BIOTRONIK Home Monitoring Information For Patients And .
BIOTRONIKHome MonitoringInformation for Patientsand Their Relatives
ContentsIntroduction4BIOTRONIK Home Monitoring 6The Secure Choice6Remote Cardiology Today8CardioMessenger12Your Patient Device12Routine Remote Medical Care14FAQs – Frequently Asked Questions16About BIOTRONIK Home Monitoring16About the CardioMessenger20About Data Transmission22Key Aspects at a Glance24
Make Life EasyEach year, more than one millionpatients worldwide receive an insertablecardiac monitor, a pacemaker, acardioverter-defibrillator (ICD) or asystem for cardiac resynchronizationtherapy (CRT). These implantabledevices now resemble tiny computerswith enormous capacity, and they arebecoming increasingly complex. Theytherefore need to be regularly checkedand adjusted. Routine checks of theimplanted devices and the heart by acardiologist are thus unavoidable.The use of BIOTRONIK HomeMonitoring provides patients withimplanted devices safety beyondroutine testing. Automatic datatransmission allows cardiologists todetect diseases at an early stage.This provides them with informationabout the state of the patients' heartsand the implanted device on a dailybasis, directly from the patients'domestic environment. Thus, doctorsare enabled to respond to changes in4patients' state of health at all times,reducing the amount of examinationsto a manageable number.Patients can flexibly structuretheir daily routines and remainunder constant medical care,even when they are not visitingtheir doctors.On the following pages we explain howthe BIOTRONIK Home Monitoringservice functions. To have your personalquestions answered, it is recommendedthat you speak to your doctor or theBIOTRONIK patient service before thedevice is implanted. We will also gladlyanswer any technical questions you mayhave. Further information in this regardis provided at the end of the brochure.5
The Secure Choice:BIOTRONIK Home MonitoringObserving Your Heart around the ClockBIOTRONIK Home Monitoring implanteddevices provide versatile options toimprove the day-to-day treatment andsafety of patients. The heart rhythm andthe implanted device are automaticallyand continuously monitored. Dailyupdates of cardiac and device statusallow the cardiologist to regularlyevaluate the patient's condition andknow if the implanted device functionsproperly. The patients are able toengage in their routine activities andremain in their familiar environment.Therapy as Individual as YouEvery heart changes over time, forexample as a result of medication orlifestyle. Home Monitoring allowsyour doctor to monitor the state ofyour health at a distance and to adaptyour treatment to changes in yourcircumstances. For patients sufferingfrom congestive heart failure, closemonitoring of certain values is aprerequisite for maintaining a stable6heart function and improving their wellbeing in the long term. For patients withan ICD, Home Monitoring can providesignificant relief, as unnecessary shockdeliveries can be clearly reduced withthe aid of reliable information.1 Patientswho are dependent on a pacemaker, onthe other hand, increase their safetylevels, as the success of their therapycan be checked at any time.You’re in Safe Hands with ReliableEarly DetectionStudy data has shown that patientswith congestive heart failure have clearsurvival advantages when under closeHome Monitoring care.2, 3, 7 Furthermore,Home Monitoring patients usuallyfeel safer and benefit from a higherquality of life as clinical events can bemore rapidly identified and treated.4, 5This means that fewer hospital staysare required.1, 5, 6 27
On the Cutting-Edge ofRemote MonitoringCare Beyond the Implant thanks toContinuous Data TransmissionAll BIOTRONIK Home Monitoringimplanted devices have a tiny antennaand are thus suitable for remotemonitoring. The device records allheart and implanted device activitiesaround the clock. Any tiny deviationin the cardiac or system function isthus recorded and saved on theimplanted device. Once a day – usuallyat night while you sleep – the HomeMonitoring device transmits all thisdata to a patient device (your CardioMessenger) by radio, without youhaving to do anything, or even noticing.Any data transmission gaps coulddelay the timely detection of criticalchanges.Your Data – Encrypted and HighlyProtectedYour implanted device (1) recordsimportant cardiac and deviceinformation each day and automaticallytransmits it to the CardioMessengerat night (2). The CardioMessengertransmits this data to the HomeMonitoring Service Center (3) inencrypted form via the cellular phonenetwork. All information is evaluated,filtered and summarized in a socalled CardioReport for each patientat the center (4). Your doctor can thenaccess all values via a secure websiteand is thus provided with a day-to-daytherapy progress report (5).Any faulty data transmissions aretherefore automatically recorded by thesystem and reported to the doctor.1823459
On the Cutting-Edge ofRemote MonitoringPrioritization According to the "TrafficLight" Principle in order to Detect andTreat Problems at an Early StageBy making use of a simple colorscheme similar to a traffic light system,your cardiologist can determine whichchanges in your state of health shouldbe classified as critical and trigger anotification. Depending on theirurgency, your doctor can divide theseinto "yellow" (important" and "red"(critical) alarm messages. Your doctorwill be automatically informed aboutany events marked as red or yellowwithin 24 hours by e-mail, fax or SMS.This means that any health andtechnical problems can be detectedlong before the next routineexamination. Your doctor can contactyou rapidly and treat the problem atan early stage. Start and duration of a rhythmdisturbance Intracardial ECG recording (IEGMOnline) Device therapies such as electricalpulses and shock delivery Current battery status of yourimplanted device State and functionality of the leads Special measuring values to evaluateexisting congestive heart failureAutomatic Transmission of Event Reports UsingBIOTRONIK Home MonitoringCriticalevent10Receipt ofevent dataData transmissionvia the cellularphone networkEvaluation ofevent data andnotification ofdoctorEventoverview11
CardioMessenger –Fully MobileCardioMessenger - Always ReadyYour doctor has given you an easy-tooperate transmitter for regulartransmission of your cardiac devicedata to take home.This so-called CardioMessengeris ready for use and will transmityour data to your doctor inencrypted form via the cellularphone network on a daily basis.The device comes in two variants.Convenient as a Smartphone – theCardioMessenger SmartThe CardioMessenger Smart is atransmitter of the latest generation,weighing a mere 127 grams. Itresembles a smartphone and has arechargeable battery that allows it tobe used as a mobile device for up to48 hours. To ensure that your cardiacdevice data can be reliably transmittedto your doctor every day, simply placeyour device on your bedside table when12going to bed and charge it via the powercable. The on /off indicator has no LEDand will thus not disturb your sleep. Ifyou wish to go on holiday or will betraveling overnight, remember to takethe power supply unit along. You shouldalso ensure that you never wear theCardioMessenger Smart directly abovethe implanted device, such as in yourbreast pocket. The same applies to yourcellular phones in day-to-day use. Moredetailed information is provided in yourtechnical manual.Easy to Use – the StationaryCardioMessenger II-SThe stationary CardioMessenger II-Smust be connected to the mainssupply throughout in order to transmitthe implanted device data. Plug theCardioMessenger into a socket nearyour bed and place it on your bedsidetable. Thus your implanted devicedata will be automatically transmittedvia the cellular phone network to yourdoctor every night while you sleep.More detailed technical information,including on the LED lights, may befound in the technical manual.13
Better Quality of Life withBIOTRONIK Home MonitoringFlexible Follow-Up Care – DemandDriven and from HomeAlthough, in an emergency, remotemonitoring cannot replace a call to yourdoctor or a stay in hospital, routinefollow-up care can be reduced to areasonable level as a result of HomeMonitoring transmissions. Such carewill no longer be required at rigid timeintervals, but in accordance with yourhealth requirements. As long as thestate of your heart and implanteddevice allows it, your doctor will beable to provide some of your routinefollow-up care in the form of remotemonitoring. Thus, you and yourrelatives will not only save time, butalso unnecessary traveling.Safety throughout the DayWhether you are at home or traveling,your CardioMessenger will allow youto have regular contact with your doctor.Wireless data transmission via thecellular phone network ensures thatyou remain flexible, yet cared for –wherever you may be.14Carefree HolidaysSimilarly to a smartphone, you caneasily take the CardioMessenger alongwhile you are traveling. The worldwidecellular phone network is used totransmit implanted device data fromover 160 countries to the practice orclinic. To avoid transmission gaps,please inform your center in advanceif you will be traveling to countries withother time zones.We Are There for You.You will find more detailedinformation about therapyand follow-up care onlineon the following website:www.biotronik.com/patientsIf you have any questionsabout your implanted deviceor about Home Monitoringcare, the BIOTRONIK serviceteam will be pleased toanswer them, either byphone at (030) 68905-0or by e-mail atpatients@biotronik.com.
Frequently Asked QuestionsQuestions AboutBIOTRONIK Home MonitoringWhat Is so Special about theBIOTRONIK Home Monitoring System?BIOTRONIK Home Monitoring is thefirst and only monitoring system thatensures fully automated and highlyreliable transmission of implanteddevice data on a daily basis.10 It is theonly system that has been speciallyapproved for the early detection ofmedical and technical complicationsand can replace medical follow-upsof your implanted device with remotemonitoring.6Study data has shown that theuse of Home Monitoring allowsfor more rapid intervention, thusimproving the survival chancesof patients with implanteddevices.2, 3, 7How Many People Are Using HomeMonitoring?Every month some 3,500 patientsdecide to make use of the increasedsafety and mobility of BIOTRONIKHome Monitoring, the world's firstcellular phone-based remotemonitoring system that allows forautomatic, reliable follow-up carefor you and your implanted device.The Home Monitoring Service isnow being used in over 60 countriesand in more than 7,300 hospitalsand practices. Over 800,000 patientsworldwide currently have the option ofbeing mobile, while still maintainingcontact with their doctors.Automatic data transmission via thecellular phone-enabled CardioMessengerallows Home Monitoring to be used withease anywhere in the world.1617
Frequently Asked QuestionsCan Any Patient with an ImplantedDevice Make Use of Home Monitoring?In order to transmit remote medicaldata via the Home Monitoring service,your implanted device must incorporatea special antenna. Not all cardiacpacemakers, ICD and CRT devices areequipped with this –, but an increasingnumber are. Whether you, as a patient,will receive an implanted device capableof transmitting medical data willdepend on your consent and on themedical evaluation of your doctor.You will need to jointly decide whetherHome Monitoring constitutes ameaningful addition to your therapy.However, remote monitoring forpatients with implanted devices isincreasingly being recommended intreatment guidelines.8, 9 There are alsomedical funds that already routinelypay for the cost of the CardioMessengerand Home Monitoring system.Can Admission to Hospital BePrevented with the Aid of HomeMonitoring?Close monitoring allows for rapididentification of malfunctioningimplanted devices or leads, as wellas any deterioration in your cardiacfunction. The early detection of atrialfibrillation, for example, can preventstrokes, while timely correctionof therapy can result in a longterm improvement of the disease18progression.1, 5, 6 Early adaptation to:your medication, settings of theimplanted device, or to your lifestyle,can help avoid hospital admission andmaintain the efficiency of the heart.3Vital pulses and shock deliveries by theimplanted device can also be reducedto the essentials by close monitoring,thereby protecting your heart.1Can Home Monitoring Replace anEmergency Call or a Visit to theEmergency Ward?Home Monitoring allows for safe andearly detection and treatment ofmedical and technical problems andchanges which you often do not perceiveat all.5 Based on this information, yourdoctor can respond at an early stageand invite you to report to the practicefor treatment. Review of the patient’sdata usually takes place during normalclinic or practice hours.Home Monitoring has not beendesigned to act as an emergencysystem. In this instance, visit theemergency ward or place anemergency call.19
Frequently Asked QuestionsQuestions About theCardioMessengerHow Do I Know that My CardioMessenger Is Working Correctly?The LED will light up in green(CardioMessenger II-S) or thesymbol will appear on the LCDscreen (CardioMessenger Smart).What Does the Telephone Symbol onthe CardioMessenger II-S and SmartSignify?If the yellow light next to the telephonesymbol on your CardioMessenger II-Sstarts flashingor if the telephoneappears on thereceiver symboldisplay of your CardioMessenger Smart,please contact your practice orclinic. The light will be activated fora maximum of three days. If you havemanaged to contact your doctor andwish to switch off the light, simplydisconnect the power plug for a shortwhile.your absence will be transferred withthe next transmission interval thatis usually taking place at night. Ifyou intentionally wish to leave yourCardioMessenger at home, pleasebriefly inform your practice or clinicin order to avoid error messages andneedless worry to your cardiologist.What Do I Need to Take into Accountif I Use the CardioMessenger Smartwhilst Traveling or on the Road?When traveling by plane, you can alsotake the CardioMessenger Smartalong and switch it off for the durationof the flight. Once you switch on thedevice after landing, all events recordedin the interim will be automaticallytransmitted to your doctor via thecellular phone network.What Happens when I Go Away andForget the CardioMessenger?From a technical point of view, this isnot a problem. Your CardioMessengerwill continue to remain functional. Assoon as you return home and are inthe proximity of your CardioMessengeragain, all information collected during2021
Frequently Asked QuestionsWhat if Smartphones Are Prohibited?Prohibitions on the use of cellularphones on airplanes or in hospitals,designed to prevent potentialinterference, also apply to your CardioMessenger Smart. Please switch offthe device in this case. Prohibitionson the use of cellular phones to avoidnoise, for example on a train, at thetheater or in a cinema, will not applyto your CardioMessenger Smart. Youcan leave it switched on in theseenvironments.How Much Power Does MyCardioMessenger Consume?The annual energy use of the CardioMessenger is minimal. The power costsfor operation amount to approximatelyEUR 2.50 per annum. Where do I placethe CardioMessenger? To ensuredata transmission, remember to placethe CardioMessenger not less than 8inches (20 cm) away from you and nomore than 6 feet (2 meters) away fromthe place where you sleep.Questions About DataTransmissionwill only take place with your explicitconsent. During data transmission,your medical data is encrypted, withoutany personal information, thus noconclusions can be drawn about youridentity as a patient. Processing of theHome Monitoring data takes placeonly in Germany and is thus subject toGerman data protection regulations,which are among the strictest in theworld.Are the Data Transmissions of theCardioMessenger Hazardous to MyHealth?No, BIOTRONIK implanted devicesand the CardioMessenger make useof a special transmission frequency(Medical Implant CommunicationService band) only reserved for medicalproducts and requiring a mere 25 μW.This excludes any risk of a healthhazard.Could My Cellular Phone Disrupt theData Transmission of theCardioMessenger?No, cellular telephones transmit onanother frequency and will not interferewith the function of the CardioMessenger.How Can I Be Sure that My Data WillRemain Secure?BIOTRONIK takes the protection of yourpersonal data very seriously. Remotemonitoring of your implanted device2223
Frequently Asked QuestionsCould Errors Occur during DataTransmission?Data transmission with HomeMonitoring is extremely reliable. If alack of cellular phone coverage shouldresult in transmission problems at anystage, your data will be temporarilystored in the CardioMessenger. If theproblem persists, your hospital orpractice will be informed. As soon asyour CardioMessenger has its cellularphone transmission restored, thetransmission process will be repeatedand the data will be updated on a dailybasis.Do Daily Data Transmissions Reducethe Service Life of My ImplantedDevice?No. All Home Monitoring data outsidethe implanted device are analyzedand processed in a specially set-upand secured computer center (HomeMonitoring Service Center). Therefore,the battery capacity is extended andthe service life of your device will notbe affected. Close monitoring with theaid of cellular phone and internettechnology helps to improve your stateof health and reduces the numberof shock deliveries required. The earlydetection of technical defects and thereduction of unnecessary therapiescontribute towards the optimal useof the battery service life by limitingall device activities to the essentials.124Key Aspects at a GlanceWhat Should I Do when I Get Dizzy, MyHeart Is Racing or I Experience AnyOther Symptoms?If you should experience any symptomssuch as dizziness, nausea or a racingheart, please inform your doctorand make a note of the exact time ofthe event. This will allow your doctor tolater determine whether the symptomsare being caused by the implanteddevice or by your heart.How Do I Behave after Shock Deliveryby the ICD?An ICD is designed to emit strong powerpulses (shocks) in the event of lifethreatening ventricular fibrillation. Assoon as your ICD delivers a shock, yourdoctor will be informed the next timeyou are near your CardioMessenger.Although shock delivery constitutesan important part of the ICD therapy,it should always be followed by anexamination in order to detect potentialchanges to your heart and the functionof your implanted device. Thereforeplease contact your doctor after eachshock delivery.25
References1 Guédon-Moreau, L., Chevalier, P., Marquié, C., Kouakam, C., Klug, D.,Lacroix, D., Brigadeau, F., et al. (2010). Contributions of remote monitoringto the followup of implantable cardioverter–defibrillator leads underadvisory. European Heart Journal, 31, 2246–2252.2 Freeman, J. V., & Saxon, L. (2015). Remote monitoring and outcomes inpacemaker and defibrillator patients: big data saving lives? Journal of theAmerican College of Cardiology, 23, 2611– 2613.3 Hindricks G, Taborsky M, Glikson M, Katz A, Heinrich U., Schumacher B,et al. Implantbased multiparameter telemonitoring of patients with heartfailure (IN-TIME): a randomised controlled trial. Lancet 2014 Aug 16;384(9943): 583–90.4 Ricci RP, Morichelli L, Quarta L, Sassi A, Porfili A, Laudadio MT, et al. Longterm patient acceptance of and satisfaction with implanted device remotemonitoring. Europace 2010 May; 12(5): 674 –9.5 Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, et al. ARandomized Trial of Long-Term Remote Monitoring of Pacemaker Recipients(The COMPAS trial). European Heart Journal 2012 May; 33(9): 1105 –11.6 Varma N, Epstein AE, Irimpen A, Schweikert R, Love C. Efficacy an
Remote Monitoring Care Beyond the Implant thanks to Continuous Data Transmission All BIOTRONIK Home Monitoring implanted devices have a tiny antenna and are thus suitable for remote monitoring. The device records all heart and implanted device activities around the clock. Any tiny deviat
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