biotronik remote assistant iii manual

/BleedBox [0 0 612 792] 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 2. The medical device REMOTE ASSISTANT is realized by BIOTRONIK SE & CO. KG. 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). An MRI scanner's field of view is the area within which imaging data can be obtained. /CS1 [/Separation /Black [/ICCBased 42 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. 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. /Font << /Type /Group Home Monitoring achieves industry leading transmission success rates, along with high levels of patient adherence and satisfaction. /TT1 64 0 R home monitoring: on; sensing: 60 bpm; daily device message via home monitoring including one automatic subcutaneous ecg per day and 2 patient- triggered subcutaneous ecgs per month mr conditional promri please refer to the technical manual " promri mr condi- tional device systems" for detailed information without scan exclusion zone and. Heart Rhythm. /Filter /FlateDecode /C2_3 62 0 R /Filter /FlateDecode here 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). Higher signal quality reduces the impact of noise and artifact, reduces ambiguity in analysis, and improves the efficiency of provider diagnosis. 2020. 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. Patient Assistant:The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. 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. endstream endobj 3 0 obj /ExtGState << /ArtBox [0 0 612 792] /StructParent 1 /Resources << BIOMONITOR III works with BIOTRONIKs fully automatic Home Monitoring. When an AF episode is ongoing during transmission, the monitor transmits both its onset episode and duration. /Parent 2 0 R /BS << Regarding the isocenter position you can find two possible scan conditions: Full body Pacemaker or ICD patient ID card. You can find detailed information about the requirements, conditions and measures for safely conducting an MRI scan in the ProMRI System Technical Manual. /CropBox [0.0 0.0 612.0 792.0] 10 0 obj >> >> >> Indications:The Reveal LINQ insertable cardiac monitor (ICM) is an implantable patient-activated and automatically activated monitoring system that records subcutaneous ECG and is indicated in the following cases: The device has not been tested specifically for pediatric use. /Contents 60 0 R 1 BIO|CONCEPT. /Resources << the centers for medicare and medicaid services ( cms) ), certified reimbursement coding professionals, other reimbursement experts, and/ or. BIOTRONIK Home Monitoring is a pioneering and award-winning remote cardiac monitoring system. biotronik home monitoring allows clinics the capability biotronik home monitoring manuale to replace device interrogation during in- office follow- up visits1 and to provide early detection of arrhythmias. Low noise also contributes to ECG clarity, which in turn can lead to easier and quicker rhythm classification. 2010, 12(5). BIOMONITOR III is theICM that delivers easier and more efficient injection andmonitoring, and our unique BIOvector design providesthe clearest signals for easier evaluation and betterinformed diagnosis. Without complicated set-up procedures, Home Monitoring demonstrates improved patient adherence. These products are not a substitute for appropriate medical attention in the event of an emergency. /ExtGState << Ousdigian K, Cheng YJ, Koehler J, et al. user manuals, guides and specifications for your biotronik renamic medical equipment. 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. /TT3 66 0 R Based on AF episodes 2 minutes and in known AF patients. See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. /XObject << 2 today, biotronik home monitoring is available in over 55 countries, optimizing patient management in more than 3, 800 clinics around the world. >> /A << MRI scans should be performed only in a specified MR environment under specified conditions as described in the device manual. You will not be able to program or interrogate the patients Reveal LINQ ICM until the patient connector and the mobile device have power. * free* shipping on qualifying offers. Presented at AHA Conference 2021. /XObject << home monitoring enhances safety for cardiac device patients. In general, the use of medical devices is only allowed if they are approved. /ExtGState << /CS0 [/ICCBased 60 0 R] your IT-Support or your BIOTRONIK contact person. BIOMONITOR III can transmit up to six ECGs to Home Monitoring each day, increasing physicians opportunity to evaluate patient status remotely. hbbd``b`?` $@b@BD$H8X5 Hr@= b"> R7Dw1QHO@k5)G RF`sih L page 1 cardiomessenger ii- llt transmitter for biotronik home monitoring technical manual sbiotronik. >> : Berlin-Charlottenburg HRA6501B, Commercial Register No. >> /MediaBox [0 0 612 792] /TT0 47 0 R >> 2017. biotronik home monitoring what is so special about the biotronik home monitoring system? Access interactive courses, videos, and educational resources to extend your learning on LINQ II ICM. General considerations /Type /Page For further information, please call Medtronic at (800) 328-2518 (Technical Services), (800) 551-5544 (Patient Services), and/or consult Medtronics website at www.medtronic.com. << /CS /DeviceRGB /Pages 2 0 R /CropBox [0 0 612 792] Hip and eye - permissible positioning zone. Overwriting older relevant episodes make classification more difficult. /GS7 22 0 R /StructParents 2 /TrimBox [0 0 612 792] endobj >> To make sure that only approved products and conditions will be shown, the country where the scan will take place must be selected. /Im0 50 0 R /Im1 51 0 R /Type /Page 2 Nlker G, Mayer J, Boldt LH, et al. The injection procedure allows for several wound closure techniques to be used, including the use of tissue adhesives. /W 0 Caution:Federal law (USA) restricts these devices to sale by or on the order of a physician. /Type /Page 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: >> The scan exclusion zone is determined by the MRI scanner's field of view and the size of the patient. /Tabs /S /Im0 67 0 R based on biotronik home monitoring information, your physician may be able. /TT3 66 0 R endobj BIOMONITOR III and /MediaBox [0 0 612 792] 35 0 obj <> endobj /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) cardiomessenger smart heart rate monitor pdf manual download. /TT0 63 0 R See product manuals for details and troubleshooting instructions. << 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. /XObject << BIOTRONIK Home Monitoring is a pioneering and award-winning remote cardiac monitoring system. /Rect [90.257 307.84 421.33 321.64] 2 0 obj OK is displayed at the top left = connected. /Resources 50 0 R /CropBox [0 0 612 792] /Resources << BIOMONITOR IIIm has longevity of 5.5 years. /C2_0 38 0 R BIOMONITOR III works with BIOTRONIKs fully automated Home Monitoring. /TT1 64 0 R 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. /TT0 63 0 R As follower of the group you will receive email notifications of events in the group. 9 0 obj The Medtronic patient connector is a portable electronic device using low frequency inductive telemetry to communicate with the Reveal LINQ ICM. var base_url = "https://www.medicaldevices24.com/"; Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA. /CS0 [/ICCBased 42 0 R] /GS0 37 0 R /Type /Page /ProcSet [/PDF /Text /ImageC] you can rest easier knowing that biotronik home monitoring manuale you are being monitored and your care team can be condent that they will be notified of clinically relevant device events in between your in- person. /Parent 2 0 R /Type /Page endobj /TT0 47 0 R /F 4 /F 4 BIOTRONIK BIOMONITOR III technical manual. Why is the selection of a country/region required? /Rect [40.95 36 85.101 45.216] /ArtBox [0 0 612 792] 17 0 obj Home Monitoring is powered by the smartphone-sized CardioMessenger Smart mobile unit. /CropBox [0 0 612 792] Every year, more and more patients are receiving ICMs all of which must be actively managed, creating additionalworkloads for everyone involved. K190548 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. /CS0 [/ICCBased 42 0 R] /Im1 51 0 R /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 HMk09$m)=&C:NJR/Rb {d3&_fw&RovmV}{0d\ &M.MU+>M,0E$T;bm`?oa; E\7P}J>e% Isocenter << Lux-Dx ICM K212206 FDA clearance letter. << what is biotronik smart? >> /ArtBox [0 0 612 792] BIOMONITOR III, data on file. /Resources << 2020. /F 4 /TT1 48 0 R /XObject << 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. /Im0 50 0 R /Resources << >> /GS8 23 0 R 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. /Type /Page BIOTRONIK BIOMONITOR III technical manual. 13 0 obj 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. /Type /Page >> 0 Lux-Dx* ICM, Confirm Rx* with SharpSense* technology, Jot Dx*, and BIOMONITOR* III have no published clinical evidence showing AF episode PPV or AF sensitivity. /GS1 45 0 R /Length 429 stream >> /Image13 24 0 R >> Please check your input. /Font << 5 0 obj 5178 0 obj <> endobj /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) An MRI scanner's field of view is the area within which imaging data can be obtained. >> HKO0"qIHJ&hl$|}u[V; - !A!S#sN8iqWN[m"i#nGd2e;k%(nJ! << /Type /Group 8 0 obj home monitoring system in. << /BleedBox [0 0 612 792] /BleedBox [0 0 612 792] /StructParents 0 Penela D, Van Huls Van Taxis C, Aguinaga L, 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. Wireless accessories available for use with LINQ II may experience connectivity or performance issues. /Rotate 0 4 BioMonitor 2 BioInsight Study. ensure with the cardiology department that the device is programmed to mri mode ( on or auto) prior to the mr scan. /Type /Pages 1 0 obj See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications / adverse events. Monitoring Devices Merlin PCS Help Manual for SJM Confirm, Confirm Rx ICM, Jot Dx Manual. var tpl_folder = "https://www.medicaldevices24.com/public/tpl"; << . /StructParents 0 /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) /CS1 [/ICCBased 61 0 R] >> /Rotate 0 However, receiver only coils can also be positioned outside this area. << Neurohormonal, structural, and functional recovery pattern after premature ventricular complex ablation is independent of structural heart disease status in patients with depressed left ventricular ejection fraction: a prospective multicenter study. BIOTRONIK BIOMONITOR IIIm technical manual. /S /URI To ensure the best printing experience, we recommend using the ProMRI SystemCheck on a desktop computer. /URI (http://www.fda.gov/) December 2017;14(12):1864-1870. HMo0B +Ra~!h'6LMjw;L&$3'&&t)g9V`']~ z.OjyS,fgD#q4'ispprh,_$mu^LpQrR]: _Dr. /Parent 2 0 R /TT1 48 0 R /TrimBox [0 0 612 792] Intelligent Memory Management ensures that the detection of both overlapping arrhythmia episodes and patient triggered episodes are stored, with corresponding ECGs always available for evaluation. 9529 Reveal XT Insertable Cardiac Monitor. /S /Transparency view and download biotronik cardiomessenger smart technical manual online. itssc central europe: itssc south europe: itssc north america: itssc asia pacific: phone: : phone: : phone:. /CS0 [/ICCBased 60 0 R] >> /BleedBox [0 0 612 792] This is an instructional video for patients with BIOTRONIK BIOMONITOR devices who use the BIOTRONIK Home Monitoring for remote monitoring.Disclaimer: This vi. /S /URI /BS << >> LINQ II ICM is ideal for patients experiencing infrequent symptoms that require long-term monitoring or ongoing management. 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. Where can I find the order number of the product? >> BIOMONITOR III features simplified programming by indication-based program sets and enhanced signal quality by improved filtering and data compression. BioMonitor 2-AF and Remote Assistant - Mediadatabase BIOTRONIK SE & Co. KG - CRM, Arrhythmia Monitoring, Cardiac Monitor, Accessories, Complete View, Product Family, Gray Background /Rotate 0 /Length 449 /S /URI Watch this video to learn more about LINQ II ICM. /ArtBox [0 0 612 792] Home Monitoring not only allows physicians to safely review cardiac function, it also sends alerts about relevant . This eliminates complicated set-up procedures that compromise adherence, limit the receipt of data and can require additional patient contact. }); ACTIVE-IMPLANTABLE CARDIAC DEVICES, DIAGNOSTIC - ACCESSORIES, SYSTEM OF ENTERING STERILE LINQ II - LNQ22TK, Complete classification of medical devices, Progressive number assigned to the medical device, End of validity is not present for the medical device. 8 0 obj /CS0 [/ICCBased 42 0 R] endobj /TT2 65 0 R /Length 525 >> LINQ II ICM System. Provides daily data trending which may be helpful in determining the need for follow-up. /ProcSet [/PDF /Text /ImageC] 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 It monitors cardiac activity round the clock, day in and day out, with excellent signal fidelity. endif; ?> /Rotate 0 /C2_0 69 0 R The injectable BIOMONITOR IIIm is a tiny device that can be quickly and easily injected into the patient and can be worn comfortably for years. 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-. >> /XObject << /Type /Page Procedural simplicity makes it ideal for in-office settings. /Font << Use of wireless devicesThe patient connector incorporates radiofrequency (RF) communications components which may affect other devices and equipment in the medical environment. Presented at HRS 2021. AccuRhythm clinician manual supplements M015316C001 and M015314C001. Environmental precautions To ensure safe and effective operation, use the device with care to avoid damage to the patient connector from environmental factors that may impair its function. /TrimBox [0 0 612 792] Country/region @ZvA(thp[x@^P@+70YCT1 5f /BS << endobj Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. /MediaBox [0 0 612 792] >> Europace. It has a small footprint 60% smaller than its predecessor and a flexible antenna, helping to make it more comfortable and cosmetically preferred for patients. /Font << /BS << with biotronik home monitoring, healthcare providers have a complementary option to routine follow- up visits, while maintaining in- person follow- ups every 12 months. endstream endobj LINQ II ICM is the world's most accurate ICM,1-13 featuring enhanced algorithms, remote programming, and 4.5-year longevity.14. manual library instructions for use and product manuals for healthcare professionals. There is no guarantee that it will not receive interference or that any particular transmission from this system will be free from interference. biotronik home monitoring biotronik home monitoring is the world s most advanced telemonitoring solution for patients with cardiac devices. BIOMONITOR III fits a variety of body types. %PDF-1.6 % 2019. K201865 FDA clearance. The Patient Assistant activates the data management feature in the Reveal insertable cardiac monitor to initiate recording of cardiac event data in the implanted device memory. This website shows the maximum for the slew rate value, which must not be exceeded during the scan. Heart Rhythm. 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. 5 Varma N et al. Security Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. 11 0 obj >> /Contents 56 0 R /CropBox [0.0 0.0 612.0 792.0] BIOMONITOR III enables up to six ECGs to be transmitted by Home Monitoring each day, increasing physicians opportunity to evaluate patient status remotely. >> /Type /Action database contains 1 biotronik renamic manuals ( available for free online viewing or downloading in pdf) : quick reference manual. BIOMONITOR III is the ICM that delivers easier and more efficient injection and monitoring, and our unique BIOvector design provides the clearest signals for easier evaluation and better informed diagnosis. Do not use the patient connector to communicate with other implanted devices. /Font << Sorry, the serial number check is currently unavailable. 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 use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization.

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