biotronik remote assistant iii manual

Hk0Q*dA)4i7KP&POn{pE0>;IF`t /Parent 2 0 R >> /ArtBox [0 0 612 792] BIOTRONIK BioMonitor 2 technical manual. biotronik home monitoring is the first and only monitoring system that ensures fully automated and highly reliable transmission of implanted device data on a daily basis. >> 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. 35 0 obj <> endobj See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications / adverse events. By clicking the links below to access the news on our International website, you are leaving this website. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) >> << 43 0 R] /Version /1.4 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. << >> It is simple to use, and requires no patient interaction for successful daily data transmissions. Warnings/Precautions:Patients with the Reveal LINQ 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 precautions manual. 9539 Reveal XT Patient Assistant: . MRI scans should be performed only in a specified MR environment under specified conditions as described in the device manual. HMo0B +Ra~!h'6LMjw;L&$3'&&t)g9V`']~ z.OjyS,fgD#q4'ispprh,_$mu^LpQrR]: _Dr. /XObject << if you need assistance. /Type /Group See the device manuals for detailed information regarding the implant procedure, indications / intended use, contraindications, warnings, precautions, and potential complications/adverse events. /CS1 [/ICCBased 61 0 R] August 1, 2021;18(8):S47. /F2 25 0 R /TT3 66 0 R /Resources << /Length 394 ]3vuOB1fi&A`$x!2`G9@?0 L /TT2 49 0 R August 1, 2021;18(8):S47. /ExtGState << #K200444 510(k) Summary Page 2 of 4 4. /Length 525 You can find detailed information about the requirements, conditions and measures for safely conducting an MRI scan in the. /URI (http://www.fda.gov/) /ExtGState << /Parent 2 0 R >> /Im0 67 0 R /Parent 2 0 R /Type /Page Biotronik home monitoring is an award- winning remote monitoring system that provides continuous and automatic wireless remote monitoring of cardiac patient and device status. home monitoring enhances safety for cardiac device patients. Home Monitoring achieves industry leading transmission success rates, along with high levels of patient adherence and satisfaction. /GS0 62 0 R The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. 2 Ricci RP et al. BIOTRONIK BIOMONITOR III. /S /URI << /ProcSet [/PDF /Text /ImageC] /F2 23 0 R designed to minimize patient effort, it sends daily, automatic cardiac device data to the patient device that then forwards biotronik home monitoring manuale the information to the home monitoring service center ( hmsc). 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. >> itssc central europe: itssc south europe: itssc north america: itssc asia pacific: phone: : phone: : phone:. K190548 FDA clearance. /Resources << For further information, call Medtronic Technical Services at (800) 328-2518 and/or consult Medtronics website at www.medtronic.com. /ExtGState << 3 Piorkowski C et al. Field of view Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 [email protected] www.biotronik.com /CS1 [/ICCBased 61 0 R] /MediaBox [0 0 612 792] /Contents 68 0 R /F 4 >> The Bluetoothword mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Medtronic is under license. /TT0 47 0 R h+L5hHJarx(|9Jx$ {K=j2|l!YF ql2-h&fG4t^*O]=:xh p)1FG4SQ.* /Parent 2 0 R Green light above OK = connected. >> In an environment likely to cause ESD, such as a carpeted floor, discharge any charge collected on your body before touching the device. There are no known adverse events associated with the use of any LINQ II ICM wireless accessory. /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\`` /Parent 2 0 R /ProcSet [/PDF /Text /ImageC] endobj /Rotate 0 /CropBox [0.0 0.0 612.0 792.0] /Im1 51 0 R Download the specifications sheet for details on the LINQ II insertable cardiac monitor. @ZvA(thp[x@^P@+70YCT1 5f /BS << Eradicates time consuming and potentially costly multi-step procedures. /BleedBox [0 0 612 792] For further information, please call Medtronic at 1-800-929-4043 and/or consult the Medtronic websiteatwww.medtronic.com. AF sensitivity may vary between gross and patient average. /Contents 49 0 R /Parent 2 0 R PACE. /CS1 [/Separation /Black [/ICCBased 42 0 R] BIOMONITOR III has a longevity of 4 years. OK is displayed at the top left = connected. >> /CS0 [/ICCBased 42 0 R] /BS << 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. endobj /C2_0 46 0 R 8 0 obj Provides daily data trending which may be helpful in determining the need for follow-up. /Contents 39 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). /Rotate 0 /CS0 [/ICCBased 60 0 R] 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 BIOMONITOR III comes ready to inject, pre-loaded into a single piece injection tool for one-step injection. 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. >> 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. Wireless accessories available for use with LINQ II may experience connectivity or performance issues. /A << << /Version /1.4 /W 0 The unit is battery operated making it easy for patients while travelling, with a battery life of up to 48 hours. /BleedBox [0 0 612 792] /Parent 2 0 R It must not be exceeded during the scan. 13 0 obj >> Pairing, initialization and data transmission are all automatic, not requiring any active patient involvement. << 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. Clear P-wave and R-wave visibility helps achieve faster, more confident ECG evaluation. 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-. Data availability and alert notifications are subject to Internet connectivity and access, and service availability. /TT0 47 0 R /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 Address: Woermannkehre1, 12359Berlin, Germany, Limited Partnership having its registered place of business in Berlin, Commercial Register No. /CS1 [/ICCBased 61 0 R] 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. 8 0 obj 3 0 obj Daily verification of data transmissions contributes to an industry leading transmission success rate of 95%. 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. << Daily verification of data transmissions contributes to an industry leading transmission success rate of 95%. Biotronik home monitoring is an award- winning remote monitoring system that provides continuous and automatic wireless remote monitoring of cardiac patient and device status. 9. Contraindications:There are no known contraindications for the implant of the Reveal LINQ ICM or for the Reveal LINQ Mobile Manager system. Penela D, Fernndez-Armenta J, Aguinaga L, et al. Heart Rhythm. /Rotate 0 biotronik home monitoring enables physicians to perform therapy management at any time. with home monitoring, the state heart to the patient device, your of your heart' s health and your implant are cardiomessenger ( 2). 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 Home Monitoring is a pioneering and award-winning remote cardiac monitoring system. hb``d``6d`a` B@q P.p1i@,`yi2*4r >> 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: >> endobj /CropBox [0 0 612 792] GMDN Names and Definitions: Copyright GMDN Agency 2015. /TT4 70 0 R /CropBox [0.0 0.0 612.0 792.0] 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. endobj endstream /Type /Page Country/region 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. /Tabs /S /ExtGState << AccuRhythm AI algorithms can save clinicians approximately 319 hours of false alert review yearly for every 200 LINQ II ICM patients.21, 84% It monitors cardiac activity round the clock, day in and day out, with excellent signal fidelity. /S /URI << 0 2019. /Type /Action /ExtGState << An MRI scanner's field of view is the area within which imaging data can be obtained. Care is exercised in design and manufacturing to minimize damage to devices under normal use. /Type /Page Disclaimer: A controlled, head-to-head study evaluating the comparative performance of these devices has not been done. 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. >> Specifically, the patient connector may be affected by electrostatic discharge (ESD). >> /Contents 36 0 R ensure with the cardiology department that the device is programmed to mri mode ( on or auto) prior to the mr scan. Based on AF episodes 2 minutes and in known AF patients. >> All entered data will be deleted when leaving the web page. >> Use of wireless devicesThe patient connector incorporates radiofrequency (RF) communications components which may affect other devices and equipment in the medical environment. The permissible positioning zone explained below must always be maintained during MR scans of patients with restricted device systems. /TT2 55 0 R % /Contents 72 0 R %PDF-1.6 % Medtronic inductive telemetry uses short-range communication to protect patient information. /Filter /FlateDecode In general, the use of medical devices is only allowed if they are approved. >> App Store is a service mark of Apple Inc. 37 0 R 38 0 R 39 0 R 40 0 R 41 0 R 42 0 R 43 0 R 44 0 R 45 0 R] /Font << the centers for medicare and medicaid services ( cms) ), certified reimbursement coding professionals, other reimbursement experts, and/ or. 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. AccuRhythm clinician manual supplements M015316C001 and M015314C001. TRUST Study, Heart, Lung and Circulation 2009, 18 (s106), 4 Ricci R. P et al HoMASQ study, Europace, 2010, 12 (5). /S /URI Pairing, initialization and data transmission are all automatic, not requiring any active patient involvement. /ArtBox [0 0 612 792] %PDF-1.4 `3$ihfxg'8hd5B_PrV^.Ps'T3=~w4?CIM- {Mk Bluetoothcommunication in the patient connector is encrypted for security. /Tabs /S << /GS1 45 0 R << /CropBox [0 0 612 792] 7 0 obj 15 0 obj >> /Im0 67 0 R /Type /Action RF interference may affect device performance. /F2 25 0 R required expertise in addition to having basic medical knowledge, the user must be thoroughly familiar with the operation of a device system. Click on your monitor for the full manual. /Rect [40.95 36 85.101 45.216] /Annots [51 0 R] Reproduced with Permission from the GMDN Agency. Information Regarding Your Patient ID Card, Team Lead HR Projects, Processes & Reporting. Penela D, Van Huls Van Taxis C, Aguinaga L, et al. 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. hbbd``b`?` $@b@BD$H8X5 Hr@= b"> R7Dw1QHO@k5)G RF`sih L /F1 22 0 R /Filter /FlateDecode /W 0 >> 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. We are working quickly to recover this service. >> << endobj /MediaBox [0 0 612 792] >> /Tabs /S 9 0 obj Caution: Federal law (USA) restricts prescription devices to sale by or on the order of a physician. database contains 1 biotronik renamic manuals ( available for free online viewing or downloading in pdf) : quick reference manual. 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. /Type /Page 13 0 obj /TrimBox [0 0 612 792] /W 0 /TT3 58 0 R /Resources << endstream >> 2010, 12(5). BioMonitor 2-AF and Remote Assistant - Mediadatabase BIOTRONIK SE & Co. KG - CRM, Arrhythmia Monitoring, Cardiac Monitor, Accessories, Complete View, Product Family, Gray Background To ensure the best printing experience, we recommend using the ProMRI SystemCheck on a desktop computer. The FIT OneStep injection tool provides a standardized pocket to accommodate the device comfortably and easily. Artificial Intelligence Enables Dramatic Reduction of False Atrial Fibrillation Alerts from Insertable Cardiac Monitors. % >> Apple and the Apple logo are trademarks of AppleInc., registered in the U.S. and other countries. biotronik home monitoring biotronik home monitoring is the world s most advanced telemonitoring solution for patients with cardiac devices. /Im0 67 0 R >> /Type /Page >> No need for unnecessarily complicated delivery tool assemblies. 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. Brand Name: Remote Assistant Version or Model: III Commercial Distribution Status: In Commercial Distribution Catalog Number: 435292 Company Name: BIOTRONIK SE & Co. KG Primary DI Number: 04035479158330 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 315620229 * Terms of Use /Rotate 0 /XObject << Prerfellner H, Sanders P, Sarkar S, et al. Ousdigian K, Cheng YJ, Koehler J, et al. /Rect [40.95 36 85.101 45.216] /Pages 2 0 R : Berlin-Charlottenburg HRA6501B, Commercial Register No. >> /GS0 62 0 R K201865 FDA clearance. /Contents 46 0 R LINQ II LNQ22 ICM clinician manual. 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. 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 /TT3 58 0 R In practice, this means that the marker line of the MRI scanner's laser positioning marks must be within this zone. /StructParents 0 Reveal LINQ Mobile Manager System:The Reveal LINQ Mobile Manager app is intended for programming and interrogating the Reveal LINQ ICM LNQ11. is remote monitoring for patients with implanted devices? Every year, more and more patients are receiving ICMs all of which must be actively managed, creating additionalworkloads for everyone involved. 55 0 obj <>/Filter/FlateDecode/ID[<427DB793BDE2D541B88ED21029101CC0>]/Index[35 38 74 1]/Info 34 0 R/Length 108/Prev 410609/Root 36 0 R/Size 75/Type/XRef/W[1 3 1]>>stream If the patient connector should fail, there is no risk of patient harm. /F 4 >> /GS0 44 0 R 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:. BIOTRONIK BIOMONITOR III, K190548, cleared July 5, 2019 . 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. 12 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. page 1 cardiomessenger ii- llt transmitter for biotronik home monitoring technical manual sbiotronik. /Group << 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. /Im0 50 0 R /MediaBox [0 0 612 792] >> %%EOF /CS /DeviceRGB >> /Rotate 0 BIOMONITOR IIIm has longevity of 5.5 years. >> << >> /Type /Page /TrimBox [0 0 612 792] >> LINQ II ICM System. /GS0 44 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. /BleedBox [0 0 612 792] Procedural simplicity makes it ideal for in-office settings. Electromagnetic Compliance (EMC) testing shows that the patient connector provides reasonable protection against harmful interference and provides EMC immunity in a typical medical installation. /Image15 26 0 R /F 4 You can find detailed information about the requirements, conditions and measures for safely conducting an MRI scan in the ProMRI System Technical Manual. /Resources 50 0 R For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website atwww.medtronic.com. >> /CropBox [0 0 612 792] /TT0 47 0 R /Tabs /S /ExtGState << Displaying 1 - 1 of 1 10 20 30 50 100 Do not use the patient connector to communicate with other implanted devices. When an AF episode is ongoing during transmission, the monitor transmits both its onset episode and duration.

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