@ZvA(thp[x@^P@+70YCT1 5f /Rotate 0 /CS1 [/ICCBased 61 0 R] 5178 0 obj <> endobj 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. /Contents 36 0 R >> /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] /ColorSpace << 2019. /CS0 [/ICCBased 42 0 R] 43 0 R] 15 0 obj /BS << OK is displayed at the top left = connected. 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). 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. Please contact your local BIOTRONIK representative. BIOMONITOR III and BIOMONITOR IIIm can be activated by the patientusing the Remote Assistant III to record cardiac rhythm during symptomatic episodes. >> % SRWKU]p3e:A[\V[`;K]>s;%.`46nQRJMzf6#Vh XeXjRj Aid.yA orV\=.I}m_QS7%bM6z~/6F#R]l^zXo{KWH3Xk /Tabs /S /Length 397 /StructParents 0 /S /Transparency 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. 2021. /Count 7 If this is not the case please try the monitor closer to a window. /Im1 51 0 R how home monitoring works your device ( 1) is equipped with a special transmitter. /TT5 49 0 R /ExtGState << /Resources << Where can I find the serial number or the product name? >> /Rotate 0 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). endobj MRI scans should be performed only in a specified MR environment under specified conditions as described in the device manual. >> >> >> AccuRhythm clinician manual supplements M015316C001 and M015314C001. /ExtGState << /CS1 [/ICCBased 61 0 R] See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. /Filter /FlateDecode >> Use of wireless devicesThe patient connector incorporates radiofrequency (RF) communications components which may affect other devices and equipment in the medical environment. 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. Home Monitoring not only allows physicians to safely review cardiac function, it also sends alerts about relevant . 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. /CropBox [0 0 612 792] Click on your monitor for the full manual. /S /URI 9 0 obj Provides daily data trending which may be helpful in determining the need for follow-up. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic websiteatwww.medtronic.com. Login with Workspace ONE <B>WARNING:</B> To maintain your login session, make sure that<BR>your browser is configured to accept Cookies. /Annots [10 0 R 11 0 R] /Subtype /Link >> 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. /ProcSet [/PDF /Text /ImageC] Country/region /Resources << 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-. %PDF-1.4 /Contents [14 0 R 15 0 R 16 0 R 17 0 R 18 0 R 19 0 R 20 0 R 21 0 R] /A << /Parent 2 0 R /A << /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] /TT2 65 0 R >> 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. /Resources 40 0 R Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. /StructParents 2 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 << December 2017;14(12):1864-1870. /ArtBox [0 0 612 792] /TT2 65 0 R >> /TrimBox [0 0 612 792] 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. /ExtGState << /MediaBox [0 0 612 792] >> /Im0 50 0 R /F2 25 0 R /Pages 2 0 R /TT0 47 0 R enable_page_level_ads: true /Pages 2 0 R /ExtGState << }ljxO4!sm4!lO4!l4!l8:7dYAs=8ug]YzYzYzYzYz_s|0s\Cuvt~:r+r8sCq4f>Q'/^dY>MQo+{mw7zyfi Av=&. Hk0Q*dA)4i7KP&POn{pE0>;IF`t Intelligent Memory Management prevents this issue, by retaining the most clinically valid episodes. 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. 2021. /StructParent 1 Reproduced with Permission from the GMDN Agency. << biotronik home monitoring home monitoring service center crm / / manual tcnico / / biotronik home monitoring l_ ga_ hmsc- iii_ es_ cover. 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). if you need assistance. /A << Care is exercised in design and manufacturing to minimize damage to devices under normal use. /Type /Pages 2020. The injection procedure allows for several wound closure techniques to be used, including the use of tissue adhesives. Caution: Federal law (USA) restricts prescription devices to sale by or on the order of a physician. /ExtGState << For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website atwww.medtronic.com. endstream J Am Coll Cardiol. /A << The medical device REMOTE ASSISTANT is realized by BIOTRONIK SE & CO. KG. 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: /Type /Action endstream 9 0 obj 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(#"'# /C2_2 61 0 R endobj /Type /Page 2017. /MediaBox [0.0 0.0 612.0 792.0] /CS /DeviceRGB if you need assistance. 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. 12 0 obj Overwriting older, more relevant episodes with newer, less relevant data makes classification more difficult. google_ad_client: "ca-pub-5568848730124950", The FIT OneStep injection tool provides a standardized pocket to accommodate the device comfortably and easily. /Resources << See product manuals for details and troubleshooting instructions. /Rotate 0 << /TrimBox [0 0 612 792] You can find detailed information about the requirements, conditions and measures for safely conducting an MRI scan in the ProMRI System Technical Manual. It is also 1.5T and 3.0T full-body MR conditional and there is no waiting period after the injection procedure. Europace November 1, 2018;20(FI_3):f321-f328. BIOMONITOR III Manual Go to ProMRI SystemCheck Injection Procedure in Less Than One Minute1 It is simple to use, and requires no patient interaction for successful daily data transmissions. 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. /CS0 [/ICCBased 42 0 R] /Image13 24 0 R 7 0 obj Every year, more and more patients are receiving ICMs all of which must be actively managed, creating additionalworkloads for everyone involved. /TT2 49 0 R >> 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. Patients with the LINQ II ICM 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 as described in the Medical procedure and EMI Warnings, Precautions and Guidance Manual. /URI (http://www.fda.gov/) 72 0 obj <>stream endobj However, the patients particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. /Parent 2 0 R /TrimBox [0 0 612 792] BIOMONITOR III, data on file. The mean specific absorption rate (SAR) for the whole body is shown in watts per kilogram (W/kg). /MediaBox [0 0 612 792] 13 0 obj /CS0 [/ICCBased 42 0 R] Cardiac Monitors /Rotate 0 Adapting detection sensitivity based on evidence of irregular sinus arrhythmia to improve atrial fibrillation detection in insertable cardiac monitors. Bluetoothcommunication in the patient connector is encrypted for security. /CS0 [/ICCBased 60 0 R] /GS8 23 0 R MRI scans should be performed only in a specified MR environment under specified conditions as described in the LINQ II MRI Technical Manual. J Cardiovasc Electrophysiol. 0 /W 0 /Type /Group /Type /Group
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