The higher the signal quality the less time physicians hampered by low quality ECGs, high levels of noise and other artefacts. }ljxO4!sm4!lO4!l4!l8:7dYAs=8ug]YzYzYzYzYz_s|0s\Cuvt~:r+r8sCq4f>Q'/^dY>MQo+{mw7zyfi Av=&. /Tabs /S 2010, 12(5). More information (see more) /Subtype /Link Intelligent Memory Management minimizes this risk, by retaining the most clinically valid episodes. endobj /TrimBox [0 0 612 792] An MRI scanner's field of view is the area within which imaging data can be obtained. 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. /GS0 44 0 R /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) /ExtGState << 1 0 obj Presented at HRS 2021. << /MediaBox [0.0 0.0 612.0 792.0] >> 7 0 obj /ArtBox [0 0 612 792] << 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. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) /TT1 64 0 R The field strength is measured in tesla (T). /W 0 PDF BIOMONITOR III - mars /W 0 /StructParents 0 /Annots [51 0 R] endstream endobj startxref /StructParents 2 endobj You will not be able to program or interrogate the patients Reveal LINQ ICM until the patient connector and the mobile device have power. << /StructParents 4 endobj /Im1 51 0 R SRWKU]p3e:A[\V[`;K]>s;%.`46nQRJMzf6#Vh XeXjRj Aid.yA orV\=.I}m_QS7%bM6z~/6F#R]l^zXo{KWH3Xk  Home Monitoring Service Center - 3.55.0 10/29/22 >> 2021. /C2_0 53 0 R /GS1 45 0 R /TT0 47 0 R view and download biotronik cardiomessenger smart technical manual online. Please contact us /Type /Group /BS << based on biotronik home monitoring information, your physician may be able. Biotronik home monitoring manuale | Peatix /TT2 65 0 R /ExtGState << /StructParents 0 >> /ProcSet [/PDF /Text /ImageB /ImageC /ImageI] /BleedBox [0 0 612 792] 5 Varma N et al. /URI (http://www.fda.gov/) . /ExtGState << /S /URI /Rect [90.257 307.84 421.33 321.64] /Rotate 0 /MediaBox [0.0 0.0 612.0 792.0] 16 0 obj /Filter /FlateDecode >> biotronik renamic manuals & user guides. /Font << 4 0 obj /ProcSet [/PDF /Text /ImageB /ImageC /ImageI] 2020. THE List - MRI Safety /Rotate 0 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. >> /MediaBox [0 0 612 792] biotronik home monitoring home monitoring service center crm / / manual tcnico / / biotronik home monitoring l_ ga_ hmsc- iii_ es_ cover. Pairing, initialization and data transmission are all automatic, not requiring any active patient involvement. /Type /Group here << here /Rotate 0 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 /CS0 [/ICCBased 42 0 R] ICD, pacemaker or cardiac monitor (BIOTRONIK products only). /Font << /Subtype /Link ; page 2: follow- up data overview physician callback signal ( 1) follow- up data transmission ( 2) ready ( cardiomessenger ii) ( 3) battery monitor light ( 4) ready ( charging station) ( 5) data interface ( 6) a view of the rear side of the device can be found on the back cover. /Rotate 0 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. /Filter /FlateDecode /CS0 [/ICCBased 42 0 R] Medtronic inductive telemetry uses short-range communication to protect patient information. 2017., The exclusive PVC detector may help identify high-risk patients.19,20, BlueSync technology within LINQ II ICM enables secure, wireless communication via Bluetooth Low Energy without compromising device longevity.14. /TT0 63 0 R K190548 FDA clearance. biotronik home monitoring manual free pdf instructions. endobj /StructParent 1 >> /ExtGState << /BleedBox [0 0 612 792] Mobile device access to the internet is required and subject to coverage availability. /TT2 55 0 R 2 0 obj /Resources << /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] 2021. /A << page 1 cardiomessenger ii- llt transmitter for biotronik home monitoring technical manual sbiotronik. ensure with the cardiology department that the device is programmed to mri mode ( on or auto) prior to the mr scan. >> /ColorSpace << << * details on these conditions and requirements can be found in the biotronik promri system technical manual ( www. BIOTRONIK Remote Assistant III NCC CCAI20LP0360T8 - FCC ID /Parent 2 0 R Home Monitoring achieves industry-leading transmission success rates, along with high levels of patient adherence and satisfaction. >> Presented at AHA Conference 2021. 3 0 obj /Group << /XObject << /Resources << it is the most user- friendly, most clinically actionable cardiac remote monitoring solution available today 1. please select your region. /MediaBox [0.0 0.0 612.0 792.0] >> 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. /CropBox [0 0 612 792] 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. Europace. /ColorSpace << /MediaBox [0 0 612 792] << itssc central europe: itssc south europe: itssc north america: itssc asia pacific: phone: : phone: : phone:. Heart Rhythm. however, remote monitoring for patients with implanted devices is increasingly being recommended in treatment guidelines. endobj com contact medtronic terms of. 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. /CS0 [/ICCBased 60 0 R] >> 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. 2019. /Tabs /S /MediaBox [0 0 612 792] 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. /TrimBox [0 0 612 792] Eliminates time consuming and potentially costly multi-step procedures. /Type /Page Penela D, Van Huls Van Taxis C, Aguinaga L, et al. Indications:The intended use of the system is to reduce false positive cardiac arrhythmia episodes. 2019, doi: 10.1111/pace.13728. /GS1 45 0 R << Download the specifications sheet for details on the LINQ II insertable cardiac monitor. 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. 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). /F 4 >> 10 it is the only system that has been specially approved for the early detection of. /Parent 2 0 R /W 0 Artificial Intelligence Dramatically Reduces Annual False Alerts from Insertable Cardiac Monitors. Where can I find the order number of the product? Medtronic, Medtronic logo, andEngineering the extraordinary are trademarks of Medtronic. /TT2 49 0 R BIOTRONIK BIOMONITOR III, K190548, cleared July 5, 2019 . /Contents 60 0 R with home monitoring, the state heart to the patient device, your of your heart' s health and your implant are cardiomessenger ( 2). BIOTRONIK Manual Library Home Monitoring is powered by the smartphone-sized CardioMessenger Smart mobile unit. December 2017;14(12):1864-1870. 12 0 obj endobj /Parent 2 0 R /CropBox [0 0 612 792] 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. /F 4 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. << BIOMONITOR IIIm comes ready to inject, pre-loaded into a single piece injection tool for one-step injection. The permissible positioning zone explained below must always be maintained during MR scans of patients with restricted device systems. /CS /DeviceRGB AccuRhythm clinician manual supplements M015316C001 and M015314C001. 10 0 obj BIOconnect Login - Biotronik Hip and eye /BleedBox [0 0 612 792] JCardiovasc Electrophysiol. 8 0 obj Confirm Rx ICM K163407 FDA clearance letter. 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. /CS1 [/ICCBased 61 0 R] hbbd``b`?` $@b@BD$H8X5 Hr@= b"> R7Dw1QHO@k5)G RF`sih L /StructParent 2 /MediaBox [0 0 612 792] 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. database contains 1 biotronik renamic manuals ( available for free online viewing or downloading in pdf) : quick reference manual. >> Care is exercised in design and manufacturing to minimize damage to devices under normal use. >> /Rotate 0 J Am Coll Cardiol. /TT2 65 0 R /XObject << hb``d``6d`a` B@q P.p1i@,`yi2*4r >> /Rect [40.95 36 85.101 45.216] 1 Prerfellner H, Sanders P, Sarkar S, et al. endobj >> /A << When an AF episode is ongoing during transmission, the monitor transmits both its onset episode and duration. 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. /Resources << biotronik home monitoring is a pioneering and award- winning remote cardiac monitoring system. /Resources 40 0 R /Pages 2 0 R Please see image below. /MediaBox [0.0 0.0 612.0 792.0] 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. /CS0 [/ICCBased 42 0 R] Products >> The medical device REMOTE ASSISTANT is realized by BIOTRONIK SE & CO. KG. manual library instructions for use and product manuals for healthcare professionals. No need for unnecessarily complicated delivery tool assemblies. Do not use the patient connector to communicate with other implanted devices. ProMRI SystemCheck - 3.1.1 /CS /DeviceRGB Overwriting older relevant episodes make classification more difficult. 2 Nlker G, Mayer J, Boldt LH, et al. It is simple to use, and requires no patient interaction for successful daily data transmissions. >> >> 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. Please contact your local BIOTRONIK representative. >> However, the patients particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. Isocenter So it is both patient and diagnostically friendly, and makes the whole process of cardiac monitoring simpler and more efficient. Contraindications:There are no known contraindications for the implant of the Reveal LINQ ICM or for the Reveal LINQ Mobile Manager system. /BS << stream /Length 429 Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. 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. /Type /Action * free* shipping on qualifying offers. You can find detailed information about the requirements, conditions and measures for safely conducting an MRI scan in the ProMRI System Technical Manual. >> what is home monitoring system? /Tabs /S /GS1 45 0 R 43 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. BIOMONITOR III and /Rotate 0 Clear P-wave and R-wave visibility helps achieve faster, more confident ECG evaluation. >> >> The serial number and product name can be found on: None of the entered data will be stored. << BIOMONITOR IIIs combination of our BIOvector design, the fractal coating on its sensing surface area, and a smart lossless compression algorithm deliver high amplitude signal quality. Starting from the feet, the permissible positioning zone for the isocenter of the high-frequency coil is at the greater trochanter level. >> /Subtype /Link /Parent 2 0 R Cardiac Monitors /StructParents 3 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. The CareLink mobile application is intended to provide current CareLink network customers access to CareLink network data via a mobile device for their convenience. >> /Resources << /Im1 51 0 R 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. kg, and we want you to feel secure when using our web pages. Confirm Rx* ICM DM3500 FDA clearance letter. 8 0 obj AccessGUDID - DEVICE: Remote Assistant (04035479158330) << /ArtBox [0 0 612 792] /TT2 65 0 R endobj /ExtGState << stream /W 0 /ArtBox [0 0 612 792] Procedural simplicity makes it ideal for in-office settings. /Rotate 0 /CS0 [/ICCBased 60 0 R] if you need assistance. 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. /C2_0 69 0 R Data availability and alert notifications are subject to Internet connectivity and access, and service availability. Clear P-wave and R-wave visibility supports faster, more confident ECG evaluation. /Length 525 var base_url = "https://www.medicaldevices24.com/"; %%EOF /Pages 2 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). 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. /XObject << /TT2 48 0 R PDF Jon Brumbaugh 6024 Jean Road Regulation Number: 21 CFR 870.1025 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. BIOMONITOR III features simplified programming by indication-based program sets and enhanced signal quality by improved filtering and data compression. 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. /Parent 2 0 R /StructParents 0 << BIOMONITOR III - Biotronik Monitoring Devices Merlin PCS Help Manual for SJM Confirm, Confirm Rx ICM, Jot Dx Manual. In practice, this means that the marker line of the MRI scanner's laser positioning marks must be within this zone. %PDF-1.6 % /Rotate 0 Using the patient connector near these devices could interfere with communication between the Reveal LINQ ICM and the patient connector. /Length 449 >> >> Miniaturized implantable cardiac monitor with a long - ScienceDirect /Font << /MediaBox [0 0 612 792] 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: /GS7 22 0 R However, electronic devices are susceptible to many environmental stresses. << /Tabs /S /URI (http://www.fda.gov/) H]o0#?KImBEhMW)IE"srV`H$G. The injection procedure allows for several wound closure techniques to be used, including the use of tissue adhesives. Adapting detection sensitivity based on evidence of irregular sinus arrhythmia to improve atrial fibrillation detection in insertable cardiac monitors. 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. home monitoring system in. dear patient: you have received a biotronik pacemaker or implantable cardioverter- defibrillator ( icd) with home monitoring function. /StructParents 2 Nlker G, Mayer J, Boldt L, et al. /CS0 [/ICCBased 42 0 R] /F1 24 0 R /S /URI >> Please check your input. /Tabs /S ||First European-approved (TV notified body) remote programmable device. /TT1 59 0 R /Font << Users must not rely solely on this information, but must carefully read and observe the ProMRI System Technical Manual for proper use of the implanted system for treatment and determination of MRI compatibility. Prerfellner H, Sanders P, Sarkar S, et al. /l%Z1ZHkDOOM/ {Ygp{ 7pv7+r:.n?PYACm?.p^h No need for unnecessarily complicated delivery tool assemblies. Patient Assistant:The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. BIOTRONIK BIOMONITOR III technical manual. /Filter /FlateDecode It may be used in the home or healthcare facility. >> /Tabs /S /Resources << /Type /Action 43 0 R] Reveal LINQ Mobile Manager System:Before inserting the Reveal LINQ ICM, verify that the patient connector and mobile device are fully charged. /StructParent 1 Unlike bulky Holter monitors, the small device is barely noticeable to the patient. See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications / adverse events. /Type /Page When an AF episode is ongoing during transmission, the monitor transmits both its onset episode and duration. %PDF-1.6 % >> 5 0 obj /Resources << 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. >> Radiofrequency (RF) interference Portable and mobile RF communications equipment can interfere with the operation of the patient connector. The website will guide you through the large variety of system-specific MR conditions by requesting information on the implanted device and lead combination. /TT2 65 0 R /TT1 64 0 R /BleedBox [0 0 612 792] >> The FIT OneStep injection tool provides a standardized pocket to accommodate the device comfortably and easily. BIOTRONIK Home Monitoring setup - YouTube Hk0Q*dA)4i7KP&POn{pE0>;IF`t The unit is battery operated making it easy for patients while travelling, with a battery life of 48 hours. Lux-Dx ICM K212206 FDA clearance letter. /BS << << home monitoring shown to safely and efficiently replace face- to- face follow- ups for pacemaker patients results just published in circulation arrhythmia and electrophysiology confirm that biotronik home monitoring provides safe and cost- effective remote management of pacemaker patients, 1 indicating that it can safely replace the common. 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. Based on AF episodes 2 minutes and in known AF patients. /Rotate 0 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. /Type /Action The MyCareLink patient monitor must be on and in range of the device. /Parent 2 0 R 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. Reveal LINQ Mobile Manager System:The Reveal LINQ Mobile Manager app is intended for programming and interrogating the Reveal LINQ ICM LNQ11. The Bluetoothword mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of suchmarks by Medtronic is under license. /C2_0 46 0 R >> >> BIOMONITOR III can transmit up to six ECGs to Home Monitoring each day, increasing physicians opportunity to evaluate patient status remotely. >> >> /A << /CS1 [/Separation /Black [/ICCBased 42 0 R] /Type /Group >> >> /C2_0 53 0 R /ProcSet [/PDF /Text] 72 0 obj <>stream /CS1 [/ICCBased 61 0 R] >> To make sure that only approved products and conditions will be shown, the country where the scan will take place must be selected. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] here /CropBox [0 0 612 792] Contraindications:There are no known contraindications for AccuRhythm AI Models ZA400, ZA410, or ZA420. /Type /Group /ColorSpace << /TT3 49 0 R 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. /C2_1 54 0 R biotronik home monitoring enables physicians to perform therapy management at any time. /TT1 64 0 R /ExtGState << endobj BIOMONITOR III Manual Go to ProMRI SystemCheck Injection Procedure in Less Than One Minute1 Penela D, Fernndez-Armenta J, Aguinaga L, et al. The MR scan with BIOTRONIK systems requires the use of a clinical MRI scanner with a closed bore, cylindrical magnets and a static magnetic field strength of 1.5T or 3T. The isocenter position is an MR condition that describes the permissible scan areas of the patient. /Subtype /Link /TT0 23 0 R Every year, more and more patients are receiving ICMs all of which must be actively managed, creating an additional workload for everyone involved. 13 0 obj PDF BIOTRONIK, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and google_ad_client: "ca-pub-5568848730124950", 2020. /GS8 23 0 R >> OK is displayed at the top left = connected. << /Type /Page /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] /Type /Catalog Healthcare Professionals 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 Combines pocket creation and ICM injection into a one-step procedure taking only seconds to administer. 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 endobj 16Radtke AP, Ousdigian KT, Haddad TD, Koehler JL, Colombowala IK. /Annots [10 0 R 11 0 R] /CS0 [/ICCBased 60 0 R] /ExtGState << 2020. /ColorSpace << See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential complications/adverse events. >> /Version /1.4 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. /Type /Page << All entered data will be deleted when leaving the web page. >> stream /CS1 [/ICCBased 61 0 R] /TT4 55 0 R >> /CS /DeviceRGB 1 0 obj /TT4 70 0 R /CS1 [/Separation /Black [/ICCBased 42 0 R] /A << 3 0 obj /ColorSpace << you have received a device with the additional home monitoring function by biotronik. BIOMONITOR III fits a variety of body types. >> /Im0 63 0 R Caution: Federal law (USA) restricts prescription devices to sale by or on the order of a physician. 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(#"'# /Contents 49 0 R /MediaBox [0 0 612 792] >> 2. To avoid interference, do not use the patient connector and mobile device within 2 m (6 feet) of other wireless communications equipment. 9529 Reveal XT Insertable Cardiac Monitor. Wireless accessories available for use with LINQ II may experience connectivity or performance issues. This website shows the maximum for the slew rate value, which must not be exceeded during the scan. /S /URI /CropBox [0 0 612 792] /Resources << /XObject << /CropBox [0 0 612 792] 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\`` Apple and the Apple logo are trademarks of AppleInc., registered in the U.S. and other countries.