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MRI-Ready Monitor Systems Manual
MRI-Ready Monitor Systems Manual. MRI Procedure Information for the Abbott Medical Jot Dx™ Insertable Cardiac Monitor. Model DM4500 ...
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MRI-Ready Monitor Systems Manual MRI Procedure Information for the Abbott Medical Jot DxTM Insertable Cardiac Monitor Model DM4500 CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov. TM Indicates a trademark of the Abbott group of companies. Indicates a third-party trademark, which is property of its respective owner. Pat. http://www.abbott.com/patents � 2021 Abbott. All Rights Reserved. Contents Introduction ............................................................................................................................................................. 1 Symbols................................................................................................................................................................... 1 MR Conditional Models ............................................................................................................................................ 1 MRI Safety Information............................................................................................................................................. 1 3T MRI Scan Parameters for Abbott Medical MR Conditional Jot DxTM ICM ............................................................... 2 1.5T MRI Scan Parameters for Abbott Medical MR Conditional Jot DxTM ICM ............................................................ 3 Instructions for Cardiac Physicians and Clinicians ..................................................................................................... 4 Confirm that No Adverse Conditions to MRI Scanning are Present.............................................................................................. 4 Review the Potential Interactions ............................................................................................................................................... 4 Instructions for Radiologists and MRI Technologists .................................................................................................. 5 Confirm that No Adverse Conditions to MRI Scanning are Present.............................................................................................. 5 Review the Potential Interactions ............................................................................................................................................... 5 Perform the Scan and Monitor the Patient ................................................................................................................................. 5 Technical Support.................................................................................................................................................... 5 Appendix A: ICM Patient Eligibility Form for MRI Scans............................................................................................. 6 i Introduction This manual explains the procedures and precautions that must be followed when scanning a patient who is implanted with an Abbott Medical MR Conditional Jot DxTM Insertable Cardiac Monitor (ICM). It is important to read the information in this manual before conducting an MRI scan on a patient with a Jot Dx ICM. Contact Technical Support if you have any questions (page 5). Testing has demonstrated that the Jot Dx ICM is conditionally safe for use in the MRI environment when used according to the instructions in this manual. Refer to the Jot Dx ICM user's manual for a complete listing of device-specific indications, contraindications, warnings, precautions, potential adverse events, and directions for use. Symbols Table 1. MR Conditional symbols Symbol Description Device with demonstrated safety in the MR environment within defined conditions including conditions for the static magnetic field, the time-varying gradient magnetic fields and the radiofrequency fields. MR Conditional Models Table 2. Approved models and implant locations Item name Jot DxTM ICM Model DM4500 Location of implanted device Device implanted completely within the region from the right parasternal line to the left midclavicular line, between the 1st rib to the 6th rib MRI Safety Information A patient with the Jot DxTM ICM may be safely scanned under the conditions given in this manual. Scanning under different conditions may result in severe patient injury or device malfunction. 1 3T MRI Scan Parameters for Abbott Medical MR Conditional Jot DxTM ICM When performing a 3T MRI scan on a patient with a Jot DxTM ICM, the following scan parameters must be followed. Table 3. 3T MRI scan parameters Parameter Item Name/Identification Setting Jot DxTM ICM Model DM4500 Refer to the MR Conditional Models table (page 1) Static Magnetic Field Strength [T] and Type of Nuclei 3 Tesla/128 MHz excitation frequency (hydrogen atom only) Magnet Type and Static Magnetic Field Orientation Cylindrical-bore magnet, horizontal field orientation Maximum Spatial Field Gradient [T/m] and [Gauss/cm] 24 T/m (2400 Gauss/cm) Maximum Gradient Slew Rate per axis [T/m/s] 200 T/m/s RF Transmit Conditions First Level Controlled Operating Mode or Normal Operating Mode Integrated Whole Body RF Transmit coil with RF excitation: Circularly polarized (CP), or Multichannel-2 (MC-2) RF Receive Coil Type Any receive coil may be used Scan Duration and Wait Time between scans No limitations on scan duration or wait time between scans Scan Region / Patient Landmarking Criteria Full body scans allowed / Any landmark is acceptable Patient Characteristics Refer to: Instructions for Cardiac Physicians and Clinicians (page 4) Instructions for Radiologists and MRI Technologists (page 5) Patient Position in Scanner Supine or prone; patient's arms must be at his or her sides Device Configuration Location of implanted device: Device implanted completely within the region from the right parasternal line to the left midclavicular line, between the 1st rib to the 6th rib Instructions to be followed before and after the MRI exam Refer to: Instructions for Cardiac Physicians and Clinicians (page 4) Instructions for Radiologists and MRI Technologists (page 5) MR Image Artifact The presence of this device may produce an image artifact. Some manipulation of scan parameters may be required to compensate for the artifact. 2 1.5T MRI Scan Parameters for Abbott Medical MR Conditional Jot DxTM ICM When performing a 1.5T MRI scan on a patient with a Jot DxTM ICM, the following scan parameters must be followed. Table 4. 1.5T MRI scan parameters Parameter Item Name/Identification Setting Jot DxTM ICM Model DM4500 Refer to the MR Conditional Models table (page 1) Static Magnetic Field Strength [T] and Type of Nuclei 1.5 Tesla/64 MHz excitation frequency (hydrogen atom only) Magnet Type and Static Magnetic Field Orientation Cylindrical-bore magnet, horizontal field orientation Maximum Spatial Field Gradient [T/m] and [Gauss/cm] 24 T/m (2400 Gauss/cm) Maximum Gradient Slew Rate per axis [T/m/s] 200 T/m/s RF Transmit Conditions Normal Operating Mode Integrated Whole Body RF Transmit coil -orDetachable RF Transmit-Receive coils (Head, Lower Extremity, or Upper Extremity) with RF excitation: Circularly polarized (CP) RF Receive Coil Type Any receive coil may be used Scan Duration and Wait Time between scans No limitations on scan duration or wait time between scans Scan Region / Patient Landmarking Criteria Full body scans allowed / Any landmark is acceptable Patient Characteristics Refer to: Instructions for Cardiac Physicians and Clinicians (page 4) Instructions for Radiologists and MRI Technologists (page 5) Patient Position in Scanner Supine; patient's arms must be at his or her sides Device Configuration Location of implanted device: Device implanted completely within the region from the right parasternal line to the left midclavicular line, between the 1st rib to the 6th rib Instructions to be followed before and after the MRI exam Refer to: Instructions for Cardiac Physicians and Clinicians (page 4) Instructions for Radiologists and MRI Technologists (page 5) MR Image Artifact The presence of this device may produce an image artifact. Some manipulation of scan parameters may be required to compensate for the artifact. 3 Instructions for Cardiac Physicians and Clinicians The role of cardiac physicians and clinicians in preparing a patient for an MRI scan is to: Confirm that no adverse conditions to MRI scanning are present (page 4). Review the potential interactions (page 4). Confirm that the patient has an MR Conditional Jot DxTM ICM. Provide the radiologists and MRI technologists with all pertinent information about the Jot Dx ICM. That includes the model name, model number, and implant location that was recorded in the patient record during the insertion procedure. Patient records must be complete and accurate because radiology uses the records to verify that the patient has an MR Conditional Jot Dx ICM. Interrogate the Jot Dx ICM and save the data to media because the MRI scan may corrupt the data stored in the Jot Dx ICM. To save the data to media prior to the MRI, any of the following methods may be used: - Interrogate the Jot Dx ICM using the MerlinTM PCS programmer. - Transmit Jot Dx ICM data to Merlin.netTM Patient Care Network (PCN) using a patient-initiated Record Symptoms transmission. - Transmit Jot Dx ICM data to Merlin.net PCN using a clinic-scheduled transmission. CAUTION: Do not bring any external control devices, such as the MerlinTM Patient Care System (PCS) Model 3650 or a mobile device, into the scanner magnet room (Zone IV). These devices are considered MR Unsafe. Inform patients to bring their patient ID card with them on the day of their MRI procedure. After the MRI procedure is complete: Clear the data that was collected during the MRI scan because the MRI scan may have temporarily affected event detection and device recording. Check the programmed parameters of the Jot Dx ICM using the Merlin PCS programmer or Merlin.net PCN. Ensure that monitoring is enabled. Confirm that No Adverse Conditions to MRI Scanning are Present If any conditions exist that could make MRI scanning unsafe, do not scan the patient. Such conditions include: A device implanted in sites other than the approved locations specified by the MRI labeling (see MR Conditional Models table (page 1)). Implant location can be confirmed by referring to the patient records. Patients who have any portion of their Jot DxTM ICM exposed due to skin erosion. The MRI scan may cause heating of the Jot Dx ICM, which could result in serious patient injury. Other non-MR Conditional implants, for example abandoned leads. NOTE: Scanning patients who have other MR Conditional implants is acceptable provided all MR Conditional requirements for each implanted device are met. Review the Potential Interactions The Jot DxTM ICM has been designed to minimize the potential adverse events that may cause patient harm. Potential interactions between the MRI scanner and the MR Conditional device include: The static magnetic and gradient magnetic fields produced by an MRI scanner may exert force, vibration, and torque effects on the Jot Dx ICM. Patients may feel a mild tugging or vibration sensation at the insertion site while in or near the MRI scanner. The gradient magnetic and RF fields generated by an MRI scanner could potentially interact with the device resulting in tissue heating, nerve stimulation, and device damage. The gradient magnetic and RF fields generated by an MRI scanner could potentially interact with the device, which may affect sensing and event detection, and could cause the Jot Dx ICM to record inappropriate data. 4 Instructions for Radiologists and MRI Technologists The role of radiologists and MRI technologists is to: Confirm that no adverse conditions to MRI scanning are present (page 5). Review the potential interactions (page 5). Confirm that the implanted ICM is MR Conditional. If you have questions about whether an MRI scan should be performed on a patient, contact Abbott Medical Technical Support (page 5). Select the correct scan parameters. Refer to the MRI scan parameters table (3T MRI table or 1.5T MRI table) for the applicable scan parameter settings. Perform the scan and monitor the patient. Confirm that No Adverse Conditions to MRI Scanning are Present If any conditions exist that could make MRI scanning unsafe, do not scan the patient. Such conditions include: A device implanted in sites other than the approved locations specified by the MRI labeling (see MR Conditional Models table (page 1)). Implant location can be confirmed by referring to the patient records. Patients who have any portion of their Jot DxTM ICM exposed due to skin erosion. The MRI scan may cause heating of the Jot Dx ICM, which could result in serious patient injury. Other non-MR Conditional implants, for example abandoned leads. NOTE: Scanning patients who have other MR Conditional implants is acceptable provided all MR Conditional requirements for each implanted device are met. Review the Potential Interactions Potential interactions between the MRI scanner and the MR Conditional Jot DxTM ICM include: The static magnetic and gradient magnetic fields produced by an MRI scanner may exert force, vibration, and torque effects on the Jot Dx ICM. Patients may feel a mild tugging or vibration sensation at the insertion site while in or near the MRI scanner. The gradient magnetic and RF fields may induce currents and voltage in the device, which could lead to tissue heating, nerve stimulation, and device damage. The gradient magnetic and RF fields may induce voltages in the sensing circuitry, which may affect sensing and event detection, and could cause the Jot Dx ICM to record inappropriate data. Perform the Scan and Monitor the Patient During the MRI scan, visually and audibly monitor the patient. CAUTION: Do not bring any external control devices, such as the MerlinTM Patient Care System (PCS) Model 3650 or a mobile device, into the scanner magnet room (Zone IV). These devices are considered MR Unsafe. Technical Support Abbott Medical maintains 24-hour phone lines for technical questions and support: 1 818 362 6822 1 800 722 3774 (toll-free within North America) + 46 8 474 4147 (Sweden) + 61 2 9936 1200 (Australia) medical.abbott/manuals For additional assistance, call your local Abbott Medical representative. 5 Appendix A: ICM Patient Eligibility Form for MRI Scans Complete this form to determine the eligibility of a patient with an implanted Abbott Medical Jot DxTM Insertable Cardiac Monitor (ICM) for an MRI scan. If the answers to all of the following questions are "Yes," consult the MRI-Ready Monitor Systems manual for complete information on conducting an MRI scan. If the answer to any of the questions is "No," do not perform the scan. If "Unsure," contact the patient's physician or Abbott Medical Technical Support for help. Scanning patients who have other MR Conditional devices is acceptable provided all MR Conditional requirements for each implanted device are met. NOTE: Before conducting an MRI scan, always ensure that you are using the most recent version of the MRI-Ready Monitor Systems manual. You can obtain the most recent version of the manual online at medical.abbott/manuals or you can contact Technical Support. Patient's name Cardiac Physician name and contact information (office name, address, phone number) Jot Dx ICM Model Number Jot Dx ICM Implant Location Eligibility Factor Yes No 1. Does the patient have an MR Conditional Jot Dx ICM implanted in the approved location? See the Patient ID card for Jot Dx ICM model number. 2. Have you confirmed that no adverse conditions to MRI scanning are present? 3. Does the intended scan meet the MRI scan parameters listed in the MRI scan parameters tables in the MRI-Ready Monitor Systems manual? 4. Are all medical devices implanted in the patient MR Conditional? 5. Has the Jot Dx ICM data been saved or uploaded via the MerlinTM PCS Programmer or Merlin.netTM Patient Care Network? Unsure Technical Support Abbott Medical maintains 24-hour phone lines for technical questions and support: 1 818 362 6822 1 800 722 3774 (toll-free within North America) + 46 8 474 4147 (Sweden) + 61 2 9936 1200 (Australia) medical.abbott/manuals For additional assistance, call your local Abbott Medical representative. 6 Abbott Medical 15900 Valley View Court Sylmar, CA 91342 USA +1 818 362 6822 2021-03 ARTEN600180897 A *600180897*