ProMRI® MR conditional device systems
Contents
1. Iforia models Model Order number Order number DF 1 connection DF4 connection Iforia 5 VR T 390 119 390 121 Iforia 5 VR T DX 390 123 Iforia 5 DR T 390 115 390 117 Iforia 5 HF T 390 111 390 113 Iforia 7 VR T 390 083 390 089 Iforia 7 VR T DX 390 095 Iforia 7 DR T 390 069 390 075 Iforia 7 HF T 390 056 390 062 MR conditional pacemakers Basic Information llesto models Model Order number Order number DF 1 connection DF4 connection llesto 5 VR T 390 118 390 120 Ilesto 5 VR T DX 390 122 llesto 5 DR T 390 114 390 116 llesto 5 HF T 390 110 390 112 llesto 7 VR T 390 082 390 088 Ilesto 7 VR T DX 390 094 llesto 7 DR T 390 068 390 074 llesto 7 HF T 390 055 390 061 Note For Evia Entovis Estella and Ecuro models up to incl serial number 66237094 a maximum slew rate of 125 T m s per axis is valid The following pacemakers are MR conditional Evia models Model Order number uncoated Order number coated Evia SR T 371 998 372 034 Evia SR 371 997 372 033 Evia DR T 371 996 372 032 Evia DR 371 995 372 031 Evia HF T 381 534 381 535 Evia HF 381 532 381 533 Entovis models Model Order number uncoated Order number coated Entovis DR T 371 992 372 028 Entovis DR 371 991 372 027 Entovis SR T 371 994 372 030 Entovis SR 371 993 372 029 Entovis HF T 381 530 381 5312. ICD lead Linoxs t ProMRI DF4 SD Lead model Order number Linoxsmert ProMRI DF4 SD 65 16 394 102 Linoxsmert ProMRI DF4 SD 65 18 394 103 Linoxsmert ProMRI DF4 SD 75 18 394 104 Coronary sinus lead Corox ProMRI OTW Lead model Order number Corox ProMRI OTW 75 BP 381 487 Corox ProMRI OTW 85 BP 381 488 Corox ProMRI OTW L 75 BP 381 492 Corox ProMRI OTW L 85 BP 381 491 Corox ProMRI OTW S 75 BP 381 489 Corox ProMRI OTW S 85 BP 381 490 Only very specific combinations of the above mentioned active devices and leads are certified as MR conditional device systems Please see Appendix B for the combinations of ICDs or pacemakers and leads which can be used as a device system that is tested MR conditional 9 Safety Warnings Safety Warnings Magnetic Resonance Imaging Possible Interactions Problematic interactions MR conditional BIOTRONIK devices Fields in the MRI scanner Force of the static and gradient magnetic fields Significant mechanisms which can lead to problematic interactions with device systems are described here Therefore the conduction of MR scans for ICD or cardiac pacemaker patients is generally contraindicated BIOTRONIK has with its MR conditional systems developed devices on which the effects listed below on device systems and patients are minimized For this combination of lead and active device conditions required for the respons
3. 1 Check and ensure that all requirements pertaining to the patient and the device system described in the sections Preconditions and Basic Conditions for all Products p 12 and Conditions for Specific Products p 14 are met 2 Make sure the technical and clinical basic conditions for the MR scan can be met and that the necessary preparations have been made Once the conditions for an MR scan have been clarified preliminary examination and programming to an MRI mode by the cardiologist are the final and definitive preparation measures Proceed as follows Step Action 1 Apply the programming head of the programmer to the chest and interrogate the pacemaker or ICD 2 Perform full follow up and check the following preconditions for the MR scan Pacing threshold max 2 0 V 0 4 ms e Lead impedance 200 1500 0 Battery charging status min 30 3 Open the MRI program There are two options Select Follow up gt MRI Select Parameters gt Program sets gt Show MRI program 4 Read the preliminary and basic conditions in the MRI checklist window carefully and activate the checkbox accept the conditions for MRI examinations 5 Select OK 17 MRI Examination Note The software will not permit further programming of an MRI mode without this confirmation 6 Select Program WARNING Risk of death due to deactivated ICD functions
4. 10 Interactions resulting from induced AC voltages Thermal interactions Image interference and artifacts Safety Warnings Gradient magnetic fields and electromagnetic high frequency fields can induce electrical AC voltages in metallic devices In some cases these electrical energies can result in undesirable pacing or have a negative impact on the ICD or pacemaker Constructive measures on the MR conditional devices and the restrictive prerequisites for the arrangement and conduction of the MR scan reduce the probability of occurrence and the strength of this effect However this effect cannot be entirely excluded The accompanying emergency precautions are among others necessary in this case High frequency electromagnetic fields induce electric voltages in the lead which cause current conduction through the lead and the tissue electrically connected to the lead This flow of current in turn causes warming at the electrical points of contact between the lead and the tissue which can result in thermal damage to the surrounding tissue This thermal tissue damage can be temporary or lasting and can cause deterioration of the lead s pacing and sensing functions Gradient magnetic fields can cause warming of the device housing which can lead to thermal exposure and damage to the surrounding tissue Due to the constructive composition of the MR conditional devices and the compliance with the tested conditions and restr
5. 0 ms Pacing rate adjustable from 70 to 160 bpm preset to 90 bpm All automatic functions are deactivated ICD therapy is inactive The magnet response is set to SYNC synchronous Home Monitoring remains active The programmed settings for the LV lead in normal mode are accepted for the biventricular MRI mode 18 MRI Examination Note You will leave the MRI program if you change parameters prior to sending exception the pacing rate for the ICD 8 Transmit the MRI program to the pacemaker or ICD Note When programming the MRI mode the original pacemaker settings are saved in the programmer or the original ICD settings are saved in the ICD These settings can be accessed again during the cardiological follow up examination after completion of the MR scan which simplifies restoration of the status from before the MR scan For pacemakers the same programmer must be used as for the preliminary examination 9 Print and document follow up data print report 10 Finish the preliminary examination of the patient Make sure that the patient can be immediately submitted to cardiological follow up after completion of the MR scan 19 MRI Examination Prerequisites Basic conditions and restrictions Completion of the examination MRI Examination The following conditions have to be met e The contraindications listed in the respective sections
6. Additionally the radiology professional is also responsible for ensuring that the restrictive conditions under which the exam is to be performed are observed both before and during the MR scan The expert knowledge required by the radiology professional includes the following areas and subjects e Handling MRI scanners e Preparation performance and analysis of MR scans Intended Medical Use Active device and lead Patient selection MRI indication Intended use Residual risk Basic Information The respective intended use of the pacemaker or ICD and lead s applies to the use of the device system Note The technical manuals for the active device and the lead s are to be observed Before a patient with an MR conditional device system is selected for an MR scan the following issues must be resolved e There must be a clear indication for the MR scan This means that there is no doubt as to the predictable diagnostic benefit of the MR scan and that comparable results cannot be achieved with other less risky procedures e Risk benefit analysis ofthe exclusion criteria listed in this technical manual have been taken into consideration e The described restrictions and conditions for the MR scan are to be observed at all times In the past MR scans were always contraindicated for ICD or pacemaker patients If the relevant prerequisites and conditions are fulfilled MR scans can n
7. Iforia 5 DR T Iforia 7 DR T llesto 5 DR T llesto 7 DR T Lumax 740 DR T Lumax 640 DR T Iforia 5 HF T Iforia 7 HF T llesto 5 HF T llesto 7 HF T Lumax 740 HF T Lumax 640 HF T 24 Appendix B Linoxs art ProMRI DF4 SD Corox ProMRI OTW BP Corox ProMRI OTW S BP Solia S Corox ProMRI OTW L BP Iforia 5 VR T DF4 Iforia 7 VR T DF4 Ilesto 5 VR T DF4 llesto 7 VR T DF4 Iforia 5 DR T DF4 Iforia 7 DR T DF4 llesto 5 DR T DF4 x x llesto 7 DR T DF4 Iforia 5 HF T DE4 Iforia 7 HF T DE4 llesto 5 HF T DF4 a 2 llesto 7 HF T DF4 CAUTION Limitation due to lead combinations that are not MR conditional Combinations of ICDs or pacemakers and leads which are not listed are considered tested non MR conditional BIOTRONIK SE amp Co KG rights reserved Specifications subject to modification revision and improvement amp ProMRI is a registered trademark of BIOTRONIK SE amp Co KG C 0123 2012 90 385 EEC 13 D 07 Revision T 2013 01 23 371712 BIOTRONIK SE amp Co KG Woermannkehre 1 12359 Berlin Germany Tel 49 0 30 68905 0 Fax 49 0 30 6852804 sales biotronik com www biotronik com BIOTRONIK excellence for life
8. as well as the required preconditions and basic conditions are taken into consideration The patient was previously examined by a cardiology professional and the pacemaker or ICD is switched to a mode especially suitable for an MR scan e The technical and organizational conditions are met to be able to comply with the restrictions and safety measures required during the MR scan Emergency equipment for resuscitation including specialist staff certified to use it are available The conditions that have to be met during an MR scan are listed in the section Preconditions and Basic Conditions for all Products p 12 under the subheading Restrictions during the MR scan The conditions listed in the section Conditions for Specific Products p 14 also have to be observed After completing the MR scan make sure the patient is again monitored by a cardiology professional who performs the required follow up cardiology examination and the reprogramming of the device system 20 MRI Examination Follow up After the MR scan Subsequent to the MR scan the patient must immediately undergo cardiological follow up This is necessary for the patient s safety for two reasons e To switch the active device back into a mode which provides the patient with adequate therapy e To check whether the device system or the heart muscle have incurred damage during the MR scan Cardiological follow up The cardiological examinatio
9. overall accumulated time required during the MR scan for imaging as displayed by the MRI scanner must not exceed 30 minutes The mean specific absorption rate for the whole body displayed by the MRI scanner must not exceed 2 0 W kg The head absorption rate displayed by the MRI scanner must not exceed 3 2 W kg Emergency equipment for resuscitation must be kept at hand and properly certified staff must be available Monitor the patient s hemodynamics during the entire MR scan by continuously recording at least one of the following parameters Blood oxygen saturation Blood pressure ECG Only use devices for this which are permitted for patient monitoring in an MRI environment Note The ECG function integrated in the MRI scanner is often not permitted for patient monitoring Any additional specific conditions only applicable to certain device systems must also be observed 14 Safety Warnings Conditions for Specific Products General information MR conditional device systems Specific conditions for device systems Several prerequisites and conditions for conducting an MR scan apply to more than one possible device combination whereas other conditions are specifically defined for one particular condition This section describes the conditions that are specific to device systems Please see Appendix B for the combinations of ICDs or pacemakers and leads which can be used as a device
10. system that is tested MR conditional In addition to the prerequisites and basic conditions for all products special conditions apply to the combinations of pacemakers or ICDs and lead s listed in the Appendix e The total length of examination for the device system must be below 10 hours Explanation of the term total length of examination When several MR scans are performed in a row on a patient with a device system the length of each examination is recorded and these times are accumulated This sum is almost equal to the total exposition time during which the devices were exposed to the strong magnetic field Adherence to the permissible positioning ranges The isocenter of the high frequency coil should not be below eye level nor above the hip bone In practice this means that the marker line of the laser light localizer which is used for subsequent positioning of the patient within the MRI scanner should not be set below eye level lower edge of eye socket and not above the hip bone two fingers above the symphysis These areas absolutely have to be adhered to during the MR scan However receiver only coils can also be positioned outside this area As a result of this limitation and due to the technical specifications of the MRI scanner no imaging data can be collected for this part of the body the scan exclusion zone 15 Permissible positioning zone and scan exclusion zone Safety Warnings The
11. Entovis HF 381 528 381 529 Estella models Model Order number uncoated Order number coated Estella DR T 377 383 377 382 Estella DR 377 381 377 380 Estella SR T 377 387 377 386 Estella SR 377 385 377 384 MR conditional lead models Basic Information Ecuro models Model Order number uncoated Order number coated Ecuro DR T 377 367 377 366 Ecuro DR 377 365 377 364 Ecuro SR T 377 371 377 370 Ecuro SR 377 369 377 368 The following leads are MR conditional Pacemaker lead Safio S Lead model Order number Safio S 45 370 944 Safio S 53 370 945 Safio S 60 370 946 Pacemaker lead Solia S Lead model Order number Solia S 45 377 176 Solia S 53 377 177 Solia S 60 377 179 Pacemaker lead Solia T Lead model Order number Solia T 53 377 180 Solia T 60 377 181 ICD lead Linox mart ProMRI S Lead model Order number Linoxs mart ProMRI S 65 377 166 Linoxsmart ProMRI S 75 377 167 ICD lead Linox smart ProMRI SD Lead model Order number Linox m rt ProMRI SD 65 16 377 169 Linoxsmart ProMRI SD 65 18 377 170 Linoxs t ProMRI SD 75 18 377 171 ICD lead Linox mart ProMRI S DX Lead model Order number Linoxsmert ProMRI S DX 65 15 377 211 Linox mert ProMRI S DX 65 17 377 212 MR conditional device systems Basic Information
12. ProMRI MR conditional device systems ProMRI9 6 BIOTRONIK excellence for life Table of Contents Table of Contents Basic Information Safety Warnings MRI Examination AppendixA Appendix uiuunt dne eher tara Zaha ah ae 2 About this 2 Target Groupe ceret ane di eet wha carat ates 3 Intended Medical Use 4 An Overview of MR Conditional BIOTRONIK Products 5 qe 9 Magnetic Resonance Imaging Possible Interactions 9 lt 11 Preconditions and Basic Conditions for all Products 12 Conditions for Specific Products 14 Me sua SLM C USE dtt 16 Preliminary 16 MRI Examination 19 20 EE eA 21 MR Conditional Symbol on the Label 21 uim uisa iu rcr 22 Combinations of Specific 22 371712 T About this Manual Subject of this manual What this manual doesn t include Frequently used terms Affected products Basic Information Basic Information The manual provides information about the safe application of an MR scan on patients with a BIOTRONIK device system which consists of a pacemaker or ICD and th
13. The MRI mode causes an ICD to be unable to detect dangerous heart rhythms and deliver any therapy shocks An ICD patient must be continuously observed between activation of the MRI program and reactivation of the therapy program and an external defibrillator must be kept constantly ready WARNING Health risk to patients due to limited pacemaker or ICD function Continuous cardiological monitoring of the patient must be ensured until the device system s full functionality is restored in the follow up examination 7 Activate one of the possible MRI modes The OFF setting is recommended for patients not dependent on their pacemaker An asynchronous mode D00 A00 V00 is recommended for pacemaker dependent patients depending on the particular indication If the patient shall receive biventricular pacing and an Evia Entovis HF T pacemaker or an llesto Iforia HF T ICD is implanted an asynchronous biventricular pacing mode is recommended depending the indication D00 BiV or V0O BiV The following parameters are set for pacemakers Pulse amplitude 4 8 V Pulse width 1 0 ms Pacing rate 80 bpm All automatic functions and Home Monitoring are deactivated The magnet response is set to SYNC synchronous For Evia HF T Entovis HF T Home Monitoring remains active The following parameters are set for ICDs Pulse amplitude 5 0 V Pulse width 1
14. d adapters Lead extensions The patient does not have fever The patient s height is at least 1 4 meters The device system has been implanted for at least 6 weeks The device system is in the patient s chest area The ascertained pacing threshold does not lie above 2 0 V at 0 4 ms pulse width The ascertained lead impedance is between 200 and 1500 ohms The pacemaker or ICD is reprogrammed to a special MRI mode immediately before the MR scan The conditions applicable to specific devices or device systems such as specific permissible positioning zones and minimum patient height are observed The MRI scanner must meet the following conditions Use of a clinical MRI system with a closed tube cylindrical magnets and a static magnetic field strength of 1 5 T The slew rate of the MRI scanner s gradient fields must not exceed 200 T m s per axis Note For Evia Entovis Estella and Ecuro models up to incl serial number 66237094 a maximum slew rate of 125 T m s per axis is valid The HF field is generated solely by the body coil built into the MRI scanner No additional local emitting coils are used 13 Restrictions during the MR scan Safety Warnings The following conditions must be met during the MR scan The MR scan must only be performed with the patient in dorsal position The permissible positioning zone defined in the Conditions for specific products section must be observed The
15. e associated leads and has been labeled MR conditional This manual will focus particularly on the restrictive prerequisites and general conditions and safety measures that are to be adhered to before and during an MR scan using a BIOTRONIK device system Correct and safe use of the respective ICDs or pacemakers and leads is described in the technical manuals provided with the products and is not a subject of this manual Likewise correct and safe use of an MRI scanner is not described in this manual unless directly related to an implanted BIOTRONIK device system An MR conditional device system allows patients who have such a system consisting of an active device and one or more leads to undergo an MR scan if certain requirements and conditions are fulfilled Such products are labeled with the MR conditional symbol on their packaging ProMRI is the BIOTRONIK name and trademark for these products The procedures for the preparation and conduction of an MR scan described in this manual relate only to implantable leads pacemakers and ICDs that are declared MR conditional by BIOTRONIK The behavior of a certain combination of one or more leads and an active device is tested under MR scan conditions for this purpose Thereby specific criteria and conditions which are each precisely defined may apply for different device systems Target Group Cooperation between professionals from two areas of expertise Knowledge r
16. equired by the cardiology specialist Knowledge required by the radiology specialist Basic Information This manual is intended for physicians and medical staff who have the knowledge and experience required to prepare and perform MRI scans on patients with an ICD or pacemaker Preparation and conduction of an MR scan on an ICD or pacemaker patient require close cooperation between a cardiology professional as a specialist for the device system and a radiology professional as a specialist for the MR scan The following sections describe the tasks that each of these specialists are responsible for A cardiology professional is required to select and or approve the patient for the MR scan Additionally they must test the device system before the exam put the device in a special MRI mode ensure its functionality after the exam and program it back to the mode which was active before the MR scan The expert knowledge required by the cardiology professional includes the following areas and subjects Performing ICD or pacemaker therapy e Handling of the BIOTRONIK programmer and especially the following activities Interrogating the active device Performing follow up Switching parameters e All associated risks possible side effects and the appropriate safety and therapy measures The radiology professional is responsible for the successful performance of the MR scan for the purposes of the desired diagnosis
17. following applies to the device systems listed in the Appendix Sketch permissible positioning zone and scan exclusion zone Legend e 1 Scan exclusion zone e 2 Permissible positioning zone Starting from the foot end the maximum allowed positioning mark for the isocenter is at the hip bone level or two fingers above the symphysis Starting from the top of the skull the maximum allowed positioning mark for the isocenter is at the level of the eyes or the lower edge of the eye socket Imaging data can be obtained within the field of view of an MRI scanner and thus the scan exclusion zone depends on the MRI scanner s field of view 16 MRI Examination MRI Examination Preliminary Examination Cooperation between specialists Checking the suitability of the patient and the implanted system Preliminary cardiological examination and MRI programming Preparation and conduction of an MR scan on a patient with an ICD or pacemaker requires close cooperation between a specialist for the device system and a specialist for the MRI technology and MR scan One of these specialists must perform the steps described in the following for preparation of the MR scan the patient and his or her device system The person responsible for each task depends on the activity or context of the scan Cardiology and radiology professionals are required for this step Proceed as follows Step Action
18. ible performance of MR scans have been tested and explained in this manual The following three types of fields are generated in an MR scan Static magnetic field This is a consistently strong homogenous magnetic field which is constantly present in the MRI scanner and its immediate surroundings even if no scan is being performed e Gradient magnetic fields These are low frequency pulsed magnetic fields with a relatively low amplitude During the MR scan the patient is exposed to three gradient magnetic fields that are perpendicular to each other e HF field high frequency field This is a high frequency electromagnetic field which activates the protons on their resonance frequency It is switched on several times during the imaging process but only for very short periods The HF field is created by so called emitting coils which also serve as receiver coils A differentiation is made between the emitting coils body coils integrated in the MRI scanner with the addition of optional local emitting coils e g head coil with transmitting function Implanted ferromagnetic materials are subject to the force of these magnetic fields This means that implanted devices can subject the surrounding tissue to pressure tensile force or vibrations The construction and choice of material in the MR conditional devices and compliance with the specified conditions serve to reduce these stresses to an acceptable minimum
19. ictions for the MR scan these thermal effects are kept to a tolerable measure Not only can the MR scan have undesirable effects on the patient or the device system but the implanted devices can also have a negative impact on the MR scan If the devices are outside the scanning area they can cause slight image distortion and interference If a device is within the area shown by the MRI scanner then artifacts distortion and interference are probable Consider this when selecting the image calculation parameters and the depicted area Note Permissible positioning zone permissible positioning zone for each MR conditional device system is specified in the relevant part of this manual The limits of the permissible positioning zones regulate the size and location of the scan exclusion zone 11 Contraindications Preliminary notes Contraindications Safety Warnings The indications and contraindications for implantation of certain leads and ICDs or pacemakers and the application of the respective cardiological therapies are not included in this manual Please refer to the technical manuals of the respective devices for this information This manual only deals with aspects that are relevant within the MR scan context The manual does not deal with the contraindications of MRI applications which do not result from interactions with a device system e An MR scan on a device system patient is always co
20. n following an MR scan is to be performed as follows procedure CAUTION Risk of death for ICD patients Reactivation of the ICD therapy functions may be life saving for an ICD patient The patient can stop being continuously monitored and an external defibrillator no longer needs to be kept ready after these functions have been reliably reactivated 1 Apply the programming head 2 Interrogate the device 3 Reactivate the program which was effective prior to programming the MRI mode 4 If the active device is an ICD reactivate ICD therapy Send the reactivated program to the device Perform a complete follow up If necessary perform further examinations Print and document follow up data print report sO QO NI Finish the follow up for the patient 21 Appendix A 4 Appendix A MR Conditional Symbol on the Label There is a sticker on the box with product information and symbols which are explained in the user manual provided in the packaging of the BIOTRONIK devices The packaging of MR conditional products under the brand name ProMRI is additionally labeled with the following symbol MR conditional Patients who have a device system with devices labeled with this symbol on the packaging can be examined using an MR scan under precisely defined conditions 22 Appendix B 5 Appendix B Combinations of Specific Products These
21. ntraindicated for device systems which have not been identified as MR conditional by BIOTRONIK and have not been certified for MRI applications by a responsible authority An MR scan on a patient with an MR conditional device system is also contrain dicated when any of the conditions listed under Preconditions and Basic Conditions for all Products p 12 is not adhered to An MR scan on a patient with an MR conditional device system is also contrain dicated when one of the specific conditions that applies to a particular device system is not adhered to 12 Safety Warnings Preconditions and Basic Conditions for all Products Basic principles Preconditions for the patient and the device system Requirements of the MRI scanner Safe conduction of an MR scan on a patient having an implanted ICD or pacemaker is only possible under highly specific prerequisites and conditions MRI use is contraindicated in all other cases The following requirements must always be fulfilled to perform an MR scan with inclusion of a BIOTRONIK device system e The device system consists only of one or more leads and a pacemaker or ICD which are each separately labeled MR conditional and can in combination constitute an MR conditional device system See An Overview of MR Conditional BIOTRONIK Products p 5 There are no other devices in the patient s body For example Other pacemakers or ICDs Abandoned leads Lea
22. ow be conducted on patients with a combination of a BIOTRONIK active device and lead that has been tested for this purpose The expected risks and hazards are minimized by the measures listed in this manual Nevertheless a residual risk remains 5 Basic Information An Overview of MR Conditional BIOTRONIK Products Devices and device systems The behavior of a precisely defined device system consisting of a pacemaker or ICD and at least one lead has been tested under the conditions of an MR scan and labeled MR conditional However due to the fact that both the active device and the lead are sold independently of each other this manual informs the user about which combinations of an active device and a lead are MR conditional and about the conditions and requirements that are to be observed for the respective combination MRI approval in the country If you are planning to perform an MR scan with an MR conditional BIOTRONIK device system please contact the responsible authorities or BIOTRONIK beforehand to determine whether these products are actually certified as MR conditional in your country or region MR conditional ICDs The following ICDs are MR conditional Lumax models Model Order number Lumax 740 VR T 381 459 Lumax 740 VR T DX 381 463 Lumax 740 DR T 381 461 Lumax 740 HF T 381 462 Lumax 640 VR T 381 468 Lumax 640 VR T DX 381 472 Lumax 640 DR T 381 470 Lumax 640 HF T 381 471
23. tables show which combinations of ICDs or pacemakers and leads can be used as a device system that is tested MR conditional a a a z z z ee 25 a amp 20 25 o o oz oz uf z z uf z oF oF oF SR T Evia DR T Entovis SR T Entovis DR T Estella SR T M Estella DR T Ecuro SR T Ecuro DR T Evia HF T x x x x Entovis HF T x x X X a a a z z z B hea es Lr oo kw Xo o m x 1 S 5 ez 23 3 o o ot ot oL SR T N Evia DR T Entovis SR T x x Entovis DR T Estella SR T x Estella DR T Ecuro SRI T x N Ecuro DR T Evia HF T x x x x x Entovis x x x x x CAUTION Limitation due to lead combinations that are not MR conditional Combinations of ICDs or pacemakers and leads which are not listed are considered tested non MR conditional The combination of Safio and Solia leads in a device system is not an MR conditional device system 23 Appendix B Solia S Linoxsmart ProMRI S Linoxsmart ProMRI SD Linoxsmart ProMRI S DX Corox ProMRI OTW BP Corox ProMRI OTW S BP Corox ProMRI OTW L BP Iforia 5 VR T Iforia 7 VR T llesto 5 VR T llesto 7 VR T Lumax 740 VR T Lumax 640 VR T Iforia 5 VR T DX Iforia 7 VR T DX Ilesto 5 VR T DX Ilesto 7 VR T DX Lumax 740 VR T DX Lumax 640 VR T DX
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