Operation of the Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device. /Filter /FlateDecode It is also 1.5T and 3.0T full-body MR conditional and there is no waiting period after the injection procedure. /Type /Page /StructParents 0 Neither data such as the serial number, product names or order numbers, nor the result will be stored. 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. Click on your monitor for the full manual. /Subtype /Link /Subtype /Link Lux-Dx ICM K212206 FDA clearance letter. /Font << /MediaBox [0.0 0.0 612.0 792.0] /Type /Page 8 0 obj /A << Please contact us Heart Rhythm. 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. BIOMONITOR III - Biotronik /Font << The device is programmed to an MRI mode before the MR scan. /StructParents 2 /Im1 51 0 R /Parent 2 0 R % 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. 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 However, receiver only coils can also be positioned outside this area. Additional inputs can be provided with BIOTRONIKs patient app, which has a symptom diary that via direct contact or our Home Monitoring Service Center, keeps patient and physicians fully informed. kg, and we want you to feel secure when using our web pages. >> 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. 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. /CS1 [/ICCBased 61 0 R] 2020. The mean specific absorption rate (SAR) for the whole body is shown in watts per kilogram (W/kg). /CS0 [/ICCBased 42 0 R] This website provides worldwide support, except for Japan. /StructParents 2 /Type /Page >> /TT1 64 0 R For further information, call Medtronic Technical Services at (800) 328-2518 and/or consult Medtronics website at www.medtronic.com. Unlike bulky Holter monitors, the small device is barely noticeable to the patient. 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. /GS0 62 0 R /GS7 22 0 R /C2_0 53 0 R @ZvA(thp[x@^P@+70YCT1 5f if you need assistance. << 7 0 obj Warning: This website provides information on the MRI compatibility of the implanted system. /Type /Page BIOMONITOR III enables up to six ECGs to be transmitted by Home Monitoring each day, increasing physicians opportunity to evaluate patient status remotely. The BIOvector provides high signal amplitudes; the fractal coating increases the sensing surfaces, and the unique lossless compression algorithm further enhances the clarity of the signals. /CS0 [/ICCBased 60 0 R] how home monitoring works your device ( 1) is equipped with a special transmitter. >> >> Language Title Revision Published Download PDF Change history Printed copy Low noise also contributes to ECG clarity, which in turn, can lead to easier and quicker rhythm classification. >> LINQ II ICM System. See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. 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. hb``d``6d`a` B@q P.p1i@,`yi2*4r >> /Im1 51 0 R Eradicates time consuming and potentially costly multi-step procedures. /Contents 60 0 R driven by purpose and integrity, biotronik has partnered with hospitals and health systems for more than 50 years, helping to deliver care that saves and improves the lives of millions of patients with heart and blood vessel diseases. /ColorSpace << %PDF-1.6 % 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. << First European-approved (TV notified body) remote programmable device. /TT0 23 0 R By clicking the links below to access the news on our International website, you are leaving this website. /ArtBox [0 0 612 792] << BIOMONITOR IIIm has longevity of 5.5 years. /CS0 [/ICCBased 42 0 R] /Contents 71 0 R Isocenter /Type /Pages /A << BIOMONITOR III is the ICM that delivers both an easy injection procedure and efficient post-procedure monitoring, and our unique BIOvector design provides clear signals for easier evaluation and a better-informed diagnosis. /ExtGState << Pacemaker or ICD patient ID card. /GS7 20 0 R /S /Transparency Penela D, Fernndez-Armenta J, Aguinaga L, et al. /Im0 67 0 R /TT1 48 0 R << /GS7 22 0 R Nlker G, Mayer J, Boldt L, et al. /TT4 59 0 R BIOMONITOR III works with BIOTRONIKs fully automatic Home Monitoring. This website shows the maximum for the slew rate value, which must not be exceeded during the scan. 2 Nlker G, Mayer J, Boldt LH, et al. /Pages 2 0 R , the largest, member- driven, healthcare performance improvement company in the united states. /BleedBox [0 0 612 792] 11 0 obj Please check your input. /W 0 Caution: Detailed information about ProMRI can be found in the ProMRI System Technical Manual. The unit is battery operated making it easy for patients while travelling, with a battery life of 48 hours. Reproduced with Permission from the GMDN Agency. /ExtGState << << << here endobj /Font << /Resources << BIOTRONIK Home Monitoring setup - YouTube /Resources << Where can I find the serial number or the product name? /XObject << /Font << /Annots [10 0 R 11 0 R 12 0 R 13 0 R] /Tabs /S >> 11 0 obj reduction in LINQ II false alerts21, 319 /F2 25 0 R BioMonitor 2-AF and Remote Assistant - Mediadatabase BIOTRONIK SE & Co. KG endobj endobj /TT0 47 0 R >> manual library instructions for use and product manuals for healthcare professionals. /Im1 51 0 R Use of wireless devicesThe patient connector incorporates radiofrequency (RF) communications components which may affect other devices and equipment in the medical environment. /TT3 58 0 R >> (adsbygoogle = window.adsbygoogle || []).push({ The permissible positioning zone explained below must always be maintained during MR scans of patients with restricted device systems. 12 0 obj hZks?a>Jr*VidhG`HHA@G3 +TTL~{GS*Xc+#chNLI $Wr9cu=_YSL'JYWEU\*E.ecNrU8+F/qng*c8l`eF\c7)q 5kxQG1]aU0\ Gs)r5GYp ^1qZ*@)fb SE.T 8GQH@^VXW~$]I0ItQc&"x J1$5Dx_Nf>x]o;A]a,eH, FP+?nMAp bi({y|0N^z(^wy8! Trade name: REMOTE ASSISTANT: Product Code: 405475: Manufacturer of the medical device: BIOTRONIK SE & CO. KG: Vat Number: 136651322: Category Name: ACTIVE-IMPLANTABLE CARDIAC DEVICES, DIAGNOSTIC - ACCESSORIES: Category Code: J010280: >> /Length 449 /Resources << Make sure you entered the device name, order number or serial number correctly. HKk09F$B`PK!7l|X;j[qz(dsqo^r}wz8;7?mv}Vg(TTA U6M>Mud+JC}&) (rJwvAZOg^ y4]KA'M/8\Lb i+3sQk^I$FkhXE7*lv]+w=U However, the patients particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated. Heart Rhythm. BIOMONITOR IIIm comes ready to inject, pre-loaded into a single piece injection tool for one-step injection. based on biotronik home monitoring information, your physician may be able. 4 BioMonitor 2 BioInsight Study. >> 2017. /Resources << 2 Ricci RP et al. >> /GS0 44 0 R /Type /Action Hip and eye /Font << ||First European-approved (TV notified body) remote programmable device. 43 0 R] Information Regarding Your Patient ID Card, Team Lead HR Projects, Processes & Reporting. 2 today, biotronik home monitoring is available in over 55 countries, optimizing patient management in more than 3, 800 clinics around the world. Please contact us Indications:The intended use of the system is to reduce false positive cardiac arrhythmia episodes. /Im1 51 0 R /Font << HMo0B +Ra~!h'6LMjw;L&$3'&&t)g9V`']~ z.OjyS,fgD#q4'ispprh,_$mu^LpQrR]: _Dr. >> Circulation. 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. /F 4 /CropBox [0 0 612 792] >> /Type /Page If this is not the case please try the monitor closer to a window. The validation study performance and time study results were projected onto 16,301 LINQ II patients to calculate the time saved per year in 200 LINQ II ICM patients. BIOMONITOR III features simplified programming by indication-based program sets and enhanced signal quality by improved filtering and data compression. /Resources << << endobj /S /URI google_ad_client: "ca-pub-5568848730124950", /Rect [40.95 36 85.101 45.216] 7 0 obj >> 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. /XObject << endstream Please check your input. 13 0 obj endstream endobj startxref >> /ProcSet [/PDF /Text] /TT4 70 0 R 9 0 obj There is no guarantee that it will not receive interference or that any particular transmission from this system will be free from interference. /MediaBox [0 0 612 792] 2020. << /CropBox [0 0 612 792] /Resources << Cardiac Rhythm /Font << 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. JCardiovasc Electrophysiol. /Rotate 0 /Annots [51 0 R] /TT0 63 0 R /StructParents 3 >> 16Radtke AP, Ousdigian KT, Haddad TD, Koehler JL, Colombowala IK. 5210 0 obj <>/Filter/FlateDecode/ID[<3A0DC8DDBFE34A84B3D7753CE76AFBE9><8F0A54EF42648D4DA9190B0BCFF18DC7>]/Index[5178 220]/Info 5177 0 R/Length 147/Prev 883076/Root 5179 0 R/Size 5398/Type/XRef/W[1 2 1]>>stream >> Based on AF episodes 2 minutes and in known AF patients. 2020. endif; ?> /CropBox [0.0 0.0 612.0 792.0] >> However, the patients particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. /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] /ArtBox [0 0 612 792] /Type /Page /ExtGState << endobj * details on these conditions and requirements can be found in the biotronik promri system technical manual ( www. Home Monitoring not only allows physicians to safely review cardiac function, it also sends alerts about relevant . OK is displayed at the top left = connected. 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. >> * free* shipping on qualifying offers. 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 /Resources 50 0 R PACE. /A << /A << 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. 9539 Reveal XT Patient Assistant: . /Parent 2 0 R /MediaBox [0 0 612 792] ensure with the cardiology department that the device is programmed to mri mode ( on or auto) prior to the mr scan. 17 0 obj The scan exclusion zone is determined by the MRI scanner's field of view and the size of the patient. >> it allows your doctor to continuously access information about your implanted system. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) >> >> /Parent 2 0 R PDF BIOMONITOR III - mars BIOMONITOR III can transmit up to six ECGs to Home Monitoring each day, increasing physicians opportunity to evaluate patient status remotely. BIOMONITOR III, data on file. << stream /Type /Page %PDF-1.4 biotronik home monitoring manual free pdf instructions. biotronik, a leading manufacturer of cardiovascular medical technology, recently announced the ce approval of cardiomessenger smart. endobj var site_url = "https://www.medicaldevices24.com/"; An MRI scanner's field of view is the area within which imaging data can be obtained. endobj /MediaBox [0 0 612 792] 13 0 obj Bluetoothcommunication in the patient connector is encrypted for security. The field strength is measured in tesla (T). /W 0 >> Biotronik home monitoring manuale | Peatix 4 0 obj >> >> /TT3 66 0 R Country/region /XObject << &#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` Provides daily data trending which may be helpful in determining the need for follow-up. The higher the signal quality the less time physicians hampered by low quality ECGs, high levels of noise and other artefacts. /CS /DeviceRGB 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. BIOTRONIK BIOMONITOR III. LINQ II Future is Here Video 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. >> /TT4 70 0 R /Contents 56 0 R are permitted for patient monitoring in an mri environment. Contraindications:There are no known contraindications for AccuRhythm AI Models ZA400, ZA410, or ZA420. >> /ExtGState << /Tabs /S /Type /Group All other brands are trademarks of a Medtronic company. /F2 25 0 R 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. %PDF-1.4 /XObject << 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. /Type /Group /Resources << /BS << /GS0 62 0 R Displaying 1 - 1 of 1 10 20 30 50 100 hours reduction in clinic review time21. /ArtBox [0 0 612 792] /Type /Group search only for biotronik home monitoring manuale. Update my browser now. 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. 9529 Reveal XT Insertable Cardiac Monitor. >> /MediaBox [0.0 0.0 612.0 792.0] BIOMONITOR III Manual Go to ProMRI SystemCheck Injection Procedure in Less Than One Minute1 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. /Parent 2 0 R << /GS0 37 0 R /Filter /FlateDecode All entered data will be deleted when leaving the web page. AccessGUDID - DEVICE: Remote Assistant (04035479158330) . /Resources << You literally just plug it into the power and it is up and running. The medical device REMOTE ASSISTANT is realized by BIOTRONIK SE & CO. KG. /Parent 2 0 R endobj 5 Varma N et al. Clinical recognition of pure premature ventricular complex-induced cardiomyopathy at presentation. /Subtype /Link >> is remote monitoring for patients with implanted devices? >> Please contact your local BIOTRONIK representative. Home Either monitor needs to be . Data on file. Daily verification of data transmissions contributes to an industry leading transmission success rate of 95%. /TrimBox [0 0 612 792] /Filter /FlateDecode 10 0 obj /TT1 48 0 R /ColorSpace << Cheng YJ, Ousdigian KT, Koehler J, Cho YK, Kloosterman M. Innovative Artificial Intelligence Application Reduces False Pause Alerts while Maintaining Perfect True Pause Sensitivity for Insertable Cardiac Monitors. >> /TT1 64 0 R /CS1 [/ICCBased 61 0 R] BIOTRONIK Manual Library Access interactive courses, videos, and educational resources to extend your learning on LINQ II ICM. Monitoring Devices Merlin PCS Help Manual for SJM Confirm, Confirm Rx ICM, Jot Dx Manual. >> /CS0 [/ICCBased 60 0 R] >> /GS1 45 0 R Overwriting older relevant episodes make classification more difficult. /GS0 62 0 R 2017. stream Make sure you enter the country/region name in the currently selected language. biotronik home monitoring enables physicians to perform therapy management at any time. << /Type /Pages BIOTRONIK Home Monitoring is a pioneering and award-winning remote cardiac monitoring system. BIOMONITOR III and /CropBox [0.0 0.0 612.0 792.0] /URI (http://www.fda.gov/) Products Nlker G, Mayer J, Boldt LH, et al. /StructParents 3 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-. Low noise also contributes to ECG clarity, which in turn can lead to easier and quicker rhythm classification. Home Monitoring Service Center - 3.55.0 10/29/22 It is simple to use, and requires no patient interaction for successful daily data transmissions. Please enter the country/region where the MRI scan will be performed. The validation study performance and time study results were projected onto 16,301 LINQ II patients to calculate the time saved per year in 200 LINQ II ICM patients. /TT2 55 0 R BIOMONITOR III fits a variety of body types. /GS0 44 0 R This eliminates complicated set-up procedures that compromise adherence, limit the receipt of data and can require additional patient contact. %%EOF >> 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. 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 GMDN Names and Definitions: Copyright GMDN Agency 2015. /Type /Page /MediaBox [0 0 612 792] For further information, please call Medtronic at 1-800-929-4043 and/or consult the Medtronic websiteatwww.medtronic.com. /Parent 2 0 R endobj 3 0 obj /Type /Group It must not be exceeded during the scan. /Font << /Type /Action 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\`` Procedural simplicity makes it ideal for in-office settings. If the patient connector should fail, there is no risk of patient harm. 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. /GS1 45 0 R /Annots [10 0 R 11 0 R] 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. %%EOF AccuRhythm AI algorithms can save clinicians approximately 319 hours of false alert review yearly for every 200 LINQ II ICM patients.21, 84% here Artificial Intelligence Enables Dramatic Reduction of False Atrial Fibrillation Alerts from Insertable Cardiac Monitors. /TrimBox [0 0 612 792] /S /URI 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. >> /Rect [90.257 280.24 421.33 294.04] >> >> /Length 397 However, electronic devices are susceptible to many environmental stresses. /TT3 66 0 R The scan exclusion zone is determined by the MRI scanner's field of view and the size of the patient. When an AF episode is ongoing during transmission, the monitor transmits both its onset episode and duration. /C2_1 46 0 R dear patient: you have received a biotronik pacemaker or implantable cardioverter- defibrillator ( icd) with home monitoring function. 2020. 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. /TT1 48 0 R >> Medtronic inductive telemetry uses short-range communication to protect patient information. M974764A001D. 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. K190548 FDA clearance. 2 0 obj /A << 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. 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. 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. J Am Coll Cardiol. /Image15 26 0 R Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. The MyCareLink patient monitor must be on and in range of the device. - (03:56), Watch this video to learn more about the LINQ II insertable cardiac monitor. Overwriting older, more relevant episodes with newer, less relevant data makes classification more difficult. /XObject << Home Monitoring Service Center - 3.55.0 10/29/22 15 0 obj /Type /Action /ExtGState << The serial number and product name can be found on: None of the entered data will be stored. /Count 7 BIOMONITOR III fits a variety of body types. 5 0 obj Why is the selection of a country/region required? Electromagnetic Compliance (EMC) testing shows that the patient connector provides reasonable protection against harmful interference and provides EMC immunity in a typical medical installation. biotronik cardiomessenger ii- llt transmitter for biotronik home monitoring technical manual ( cardio messenger ii- llt, transmitter for biotronik home monitoring) [ biotronik] on amazon. 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. /BleedBox [0 0 612 792] /F 4 The BIOvector provides high signal amplitudes; the fractal coating increases the sensing surface area, and the unique lossless compression algorithm enhances the clarity of the signals. hVR8 $[lMQ$d "pD/[_-9 ;eVw[X" 09 (a1%#$($@, !$"B &G?&!z4 >A00vJBjA}:*lu-:GGk+]+YVQ])i[l/tlVJ>}uThtd$ZAe a)\f[Gf65d~bNFtf)wvKH.pjT0+4 _^(604~Vz<18Y Z g`Vp }| 2 s CP0m Ycd>4P@ 6)];TP &1L0J)zgx9r{N29})j/w,a\nD:uLL:YnBLI100* "V_)-|W*^RTW#Xm>\h_F`[ CBA{X )8~f @2pE%]AG?HhIGlD@k(5n^M|r(#"'# stream endobj With an updated browser, you will have a better Medtronic website experience. home monitoring system in. In an environment likely to cause ESD, such as a carpeted floor, discharge any charge collected on your body before touching the device. /TrimBox [0 0 612 792] 72 0 obj <>stream Security Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. Adapting detection sensitivity based on evidence of irregular sinus arrhythmia to improve atrial fibrillation detection in insertable cardiac monitors. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) HKO0"qIHJ&hl$|}u[V; - !A!S#sN8iqWN[m"i#nGd2e;k%(nJ! See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential complications/adverse events.