Guardian Sensor (3) - Medtronic Diabetes

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Guardian Sensor (3)User Guide

EnglishIntroductionThe Guardian Sensor (3) glucosesensor is part of your ContinuousGlucose Monitoring (CGM) system.The sensor continuously converts tinyamounts of glucose from the interstitialfluid under your skin into an electronicsignal. Your system then uses thesesignals to provide sensor glucosevalues.ABCDA. pedestalB. needlehousingC. sensorD. clear linerPotential risks related to sensor useGeneral risks with sensor use include: Skin irritation or other InfectionRaised bumpAppearance of a small “freckle-like” dot where needle wasinsertedAllergic reactionFainting secondary to anxiety or fear of needle insertionSoreness or tendernessSwelling at insertion siteSensor fracture, breakage or damageMinimal blood splatter associated with sensor needle removalResidual redness associated with adhesive or tapes or bothScarringIndications for useThe Guardian Sensor (3) is intended for use with the MedtronicMiniMed 670G system to continuously monitor glucose levelsin persons with diabetes. It is intended to be used for detectingtrends and tracking patterns in persons aged fourteen yearsand older, and to be used by the MiniMed 670G system toautomatically adjust basal insulin levels. It is indicated for useas an adjunctive device to complement, not replace, information-1-

obtained from standard blood glucose monitoring devices. Thesensor is intended for single use and requires a prescription. TheGuardian Sensor (3) is indicated for 7 days of continuous use.ContraindicationsNone known.AssistanceDepartmentTelephone Number24 Hour HelpLine (callswithin the United States)800 646 463324 Hour HelpLine (callsoutside the United States) 1 818 576 5555Websitewww.medtronicdiabetes.comGeneral warningsRead this entire user guide before attempting to insert the sensor.The one-press serter (MMT-7512) does not work the same asother Medtronic insertion devices. Failure to follow directions orusing a different serter may result in improper insertion, pain, orinjury.The Guardian Sensor (3) was developed for use with and theperformance evaluated with the approved system only. The sensorshould not be used as part of unapproved systems, as it mayprovide inaccurate sensor glucose readings.The sensor is designed to work with approved transmitters only.It is not interchangeable with transmitters and recorders thatare not compatible with the sensor. Connecting your sensor to atransmitter or recorder that is not approved for use with the sensormay cause damage to the components or inaccurate sensorglucose values.Do not make therapy decisions based on sensor glucose valuesbecause sensor glucose and blood glucose (BG) values maydiffer. If your sensor glucose reading is low or high, or if you feelsymptoms of low or high glucose, do the following prior to makingtherapy decisions. Confirm your blood glucose with your meterusing a fingerstick blood sample.Taking medications with acetaminophen, such as Tylenol , feverreducers, or cold medicine, while wearing the sensor may falselyraise your sensor glucose readings. The level of inaccuracydepends on the amount of acetaminophen active in your bodyand may be different for each person. Always check the label of-2-

any medications to confirm whether acetaminophen is an activeingredient.Do not expose your sensor to MRI equipment, diathermy devices,or other devices that generate strong magnetic fields as theperformance of the sensor has not been evaluated under thoseconditions and may be unsafe. If your sensor is inadvertentlyexposed to a strong magnetic field, discontinue use and contactthe 24 Hour HelpLine for further assistance.A retractable needle is attached to the sensor and minimalblood splatter may occur. If you are a healthcare professionalor caregiver, wrap sterile gauze around the sensor to minimizecontact with blood. Keep as much distance as possible betweenyou and the patient when removing the needle.Keep the needle housing within sight at all times to avoid anaccidental needlestick or puncture.Always inspect the packaging for damage prior to use. Sensorsare sterile and non-pyrogenic, unless the package has beenopened or damaged. Do not use the sensor if the sterile packagehas been opened or damaged. Use of an unsterile sensor cancause site infection.This product contains small parts and may pose a choking hazardfor children.Watch for bleeding at the insertion site (under, around, or on top ofthe sensor).If bleeding occurs, do the following:1. Apply steady pressure, using sterile gauze or a clean clothplaced on top of the sensor, for up to three minutes. The use ofunsterile gauze can cause site infection.2. If bleeding stops, connect the transmitter (or recorder) to thesensor.If bleeding does not stop, do not connect the transmitter to thesensor because blood can get into the transmitter connector,and could damage the device.If bleeding continues, causes excessivepain or discomfort, or is significantly visiblein the plastic base of the sensor, do thefollowing:1. Remove the sensor and continue to applysteady pressure until the bleeding stops.Discard the sensor in a sharps container.-3-plastic base

2. Check the site for redness, bleeding, irritation, pain,tenderness, or inflammation. Treat based on instructions fromyour healthcare professional.3. Insert a new sensor in a different location.General precautionsWash your hands with soap and water before inserting the sensorto help prevent site infection.Wear gloves when inserting the sensor into someone other thanyourself to avoid contact with patient blood.Do not insert the sensor through tape. Inserting the sensor throughtape may cause improper sensor insertion and function.Only use alcohol to prepare the insertion site, to ensure thatresidue is not left on the skin.Rotate the sensor insertion site so that sites do not becomeoverused.Discard used sensors and needle housings in a sharps containerafter each use to avoid accidental needlestick or puncture.Do not clean, resterilize, or try to extract the needle from theneedle housing. An accidental needlestick or puncture may occur.Do not reuse sensors. Reuse of a sensor may cause damage tothe sensor surface and lead to inaccurate glucose values, siteirritation, or infection.Where to insert the sensorCAUTION: Avoid the 2 inch (5.0 cm) area around the navelto help ensure a comfortable insertion site and to help withsensor adhesion.Choose an insertion site that has an adequateamount of subcutaneous fat. Shown hereare the best body areas (shaded) for sensorinsertion.-4-

Do not insert the sensor in muscle or areas constrained byclothing or accessories, areas with tough skin or scar tissue, sitessubjected to rigorous movement during exercise, or in sites undera belt or on the waistline for best sensor performance and to avoidaccidental sensor removal.Removing the sensorWhen you are ready to change your sensor, disconnect thetransmitter from the sensor as described in your transmitter userguide. Gently pull the sensor from your body to remove it. Placethe sensor in a sharps container.ReagentsThe sensor contains two biological reagents: glucose oxidase, andhuman serum albumin (HSA). Glucose oxidase is derived fromAspergillus niger and manufactured to meet industry requirementsfor extraction and purification of enzymes for use in diagnostic,immunodiagnostic, and biotechnical applications. The HSA usedon the sensor consists of purified and dried albumin fraction V,derived from pasteurized human serum which is cross-linkedvia glutaraldehyde. Approximately 3 μg of glucose oxidase andapproximately 10 μg of HSA are used to manufacture each sensor.HSA is approved for IV infusion in humans at quantities muchlarger than in the sensor.Storage and handlingCAUTION: Do not freeze the sensor, or store it in directsunlight, extreme temperatures, or humidity. These conditionsmay damage the sensor.Only store sensors at room temperature between 36 F to 80 F(2 C to 27 C).Discard sensor after the “Use by date” indicated on the label, if thepackage is damaged, or the seal is broken.Sensor life of useThe sensor can be used one time, and it has a maximum life of170 hours (seven days). The 170-hour life span of the sensorbegins when the sensor is connected to the transmitter.-5-

ComponentsABCABOne-press serterA. bump on both buttonsB. thumbprint markingGlucose sensor assemblyA. pedestalB. needle housingC. sensorD. clear linerDASensor baseA. sensor connectorB. sensor snapsBTransmitterABCTape and sensor componentsA. adhesive tabB. sensor baseC. oval tape-6-

Inserting the sensorWARNING: Wear gloves when inserting the sensor intosomeone other than yourself to avoid contact with patientblood. Minimal bleeding may occur. Contact with patientblood can cause infection.11. Wash your hands.22. Choose an insertion site on theabdomen that has an adequateamount of fat.33. Clean the insertion site withalcohol. Let the area air dry.44. Open the sensor package.-7-

55. Hold the pedestal and remove theglucose sensor assembly from thepackage. Place the pedestal on aflat surface.Note: The pedestal and glucosesensor assembly are the establisheddefinitions in the component table.6. Make sure that theadhesive tab of thesensor is tuckedunder the sensorconnector and sensorsnaps.67. Holding sertercorrectly7Place your thumbon the thumbprintmarking to holdthe serter withouttouching the buttons.Holding serterincorrectlyYour fingers shouldnot be touching thebuttons.-8-

8a8a–8b. Grip the serter, placing yourthumb on the thumbprintmarking, without holdingthe buttons. Carefully pushthe serter down onto thepedestal until the base of theserter sits flat on the tableand you hear a click.8b9a9b9a. To detach the serter from thepedestal, place the thumb of onehand on the thumbprint markingand grip the serter withouttouching any buttons. With yourother hand, place two fingers onthe pedestal arms.9b. Slowly pull the serter straightup without holding the buttons.Do not detach the pedestal fromthe serter in midair, as this mightdamage the sensor.Note: The arrow on the side of theserter aligns with the needle insidethe serter.-9-

WARNING: Never point a loaded serter toward any body partwhere insertion is not desired. An accidental button-push maycause the needle to inject the sensor in an undesired location,causing minor injury.10a. Hold the serter steady againstyour cleaned insertion site,without pushing the serter toodeeply into your skin.10aNote: Failing to hold the sertersecurely flat against your body duringinsertion may let the serter springback after pressing the buttons, andresult in improper insertion of thesensor.10b10d10e10b-10c. Press andrelease the bumpon both buttons atthe same time, whileholding the serter flatagainst your body.10c10d. Continue holding the serter flatagainst your body for at leastfive seconds to let the adhesivestick to your skin.10e. Slowly lift the serter away fromyour body, making sure that thebuttons are not pressed.- 10 -

If you inserted the sensor into yourself, complete step 11a. If youare a healthcare professional or caregiver who inserted the sensorinto a patient, complete step 11b.11aPatient:11a. Gently hold the sensorbase against the skin atthe sensor connector andthe opposite end of sensorbase. Hold the needlehousing at the top andslowly pull straight out,away from the sensor.OR11bHealthcare professional orcaregiver:11b. Wrap sterile gauze aroundthe sensor (as shown inimage 11b). Gently holdthe sensor base againstthe skin at the sensorconnector and the oppositeend of sensor base. Holdthe needle housing at thetop and slowly pull straightout, away from the sensor.WARNING: Watch for bleeding at the insertion site. If bleedingoccurs under, around, or on top of the sensor, apply steadypressure using sterile gauze or a clean cloth placed on top ofthe sensor for up to three minutes. The use of unsterile gauzecan cause an infection. If bleeding does not stop, remove thesensor and apply steady pressure until the bleeding stops.- 11 -

Note: Medtronic adhesives are pressure-sensitive. Pressingthe adhesive against the skin ensures that the sensor remainsadhered to the skin throughout the wear period.Note: After insertion, useof adhesive productssuch as Skin Tac inaddition to the tapeis optional. If optionaladhesive products areused, apply to the skinunder the adhesivepad prior to removingthe liner. It can also beapplied to the adhesivepad or the skin aroundthe sensor base. Allowfor product to dry.12a12b13a12a. Hold the sensor in place and gentlyremove the adhesive liner fromunder the adhesive pad. Do notremove the adhesive liner from therectangular adhesive tab. This tabwill be used to secure the transmitterin a later step.12b. Firmly press the adhesive padagainst the skin to make sure thatthe sensor remains adhered to theskin.13a. Untuck the adhesive tab from underthe connector.- 12 -

13b13b. Straighten the sensor adhesive tabso that it lies flat against the skin.Applying Oval Tape121. Remove liner 1 and liner 2.2. Apply the tape as shown andpress down firmly.Wide part of tape covershalf of sensor base.33. Remove liner 3 from each side.- 13 -

454. Smooth the tape.5. Connect the transmitter to thesensor.Note: Wait for the green light onthe transmitter to flash. If the greenlight does not flash, refer to theTroubleshooting section of yourtransmitter user guide.66. Cover the transmitter with theadhesive tab.Note: Do not pull the tab too tightly.77. To apply a 2nd tape, removeliner 1 and liner 2.- 14 -

8. Apply the 2nd tape in theopposite direction to thefirst tape and place it on thetransmitter. Press down firmly.8Wide part of tape covers endof transmitter and skin.9. Remove liner 3 from each side.910. Smooth the tape.10Note: Be sure to regularly checkyour sensor site. If the device is notsecure, apply an additional off-theshelf adhesive.1111. For details on how to enteryour sensor settings into yourpump or monitor, refer to thecorresponding user guide.MiniMed XXXGXxxx XxxxxxxIcon tableUse by date- 15 -

Do not reuse(1x)One sensor per container/package(5x)Five sensors per container/package(2x)Two tapes per package(10x)Ten tapes per packageConsult instructions for useCatalogue or model numberBatch codeSterilized using irradiationTemperature limitOpen hereManufacturerPrescription onlyDo not resterilizeFragile, handle with careKeep dryRecycle cardboard, paper, plastic packaging suppliesand unwanted written material.Magnetic Resonance (MR) unsafe: keep away frommagnetic resonance imaging (MRI) equipment.Non-pyrogenic - Does not contain endotoxins. 2016 Medtronic MiniMed, Inc. All rights reserved.MiniMed and Guardian are trademarks of Medtronic MiniMed, Inc.Skin Tac is a trademark of Torbot Group, Inc.Tylenol is a registered trademark of Johnson & Johnson consumer Inc.- 16 -

MMT-70206026096-011 a

Discard sensor after the “Use by date” indicated on the label, if the package is damaged, or the seal is broken. Sensor life of use The sensor can be used one time, and it has a maximum life of 170 hours (seven days). The 170-hour life span of the sensor begins when the sensor is connected to the transmitter.

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USA: Medtronic Diabetes Global Headquarters Tel: 1-800-646-4633 24 Hour HelpLine: 1-800-826-2099 To order supplies: 1-800-843-6687 Ukraine: Med EK Service Ltd. Tel: 380 44 545 7705 United Kingdom: Medtronic Ltd. Tel: 44 1923-205167 Österreich: Medtronic Österreich GmbH

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Medtronic Diabetes Global Headquarters Tel: 1-800-826-2099 24 Hour HelpLine: 1-818-576-5555 To order supplies: 1-800-843-6687 United Kingdom: Medtronic Ltd. Tel: 44 1923-205167 Yisrael: Agentek Tel: 972 3649 3111 Österreich: Medtronic Österreich GmbH Tel: 43 (0) 1 240 44-0 24 – Stunden – Hotline: 0820 820 190 Česká republika .