Boston Scientific Incepta Manual

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Boston Scientific Incepta ManualInformation included may not apply to all previous versions of product. Review manuals before using or implanting a device, or performing follow-up care. Use the three filter settings below to reduce the list size. Use only product literature from the region where the patient procedure is performed. For Male Patients. Information included may not apply to all previous versions of product. Review manuals before using or implanting a device, or performing follow-up care. Use the three filter settings below to reduce the list size. Use only product literature from the region where the patient procedure is performed. Other health care professionals should select their country in the top right corner of the website. To the extent this site contains information, reference guides and databases intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions. It is strictly forbidden to make copies, whether partial or total and on whichever media without prior approval. EMBLEM MRI provides protection for patients at risk of sudden cardiac death (SCD), while avoiding complications associated with transvenous leads. Sign in Forgot Password. My Bench Close Sign In Not A Member. Sign Up Join MedWrench OK name type Receive Summary Emails. FORUMS View All (1) Ask a New Question 2 Replies -tel04073 3 years ago 3 years ago PM requirements Any PM required for this device.By continuing to browse the site you are agreeing to our use of cookies. Please review our Privacy Policy for more details. All Rights Reserved. Sign in Forgot Password. My Bench Close Sign In Not A Member. Sign Up Join MedWrench OK name type Receive Summary Emails. By continuing to browse the site you are agreeing to our use of cookies. Please review our Privacy Policy for more details. All Rights Reserved.http://esprimagroup.com/userfiles/boxcar-pro-4_3-manual.xml

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The purpose of this review is to provide to the cardiologist practical information about RM systems’ specificities with respect to the different technical and clinical alerts. Clinically based indications and programming suggestions are provided. Central Illustration Download: Download high-res image (647KB) Download: Download full-size image Previous article in issue Next article in issue Key Words arrhythmia implantable cardioverter-defibrillator lead failure remote monitoring telemedicine Abbreviations and Acronyms AF atrial fibrillation ATP antitachycardia pacing EGM electrogram ICD implantable cardioverter-defibrillator LIA lead integrity alert LV left ventricular NSVT nonsustained ventricular tachycardia RA right atrial RM remote monitoring RV right ventricular SVT supraventricular tachycardia VF ventricular fibrillation VT ventricular tachycardia Recommended articles Citing articles (0) This study received financial support from the French government as part of the “Investments of the Future” program managed by the National Research Agency (ANR), Grant reference ANR-10-IAHU-04. Dr. Strik has received grant support from the Dutch Heart Foundation and the Netherlands Heart Institute. Dr. Ploux is a consultant for Biotronik, Boston Scientific, LivaNova, Medtronic, and St. Jude Medical. Dr. Varma is a consultant for Biotronik, Boston Scientific, Medtronic, St. Jude Medical, and LivaNova; and has received research funding from Zoll, Medtronic, Biotronik, St, Jude Medical, and Boston Scientific. Dr. Strik has received a grant from Biotronik. Dr. Lazarus is a consultant for Biotronik, Boston Scientific, Medtronic, and LivaNova. Dr. Bordachar has reported that he has no relationships relevant to the contents of this paper to disclose. All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate.http://www.frimaslovakia.sk/userfiles/file/boxdg45id-manual.xml For more information, visit the JACC: Clinical Electrophysiology author instructions page. Published by Elsevier. Recommended articles No articles found. Citing articles Article Metrics View article metrics About ScienceDirect Remote access Shopping cart Advertise Contact and support Terms and conditions Privacy policy We use cookies to help provide and enhance our service and tailor content and ads. By continuing you agree to the use of cookies. Incidence of sleep apnea and association with atrial fibrillation in an unselected pacemaker population: Results of the observational RESPIRE study. Heart Rhythm. 2019 Sep 4. pii: S1547-5271(19)30822-7. Dedicated to improving and reshaping patient lives through the application of innovative science and technology. Minimize ventricular pacing for SND and AVB patients.Some cookies are essential to the operation of our site, while others are designed to improve the user experience. By browsing our site, you agree to the use of these cookies. You can change the cookie settings at any time. For more information, see our Cookies policy. I have read and accept the Wiley Online Library Terms and Conditions of Use Shareable Link Use the link below to share a full-text version of this article with your friends and colleagues. Learn more. Copy URL Although some of these devices are currently under advisory, other devices manufactured during this timeframe carry a lower risk of the same malfunction. These same devices are known to have superior longevity in general, and the overall mean lifespan of the devices remains long. However, with enrollment in remote monitoring, regular follow?up, and attention to audible alerts, the risk of therapy loss due to low?voltage state can be effectively mitigated. For these reasons, prophylactic generator replacement is not recommended. Information included may not apply to all previous versions of product. Review manuals before using or implanting a device, or performing follow-up care.http://www.drupalitalia.org/node/72792 Use the three filter settings below to reduce the list size. Use only product literature from the region where the patient procedure is performed. Depending on the model, the device warranties are also up to twice as long as other currently-marketed comparable devices. For more information, please visit: www.bostonscientific.com. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding, regulatory approvals, clinical trials, clinical outcomes, financial savings associated with the use of our products, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document. All Rights Reserved Learn more.http://faraznovin.com/images/boston-scientific-rf-3000-manual.pdf COVID cases, death, but no sign of trend yetBrewers on GameviewNot long after, and not to be outdone, competitor Boston Scientific sent an ad to doctors basically saying its device is better. Boston Scientific said when set at similar energy levels, its device has a 7.7-year life span while Medtronic's Viva lasts only 4.6 years. Viva, Medtronic said, has better medical outcomes than previous products introduced to the market over the last 10 years — and Boston Scientific is wrong it its comparisons. This improves the heart's ability to pump blood and oxygen to the body. A CRT-D combines that therapy with a defibrillator to detect and treat dangerously fast heart rhythms. Dr. Jagmeet Singh, director of the advanced therapeutics program at Massachusetts General Hospital in Boston, said the device improves patients' response to CRT-D therapy by 12 percent, which can help reduce medical costs and hospital admission rates. Jude Medical split most of the rest, he said. In this highly competitive arena, Gunderson said that companies jockey to differentiate themselves not just along the lines of quality, but affordability. And everything from longer battery life to decreasing hospital admission rates becomes a factor in making the affordability argument. COVID cases, death, but no sign of trend yet. The t echnical reports and exhibi ts previously provided under authorization FCC ID ESCCRMN11906 e qually demonstrate compliance of the 916.5 MHz radio incorporated in all of the listed AICD models in this lette r with the requirem ents specified in FCC Title 47 CFR, Part 15, Section 249. Effective September 15, 2010, the FCC granted Boston Scientific an extended waiver (DA 10-1744). The company said the new warranty program is the longest available in the industry and provides physicians, patients and payers across Europe warranties up to five years longer than other currently-marketed cardiac devices. Following are the devices and their warranties.http://plenar.hr/wp-content/plugins/formcraft/file-upload/server/content/files/162743bef7775d---brookstone-rover-20-manual.pdf Heart failure is associated with frequent hospital admissions, which represent the main driver of treatment costs (67-75 percent). On average, heart failure treatment costs amount to 1-2 percent of each country's total healthcare budget in Europe. Image courtesy of Biotronik. In a double blinded study 27 out of 30 ICD patientsINDICATIONS AND USAGE: Boston Scientific implantable cardioverter defibrillators (ICDs) are intended to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillationCONTRAINDICATIONS: Use of these Boston Scientific pulse generators are contraindicated for the following: patients whose ventricular tachyarrhythmias may have reversibleFor single patient use only. Do not reuse, reprocess, or resterilize. Program the pulse generator Tachy Mode(s) to Off during implant, explant, or postmortem procedures to avoid inadvertent high voltage shocks. Always have external defibrillationEnsure that an external defibrillator and medical personnel skilled in CPR are present during post-implant devicePatients should seek medical guidance before entering environments that could adversely affect the operation of the activeDo not expose a patient to MRI scanning. Do. If desired, ensure that Patient Triggered Monitor is enabled prior to sending the patient home. OnceDo not use this pulse generator with another pulse generator. Do not kink, twist, or braid the lead with other leads as doing so could cause leadDo not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tiny can,The world’s smallest and thinnest ICD.1. Boston Scientific provides devices tailored to individual needs. Up to 20 smaller andScientific ICD in a device that is the industry’s sleekest and designed for patient comfort. For leads that require the use of a Connector Tool, use caution handling the lead terminal when the Connector Tool is not present on the lead.3dtechgroup.com/uploads/image/files/carbide_ui-manual.pdf Do not directly contact the lead terminalPRECAUTIONS: For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, deviceSources. Competitive comparisons:Double-blind focus group and questionnaire administered by 3rd partyPatients care about device sizeMANUAL 2012 page 40-41.DVBB1D4 2013 page 24.I just don’t want to notice it. I’m going to beI’d rather have it be smaller.”Based on historical industry average longevity from published sources.Implantable cardioverter-defibrillator longevity under clinical circumstances:Heart Rhythm. April 2012;9(4):513-519. Horlbeck FW, Mellert F, Kreuz J, Nickenig G, Schwab JO. Real-world data on the lifespan of implantableJ Cardiovasc Electrophysiol. December 2012;23(12):1336-1342. Kallinen L, et al. 2009. Schaer BA, Koller MT, Sticherling C, Altmann D, Joerg L, Osswald S. Longevity of implantable cardioverter defibrillators, influencing factors, and comparison to industry-projected longevity. Heart Rhythm. December 2009;6(12):1737-1743. Knops P, Theuns DA, Res JC, Jordaens L. Analysis of implantable defibrillator longevity under clinical circumstances: implications for device selection. Pacing Clin Electrophysiol. October 2009;32(10):1276-1285. Rhythm Management. One Boston Scientific Place. Natick, MA 01760-1537 USAMedical Professionals:History of Innovation. The MINI ICD provides up to a 20 reduction in pocket bulkUncompromised Feature Set. Lead Reliability. ENDOTAK RELIANCETM Lead Family maintains the same coreVolume Thinness. Boston Scientific MINIBoston Scientific INCEPTA, ENERGENMedtronic EveraSt Jude EllispseBiotronik Ilesto 7AcuShockTM Advanced Therapy is designed to help youIn 2014 we are introducing the world’s. Appropriate PacingSmallest and Thinnest ICDDiagnostics for HF Management. HF PERSPECTIV TM feature provides the only system with aRRT (Respiratory Rate Trend).http://lichnyiybrand.ru/wp-content/plugins/formcraft/file-upload/server/content/files/162743bfe20089---brookstone-rover-owners-manual.pdf Device settings which allow safe operation during an MRI examination are automatically enabled when KORA 100 pacemakers detect the scanner’s magnetic field. Similarly the devices sense when a patient leaves the MRI field, and return to normal operation within five minutes. The Automatic MRI Mode feature, which is patented and available exclusively on Sorin Group pacemakers, limits the amount of time that KORA 100 pacemakers operate in MRI mode. The report has been endorsed by the Heart Failure Association. This task force believes that an overview on these technologies is important. Special focus is given to patients with HF New York Heart Association Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex. An overview on potential device options in addition to optimal medical therapy will be helpful for all physicians treating HF patients. According to the press release: Jude Medical The acquisition adds the world’s first and only leadless pacemaker to the St. Jude Medical product portfolio. It also recently received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating Nanostim leadless technology in the U.S. AIGISRx is a dual component (resorbable and non-resorbable), sterile prosthesis designed to reduce infection and to stabilize the implantable pacemaker or defibrillator when implanted in the body. The capability to deliver two LV pulses per cycle allows physicians to tailor CRT pacing for each patient, potentially leading to more effective outcomes compared to single site pacing, which may be particularly beneficial in patients not responding to traditional bi-ventricular pacing therapy.https://www.adler-leitishofen.de/wp-content/plugins/formcraft/file-upload/server/content/files/162743c0a55bad---brookstone-scanner-manual.pdf According to the press release: It increases the mortality risk and the risk of common cardiovascular co-morbidities such as hypertension, atrial fibrillation (AF) and heart failure (HF). Moreover, sleep apnea complicates the management of common cardiovascular co-morbidities. The Respiratory Disturbance Index (RDI), calculated and reported by the pacemaker, has been validated against polysomnography, the gold standard method used to diagnose sleep apnea. The new devices are designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery. In addition, the next-generation Ellipse and SJM Assura portfolio of implantable defibrillators have a low-friction coating on the device can, which has been demonstrated in testing to significantly reduce the friction between the device and leads. As such, the low-friction coating provides an extra layer of insulation and is designed to reduce the risk for lead-to-can abrasion, the most common type of lead insulation failure in the industry. From the press release: Sorin launched the PARADYMTM RF VR and DR implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices in the United States in May 2012. According to the press release: With this device, physicians can receive atrial information to ensure diagnostic accuracy and identify previously undetected atrial fibrillation. They also receive peace of mind that there is less risk of complications due to the single lead,” said Paul Woodstock, executive vice president of sales and marketing at BIOTRONIK, Inc., USA. “Ilesto’s smaller footprint will be more comfortable as well, which may present a win-win solution for patients and physicians alike.” According to the press release: According to economic analyses presented at ISPOR Europe, with this device both payers and hospital providers will experience reductions in overall healthcare costs as compared to CRT-D devices with traditional programming.https://localhost/travestismexico/paneldecontrol/files/carbide-150-manual.pdf Jude Medical The trial will study the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with advanced heart failure. RESPOND CRT is a multi-center, randomized, two-arm, double-blinded, prospective trial that will enroll more than 1,000 patients in the United States and other geographies. While there are several CRT systems on the market, studies have shown that approximately one-third of patients with advanced heart failure do not effectively respond to CRT. The SonR system is the first and only CRT hemodynamic sensor based system designed to automatically adjust on a weekly basis. Typically this device re-programming is done manually in the clinic using echocardiography. The longevity projections are based on data submitted to the European authorities and vary for each device dependent on the model type and settings. The company supports these devices with warranties of up to 10 years. Bring your confirmation(s) to the registration area to print your badge(s). If you do not have your confirmations, contact Customer Service at or to have them resent. One individual can pick up an entire groups staff badges. If you have not pre-registered your booth staff, please do so via the online exhibitor manual at Go to the Registration tab and click on Exhibitor Badge Online Registration. Freeman and the BCEC services can also be found at the satellite service desk located between the Hall A escalators behind the 100 aisle. You will line up and then be told when to enter the POV loading area. Vehicles will be marshaled in one at a time. During move-out, before your vehicle will be allowed access to the loading dock, all of your exhibit materials must be ready to load. Your vehicle will be allowed to enter the loading area only after we have made contact with your representative and are assured that materials are packed. Please do not leave your vehicle unattended, as it will be ticketed and towed. A representative from your company must be with your vehicle at all times. All materials must leave through the loading docks as a result of new security regulations implemented by the BCEC. There will be NO loading dock access before obtaining a check-in card at the Marshalling Yard. Any vehicle (including POVs) wanting to access the loading dock area to unload during move-in, and re-load during move-out, must first proceed to the marshalling yard (see below for details). Any vehicle not needing access to the loading docks during move-in or move-out may park in the South Parking Lot and walk to the BCEC (see below for details). Marshalling Yard Procedure (In affect for both move-in and move-out) The Marshalling Yard is located in the South Parking Lot of the BCEC. There are two entrances to the South Parking Lot: one entrance is for outside carriers for the marshalling yard, the other entrance is for POVs for the marshalling yard and general parking. There will be TWO lines formed at the Marshalling Yard. One line for POVs and one line for outside carriers. Vehicles will be sent to the loading dock in number-order. Vehicles in the POV line will be sent over to the BCEC as POV dock space becomes available. Vehicles in the outside carrier line will be sent over to the BCEC as outside carrier dock space becomes available. Make sure you are in the correct line. The BCEC Transportation Manager will check you in at the entrance to the loading dock and direct you toward the open dock space. After unloading you must move your vehicle away from the docks. POVs have 20 minutes to unload and may not leave their vehicle at the docks during booth set-up. POVs left unattended will be towed away at the exhibitor s expense. POVs may park at the South Parking Lot adjacent to the BCEC after unloading at the dock and then return to the BCEC for booth set-up. 7 GENERAL INFORMATION UNLOADING AND PARKING INFORMATION No parking is allowed at the lobby entrance of the BCEC; unattended vehicles will be towed at the exhibitor s expense. Nothing may be wheeled through the lobby of the BCEC. Exhibitors with luggage cards, rolling exhibits cases, dollies, etc.There are two entrances to the South Parking Lot: one entrance is for outside carriers for the marshalling yard, and the other entrance is for POVs for the marshalling yard and general parking. Exhibitors may walk via a paved walkway to the exhibit hall through the Loading Dock area. PLEASE NOTE: As parking at the BCEC South Parking Lot is limited and we anticipate the lot to fill (especially on expo days), make plans now to park at an alternate location on expo days, such as the North Jetty Massport Parking Lot (BCEC s overflow parking lot which will have a complimentary shuttle service to the BCEC), or at one of the nearby available Waterfront Parking Lots. For detailed information, please visit: HOTEL RESERVATIONS To make hotel reservations for the 2016 and 2017 events, please visit onpeak at the Official Reservations Desk located on Level 0, East Registration Lobby EXHIBIT SPACE To reserve exhibit space for 2017, please visit our Sales Team in booth AISLE SELLING Exhibitors are permitted to conduct business only within their booth space. Distribution of materials outside your exhibit booth space is strictly prohibited. SOLICITATION For the protection of all exhibitors, only those companies whose Application for Exhibit Space has been received and approved by Expo Management will be allowed to present and sell their products. If you are solicited by a non-exhibiting company, please collect that person s business card and bring it to the Expo Management Office in Room 052. Expo Management will take steps to curtail this activity. 8 WELCOME GENERAL INFORMATION COMPLIMENTARY SHUTTLE SERVICE A Complimentary Shuttle Service is provided between the Boston Convention and Exhibition Center and all of the hotels on our block from March 5 8. See below for additional shuttle information. 9 GENERAL INFORMATION 10 SERVICES AT THE VENUE CONCIERGE ELITE Customer service anywhere. Available as a free mobile app for Apple, Android and Window devices, Concierge Elite gives you convenient access to important information and customer service no matter where you are. Then download the free Concierge Elite app from Apple App Store, Android Google Play or Windows App Store (search for Concierge Elite) or visit Once at expo site, open the app and login using your Freeman Online username and password to get started. EMPTY CRATE REMOVAL AND STORAGE If you wish to have your empty crates and cartons stored by Freeman, they must be labeled with Empty crate stickers, which can be obtained from the Service Desk in Room 052 and between the Hall A escalators behind the 100 aisle. We ask your cooperation in labeling your crates as soon as they have been emptied so that we can clean the exhibit floor and install the aisle carpeting. Items that are not labeled with an Empty crate sticker can be subject to being considered trash and discarded. The TRASH label should be used for any small trash items you need taken away. After the expo closes each night, please place trash items in the aisle and place these labels on them so that the cleaners know what to remove. The DO NOT Throw This Item Away label should be used for any items you need that may be accidently mistaken for trash. Ice deliveries will take place in the morning on each expo day between 8:00 10:00am. For additional labels, please visit the Expo Management Desk in Room 052. ICE DELIVERY Expo Management will supply complimentary ice on a daily basis. On Sunday, Monday and Tuesday mornings between 8:00am and 10:00am, 40lb bags of flaked ice will be distributed to those booths that have Ice labels in the booth. Labels will be delivered to your booth on Saturday. Additional labels will be available at the Expo Management desk in Room 052 if needed. 11 SERVICES AT THE VENUE PERISHABLE PRODUCTS AND STORAGE During Move-In Freezer and refrigerator storage space is provided free of charge by Expo Management. The reefer units are located on the loading dock in the rear of the exhibit hall. They are open the following hours: Thursday Saturday Sunday Monday Tuesday 8:00am 5:00pm 7:00am 6:30pm 7:00am 6:00pm Product can be removed and returned daily. Labor for product transport between your booth and the reefer units may be ordered through Freeman at the reefer labor desk on the docks. Pre-ordering of reefer labor is encouraged. The reefer labor desk will be staffed by Freeman who will oversee the storage of your product whether you store it yourself or hire labor. Exhibitors can hand-carry their own product, or hire labor and pay the labor fees.Labels will be delivered to your booth on Saturday and additional labels will be available at the Expo Management office in room 052. Be sure to label all products to clearly distinguish between that which you wish to keep. During Move-Out All items must be labeled by 4:00pm if you wish to ship perishables. Arrangements must be made in advance with your carrier to check in by 4:00pm on Tuesday, March 8th. Any product that is not labeled by 6:00pm will be donated to the Greater Boston Food Bank. FOOD PREPARATION AREAS There are four sink prep areas on the expo floor for prepping food and washing dishes. One is located in Hall A behind booth 152, one is in Hall A between the escalators, one in the back of the 2100 aisle and one behind the Demonstration Theater, booth Please use these areas to clean utensils, trays, etc. FOOD DONATION Absolutely no perishable seafood may be removed from the Exhibit Hall. Product may have been part of a display and with improper refrigeration for several days, so in the interest of food safety, all perishable seafood that is being carried out will be destroyed at the exits. Instead of giving product away to people from your booth, please make the appropriate arrangements to ship samples to attendees if required, or donate your product to The Greater Boston Food Bank. The Food Bank is New England s largest food assistance program and they will be onsite at the close of the expo on Tuesday, March 8th, to pick up surplus product that exhibitors wish to donate. Refrigerated and frozen storage trucks are open until 6:00pm on Tuesday, March 8th. All items must be labeled by 4:00pm if you wish to ship perishables back in lieu of donating them. Arrangements must be made in advance with your carrier to check in by 4:00pm on Tuesday, March 8th. Any product left in the storage trucks that is not labeled by 6:00pm will be donated to The Greater Boston Food Bank.