Instructions For Use - Preventice

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Instructions for Use0086This IFU document is available in other languages upon request.

Hereby, Preventice declares that this remote monitoring device isin compliance with the essential requirements and other relevantprovisions of Directive 1999/5/EC. The declaration of conformity isavailable at:3605 Hwy 52 NRochester, MN 55901USA

QUESTIONS AND CONCERNSProper use of this device requires training provided byyour health care provider.If you have questions or encounter problems while youare using the BodyGuardian Heart Remote MonitoringSystem, contact your health care provider.Use this space to write down the name andphone number of your health care provider.Health care providerPhone numberCONFIDENTIAL AND PROPRIETARYThe information contained in this document is confidential andproprietary to Preventice Technologies, Inc. This document may not bedisclosed, copied, or distributed in any form to any third party withoutwritten permission of Preventice Technologies, Inc.BodyGuardian Heart Remote Monitoring System is a registeredtrademark of Preventice Technologies, Inc.Copyright Preventice Technologies, Inc.December 2018All rights reserved.LA1001-DLL-60003-R i

ContentsBodyGuardian Heart kitAbout BodyGuardian Heartiv1How BodyGuardian Heart worksGetting started34Before you beginBegin using BodyGuardian HeartUsing the smartphone4511Keep the smartphone with youCharge the smartphone nightlyIf the touch screen dimsSmartphone displayRecording symptoms1111121217ManuallyAutomaticallySelecting your symptoms181819Switching monitors with Strips20Removing a monitor from the StripAttaching a charged monitor to the StripReplacing the StripSwitching monitors with a BaseRemoving a monitor from the BaseAttaching a charged monitor to the BaseReplacing the electrodesDaily usage2222232324Showering, bathing, or swimmingTraveling on aircraftUndergoing an MRICleaning the monitorStoring the monitor and charging cradleii2020212424252525BodyGuardian Heart Instructions for Use

BodyGuardian Heart monitor lightsIndications for UseIntended UseWarnings / PrecautionsAppendix A: Specifications & symbolsAppendix B:Electromagnetic environmentIndex262728293133FiguresFigure 1. BodyGuardian Connect smartphoneFigure 2. BodyGuardian Heart Remote Monitoring SystemFigure 3. Monitor on StripFigure 4. Monitor alignment on BaseFigure 5. Monitor on Base with electrodesFigure 6. Monitor orientation on chestFigure 7. Smartphone – home screenFigure 8. BodyGuardian Connect – status screenFigure 9. Monitoring statusFigure 10. Selecting symptomsContents23667812141619iii

BodyGuardian Heart kitBodyGuardian Heartmonitors (2)Note: Your monitors maybe white or black.Both versions operateidentically.BodyGuardianConnect smartphonemonitor charging cradle /power cord with adaptersmartphone chargerYour health care provider will supply you with either:BodyGuardian StripsBodyGuardian BaseBaseStripsstandard ECG electrodesivBodyGuardian Heart Instructions for Use

About BodyGuardian Heart1BodyGuardian Heart Remote Monitoring System is awearable, remote cardiac monitoring system prescribed byyour health care provider. Wearing BodyGuardian Heart allowsyour doctor to measure your electrocardiography (ECG) data,as well as other physiological information, such as breathingrate, heart rate, and activity level.BodyGuardian Heart includes the following components:BodyGuardian Heart monitors2 – monitors1 – charging cradle1 – charging cradle power cord with adapterBodyGuardian Connect smartphone1 – cellular smartphone1 – chargerStrips or Base and standard ECG electrodes(supplied by your health care provider)BodyGuardian Heart does not summon physiciansor emergency assistance (911 US, 112 EU, 000 AU)and does not replace direct communication with yourhealth care providers.WarningUse only the approved power cords supplied with thesystem when charging the monitors and smartphone.All BodyGuardian Heart components must comply withrelevant IEC or ISO safety standards.About BodyGuardian Heart1

BodyGuardian Connect smartphone referenceBodyGuardian Connect is configured to work as acomponent of BodyGuardian Heart. It cannot be used tomake phone calls, including calls to 911 (US), 112 (EU),000 (AU), or perform other smartphone functions.Power / Lock keyPhone batteryCellular signal strengthTouch screenVolume keyPhone keys (disabled)Note:The phone keys aredisabled for use withBodyGuardian Heart.Power connectorFigure 1. BodyGuardian Connect smartphone2BodyGuardian Heart Instructions for Use

How BodyGuardian Heart worksThe complete BodyGuardian Heart Remote MonitoringSystem, as shown in Figure 2, consists of components tomonitor and collect your physiological data. That data is sentover the Internet and stored in secure databases, available tobe accessed and reviewed by your health care professionals.cellularPatientMonitor on chestcommunicateswith smartphone.InternetSecure databaseSmartphone sendscardiac data tosecure databaseservers.DoctorDoctor viewspatient data viasecure Internetconnection.Figure 2. BodyGuardian Heart Remote Monitoring SystemAbout BodyGuardian Heart3

2Getting startedThis chapter will help you set up and start wearingBodyGuardian Heart for the first time.Before you beginBefore you begin wearing BodyGuardian Heart: Allow time for BodyGuardian Heart and all accessories toreach operating temperature (10 to 45 C). Charge your devices, and, if necessary, shave the chestlocation where you will wear the monitor. Use the following instructions to guide you.Charge the smartphonePlug the phone charger into the smartphone and a wall outlet.The phone is fully charged when the battery indicator on thephone screen is completely green.charging4fully chargedBodyGuardian Heart Instructions for Use

Charge one of the monitorsYou must fully charge one of the two monitors before youbegin wearing the device:1. Plug the monitor charger into the charging cradle and apower outlet.2. Snap one of the monitors into the cradle.Tip: The snaps aren’t evenly spaced. The three monitorlights should be adjacent to the power cord that isplugged into the charging cradle.chargingfully charged3. Allow the monitor to charge completely. All lights willgo out when it is fully charged.Charging a monitor just out of the kit can takeapproximately 2-3 hours.Begin using BodyGuardian HeartYou are now ready to begin using BodyGuardian Heart.?Do you have Strips or the Base?Your health care provider has supplied you with eitherBodyGuardian Strips or a BodyGuardian Base (with standard ECGelectrodes). Follow the instructions applicable to your equipment.StripGetting startedBase5

This section is for STRIP patients onlyAttach charged monitor to StripBe sure you are using a fully-charged monitor.1. Line up the monitor and Strip, as shown in Figure 3.Figure 3. Monitor on StripTip: The snaps aren’t evenly spaced. The orientation ofthe logo on both the monitor and the Strip must be thesame.2. Press firmly so all four snaps are connected.This section is for BASE patients onlyAttach charged monitor to BaseBe sure you are using a fully-charged monitor.1. Line up the monitor and Base, as shown in Figure 4.Tip: The snaps aren’tevenly spaced. Theorientation of the logoon both the monitorand the Base must bethe same.Figure 4. Monitor alignment on Base2. Press firmly so all four snaps are connected.6BodyGuardian Heart Instructions for Use

3. Snap the electrodes to the Base.Figure 5. Monitor on Base with electrodesPrepare your skin If hair is present on the chest location identified by yourhealth care provider, shave the area.Clean the area with soap and water or an alcohol wipe.Dry your skin completely.Do not apply anything to your skin, such as lotions, oils,sprays.Do not apply BodyGuardian Heart over open wounds,lesions, infected or inflamed areas. Apply only tointact, clean skin. If you have known skin allergies orhypersensitivities to adhesives, consult your doctor.Getting started7

Attach BodyGuardian Heart to your chest1. Peel away the adhesive backing on the Strip or Baseelectrodes.2. Place the monitor on your chest in one of the placementoptions shown at right.3. Whether you wear the monitor horizontally or vertically,one of the arrows should be pointing up (Figure 6).HorizontalVerticalFigure 6. Monitor orientation on chest4. For Strip users, apply finger pressure over the gel padson the Strip to achieve a tight, smooth connection withthe skin. It may take a minute or so to form a goodconnection with the skin and contours of the chest.Gel pads8BodyGuardian Heart Instructions for Use

Important Avoid placement over thick muscle and fatty tissue.Preferred placement options (vertical) Offset slightly to your left side, closer to your heart.RightLeftRightLeftYou can angle this placement up to 30 clockwise fromtrue vertical to avoid muscle, fat, and bra.0 AngleOrientation30 Do not exceed 30 clockwise from verticalAlternate placement options (horizontal) Two fingers below the collarbone.RightLeftRightLeftYou can angle this placement up to 30 clockwise fromtrue horizonal to avoid muscle, fat, and bra.AngleOrientation30 0 Do not exceed 30 counterclockwise from horizontalGetting started9

Examples of incorrect placementToo far toright side ofchestToo low, toofar to leftside of chestToo lowToo lowPower on the monitor1. Press and release the center button on the monitor.Do not hold the button down.2. The green center light on the monitor will remain lit orblinking once it has powered on.3. Firmly snap the second monitor into the plugged-incharging cradle to begin charging. The amber batterylight will come on.Link monitor to the smartphone1. Press and hold the Power / Lock keyto turn on the smartphone. ThePower / Lock key is located in one oftwo locations, depending on themodel of your phone.2. Once you turn on the smartphone, you will beprompted to view a series of screens that assist you ingetting the monitor set up and attached to your chest.3. After you have completed the setup screens and tapFinish, the smartphone will automatically connect to themonitor on your chest. This may take up to 2 minutes.Tip: Stay within 3 feet of the phone, remain still, andwatch the smartphone for contact errors.10BodyGuardian Heart Instructions for Use

Using the smartphone3The BodyGuardian Connect smartphone is specificallyconfigured to work with BodyGuardian Heart. It cannotbe used make phone calls, including calls to 911 (US),112 (EU), and 000 (AU), or perform other functionsoutside of the BodyGuardian Heart.Keep the smartphone with youIt is best to keep the phone in the same room with you whenwearing the monitor.If you are away from the smartphone or the smartphonebattery drains:The monitor will continue to collect your data andautomatically send it to the smartphone when thesmartphone is available again.If the smartphone goes out of cellular network range:The monitor will continue to collect your data. Once thecellular network is available again, your smartphone willautomatically send your cardiac data to your health careprovider.Charge the smartphone nightlyPlug your smartphone into the charger near your bed eachnight before you go to sleep.1. If you don’t want to be disturbed by alerts whilesleeping, tap Do Not Disturb on the smartphone.2. Leave the smartphone on.3. Plug the smartphone into the plugged-in smartphonecharger in your bedroom.Continue wearing the monitor while the smartphone charges.Using the smartphone11

If the touch screen dimsEven when the smartphone is collecting data, the smartphoneturns off the touch screen when you do not use the phone fora specified period. If you need to turn on the screen, press thePower/Lock key on the right edge of the smartphone.Smartphone displayThe smartphone has a dedicated interface to help you monitorsystem status, record symptoms, and understand indicatorlight symbols.Smartphone – home screenThe smartphone home screen (Figure 7) is displayed when youpower on or wake your phone.Figure 7. Smartphone – home screen12BodyGuardian Heart Instructions for Use

Monitoring StatusTap to view monitor status and battery level, strength ofskin contact with Strip or Base, as well as current heart rate,breathing rate, and activity level.PauseTap to temporarily suspend the collection of data from themonitor. This can be used when you need to remove themonitor for a short time.Example uses: When showering, bathing, or swimming While undergoing an MRIDo Not DisturbTap to turn off sound and vibration alerts associated withthe BodyGuardian Connect status monitors.Example uses: Before you go to bed While attending churchMy TasksTap to access screens to record weight, blood pressure,and monitor chest placement.Help & SettingsTap to display information to help you use BodyGuardianHeart. This button does NOT call for medical help.Using the smartphone13

BodyGuardian Connect – status screenThe BodyGuardian Connect status screen (Figure 8) displays: Monitor status and battery levelStrength of skin contact with Strip or Base electrodesCurrent heart rate, breathing rate, and activity levelBackStatus barMonitor toggleContact strengthMonitor batteryindicatorHeart RateBreathing RateActivity LevelNote: These are optionalfeatures that may notbe activated for you.Figure 8. BodyGuardian Connect – status screenThe information on this screen refreshes automaticallyevery 60 seconds.14BodyGuardian Heart Instructions for Use

BackTap to return to the previous screen.Status barDisplays the current status of the displayed monitor.Monitor toggleTap to view your other monitor. Allows you to view thestatus of your other monitor while it is in the cradledownloading, for example.Contact strengthDisplays the strength of the ECG signal. A strongconnection between the Strip or Base electrodes andyour skin is necessary for the monitor to read your ECGinformation. To achieve strong contact: All four monitor snaps must securely fasten the monitorto the Strip or Base. For Base users, the standard ECG electrodes must besecurely snapped to the Base. The Strip or Base electrodes must be securely attachedto chest.Monitor BatteryDisplays the current battery level of the monitor.Heart Rate(optional feature, may not be activated)Displays your heart beats per minute.Breathing Rate(optional feature, may not be activated)Displays your number of breaths per minute.Activity Level(optional feature, may not be activated)Displays a relative characterization of your physical activityon a scale of 1-100.Using the smartphone15

Monitoring statusThe status bar displays the monitor status.Status barFigure 9. Monitoring statusPossible statuses are:MonitoringBodyGuardian Heart is monitoring your cardiac informationnormally.SearchingThe phone is actively looking for a monitor. It is possiblethat both monitors are powered off or the monitor is out ofrange.ConnectingThe phone has found a monitor that is powered on and isestablishing contact.Re-connectingThe phone is re-establishing contact with the monitor.Checking contactBodyGuardian Connect is checking to see if contact isstrong enough to begin a monitoring session.ConnectedBodyGuardian Connect has established contact with amonitor and will begin monitoring momentarily.Downloading dataThe phone is downloading your cardiac data from themonitor.Not availableThe monitor is not in use. BodyGuardian Heart is activelymonitoring with another monitor.16BodyGuardian Heart Instructions for Use

Recording symptoms4This chapter describes the symptoms function. Thisfeature may not be activated for you by your healthcare provider.If you experience any symptoms – such as trouble breathing,dizziness, or racing heartbeat – while wearing the monitor,it can be useful for your doctor to be able to identify whenyou experienced them. This allows your doctor to assess yourcardiac information during the time you were feeling particularsymptoms.When symptoms occur, you will be prompted on yourBodyGuardian Connect smartphone to select the symptomsyou were feeling at that time.There are two types of triggers that will prompt you to selectand record your symptoms:ManualYou click the center button on the monitor on your chestwhen you are feeling symptoms.AutomaticThe monitor automatically detects that you may beexperiencing cardiac symptoms, even something mild.Recording symptoms17

ManuallyYour doctor may ask you to keep track of certain symptoms,such as dizziness or racing heartbeat. When you feel any ofthese symptoms:1. Press and release the button in the center of themonitor.2. BodyGuardian Heart will record and send yourcardiac information to your care team. This helpsthem understand your symptoms and review yourinformation.BodyGuardian does not summon physicians oremergency assistance (911 US, 112 EU, 000 AU) anddoes not replace direct communication with yourhealth care providers.AutomaticallyAs BodyGuardian Heart monitors your cardiac information,it detects when you may be experiencing important cardiacevents, even mild ones.If this occurs, your BodyGuardian Connect smartphone willautomatically prompt you to select the symptoms you arefeeling at that time.18BodyGuardian Heart Instructions for Use

Selecting your symptomsWhen your BodyGuardian Connnect smartphone prompts you,either manually or automatically, select all of the symptomsyou are feeling at the time (Figure 10).TipScroll to see the entirelist of symptoms.Figure 10. Selecting symptomsIf you accidentally click the monitor button and are not feelingany symptoms, select:No symptomsRecording symptoms19

Switching monitors withStrips?5Do you have Strips or the Base?This chapter applies to patients with BodyGuardian Strips.If you are using the BodyGuardian Base, see Chapter 6.Wear one of the monitors while the other one remains in thecharging cradle. Switch the monitor on your chest: In the morning after you wake upAt night before you go to bedDuring the day if the battery is lowRemoving a monitor from the StripYou can switch monitors without removing the Strip from yourbody. You do not need to perform any tasks on the phonewhen switching monitors.1. Use finger pressure to hold the Strip against your skin.2. Gently lift a corner of the monitor. Continue liftinggently until all four snaps release.123. Snap the used monitor into the plugged-in chargingcradle.Do not pause or power off the monitor.The monitor will automatically power off when it isdone transferring data.Attaching a charged monitor to the Strip20BodyGuardian Heart Instructions for Use

Remain near the phone when switching monitors. You canattach the fully charged monitor while the other monitor is inthe charging cradle and transferring data before it powers off.1. Snap the fully-charged monitor to Strip.2. Power on the monitor by pressing and releasing thecenter button. Do not hold the button down.123. If prompted by the smartphone, select the locationwhere you positioned the monitor on your chest.Replacing the StripChange the Strip every three days OR when it no longeradheres to the skin.1. Remove the monitor from the Strip.2. Remove the Strip while showering or use a warm, dampcloth to soften the edges of the Strip.3. Slowly peel back and roll the adhesive away from yourchest. Continually blot the chest and adhesive with awarm, damp cloth.Do not rip or tear off the Strip quickly.Improper removal may cause skin irritation.Note: Strips are disposable.Switching monitors with Strips21

Switching monitors with aBase?6Do you have Strips or the Base?This chapter applies to patients with the BodyGuardianBase. If you are using BodyGuardian Strips, see Chapter 5.Wear one of the monitors while the other one remains in thecharging cradle. Switch the monitor on your chest: In the morning after you wake upAt night before you go to bedDuring the day if the battery is lowRemoving a monitor from the BaseYou can switch monitors without removing the electrodes fromyour body. You do not need to perform any tasks on the phonewh

12 BodyGuardian Heart Instructions for Use If the touch screen dims Even when the smartphone is collecting data, the smartphone turns off the touch screen when you do not use the phone for a specified period. If you need to turn on the screen, press the Power/Lock key on the right edge of the smartphone. Smartphone display

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