Medtronic Guardian Real-time Guia do Utilizador

CONTINUOUS GLUCOSE MONITORING SYSTEMUser Guide

AUC calculation ... 31Setting the Alarm Snooze ...

LOST SENSORReason: The monitor has not received a signal from the transmitter for more than 40 minutes.Action: Make sure that the sensor is inserted

Action: If the alert resulted from two Cal Errors in a row, replace the sensor. If the alert happenedwithout two Cal Errors, use the transmitter'

METER BG BYReason: A meter BG measurement is required for calibration purposes by the time that is shown on yourmonitor. The METER BG BY alert is al

FALL RATEReason: The sensor glucose measurements are falling at a rate that is equal to or faster than the Set FallRate Limit you selected for the a

Sensor Alarm History display = this alert• CalErr = CAL ERROR• ChgSen = CHANGE SENSOR• ChgXtr = CHARGE TRANSMITTER•DwnSlp = FALL RATE•Hi = HIGH SG•Lo

System alarmsAlarms put the monitor in Attention mode. You may encounter the alarms listed below while using thesystem. These alarms include informati

FAILED BATT TESTThe battery does not have enough energy to make the monitor work and the battery cannot be used.Install another battery, and always

• BadBat = FAILED BATT TEST•ChkSet = CHECK SETTINGS• Exx = Any E-Alarm• NoPwr = OFF NO POWER• Reset = RESET• WeakBt = WEAK BATTERY To view your system

Question: Why do I see a mix of quick andlong flashing red lights on the charger?Answer: Your charger and transmitterbatteries are very low. Replace t

Connecting the tester1 Hold the transmitter and the tester as shown. Line up the flat side of the testerwith the flat side of the transmitter.2 Push t

3 hour graph ... 576 hour graph ...

Troubleshooting the monitorMy monitor will not display my BG measurement from my meter1 Make sure you are using the correct meter (a blood glucose met

MAIN MENU > Sensor > Sensor StartThe SENSOR START MENU appears with New Sensor selected.2 Select Find Lost Sensor.Press ACT. A message tells you

Why doesn't my monitor battery last very long?• A short battery life does not always mean something is wrong with your monitor. Battery life in y

I submerged my monitor in waterYour monitor is designed to resist brief, accidental contact with water. Do not submerge the monitor inwater when bathi

System maintenanceReplacing the batteryYou must replace the monitor battery with a new battery as part of your normal system maintenance. Seethe Insta

Cleaning the systemThis procedure shows you how to clean the different parts of your system. To avoid accidentally damagingyour system during cleaning

CAUTION:• Never place your monitor directly in water.• Keep the battery compartment dry and away from moisture.• Never try to clean the inside of your

For details on attaching and disconnecting the tester, see Connecting the tester, on page 94 andDisconnecting the tester, on page 94.Inspecting the tr

For single-patient useAlways clean the transmitter after each use.To clean the transmitter, you will need the following materials: Ivory® liquid soap,

5 Prepare a mild liquid soap solution using one (1) teaspoon of Ivory liquid soap per one (1) gallon ofroom temperature tap water.6 With tester still

Logbook ... 82Chapter 9: Troubleshooting and alarms/

10 Holding the tester, wipe the transmitter with 70% isopropyl alcohol.11Place the transmitter and tester on a clean, dry cloth and air dry them compl

For multiple-patient useWhen using the transmitter in a healthcare facility, always clean and disinfect the transmitter after eachuse.Warning: You mus

Warning: If you see any body fluid in the connector opening, you must discard the transmitter.Because the transmitter contains a battery, do not disca

8 Holding the tester, remove the transmitter from the solution. Brush the entire surface of thetransmitter using a soft-bristled brush, paying close a

13 Rinse the transmitter under room temperature tap water for three minutes.14 Holding the tester, wipe the transmitter with 70% isopropyl alcohol.15

18 Inspect the housing of the transmitter for any signs of cracking, flaking, or damage. If you see any ofthese signs, you must now discard the disinf

System specificationsAlarm/alert types• Audible tone (beep) — To make sure that you are aware of the alarm/alert, the sound goes from abeep to a siren

Sensor glucose graph timeout• Default: 2 minutes•Options•2 minutes•4 minutes•6 minutes• NONE (no timeout)High and low Glucose Limits (CSS7100)• Maximu

Daily totals• Maximum number of daily totals recorded: 31 daysDefault screen• The HOME screen. The time always shows across the top of the HOME screen

Feature Options Default Setting Limits, Range of ValuesAUC Limits Always on Low Limit 70 (mg/dL) 3.9 (mmol/L)High Limit 180 (mg/dL) 10.0 (mmol/L)Low L

Connecting the tester ... 94Disconnecting the tester ...

Feature Options Default Setting Limits, Range of ValuesGlucose Alarms•On•OffOff You set the thresholds(limits) for the GlucoseAlarms using the Glucose

Feature Options Default Setting Limits, Range of ValuesGlucose Limits2throughGlucose Limits 8CSS7100Low: Off, OnHigh: Off, OnCSS7100KLow• Off, or vali

Feature Options Default Setting Limits, Range of ValuesLanguage•Cesky•Dansk•Deutsch•English• Español•Français•Italiano•Magyar• Nederlands• Norsk•Polsk

Feature Options Default Setting Limits, Range of ValuesMissed Data (Always on - cannot beturned off)30 minutes Range:0:05 – 0:40 (5 to 40 minutes)Pred

Feature Options Default Setting Limits, Range of ValuesSensor glucosegraph timeout• 2 minutes• 4 minutes• 6 minutes•NONEa2 minutes Possible values: Sh

Radio frequency (RF) communication specifications• Monitor to transmitter frequency: 916.5 MHz; proprietary Medtronic protocol; range up to 6 feet(1.8

Monitor size• Inches•Heightapproximately 2.0 inches•Widthapproximately 3.2 inches• Depth (thickness)approximately 0.77 inches• Centimeters (cm)•Height

Screen item DescriptionBattery: Shows battery condition (how much energy is left in the battery). This alwaysappears.BG meter value: Shows the most re

Guidance and manufacturer's declarationGuidance and Manufacturer's Declaration - Electromagnetic EmissionsThe Guardian REAL-Time system (con

Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Guardian REAL-Time system (consisting of the CSS7100/CSS7100K Receiver and

High and low Glucose Limits (CSS7100) ... 112High and low Glucose Limits (CSS7100K) ...

Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Guardian REAL-Time system (consisting of the CSS7100/CSS7100K Receiver and

Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Guardian REAL-Time is intended for use in the electromagnetic environment s

Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Guardian REAL-Time is intended for use in the electromagnetic environment s

Recommended separation distances between portable and mobile RF communicationsequipment and the Guardian REAL-Time systemThis section provides informa

MiniLink specificationsBiocompatibility MiniLink: Complies with ISO 10993-1 for long-term body contactOperating Conditions MiniLink Temperature: +32°

WarrantyMedtronic MiniMed warrants the Medtronic MiniMed Guardian® REAL-Time Continuous Glucose Monitoring(CGM) System against defects in material and

Icon table Attention: Read all warnings and precautions in instructions for use.Date of manufacture (year - month)ManufacturerBatch codeUse by (year -

Magnetic Resonance (MR) unsafe:System specifications132

Sensor accuracyThe information in this section is meant to be reviewed by you with your healthcare professional. Pleasealso note: The Guardian RT is n

Performance results in adultsThe performance of the Guardian RT in adults was evaluated in a clinical study.3 Guardian RT results werecompared to plas

Glossary ... 155Index ...

Agreement between the matched pair was estimated by evaluating the difference between the GuardianRT reading and the YSI measurement. The difference b

The Clarke Error Grid was used to assess the clinical relevance of the differences between the Guardian RTreadings and the comparative YSI measurement

The plot below is a correlation plot of Guardian RT readings versus readings from the reference method,the YSI 2300 Glucose Analyzer. It is overlaid w

The percent of Guardian RT readings in the previous graph are presented in the following table accordingto the percentage of points falling within eac

Time of dayGlucose Conc (mg/dL)The above chart, Guardian RT device #2 is represented by a solid line, and the Guardian RT device #4 by alight-gray lin

The Low Glucose AlertThe Low Glucose Alert was evaluated for its ability to detect glucose levels at 70 mg/dL (3.9 mmol/L), orbelow, using the YSI 230

high blood glucose can be obtained by setting the High Glucose Alert level lower. For example, setting theHigh Glucose Alert at 190 mg/dL (10.6 mmol/L

As per the stratified Clarke Error Grid analysis above, agreement between Guardian RT values and YSIvalues tends to be less at low and high glucose co

An analysis of the mean percentage of Absolute Relative Error (ARE percentage) and standard deviations,across 12-hour increments of wear periods, appe

The percentage of Guardian RT readings within 20 percent and 30 percent of YSI readings was analyzedaccording to time after sensor insertion and accor

IntroductionThank you for choosing Medtronic Diabetes (legally known as Medtronic MiniMed, Inc.) as your diabetesmanagement partner.Your new Guardian®

Time-Elapsed PlotsThe plot graph below is a representative example of continuous sensor tracing vs. reference blood glucosereading, where sensor showe

The plot graph below is a representative example of continuous sensor tracing vs. reference blood glucosereading, where sensor showed average (typical

The plot graph below is a representative example of continuous sensor tracing vs. reference blood glucosereading, where sensor showed poor performance

Agreement between the matched pair was estimated by evaluating the difference between the GuardianRT reading and the blood glucose meter measurement.

The accuracy of the Guardian RT was also evaluated by calculating the percentage of Guardian RTreadings within 20% and within 30% of the blood glucose

The following figure is a correlation plot of Guardian RT readings versus readings from the referencemethod, the blood glucose meter. It is overlaid w

Stratified Clarke Error Grid AnalysisRange ofComparativeGlucoseReadings(mg/dL)TotalCount A + B A B C D E40-80 360 (13.9%) 201(55.8%)141(39.2%)60 (16.7

low blood glucose can be obtained by setting the Low Glucose Alert level higher. For example, setting theLow Glucose Alert at 90 mg/dL (5.0 mmol/L), i

Sometimes the Guardian RT will alert when the blood glucose levels are not high. When the Guardian RTHigh Alert was set at 250 mg/dL (13.8 mmol/L) in

Appendix A154

Department Telephone number24 Hour HelpLine (calls within the United States) 800.646.463324 Hour HelpLine (calls outside the United States) +1 818 576

Glossary AAdverse reaction - Anunexpected, unpleasant ordangerous reaction to asensor when it is inserted intothe body. An adverse reactionmay be sudd

METER BG BY alert will occurtwo hours before thecalibration is required.Calibrate - Check, adjust, or setto a standard (calibrate yourmonitor).Circums

High Snooze - For the HighGlucose, High Predictive, andRising Rate of change alerts,allows you to set the delaybetween the first alert andany subseque

PPredictive alerts - These alertscan be used so that youreceive alarms before thesensor glucose measurementsreach your glucose limits. Thisalert predi

Sterile gauze - A thin medicalbandage with loose weavethat is free from substancesor germs that could causeinfection.Submerge - To place underwater or

Glossary160

Index Numerics3 hour graph 576 hour graph 5812 hour graph 5924 hour graph 60AA (alarm) condition 90accessoriesCareLink USB 3holster 3leather ca

Bbacklight 13, 14, 16, 88, 97specifications 111bad transmitter battery 92Batt Out Limit alarm 11Batt out limit alarmcondition 90battery 16, 17,

Glucose Alarms 115Glucose Limits 115Glucose Limits 1 115Glucose Limits 2 through8 116High Glucose Limit 116High Snooze 116Language 117Lock Keyp

High Predictive alertcondition 87High Snoozedefault settings 116setting 28High Snooze alarmsetting 28historysensor updates 65How to make glucose

• Sensor — The sensor (MMT-7002/MMT-7003) is a membrane-coveredelectrode inserted through the skin into the fatty layer underneathwith an insertion de

Next Cal 63Normal mode 17OOff no power alarm condition 91on an aircraftentering meter bloodglucose measurements 8OTHER screen 54PPrecautions 7ex

Sensor icon 15Sensor Isig 63SENSOR MENU 18SENSOR ON/OFF screen 25, 36SENSOR READY 2 HRS screen 40SENSOR STATS screen 71, 72sensor status 62Next

Storing the system 99supplies, ordering 3System alarm conditions 90system alarm/alert historyviewing 91system settingsclearing 76, 78restoring 7

Index168

6025254-018C_a

Conventions used in this guideThe conventions used in this guide are defined in the following table.Conventions MeaningPress Push and release the butt

Guardian® REAL-TimeContinuous Glucose Monitoring SystemUser Guide

User safetyThis section includes important safety information such as indications, contraindications, safety warnings,potential adverse reactions, and

The Guardian REAL-Time CGM System (CSS7100K) provides real-time glucose values that allow users totrack patterns in glucose concentrations and to poss

MeterDo not use an RF-capable meter to send blood glucose measurements to your monitor while traveling on anaircraft or if it interferes with another

Damage due to radiationIf you are going to have an X-ray, MRI, diathermy treatment, CT scan, or be exposed to other types ofradiation, REMOVE YOUR MON

These devices generate, use, and can radiate radio frequency energy and may cause interference to radioor television communications, even if installed

RF interference from other devicesCommon consumer electronic devices that transmit in the same frequency band used by the MMT-7703MiniLink transmitter

The basicsCAUTION: Never use sharp objects to press the buttons on your monitor as this can damage thebuttons or compromise the seal on the monitor. S

Battery life varies widely depending on the way you use your monitor. Some of the use factors that affectbattery life include:• the alert type you cho

6 If the HOME screen appears, then go to the next step. If the HOME screen does not appear:a. Make sure that the battery is inserted correctly. If not

Button Description• Accept the selected menu item.• Choose a setting when entering or changing settings.• Open the MAIN MENU from the HOME screen.• Cl

©2006, Medtronic MiniMed, Inc. All rights reserved.This product is covered by U.S. Patents. Other U.S. and/or foreign patents may be pending. Pleasevi

The monitor screenThe screen shows five lines of text at one time. The first is the operating mode. The second is the currentopen menu or function. Th

Battery iconThis icon shows when a battery is installed in the monitor. Thereare four segments in the icon. Each segment representsapproximately 25 pe

Alarm/alert typesYou can set up your monitor to either beep or vibrate when an alarm or an alert occurs. See the nextchapter for details on setting th

The screen shows the name of the alarm and information about how to clear it (press to see theinformation on clearing the alarm). In this example, t

The STATUS screenThe STATUS screen shows any recent activity, the condition of the monitor battery, and which specialfeatures are active, if any.• To

The basics20

Entering your settingsBasic stepsPerform these basic steps in the order shown.1 Make sure that you have installed the battery in your monitor.2 Make s

4Use / to set the correct time and date as follows:a. Set the correct hour, then press ACT.b. Set the correct minutes, then press ACT.c. Set the co

Selecting the languageIf you do not read English, the next step is to change the Language setting so that all text information,alarms, alerts, sensor

Setting your Alarm/Alert TypeYou can set your monitor three different ways to let you know when there is an alarm, alert, or specialconditions or prog

Contacts: Africa:Medtronic Africa (Pty) Ltd.Tel: +27 (0) 11 677 4800Australia:Medtronic Australasia Pty. Ltd.Tel: 1800 668 670 (product orders)Tel: 18

Turning on the sensorThe sensor must be turned on, started and initialized to report glucose measurements.1 Open the EDIT SETTINGS screen.MAIN MENU &g

Setting the Glucose LimitsAfter you turn the Glucose alerts On, then you need to set the high and low Glucose Limits recommendedby your healthcare pro

12:00 AM 9:00 AM12:00 AMGlucose Limits 1High Glucose Limit: 240 mg/dL (13.3 mmol/L)Low Glucose Limit: 60 mg/dL (3.3 mmol/L)12:00 AM - 9:00 AM(9 hour

10 Select your Low Glucose Limit. The available range is:• 40 to 390 mg/dL (2.2 to 21.6 mmol/L) for CSS7100• 90 to 390 mg/dL (5.0 to 21.6 mmol/L) for

4 Press ACT. The EDIT SETTINGS screen shows that the High Snooze is set.Setting the Low SnoozeAfter you receive and clear a Low Glucose, Fall Rate of

4 Select the Time Sensitivity (how many minutes before you reach your Low Glucose Limit).•Range:5 to 30 minutes (0:05 to 0:30)• Increments:5 minutes5

3 Select the Fall Rate Limit.•Range:mmol/L/minmg/dL/minfrom 0.061 to 0.277from 1.1 to 5.0• Increments:mmol/L/minmg/dL/min0.0050.14 Press ACT. The SET

12:00 A 4:00 A8:00 A 12:00 P4:00 P 8:00 P12:00 A4003502802101407040mg/dL (mmol/L)AUC High Average = 30 mg/dL (1.7 mmol/L) AUC Low Average = 3.9 mg/

Setting the Alarm SnoozeAfter you receive and clear a METER BG NOW alert, the monitor will repeat the alert until you enter a newmeter blood glucose m

Entering the transmitter identification numberThe Transmitter ID starts with 2 and is found on the flat side of your transmitter. You must enter thetr

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4 Press ACT. The EDIT SETTINGS screen shows the length of time you entered for the Missed Dataoption.Setting the sensor glucose graph timeoutThe senso

4 Save your settings after you have set your preferences so that you can restore the settings you havesaved if you receive an alarm/alert or error tha

Setting up your transmitter and sensorBasic stepsAfter you have set up your monitor, there are a few basic steps that you must complete to set up your

2 Insert a new AAA or LR-03 battery with the flat (-) end first. Make sure that youalign the small bumps on the battery cap with the small notches in

green light4 When charging is complete, the green light on the charger will stay on, without flashing, for 15 to20 seconds and then turn off.5 After t

3 Hold the transmitter as shown. Line up the two notches on the transmitter withthe side arms of the sensor. The flat side of the transmitter should f

Entering the first meter blood glucoseYou cannot enter a meter blood glucose (meter BG) measurement into your monitor until you receive aMETER BG NOW

Setting up your transmitter and sensor42

Meter optionAbout metersBayer's CONTOUR® NEXT LINK Wireless Meter (Model No. 6201/9624), the LifeScan OneTouch® UltraLink®meter, or the BD Paradi

Meter rules If you want your monitor to communicate with the meter, the following conditions must apply:1 The meter option must be turned on and progr

Österreich:Medtronic Österreich GmbHTel: +43 (0) 1 240 44-024 – Stunden – Hotline: 0820 820 190Česká republika:Medtronic Czechia s.r.o.Tel: +420 233 0

Reviewing meter IDsa. Select Review ID, then press ACT.b. The programmed IDs will show in the REVIEW METER ID screen.4Exit the menus when you are done

Meter option46

Using your systemCalibrating your systemCalibrating your system helps to make sure that the glucose readings from the sensor are as accurate andreliab

What are the best times to calibrate the system?It is suggested that you calibrate your system at the following times:•Before meals• Before going to b

Time since last calibration What happens• The system will not take glucose measurements again until you enter anew Meter BG measurement. To calibrate

Capturing EventsThe Capture Event feature allows you to electronically save certain types of information that is used withMedtronic CareLink Personal

4 Make sure that the number shown on the screen is correct.• If the information is correct, press ACT.• If the information is not correct, select No,

6 Make sure that the type and amount of insulin shown on the screen is correct.• If the information is correct, press ACT. The information you entered

6 If the number on the screen is correct, press ACT. The information you entered is saved and can beused in reports. If the information is not correct

Entering Other markersThis section shows you how to enter markers other than Enter BG, Insulin Marker, Meal Marker, or ExerciseMarker. When you enter

• Reconnect old sensor (two hours).• A meter BG entry is needed for calibration.Two other conditions also prevent a real-time SG value and generate a

The graphsAll graphs show High and Low Glucose Limits lines, a real-time SG measurement line, a data section, andthe cursor (flashing vertical line).

Examples of real-time sensor glucose graphsThe following pages show examples of the different graph types.3 hour graphEach part of the graph between t

6 hour graphEach part of the graph between the vertical dashed lines represents one hour. In this example, theselected SG measurement was taken at 1:1

12 hour graphEach part of the graph between the vertical dashed lines represents one hour. In this example, LOSTSENSOR is the reason no measurement is

24 hour graphEach part of the graph between the vertical dashed lines represents six hours. The shaded area helps youmore easily see the sensor glucos

How to check for rapid changes in sensor glucoseIf your sensor glucose (SG) rises or falls faster than a certain rate, Rapid Change arrows automatical

Checking the status of the systemThe system allows you to check its status (condition) in the following areas:• Condition of the batteries.• The age o

Status DescriptionNext Cal Shows when your next calibration is due.Sensor Age The total number of days and hours that the sensor has been used.Sensor

How to make glucose alerts silentThe Alert Silence feature allows you to make glucose alerts silent for a preset amount of time between30 minutes and

ContentsChapter 1: Introduction ... 1Assistance ...

5 Select the alert silence option you want, then press ACT. The SET DURATION screen flashes one of thefollowing:• A set of dashes (if this is the firs

Viewing your current settingsYou can review your current settings at any time. This is useful for making sure that you use the correctsettings when tr

Removing the sensorGently pull the sensor from your body to remove it. Place it in a sharps container.Using your system in waterYour monitor is NOT wa

Using your system68

UtilitiesThe data management featureThe system keeps a daily record of the following types of information for up to 31 days:• Daily totals — Daily tot

Sensor glucose informationThe following table lists the different types of SG information that the system automatically records. TheSG information is

Item DescriptionBG Average The average meter blood glucose measurement.Number BGs The total number of meter blood glucose measurements taken.Meter L/H

2 Press ACT. The DAYS TO AVERAGE screen flashes the number of days you selected the last time youused this feature.3 Select the number of days that yo

Reviewing your current Alarm Clock remindersThis procedure shows you how to view your current Alarm Clock reminders. The dashes in this exampleshow th

The Block featureWhen this feature is turned on, anyone who may have access to your monitor cannot set or change any ofyour settings. The only feature

The monitor screen ... 15The HOME screen ...

The Lock Keypad featureLock Keypad prevents accidental keypad presses. When the keypad is locked, you can still press ESC toview the STATUS screen, th

3 Press ACT. The system automatically runs the Selftest in the following order:a. Screen Test:The screen appears all black.b. Selftest:The monitor cou

3 Press ACT. If you have saved your settings before, then a message shows the last time you saved yoursettings and asks if you want to overwrite them.

Clearing your settingsUse this utility only if you want to clear your current monitor settings and restore the system defaultsettings.CAUTION: Do not

Viewing your User Settings historyThis feature allows you to view your most recent User Settings operations. The system can store up to 20User Setting

Utilities80

Therapy management softwareMedtronic provides software to optimize your monitor use. Contact our 24 Hour HelpLine for moreinformation.CareLink® Person

You can share your reports with your healthcare professional. These reports can help you and yourhealthcare professional to discover trends and other

Troubleshooting and alarms/alertsAbout alarms and alertsTo receive the full benefits of your Guardian REAL-Time CGM System, all parts of the system mu

Follow these steps when you get an alarm or alert: To view the alarm/alert:1 From the HOME screen, review the alarm/alert by pressing any button to se