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 Eliminates time consuming and potentially costly multi-step procedures. GMDN Names and Definitions: Copyright GMDN Agency 2015. With BIOMONITOR IIIm Vital Data Sensor, fever can be monitored remotely and hands-free which enables more effective at home care. the device, about the size of a smartphone, keeps pacemaker and implantable cardioverterdefibrillator ( icd) wearers connected to their physician enabling safer, more efficient treatment anywhere in the world. The MyCareLink patient monitor must be on and in range of the device. Low noise also contributes to ECG clarity, which in turn, can lead to easier and quicker rhythm classification. /BleedBox [0 0 612 792] /MediaBox [0 0 612 792] kg, and we want you to feel secure when using our web pages. It monitors cardiac activity round the clock, day in and day out, with excellent signal fidelity. The injection procedure allows for several wound closure techniques to be used, including the use of tissue adhesives. K201865 FDA clearance. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. It is also 1.5T and 3.0T full-body MR conditional with no post-injection waiting period limitations. &#B\ GcT.B8 oHaWqjHw~c1Hg"M;#?5XR);#lEaQkWao]O9&lPbr 3y?wC~[UL)ulkH~X@Tb4'a4(aG~PCJ5Tm.6jainn+27u|;e -{)pu7Lz$y6=+.Pwe|KjtD3(U6mNa.jM h\^30zm)Hp` << if you need assistance. /GS0 37 0 R Update my browser now. The LINQ II insertable cardiac monitoring system is personalized for the patient's lifestyle and customized for the clinician's workflow. /Contents 41 0 R /Length 449 /Font << >> /Rotate 0 /MediaBox [0 0 612 792] August 1, 2021;18(8):S47. % /C2_0 53 0 R The Bluetoothword mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Medtronic is under license. crm / / biotronik home monitoring cardiomessenger smart enechnical manual t es manual tcnico fr manuel techniqueh_ ga_ cardiomessenger- smart_ e- mul_ cover. kg biotronik, inc. home monitoring also has been shown to reduce: hospitalizations caused by atrial arrhythmias or strokes by 66% ( compas) in- office visits by 45%, and inappropriate shock delivery by 52% early detection biotronik home monitoring provides early detection of arrhythmias, including silent, asymptomatic arrhythmias, allowing for earlier intervention. This website shows the maximum for the slew rate value, which must not be exceeded during the scan. /StructParents 0 /Subtype /Link source exif data [ ] : file type : pdf file type extension : pdf mime type : application/ pdf pdf version : 1. technical manual for the device technical manual for the home monitoring service center ( hmsc) technical manuals for the programmer and the remote assistant iii technical manuals for the user interface technical manuals are either included in hard copy form in the product package or are available in digital form on the internet:. 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. @ZvA(thp[x@^P@+70YCT1 5f Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, patients with clinical syndromes or situations at increased risk of cardiac arrhythmias, patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia, Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias, Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia, patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia, To verify whether the implanted device has detected a suspected arrhythmia or device related event, To initiate recording of cardiac event data in the implanted device memory, Medtronic Get Connected and Stay Connected, Monitor automatically detects if new data is available, Event notification triggers an actionable alert, Remote access to full ECGs eliminates the need for manual transmissions, Automatic smartphone notifications help patients stay connected, Reduces clinic time spent on patient follow-up. The injection procedure allows for several wound closure techniques to be used, including the use of tissue adhesives. Grant and Donation Requests to BIOTRONIK, Inc. Information Regarding Your Patient Identification Card, Senior Director Microelectronics Engineering. ICD, pacemaker or cardiac monitor (BIOTRONIK products only). >> /Parent 2 0 R /W 0 2017. Regarding the isocenter position you can find two possible scan conditions: Full body 10 0 obj 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. 8 0 obj << /Contents [52 0 R 53 0 R 54 0 R 55 0 R 56 0 R 57 0 R 58 0 R 59 0 R] /StructParents 4 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-. endobj are permitted for patient monitoring in an mri environment. Displaying 1 - 1 of 1 10 20 30 50 100 The FIT OneStep injection tool provides an ideal pocket to accommodate the device securely and easily. The scan exclusion zone is determined by the MRI scanner's field of view and the size of the patient. /Tabs /S ProMRI Please refer to the technical manual "ProMRI MR condi-tional device systems" for detailed information Without scan exclusion zone and post-operative waiting period 1.5T and 3.0T Tools FIT OneStep injection tool 201mmx24mm (handle) Incision tool 130mmx13mm (handle) Remote Assistant III It has a projected battery life of 4 years and is compatible with Magnetic Resonance Imaging for full-body scans at 1.5 and 3 Tesla. The field strength is measured in tesla (T). There is no guarantee that it will not receive interference or that any particular transmission from this system will be free from interference. /TT0 23 0 R >> If the patient connector does cause harmful interference to other devices or is negatively impacted by other devices, correct the interference by one or more of the following measures: reorient or relocate the patient connector and other devices; increase the separation between the patient connector and other devices by at least two meters (approximately 6 feet); and/ or turn off any interfering equipment. The permissible positioning zone explained below must always be maintained during MR scans of patients with restricted device systems. >> /Resources << Precautions:The AccuRhythm AI ECG classification system may incorrectly adjudicate a true positive episode as an AI false episode, causing that episode to be suppressed in the remote monitoring system. You literally just plug it into the power and it is up and running. Artificial Intelligence Enables Dramatic Reduction of False Atrial Fibrillation Alerts from Insertable Cardiac Monitors. 5397 0 obj <>stream endobj /Type /Page /A << biotronik renamic manuals & user guides. /Type /Page The device is programmed to an MRI mode before the MR scan. >> << 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. /TT1 64 0 R /MediaBox [0 0 612 792] >> with biotronik home monitoring, healthcare providers have a complementary option to routine follow- up visits, while maintaining in- person follow- ups every 12 months. Heart Rhythm. Starting from the feet, the permissible positioning zone for the isocenter of the high-frequency coil is at the greater trochanter level. Artificial Intelligence Enables Dramatic Reduction of False Atrial Fibrillation Alerts from Insertable Cardiac Monitors. /Type /Catalog Starting from the top of the skull, the permissible positioning zone for the isocenter is at the level of the eyes or the lower edge of the eye socket. /Rotate 0 /Parent 2 0 R BIOTRONIK BioMonitor 2 technical manual. The CareLink mobile application is intended to provide current CareLink network customers access to CareLink network data via a mobile device for their convenience. /CS0 [/ICCBased 60 0 R] J Cardiovasc Electrophysiol. biotronik, a leading manufacturer of cardiovascular medical technology, recently announced the ce approval of cardiomessenger smart. Medtronic inductive telemetry uses short-range communication to protect patient information. 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. will be shown for BIOTRONIK products that have been tested under the conditions of an MR scan and are approved as MR conditional with a scan exclusion zone. 10 0 obj /GS8 21 0 R %PDF-1.6 % endstream endobj startxref Country/region >> however, remote monitoring for patients with implanted devices is increasingly being recommended in treatment guidelines. /Type /Page /Annots [25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R /ProcSet [/PDF /Text /ImageB /ImageC /ImageI] /Resources << However, receiver only coils can also be positioned outside this area. endobj cardiomessenger smart with biotronik home monitoring enhances safety for cardiac device patients new patient device allows for earlier therapy adjustments in heart patients with pacemakers, icds, crt and biomonitor devices. >> << /Group << 43 0 R] google_ad_client: "ca-pub-5568848730124950", ||First European-approved (TV notified body) remote programmable device. Designed to minimize patient effort, it sends daily, automatic cardiac device data to the patient device that then forwards the information to the Home Monitoring Service Center (HMSC). /Resources << biotronik home monitoring biotronik home monitoring is the world s most advanced telemonitoring solution for patients with cardiac devices. Caution:Federal law (USA) restricts these devices to sale by or on the order of a physician. >> /GS0 62 0 R /ExtGState << hbbd``b`?` $@b@BD$H8X5 Hr@= b"> R7Dw1QHO@k5)G RF`sih L endstream Heart Rhythm. If the monitor is connected to the cellular network in your area there will be a green light or "OK" displayed on your unit. 11 0 obj >> Data on file. You can find detailed information about the requirements, conditions and measures for safely conducting an MRI scan in the. /BleedBox [0 0 612 792] /StructParent 2 >> 2017. 2019. /Tabs /S /Type /Action h+L5hHJarx(|9Jx$ {K=j2|l!YF ql2-h&fG4t^*O]=:xh p)1FG4SQ.* /CS /DeviceRGB /Parent 2 0 R /CS1 [/Separation /Black [/ICCBased 42 0 R] >> In general, the use of medical devices is only allowed if they are approved. /TT0 63 0 R /CS0 [/ICCBased 42 0 R] Wireless accessories available for use with LINQ II may experience connectivity or performance issues. BIOMONITOR III features simplified programming by indication-based program sets and enhanced signal quality by improved filtering and data compression. >> cardiomessenger smart sends information from the device to the biotronik home monitoring service center over the global system for mobile communication ( gsm) cellular network using wireless rf 2 telemetry and coded data transmission for maximum safety and security. Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 sales@biotronik.com www.biotronik.com No need for unnecessarily complicated delivery tool assemblies. %%EOF Cardiac Rhythm >> /CropBox [0 0 612 792] LINQ II Future is Here Video Ousdigian K, Cheng YJ, Koehler J, et al. /CropBox [0 0 612 792] biotronik home monitoring allows follow- up appointments to be catered to you, so that your data is reviewed as necessary, rather than only on a pre- set schedule. Home /CS1 [/Separation /Black [/ICCBased 42 0 R] Trade name: REMOTE ASSISTANT: Product Code: 405475: Manufacturer of the medical device: BIOTRONIK SE & CO. KG: Vat Number: 136651322: Category Name: ACTIVE-IMPLANTABLE CARDIAC DEVICES, DIAGNOSTIC - ACCESSORIES: Category Code: J010280: BIOMONITOR III comes ready to inject, pre-loaded into a single piece injection tool for one-step injection. /Resources << /W 0 /C2_0 38 0 R enable_page_level_ads: true /BleedBox [0 0 612 792] endstream endobj 36 0 obj <>/OCGs[56 0 R 57 0 R]>>/OpenAction 37 0 R/Outlines 28 0 R/Pages 33 0 R/Type/Catalog>> endobj 37 0 obj <> endobj 38 0 obj <>/Resources<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>/XObject<>>>/Rotate 0/Thumb 14 0 R/TrimBox[0 0 595.27557373 790.866149902]/Type/Page>> endobj 39 0 obj <>stream This website provides worldwide support, except for Japan. /Filter /FlateDecode /Type /Action /Im0 63 0 R The Bluetoothword mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of suchmarks by Medtronic is under license. Confirm Rx ICM K163407 FDA clearance letter. /Type /Action /MediaBox [0 0 612 792] >> Confirm Rx ICM K182981 FDA clearance letter. Make sure you enter the country/region name in the currently selected language. /Rotate 0 Please contact us /TT2 48 0 R /S /Transparency >> 0 >> /MediaBox [0 0 612 792] /ProcSet [/PDF /Text /ImageC] >> We are working quickly to recover this service. Based on AF episodes 2 minutes and in known AF patients. 43 0 R] it is the most user- friendly, most clinically actionable cardiac remote monitoring solution available today 1. please select your region. /F4 48 0 R it sends information on your heart to the transmitter, your cardiomessenger ( 2), usually at night. /BS << >> %PDF-1.4 /F 4 14 0 obj book page 4 tues day, m ay 6, 1: 11 pm transmits it to the biotronik service center ( 4) as encoded messages via a mobile connection ( 3). However, the patients particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. << /Rect [90.257 307.84 421.33 321.64] /Type /Group 1 0 obj database contains 1 biotronik renamic manuals ( available for free online viewing or downloading in pdf) : quick reference manual. /MediaBox [0 0 612 792] /CropBox [0 0 612 792] /TT2 65 0 R Nlker G, Mayer J, Boldt L, et al. Starting from the top of the skull, the permissible positioning zone for the isocenter is at the level of the eyes or the lower edge of the eye socket. gerhard hindricks, leipzig heart center, germany, presented results of a meta- study showing that biotronik home monitoring is associated with a 38 percent reduced risk for all- cause mortality after one ye. /TT4 70 0 R 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. /MediaBox [0.0 0.0 612.0 792.0] /GS0 62 0 R TRUST Study, Heart, Lung and Circulation 2009, 18 (s106), 4 Ricci R. P et al HoMASQ study, Europace, 2010, 12 (5). >> cardiomessenger smart heart rate monitor pdf manual download. endobj /Parent 2 0 R /ExtGState << : Berlin-Charlottenburg HRA6501B, Commercial Register No. JCardiovasc Electrophysiol. los resultados publicados recientemente en circulation arrhythmia and electrophysiology confirmaron que biotronik home monitoring proporciona un manejo seguro y econmico de pacientes con marcapasos1, lo que indica que puede reemplazar de manera segura la prctica comn de monitoreo y rutina en consultorio para pacientes con marcapasos. M974764A001D. /Font << The serial number and product name can be found on: None of the entered data will be stored. This is an instructional video for patients with BIOTRONIK BIOMONITOR devices who use the BIOTRONIK Home Monitoring for remote monitoring.Disclaimer: This vi. Intelligent Memory Management minimizes this risk, by retaining the most clinically valid episodes. /S /Transparency /GS1 45 0 R If this is not the case please try the monitor closer to a window. what is cardiomessenger smart with biotronik home monitoring? >> << However, receiver only coils can also be positioned outside this area. See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications / adverse events. /TT0 63 0 R endobj endif; ?> /CropBox [0.0 0.0 612.0 792.0] 5178 0 obj <> endobj /Contents 36 0 R Confirm Rx* ICM DM3500 FDA clearance letter. Warnings/Precautions:Patients with the Reveal XT insertable cardiac monitor should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound, and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing. /XObject << endobj /StructParents 3 /XObject << /Im1 51 0 R Caution: Federal law (USA) restricts prescription devices to sale by or on the order of a physician. /GS0 44 0 R home monitoring pacemakers and icds are additionally equipped with a special transmitter. 6 linearized : no author : biotronik se & co. biotronik today announced that it has received a group purchasing contract from vizient, inc. biotronik home monitoring is a pioneering and award- winning cardiac remote monitoring system. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. 3 Piorkowski C et al. /Rotate 0 /Type /Pages This website will assist you in determining whether an implanted BIOTRONIK ProMRI system is MR conditional in the country/region where the MRI scan will be performed. /Font << Field of view It is simple to use, and requires no patient interaction for successful daily data transmissions. biotronik cardiomessenger ii- llt transmitter for biotronik home monitoring technical manual ( cardio messenger ii- llt, transmitter for biotronik home monitoring) [ biotronik] on amazon. /ExtGState << J Am Coll Cardiol. /Contents 68 0 R /Resources 40 0 R /TT0 47 0 R << >> /TT3 49 0 R ensure with the cardiology department that the device is programmed to mri mode ( on or auto) prior to the mr scan. /A << some of the most noteworthy innovations in this eld include biotronik home monitoring, the only fda- and ce- approved remote monitoring system for the early detection of clinically relevant events, and promri technology, allowing implant patients to undergo crucial mri scans. The higher the signal quality the less time physicians hampered by low quality ECGs, high levels of noise and other artefacts. /CropBox [0 0 612 792] Less information (see less), For greater confidence, the Atrial Fibrillation (AF) and Pause AccuRhythm AI algorithms further enhance the accuracy of the LINQ II ICM data.15-17, LINQ II ICM delivers eight times fewer false positives1,2,7,18. /Version /1.4 Nlker G, Mayer J, Boldt LH, et al. This website shows the maximum value for the whole body SAR. For MRI information in Japan please check the following webpage: www.pro-mri.jp. /Length 471 For further information, please call Medtronic at 1-800-929-4043 and/or consult the Medtronic websiteatwww.medtronic.com. >> 4 0 obj /Tabs /S /Tabs /S Unlike bulky Holter monitors, the small device is barely noticeable to the patient. /F 4 << /CS1 [/Separation /Black [/ICCBased 42 0 R] /S /URI << /Im0 67 0 R This eliminates complicated set-up procedures that compromise adherence, limit the receipt of data and can require additional patient contact. /Image15 26 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. Pacemaker or ICD patient ID card. /ProcSet [/PDF /Text /ImageC] Device Descriptions . With an updated browser, you will have a better Medtronic website experience. /Contents [12 0 R 13 0 R 14 0 R 15 0 R 16 0 R 17 0 R 18 0 R 19 0 R] /ColorSpace << K190548 FDA clearance. >> /Type /Group >> /Type /Page /TrimBox [0 0 612 792] Remote access to full ECGs eliminates the need for manual transmissions 14; . what is biotronik smart? 16 0 obj 13 0 obj >> * details on these conditions and requirements can be found in the biotronik promri system technical manual ( www. /BS << here %PDF-1.6 % You can find detailed information about the requirements, conditions and measures for safely conducting an MRI scan in the ProMRI System Technical Manual. /S /URI Standard text message rates apply. you have received a device with the additional home monitoring function by biotronik. /XObject << home monitoring system in. >> September 24, 2013;62(13):1195-1202. /TT2 49 0 R }ljxO4!sm4!lO4!l4!l8:7dYAs=8ug]YzYzYzYzYz_s|0s\Cuvt~:r+r8sCq4f>Q'/^dY>MQo+{mw7zyfi Av=&. /TT1 64 0 R /Rect [40.95 36 85.101 45.216] how home monitoring works your device ( 1) is equipped with a special transmitter. reduction in LINQ II false alerts21, 319 /Filter /FlateDecode << 10 it is the only system that has been specially approved for the early detection of. >> << endobj monitoring using the home m onitoring function does not serve to replace regular in- office appointments with the physicia n required for othe r medical reasons. /TT2 55 0 R is remote monitoring for patients with implanted devices? /C2_0 57 0 R No need for unnecessarily complicated delivery tool assemblies. /XObject << /ProcSet [/PDF /Text /ImageC] Penela D, Fernndez-Armenta J, Aguinaga L, et al. A hand-held, electrically-powered device designed to be operated by a clinician or patient to non-invasively change the settings (e.g., turn on/off) of an implantable cardiac monitor (ICM), and/or extract data from the implant, and/or provide an alarm function; it is not intended to communicate with a therapeutic cardiac implant. /TT1 48 0 R Designed to minimize patient effort, it sends daily, automatic cardiac device data to the patient device that then forwards the information to the Home Monitoring Service Center (HMSC). /TT3 66 0 R /GS1 45 0 R It has a small can 60% smaller than its predecessor and a flexible antenna, helping to make it comfortable and discreet for patients. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website atwww.medtronic.com. >> endobj >> endobj /Rotate 0 /Contents 39 0 R Please enter the country/region where the MRI scan will be performed. Do not use the patient connector to communicate with other implanted devices. /Type /Catalog /A << /Resources << /Contents 71 0 R /ExtGState << Potential Complications:Potential complications include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin. 9. 12 0 obj BioMonitor 2-AF and Remote Assistant - Mediadatabase BIOTRONIK SE & Co. KG - CRM, Arrhythmia Monitoring, Cardiac Monitor, Accessories, Complete View, Product Family, Gray Background The Medtronic patient connector is a portable electronic device using low frequency inductive telemetry to communicate with the Reveal LINQ ICM. SRWKU]p3e:A[\V[`;K]>s;%.`46nQRJMzf6#Vh XeXjRj Aid.yA orV\=.I}m_QS7%bM6z~/6F#R]l^zXo{KWH3Xk  >> << << /Type /Page >> Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. 4 BioMonitor 2 BioInsight Study. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA. biotronik home monitoring what is so special about the biotronik home monitoring system? 2017. The Patient Assistant activates one or more of the data management features in the Reveal insertable cardiac monitor: Contraindications:There are no known contraindications for the implant of the Reveal XT insertable cardiac monitor. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) /F 4 >> August 1, 2021;18(8):S47. However, the patients particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated. /ColorSpace << 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). %%EOF It may be used in the home or healthcare facility. /MediaBox [0 0 612 792] Prerfellner H, Sanders P, Sarkar S, et al. /Font << Note: A maximum slew rate of 125 T/m/s per axis is valid for Evia, Entovis, Estella and Ecuro models up to and including serial number 66237094. kg, and we want you to feel secure when using our web pages. Adapting detection sensitivity based on evidence of irregular sinus arrhythmia to improve atrial fibrillation detection in insertable cardiac monitors. /Rect [90.257 280.24 421.33 294.04] 2010, 12(5). Europace. endobj /F2 23 0 R In an environment likely to cause ESD, such as a carpeted floor, discharge any charge collected on your body before touching the device. /GS8 23 0 R BIOTRONIK BIOMONITOR IIIm. An MRI scanner's field of view is the area within which imaging data can be obtained. BIOMONITOR III works with BIOTRONIKs fully automated Home Monitoring. /Type /Page BIOMONITOR III and BIOMONITOR IIIm can be activated by the patientusing the Remote Assistant III to record cardiac rhythm during symptomatic episodes. /A << /ArtBox [0 0 612 792] endobj Penela D, Van Huls Van Taxis C, Aguinaga L, et al. * free* shipping on qualifying offers. The patient connector uses Bluetoothtechnology to transmit implantable heart device data to the Reveal LINQ Mobile Manager app for further processing. >> /URI (http://www.fda.gov/) /StructParent 1 manual library instructions for use and product manuals for healthcare professionals. >> General considerations 9529 Reveal XT Insertable Cardiac Monitor. what is home monitoring system? If the patient connector should fail, there is no risk of patient harm. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] Contraindications: There are no known contraindications. /Type /Page /StructParents 0 endstream endobj 5179 0 obj <>/Metadata 174 0 R/Names 5213 0 R/OpenAction 5180 0 R/Outlines 5278 0 R/PageLabels 5170 0 R/PageLayout/OneColumn/PageMode/UseOutlines/Pages 5172 0 R/StructTreeRoot 246 0 R/Threads 5211 0 R/Type/Catalog>> endobj 5180 0 obj <> endobj 5181 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>>>/Rotate 0/StructParents 1/Type/Page>> endobj 5182 0 obj <>stream The LINQ II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases: There are no known contraindications for the insertion of the LINQ II ICM or its accessories. /ExtGState << >> /Length 394 /Count 7 In practice, this means that the marker line of the MRI scanner's laser positioning marks must be within this zone. /TT0 47 0 R /ExtGState << HoMASQ Study. /Pages 2 0 R There are no known adverse events associated with the use of any LINQ II ICM wireless accessory. Potential Complications:Potential complications of the Reveal LINQ device include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin. /ProcSet [/PDF /Text /ImageB /ImageC /ImageI] /ProcSet [/PDF /Text] 147326, / 08/ 23- 13: 03: 03 format : application/ pdf creator. page 1 cardiomessenger ii- llt transmitter for biotronik home monitoring technical manual sbiotronik. /C2_0 69 0 R AF sensitivity may vary between gross and patient average.