Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Medtronic Australasia Pty Ltd
AIMD
Included
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 read_full_document