EVERA MRI™ SURESCAN™ DEFIBRILLATION SYSTEM
MRI procedural information for Evera MRI SureScan defibrillators and SureScan leads
MRI Technical Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United States and
possibly in other countries. All other trademarks are the property of their respective owners.
Capture Management, Evera, Evera MRI, Medtronic, Quick Look, SureScan
Contents
1 Introduction 4
2 MRI conditions for use 4
2.1 Cardiology requirements 4
2.2 Radiology requirements 4
2.3 Patient monitoring and rescue requirements 6
2.4 Training requirements 6
3 MRI warnings and precautions 6
4 Potential adverse events 7
5 Patient monitoring requirements 7
6 Cardiology-specific considerations 8
7 Radiology-specific considerations 8
7.1 MRI considerations 8
8 Pre-MRI scan operations 9
8.1 Identification of SureScan defibrillation system components 9
8.2 Required patient care 9
9 Performing an MRI scan 10
9.1 SureScan defibrillation system integrity verification 10
9.2 Programming the MRI SureScan parameter to On 11
9.3 Device considerations 12
10 Following the MRI scan 13
10.1 Returning the device to the pre-MRI configuration 13
11 Medtronic warranty information 14
12 Explanation of symbols 14
13 Service 14
3
1 Introduction
The Medtronic SureScan defibrillation system is MR Conditional and, as such, is designed to allow patients to be
safely scanned by an MRI machine when used according to the specified MRI conditions for use. When
programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues
to provide appropriate pacing. It is important to read this manual before conducting an MRI scan on a patient with
an implanted SureScan defibrillation system. Contact a Medtronic representative if you have further questions.
Refer to the appropriate Medtronic device and reference manuals or lead technical manuals for non-MRI
related instructions for use.
2 MRI conditions for use
A complete SureScan defibrillation system is required for use in the MR environment. A complete
SureScan defibrillation system includes an Evera MRI SureScan DR ICD device with a SureScan right
atrial pacing lead and a SureScan defibrillation lead, or an Evera MRI SureScan VR ICD with a SureScan
defibrillation lead. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com.
Any other combination may result in a hazard to the patient during an MRI scan.
Warning: Do not scan a patient without first programming the MRI SureScan mode to On. Scanning the patient
without programming the MRI SureScan mode to On may result in patient harm or damage to the SureScan
defibrillation system.
Note: The MRI SureScan mode cannot be programmed to On if the device is recommended for replacement.
2.1 Cardiology requirements
Patients and their implanted systems must be screened to meet the following requirements:
●
The patient has no implanted lead extenders, lead adaptors, or abandoned leads.
●
The patient has no broken leads or leads with intermittent electrical contact, as confirmed by lead impedance
history.
●
The SureScan defibrillation system is implanted in the left or right pectoral region.
●
The SureScan device is operating within the projected service life.
●
For patients whose device will be programmed to an asynchronous pacing mode when the MRI SureScan
mode is programmed to On, no diaphragmatic stimulation is present when the paced leads have a pacing
output of 5.0 V and a pulse width of 1.0 ms.
Caution: It is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold
is greater than 2.0 V at 0.4 ms for pacemaker-dependent patients. A higher pacing capture threshold may indicate
an issue with the implanted lead.
2.2 Radiology requirements
The safety and reliability of the SureScan defibrillation system has been evaluated for scanning patients using MRI
equipment that has the following operating characteristics:
4
Scanner type Horizontal field, cylindrical bore, clinical system for hydrogen proton imaging
B
1+RMS
not to
exceed 2.8 μT
No B
1+RMS
restrictions
Scanner characteristics
●
Static magnetic field of one of the following strengths:
– 1.5 T
– 3 T
●
Maximum spatial gradient of ≤ 20 T/m (2000 gauss/cm)
●
Gradient systems with maximum gradient slew rate performance per axis of
≤ 200 T/m/s
Scanner operation 1.5T – MRI radio frequency (RF) power – Normal Operating Mode
●
The whole body averaged specific absorption rate (SAR) must be
≤ 2.0 W/kg.
●
The head SAR must be ≤ 3.2 W/kg.
3T – MRI radio frequency (RF) power – First Level Controlled Operating Mode or
Normal Operating Mode:
●
B
must be ≤ 2.8 µT when the isocenter (center of the MRI bore) is
1+RMS
inferior to the C7 vertebra.
●
Scans can be performed without B
restriction when the isocenter is at
1+RMS
or superior to the C7 vertebra (see Figure 1).
Figure 1. 3T Scan location requirements
5
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