biotronik remote assistant iii manual

Reproduced with Permission from the GMDN Agency. The mean specific absorption rate (SAR) for the whole body is shown in watts per kilogram (W/kg). >> /C2_1 54 0 R /ExtGState << It is comfortable, discreet, suits different body forms, and MRI scanning can be performed without any waiting period after injection, as the device is 1.5 T and 3.0 T full-body MR conditional. Indications:The Reveal XT insertable cardiac monitor is an implantable patient-activated and automatically activated monitoring system that records subcutaneous ECG and is indicated in the following cases: The Reveal XT Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. 2019, doi: 10.1111/pace.13728. Grant and Donation Requests to BIOTRONIK, Inc. Information Regarding Your Patient Identification Card, Senior Director Microelectronics Engineering. /Tabs /S Users must not rely solely on this information, but must carefully read and observe the ProMRI System Technical Manual for proper use of the implanted system for treatment and determination of MRI compatibility. /Parent 2 0 R /ColorSpace << /GS1 45 0 R BIOMONITOR III features simplified programming by indication-based program sets and enhanced signal quality by improved filtering and data compression. %PDF-1.4 /Subtype /Link endobj /Type /Page Adapting detection sensitivity based on evidence of irregular sinus arrhythmia to improve atrial fibrillation detection in insertable cardiac monitors. Home Monitoring achieves industry-leading transmission success rates, along with high levels of patient adherence and satisfaction. BIOMONITOR III fits a variety of body types. >> /TT1 48 0 R Caution: Detailed information about ProMRI can be found in the ProMRI System Technical Manual. 10 0 obj >> endstream endobj startxref The scan exclusion zone is determined by the MRI scanner's field of view and the size of the patient. Low noise also contributes to ECG clarity, which in turn, can lead to easier and quicker rhythm classification. page 5: about this technical manual about this technical manual about this technical manual user group the cardiomessenger is to be used by patients with a biotronik pacemaker or an implantable cardio- verter- defibrillator ( icd) with the home monitoring function. /TrimBox [0 0 612 792] >> Intelligent Memory Management prevents this issue, by retaining the most clinically valid episodes. 12 0 obj RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION), Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal, Storage Environment Humidity: between 30 and 95 Percent (%) Relative Humidity, Handling Environment Temperature: between 14 and 113 Degrees Fahrenheit. >> /Type /Page if you need assistance. Green light above OK = connected. /ProcSet [/PDF /Text /ImageB /ImageC /ImageI] endobj In practice, this means that the marker line of the MRI scanner's laser positioning marks must be within this zone. this transmitter automatically transmits medical and technical information to a mobile device, the cardiomessenger. The Bluetoothword mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of suchmarks by Medtronic is under license. >> /StructParents 3 /TT5 49 0 R Unlike bulky Holter monitors, the small device is barely noticeable to the patient. /Im0 67 0 R >> Low noise also contributes to ECG clarity, which in turn can lead to easier and quicker rhythm classification. /Contents 39 0 R /Count 7 The patient connector and mobile device may run out of power during the insertion procedure if they are not fully charged. BIOTRONIK Home Monitoring is a pioneering and award-winning remote cardiac monitoring system. /Parent 2 0 R As the approval process takes a different amount of time in each country, MR conditions and available MR conditional systems may differ from country to country. biotronik se & co. berlin, germany and rome, italy, aug during a scientific talk at the european society of cardiology ( esc) congress, dr. kg / / woermannkehre 1 / / d- 12359 berlin / / germany create date : : 12: biotronik home monitoring manuale 13 13: 18: 51+ 01: 00 modify date : : 12: 13 14: 44: 26+ 01: 00 xmp toolkit : adobe xmp core 5. follow- up supported by home monitoring ca n be used to functionally replac e in-. /Count 7 Artificial Intelligence Enables Dramatic Reduction of False Atrial Fibrillation Alerts from Insertable Cardiac Monitors. 9529 Reveal XT Insertable Cardiac Monitor. For further information, call Medtronic Technical Services at (800) 328-2518 and/or consult Medtronics website at www.medtronic.com. /Type /Page >> /Type /Page 6 0 obj Potential adverse events from the LINQ II ICM include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin. /Version /1.4 /TT0 63 0 R The website will guide you through the large variety of system-specific MR conditions by requesting information on the implanted device and lead combination. #K200444 510(k) Summary Page 2 of 4 4. Heart Rhythm. /GS7 22 0 R /CropBox [0.0 0.0 612.0 792.0] It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. /StructParents 4 LINQ II ICM enables remote programming capability for all device parameters post-insertion from the clinic, which may reduce patient office visits and scheduling hassles. >> It monitors cardiac activity round the clock, day in and day out, with excellent signal fidelity. >> See the device manuals for detailed information regarding the implant procedure, indications / intended use, contraindications, warnings, precautions, and potential complications/adverse events. with home monitoring, the state heart to the patient device, your of your heart' s health and your implant are cardiomessenger ( 2). With an updated browser, you will have a better Medtronic website experience. BIOMONITOR IIIs combination of our BIOvector design, the fractal coating on its sensing surface area, and a smart lossless compression algorithm deliver high amplitude signal quality. 2 0 obj The field strength is measured in tesla (T). /F 4 16Radtke AP, Ousdigian KT, Haddad TD, Koehler JL, Colombowala IK. >> 2019. App Store is a service mark of Apple Inc. Ousdigian K, Cheng YJ, Koehler J, et al. J Am Coll Cardiol. /ProcSet [/PDF /Text] BIOTRONIK Home Monitoring is a pioneering and award-winning remote cardiac monitoring system. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) >> /Resources << it allows follow- up appointments to be catered to each patient, so that patients are seen when needed, rather than on a pre- set schedule. /Rotate 0 Hip and eye - permissible positioning zone. This website shows the maximum value for the whole body SAR. BIOMONITOR IIIm has longevity of 5.5 years. /Rect [90.257 307.84 421.33 321.64] 1 Prerfellner H, Sanders P, Sarkar S, et al. /C2_3 62 0 R The LINQ II insertable cardiac monitoring system is personalized for the patient's lifestyle and customized for the clinician's workflow. >> >> /CropBox [0 0 612 792] /Im1 51 0 R << /F 4 /Font << /C2_0 69 0 R 2017. /Contents 52 0 R /TT3 66 0 R Please check your input. Data availability and alert notifications are subject to Internet connectivity and access, and service availability. /Annots [27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R 35 0 R 36 0 R /StructParents 0 See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. page 7 car di om es s enger _ i i - s_ en. endobj /Font << kg, and we want you to feel secure when using our web pages. /Subtype /Link >> /ArtBox [0 0 612 792] 2 0 obj Biotronik, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, Oregon 97035 Re: K190548 Trade/Device Name: BIOMONITOR III, Remote Assistant III Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II /CropBox [0 0 612 792] The slew rate of the MRI scanner's gradient fields is shown in tesla per meter per second per axis (T/m/s per axis). ]3vuOB1fi&A`$x!2`G9@?0 L Cardiac Monitors /TrimBox [0 0 612 792] 3 0 obj /ExtGState << /Type /Page endobj >> >> LINQ II LNQ22 ICM clinician manual. If the patient connector should fail, there is no risk of patient harm. /Im0 67 0 R Every year, more and more patients are receiving ICMs all of which must be actively managed, creating additionalworkloads for everyone involved. Healthcare Professionals hb```b``u``e`` B,@QL@"rIT|;x28PvA+~)g,a0"_2^?h&9s3Jb(i/QY9r3='-8,(S{@Dac*.i.1n(39.q2=G uh`3 T|D hG @;LFo`V 9P$@ah@D LF * P}bEA|l2._bua_,N i\`` /Contents 60 0 R K201865 FDA clearance. Only use the patient connector to communicate with the intended implanted device. December 2016;27(12):1403-1410. /Rect [40.95 36 85.101 45.216] >> /Rotate 0 /Parent 2 0 R JCardiovasc Electrophysiol. Home Monitoring not only allows physicians to safely review cardiac function, it also sends alerts about relevant . /MediaBox [0 0 612 792] /Contents 71 0 R /Rotate 0 << are permitted for patient monitoring in an mri environment. BIOMONITOR III, data on file. /Group << /Resources << << endobj dear patient: you have received a biotronik pacemaker or implantable cardioverter- defibrillator ( icd) with home monitoring function. The permissible positioning zone explained below must always be maintained during MR scans of patients with restricted device systems. * Third-party brands are trademarks of their respective owners. endobj 2021. >> HoMASQ Study. /Resources << Indications:The intended use of the system is to reduce false positive cardiac arrhythmia episodes. /ArtBox [0 0 612 792] /Resources << 2010, 122(4). Patient data transmitted to CareLink network via MyCareLink Relay or MyCareLink Heart, Clinician-initiated reprogramming via CareLink network, Device settings automatically update without need for an office visit. BIOMONITOR III has a longevity of 4 years. *S#5;`65|F 2&Z=Z@Cr.)LOI"sO. /CS0 [/ICCBased 60 0 R] 2 today, biotronik home monitoring is available in over 55 countries, optimizing patient management in more than 3, 800 clinics around the world. /BS << Combines pocket creation and ICM injection into a one-step procedure taking only seconds to administer. biotronik home monitoring enables physicians to perform therapy management at any time. Overwriting older relevant episodes make classification more difficult. BioMonitor 2-AF and Remote Assistant - Mediadatabase BIOTRONIK SE & Co. KG - CRM, Arrhythmia Monitoring, Cardiac Monitor, Accessories, Complete View, Product Family, Gray Background Nlker G, Mayer J, Boldt LH, et al. the home monitoring system is comprised of a home monitoring- enabled biotronik pacemaker or defibrillator, cardiomessenger home transmitter, which wirelessly and automatically collects and transmits implant data, and the biotronik home monitoring service center, which allows clinics to review and assess. Please contact your local BIOTRONIK representative. 10 it is the only system that has been specially approved for the early detection of. /Type /Page biotronik strongly encourages health care providers to submit accurate and appropriate claims for services and recommends that you consult directly with payers ( e. 8, 9 there are also medical funds that already routinely pay for the cost of the cardiomessenger and home monitoring system. BIOTRONIK Manual Library BIOTRONIK Manual Library This website will assist you in finding a specific BIOTRONIK manual for the country/region in which a specific product is used. endstream /Image15 26 0 R For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic websiteatwww.medtronic.com. /GS0 44 0 R >> August 1, 2021;18(8):S47. * free* shipping on qualifying offers. J Cardiovasc Electrophysiol. 9539 Reveal XT Patient Assistant:Operation of the Model 9539 Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device. /TT1 48 0 R Where can I find the serial number or the product name? Alert notifications are not intended to be used as the sole basis for making decisions about patient medical care. the privacy of your personal data is very important to biotronik se & co. the storage package includes the following: sterile packaging with device serial number label patient id card technical manual for the device biotronik home monitoring the biotronik cardiac monitor provides a complete diagnosis management system: with home monitoring, diagnostic information as well as technical data of the. /Resources << RF interference may affect device performance. << 14 0 obj It is also 1.5T and 3.0T full-body MR conditional and there is no waiting period after the injection procedure. h+L5hHJarx(|9Jx$ {K=j2|l!YF ql2-h&fG4t^*O]=:xh p)1FG4SQ.* will be shown for BIOTRONIK products that have been tested under the conditions of an MR scan and are approved as MR conditional without a scan exclusion zone. /A << << /TT2 55 0 R ; page 2: follow- up data overview physician callback signal ( 1) follow- up data transmission ( 2) ready ( cardiomessenger ii) ( 3) battery monitor light ( 4) ready ( charging station) ( 5) data interface ( 6) a view of the rear side of the device can be found on the back cover. var site_url = "https://www.medicaldevices24.com/"; home monitoring system in. it allows your doctor to continuously access information about your implanted system. Using the patient connector to communicate with other implanted devices can interfere with those devices, potentially affecting the other implanted devices functionality or therapy delivery. << You literally just plug it into the power and it is up and running. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. /TT4 70 0 R /Contents 41 0 R %PDF-1.6 % we collect, process, and use data in compliance with applicable privacy laws, in particular the eu general data protection regulation ( gdpr), german federal data protection act ( bundesdatenschutzgesetz, bdsg) and the telemedia act ( telemediengesetz, tmg). /URI (http://www.fda.gov/) download manuals pdf files on the internet quickly and easily. biotronik home monitoring is a pioneering and award- winning remote cardiac monitoring system. To make sure that only approved products and conditions will be shown, the country where the scan will take place must be selected. /Annots [10 0 R 11 0 R 12 0 R 13 0 R] /Font << stream /Filter /FlateDecode /GS0 62 0 R /Filter /FlateDecode /CS /DeviceRGB Intelligent Memory Management ensures that the detection of both overlapping arrhythmia episodes and patient triggered episodes are stored, and the ECGs are available for evaluation. However, the patients particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. << /Subtype /Link /C2_2 61 0 R Labeling does not contain MRI Safety Information, Implantable cardiac monitor programmer/transmitter/alarm. Lux-Dx ICM K212206 FDA clearance letter. For further information, please call Medtronic at 1-800-929-4043 and/or consult the Medtronic websiteatwww.medtronic.com. Specifically, the patient connector may be affected by electrostatic discharge (ESD). 43 0 R] Isocenter Penela D, Fernndez-Armenta J, Aguinaga L, et al. stream it is the most user- friendly, most clinically actionable cardiac remote monitoring solution available today 1. please select your region. /CS /DeviceRGB /TT0 63 0 R stream Medtronic inductive telemetry uses short-range communication to protect patient information. /Type /Page >> /Resources 50 0 R /Length 449 /S /URI : Berlin-Charlottenburg HRB118866B, Managing Directors: Dr. Alexander Uhl (Chairman), Dr. Andreas Hecker, Stephan Schulz-Gohritz. /GS8 23 0 R The scan exclusion zone is determined by the MRI scanner's field of view and the size of the patient. /CropBox [0.0 0.0 612.0 792.0] `3$ihfxg'8hd5B_PrV^.Ps'T3=~w4?CIM- {Mk /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) /C2_0 69 0 R /W 0 By clicking the links below to access the news on our International website, you are leaving this website. Please contact us /CS0 [/ICCBased 42 0 R] /Parent 2 0 R 7 0 obj The CareLink mobile application is not replacing the full workstation, but can be used to review patient data when a physician does not have access to a workstation. >> /TT3 66 0 R /MediaBox [0 0 612 792] /MediaBox [0 0 612 792] BIOTRONIK Remote Assistant III NCC CCAI20LP0360T8 NCC CCAI20LP0360T8 Remote Assistant III (17 kHz) The following details are provided for BIOTRONIK Remote Assistant III from the Taiwanese National Communication Commission type approval licensing registration system. HKO0"qIHJ&hl$|}u[V; - !A!S#sN8iqWN[m"i#nGd2e;k%(nJ! CareLink network availability and mobile device accessibility may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area. Intended Use:The Medtronic MyCareLink patient monitor and CareLink network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual.