Primo MRI VR SureScan Model DVMD3D4 - Defibrillator, implantable, automatic

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Medtronic Australasia Pty Ltd

Class:

AIMD

Authorization status:

Included

Summary of Product characteristics

PRIMO MRI™ / MIRRO MRI™ SURESCAN™
DEFIBRILLATION SYSTEM
MRI procedural information for SureScan defibrillators and SureScan
leads
MRI Technical Manual
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.
Medtronic, Mirro MRI, Primo MRI, Quick Look, SureScan
CONTENTS
1 INTRODUCTION 4
1.1
CE mark of conformity 4
1.2
About the system 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
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 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 13
12 EXPLANATION OF SYMBOLS 13
13 SERVICE 14
3
1 INTRODUCTION
1.1 CE MARK OF CONFORMITY
2017
1.2 ABOUT THE SYSTEM
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