COBALT™ XT/ COBALT™/ CROME™ SURESCAN™
SYSTEMS
MRI procedural information for SureScan™ defibrillators with or without cardiac
resynchronization therapy 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, Medtronic, Quick Look, SureScan
Contents
1 Introduction 4
2 MRI conditions for use 4
2.1 Cardiology requirements 4
2.2 Radiology requirements 5
2.3 Patient monitoring and rescue requirements 6
2.4 Training requirements 6
3 MRI warnings and precautions 7
4 Potential adverse events 7
5 Patient monitoring requirements 8
6 Cardiology-specific considerations 8
7 Radiology-specific considerations 9
7.1 MRI considerations 9
8 Pre-MRI scan operations 9
8.1 Identification of SureScan defibrillation system components 9
8.2 Required patient care 10
9 Performing an MRI scan 10
9.1 SureScan defibrillation system integrity verification 11
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 13
12 Explanation of symbols 14
13 Service 14
3
1 Introduction
The Medtronic SureScan implantable cardioverter defibrillator system is MR Conditional. As such, the system 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 system is required for use in the MR environment. 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.
A complete SureScan CRT-D system includes the following components:
●
The SureScan CRT-D device
●
A SureScan right atrial pacing lead or a Model 6725 pin plug for the right atrial port
●
A SureScan left ventricular pacing lead
●
A SureScan defibrillation lead
A complete SureScan DR ICD system includes the following components:
●
The SureScan DR ICD device
●
A SureScan right atrial pacing lead
●
A SureScan defibrillation lead
A complete SureScan VR ICD system includes the following components:
●
The SureScan VR ICD device
●
A SureScan defibrillation lead
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 the 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.
4
Caution: It is not recommended to perform an MRI scan of pacemaker-dependent patients if the pacing capture
threshold for the right ventricular (RV) lead is greater than a pacing output of 2.0 V at a pulse width of 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 have been evaluated for scanning patients using
MRI equipment that has the following operating characteristics:
Scanner type Horizontal field, cylindrical bore, clinical system for hydrogen proton imaging
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).
5
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