use this mode most of the time. I

OVERGlucose Trend ArrowsArrows shown on the receiver that let you know whether your glucose levels are stable, increasing, or decreasing, and how quic

20 Glossary (con’t)Line Graph ReportsShow continuous glucose lines (plotted at 10-minute intervals) for several dierent periods (2, 4, 6, 12, or 24

OVER20 Glossary (con’t)ReportsInformation about your glucose levels shown in a way to help you and your healthcare team analyze changes in your gluco

OVERBefore You Get Started (con’t)Cautions:Low or high glucose measurements can indicate a potentially serious medical condition.•If you have hypogly

State of HealthEvent A record of health-related events, symptoms, and other observations that may help you see patterns in your glucose levels.Statis

21 Index

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21OVER21 IndexAdd Events 111Adhesive Adhesion To Skin 40, 105 Adhesive Enhancers 147 Adhesive Removers 37Alarms Change e Alarms 67 Mute Al

21 Index (con’t)Icons 84Insertion Sensor Insertion 41 Insertion Site 38, 39Insulin 112, 113Interference 165Interstitial Fluid 1, 10, 162Line

Helpful health related information: e following pertain to your health and should always be kept in mind:e system is intended to assist you in bette

OVERWhat is Hypoglycemia Unawareness?Hypoglycemia unawareness is a condition where you are having hypoglycemia but you do not have any of the usual wa

What are the Continuous Monitoring mode and Blood Glucose mode?Your FreeStyle Navigator system operates in two modes:Continuous Monitoring mode (Gluco

2 Install or Replace Transmitter and Receiver Batteries

Section 2 – Key Terms n Alarm n Icon n Receiver n Transmitter n Battery Life n Alkaline Batteries n 357 HC Silver Oxide Battery n ReconnectCu

2OVER2 Install or Replace Transmitter and Receiver BatteriesPurpose To ensure that your FreeStyle Navigator system has power to operate properly.Sta

Install or Replace the Transmitter BatteryTurn the circular battery door counterclockwise witha. either a coin or your ngernail. (Fig. 1)Carefully

OVERMatch what you see on your Receiver with ONE of the screen shots shown below.If the display is enPress the RIGHT Option button to see if the scre

Reconnect the Receiver to the Transmitter.Place the receiver within 10 feet of the transmitter.a. Press theb. RIGHT Option button twice to display t

3 Set the Time and Date

Indications for Usee FreeStyle Navigator® Continuous Glucose Monitoring System is indicated for continually recording interstitial uid glucose level

Section 3 – Key Terms   n LEFT/RIGHT Option Buttons  n Main Menu  n Receiver  n System Menu n Transmitter n UP/DOWN Arrow Buttons Customer Car

3OVER3 Set the Time and DatePurpose To ensure the correct time and date are associated with your data.Start Do this procedure:•ersttimeyouu

Steps Do This2. Go to the System screen.a. Press the DOWN Arrow button to highlight System.b. Press the RIGHT Option button (Select) to go to the S

Steps Do This5. Set the date.a. Press the LEFT Option button (Next) to move to the Month eld.b. Use the UP/DOWN Arrow buttons to set the current m

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4 Perform a Control Solution Test

Section 4 – Key Terms n Control Solution Test  n FreeStyle Control Solution  n FreeStyle Test Strips   n LEFT/RIGHT Option Buttons  n Receiver n

4OVER4 Perform a Control Solution TestPurpose e purpose of the control solution test is to:• Ensure that your receiver and test strips are workin

Steps Do This1. Verify that your FreeStyle Control Solution is current.Note: FreeStyle Control Solution is good for three months aer opening the bo

OVERSteps Do This3. Insert test strip into the receiver.a. Tu rn the test strip so “FreeStyle” text faces up.b. Grasp the test strip by the end wit

Steps Do This5. Apply control solution.Important: Do NOT apply control solution to both edges of the test strip.Notes:• GentlytouchONLY ONE EDGE

Steps Do This7. Evaluate the test results.Compare the test results displayed on the screen to the range printed on the vial of test strips.8. Check

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5 Insert or Remove Your Sensor

Section 5 – Key TermsNow that you are ready to insert a sensor, here are a few helpful tips. Rec• onnect your transmitter and receiver BEFORE inserti

5OVER5 Insert or Remove Your SensorPurpose To insert, remove, or replace a small, thin, plastic sensor under your skin so that your FreeStyle Naviga

Important ings to Know About Getting Reliable Results Caution: Movement of the sensor support mount or excessive perspiration at the sensor insertion

OVERSteps Do This2. Remove the sensor.a. Wipe a small amount of isopropyl alcohol around the edges of the sensor support mount. Note: You can use a

Steps Do This3. End sensor session.a. Press the RIGHT Option button twice to get to the Main menu.b. Press the UP/DOWN Arrow button to highlight Sy

OVERSteps Do This6. Prepare the insertion site.a. Wash your hands thoroughly with soap and water.b. Clean the selected insertion site area with soap

How to Use this Guide?is guide has many Sections arranged in a logical sequence that will be useful for the rst time use and every use thereaer. Mo

Top of the Sensor Support MountSteps Do This9. Attach the sensor delivery unit to your skin.a. Locate the top of the sensor support mount.b. Follow t

OVERBlue Release Tab13. Remove inserterSteps Do This11. Remove the locking pin.a. Grasp the top of the locking pin with your thumb and index nger.

Steps Do This14. Check the sensor support mount.a. Conrm the sensor support mount remains tightly adhered to your skin by sliding your nger alo

Steps Do This15. Discard the sensor inserter safely. We recommend a sharps container or a puncture-proof container with a tight lid. 16. Check

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6 Attach Your Transmitter

Section 6 – Key Terms n LEFT/RIGHT Option Buttons  n Receiver n Sensor Code n Sensor Support Mount n System n Transmitter n UP/DOWN Arrow Butt

6OVER6 Attach Your TransmitterPurpose To enable the transmitter to send glucose data to the receiver.Start Do this procedure aer inserting a new s

Steps Do This1. Attach the transmitter to the sensor support mount.a. Position the transmitter over the sensor support mount so that the battery sid

OVERSteps Do This3. Apply an over-bandage (Optional).Apply an over-bandage to hold down the transmitter and sensor support mount. Use an over-bandage

Table of Contentsn  Section 1: Getting Acquainted. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Steps Do This5. Check your work.Result: A transmitter ready to send glucose data.You have done this procedure correctly when:o e transmitter is se

7 Calibrate Your System/Test Blood Glucose Manually

Section 7 – Key Terms n BG Mode n Calibrate n Calibration BG n Control Solution n FreeStyle Test Strips n Icon n Lancet n Lancing Device n L

7OVER7 Calibrate Your System/Test Blood Glucose ManuallyPurpose To ensure the receiver will calculate your glucose readings accurately.Start Do thi

Helpful Information (con’t)Yo u • MUST successfully complete 4 calibration tests. You will calibrate at approximately 10, 12, 24 and 72 hours aer s

OVEROVERHelpful Information (con’t)Some common reasons for unsuccessful calibrationsYour BG test result is below 60 mg/dL (3.3 mmol/L) or above 300 mg

Steps Do This1. 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

OVERSteps Do This3. Select a test site.Note 1: Vary the sites from test to test to avoid tenderness and to avoid creating calluses.Note 2: Avoid mole

Steps Do This4. 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.

OVERSteps Do This4. Prepare for lancing. (con’t)g. Select the lancing device depth setting.• eFreeStyle®LancingDeviceoersfourdierentdepth

n  Section 10: Respond to Alarms, Errors, and Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 – 108 Alarm Messages: What are

Steps Do This5. Lance the site.To lance your nger (grey cap):a. Lightly touch the lancing device against the side of your ngertip.b. Press the rel

OVER Steps Do This6. Test the sample. Do Not:•Useteststripsmorethanonce.Discardusedteststrips.•Scrape the blood.•Applybloodtothe

Steps Do This7. Interpret the blood glucose results.8. Conrm you did NOT use Control Solution.Press the RIGHT Option button to indicate that you di

END OF Section 7Steps Do This9. Remove and discard the test strip. Important: Test strips may be used only once. Discard usedtest strips.10. Discar

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8 Set, Review, or Change the Alarm Settings

Section 8 – Key Terms n Alarm Menu n Alarm Sensitivity n Alarm Type n Data Loss n High Glucose Alarm n High Glucose reshold n LEFT/RIGHT Opti

8OVER8 Set, Review, or Change the Alarm SettingsPurpose To set the receiver to:• Alertyouwhenyourglucoseconditionschange.• Notifyyouwhenth

About Glucose Alarms Example of a High Glucose reshold Alarm - e alarm sounds when the glucose level crosses the preset threshold value.In addition

OVERFollow the guidelines below when selecting your alarm settings for detection of high and low glucose conditions. When the detection rate is maxim

Steps Do This1. Access the Alarms menu from the Main menu.Note: If you don’t press any buttons within 12 seconds, the receiver screen will go blank a

OVERSteps Do This3. Set, review, or change the Low Glucose alarm.a. Select Low Glucose from the Alarms menu.•Use the UP/DOWN Arrow buttons to high

Steps Do This4. Set, review, or change the High Glucose alarm.a. Select High Glucose from the Alarms menu.•UsetheUP/DOWN Arrow buttons to high

OVERSteps Do This5. Set, review, or change your Projected Low glucose alarm.a. Select Projected Low from the Alarms menu.•UsetheUP/DOWNArrowbu

Steps Do This6. Set, review, or change your Projected High glucose alarm.a. Select Projected High from the Alarms menu.•UsetheUP/DOWNArrowbu

OVERSteps Do This7. Set, review, or change the Data Loss alarms.Important: If you turn o your Data Loss alarms, you must also turn o your Low Gluc

Steps Do This8. Set System Alarms.Important: If you turn o the System Alarms, the receiver will NOT prompt you to do the calibration tests aer you

OVERDecide what settings you want:• Turnprogresstonesonoro.• Setprogresstonesvolumelow or high.Steps Do This9. Set Progress Tones.a. Se

END OF Section 8Steps Do This10. Mute all audible alarms for 1 hour.Note 1: You will still get vibration, visual alarms will still be displayed and y

9 Daily Use

1 Getting Acquainted

Section 9 – Key Terms n BG Mode n CM Mode n Directional Glucose Trend Arrows n Icon n Receiver n Transmitter n Transmitter Receiver Connection

9OVER9 Daily UsePurpose To read and understand your display screen.Start Do this procedure:  •AnytimeyouareusingyoursystemintheContinuous

Steps Do This1. Decide what to do.2. Reconnect the receiver to the transmitter.a. Place the receiver within 10 feet of the transmitter.b. Decide what

OVERSteps Do This3. Interpret the CM screen.Press the RIGHT Option button to turn the display on.Result: e Glucose CM screen is displayed. Location

Steps Do This4. Interpret the icons. Note: e directional trend arrows are dierent from the projected glucose alarms (Section 8). For example, you c

END OF Section 9Steps Do This5. Turn the Backlight on.a. In order to turn the backlight on, your receiver has to be turned o. If the receiver is on,

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10 Respond to Alarms, Errors, and Problems

Section 10 – Key Terms n Alarms Menu n Calibration BG n CM Status n Calibration n High Glucose Alarm n Icon n Low Glucose Alarm n Projected H

10OVER10 Respond to Alarms, Errors, and ProblemsPurpose To resolve alarm messages, error codes, or problems.Start Do this any time you:•Receiveeit