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: /Rect [40.95 36 85.101 45.216] Potential Complications:Potential complications of the Reveal LINQ device include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin. Higher signal quality reduces the impact of noise and artifact, reduces ambiguity in analysis, and improves the efficiency of provider diagnosis. >> Nlker G, Mayer J, Boldt LH, et al. Wireless accessories available for use with LINQ II may experience connectivity or performance issues. /CropBox [0.0 0.0 612.0 792.0] /TT4 55 0 R ]3vuOB1fi&A`$x!2`G9@?0 L
It is also 1.5T and 3.0T full-body MR conditional and there is no waiting period after the injection procedure. /Count 7 Make sure you entered the device name, order number or serial number correctly. 10 0 obj /Rect [90.257 307.84 421.33 321.64] /W 0 Home Monitoring achieves industry-leading transmission success rates, along with high levels of patient adherence and satisfaction. Click on your monitor for the full manual. /Tabs /S 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 No need for unnecessarily complicated delivery tool assemblies. >> 35 0 R] /Contents 41 0 R >> Isocenter /S /URI >> See the device manuals for detailed information regarding the implant procedure, indications / intended use, contraindications, warnings, precautions, and potential complications/adverse events. /CS /DeviceRGB Eradicates time consuming and potentially costly multi-step procedures. endstream
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/CS0 [/ICCBased 42 0 R] /GS7 22 0 R /Type /Page For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website atwww.medtronic.com. /Font << /Type /Group /A << 2 0 obj /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] /Filter /FlateDecode Remote access to full ECGs eliminates the need for manual transmissions 14; . /Im0 67 0 R /Rect [40.95 36 85.101 45.216] %PDF-1.4 >> /ProcSet [/PDF /Text /ImageB /ImageC /ImageI] /Parent 2 0 R }ljxO4!sm4!lO4!l4!l8:7dYAs=8ug]YzYzYzYzYz_s|0s\Cuvt~:r+r8sCq4f>Q'/^dY>MQo+{mw7zyfi
Av=&. Please see image below. /Resources << /Type /Action December 2016;27(12):1403-1410. Warnings and Precautions: The MyCareLink patient monitor must only be used for interrogating compatible Medtronic implantable devices. /TT1 64 0 R /F 4 /MediaBox [0 0 612 792] >> >> BIOMONITOR III and BIOMONITOR IIIm can be activated by the patientusing the Remote Assistant III to record cardiac rhythm during symptomatic episodes. 2020. Update my browser now. /ExtGState << endstream
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>> In an environment likely to cause ESD, such as a carpeted floor, discharge any charge collected on your body before touching the device. To ensure the best printing experience, we recommend using the ProMRI SystemCheck on a desktop computer. endobj /ColorSpace << /A << /CropBox [0 0 612 792] Home Monitoring achieves industry leading transmission success rates, along with high levels of patient adherence and satisfaction. /BS << /ArtBox [0 0 612 792] /F2 23 0 R 16Radtke AP, Ousdigian KT, Haddad TD, Koehler JL, Colombowala IK. home monitoring system in. /Version /1.4 /Parent 2 0 R /Resources << The field strength is measured in tesla (T). AF sensitivity may vary between gross and patient average. endstream
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/ColorSpace << endif; ?> The scan exclusion zone is determined by the MRI scanner's field of view and the size of the patient. << 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. /StructParent 2 << /MediaBox [0.0 0.0 612.0 792.0] /Font << /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] /Subtype /Link >>
/Type /Page /BS << endobj /Im0 50 0 R Reveal LINQ Mobile Manager System:The Reveal LINQ Mobile Manager app is intended for programming and interrogating the Reveal LINQ ICM LNQ11. Home Monitoring is powered by the smartphone-sized CardioMessenger Smart mobile unit. /Tabs /S /CS1 [/ICCBased 61 0 R] /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) >> December 2017;14(12):1864-1870. /ArtBox [0 0 612 792] LINQ II ICM is ideal for patients experiencing infrequent symptoms that require long-term monitoring or ongoing management. 9 0 obj Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. Clinical recognition of pure premature ventricular complex-induced cardiomyopathy at presentation. %%EOF
/TT0 47 0 R >> However, the patients particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated. BIOMONITOR III fits a variety of body types. >> >> dear patient: you have received a biotronik pacemaker or implantable cardioverter- defibrillator ( icd) with home monitoring function. /TT1 59 0 R 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] Monitoring Devices Merlin PCS Help Manual for SJM Confirm, Confirm Rx ICM, Jot Dx Manual. /ArtBox [0 0 612 792] << >> /Subtype /Link 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). /Type /Page /Type /Catalog /XObject << /CropBox [0.0 0.0 612.0 792.0] 43 0 R] /TT3 66 0 R endobj The Medtronic patient connector is a portable electronic device using low frequency inductive telemetry to communicate with the Reveal LINQ ICM. @ZvA(thp[x@^P@+70YCT1 5f
/Tabs /S Home Based on AF episodes 2 minutes and in known AF patients. However, the patients particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. /MediaBox [0.0 0.0 612.0 792.0] /CS1 [/ICCBased 61 0 R] 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. hbbd```b``z "XDH`RLE`5[E|H R0Dr 6$d`$4&_ O
/GS0 62 0 R /ExtGState << /TrimBox [0 0 612 792] Without complicated set-up procedures, Home Monitoring demonstrates improved patient adherence. endobj /F 4 Watch this video to learn more about LINQ II ICM.
/ColorSpace << /TT0 63 0 R >> , the largest, member- driven, healthcare performance improvement company in the united states. The mean specific absorption rate (SAR) for the whole body is shown in watts per kilogram (W/kg). The slew rate of the MRI scanner's gradient fields is shown in tesla per meter per second per axis (T/m/s per axis). Intelligent Memory Management prevents this issue, by retaining the most clinically valid episodes. 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. There are no known adverse events associated with the use of any LINQ II ICM wireless accessory. >> >> /Contents 72 0 R Heart Rhythm. /StructParents 0 /TT2 55 0 R 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. Programmer user interface / Programmer printout. /Filter /FlateDecode Please contact your local BIOTRONIK representative. App Store is a service mark of Apple Inc. /Group << it allows your doctor to continuously access information about your implanted system. biotronik home monitoring is a patient- oriented technology for those with pacemakers, icds and crts. endobj /C2_0 69 0 R >> If this is not the case please try the monitor closer to a window. var site_url = "https://www.medicaldevices24.com/"; endobj endobj Mobile device access to the internet is required and subject to coverage availability. %
No manual transmissions. 1. 6 Subject to availability by region and as prescribed by a health care professional. /F 4
/Subtype /Link 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. << }); 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. 2. #K200444 510(k) Summary Page 2 of 4 4. >> is remote monitoring for patients with implanted devices? /C2_0 38 0 R BIOMONITOR IIIm comes ready to inject, pre-loaded into a single piece injection tool for one-step injection. hVR8
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CBA{X )8~f @2pE%]AG?HhIGlD@k(5n^M|r(#"'# endobj 8 0 obj /F1 24 0 R 2 0 obj 2019, doi: 10.1111/pace.13728. >> By clicking the links below to access the news on our International website, you are leaving this website. Apple and the Apple logo are trademarks of AppleInc., registered in the U.S. and other countries. 2017. BIOTRONIK BioMonitor 2 technical manual. << A hand-held, electrically-powered device designed to be operated by a clinician or patient to non-invasively change the settings (e.g., turn on/off) of an implantable cardiac monitor (ICM), and/or extract data from the implant, and/or provide an alarm function; it is not intended to communicate with a therapeutic cardiac implant. H]o0#?KImBEhMW)IE"srV`H$G. /W 0 ICD, pacemaker or cardiac monitor (BIOTRONIK products only). >> /GS0 44 0 R 17 0 obj /ExtGState << 5 0 obj 1 0 obj /W 0 biotronik home monitoring manual free pdf instructions. : Berlin-Charlottenburg HRA6501B, Commercial Register No. /Resources << /GS1 45 0 R /CS0 [/ICCBased 42 0 R] /Rotate 0 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. /TT0 63 0 R endobj what is home monitoring system? >> 1 BIO|CONCEPT.BIOMONITOR III, data on file, 3 Varma N et al. /C2_1 46 0 R Heart Rhythm. Every year, more and more patients are receiving ICMs all of which must be actively managed, creating additionalworkloads for everyone involved. /F1 22 0 R You can find detailed information about the requirements, conditions and measures for safely conducting an MRI scan in the. /CS0 [/ICCBased 42 0 R] An MRI scanner's field of view is the area within which imaging data can be obtained. 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. page 7 car di om es s enger _ i i - s_ en. com contact medtronic terms of. /CS0 [/ICCBased 60 0 R] Provides daily data trending which may be helpful in determining the need for follow-up. M974764A001D. << %%EOF
/Rotate 0 13 0 obj >> Specifically, the patient connector may be affected by electrostatic discharge (ESD). 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. 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. /Filter /FlateDecode 9529 Reveal XT Insertable Cardiac Monitor.
2017. /StructParents 4 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. /MediaBox [0 0 612 792] << /TT0 23 0 R /GS0 62 0 R /F 4 2019. /CS0 [/ICCBased 42 0 R] 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 Home Monitoring is a pioneering and award-winning remote cardiac monitoring system.
the transmission power from your device is low and does not impair your health in. /ProcSet [/PDF /Text /ImageC] /A << For MRI information in Japan please check the following webpage: www.pro-mri.jp. the centers for medicare and medicaid services ( cms) ), certified reimbursement coding professionals, other reimbursement experts, and/ or. Penela D, Van Huls Van Taxis C, Aguinaga L, et al. 11 0 obj Why is the selection of a country/region required? Eliminates time consuming and potentially costly multi-step procedures. 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. 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. << ||First European-approved (TV notified body) remote programmable device. /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] biotronik cardiomessenger ii- llt transmitter for biotronik home monitoring technical manual ( cardio messenger ii- llt, transmitter for biotronik home monitoring) [ biotronik] on amazon. /MediaBox [0 0 612 792] endobj /TT1 48 0 R /StructParents 0 This information on MRI compatibility does not, however, replace the product and application instructions in the. /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 /GS0 44 0 R /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] >> /A << Reproduced with Permission from the GMDN Agency. However, the patients particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. The permissible positioning zone explained below must always be maintained during MR scans of patients with restricted device systems. For further information, please call Medtronic at 1-800-929-4043 and/or consult the Medtronic websiteatwww.medtronic.com. Heart Rhythm. /BleedBox [0 0 612 792] 2020. >> Nlker G, Mayer J, Boldt L, et al. Artificial Intelligence Dramatically Reduces Annual False Alerts from Insertable Cardiac Monitors. Please contact us 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. /ArtBox [0 0 612 792] << 35 0 obj
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Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 sales@biotronik.com www.biotronik.com /Length 397
The patient connector and mobile device may run out of power during the insertion procedure if they are not fully charged. TRUST Study, Heart, Lung and Circulation 2009, 18 (s106), 4 Ricci R. P et al HoMASQ study, Europace, 2010, 12 (5). The device is programmed to an MRI mode before the MR scan. >> endobj /S /URI /Font << 4 BioMonitor 2 BioInsight Study. /MediaBox [0 0 612 792] crm / / biotronik home monitoring cardiomessenger smart enechnical manual t es manual tcnico fr manuel techniqueh_ ga_ cardiomessenger- smart_ e- mul_ cover. /MediaBox [0 0 612 792] /MediaBox [0.0 0.0 612.0 792.0] /TT3 66 0 R (adsbygoogle = window.adsbygoogle || []).push({ /Contents 68 0 R biotronik home monitoring enables physicians to perform therapy management at any time. /ProcSet [/PDF /Text /ImageC] /XObject << 43 0 R] /BleedBox [0 0 612 792] >> /TrimBox [0 0 612 792] K201865 FDA clearance. 2021. 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. 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. /TrimBox [0 0 612 792] /Contents 52 0 R home monitoring enhances safety for cardiac device patients. 9 0 obj You can find detailed information about the requirements, conditions and measures for safely conducting an MRI scan in the ProMRI System Technical Manual. quality of life by monitoring the heart. Please enter the country/region where the MRI scan will be performed. The CareLink mobile application is intended to provide current CareLink network customers access to CareLink network data via a mobile device for their convenience. endobj 147326, / 08/ 23- 13: 03: 03 format : application/ pdf creator. >>
August 1, 2021;18(8):S47. endstream /F 4 /S /Transparency /S /Transparency Home Monitoring not only allows physicians to safely review cardiac function, it also sends alerts about relevant . /MediaBox [0.0 0.0 612.0 792.0] The injection procedure allows for several wound closure techniques to be used, including the use of tissue adhesives. /Parent 2 0 R 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. >> BIOMONITOR IIIs combination of our BIOvector design, the fractal coating on its sensing surfaces, and a smart lossless compression algorithm deliver high amplitude signal quality. 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. It has a small can 60% smaller than its predecessor and a flexible antenna, helping to make it comfortable and discreet for patients. /Resources << - (03:56), Watch this video to learn more about the LINQ II insertable cardiac monitor. >> /Rotate 0 << The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. /Tabs /S Only use the patient connector to communicate with the intended implanted device. endobj endobj 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. 7 0 obj `3$ihfxg'8hd5B_PrV^.Ps'T3=~w4?CIM- {Mk
Presented at HRS 2021. /GS0 62 0 R /Resources << See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. 10 0 obj /TT4 70 0 R /Resources 40 0 R /TT3 66 0 R The unit is battery operated making it easy for patients while travelling, with a battery life of up to 48 hours. The patient connector is intended to be used by healthcare personnel only in a clinical or hospital environment. >> No need for unnecessarily complicated delivery tool assemblies. /TT2 65 0 R 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. /URI (http://www.fda.gov/) 2020. Where can I find the order number of the product? BIOMONITOR III enables up to six ECGs to be transmitted by Home Monitoring each day, increasing physicians opportunity to evaluate patient status remotely. The system works via a smartphone-sized CardioMessenger. /Type /Catalog if you need assistance. 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. reduction in LINQ II false alerts21, 319
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/Contents 46 0 R /CropBox [0 0 612 792] 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. When an AF episode is ongoing during transmission, the monitor transmits both its onset episode and duration. /Type /Page Lux-Dx ICM K212206 FDA clearance letter. << The Bluetoothword mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of suchmarks by Medtronic is under license. >> endstream
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/TT3 58 0 R << /TT0 47 0 R Confirm Rx* ICM DM3500 FDA clearance letter. 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. If the patient connector should fail, there is no risk of patient harm. 3 0 obj
BIOTRONIK BIOMONITOR IIIm technical manual. BIOTRONIK BIOMONITOR IIIm. hZks?a>Jr*VidhG`HHA@G3 +TTL~{GS*Xc+#chNLI
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Gs)r5GYp ^1qZ*@)fb SE.T 8GQH@^VXW~$]I0ItQc&"x J1$5Dx_Nf>x]o;A]a,eH, FP+?nMAp bi({y|0N^z(^wy8! /TT2 65 0 R /GS0 44 0 R 2 Ricci RP et al. /MediaBox [0 0 612 792] Designed to minimize patient effort, it sends daily, automatic cardiac device data to the patient device that then forwards the information to the Home Monitoring Service Center (HMSC). h+L5hHJarx(|9Jx$
{K=j2|l!YF ql2-h&fG4t^*O]=:xh p)1FG4SQ.* 16 0 obj >> /TT1 48 0 R >> /GS8 23 0 R /Rect [90.257 280.24 421.33 294.04] /Filter /FlateDecode >> /Im1 51 0 R In practice, this means that the marker line of the MRI scanner's laser positioning marks must be within this zone. >> Hip and eye /l%Z1ZHkDOOM/ {Ygp{
7pv7+r:.n?PYACm?.p^h 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. The Medtronic MyCareLink patient monitor and the Medtronic CareLink network are indicated for use in the transfer of patient data from Medtronic implantable cardiac devices. Europace. /ArtBox [0 0 612 792] /Im1 51 0 R /TT3 58 0 R with biotronik home monitoring, healthcare providers have a complementary option to routine follow- up visits, while maintaining in- person follow- ups every 12 months.
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P.p1i@,`yi2*4r /C2_3 62 0 R AF sensitivity may vary between gross and patient average. The medical device REMOTE ASSISTANT is realized by BIOTRONIK SE & CO. KG. >> kg, and we want you to feel secure when using our web pages. << You will not be able to program or interrogate the patients Reveal LINQ ICM until the patient connector and the mobile device have power. /C2_0 46 0 R Jot Dx ICM K212206 FDA clearance letter. /CropBox [0 0 612 792] The Bluetoothword mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Medtronic is under license. endstream Please contact us /Font << /Im0 50 0 R endstream /Font << 55 0 obj
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/CS /DeviceRGB 2017. >> /Parent 2 0 R 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. page 1 cardiomessenger ii- llt transmitter for biotronik home monitoring technical manual sbiotronik. Hk0Q*dA)4i7KP&POn{pE0>;IF`t if you need assistance. /Rotate 0 Make sure you enter the country/region name in the currently selected language. this transmitter automatically transmits medical and technical information to a mobile device, the cardiomessenger. More information (see more) Standard text message rates apply. Low noise also contributes to ECG clarity, which in turn, can lead to easier and quicker rhythm classification. General considerations /F3 47 0 R /XObject << /BleedBox [0 0 612 792] If the monitor is connected to the cellular network in your area there will be a green light or "OK" displayed on your unit. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA. /StructParents 3 /F4 48 0 R /Resources 50 0 R /C2_0 53 0 R 6 0 obj /TT2 65 0 R stream
/Resources << /S /Transparency 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. 4 0 obj /ArtBox [0 0 612 792] In practice, this means that the marker line of the MRI scanner's laser positioning marks must be within this zone. Patient Assistant:The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. view and download biotronik cardiomessenger smart technical manual online. >> /Tabs /S The patient connector uses Bluetoothtechnology to transmit implantable heart device data to the Reveal LINQ Mobile Manager app for further processing. endstream % >> 2020. /ProcSet [/PDF /Text /ImageC] >> /CropBox [0 0 612 792] << /Im1 51 0 R >> Indications:The intended use of the system is to reduce false positive cardiac arrhythmia episodes. Third-party brands are trademarks of their respective owners. here required expertise in addition to having basic medical knowledge, the user must be thoroughly familiar with the operation of a device system. here /Parent 2 0 R It may be used in the home or healthcare facility. /XObject << /CS1 [/ICCBased 61 0 R] Information Regarding Your Patient ID Card, Team Lead HR Projects, Processes & Reporting. /Type /Group Caution:Federal law (USA) restricts these devices to sale by or on the order of a physician.
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