MRI-Ready Systems Manual

1 MRI-Ready Systems Manual MRI Procedure Information for the St. Jude Medical MR Conditional System Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies. Pat. 2018 St. Jude Medical, LLC. All Rights Reserved. i Contents Introduction .. 1 Symbols .. 1 St. Jude Medical MR Conditional Systems .. 1 3T MRI Scan Parameters for St. Jude Medical MR Conditional Systems .. 2 3T MR Conditional Systems Device/Lead Combinations .. 2 MRI Scan Parameters for St. Jude Medical MR Conditional Systems .. 3 MR Conditional Systems Device/Lead Combinations .. 4 Instructions for Cardiac Physicians and Clinicians .. 6 I. Confirm that the Patient has an MR Conditional System .. 6 II. Confirm that No Adverse Conditions to mri scanning are Present .. 6 III. Review the Potential Adverse Events.

2 7 IV. Generate a Report of the Patient's Permanently Programmed Parameters .. 8 V. Select and Save MRI Settings .. 8 VI. Review the MRI checklist .. 11 VII. Disable the MRI 13 Instructions for Radiologists and MRI Technologists .. 13 I. Confirm that the Patient has an MR Conditional System .. 13 II. Confirm that No Adverse Conditions to mri scanning are Present .. 13 III. Review the Potential Interactions .. 14 IV. Select the Correct Scan Parameters .. 14 V. Check the MRI Settings Status .. 14 VI. Perform the Scan and Monitor the Patient .. 17 VII. Disable the MRI 17 Technical Support .. 17 1 Introduction This Manual explains the procedures and precautions that must be followed when scanning a patient who is implanted with a St. Jude Medical MR Conditional system. It is important to read the information in this Manual before conducting an MRI scan on a patient with an implanted St. Jude Medical MR Conditional system. Contact Technical Support (page 17) if you have any questions.

3 Refer to the Merlin Patient Care System (PCS) on-screen help or to the appropriate device or lead user's Manual for non-MRI related information. The St. Jude Medical MR Conditional system includes a St. Jude Medical MR Conditional device connected to one or more St. Jude Medical MR Conditional leads. For a list of the device/lead combinations that have been tested, see the device/lead combinations tables. Testing has demonstrated that the St. Jude Medical MR Conditional system is conditionally safe for use in the MRI environment when used according to the instructions in this Manual . Enable the MRI Settings to turn on a mode of operation that allows a patient with an MR Conditional system to be safely scanned by an MRI scanner when used according to the instructions in this Manual . CAUTION: Not all of the products listed as MR Conditional are approved for MR Conditional use in all countries or regions. Before performing an MRI scan on patients implanted with any of these devices, contact St.

4 Jude Medical or consult your regulatory authorities to determine if the products have been certified as MR Conditional. Symbols Table 1. MR Conditional symbols Symbol Description Device has been demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use. St. Jude Medical MR Conditional Systems Personnel planning or performing an MRI scan of a patient with an MR Conditional system must follow the procedures and restrictions outlined in this Manual . Failure to follow the procedures outlined here may result in serious harm to the device and the patient. NOTE: All St. Jude Medical MR Conditional Systems can be scanned using Tesla ( ) MRI scanners and some MR Conditional Systems can also be scanned using Tesla (3T) MRI scanners. Refer to the sections below to identify the MRI scanner type and scan parameters for the MR Conditional device/lead combinations. 2 3T MRI Scan Parameters for St. Jude Medical MR Conditional Systems When performing a 3T MRI scan on a patient with a St.

5 Jude Medical MR Conditional system, the following scan parameters must be followed. Table 2. 3T MRI scan parameters Scan Parameters Setting Scanner Type Cylindrical-bore magnet, horizontal field orientation Magnet Strength 3 Tesla/128 MHz excitation frequency (hydrogen atom only). Spatial Field Gradient 30 T/m (3000 G/cm) RF Power The RF Power requirements will be met if the scanner is in the specified operating mode. See the device/lead combinations table below (page 2). Gradient Slew Rate 200 T/m/s per axis Scan Regions See the device/lead combinations table below (page 2). The above scan parameters are applicable for use with Full Body RF transmit coil with any receive coil CAUTION: For 3T MRI system RF excitation, ensure your scanner is operating as circularly polarized (CP) or quadrature (QD). CAUTION: Multiple leads can be connected to an MR Conditional device. Confirm that each individual lead meets MRI conditions for use. Not all lead lengths are MR Conditional. The device/lead combinations table below (page 2) lists the MR Conditional lead lengths.

6 3T MR Conditional Systems Device/Lead Combinations Pacemakers Table 3. 3T MR Conditional Systems Device/Lead Combinations for Assurity MRI and Endurity MRI Pacemakers Device model Lead model (lengths) RF Power Scan regions Assurity MRI PM1272 PM2272 Endurity MRI PM1172 PM2172 Tendril STS leads 2088TC (46 cm, 52 cm, 58 cm) Normal Operating Mode RF excitation: Circularly polarized or quadrature Full body IsoFlex leads 1944 (46 cm, 52 cm) 1948 (52 cm, 58 cm) Normal Operating Mode RF excitation: Circularly polarized or quadrature Full body 3 MRI Scan Parameters for St. Jude Medical MR Conditional Systems When performing a MRI scan on a patient with a St. Jude Medical MR Conditional system, the following scan parameters must be followed. Table 4. MRI scan parameters Scan Parameters Setting Scanner Type Cylindrical-bore magnet, horizontal field orientation Magnet Strength Tesla/64 MHz excitation frequency (hydrogen atom only). Spatial Field Gradient 30 T/m (3000 G/cm) RF Power Varies for each device/lead combination.

7 The RF Power requirements will be met if the scanner is in the specified operating mode. See the device/lead combination tables below (page 4). Gradient Slew Rate 200 T/m/s per axis Scan Regions Varies for each device/lead combination. See the device/lead combination tables below (page 4). The above scan parameters are applicable for use with the following RF coil types: 1. Full Body RF transmit coil with any receive coil 2. Local RF transmit-receive coil in Normal Operating Mode - RF transmit-receive head coil (quadrature only) - RF transmit- receive lower extremity coil (quadrature only) - RF transmit-receive upper extremity coil (quadrature only) WARNING: Do not place local RF transmit coils directly over the device because this has not been tested. CAUTION: Multiple leads can be connected to an MR Conditional device. Confirm that each individual lead meets MRI conditions for use. If the implantable system is comprised of a combination of leads that have different scan parameters, use the most restrictive of each scan parameter to determine the overall set of scan parameters applicable for the total system.

8 CAUTION: Not all lead lengths are MR Conditional. The device/lead combination tables below (page 4) list the MR Conditional lead lengths. 4 MR Conditional Systems Device/Lead Combinations Pacemakers Table 5. MR Conditional Systems Device/Lead Combinations for Accent MRI Pacemakers Device model Lead model (lengths) RF Power Scan regions Accent MRI PM1124 PM1224 PM2124 PM2224 Tendril MRI leads LPA1200M (46 cm, 52 cm, 58 cm) First-Level Controlled Operating Mode Full body IsoFlex leads 1944 (46 cm, 52 cm) 1948 (52 cm, 58 cm) Normal Operating Mode Superior: Isocenter at or above the eye level Inferior: Isocenter at or below the L4 vertebra Tendril STS leads 2088TC (46 cm, 52 cm, 58 cm) Normal Operating Mode Superior: Isocenter 10 cm above the eye level Inferior: Isocenter at or below the L4 vertebra Table 6. MR Conditional Systems Device/Lead Combinations for Assurity MRI , Endurity MRI , Endurity , and Endurity Core Pacemakers Device model Lead model (lengths) RF Power Scan regions Assurity MRI PM1272 PM2272 Endurity MRI PM1172 PM2172 Tendril MRI leads LPA1200M (46 cm, 52 cm, 58 cm) First-Level Controlled Operating Mode Full body IsoFlex leads 1944 (46 cm, 52 cm) 1948 (52 cm, 58 cm) Normal Operating Mode Full body Tendril STS leads 2088TC (46 cm, 52 cm, 58 cm) Endurity PM1162 PM2162 Endurity Core PM1140 PM1152 PM2140 PM2152 Tendril MRI leads LPA1200M (46 cm, 52 cm, 58 cm) Normal Operating Mode Full body IsoFlex leads 1944 (46 cm, 52 cm) 1948 (52 cm, 58 cm) Tendril STS leads 2088TC (46 cm, 52 cm, 58 cm) 5 CRT-Ps Table 7.

9 MR Conditional Systems Device/Lead Combinations for Quadra Allure and Quadra Allure MP CRT-Ps Device model Lead model (lengths) RF Power Scan regions Quadra Allure PM3542 Quadra Allure MP PM3562 Quartet leads 1456Q (86 cm) 1457Q (86 cm) 1458Q (86 cm) 1458QL (86 cm) Normal Operating Mode Full body Tendril STS leads 2088TC (46 cm, 52 cm, 58 cm) IsoFlex leads 1944 (46 cm, 52 cm) 1948 (52 cm, 58 cm) ICDs Table 8. MR Conditional Systems Device/Lead Combinations for Ellipse ICDs Device model Lead model (lengths) RF Power Scan regions Ellipse CD1377-36Q CD1377-36QC CD2377-36Q CD2377-36QC Durata leads 7120Q (58 cm, 65 cm) 7122Q (58 cm, 65 cm) Normal Operating Mode Full body Optisure leads LDA220Q (58 cm, 65 cm) LDA210Q (58 cm, 65 cm) Tendril MRI leads LPA1200M (46 cm, 52 cm, 58 cm) Tendril STS leads 2088TC (46 cm, 52 cm) IsoFlex leads 1944 (46 cm, 52 cm) Table 9. MR Conditional Systems Device/Lead Combinations for Fortify Assura ICDs Device model Lead model (lengths) RF Power Scan regions Fortify Assura CD1359-40Q CD1359-40QC CD2359-40Q CD2359-40QC Durata leads 7120Q (58 cm, 65 cm) 7122Q (58 cm, 65 cm) Normal Operating Mode Full body Optisure leads LDA220Q (58 cm, 65 cm) LDA210Q (58 cm, 65 cm) Tendril MRI leads LPA1200M (46 cm, 52 cm, 58 cm) Tendril STS leads 2088TC (46 cm, 52 cm) IsoFlex leads 1944 (46 cm, 52 cm) 6 CRT-Ds Table 10.

10 MR Conditional Systems Device/Lead Combinations for Quadra Assura and Quadra Assura MP CRT-Ds Device model Lead model (lengths) RF Power Scan regions Quadra Assura CD3367-40Q CD3367-40QC Quadra Assura MP CD3371-40Q CD3371-40QC Quartet leads 1456Q (86 cm) 1457Q (86 cm) 1458Q (86 cm) 1458QL (86 cm) Normal Operating Mode Full body Durata leads 7120Q (58 cm, 65 cm) 7122Q (58 cm, 65 cm) Optisure leads LDA210Q (58 cm, 65 cm) LDA220Q (58 cm, 65 cm) Tendril STS leads 2088TC (46 cm, 52 cm) IsoFlex leads 1944 (46 cm, 52 cm) Instructions for Cardiac Physicians and Clinicians NOTE: Radiologists and MRI technologists should see Instructions for Radiologists and MRI Technologists (page 13). The role of cardiac physicians and clinicians in preparing a patient for an MRI scan is to: Confirm that the Patient has an MR Conditional System (page 6) Confirm that No Adverse Conditions to mri scanning are Present (page 6) Review the Potential Adverse Events (page 7) Generate a Report of the Patient's Permanently Programmed Parameters (page 8) Select and Save MRI Settings (page 8) Review the MRI checklist and Program the MRI Settings (page 11) Disable the MRI Settings (page 13) I.