BIOTRONIK ProMRI User manual

ProMRI®
hecklst and Quck Reference ude
ardac Rhythm Therapy // Advanced Features // ProMRI®

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Usage of an MR scan on a patient having an implanted
pacemaker (single- or dual-chamber), ICD, or CRT-D
is only possible under highly specific prerequisites and
conditions. BIOTRONIK offers a comprehensive,
breakthrough portfolio of device systems approved for
MR scans. These products are marked as “ProMRI®.”
Please use the matrices starting on page 10 of this brochure
or the BIOTRONIK ProMRI®System Technical Manual to
check whether the patient’s ProMRI®device-lead combination
is approved for full body MR scans. The requirements listed in
this guide apply to all ProMRI®systems.
Conditions for MR scans with a
BIOTRONIK ProMRI®system

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Restrictions for the patient and the cardiac device system
The devce system conssts of a pacemaker, ID, or RT-D wth the
respectve leads that are separately labeled MR condtonal and,
when combned, consttutes an MR condtonal devce system (See
charts on p 10)
There are no other actve or abandoned cardac mplants (eg, lead
extensons, lead adapters or abandoned leads) n the patent’s body
Other actve or passve mplants are permtted f they are dented
as MR condtonal by the manufacturer
Note An MRI scan s permtted only f the product-specc
condtons are met for all mplants and f no metal mplantable
devce longer than 5 cm s n the vcnty of a BIOTRONIK lead wthn
a dstance of less than 4 cm
The leads have been mplanted for at least 6 weeks
The devce system s mplanted pectorally
The measured pacng threshold s not above 20 V at 04 ms
pulse wdth
The devce system should be functonng normally pror to an MRI
The battery status s nether ERI nor EOS
The devce s programmed to an MRI mode before the MR scan
Conditions for MR scans with a BIOTRONIK ProMRI®
system (continued)

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Conditions for MR scans with a BIOTRONIK ProMRI®
system (continued)
Requirements of the MRI scanner
Use of a clncal MRI machne wth
A closed tube
ylndrcal magnets
A statc magnetc eld strength of 15 tesla
The slew rate of the MRI scanner’s gradent elds should not exceed
200 T/m/s per axs
Restrictions during the MRI scan
The mean specc absorpton rate (SAR) for the whole body dsplayed
by the MRI scanner must not exceed 20 W/kg
The head absorpton rate dsplayed by the MRI scanner must not
exceed 32 W/kg
Emergency equpment for resusctaton must be kept at hand and
properly certed staff must be avalable
ontnuously montor the patent’s condton durng the entre MR
scan usng at least one of the followng parameters blood oxygen
saturaton, blood pressure or E
Note The E functon ntegrated n the MRI scanner s often not
permtted for patent montorng Therefore, only use devces whch
are permtted for patent montorng n an MRI envronment

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Checklist before MRI scanning
This checklist will help to ensure the safe application of an MR scan on
patients with a BIOTRONIK device system that has been labeled MR
Conditional.*
We recommend checking the boxes off while using this checklist to
ensure that an MR Conditional scan with BIOTRONIK ProMRI®systems
is permissible. Please check to see whether the patient’s ProMRI®
device-lead combination is approved for a full body MR scan.
(See charts on p. 10.)
General requirements for patients with ProMRI®systems
Use of a clncal MRI system wth a closed tube, cylndrcal
magnets and a statc magnetc eld strength of 15 tesla
The slew rate of the MRI scanner’s gradient fields should not
exceed 200 T/m/s per axis.
The mean specc absorpton rate for the whole body dsplayed by
the MRI scanner must not exceed 20 W/kg
The head absorpton rate dsplayed by the MRI scanner must not
exceed 32 W/kg
Emergency equpment for resusctaton must be kept at hand and
properly certed staff must be avalable
ProMRI®checklist for the radiology
department

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The patent should be contnuously montored n an approprate
manner durng the entre MR scan The followng parameters can
be observed blood oxygen saturaton, blood pressure, E
Note The E functon ntegrated n the MRI scanner s often not
permtted for patent montorng Therefore, only use devces whch
are permtted for patent montorng n an MRI envronment
Ensure wth the cardology department that the devce s
programmed to MRI mode pror to the MR scan
*
Detals on these condtons and requrements can be found n the BIOTRONIK ProMRI®System
Techncal Manual (wwwbotronkusacom/manuals) Alternatvely, contact your local BIOTRONIK
representatve or vst wwwbotronkusacom/promr
Date
Name and signature
ProMRI®checklist for the radiology department (continued)

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Use the following checklist to ensure that patients who have been
implanted with a BIOTRONIK device system labeled “MR Conditional”
can receive an MR scan safely.*
We recommend that you check off the boxes in order to be certain
that a full body MR Conditional scan with BIOTRONIK ProMRI®
systems is permissible.
ProMRI®checklist for the cardiology
department
Patient
Name
Address
City
Cardiac device system (please complete)
Device
Leads

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The device system consists of a pacemaker, ICD, or CRT-D with the
respective leads that are separately labeled MR conditional and,
when combined, constitutes an MR conditional device system
(See charts on p. 10).
There are no other active or abandoned cardiac implants (e.g., lead
extensions, lead adapters or abandoned leads) in the patient’s body.
Other active or passive implants are permitted if they are identified
as MR conditional by the manufacturer.
Note: An MRI scan is permitted only if the product-specific
conditions are met for all implants and if no metal implantable
device longer than 5 cm is in the vicinity of a BIOTRONIK lead
within a distance of less than 4 cm.
The leads have been implanted for at least 6 weeks.
The device system is implanted pectorally.
The measured pacing threshold is not above 2.0 V at 0.4 ms
pulse width.
The device system should be functioning normally prior to an MRI.
The battery status is neither ERI nor EOS.
Ensure that the device is programmed to an MRI mode before the
MR scan and reprogrammed to the initial settings after the scan.
Post MR scan requirements met (See p. 10).
Date
Name and signature
ProMRI®checklist for the cardiology department (continued)
*
Detals on these condtons and requrements can be found n the BIOTRONIK ProMRI®System
Techncal Manual (wwwbotronkusacom/manuals) Alternatvely, contact your local BIOTRONIK
representatve or vst wwwbotronkusacom/promr

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* Detaled nformaton about ProMRI®can be found n the BIOTRONIK ProMRI®System Techncal
Manual You can download ths document as a PDF le from the webste
wwwbotronkusacom/manuals Alternatvely, contact your local BIOTRONIK representatve or vst
the webste wwwbotronkusacom/promr
ProMRI®system check
Post MR scan requirements
eneral consderatons
The patent must undergo follow-up devce nterrogaton, whch s
necessary for the patent’s safety for two reasons
To reprogram device to original pacing parameters.
To access the device system for any adverse effects caused by
the MR scan.
MRI AutoDetect
For patients with the MRI Program set to AUTO, a post-MR follow-up
to reprogram the implant is not necessary, since the implant
automatically switches back to the permanent program after the
patient exits the MRI scanner.
Pacemakers
DX ICDs
Leads Bradycarda Devces
Eluna DR-T
Entovs DR-T
Eluna SR-T
Entovs SR-T
Edora 8 DR-T
Edora 8 DR
Evty 8 DR-T
Entra 8 DR-T
Evty 6 DR-T
Entra 6 DR-T
Entra 6 DR
Edora 8 SR-T
Edora 8 SR
Evty 8 SR-T
Entra 8 SR-T
Evty 6 SR-T
Entra 6 SR-T
Entra 6 SR
Setrox 53
ProMRI® ProMRI® ProMRI®
Setrox 60
Sello S 45
Sello S 53
Sello S 60
Sola S 45
Sola S 53
Sola S 60